medicine management procedures toolkit - north west ambulance … · the purpose of this toolkit is...

NWAS Medicine Management Toolkit Page: of 92

Author: Clinical Governance Co-ordinator Version: 1.0

Date of Approval: 19 September 2011 Status: Final

Date of Issue: 19 September 2011 Date of Review September 2013

MEDICINE MANAGEMENT

PROCEDURES

TOOLKIT



Date of Approval:

19 September 2011 Status: Final

Date of Issue:

19 September 2011 Date of Review September 2013

Recommended by Clinical Governance Management Group

Approved by Executive Management Team

Approval date 19 September 2011

Version number 1.0

Review date September 2013

Responsible Director Medical Director

Responsible Manager (Sponsor) Assistant Director, Clinical Practice

For use by All Trust employees

This policy is available in alternative formats on request.

Please contact the Clinical Governance Co-ordinator on

01204 498392



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Change record form

Version Date of change Date of release Changed by Reason for change

0.1 May 2011 May 2011 M Peters Draft document

0.2 Sep 2011 Sep 2011 M Peters Service Delivery Review

1.0 Sep 2011 Sep 2011 M Peters EMT approved version



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Medicine Management Toolkit Contents Introduction ................................................................................................................................ 6

Duties .......................................................................................................................................... 6

Legal Framework ......................................................................................................................... 8

Toolkit Layout ............................................................................................................................. 9

Section A: General Medicines

Daily Stock Checks: Ambulance Vehicles ................................................................................. 10

Daily Stock Checks: Pharmacy & Station Cabinets ................................................................... 12

Damaged, Expired Medicines Disposal .................................................................................... 15

Documentation for Administration and Receipt of Drugs ........................................................ 17

Documentation Audit Trail: MD01 – MD05 management ...................................................... 19

Drug Alerts ............................................................................................................................... 21

Mitigation Process: Suspected or Known Theft / Loss of medicines ....................................... 22

Procedure for Adverse Drug Reactions (ADR) reporting .......................................................... 26

Procedure for Defective Medicines reporting .......................................................................... 28



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Section B: Controlled Drugs

Authorised Signatures .............................................................................................................. 31

CD Daily Stock Check Procedure .............................................................................................. 33

CD requisition of Vehicle Stocks: Hospital Pharmacy .............................................................. 34

CD Requisition of Vehicle Stocks: Lloyds Pharmacy ................................................................ 36

CD Requisition of Vehicle Stocks: transfer of CDs/supplies by Courier ................................... 39

CD Management of Vehicle Stocks .......................................................................................... 41

CD Security Management: Ambulance Vehicles ...................................................................... 45

CD Security: Key Management ................................................................................................. 47

CD Security: Key Cabinet Management ................................................................................... 50

CD Security: Station CD Cabinet Management ........................................................................ 52

CD Security: Response Vehicles (RVs) ...................................................................................... 54

Damaged Stock Disposal: Morphine ........................................................................................ 55

Expired Stock Disposal: Morphine ........................................................................................... 58

Mitigation Process: Suspected or Known Theft / Loss of Morphine ........................................ 60

Mitigation Process: Suspected or Known Theft / loss of CD Cabinet Key ............................... 63

Patient Administration of Morphine ........................................................................................ 66

Pool, Reserve, Spare or Event Vehicles .................................................................................... 68

Unique Procedures: Event Stadia CD Cabinet Stock Check and Requisitions ......................... 71

Unique Procedures: Re- Designated or Decommissioned Vehicles ......................................... 73

Unique Procedures: Issue of MD07 - AP Procedure ................................................................. 75

Appendix 1: Reference Indicative Medicine Management Forms .......................................... 76

Appendix 2: Authorised Officers of Morphine Destruction .................................................... 91



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Introduction

The purpose of this toolkit is to provide a series of standard operating procedures to

ensure the safe and secure handling of medicines, including Controlled Drugs, within

the North West Ambulance Service NHS Trust (NWAS). The procedures will ensure

compliance with current legislation and national guidance, while meeting the needs of

the service.

It is not the intention of this toolkit to inform staff of the clinical indications for use of

specific drug protocols. The standards of clinical quality will be assessed against the

NWAS Drug Formulary, the Trust’s Patient Group Directions, the British National

Formulary and the JRCALC pre hospital clinical guidelines.

Duties

A full description of the duties is located in the Medicine Management policy, a

summary is presented here.

The Chief Executive has the overall statutory responsibility for the safe and secure

handling of medicines.

The Trust Board are responsible for ensuring that adequate resources are made available to facilitate Medicines Management, including the provision of a Trust Pharmacist Advisor.

The Chief Executive has devolved responsibility for the day to day management of

medicines to the Trust’s Medical Director.

The Medical Director with specialist advice from the Trust’s Pharmacist Advisor and

the Medical Directorate Senior Management Team will determine the medicines

management strategy for the Trust and will determine the standards to be used for the

administration of all medicines used by the Trust. The Medical Director is the named

NWAS Controlled Drugs Accountable Officer (AO). The day to day responsibilities can

be devolved to a named member of staff, the Head of Clinical Governance.

The Assistant Clinical Director is responsible for ensuring that the Trust has the

necessary policies and procedures in place, including sufficient resources to support

their implementation and performance management.

The Head of Clinical Governance is responsible for the corporate development,

implementation and performance management of policies and procedures, including

the provision of expert advice. The Head of Clinical Governance (HoCG) is responsible



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for managing and supporting the development process of all Patient Group Directions

(PGDs). The day to day responsibilities of the AO are devolved to the HoCG.

The Head of Clinical Education is responsible for ensuring that suitable and sufficient

education and training is developed to support the implementation of any PGDs and

medicine management procedures.

The Clinical Governance Co-ordinator is responsible for co-ordinating the

implementation and performance management of medicine management related

policies and procedures across the Trust. The co-ordinator will also be responsible at

corporate level for managing day to day medicine management issues, and co-

ordinate the development and registration of PGDs and is responsible for ensuring

that the appropriate pharmaceutical support is provided via the Trust’s Pharmacist

Advisor.

The Clinical Governance & Safety Manager is responsible for the day to day provision

of advice and support for medicine management issues and supports the operational

implementation and performance management of policies and procedures.

The Sector Managers and Operational Managers within Service Delivery are

responsible for:

Supporting the operational implementation and performance

management of policies and procedures.

Making checks to ensure compliance with the Medicine Management

Policy at least every 3 months. Such checks are to be recorded and

retained for audit purposes for at least 2 years.

Ensuring that the Head of Clinical Governance and the Clinical

Governance Co-ordinator are made aware in a timely manner of any

adverse incidents regarding medicines management.

The Advanced Paramedics within Service Delivery are responsible for:

Supporting all Trust personnel, who are responsible for medicines, in

familiarisation and maintenance of the standards identified in the policy

and procedures.

Supporting the Sector Managers and Operational Managers in their role

with regard to the management of medicines.

Undertaking random audit checks of Controlled Drugs

Support the local implementation of PGDs by being responsible for

ensuring staff are informed at local level.



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Paramedics, Student Paramedics, EMT2, and EMT1s are trained according to their

profession and level of competency in good practice and legislative requirements in

the supply, administration, storage and disposal of medicines. It is their responsibility

to remain up to date and to attend any training provided by the Trust maintaining full

CPD records.

It is the responsibility of all Trust personnel, who are responsible for medicines:

To be familiar with the policy and procedure and adhere to them at all

times.

To be personally responsible for the security, safe storage and

management of all medicines whilst they are in their possession.

The Clinical Governance & Safety Sub-committee is accountable to the Trust Board

and operates within agreed terms of reference.

The sub-committee will:

Monitor standards and performance in relation to Medicine

Management and provide assurance to the Trust Board with regards to

Medicine Management standards.

It is the responsibility of Organisational Performance Group to:

Monitor standards and area performance in relation to agreed medicine

management quality indicators.

Ensure that any issues relating to medicines management are

appropriately managed with necessary actions.

Legal Framework

For the purpose of these procedures, medicines are defined as substances included in

the 1968 Medicines Act as medicinal products. The MHRA defines a medicinal

product under Article 1 of Directive 2001/83/EC as:

a) Any substance or combination of substances presented as having properties

for treating or preventing disease in human beings; b) Any substance or combination of substances which may be used in or

administered to human beings either with a view to restoring, correcting in modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

Further details with regard to the Legal Framework within which NWAS operates are located in the Medicine Management Policy.



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Toolkit Layout

The Medicine Management Toolkit is split into 2 sections.

Section A contains Standard Operating Procedures (SOPs) for General Medicines – that

is all medicines with the exception of Controlled Drugs.

Section B contains SOPs for Controlled Drugs.

The SOPs are in the order that they might be used by a clinician during a shift.

The most frequently used SOPs such as vehicle stock checks located in the front part of

each section and the less frequently used SOPs such as Reporting of Defective

Medicines, located towards the back of the section.



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Daily Stock Checks: Ambulance Vehicles

SOP Title: Vehicle Stock

Checks

Reference Number:

A1.0

Author Name & Designation:

Clinical Governance

Directorate: Medical Directorate Version Number & Date:

1.1

Supersedes: 4.0 (2008) Changes made: (in detail)

Objectives altered to provide assurance in having the right drugs available in the right format to treat the patient

Approved by EMT (date):

19 September 2011

Review Date: September 2013 Date Obsolete:

Background Information:

Objectives

To provide assurance that NWAS will have the correct drugs in the appropriate

formats in place at all times to be able to treat the patient.

Scope

All general drug/medicines held on the vehicle.

All NWAS Emergency vehicles including: Ambulances, RVs, Cycle Response and HART

(Heavy Equipment, Command, Reconnaissance, USAR, Inland Water and Crew)

vehicles.

Manchester Airport Team

Staff Responders and Manager Responders

North West Air Ambulance



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Procedure

1. At the commencement of Duty it is the responsibility of the crew members and

response vehicle personnel (including Managers with drug packs) to perform

the following checks on all medicines on the vehicle:

2. Medicine stock levels will be checked and recorded using the MD01 form.

Visual acknowledgement on sealed boxes

Visual Check

Physical Count

3. The number of signatures should reflect the number of staff present and

wherever possible 2 signatures should be obtained

4. Medicines should be inspected for expiry date, damage and integrity of

packaging

If the packaging is sealed do not open until needed

5. On the last day of each month the expiry dates of all medicines (including

Morphine) will be checked and recorded on the MD03.

6. A stock check must be performed on un-resourced (i.e. Spare or Pool vehicles) vehicles on at least a weekly basis. Local arrangements must be made by the local Service Delivery team to ensure that this takes place.

You must not delay an Emergency due not having performed a medicine stock

check.

Visual check is appropriate for: Aspirin, Paracetamol, Ibuprofen, GTN

Physical count is required for all other medicines (if the packaging has been

opened).



Date of Approval:


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Daily Stock Checks: Pharmacy and Station Cabinets

SOP Title: Management of Documentation

Reference Number:

A2.0


Clinical Governance


1.1


Procedure: updated to read nominated member of staff & their responsibilities


19 September 2011



Objectives

To ensure there are sufficient medicines stocks available to re-stock vehicles as and

when required. The pharmacy/station cabinet stocks are monitored /audited on a

daily basis to ensure a robust audit trail of issue and receipt.

Scope

All general drugs/medicines held in the cabinets.

Procedure

Emergency Department Pharmacy Cabinets and Station Drug Cabinets are both

utilised across NWAS NHS Trust for the re-stocking of drugs. The principles of

managing these cabinets are the same from a Trust perspective.

1. It is the responsibility of the designated supervisory/management lead for

medicine management to ensure that:

There is a nominated vehicle or staff member(s) for checking the

pharmacy/station cabinet(s) within their sector.

Nominated member(s) details are communicated to the

appropriate stations



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2. It will be the responsibility of the nominated vehicle or staff member(s) to:

Perform a stock check of the pharmacy/station cabinet on a daily

basis.

The MD04 must be completed and ideally signed by a co-

signatory when the cabinet stock check is completed.

The number of signatures required must reflect the number of

Emergency Service personnel present

Inform the pharmacy department if pharmacy cabinet stock

levels are considered to be insufficient to last until the next

pharmacy top up.

Place an order with the relevant hospital pharmacy if the station

cabinet stock levels are considered to be insufficient.

3. When medicines are received on station from a pharmacy order, they must be

checked against the pharmacy supply record. Any discrepancies must be

reported to the supplying pharmacy immediately. If the discrepancy is not

immediately resolvable then the mitigation process on page 20 suspected or

known theft/ loss of medicines (SOP ref A7) should be followed.

4. Once pharmacy orders have been checked,

They must be secured without delay within the station drug

cabinet.

The received medicines must be recorded within the ‘Medicines

received’ section of the MD05 form.


ambulance personnel present i.e. wherever possible, two

signatures should be obtained.

The pharmacy supply record should also be signed as received,

including the date.

The supply record should then be stored within the station

cabinet’s medicine folder.

5. When issuing a drug from the pharmacy or station cabinet:

The ‘Medicine Issues’ section of MD05 must be completed.


Emergency Service personnel present



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6. At the end of each month, the designated supervisory/management lead for

Medicine Management is responsible for

Collecting the MD04 and MD05 forms for each drug from the

pharmacy or station cabinet (including pharmacy supply sheets).

Filing the MD04 and MD05 together for each pharmacy or

station cabinet.

The files must be stored securely at an agreed central location

within each sector or station.

Acting as a liaison with the pharmacy departments within their

sector or station.



Date of Approval:


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Damaged, Expired & Used Medicines Disposal (Excludes Controlled Drugs)

SOP Title: Disposal of Medicines (Excludes CDs)

Reference Number:

A3.0


Clinical Governance


1.1


Scope: Amended to capture teams & vehicles in the Trust


19 September 2011



Objectives

To ensure the disposal of general medicines is in line with relevant legislation

including the provision of a robust audit trail.

Scope

All general drugs/medicines held on the vehicle.



vehicles.

Pharmacy and Station General Drug Cabinets






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Procedure

NB Please note this procedure does not refer to the disposal of Morphine or any

other Controlled Drugs. Please refer to Section 2 – Management of Controlled

Drugs

For specific guidance on the disposal of sharps bin waste from ambulances, please

refer to the Trust Infection Control Procedures.

1. When a medicine has been used, expired or become damaged it must be

disposed of in the appropriate yellow clinical waste receptacle situated on each

vehicle.

2. The MD02 must be completed with the

The name of the medicine, its strength, batch number and

quantity

The route of disposal must be recorded within the ‘Total Dose

Administered’ box i.e. sharps bin.

The reason for destruction must be recorded in the ‘Incident No.’

box i.e. damaged or expired.




3. New medicine stock must be obtained from the local pharmacy or station

cabinet as per SOP: A2.0

4. The restocking of medicines must follow SOP: A4.0



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Documentation for Patient Administration and Receipt of Drugs

SOP Title: Documentation of Drug Administration and Receipts

Reference Number:

A4.0


Clinical Governance


1.1


Objectives: addition of: to provide assurance that a full and complete patient record is maintained.


19 September 2011



Objectives

To ensure that there is a robust and easily identifiable audit trail and record of all

drugs on the vehicle at all times, and to provide assurance that a full and complete

patient record is maintained

Scope




vehicles.






Date of Approval:


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Procedure

1. When a medicine has been administered to a patient, it is the responsibility of

the person who has administered it to record its use on both the

Patient Report Form (PRF) /ePR and

The appropriate MD02 form (RRV MD02 if RRV medicine stock;

Ambulance MD02 if ambulance medicine stock).

2. Where the administering staff member is working on the RRV and does not

travel with the patient then the attending ambulance crew must ensure that

the medicine is recorded on the PRF/ePR.

3. All fields within the ‘Medicine Issues’ section of the MD02 form must be

completed. This must be recorded prior to clearing from the incident.

For each medicine administered, the number of signatures

required must reflect the number of ambulance personnel

present, i.e. wherever possible, two signatures should be

obtained.

When required, the re-stocking of medicines should be

undertaken as soon as practicably possible i.e. before the end of

shift.

4. When restocking

It is the responsibility of the person who receives/collects the

medicine to complete all fields within the ‘Medicines Received’

section of the MD02 form.




Note: Notwithstanding the above procedure it is the responsibility of the senior

clinician to be assured paperwork is completed adequately, correctly,

contemporaneously and as fully as possible.



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Documentation Drug Audit Trail – MD01 to MD05 Management

SOP Title: Management of Documentation

Reference Number:

A5.0


Clinical Governance


1.1


Objectives: addition of: to provide assurance that a full and complete patient record is maintained.


19 September 2011



Objectives

To monitor the quality and compliance of documentation completion and take

action as necessary; to ensure that there is an easily identifiable audit trail and

record of all drugs on the vehicle at all time. Documentation is to be stored for a

minimum of 2 years.

Scope




vehicles.






Date of Approval:


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Procedure

It is the responsibility of all NWAS personnel to ensure the safe storage of

medicines documentation within designated folders on all NWAS vehicles.

All medicine documentation must remain on the vehicle and be available for

inspection.

1. On the last day of each month the designated supervisory/ management

lead staff member responsible for Medicines within the Station must

receive from each vehicle:

a) MD01: Vehicle Medicine Check Sheet

b) MD02: Vehicle Medicine Issue and Receipt Record

c) MD03: Monthly Expiry Sheet

2. Upon receipt of the documentation, the designated supervisory /

management lead will then be responsible for filing the MD01, MD02 and

MD03 together for each vehicle. The files must be stored securely at an

agreed central location within each sector or station.

3. The designated supervisory/management lead will be responsible for

collecting the following documents from the local A&E pharmacy

cabinet(s)/station drug cabinet(s) that serve their station on the last day of

each month:

a) MD04: Pharmacy/Station Cabinet Stock Check

b) MD05: Pharmacy/Station Cabinet Stock Issues and Receipts

4. The designated supervisory/management lead will then be responsible

for filing the MD04 and MD05 forms together for that month. The files

must be stored securely at an agreed central location within each sector

or station.

5. The designated supervisory/management lead will monitor the quality

and compliance of documentation completion and if necessary, take

appropriate action.

6. All medicines documentation must be stored securely for a minimum of 2

years.

7. The Sector Managers supported by the Advanced Paramedics have

overall responsibility for the safe and secure storage of medicine

documentation.



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Date of Issue:


Drug Alerts

SOP Title: Drug Alerts Reference Number:

A6.0


Clinical Governance


1.1


Procedures: Update to include ECC actions


19 September 2011



Objectives

To ensure Trust responds appropriately and robustly to any drug alerts received,

reducing the risk to staff, patients and the Trust.

Scope

All general drugs and medicines held by the Trust.



vehicles.






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Procedure

Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a ‘Drug Alert’ letter. This Alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product.

Class 1 is the most critical, for example serious mislabelling,

microbial contamination or incorrect ingredients, and requires

immediate recall;

Class 4 is the least critical and advises ‘caution in use’.

1. During working hours, Quality Control North West will communicate

alerts by fax or email to the Clinical Governance Co-ordinator, Clinical Governance Department, NWAS NHS Trust Headquarters.

2. The relevance of the alert will be assessed and if necessary, communicated to the Head of Clinical Governance and Clinical Governance & Safety Manager.

3. The Clinical Governance Co-ordinator will ensure that all alerts are recorded and when action is required the Head of Clinical Governance must ensure that the alert is communicated to all relevant individuals and that all necessary actions are undertaken immediately.

Outside working hours:

1. Quality Control North West will communicate alerts by fax or telephone to the Manchester Area Emergency Control Centre.

2. The Emergency Control Centre Manager will notify the other Control Centres and provide them with the relevant information.

3. The ECCs must notify the relevant Duty Service Delivery Managers

4. The Duty SD Managers must assess the relevance of the alert and if necessary ensure any immediate actions required are undertaken.

Any alerts or actions undertaken outside working hours;

Must be reported to the Clinical Governance Co-ordinator and the Clinical Governance & Safety Manager as soon as practicably possible.

The Incident Reporting and Investigation Policy must be followed to record the event and actions taken.

5. In the event of a drug alert involving a recall, arrangements must be made to return the medicines to the supplying pharmacy.

6. All Drug Alerts received will be recorded, reviewed and reported using the Trust Clinical Guidance Review Process.



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Mitigation Process: Suspected or Known Theft / Loss of Medicines and the Reporting of Discrepancies

SOP Title: Theft or Loss of Medicines and the reporting of discrepancies

Reference Number:

A7.0


Clinical Governance


1.1


Procedure: Updated to reflect the changes in terminology such as ECC


19 September 2011



Personal Safety is paramount – do not obstruct or attempt to stop somebody in the

event of being threatened to hand over medicines or when witnessing a person

stealing medicines.

Comply with demands and offer no resistance.

Objectives

To ensure the management of drugs is robust and any discrepancies are identified

at the earliest opportunity reducing the Trust risk with regard to the management

of medicines.

Scope




vehicles.


All Station and Pharmacy Cabinets





Date of Approval:


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Procedure

N.B.: Under no circumstances should you obstruct or attempt to stop somebody

in the event of being threatened to hand over medicines or when witnessing a

person stealing medicines.

PERSONAL SAFETY IS PARAMOUNT

When being threatened by somebody, offer no resistance, comply with their

demands and allow them to leave.

If a medicine is known or suspected to have been stolen:

1. The appropriate ECC must be informed immediately and request that the

Police are contacted

2. The ECC must contact and inform the Duty SD Manager or Advanced

Paramedic of the incident

3. The Duty SD Manager or Advanced Paramedic must visit the crew to

provide support and identify if any further assistance is required.

4. The relevant Sector Manager must be notified as soon as possible.

5. An incident report form must be completed immediately by the crew

involved and forwarded to the appropriate Manager for investigation.

6. The Clinical Governance & Safety Manager and the Security & Safety

Practitioner must be notified as soon as practicably possible.

7. The Trust Incident Reporting and Investigation Policy must then be

followed. The Security & Safety Practitioner will provide advice and

support with regard to how the investigation should be conducted.

8. Following the investigation a diary note must be made in the vehicle

documentation.



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When a discrepancy is identified that cannot be explained:

1. The Duty Service Delivery Manager or Advanced Paramedic must be

notified immediately.

2. The discrepancy should be confirmed with another colleague where

possible.

3. The vehicle’s documentation must be inspected in an attempt to

identify the reason for the discrepancy.

4. If the discrepancy remains unresolved, the previous crew to work on the

vehicle must be interviewed at the earliest opportunity by a Duty

Service Delivery Manager.

5. An incident report form must be completed immediately by the crew

involved and forwarded to the appropriate Manager for investigation.

6. The Clinical Governance & Safety Manager and the Security & Safety

Practitioner must be notified as soon as practicably possible.

7. The Trust Incident Reporting and Investigation Policy must then be

followed. The Security & Safety Practitioner will provide advice and

support with regard to how the investigation should be conducted.

8. Following the investigation a diary note must be made in the vehicle

documentation.



Date of Approval:


Date of Issue:


Procedure for Reporting Adverse Drug Reactions (ADR) for Medicines Administered by Ambulance Staff

SOP Title: Procedure for reporting Adverse Drug Reactions (ADR) for medicines administered by ambulance staff

Reference Number:

A8.0


Clinical Governance


1.1


Throughout: Focus on patient safety


19 September 2011



Objectives

To ensure that any Adverse Drug Reaction (ADR) is managed appropriately in line

with legislation, whilst also providing assurance to the Trust with regard to patient

safety.

Scope

All general drugs/medicines administered by ambulance staff (including the

patient’s own medications) in line with exemptions from legislation and the NWAS

Drug Administration Protocol Reference (DAPR) Guide.



vehicles.






Date of Approval:


Date of Issue:


Procedure

When an ADR occurs the following procedure must be followed:

1. If the drug is still being administered stop immediately.

2. Assess patient’s condition and treat accordingly.

3. Retain a sample of the drug and its container if possible.

4. Transport the patient to hospital.

5. Pre- alert the receiving hospital if required.

6. Record all information on the Patient Report Form/ePR, including signs and symptoms of the reaction, and their time and duration.

7. Provide a full verbal and written handover on arrival at hospital.

8. Discuss the ADR with an Emergency Department doctor and confirm if a Yellow Card is to be completed.

Further advice may be sought from an Advanced Paramedic if required

If a Yellow Card is to be completed,

1. Provide all necessary information to the doctor completing it.

2. Record the fact that a Yellow Card has been completed and the name of the doctor on the Patient Report Form/ePR.

An ADR is considered to be a clinical incident, therefore an incident report form must be completed and the Trust Incident Reporting and Investigation Policy followed.

When completing the incident report the following information must be recorded:

1. The drug to which the reaction occurred. 2. The batch no. and expiry date of the drug. 3. The signs and symptoms of the reaction. 4. The date and time the reaction occurred and it’s duration. 5. State if a Yellow Card was completed and the name of the doctor

who completed it.



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Date of Issue:


Procedure for Reporting of Defective Medicines

SOP Title: Reporting of Defective Medicines

Reference Number:

A9.0


Clinical Governance


1.1


Procedures: Update to include examples as to what is meant by concerns.


19 September 2011



Objectives

To ensure the Trust responds appropriately and robustly to any suspected

defective medicines reducing the risk to staff, patients and the Trust.

Scope

All general drugs and medicines held by the Trust.



vehicles.






Date of Approval:


Date of Issue:


Procedure

1. When a member of staff has concerns about the quality of a medicine:

a) if identified post treatment:

Monitor the patient closely for any adverse signs and symptoms

Record the concerns on the Patient Report Form/ePR

Inform the Advanced Paramedic and seek further advice if required

Refer the matter to an Emergency Department Doctor immediately

A sample of the medicine should be retained if possible

A full verbal and written handover must be provided to the receiving hospital

The doctor will decide if the Defective Medicines Report Centre needs to be contacted

b) if identified pre treatment:

Refer the matter to the Duty Advanced Paramedic who will contact the hospital pharmacist in the first instance

The pharmacist will decide if the Defective Medicines Report Centre needs to be contacted.

2. If a potential risk is indentified the member of staff must inform the

Duty Advanced Paramedic to activate the Trust Incident Reporting

Procedure; and inform the Emergency Control Centre Manager.

3. The Emergency Control Centre Manager will notify the other locality

Emergency Control Centres and provide them with the relevant

information.

4. The Emergency Control Centres must notify the relevant Duty Service Delivery Managers within their respective areas.

5. The Duty Service Delivery Manager must ensure that the relevant information (drug presentation, batch number, brand, strength etc) is communicated to all vehicles and personnel for checking and removal if necessary via the in vehicle bulletin boards (MDT Screens).

6. Affected batches of the medicine must be withdrawn from use and stored securely on stations.

7. The Duty Service Delivery Manager must also ensure arrangements are made to identify affected medicines within all the Emergency Department Pharmacy/Station Cabinets.

8. Affected medicines within the Emergency Department Pharmacy/Station Cabinets must be marked clearly with ‘DO NOT USE’.



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In the event of a drug alert involving a recall, arrangements must be made to return the medicines to the supplying pharmacy.

9. The Clinical Governance Co-ordinator and the Clinical Governance & Safety Manager must be notified at the earliest opportunity.

10. The Clinical Governance Department will follow the North West Drug Defect Reporting Procedure as defined by Quality Control North West, Stepping Hill Hospital.

11. An incident report form must be completed and the Trust Incident

Reporting and Investigation Policy followed.



Date of Approval:


Date of Issue:


Authorised Signatures

SOP Title: Authorised

Signatures

(Morphine)

Reference Number:

B 1.0


Clinical Governance


1.1


Objectives altered to assurance in having the right drugs available in the right format to treat the patient


19 September 2011



Objectives

To provide assurance that NWAS will have the correct drugs in the appropriate

formats in place at all times to be able to treat the patient and requisition is made

only by authorised personnel in accordance with best practice guidance and

legislation.

Scope

Morphine Sulphate stocked by the Trust

All NWAS Emergency vehicles including: Ambulances, RVs, and HART (USAR and

Inland Water) vehicles.





Date of Approval:


Date of Issue:


Procedure

Each pharmacy department that supplies Morphine to NWAS will have a file of

approved signatories for State Registered Paramedics working within that

hospital’s receiving area, that are entitled to requisition Morphine. This will also

include courier staff, which are authorised to collect and transfer requisitions and

completed orders.

1. An Operational Manager may add a Paramedic to the signatory list by

completing an MD12.

2. A copy of the completed MD12 must be retained by Service Delivery for

reference purposes

3. The completed MD12 document will be issued to the appropriate

pharmacy.

4. Paramedics who requisition Morphine directly from pharmacy must be on

Duty, in recognised uniform with photographic identification (an NWAS

identification badge).

5. The Service Delivery Management Team will be responsible for ensuring

that pharmacy signature lists are updated when staff join or leave the

organisation.

6. The pharmacy signature lists must also be reviewed by local Service

Delivery Management every two years to ensure that it is up to date.

The Head of Clinical Governance will authorise the Operational Managers ability to

complete the MD12 by the completion of the MD12a.



Date of Approval:


Date of Issue:


CD Daily Stock Check Procedure

SOP Title: Stock Check

Procedures

Reference Number:

B 2.0.


Clinical Governance


1.1


Objectives altered to ensure access to the CD safe is made only by an authorised Paramedic


19 September 2011



Objectives

To provide assurance that NWAS will have the correct controlled drugs in the

appropriate format in place at all times to be able to treat the patient.

Scope

All CDs stocked by the Trust including Morphine Sulphate.





N.B.: Please refer to SOP B 11.0 for additional guidance on Rapid Response

Vehicle personnel.

Procedure

1. Two members of staff – the Paramedic starting Duty and the Paramedic

finishing Duty must check the Morphine at the beginning of the shift.



Date of Approval:


Date of Issue:


2. A single shift check is acceptable, but it is recognised as good practice that a

Morphine stock check is performed at handover/beginning of each shift.

3. In the event of an incident being allocated to the vehicle prior to or during

the handover, it will be acceptable for both personnel commencing Duty

to complete the stock check immediately after clearing from the incident.

(It is imperative that the response to the incident is not delayed by the

checking procedure)

4. When there is no Paramedic commencing Duty it must be verified with one

of the EMT staff commencing Duty. The EMTs will then have no access to

the CD Cabinet (see SOP B9.0. CD Key Management).

5. When an ambulance or Response Vehicle is resourced solely by EMT staff,

a Paramedic working from the same base station must perform a stock

check at least once during the shift.

6. At the commencement of Duty, both the Paramedic and other crew

member must complete a stock check if the vehicle has not been

resourced.

7. When the vehicle is not resourced for the following shift, both crew

members must complete a stock check at the end of their shift.

8. When a vehicle (including pool/reserve vehicles) is not resourced,

designated supervisory/management or Paramedic staff on that station

must ensure a stock check is completed at least once a day. These

arrangements must be organised within the SD management Band 6 staff at

Station level.

9. All stock checks must be recorded in the Morphine MD08, writing ‘stock

check’ in the Incident No. box and recording the stock level.

10. Two signatures must be recorded by the two personnel performing the

stock check.

11. Stock checks must be completed accurately, including the date and times

when they are completed.

N.B.: In the event of staff not being able to complete a witnessed stock check, the locality Control Centre must be informed for entry on the Control Manager’s Log, including a reason why the witnessed stock check was not performed.



Date of Approval:


Date of Issue:


CD Requisition of Vehicle Stock (From Hospital Pharmacy)

SOP Title: Requisition of

Vehicle Stock

(Morphine)

Hospital Pharmacy

Reference Number:

B 3.0.


Clinical Governance


1.1


Objectives altered to assurance in having the right drugs available in the right format to treat the patient.


19 September 2011



Objectives

To ensure the requisition of Morphine is in accordance with best practice guidance

and legislation and that NWAS will have the correct drugs in the appropriate formats

in place at all times to be able to treat the patient.

Scope

Morphine Sulphate requisitioned by the Trust





GM & C&L Only

Procedure

Every emergency vehicle shall have a Morphine requisition book (MD07). The book will contain the following details on numbered, duplicate pages:

Vehicle Registration number and Call Sign

Date



Date of Approval:


Date of Issue:


The name of the drug requested, pharmaceutical form and the total quantity requested in words and figures.

The name and signature of the Paramedic.

The purpose for which the drug supplied is required (vehicle stock).

The total quantity supplied.

The signature of the supplier.

The location of the supplier.

The signature of the recipient.

1. The Paramedic on Duty shall submit the Morphine MD07, as per local

procedure, when a vehicle requires re-stocking, to a locally agreed hospital

pharmacy department.

2. Morphine can only be requisitioned from pharmacies from Monday to

Friday, during normal working hours. There is no out-of-hours service

available.

3. A vehicle that is regularly operational on days should be designated by the

local management to perform the re-stocking of these vehicles.

4. The Morphine MD07 must be submitted to the pharmacy department

before a specified time – where to local agreements exist.


duty, in recognised uniform with photographic identification (an NWAS


6. Upon submission of the MD07 the pharmacy department will confirm a

collection time.

7. Once orders are completed or dispensed, the pharmacy department must

retain the top copy of the Morphine MD07.

8. The second copy of the Morphine MD07, for orders received, must be

retained within the book.



Date of Approval:


Date of Issue:


CD Requisition of Vehicle Stock (From Lloyds Pharmacy)

SOP Title: Requisition of Vehicle Stock

(Morphine) Lloyds Pharmacy

Reference Number:

B 4.0.


Clinical Governance


Supersedes: Changes made: (in detail)

Objectives altered to assurance in having the right drugs available in the right format to treat the patient.


19 September 2011



Objectives

To ensure the requisition of Morphine is in accordance with best practice guidance

and legislation and that NWAS will have the correct drugs in the appropriate formats

in place at all times to be able to treat the patient.

Scope

Morphine Sulphate requisitioned by the Trust

All NWAS Emergency vehicles including: Ambulances, RVs, Event & Stadia and HART

(USAR and Inland Water) vehicles.

C&M Area Only



Date of Approval:


Date of Issue:


Procedure

Every emergency vehicle shall have a Morphine requisition book (MD07). The book will contain the following details on numbered, duplicate pages:

Vehicle Registration number and Call Sign

Date

The name of the drug requested, pharmaceutical form and the total quantity requested in words and figures.


The purpose for which the drug supplied is required (vehicle stock).





1. The Paramedic on Duty identifies the vehicle requires additional Morphine

stock

Replenishment occurs when stock level is 10 ampoules or less

2. Morphine can only be requisitioned from Lloyds Pharmacies from Monday

to Saturday, during normal working hours. There is no out-of-hours service

available.

3. Paramedic on Duty informs Emergency Control Centre (ECC) that they

require to collect Morphine from pharmacy.

4. ECC acknowledge and manage request dependent on operational

activity/pressure

5. ECC authorise collection from designated Lloyds site and pre-alert the

pharmacy

Vehicles will have postcodes for pharmacies

Vehicles must remain available throughout - no requirement for

operational down time

6. The Morphine MD07 must be completed by the on Duty Paramedic.

7. On arrival at Lloyds, the Paramedic hands over the completed CD Morphine

Book MD07 and the MD08 CD Morphine Stock Check book in at the

pharmacy.



Date of Approval:


Date of Issue:


Paramedics who requisition Morphine must be on Duty, in

recognised uniform with photographic identification (an NWAS

identification badge)

Lloyds Pharmacies will have a specimen signature of Paramedics

authorised to requisition Morphine for NWAS

8. The Lloyds Pharmacy prepares and issues completed requisition to on Duty

Paramedic.

The on Duty Paramedic prepares the Morphine MD08 Vehicle CD

Book for stock entry

Pharmacy consulting rooms can be used for the issue of Morphine

and completion of documentation

9. On Duty Paramedic signs Morphine CD Order Book MD07 to confirm

receipt of the Morphine

10. On Duty Paramedic and Pharmacy staff sign stock entry in Morphine MD08

book.

11. On Duty Paramedic secures Morphine and documentation into vehicle CD

cabinet immediately.

Lloyds Pharmacy maintains an electronic register/database of all

completed requisitions; and monthly reports of completed

requisitions, by Paramedic, to the Clinical Governance & Safety

Manager.



Date of Approval:


Date of Issue:


CD Requisition (Transfer of CD/supplies by Courier)

SOP Title: Transfer of CD requisitions/supplies

by courier (Morphine)

Reference Number:

B 5.0.


Clinical Governance


1.1




19 September 2011



Objectives

To ensure the courier Morphine CD requisition/supply process is in accordance with

best practice guidelines and compliant with legislation whilst providing assurance

that NWAS will have the correct drugs in the appropriate formats in place at all times

to be able to treat the patient.

Scope





Procedure

Only couriers employed by the Trust are authorised to transport CD requisitions or

supplies for delivery to pharmacies, vehicles or stations.

1. All completed Morphine MD07 CD requisitions (as per SOP B3.0.) must be

placed in the designated collection area on station.



Date of Approval:


Date of Issue:


2. The Station CD Requisition Record (Appendix 1) sheet must also be

completed and signed by the requisitioning Paramedic.

3. When the courier collects the completed Morphine MD07 requisitions, they

must check them against the Station CD Requisition Record and sign to

confirm for each Morphine MD07 collected.

4. The courier must then place the completed Morphine MD07 requisitions

individual CD bags (marked with the vehicle call sign, registration and

station) for transport to pharmacy, with the completed Station CD

Requisition Record.

5. The courier must then deliver the Morphine MD07 requisitions to the

agreed pharmacy.

6. The pharmacy department must check and sign for each Morphine MD07

requisition received on the Station CD Requisition Record.

7. The courier will then agree a collection time/date for completed orders.

8. The courier must present a Trust identification card that includes a

photograph before they are allowed to collect any Morphine orders from

pharmacy.

9. The pharmacy department will also have a copy of authorised courier

signatures for the collection of Morphine as per section 10.0.

10. Completed orders with the Morphine MD07 book, will be placed in the

individual (marked with vehicle call sign, registration, station, sealed and

tamper evident) bags.

11. The pharmacy department will supply the courier with the completed

orders in sealed bags.

12. The courier must check the sealed bags against the Station CD Requisition

Record and then sign to confirm that they are all present.

13. The courier will then deliver the completed, sealed orders to the relevant

vehicles or stations.



Date of Approval:


Date of Issue:


CD Management of Vehicle Stocks

SOP Title: CD Management of Vehicle Stocks

(Morphine)

Reference Number:

B6.0.


Clinical Governance


1.1

Reference Number: B6.0. Supersedes: 5.2 (2008) Changes made: (in detail)



19 September 2011



Objectives

To ensure the management of vehicle stocks is in accordance with best practice

guidelines and compliant with legislation whilst providing assurance that NWAS will

have the correct drugs in the appropriate formats in place at all times to be able to

treat the patient.

Scope






Procedure

1. Once stock has been received from the pharmacy or courier it must be placed in the vehicle CD Cabinet and secured immediately before continuing with any ambulance duties.

2. When the courier deliveries cannot be placed directly onto an emergency vehicle they must be secured on the vehicle’s base station, within the



Date of Approval:


Date of Issue:


designated station CD cabinet. The ambulance crew will be notified of this and re-stock the vehicle upon their next return to station.

3. Courier deliveries can only be received on station when an ambulance Paramedic is present to receive it.

4. Where possible, the courier should liaise and coordinate with the appropriate Paramedic/Service Delivery staff to ensure deliveries can be received.

5. If the courier is unable to complete delivery of Morphine orders on the same day arrangements must be made to deliver them to a Paramedic-qualified Manager/supervisor who can make arrangements to ensure that the vehicles are supplied.

6. Each vehicle shall have a Morphine CD Register (MD08) for issues and

receipts, containing the following information:

Drug preparation and strength

Vehicle Registration Number and Call Sign

Date

Issue / received / stock check

Quantity Administered

Quantity Issued

Stock Level

Patient Report Form number

Signatures (both crew members)

Print names (both crew members)

7. Entries must be made in the Morphine MD08 immediately after any issue

or receipt of Morphine.

Entries must always be made in ink and be legible.

8. Two signatures must be recorded on the Morphine MD08 for all Morphine

issued or received – the person who received or issued it and a witness. In

the event of Rapid Response personnel administering Morphine, a

signature must be obtained from a crew member of the responding

ambulance to that incident.

9. All entries must be made on the same day as the issue or receipt of

Morphine.

10. Entries must always be in chronological order.



Date of Approval:


Date of Issue:


11. The Morphine MD07 and Morphine MD08 books and Morphine must be

stored together in the CD Cabinet at all times.

12. The Morphine MD08 can be used to record any issues, notes or records of

audits that occur. This will ensure that the Morphine MD08 acts as a

‘diary’ for all activities concerning the Morphine stock. Each entry must

have the date recorded and the name and signature of the person making

the entry.

13. A maximum stock level of 20 X 10mg ampoules can be stored on

emergency vehicles at any given time (this does not include expired stock).

14. When the vehicle stock level reaches 10 ampoules, a box of 10 ampoules

must be requisitioned from pharmacy.

15. It is the responsibility of Paramedics working during day shifts – Monday

to Friday – to requisition Morphine.

N.B.: Pharmacy orders can only be placed in units of 10 x 10mg ampoules

16. Morphine must not be transferred from one vehicle stock to supplement

another vehicle stock.

17. In the event of Morphine having to be moved from a vehicle (e.g. if the

vehicle is going off site), it must be transferred with the Morphine MD07

and Morphine MD08 books into the station safe and a note made within

the MD08 book to record the move – as a ‘diary’ entry.

The same Daily Checks must be made on this stock as if it was still on the vehicle.



Date of Approval:


Date of Issue:


CD Security Management: Ambulance Vehicles

SOP Title: CD Security management:

Ambulance Vehicles

Reference Number:

B 7.0.


Clinical Governance


1.1

Reference Number: B 7.0. Supersedes: 5.7 (2008) Changes made: (in detail)

Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to vehicle security


19 September 2011



Objectives

To ensure all authorised staff adhere to a robust procedure in relation to vehicle

security that is in accordance with best practice guidance and legislation with a

complete and robust audit trail.

Scope








Date of Approval:


Date of Issue:


Procedure

1. Vehicles containing controlled drugs should be locked at all times when

left unattended in public places – this includes hospital sites.

Note: It is accepted that this is not always immediately possible at Major

Incidents, Motorway incidents or hospital sites where the patient is not self

perambulatory; however it is important that in these circumstances staff

mitigate the security risk by locking the vehicle as soon as it is practicable.

2. When vehicles are not resourced and parked on station they must be

locked and the keys stored within a designated area on station.

3. Vehicles with defective or broken locks must be reported and the

appropriate workshops or Duty mechanic notified.

4. The repair of the locks should be treated as a priority.

In the event of repairs being excessively delayed, arrangements

must be made for the crew to transfer onto a pool/reserve

vehicle (see SOP B17.0)

5. If the actual CD Cabinet is damaged or defective the crew must transfer

onto a pool/reserve vehicle immediately (see SOP B17.0.).

The Morphine must then be removed from the vehicle and

stored within the station CD Cabinet (see SOP B17.0.).

6. If there are no pool/reserve vehicles available or service demand prevents

the changeover, the Morphine may be removed and stored temporarily

within a Station CD Cabinet (see SOP B17.0.).

7. Stocked vehicle CD Cabinets must not be opened by workshop personnel

unless in the presence of a qualified Paramedic.



Date of Approval:


Date of Issue:


CD Security: Key Management

SOP Title: CD Security : Key Management Reference Number:

B 8.0.


Clinical Governance


1.1




19 September 2011



Objectives

To ensure the CD cabinet is accessed only by the on Duty Paramedic and describes

processes should keys be taken home, lost or stolen in accordance with best practice

guidance and legislation.

Scope


All NWAS Emergency vehicles including: Ambulances, RVs and HART (USAR and




Only Paramedic Staff are authorised to be in possession of CD Keys.

Non-Paramedics are authorised to be in possession of CD keys only under the

supervision of Paramedics: i.e. to assist with stock checks or patient

administration



Date of Approval:


Date of Issue:


Procedure

1. At the commencement of Duty the Paramedic shall remove the CD cabinet

key from the station key cabinet for the vehicle they are working on.

2. The on Duty Paramedic will be responsible for the CD cabinet key and the

contents of the CD cabinet for the duration of the shift.

3. The CD cabinet key must be kept in the possession of the on Duty

Paramedic at all times, for the duration of their shift.

4. At the end of the shift the on Duty Paramedic must hand the CD cabinet

key over to the Paramedic commencing Duty. (It is good practice to

complete the handover stock check at this time also).

5. When the vehicle is not to be resourced or resourced without a Paramedic

then, at the end of shift, the on Duty Paramedic must then ensure the CD

cabinet is locked and return the CD cabinet key to the station key cabinet.

6. A spare key for every CD cabinet shall be securely stored within Clinical

Governance Department.

N.B: Access to the spare keys is subject to authorisation by the Clinical

Governance & Safety Manager, Clinical Governance Co-ordinator or Head

of Clinical Governance.

7. The spare key located at Clinical Governance will only be issued if the

original is confirmed lost or stolen.

8. The spare key located at Clinical Governance will not be released due to a

key being taken home by a member of staff.

9. It is the responsibility of the staff member that has taken a key home, to

return it as soon as possible.

N.B.: An ambulance or response vehicle can remain operational without

having access to the CD cabinet.

10. Incidents of CD keys being lost or stolen must be recorded on an incident

report form and the Trust Incident Reporting and Investigation Policy

followed.



Date of Approval:


Date of Issue:


CD Security: Key Cabinet Management – access codes

SOP Title: CD Security: CD Key Cabinet

Management- access codes

Reference Number:

B9.0.


Clinical Governance


Reference Number: B9.0. Supersedes: Changes made: (in detail)


19 September 2011



Objectives

To ensure the CD Key cabinet code is regularly changed to ensure the access to CD

keys is restricted to Paramedic staff in accordance to legislation and guidance.

Scope

All Station key cabinets.

All vehicles with a CD key cabinet in situ



Event Stadia with CD Key Cabinet in situ

Only Paramedic Staff are authorised to know the access code for the CD Key

cabinet.

Non-Paramedics are authorised to be in possession of CD keys only under the


administration



Date of Approval:


Date of Issue:


Procedure

1. The local Service Delivery (SD) Manager or nominated lead for Medicine

Management is responsible for regularly changing the access code for the

CD Key Cabinet either on station or on a vehicle with a CD key cabinet in

situ.

2. The CD Key Cabinet access code must be changed every 3 months.

3. The code change must be notified to Paramedics in such a way that Non-

Paramedics are not made aware of the CD Key cabinet code.

4. It is the responsibility of Paramedics to maintain the security of the access

code.

Where an access code has become known by Non-Paramedics:

1. The Duty SD Manager or AP must be informed without delay.

2. The CD Key Cabinet in question must have its code changed immediately

3. The new code must be notified to Paramedics in such a way that Non-

Paramedics are not made aware.

4. An incident report form must be completed by the Non-Paramedic and the

Trust Incident Reporting and Investigation Policy followed.

5. The Clinical Governance & Safety Manager will be responsible for

monitoring the occurrence and recording the incidence on the Monthly

Occurrence Report.



Date of Approval:


Date of Issue:


CD Security: Station CD Cabinet Management – access

SOP Title: CD Security: Station CD Cabinet

Management - access

Reference Number:

B 10.0.


Clinical Governance




19 September 2011



Objectives

To ensure the CD cabinet (where on an access code) the code is regularly changed to

ensure access cannot be made by anyone other than the on Duty Paramedic;

restricting access to CDs by Non-Paramedic staff in accordance to legislation and

guidance.

Scope

All Station CD Cabinets



Only Paramedic Staff are authorised to know the access code for the CD Cabinet.

Non-Paramedics are authorised to be in possession of CDs only under the


administration



Date of Approval:


Date of Issue:


Procedure

1. The local SD Manager or nominated lead for Medicine Management is

responsible for regularly changing the access code for the CD Station

Cabinet.

2. The CD Station Cabinet access code must be changed every 3 months.

3. The code change must be notified to Paramedics in such a way that Non-

Paramedics are not made aware of the CD Station cabinet code.

4. It is the responsibility of Paramedics to maintain the security of the access

code.

Where an access code has become known by Non-Paramedics:

5. The Duty SD Manager, and Advanced Paramedic must be informed without

delay.

6. The CD Station cabinet in question must have its code changed

immediately

7. The new code must be notified to Paramedics in such a way that Non-

Paramedics are not made aware.

8. An incident report form must be completed by the Non-Paramedic and the

Trust Incident Reporting and Investigation Policy followed.


monitoring the occurrence and recording the incidence on the Monthly

Occurrence Report.



Date of Approval:


Date of Issue:


CD Security: Response Vehicles (RVs)

SOP Title: CD Security: Response Vehicles

(RVs)

Reference Number:

B11.0.


Clinical Governance


1.1




19 September 2011



Objectives

To ensure the CD cabinet is accessed only by the on Duty Paramedic and describes

processes should keys be taken home, lost or stolen in accordance with best practice

guidance and legislation.

Scope







Date of Approval:


Date of Issue:


Procedure

Paramedics working on response vehicles must follow the same Medicine Management procedures as for ambulances with the following exceptions:

1. When Morphine has been administered the on Duty Paramedic must

obtain the signature of a crew member from the attending ambulance.

2. The details of the Morphine administered must be entered on the Patient

Report Form/ePR the ambulance crew are using.

3. Ideally at the commencement and finish of the shift the Paramedic RV staff

may perform routine stock checks on their own, recording single signatures.

If another member of staff is available a second signature must be obtained.

4. When a Paramedic is working on an RV and is unable to have the stock

check witnessed at the commencement of shift, they must ensure that a

witnessed check is completed at some point during their shift.



Date of Approval:


Date of Issue:


Damaged Stock Disposal (Morphine)

SOP Title: Damaged Stock Disposal

(Morphine)

Reference Number:

B 12.0.


Clinical Governance


1.1


Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to when Morphine is damaged


19 September 2011



Objectives

To ensure all authorised staff adhere to a robust procedure in relation to when

Morphine is damaged in accordance with best practice guidance and legislation

ensuring a robust audit trail is completed.

Scope








Date of Approval:


Date of Issue:


Procedure

1. In the event of a damaged ampoule of Morphine the on Duty Paramedic

must ask the other crew member to verify the incident.

Paramedics working on RVs must attempt to retain it as best as

possible for verification by another member of staff at the next

available opportunity.

2. The damaged stock must then be disposed of in the yellow sharps bin,

situated on each A&E vehicle (including RVs).

3. The damaged stock must then be recorded as an issue in the MD08.

‘Damaged Stock’ must be recorded within the Incident No. box of the

MD08.

4. An incident report form must be completed by the Paramedic and the

Trust’s Incident Reporting and Investigation Policy followed.


monitoring the occurrence of damaged stock and recording the incidence

on the Monthly Occurrence Report.



Date of Approval:


Date of Issue:


Expired Stock Disposal (Morphine)

SOP Title: Expired Stock (Morphine) Reference Number:

B 13.0.


Clinical Governance


1.1


Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to when Morphine is destroyed.


19 September 2011



Objectives

To ensure all authorised staff adhere to a robust procedure in relation to where

Morphine is destroyed in accordance with best practice guidance and legislation


Scope








Date of Approval:


Date of Issue:


Procedure

N.B.: Expired vehicle stock must not be moved from the vehicle.

1. When expired stock is identified it must be clearly marked ‘EXPIRED NOT

FOR USE’ the box sealed with tape with the number of ampoules therein

written clearly on the outside of the box. The stock must remain within

the CD cabinet.

New stock must be requisitioned from pharmacy as per SOP B3.0

and SOP B4.0.

2. The expired stock must still be included in the vehicle stock level.

3. A member of the Local Clinical Governance team must be notified at the

earliest opportunity.

4. The Accountable Officer will designate Executives or Senior Management

Representatives as officers responsible for witnessing the destruction of

expired CD stocks. A list of the approved officers is located in Appendix 2.

Designated officers must have undertaken training regarding the

destruction of CDs; provided by the Trust Pharmacist Advisor.

5. The appropriate designated officer will make arrangements, as soon as

practicably possible, to meet the vehicle(s) with expired stock.

6. A vehicle stock check must be conducted by the Paramedic and the

designated officer to reconcile CD stocks prior to the removal of any CDs

for destruction. This must be recorded in the vehicle stock book (see SOP

11.0. Stock Check Procedures).

7. The Paramedic on the vehicle will be asked to destroy the CDs in the

presence of the designated officer.

All CDs must be destroyed in a way so as to denature them

beyond retrieval.

Absorbent granules should be used in the base of a sharps bin to

denature the CDs.

All ampoules must be opened and the contents emptied onto

the absorbent granules in the sharps bin. The ampoule should

also be disposed of in the sharps bin.



Date of Approval:


Date of Issue:


The sharps bin containing the denatured CDs should be labelled

‘contains mixed pharmaceutical waste and sharps – for

incineration’.

Where small quantities of CDs are to be destroyed a CD

denaturing kit may be used.

The number of expired ampoules must be recorded in the

vehicle stock book, with ‘expired’ written in the incident number

box.

The date of destruction must also be recorded.

The entry must then be signed by the Paramedic who destroyed

the CDs and the designated officer who witnessed the

destruction.

8. The designated officer must maintain a CD Expiry Record (MD09) to

record all the destructions they have witnessed.

9. The designated officer must provide details of any witnessed destructions,

on a monthly basis, to the appropriate Area Clinical Governance & Safety

Manager for recording on the Area Occurrence Report.

10. The Accountable Officer will be provided with a copy of the Trust-wide

Occurrence Report on a monthly basis.



Date of Approval:


Date of Issue:


Mitigation Process: Suspected or known Theft/ Loss of Morphine

SOP Title: Mitigation Process: Suspected or

Known Theft/Loss of Morphine

Reference Number:

B 14.0.


Clinical Governance


1.1


Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to where there is an incidence of lost or stolen Morphine.


19 September 2011



Objectives


there is incidence of lost or stolen Morphine the incident is managed in accordance

with best practice guidance and legislation ensuring a robust audit trail is

completed.

Scope








Date of Approval:


Date of Issue:


Procedure

In the event of Morphine being stolen:

All steps must be taken as for a Morphine being lost with the addition of:

1. The Locality ECC Manager must inform the Police and request their

attendance without delay.

In the event of Morphine being lost:

2. The Paramedic responsible for Morphine must inform the locality

Emergency Control Centre (ECC) immediately.

3. The ECC Manager must inform the Duty Service Delivery (SD) Manager and

Advanced Paramedic.

4. The SD Manager must co-ordinate a stock check of all vehicles within the

relevant sector.

5. The ECC Manager must inform the police as soon as possible (same working

day).

6. An incident report form must be completed immediately by the Paramedic

who was responsible for the Morphine.

7. The incident reporting procedure must be followed and the Clinical

Governance & Safety Manager, Security and Safety Practitioner and the

Trust Clinical Governance Co-ordinator notified as soon as practicably

possible.

8. The incident will also be recorded in the monthly Occurrence Report by the

Clinical Governance & Safety Manager.

9. The Trust Medical Director, as Accountable Officer and Trust Pharmacist

Advisor must be notified in writing as soon as practicably possible by the

Clinical Governance Co-ordinator.



Date of Approval:


Date of Issue:


10. The Accountable Officer, having assessed the incident, will then decide how

the investigation should be undertaken. The options available include:

Conducting the investigation themselves

Submitting a written request for another officer in the Trust to

undertake the investigation

Submitting a written request for a person or team of people from one

or more responsible bodies to undertake the investigation

Using their powers under the regulations to request an investigation

by the NHS Security Management Service (SMS), solely or jointly

with another responsible body. The Security and Safety Practitioner,

as the nominated advocate for NHS SMS, would be responsible for

conducting such an investigation on behalf of the NHS SMS

11. A Senior Clinical Governance Manager will notify the Home Office Drugs

Branch of the incident by telephone within 7 days. Telephone number:

0113 2204571.

12. The Clinical Governance Management Group shall review the investigation

and authorise/make recommendations at the earliest opportunity.



Date of Approval:


Date of Issue:


Mitigation Process: Suspected of Known Theft/ Loss of Controlled Drug

(CD) Cabinet Key

SOP Title: Lost or stolen CD cabinet keys Reference Number:

B 15.0.


Clinical Governance


1.1


Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to where there is an incidence of lost or stolen CD key.


19 September 2011



Objectives


there is incidence of lost or stolen CD cabinet keys the incident is managed in

accordance with best practice guidance and legislation ensuring a robust audit trail

is completed.

Scope








Date of Approval:


Date of Issue:


Procedure

In the event of a CD cabinet key being stolen:

All steps must be taken as for a CD cabinet key being lost with the additional:

1. The Locality ECC Manager must inform the Police without delay

2. If the perceived risk of further theft is high then the Morphine must be

removed and stored temporarily within a Station CD Safe.

In the event of a CD cabinet key being lost:

3. The Paramedic responsible for the key must inform the locality Emergency

Control Centre (ECC) immediately.

4. The ECC Manager must inform the Duty Service Delivery (SD) Manager or

Advanced Paramedic (AP).

5. The Duty SD Manager or AP will contact the appropriate Clinical

Governance Manager or Clinical Governance Co-ordinator to receive

authorisation for the spare CD cabinet key to be released.

The spare CD cabinet keys will be located within Clinical Governance.

The cabinet will be secured and accessed only by Clinical Governance

Managers or the Clinical Governance Co-ordinator.

6. The Duty locality ECC Manager must complete a MD11 spreadsheet to

record the events.

The MD11 register will be maintained by the Clinical Governance

Managers or the Clinical Governance Co-ordinator.

7. The appropriate SD Manager in consultation with Clinical Governance must

arrange for a new lock to be fitted to the CD cabinet as soon as possible

(ideally within 24 hours).

8. It is the responsibility of the Locality Workshop Managers to ensure that

sufficient stocks of spare locks are stored at workshops to enable the rapid

replacement of CD cabinet locks.

9. An incident report form must be completed immediately by the Paramedic

who was responsible for the key.



Date of Approval:


Date of Issue:


10. The incident reporting procedure must be followed and the Clinical

Governance & Safety Manager, Security and Safety Practitioner and the

Trust Clinical Governance Co-ordinator notified as soon as practicably

possible.

11. The incident will also be recorded in the monthly Occurrence Report by the

Clinical Governance & Safety Manager.

12. The Trust Medical Director, as Accountable Officer and Trust Pharmacist

Advisor must be notified in writing as soon as practicably possible by the

Clinical Governance Co-ordinator.

13. The Clinical Governance Department and Service Delivery shall review the

incident and make recommendations at the earliest opportunity.



Date of Approval:


Date of Issue:


Patient Administration of Morphine

SOP Title: Patient Administration of

Morphine

Reference Number:

B 16.0.


Clinical Governance


1.1


Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to the patient administration of Morphine.


19 September 2011



Objectives

To ensure all authorised staff adhere to a robust procedure in relation to the patient

administration of Morphine in accordance to best practice guidance and legislation,


Scope

N.B. This section does not deal with the clinical aspects of Morphine

administration.








Date of Approval:


Date of Issue:


Procedure

1. When Morphine is administered to a patient the following must be

recorded on the Patient Report Form/ePR:

The patient’s full name.

The patient’s home address.

The patient’s date of birth.

Morphine recorded in the ‘drug’ box, including the dose(s) administered.

The time each dose was administered.

The signature of the Paramedic and their PIN.

2. The vehicle MD08 must also be completed to record the issue at the

earliest opportunity i.e. when the patient condition allows.

3. The MD08 will contain the Incident Number for cross-reference purposes.

4. Any unused Morphine remaining in the syringe must be disposed of by

emptying into the appropriate yellow clinical waste receptacle situated

within the vehicle.

5. The second crew member must verify the quantity of Morphine being

disposed of. RRV staff must ask a crew member from the responding

ambulance to verify the quantity of Morphine being disposed of.

6. The quantity being disposed of must match the discrepancy between the

quantity administered and the quantity issued that is recorded on the

MD08.



Date of Approval:


Date of Issue:


Pool/Reserve or Spare Vehicles

SOP Title: Pool/Reserve Vehicles Reference Number:

B 17.0.


Clinical Governance


1.1


Objectives altered to ensure all authorised staff adhere to a robust procedure in relation to pool/reserve vehicles that carry CDs.


19 September 2011



Objectives

To ensure all authorised staff adhere to a robust procedure in relation to

pool/reserve vehicle stocks of CDs. To ensure they are managed in accordance with

best practice guidance and legislation, ensuring a robust audit trail is completed.

Scope








Date of Approval:


Date of Issue:


Procedure

1. All emergency pool/reserve vehicles will have a permanent stock of 10 x

10mg Morphine, including Morphine MD07 and Morphine MD08 books.

USAR & Inland Water vehicles have a permanent stock of 20 x

10mg Morphine, including Morphine MD07 and Morphine

MD08 books.

2. The key for the CD cabinet will be stored in a key cabinet located on the

pool/reserve vehicle (where key safes are available).

3. The pool/reserve vehicle key cabinet will be fitted with a combination lock

similar to that of the station key cabinets.

4. Only Paramedics, the NWAS Service Delivery Management and Clinical

Governance Management Teams will possess the codes to access the

pool/reserve vehicle key cabinets.

5. When an emergency vehicle is booked in at workshops for service or

repair, the Morphine can be left securely on the vehicle – providing it is

known not to be leaving NWAS premises e.g. Renault or Mercedes

Garages etc.

6. In the event of a vehicle having to leave NWAS premises for repair or

modification, the Morphine and associated documentation must be

removed by a Paramedic and stored within a station CD cabinet.

The key for the station CD cabinets will be stored in the station

CD key cabinet.

7. The station CD Cabinet should be utilised to store Morphine in any other

circumstance when removal from a vehicle is required.

The station CD Cabinet must not be used for any other

purpose.

8. Whenever Morphine is removed from a vehicle the Morphine Tracking

Form – MD13 must be completed.



Date of Approval:


Date of Issue:


Unique Procedures: Events Stadia CD Cabinet Stock Checks and

Requisitions

SOP Title: Unique Procedures: Events Stadia

CD Cabinet Stock Checks and

Requisitions

Reference Number:

B 18.0.


Clinical Governance




19 September 2011



Objectives

To provide assurance that NWAS will have the correct controlled drugs in the

appropriate format in place at events stadia.

Scope


Events Stadia where a CD Cabinet is in situ

Clinical Governance will hold a Central Register of Events Stadia where CDs are

stored on site.

CDs can be stored in Events Stadia provided an appropriate CD cabinet and CD

key safe are installed.

Vehicles attending Events Stadia as Events vehicles fall under SOP guidance B 2.0

and B 17.0 for daily stock checks.



Date of Approval:


Date of Issue:


Procedure

1. Event Stadia will have a permanent stock of 10 x 10mg Morphine,

including Morphine MD07 and Morphine MD08 books.

2. The key for the CD cabinet will be stored in a CD key cabinet located in the

vicinity of the CD Cabinet.

3. The CD key cabinet will be fitted with a combination lock similar to that of

the station CD key cabinets.

4. Only Paramedics, the NWAS Service Delivery Management and Clinical

Governance Management Teams will possess the codes to access the

Events Stadia key cabinets.

Requisition Process:

Events Stadia shall have a Morphine requisition book (MD07). The book will contain the following details on numbered, duplicate pages:

Event Stadia Name

Date

The name of the drug requested, it’s pharmaceutical form and the total quantity requested in words and figures.


The purpose for which the drug supplied is required (Stadia stock).





1. The Paramedic on Duty shall submit the Morphine MD07, as per local

procedure when Event Stadia requires re-stocking, to a locally agreed

hospital pharmacy department.

2. Morphine can only be requisitioned from pharmacies from Monday to

Friday, during normal working hours. There is no out-of-hours service

available.

3. The Morphine MD07 must be submitted to the pharmacy department

before a specified time – where to local agreements exist.


Duty, in recognised uniform with photographic identification (an NWAS




Date of Approval:


Date of Issue:


5. Upon submission of the MD07 the pharmacy department will confirm a

collection time.

6. Once orders are completed or dispensed, the pharmacy department must

retain the top copy of the Morphine MD07.

7. The second copy of the Morphine MD07, for orders received, must be

retained within the book.

Stock Check Procedure

1. Two members of staff – the Paramedic starting Duty and another staff

member on Duty must check the Morphine at the beginning of the shift.

2. All stock checks must be recorded in the Morphine MD08, writing ‘stock check’ in

the Incident No. box and recording the stock level.

3. Two signatures must be recorded by the two personnel performing the

stock check.

4. Stock checks must be completed accurately, including the times when they

are completed.

End of Season Procedure

1. At the end of the Event Season the Morphine and associated

documentation must be removed by a Paramedic and stored within a

station CD cabinet.

The key for the event stadia CD cabinets will be stored in the

station CD key cabinet.

2. Whenever Morphine is removed from Event Stadia the Morphine Tracking

Form – MD13 must be completed.



Date of Approval:


Date of Issue:


Unique Procedures: Re-designated or Decommissioned Vehicles

SOP Title: Unique Procedures: Re-designated

or Decommissioned Vehicles

Reference Number:

B 19.0.


Clinical Governance




19 September 2011



Objectives

To ensure the management of decommissioned vehicle stocks is in accordance with

best practice guidelines and compliant with legislation whilst providing assurance

that NWAS will have the correct drugs in the appropriate formats in place at all times

to be able to treat the patient.

Scope








Date of Approval:


Date of Issue:


Where a vehicle is being replaced by a new vehicle and the original vehicle is being

decommissioned (not resourced or moved elsewhere in the Trust).

1. Remove from the decommissioned vehicle the:

Morphine,

Morphine MD07 book

Morphine MD08 book

Morphine tracking form

2. Place all of the above on the new vehicle

3. Ensure that all vehicle details on the Morphine MD07 and MD08 books are

amended with the new registration number and call sign.

Do not alter the unique GM, CM, CL or NWAS numbers

4. Enter a diary note in the Morphine MD08 Stock Check book detailing the

date of decommissioning, new registration and call sign.

5. Ensure that the spare CD Cabinet key is sent to the appropriate Clinical

Governance Manager

6. The Clinical Governance Manager will ensure that the spare key is tagged

and referenced to the vehicle

Where a vehicle is being replaced by a new vehicle and the original vehicle is not

being decommissioned (is to be resourced or moved elsewhere in the Trust).

1. Ensure that the Morphine MD07 and MD08 books are amended with the

new call sign.

Do not alter the unique GM, CM, CL or NWAS numbers

2. Enter a diary note in the Morphine MD08 Stock Check book detailing the

date of call sign change.

3. Inform the Clinical Governance Manager of the call sign change and location

details so that the spare CD keys can be tagged appropriately.



Date of Approval:


Date of Issue:


Unique Procedures: Issue of MD07 - AP Procedure

SOP Title: Unique Procedures: Re-designated

or Decommissioned Vehicles

Reference Number:

B 20.0.


Clinical Governance




19 September 2011



Objectives

To ensure the management of MD07 CD Stock Requisition books is in accordance

with best practice guidelines and compliant with legislation whilst providing

assurance that NWAS will have the correct drugs in the appropriate formats in place

at all times to be able to treat the patient.

Scope








Date of Approval:


Date of Issue:


Procedure

1. Where an MD07 Stock Requisition books reaches near capacity, the EPS

staff must inform their Service Delivery Manager and Advanced

Paramedic.

2. The Advanced Paramedic will contact the Clinical Governance & Safety

Manager with the following details:

Vehicle Registration

Vehicle Call sign

Vehicle Location or Base

Unique current CL, CM, GM or NWAS number

3. The Clinical Governance & Safety Manager will issue a new MD07 to the

vehicle complete with unique central registration number to the

requesting Advanced Paramedic.

4. The Advanced Paramedic:

Removes the completed MD07 from the vehicle and places it in the

local storage repository.

Places the replacement MD07 on the vehicle

If at the time of receipt of the replacement book the original MD07 still has

requisition pages available, re-dact these pages and place in the local storage

repository.



Date of Approval:


Date of Issue:


Appendix 1: Reference Indicative Medicine Management Forms:

MD01: Vehicle Medicine Stock Check



Date of Approval:


Date of Issue:






Appendix 1: Reference Indicative Medicine Management Forms: MD02: Vehicle Medicine Issue & Receipt






MD03: Vehicle Medicine Expiry Check



Date of Approval:


Date of Issue:



MD04: Pharmacy/Station Cabinet Stock Check



Date of Approval:


Date of Issue:






Appendix 1: Reference Indicative Medicine Management Forms: MD05: Pharmacy/Station Cabinet Issue & Receipt





Appendix 1: Reference Indicative Medicine Management Forms: MD07: CD Requisition

Date

Vehicle Call Vehicle

Sign

Base Station

Vehicle

Registration

Name of drug requested, it's presentation, strength and total quantity requested (Total quantity in words and figures)

Name of recipient

PIN

Total Quantity

Pharmacy

Supplied

supplied from

Supplier's Signature

Recipient's Signature

MD07





Vehicle

Drug Call

Sign

Preparation

Date PRF No. Qty Qty Issued By Issued By Stock Qty Received

Received By Received By

Admin. Issued (PRINT) (Signature) Level Received From (PRINT) (Signature)

Balance brought forward

Balance carried forward For stock checks please state 'stock check' in received section and sign

For Expired or Damaged stock please state in the PRF No. box

MD08

Appendix 1: Reference Indicative Medicine Management Forms: MD08: CD Stock Check Record





DESTRUCTION OF CONTROLLED DRUGS RECORD MD09

AREA: C&M, C&L, GMA (delete as appropriate)

Date of Destruction

Number of Ampoules

Batch Number

Date of Expiration

Reason for Destruction

Vehicle Registration Number/ Call

sign

Paramedic name / signature

Designated Officer name / signature

Date forwarded to Clinical Governance Co-ordinator: By whom: (copy to be retained in Area for reference)

Appendix 1: Reference Indicative Medicine Management Forms: MD09: CD Destruction – Authorised Officers Only



Date of Approval:


Date of Issue:


DATE

SHEET NO. STARTED

DATE

COMPLETE

DATE TIME OPERATIONAL KEY NO. REMOVED REASON KEY SIGN

KEY RETURNED DATE

MANAGER

(VEHCILE CALL SIGN) REQUIRED (SIGN)

Appendix 1: Reference Indicative Medicine Management Forms: MD10: Morphine Key Tracking Form



Date of Approval:


Date of Issue:






CONTROLLED DRUG REQUISITIONS

APPROVED SIGNATURES FOR AUTHORISING

PARAMEDIC SIGNATURES

The following signatures are that of NWAS NHS Trust Paramedic Emergency

Service Operational Managers and their respective groups. These persons are

authorised to approve Paramedic signatures for the requisitioning of morphine

sulphate from hospital pharmacy departments.

Name Operational Group Signature

I confirm that the above persons are authorised to approve Paramedic signatures

for the requisition of morphine sulphate.

Mr Kevin Mackway Jones Medical Director, NWAS NHS Trust


MD12a: Service Delivery Manager Authorised Signature Form



Date of Approval:


Date of Issue:



MD12b: Service Delivery Controlled Drug Signature Form



Date of Approval:


Date of Issue:



MD13: Morphine Tracking Form



Date of Approval:


Date of Issue:


Appendix 2: Officers Authorised to perform the destruction of Controlled Drugs

Steve Barnard Head of Clinical Governance

Fiona Buckley Head of Risk and Safety

Deborah Bullock Head of Clinical Safety

Mary Peters Clinical Governance Co-ordinator

Ian Brown Clinical Governance & Safety Manager

medicine management procedures toolkit - north west ambulance … · the purpose of this toolkit is...

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