POLICY FOR THE DEVELOPMENT, APPROVAL AND IMPLEMENTATION OF PATIENT GROUP DIRECTIONS

(PGDs)

Policy Number MM11004

Title of Policy Policy for the Development, Approval and Implementation of Patient Group Directions (PGDS)

Author: Linda Fox - Community Services Pharmacy Manager

Approved at Locala Policy Group

Responsible Director: Director of Clinical and Operational Services

Date Ratified 7th September 2011

Ratified by: Executive Management Group (EMG)

Review Date November 2013

Contents

CONTENTS

Section Page 1 Introduction 1

2 Associated policies, procedures and guidance 1

3 Aims and objectives 1

4 Scope of the policy 2

5 Accountabilities and responsibilities 2

6 Foreword 2

7

CHOOSING THE MOST APPROPRIATE MECHANISM FOR THE SUPPLY/ADMINISTRATION OF MEDICINES

7.1 Definitions

7.2 When are PGDs not required?

7.3 Medicines which can and cannot be included in a PGD

7.4 Other methods of supply/administration of medicines

3 -5

8

DEVELOPING PATIENT GROUP DIRECTIONS

8.1 Who should be involved?

8.2 Information that should be contained in the PGD

8.4 Example PGDs

5 – 7

9

APPROVAL AND IMPLEMENTATION

9.1 Review of PGDs

9.2 PGD amendments

9.3 Distribution of PGDs

9.4 PGD Review Group

9.5 Current List of PGDs

7 – 10

10

RESPONSIBILITIES

10.1 Staff responsibilities

10.1.1 Health professionals

10.1.2 Team Leaders/Service Managers

10.1.3 Responsibilities of those authorising practitioners to work under PGDs

10.1.4 PCT Head of Medicines Management

10 – 12

11 Competency Framework 12

12 Audit 12

Contents

Section Page 13 Equality Impact Assessment 12

14 Training Needs Analysis 12

15 References 13

Appendices 1 Flowchart for the Development of a New PGD 14

2 Proposal Form for the Development of a New or Extended Patient Group Direction

15

3 Checklist of Contents and Service Sign off Form 18

4 PGD Template 20

5 PGD Revision checklist 31

6 To PGD or Not to PGD 34

7 Glossary 36

8 Key stakeholders consulted in the development of this document 38

9 Equality Impact Assessment Tool 39

1

Policy Statement

Locala Community Partnerships Community Interest Company (LCP) will endeavour to ensure the safe and secure handling of medicines to protect patients, staff and the public in accordance with current legislative requirements and best practice.

This policy has been developed to ensure that LCP complies with the requirements of Health Service Circular – HSC 2000/026, Patient Group Direction (England Only), which outlines the legal position regarding Patient Group Directions and follows good practice guidance issued by the National Prescribing Centre.

1. Introduction

This document outlines the process to be followed within LCP for the development of Patient Group Directions. It gives practical guidance on the development of Patient Group Directions, including details of criteria to be included, in order that the practice it supports is within the law and has the approval of LCP. It also addresses the approval of PGDs. Staff developing PGDs should take account of current LCP policies; guidelines and best practice and be aware of the strategy for non-medical prescribing and PGDs.

2. Associated Policies, Procedures and Guidance

This policy should be read in accordance with the following LCP policies, procedures and guidance:

Medicines Management Policy – A Guide to the Safe and Secure Handling of Medicines

Non Medical Prescribing Policy and in conjunction with:

The PGD guide published by the National Prescribing Centre, “A Practical Guide and Framework of Competencies for all Professionals using Patient Group Directions”, December 2009

Other Relevant Legislation The main relevant legislation covering the use of PGDs is found in:

The Medicines Act 1968 as contained in the Prescription Only Medicines (Human Use) Amendment Order 2000 (SI 2000/1917)

The Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000 (SI 2000/1918)

The Medicine (Pharmacy and General Sale - Exemption) Amendment Order 2000 (SI 2000/1919)

Further guidance is contained in Health Service Circular HSC 2000/026. The Prescription Only Medicines (Human Use) Amendment (No 2) Order 2004 (SI 2004/1189) covers additional professional groups: registered dietitians, registered occupational therapists, registered orthotists and prosthetists, registered speech and language therapists, who may supply or administer under a Patient Group Direction. All professions must act within their relevant Code of Professional Conduct.

2

3. Aims and Objectives

To provide policy for LCP covering the development, approval and implementation of PGDs.

To provide staff with clear guidelines on the requirements for developing and reviewing PGDs within LCP.

To detail the responsibilities both of LCP and of staff in respect of PGDs

To provide a template proforma for developing PGDs.

To provide a flow chart detailing the approval and implementation process within LCP.

4. Scope of the Policy

All LCP employees including those on temporary or honorary contracts, bank staff and students who are involved in developing, reviewing or working under Patient Group Directions must follow the process set out in this document.

Independent Contractors are responsible for the development and management of their own Patient Group Directions and for ensuring compliance with relevant legislation and best practice guidelines. NHS Kirklees will provide such advice and support as required.

5. Accountabilities & Responsibilities

All activities by LCP employees, which include the supply and administration of medicines to patients not covered by a prescription, patient specific direction or exemptions under the Medicines Act, MUST comply with the criteria set out in this policy. Any practice failing to comply with the criteria falls outside of the law and could result in criminal prosecution under the Medicines Act. This general policy outlines the responsibilities of authorised practitioners, professional groups, and LCP with regard to Patient Group Directions and encompasses all the criteria required for their preparation.

All professionals are required to work within their Professional Code of Practice and terms of service.

6. FOREWORD This policy incorporates the guidance provided in the 1998 Crown Report on the supply and administration of medicines under group protocol (the legal term for which is now Patient Group Direction); the legal requirements and guidance set out in HSC 2000/026: Patient Group Directions; and the National Prescribing Centre document, „Patient Group Directions A Practical Guide and Framework of Competencies for all Professionals using Patient Group Directions‟. To meet the changes taking place within the NHS, it is desirable that highly trained health care professionals should be able to use their full range of skills in the interests of better patient care, the efficient use of resources and enhanced job satisfaction. It is essential,

3

however, that the extension of professional roles is accompanied by clear arrangements for accountability. The extended role of health care practitioners must take into account the need to protect patient safety, ensure continuity of care and safeguard patient choice and convenience. It also has to be cost effective and bring demonstrable benefits to patient care. The majority of clinical care will continue to be provided on an individual, patient specific basis by a doctor, dentist or authorised non medical prescriber. Supply and administration of medicines under Patient Group Direction is reserved for those limited situations where advantages to patient care can be demonstrated (without compromising patient safety) and where it is consistent with appropriate professional relationships and accountability.

Currently, the following health care professionals are permitted to supply or administer medicines under a Patient Group Direction:

Pharmacists

Registered nurses

Registered Health Visitors

Registered Midwives

Registered Dieticians

Registered Physiotherapists

Registered Occupational Therapists

Registered Speech & Language Therapists

Registered Optometrists

Registered Orthoptists

Registered Orthotists and Prosthetists

Registered Dental hygienists and Dental therapists.

State registered Chiropodists (Podiatrists)

State registered Physiotherapists

State registered Radiographers

State registered Paramedics or qualified Ambulance Paramedics The above professionals may only supply or administer medicines under a Patient Group Direction as named individuals. For further information: www.mhra.gov.uk

7. CHOOSING THE MOST APPROPRIATE MECHANISM FOR THE SUPPLY/ADMINISTRATION OF MEDICINES The majority of clinical care should be provided on an individual, patient-specific basis. The supply and administration of medicines under Patient Group Directions should be reserved for those limited situations where this offers an advantage to patient care, without compromising patient safety, and be consistent with appropriate professional relationships and accountability. The decision on whether to use a PGD or other mechanism will depend on how an individual service is structured. Services in different organisations may choose, because of differences in the way their services are organised, to supply and/or administer medicines to their patients in different ways. For example, doctors referring patients to nurse-led clinics may write a Patient Specific Direction, (PSD – see „definitions‟ below), in the patient‟s notes for the nurse to supply

4

and/or administer a particular medicine. Alternatively, the nurse-led clinic may have several PGDs which cover the patient groups likely to be seen in the clinic.

It is important to ensure that a PGD is the most appropriate mechanism for delivery of the service in question and that all the options have been considered. For further guidance on deciding whether to use a PGD see „To PGD or not to PGD – that is the question‟ (appendix 6) and „Option Appraisal – are PGDs the safest route for your service‟ on the PGD website at: www.pgd.nhs.uk/

7.1 Definitions

A Patient Group Direction (PGD) can be defined as:

“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, and approved by the organisation, advised by the relevant professional advisory committees. It applies to groups of patients or other service users who may not be individually identified before presentation for treatment.”

A Patient Group Direction is NOT an authorisation to prescribe, but provides a legal authorisation for the supply and/or administration of medicines by a range of healthcare professionals within specified criteria.

A Patient Specific Direction (PSD) can be defined as:

“a written instruction from an independent prescriber (doctor, dentist or independent nurse/pharmacist prescriber), to another healthcare professional, to supply and/or administer a medicine directly to a named patient, or to several named patients.” 7.2 When are PGDs NOT Required?

A PGD is unnecessary if:

An exemption exists under the Medicines Act for a podiatrist (chiropodist), paramedic or midwife to supply or administer the specified medicine. Full details can be found on the MHRA website at: www.mhra.gov.uk/howweregulate/medicines/index.htm

The medicine involved is classified as a General Sales List Medicine (GSL): Medicines legislation states that a PGD is not necessary to supply a GSL medicine provided the supply takes place from lockable premises and the medicines are pre-packed and fully labelled. For services supplying GSL medicines in this way, good practice (from a clinical governance perspective) is to use a simple protocol.

The medicine is exempt under the Medicines Act when used in an emergency, i.e. in a life threatening situation e.g. Adrenaline (epinephrine) – no prescription is required.

Medical gas – as medical gases are not usually classified as prescription-only medicines

Dressing, medical device or chemical agent – these are not legally classed as medicines

7.3 Medicines Which Can and Cannot be Included in a Patient Group Direction The following drugs should NOT be included in a PGD:

Unlicensed medicines

5

Controlled Drugs (except Diamorphine for treating cardiac pain following MI, Midazolam, part 1 Schedule 4 CDs and all drugs listed in Schedule 5)

In special circumstances the following medicines can be included in a PGD:

Medicines used outside the terms of their license

Recently licensed drugs under intensive monitoring and subject to special adverse drug reaction reporting requirements („Black Triangle Drugs‟)

In both of the above cases such use is exceptional, and should be justified by current best practice e.g. NICE guidance, or recommendations of the Joint Committee on Vaccination and Immunisation (JCVI) for vaccine use. Each PGD should clearly state when the product is being used outside the terms of the Summary of Product Characteristics (SPC) and documentation should include the reasons why such use is necessary. A PGD can include a flexible dose range so the healthcare professional can select the most appropriate dose for the individual patient. Antimicrobials The inclusion of antimicrobial agents in a Patient Group Direction must be absolutely necessary and in line with current PCT antibiotic guidelines. A Consultant Microbiologist must be involved when developing any PGD that includes antimicrobial therapies. 7.4 Other Methods of Supply/Administration of Medicines This policy should be read in conjunction with LCP Medicines Management Policy which gives full details on the different methods of supply / administration and prescribing of medicines.

8. DEVELOPING PATIENT GROUP DIRECTIONS Refer to appendix 1 for a flowchart detailing the process for the development of a new PGD.1 For the development of a new or extended Patient Group Direction, the Service manager/ Clinical lead should complete a proposal form (appendix 2) and send to the LCP Head of Medicines Management for consideration at the next LCP Medicines Management Committee meeting. The development of a new/extended Patient Group Direction should not be initiated until approval to proceed has been received. Following approval by the Medicines Management Committee the Community Services Pharmacy Manager will enter the PGD onto the LCP database of PGDs and allocate the PGD a number. The Service/Clinical Lead will then draft the Patient Group Direction using the LCP template, (appendix 4), and ensuring guidance contained within sections 8.1 and 8.2 (below) is followed. This draft document should then be sent for comments to:

Representatives of any professional group expected to supply or administer medicines under the PGD.

1 Development of vaccination and immunisation PGDs for LCP are undertaken by the PGD Review

Group and do not follow this process – see 9.4

6

Relevant clinicians/health professional leaders

A specialist if appropriate e.g. microbiologist. A consultant microbiologist must be involved in a PGD that includes an antimicrobial medicine.

The final draft must then be submitted to the LCP Head of Medicines Management and Community Services Pharmacy Manager, together with the Checklist of Contents and Service Sign Off Form (appendix 3). A peer review will then be undertaken by the Community Services Pharmacy Manager/Head of Medicines Management and any comments fed back as necessary. The Community Services Pharmacy Manager will then take the final draft document through LCP approval and authorisation process (refer to section 9).

The PGD will be returned to the lead author with comments and appropriate support if not approved at any point of the process. It can be resubmitted once amendments have been made and agreed with all authors.

8.1 Who should be Involved?

Development of the Patient Group Direction is the responsibility of the Service/Clinical Lead, with pharmacist support from LCP Medicines Management Team.

A multidisciplinary group, including a doctor, a pharmacist, and a representative of the professional group involved in the specialist area concerned, should draw up the Patient Group Direction.

Clear records of draft documents produced should be kept to show the comments and decisions made during preparation.

8.2 Information that should be contained in a PGD

The Checklist of Contents (appendix 3) and PGD template (appendix 4) should be used together when writing a PGD. It is important to ensure all areas are completed in full as failure to do so may result in the PGD not fulfilling all the legal requirements, leading to unnecessary delay in the implementation and use of the PGD. The pre-populated information contained within the PGD template should not be amended unless absolutely necessary. Any changes must be brought to the attention of the Head of Medicines Management.

All PGDs should be underpinned by the best possible evidence-base (e.g. clinical guidelines, consensus statements). These guidelines do not need to form part of the PGD but should be used as a basis for producing it and the PGD should contain relevant and most up-to-date references. For more information, the following may be of use: National PGD website -

http://www.portal.nelm.nhs.uk/PGD/default.aspx MHRA: Patient Group Directions in the NHS -

http://www.mhra.gov.uk/index.htm search “PGD” DH: HSC 2000/026 -

http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004179

NPC: Competency framework for Healthcare Professionals -

http://www.npc.co.uk/non_medical/resources/patient_group_directions.pdf

7

If the multidisciplinary working group developing a PGD have any doubts or difficulties when completing any section of the PGD, advice should be sought from the Head of Medicines Management or Community Services Pharmacy Manager by contacting the Medicines Management Team on 01924 351525. 8.3 Example PGDs

Examples of currently approved PGDs can be viewed on the NHS Kirklees website.

Examples of PGDs from other organisations can be viewed on the national PGD website at:

http://www.nelm.nhs.uk/en/Communities/NeLM/PGDs/

9. APPROVAL AND IMPLEMENTATION Each PGD must be ratified by the LCP Medicines Management Committee and authorised by NHS Kirklees for use within Locala Community Partnerships. The Community Services Pharmacy Manager is responsible for ensuring the PGD goes through the correct approval process, which can take up to 3 months depending on timing of meetings. The procedure is outlined below:

1) Draft PGD(s) to be submitted to the first available Medicines Management Committee meeting for consultation and endorsement.

2) Draft PGD(s) to be sent electronically to relevant consultees for consultation. 3) Following consultation, and if no comments are received, the draft PGD will be sent

to LCP Medicines Management Committee for final ratification and to NHS Kirklees for authorisation.

4) If at any stage approval is not obtained, the PGD will be returned to the Service/Clinical Lead with an explanation as to why approval has not been granted.

5) Once ratified an organisational copy of the PGD is printed and forwarded to the organisations Commissioner (NHS Kirklees) for signing. For NHS Kirklees these signatories are: Director of Patient Care and Professions (Lead Nurse) Assistant Director of Prescribing and Medicines Management (Lead Pharmacist) Medical Director Clinical Commissioning Group (CCG) Leads (Lead GPs)

This final ratification and authorisation of the PGD ensures that legal liability and hence indemnification of staff is given full consideration. The organisational copy is retained by the Medicines Management Team and copies sent out to the relevant individuals/teams. The PGD will also be made available on the Locala section of NHS Kirklees website. . Until final approval by LCP Medicines Management Committee AND Commissioner organisational ‘sign off’, a PGD, or amendment of an existing PGD, is invalid. LCP accepts no responsibility for an authorised practitioner who acts in accordance with a PGD that is not signed by the organisational leads listed above (bullet 5).

8

9.1 Review of PGDs The content of a Patient Group Direction must be reviewed every two years, or earlier, if there are changes in clinical practice or updates to the Summary Product Characteristics. Six months prior to the expiry date of an individual PGD, the Community Services Pharmacy Manager will inform both the service lead and Head of Integrated Governance and Quality, that the PGD requires reviewing.

The service/clinical lead should first consider whether the PGD is still required and that the PGD is still the most appropriate/safest route for the supply or administration of medicines in their service – refer to „To PGD or not to PGD‟, appendix 6.

If the PGD will still be needed after the expiry date, it must be reviewed and re-approved for use before it expires.

Before undertaking this review the PGD should be audited for its effectiveness in the practice environment for a period of 1 month (see audit of PGD on Revision Checklist, appendix 5).

The service lead is responsible for undertaking/initiating review of an existing PGD ensuring guidance contained within sections 8.1 and 8.2 is strictly adhered to.

Amended draft(s) must then be sent for comments to:

Representatives of any professional group expected to supply or administer medicines under the PGD.

Relevant clinicians/health professional leaders

A specialist if appropriate e.g. microbiologist. A consultant microbiologist must be involved in a PGD that includes an antimicrobial medicine.

The final draft must then be submitted to the Community Services Pharmacy Manager, together with the Revision Checklist (appendix 5). This must be no less than two months prior to the expiry date to allow time for peer review and final approval. A peer review will then be undertaken by the Community Services Pharmacy Manager and the PGD taken through the approval process as described above. 9.2 PGD Amendments Should there be a significant change in practice and/or a change in the Summary of Product Characteristics (SPC) during the life of an approved PGD the service/clinical lead, (or another professional involved in the use of the PGD), should notify the Head of Medicines Management who will decide whether the PGD needs to be amended accordingly and submitted for re-approval, or whether another method of communication is appropriate.

Any proposed changes to an existing PGD must be actioned by following the process described in 9.1. The amended PGD must then be resubmitted to the LCP Medicines Management Committee and NHS Kirklees in accordance with the original approval procedure described in section 9. Where there are significant changes to a PGD the document must go through the full application and approval process – see section 8. Until final approval and distribution by the Medicines Management team, a PGD, or amendment of an existing PGD, is invalid.

9

9.3 Distribution of PGDs The original signed document will be held by the Medicines Management Team, and a copy sent to the Service Lead/Manager which should be used as a „master‟ to prepare individual copies for staff. Immunisation and vaccination PGDs will be sent out to Practice Managers and Team Leaders as appropriate. Acknowledgement slips will be sent out when distributing Patient Group Directions and Service Leads/Managers must ensure that these are returned on receipt of the document(s). On receipt of a new Patient Group Direction:

A senior practitioner in each professional group (usually the Service/Clinical Lead or GP for Practice Nurses) is designated the responsibility to ensure that only fully competent, qualified and trained professionals operate under the Patient Group Direction.

The Patient Group Direction „master‟ MUST be signed by all health care professionals who intend to work under it. This must also be signed by the authorising manager to confirm that the health care professional has undertaken the necessary training and is competent to work under the PGD.

Authorised staff should be provided with an individual copy of the PGD.

On receipt of updated/reviewed Patient Group Directions a new „master‟ will be sent to the service lead/manager who is responsible for:

Ensuring all copies of the previous PGD are removed from use. The „master‟ should be stored safely away and retained. For adults, all PGD documentation should be kept for 10 years and for children until the child is 25 years old.

All practitioners authorised under the previous PGD are advised of the changes and any additional training required under the new PGD is provided

All practitioners are provided with a copy of the new PGD and sign a new agreement of authorisation as above

LCP accepts no responsibility for an authorised practitioner who acts in accordance

with a PGD that has been superseded. 9.4 The PGD Review Group Vaccination and immunization PGDs for LCP and GP practice staff are developed, reviewed and updated by the PGD Review Group. The PGD Review group is a multidisciplinary working group and has membership drawn from clinicians belonging to the areas listed below: Community Services Pharmacy Manager (Group Facilitator) Pharmacists (LCP Head of Medicines Management and Community Services Pharmacist) GP (or other medic) GP Practice Nurse School Nurse Team leader Immunisation Team Nurse Lead Childrens‟ Community Matron Public Health - Deputy Director Infection Control

10

9.5 Current List of Patient Group Directions

The current list, along with the archived documents, is kept by the LCP Medicines Management Team.

Current PGDs are published on the NHS Kirklees website.

10. RESPONSIBILITIES It must be acknowledged by all members of staff that the interests and safety of every patient are paramount. Patient Group Directions should specify clear arrangements for professional responsibility and accountability, and contribute to effective use of resources.

10.1 Staff Responsibilities

10.1.1 Health Professionals

All authorised practitioners intending to supply or administer medicines under a PGD must first read it.

All authorised practitioners supplying or administering medicines under PGDs MUST be named. Therefore all staff working under a PGD MUST sign the individual authorisation section on the service „master‟, (near the back of the PGD document), and have it countersigned by their authorising manager BEFORE working under a PGD. This must be done for every PGD that they intend to work under. The „master‟ PGD will be held by the Service Lead/Manager.

Only health professionals who hold the relevant qualifications and have undertaken the specified training as stated under “Staff Characteristics” of the PGD must operate under it.

Authorised practitioners MUST only undertake the extended role under a PGD in circumstances where they are competent to assess all relevant aspects of the patient‟s clinical condition, take responsibility for supply and administration of the medicine and make related decisions.

All authorised practitioners supplying or administering medicines under PGDs MUST be named and have written evidence of competence, training, knowledge, experience and continuing education relevant to the clinical condition/situation to which the PGDs apply. The practitioner must take personal responsibility for ensuring they maintain their competence and knowledge, and attend additional training when appropriate.

No authorised practitioner should undertake any aspect of patient care for which they are not trained and which is beyond their professional competence. If the authorised practitioner is in any doubt about their competency they should not administer or supply in accordance with the PGDs and should seek advice.

The authorised practitioner undertaking this extended role must do so in accordance with the appropriate current PGD.

Practitioners should have a copy of the current PGD available for reference when supplying and/or administering a medicine.

Practitioners should keep a record of the supply/administration made under a PGD, to be made available for audit purposes when necessary.

11

Practitioners MUST act only in accordance with the PGD.

Where patients who require treatment according to recognised national or local guidance cannot be treated under the criteria of the PGD the health professional should refer the patient to a suitable prescriber to ensure treatment can be given. Refer to „action if patient declines or is excluded‟ of the PGD.

Any clinical incidents relating to the actions of a healthcare professional operating under a PGD must be reported as per local policy and procedure.

An adverse drug reaction should be reported by the healthcare professional identifying it using the „Yellow Card‟ scheme – www.mhra.gov.uk

NOTE: A practitioner authorised to work under a PGD cannot delegate the responsibility to another person LCP accept no responsibility for an authorised practitioner who attempts to act under a PGD in an area of practice to which the PGD does not apply.

10.1.2 Team Leaders/Service Managers

Are responsible for maintaining the „master‟ file of PGDs currently in use by their service.

Are responsible for ensuring that everyone using PGDs in their service/team has signed up to the service „master‟ and are authorised by the relevant clinical team leader or clinical manager. This may be the team leader in most circumstances (see 10.1.3).

Ensuring that PGDs currently in use have not passed their review dates.

Are responsible for maintaining a file of all PGDs no longer in use which should be stored safely away and retained.2

10.1.3. Responsibilities of those Authorising Practitioners to Work under PGDs

Before any individual is allowed to work under a PGD it is essential that they are assessed as competent to do so. They should be familiar with the situation to which the PGD relates to and also be trained and possess the skills specified in the PGD to which they sign up to. These competencies should be assessed and agreed by the relevant clinical team leader or manager before the individual is signed off to work under a PGD. The clinical manager who assesses these competencies must be familiar with the situation and they must be deemed as competent to assess others.

For example:

A Community Nurse Practitioner expected to administer Influenza vaccine under the terms and conditions of a PGD could be assessed as competent by their team leader or clinical manager.

A Contraception and Sexual Health (CaSH) nurse might have their competencies assessed by either their team leader or the CaSH Clinical Lead.

2 For adults, all PGD documentation should be kept for 10 years and for children until the child is 25

years old.

12

Those authorising practitioners to work under PGDs must ensure that:

The authorised practitioner is trained and has the required skills as specified in the PGD to which they are signing up to.

The authorised practitioner has received the necessary training and is competent to practice under the PGD.3

They countersign the individual authorisation section on the service „master‟ which confirms that they have assessed the practitioner as being competent to work under the PGD.

10.1.4 Responsibility of LCP Head of Medicines Management

LCP Head of Medicines Management is responsible for ensuring that PGDs are developed in line with legislative requirements and provide advantages to patients without compromising safety. This includes ensuring that any relevant groups have approved its content.

11. COMPETENCY FRAMEWORK All practitioners authorised to work to PGDs should understand the legal framework, have received the required training in the area covered by the PGD and maintain their competence. The National Prescribing Centre (NPC) has produced a competency framework for professionals using PGDs and copies can be downloaded from: http://www.npc.co.uk/non_medical/resources/patient_group_directions.pdf

12. AUDIT It is a legal requirement to keep records of administration / supply under PGD for audit purposes. Care provided under a PGD must be audited, as stated in HSC 2000/026. It is recommended that audit is undertaken annually as part of staff IPR.

For new staff, practice should be audited six months after commencing the post.

Audits on the use of PGDs will be initiated and carried out by service leads / managers to ensure compliance with procedures. The results of the audit should be shared within the service and made available to the LCP Medicines Management Committee upon request.

13. EQUALITY IMPACT ASSESSMENT

This policy has been assessed for the potential adverse impact as set out in Appendix C. On initial screening no impact has been identified for this policy.

14. TRAINING NEEDS ANALYSIS

All practitioners who operate under a PGD should receive training prior to operating under a PGD. Training should include the legal aspects, practitioner responsibilities and specific information relating to the clinical indication being treated under the PGD.

All practitioners who operate under a PGD must ensure that they undertake CPD within the relevant therapeutic area and where refresher training is available; they should attend on a periodic basis.

3 There is currently no specific national training programme for healthcare professionals using PGDs.

However the competency framework for healthcare professionals using PGDs (NPC) may be useful: http://www.npc.co.uk/non_medical/resources/patient_group_directions.pdf

13

The practitioner or service manager with responsibility for ensuring that „training records are up to date‟ must review the PGDs being used by a health professional on a regular basis (e.g. current document), check that those named to operate under the PGD are trained and update training record accordingly.

15. REFERENCES

Statutory Instrument 2000 No. 1917, The Prescription Only Medicines (Human Use) Amendment Order 2000; http://www.opsi.gov.uk/si/si2000/20001917.htm Statutory Instrument 2000 No. 1918, The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No. 2) Regulations 2000; http://www.opsi.gov.uk/si/si2000/20001918.htm Statutory Instrument 2000 No 1919 The Medicines (Pharmacy and General Sale -Exemption) Amendment Order 2000; http://www.opsi.gov.uk/si/si2000/20001919.htm Health Service Circular HSC 2000/026 9 August 2003 Patient Group Directions http://www.dh.gov.uk/assetRoot/04/01/22/60/04012260.pdf Statutory Instrument 2004 No.1189, The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2004; http://www.opsi.gov.uk/si/si2004/20041189.htm

National Prescribing Centre December 2009, Patient Group Directions – A Practical Guide and Framework of Competencies for all Professionals using Patient Group Directions; http://www.npc.co.uk/non_medical/resources/patient_group_directions.pdf

Southwark Primary Care Trust. Policy for the Development, Approval and Implementation of Patient Group Directions. February 2007.

Leeds Primary Care Trust. Policy for the Development and Review of Patient Group Directions. April 2007.

Appendix 1

18

FLOWCHART FOR THE DEVELOPMENT OF A NEW PGD

Draft PGD to be drawn up by Service/Clinical Lead, involving all relevant specialists. Follow PGD policy on how to write a PGD. Use appendix 3 as an aid to writing and the template (appendix 4)

Determine if a PGD is the most appropriate method of supply/administration for your service.

Justify the clinical/organisational need – must be exceptional and lead to improvement in patient care.

Refer to „PGD or not to PGD‟ via

http://www.nelm.nhs.uk/en/Communities/NeLM/PGDs/PGD-Legislation-Guidance/PGD-Website-Tools/To-PGD-or-not-to-PGD-that-is-the-question/

Need for PGD identified

Complete „Proposal for the Development of a new PGD‟ form (appendix 2) and submit to the LCP Medicines Management Committee for approval (this group meets bi-monthly).

Check by the Community Services Pharmacy Manager

Final draft to be submitted to the to the Community Services Pharmacy Manager WITH checklist of contents and service sign off form

Circulate draft for comments

Once approval has been received from the Medicines Management Committee

Submit to the LCP Medicines Management Committee (MMC) for consultation and ratification

If any comments received from MMC, PGD to be returned to lead author for further

action/amendment

NHS Kirklees organisational leads to „sign off‟ PGD

Submit to NHS Kirklees for commissioner authorisation

Ratified by MMC

PGD distributed by Medicines Management Teams

REMEMBER – THE SERVICE/CLINICAL LEAD IS RESPONSIBLE FOR THE REVIEW OF THE PGD, WHICH MUST BE REVIEWED EVERY 2 YEARS OR EARLIER IF REQUIRED.

AC

TIO

NS

BY

TH

E S

ER

VIC

E/C

LIN

ICA

L L

EA

D

AC

TIO

NS

BY

TH

E C

OM

MU

NIT

Y S

ER

VIC

ES

PH

AR

MA

CY

MA

NA

GE

R/H

EA

D O

F M

ED

ICIN

ES

MA

NA

GE

ME

NT

Appendix 2

15

PROPOSAL FORM FOR THE DEVELOPMENT OF A NEW OR EXTENDED PATIENT GROUP DIRECTION

The completed document should be submitted to the Head of Medicines Management for approval by the LCP Medicines Management Committee prior to the development of the PGD.

PART 1 – (To be completed by proposer of the PGD)

PGD FOR ……………………………………………………….(insert name, strength and form of medicine)

I/we have applied the flowchart „to PGD or not to PGD‟,(available at: www.pgd.nhs.uk/), to this clinical situation and a PGD is the most appropriate route to provide this clinical activity.

NAME AND POSITION OF PROPOSER

Contact details (Tel No/Email)

NAME AND POSITION OF LEAD AUTHOR RESPONSIBLE FOR THE DEVELOPMENT OF THE PGD (if different to above)

Contact details (Tel No/Email)

DEPARTMENT

STATEMENT OF SUPPORT FROM PROFESSIONAL LEAD e.g. clinical/service lead

NAME, SIGNATURE AND POSITION:

………………………………. …………………………………………… ………………………..

Date:……………………………………

Appendix 2 Continued

16

Is this a new PGD or a revision of an existing one?

Proposed title of PGD Names, formulation and dosage of drug(s) to be supplied or administered.

What are the proposed indications for this PGD?

Please list local/national guidance which supports the use of this drug

Clearly describe why there is a need for this PGD within your service.

What are the benefits to patients having a PGD?

What are the benefits to staff having a PGD?

Who is to use this PGD? What are the training implications?

Are there any resource implications? (e.g. cost of drugs/staff training)

What are the potential risks involved with this PGD – in developing or not developing it? Are there any financial or clinical risks involved?

NAMES OF ANTICIPATED PGD AUTHORS

JOB TITLE EMPLOYER CONTACT DETAILS

Doctor

Pharmacist

Rep(s) of professionals who will work to the PGD

Other parties

Please return to:

Lucianne Ricketts, Head of Medicines Management, Medicines Management Team, Beckside Court, Bradford Road, Batley, WF17 5PW.

Appendix 2 Continued

17

Non Medical Prescribing Lead

Non Medical Prescribing Lead

PART 2 – (To be completed by the Head of Medicines Management following discussion at LCP Medicines Management Committee {MMC})

PGD TITLE: ……………………………………………………….

SERVICE:……………………………………………………………..

This PGD was considered by MMC on …………………….(insert date)

and was:

Approved for development into Patient Group Direction on behalf of LCP

…………………………………………………………………. Date………………………………

OR

NOT approved for development into Patient Group Direction on behalf of LCP

…………………………………………………………………. Date………………………………

NUMBER ASSIGNED: ………………..

Head of Medicines Management to return to the proposer

COMMENTS

Appendix 3

18

CHECKLIST OF CONTENTS AND SERVICE SIGN OFF FORM

The following is a list of the elements, which must be included in any Patient Group Direction prior to it being submitted for approval to the Medicine Management Committee.

1. Clinical Condition or Situation to which the PGD Applies

Clinical situation stated

Objective of care defined

Clinical condition or situation clearly defined

Criteria for confirmation of the clinical condition defined

Clinical criteria for inclusion of a patient in the PGD defined

Clinical criteria for exclusion of a patient from the PGD defined

Clinical criteria for situations where further advice must be sought

Action to be followed for patients excluded from the PGD defined

Action to be followed for patients who do not wish to receive, or do not adhere to, care under the PGD

2. Description of treatment available under the PGD

Name of medicine to be supplied or administered.

Legal status of medicine.

The pharmaceutical form of the medicine.

The dose which can be supplied or administered under the PGD.

Route or method of administration defined

Frequency of administration defined

Total dose, number of times treatment can be administered or supplied, and over what period of time defined

Follow-up treatment or review time defined

Advice, verbal and written to be given to the patient or carer, before or after treatment, defined, including access to patient information leaflets

Instructions on identifying and managing possible adverse outcomes included

Arrangements for obtaining medical advice defined

Records to be kept to enable a clear audit trail described

Method of keeping a record of drugs supplied under PGD

Details of any special considerations to be made for patients taking concurrent medications included

3. Characteristics of staff authorised to supply/administer medicines under the PGD

Professional qualifications and/or registration details stated

Specialist qualifications, training and experience stated

System set up for continued training and education of staff involved in PGD

System for recording names of individuals authorised to supply or administer drugs under the PGD described

Appendix 3 Continued

19

4. Records

Details of the records to be kept following supply or administration via the PGD should be specified

5. Management and monitoring of the PGD

Names, job titles and signatures of professionals drawing up the PGD included

Includes date of PGD and the review date after which the PGD is no longer valid

6. References*

A list of the reference sources used during the development of the PGD should be included

8. Agreement by authorised practitioner

Authorisation/agreement form for authorised practitioner to acknowledge their responsibilities and manager to provide assurance of that practitioner‟s competence to work under PGD

* References

Please state which reference sources have been used during the development of this PGD (please tick):

Current BNF State the edition number here: ……………………

Summary Product Characteristics (SPC) Date accessed: …………………………………………………

NICE guidance Please state title and version no: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….

Other guidance Please state title and version no: :……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

I confirm that the use of this medicine is consistent with the current edition of the BNF Y/ N

I confirm that the use of this medicine is consistent with the relevant SPC Y / N

I confirm that the use of this medicine is consistent with relevant NICE guidance Y / N

SIGNED:…………………………………………………..(Service/Clinical Lead)

NAME: ……………………………………………………… DATE: ……………………………………………………….

If the answer is N to any of

these questions please give a

brief explanation overleaf.

Appendix 4

BASIC TEMPLATE FOR DEVELOPING A NEW PGD

NB. Dark coloured font is standard wording which must be included.

Italic light font lists criteria to be included specifically for that PGD

20

Patient Group Direction (PGD) for the (state Supply or Administration) of:

NAME OF MEDICINE

Insert legal classification

of drug

YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES

Indication A clear and unambiguous definition of the clinical condition/situation, including criteria for confirmation of condition/situation.

Inclusion Criteria

Informed consent has been given in accordance with current PCT guidelines for the supply/administration of the medicine.

State here the characteristics of the patient population you wish to treat for the above condition. Use bullet points

Who is eligible to receive drug

Clinical criteria

Relevant local/national policies/guidelines Consider such characteristics as: The age range of patients The sex of patients Diagnosis or assessment the patient must have received prior to treatment. “At risk” groups that the patient must fall into (reference to national guidance is acceptable).

Exclusion Criteria

Informed consent has NOT been given in accordance with current PCT guidelines for the supply/administration of the medicine.

State here those characteristics or situations that would prevent treatment under this PGD. Use bullet points. For example:

Age

Concurrent conditions

Concurrent treatment (contraindications and dangerous interactions with essential medication).

Previous adverse reactions/hypersensitivity

Other exclusions listed in the product SPC.

Are there any exclusions published by NICE or other DH publications such as the Green Book.

21

Please also see Cautions/Need for further advice section

Cautions/Need for

Further Advice

Use bullet points. These may not be exclusions but require further consideration and discussion with an appropriate clinician.

POTENTIAL DRUG INTERACTIONS

This list is not exhaustive. Concurrent medication MUST always be checked for interactions before supply under this PGD

List here (using bullet points) some of the more common drug, less serious drug interactions as listed in appendix 1 of the BNF. The more serious interactions should be listed in exclusions.

Action if Patient Declines or is Excluded

Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient‟s record.

Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient‟s record.

Give information about risks of infection and benefits of treatment (where appropriate).

Give information about how to recognise signs and symptoms of infection (where appropriate).

Give information about when the medicine may be given.

DESCRIPTION OF TREATMENT

Name, Form & Strength of Medicine

State clearly in full using the generic name of the medicine. Only use brand names of the medicine if you are insisting that a particular brand is used. Include the ▼ symbol for black triangle drugs adjacent to the drug name.

State the formulation e.g. sterile suspension for injection.

State the strength including units.

Route/Method State the route and if necessary the preferred site of administration

22

Dosage & Frequency State clearly in full.

Provide practical information where appropriate, e.g. with food and ensure the period in which the maximum dose can be administered is stated (where applicable).

A dosage range is permitted but the PGD must state how to calculate/decide which dose to use.

Duration of Treatment

Maximum or Minimum Treatment Period

State minimum and maximum treatment period

Quantity to

Supply/Administer

State here the number of doses or units to be supplied or administered in this course of treatment.

Licensing Information Include a statement that the drug is licensed for this condition in this patient group or if relevant, include a statement supporting use if used outside terms of licence. See below for example wording to be used in this instance.

‘Off-label’ Use of (insert name of drug)

Describe here the difference between the licensed use of the drug and its use in this PGD.

The use of INSERT NAME OF DRUG under this PGD is therefore outside the specifications in the manufacturer‟s SPC and is classed as „off label‟ use.

Medicines can be used outside their licensing indication and be given under a PGD if such use is exceptional, justified by best practice and the status of the product is clearly described. In addition, you should be satisfied that you have sufficient information to administer the drug safely and, wherever possible, that there is acceptable evidence for the use of that product for the intended indication. (NMC 2004).

This PGD follows INSERT guidance which differs from the product SPC.

23

Side Effects As a minimum, include here those all adverse reactions that may be observed at the time of administration, all common reactions that could be perceived by the patient within a few days of administration and any serious reactions that may be perceived by the patient. Always include drowsiness where this is a potential reaction

Where the listed adverse reactions are not comprehensive reference should be made to the summary of product characteristics using the standard wording below:

This list is not exhaustive. Please refer to current BNF and product SPC for full details.

The following statement should be included for drugs:

Report all suspected adverse reactions, however minor, to the Medicines and Healthcare products Regulatory Agency (MHRA), Commission on Human Medicines using a Yellow Card or on-line via www.yellowcard.gov.uk. Report all suspected reactions even if they are listed above, in the BNF or in the Summary of Product Characteristics (product data sheet). Yellow Cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it.

And for all other drugs:

Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk.

Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant.

Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it.

Special Considerations/Additional Information

Immediate access to adrenaline/epinephrine for treatment of anaphylaxis.

Access to a telephone

State the storage requirements Include any other details considered important.

24

Advice to Patient/Carer

Explain the treatment, why it is needed, and further action where required.

Provide the product patient information leaflet and advise the patient to read it.

The patient should be warned to discontinue treatment immediately and seek medical advice if hypersensitivity reactions occur. If severe drug reaction occurs advise to attend Accident and Emergency. (See side effects).

Consider:

Advice on reactions and their management (always include advice on driving, or activities requiring a high level of concentration for medicines that may cause drowsiness).

Advice specific to the condition being treated.

Advice on the expected outcome of treatment.

Advice on how the treatment is to be used if it is supplied rather than administered on site.

Advice that is specific to the service such as future access to the service

Advice on how the treatment will be followed up and by whom including when to make a future appointment.

Advice on where to seek further advice or discuss concerns etc.

Indicate whether this advice will be given verbally or in writing (or other presentation) or both.

Follow Up Advise patient to seek further medical advice if:

The condition worsens, does not improve, or they have not fully complied with treatment.

They experience any hypersensitivity reaction

State any other requirements for follow up specific to your service

25

REFERRAL ARRANGEMENTS AND AUDIT TRAIL

Referral Arrangements Referral arrangements (including self-care) to be documented in patients notes.

If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct or A&E for further assessment and advice.

Records/Audit Trail The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary:

Patient‟s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented.

Diagnosis

Contact details of GP if applicable

Dose supplied and route

Duration of treatment

Indication that the patient was treated under PGD (including PGD number if practicable).

Batch number, expiry date, manufacturer and brand name.

Advice given to patient (including side effects)

Date supplied

Name of staff who supplied the medicine

Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient‟s medical record.

Current medication

Known allergies

Referral arrangements (including self-care) State any additional service specific records here.

26

STAFF CHARACTERISTICS

Qualifications All nurses with valid Nursing and Midwifery Council (NMC) registration working within Locala (Use here the equivalent statement for other professions the PGD applies to). Also include any additional requirements you would expect. E.g. “holding a nurse practitioners qualification” or “who can demonstrate competence in following PGDs” or “holds a diploma or certificate in first contact medicine” or “working in the PCT managed CaSH service” etc.

Specialist Competencies or Qualifications

Has undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD

Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines

Has undertaken training appropriate to this PGD – e.g. understanding concepts of antimicrobial resistance and appropriate use of antimicrobials

Has undertaken training and is competent in resuscitation skills.

Has undertaken training and is competent in the recognition and treatment of anaphylaxis

Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD.

State any additional service specific competencies here.

Continuing Training & Education

The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice.

Practitioner should have access to current BNF and updated DH advice where appropriate.

Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation.

Keeps undated via departmental updates and meetings.

State anything specific to your service here.

References & Resources Include all references that have been source material for the PGD e.g. BNF, SPC and any references that form the basis of the treatment being “best practice” such as NICE guidance, other national guidance or published evidence.

27

PATIENT GROUP DIRECTION FOR THE SUPPLY AND/OR ADMINISTRATION OF

(INSERT NAME OF MEDICINE)

**This PGD has been developed/updated for use by the individuals listed below:

OR

**This PGD replaces: state title and number, and has been prepared by:

NAME DESIGNATION POSITION SIGNATURE DATE

Doctor

Pharmacist

Service Manager/Clinical

Lead

**Delete as appropriate

28

Individual Authorisation for the Supply/Administration of (INSERT NAME AND STRENGTH OF DRUG) by (INSERT WHO CAN WORK TO THIS PGD) Working at (INSERT NAME OF

SERVICE)

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY.

It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct.

I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. In signing this declaration the healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct.

Authorising Managers

For PCT staff this will be the team leader, or relevant clinical manager.

Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.

Name of Professional Signature Authorising Manager Date

Staff who are no longer required to administer under this PGD should be removed from it. This can be

done by crossing through the relevant name, adding date and initials.

29

CONSULTATION PROCESS ADOPTED IN DEVELOPING THIS PATIENT GROUP DIRECTION

TITLE OF DOCUMENT: PGD for

NUMBER:

New Document (Y/N)

Review of Document (Y/N)

Revised Document (Y/N)

If revised – what revisions were required?

See appendix 5

Director Lead

(Name and job title)

Author

(Name and job title)

List of persons involved in developing/updating PGD (include job titles)

List of persons involved in consultation process (include job titles)

30

AUTHORISATION

This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala should hold the original signed copy. The PGD must be easily accessible in the clinical setting

ORGANISATION KIRKLEES PRIMARY CARE TRUST on behalf of Locala.

Director of Patient Care & Professions

Name:

Signature: Date:

Assistant Director of Medicines Management and Prescribing

Name:

Signature: Date:

Medical Director Name:

Signature: Date:

CCG Leads Name:

Signature: Date:

Name:

Signature: Date:

Appendix 5

31

PATIENT GROUP DIRECTION – REVISION CHECKLIST

(To accompany an existing PGD that has been reviewed and revised)

PGD Title

Existing PGD Number

Have you considered alternative mechanisms for supplying/administering this drug in your service?

Has this PGD been audited for

effectiveness?**

Date of Review

Reason(s) for revision

List of persons/groups

involved in revising PGD

(including job titles)

Pharmacist Reviewer

Doctor Reviewer

List of persons/groups

involved in consultation

process

(including job titles)

**Audit of PGD

Key aspects for audit of the effectiveness of a PGD should include:

That the patients treated under the PGD have met the stated inclusion criteria.

Any adverse reactions that have been noted

Patients that have been exclude and why

Circumstances where further advice/referral has been required.

32

Minimum and maximum doses of medication.

Documentation in the patients records (record keeping)

Where the PGD is for the supply of medicines, that receipts and outgoings of medicines can be reconciled.

The storage facilities and security of medicines

References

Please state which reference sources have been used during the review of this PGD (please tick):

Current BNF State the edition number here: ……………………

Summary Product Characteristics (SPC) Date accessed: …………………………………………………

NICE guidance Please state title and version no: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….

Other guidance Please state title and version no: :……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

I confirm that the use of this medicine is consistent with the current edition of the BNF Y/ N

I confirm that the use of this medicine is consistent with the relevant SPC Y / N

I confirm that the use of this medicine is consistent with relevant NICE guidance Y / N

SIGNED:…………………………………………………..(Service/Clinical Lead)

NAME: ……………………………………………………… DATE: ……………………………………………………….

PLEASE COMPLETE THE RECORD OF CHANGES MADE, (NEXT PAGE), BEFORE SUBMISSION WITH THE REVISED PGD TO THE COMMUNITY SERVICES PHARMACY

MANAGER

If the answer is N to any of

these questions please give a

brief explanation below

33

Record of Changes made to Previous Version

SECTION EXPIRED VERSION REVIEWED VERSION Indication Inclusion Criteria Exclusion Criteria Cautions/Need for Further Advice

Action if Patient Declines or is Excluded

Name, Form and Strength of Medicine

Route/Method Dosage & Frequency

Duration of Treatment

Maximum of Minimum Treatment Period

Quantity to Supply/Administer

Licensing Information

Side Effects Special Considerations/Additional Information

Advice to Patient/Carer

Follow Up Referral Arrangements

Records/Audit Trail Qualifications Specialist Competencies or Qualifications

Continuing Training & Education

References & Resources

Appendix 6

34

35

Appendix 7

36

DEFINITIONS

Administer To give a medicine orally, by injection, by intravenous infusion, by suppository, pessary or by external application (e.g. cream/ointment/patch).

Authorised Practitioner A healthcare professional who has been given authorisation to work under a PGD

Black Triangle Drugs Newly-introduced drugs, still subject to special monitoring for potential side effects by the Medicines Control Agency (so called because they are identified by a black triangle symbol in the British National Formulary).

Clinical Responsibility Accountability for a particular aspect of the clinical assessment or management of a patient‟s condition.

Controlled Drugs Narcotic drugs or other drugs liable to misuse, which are subject to special controls under the Misuse of drugs Act 1971.

Dispense To prepare and tTo To make up or give out a clinically appropriate

medicine to a patient for self-administration or administration by another, usually another professional. In the case of prescription only (POM) medicines, dispensing must be in response to a legally valid prescription. The act of dispensing is combined with advice on safe and effective use.

General Sales List (GSL) Medicine A medicinal product which can be sold or supplied direct to the public in an unopened manufacturer‟s pack from any lockable business premises. Such products are listed in the Medicines (Products Other than Veterinary Drugs) (General Sales List) Order 1984.

Patient Group Directions 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, and authorised by the employer, advised by the relevant professional advisory committees. It applies to groups of patients or other service users who may not be individually identified before presentation for treatment.

Appendix 7

37

Licensed Indication Treatment purpose for which a product may be used under the terms of the marketing authorisation granted by the Licensing Authority.

Licensed Medicine A medicine which falls within the definition of a medicinal product and which is granted a marketing authorisation by the Licensing Authority when the safety, quality and efficacy of the product have been satisfactorily demonstrated by the License Holder (holder of marketing authorisation) in accordance with EC Directives 65/65.

Medicinal Product Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product (Article 1.2 EC Directive 65/65).

Pharmacy (P) Medicine Any medicinal product other than those designated as GSL or POM products. Pharmacy medicines can be sold or supplied only from a registered pharmacy by, or under the supervision of a pharmacist.

Prescription Only Medicine (POM) A medicinal product which may only be supplied against the signed prescription of an appropriate practitioner i.e. doctors, dentists, independent prescribers.

Summary Product Characteristics (SOP) A description of a medicine‟s approved conditions of use.

Supply To provide a medicine directly to the patient or carer for administration

Appendix 8

38

Key Stakeholders Consulted/Involved in the Development of the Policy/Procedure

Stakeholders name and designation Key

Participant Yes/No

Feedback requested

Yes/No

Feedback accepted Yes/No

Lucianne Ricketts – Head of Medicines Management Yes Yes Yes

Medicines Management Team Yes Yes Yes

Gwen Ruddlesdin – Head of Integrated Governance and Quality

Yes Yes Yes

Key Stakeholders Consulted/Involved in the Development of the original

NHS Kirklees Document

Stakeholders name and designation

Date feedback requested

Detail of feedback received

Date feedback received

Action taken

Medicines Management Committee

22/6/10

Head of Integrated Governance and Quality to be notified in addition to Service Manager when a PGD is due for review.

21/7/10 Actioned

Medicines Management Committee

6/710

Clinical Executive Committee

7/7/10

Appendix 9

39

Equality Impact Assessment Tool

To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

Insert Name of Policy / Procedure

Yes/No Comments

1. Does the policy/guidance affect one group less or more favourably than another on the basis of:

Race No

Ethnic origins (including gypsies and travellers) No

Nationality No

Gender No

Culture No

Religion or belief No

Sexual orientation including lesbian, gay and bisexual people No

Age No

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2. Is there any evidence that some groups are affected differently?

No

3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

NA

4. Is the impact of the policy/guidance likely to be negative?

No

5. If so can the impact be avoided? NA

6. What alternatives are there to achieving the policy/guidance without the impact?

NA

7. Can we reduce the impact by taking different action?

NA

If you have identified a potential discriminatory impact of this procedural document, please refer it to [insert name of appropriate person], together with any suggestions as to the action required to avoid/reduce this impact.

For advice in respect of answering the above questions, please contact [insert name of appropriate person and contact details].