cddft policy

Trust Medicine Policy

POL/MM/0001 Version 4.3

CDDFT Policy

Reference Number POL/MM/0001

Title TRUST MEDICINE POLICY

Version number 4.3

Document Type Policy

Original Policy Date September 2005

Date approved 23rd February 2012

Effective date 1st March 2012

Approving body Quality and Healthcare Governance Committee

Originating Directorate Pharmacy and Medicines Management

Scope Trust Wide

Last review date March 2012

Next review date September 2012

Reviewing body Quality and Healthcare Governance Committee

Document Owner Pharmacy Performance and Quality Manager

Equality impact assessed Yes

Date superseded N/A

Status Approved

Confidentiality Unrestricted

Keywords Medicines

Approval

Signature of Chairman of Approving Body

Name / job title of Chairman of approving Body:

Chair of Quality and Healthcare Governance Committee

Signed paper copy held at (location): DMH library


POL/MM/0001 Version 4.3 2 of 125

CONTENTS SECTION

PAGE

PHARMACY INTRANET SITE INTRANET

INTRODUCTION SECTION 1 11

PURPOSE SECTION 2 11

DUTIES AND RESPONSIBILITIES The Trust Board Responsibilities Committees Dealing with Medicine Issues Lead Clinician Responsibilities Staff Responsibilities Medical Staff and Other Registered Prescribers Pharmacy Staff Ward/Department and Service Managers Other Healthcare Staff

SECTION 3 Section 3.1 Section 3.2 Section 3.3 Section 3.4 Section 3.5 Section 3.6 Section 3.7 Section 3.8

12 12 12 13 13 13 14 15 15

TRAINING SECTION 4 15

7. THE MEDICINES TRAIL 8. Prescribing and Initiation of Treatment

Medicines Reconciliation Patient orientated medicines management service (POMMS) Procurement of Medicines Issue, Supply and Dispensing Receipt and Storage of Medicines Administration of Medicines Disposal of Medicines Links between Stages

9. SECTION 5 Section 5.1 Section 5.2 Section 5.3 Section 5.4 Section 5.5 Section 5.6 Section 5.7

Section 5.8

10. Section 5.9

16 16 16 17 17 17 17 18 18 18

PROCESS FOR PRESCRIBING AND INITIATION OF TREATMENT Prescribing of Medicines Non-Medical Prescribing High Risk Medicines Consultant Only Medicines Insulin prescribing Omitted or delayed medicines Standard Procedure and process for Prescribing Outpatients Prescriptions Prescription Pad Security Process for ensuring the accuracy of prescribing on prescription charts Process for monitoring the accuracy of prescribing on prescription charts

11. SECTION 6

12. Section 6.1 Section 6.2 Section 6.3 Section 6.4 Section 6.5 Section 6.6 Section 6.7

Section 6.8

13. Section 6.9

14. Section 6.10

15. Section 6.11

19 19 20 21 22 23 25 25 30 30 32 33

PROCUREMENT Contracting Procurement of Medicines Performance Indicators Company Representatives

16. SECTION 7

17. Section 7.1 Section 7.2 Section 7.3 Section 7.4

34 34 34 35 35

ISSUE, SUPPLY, DISPENSING Ward, Department and Service Stock Medicines Non- Stock Medicines

Borrowing Medicines

Verbal Requests for Supplies Patients Discharge Medication Issue of ‘Pre-Packed, Pre-Labelled’ Packs Labelling of Medicine Containers Dispensing

18. SECTION 8

19. Section 8.1 Section 8.2 Section 8.3 Section 8.4 Section 8.5 Section 8.6 Section 8.7

20. Section 8.8

36 36 37 38 38 38 38 39

40

http://cddah-spweb/sites/pharmacy/default.aspx?RootFolder=%2fsites%2fpharmacy%2fShared%20Documents%2fDrug%20Alerts&View=%7b98600EB1%2dDBF3%2d495D%2d8F80%2d32681B80D595%7d



RECEIPT AND STORAGE Receipt Patients Own Medicines Algorithm for the use of Patients Own medicines Transfer of Patients Medicines Access to the ‘Out of Hours Emergency Drug Cupboard’ Storage Security Transport of patient’s own medicines in the community Use of contract taxis to transport medication

SECTION 9 21. Section 9.1

Section 9.2 Section 9.3 Section 9.4 Section 9.5 Section 9.6 Section 9.7 Section 9.8 Section 9.9

40 40 41 44 45 45 46 48 50 51

PROCESS FOR THE ADMINISTRATION OF MEDICINES Administration of medicines by midwives Process r the Administration of Medicines Oral administration of medicines Administration of Medicines to Children Disguising Medication in Food and Drink Process for the Self Administration Of Medicines Guidelines and process for Administering Medicines Administering cytotoxic medicines Homely remedies –Non-prescription medicines policy Process for monitoring of administration medication incidents

SECTION 10 Section 10.1 Section 10.2 Section 10.3 Section 10.4 Section 10.5 Section 10.6 Section 10.7 Section 10.8 Section 10.9 Section 10.10

51 52 53 54 55 55 56 56 58 60 61

DISPOSAL OF MEDICINES Procedure for the safe disposal of drugs Process for monitoring the safe disposal of medicines

SECTION 11 Section 11.1 Section 11.2

61 61 63

MANAGEMENT OF UNTOWARD OCCURRENCES Medication Incidents Process for monitoring medication incidents Process for monitoring Controlled drug incidents Adverse Drug Reaction Reporting Drug Defects

SECTION 12 Section 12.1 Section 12.2 Section 12.3 Section 12.4 Section 12.5

63 63 64 64 64 65

CONTROLLED DRUGS Legislation Responsibilities and Inspection Prescribing responsibilities Controlled stationery and authorised signatories Ordering and Transport of controlled drugs Receipt of controlled drugs on wards, departments or services Outpatient prescriptions for controlled drugs Storage and security of controlled drugs Key holding and access to controlled drugs Missing controlled drug keys Checking of controlled drug Stocks Recording of controlled drugs on wards, departments or services Process for prescribing controlled drugs Process for administration of controlled drugs Transfer of controlled drugs Destruction of controlled drugs Returning controlled drugs to pharmacy Discrepancy in controlled drug stock Controlled drugs Brought into Hospital by Patients Contingency for long term closure or relocation of a ward, department or service Merging of controlled drug stocks on wards, departments or services Controlled drugs in Midwifery Controlled drugs in Theatres Schedules of Controlled Drugs

SECTION 13 Section 13.1 Section 13.2 Section 13.3 Section 13.4 Section 13.5 Section 13.6 Section 13.7 Section 13.8 Section 13.9 Section 13.10 Section 13.11 Section 13.12 Section 13.13 Section 13.14 Section 13.15 Section 13.16 Section 13.17 Section 13.18 Section 13.19 Section 13.20 Section 13.21 Section 13.22 Section 13.23 Section 13.24

67 67 69 70 71 71 74 75 75 76 76 76 77 78 79 80 80 81 82 84 85 85 86 87 89



UNLICENSED DRUGS Scope and Definitions Consent Of Patients, Carers and Parents Informing the Outpatient/Discharged Patient Responsibility of Prescribers and Pharmacists Prescriber Request and Risk Assessment Form Evaluation of Unlicensed Medicines Procurement, Receipt, Quality Assurance and Storage Arrangements Record Keeping Adverse Drug Reactions and Defective Products

SECTION 14 Section 14.1 Section 14.2 Section 14.3 Section 14.4 Section 14.5 Section 14.6 Section 14.7 Section 14.8 Section 14.9

92 92

93 93 93 96 96 97 98 99

ADMINISTRATION OF DRUGS THROUGH ENTERAL FEEDING TUBES Unlicensed Administration General Principles Formulations Practical Aspects of Administration Administration of Drugs via Jejunostomy Tube Decision Tree on Use of Ng/Peg Route

SECTION 15 Section 15.1 Section 15.2 Section 15.3 Section 15.4 Section 15.5 Section 15.6

99 99 100 101 102 104

105

DRUGS IN THEATRES Registered Practitioners and Drug Administration Preparation of drugs by Registered Practitioners Controlled Drugs and ODP’s Controlled Drugs in Theatres Custody and Safe Keeping of Keys

SECTION 16 Section 16.1 Section 16.2 Section 16.3 Section 16.4 Section 16.5

106 106 106 106 107 107

CLINICAL TRIALS DRUGS Guidance for Discussions Regarding New Clinical Trials Designation of Responsibility Regulatory Status and the Ethics Review Supply Procedures Stock Accountability Access to Protocols, Randomisation Lists and Other Information Conduct of Trials

SECTION 17 Section 17.1 Section 17.2 Section 17.3 Section 17.4 Section 17.5 Section 17.6 Section 17.7

108 108 108 108 109 109 109 110

STRONG POTASSIUM CHLORIDE CONCENTRATE AND POTASSIUM ACID PHOSPHATE INJECTION

SECTION 18

111

GUIDELINES FOR NEW DRUG APPLICATIONS Use of New Medicines Within the Trust Guidelines for new drug applications

SECTION 19 Section 19.1 Section 19.2

112 112 114

SUPPLY OF MEDICINES UNDER PATIENT GROUP DIRECTIONS

SECTION 20 115

ANTIBIOTICS Guidance on the use of anti-infective drugs (Trust Antibiotic policy) Guidance on Using Gentamicin Management of Patients Reporting a History of Penicillin Allergy

SECTION 21 Section 21.1 Section 21.2 Section 21.3

115 115 115 115

PRESCRIBING OF MEDICINES IN THE PERI-OPERATIVE PERIOD

SECTION 22

116

MEDICAL GASES SECTION 23

116

PROCESS FOR MONITORING COMPLIANCE WITH THE POLICY

SECTION 24

117

REFERENCES SECTION 25 119

ASSOCIATED DOCEMENTATION SECTION 26 120

EQUALITY IMPACT ASSESSMENT SECTION 27 121



Document Control Information

Version control table

Date of issue Version number Status

September 2005 1.0 Superseded


October 2007 3.0 Superseded


December 2010 3.2 Superseded

April 2011 4.0 Superseded


Not issued 4.2 Superseded

March 2012 4.3 Approved (with extended review date)

Table of Revisions February 2012

Date Section Revision Author 2/2012 All Policy reviewed to reflect peer review and policy

standardisation requirements, in line with NHSLA standards Pharmacy PQS Team

2/2012 Page 1 Review date extended to September 2012 for full review and sub division of the policy

Pharmacy PQS Team

2/2012 Page 6 Table of revisions changed to reflect January review date as per peer review

Pharmacy PQS Team

2/2012 Page 85: 13.16

Destruction of CDs – procedure for the disposal for controlled drugs shown in Dec 2011 revisions removed– review pre September 2012 in line with policy sub division

Pharmacy PQS Team

Table of Revisions Dec 2011

Date Section Revision Author 12/2011 All Policy reviewed to reflect policy standardisation

requirements and NHSLA requirements Pharmacy PQS Team

12/2011 27 EIA completed Pharmacy PQS Team

12/2011 ALL Community health services reviewed in line with post integration corporate structure changes

Pharmacy PQS Team

12/2011 ALL Removed clinical director from chief pharmacist title- changed to Trust Chief Pharmacist

Pharmacy PQS Team

12/2011 Page 16 Removed technician registration date as now mandatory Pharmacy PQS Team

12/2011 Page 22 Removed reference to antibiotic stop policy and IV to oral switch policy as within Antibiotic Formulary

Pharmacy PQS Team

12/2011 Page 26 Removed guide to completion of the insulin and diabetic record

Pharmacy PQS Team

12/2011 Page 28 Merged CDDFT and CHS Critical list of medicines Pharmacy PQS Team

12/2011 All Trust IR1/ incident form changed to safeguard incident report Pharmacy PQS Team

12/2011 Page 39 Removed company representative policy Pharmacy PQS Team

12/2011 Page 42 Removed borrowed stock form as not in use Pharmacy PQS Team

12/2011 Page 47 Removed procedure for use of PODs on POMMS wards Pharmacy PQS Team



12/2011 Page 51 Removal of vaccine cold storage guidelines from body of policy

Pharmacy PQS Team

12/2011 ALL Removed reference to directorate senior nurse and changed divisions where appropriate in line with revised corporate structures

Pharmacy PQS Team

12/2011 9 Added reference to incident policy, policy for supporting staff and being open policy

Pharmacy PQS Team

12/2011 Page 82 Removed the need to hold only one controlled drug register – for review in March 2012

Pharmacy PQS Team

12/2011 Page 85 Destruction of CDs – changed re procedure for the disposal for controlled drugs – review 2012

Pharmacy PQS Team

12/2011 Page 117

Removed clinical trial checklist and section 17.7 Pharmacy PQS Team

12/2001 Page 127

Removed reference to gentamicin policy as contained within Antibiotic Formulary

Pharmacy PQS Team

Table of Revisions August 2011

Date Section Revision Author 8/2011 5 –page 18 -Audit and

monitoring Changes to monitoring template of policy in line with NHSLA standard 4 :criterion 5 with respect to the accuracy of prescribing on prescription charts

Pharmacy PQS Team

8/2011 6- page 19 -Training Added requirements for access to Training Needs Analysis in line with NHSLA standard 4;criterion 5

Pharmacy PQS Team

8/2011 8- page 38-Prescribing Section 8.10 added – process for ensuring the accuracy of prescription charts in line with NHSLA standard 4;criterion 5

Pharmacy PQS Team

8/2011 12-page 67-Administration incidents

Process for monitoring added in line with NHSLA standard 4;criterion 5

Pharmacy PQS Team

8/2011 13- page 67- Disposal of medicines

Process for monitoring added in line with NHSLA standard 4;criterion 5

Pharmacy PQS Team

8/2011 14 – page 71- Medication incident reporting

Added specific monitoring of medication incidents in line with NHSLA standard 4;criterion 5

Pharmacy PQS Team

8/2011 15.2.3 –page 76- CD management Group monitoring

Added specific monitoring of CDs to CD management group responsibilities

Pharmacy PQS Team

Table of Revisions January 2011

Date Section Revision Author 1/2011 All applicable sections Amended Royal Pharmaceutical Society Of

Great Britain (RPSGB) to General Pharmaceutical Council (GPhC)

Senior Pharmacy Team

1/2011 All applicable sections Removed Joint Prescribing Guide until agreement to reform


1/2011 I –Introduction Addition of purpose for review Senior Pharmacy Team

1/2011 2- Scope Identification of CHS division Senior Pharmacy Team

1/2011 3.7- Responsibilities of ward/department/service managers

Addition of ward/department/service development of SOPs covering activities concerned with medicines to ensure the safety and security of those medicines




1/2011 5 - Monitoring Addition of NHSLA Monitoring Template Senior Pharmacy Team

1/2011 6 – Training Training updated Senior Pharmacy Team

1/2011 7.3 – The Medicines Trail (POMMS)

Addition of definition of Patient Orientated Medicines Management Service (POMMS)


1/2011 7.4 – The Medicines Trail (procurement of medicines)

Updated procurement regional group Senior Pharmacy Team

1/2011 8- 1 – Prescribing of medicines

Nurse Independent Prescribers - Updated prescribing responsibilities

Addition of Optometrists Independent Prescribers

Addition of Pharmacist authority to change some typographical errors on controlled drug prescriptions


1/2011 8.2 – Non-medical prescribing

Addition of optometrist and community practitioner nurse prescribers


1/2011 8.2.2 –Supplementary prescribers

Addition of physiotherapists, radiographers, chiropodists, podiatrists and optometrists


1/2011 8.5 – Insulin preparations and devices

Update of insulin requirements and addition of adult insulin prescription chart and diabetes record

Use of insulin in non-inpatient community settings


1/2011 8.6 – Omitted or delayed medicines

Addition of section and reference to „CDDFT /CHS critical medicines list‟


1/2011 8.7.1 – General principles of prescribing practice

8.7.2 – Content of prescriptions

Updated to reflect any new practice Senior Pharmacy Team

1/2011 8.7.3 –Verbal prescriptions

Changed to Remote Prescriptions with addition of CHS exceptional circumstances and changes to inpatient settings


1/2011 8.7.4 -Text Messaging in Community Health Services

Added procedure for CHS Senior Pharmacy Team

1/2011 8.9 - Prescription pad security

Amended to include prescribers working for more than one organisation


1/2011 8.9.1 – Ordering prescription pads

Updated to include prescribing in an inpatient setting and community health services setting


1/2011 8.9.2 – Security procedure

Updated to include prescribing in an inpatient setting and community health services setting


1/2011 8.9.3 –Loss or suspected theft of prescription pads

Updated to include reporting procedure Senior Pharmacy Team



Procedure for surrendering prescription pads on leaving employment – 8.9.4

Procedure in the event of a changes in Non Medical Prescriber circumstances 8.9.5

1/2011 9 -Procurement Updated contracting and purchasing groups Senior Pharmacy Team

1/2011 9.4 – Company representatives

Added new Senior Pharmacy Team

1/2011 10.1 – Ward/department/service stocks

Changed to allow stocks to be ordered by top-up, by a nurse or other suitable competent person


1/2011 10.2 – Non stock medicines

Addition of specific individual patient temporary stock medicines labelling procedure


1/2011 10.6 –Issue of pre-packed or pre-labelled packs

Removal of the requirement for a second practitioner to check a supply of a pre-packed/labelled pack in Community Health Service only

Senior Nursing Team

1/2011 11.1.1 – Receipt of medicines from external sources

Added CHS requirements Senior Pharmacy Team

1/2011 11.8 – Use of contract taxis

Added for transfer between CDDFT sites Senior Pharmacy Team

1/2011 11.2.1 – Re-use of patients own medicines

Review of re-use of patients own medicines in the inpatient setting


1/2011 11.3 – Transfer of medicines between inpatient wards

Added reference to „ward stock borrowing form‟


1/2011 11.5 - Storage Updated storage of medicines Senior Pharmacy Team

1/2011 11.5.3 - COSHH Addition of reference to Control of Substances Hazardous to Health Regulation (COSHH)


1/2011 11.6.2- Security in wards/departments/services

Updated to include CHS requirements Senior Pharmacy Team

1/2011 11.6.3/4 – medicine keys Updated to include CHS requirements Senior Pharmacy Team

1/2011 11.7 – transport of medicines in CHS

Updated for CHS requirements Senior Pharmacy Team

1/2011 11.8 –transfer of medicines using contract taxi service

Added Senior Pharmacy Team

1/2011 Administration of medicines by midwives

Addition of midwives exemption list Midwifes

1/2011 12.2 – General principles for administration of medicines

Removed requirement for a second competent witness to check the calculation of complex calculations to minimise the risk of errors

Senior Nursing Team

1/2011 12.7– Guidelines for administering medicines

Added requirement for a nursing auxiliary or healthcare assistant be used for the checking

Senior Nursing Team



in adults of medicines in a community health case setting only and updated guidelines for adults

1/2011 12.8 – Administering cytotoxic medicines

Added safe handling and administration of cytotoxic medicines


1/2011 12.9. – Homely Remedies or Non prescription medicines

Added section re homely remedies /non prescription medicines


1/2011 13.- Disposal of waste Updated and included disposal of waste in Community Health Services


1/2011 14 –Medication incidents Added reference to Trust Medication Error Management Policy


1/2011 14.2 – Controlled Drug Incidents

Amended changes to reporting committees Senior Pharmacy Team

1/2011 14.3 – Adverse Drug Reaction Reporting

Updated to include further BNF information Senior Pharmacy Team

1/2011 14.4 – Drug defects Updated action to be taken in the event of receiving a drug defect alert


1/2011 15.1 – Controlled Drug

15.1 – Table of schedules

Amended to include primary care legislation

Schedules of controlled drugs added and also referenced through section


1/2011 15.3 Prescribing responsibilities for Controlled Drugs

Added supplementary prescribers responsibilities


1/2011 15.3.4 - Midwives Deleted pentazocine from list of drugs a midwife is allowed to possess

Midwives

1/2011 15.4 – Controlled stationary and authorised signatures

Updated to include CHS requirements Senior Pharmacy Team

1/2011 15.5 – Ordering of controlled drugs

Added requirement for a list of controlled drugs to be held


Added requirements for Community Health Services


Specified ordering for schedules 2 and 3 , and 4 and 5


1/2011 15.6 –Receipts of controlled drugs on wards/departments/services

Added requirement to retain CD register for 7 years if CD destruction has taken place


Added requirement to place CDs immediately in a CD cupboard on receipt


1/2011 15.8 Storage and security of controlled drugs

Updated to include schedules Senior Pharmacy Team

1/2011 15.11 – Checking of controlled drug stocks

Added that it is the responsibility of the ward/department/service manager to regularly check all stocks of controlled drugs in their area. Updated schedules


1/2011 15.12 – Recording of controlled drugs on

Updated to include schedules and Senior Pharmacy



wards/ depts/services exemptions

Added requirement to retain CD register for 7 years if CD destruction has taken place

Team

1/2011 15.13 – Prescriptions for controlled drugs

Updated to include schedules Senior Pharmacy Team

1/2011 15.14 – Administration of controlled drugs

Added procedure to assess the competency of a non registered individual to witness controlled drug activity in community health services


1/2011 15.15 –Transfer of controlled drug stock

Added transfer of controlled drugs from a community pharmacy


1/2011 15.16 – Destruction of controlled rugs on wards/depts/services

Updated to include current destruction legislation


1/2011 15.17 – Returning Controlled drugs to pharmacy

Added two witnesses are required on receipt of a returned controlled drug into pharmacy (one to be a pharmacist)


1/2011 15.18 – Discrepancies in controlled drug stock

Updated to include reference to policy for the Policy for the management of Controlled drug incidents


1/2011 15.22 – Controlled drugs in midwifery

15.22.1 – changes made acquisition of controlled drugs by midwives

Midwives

15.22.2 – changes made to midwives working in the community

1/2011 15.23.4 – Administration of controlled drugs in theatres

Added the use of a dedicated controlled drug theatre register and current destruction legislation


15.23.6 – Disposal of controlled drugs in theatres

Updated to include current destruction legislation


1/2011 Appendix 1 – Definition of Schedules of controlled drugs

Added Senior Pharmacy Team

1/2011 17 – Administration of drugs through enteral feeding tubes

Full review completed, including decision tree on use of NG/PEG route


1/2011 21- Guidelines for new drug applications

Reference to formulary /non formulary drugs and Joint prescribing guide removed until decision made by Drug and Therapeutics Committee


1/2011 22- Supply and administration of medicines under patient group direction (PGDs)

Full review completed in line with PGD policy. Section reduced with link to policy


1/2011 23- Antibiotics Reduced section with link to antibiotic policy. Senior Pharmacy Team

1/2011 24- Prescribing and administration of medicines in peri-operative period

Reduced section with link to guidelines Senior Pharmacy Team

1/2011 25 - References Uplifted from bibliography Senior Pharmacy Team



1 INTRODUCTION

A medicine is the most frequent treatment provided for patients in the NHS. Medicines must be prescribed, dispensed, administered, stored and handled safely and effectively. All aspects of medicines management are important elements of clinical care. In order to enhance care and protect patients by minimising risk of error at all stages of the medicines management process it is vital that those involved understand their roles and responsibilities and adhere to agreed procedures and current legislation.

As part of its commitment to ensuring that high standards of patient care are achieved and maintained County Durham and Darlington Foundation Trust (CDDFT) recognises the importance of medicines management and the multidisciplinary team approach required to achieve safe and effective practice in this area.

CDDFT is committed to ensuring that all healthcare professionals employed by the Trust involved in patient care understand the principles of medicines management and the legal and professional requirements of them in relation to this area of practice.

This document outlines the responsibilities of those involved in the process of managing medicines.

As with all other aspects of care, it is recognised that every patient has the right to make his or her own decision regarding treatment and care and, in order to make that decision, is entitled to have full information about the material risks. It is the clinician‟s duty to supply the information in sufficient detail to enable the patient to make that decision.

The Medicine Policy (Version 4.2) will be subject to further review and audit during the next 3 months.

2 PURPOSE

The Medicines Policy relates to all the processes associated with the physical management of medicines in CDDFT– initiation of treatment, prescribing, procurement, production, storage, distribution, dispensing, preparation, administration to patients and the safe handling and disposal of medicines. The policy aims to ensure that CDDFT staff comply with current legislation, follow guidance issued by the Department of Health and manage the risks to patients and staff arising from the use of medicines. The clinical elements of the management of medicines, such as choice of medication are beyond the scope of the policy. In the policy the term medicines has the same meaning as medicinal products in the Medicines Act 1968. Other substances, which may not traditionally be thought of as medicines e.g. medical gases, essential oils, medicated dressings, dietetic products are also included in this policy. The policy applies to all Trust staff. The application of the Medicines Policy is a multidisciplinary activity. The main groups of staff involved will be pharmacists, pharmacy technicians, pharmacy assistants, medical practitioners, prescribers, nurses, midwives, and health visitors, but will also include allied healthcare professionals, healthcare scientists, operating department practitioners and healthcare assistants. The policy also applies to locum staff and visiting healthcare professionals treating CDDFT patients. The policy is not intended to supersede or conflict with professional standards or codes of practice which are in place.



The policy gives broad guidelines and principles governing the use of medicines and establishes good practice. The Trust Medicine Policy and related policies within this document can be found on the pharmacy intranet site. More detailed local procedures may be required in particular departments. These must have included input from a pharmacist and be agreed with the Care Group clinical governance group or policy group. Newly appointed staff who will be involved in dealing with medicines must read the policy and know how to apply it to their practice. It is the responsibility of the appropriate manager to ensure that this is part of the local induction programme.

3 DUTIES AND RESPONSIBILITIES FOR MEDICINES 3.1 The Trust Board is responsible for:

Ensuring that Trust policy, guidance and practice on medicines follow accepted legal and professional requirements.

Ensuring that health care professionals are informed of and follow Trust policy and guidance on medicines management.

Ensuring that an effective and economical system by which medicines are managed safely, securely and effectively to meet the patients clinical needs is established, documented and maintained.

The Chief Executive of the Trust has overall responsibility for the safe use of medicines as part of the Standards for Better Health Domain 1- Safety. The Medical Director of the Trust has executive responsibility for Pharmacy and Medicines Management. The Trust Board has designated the responsibility for delivery, management and development of the above to, the Trust Chief Pharmacist,Pharmacy and Medicines Management. The Trust Chief Pharmacist reports directly to the Medical Director and to the Chief Executive via the Quality and Healthcare Governance Committee, Safety Committee and the Trust Management Boards.

3.2 Committees Dealing with Medicine Issues A number of committees deal with medicine issues; 3.2.1 The Trust‟s Drugs and Therapeutics Committee (DTC) exists to promote and

ensure the cost effective, evidence based and safe use of medicines.

3.2.2 The Drugs and Therapeutics Committee is accountable to the Quality and Healthcare Governance Committee with responsibility for ensuring that the use of medicines within the Trust is clinically effective and that clinicians are provided with information that ensures appropriate prescribing practice across the Trust. (refer to Drugs and Therapeutics Committee Terms of Reference)

3.2.3 Safe Medication Practice Group (SMPG) is accountable to the Safety Committee

and is responsible for producing and applying local solutions to medication incidents and ensuring safe medication practice across the Trust. See SMPG Terms of Reference. Regular Drug alerts are produced by the group and are available on the pharmacy intranet site.



3.2.4 Controlled Drug Management Group (CDMG) is accountable to the Trust Accountable Officer for Controlled Drugs and has a key objective to ensure that Controlled Drugs are managed and used safely across the Trust and meet all legal requirements, or Trust good practice policies and procedures. The Trust Chief Pharmacist is the Accountable Officer for Controlled Drugs within the Trust.

3.2.5 Medical Gas Committee is accountable to the Trust Safety Committee and has a

key objective to ensure that medical gases are managed safely across the Trust and meet requirements of the HTM 02.

3.3 Lead Clinician Responsibilities

Lead Clinicians are responsible for:

ensuring awareness of medicines policies and procedures is included in local induction programmes for new staff in the relevant areas

ensuring all staff within their care group who are involved in the medicines management process are aware of Trust policies and procedures and have undergone training relevant to their involvement in practices associated with the storage, supply, prescription and admi

nistration of medicines

ensuring that staff who are undertaking tasks involving medicines have an appropriate level of knowledge and are competent

ensuring any issues, risks and adverse events related to medicines management are identified, documented, reported, investigated and appropriate action taken

The Lead Clinician may delegate these responsibilities to other staff within their clinical service group but it must be clear who has responsibility for each of the above medicines issues in each specialty.

3.4 Staff Responsibilities

All Staff involved in the processes associated with medicines are responsible for:

ensuring they are aware of Trust policies and procedures relating to medicines and have a clear understanding of their role and responsibilities in this area of practice

practice according to legal, professional and Trust guidance

reporting promptly to their manager/professional lead any issues related to medicines management

3.5 Medical Staff and Other Registered Prescribers

Medical staff and other prescribers must comply with legislation, Trust policies and professional guidance when performing their duties. Prescribers must ensure that their knowledge is up to date regarding the medicines they prescribe and that they are aware of any potential adverse reactions or interactions with other drugs. Non-medical prescribers must be registered with the Trust. The Trust register of non-medical prescribers is held by the Trust Chief Pharmacist. Prescribers have a responsibility to prescribe in accordance with the appropriate product licence/marketing authorisation of a medicine. Where a product does not have a product licence or marketing authorisation prescribers must follow the policy section for prescribing unlicensed medicines.



A medicine which has been classed as high risk within the Trust may only be prescribed by a consultant, specialist registrar or specialist non-medical prescriber who is deemed competent by the relevant consultant or lead clinician. (Refer to section 6.3) A list of authorised prescriber‟s signatories is held by pharmacy.

Prescribers must not prescribe for themselves or their families or other members of hospital staff. Members of staff should obtain drugs they need for their own treatment or for their families in the same way as members of the public. Where it is necessary to prescribe for friends, relatives or colleagues this should only be undertaken in the context of that friend, relative or colleague being seen in a professional capacity e.g. where a friend, relative or colleague is a registered patient.

3.6 Pharmacy Staff The Trust Chief Pharmacist has the overall responsibility for the pharmaceutical service.

3.6.1 Pharmacists

Pharmacists are responsible for managing the safe and effective use of medicines in the Trust and may be involved in any of the medicines management processes including prescribing. Pharmacists must ensure that their pharmaceutical knowledge is up to date regarding the medicines that they deal with and they are aware of any potential adverse drug reactions and interactions.

Pharmacists have a professional responsibility to monitor prescriptions to determine suitability for the patient. A pharmacist who has concerns regarding a prescribed medicine must take all reasonable steps to contact the prescriber to discuss the medicine and must only allow the medicine to be dispensed if satisfied that it is safe to use. It is not sufficient for a prescriber to confirm that what is written on the prescription is what he or she intended to prescribe and that he or she will take full responsibility. The pharmacist must be satisfied that the product, as prescribed, will not harm the patient. If there is any doubt the pharmacist will refuse to let the medicine be dispensed and refer the patient back to the prescriber.

3.6.2 Pharmacy Technicians

Pharmacy technicians undertake work to support, provide and develop pharmacy services, and as registered practitioners with the General Pharmaceutical Council (GPhC), are responsible for their professional actions. Pharmacy technicians may be involved in many of the medicines management processes and must ensure that their knowledge, skills and performance are of high quality, up to date, evidence based and relevant to their field of practice.

3.6.3 Pharmacy Assistants

Pharmacy Assistants provide essential support for pharmacists and pharmacy technicians. Duties are varied and include ensuring that hospital wards/departments/services have all routinely used medicines available, managing agreed stocks with the nursing staff, assisting with the preparation of medicines and dispensing prescriptions. Pharmacy assistants have a responsibility to check storage conditions of drug stocks on wards/departments/services to ensure they comply with manufacturers and local guidelines. Pharmacy managers must ensure that pharmacy assistants are competent to fulfil these duties.



3.7 Ward, Department and Service Managers The ward/department/service manager who will usually, but not always, be a registered nurse, is accountable for the safe custody and administration of medicines on a ward/department/service and is responsible for ensuring that staff are adequately trained, have access to up to date medicines information and that medicines policies and procedures are correctly followed by staff.

Each registered practitioner is responsible for ensuring that they administer medicines safely and appropriately.

Each ward/department/service within CDDFT should be familiar with the contents of this policy, and apply it as necessary. Thus, where medicines are handled in any way within the service the service should have a system of standard operating procedures (SOPs) covering each of the activities concerned with medicines use to ensure the safety and security of medicines stored and used in it.

This policy should be used to develop these SOPs taking into account the specific needs and risks in each particular service. Areas that have a high degree of public access may need special precautions. Appropriate pharmaceutical advice should be taken as necessary.

The responsibility for establishing and maintaining a system for the security of medicines rests with the Trust Chief Pharmacist in consultation with medical staff and appropriate nurse manager.

3.8 Other Healthcare Staff

Other healthcare staff may be involved in medicine administration in accordance with a prescription, the directions of a prescriber or a patient group direction. All practitioners who engage in the handling or administration of medicines must be deemed competent by the appropriate manager and must adhere to the profession specific protocols, which must be approved by the Trust.

4. TRAINING

All staff involved in the handling of medicines should be appropriately trained with regard to safety and security of medicines and with regard to safeguarding themselves and those under their supervision from any risks posed by products (e.g. cytotoxic medicines).

Such training should include education about locally agreed Standard Operating Procedures (SOPs) as well as defining lines of responsibility. It should also include advice on secure delegation of work.

All staff should understand their scope of practice and work within it and must be clearly instructed as to what documentation they may and may not complete.

Both staff and line managers have a responsibility to ensure individuals are aware of the contents of this policy at all times.

Line managers are responsible for ensuring all staff are up to date with training as part of their personal development. This is accessed via the training needs analysis for each area held within P&OD. Records of training are maintained and monitored by P&OD.



Competence to handle medicines will be assessed by the individual‟s line manager, and reviewed with each new draft of this policy. Evidence of this must be documented in the individual‟s personal file.

Clear instruction should be given in the procedures for dealing with breaches of security such as intruders, discovery of evidence of tampering with medicines etc. or delivery of medicines outside the pharmacy department, including receipt of samples.

Personnel whose duties may expose them to risk (e.g. portering staff, drivers, and those carrying medicines in the community) should be trained to understand the need for safety, security and Standard Operating Procedures. This should include instruction on the action to be taken in the event of a physical threat or spillage.

Personnel involved in handling medicines should be trained to ensure understanding of the need for risk management in relation to drug products and procedures.

Medication safety training has been developed for CCDFT and is available as an e- learning programme.

Attendance at Essential Training is recorded by P &OD and entered onto the Trust Training Management System, OLM. Monitoring of non-attendance will be in line with the Training Needs Analysis, Monitoring and Evaluation Policy and carried out by P &OD. Please refer to this policy for detailed information.

5 THE MEDICINES TRAIL

The medicines trail covers all potential activities that are associated with a medicinal product, from the initiation of the patient treatment through a prescription or patient group direction to the administration of the medicine and the disposal of any waste material.

As this is a multistage process there is a need to introduce controlled links between the relevant stages. These links must be included to ensure full consideration of all aspects throughout the trail from the perspective of safe and secure handling.

5.1 Prescribing and Initiation of Treatment

A patient‟s medical treatment is initiated after a diagnosis either by prescribing by a member of the medical staff or other Trust registered prescriber, through a patient group direction which has been approved by the Drug and Therapeutics Committee or by using a care pathway which has been approved by the integrated care pathways team.

In life threatening circumstances the process may not be formally initiated in full but retrospective records must be made to cover the treatment given. Standard Operating Procedures and guidelines cover all non-clinical aspects of prescribing.

5.2 Medicines Reconciliation

Medicine reconciliation is a process designed to ensure that all medication a patient is currently taking is correctly documented on admission and at each transfer of care. It encompasses; Collection of the medication history from a variety of sources, checking that medicines prescribed on admission for the patient is correct, (the „checking‟ step involves ensuring that the medicine and the doses that are now prescribed for the patient accurately reflect the sources consulted. Discrepancies intentional and unintentional may be identified at this stage) and communicating any changes in



medicine so that they are readily available to the next person(s) caring for the patient. Communication must include all intentional and unintentional discrepancies. The Medicine Reconciliation Policy is available on the pharmacy intranet page.

5.3 Patient Orientated Medicines Management Service (POMMS) in an Inpatient Acute

Setting

Patient Orientated Medicines Management Service (POMMS) is a whole systems approach to medicines management for hospital patients. It is focussed on the needs of the patient and combines the inpatients supply with the discharge medication to individual patients. There is increased involvement of the pharmacy team on POMMS wards, compared with other wards.

The Trust Medicines Policy applies to POMMS wards in the same way as to all other areas of the Trust. Additional detailed guidance for POMMS procedures is available from the pharmacy department.

5.4 Procurement of Medicines

Procurement of medicines is managed through the pharmacy department except for the procurement of radiopharmaceuticals which is managed by medical physics. Contracting for the majority of medicines is undertaken by the North East Pharmacy Procurement Group and contracts are subject to a tendering process. Other contracts are awarded on a national level or negotiated locally according to Trust Standing Financial Instructions. There are separate policies to cover specialist products, such as clinical trial medicines and unlicensed medicines. Pharmacy Standard Operating Procedures cover all aspects of procurement including ordering, invoicing and receipt.

5.5 Issue, Supply and Dispensing

Issue or supply of medicines are the activities undertaken in response to formal orders when medicines are issued to the place they will be used or supplied directly to the patient for administration at a later date. Medicines may be supplied as ward/department/service stocks or as items for specific patients. Issue or supply in an acute setting is usually the responsibility of the pharmacy department.

Dispensing is the supply after manipulation of the medicine. Manipulation may include preparation, reconstitution, repackaging, and labelling. The dispensing process requires a consideration of all the factors which may endanger the safety, effectiveness and stability of the preparation plus adherence to legal requirements. Dispensing is the responsibility of the pharmacy department.

Pharmacy Standard Operating Procedures cover all aspects of issue, supply and dispensing.

5.6 Receipt and Storage of Medicines

The receipt of medicines describes the formal activities undertaken when medicines are received by the Trust from any external source or transferred from one location to another within the organisation.

All medicines received by the Trust (including those brought in by patients) must be of a specified quality and suitable for the purpose for which they are intended. Processes must be in place which can confirm the suitability of medicines. Ward/department/service



managers must ensure that the environmental and security aspects of transfer conditions and storage locations comply with the guidance.

Standard Operating Procedures cover all aspects of receipt and storage including transport of medicines between locations.

5.7 Administration of Medicines

Medicines are administered to a patient according to the written directions of a prescriber, a patient group direction or a care protocol. Guidance on the remote prescribing of medicines is available in section 6.7.3.

Administration may require the calculation and selection of doses and the preparation of injections or mixtures.

„The administration of medicines is an important aspect of the professional practice of a number of registered healthcare practitioners. It is not solely a mechanistic task to be performed in strict compliance with the written prescription of a registered practitioner. It requires thought and the exercise of professional judgment‟

Standard Operating Procedures and detailed guidance cover all aspects of administration.

5.8 Disposal of Medicines

Medicines which are no longer required or are no longer suitable for their intended use must be removed and either re-used or disposed of safely and securely in line with local procedures, legal requirements and environmental regulations.

Standard Operating Procedures cover all aspects of disposal. Appropriate records should be made to complete the audit trail of the medicine from purchase or receipt to destruction or re-use.

5.9 Links between Stages

Transfer between stages of the medicines trail will usually involve the physical movement of medicines and necessitate the transfer of information.

When medicines are moved between locations it is the responsibility of the manager of the issuing ward/department/service to ensure that policies are adhered to which ensure that the medicines remain safe and secure during transfer with minimum risks of misappropriation and that product integrity is maintained. It is the responsibility of both the healthcare professionals who are issuing and receiving the medication to ensure that accurate and complete communication of information accompanies the transfer so that patient safety is not compromised and the audit trail is maintained.



6 PROCESS FOR PRESCRIBING OF MEDICINES AND INITIATION OF

TREATMENT (NHSLA 1.4.5a)

A patient‟s medical treatment is initiated after a diagnosis either by prescribing by a registered medical practitioner or other Trust registered prescriber, (non-medical prescriber), through a patient group direction which has been approved by the Drug and Therapeutics Committee or by using a care pathway which has been approved by the integrated care pathways team and has been signed off for the individual patient by a medical practitioner.

6.1 Prescribing of Medicines

A prescription is a written order for the supply or administration of a medicinal product to an individual who is a patient of the Trust.

A prescription can be written by a registered medical practitioner, dentist, independent or supplementary prescriber or community nurse practitioner prescriber. Non-medical prescribers must have their prescribing status denoted on their professional body register and must be registered to prescribe within the Trust.

The detailed guidance on prescribing contained in the British National Formulary (BNF) must be observed.

Prescribers must prescribe within their own competencies and comply with current legislation and Trust policies for prescribing and professional guidance, including the:

Policy on the Safe Administration of Cytotoxic Drugs

Policy on the Administration of Intrathecal Chemotherapy

Nurse Independent Prescribers are able to prescribe any licensed medicine (i.e. products with a UK marketing authorisation) within their area of competence, for any medical condition, including certain Controlled Drugs for specified indications. The list of approved controlled drugs and indications can be found in the BNF. Nurse Independent Prescribers must only ever prescribe within their own level of experience and competence, acting in accordance with the NMC‟s „code of professional conduct: Standards of conduct, performance and ethics for nurses and midwives.

Pharmacist Independent Prescribers can prescribe any licensed medicine for any medical condition, with the exception of all Controlled Drugs. Pharmacist Independent Prescribers must only ever prescribe within their own level of experience and competence and in accordance with „Medicines, Ethics and Practice – A Guide for Pharmacists‟, published by the General Pharmaceutical Council.

Optometrist independent prescribers may prescribe any licensed medicine for conditions affecting the eye and the tissue surrounding the eye, within their recognised area of expertise and competence, except for controlled drugs or medicines for parenteral administration.

Supplementary prescribers may prescribe any licensed or unlicensed medicine, within their area of competence, but only as part of an agreed patient-specific clinical management plan.

Medical students are not allowed to prescribe.

Some medications are subject to more stringent prescribing restrictions in the Trust e.g. controlled drugs, unlicensed medicines, high-risk medications and clinical trials. (See relevant sections in policy and via the pharmacy intranet site).



Some medications can only be prescribed by individual consultants due to their specialist nature or current status which is agreed by the Drug and Therapeutics Committee.

Pharmacists have the authority to change certain prescriptions in line with Trust guidelines, e.g., automatic antibiotic stop, Intravenous drugs to oral switches and some typographical errors on Controlled Drug prescriptions.

Prescribers must not write prescriptions for themselves or their families or other members of hospital staff. Members of staff should obtain drugs they need for their own treatment or for their families in the same way as members of the public. Where it is necessary to prescribe for friends, relatives or colleagues this should only be undertaken in the context of that friend, relative or colleague being seen in a professional capacity e.g. where a friend, relative or colleague is a registered patient.

6.2 Non-Medical Prescribing

The term „non-medical prescriber‟ refers to prescribers who are not registered medical practitioners.

The categories of non-medical prescribers are independent nurse, pharmacist and optometrist prescribers, supplementary prescribers and community practitioner nurse prescribers. All non-medical independent and supplementary prescribers must have successfully completed the relevant recognised prescribing course, be registered both with their professional body as supplementary or independent prescribers and with the Trust, as non-medical prescribers. The Trust registers are held by the Trust Chief Pharmacist.

6.2.1 Independent nurse, pharmacist and optometrist prescribers

Registered nurses and midwives must undergo a specialist training programme to become Independent Nurse Prescribers. A Nurse Independent Prescriber must be a 1st level Registered Nurse, Registered Midwife or Registered Specialist Community Public Health Nurse whose name in each case is held on the Nursing and Midwifery Council professional register, with an annotation signifying that the nurse has successfully completed an approved programme of preparation and training for nurse independent prescribing or community practitioner nurse prescribing. A Pharmacist Independent Prescriber must be a registered pharmacist whose name is held on the membership register of the General Pharmaceutical Council (GPhC), with an annotation signifying that the pharmacist has successfully completed an education and training programme accredited by the GPhC and is qualified as an independent prescriber. An Optometrist Independent Prescriber must be a registered optometrist who has successfully completed an approved programme of training of education and training as an independent optometrist prescriber and is registered as an independent prescriber with the General Optical Council.



6.2.2 Supplementary Prescribers Supplementary Prescribing is a voluntary prescribing partnership between an independent prescriber and a supplementary prescriber, to implement an agreed patient-specific clinical management plan with the patient‟s agreement. Supplementary Prescribers (nurses, pharmacists, physiotherapists, radiographers, chiropodists/podiatrists and optometrists) can prescribe in partnership with a doctor (or dentist) who acts as the independent prescriber in this case. Supplementary prescribers are able to prescribe any medicine, including Controlled Drugs and unlicensed medicines within their area of competence that are listed in an agreed patient specific Clinical Management Plan (CMP). All supplementary prescribers may prescribe for any medical condition, provided that they do so under the terms of a patient-specific CMP agreed with a doctor (or dentist) and within the boundaries of their knowledge, expertise and competence. There must be a written CMP relating to a named patient and to that patient‟s specific condition(s) to be managed by the supplementary prescriber. Signed agreement to the plan must be recorded by both the independent and supplementary prescriber in voluntary partnership with the patient before supplementary prescribing begins. The CMP sets out how much or how little responsibility is delegated to the supplementary prescriber. It specifies the range of medicines that can be prescribed, the clinical conditions which can be treated, the adverse drug reaction arrangements and a date of review. Supplementary prescribers may prescribe any medicine within their area of competence that is referred to in the patient‟s clinical management plan including controlled drugs and unlicensed medicines. The supplementary prescriber must not be required to enter into a prescribing partnership that entails them prescribing any medicine that they do not feel competent to prescribe. The supplementary prescriber must not prescribe outside the parameters of the clinical management plan. Clinical Management Plans are agreed between the independent and supplementary prescribers and are written using a Trust approved Clinical Management Plan template. The plan must be reviewed a minimum of every two years by the doctor and the registered supplementary prescriber. The independent and supplementary prescriber must share access to, consult and use the same common patient record. A copy of the Clinical Management Plan must be included in the shared medical record. The patient‟s agreement to treatment under a supplementary prescribing arrangement must be documented in the shared medical record

6.3 PRESCRIBING HIGH RISK MEDICINES

There are a number of medicines which have been classed as a high risk to patient safety if prescribed incorrectly. The high risk medicines are largely all cytotoxic agents in BNF chapter 8.1 and immunosuppressants in BNF chapter 8.2.



These medicines may only be prescribed by a Consultant, specialist registrar or specialist non-medical prescriber who is deemed competent by the relevant consultant or clinical director. This applies to all types of prescriptions including FP10s, outpatient prescriptions and inpatient prescription charts. A consultant may write to the Trust Chief Pharmacist requesting that their specialist registrar or specialist non-medical prescriber be allowed to write prescriptions for the consultant only medicines within the speciality. The consultant must confirm that the individual is a specialist in the area and is competent to prescribe the high-risk medications.

6.4 CONSULTANT ONLY MEDICINES

High risk medicines should not be administered or dispensed without the appropriate signature. Any high risk medicine prescribed by a junior doctor must be countersigned by a consultant/specialist registrar as soon as possible to avoid missing doses that may be detrimental to the patient. Cytotoxics for Parenteral use will be prescribed by a consultant/specialist registrar on a standard chemotherapy prescription form (for medicines prepared by pharmacy).

Methotrexate prescribing

METHOTREXATE

ALL prescriptions for Methotrexate MUST be both written and signed by a consultant or competent specialist registrar/non-medical prescriber.

For further information and good practice on prescribing Methotrexate please refer to Drug Alert no 18 on the pharmacy intranet site.

Lithium Prescribing Lithium is used for the prophylaxis and treatment of mania, bipolar disorder, recurrent depression and aggressive or self-mutilating behaviour. It is supported by NICE as a first-line mood stabiliser. Lithium is an „exceptional‟ high risk medicine as unlike many of the medicines on the „High Risk List‟, non- specialist consultants may see it prescribed relatively frequently for their patients. However, failure to understand the significance of ensuring the medication is prescribed appropriately has led to harmful incidents, including fatalities, both nationally and locally.

LITHIUM

ALL prescriptions for Lithium MUST be both written and signed by a consultant or

competent specialist registrar/non-medical prescriber.

For further information and good practice on prescribing Lithium please refer to Drug Alert No 27 on the pharmacy intranet site.



HIGH RISK MEDICINES

Oral Cytotoxics/DMARDS Immunosuppressants/Others Busulphan Capecitabine Chlorambucil Cyclophosphamide Dasatinib Erlotinib Estramustine Etoposide Fludarabine Gefitinib Hydroxycarbamide (hydroxyurea) Idarubicin Imatanib Lapatanib Lenalidomide Nilotinib Methotrexate Melphalan Mercaptopurine Procarbazine Sunitinib Temozolmide Thalidomide Thioguanine Topotecan Vinorelbine

Anakinra Adalimumab Azathioprine Ciclosporin Etanercept Infliximab Mycophenolate mofetil Sirolimus Tacrolimus Etanercept Adalimumab Efalizumab

Lithium

6.5 INSULIN PREPARATIONS AND DEVICES

Serious untoward incidents involving insulin have been reported nationally and locally. These have related to transcription, prescribing, dosing, administration and dispensing errors, including; confusion between similarly named insulin, ten –fold overdose due to handwritten abbreviations of units being misread as zero, selection of the wrong type of insulin, unclear dosing instructions and incorrect administration device. To prevent insulin incidents the following must be followed:

In-patient setting:

Insulin must be prescribed clearly on the patient‟s prescription chart and insulin chart.

An Adult insulin prescription chart and diabetes record is available and intended for use by all adult in-patients who have a diagnosis of diabetes, not only those requiring insulin. The chart includes a pre-printed prescription to manage hypoglycaemia and a blood glucose monitoring section. A guide to the completion of the adult insulin prescription chart and diabetes record is available.

„Units‟ should be written in full and never abbreviated. DO NOT use „iu‟ or „u‟.

Avoid adding a zero to the units required as for example, 14.0 may be misread as 140. The correct way to prescribe the dose is, for example, 14 units. The adult insulin prescription chart has „units‟ pre-printed requiring the dose to be entered in figures ONLY.



Always check that the correct type of insulin is being administered. Note particularly the differences between NovoRapid (fast acting) and NovoMix (biphasic) and Humalog (fast acting) and Humalog Mix (biphasic) preparations.

Always think “does this dose seem reasonable?” before administering insulin.

Check the dose and device with the patient if possible. A CDDFT Insulin Device Guide is available and can be used to visually identify and check devices with patients.

Patients should always be counselled when changing insulin preparations.

Pre-filled pens and cartridges should not routinely be kept as stock.

Vials should be stocked routinely.

For patients requiring pre-filled pens or cartridges on non-POMMS wards/departments/services (i.e. those with no pharmacist/ technician input) the pharmacy requisition must be accompanied by either the prescription chart or discharge prescription signed by the doctor stating the type of insulin required, device and frequency of administration. The order will not be processed without this information.

The item will be supplied labelled for discharge with each pen or pack of cartridges stating the patient‟s name so there is no sharing of pens between patients. These must be issued at discharge and not retained in the fridge.

Wards/departments/services with POMMS will have supplies of pre filled pens or cartridges initiated by the technician as is current practice.

Vials when opened should have the date of opening and patient‟s name clearly written on the vial and used within one month. Vials must not be shared between patients.

Ward/department/service staff should regularly clear the fridge of pens/cartridges of patients no longer on the ward/department/service and of vials past their „post opening‟ expiry.

Always complete an accurate discharge letter, clearly stating the type of insulin, administration device and the units on discharge.

Complete a Nurse Discharge Letter when patients are referred to a district nurse or other care provider. This should state the type of insulin and the units prescribed.

Take care when selecting the insulin preparation from the electronic discharge catalogue.

Patients should be always counselled when changing insulin devices PRIOR to being discharged.

In order to support the paediatric diabetes service limited amounts of some insulin cartridge preparations are required to be kept as stock. This is to allow immediate initiation of insulin via a presentation which is more acceptable in paediatrics. The protocol is available on the pharmacy intranet site.

Non-inpatient Community Settings:

The patient‟s own labelled insulin must be available.

The medication label must contain the following correct information: the patient‟s name, the insulin name in full, the insulin strength.

A supporting document must also be available which has been signed and dated by a prescriber (either a physical or electronic signature) and confirms: the patient‟s name, the insulin name, the insulin strength, the dose in units and the frequency.

The supporting document must be one of the following: a hospital discharge prescription (signed by prescriber) or a written „direction to administer‟ on the administration chart signed by a prescriber, or another form of prescription.



The supporting document CANNOT be a handwritten nursing discharge letter or notification from a non-prescribing practice nurse.

Where there is unclear or ambiguous labelling, or ambiguous information about the dose, the prescriber must be asked to write and sign a clear „direction to administer‟ („As required‟ is not acceptable in a direction to administer).

„Units‟ should be written in full and never abbreviated.

Insulin already in use may be stored at room temperature for up to 28 days.

The date an insulin pen or vial commenced in use must be written on the vial or

pen and recorded in the patient records.

6.6 OMITTED OR DELAYED MEDICINES

Medicine doses may be frequently omitted or delayed in hospital for a variety of reasons. Whilst only a small percentage of these occurrences may result in or have the potential to cause harm, it is important to recognise that serious harm or death can arise from the omission or delay of some critical medicines. To ensure that critical medicines are administered correctly and without delay, a list of medicines has been produced of those regarded as critical in CDDFT This list includes anti-infectives, anticoagulants, insulin, resuscitation medicines, medicines to treat Parkinson‟s disease and other medicines identified locally. The CDDFT list is available as an appendix to Drug Alert No 28 Reducing Harm from Omitted and Delayed Medicines in Hospital - NPSA Rapid Response Report NPSA/2010/RRR009. Note that omission of other medicines not on the attached list may be as important. Many of the listed medicines are readily available as ward/department/service stocks. Back up stocks are held in the Emergency Drug Cupboard. This includes a range of Parkinson‟s drugs (but note it is impossible to keep every preparation available). To ensure medicines are not omitted or delayed when admitting a patient:

Establish as soon as possible the medicines they are taking

Identify those regarded as critical medicines and take steps to see they are prescribed and administered

If appropriate patients own drugs should be obtained as soon as is practical and utilised

Check medicines have been taken, not just given, and act when drugs have been missed

Note that omission of other medicines not on the attached list may be as important. If in doubt contact pharmacy or the on-call pharmacist out of hours.

6.7 STANDARD PROCESS FOR PRESCRIBING

6.7.1 General Principles and process for Good Prescribing Practice

A number of adverse medication incidents in the Trust have been attributable to bad prescribing practice where nursing staff have misinterpreted the prescriber‟s instructions due to poor handwriting or incomplete prescriptions e.g. drug name, dose or frequency unclear.



There have also been cases where outpatient prescriptions or FP10 prescriptions have been deliberately altered by patients e.g. alteration of the quantity or addition of a drug not written by the prescriber. The following principles must be applied in the prescribing of drugs for administration or supply to patients: All Trust prescriptions must be written on official Trust controlled stationery or electronically generated. For discharge prescriptions this must follow the Trust policy for discharge. This may be the authorised inpatient prescription chart or A&E chart, an authorised drug chart or medication administration chart, a discharge prescription sheet, an FP10 or outpatient prescription. Prescription pads must be securely locked away when not in use and should never be left lying around. All handwritten prescriptions must be clearly written and be indelible. All, typed, computer generated, as in electronic discharges, or FP10s must be clearly printed and indelible. All prescriptions must be dated and signed by the registered medical practitioner on the appropriate prescription form. Non-medical prescribers must, in addition, include their personal identification number beside their name (if not already identified on the form). The prescription must clearly identify the patient for whom the medicine is intended. In most settings this will include name, address, date of birth and NHS number / hospital number. In the case of a prescription chart / administration chart the following also applies: The prescription chart must be available to the doctor or other health practitioner whenever he or she is reviewing the patient. The prescription must include information known about the patient relating to drug allergies/intolerances. It is the prescriber‟s responsibility to confirm whether or not the patient has a drug allergy/intolerance before the prescription is written. This status must be documented on the prescription chart. Not more than one prescription chart must be in use at any one time for any one patient, unless the number of medications prescribed for one patient exceeds the number of lines on the prescription chart. If more than one prescription chart needs to be used, then the charts should be numbered as a set, i.e. Number 1 of 2, Number 2 of 2. If more than one prescription chart needs to be used, a prescribed medication must not be duplicated. Prescription charts must be used only for the maximum period for which designed. When the end of the chart is reached all current prescriptions must be cancelled by a prescriber, signed and dated. The current therapy must then be reviewed and re-written on to a new chart. The cancelled sheets must be filed in the patient‟s case notes.



Anticoagulants should be prescribed on the Anticoagulant Record Sheet and also identified on the prescription chart to indicate the patient is undergoing anticoagulant therapy. Insulin should be prescribed on the Insulin Prescription Chart and Diabetes Record and also identified on the prescription chart to indicate the patient is undergoing insulin therapy. Requests for insulin must be written as stated before. Pharmacists, nurses or other healthcare professionals who wish to query or comment on a patient‟s prescription should speak to the prescriber directly. When the query relates to a potentially serious error or risk the healthcare professional must make a record of the conversations with the prescriber in the patient‟s notes and via a Safeguard Incident Report. Dieticians, in an in-patient setting, are authorised to initiate the use of an approved dietetic product by writing it on the inpatient prescription chart. The prescription must be signed by the prescriber before the product is administered to the patient. Dietary supplements can interact with medicines. It is the responsibility of both the dietician and the prescriber to ensure that the prescribed dietetic product does not interact with medicines already prescribed.

6.7.2 Content of Prescriptions The prescription must clearly specify:

The approved name of the medicine as recommended in the British National Formulary (BNF).This should be clearly written. Abbreviations are not acceptable. The approved name is usually the generic name. Exceptions are: When different proprietary brands of a medicine are known to have differing

bioavailabilities which are clinically significant the brand name may also be indicated (e.g. as recommended in the BNF, modified release nifedipine or diltiazem)

If a medicine is a combination of two or more medicines then a brand name may be used

If there is potential for confusion, e.g. MST Continus tablets, Zomorph capsules, then a brand name may be used

The form of the medicine if relevant, e.g. liquid for patients who cannot swallow tablets. Note – this must be recorded if prescribed on an FP10

The dose expressed in metric units, avoiding decimal points wherever possible. The dose should be stated in terms of the quantity of the active ingredient, not the number of tablets or volume of liquid except in the case of compound preparations. Frequently used approved dose abbreviations are: G Gramme, e.g. Glucose 75G mg milligram, e.g. Frusemide 40mg microg microgrammes ml millilitres. The term units should not be abbreviated, e.g. Insulin 20 units If small volumes are prescribed put a zero in the front of the decimal point, e.g.

0.5ml. (not .5ml)

Route of administration. Only the following approved abbreviations are permitted: PO by mouth IM intramuscular IV intravenous



SC subcutaneous PR per rectum PV per vaginum SL sublingual TOP topical INH inhaled PEG percutaneous endoscopic grastrostomy

The specific time of administration if the effectiveness of the drug will be affected by the time of administration.

Frequency of administration. For regular medicines on a prescription chart or administration chart the timings should be indicated. When prescribing drugs to be taken „as required‟, the frequency must be clearly stated by clearly defined intervals and should include indications, e.g. „for pain‟

For once weekly administration clearly state the dose on the defined day and on a prescription chart or administration chart strike out the six days of the week when a dose must not be administered i.e. Methotrexate once weekly prescribing

Avoid the use of „as directed‟ in prescribing

When administration is to be over specific days or time periods i.e. one tablet once daily on day one, day two and day three for one week, this must be clearly written in full to ensure there are no ambiguities

Site, if appropriate, e.g. „left eye‟

Height, weight and surface area where appropriate

Weight of the patient where the dosage of medication is related to weight

Duration of the course where appropriate, e.g. medication is prescribed for a certain period of time only. Abbreviations are not acceptable i.e. 1/7 should be written as for one day

Where a dose, frequency, time or route of administration is altered, a new prescription must be written

When treatment is completed or discontinued, the prescription must be cancelled clearly and the cancellation signed and dated - this is usually carried out by a registered medical practitioner. A nurse or pharmacist can cancel or discontinue specific treatments according to Trust policies. If a nurse or pharmacist discontinues treatment in the best interests of the patient this must be recorded and communicated with the prescriber as soon as possible

For FP10 or outpatient prescriptions any deliberate alterations should be clearly initialled by the prescriber. It is good practice to ensure that „illegal‟ additions cannot be made to the prescription by scoring through any unused space on the prescribing area

Each prescription must be signed and dated and include a contact number for the prescriber.

6.7.3 Remote Prescriptions

A remote prescription can be a verbal (by phone) message, a fax, e-mail or a text message instruction to a practitioner. A verbal instruction must be followed up with a fax, email or text message prior to administration. A registered nurse may accept a remote prescription in exceptional circumstances when the prescriber is unable to issue a new prescription, but where changes to the dose are considered necessary. The decision to accept the remote prescription is based on the registered nurse‟s professional judgement. The use of fax or email is the preferred method. When this is not possible in a community setting a text message instruction may also be considered.



In the Acute hospital setting an example of an exceptional circumstance would be where the nurse judges the prescriber is unable to leave another patient for medical reasons.

Exceptional circumstances include out of hours when Urgent Care Centres are accessed for medical support by the community hospitals and during out of hours and working hours for community nurses working in remote areas where immediate administration is required to provide essential patient care or where an actual prescription will not be received in time for future administration.

A supply of the required medication must be available

Regular and once only drugs are included

Schedule 2 – 5 Controlled Drugs are excluded as they always require a prescription

A registered nurse has the right to refuse to accept a remote prescription. When doing so the nurse must notify the prescriber of refusal and document the reasons in the patient‟s record

A non-medical prescriber may also prescribe remotely but only if they have assessed the patient and prescribed the original medication that now requires an amendment

The remote prescription must be received by a registered nurse before the new dosage is administered. The dose must be stated by the prescriber and confirmed by the nurse in words and numbers e.g. fifteen (15) mg/milligrams. The nurse is accountable for ensuring all relevant information is communicated to the prescriber and for recording the details of the prescription in the patient‟s notes In an acute hospital setting and where available in the community setting the remote prescription should be witnessed by a second registered nurse who independently hears/reads the prescription from the prescriber. The nurse taking the message is responsible for ensuring the fax, email prescription or verbal or text details is stapled to the patient‟s existing medication chart. A fax must have the correct date and time (24hour clock) on so that it can be shown exactly when the direction was received

The following information should be recorded by the nurse on the prescription sheet, patient notes and nursing notes: name of the doctor, date, time, approved name of drug, dose and route of administration. The entry must be signed in full name by the registered nurse and witness

In the Acute hospital setting the prescriber is responsible for endorsing the drug on the prescription sheet as soon as possible and within 24 hours

In the community setting a new prescription signed by the prescriber who sent the remote prescription must be written and sent to the person performing the drug administration within 24 hours. The nurse taking the original remote prescription is responsible for ensuring this is received and that the remote prescription details are filed in the patient‟s notes after the new prescription is received/prescription sheet is amended.

6.7.4 Text Messaging in Community Settings

The message has to be written down verbatim and witnessed by another person

The registered nurse must also document the name of the person who sent the text, the telephone number it was sent from, the time sent, any response given and the date when received



The nurse must sign the details and there must be a second signature to confirm the documentation agrees with the text message. The second signature should normally be another registered nurse but where this is not possible another person e.g. the patient, a carer or another healthcare professional

All received messages should be deleted from the receiving handset after documentation to maintain high standards of confidentiality

Where possible the remote prescriber should send the text via an nhs.net email address. This can be achieved by entering the recipient‟s mobile telephone number followed by @sms.nhs.net (e.g. [email protected]). The remote prescriber should copy this to the recipient‟s nhs.net email address to maintain an audit trail. The recipient should print off the email as soon as practicable and enter the print out into the patient‟s notes.

6.8 Outpatient Prescriptions

The care of a patient attending the Out-patient Department is shared by the hospital practitioner and the GP. The hospital practitioner who recommends a change in treatment is responsible for ensuring either the treatment is prescribed or a prompt and appropriate communication is sent to the GP. The continuation of regular medication is normally the responsibility of the GP. Exceptions to this general approach may be when the medication is a hospital only product, the medication is required urgently or when, in the interests of patient care, the hospital practitioner needs to retain clinical responsibility.

6.9 Prescription Pad Security

Prescription pads are controlled stationery and depending on the form used remain the property of CDDFT or the Secretary of State for Health.

The security of prescription forms is the responsibility of the Trust and the prescriber. Prescribers who work for more than one employer must have separate prescription pads for each organisation, printed with the correct organisation details in the prescriber details area of the prescription form.

6.9.1 Ordering Prescription Pads

The system of prescription pad ordering is dependent on the environment in which subsequent prescribing will occur. For prescribing that occurs in hospital departments or wards: Prescription pads are ordered by wards and departments from the Pharmacy Department. The control numbers of the pads are logged in Pharmacy against the ward/department supplied. The safe handling and security of the prescription pads remains the responsibility of the prescriber and nurse in charge of the individual department or ward to which the pad was supplied.

For prescribing that occurs in the community setting:

The administrative manager in each locality is responsible for the ordering, receipt, storage, distribution and destruction of individual non-medical prescribing prescription pads. Records of quantity, type and serial numbers of prescription pads issued to individual non-medical prescribers must be retained for a minimum of 18 months.

mailto:[email protected]



6.9.2 To ensure security, the following must be complied with:

Prescription pads must not be left on a desk or in any unattended patient accessible area

Prescription pads not in use must be locked within a secure environment

All staff requiring access to prescription pads are to be informed of the location of the secure environment

Prescription pads must not be pre-signed or pre-dated

For prescribers working in a hospital clinic setting the number of pads issued at the start of a clinic must equate to those returned at the end of clinic using an appropriate log

The number of prescription pads available at any time must be the minimum to facilitate the effective clinic

For prescribers working in a community setting, when travelling between patients, prescription pads must be kept in a bag out of sight and must never be left unattended in the car. A maximum of one full pad of forms should be carried on a person at any one time

Non-medical prescribers must keep a record of the prescription pad they are using by recording the serial numbers of prescriptions in a work journal or diary

Prescribers working in an outpatient or community setting must refer to the Policy for the management of FP10 (HP) prescriptions for outpatient prescriptions or Standard operating procedures.

6.9.3 Loss or Suspected Theft of Prescription Pads

In the event of loss or suspected theft of prescription pads the prescriber and nurse in charge must:

Inform the consultant and senior nurse manager responsible for that ward/department/service or the administrative manager

Inform the Pharmacy Department of the suspected loss/theft. The pharmacy team will ensure that neighbouring hospitals, Primary Care Trusts, The North East Family Health Services Agency, the Police and Community Pharmacies are informed as appropriate

When the incident occurs at a weekend or bank holiday and involves the loss or suspected theft of prescription forms that could be presented and dispensed at a community pharmacy it is the responsibility of the prescriber to contact the police directly and then to report the incident to their line manager, professional lead or consultant and senior nurse manager on the next working day. The incident must also be reported to the pharmacy team on the next working day

Provide the following information: Details of number of prescription forms lost or stolen including the serial

numbers of affected forms Prescriber details and professional registration number Prescriber contact details

Complete a Safeguard Incident Report.

6.9.4 On leaving employment

Prescribers must ensure that any prescriptions pads or forms in their possession are returned to their line manager and logged for destruction as appropriate

Non-medical prescribers must return unused individual prescription forms to the administrator who supplied the prescriptions for destruction and to maintain the audit trail



It is the responsibility of the prescriber and line manager to ensure this takes place on or before the last day of employment

The serial numbers of prescription forms to be destroyed must be recorded before prescription forms are destroyed by shredding

Details of prescription forms that have been destroyed must be retained for a minimum of 18 months

The destruction of prescription forms must be witnessed by another member of staff

For prescribers who are registered with the NHS Business Service Authority (NHSBSA), the NHSBSA must be informed of the prescriber‟s change in circumstance. For non-medical prescribers working in community settings this is the responsibility of the locality administrative manager.

6.9.5 Change of Non-Medical Prescriber Circumstance

For non-medical prescribers it is the responsibility of the non-medical prescriber to inform the locality administrative manager of any change in personal circumstances in order that the NHS Business Services Agency can be informed of any relevant changes.

6.10 PROCESS FOR ENSURING THE ACCURACY OF ALL PRESCRIPTION CHARTS

(NHSLA 1.4.5b)

To ensure the accuracy of prescribing on prescription charts, prescribers should comply with the relevant sections detailed in the Medicine Policy, professional standards of practice and Department of Health guidance INPATIENTS Medicines Reconciliation Medicine reconciliation is the responsibility of all CDDFT medical staff, nursing & midwifery staff, pharmacy staff i.e. pharmacists, pharmacy technicians, and pre-registration pharmacists when involved in the admission of patients. The Medicine Reconciliation Policy defines the term „medicine reconciliation‟, its various levels and outlines roles and responsibilities of individuals involved in the process for the admission of adult patients, to ensure that the safety of patients are not compromised during the medicine reconciliation process.

Medical Staff responsibilities: Medical staff have a responsibility to carry out medicine reconciliation on patient admission and in accordance with the medicine reconciliation policy. This involves clearly documenting all intentional discrepancies and to action any unintentional or intentional discrepancies highlighted by staff carrying out level 2 or level 3 medicine reconciliation. Medical staff must ensure that they prescribe the correct medication for the patient in line with the prescribing guidelines detailed in section 6 of the Trust Medicine Policy. Pharmacy Staff responsibilities: Pharmacy staff have a responsibility to carry out medicine reconciliation in accordance with the medicine reconciliation policy. This involves clearly documenting and communicating all intentional and unintentional discrepancies and to ensure appropriate follow up of unintentional discrepancies. During the inpatient stay, medication charts are checked and validated at ward level by pharmacists on medicines management wards to ensure the charts are appropriately annotated and the dosing instructions are unambiguous. Interventions take place on the ward usually with the prescriber involved.



Nursing staff responsibilities: Nursing staff have a responsibility to carry out medicine reconciliation on patient admission and in accordance with the medicine reconciliation policy. Any discrepancies highlighted by nursing staff regarding a patient‟s medication chart prescription must be referred back to the prescribing doctor or pharmacist for clarification.

Antibiotic prescribing Prescribers have a responsibility to ensure prescribing follows the Trust Antibiotic Policy. Antibiotic prescribing is monitored by the antibiotic pharmacy team via 3 indicators; appropriateness of the antibiotic, appropriateness of IV therapy and provision of stop and review dates. This is added to the Trust performance dashboard. Monitoring is discussed with the Trust multi professional antibiotic monitoring team (AMT) at AMT meetings. High risk medicines Prescribers have a responsibility to ensure that high risk medicines are prescribed according to section 6.3 of the Trust Medicine Policy. All high risk medicine orders are checked and validated by a pharmacist to ensure they comply with the Trust Medicine Policy and are clinically appropriate before issue by the pharmacy department. DISCHARGE PRESCRIPTIONS All discharge prescriptions received into the pharmacy department are checked and validated against the inpatient medication chart including any accompanying supplementary charts (i.e. insulin chart). This will include charts from non-medicine management wards. Validation will include consideration of the clinical appropriateness of the medicine for discharge, and communication of appropriate information such as if the medication is to be continued long term by the General Practioner (GP). All medication supplied on discharge prescription is checked for accuracy by pharmacist or accuracy checking technician. CHEMOTHERAPY PRESCRIPTIONS Chemotherapy prescriptions from all wards, out-patient and day case areas are received into the pharmacy department and validated by a pharmacist with specialist training according to pharmacy standard operating procedures. Oral chemotherapy is subject to a double checking process (pharmacist and accuracy checking technician) at the completion of dispensing. OUTPATIENT Outpatient prescriptions received into the pharmacy department are clinically checked and validated by a pharmacist prior to dispensing and then the dispensed product(s) checked for accuracy by a pharmacist or a trained „accuracy checker‟. NON MEDICAL PRESCRIBERS As with all prescribers, non-medical prescribers are responsible for ensuring that their knowledge is up to date regarding the medicines they prescribe and that they are aware of any potential adverse reactions or interactions with other drugs.

6. 11 PROCESS FOR MONITORING THE ACCURACY OF PRESCRIPTIONS NHSLA1.4.5g

The process for monitoring the accuracy of prescribing is via the Safe Medication Practice Group and includes:

Monitoring of all prescribing related medicine incidents

Completion of a pharmacy prescribing error intervention reporting form detailing clinical prescribing interventions by pharmacists



A rolling programme of audits of inpatient prescription charts to audit practice against the prescribing standards for documentation detailed in section 6 of the Medicines Policy, across a range of specialties

This thematic and analytical review is utilised to highlight recurrent or high risk issues, as well as reviewing practice against the systems and processes within the Medicine Policy. Action plans to minimise prescribing errors are discussed and agreed at Safe Medication Practice Group and escalated to Safety Committee. These also include any training identified for junior doctors or other groups of prescribers.

7 PROCUREMENT

Procurement of medicines is largely managed by the pharmacy department except for the procurement of radiopharmaceuticals which is managed by medical physics and blood products which is managed by pathology.

The aim of the service is to ensure that all medicines procured are of the highest quality and that continuity of supply and value for money can be guaranteed. The service needs to be flexible enough to meet the demands of the clinician in the provision of the best possible treatment of patients, but must balance this with the financial cost to the Trust.

7.1 Contracting

Contracting for a large proportion of medicines purchased, particularly high spend, high volume items, is undertaken by the North East Pharmacy Procurement Group. A representative buyer from the NHS Commercial Medicines Unit (NHS CMU) is assigned to each of the regional purchasing groups in the UK. NHS CMU work with the groups to arrange Framework Agreements for the medicines. Medicines are then purchased locally on a call-off basis. This system enables individual Trust to benefit from regional purchasing power. All NHS contract arranged this way are subject to a tendering process, which is covered by procurement law.

Where there is no national or regional contract for a product, contracts are negotiated at local level in line with Trust Standing Financial Instructions (SFI) or in consortium with other hospitals to increase purchasing power. Contracts for specific goods are placed directly with a company either for direct delivery of supply via a nominated wholesaler.

All contracts must be signed by the Trust Chief Pharmacist or the Chief Executive, or the delegated signatory on behalf of the Trust.

7.2 Procurement of Medicines

The Pharmacy store at UHND has responsibility for the procurement of the majority of medicines throughout the Trust.

All orders for the procurement of medicines must be by an authorised signatory. A copy

of all signatures must be supplied to the Financial Services Department and on request to Internal Audit. Only Procurement Managers and Senior Pharmacists/Managers may act as signatories.



An authorised signatory must ensure that all invoices are reconciled to a Goods Received Note, are examined for correctness and stamped and signed before submitting to financial services for payment.

Procurement Managers are responsible for and provide training to all pharmacy staff

involved in distribution and purchasing, including invoicing of medicines and to ensure that a clear audit trail exists for all medicines from procurement to issue to ward/department/service or patient level. This includes health and safety and COSHH requirements.

Only medicines which have gone through the process for the introduction of new

medicines into the Trust will be procured. Pharmaceutical products are procured:

Direct from the manufacturer

Via a Pharmaceutical Wholesaler

Wholesalers are the major supply route for most pharmaceutical products, the reliance on this service underpins the service provided by Pharmacy and can directly affect patient care. Local pharmacy Standard Operating Procedures covers all aspects of procurement including ordering, invoicing and receipt.

7.3 Performance Indicators

Wholesaler/Supplier performance is monitored using a number of factors including order

fill rate, error rate, supply of damaged stock, price discrepancies etc. This is a continuous monitoring process with a formal audit carried out on wholesaler performance for a two-week period on a twice-yearly basis. The information produced is supplied by the NHS CMU to the North East Pharmacy Procurement Group.

Pharmacy Stores and stocks are subject to regular Internal Audit reviews, the findings of which are reported to the Chief Executive and members of the Trust Board.

7.4 Company representatives

An „Application to Visit „form must be completed by the company representative for any company representative visit (this is available from the Pharmacy Secretaries). On completion it must be sent to the pharmacy department at the relevant hospital for registration and approval. Any representative who bypasses this process risks being escorted off-site.

Samples, clinical trial material or any other medicine (including interactive dressings) must not be left by company representatives in wards/departments/services. Medicines must be supplied to hospital wards/ departments/services by the pharmacy department. This is essential to ensure an appropriate audit trail exists and to ensure that all medicines are assessed by the appropriate body, before use in the Trust



8. ISSUE SUPPLY AND DISPENSING Medicines may only be supplied in response to a formal order, individual patient prescription or patient group directions, unless the health professional has a specific exemption in medicines legislation to supply medicines. For example, nurses providing occupational health schemes have specific exemptions in medicines legislation which allows them to supply or administer a range of medicines, within the scope of the occupational health scheme. Issue and supply of medicines is usually but not always, the role of the pharmacy department. Medicines are issued to wards/departments/services as stock or temporary stock or items for specific patients. Dispensing is the supply after manipulation of the medicine. Manipulation may include preparation, reconstitution, repackaging and labelling. Dispensing is the responsibility of the pharmacy department. Once medicines are dispensed by the pharmacy department and transferred to wards/ departments/services within the Trust, the responsibility for maintaining the system for security of all medicines within their area rests with the ward/department/service manager. Patient orientated medicines management service (POMMS) has been introduced into some areas, which combines the inpatients supply with the discharge medication, to individual patients. 8.1 Ward, Department and Service Stock Medicines

Each ward/department/service should have a stock list specifying which medicines are held and the quantity of each medicine. The list of stock medicines will vary with the nature of the clinical area. The pharmacy team, comprising of the pharmacist, technician and assistant, responsible for the ward/department/service and the ward/department/service manager in consultation with relevant medical staff, should agree the list and review it at least every six months or more frequently if necessary. No medicines can be held as part of a stock list unless it has been approved for use by the Drug and Therapeutics Committee. Trust approval through the Drug and Therapeutics Committee is also required for specific medicines, for example, unlicensed medicines, potassium chloride injection. The ward/department/service manager with the pharmacy team, are responsible for maintaining stocks. This can be undertaken by a pharmacy ordering top-up service or by a nurse or other suitable competent person using a pre-printed stock order sheet. Orders should be in a permanent record and any requisition book stored securely. If a ward/department/service runs out of stocks or requires additional supplies, they can be obtained within pharmacy working hours by requesting further supplies directly from the pharmacy department by completing an order in the non stock requisition book and marking the order as „stock‟. Outside of the pharmacy department‟s working hour‟s supplies can be obtained:

from the emergency medicines stock cupboard by following local procedures

by borrowing from another ward/department/service when the pharmacy is closed



by contacting the „on-call‟ pharmacist for emergency items not available, by following local procedures. See On -call pharmacist procedure.

Stock order forms and pre-printed top-up sheets are official records and must be retained for two years by the pharmacy department.

A designated person should be responsible for the receipt of stocks delivered to the wards/departments/services. The medicines delivered should be then checked against the delivery note, signed and dated. Any discrepancies should be reported to the pharmacy department immediately. Delivery notes should be retained on the ward/department/service for one month.

8.2 Non-Stock Medicines

Medicines not kept as stock by the ward/department/service are supplied by the pharmacy department as a „temporary stock‟ or to an individual patient. Supplies of non-stock medicines can be obtained by either:

POMMS wards: Contacting the POMMS team who will arrange a supply if deemed appropriate. The clinical pharmacist will review prescription charts at each visit and assess safety and appropriateness of the prescription and compliance with relevant good practice guidelines. In the acute hospitals a technician will arrange supply for a named patient. In the community hospitals a registered nurse will arrange the supply. No medicines for POMMS wards will be issued without seeing the prescription.

Other wards/departments/services: Procedure for obtaining supply will depend on whether or not the item is needed specifically for that individual patient use. For items that are not patient-specific:

Present a completed non-stock requisition form to the pharmacy department. Supplies will be made as a temporary stock supply (i.e. no patient‟s name will be added) and returned to the pharmacy department when no longer required. Temporary stock orders received into the pharmacy from non POMMS wards/departments/services are not routinely checked by a pharmacist.

For items that are intended for a specific individual patient (e.g. insulin devices, inhaler devices, topical preparations (ointment/creams), eye/ear/nasal drops and sprays) by presenting a completed non-stock requisition form to the pharmacy department accompanied by the prescription chart, stating the patient‟s name, name and strength of the item required, device (where appropriate) and frequency of administration. The order will not be processed without this information. A pharmacist will perform a professional check of the requisition and endorse the prescription chart against the date a supply has been made and the quantity issued. The item will be supplied labelled for discharge stating the patient‟s name and full directions so there is no sharing of items intended for individual patient use. Items supplied in this way must be issued at discharge against a discharge prescription. Patient specific items will not be re-dispensed at discharge if a recent supply has been made.

Temporary stock order books are restricted stationery and should be stored and secured appropriately in the ward/department/service. They are stocked only by the pharmacy department and a formal order signed by an authorised registered nurse or ward/department/service manager is required to obtain a book and to sign orders for temporary stocks.



8.3 Borrowing Medicines

Medicines should not be borrowed from another area when a supply can be obtained from the pharmacy department or the emergency medicines cupboard. When the pharmacy department is closed medicines can be borrowed from other ward/department/services. Medicines should never be decanted from one container to another or parts of blister packs borrowed. The complete, original, labelled container supplied by the pharmacy department must be transferred to the borrowing area. Lists of individual ward/department/service stocks are available on the pharmacy department‟s intranet site for reference. Controlled drugs should not be borrowed except in a case of urgent clinical need or life-threatening situation. The on-call pharmacist must agree to all instances of borrowing controlled drugs. See section 13 of the policy for controlled drugs. High risk medicines or insulin should not be borrowed except in a case of urgent clinical need or life-threatening situation. The on-call pharmacist must agree to all instances of borrowing high risk medicines.

8.4 Verbal Requests for Supplies Verbal requests for either stock or non-stock items are not routinely accepted, except in

exceptional circumstances. If a verbal order from a doctor/nurse in charge is accepted a supply will be made with the appropriate documentation provided retrospectively within 24 hours. An example of an exceptional circumstance is when an emergency drug is required and the doctor/nurse cannot leave the patient to complete an order.

8.5 Patients Discharge Medication

All discharge medications must be supplied specifically for that purpose by the pharmacy department as either individually prepared for the patient, as a pre-packed medication, following a Patient Group Direction (PGD) or on the authorisation of an authorised prescriber. Discharge medications must not be supplied from ward/department/service stocks or temporary stocks unless specifically pre-packed or labelled for the purpose of the supply. All discharge medication must be kept in a locked cupboard on the ward/department/service until the patient is ready for discharge. A system should be in place that allows them to be readily identified and separated from ward stocks. When issuing a discharge prescription the discharge policy should be adopted and all medicines for that patient reconciled and provided at discharge, ensuring that any changes to medicines are clearly communicated.

8.6 Issue of ‘Pre-Packed, Pre-Labelled’ (Over labelled) Packs

For some wards and departments procedures to enable nursing, medical or other staff to supply a pre-packed, pre-labelled container of medicine to a patient to take home is employed. The container must have been dispensed and labelled by the pharmacy department for the specific purpose.



Where a pre-packed/pre-labelled medication is issued to a ward/department/service, the manager in conjunction with a clinical pharmacist is responsible for ensuring that there is an agreed local system in place on the ward/department/service. To ensure that there is a clear audit trail for all such supplies and replenishment of future stocks, all medicines handed out to patients are recorded on a prescription or formal record form, and properly labelled.

The ward/department/service manager and the pharmacist must agree the range of pre-packed discharge medication kept on any ward/department/service.

To supply an over-labelled or pre-packed medicine:

The discharge prescription must be written and signed and the appropriate pre-packed medicine picked against the prescription

Pre -printed discharge prescriptions must clearly indicate the appropriate drugs required for discharge and be signed

One registered practitioner (from nursing, medical or pharmacy) must pick the medication, check the expiry date, add the patient name and date of supply, fill in the amount of medication supplied and sign the prescription

It is best practice that a second practitioner checks the supply against the prescription and signs the prescription. In the community setting, a second practitioner is not always available and as such is not essential

A second practitioner must check the supply against the prescription and sign the prescription as checked

The medicine is then handed to the patient with advice on how to take the medicine

The prescription is annotated „supplied from ward/department/service‟. The prescription is either sent to pharmacy to allow the stock to be replenished or retained on the ward/department/service to be reconciled with stock held by the pharmacy staff responsible for reconciliation/top-up, as agreed in the local policy

In the case of medicines being issued via Patient Group Directions, a formal record form must be completed as well as the information recorded in the patient‟s notes.

Nurses must not supply any other medication for patients to take home.

When handing over medicines to patients to take home the nurse, medical practitioner or pharmacist has a responsibility to:

Ensure the prescription is complete, comparing the prescription and the dispensed medicine(s) with the patients prescription chart and raising any concerns with appropriate medical staff or pharmacy staff

Ensure that all medicines are collected and reconciled e.g. controlled drugs, fridge items

Discuss with and check understanding of, the patients and/or carer, the name and dose of the medicine, the time interval for administration and any special instructions. If applicable, the patient/carer must be made aware of any changes to their medicine regimen following inpatient stay and how to obtain further supplies if required.

8.7 Labelling of Medicine Containers

All labelling must comply with legal requirements. Pharmacy staff are usually responsible for the labelling of containers.

Exceptions include:



Theatre staff label filled syringes prepared for immediate administration to a patient undergoing surgery

Nursing staff indicating the addition of a prescribed drug to a container of intravenous fluid, the patient‟s name to a Total Parenteral Nutrition (TPN) bag or to mark the date of first use on a container

Nursing/medical staff add the name of the patient and date of supply to a label on a pre-dispensed item

When transferring medicines (i.e. when adding additives to fluids, preparing syringes in theatres) procedures, which reduce the risk of a medication error occurring, must be available and be followed. Any other alterations to a label must not be made. If a label on any container is damaged, altered or obliterated the container must be returned to the pharmacy department for replacement. All medicines being transported between departments should be in a tamper–evident container or be in the custody of a designated responsible person.

8.8 Dispensing

Dispensing is the supply after manipulation of the medicine, for administration at a later date. Manipulation may include preparation, reconstitution, repackaging and labelling.

The dispensing process requires a consideration of all the factors, which may endanger the safety, effectiveness, and stability of the preparation, plus adherence to legal requirements. All dispensing procedures must conform to the GPhC Standards and Procedures.

Dispensing must only be undertaken by a member of the pharmacy staff. Pharmacy Standard Operating Procedures cover all aspects of dispensing.

Nursing staff must not dispense from ward/department/service stocks to patients on discharge.

9 RECEIPT AND STORAGE OF MEDICINES

The receipt of medicines describes the formal activities undertaken when medicines are received by the Trust from any external source or transferred from one location to another within the organisation.

Once a medicine is received the ward/department/service manager is responsible for ensuring the safekeeping of the medicine which includes both environmental and security aspects. Pharmacy staff undertake audit to ensure that the physical storage conditions and security of the medicines are maintained.

9.1 Receipt

Medicines are received both from external sources and by transfer within the Trust. Medicines received must be checked by a designated person against the order to ensure they match the order and are of the quantity and quality specified. This check



must also include confirmation of product identity, confirmation that deterioration through inappropriate storage, such as breakage of the cold chain, has not occurred and confirmation of compliance with legal and/or local requirements.

9.1.1 Receipt from External Sources

Medicines are received directly from a number of external sources in response to formal orders. (Manufacturers, Wholesalers). Delivery is usually into the pharmacy store, but may be direct to the wards/departments/services (in the case of direct delivery intravenous fluids), to medical physics (radiopharmaceuticals), to community clinics (for an agreed range of drugs not ordered through the CDDFT pharmacy department) or pathology (blood products).

All goods received by the CDDFT pharmacy department are entered into the pharmacy stock system.

9.1.2 Receipt from within the Trust

Medicines are received into wards/departments/services in response to formal orders. Medicines transported between wards/departments/services must be in secure tamper-evident boxes or bags or be in the custody of a designated person. Delivery documents accompany all stock issues. Ward/ department/service staff must check these upon receipt and report any discrepancy to pharmacy.

Signatures are required on receipt of medicines in all areas.

9.2. Patients Own Medicines in an in-patient setting

Patients are encouraged to bring in their own medicines into hospital on admission. This allows doctors, nurses and pharmacists to compile an accurate medication history. It is important to ensure that any patients‟ own medicines reused have been properly assessed since many may no longer be appropriate or suitable. The instructions sent to patients prior to a planned admission should include a request for patients to bring any medicines in with them. For those patients admitted as an emergency, a friend or relative should be asked to bring the medicines into hospital. On admission, the medicines are taken from the patient and brought to the attention of the healthcare professional responsible for producing the medication history. Usually containers are labelled with the patient‟s name and the name of the medicine, therefore, identification should not present a problem.

If the drugs are in an unsatisfactory condition, inadequately labelled or not required, the patient‟s permission should be sought to have them destroyed. If the patient refuses then an entry should be made in the patient‟s record of the reasons why destruction of the medicine is considered necessary and the patient‟s refusal to consent to this destruction. These should be returned to the patient on discharge or sent home with a relative. However, patients should be advised that continued possession and use is medically inadvisable. The risk of use of medicines which are of an unsatisfactory quality should be clearly stated. Such drugs in an acute hospital setting should be sent to the pharmacy department for disposal.



In a community hospital the medication is documented in a disposal log and placed in an appropriate waste bin and in community settings e.g. patients own homes, the patient is encouraged to return unsuitable medication to their local pharmacy for destruction.

9.2.1 Reuse of Patients’ Own Medicines

Assessment

Patients‟ own medicines should not be used for administration until they have been formally assessed as suitable against the assessment algorithm and found to be suitable. Assessment may be performed by a registered nurse, pharmacy technician or pharmacist, who is familiar with the procedure for the re-use of patients own medicines.

Medicines are considered unsuitable for reuse where: a) medicines are discontinued in hospital b) uncertain identity on examination c) unlabelled medicines. Label must state name of patient, date of dispensing,

name of medicine and name of supplier (unless it is an „over the counter‟ medicine)

d) uncertain quality. Contents should be examined as in (b). If no expiry date is available, the date of dispensing should be taken into consideration (medicine considered expired if more than 6 months since dispensing date)

If the prescribed dose on the prescription chart is different to that on the product/container CHECK with the prescriber before administration.

Medicines dispensed in compliance aids are generally not suitable for re-issue. However, it may be appropriate to re-use patients‟ own medicines which are individually packed in sealed packs such as the „Venalink‟ system.

Any patients own homeopathic, herbal or other bought over the counter medication, must be written on the prescription chart before it can be administered.

Patients‟ own medicines should be stored in the ward drug cupboard, drugs trolley or in the individual patient locker on a POMMS ward. Exceptions include inhalers and GTN spray, which may be kept out of sight at the patient‟s bedside. For each item available as „patients own‟, the prescription chart should be marked „POD‟.

In a hospital setting patients‟ own controlled drugs should not be stored in the individual patient locker or drugs trolley. These should be stored in the ward/department/service controlled drug cupboard and recorded in the back of the controlled drug register in the usual manner and returned on discharge.

Discharge from an in-patient setting

Patients‟ own medicines can be reissued on discharge. They MUST be checked against the discharge summary to ensure that there have been no further changes i.e. ensure that none of the medicines have been discontinued or that the label directions have been changed. If there are insufficient supplies of any item a fresh supply should be made.

Discharge prescriptions should be endorsed with „patients‟ own‟ or „POD‟ where appropriate prior to the prescription being sent to the pharmacy department or community pharmacy to indicate that the patient has an appropriate supply of medication.



All patients‟ own medicines suitable for re-issue should be returned to the patient. When supplying discharge medication to the patient the drug cupboard should be checked for any patients‟ own medicines that need to be returned.

Consent for Reuse/Destruction Of Patients’ Own Medicines in an in-patient setting.

Medicines brought from home are the patient‟s own property. Consent for their use or destruction must be obtained. Consent can either be made verbally or by writing in the patient‟s nursing records by the admitting nurse or pharmacist.

If patients disagree to the destruction of their medicines then they should be returned to the patient on discharge or sent home prior to this with a relative. However, patients should be advised that continued possession and use is medically inadvisable. The risk of use of medicines which are of an unsatisfactory quality should be clearly stated.



9.3 Algorithm for the use of Patients Own Medicines in an inpatient setting

1. Prescribed by their GP or bought over the counter? Y do not use

2. In original dispensed container?

Y do not use 3. Label, container and medicine in good condition?

Y do not use 4. The patient‟s name on the label is the same as the patient? (does not apply to OTC‟s)

Y do not use 5. If no expiry on container/label, dispensed within the last 6 months? Y do not use 6. Within the expiry on the original manufactured container or within the expiry date on

the label of the dispensed container if there is one?

Y do not use 7. If there are tablets or capsules in a bottle do not use or refer to

do not use pharmacist

8. Drug name, form, strength on the label agrees with the actual drug? Y do not use 9. If the medicine is a liquid, injection, eye-drop, eye ointment, suppository or pessary

do not use do not use

Reference: Dua S. Establishment and audit of a patients‟ own drug scheme. Hospital Pharmacist 2000; 7(7):196-198

Y

Y

Y

Y

Y

Y

Y

Y

N

N

N

N

N

N

N

N

No expiry

rogue tablets/capsule

s

easily identifiable by colour and markings

N Y Y N

unopened? cold storage required?

N Y

medicine is safe to use



9.4 Transfer of Patients and their Medicines between in-patient

wards/departments/services.

When a patient is transferred from one ward/department/service to another their current prescription chart and current medication specifically prescribed for them must be transferred with the patient.

It is the responsibility of both the healthcare professionals who are issuing and receiving the medication to ensure that accurate and complete communication of information accompanies the transfer so that patient safety is not compromised and the audit trail is maintained.

When a patient is transferred between Trust ward/department/service sites robust systems for handover or transfer should be in place and the following should be noted:

No controlled drugs to be transferred unless they are the patient‟s own drugs

No stock drugs to be transferred

Only drugs, which have the patient name on the container, are transferred

Drugs must not be transferred between containers

Before transfer the medicines must be checked against the patients prescription chart by the responsible nurse on the transferring ward/department/service

Remember to check patient lockers and fridges

Medicines should be transferred securely in a sealed bag or box

Ensure that if there is a significant allergy the next team caring for the patient is made aware of the potential risk

The responsible nurse on the receiving ward/department/service should check the medicines against the patients prescription sheet

Only in exceptional circumstances should medicines supplied for as stocks be used on another ward/department/service. Should this be necessary the following precautions must be applied:

The ward/department/service supplying the medicines must only supply medicines issued as stock or for the individual

A record should be kept by the ward/department/service supplying the medicines of medicines borrowed.

Medicines for oral use should only be transferred between wards/departments/services in the container as originally dispensed by the pharmacy – new containers must not be created.

Medicines which come in single dose units, e.g. ampoules, may be transferred separate from their container once the expiry date has been checked

Where practitioners working in the community become involved in obtaining prescribed medicines for patients, they must follow relevant Standard Operating Procedures.

NB Only in exceptional circumstances should practitioners take responsibility for the transportation of controlled drugs either to or from patients‟ homes.

9.5 Access to the ‘Out of Hours Emergency Drug Cupboard’

Access to the cupboard is restricted to times when pharmacy is closed

Access to the Emergency Pharmacy stock for in-patients is the responsibility of the senior nurse bleep holder

The senior nurse bleep holder will accompany a registered nurse to the cupboard and ensure a record of the medicines removed is documented

The medicine required should be removed from the cupboard in an original pack



Packs must not be split

Expiry dates must be checked

Records must be made of removal of drug so appropriate replacement can be made, including patient‟s details so an audit trail is in place.

9.6 Storage

9.6.1 Storage within the Pharmacy Department

All drugs received into the pharmacy department are stored in accordance with their storage conditions. Storage conditions of both ambient and refrigerated products are monitored continuously with the refrigerators/cold rooms being linked to the hospital BMS system that will activate in case of a system breakdown. Out of normal opening hours, procedures are in place to deal with such events.

9.6.2 Storage on Wards, Departments and in Services

All ward/department/service managers are responsible for medicines once they are received at ward/department/service level. However, audit is undertaken by pharmacy staff to ensure that the physical conditions and environmental/storage requirements of the medicines are maintained.

All medicines must be stored in locked cupboards, refrigerators, trolleys, bags and boxes reserved solely for the storage of medicines. Account must be taken of the manufacturers‟ storage instructions and safe practice recommendations.

Medical gases should be stored in a secure area away from sources of direct heat. Safety chains or cylinder stands should be used to ensure that non-portable cylinders are physically safe. Medical gases should be stored in accordance with their product safety data sheet.

Medicine cupboards, refrigerators, trolleys, bags and boxes should be sited in a non-public area, in a clean utility room with restricted access, or be sited in an area under constant surveillance by nursing staff. Cupboards should not be sited above or near radiators or major sources of heat.

Within Trust premises cupboards used for the storage of medicines shall comply with BS2881:1989 “Cupboards used for the Storage of Medicines in Health Care Premises” i.e. the cupboard must meet the following criteria or be approved by pharmacy:

Be lockable

Solely for the use of medicines

Metal

Fixed in position on an internal wall

It is required that each ward/department/service has separate lockable storage cupboards for medicines for each of the following categories:

Controlled drugs cupboard –contain medicines controlled by the Misuse of Drugs Act 1971 and other medicines specifically designated by the Trust, e.g. potassium chloride ampoules

Internal medicines cupboard – to contain preparations for internal administration excluding controlled drugs



External medicines cupboards or separate area – to contain preparations for external use (segregation of internal and external medicines should be made if no separate cupboard is available)

Cupboard for disinfectants and antiseptics

Reagent cupboard or separate area – substances for clinical tests, e.g. urine testing

Medicine trolley – contains medicines in current use and must be securely immobilised when not in use

Individual locked cupboards – for patients involved in self-medication programmes and POMMS (i.e. patient‟s own drugs)

Drug refrigerator – specifically for the storage of medicines.

It should be a separate refrigerator solely for the storage of medicines requiring refrigeration

It must be kept locked when not in use A maximum/minimum thermometer must be kept in the refrigerator. Only use

one thermometer for each fridge preferably integral (probe) but if not available a calibrated digital external thermometer can be used. The thermometer from which the temperature is taken should be clearly marked as such

The ward/department/service manager must ensure that the maximum and minimum temperature is recorded daily on a refrigerator temperature chart which is kept next to the refrigerator (available from the pharmacy department)

The thermometer should be reset after each temperature reading and the reset recorded on the refrigerator temperature chart

Any reading outside the acceptable range is investigated and remedial action taken. The acceptable temperature range is 2 - 8c

All readings outside of the acceptable temperature range should be documented on the refrigerator temperature chart along with details of action taken

Temperature breaches should be reported on the Safeguard reporting system. All staff should be aware of the procedure to follow if the temperature is found to be out of range

Staff accessing the refrigerated medicines should be suitably trained In the event of either the minimum or maximum temperature being breached,

advice should be sought immediately from staff in the pharmacy department Food or pathological specimens must not be stored in the refrigerator

Wards/departments/services storing Intrathecal chemotherapy products must have a dedicated refrigerator for this purpose only.

In addition, there should be designated storage areas for intravenous fluids, flammable liquids and medical gas cylinders. Flammable liquids and medical gases should be stored in accordance with their product safety data sheet.

In a community setting where services share premises with other clinics or practices, stocks of medicines for each clinic/practice should be stored separately.

Medicines MUST not be stored overnight in car boots.

When specific drugs are prescribed in hospital for a particular patient and are no longer required by that patient, they must be returned to the pharmacy department.



The ward/department/service manager must ensure that all medicines stocked on their ward/department/service have expiry dates checked at least once a month, with the exception of controlled drugs which should be checked daily as detailed in controlled drug section 13. Expired stock with the exception of controlled drugs, will be sent back to the pharmacy department for destruction.

Each ward/department/service or area should have a list of current stock which should include details of the drug name, form, strength, pack size and stock level to be maintained. This list should be approved by the service manager and the pharmacy team. This list and stock levels should be reviewed at least every 6-12 months.

9.6.3 Control of Substances Hazardous to Health Regulation (COSHH)

Some medicines are, by their nature, hazardous. It is the responsibility of the Ward/department/service Manager to perform an assessment of hazard and risk of medicines kept. Specific product safety information can be supplied by the manufacturer. All flammable liquids and gases should be stored in a metal cabinet. To reduce the risk of harm • stocks should be kept to a minimum • store on the lower shelves • avoid spillage • keep containers well closed, replacing caps immediately after use • keep away from naked flames

9.7 Security

9.7.1 Security in the Pharmacy Departments

From the time of receipt to issue, all drugs are stored under secure conditions within the pharmacy store with access restricted to pharmacy staff and authorised personnel only. Access is controlled via swipe cards/push button codes at all entries to the store and the departments are alarmed when closed. Access to the departments is restricted to authorised key holders and the alarm system is maintained in accordance with standing operating procedures.

9.7.2 Security in Wards, Departments and Services

All medicines must be stored in separate, locked cupboards, trolleys or other secure receptacles. This includes medicines for self-medication and discharge. The only exceptions to this requirement are:

the storage of intravenous fluids and sterile topical fluids which, because of their bulk, are stored in a secure clean area

drugs required for clinical emergencies, which need to be held at strategic accessible sites where surveillance which will prevent unauthorised access

medicines for clinical emergencies should be secured when the clinic is not in session/out of hours if applicable

medication that patients are self-administering e.g. inhalers, should be kept out of sight of other patients and visitors, not locked away

Cupboards and trolleys should be kept locked and secured when not in use and sited where it is most convenient for nursing staff, allowing adequate space and permitting surveillance to afford maximum security against unauthorised entry.



The necessity for checking stock balances of medicines other than controlled drugs should be left to the discretion of individual ward/department/service managers. If, however, there is a suspicion of medicine abuse this should be reported to the nurse manager / service lead and the pharmacy department. The stock balance should be recorded and regular checking introduced. If this shows discrepancies further investigation under the guidance of the police should be considered.

When a hospital ward/department/service is closed for a period longer than seven days, all medicines, including controlled drugs, must be returned to the pharmacy department for safe and secure storage.

9.7.3 Medicine Cupboards and Keys Medicine cupboard keys are the responsibility of the senior nurse in charge of the hospital ward/department/service. These keys should remain on the hospital ward/department/service at all times and must be carried by a registered nurse who is competent to administer medicines and is assigned to the ward/department/service.

The safekeeping of the medicine cupboard and refrigerator keys is the responsibility of the senior nurse or practitioner in charge. In situations where a number of authorised practitioners may require access to the medicine cupboards at different times a secure system must be agreed between the senior nurse or practitioner in charge and a designated representative from the pharmacy department. This may be delegated to another health care professional but responsibility will remain with the senior nurse or practitioner in charge.

On each ward/department/service, the keys for the medicine cupboard and medicines refrigerator should be on one key ring reserved solely for these keys. The keys must be clearly identified and kept by the designated staff only.

The key to the controlled drugs cupboard must be held separately from other keys and remains the responsibility of the nurse in charge/clinical lead of the ward/department/service at all times.

In community settings arrangements should be made for a spare set of keys to be securely stored and held where they can be easily accessed in an emergency.

Keys must not be given to any unauthorised person, e.g. nurses or staff not assigned to the ward/department/service and medical staff or other personnel.

Pharmacists, pharmacy technicians and pharmacy assistants may have access to the keys in the course of their duties

Operating department assistants/practitioners may, under the delegation of the nurse in charge, have access to medicines cupboards and hold the keys providing the anaesthetist remains responsible for all supplies made from the cupboards.

9.7.4 Loss of Medicine Cupboard Keys

In the event of medicine cupboard or trolley keys being misplaced a search and investigation must be undertaken immediately. If the keys are not located, a Safeguard incident report must be completed and the nurse in charge/department or clinical lead must follow the agreed procedure.



The nurse in charge/department or clinical lead must ensure that the keys are kept secure and are available as necessary to staff running the service, and that staff going off duty do not remove the keys from the service. If keys are removed from the service every effort must be made to retrieve them from off duty staff. Should access to the medicine cupboard be required before the keys are retrieved the nurse in charge, service or clinical lead must be informed and a duplicate set of keys may be obtained.

If keys to drug cupboards are out of possession of the hospital/service for an extended period of time and there is no duplicate set of keys, the matron /head of department should consider the advisability of changing the locks to the drug cupboards. If there is any concern regarding the security of the keys the locks must be changed. The Trust Chief Pharmacist should be informed on the next working day and a safeguard incident report should be completed in these circumstances.

9.8 Transport of patients own medicines in the community

Community nursing staff should avoid carrying patients' own medicines in their cars. Only in exceptional circumstances should patients' own medicines be transported, when they should be taken directly to the patient's home.

In all circumstances medication for a specific patient should be prescribed. If it is the intention that a community nurse is to administer the drug to a housebound patient then the drug must be dispensed either by a community pharmacy, dispensing practice or hospital pharmacy. It must be appropriately labelled with the patients name and directions for use (as well as all other standard labelling requirements).

Under most circumstances it would be anticipated that arrangements should be made for the patient, carer or relative to collect the medication or that the pharmacy deliver it to the patient. As per NMC guidance (Standards for Medicines Management Section 3, Standard 7) it is possible for the community nurse to collect the medications on the patient‟s behalf and transport the drug in their car. This should only happen in exceptional circumstances and should not be routine practice.

Examples of exceptional circumstances could be:

access to drugs where timeliness of administration is crucial (e.g. starting an urgently required antibiotic course or urgent palliative care medication)

where the patients cognitive function has proved problematic in the safe keeping of medication

during out of hours periods

geographical issues

where no other method of delivery is possible within a timeframe convenient for the community nurse

Exceptional circumstances will be at the discretion of the community nurse who will need to take into account the patient‟s circumstances as well as professional and organisational considerations.

Patient Group Direction medication: A flu vaccine is not the patient‟s property and is instead a stock drug being administered to a pre identified group of patients as opposed to a medication required for an individual. Therefore, standard operating procedures will apply and the flu vaccine can be transported from appropriate medication stocks.



9.9 Transfer of medicines between CDDFT sites using the contract taxi service

Transfer by taxi is expensive and must be avoided wherever possible by using scheduled transport arrangements.

Taxis must be ordered via switchboard to ensure that ONLY CDDFT contracted taxis are used.

The taxi driver must show their staff badge which must be confirmed by the member of staff requesting the taxi. No drugs must ever be supplied unless the member of staff is convinced the taxi driver is genuine. If in any way concerned, the staff member must seek advice from their manager and/or seek confirmation.

The taxi driver must be given explicit instructions regarding delivery i.e. not to be left unattended, to be given to a registered nurse.

When the package is delivered to the destination, the drugs should be received by a suitably qualified staff member (e.g. sister, staff nurse, member of pharmacy staff etc.).

On receipt of controlled drugs transferred by taxi, a qualified staff member must phone the area that transferred the drugs to confirm receipt.

10 PROCESS FOR THE ADMINISTRATION OF MEDICINES (NHSLA 1.5.4.c)

„The administration of medicines is an important aspect of the professional practice of a number of registered healthcare practitioners. It is not solely a mechanistic task to be performed in strict compliance with the written prescription of a medical practitioner. It requires thought and the exercise of professional judgement‟.

The administration of medicines is usually a nursing activity but other registered practitioners may be involved e.g. operating department practitioners, physiotherapists, emergency care practitioners, medical physicists, medical practitioners, pharmacists.

All practitioners involved in the handling or administration of specific medicines must be assessed as competent to do so by the appropriate manager and must adhere to the profession specific protocol.

Student nursing staff must be supervised when administering medicines. The responsibility for this lies with the supervising qualified health care professional and they must clearly countersign the signature of the student.

Medicines may only be administered according to the directions of a registered prescriber or medical practitioner, an authorised patient group direction or a care pathway unless the health professional has a specific exemption in medicine legislation to administer medicines.



10.1 Midwives can administer for parenteral use prescription only medicines containing any of the following substances:

Registered midwives have exemptions under medicines legislation for parenteral administration of some medicines in the course of their professional practice, including lidocaine and pethidine.

Midwives Exemptions List

Drug Name Use Route NMC advice for professional practice

Adrenaline 1:1000 Adult IM For use in anaphylaxis only

Anti-D immunoglobulin

Adult IM For antenatal and postnatal use to protect against haemolytic disease of the newborn

Carboprost Adult IM No particular uterotonic drug can be recommended over another for the treatment of postpartum haemorrhage. Treatment combinations for postpartum haemorrhage might include repeat bolus of Oxytocin (intravenous), Ergometrine (initramuscular or cautiously intravenously), intramuscular oxytocin with Ergometrine (Syntometrine), Oxytocin infusion (Syntocinon) or carboprost (intramuscular)

1.

Diamorphine Adult IM Diamorphine hydrochloride for pain relief in labour

Ergometrine Maleate

Adult IM/IV IV use with caution – risk of hypertension

Gelofusine Adult IV For maternal resuscitation

Haemaccel Adult IV For maternal resuscitation

Hartmann‟s solution

Adult IV For maternal resuscitation

Lidocaine Adult SC/IM For perineal infiltration

Lidocaine Hydrochloride

Adult SC/IM For perineal infiltration

Morphine Adult IM Morphine sulphate for pain relief in labour

Naloxone Hydrochloride

Adult IM For reversal of respiratory depression resulting from opioid administration

Oxytocins, natual and synthetic

Adult IM/IV No particular uterotonic drug can be recommended over another for the treatment of postpartum haemorrhage. Treatment combinations for postpartum haemorrhage might include repeat bolus of Oxytocin (intravenous), Ergometrine (initramuscular or cautiously intravenously), intramuscular oxytocin with Ergometrine (Syntometrine), Oxytocin infusion (Syntocinon) or carboprost (intramuscular)

1.

Pethidine Hydrochloride

Adult IM For pain relief in labour

Prochlorperazine Adult IM For management of actual or potential nausea and vomiting

Sodium Chloride 0.9%

Adult IV For maternal resuscitation and IV flush

Hepatitis B Vaccine

Neonate IM For use in protection against Hepatitis B

Hepatitis B Immunoglobulin

Neonate IM For use in protection against Hepatitis B

Naloxone Hydrochloride

Neonate IM For reversal of respiratory depression resulting from opioid administration to mother

Phytomenadione Neonate IM Prophylactic use to prevent vitamin K deficiency bleeding (haemorrhagic disease of the newborn)



10.2 General Principles for the Administration of Medicines

The process adopted for supplying or administering a medicine to any patient should ensure that:

The right drug in the right formulation is given;

To the right patient

At the right time and date

Via the right route and

At the right dose

The registered practitioner must exercise their professional judgement and act in the best interests of the patient when administering medicines. Before administering medicines to a patient, they must:

Be familiar with the medicine indications, the BNF dose range, side effects, cautions and contra-indications

Check the patient‟s identity

Check the patient‟s care plan

Check that the prescription and the label on the medicine are the same, are clearly written and unambiguous

Have considered the dose, method of administration, route and timing of the administration in the context of the condition of the patient and co-existing therapies

Check the expiry date of the medication to be administered

Check that the patient is not allergic to the medication before administering it. Medicines should be not be administered if the allergy box on the prescription chart and administration record chart is blank

STOP, THINK, DOES THE DOSE AND CALCULATION SEEM REASONABLE IF NOT THEN CHECK

The prescriber or another registered prescriber must be contacted without delay if contra-indications to the prescribed medication are discovered, where the patient develops a reaction to the medication, or where assessment of the patient indicates that the medication is no longer suitable.

A clear and immediate record must be made of all medication administered, intentionally withheld or refused by the patient, ensuring that any written entries and the signature are clear and legible. The administering practitioner must ensure that the patient takes or uses the medicine appropriately. If errors or incidents in the administration of medicines are observed or discovered the reporting processes outlined in the Incident Reporting section of this policy should be followed. Single practitioner administration of medicines is normal practice. Witnessing by a competent other is only required when:

a controlled drug (CD) is to be administered (see section 13 – single person administration may be necessary in a community setting)



a complex calculation of dosage is required – a second practitioner is required to check the calculation (although they do not necessarily have to be involved in the administration) in order to minimise the risk of error (the two practitioners to perform the calculations independently and make an entry of the calculation details in the patients notes)

administering medicines to children under 16 years of age

there is a locally agreed policy in specialist areas

the patient‟s condition makes it necessary

the practitioner is instructing a learner (responsibility for the administration of the medicine rests with the senior practitioner, although each practitioner remains accountable for their own practice).

10.2.1 Injections

Injectable medicines are packed in ampoules or vials. Most are intended for single use only. Exceptions include:

some insulin

heparins

some local anaesthetics

vaccines

Injections for multiple use generally contain antibacterial preservatives. These prevent the proliferation of any bacteria introduced during use, but are not effective against viruses, protozoa, or other organisms, such as those causing malaria.

Injections licensed for single use must not be used on more than one occasion, either for one or several patients

Injections licensed for multiple use should be used in accordance with their Marketing Authorisation

Each container of an injection licensed for multiple use should be reserved for a single patient and adequate systems put in place to ensure this occurs

A new needle and syringe should be used for each withdrawal, even if a single dose requires more than one withdrawal

Injections should be manipulated observing normal no-touch techniques Substances for injection should be prepared at the time of administration. An exception to this is an already established infusion which has been instigated

by another practitioner following the above principles or medication prepared under the direction of a pharmacist from a central additive service and clearly labelled for that patient

To aid compliance with NPSA Patient Safety Alert 20 – „Promoting Safer Use of Injectable Medicines‟ and to ensure essential technical information on injectable medicines is made available and accessible to healthcare staff in clinical areas at the point of use, a detailed guide to the safe preparation and administration of common intravenous medicines is now available via the „IV Guide‟ link from the Pharmacy & Medicines Management homepage or click here. Access is via a username [cddward] and a password (ivguide)

10.3 Oral Administration of Medicines

The use of intravenous syringes for the measurement and administration of oral medicines has resulted in accidental administration of oral medication via the parenteral route.

http://medusa.wales.nhs.uk/



CDDFT use PURPLE oral/enteral syringes to distinguish between oral and IV syringes and minimise the risk of accidental administration. Furthermore, the use of PURPLE oral syringes to measure and administer oral medicines provides a visual reminder that the medication must be given via the oral or enteral route. Whenever it is necessary to administer oral medications via an oral syringe and other solutions for either IM/IV injection via an IV syringe at the same time, the two procedures should be carried out separately. Standard IV syringes MUST NEVER be used to measure or administer liquid medicines either orally or through an enteral feeding tube.

A medicine cup may be used to measure and administer oral liquid medicines except in the following situations where a PURPLE oral syringe is appropriate:

The dose cannot be accurately measured using a medicine cup e.g. less than 5ml or not a multiple of 5ml, or where dose measurement is critical e.g. digoxin, phenytoin

Administration via an enteral feeding tube

Administration from a medicine cup is unsuitable e.g. babies, young children 10.4 Administration of Medicines to Children

The general principles for the administration of medicines to patients apply equally to adults and children. When preparing and administering medicines for children, consideration should be given to the following additional principles:

Medicines which are safe for adults may not be safe when administered to children e.g. aspirin

Doses are smaller, as is the margin for safety and complex calculations may be necessary

Routes of administration may differ Skill is required in the administration of medicines to children

Doses of less than 1ml in volume must be drawn up in a 1ml syringe graduated to 0.01mls. Purple oral syringes must be used for oral medication

Paediatric formulation must be used whenever possible. Extreme vigilance must be exercised when they are not available and adult strength preparations are used

The weight of the patient must be recorded in kilograms on the front of the prescription chart. A new prescription must be written if a change in weight occurs necessitating a change in dose

In the event that a weight or surface area is estimated, in Emergency Departments, two nurses must document that they agree with the weight or surface area estimated in the nursing record.

10.5 Disguising Medication in Food and Drink

It is unacceptable to disguise a patient‟s medication in food or drink, resulting in the covert administration of medication.



10.6 Process for Patient Self Administration of Medicines (NHSLA 1.4.5.d)

The decision to allow patients to self-administer their medication should be made by the multidisciplinary team in conjunction with the patient, ensuring the necessary safety, security and storage arrangements are in place. This process must be clearly documented, taking into account:

Robust reasons for patient self-administration of medicines e.g. preparation for discharge and education of the patient about their medication with the aim of preventing problems which may arise from non-compliance with a medication regime

Patient understanding of the importance of their responsibilities in administering their medication

Satisfaction of clinical staff that the patient has been assessed as able to manage the self-administration process

A written prescription must be available for medications to be self-administered and the nurse will record on the prescription chart when patients self-administer. The patient must be informed of the importance of notifying the nurse when they have administered the medication

When self-administration of medicines is in place individual locked cupboards with access limited to the specific patient must be used

When patients self-administer it is the responsibility of the senior nurse on the ward/department/service to ensure that the medication to be self-administered is the same as the prescribed medication i.e. the right drug in the right formulation and the right dose, before the first dose is self-administered. This check must be carried out even if the patient has brought the medication to be self-administered into hospital with them.

10.7 Guidelines for Administering Medicines

10.7.1 Guidelines and process for Administering Medicines in Adults including

NHSLA 1.4.5c (patient identification)

Medicines must be prepared and administered by a registered nurse or registered practitioner who has completed appropriate training, either alone or witnessed by a student nurse or practitioner in training (as part of their education). See section 10.1 for exceptions, when witnessing is required by a competent other.

Nursing auxiliaries/support workers/health care assistants must not be used as a witness for the checking of medicines. They may participate in the administration of medicines at the discretion of and under the supervision of the qualified nurse.

The prescription for each patient should be read carefully. Check that the patient is not allergic to the medication and that there are no interactions with other prescribed medicines.

Ensure the prescription is legible, dated and signed and confirm that the prescribed medication has not already been administered as a regular or „when required‟ medicine.

All checks must be completed before commencing the administration of medicine. This will reduce the risk of disruption, minimise risk of error, and ensure safety and concentration.



The practitioner will:

Explain the procedure to the patient

Identify the required medicine, right dose, date, time, route of administration etc. as per the prescription chart, ensuring the prescription is legible, dated and signed

Select the medicine required, check expiry date, and check all details comply with the prescription

Make and check any calculations necessary

Clearly identify the patient for whom the medication is intended. This will be by: - checking the patient‟s identity band (where applicable) - checking the patient‟s NHS number or case record number - checking the patient‟s date of birth

N.B. if the prescription is not legible, the allergy box has not been completed or there is any uncertainty regarding the medicine e.g. suitability of the dose, frequency, route etc. then the medicine should not be administered and the prescription must be referred back to the prescriber.

Purple oral/enteral syringes should be used for oral/enteral medication administration if the patient is unable to take a dose from a medicine spoon or cup

The practitioner should remain with the patient until the medicine has been administered

The details of administration should be entered in the appropriate record. The practitioner who administered the medication is to sign and if a second individual has acted as witness or checked a calculation that individual should also sign

If a prescribed medicine is omitted for any reason this should be recorded on the prescription chart and the appropriate medical staff informed. Refer also to „omitted or delayed medicines‟

Medicines prepared for administration and subsequently omitted must be destroyed

10.7.2 Guidelines and process for the Administration of Oral Medication to

Paediatric Patients

A Registered Sick Children‟s Nurse or a Registered Nurse with Paediatric experience who is familiar with paediatric drug calculations should perform the administration of medications. It should be carried out in accordance with guidelines for the Administration of Medicines.

In addition to steps detailed in 10.7.1: Prepare the patient:

Assess the child‟s level of understanding. All explanations should be appropriate to the child‟s level of cognitive development

Explain to the child and parents about the medication

Explain the method of administration e.g. cup, spoon, tablet, syringe

Prepare the medicines:

Identify the required medicine, right dose, date, time, route of administration etc. as per prescription chart. Ensure the prescription is legible, dated and signed.

Select the medicine required and check with the prescription:-

The label/name of the drug

The expiry date



The calculation if any

The measured dose

The route

The time of administration

Interactions with other medicines

Allergy status

NB if the prescription is not legible, the allergy box has not been completed or there is any uncertainty regarding the medicine e.g. suitability of the dose, frequency, route etc. then the medicine must not be administered and the prescription should be referred back to the prescriber.

BEFORE ADMINISTERING A MEDICINE TO A PATIENT – STOP AND THINK DOES THE DOSE AND CALCULATION SEEM REASONABLE? IF NOT THEN STOP AND CHECK

Administration

Check equipment is available for administration e.g. spoon, medicine glass, oral syringe or dropper

Position the child correctly - Infants and toddlers may sit on the nurse or carer‟s knee - All children should be sat up where possible - Do not tip the child‟s head backwards

Administer the medication slowly

It may be preferable to allow the carer/parent to administer medicines when possible, whilst observed

The medication is taken to the child and Identification bracelets must be checked (2 x identity bracelets if under 1 year)

The information on the identity bracelet should correspond to that on the prescription chart

Tablets may be used when a child is assessed capable of swallowing them with a drink

Infants and toddlers may receive oral medication via oral syringe or dropper by slow administration, just inside the mouth, pointing towards inside of cheek

Oral medicines must never be drawn up in IM/IV syringes

Whenever it is necessary to administer oral medications via a syringe and other solutions for either IM/IV injection at the same time, the two procedures should be carried out separately

10.8 Administering Cytotoxics medicines

Cytotoxic medicines are defined as any medicinal product that has one or more of the following hazardous properties:

Toxic

Carcinogenic

Mutagenic

Toxic to reproduction. (Note toxic for reproduction should not be confused with contra-indicated in pregnancy)

The current edition of the British National Formulary Section 8 provides further details of which medicines may be classed as cytotoxic.



Also refer to the Trust Policy on the safe administration of cytotoxic drugs.

A Trust policy on administration of Intrathecal therapy is separate and available within designated departments only.

Health Care professionals should be trained in the administration of cytotoxics medicines and specific detailed procedures should be available.

Staff who are breast feeding or who are or suspect they are pregnant should be risk assessed before being involved in the administration of cytotoxics drugs and should inform their line manager accordingly.

When administering cytotoxic medicines:

Appropriate protective clothing should be worn in clinic areas or the patient‟s home

Vomit and excreta of patients receiving chemotherapy may contain measurable levels of cytotoxic drugs and their metabolites in addition to the normal hazards and appropriate handling procedures should be applied

Measures should be taken to avoid skin contact with ORAL cytotoxic medicines. If handling tablets or capsules is unavoidable, disposable gloves must be worn. Measuring spoons/cups etc. must be washed thoroughly after use and reserved for the use of that patient only

Tablets/ capsules of cytotoxic medicines must not be crushed or opened. If a patient is unable to swallow tablets or capsules or a fraction of a tablet is required pharmaceutical advice should be sought or the prescriber contacted

Particular care should be taken when handling oral liquid cytotoxic medicines to avoid accidental spillage/contact with handler

A designated hazardous waste disposal bin must be used for disposal of all cytotoxics & cytotoxics contaminated material, sharps etc. Special arrangements must be made for the recording and removal of the cytotoxic waste.

If the cytotoxic medicine comes into contact with the skin or mucous membranes wash immediately with copious amounts of water:

If there is any contact with the eyes, irrigate with sodium chloride 0.9% or water and seek immediate medical attention and complete an incident report

Needle stick injury – make the injury bleed and wash with copious amounts of water and follow the Trust Infection Control Policy and Blood Borne Virus Policy, seek medical attention and complete an incident report.

Any person who has been involved in the administration of cytotoxic medicines and presents with a possible local or systemic effect (such as nausea, dizziness, vomiting) after handling the medicine, should inform their line manager and seek medical attention and follow the Trust Occupational Health policy

Any department using cytotoxics should ensure that they have clear instructions for staff for actions to take in the event of a spillage.

The dosage and clinical appropriateness (clinical indication, relevant blood tests etc.) of all cytotoxics should always be confirmed prior to administration of any cytotoxic.

Patients who have been admitted to hospital while taking cytotoxic treatment may have clinically deteriorated from when they were prescribed treatment.



Advice from specialist teams should be sought to ensure that continuation of treatment and dosage (dose, frequency and duration) are appropriate.

IF IN DOUBT – DELAY ADMINISTRATION

10.9 Homely Remedies – Non Prescription Medicines

Patient‟s often develop symptoms that require assessment and simple interventions with medicines that are on the general sales list (GSL) or pharmacy only (P) lists. These cannot be prescription only medicines (POM) or controlled drugs. Historically this assessment has been undertaken by a medical practitioner and the medicines prescribed for the patient. However there are circumstances in which a registered nurse can safely undertake this assessment and administer GSL and P medicines safely. The NMC standards for medicines management (NMC, 2007) allows for registered nurses to administer a medicinal product using a homely remedies policy. Registered nurses using this policy must be fully aware of their accountability for the administration of medicines and in particular refer to the NMC standards for medicines management (NMC, 2007). Prescription only medicines (POM‟s) must be prescribed be either a medical practitioner or independent nurse/pharmacist prescriber or be administered under an appropriate patient group directive. The „Non Prescription Medicine Policy „(for homely remedies) allows for the timely management and relief of symptoms in patients using GSL and P medicines. Only the medicines contained in this policy may be administered. This policy is filed in nursing policies. Registered Nurses must ensure that they undertake a comprehensive assessment of the patient to ensure that medicines are only administered under the policy when necessary to relieve the symptoms indicated. Registered Nurses must ensure that the maximum dose for that medicine is not exceeded. Registered Nurses must ensure that there is no delay in the referral, diagnosis or management of a more serious underlying deterioration in the patient‟s medical condition. Registered nurses must ensure that there are no contraindications to the administration of the medicine. Only the remedies detailed in the policy may be administered. If there is no improvement in the patient‟s symptoms within 24 hours, or there is deterioration in their condition, then appropriate referral to a medical practitioner/nurse practitioner should take place. Administration of medicines must be clearly recorded on both the prescription chart and in the nursing record. The once only section of the prescription chart should be used to record medicines administered under the policy.



10.10 Process for monitoring of administration medication incidents NHSLA 1.4.5g

The process for monitoring medication incidents is via the Safe Medication Practice Group and includes monitoring of all administration incidents.

This thematic and analytical review is utilised to highlight recurrent or high risk issues, as well as reviewing practice against the systems and processes within the Medicine Policy.

Action plans to minimise administration incidents are discussed and agreed at Safe Medication Practice Group and escalated to Safety Committee.

11 DISPOSAL OF MEDICINES Medicinal waste must be destroyed in accordance with the following documents:

CDDFT Waste Policy

Waste procedures Acute Trust

Waste procedures PCT

Controlled Drugs are destroyed according to legal and local policy – see Section 13 of this policy for Controlled Drug Destruction

11.1 Procedure for the safe disposal of all drugs (NHSLA 1.5.4.e)

Medicinal waste includes expired, unused, split and contaminated pharmaceutical products, drug and vaccines that are no longer required and need to be disposed of appropriately.

This also includes discarded items from use in the handling of pharmaceuticals, such as bottle or boxes with residues, gloves, masks, connecting tubing, syringe bodies and drug vials.

Exceptions to this include controlled drugs, radiopharmaceuticals or blood products for which additional requirements apply.

For the purpose of the Hazardous Waste Regulations, medicinal waste is classified into two categories: 1. cytotoxic and cytostatic medicines 2. medicines other than those classified as cytotoxic and cytostatic

All cytotoxic and cytostatic medicines must be disposed of in purple lidded sealed boxes. If in doubt about whether a medicine is hazardous please seek advice from the pharmacy department or the waste collector. Cytotoxic medicines are defined in Chapter 8 of the current British National Formulary.

Other medicinal waste should be placed in yellow medicinal waste containers and marked appropriately.

Medicinal liquids should be placed in leak proof approved containers. Liquids medicine containers must have the lids secured and wrapped if necessary to prevent leakage before placing into the designated waste bin.



Medicines and hazardous substances must never be placed in household waste, down sinks or flushed into the sewage system.

Handling of waste is also regulated by legislation therefore all medicines should be placed in the waste bin in their original pack. Blister packs can be removed from their outer container if in doing so the handler does not come into contact with the medicines. However, the emptying of bottles, for example is not allowed, except for controlled drugs (see controlled drug section 13).

The pharmacy department must follow the pharmacy Medicine Returns Guidelines and Standard Operating Procedures for waste disposal.

Patients own drugs (PODs) are the property of the patient. PODs for disposal in hospital may be returned to the pharmacy department after consent from the patient is obtained. Patient identifiable labels must have the patient‟s name made illegible or the label removed and disposed of in a confidential waste bin before the container is disposed of.

Community based patients should be instructed to return PODs to a community pharmacy for destruction. Community based patients should also be directed to return „sharps bins‟ to their GPs for safe disposal or use arrangements made through their local authority for collection of clinical waste.

Waste containers should not be over filled. Once the bin is full to the indicated line, it must be sealed and collected by either a porter or waste contractor.

Expiry dates explained: Date on box Actual expiry date Use by Dec 11 01.12.11 Exp. Dec 11 31.12.11 Use before Dec 11 30.11.11

Hospital wards and departments Medicines which are no longer required, expired or no longer fit for their intended use must be returned to the pharmacy department with the exception of controlled drugs, radiopharmaceuticals or blood products for which additional requirements apply and PODs if the patient chooses to take them home.

Medicines should be returned to the pharmacy department in their original containers, in a locked box or tamper evident bag, along with a record of the items being returned. The record should state the name and quantity of the medicine and be signed by the registered nurse or member of pharmacy staff returning the medicine.

For patients‟ own drugs on POMMS wards the nurse must record what has happened to them i.e. destroyed or returned to the pharmacy department, transferred with patient, sent home with patient.

Nominally empty medicine containers, all part-used infusion or injection containers (including those for cytotoxic medicines) and anything which may be contaminated with blood or body fluids must be disposed of on the ward/department/service, accordingly. Community Settings Stock medicines which are past their expiry date or unsuitable for use due to damage, breakages, inadequate labelling etc. should be disposed of on the premises in the



appropriate medicinal waste disposal container (Exceptions to this are controlled drugs, radiopharmaceuticals or blood products for which additional requirements apply and patients‟ own drugs which the patient refuses to surrender. Any medicines requiring disposal should be segregated and placed into a dedicated medicinal waste container. Empty medicine containers e.g. ampoules, vials, discharged syringes and giving sets must be disposed of by placing into either a medicinal sharps container or a dedicated medicinal waste container. Where cytotoxic or cytostatic waste is produced it must be placed into purple lidded waste containers, special handling and disposal arrangements should be made and pharmaceutical advice should be taken. Staff in community settings must only remove from the premises or dispose of a patient‟s own medicine in exceptional circumstances. A record should be made and signed by a witness. In some circumstances if a second healthcare professional is unavailable, a patient or their representative may be a suitable witness. For controlled drugs see separate guidance. Once waste containers are sealed it must be ensured that they are signed, dated and labelled with the relevant premises name. Medicinal waste must only be collected by the Trust‟s approved waste contractor. Replacement medicinal waste bins are available from to order from Cardea.

11.2 Process for monitoring of the disposal of medicines NHSLA 1.4.5.g

The process for monitoring the disposal of medicines is via:

Safe Medication Practice Group review all medication incidents relating to the disposal of medicines

Audits are carried out across the Trust in relation to waste, manual handling & Health & Safety. These audits are monitored by the Health & Safety Committee on a 6 monthly basis via a traffic light system.

An annual report to show compliance with the pre-acceptance auditing requirements as set out by the Environmental Permitting Regulations completed by the Risk Management Team.

12. MANAGEMENT OF UNTOWARD OCCURENCES

An untoward occurrence includes medication incidents, adverse drug reactions and drug defects. Reporting of untoward occurrences is essential to facilitate thorough investigation, subsequent identification of issues of risk, review of systems, processes, policies and procedures. Only if this is achieved can change be introduced which reduces risk to patients.

12.1 Medication Incidents

A medication incident is a preventable event associated with the use of medicines that results in harm or could have resulted in harm to a patient. Medication incidents can occur in any step of the medicines process, including prescribing, dispensing and administration of the medicine as well as in the transfer of information. Inappropriate omission of a dose of a medicine may be considered an error of administration.

If a medication incident is observed or discovered, then:

Immediate action should be taken to ensure the safety of the patient and/or staff



The doctor or health care professional responsible for the care of the patient should be notified. In some incidences it may also be appropriate to inform the patient‟s GP. In line with the Trust „Being Open‟ Policy the patient and / or carer should also be informed.

All incidents should be reported to the ward/service manager or Matron as soon as possible (regardless of staff involved). The manager is responsible for the coordination of further investigation or action, if required. The Policy for Supporting Staff is available for further reference.

A Safeguard incident report should be completed for all medication incidents as detailed in the Trust Incident Management Policy. Medication incident reports should include those situations of a „near miss‟ category. Near misses are often useful warning signs of incidents that can happen again.

12.2 Process for monitoring of medication incidents NHSLA 1.4.5.g

The process for monitoring medication incidents is via the Safe Medication practice Group and includes monitoring of:

All prescribing incidents

All administration of medicines incidents

All safe disposal of medicine incidents


Action plans to minimise medication incidents are discussed and agreed at Safe Medication Practice Group and escalated to Safety Committee.

12.3 Process for monitoring Controlled drug incidents NHSLA 1.4.5.g

Reported incidents that involve controlled drugs are escalated to the Accountable Officer for the Trust. In CDDFT this is the Trust Chief Pharmacist. Controlled drug incidents are discussed at Controlled Drug Management Group meetings.

Action plans to minimise controlled drug medication incidents are discussed and agreed at Safe Medication Practice Group and escalated to Safety Committee and the County Wide Controlled Drug Local Intelligence Network (CDLIN).

A policy for the management of Controlled drug incidents is available on the pharmacy intranet site

12.4 Adverse Drug Reaction Reporting

Any drug may produce unwanted or unexpected adverse reactions.

If a patient experiences an adverse drug reaction to a medication, action must be taken to remedy any harm caused by the reaction. This must be recorded in the patient‟s notes.

Suspected adverse reactions should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the yellow card system (copies available



in the BNF or online via yellowcard.mhra.gov.uk). Patients are also encouraged to report adverse reactions.

For intensively monitored medicines (identified by) report all suspected reactions (including any considered not to be serious)

For newly licensed medicines all suspected adverse reactions should be reported, including those not considered to be serious, even if it is not certain that the drug has caused it.

For established drugs and herbal remedies report all serious adverse reactions in adults and all serious and minor adverse reactions in children (under 18 years).

12.5 Drug Defects and Drug Alerts

All defects, including minor defects and suspected defects in medicines are to be reported to the Pharmacy (or the on-call pharmacist out of hours) who will report this to the Regional Quality Control Specialist Pharmacist following the Regional Drug Defect Reporting procedure.

Drug defects which result in drug recalls are cascaded to hospital pharmacy departments. It is the responsibility of the senior pharmacy manager or pharmacy procurement manager, (or the on-call pharmacist, out of hours) as the responsible person to action the recall according to the policy.

The action taken is determined by the class of medicines recall received:-

Class 1 - Action now (including out of hours) Class 2 - Action within 48 hours Class 3 - Action within 5 days Class 4 - Caution in Use

12.5.1 Action to be taken for Recall of Products Stocked, Purchased or Prepared by Pharmacy

Using the pharmacy ASCribe computer system the responsible person must establish if the affected batch has been received by pharmacy. If the affected batch has been received, then a trace must be run to establish all issues. A physical check should be made in all the following pharmacy locations:- CDDFT Pharmacy Store CDDFT Dispensaries Aseptic unit preparation areas – follow all procedures for entry and exit of the aseptic unit EMSU Cupboards, CDDFT List of contents in emergency cupboards.

Wards/departments/services who may stock or have been issued with the recalled drug, or product made with it, must be contacted as soon as possible. If the recalled product is used in the preparation of an aseptically dispensed chemotherapy injection, a check of the aseptic unit workload record log book and relevant batch sheets must be made to identify any items prepared with the recalled



product that may have not yet been administered e.g. a 3 day course that was prepared all in one session. If necessary, advice from the Aseptic Services Pharmacist may be sought.

12.5.2 Responsibilities of the Responsible Person

The responsible person must request the ward/department/service manager check the stocks held within their area and if necessary to withdraw the drug from use and quarantine it until:-

It is collected by pharmacy personnel Pharmacy arranges for the drug to be returned to a CDDFT Pharmacy The ward/department/service manager is advised by pharmacy of further

action to be taken.

If the recalled product was prepared in the aseptic unit a replacement injection will be made as soon as possible. (the next working day if out of hours). The nurse will need to contact the consultant if treatment is to be interrupted. The responsible person must ensure all withdrawn stock is quarantined in the quarantine area of the pharmacy store. The responsible person must inform the Aseptic Services Pharmacist or deputy, of any relevant drugs recalled and the action taken as soon as possible.

The responsible person must ensure that all drug alerts are followed by communication to advise of the recall situation and outcome. The responsible person must ensure all documentation is completed and that the hazard warning notice is attached and filed in the appropriate pharmacy file. Standard operating procedures are available in the pharmacy department for the action to be taken by pharmacy in the event of a drug recall.



13 CONTROLLED DRUGS

13.1 Legislation

The Misuse of Drugs Act 1971 and Medicines Act 1968, prohibits the possession, supply and manufacture of medicinal and other products except where such possession, supply and manufacture is in accordance with the Misuse of Drugs Regulations 2001, Misuse of Drugs (Safe Custody) Regulations 1973, and Controlled Drugs (Supervision of Management and Use) Regulations 2006. Additional statutory measures for the management of controlled drugs are laid down in the Health Act (2006) and its associated regulations.

This controlled drug section of the medicine policy is based on guidance and recommendations from the following documents:

‘Safe and Secure Handling of Medicines; a team approach (Revised Duthie 2005’) specifies the administration and storage of controlled drugs.

The government‟s response to the Shipman Inquiry‟s Fourth Report ‘Safer management of controlled drugs’ - sets out a substantial programme of work to strengthen the current systems for the management of controlled drugs .

‘Safer management of controlled drugs – a guide to good practice in secondary care (England) 2007’, provides guidance on management of controlled drugs in secondary care.

National Prescribing Centre Guide to Good Practice in the Management of Controlled Drugs in Primary Care 2009 (England) provides guidance on management of controlled drugs in primary care

13.1.1 Schedules of Controlled Drugs

The 2001 regulations divide Controlled Drugs (CDs) into 5 schedules which dictate the degree to which a CD use is regulated, which in turn depends upon the therapeutic benefit versus harm when misused. Schedule 1 CDs are subject to the highest control whereas Schedule 5 CDs are subject to much lower levels of control.

The relevant legislation and guidance is summarised briefly in Section 13.24. Readers are encouraged to refer to relevant websites for detailed, up to date information.

The legal requirements pertaining to the main groups of controlled drugs are summarised in Table 1 below. Schedule 1 drugs have been omitted from the table as drugs in this group have virtually no therapeutic uses



TABLE 1: Summary of legal requirements that apply to controlled drugs in Schedules 2,3,4 and 5 of the Misuse of Drug Regulations

Schedule (refers to schedules of Misuse of Drugs Regulations)

Schedule 2

Includes – Opioids (e.g. diamorphine, morphine, methadone) *see below Major stimulants (e.g. amphetamines, remifentanil, secobarbital).

Schedule 3

Includes minor stimulants, Temazepam, dethylpropion, buprenorphine, flunitrazepam. Barbiturates except secobarbital

Schedule 4,

part 1 Includes benzo-diazepines

Schedule 4,

part 11 Includes anabolic steroids, clenbuterol, growth hormones

Schedule 5

Includes low strength opiods

Designation CD CD No Reg CD Benz CD Anab CD Inv

Safe Custody Yes, except quinalbarbitone

Yes with certain exemptions (i.e. Midazolam does not need to be stored in a CD cupboard)

No No No

Prescription requirements (including handwriting**) –apply to discharge and OP prescriptions

Yes Yes, except Temazepam

No No No

CD requisitions required

Yes Yes No No No

Records to be kept in CD register

Yes Yes in CDDFT with the exception of Midazolam

No No No

Pharmacist must ascertain the identity of the person collecting CD

Yes No No No No

Emergency supplies allowed

No No, except Phenobarbitone for epilepsy

Yes Yes Yes

Validity of prescription

28 days 28 days 28 days 28 days 6 months (IF POM)

Maximum duration that may be prescribed

30 days as good practice




Destruction requirements apply

Yes Yes with the exception of Midazolam

Yes No No

Table adapted from Medicines, Ethics and Practice Guide (http://www.rpsgb.org/pdfs/MEP30s1-2b.pdf)

* Please note: In addition to those controls in place for controlled drugs in CDDFT Temazepam, Phenobarbitone, Ketamine injection 50mg/ml and 100mg/ml, strong potassium chloride solution, potassium acid phosphate and Addiphos injections are also treated the same as schedule 2 controlled drugs in respect to ordering, recording, storage and destruction requirements

*prescriptions for Schedule 2 and 3 CDs may be typed or computer generated but must be signed by the prescriber.

http://www.rpsgb.org/pdfs/MEP30s1-2b.pdf



13.2 Responsibilities and accountability

13.2.1 Inspection

CDDFT will be subject to inspection by external designated bodies, for example General Pharmaceutical Council, Care Quality Commission, covering areas such as compliance with policy.

13.2.2 Accountable Officer

The Trust Chief Pharmacist as Trust Accountable Officer for controlled drugs has statutory responsibility for all aspects for the safe use and management of controlled drugs within CDDFT.

This includes ensuring systems are in place for the management and use of controlled drugs, monitoring and auditing of the management systems and the investigation of concerns and incidents relating to controlled drugs.

13.2.3 Controlled Drug Management Group and Monitoring NHSLA 1.4.5.g

The process for monitoring the management of controlled drugs is via the Controlled Drug Management Group and includes monitoring of:

All controlled drug prescribing related incidents

All controlled drug administration related incidents

All controlled drug safe disposal of medicines related incidents

6 month rolling controlled drug audits across all wards/services that hold controlled drugs as stock.


Action plans to minimise controlled drug medication incidents are discussed and agreed at Safe Medication Practice Group and the County wide Controlled Drug Local Intelligence Network, if applicable.

13.2.4 Management of controlled drugs on wards, departments or in services

The registered nurse or midwife in charge of a ward/department/service is responsible for the safe and appropriate management of controlled drugs within that area. The registered nurse or midwife can delegate access (i.e. key holding) to another, such as a registered nurse or operating department practitioner, however, legal responsibility remains with the registered nurse or midwife in charge. All aspects of the management of controlled drugs on wards/departments/services is governed by the Trust Medicine Policy. Wards/departments/services should develop more detailed standard operating procedures in collaboration with the pharmacy department.

13.2.5 Management of Controlled Drugs in pharmacy

The Trust Chief Pharmacist is responsible for the safe and appropriate management of controlled drugs within pharmacy. Day to day management



(i.e. receipt and issue) is delegated to a suitably trained pharmacy practitioner. However, responsibility remains with the Trust Chief Pharmacist.

All aspects of the management of controlled drugs in pharmacy is governed by standard operating procedures that cover all legal and local requirements of the process including responsibilities, procurement, receipt into the organisation, security and storage, supply, destruction, record keeping, audit and transport arrangements. All standard operating procedures are formally approved by the Accountable Officer via the Controlled Drug Management Group.

13.3 Prescribing Responsibilities

13.3.1 Registered Medical Doctors

Registered Medical Doctors may prescribe controlled drugs in accordance with requirements of the Misuse Of Drugs Regulations 2001.

13.3.2 Supplementary Prescribers

Supplementary Prescribers can prescribe controlled drugs within their competencies that form part of a clinical management plan.

13.3.3 Nurse Independent Prescribers

Nurse independent prescribers can prescribe the following controlled drugs solely for the medical conditions indicated and within their competencies.

Controlled Drugs that can be prescribed and administered for specified indications by Nurse Independent Prescribers

Drug Indication Route of Administration

Buprenorphine Transdermal use in palliative care Transdermal

Chlordiazepoxide hydrochloride

Treatment of initial or acute withdrawal of alcohol from persons habituated to it

Oral

Codeine phosphate N/A Oral

Co-phenotrope N/A Oral

Diamorphine hydrochloride

Use in palliative care, pain relief in respect of suspected myocardial infarction or for relief of acute or severe pain after trauma, including in either case postoperative pain relief

Oral or parenteral

Diazepam Use in palliative care, treatment of initial or acute withdrawal symptoms caused by the withdrawal of alcohol from persons habituated to it, tonic-clonic seizures

Oral, parenteral or rectal



13.3.4 Midwives

Unless an Independent prescriber, midwives are not authorised to prescribe controlled drugs. They can supply and administer a number of specified controlled drugs parenterally within the course of their professional practice.

The Misuse of Drugs Regulations 2001 in conjunction with the Medicines Act allows a registered midwife to possess pethidine, morphine and diamorphine in their own right so far as is necessary for the practice of their profession. See Section 13.22.

13.4 Controlled stationery and authorised signatures

All controlled drug stationery is controlled by the pharmacy department and audited by the internal audit department. This includes controlled prescriptions, orders books and ward registers. A list of authorised signatures is held by pharmacy of Trust staff authorised to order controlled drugs and controlled stationery for the ward/department/service by the ward/department/service manager. It is the responsibility of the ward/department/service manager to ensure that these signatures are forwarded to pharmacy. If a signature is not recognised on an order a supply will not be made.

The one exception to this is FP10CDF forms which can be used by community sites. These forms are ordered directly from the North East Family Health Service Agency by the service lead or practioner with delegated responsibility.

13.5 Ordering and transport of Schedule 2 and 3 controlled drugs from a CDDFT pharmacy department

A list of Schedule 2 and 3 controlled drugs to be held in each ward/department/service as stock items should be available on the ward/department/service and in pharmacy. The contents of the list should reflect current patterns of usage and should be agreed between a pharmacist, ward/department/service manager or appropriate medical staff. Only the controlled drugs listed should be routinely ordered or „topped up‟.

Nurse Independent Prescribers

Nurse Independent Prescribers Nurse Independent Prescribers

Fentanyl Transdermal use in palliative care Transdermal

Lorazepam Use in palliative care, tonic-clonic seizures Oral or parenteral

Midazolam Use in palliative care, tonic-clonic seizures Parenteral or buccal

Morphine hydrochloride

Use in palliative care, pain relief in respect of suspected myocardial infarction or for relief of acute or severe pain after trauma, including in either case postoperative pain relief

Rectal

Morphine Sulphate Use in palliative care, pain relief in respect of suspected myocardial infarction or for relief of acute or severe pain after trauma, including in either case postoperative pain relief

Oral, parenteral or rectal

Oxycodone hydrochloride

Use in palliative care Oral or parenteral administration in palliative care



Naloxone injection, an antidote to opiate-induced respiratory depression, should be available in all clinical locations where diamorphine and morphine injections are stored and administered, including GPs bags; as per the National Patient Safety Agency alerts.

Controlled drugs are issued by the pharmacy practitioner on receipt of a controlled drug order signed by an authorised registered nurse. Copies left in the controlled drug order book are kept for two years. 13.5.1 Orders for Schedule 2 and 3 controlled drugs This includes those drugs treated as Schedule 2 controlled drugs within CDDFT. A separate page for each order (in the controlled drug order book) must be used to order controlled drugs and must contain the following information:

Name of hospital

Ward/Department/Service

Drug name, form, strength, ampoule size if more than one available

Total quantity

Signature and printed name of authorised registered nurse ordering the controlled drug

Date

Signature of person issuing the item from the pharmacy A list is kept in the pharmacy of authorised registered nurse‟s signatures – if pharmacy does not recognise any signatures the drugs will not be issued. Pharmacy staff may operate a controlled drug „top up‟ system but the requisition must be signed by an authorised registered nurse. Pharmacists can alter the controlled drug order to ensure that whole tamper evident packs are supplied. This will be endorsed on the original order and carbon copy of the order by the pharmacist involved. Once an order has been written at ward/department/service level it cannot be amended by ward/department/service staff. If a change is required, the unwanted order must have a line drawn through it and signed as „ordered in error‟ and a new order on a new page produced. The controlled drug order book is transported to pharmacy in a tamper evident container and all controlled drugs in transit from pharmacy to wards/departments/services will be transported in a tamper evident container. Controlled drugs must not be sent to wards via the pneumatic tube system. Trust staff collecting Schedule 2 and 3 controlled drug orders or prescriptions from pharmacy must show a Trust identity badge and sign the order book or discharge prescription „tear off‟ slip to receive the controlled drug order or prescription. It is their responsibility to ensure the safe transit of the drug back to the ward/department/service as well as the secure storage of the drug on arrival at the ward/department/service. Controlled drugs leaving pharmacy for delivery to wards/departments/services via the standard delivery routes (i.e. via porter delivery) or other (i.e. via Trust transport) must follow standard operating procedures for the secure delivery of controlled drugs.



Schedule 2 and 3 controlled drugs must be handed to an appropriate registered nurse on the ward/department/service who must sign for its receipt and who will be responsible for ensuring its safe storage. Controlled drugs must never be left unattended.

In exceptional circumstances it may be necessary for community services to order required controlled drugs from community pharmacies using FP10CDFs. Standard Operating Procedures must be in place within the service to cover this practice which should usually only occur when delivery from the hospital pharmacy is not possible within the required timescale for the patient using the principles above. 13.5.2 Schedule 4 and 5 controlled drugs Orders for Schedule 4 and 5 controlled drugs are exempt from the specific ordering requirements.

13.5.3 Community Dental Services Community Dental Services only hold stocks of Midazolam. The service works to Dental standard operating procedures covering all controlled drug use. If the service wish to store any other controlled drug they must contact the Trust Chief Pharmacist. 13.5.4 Community Nurses Community nurses (e.g. district nurses) working in patient‟s own homes (including care homes) should record controlled drug activity on the approved Controlled Drug Record Card (CDRC). This process is governed by standard operating procedures to ensure accurate record keeping. Community nurses working within patient‟s own homes (including care homes) must not routinely destroy unwanted, unused or expired controlled rugs that have been supplied to patients. The patient or carer (relatives/next of kin) must be advised to return the controlled drugs to a community pharmacy for safe destruction. If in a care home then it is the responsibility of the care staff employed by the home to arrange safe disposal. There may be exceptional circumstances where the community nurse needs to become involved in the disposal of unwanted controlled drugs. Exceptional circumstances are:

Where, following the death of a patient, there is no relative or carer available to return unwanted controlled drugs to the pharmacy for destruction

Where there is concern that controlled drugs may be diverted for illicit use if left in the home for relatives to return to the pharmacy

Where leaving the drugs with the patient or carer could be considered likely to represent significant risk of harm.

Where possible and/or appropriate verbal consent should be obtained from the patient or family member to destroy the controlled drug(s). A record of destruction will be made on the CDRC. 13.5.5 Urgent Care – Home Visits All controlled drugs that are anticipated to be required by a GP on a home visit must be booked out of the Urgent Care Centre (UCC) controlled drug stock into the doctor‟s bag. The amount of controlled drugs taken on a home visit must be reasonable for the anticipated requirement (i.e. usually only one vial of an appropriate controlled drug



should be taken unless it is anticipated that a higher dose will be required). The must only be done immediately prior to leaving the UCC on such visits and not at the beginning of the UCC shift „in anticipation‟ of such visits.

The storage and safe custody of UCC stock that has been transferred to the UCC doctor‟s bag for home visits is the responsibility of the doctor using the bag. Another doctor, nurse PCP/ECP must witness the transfer of stock from the UCC cupboard and register to the bag and bag register. Record keeping must be in line with this policy and UCC standard operating procedures.

If unused the controlled drug stock must be returned and booked back to the UCC controlled drug register and controlled drug cupboard with an appropriate witness. This should be done immediately on return to the UCC or as soon as practicably possible. This latest this can be done is the end of the doctor‟s shift.

13.6 Receipt of Schedule 2 and 3 controlled drugs on wards, departments or services

As soon as possible after delivery the registered nurse or midwife in charge must check the controlled drug against the order, including the number ordered and received, in the presence of another competent registered health professional. If this is correct then the duplicate sheet in the controlled drug order book must be signed in the „received by‟ section. Any tamper evident seals on packs should be left intact. This will simplify and speed up routine checks. A seal should only be broken when the pack is required for administration. If when the seal is broken, the contents do not match the expected amount stated on the pack, the nurse in charge must contact the pharmacy department. Any discrepancies between the controlled drug ordered and the one received must be reported to the pharmacy department as soon as possible. Details of the date, drug, quantity and serial number of the requisition are recorded in the controlled drug register, the running balance updated and a check made to ensure the balance tallies with the physical quantity present. The details of the person who has received them and the signature of the witness (another competent registered health professional) should also be recorded. The controlled drug order book and controlled drug register are the records of issue and receipt of controlled drugs and must be kept for 2 years from the date of last entry. If controlled drug destruction has taken place and been recorded in the register this then must be retained for 7 years from the last date of entry. The controlled drug register must be a bound (not loose leaf). Controlled drugs must be placed immediately in the controlled drug cupboard. On no account must controlled drugs be left unattended.



13.7 Outpatients Prescriptions For Schedule 2 Controlled Drugs

When an outpatient prescription for a Schedule 2 controlled drug is collected from the pharmacy department, the pharmacy staff must confirm the details of the patient or the person collecting the prescription, in accordance with pharmacy standard operating procedures.

13.8 Storage and Security of Schedule 2 and 3 Controlled Drugs

Controlled drug cupboards should conform to the British Standard Reference BS2881 or be otherwise approved by the pharmacy department. Controlled drugs must be stored separately in a locked cupboard within a locked cupboard (or a locked cupboard within a locked room) which can only be opened by a person who can lawfully be in possession, such as a pharmacist or the registered nurse/midwife in charge, or a person working under their authority e.g. a nurse or pharmacy technician. Any extra storage requirements of the controlled drug must be adhered to (e.g. locked cold storage or safe practice recommendations e.g. store high strength diamorphine or morphine separate to the lower strengths to avoid the risk of accidental overdose). No other medicines or items should be stored in the controlled drug cupboard unless they are agreed to be controlled locally (i.e. potassium chloride concentrate solution). In certain circumstances controlled drug discharge medication sent to wards/departments/services several hours before the patients is due for discharge may be stored in the controlled drug cupboard. These must be kept separate from the main controlled drug stock and clearly marked and should remain in a sealed bag. Midazolam (Schedule 3) is exempt from safe custody requirements and does not require storage in a controlled drug cabinet. However, it will need to be securely stored in a drug cupboard. Schedule 2 and 3 controlled drugs must never be stored in the medicines trolley. Cupboards must be kept locked when not in use. Controlled drugs and controlled stationery must be locked away when not in use. There must be arrangements for keeping wards/department/service keys secure, particularly important for areas such as day surgery units and five day wards that are not operational at all times. Schedule 4 and 5 controlled drugs must be locked in a medicine cupboard.

13.9 Key holding and access to controlled drugs

The registered nurse or midwife in charge can delegate control of access (i.e. key holding) to the controlled drug cupboard to another such as a registered nurse or operating department practitioner. However, legal responsibility remains with the registered nurse or midwife in charge. Whilst the task can be delegated, the responsibility cannot.



For the purpose of checking stock, the controlled drug key may be handed to a member of the pharmacy staff as part of their day to day duties.

13.10 Missing controlled drug keys

If the controlled drugs keys cannot be found then urgent efforts should be made to retrieve the keys as speedily as possible for example, by contacting staff who have just gone off duty. The senior registered nurse, midwife or matron or the duty nurse or midwife manager is informed as soon as possible and the duty pharmacist informed if during working hours or next morning if out of hours/overnight. The security of the stocks must be maintained but access to medicines for patients must be facilitated as soon as possible and not be impeded. If the keys cannot be found the Accountable Officer must be informed. A Safeguard incident report must be completed. Depending on the circumstances it may also be appropriate to contact the police.

THE CONTROLLED DRUG KEYS MUST BE SEPARATE FROM OTHER WARD KEYS

13.11 Checking of Schedule 2 and 3 controlled drug stocks

All stocks of Schedule 2 and 3 controlled drugs must be checked regularly. This is the responsibility of the ward/department/service manager. Within CDDFT all Schedule 2 and 3 controlled drug stocks will be checked on a daily basis – this is the minimum. More frequent checks may be appropriate in specific areas - this will be agreed between the matron or manager with responsibility for the ward/department/service and the pharmacy department. Stocks of controlled drugs held on wards/departments/services should not be excessive. Agreed stock lists should be held and ward/department/service managers should monitor stocks and seek advice from the pharmacy department as appropriate. It is acknowledged that the process of checking of controlled drugs, due to removal of drugs from the locked cupboard, handling during checking, etc., carries risk of breakage and/or loss of drugs. However, the longer the time period between checks the more difficult to „track back‟ and trace the likely source should a discrepancy occur. The risks associated with checks need to be balanced against issues such as amount of controlled drug stock held, frequency of administration of controlled drugs, etc. The check of the balance in the register against the physical stock held will be carried out by a registered nurse and another competent registered health professional and recorded in the back of the controlled drug register, (or on a separate form negotiated by the nurse in charge stating „all drugs checked and correct‟, dated and signed by the two health professionals.



For ampoules in sealed packs it is sufficient to check that the label is correct and that the seal is unbroken. Only the current stock in use should be opened. Stock balance of liquid controlled drugs should generally be checked by visual inspection but periodic volume checks should be undertaken. The balance must be confirmed to be correct on completion of a bottle. The stocks of Schedule 2 and 3 controlled drugs should be checked by pharmacy staff or members of the Controlled Drug Management Group with audit and reconciliation every six months and when overall responsibility for the drug changes (i.e. change in appointments).

13.12 Recording of Schedule 2 and 3 controlled drugs on wards, services or

departments

This includes Schedule 2 and 3 controlled drugs with the exception of Midazolam However, local procedures may allow this recording to take place. The controlled drug register, order book and FP10CDFs must be kept in a locked cupboard or drawer when not in use. A page for each product stocked (not each order received) must be used so a running balance may be maintained and an Index in the front of the register must be kept and updated accordingly. Drugs entered into the controlled drugs register must be recorded on the page number that corresponds with the index. When the page is full, details must be transferred to a new page in the controlled drug register and signed by the registered nurse and competent registered health professional. Balances of controlled drugs kept must be checked after each administration to ensure an „accurate running balance „is maintained. All relevant details of the drug must be transferred from the order book into the controlled drugs register. This includes:- The full approved name of the drug, the strength and type of preparation at the

top of the page, e.g. DIAMORPHINE 10mg INJECTION The date and quantity received plus the signatures of the nurse and witness

receiving and recording the drugs

Old stock may be transferred into a new book by a registered nurse and another competent registered health professional if the following points are ensured:-

Page numbers of old and new books must be entered in both books i.e. „transferred to‟ and „transferred from‟ page .......

The details must be transferred to a new page in the new controlled drug book, signed by the registered nurse and competent registered health professional and the appropriate one in the old book cancelled

Once details have been transferred from the old register, the page should be cancelled and signed by both staff

The register must be kept on the ward/department/service for two years unless controlled drug destruction has been recorded in the register. This then will be retained for 7 years from the last entry. Every drug administered must be recorded in chronological order and countersigned by the registered nurse administering the drug and the witness.



Wastage of drug (any surplus drug i.e. part of an ampoule or infusion not required) must be recorded in the controlled drugs register as amount given and amount wasted and witnessed by a registered nurse or another competent healthcare professional. For example; if a patient is prescribed diamorphine 2,5mg and a 5mg preparation is available and used, the record should show „2.5mg given and 2.5mg wasted‟. Individual doses of controlled drugs prepared but not administered should be destroyed by a registered nurse and the competent witness on the Ward/department/service and the reason documented in the controlled drug register, according to policy. The witness must countersign any error in the controlled drugs register. Errors must be bracketed, amended, initialled by person making the entry and “written in error” entered adjacent to the mistake or an * added to the error and a comment made at the bottom of the page. Correction fluid must not be used.

13.13 Process for prescribing prescriptions for schedule 2 and 3 controlled drugs

(except Temazepam) Responsibilities for prescribing is detailed in section 13.2

Hand written controlled drug prescriptions must be in ink or such as to be indelible and be signed and dated by the prescriber issuing it in their usual handwriting with their signature. Computer generated FP10s must also be signed and dated by the prescriber issuing it in their usual handwriting with their signature. The prescriber must ensure that they are clearly identifiable from information provided on the prescription i.e. print name as well as providing a signature. Addressographs on hand written prescriptions are not acceptable within CDDFT and the patients name and address must still be written in the prescribers own hand. Electronically produced discharge prescriptions that include a controlled drug can be produced by a pharmacist but must be countersigned by the appropriate prescriber unless the pharmacist is a supplementary prescriber in line with the clinical management plan.

Prescribers are strongly advised to restrict prescriptions for controlled drugs to amounts no more than is sufficient to meet the patient‟s clinical need for up to 30 days‟ supply. In exceptional circumstances where the prescriber believes that a supply of more than 30 days is clinically indicated and would not pose an unacceptable risk to patient safety, the prescriber should make a note of the reasons in the patients notes and should be ready to justify his/her decision if required. Prescribers must not prescribe or administer controlled drugs for themselves or for close family or friends except in exceptional circumstances.

The Legislation states that the prescription for a controlled drug must:

Specify the dose to be taken and in the case of a prescription containing a controlled drug which is a preparation, the form and where appropriate the strength of the preparation and either the total quantity (in both words and figures) of the preparation or the number (in both words and figures) of dosage units, as appropriate, to be supplied; in any other case, the total quantity (in both words and figures) of the controlled drug to be supplied. If a prescriber orders a



strength of a controlled drug that does not exist the prescription must be amended to specify the total quantity of controlled drug in terms of available strengths

A pharmacist will be able to supply controlled drugs against some prescriptions that have a minor technical error but where the prescribers intention is clear

Where a prescription is received which requires amending, the person who originally signed the prescription must amend it. An amendment by another doctor is not acceptable. If the original prescriber is not available another prescriber must issue a completely new prescription

Under no circumstances can a carbon copy or faxed prescription be accepted for a Schedule 2 or 3 controlled drug

It is an offence for a pharmacist to supply a controlled drug before, or 28 days after, the date specified on the prescription. This includes supply of any controlled drug owing

Records must be made of the prescriber in the pharmacy controlled drug register

13.14 Administration of Schedule 2 and 3 controlled drugs

Nurses and midwives must follow Nursing and Midwifery Council standards and guidance. Guidance detailed in section 10.7 „guidelines for administering medicines‟ must be followed. As an example of good practice the Trust recommends that all aspects of the administration of controlled drugs is checked by a second competent registered health professional. The Trust recognises that, in certain circumstances this is not possible, for example; community nurses and midwives administering controlled drugs in the patients home. A procedure is available to assess the competency of a non-registered individual to witness controlled drugs activity in the community setting ONLY. In a community setting it is preferable to have a non-registered competent witness than no witness. SOPs should be developed for the service to ensure this process is robust. The controlled drug required must be taken from the cupboard and the registered nurse and a second competent registered health professional must check that the controlled drug is correct and the dose required is correct, including any reconstitution. The physical stock balance remaining and the number in the register must be checked and reconciled and signed by both the nurse and the second competent registered health professional. The controlled drug must be taken to the patient and administration witnessed by the nurse and the second competent registered health professional, including the destruction of any surplus drug (i.e. Part of an ampoule or infusion not required), following procedures for administration of drugs. Individual doses of controlled drugs prepared but not administered should be destroyed using a controlled drug denaturing kit by a registered nurse and competent registered health professional on the ward/department/service and the reason documented in the controlled drug register.

Where it is not possible to perform the check with both a registered nurse and second competent registered health professional, a risk assessment must be carried out. This



must be recognised and sanctioned by the appropriate manager and form part of their local procedures – such exceptions must be proven to be necessary. If appropriate, this practice must be added to the directorate risk register. For controlled drugs administered the following details should be recorded in the controlled drug register: Date and time dose administered Name of patient Quantity administered (including quantity wasted if appropriate) Form in which administered Name/signature of nurse who administered the dose Name/signature of witness (where there is a second person witnessing

administration) Balance in stock

13.15 Transfer of schedule 2 and 3 controlled drug stock

Controlled drug stock cannot be transferred from one ward/department/service to another except in exceptional circumstances. The Misuse of Drugs Regulations 2001 stipulates that a sister or acting sister being in charge of a ward/department/service may not supply any controlled drug other than for the administration to a patient. In the event of a controlled drug being unavailable supplies must be obtained from a pharmacy department. Controlled drugs should not be borrowed except in a case of urgent clinical need or life-threatening situation. The on-call pharmacist must agree to all instances of borrowing controlled drugs. If wards/department/services need to borrow a controlled drug then the following procedure should be used:

The senior nurse bleep holder/rota sister should be informed

The on-call pharmacist must be informed

The registered nurse from the ward/department/service supplying the drug must take the box(es) of the drug in use and the ward/departments/service controlled drugs register to the ward/department/service borrowing the drug

The nurse must act as witness to the administration together with the ward/department/service nurse

Details of the patient and the drug must be recorded in both registers, indicating which ward/service/department the controlled drug was obtained from and also the ward/service/department the controlled drug was given to.

13.16 Destruction of controlled drugs on wards, departments and in services

Schedule 2 and 3 stocked controlled drugs for destruction (i.e. expired drugs and unused/not required portions of drugs) can be destroyed on the ward/department/service by a registered nurse. The destruction must be witnessed by a second competent registered health care professional who has been approved by the Accountable Officer and delegated responsibility to witness destruction. All destruction must be documented in the appropriate section of the controlled drug register with the reason for the destruction given accompanied by the two witness‟s signatures. Destruction must occur in a timely fashion, so that excessive quantities are not stored awaiting destruction.



All destruction must be documented in the appropriate section of the controlled drug register with the reason for the destruction given accompanied by the two witness‟s signatures. Destruction must occur in a timely fashion, so that excessive quantities are not stored awaiting destruction. Ward/department/service stock close to expiry date should remain on the ward/department/service unless it can readily be used elsewhere. It should not be returned in order to expire in pharmacy. Destruction must occur in such a way that the drug is denatured or dissipated via a controlled drug destruction kit so that it is incapable of being retrieved, reconstituted or used, according to policy.

13.16.1 Denaturing and disposal of Schedule 2, 3 and 4 part 1 controlled drugs on wards/departments/services

Tablets, powders, liquids, patches and ampoules are destroyed using a controlled drug destruction kit following the instructions on the kit. Controlled drug destruction kits are commercially available kits specifically for the destruction of controlled drugs, ordered via cardea.

Part vials, small or large unused/waste doses of controlled drugs to be discarded should be rendered irretrievable by emptying the contents of the ampoule/vial/syringe into a controlled drug destruction kit. This is recorded and witnessed, except for Midazolam.

The emptied vial/ampoule/syringe should then also be placed in the appropriate sharps bin. The used controlled drug destruction kit should be sent to pharmacy for disposal if no appropriate disposal bins are available.

A patient or his representative may surrender unwanted prescribed controlled drugs to a pharmacist and these will be recorded for destruction according to pharmacy standard operating procedures.

If permission is given by the patient in the clinical environment for staff to destroy the controlled drug this is denatured, recorded and witnessed as for a regular controlled drug.

13.17 Returning schedule 2 and 3 controlled drugs to pharmacy

Unused controlled drugs from wards/departments/services may be returned to pharmacy as long as they are fit for re-use, i.e. not short expiry dated. The controlled drug order book will be used to return controlled drugs to pharmacy by scoring out „order‟ and adding „return‟. One page per drug is to be used. The following details should be recorded in the controlled drug order book and register when returning controlled drugs to pharmacy: Date Name, form, strength and quantity of drug being returned Reason for return Name and signature of registered nurse(s) or midwife

The returns when received into pharmacy will be checked in the presence of two members of pharmacy staff (one to be a pharmacist) and the top copy signed and removed for record retention. All controlled drugs returned to pharmacy must be transported in tamper evident proof containers.



13.18 Discrepancy in controlled drug stock

FOR SCHEDULE 2 AND 3 CONTROLLED DRUGS The balances in the controlled drug register must always tally with the amounts of controlled drug stock held in the controlled drug cupboard. If they do not, the discrepancy must be reported, investigated and resolved. It is important to remember that a discrepancy can indicate misuse. A policy for the management of controlled drug incidents is available via the pharmacy intranet site In the first instance:

Ensure a Safeguard incident report is completed and reported to the Clinical Risk Manager to facilitate a timely alert and response

Inform the Accountable Officer of any concerns if not already part of the incident report

Check the controlled drug register to ensure that all administrations have been recorded

Note the date of the last stock check to determine the last correct entry for the drug

Speak to staff on duty at the time, whether at work or home to clarify whether records etc. have been made or any untoward occurrences have taken place that may not have been recorded

Check calculations and balances entered (including balances transferred to new pages)

Check the balance in the register with all physical stock held to ensure that there are no other discrepancies

Annotate the register with „discrepancy noted‟ and signing against the entry, so other administrations can be made and patient care is not compromised

Check to ensure all requisitions received have been entered into the correct page of the register (this should be cross referenced with the controlled drug order book)

check to ensure stock hasn‟t been accidentally placed in the wrong cupboard (i.e. stored in the routine medicine cupboard)

If the error or omission is traced the registered nurse/midwife in charge should make an entry in the controlled drug register clearly stating the reason for the entry and the correct balance added. This entry should be witnessed by a second competent registered health professional. Both persons must sign the controlled drug register.

FOR SCHEDULES 4 AND 5 CONTROLLED DRUGS

Ensure a Trust IRI is reported to the Clinical Risk Manager to facilitate a timely alert and response

Inform the Accountable Officer of any concerns if not already part of the incident report

Monitor supplies made to the ward or dept. from pharmacy

Request confidential reports from pharmacy regarding supply of the drug

Audit supply against administration where possible

Speak with all staff who were on duty at the time of the incident and requesting statements where necessary, following Trust procedure



When all reasonable efforts to discover the reason for the discrepancy have been made and no omissions or errors are detected, the following action should be taken in conjunction with the Policy for the management of controlled drug incidents.

The senior registered nurse on the ward/department/service and the Matron must be notified immediately

In the event that the Matron is not on duty the Site bleep holder or On Call Manager must be notified

The pharmacy department to be notified at the earliest opportunity (i.e. next working day)

The senior nurse, the Matron or the bleep holder/ On Call Manager and clinical risk manager, in conjunction with the pharmacy department will commence an investigation and may make the decision as to whether to notify the police

The Senior Nurse or Matron will annotate the register with „discrepancy noted‟ and sign against the entry, so other administrations can be made and patient care is not compromised

A Safeguard incident report should be completed by the ward/department/service manager on duty at the time of the loss

The Accountable Officer must be made aware of all incidents relating to controlled drug discrepancies.

An entry recording the stock levels should be recorded on the appropriate page of the controlled drugs register and the deficit noted on the record of checking between shifts.

13.19 Schedule 2 and 3 controlled drugs brought into hospital by patients

When a patient is admitted with a prescribed Schedule 2 or 3 controlled drug in his/her possession, the doctor should be informed. Drugs dispensed are the property of the patient to whom they are supplied. The patient may send the controlled drug home in the custody of a responsible adult otherwise the drug must be handed over to the nurse/midwife in charge, stored immediately in the controlled drug cupboard and a record made in the back of the controlled drug register. Only in specific circumstances may these be administered to the patient; when the pharmacy department is closed and the controlled drug is not routinely stocked: In these circumstances:

The controlled drug must be prescribed

The patients own controlled drug must be assessed as appropriate for use. This may be done by using the algorithm for assessing patient‟s own drugs.

The patients own controlled drug must be written in the back of the controlled drug register with sufficient space given to record administration

A record must be made in the register if administered to the patient, if the patient is to take the drug home on discharge or they are to be destroyed

A supply should be obtained from pharmacy as soon as possible

Patients own drugs must not be administered to another patient. It is an offence for an individual to be in possession of a controlled drug unless an appropriate independent or supplementary prescriber has prescribed it. 13.19.1 Controlled drugs brought into hospital on POMMS or admissions units



Patients own controlled drugs can be kept on POMMS wards and may be either administered during the patients inpatient stay if deemed suitable or kept for re-issue on discharge, where appropriate. Nursing staff must ensure that patients own controlled drugs are transferred with the patient from admission wards to a POMMS ward Schedule 2 and 3 controlled drugs must be entered in the back of the controlled drug register as patients own drugs, stored in the controlled drug cupboard and a record made in the register if administered to the patient, if the patient is to take them home on discharge or they are to be destroyed. Controlled drugs must not be sent home with the patient or destroyed without discussion with the ward pharmacist and the patient on POMMS wards.

13.19.2 Unknown Substances Brought into the Hospital by Patients

If a patient is admitted with a drug or substance which is unknown or suspected to be illegal, including a controlled drug which has not been prescribed for the individual, then it must be handed to the nurse/midwife in charge who will describe the drug e.g. “unknown substance” in the nursing/midwifery record and store the substance immediately in a signed container, e.g. envelope, and will place it in the controlled drug cupboard. The Matron, site bleep holder or on- call manager must be informed. At the earliest opportunity, the drug must be handed over to the pharmacist for destruction. If the patient is unwilling to hand the substance over, the nurse/midwife should contact the Matron, site bleep holder or on-call manager. The Police may then be involved. Under no circumstances can the drug be handed back to the patient on discharge as the person doing so would be guilty of an offence of unlawful supply which could result in a custodial sentence.

13.20 Contingency for long term closure or relocation of a ward, department or service

In the event of a long term closure of a ward/department/service (more than 7 days)

the pharmacy department should be notified in good time. Managers of areas that expect to close for less than 7 days should consider the period for which the area will remain unoccupied and carry out a risk assessment to ensure that the stock will be safe and secure for this time.

A physical count of the Schedule 2 and 3 controlled drugs will be made against the

balance recorded in the register by a registered nurse and a second competent registered health professional, or a registered nurse and a pharmacist or pharmacy technician.

The drugs, order book and register will be sealed into a tamper evident container and

returned to pharmacy for safe keeping. On receipt in pharmacy the tamper evident seal will be checked as intact and the

sealed bag locked in the controlled drug cupboard (or room) until the ward/department/service re-opens and the stock is required.

Pharmacy staff should be made aware that the ward/department/service is closed so

no orders can be issued and informed when the decision is made to re-open the ward/department/service.

The stock should then be transferred back to the ward/department/service and counted out of the tamper evident container by a registered nurse and second competent registered health professional, ensuring that the drugs are in date, fit for use and the balance correct.



The list of authorised signatures must be reviewed with a pharmacist and

ward/department/service manager to ensure that signatures are valid and up to date. 13.21 Merging of wards, department or service schedule 2 and 3 controlled drug

stocks

In the event of a ward /department/service merger a decision must be made by the ward/department/service manager(s) as to whether the controlled drugs and controlled drug record books will be transferred. This will depend upon the appropriateness of the stock list and the quantities of stock required.

If a decision is made to transfer and merge the stock then a physical count of the controlled drugs will be made against the balance recorded in the register by a registered nurse and a second competent registered health professional.

The drugs, order book and register will be sealed into a tamper evident container and

transferred to the appropriate ward/department/service.

On receipt at the designated ward/department/service the stock must be counted out of the tamper evident container by a registered nurse and a second competent registered health professional and the stock merged and recorded with the existing stock on the ward/department/service, ensuring that balances are correct.

Controlled drug record books not required must not be used and stored for two years

from date of last entry, unless controlled drug destruction has been recorded in the register. This then will be retained for 7 years from the last entry prior to destruction.

The list of authorised signatures must be reviewed with the pharmacist or technician

and ward/department/service manager to ensure that signatures are valid and up to date and reflect the new location.

Pharmacy staff should be made aware of the merger of the wards/department/service

and the new location.

13.22 Controlled drugs in midwifery

A practising midwife shall not on her own responsibility administer any medicine, including analgesics unless in the course of her training, whether before or after registration as a midwife, she has been thoroughly instructed in its use and is familiar with its dosage and methods of administration or application. In the administration of controlled drugs and other medicines, midwives must comply with the Trust policies and guidelines.

13.22.1 Acquisition of Schedule 2 and 3 controlled drugs by midwives

The Misuse of Drugs Regulations 2001 in conjunction with the Medicines Act allows a registered midwife to possess pethidine, morphine and diamorphine in her own right so far as is necessary for the practice of their profession.

13.22.2 Midwives working in community



Controlled drugs for home delivery will be supplied direct to the mother on a prescription from her appointed local Trust obstetrician and therefore remain the property of the mother.

The policy for Administering Controlled Drugs in Hospital Practice should be followed EXCLUDING:

Witnessing of the checking and administration by a second registered midwife or nurse is not normally possible and therefore the community midwife may carry out the checking and administration alone

A prescription chart will be used: Administration details are recorded in the patient‟s records and the midwife‟s Register of Births

13.22.3 Surrender and Destruction of Schedule 2 and 3 Controlled Drugs by

Midwives

When controlled drugs are obtained by a woman on prescription for use in her home confinement, the responsibility for the surrender or destruction of unused/ unrequired drugs remains with the mother and not the midwife.

In such a situation a midwife should advise the mother to return the drugs to a pharmacy for destruction or explain how to destroy the drugs (and may suggest that she does so in the presence of the midwife). Where this is not possible, the midwife should obtain the patient‟s permission in writing before removing it from the patients home and returning it to a pharmacy for safe disposal on behalf of the mother. Surplus or expired stock held by a midwife may only be destroyed by the midwife in the presence of an authorised witness. Controlled drugs for destruction should be denatured using an approved denaturing kit and sent for incineration. They should not be disposed of in the sewerage system. The midwife could also return the surplus or expired stock to the pharmacy from which it was issued for safe destruction and onward disposal. When a Schedule 2 or 3 controlled drug has been prepared/drawn up but is no longer required and/or no longer usable, it should be denatured/destroyed by the midwife using a CD denaturing kit. Where possible a member of the family should witness this destruction/denaturing and a record made in the midwifes record. The advice given by the midwife and any action taken should be recorded in the mother‟s notes, together with the details of the nature and amounts of drugs involved. Records of controlled drugs returned or destroyed should be made in the midwives controlled drug register. Supervisors of midwives should as part of their duties periodically audit and reconcile the records of controlled drugs kept by each midwife and investigate any discrepancies. Any discrepancies should be communicated to the Trust Accountable Officer for Controlled Drugs.



13.23 Controlled drugs in theatres

13.23.1 Accountability and responsibility The most senior registered nurse or midwife in charge of an operating theatre or theatre suite is responsible for the safe and appropriate management of controlled drugs. Even if the theatre or suite is managed by an operating department practitioner (ODP) the most senior nurse or midwife holds responsibility.

The registered nurse or midwife in charge can delegate control of access, for example:

An ODP can hold the keys to the controlled drugs cupboard on the instruction of the senior registered nurse

Registered practitioners can check controlled drugs prior to operating sessions with another registered practitioner.

ODPs can remove controlled drugs from the controlled drugs cupboards on the specific authority of an anaesthetist or senior registered nurse in charge (or deputy) and convey these to an anaesthetist or registered practitioner

However, responsibility remains with the senior registered nurse in charge. The person to whom the task has been delegated is still professionally accountable for his/her actions. ODPs cannot order controlled drugs. 13.23.2 Controlled drug stock management

The principles remain the same as laid out in section 13. There should be a separate controlled drug register for each theatre but only one controlled drug order book for the theatre suite.

The stock balance of all controlled drugs entered in the controlled drug register must be checked and reconciled with the amounts in the cupboard after each theatre list or handover to ensure that discrepancies can be identified in a timely way. The registered nurse or midwife in charge is responsible for ensuring that stock checks are carried out and recorded.

13.23.3 Prescribing of Schedule 2 and 3 controlled drugs

Prescribing of controlled drugs must follow the general provisions set out in paragraph 13.13. The anaesthetist on duty is usually responsible for prescribing controlled drugs but other prescribers may also be involved. Nurse Independent Prescribers may also be responsible for prescribing or administration of diamorphine and morphine for postoperative pain. Where separate charts are used e.g. epidural charts, anaesthetic charts they should be cross-referenced on the patient‟s main medicines chart.



13.23.4 Administration of Schedule 2 and 3 controlled drugs

The practice of issuing “active stock” to the anaesthetist and then returning the unused portion to stock, recording both issues and returns in the theatre controlled drug register, should be avoided. [See Controlled Drugs in Perioperative Care. January 2006. www.aagbi.org] An amount should be issued to the anaesthetist for a specific patient and any surplus drug should be destroyed and witnessed. E.g. if the patient is prescribed diamorphine 2.5mg and only a 5mg preparation is available, the record should show, “2.5mg given and 2.5mg wasted “ A dedicated theatre controlled drug register must be used.

The controlled drug to be discarded should be rendered irretrievable by emptying small amounts from the ampoule or vial into a CD denaturing kit. The emptied vial or ampoule should then also be placed in the sharps bin.

Injectables should be treated as intended for single use only unless the label specifically indicates that they are licensed and intended for use on more than one occasion or to provide more than a single dose on any one occasion. A record of administration should be made on the appropriate chart immediately after administration by the person who administered the controlled drug. This should include the identity of the person, the dose administered and the time of administration.

13.23.5 Patient-controlled analgesia

There should be a local procedure for all aspects of the management of patient controlled analgesia. This should include:

A description of the controlled drug preparations available and the

medical devices (for example, pumps, syringe drivers) used for administration

Arrangements for requisitioning the appropriate medical devices

Instructions for prescribing and requisitioning the controlled drug preparations (for example, pre-loaded syringes, small volume infusion bags)

Specification of the entries required in the controlled drug register

Arrangements for documentation when the patient is moved from theatre to wards/departments/services

Arrangements for recording administration

Arrangements for disposal of surplus controlled drugs

13.23.6 Disposal of Schedule 2 and 3 controlled drugs in theatres

The disposal of controlled drugs in theatres should conform to the general provisions set out in „disposal of controlled drugs in wards/ departments/services‟. Unused part-doses should be discarded promptly and witnessed by a registered nurse or registered ODP from the authorised signatory list.

http://www.aagbi.org/



The controlled drug to be discarded should be rendered irretrievable by emptying amounts from the ampoule or vial into a CD denaturing kit. The emptied vial, ampoule or syringe should then also be placed in the sharps bin.

13.24 Schedules of Controlled Drugs

Schedule 1 (CD Licence) Whilst virtually all drugs listed in Schedule 1 have no recognised medicinal use, Sativex® (Cannabis Sativa L.Extract) is an unlicensed medicine in the UK and is being used in the treatment of multiple sclerosis. Other Schedule 1 drugs include hallucinogenic drugs such as lysergide (LSD), cannabis, Ecstasy, and mescaline and raw opium. Only certain people licensed by the Home Office may possess Schedule 1 drugs for research or other special purposes. Practitioners and pharmacists may not lawfully produce, supply or possess Schedule 1 drugs except under licence from the home office.

Schedule 2 (CD) Schedule 2 includes more than 100 drugs such as the opiates and the major stimulants, secobarbital and amphetamine.

Schedule 2 CDs (except quinalbarbitone) are subject to safe custody requirements (under the Misuse of Drugs Safe Custody Regulations 1973).They must be stored in a locked receptacle, such as an appropriate CD cabinet or approved safe, which can be opened by the person in lawful possession of the CD or a person authorised by them.

Although Quinalbarbitone is exempt from safe custody requirements it is considered good practice to store with other CDs. A licence is required to import and export drugs in Schedule 2. They may be manufactured or compounded by a licence holder, a practitioner, a pharmacist or a person lawfully conducting a retail pharmacy business acting in their capacity as such.

Supply is restricted to licensed wholesalers, practitioners, hospitals and registered pharmacies. Wholesalers are permitted to supply only to a person authorised to possess. Practitioners are restricted to supplying their patients. Hospitals (in so far as it represents the business of the hospital) may supply patients, wards and practitioners. Pharmacies may supply on receipt of a valid prescription or signed order. Additional prescription writing requirements exist. A pharmacist may only supply Schedule 2 CDs for the purpose of stock in primary care on the authority of a requisition in the required form issued by an appropriate person.

Schedule 2 CDs may be administered to a patient by a doctor or dentist or by any person acting in accordance with the directions of an appropriately qualified prescriber. Nurse independent prescribers are permitted to prescribe, administer or direct anyone to administer some CDs for specific conditions and routes of administration. Full details are given at www.doh.gov.uk/nonmedicalprescribing

A CD register must be kept for Schedule 2 CDs and this must comply with the requirements of the 2001 regulations. The destruction of Schedule 2 CDs stock must only take place in the presence of an appropriately authorised person. Patient returns do not currently have to be witnessed but good practice would deem that another person should witness their destruction.



Schedule 3 (CD No Register) Schedule 3 contains a number of substances that are perceived as being open to abuse, but less likely to be so than schedule 2 CDs. It contains a number of synthetic opioids together with other substances including temazepam.

The majority of Schedule 3 drugs are exempt from safe custody requirements. Exceptions are: Flunitrazepam, Temazepam, Buprenorphine, Diethylpropion, which must be stored in a locked receptacle, such as an appropriate CD cabinet or approved safe, which can be opened by the person in lawful possession of the CD or a person authorised by them.

A pharmacist may only supply Schedule 3 CDs for the purpose of stock on the authority of a requisition in the required form issued by an appropriate person.

Certain prescription requirements apply. There is no legal requirement to record transactions of Schedule 3 CDs in a CD register.

The requirements for destruction do not apply unless the CDs are manufactured by the individual. Schedule 3 drugs are subject to full import and export control.

Schedule 4 (CD Benzodiazepines and CD Anabolic steroids) Schedule 4 is divided into 2 parts

• Part 1 (CD Benzodiazepines) contains most of the benzodiazepines (with the exception of flunitrazepam, midazolam and temazepam which are Schedule 3), plus eight other substances including zolpidem, fencamfamin and mesocarb.

• Part 2 (CD Anabolic steroids) contains most of the anabolic and androgenic steroids such as testosterone, together with clenbuterol (adrenoreceptor stimulant) and growth hormones. (5 polypeptide hormones).

There is no restriction on the possession of a Schedule 4 Part 2 (CD Anabolic steroids) drug when it is in the form of a medicinal product.

Possession of a drug from Schedule 4 Part 1 (CD Benzodiazepines) is an offence without the authority of a prescription in the required form. Possession, by practitioners and Pharmacists acting in their professional capacities, is authorised.

Drugs in Part 1 (CD Benzodiazepines are subject to full import and export control and a Home Office licence is also required for importation and exportation of Part 2 Anabolic Steroids unless the substance is in the form of a medicinal product and is for personal use/administration.

All substances from Schedule 4 are exempt from safe custody requirements and can be stored on the open dispensary shelf.

Supply is restricted to supplies against practitioners‟ prescriptions or in accordance with Patient Group Directions (PGDs) but there are no additional requirements as to the form of prescription other than those that apply to all Prescription Only Medicines (POMs).

CD registers do not need to be kept for Schedule 4 drugs, although records should be kept if such CDs are compounded.



The requirements relating to destruction do not apply to Schedule 4 controlled drugs unless the controlled drugs are manufactured by the individual). An exception to this is for Schedule 4 part 1 controlled drugs which are required to be denatured before disposal unless the waste contractor has a licence to carry Schedule 4 part 1 Controlled Drugs.

Schedule 5 (CD Invoice) Schedule 5 contains preparations of certain CDs e.g. codeine, pholcodine, morphine, which are exempt from full control when present in medicinal products of low strength, as their risk of misuse is reduced. There is no restriction on the import, export, possession, administration or destruction of these preparations and safe custody Regulations do not apply.

Schedule 5 drugs are exempt from safe custody requirements.

Some of the controlled drugs in Schedule 5 are available for over-the-counter sale in registered pharmacies. It is for the pharmacist to use their professional judgement to determine the appropriateness of any supply and be alert to potential misuse of products. The Schedule 5 controlled drugs that are prescription only medicines (including codeine, dextropropoxyphene and dihydrocodeine tablets) can only be supplied in accordance with a valid prescription or Patient Group Direction.

The requirements relating to destruction do not apply to Schedule 5 controlled drugs.

A practitioner or pharmacist acting in his capacity as such, or a person holding an appropriate licence, may manufacture or compound any CD in schedule 5.

Please note: In addition to those controls in place for controlled drugs in CDDFT Temazepam, Phenobarbitone, Ketamine injection 50mg/ml and 100mg/ml, strong potassium chloride solution, potassium acid phosphate and Addiphos injections are also treated the same as schedule 2 controlled drugs in respect to ordering, recording, storage and destruction requirements.

14 PRESCRIBING, SUPPLY AND USE OF UNLICENSED MEDICINES

Under the Medicines Act 1968 all medicinal products should be marketed for sale, or supply with an appropriate Marketing Authorisation (MA). There are a few exemptions. The Marketing Authorisation is intended to guarantee the quality, safety and efficacy of medicinal products and states the indication, dose, route of administration and the age group for whom the drug may be used. To some extent this places liability on the MA holder for adverse effects arising from the use of their product.

Unlicensed medicinal products (often called „specials‟) are unlicensed medicines, which have been specially prepared by the holder of a Manufacturers Specials Licence or imported in response to or in anticipation of the order of a doctor or dentist to meet the special needs of individual patients.

Unlicensed medicinal products are only used when no pharmaceutically equivalent licensed product or suitable alternative licensed product is available for use at the time the patient requires it. Such uses are informed and guided by a respectable and responsible body of professional opinion. Products are considered pharmaceutically equivalent if they contain the



same amount (or concentration) of the same active substance in the same dosage form, and meet the same or comparable standards considered in the light of the clinical needs of the patient at the time of its use.

All unlicensed medicines used by the Trust are supplied by the pharmacy department and in accordance with policy. Unlicensed medication requests forms are available on the pharmacy intranet site

14.1 Exclusions This policy does not cover products used outside their licensed indications (“off-label” use), investigational medicinal products (clinical trials materials), products extemporaneously dispensed within the Trust in response to a prescription, products prepared under section 9, 10 or 11 of the Medicines Act, non-medicines, medical devices, intermediate products, repackaged licensed products, or reconstituted IV additives and CIVAS (central intravenous additive service) products. Products Prepared under Section 10 of the Medicines Act are unlicensed medicines, which have been prepared in a registered pharmacy, hospital or health centre by, or under the supervision of, a pharmacist, in accordance with a prescription given by a practitioner or in anticipation of such a prescription and with a view to dispensing the product. They can be prepared for stock, from which to dispense to named patients in accordance with a prescription, When preparing medicinal products under Section 10, the pharmacist must act in accordance with a prescription given by a practitioner, (unless preparing stock in accordance with the above limitations). This does not necessarily mean that the prescription must be to hand. However, the pharmacist must have means of ensuring that he/she is acting in accordance with a prescription, and appropriate records must be kept to confirm this.

The supervising pharmacist as the supplier of Section 10 items is responsible for preparing the product to meet the prescriber‟s requirements. These products are exempt from the controls described in the policy document. However, all section 10 items procured from outside the Trust must be held on receipt until an authorised pharmacist is satisfied as to their quality and releases them for use.

14.2 Consent of Patients, Carers and Parents

Health professionals must respect the right of patients, carers and parents to participate in discussions regarding the health care of the patient and to seek to ensure that these decisions are properly informed. No additional steps, beyond those taken when prescribing licensed medicines, are required to obtain the consent of patients and parents/carers for the use of unlicensed medicines.

14.3 Informing the Out Patient/Discharged Patient

The patient should receive a generic Patient Information Leaflet. The Patient Information Leaflet should explain why it is necessary to prescribe unlicensed medicines and should be widely available in hospitals and pharmacies which may help to allay any concerns that patients and carers may have about unlicensed medicines.



14.4 Responsibility of Prescribers and Pharmacists

14.4.1 Prescribers

Prescribers of unlicensed products carry their own responsibility and are professionally accountable for their judgement in so doing. Unlicensed medicines can be restricted to only consultant prescribing on the decision of the Drug & Therapeutic Committee. Prescribers are responsible for the patient‟s welfare and in the case of adverse events they may be called upon to justify their actions.

14.4.2 Pharmacists

Pharmacists are responsible for ensuring that prescribers are always aware that a medicine they have requested is only available as an unlicensed product. Pharmacists will share responsibility as the purchaser of the product, particularly where this involves specifying the product to be purchased, or if their actions or omissions have contributed to the harm. Pharmacists are responsible for ensuring that the manufacturer holds the appropriate licence to manufacture and that the product complies with the product specification. In the community, dispensing doctors who order unlicensed medicines from a „Specials‟ manufacturer carry the same responsibility as pharmacists procuring a special. Pharmacists or other pharmacy staff who dispense or supply unlicensed medicines in response to prescriptions are professionally accountable for any harm caused by a defect in the medicine which is attributable to their own actions or omissions. A senior pharmacist is designated as having overall responsibility for controlling the procurement and supply of unlicensed medicines, the “Designated Pharmacist”. However, it is not unusual for several pharmacists to be involved in the decision making process from the Ward/Clinical Pharmacist who receives the request through to the person who signs the order or authorises the invoice. When an unlicensed medicine is to be ordered for the first time there needs to be critical, evidence based evaluation for its use and the designated pharmacist has an important and responsible role in assessing the evidence and challenging use. The pharmacist must also ensure that all the controls specified within this policy are applied including the maintenance of appropriate records of use.

14.4.3 Drugs and Therapeutics Committee The Drug and Therapeutics Committee is responsible for the approval for use of new unlicensed medicines in the Trust. However, in the case of urgent clinical need, the Drug and Therapeutics Committee Chair and/or Professional Secretary may authorise use subject to formal ratification at the next Committee meeting. The Committee approves, monitors and reappraises all unlicensed medicines used within the Trust on a rolling programme. It risk assesses unlicensed medicines and ensures that their use is justified by published evidence or sound therapeutic argument. The Committee also ensures appropriate audit systems are in place to monitor compliance with this policy.

14.4.4 Prescriber Responsibilities for the Care of the Patient This may be the medical consultant or other clinical specialist responsible for the care of the patient: e.g. podiatrist, tissue viability nurse, diabetes practitioner.



Ensures that the use of the unlicensed medicine is justified by the clinical condition of the patient.

Ensures that junior doctors who may initiate treatment are familiar with the status of the medicine and know the protocols that control its use.

Ensures that Trust policy relating to informed patient consent is complied with.

Ensures that records are kept.

Ensures that incidents of patient reactions are recorded and reported via the yellow card scheme and the Trust‟s incident reporting scheme.

Ensures that where responsibility for ongoing care is to be transferred to the patient‟s general practitioner, that the general practitioner is informed of the unlicensed status of the medicine and that he or she is willing to accept clinical and legal responsibility for prescribing.

The hospital doctor is responsible for continuing treatment if the GP will not accept responsibility for continuing care.

Subject to risk assessment, communicate with patients the implications of using the unlicensed medicine.

14.4.5. Pharmacy Staff

Trust Designated Pharmacist

Ensures that written procedures to cover all aspects of the procurement and issue of unlicensed medicines are produced, authorised, and reviewed.

Ensures that arrangements are in place to ensure that Prescribers are aware of the unlicensed status and accept the responsibility for the use of each unlicensed medicine.

Ensures that arrangements are in place to make sure that unlicensed medicines are used only when an equivalent licensed product is unavailable.

Monitors and audits the handling of unlicensed medicines in the Pharmacy Department.

Monitors the range and quantities of unlicensed medicines purchased, keeping a list of unlicensed medicines currently approved by the Trust.

Reports to the Drug and Therapeutics Committee the use of unlicensed medicines in the Trust

Communicates with the MHRA and the prescriber to process any reports of adverse reaction.

Prepares specifications for unlicensed medicines in conjunction with Quality Control Northern Region.

Ensures that submissions are made to the Drug and Therapeutics Committee for approval to use unlicensed medicines that have not previously been used in the Trust.

Authorises for use new products that are needed for urgent clinical use before they can be formally assessed and approved by the Drug and Therapeutic Committee.

Quarantines all unlicensed medicines from non-NHS suppliers on receipt within the Trust until the following assessment is carried out.

On receipt of unlicensed medicines from non-NHS suppliers, ensures that their packaging and labelling are inspected, Certificates of Analysis are assessed. If necessary arranges testing of samples with Quality Control.

Releases all batches of unlicensed medicines for use within the Trust.

Procurement Function



Pharmacy staff involved in procurement of unlicensed medicines: -

Ensure that the person making the request is authorised to do so.

Ensure that purchases of unlicensed medicines are in accordance with written procedures, and that the Designated Pharmacist is aware of the purchase.

Obtain advice from Quality Control as required.

Liaise with the supplier as appropriate.

Ensure any special requirements of suppliers are met.

Process deliveries in accordance with procedure.

Confirm the original approved use when reordering.

Ensure correct storage arrangements.

Clinical Function

The clinical pharmacist, in conjunction with the Trust Designated Pharmacist:

Ensures that the use of an unlicensed medicine is justified by the clinical circumstances.

In conjunction with the Designated Pharmacist ensures that the use of an unlicensed medicine is justified by published evidence or sound therapeutic argument.

Ensures that no licensed alternative product is available.

Ensures that the prescriber is made fully aware of the clinical and legal implications of using the selected medicine.

Ensures that the Designated Pharmacist is fully briefed on the pharmaceutical requirements of the product.

Dispensing/Supply Function

Pharmacy staff involved in the dispensing of unlicensed medicines: -

Ensure that requests for unlicensed medicines are processed in accordance with Trust procedures.

Where appropriate, communicate with patients the implications of using the unlicensed medicine.

If appropriate, make arrangements for patients to have continuing supplies of treatment.

14.5 Prescriber Request and Risk Assessment Form

The prescriber completes the form, in conjunction with the Trust Designated Pharmacist and submits it to the Drug and Therapeutics Committee for approval each time a new unlicensed drug is requested.

However, in the case of urgent clinical need, the consultant, chairman of the Drug

and Therapeutics Committee and Trust Designated Pharmacist may authorise use subject to formal ratification at the next D & T Committee meeting.

The Drug and Therapeutics Committee will ensure that the completed documentation is retained appropriately.

14.6 Evaluation of Unlicensed Medicines

A list is maintained by the Trust Designated Pharmacist detailing the current usage of unlicensed medicines and is reviewed over a five-year cycle and re-approved using the current documentation. The review includes a re-assessment of the



original clinical data, any new clinical data and newly licensed products that may be appropriate.

The Drug and Therapeutics Committee monitors the review process and approves the continued use of the product. 14.6.1 Risk Assessment

The form is completed by the prescriber in conjunction with the clinical pharmacist and the Trust Designated Pharmacist, and submitted to the Drug and Therapeutics Committee as part of the submission for approval to use the product.

The exact product details are clearly identified.

Consideration is given to the clinical reasons for using an unlicensed product in preference to a similar UK licensed one. The risk assessment identifies clear clinical evidence in support of the product use. Reference sources are quoted.

Contraindications, side effects, precautions and the potential for harm are identified and accurately assessed in relation to the clinical condition.

14.6.2 Procurement Risk Assessment

The country of origin is determined. For countries outside the EU or for those without a mutual recognition agreement, Quality Control Northern Region is contacted for advice.

The language used on the packaging is determined along with details of who will supply the translation of the patient information leaflet and label.

An assessment of the supply chain is carried out, and the ease at which further supplies can be obtained. The cost of the drug and any special funding needs are determined. Responsibility for continued supply is identified.

The assessment process should take into account any issues raised by Quality Control Northern Region.

14.6.3 Approval Process

The Drug and Therapeutics Committee approves the use of all unlicensed medicines new to the Trust. This can be a retrospective process in the case of urgent clinical need.

When considering a request to approve an unlicensed medicine, the Committee must be certain that there is no suitable licensed alternative product available. It reviews the supporting clinical data and takes a view on the likelihood of supply chain difficulties, the possibility of interruptions to patient treatment, and any consequences.

The Committee has a monitoring role and reappraises all specials used within the Trust on a rolling programme.

14.7 Procurement, Receipt, Quality Assurance and Storage Arrangements



14.7.1 Procurement

Orders for unlicensed medicines from non-NHS suppliers must include a request for a Certificate of Analysis. Unlicensed medicines may be obtained:

From the holder of a Manufacturer‟s Specials Licence, either a commercial company or an NHS hospital

By importation from the holder of a Wholesale Dealer‟s Licence (for importing from member states of the European Economic Area) or a Wholesale Dealer‟s Import Licence (for importing from outside the European Economic Area)

Guidance on the supply of unlicensed relevant medicinal products and the legislative background can be found in national documents.

Procurement of unlicensed medicines is carried out in line with Regional Guidance.

Products will be purchased, wherever possible, from manufacturers who hold an appropriate licence.

The Trust Designated Pharmacist ensures that unlicensed medicines are identified as such on receipt and that they are held until released for use.

14.7.2 Receipt

Upon receipt, the unlicensed medicine and associated documentation is formally checked, and any testing deemed necessary carried out, before it is released for use by the designated pharmacist.

14.7.3 Quality Assurance

The designated pharmacist liaises closely with contacts at Quality Control Northern Region (QCNR) in:

sending samples of high risk products to Quality Control North West for testing where appropriate.

discussing with QCNR any deficiencies in supplied Certificates of Analysis.

discussing with QCNR the information available from manufacturers on the purchasing specifications

checking for the availability of a purchasing specification.

14.7.4 Storage

Unlicensed Medicines are allocated specific area(s) within the Pharmacy store which are clearly designated to staff as the unlicensed medicines storage area(s).

Dependent upon which computer stores systems are in use, unlicensed medicines may be allocated bin numbers relevant to product type (or class) and information/codes/PILs linked to each product.

14.8 Record Keeping

14.8.1 Receipt Records

On receipt of unlicensed medicines into the pharmacy, the following record is available as a delivery note.



Product Description

Order No

Date received

Quantity received

Approval for use/Date approved

Supplier Name

Batch No.

Expiry date

Confirmation of receipt of Certificate of Analysis

The records show the source of supply and batch number of each unlicensed medicine in use in the Trust at any point in time. Records should be kept for 5 years.

14.8.2 Issue Records

Records of issue of unlicensed medicines to patients or to ward/clinical area stock are made in the pharmacy computer system. These records include:-

The person or ward/clinical area supplied, and the date on which supply was made

The quantity of each supply

Also, records of details of any suspected adverse reaction to the product supplied must be kept.

14.9 Adverse Drug Reactions and Defective Products

Adverse drug reactions and defective products are handled and reported in the same way as licensed medicines.

15 ADMINISTRATION OF DRUGS THROUGH ENTERAL FEEDING TUBES

Crushing medication or opening a capsule to aid administration results is unlicensed administration.

It is recommended that unlicensed administration methods are authorised by the prescriber and documented in writing.

15.1 Unlicensed Administration

Although nurses, midwives and health visitors are advised not to crush medication there will be occasions where the patient is unable to swallow solid oral dosage forms, or medication is required to be administered via enteral tube.

In many cases an alternative route of administration or suitable liquid formulation is available and should be used in the first instance, although the administration of a liquid formulation via enteral feeding tube may also be unlicensed.

If alternative formulations or methods of administration are unavailable and the medication is still indicated then it may be necessary to crush tablets or open capsules. The practitioner involved should bring this to the attention of the prescriber (and the pharmacist).

Authorisation for this unlicensed administration together with the reasons why must be documented in the patient’s medical record by the prescriber.



Crushing medication or opening capsules prior to administration usually results in unlicensed administration. Under the Medicines Act 1968 only Medical and Dental practitioners can authorise the administration of unlicensed medicines. It may therefore be illegal to open a capsule or crush a tablet before administration without the authorisation of the prescriber.

Where such administration results in harm to the patient then the manufacturer has no liability for any harm that ensues and if the unlicensed administration is unauthorised by the prescribing doctor then liability may lie solely with the administering nurse.

Where unlicensed administration is authorised by a prescriber then the liability is shared between the prescriber and the administering nurse. If this is on the advice of a pharmacist then the liability is shared between all three professionals. The balance of this liability would be assessed in a court of law on an individual case basis.

In practice providing the prescriber has authorised the administration and advice has been taken from a pharmacist regarding the suitability of a preparation for unlicensed administration then the nurse would usually be seen as having acted in an appropriate and professional manner. Providing these steps have been taken any adverse effects resulting from the unlicensed administration are unlikely to occur.

It should be borne in mind that often it is in the best interests of the patient to administer the drug even if this is in an unlicensed manner providing every effort has been taken to determine that the method of administration is safe and effective. The consequences of not giving the medication should also be borne in mind.

Nursing staff should take reasonable steps to ensure that unlicensed administration does not cause harm to the patient even if this is at the request of a prescriber.

Advice from a pharmacist or referral to these guidelines should be the absolute minimum action undertaken. Within the acute Trust pharmacy advice is available 24 hours a day via the on call pharmacist.

Any adverse effects, including problems with feeding tubes, should be reported to the prescriber and pharmacist immediately.

15.2 General Principles

When administering medication via enteral tube consideration needs to be taken regarding drug formulation, interactions with feed, type of tube, site of placement, and site of drug absorption. Usually drugs are not licensed for enteral administration and there is little information available in the literature on any aspects of enteral drug administration. Most recommendations are therefore theoretical. 15.2.1 Choice of route

Where a drug is needed but the oral route is unavailable or available by tube only, consideration should be given to alternative methods of administration. Intravenous administration is often an option but requires trained staff to administer, is associated with increased risk to the patient from complications and is usually more expensive. Other routes for consideration include transdermal, rectal, buccal or sublingual, nebulisation, vaginal, as well as alternative parenteral routes – im, iv, sc.



The Need for Medication Should be Reviewed Before Searching for an alternative Route

In patients who are very unwell previous medication may no longer be necessary both in the short and long term and prescribed items should be reviewed and stopped if no longer indicated or of benefit to the patient. Patients undergoing surgery who are nil by mouth can often have medication discontinued temporarily without harm. Sometimes an alternative preparation from the same or even a different therapeutic group may be more suitable Where drugs need to be continued and no other route is available then enteral administration may need to be considered.

Pharmacists should identify patients receiving medication via the enteral route and be proactive in reviewing their medication and in advising nursing staff/medical staff to facilitate drug administration. Equally nursing staff should request pharmacy advice in patients where drug administration via the enteral route is deemed necessary and refer to current policies and guidelines where available.

Staff are reminded that health care professionals other than doctors or dentists cannot authorise unlicensed administration and the consent of the prescriber must be obtained.

15.2.2 Potential Problems

May include: unavailability of suitable formulation, blocking of tubes, diarrhoea due to hyperosmolar formulation and drug interactions (between different drugs, between drug and feeds, between drug and tube).

Tube types Fine bore tubes are unsuitable for some thick liquid formulations e.g. lansoprazole suspension sachets, cholestyramine. Granules may also block fine bore tubes

Tube Placement There are more likely to be problems with drug absorption where the tube is placed beyond the stomach e.g. percutaneous endoscopic jejunostomy (PEJ) tubes. Staff should be aware that the drug may be administered beyond its main site of absorption. It is important to monitor for signs of reduced drug efficacy. Therapeutic drug monitoring may be necessary. When a tube is placed beyond the stomach sterile water must be used for flushing and drug administration.

15.3 Formulations

15.3.1 Liquid Formulations

Drugs for administration via enteral feeding tubes should ideally be liquids or dispersible/soluble formulations. Not all drugs are commercially available as liquids but pharmacy may be able to organise certain liquid preparations on request if feeding is likely to be long term. In addition to proprietary products listed in the BNF liquid medicines may also be available as a 'special' from other hospitals or manufacturers, although this may not always be the most appropriate or cost effective method for long-term use especially where patients are to be transferred to primary care.

When transferring a patient to a liquid formulation the use of a different salt may require dosage adjustment due to differing bioavailabilities e.g. phenytoin, mebeverine, and chlormethiazole. Liquid formulations of high osmolality particularly those containing sorbitol can be associated with osmotic diarrhoea, bloating, stomach cramps, and delayed gastric emptying. This is more likely to be a problem when a lot of medicines are given as liquid formulations in high volumes. Many liquids have an osmolality as high as



1000 mOsm/kg compared with the normal osmolality of GI secretions which is 100-400 mOsm/kg. This is not usually a problem where small volumes are administered e.g. digoxin elixir, but may be avoided by dilution with water immediately prior to administration. The sorbitol content of most liquid medicines is not readily available but can be obtained where necessary from individual manufacturers. Cumulative sorbitol doses above 20g may cause particularly severe adverse effects. Administration of hyperosmolar solutions may be particularly problematical when administered through a jejunostomy tube.

Generally elixirs or suspensions should be used rather than syrups. Syrups because of their low pH are prone to clumping in contact with GI feeds. Where a liquid preparation is unavailable or unsuitable soluble or dispersible tablets may be available. Often tablets not specifically marketed as dispersible will disperse in water. Again advice should be sought from pharmacy.

15.3.2 Solid Dosage Forms – Tablets and Capsules

Sometimes it may be necessary to crush tablets or open capsules prior to flushing down enteral tubes. Not all solid dosage forms are suitable for crushing. Generally plain uncoated tablets will either disperse in water or can be crushed to a fine powder for dispersal in water. Film coated or sugar coated tablets can often be crushed . Advice should be sought from pharmacy.

THE FOLLOWING FORMULATIONS SHOULD NOT BE ADMINISTERED THROUGH ENTERAL FEEDING TUBES WITHOUT PHARMACY ADVICE

Enteric or other coated tablets-

Enteric coatings are designed to protect drugs from attack by stomach acid or to protect the stomach from irritation by the drug. Beyond the stomach the coating breaks down to allow drug absorption. Enteric-coated tablets should not be crushed as this destroys the coating resulting in inactivation of drug or increased risk of adverse effect

Controlled, slow, or extended release products-

These products are formulated to allow a gradual release of drug as the preparation passes down the GI tract. This may enable less frequent dosing or minimise side effects due to peak concentrations of drug in the body. Crushing controlled release formulations may destroy their controlled release properties resulting in adverse effects and shortening duration of action

Deaths have been reported as a result of crushing controlled release morphine preparations. These types of preparation must never be crushed

Some controlled release products are formulated as granules inside a capsule. Similarly these granules must not be crushed but may be suitable for administration via enteral tube

Buccal/ Sublingual tablets should not be crushed and administered via an enteral tube as this can result in reduced effectiveness due to increased first pass metabolism in the liver

Hard gelatin capsules may often be opened and the contents mixed with water prior to tube administration. Some capsules contain enteric-coated granules e.g. lansoprazole, or granules with a slow release coating e.g. Slophylline and should not be crushed prior to administration. The administration of such granules intact may block fine bore tubes



Doxycycline capsules contain an irritant salt and should not be opened to facilitate administration. Dispersible tablets should be used instead

15.3.3 Injections

Occasionally parenteral formulations may be given orally e.g. vancomycin injection but this is usually an expensive option and not all injectable formulations are suitable for this route. e.g. gentamcin is not absorbed, amiodarone injection is not suitable because of its high polyethylene glycol content. Advice should be sought from pharmacy.

15.3.4 Cytotoxics Advice must be sought from pharmacy regarding the administration of cytotoxic drugs via enteral tube. The document „Policy on the safe administration of Cytotoxic Drugs‟ should also be referred to.

15.4 Practical Aspects of Administration

15.4.1 Oral Syringes

PURPLE oral syringes should be used to draw up and administer medicines. Fatalities have been reported when medicines intended for oral administration have accidentally been given intravenously because they were drawn up in IV syringes. Ideally oral syringes should be incapable of attachment to IV lines or needles by virtue of their design.

Medications should not be added directly to nutrition formulations.

Liquid dosage forms should be used where available (Check with pharmacy re liquid availability.) Most liquid formulations should be diluted with 30ml sterile water to reduce their osmolality prior to administration. Some liquid medicines however should not be diluted. Please refer to pharmacy. If tablets must be used the nurse should first check to see whether the tablet can be crushed. If so the tablet should be crushed into a fine powder and mixed with 10 to 15ml of water. Generally sustained release or enteric-coated medication should not be crushed. If in doubt advice should be sought from pharmacy. If capsules can be opened then they should be opened and the powder mixed with 10 to 15ml of sterile water. The tube should be flushed with 15 - 30ml of sterile water prior to administration of the drug. The medication should be remixed immediately prior to administration by swirling the medication in the cup. In the case of liquid formulations these should be shaken prior to withdrawal from the bottle. The medication should be drawn up into a needle less oral or catheter tipped syringe. When more than one medication is administered then the tube should be flushed between drugs to avoid drug interactions. Medications should never be mixed together in a syringe.



After administration the tube should be flushed with 15-30ml of sterile water. The amount of water used should be documented on fluid balance sheets. Holding enteral nutrition in order to administer medications may become problematic. For products that require enteral nutrition to be held for one hour before and one or two hours after drug administration then the following procedure should be adopted:- 1) If enteral nutrition is administered in bolus doses then the drug should be

scheduled during the off periods. 2) If enteral nutrition is administered continuously and the drug is available in an

alternative dosage form (e.g. suppository, injection) the oral dosage form should be switched to a therapeutically equivalent dosage form and the patient‟s clinical response to therapy monitored.

3) If enteral nutrition is administered continuously and the drug is not available in an alternative dosage form, or can be given via an alternative route, enteral nutrition should be withheld for 1 hour before and 1 hour after drug administration. Drug levels should be monitored where appropriate and the patient‟s clinical response to therapy monitored.

If it is not feasible to hold enteral feeding then it may be necessary to adjust the dose administered. Advice can be obtained from pharmacy. Clinical response and/or drug serum levels should be monitored where appropriate.

Where there is doubt about compatibility further information should be obtained from pharmacy.

15.5 Administration of Drugs via Jejunostomy Tube

There are no drugs licensed for intrajejunal administration in the UK and little data on absorpion of drugs via this route. Other routes or alternative methods of treatment should therefore be sought wherever possible. Clinical response and drug levels should be monitored as a guide to treatment success.

The normal secretions in the jejunum has an osmolality of 28510 mOsm/kg. When a hypertonic solution is rapidly infused via a jejunostomy tube there is an influx of water and electrolytes into the small intestine leading to an osmotic diarrhoea. Many liquid drug formulations have osmolalities exceeding 1000 mOsm/kg particularly those sugar free preparations containing sorbitol. In circumstances where this is likely to be a problem the following may be considered: 1) Sterile water should be used to flush jejunostomy tubes and disperse tablets 2) Dispersible tablets or finely crushed tablets dispersed in water may be an

alternative to liquid formulations; contact pharmacy for advise. 3) If the parenteral form is isotonic or hypotonic this may be used as an alternative

to liquid formulations. Check with pharmacy re suitability. Not all injections can be given in this manner.

4) Only where a drug has been shown to be compatible with enteral feed may a liquid preparation be mixed with feeding solution to reduce osmolality. In practice there is little data regarding compatibility with feeds and most feed manufacturers do not recommend this.


POL/MM/0001 Version 4.2 DRAFT 105 of 125

DECISION TREE ON USE OF NG/PEG ROUTE Is the drug prescribed via the NG/PEG route?

May wish to consider

alternative routes of administration, e.g. topical, buccal, transdermal, rectal

Is there a commercially available liquid preparation? (check BNF)

Is the drug available in tablet form?

Is there a commercially available soluble/dispersible tablet?

Can the tablet be dispersed?

Can the tablet be crushed? Seek pharmacy advice.

Is the drug available in capsule form?

Is the sorbitol content and osmolality of the liquid suitable for NG/PEG admin- iteration and are there no known interactions/incompatibilities with feed?

Use liquid

Is it a hard gelatin capsule that can be opened?

Can the capsule contents be flushed down the tube with water? Contact pharmacy for advice.

Contact pharmacy for advice

Can the pharmacy obtain a solution/suspension?

Can the injection be used?

CONSIDER ALTERNATIVE DRUG OR CONTACT PHARMACY FOR ADVICE

If not appropriate

No

Yes

Yes

Yes

No

No

No

No

No

Yes No

No

No

No

Yes

No

No

Remember to confirm unlicensed administration with prescriber

Yes


POL/MM/0001 Version 4.2 DRAFT 106 of 125

16 THEATRES All parts of the policy apply to theatres but with the following additional requirement and/or exceptions.

Where Registered Practitioner is stated, this includes Registered Operating Department Practitioners (ODP) and Registered Nurses (RN).

16.1 Registered Practitioners and Drug Administration

A registered practitioner who has completed appropriate training (which includes the administration of oral, rectal, subcutaneous and intramuscular drugs), can administer medicines via these routes in the presence of another registered practitioner or anaesthetist.

Newly qualified registered practitioners working in theatre and anaesthetic areas must undergo a period of practice supervised by an experienced registered practitioner during their preceptorship period to demonstrate their competence in administering medicines.

Registered practitioners must not administer drugs via the intravenous route (through an established cannula or line) until they are assessed as fully competent to administer drugs via all other routes and have completed the in house training package in IV drug administration. A period of supervised practice will also be required during which the registered practitioner will be assessed for competence in the administration of IV drugs. All drug administration should be in the presence of a registered practitioner who is qualified to give IV drugs or an anaesthetist.

The prescribing doctor or registered practitioner must check all drugs prior to administration.

16.2 Preparation of Drugs by Registered Practitioners

Registered practitioners may only prepare drugs on the direct verbal or written instructions of a medical practitioner and when the anaesthetist or surgeon is present in theatre. Controlled drugs may only be prepared against written orders.

An anaesthetist or another registered practitioner must check all prepared drugs. The anaesthetist or prescribing doctor must clarify any uncertainties. All syringes must be correctly labelled (but not pre-labelled in advance of being drawn up).

Registered practitioners can dilute agents in the presence of and checked by a registered practitioner or medical practitioner. The bottles/syringes must be labelled detailing the name of the drug, diluent and concentration, the date and signatures of the practitioner and checker concerned.

Registered practitioners can add drugs to an infusion only in the presence of and checked by a registered practitioner or medical practitioner. The bottles/bags must be labelled, dated and detail the drug, diluent and concentration. The practitioner and checker must sign the product.

16.3 Controlled Drugs and ODPs

An ODP can hold the keys to the controlled drugs cupboard on the instruction of the senior registered nurse.

Registered practitioners can check controlled drugs prior to operation sessions with another registered practitioner.



ODP‟s can remove controlled drugs from the controlled drugs cupboards on the specific authority of an anaesthetist or senior registered nurse in charge (or deputy) and convey these to an anaesthetist or registered practitioner.

ODP‟s must not order controlled drugs. 16.4 Controlled Drugs in Theatres This should be read in conjunction with Section 13 on controlled drugs

A check of stock balance against registers should be undertaken twice in every 24 hours by two registered practitioners. These checks should occur before the start and at the end of the full days operating session.

Any discrepancy must be reported immediately to the senior registered Nurse in charge on duty or deputy who will investigate the discrepancy. If the discrepancy cannot be satisfactorily resolved it must be reported to the directorate manager, the appropriate documentation completed and further investigation carried out according to policy.

16.5 Custody and Safe Keeping of Keys

The keys for all departmental medicines, controlled drug cupboards and drug refrigerators are stored in a locked key cupboard. The key cupboard key must remain at all times with the senior registered nurse in charge of the department or most senor nurse in the department.

Access to the key and drug cupboards can be delegated to another registered practitioner provided the most senior nurse is responsible for all supplies made from the controlled drug cupboards.



17 CLINICAL TRIALS

In the management and operation of clinical trials the achievement of Good Clinical Practice (GCP) is necessary and relies upon co-operation between disciplines, including pharmacy. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. These standards are defined in “Good clinical practice for trials on medical products in the European Community.”

17.1 Guidance for Discussions Regarding New Clinical Trials

In the management and operation of clinical trials the achievement of Good Clinical Practice (GCP) is necessary and relies upon co-operation between disciplines, including pharmacy. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. These standards are defined in “Good clinical practice for trials on medical products in the European Community.”

On the 1 May 2004 the Medicines for Human Use (Clinical Trials) Regulations 2004 came into force. These brought into UK law the provisions of the EC Directive 2001.20.ED.

This section includes these guidelines and standards with the aim of providing all staff with clear guidance as to their duties and responsibilities when dealing with all aspects of clinical trials

17.2 Designation of Responsibility

One pharmacist should be designated the “Clinical Trials Pharmacist” to take special responsibility for clinical trials at each site. This pharmacist or another designated by him/her should be involved in discussions of a proposed new trial as early as possible and should be able to advise on many aspects of trial design, management, operation and documentation.

17.3 Regulatory Status and the Ethics Review

The clinical trials pharmacist should establish the regulatory status of the drug(s) being studied and confirm whether the necessary exemption and/or certificate has been applied for and received prior to the start of the trial. It should be remembered that an appropriate clinical trial certificate or clinical trial exemption certificate is required when a licensed medicine is involved and used outside the terms of its product licence.

It would be advantageous for the pharmacist or another senior pharmacist/pharmacy manager to be a member of the local research ethics committee (LREC). This would ensure that pharmaceutical aspects of the trials would be considered at the early stages and that a contribution could be made with respect to the trial protocol. Presently a senior pharmacy manager attends the LREC meetings and the minutes are available in the pharmacy department.

The pharmacist must be aware of and declare any possible conflict of interest between his/her role on the ethics committee and involvement with the design and conduct of a trial.

Prior to the commencement of a clinical trial the pharmacist should ensure that it has been approved by the Local Research Ethics Committee and that pharmacy is in receipt of a letter of approval from the Trust



17.4 Supply Procedures

All clinical trial drug supplies should be ordered, stored and dispensed by the hospital pharmacy in accordance with the requirements of “Good clinical practice for trials on medical products in the European Community” and the Department of Health‟s guidelines on the safe and secure handling of medicines.

Clinical trial medication must be delivered to the pharmacy department and should be addressed to a named individual (the clinical trials pharmacist or delegated person). The trial medication received should be checked against the paperwork and receipt should be acknowledged in writing.

The trial drugs should be stored in a designated location separate from other medication. The storage requirements for the medication should be met as laid down in the trial protocol (ie consideration should be given to quantity, temperature of storage, protection from light requirements etc).

Clinical trial medication should only be dispensed against a formal clinical trial prescription that carries the title of the study.

In certain circumstances clinical trial medication will not be received, stored and dispensed by the pharmacy department as stated in the Duthie report. For some trials, usually large national studies, the medicines must be available immediately and outside of normal working hours. However, this is the exception to the rule and may only be permitted following agreement by the clinical trials pharmacist who should ensure that the supply, storage and dispensing arrangements are acceptable.

Prior to the start of a new trial consideration should be given to the arrangements for continuation of drug supply if treatment may continue after cessation of the trial.

17.5 Stock Accountability

The clinical trials pharmacist is responsible for stock accountability and for ensuring that dispensary staff keep accurate dispensing records of all clinical trial medication. All returned trial medication must be counted and recorded and be dealt with according to the trial protocol. This also applies to any unused supplies of trial medication. This may involve returning the medication to the supplying company or destroying the supplies locally in accordance with the supplier‟s instructions.

Clinical trial prescriptions are usually filed with the dispensing records for the trial and once a trial is complete all records and prescriptions are kept for 15 years.

17.6 Access to Protocols, Randomisation Lists and other Information

The clinical trials pharmacist must ensure that up-to-date copies of the full trial protocols are readily available to the pharmacy staff involved with clinical trials. As the pharmacist has an important role to play in supporting patients through counselling then it is important that pharmacy staff have access to all relevant information. The clinical trials pharmacist



should hold, where appropriate, a copy of the randomisation code whether or not randomisation is his/her responsibility. The pharmacist should ensure that arrangements are in place so that the code can be broken after discussion with the principal investigator or authorised deputy should the need arise.

The clinical trials pharmacist, to achieve the above, has produced an information file for dispensary staff which provides the location of trial medicines, protocols and code breaks for all existing trials. The clinical trials pharmacist is responsible for keeping this file up to date. This information file will assist the on-call pharmacist who may be called upon to locate the randomisation codes and break the code in an emergency.

17.7 Conduct of Trials

The pharmacist may be involved with monitoring of adherence to inclusion/exclusion criteria of pharmaceutical relevance, such as previous or concurrent drug treatment.

17.7.1 Reimbursement of Pharmacy Costs

For commercially sponsored clinical trials the pharmacy department should enter into a signed agreement relating to the reimbursement of pharmacy costs. The clinical trials pharmacist must clearly justify the costs, however, if a clinical trials service is to be provided then it is important that realistic funding be provided.

There have, in the past, been large variations in charges being made by hospital pharmacies doing the same clinical trial and so it seems sensible when negotiating reimbursement to be aware of the criteria used by neighbouring hospitals for determining fees. Guidelines for the reimbursement of pharmacy costs have been prepared for this Trust taking into consideration costings used by local hospital pharmacies.

17.7.2 Prescription Charges

Prescription charges may apply to clinical trial supplies in accordance with DHSS letter DS21/75.

Whether the patient is liable for prescription charges or not does not depend on whether or not the study drug(s) are supplied to the investigator free of charge. If the trial is comparative and involves a placebo then payment of prescription charges by outpatients is not required.

In all other cases patients are liable for prescription charges in the normal way. If however for the purposes of the trial a greater number of items is prescribed than would otherwise be needed then the patient should not have to pay an abnormally high number of charges. The Department of Health will therefore regard a batch of drugs as one item. Where doubt exists the deciding factor should be whether the drugs supplied are for the purpose of the trial subject‟s treatment.

Prior to a clinical trial commencing the pharmacist should discuss with the investigator/sponsor any proposed arrangements to recover the charge from the sponsor or the investigator‟s research funds.



18 STRONG POTASSIUM CHLORIDE CONCENTRATE AND POTASSIUM ACID PHOSPHATE INJECTION

Several critical incidents that have occurred nationally with strong potassium chloride concentrate demonstrate the need for a clear management policy for this high-risk agent. .

Due to the level of risk associated with potassium chloride injection, ampoules of strong potassium chloride will NOT be issued to, or kept as a stock item on general wards/departments/services where reconstitution and/or administration of medicines takes place.

In clinical areas where doses of potassium chloride are routinely utilised under specialist advice and monitoring (e.g. Intensive Care Unit, Coronary Care Unit, Neonatal Unit) potassium chloride concentrate will still be available. In those areas potassium chloride concentrate and potassium acid phosphate injection must be stored in the ward/department/service controlled drugs cupboard away from common diluting solutions such as sodium chloride solution. Procedures for the order, supply, receipt, and administration of potassium chloride concentrate and potassium acid phosphate are the same as for controlled drugs.

Potassium chloride concentrate or potassium acid phosphate injection must not be transferred between clinical areas. All supplies should be made directly from the pharmacy department. In exceptional circumstances a supply of potassium chloride concentrate sufficient for the preparation of a single infusion may be made from another clinical area holding stock, only after authorisation by the on-call pharmacist.

Medical staff should prescribe from the range of pre-mixed potassium containing intravenous fluids available (using licensed products whenever possible). Potassium chloride ampoules must not be used to prepare intravenous fluids when pre mixed bags are available.

Prescriptions for potassium chloride/acid phosphate infusions must state clearly the dose and infusion fluid required as well as all other requirements stated within the Prescribing Process.

A second practitioner must check for correct product, dosage, dilution, mixing, and labelling during the preparation of, and again prior to the intravenous administration of, solutions prepared from potassium chloride concentrate or potassium acid phosphate.

Drug Alert no 3 regarding strong potassium solutions is available on the pharmacy intranet.



19 GUIDELINES FOR NEW DRUG APPLICATIONS 19.1 Use of New Medicines within the Trust

19.1.1 Addition of a Licensed or Unlicensed Medicine

Consultants wishing to apply for a new drug must gain approval from the Drug & Therapeutics Committee.

Consultants must complete a new product application form (available from pharmacy or via the pharmacy intranet site and the relevant Care Group Clinical Director, Associate Chief Operating Officer and Accountant must countersign the form. An application form for an unlicensed medicine (or a licensed medicine to be used „off licence‟) must be accompanied by the relevant form(s).

19.1.2 Use of an Approved Medicine for a New Licensed Indication

Consultants wishing to use an approved medicine for an indication that did not form part of the original application will have to reapply through the Drug & Therapeutics Committee for the new indication to be added. A new product application form will have to be completed for the new indication(s).

19.1.3 Use of a New Form of an Approved Drug

When a new form of a previously approved drug is requested (e.g. if a new strength or a modified release preparation is launched) the Trust Chief Pharmacist (or deputy) can approve the use of the new form without referring to the Drug & Therapeutics Committee except if the new form is associated with a new indication.

If the Trust Chief Pharmacist (or deputy) does not feel that the new product should be automatically approved it may be referred to the Drug & Therapeutics Committee for approval and in this instance a new product application would have to be completed.

19.1.4 Use of a Medicine for an Individual Patient on compassionate

grounds

Licensed Medicine The Trust recognises that there are instances when consultants may wish to use a licensed medicine that is not on the formulary for a single patient on compassionate grounds. In these instances, the consultant should contact the Trust Chief Pharmacist (or deputy) before initiating discussion with the patient.

Unlicensed Medicine: The Trust recognises that there are instances when consultants may wish to use an unlicensed medicine (or a licensed medicine „off-license‟) for a single patient on compassionate grounds. In these instances, the consultant should contact the Trust Chief Pharmacist (or deputy) before initiating discussion with the patient and complete the relevant form(s), as detailed in the Trust‟s policy on the use of unlicensed medicines, and return it to the Trust Chief Pharmacist.

The Trust Chief Pharmacist (or deputy) will use their professional judgment in deciding whether to approve the use of the medicine. He/she may choose to seek advice from colleagues, the Research & Development Committee or the Drug & Therapeutics Committee.



A decision will be made within one week of receiving the request. If the Trust Chief Pharmacist receives more than three requests for the same medicine in a 12 month period, the use of the medicine within the Trust will automatically be referred to the Drug and Therapeutics Committee and a new product application will have to be completed

19.1.5 Use of a Medicine for an Evaluation Study

Licensed Medicine: Consultants may wish to use a licensed medicine, prior to submission of a new drug application to the Drug and Therapeutics Committee, as part of an evaluation study.

In all cases, irrespective of the size of the study, approval must be gained from the Drug and Therapeutics Committee to undertake an evaluation study. The consultant should write to the secretary of the committee detailing the medicine to be used, for what indication, in how many patients and for how long. The consultant should also detail what outcome measures will be used to evaluate the use of the drug.

In many cases, evaluation studies are initiated after a pharmaceutical company has offered the consultant free „evaluation‟ stock. In all instances, regardless of whether stock has been obtained from a pharmaceutical company or through pharmacy, the evaluation stock should be issued via a prescription from pharmacy. If clinics are to be held out with pharmacy working hours then the consultant should contact the Trust Chief Pharmacist to make alternative arrangements.

At the earliest appropriate meeting the Drug and Therapeutics Committee will make a decision.

Unlicensed Medicine: Consultants may wish to use an unlicensed medicine, prior to submission of a new drug application to the Drug and Therapeutics Committee, as part of an evaluation study.

In all cases, irrespective of the size of the study, approval must be gained from the Research and Development Committee to undertake an evaluation study. The consultant should write to the Research and Development Manager or Chairman of Research and Development Committee to obtain advice and the appropriate paperwork.

19.1.6 The Use of a Medicine as Part of a Clinical Trial

All research and development within the Trust is co-ordinated through the Research and Development Department. All consultants planning to undertake a clinical trial within the Trust should liaise with the Director of Research and Development / Research and Development Manager who can offer advice concerning the initiation of clinical trials.

Inevitably, there will be instances when consultants wish to use a new medicine within the Trust and are unsure as to the best way to proceed. In all cases, the Trust Chief Pharmacist should be contacted as soon as possible prior to the planned initiation of the new medicine to allow sufficient time to ensure the proper procedures are followed. By doing this the Trust will ensure that patients receive the most appropriate



medicines whilst considering the clinical and corporate governance issues related to the use of new medicines within the Trust.

19.2 Guidelines for New Drug Applications

19.2.1 Application Process

An application form should be obtained from the Pharmacy Secretary, UHND.

The consultant making the application should complete the form as fully as possible, following the notes on the first page, and attach supporting references. It is strongly advised that consultants seek the help of their directorate pharmacist in completing the application. The pharmacist will be able to supply independent supporting references, financial information and ensure a robust application is submitted.

The completed form, including supporting references and financial information, should be signed by the Care Group Clinical Director (who should ensure that the application is in line with best practice, that support has been sought from colleagues and that the risks of any change in practice have been considered), Associate Chief Operating Officer (who should consider the implications of the application on the service and whether a business case is required to support the application) and Accountant (who should consider the financial impact of the application). Signatures should be obtained before the application is returned to the Secretary of the Drug and Therapeutics Committee. If financial information is not included with the initial application then the Clinical Director, Associate Chief Operating Officer or Accountant may refuse to support the application. In this instance, Finance will liaise with pharmacy to obtain cost comparison information and this will delay the application being processed.

Failure to obtain authorisation will result in your application being returned for completion.

Please note that the Drug and Therapeutics Committee is keen to see evidence that all consultants within the Trust who may have an interest in this drug support the application. The appropriate section on the application form must be completed.

Where appropriate, applications should be accompanied by guidelines indicating the place in therapy of the new drug. Failure to provide supporting guidelines may delay approval of the application.

Pharmaceutical companies are very keen to help consultants with the application process as it is in their vested interest. Input from pharmaceutical companies should be restricted to providing supporting information only. Applications must be completed by the applying consultant.

The Secretary of the Drug and Therapeutics Committee reserves the right to return applications that are not fully completed or where the supporting evidence is not robust enough.

19.2.2 Applications outcome

The Trust‟s Drug and Therapeutics Committee will consider all applications



The consultant submitting the application will be asked to attend the Drug and Therapeutics Committee meeting at which his/her application is being considered. If the consultant cannot attend the meeting themselves then another appropriate consultant from within the Trust may attend on their behalf. If no representative is able to attend the meeting then the application will deferred to a future meeting.

The Secretary of the Drug and Therapeutics Committee will formally write to the applicant detailing the outcome of the approval process. Prescribing of the new drug, if approved, will be allowed from the date of the letter.

20 SUPPLY AND ADMINISTRATION OF MEDICINES UNDER PATIENT GROUP DIRECTIONS

A patient group direction (PGD) is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by doctors, pharmacists and other appropriate professionals, approved by the employer and advised by the relevant professional advisory committee. It applies to groups of patients or other service users who may not be individually identified before presentation for treatment (Crown Review 1998). It allows medicines to be supplied or administered within the parameters of the PGD without the need for a written direction from a qualified prescriber.

A patient group direction DOES NOT enable Practitioners to prescribe medication to be supplied or administered by others.

The policy for the supply and administration of medicines under patient group directions (PGD) is available on the pharmacy intranet. 21 ANTBIOTICS 21.1 Policy for the use of anti-infective drugs

The Trust Antibiotic Formulary will be the policy for the prescribing and use of anti-infective drugs within the Trust.

The Antibiotic Formulary is available on the Pharmacy intranet site.

21.2 Guidance on Using Gentamicin

Gentamicin is an amino glycoside antibiotic used primarily to treat serious Gram negative infections. It may also be used as a single dose of up to 120mg as prophylaxis against infection in certain surgical procedures. Whilst Gentamicin is effective, it has a narrow therapeutic index and will accumulate in renal impairment, leading to further renal failure and possible ototoxicity. When using Gentamicin as part of a treatment regime it is very important that an assessment of renal function is made and the dose adjusted accordingly. On wards other than those approved to use Gentamicin, treatment involving more than a single dose should only be continued on the advice of a Consultant Microbiologist.

21.3 Management of Patients Reporting a History of Penicillin Allergy

Penicillin containing antibiotics remain important first line antibiotics in all areas of health care. It is well recognised that penicillin allergy is the most commonly



reported drug allergy and severe life threatening hypersensitivity reactions may occur in a minority of patients. However the use of penicillin containing compounds is often limited by an unconfirmed or questionable history of penicillin intolerance. It is important to differentiate an adverse reaction, which would not preclude the use of a penicillin containing drug, from a hypersensitivity reaction that would preclude its use. Cephalosporin and carbapenem antibiotics share a common beta-lactam ring structure with penicillins and cross sensitivity may occur.

Guidance on assessing penicillin allergy can be found in the Trust Antibiotic Formulary. This policy gives a framework within which the seriousness and reliability of a reported reaction may be assessed.

22 PRESCRIBING AND ADMINISTRATION OF MEDICINES IN THE PERI-OPERTIVE PERIOD

In the peri-operative period medicines are often omitted in response to the instruction “nil by mouth”. Omitting some medicines in the peri-operative period can pose serious risks to the patient. Equally not omitting some medications for a suitable time prior to surgery can result in surgery having to be postponed. The prescriber must make clear on the medicines chart, which medicines need to be omitted and for how long, in the peri-operative period. To access the Oral drug therapy guidelines in surgical patients see pharmacy intranet site. For further information regarding the management of anticoagulants in patients undergoing surgery advice should be sought from a clinical pharmacist, haematologist or cardiologist,

For further information regarding the use of oral contraceptives and hormone replacement therapy in the Peri-operative Period and Hormone Replacement Therapy (HRT) advice should be sought from a clinical pharmacist.

23 MEDICAL GASES

All medical gases used in the Trust are Licensed Medicines and as such are subject to the Medicines Act and must be treated in the same way as any other medicines.

The Medical Gas Pipeline Systems (MGPS) are the means by which the Trust provides a safe, convenient and cost-effective supply of medical gases to points where these gases can be used by clinical and nursing staff for patient care.

The MGPS has developed to meet the increased demands of modern healthcare. The system forms an integral part of the building systems supporting the Trust‟s clinical activities. It is a safe and effective method of supplying a medical gas from its source of supply, through a pipeline system, to the patient via a terminal unit. It also provides a cost effective alternative to the use of portable cylinders, compressors and suction units, providing gas or vacuum for clinical needs without the associated problems of portage, noise and waste. The Trust recognises it‟s responsibility to implement in full the safe management of the MGPS in accordance with statutory requirements and guidelines listed in site-specific polices.

Before a medicine is administered to a patient, written authority from a doctor or a non-medical prescriber registered with the Trust must be obtained. This authority must include the name and concentration of the medical gas (where appropriate), the method of administration and the rate of flow. A Designated Practitioner administering a medical gas to a patient must make a written record that treatment with the particular medical gas has been initiated on the prescription chart.



The Trust recognises that it is essential for key personnel to receive appropriate training relevant to their particular roles and activities. Operational Policies and Procedures for the Management of Medical Gas are available for each site within the Trust. All Trust personnel (including contractors) with responsibilities for medical gases must read and understand the policies before use.

24 PROCESS FOR MONITORING COMPLIANCE OF THE POLICY (NHSLA 1.4.5g)

Monitoring Criterion Response

Who will perform the monitoring?

Safe Medication Practice Group

What are you monitoring? To meet the requirements of NHSLA Standard 4; Criterion 5; Medicines Management, compliance of the policy will be monitored with respect to: Level 1 monitoring 1.4.5g Will include monitoring of:

all prescribing incidents

all administration of medicines incidents

all safe disposal of medicines incidents

accuracy of prescribing on prescription charts Level 2 monitoring 2.4.5 The priority for monitoring within the policy will be the process for ensuring the accuracy of all prescription charts.

When will the monitoring be performed?

Monthly in pharmacy Bi Monthly for Safe Medication Practice Group Monthly for Safety Committee

How are you going to monitor? Medication incidents are reviewed to monitor

compliance against the Trust Medicine Policy and to identify themes and trends

Specific monitoring of the accuracy of prescribing on prescription charts identified from Trust reported incidents and the prescribing error reporting forms completed by pharmacists.

A rolling programme of an annual audit of prescription charts across a range of specialties

Progress against the Medicines Management NHSLA Action Plan

What will happen if any shortfalls are identified?

The Medicines Management NHSLA Action Plan will be updated and deadlines agreed to address any shortfalls.

Where will the results of the monitoring be reported?

Safe Medication Practice Group with escalation to Safety Committee.

How will the resulting action plan be progressed and monitored?

Action plans will be monitored bi-monthly at Safe Medication Practice Group Meetings.

How will learning take place?

Outcomes will be shared via: the pharmacy intranet page, Trust intranet, e-mail forum, education opportunity, change in practice, re-audit, Pharmacy and Medicines Management Communication Bulletin



TRAINING In addition to the monitoring outlined in the table, attendance at Essential Training is recorded by P &OD and entered onto the Trust Training Management System, OLM. Monitoring of non-attendance will be in line with the Training Needs Analysis, Monitoring and Evaluation Policy and carried out by P & OD. Please refer to this policy for detailed information.



25 REFERENCES

Great Britain (1972) Medicines Act 1968 (as amended)

Great Britain Health Act 2006 and associated regulations

Great Britain (1984) The Misuse of Drugs Act 1971

Great Britain (2001) The Misuse of Drugs Regulations 2001 SI No 3998

Great Britain (1973). Misuse of Drugs (Safe Custody) Regulations 1973 [SI 1973 No 798]

Controlled Drugs (Supervision of Management and Use) Regulations 2006 (S1 2006 No 3148)

Safer Management of Controlled Drugs (A guide to good practice in secondary care (England)) – May 2007

National Prescribing Centre (2004). A guide to Good Practice in the management of Controlled Drugs in Primary Care (England)

Great Britain (1999) Control of Substances Hazardous to Health (COSHH) Regulations 1999. The Stationery Office, London.

NMC standards for Medicines Management 2010

Implementation of Medicines for Human Use (miscellaneous Amendments) order 2010 – Midwives Exemption List

The Safe and secure handling of medicines: a team approach. A revision of the Duthie Report (1988) Royal Pharmaceutical Society of Great Britain March 2005

Crown Report 1998 and 1999

NHS Executive (2000) Patient Group Directions HSC20000/026

Guidance on Patient Group Direction. National Prescribing Centre 2004

MHRA Patient Group Directions in the NHS

Royal Pharmaceutical Society: Medicines, Ethics and Practice: A Guide for Pharmacists.

Medicines Control Agency (1997) Rules and Guidance for Pharmaceutical Manufacturers and Distributors. (Also known as "The Orange Guide")

GMC Guidance Doctors should not treat themselves or their families http://www.gmc-uk.org/standards/selftreat.htm

Good clinical practice, 75/318/EEC as amended July 1996. Rules governing medicinal products in the European Community. Col. 3C. Luxembourg: Office for Official Publications of the EEC.

MDA/2004/001 - Reporting Adverse Incidents and disseminating Medical Device Alerts. Medicines and Healthcare Products Regulatory Agency www.mhra.gov.uk

NHS Estates HTM 2022 Medical gas pipeline systems.

Medicines for Human Use (Clinical Trails) Regulations 2004./EC Directive 2001.20.ED

NHSLA standards for medicines management; standard 4, criterion 5

Ionising Radiation Regulations 1999 and Ionising Radiation (Medical Exposures) (Amendment) Regulations 2006

Medical Administration of Radioactive Substances

Radioactive Substances Act 1993

Medicinal products: Prescription by Nurses Act 1992

Health and Safety at Work Act 1974

Disposal of Hazardous Waste Act

Blood and blood products

BS2881:1989 Cupboards for storage of medicines in health care premises



26 ASSOCIATED DOCUMENTATION

This policy refers to the following CDDFT policies and procedures:

Medicine Reconciliation Policy

Discharge and Transfer Policy

Antibiotic Formulary

Paediatric diabetic Protocol

Policy for the management of FP10(HP)

Policy for the safe administration of chemotherapy drugs

Administration of Intra-Thecal medicines

Blood Borne virus Policy

Occupational Health Policy

Waste Policy

Waste Procedure Acute

Waste Procedures PCT

Incident management Policy

Being open Policy

Supporting staff in potentially traumatic stressful work related incidents

Management of controlled drug incidents

Patient Group Directive Policy

Oral drug guidelines in surgical patients

Medical gas Policy and procedures

This Policy is referenced from the following CDDFT policies and procedures:

Training needs analysis

Blood borne virus Policy

Resuscitation Policy

Discharge and Transfer Policy

Clinical Audit Policy

Policy for the management and development of policy and guidance documents



27 Equality Analysis / Impact Assessment

Full Assessment Form v2/2011

Division/Department:

Pharmacy and Medicines Management

Title of policy, procedure, decision, project, function or service:


Lead person responsible:

Dawn Ledger

People involved with completing this:

Dawn Ledger Pauline Lockey Jillian Wilkins

Type of policy, procedure, decision, project, function or service: Existing x New/proposed

Changed

Step 1 – Scoping your analysis



What is the aim of your policy, procedure, project, decision, function or service and how does it relate to equality? To ensure that CDDFT staff comply with current legislation, follow guidance issued by the Department of Health and manage the risks to patients and staff arising from the use of medicines.

Who is the policy, procedure, project, decision, function or service going to benefit and how? All staff who manage any process within the policy and the patients that are treated within the organisation.

What outcomes do you want to achieve? The aims as detailed above

What barriers are there to achieving these outcomes? Access to an electronic version of the Medicine Policy filed on the Trust intranet in some community settings. In exceptional circumstances where access is not immediate there is provision within the policy to use telephone contact

How will you put your policy, procedure, project, decision, function or service into practice? Dissemination of the policy via the Pharmacy and Medicines Management bulletin and email communication

Does this policy link, align or conflict with any other policy, procedure, project, decision, function or service? The policy links to the following policies - •Medicine Reconciliation Policy •Discharge and Transfer Policy •Antibiotic Formulary • Policy for the management of FP10(HP) • Policy for the safe administration of chemotherapy drugs •Administration of Intra-Thecal medicines • Blood Borne policy • Waste policy •Waste procedure Acute Settings •Waste procedures PCT •Incident policy •Being open policy •Supporting staff policy •Management of controlled drug incidents policy • Patient Group Directive Policy •Oral drug guidelines in surgical patients •Medical gas policy and procedures



Step 2 – Collecting your information

What existing information / data do you have? Information around medicine related incidents

Who have you consulted with? Safe Medication Practice Group and Safety Committee

What are the gaps and how do you plan to collect what is missing? Current incident analysis and trend reviews do not identify specific staff groups. This will be considered for future monitoring

Step 3 – What is the impact?

Using the information from Step 2 explain if there is an impact or potential for impact on staff or people in the community with characteristics protected under the Equality Act 2010? Ethnicity or Race Potential for issues around communication and understanding. Currently there is no evidence to support this.

Sex/Gender No impact

Age



Potential impact if related to a particular occupational or department staff group were there issues or concerns. Currently there is no evidence to support this

Disability Potential impact around undetected learning difficulties, hearing problems and sight related problems in terms of medicines processes. Currently there is no evidence to support this.

Religion or Belief Potential impact around certain ethical prescribing and administration which may conflict with an individual‟s religion or belief. Currently no evidence to support this

Sexual Orientation No impact

Marriage and Civil Partnership No impact

Pregnancy and Maternity Potential impact in terms of administration which will be addressed at local level by the line manager through the pregnancy risk assessment process.

Gender Reassignment No impact



Other socially excluded groups or communities e.g. rural community, socially excluded, carers, areas of deprivation, low literacy skills No impact

Step 4 – What are the differences?

Are any groups affected in a different way to others as a result of the policy, procedure, project, decision, function or service? Potential for impact but currently there is no evidence to support this

Does your policy, procedure, project, decision, function or service discriminate against anyone with characteristics protected under the Equality Act? Yes No x If yes, explain the justification for this. If it cannot be justified, how are you going to change it to remove or mitigate the affect? n/a

Step 5 – Make a decision based on steps 2 - 4

If you are in a position to introduce the policy, procedure, project, decision, function or service? Clearly show how this has been decided. Yes in a position to introduce the policy to ensure a standard approach and meet legal requirements



If you are in a position to introduce the policy, procedure, project, decision, function or service, but still have information to collect, changes to make or actions to complete to ensure all people affected have been covered please list: Consider a process to monitor the incidents and complaints in relation to staff within protected characteristics as identified in stage 3

How are you going to monitor this policy, procedure, project or service, how often and who will be responsible? This policy will be monitored via the following by Safe Medication Practice Group and where possible including information from protected characteristics: •Medication incidents are reviewed to monitor compliance against the Trust Medicine Policy and to identify themes and trends •Specific monitoring of the accuracy of prescribing on prescription charts identified from Trust reported incidents and the prescribing error reporting forms completed by pharmacists. • A rolling programme of an annual audit of prescription charts •Progress against the Medicines Management NHSLA Action Plan

Step 6 – Completion and central collation

Once completed this Equality Analysis form must be attached to any documentation to which it relates and must be forwarded to Jillian Wilkins, Equality and Diversity Lead. [email protected]

mailto:[email protected]