medicine management procedures toolkit

MEDICINE MANAGEMENT PROCEDURES TOOLKIT Page: of 117

Author: Senior Clinical Quality Manager Version: 1.3

Date of Approval: March 2015 Status: Final

Date of Issue: April 2015 Date of Review March 2017

MEDICINE MANAGEMENT

PROCEDURES TOOLKIT





Recommended by Clinical Governance Management Group

Approved by Executive Management Team

Approval date March 2015

Version number 1.3

Review date March 2017

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 Senior Clinical Quality Manager

on 01204 498392





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

1.1

July 2012

July 2012

M Peters

Addition of ECFR SOPs

1.2

Sep 2012

Sep 2012

M Peters

Addition of Commercial Courier,

Community Pharmacy and HART

(MCV) SOPs

0.3 March 2015 March 2015 M Peters Updated document following feedback from Senior Clinical Leadership Team

1.3 March 2015 April 2015 M Peters EMT approved version





Medicines Management Procedure Toolkit

Contents 1 Introduction .................................................................................................................................... 6

2 Duties .............................................................................................................................................. 6

3 Legal Framework ............................................................................................................................. 9

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

5 Summary to changes to the SOPs ................................................................................................. 10

A1.1. Daily Stock Checks: Ambulance Vehicles ..................................................................................... 11

A2.1. Daily Stock Checks: Pharmacy and Station Cabinets ................................................................... 14

A3.1. Damaged, Expired & Used Medicines Disposal (Excluding Controlled Drugs). ........................... 18

A4.1. Documentation for Administration and Receipt of Medicines and Fluids .................................. 20

A5.1. Management of Documentation: Medicine Management Audit Trail ........................................ 22

A6.1. Drug Alerts ................................................................................................................................... 24

A8.1. Procedure for reporting Adverse Drug reactions (ADR) for Medicines administered by

ambulance staff. ................................................................................................................................... 32

A9.1. Reporting of Defective Medicines ............................................................................................... 35

A11.0 Transportation of Patients own Medicines ................................................................................ 38

A12.0. Administration of Patients own Medicines ............................................................................... 40

B1.1. Authorised Signatures .................................................................................................................. 43

B2.1. CD Daily Stock Check .................................................................................................................... 45

B3.2. EOC Procedure – requisition of CDs from nominated community pharmacies .......................... 49

B4.2. Requisition of vehicle stock CDs from Community Pharmacy ..................................................... 51

B7.1. CD Security: Ambulance Vehicles ................................................................................................ 58

B8.1. CD Security: Key Management .................................................................................................... 61

B9.1. CD Security: Key Cabinet Management – access codes .............................................................. 64





B10.1. CD Security Station CD Cabinet Management -access .............................................................. 66

B.11.1. CD Security: Rapid Response Vehicles – Stock Checks ............................................................. 68

B.12.1. Damaged Stock Disposal – Controlled Drugs ............................................................................ 70

B13.1. Expired Stock Disposal – Controlled Drugs ................................................................................ 74

B14.1. Suspected or Known Theft or Loss of Controlled Drugs ............................................................ 77

B15.1. Suspected or Known Theft or Loss of Controlled Drugs cabinet Key ........................................ 81

B.16.1. Patient Administration of Controlled Drugs: ............................................................................ 84

B17.1. Pool/ Reserve or Spare Vehicles ................................................................................................ 86

B18.1. Events Stadia CD Cabinet Stock Checks and Requisitions ......................................................... 89

B19.1 Decommissioned or Re-Designated Vehicles ............................................................................. 93

B20.1: Issue of MD07: AP Procedure .................................................................................................... 96

B21.1: Unique Procedures: New Vehicles into the NWAS Fleet ........................................................... 98

C1.0: ECFR Medicine Management ..................................................................................................... 100

D1.1 HART: Mass Casualty Vehicle Check Daily/Weekly requirements ............................................. 103

D2.1: HART: Mass Casualty Vehicle Refrigerator Monitoring ............................................................. 106

E1.1: Commercial Courier: Deliveries of Pharmaceutical Supplies from Lancashire Teaching Hospitals

NHS Trust ............................................................................................................................................ 108

E2.1: Commercial courier: Delivery of General and Controlled Drugs to Prisons .............................. 111

E3.1: Commercial Courier: Transportation of Cytotoxic Pharmaceuticals ......................................... 116





1 Introduction

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

to ensure the safe and secure handling of medicines, including general

medic ines, controlled drugs, fluids and medical gases 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.

2 Duties

2.1 A full description of the duties is located in the Medicine Management

policy, a summary is presented here.

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

secure handling of medicines.

2.2.1 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. 2.2.3 The Chief Executive has devolved responsibility for the day to day management

of medicines to the Trust’s Medical Director. 2.2.4 The Medical Director, with specialist advice from the Trust’s Pharmacist Advisor

and the Clinical Leadership Board, 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

Quality.





2.2.5 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

2.2.6 The Head of Clinical Quality is responsible for the corporate development,

implementation and performance management of policies and procedures,

including the provision of expert advice. The Head of Clinical Quality (HCQ) is

responsible 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 HCQ.

2.2.7 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.

2.2.8 The Senior Clinical Quality Manager (SCQM) is responsible for coordinating the

implementation and performance management of medicine management related

policies and procedures across the Trust. The SCQM will also be responsible at

corporate level for managing day to day medicine management issues, to 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.

2.2.9 Medicines Performance Facilitator 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.

2.3 Operational Summary Responsibilities

2.3.1 Consultant Paramedics Service Delivery are responsible for ensuring that the

service delivery Areas have the necessary policies and procedures in place,

monitoring trends and identifying reporting and acting on areas of risk.

2.3.1 Sector and Operational Managers are responsible for:

Supporting the operational implementation and performance management

of policies and procedures

Making quarterly checks to ensure compliance with the medicine

management policy and procedures – such checks are to be retained for





audit purposes for at least 2 years.

Ensuring the HCQ and the SCQM are made aware in a timely manner of any

adverse incidents relating to medicines management.

2.3.2 Advanced Paramedics are responsible for:

Supporting all Trust personnel who are responsible for medicines through

familiarisation and maintenance of the standards 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

2.3.3 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 procedures 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

2.4 Management Group Summary Responsibilities

2.4.1 The Clinical Governance Management Group (CGMG) is accountable to the Trust

Board and operates within agreed terms of reference. The CGMG will:

Monitor standards and performance in relation to Medicine Management

and provide assurance to the Trust Board with regards to Medicines

Management Standards.

2.4.2 Organisational Performance Group is required 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.

3 Legal Framework

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

in the Human Medicines Regulations 2012 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.

4 Toolkit Layout

4.1 The medicines Management Toolkit is split into a number of 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.

Section C contains SOPs for ECFRs

Section D contains SOPs for HART MCVs

Section E contains SOPs for Commercial Couriers

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.

5 Summary to changes to the SOPs

5.1 A10.0 EZIO Requisition Procedure: Lignocaine 1% has been removed from circulation

following a decision made by the Clinical Leadership Board (formerly the Medical

Directorate SMT).





A1.1. Daily Stock Checks: Ambulance Vehicles

SOP Title: Vehicle Stock Checks Reference Number: A1.1

Author Name & Designation: Clinical Quality

Directorate: Medical Directorate

Version Number & Date: A1.1 December 2014

Supersedes: A1.0 (2011)

Changes made: Format revision

Approved by EMT (date): March 2017

Review Date: March 2017

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 effectively and safely.

SCOPE

All general medicines and fluids stocked on the vehicle.

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

vehicles.

Manchester Airport Team

Staff Responders and Manager Responders

North West Air Ambulance





PROCEDURE

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:

Medicine stock levels will be checked and recorded using the MD01 form – located in the

monthly vehicle clinical check book. A new MD01 form should be used at the start of each

week (for the purpose of recording medicines the start of the week is Monday).

1. Correct drug, strength and presentation is present

2. Drug is within its expiry date.

3. Drug is stored in its original pack including a patient information leaflet.

4. Drugs of mixed batches and expiry dates should not be stored in one packet, each

batch /expiry should have its original box present.

5. Where the MD01 form is marked with a a minimum stock level check must be

performed. Open each box and verify that the minimum stock level is present for

that drug. If the minimum stock level is not present i.e. salbutamol 5mg x 4 nebules,

the box should be marked with an X and the stock replenished at the earliest

opportunity in the shift.

6. Perform a stock count on all other drugs indicated in the MD01 form. This requires

all stock to be individually counted and recorded on the MD01 form.

Note: manufacture sealed boxes do not need to be opened to verify the contents –

count these as the full stock indicated on the box.





STOCK VERIFICATION: SIGNATURES

The number of signatures should reflect the number of staff present and wherever

possible 2 signatures should be obtained.

Best practice: is for 2 members of staff to conduct the medicines checks with one member of

staff checking the stock with the second witnessing and conducting the documentation

aspect.

RRV and solo responders should always try to obtain a witness verification signature

wherever possible.

EXPIRY CHECKS

Within the first 7 days of each month that a vehicle is operational the expiry dates of all

medicines (including Controlled drugs) will be checked and recorded on the MD03 expiry

check sheet located in the Monthly Vehicle Clinical Check Book.

Any medicines due to expire before the following month should be replaced and the

expiring stocks discarded at the earliest opportunity within the month – the MDO2 should

reflect the disposal of medicines in this way.

UN-RESOURCED AND POOL VEHICLES

A stock check of all drugs / fluids as detailed above must be performed on un-resourced (i.e.

Spare or Pool vehicles) and vehicles off the road for repair. The drugs checks must be

performed as a minimum – once each week. Local arrangements must be made by the local

Service Delivery team to ensure that this takes place – even if the vehicle is not normally

located at the station.

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

REPORTING DISCREPANCIES

Any medicines discrepancies must be reported via the Datix online incident reporting

system under incident type ‘Clinical Incident’ or if appropriate ‘Clinical Near miss’

referencing in either case category type ‘Medicines Management’.





A2.1. Daily Stock Checks: Pharmacy and Station Cabinets

SOP Title: Management of Documentation Reference Number: A2.1








Date Obsolete:


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.

It is the responsibility of the designated supervisory/management lead for medicine

management to ensure that:

there are nominated staff member(s) assigned to checking the pharmacy cabinet(s)

within their station group

nominated member(s) details are communicated to the appropriate stations

the nominated members provide liaison with the NWAS Medic ines

Performance Faci l i t ator and with the loca l pharmacy departments within

their sector or station group.

HOSPITAL & STATION BASED MEDICINES CABINETS: RESPONSIBILITIES

It will be the responsibility of the nominated staff member(s) to:

Perform a stock check of the medicines cabinet on a twice weekly basis.

Complete the MD04 (medicine cabinet stock check form) and wherever possible

signed by a co- signatory. The number of signatures required must reflect the

number of Emergency Service personnel present at the time of the audit.

Inform the pharmacy department if:

o pharmacy cabinet stock levels are considered to be insufficient to last

until the next pharmacy top up, or

o incorrect stock presentations are present in the medicines cabinet





STATION BASED MEDICINES CABINETS: RESPONSIBILITIES

It will be the responsibility of the nominated staff member(s) to manage the stock levels

within the station cabinets.

STATION BASED MEDICINE CABINETS: STOCK REQUISITION

Inform the pharmacy department if station cabinet stock levels are considered to be

insufficient by completing a pharmacy order stating the quantity of each medicine required.

Sign, Print and Date each order sent and keep the original copy for the station medicines

records.

STATION BASED MEDICINE CABINETS: STOCK VERIFICATION

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.

STATION BASED MEDICINE CABINETS: STOCK RECEIPTS

Once pharmacy orders have been checked, medicines 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. The pharmacy supply record should also be signed as received, including the

date, and the record stored within the station cabinet’s medicine folder. The number of

signatures should reflect the number of staff present and wherever possible 2

signatures should be obtained.





MEDICINES ISSUING: PHARMACY AND STATION MEDICINE CABINETS

It is the responsibility for all PES staff when restocking their vehicle from a hospital or

station cabinet to follow this process in full:

1. Complete the ‘Medicine Issues’ section of MD05. The medicine(s) must be booked

out to a vehicle call sign and registration number.

2. The remaining stock balance on the MD05 must be double checked against the

remaining stock in the medicines cabinet. Any stock discrepancies should be

reported immediately to your line manager for further investigation and reported via

DATIX online incident reporting system.

3. Sign the MD05 form for confirmation of stock issue to the vehicle. The number of

signatures required must reflect the number of Emergency Service personnel

present.

END OF MONTH PROCESS: PHARMACY AND STATION MEDICINE CABINETS

The designated supervisory/management lead for Medicine Management is responsible for:

1. Collecting the MD04 and MD05 forms for each drug from the hospital or station

cabinet (including pharmacy supply sheets).

2. Filing the MD04 and MD05 together for each hospital or station cabinet. The paperwork must be stored securely at an agreed central location within each sector or station group. All medicines documentation must be stored securely for a minimum of 2 years. The documentation archive location should be identified and documented by the staff member responsible for medicines management for each sector and notified to the Medicines Performance Facilitator for NWAS.

REPORTING DISCREPANCIES

Any medicines discrepancies must be reported via the Datix online incident reporting

system under incident type ‘Clinical Incident’ or if appropriate ‘Clinical Near miss’

referencing in either case category type ‘Medicines Management’.





A3.1. Damaged, Expired & Used Medicines Disposal (Excluding Controlled Drugs).

SOP Title: Disposal of Medicines (Excludes CDs) Reference Number: A3.1



Version Number & Date: A3.1. December 2014





Date Obsolete:


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 medicines and fluids stocked on the vehicle.


vehicles.

Hospital and Station General Drug Cabinets








PROCEDURE

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 and recorded on

the MD02 ‘Medicine Issue & Receipt Record’ located in the monthly vehicle clinical check

book.

ISSUES AND RECEIPTS:

1. The MD02 Medicines Issue and Receipt Record must be completed with the

following details:

o The date, name of the medicine and strength, incident number (if administered

or refused), quantity issued, quantity administered to the patient / quantity

being disposed of and batch number / expiry date.

o Tick the reason for medicine issue i.e. ‘used’ ‘expired’ or ‘damaged’.

o Complete the signature and witness signature for each transaction. The number

of signatures should reflect the number of staff present and wherever


o Record the final stock level remaining of each medicine administered/disposed.

NEW MEDICINES STOCK:

If the current stock level indicates more stock is to be added to the vehicle – the new

medicine stock must be obtained from the local hospital or station cabinet following SOP

A2.1. Daily Sock Checks: Pharmacy and Station Cabinets and SOP A4.1 Documentation for

Administration and Receipt of Medicines and Fluids.





A4.1. Documentation for Administration and Receipt of Medicines and Fluids

SOP Title: Documentation of Medicines and Fluid

Administration and Receipt

Reference Number: A4.1








Date Obsolete:


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

All general medicines and fluids held on the vehicle.


vehicles.








PROCEDURE

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:

1. Patient Report Form (PRF) /ePR and

2. MD02 form located in the monthly vehicle clinical check book.

MEDICINE OR FLUID ADMINISTRATION: MDO2 DOCUMENTATION

On preparing a medicine or fluid for administration the following must be completed on the

MD02:

The date, name of the medicine and strength, incident number (if administered

or refused), quantity issued, quantity administered to the patient / quantity

being disposed of and batch number / expiry date.

Tick the reason for medicine issue i.e. ‘used’ ‘expired’ or ‘damaged’.

Complete the signature and witness signature for each transaction. The number

of signatures should reflect the number of staff present and wherever


Record the final stock level remaining of each medicine administered/disposed.

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.

The MD02 must be completed prior to clearing from the incident.

NEW MEDICINES STOCK:

If the current stock level indicates more stock is to be added to the vehicle – the new

medicine stock must be obtained from the local hospital or station cabinet following SOP

A2.0.The re-stocking of medicines should be undertaken as soon as practicably possible

before the end of the shift.

Note: Notwithstanding the above it is the responsibility of the senior clinician to be

assured paperwork is completed adequately, correctly, contemporaneously and as fully as

possible.





A5.1. Management of Documentation: Medicine Management Audit Trail

SOP Title: Management of Documentation Reference Number: A5.1








Date Obsolete:


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 from the last

dated entry.

SCOPE

All general drugs/medicines held on the vehicle.









PROCEDURE

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

documentation in the form of the Monthly Vehicle Clinical Check books.

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

the end of the current month. On completion of the monthly book it should be archived in

line with station documentation procedures for a period of 2 years from the last dated

entry.

MD04 AND MD05 DOCUMENTATION

The designated supervisory/management lead for medicines management must

1. 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:

o MD04: Pharmacy/Station Cabinet Stock Check

o MD05: Pharmacy/Station Cabinet Stock Issues and Receipts

2. File 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 group.

3. Monitor the quality and compliance of documentation completion and if necessary,

take appropriate action.

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

documentation archive location for each vehicle should be identified and documented by

the staff member responsible for medicines management for each sector and notified to the

Medicines Performance Facilitator for NWAS.

OVERALL RESPONSIBILITY: SECURITY AND STORAGE OF MEDICINE DOCUMENTATION

The Sector Managers supported by the Advanced Paramedics have overall

responsibility for the safe and secure storage of medicine documentation.





A6.1. Drug Alerts

SOP Title: Drug Alerts Reference Number: A6.1








Date Obsolete:


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.








PROCEDURE

Manufacturers and importers are obliged to report to the MHRA any quality defect in a

medicinal product which could result in a recall or restriction on supply. Other users and

distributors of medicinal products are encouraged to do this.

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 requires immediate recall, because the product poses a serious or life threatening

risk to health.

Class 2 specifies a recall within 48 hours, because the defect could harm the patient but is

not life threatening.

Class 3 requires action to be taken within 5 days because the defect is unlikely to harm

patients and is being carried out for reasons other than patient safety.

Class 4 alerts advise caution to be exercised when using the product, but indicate that the

product poses no threat to patient safety.

DURING OFFICE HOURS

Quality Control North West notifies NWAS of drug alerts by email to the Medicines

Performance Facilitator and the Senior Clinical Quality Manager.

The alert is assessed for its potential impact on NWAS medicines stocks and if

necessary, communicated to the Head of Clinical Quality and Trust Pharmacist.

Further communication with then be issued to all Operations Managers and Advanced

Paramedics for action.

The Senior Clinical Quality Manager will ensure that all alerts are recorded. When an action

is required the Head of Clinical Quality must ensure that the alert is communicated to all

relevant individuals and that all necessary actions are undertaken immediately.





The Medicines Performance Facilitator will liaise with all NWAS supplying pharmacy

departments to assess if any affected stocks are currently stocked in the NWAS medicines

stock cabinets (hospital based).

The designated supervisory/management lead for medicines management will be

notified to check station based stock cupboards. Any affected stocks must be

notified to the Medicines Performance Facilitator.

ALERT CLASS: ACTION REQUIREMENT

The classification of the alert will determine the action that will be required where any

affected batches of stock is stocked by NWAS.

Alert Class

Timescale Action Notification

Class 1 Immediate

Check all stocks of affected product. Remove all affected batches from stock with immediate effect and quarantine. Replacement stocks must be verified to ensure they are not included in the affected batches of stock.

Immediately notify the Medicines Performance Facilitator if any affected stock is found

Class 2 Within 48

hours

Check all stocks of affected product. Source replacement unaffected stocks Exchange all affected stocks from the vehicles / stock cupboards with unaffected stocks.

Notify the Medicines Performance Facilitator if any affected stock is found - within 48 hours.

Class 3 Within 5

days

Check all stocks of affected product. Source replacement unaffected stocks Exchange all affected stocks from the vehicles / stock cupboards with unaffected stocks.

Notify the Medicines Performance Facilitator if any affected stock is found - within 5 days.

Class 4 None set

Check all stocks of affected product. Communicate any cautions in use issued via clinical bulletin to all staff involved in medicine preparation or administration.

Communicate to all local staff any cautions in use for the product.





All designated personnel dealing with the action of the alert must complete a ‘Drug

Alert Action Log’. The log, on completion, must be returned via email to the

Medicines Performance Facilitator.

Details to be recorded include the action taken, timescales actions were conducted

in and the outcome of the action taken.

The Medicines Performance Facilitator will collate all the information received as

evidence of the actions being completed for the Trust within the permitted

timescales

OUTSIDE WORKING HOURS:

Quality Control North West will communicate alerts by fax or telephone to the Manchester

Area Emergency Operations Centre (EOC). The Emergency Operations Centre Duty Manager

will notify the other Control Centres and provide them with the relevant information.

The EOCs must notify the relevant on duty Advanced Paramedic who must assess the

relevance of the alert and if necessary ensure any immediate actions required are

undertaken.

ALERTS OR ACTIONS UNDERTAKEN OUTSIDE WORKING HOURS

Must be reported to the Medicines Performance Facilitator and the Senior Clinical

Quality Manager as soon as practicably possible via email at

[email protected].

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

and actions taken.

All designated personnel dealing with the action of the alert must complete a ‘Drug

Alert Action Log’. The log, on completion, must be returned via email to the

Medicines Performance Facilitator.

Details to be recorded include the action taken, timescales actions were conducted

in and the outcome of the action taken.

The Medicines Performance Facilitator will collate all the information received as

evidence of the actions being completed for the Trust within the permitted

timescales





DRUG RECALL

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

medicines to the supplying pharmacy; this will be co-ordinated by the Medicines

Performance Facilitator.

All Drug Alerts received will be recorded, reviewed and reported using the Trust

Healthcare Governance Alert and Guidance Review Process.





A7.1. Suspected or known Theft or Loss of Medicines and the reporting of

discrepancies

SOP Title: Theft or Loss of Medicines and the

reporting of discrepancies

Reference Number: A7.1.








Date Obsolete:


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

All general medicines held on the vehicle or stocked in the hospital / station medicines stock

cabinet.

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








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 person(s) 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 EOC must be informed immediately and request that the Police are

contacted. Provide details of the vehicle, crew names, medicines involved and

circumstances of the incident.

2. The EOC must contact and inform the on-call Operational Commander (Bronze on-

call) or Advanced Paramedic of the incident

3. The on-call Operational Commander (Bronze on-call) or Advanced Paramedic must

visit the crew to provide support and identify if any further assistance is required.

4. The relevant on-call Tactical Commander (Silver - on call) must be notified as soon as

possible.

5. A DATIX incident report must be completed immediately by the crew involved and

assigned to the appropriate Manager for investigation. The incident must be logged

under ‘Clinical Incident’ and the appropriated category type selected as either

‘Medicines Management’ or ‘Controlled Drugs’ and the appropriate sub category

selected.

6. The Medicines Performance Facilitator, Senior Clinical Quality Manager and the

Security & Safety Practitioner must be notified as soon as practicably possible via

email [email protected].

7. The Trust Incident Reporting and Investigation Policy must 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 note must be made in the Clinical Checks Log of the

vehicle’s Monthly Clinical Check Book.





WHEN A DISCREPANCY IS IDENTIFIED THAT CANNOT BE EXPLAINED:

1. The on-call Operational Commander (Bronze on-call) 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 on-call operational (Bronze

Commander)

5. A DATIX incident report must be completed immediately by the crew involved and

assigned to the appropriate Manager for investigation. The incident must be logged

under ‘Clinical Incident’ and the appropriated category type selected as either

‘Medicines Management’ or ‘Controlled Drugs’ and the appropriate sub category

selected.

6. The Medicines Performance Facilitator, Senior Clinical Quality Manager and the

Security & Safety Practitioner must be notified as soon as practicably possible.

7. The Trust Incident Reporting and Investigation Policy must 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 note must be made in the Clinical Checks Log of the

vehicle’s Monthly Clinical Check Book.





A8.1. 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









Date Obsolete:


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 medicines (including fluids and medical gases) administered by ambulance staff

(including the patient’s own medications).


vehicles.








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/ePRF, 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 must be sought from an Advanced Paramedic

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/ePRF.

An ADR is considered to be a clinical incident, therefore a DATIX incident report must be

completed and the Trust Incident Reporting and Investigation Policy followed (this should

always be completed regardless of whether a Yellow Card was completed or not)





WHEN COMPLETING THE INCIDENT REPORT THE FOLLOWING INFORMATION MUST BE

RECORDED:

1. The drug to which the reaction occurred.

2. The brand / manufacturer, 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.

All adverse medication incidents including administration errors and adverse reactions will

be reviewed by the Medicines Performance Facilitator for further learning from incidents

to reduce future errors. If deemed necessary the incident will be reported to the National

Reporting and Learning System (NRLS).





A9.1. Reporting of Defective Medicines

SOP Title: Reporting of Defective Medicines Reference Number: A9.1








Date Obsolete:


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 medicines (including fluids and medical gases) held by the Trust.


vehicles.








PROCEDURE

WHEN A MEMBER OF STAFF HAS CONCERNS ABOUT THE QUALITY OF A MEDICINE:

a) Identified post treatment:

Monitor the patient closely for any adverse signs and symptoms

Record the concerns on the Patient Report Form/ePRF

Inform the Advanced Paramedic and seek further advice if required

Refer the matter to an Emergency Department Doctor

immediately

If possible a sample of the medicine should be retained. If not the manufacturer / brand,

batch number and expiry date should be recorded.

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) Identified pre- treatment:

Refer the matter to the Duty Advanced Paramedic who will contact the

Medicines Performance Facilitator in the first instance

The Medicines Performance Facilitator will inform the Advanced Paramedic what

action is required with the product i.e. discarded or sent to the Clinical

Governance Department to submit for sampling.

If the product is deemed to be defective the Medicines Performance Facilitator

will liaise with the local pharmacy department to arrange restocks or unaffected

product to be made available to replace any defective medicines located on

NWAS vehicles.

1. If a potential risk is identified the member of staff must inform the Duty Advanced

Paramedic to activate the Trust Incident Reporting Procedure; and inform the

relevant EOC Manager.

2. The EOC Manager will notify the other locality EOC and provide them with the

relevant information.

3. The EOC must notify the relevant on-call Operational Commander (Bronze on-call)

within their respective areas.





4. The on-call Operational Commander (Bronze on-call) 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).

5. Affected batches of the medicine must be withdrawn from use and stored securely

on stations.

6. The on-call Operational Commander (Bronze on-call) must also ensure arrangements

are made to identify affected medicines within all the Emergency

Department Hospital /Station Cabinets.

7. Affected medicines within the Emergency Department Hospital / Station cabinets

must be clearly marked ‘DO NOT USE’

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

the medicines to the supplying pharmacy.

9. The Medicines Performance Facilitator and the Senior Clinical Quality Manager must

be notified at the earliest opportunity.

10. The Medicines Performance Facilitator will follow the North West Drug Defect

Reporting Procedure as defined by Quality Control North West, Stepping Hill

Hospital.

11. A DATIX incident report must be completed and the Trust Incident Reporting

and Investigation Policy followed and a Drug Alert Action Log completed for each

station to evidence the actions completed for the checking and subsequent removal

of any defective medicines.





A11.0 Transportation of Patients own Medicines

SOP Title: Transportation of Patients Own

Medications





Supersedes:

Changes made:



Date Obsolete:

BACKGROUND INFORMATION

OBJECTIVES:

To ensure the Trust appropriately and securely transport patients own medications to and

from hospital as part of the patient’s journey.

SCOPE

All general and controlled medicines belonging to the patient being conveyed by NWAS staff

All NWAS Emergency vehicles including: Ambulances, RRVs, HART vehicles, Urgent Care and

Patient Transport Services.







PROCEDURE

The patient or person accompanying the patient should be asked to collect all their current

medications and a copy of their most recent prescription list before being transported to /

from hospital.

1. The patient’s medications should all be placed into a ‘Patients Own Medication’ bag

(usually a green / orange bag). Write on the front of the bag the patient’s details i.e.

name, date of birth, address.

2. Seal the bag and mark on the front of the bag if any fridge items or controlled drugs

are located within the bag.

3. Transport the patient’s own medications to the hospital with the patient and the rest

of their personal belongings.

4. Document of the PRF/ePRF to confirm the patient’s own medications were

transferred with the patient.

5. Hand over all patients’ belongings including patients own medications to the

receiving unit staff.

IN AN EMERGENCY SITUATION

Do not unnecessarily delay any emergency transfer to hospital to collect a patient’s own

medication. If the situation is an emergency the patient’s conveyance to hospital remains

the priority.

PATIENTS OWN CONTROLLED DRUG MEDICINES

Patients own Controlled drugs do not need to be secured in the CD safe on the vehicle.

They remain the property of the patient and should be conveyed like all other patient

property.





A12.0. Administration of Patients own Medicines

SOP Title: Administration of Patients Own

Medications





Supersedes:

Changes made:



Date Obsolete:

BACKGROUND INFORMATION

There may be occasion when, on arrival at scene, NWAS clinicians are requested to

administer the patient’s prescribed medication to them. The law currently allows any

person to administer a drug to a patient, providing it has been prescribed for them by an

appropriate prescriber and the person administering it is trained and competent in the

required administration route.

OBJECTIVES

Ensure that the patient receives the medicine treatment appropriate to their needs

SCOPE

Patient’s own medications prescribed for them and requested for administration by NWAS

staff.

All NWAS clinicians operational on emergency vehicles including: Ambulances, RRVs, HART

vehicles, Cycle Responders.








PROCEDURE

You must not exceed your clinical scope of practice in terms of drug administration; you

may only administer medications according to the NWAS skill level that you have

acquired. For example IV access: Paramedics only.

YOU SHOULD ONLY ADMINISTER A PATIENT’S OWN MEDICATION IF ALL THE FOLLOWING

APPLY:

a) The circumstance or situation requires you to administer the medication (check that

a dose is due).

b) The medication is prescribed for the patient you are treating (check the date of

dispensing on the label of the item to confirm it is not from an old prescription).

c) The medication is clearly labelled so that you are sure of what it is that you are

administering.

d) The dose administration regimen is written clearly on the medication and, if present,

the patient care plan.

e) The route of administration is clearly written on the medication and, if present, the

patient care plan.

Once you have administered the medication to the patient you must document the details

fully on the Patient Report Form and include:

Drug Name

Dose

Unit

Route of Administration

Time of administration

Wherever possible, these patients should be transferred to an appropriate treatment

centre.





In some cases it may be appropriate for the patient to be left at home as part of an agreed

care plan.

A referral should be made to the patient’s GP or other relevant Health Care Professional.

IN ALL CASES:

A full handover must be provided including details of the medication administered.

The yellow audit copy of the Patient Report Form must be stored in the designated audit

folder on your return to station. APs and SPs will be responsible for auditing the PRFs as

part of the Trust’s agreed annual Clinical Audit Plan.





B1.1. Authorised Signatures

SOP Title: Authorised Signatures CDs Reference Number: B1.1



Version Number & Date: B1.1 December 2014

Supersedes: B1.0 (2011)

Changes made: Format Revision



Date Obsolete:


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

Controlled Drugs stocked by the Trust

All NWAS Emergency vehicles including: Ambulances, RRVs, and HART vehicles.







PROCEDURE

Each nominated community pharmacy that supplies Controlled Drugs to NWAS will have a

file of approved signatories for State Registered Paramedics that are entitled to requisition

CDs (MD12s). The Head of clinical Quality will authorise the Operational Managers ability to

complete the MD12 by the completion of the MD12a.

The approved signatory list must be reviewed by local service delivery management at least

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

ADDITIONS TO THE APPROVED SIGNATORY LIST

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

1. Completing an MD12.

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

purposes

3. A copy of the completed MD12 document will be emailed to the Medicines

Performance Facilitator ([email protected]) who will inform the

community pharmacy of the addition to the list.

REMOVAL FROM THE APPROVED SIGNATORY LIST

When a paramedic resigns from NWAS or is otherwise no longer required to have contact

with CDs through a change in their scope of practise, the Operational management team

must:

Inform the Medicines Performance Facilitator of the change using the email address

[email protected]

On receipt of the email the Medicines Performance Facilitator will advise the

community pharmacy of the change.

CONTROLLED DRUG REQUISITION FROM COMMUNITY PHARMACY

Paramedics who requisition controlled drugs directly from the community pharmacy must:

be on duty,

in recognised uniform with

photographic identification (an NWAS identification badge)

mailto:[email protected]






B2.1. CD Daily Stock Check

SOP Title: CD Daily Stock Check Procedure Reference Number: B2.1





Changes made: The inclusion of Diazepam product stock location removes

the need for SOP 23.0



Date Obsolete:


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





N.B.: Please refer to SOP B 11.1 - additional guidance for Rapid Response

Vehicle personnel





PROCEDURE

RESOURCED VEHICLE – BOTH THE ONCOMING AND DEPARTING SHIFT HAVE PARAMEDIC

STAFF:

Two members of staff – the Paramedic starting Duty and the Paramedic finishing

Duty must check the CDs at the beginning of the shift. A single shift check is

acceptable, but it is recognised as good practice that a CD stock check is performed

at handover/beginning of each shift.

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)

RESOURCED VEHICLE – ONCOMING SHIFT HAS NO PARAMEDIC STAFF

When there is no Paramedic commencing Duty the stock check 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).

RESOURCED VEHICLE – DEPARTING AND ONCOMING SHIFT HAVE NO PARAMEDIC STAFF

When an ambulance or rapid 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.

The EMT staff have responsibility to highlight to the Paramedic on station that the

stock check is required.





UN-RESOURCED VEHICLE – ONCOMING SHIFT HAS PARAMEDIC STAFF

At the commencement of Duty, both the Paramedic and other crew member

must complete a stock check if the vehicle has not been resourced.

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

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

UN-RESOURCED VEHICLE – INCLUDING POOL AND RESERVE VEHICLES

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.

STOCK CHECKS

All stock checks must be recorded in the MD08, writing ‘stock check’ in the Incident No. box

and recording the stock level. It is important to ensure that the stock check is performed

fully and accurately for each of the CDs used by NWAS.

Two signatures must be recorded by the two personnel performing the stock check.

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 local

EOC must be informed for entry on the Control Manager’s Log, including a reason

why the witnessed stock check was not performed.





STOCK LOCATION: DIAZEPAM / DIAZEMULS

To ensure the safe management of all Diazepam products, all Diazepam products

will be stored in the vehicle CD safe.

It is recognised that rapid access to Diazepam products in time critical incidents is

essential, therefore:

ON COMMENCING DUTY

The paramedic can remove the Diazepam products from the vehicle CD safe and place the

Diazepam / Diazemuls in its original packaging into the medicine bag for the duration of the

shift.

AT THE END OF DUTY

If the vehicle is unmanned or the oncoming crew are EMTs the Diazepam products must

be returned to the CD safe and securely locked.

If an oncoming EMT crew discover Diazepam products have not been secured in the vehicle

CD safe it must be reported to a senior staff member. Arrangements should be made

for the Diazepam to be secured in the CD safe as soon as possible. A stock check must be

completed when securing the Diazepam in the safe. An investigation must follow and an IRF

completed in accordance with the Trust Incident Reporting Policy.

REPORTING DISCREPANCIES – ALSO SEE SOP B12.1, B13.1 & B14.1

All controlled drug discrepancies must be reported via the Datix online incident reporting

system under incident type ‘Clinical Incident’ referencing in category type ‘Controlled Drugs’

and also included in the station level AO report each month.





B3.2. EOC Procedure – requisition of CDs from nominated community

pharmacies

SOP Title: EOC Procedure for the requisition of

CDs from nominated community

pharmacies

Reference Number: B3.2



Version Number & Date: B3.2. December 2014





Date Obsolete:


OBJECTIVES

To ensure the requisition of Controlled Drugs:

Morphine Sulphate 10mg/1ml

Diazemuls 10mgs/2ml

Diazepam (Rectal Tube) 5mg/2.5ml

Ketamine 200mg in 20ml…Consultant and Advanced Paramedics only

Midazolam 5mg in 5ml…Consultant and Advanced Paramedics only

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









PROCEDURE:

1. A requisition request for Controlled drugs (CDs) stock to be made where possible

before 1200hrs.

2. All requests will be made via MDT text to EOC (Phone only if system failure) to pick

up Controlled Drugs from designated Pharmacy. (list of numbers are supplied both in

hard copy and electronic back up)

3. EOC manager to contact Pharmacy, to accommodate the request with an ETA if

possible

4. EOC manager to confirm with pharmacy that drug being ordered is available to be

supplied. (Pharmacy to check against overarching requisition that quantity ordered

can be accommodated).

5. EOC to confirm with vehicle that nominated Pharmacy can complete the order. (Or

next available time or date) if Ambulances is diverted to emergency call, the above

must be repeated.

6. Vehicle attending Pharmacies, will follow actions laid down in risk assessments

7. Crews will be available to EOC at all times throughout the process.

A vehicle remains available even when a nil stock of morphine exists on the vehicle. In this

case the crew must complete an IRF, and EOC managers will e-mail details of the incident

to the Medicines Performance Facilitator using the [email protected] email

address.






B4.2. Requisition of vehicle stock CDs from Community Pharmacy

SOP Title: Requisition of Vehicle stock CDs from

Lloyds pharmacy

Reference Number: B.4.2





Changes made: The inclusion of reference to all CDs makes SOP 22.0

redundant



Date Obsolete:


OBJECTIVES

To ensure the requisition of all Controlled Drugs (CDs)


Diazemuls 10mgs/2ml





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

SCOPE

Controlled Drugs requisitioned by the Trust








PROCEDURE

Every emergency vehicle will be allocated with a Controlled Drugs 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 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.

CONTROLLED DRUG REQUISITION

The Paramedic on Duty identifies additional Controlled Drugs vehicle stock is required.

Replenishment of stock can occur when:

Morphine Sulphate stock level is 10 ampoules or less (max stock level 20 ampoules)

Diazepam Rectal Tubes stock level is 4 tubes or less (max stock levels 10 tubes)

Diazemuls stock level is 4 ampoules or less (max stock levels 15 ampoules)

Controlled Drugs can only be requisitioned from Lloyds Pharmacies from Monday to

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

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

controlled drugs

2. EOC acknowledge and manage request dependent on operational activity/pressure

3. EOC authorise collection from designated Lloyds site and pre-alert the pharmacy





Vehicles will have postcodes for pharmacies, and must remain available throughout - no

requirement for operational down time

AT THE COMMUNITY PHARMACY SITE:

The Controlled Drugs book MD07 must be completed by the on Duty Paramedic.

1. On arrival at Lloyds, the Paramedic hands the completed CD requisition (MD07) and

the CD Stock Check (MD08) books in at the pharmacy.

Paramedics who requisition Controlled Drugs must be:

o on Duty,

o in recognised uniform with

o Photographic identification (a NWAS identification badge)

Lloyds Pharmacies will have a specimen signature of Paramedics authorised to

requisition Controlled Drugs for NWAS.

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

Paramedic.

3. The on Duty Paramedic prepares the MD08 Vehicle CD Book for stock entry.

Pharmacy consulting rooms can be used for the issue of CD and completion of

documentation

4. The on Duty Paramedic signs CD Order Book MD07 to confirm receipt of the CDs.

5. The on Duty Paramedic and Pharmacy staff signs stock entry in CD MD08 book.

6. The on Duty Paramedic secures CDs and documentation into vehicle CD cabinet

immediately.

NB: Lloyds Pharmacy maintains an electronic register/database of all completed

requisition and issues a report of completed requisitions to the Senior Clinical Quality

Manager.

A vehicle remains available even when a nil stock of morphine exists on the vehicle. In this

case the crew must complete an IRF, and EOC managers will e-mail details of the incident

to the Medicines Performance Facilitator using the [email protected] email

address.






B.5.2. Requisition of Vehicle Stock – contingency supply route – restrictions apply.

SOP Title: Requisition of Vehicle stock CDs from

Lloyds pharmacy- contingency supply

route






Changes made: The inclusion of reference to all CDs makes SOP 22.0

redundant



Date Obsolete:


OBJECTIVES

To ensure the requisition of all Controlled drugs (CDs)


Diazemuls 10mgs/2ml





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

To ensure that remote regions affected by adverse weather conditions / long journey times

have a secondary route for obtaining controlled drugs.

SCOPE

All CD requisitioned by the Trust in the Cumbria & Morecambe Bay regions only.






PROCEDURE

Every emergency vehicle will be allocated with a Controlled Drugs 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 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.

CONTROLLED DRUG REQUISITION

The Paramedic on Duty identifies additional Controlled Drugs vehicle stock is required.

Replenishment of stock can occur when:

Morphine Sulphate stock level is 10 ampoules or less (max stock level 20 ampoules)

Diazepam Rectal Tubes stock level is 4 tubes or less (max stock level 10 tubes)

Diazemuls stock level is 4 ampoules or less (max stock level 15 ampoules)

Controlled Drugs can only be requisitioned from Lloyds Pharmacies from Monday to

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

4. Paramedic on Duty informs Emergency Operations Centre (EOC) that they

require controlled drugs

5. EOC acknowledge and manage request dependent on operational activity/pressure

6. EOC authorise collection from designated Lloyds site and pre-alert the pharmacy

Vehicles will have postcodes for pharmacies, and must remain available throughout -

no requirement for operational down time

If crew are unable to access the pharmacy to collect controlled drugs AND their stock

levels fall below unsafe levels they can request their contingency supply route.





CONTINGENCY SUPPLY ROUTE

If crew are unable to access the pharmacy to collect controlled drugs AND their stock levels

fall below safe levels they can request their contingency supply route.

N.B: A vehicle remains available even when a nil stock of morphine exists on the vehicle. In

this case the crew must complete an IRF, and EOC managers will e-mail details of the

incident to the Medicines Performance Facilitator using the [email protected]

email address.

1. Crew to contact OM / AOM / SP or AP as soon as possible and notify the reason for

needing the contingency supply route.

2. If the OM / AOM / SP or AP is satisfied for the need to contingency supply they will

contact their Designated Person to liaise with the crew. (Designated Persons include

OM/AOM/AP/SP – and must be registered Paramedics).

3. The Designated Person will contact the crew to arrange a meeting point to collect

the MD07 and MD08 in a Trust vehicle containing a CD safe.

4. Designated Person will meet with the crew to collect both the MD08 and MD07

books. On this occasion the Designated Person completes the controlled drugs

requisition book (MD07) on behalf of the crew.

5. On arrival at Lloyds, the Designated Person hands the completed CD requisition

(MD07) and the CD Stock Check (MD08) books in at the pharmacy.


o on Duty,



Lloyds Pharmacies will have a specimen signature of Paramedics authorised

to requisition Controlled Drugs for NWAS.

NB: Lloyds Pharmacy maintains an electronic register/database of all

completed requisitions; and monthly reports of completed requisitions, by Paramedic,

to the Senior Clinical Quality Manager.






6. The Lloyds Pharmacy prepares and issues completed requisition to the Designated

Person.

7. The Designated person prepares the MD08 Vehicle CD Book for stock entry


documentation

8. The Designated Person signs CD Order Book MD07 to confirm receipt of the CD.

9. The Designated Person and Pharmacy staff signs stock entry in CD MD08 book.

10. The Designated Person secures CDs and documentation into vehicle CD safe

immediately.

11. The Designated Person will contact crew to arrange meeting point for repatriation of

controlled drugs and CD books back to the Ambulance / RRV. CDs are to be stored in

the vehicle safe with CD books for the duration of the journey.

12. The Designated Person will meet with ambulance / RRV and put stock back into the

originating ambulance. A witnessed stock check must be performed at this point.

IF THE VEHICLE IS NOT ABLE TO MEET WITH THE DESIGNATED PERSON FOR

REPATRIATION:

The CDs and CD books must be stored in the station safe at the designated Resilience Point.

They will remain there until they can be put back onto the vehicle and stock checked. CDs

and CD books must be clearly labelled with the vehicle call sign and registration number

when being stored in a station safe.

Cumbria Resilience points are Carlisle, Distington and Penrith ambulance stations.

Morecambe Bay Resilience point are Lancaster, Kendal and Barrow ambulance

stations

N.B: A vehicle remains available even when a nil stock of morphine exists on the vehicle. In

this case the crew must complete an IRF, and EOC managers will e-mail details of the

incident to the Medicines Performance Facilitator using the [email protected]

email address.






B7.1. CD Security: Ambulance Vehicles

SOP Title: CD Security: Ambulance Vehicles Reference Number: B.7.1.





Changes made: Updated to include guidance for vehicles in workshops or

leaving premises for repair.



Date Obsolete:


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

All CDs stocked by the Trust


Diazemuls 10mgs/2ml











PROCEDURE

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

When vehicles are not resourced and parked on station they must be locked and the keys

stored within a designated area on station.

DEFECTIVE OR BROKEN VEHICLE LOCKS

Vehicles with defective or broken locks must be reported and the appropriate

workshops or Duty mechanic notified.

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)

If the actual vehicle CD safe is damaged or defective the crew must transfer onto a

pool/reserve vehicle immediately (see SOP B17.0.). The incident must be reported via the

Datix online incident reporting system under incident type ‘Clinical Incident’ referencing in

category type ‘Controlled Drugs’ and also included in the station level AO report each month.

The controlled drugs must be removed from the vehicle and stored within the station

CD Cabinet (see SOP B17.0.).

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

changeover, the controlled drugs may be removed and stored temporarily within a

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

Stocked vehicle CD Cabinets must not be opened by workshop personnel unless in the

presence of a qualified Paramedic.





EMERGENCY VEHICLES IN WORKSHOPS FOR REPAIR

When an emergency vehicle is booked in at workshops for service or repair, the Controlled

Drugs can be left securely on the vehicle – providing it is known not to be leaving NWAS

premises e.g. Renault or Mercedes Garages

EMERGENCY VEHICLES LEAVING NWAS PREMISES FOR REPAIR

In the event of a vehicle having to leave NWAS premises for repair or modification, the

Controlled Drugs and associated documentation must be removed by a Paramedic and

stored within a station CD cabinet.

The key for the station CD cabinet will be stored in the single Station CD key safe.

The station CD Cabinet should not be utilised to store Controlled Drugs in any other

circumstance other than when CD removal from a vehicle is required due to vehicle going

off site for repair.

The station CD Cabinet must not be used for any other purpose.

Whenever controlled drugs are removed from a vehicle the Controlled Drug Tracking Form –

MD13 must be completed.





B8.1. CD Security: Key Management

SOP Title: CD Security: Key Management Reference Number: B.8.1








Date Obsolete:


OBJECTIVES

To ensure the vehicle CD safe 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 CDs stocked by the Trust.


Diazemuls 10mgs/2ml




All NWAS Emergency vehicles including: Ambulances, RRVs and HART vehicles.



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





PROCEDURE

At the commencement of Duty the Paramedic shall either

a) remove the CD safe key from the station key cabinet for the vehicle they are working

on; or

b) receive the CD safe key from the departing shift paramedic

VEHICLE CD KEY SAFE RESPONSIBILITIES: RESOURCED VEHICLES

1. 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.

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

at all times, for the duration of their shift.

3. 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).

VEHICLE CD KEY SAFE RESPONSIBILITIES: UN- RESOURCED VEHICLES

When the vehicle is not to be resourced or resourced without a Paramedic then, at the end

of shift, the departing shift Paramedic must ensure;

the vehicle CD safe is locked, and

return the vehicle CD safe key to the station key cabinet

SPARE VEHICLE CD SAFE KEYS

A spare key for every vehicle CD safe shall be securely stored at the following locations:

Greater Manchester: Medicines Performance Facilitator

Cheshire & Merseyside: Clinical Quality Manager

Cumbria & Lancashire: Sector level Advanced Paramedic

In All cases: access to the spare keys is subject to authorisation by the Medicines

Performance Facilitator, Senior Clinical Quality Manager, or Head of Clinical Quality.





LOST, MISSING OR STOLEN VEHICLE CD SAFE KEYS: SEE ALSO SOP B15.1

Spare vehicle CD safe keys will only be issued if the original is confirmed lost or stolen.

The spare vehicle CD safe keys will not be released due to a key being taken home by a

member of staff. 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 rapid response vehicle can remain operational without having

access to the CD cabinet.

REPORTING OF LOST, MISSING OR STOLEN CD SAFE KEYS: SEE ALSO SOP B15.1

All lost, missing or stolen CD safe keys must be reported via the Datix online incident

reporting system under incident type ‘Clinical Incident’ referencing in category type

‘Controlled Drugs’.

The incident must also be included in the station level AO report each month.





B9.1. CD Security: Key Cabinet Management – access codes

SOP Title: CD Security: Key Cabinet management

– access codes









Date Obsolete:


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 supervision

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





PROCEDURE

RESPONSIBILITIES:

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.

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

2. 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.

3. 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.

REPORTING OF ACCESS CODE KNOWN BY NON-PARAMEDICS:

An incident report form must be completed by the Non-Paramedic and the Trust Incident

Reporting and Investigation Policy followed.

All incidents of access codes becoming known to Non- Paramedics must be reported via the


category type ‘Controlled Drugs’.


The Medicines Performance Facilitator will be responsible for monitoring the occurrence in

the Monthly Occurrence AO Report.





B10.1. CD Security Station CD Cabinet Management -access

SOP Title: CD Security: Station CD Cabinet –

access code management









Date Obsolete:


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



Stadia and Event Sites where a CD Cabinet is in situ

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

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

administration





RESPONSIBILITIES:

The local Service Delivery (SD) Manager or nominated lead for Medicine Management is

responsible for regularly changing the access code for the CD Station Cabinet.

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

2. 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.

3. 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 on-call Operational Commander (Bronze on-call) or AP must be informed

without delay.

2. The CD Station 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.

REPORTING OF ACCESS CODE KNOWN BY NON-PARAMEDICS:

An incident report form must be completed by the Non-Paramedic and the Trust Incident

Reporting and Investigation Policy followed.

All incidents of access codes becoming known to Non- Paramedics must be reported via the










B.11.1. CD Security: Rapid Response Vehicles – Stock Checks

SOP Title: CD Security: Rapid Response Vehicles

stock checks









Date Obsolete:


OBJECTIVES


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

.

SCOPE



Diazemuls 10mgs/2ml










PROCEDURE

Paramedics working on rapid response vehicles must follow the same Medicine

Management procedures as for ambulances with the following exceptions:

CONTROLLED DRUG ADMINISTRATION

1. When a Controlled Drug has been administered by the RRV Duty Paramedic, he or

she must obtain a counter-signature from a crew member from the attending

ambulance.

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

Report Form/ePR the ambulance crew are using.

CONTROLLED DRUGS STOCK CHECK

Ideally at the commencement and finish of the shift the Paramedic RRV 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.

When a Paramedic is working on an RRV 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.





B.12.1. Damaged Stock Disposal – Controlled Drugs

SOP Title: Damaged Stock Disposal –

Controlled Drugs






Changes made: Inclusion of damage stock disposal guidance for all CDs

carried by NWAS



Date Obsolete:


OBJECTIVES

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

drugs are damaged in accordance with best practice guidance and legislation ensuring a

robust audit trail is completed.

SCOPE

All CDs stocked by the Trust:


Diazemuls 10mgs/2ml











PROCEDURE

CONTROLLED DRUG: MORPHINE, KETAMINE, MIDAZOLAM DAMAGED

1. In the event of a damaged ampoule of Morphine, Ketamine or Midazolam the on

Duty Paramedic must ask the other crew member to verify the incident.

2. Paramedics working on RRVs must attempt to retain it as best as possible for

verification by another member of staff at the next available opportunity.

3. The damaged stock must then be disposed of in the yellow sharps bin, situated on

each A&E vehicle (including RRVs).

4. The damaged stock must be recorded as an ‘issue’ in the Daily Stock Check book -

MD08.

‘Damaged Stock’ must be recorded within the Incident No. box of the MD08.

REPORTING DAMAGED MORPHINE, KETAMINE, MIDAZOLAM:

All incidents of damaged morphine ketamine or midazolam must be reported via the Datix

online incident reporting system under incident type ‘Clinical Incident’ referencing in









CONTROLLED DRUG: DIAZEPAM AND DIAZEMULS

1. In the event of a damaged ampoule of diazemul or rectal diazepam, the on Duty

Paramedic must ask the other crew member to verify the incident.





4. The damaged stock must be recorded as an ‘issue’ in the Daily Stock Check book -

MD08.


REPORTING DAMAGED DIAZEPAM/DIAZEMULS:

All incidents of damaged diazepam and or diazemuls must be reported via the Datix online

incident reporting system under incident type ‘Clinical Incident’ referencing in category type









CONTROLLED DRUG: CODEINE PHOSPHATE

1. In the event of a damaged bottle of codeine phosphate, the on Duty Paramedic must

ask the other crew member to verify the incident.





4. The damaged stock must be recorded as an ‘issue’ on the MD02 located in the

vehicle clinical record book.


REPORTING DAMAGED CODEINE PHOSPHATE:

All incidents of damaged codeine phosphate must be reported via the Datix online incident

reporting system under incident type ‘Clinical Incident’ referencing in category type









B13.1. Expired Stock Disposal – Controlled Drugs

SOP Title: Expired Stock Disposal –

Controlled Drugs




Version Number & Date: B.13.1. December 2014


Changes made: Inclusion of expired stock disposal guidance for all CDs

carried by NWAS



Date Obsolete:


OBJECTIVES

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

incidence of expired controlled drugs the incident is managed in accordance with best

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

SCOPE



Diazemuls 10mgs/2ml







For the destruction of Diazepam please follow SOP A.3.1 Damaged, Expired & Used

Medicines Disposal





PROCEDURE

EXPIRED CONTROLLED DRUGS: MORPHINE SULPHATE, KETTAMINE, MIDAZOLAM

Paramedics should, whenever possible, arrange for the destruction of Morphine, Ketamine

or Midazolam to occur on the same visit as ordering new CD stocks (see SOP B4.1 for

requisition procedure).

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.

The expired morphine stock must still be included in the vehicle stock level

until it is transferred to Lloyd’s pharmacy for destruction.

2. Contact EOC to report the vehicle has expired Morphine stock in need of destruction.

3. EOC will contact Lloyds to report that the vehicle will be visiting the designated

Lloyd’s pharmacy with an ETA. When clearance is received from EOC to attend the

designated Lloyds pharmacy the paramedic must make an entry in the controlled

drugs requisition book (MD07) to reflect the transfer of out of date stock to the

pharmacy.

4. The Paramedic completes an entry in the CD requisition book (MD07) to include:

• Drug being returned

• Quantity being returned (words and numbers)

• Reason for return

Example: ‘Expired Morphine Sulphate 10mg/1ml x 4 (Four) ampoules returned to

Lloyds Pharmacy for destruction’.

• Signature of Paramedic

• Date of return

• Address of pharmacy being returned to for destruction i.e. Lloyds

Brunswick St, Manchester or Lloyds M13 9TQ if postcode known.

5. The pharmacist will verify the quantity and drug being returned for destruction.

They will sign the requisition for acceptance of the returned stock and stamp the

carbon copy (pink/beige page) of the requisition record with a Lloyd’s pharmacy

stamp.





6. The pharmacy will keep the top white copy of the requisition and will take receipt of

the expired stock.

7. The paramedic will also make an entry in the CD record book (MD08) to record the

transfer of stock. i.e. ‘4 ampoules transferred to pharmacy for destruction’.

8. The new stock balance is recorded in the stock balance column and the pharmacist

and paramedic both sign to confirm that the stock was returned for destruction.

9. The controlled drugs requisition book (MD07) and CD record book (MD08) must then

be secured back in the vehicle safe.

10. A witnessed and recorded stock check must be performed at the next available

opportunity.

REPORTING OF EXPIRED MORPHINE SULPHATE, KETAMINE, MIDAZOLAM:

Lloyds Community Pharmacy will submit details of destructions in the monthly reports

submitted to the Medicines Performance Facilitator for recording on the Area Occurrence

Report.

The Accountable Officer will be provided with a copy of the Trust-wide Occurrence Report

on a monthly basis.

EXPIRED CONTROLLED DRUGS: DIAZEPAM, DIAZEMULS & CODEINE PHOSPHATE: SOP A3.1

When Diazepam, Diazemuls and/or Codeine Phosphate has been used, expired or

become damaged it must be disposed of in the appropriate yellow clinical waste

receptacle situated on each vehicle and recorded on the MD02 ‘Medicine Issue & Receipt

Record’ located in the monthly vehicle clinical check book.





B14.1. Suspected or Known Theft or Loss of Controlled Drugs

SOP Title: Suspected or known theft or loss of

Controlled Drugs









Date Obsolete:


OBJECTIVES

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

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



Diazemuls 10mgs/2ml











PROCEDURE

CONTROLLED DRUG KNOWN OR SUSPECTED THEFT: MORPHINE SULPHATE, KETAMINE,

MIDAZOLAM

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

The Locality EOC Manager must inform the Police and request their attendance

without delay.

CONTROLLED DRUG LOST: MORPHINE SULPHATE, KETAMINE, MIDAZOLAM

1. The Paramedic responsible for Morphine must inform the locality

Emergency Operational Centre (EOC) immediately.

2. The EOC Manager must inform the on-call Operational Commander (Bronze on-call)

and Advanced Paramedic.

3. The on-call Operational Commander (Bronze on-call) must co-ordinate a stock check

of all vehicles within the relevant sector.

4. The EOC Manager must inform the police as soon as possible (same working day).

5. An incident report form must be completed immediately by the Paramedic who was

responsible for the Morphine.

REPORTING OF CONTROLLED DRUG KNOWN OR SUSPECTED THEFT OR LOSS: MORPHINE

SULPHATE, KETAMINE, MIDAZOLAM

1. All incidents of controlled drug known or suspected theft of loss must be reported

via the Datix online incident reporting system under incident type ‘Clinical Incident’

referencing in category type ‘Controlled Drugs’. The incident must also be included

in the station level AO report each month.

2. The Senior Clinical Quality Manager and the Medicines Management Facilitator must

be notified as soon as practicably possible.





The Trust Medical Director, as Accountable Officer and Trust Pharmacist Advisor

must be notified in writing as soon as practicably possible by the Senior Clinical

Quality Manager.

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

investigation should be undertaken. The options available include:

o Conducting the investigation themselves

o Submitting a written request for another officer in the Trust to

undertake the investigation

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

more responsible bodies to undertake the investigation

o 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

4. A Senior Clinical Quality Manager will notify the Home Office Drugs Branch of the

incident by telephone within 7 days. Telephone number: 0113 2204571.

5. The Clinical Governance Management Group shall review the investigation and

authorise/make recommendations at the earliest opportunity.

KNOWN OR SUSPECTED THEFT OR LOSS: DIAZEPAM, DIAZEMULS, AND /OR CODEINE

PHOSPHATE

1. The Paramedic responsible for Morphine must inform the locality

Emergency Operational Centre (EOC) immediately.

2. The EOC Manager must inform the on-call operational (Bronze Commander) and

Advanced Paramedic.





3. The on-call Operational Commander (Bronze on-call) must co-ordinate a stock check

of all vehicles within the relevant sector.

4. An incident report form must be completed immediately by the Paramedic who was

responsible for the Diazepam, Diazemuls and/or Codeine Phosphate.

KNOWN OR SUSPECTED THEFT OR LOSS: DIAZEPAM, DIAZEMULS AND OR CODEINE

PHOSPHATE

1. All incidents of controlled drug known or suspected theft of loss must be reported








Quality Manager.

3. The Local Advanced Paramedic, having assessed the incident, will then decide how

the investigation should be undertaken. The options available include:






4. The Local Advanced Paramedic will complete the investigation and advise the

Medicines Performance Facilitator of the outcome.

5. The Clinical Quality and Service Delivery Management teams shall review the

investigation and authorise/make recommendations at the earliest opportunity.





B15.1. Suspected or Known Theft or Loss of Controlled Drugs cabinet Key

SOP Title: Suspected or known theft or loss of

Controlled Drugs cabinet key

Reference Number: B.15.1.








Date Obsolete:


OBJECTIVES

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



Diazemuls 10mgs/2ml











PROCEDURE

CONTROLLED DRUG CABINET KEY: SUSPECTED OR KNOWN THEFT

All steps must be taken as for a CD Cabinet key being lost with the addition of:

The Locality EOC Manager must inform the Police without delay.

If the perceived risk of further theft is high then the controlled drugs must be

removed and stored temporarily within a Station CD Safe.

CONTROLLED DRUG CABINET KEY: LOST

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

Operational Centre (EOC) immediately.

2. The EOC Manager must inform the on-call Operational Commander (Bronze on-call)

or Advanced Paramedic (AP).

3. The on-call Operational Commander (Bronze on-call) or AP will be required to

seek and receive authorisation by the Medicines Performance Facilitator, Senior

Clinical Quality Manager or Head of Clinical Quality before the spare CD cabinet key

will be released.

A spare key for every vehicle CD safe shall be securely stored at the following

locations:

Greater Manchester: Medicines Performance Facilitator

Cheshire & Merseyside: Clinical Quality Manager

Cumbria & Lancashire: Sector level Advanced Paramedic

In All cases: access to the spare keys is subject to authorisation by the Medicines

Performance Facilitator, Senior Clinical Quality Manager, or Head of Clinical Quality.





4. The Duty locality EOC Manager must complete a MD11 spreadsheet to record the

events.

The MD11 register will be maintained Medicines Performance Facilitator

5. The appropriate SD Manager in consultation with Medicines Performance Facilitator

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

within 24 hours).

6. 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.

REPORTING OF KNOWN OR SUSPECTED THEFT OR LOSS: CD CABINET KEY

1. All incidents of CD Cabinet Key known or suspected theft of loss must be reported








Quality Manager.

3. The Local Advanced Paramedic, having assessed the incident, will then decide how

the investigation should be undertaken. The options available include:






4. The Local Advanced Paramedic will complete the investigation and advise the

Medicines Performance Facilitator of the outcome.

5. The Clinical Quality and Service Delivery Management teams shall review the

investigation and authorise/make recommendations at the earliest opportunity.





B.16.1. Patient Administration of Controlled Drugs:

SOP Title: Patient Administration of controlled

drugs









Date Obsolete:


OBJECTIVES

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

administration of controlled drugs in accordance to best practice guidance and legislation,

ensuring a robust audit trail is completed.

SCOPE

N.B. This section does not deal with the clinical aspects of controlled drug administration.



Diazemuls 10mgs/2ml











PROCEDURE

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

recorded on the Patient Report Form/ePRF:

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 CD remaining in the syringe or rectal the 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 controlled drug being disposed

of.

RRV staff must ask a crew member from the responding ambulance to verify

the quantity of controlled drug being disposed of.

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

administered and the quantity issued that is recorded on the MD08.





B17.1. Pool/ Reserve or Spare Vehicles

SOP Title: Pool/ Reserve or Spare Vehicles Reference Number: B.17.1





Changes made: Guidance includes clarity about expected stock checks to

be performed on pool/reserve or spare vehicles.



Date Obsolete:


OBJECTIVES

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

administration of controlled drugs in accordance to best practice guidance and legislation,

ensuring a robust audit trail is completed.

SCOPE



Diazemuls 10mgs/2ml









PROCEDURE

STOCK LEVELS:

All emergency pool/reserve or spare vehicles will have a permanent stock of:

10 x 10mg/ 1ml Morphine,

10 x 10mg/2ml Diazemul

5 x 5mg/2.5ml Diazepam (rectal tube)

Controlled Drug MD07 and Controlled Drug MD08 books.

STOCK CHECKS

SOP B.2.1. is applicable to all vehicles including pool / reserve or spare vehicles and must be

followed at all times.

1. 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.

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

No. box and recording the stock level. It is important to ensure that the stock check

is performed fully and accurately for each of the CDs used by NWAS.

o Two signatures must be recorded by the two personnel performing the stock

check.

o 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.

STOCK REQUISITION

SOPs B 4.2 and B5.2 must be followed for stock requisition.

REPORTING DISCREPANCIES – also see SOP B12.1, B13.1 & B14.1 All controlled drug

discrepancies must be reported via the Datix online incident reporting system under

incident type ‘Clinical Incident’ referencing in category type ‘Controlled Drugs’ and also

included in the station level AO report each month.





CD KEY SECURITY: POOL/RESERVE OR SPARE VEHICLES

1. The key for the CD cabinet will be stored in a key cabinet located on the pool/reserve

vehicle (where key safes are available).

2. The pool/reserve vehicle key cabinet will be fitted with a combination lock similar to

that of the station key cabinets.

3. Only Paramedics, the NWAS Service Delivery Management and Clinical Quality

Teams will possess the codes to access the pool/reserve vehicle key cabinets.

4. When an emergency vehicle is booked in at workshops for service or repair, the

Controlled Drugs may be left securely on the vehicle – providing it is known not to be

leaving NWAS premises e.g. Renault or Mercedes Garages etc.

EMERGENCY VEHICLES IN WORKSHOPS FOR REPAIR

When an emergency vehicle is booked in at workshops for service or repair, the Controlled

Drugs can be left securely on the vehicle – providing it is known not to be leaving NWAS

premises e.g. Renault or Mercedes Garages

EMERGENCY VEHICLES LEAVING NWAS PREMISES FOR REPAIR

In the event of a vehicle having to leave NWAS premises for repair or modification, the

Controlled Drugs and associated documentation must be removed by a Paramedic and

stored within a station CD cabinet.

1. The key for the station CD cabinet will be stored in the single key safe for the station

CD cabinet key.

2. The station CD Cabinet should not be utilised to store Controlled Drugs in any other

circumstance other than when CD removal from a vehicle is required due to vehicle

going off site for repair.

The station CD Cabinet must not be used for any other purpose.

3. Whenever controlled drugs are removed from a vehicle the Controlled Drug Tracking

Form – MD13 must be completed.





B18.1. Events Stadia CD Cabinet Stock Checks and Requisitions

SOP Title: Events Stadia CD Cabinet Stock Checks

and Requisitions

Reference Number: B.18.1.








Date Obsolete:


OBJECTIVES


appropriate format in place at events stadia.

SCOPE



Diazemuls 10mgs/2ml


Events Stadia where a CD Cabinet is in situ





Clinical Quality 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 2.1 and

B17.1 for daily stock checks

PROCEDURE

STOCK LEVELS: EVENTS STADIA

Event Stadia will have a permanent stock of:

10 x 10mg/ 1ml Morphine,

10 x 10mg/2ml Diazemul

5 x 5mg/2.5ml Diazepam (rectal tube)

Controlled Drug MD07 and Controlled Drug MD08 books.

CD STOCK CHECK: EVENTS STADIA

A CD stock check must be performed at least weekly.

REPORTING DISCREPANCIES – ALSO SEE SOP B12.1, B13.1 & B14.1


system under incident type ‘Clinical Incident’ referencing in category type ‘Controlled Drugs’

and also included in the station level AO report each month.





CD SECURITY: EVENTS STADIA

1. The key for the CD cabinet will be stored in a CD key cabinet located in the vicinity of

the CD Cabinet.

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

station CD key cabinets.

3. Only Paramedics, the NWAS Service Delivery Management and Clinical Quality

Management Teams will possess the codes to access the Events Stadia key cabinets.

CD REQUISITION: EVENTS STADIA

A Designated Person to liaise with EOC and arrange an appropriate time to collect the CDs

from the community pharmacy. (Designated Persons include OM/AOM/AP/SP currently on

their admin day – and must be registered Paramedics).

1. The Designated Person will collect the MD07 and MD08 in a Trust vehicle containing

a CD safe.

2. Designated Person completes the controlled drugs requisition book (MD07) on

behalf of the crew.

3. On arrival at Lloyds, the Designated Person hands the completed CD requisition

(MD07) and the CD Stock Check (MD08) books in at the pharmacy.


o on Duty,



Lloyds Pharmacies will have a specimen signature of Paramedics authorised

to requisition Controlled Drugs for NWAS.

NB: Lloyds Pharmacy maintains an electronic register/database of all

completed requisitions; and monthly reports of completed requisitions, by Paramedic,

to the Senior Clinical Quality Manager.





4. The Lloyds Pharmacy prepares and issues completed requisition to the Designated

Person.

5. The Designated person prepares the MD08 Vehicle CD Book for stock entry


documentation

6. The Designated Person signs CD Order Book MD07 to confirm receipt of the CD.

7. The Designated Person and Pharmacy staff signs stock entry in CD MD08 book.

8. The Designated Person secures CDs and documentation into vehicle CD safe

immediately.

9. The Designated Person will return to the Events Stadia and put stock into the site CD

Safe. A witnessed stock check must be performed at this point.

SOPS ALSO ARE APPLICABLE TO EVENTS STADIA ARE:

B2.1. CD Daily Stock Check – exception being that the frequency is reduced to at least once

a week

B8.1. CD Security: Key management

B10.1. CD Security: Station CD Cabinet Management Access

B12.1 Damaged Stock Disposal

B13.1. Expired Stock Disposal

B14.1 Suspected or Known Theft or Loss of CDs





B19.1 Decommissioned or Re-Designated Vehicles

SOP Title: Decommissioned or Re-designated

Vehicles









Date Obsolete:


OBJECTIVES

To ensure the management of re-designated and 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



Diazemuls 10mgs/2ml









N.B: This procedure applies only to Re-designated and Decommissioned Vehicles

PROCEDURE

DECOMMISSIONED VEHICLE

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

decommissioned (not resourced or moved elsewhere within the Trust)

1. Remove from the decommissioned vehicle the:

Morphine

Diazepam

Diazemuls

MD07 CD Requisition book

MD08 CD Daily Check book

Controlled Drug tracking form

2. Place all of the above on the new vehicle

3. Ensure all vehicle details on the MD07 and MD08 books are amended with the new

registration number and call sign.

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

4. Enter a signed diary note in the MD08 CD Daily Stock Check book stating:

the date of decommissioning,

new vehicle registration and

new call sign

Ensure all sections are updated (morphine, diazemuls and diazepam)

5. Ensure that the spare CD Cabinet key for the new vehicle is sent to the appropriate

location (SOP B8.1 CD Security: Key Management), and notify the medicine

management team through the [email protected] email address.






RE-DESIGNATED VEHICLE

When 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 area or Trust).

1. Ensure that the Morphine MD07 and MD08 books remain on the original vehicle and

are amended with the new call sign.

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

2. Enter a signed diary note in the MD08 CD Daily Stock Check book stating:

the date of call sign change

Ensure all sections are updated (morphine, diazemuls and diazepam)

3. Ensure that the spare CD Cabinet key for the re- designated vehicle is sent to the

appropriate location (as appropriate) (SOP B8.1 CD Security: Key Management), and

notify the medicine management team through the [email protected]

email address.






B20.1: Issue of MD07: AP Procedure

SOP Title: Issue of MD07: AP Procedure Reference Number: B.20.1








Date Obsolete:


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



Diazemuls 10mgs/2ml











PROCEDURE

When a MD07 Stock Requisition book is almost full, (under 5 order pages left) the PES staff

must inform their Service Delivery Manager and Advanced Paramedic.

1. The Advanced Paramedic will contact the medicine management team using the

[email protected] email address with the following details:

Vehicle Registration

Vehicle Call sign

Vehicle Location or Base

Unique current CL, CM, GM or NWAS number

2. The medicine management team will issue a new MD07 to the vehicle complete

with unique central registration number to the requesting Advanced Paramedic.

THE ADVANCED PARAMEDIC WILL:

1. Remove the completed MD07 from the vehicle and place the completed book in the

local storage repository. All medicines documentation must be stored securely for a

minimum of 2 years. The documentation archive location for each vehicle should be

identified and documented by the staff member responsible for medicines

management for each sector and notified to the Medicines Performance Facilitator

for NWAS.

2. Place the replacement (new) MD07 on the vehicle

IF THE ORIGINAL BOOK STILL HAS REQUISITION PAGES AVAILABLE:

The Advanced Paramedic will:

1. Redact each of these pages (score through and mark as void), and

2. Place in the local storage repository.






B21.1: Unique Procedures: New Vehicles into the NWAS Fleet

SOP Title: New vehicles to NWAS Fleet Reference Number: B.21.1








Date Obsolete:


OBJECTIVES

To ensure the management of new 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



Diazemuls 10mgs/2ml









N.B: This procedure applies to NEW additional vehicles only.

Please see SOP B19.1 for decommissioned vehicles being replaced by new vehicles.

PROCEDURE

Where a new vehicle is coming in as an additional vehicle to the fleet (and no other vehicle

is being swapped or decommissioned):

1. New MD07 and MD08 books will be issued for the new vehicle, and a new unique

NWAS number will be allocated, by the medicine management team.

2. The outer front cover of the MD07 and the vehicle registration number will be

clearly printed in the top left hand corner of the new book.

3. A new supply of controlled drugs will be obtained for the vehicle. (SOP B4.2

Requisition of vehicle stock CDs from Community Pharmacy)

4. The spare CD Cabinet key for the new vehicle is sent to the appropriate location (SOP

B8.1 CD Security: Key Management), and notify the medicine management team

through the [email protected] email address.






C1.0: ECFR Medicine Management

SOP Title: Medicine Management including

requisition and stock checks

Reference Number: C1.1



Version Number & Date: C1.1 December 2014

Supersedes: C1.0 July (2012)




Date Obsolete:


OBJECTIVES

To ensure the management of medicines used within the Extended Community First

Responder(ECFR) scope of practice 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

All NWAS Extended Community First Responders

Oxygen

Entonox

Aspirin 300mg Dispersible Tablets

Dextrose Gel (40%)

This procedure applies only to Extended Community First Responders / Team

Leaders





PROCEDURE

MEDICINE REQUISITION

When making a medicines requisition the ECFR must

1. Complete form DU02 to order the following items:

Oxygen

Entonox

Aspirin 300mg Dispersible Tablets

Dextrose Gel (40%)

2. Form DU02 should be passed to group Team Leader

3. Team Leader must send form DU02 to designated station and contact.

Contact must be an SP / AOM or senior

4. Designated contact will inform Team leader when medicines are available and agree

collection time.

5. At time of collection form DU02 must be:

Signed and dated by station contact and team leader.

Expiry dates and batch numbers should be entered on to form DU02 and

checked for accuracy.

6. The Team Leader will then allocate the medicines to the appropriate ECFR kit.

Documentation must be stored in a medicine management folder by Team Leader

Documentation must be available for audit by Community Resuscitation Defibrillation

Officer, Community Resuscitation Manager or NWAS Clinical Quality Team upon request.





MEDICINES ADMINISTRATION

Where an Extended Community First Responder administers medicine to a patient: 1. Medicine name and expiry date should be carefully checked by the responder

and confirmed if a second responder is on scene.

2. Administration of the medicine must be accurately recorded on form DU01 by the

responder administering the medicine. Information recorded should be:

Date

Incident Number

Medicine Name

Batch Number

Expiry Date

Quantity

Issuing ECFR signature and PIN number.

3. Completed DU01 forms should be passed to Team Leader for filing when full.


Officer, Community Resuscitation Manager or NWAS Clinical Quality Team upon

request.

MEDICINES STOCK CHECK

Where an Extended Community First Responder is in possession of medicines:

1. Medicines should be checked on a daily basis and when possession of kit changes

between responders. Checks should include:

Packaging intact

Information sheet present (where applicable)

Medicines in date

Number/quantity

Form DU03 should be completed and signed.

2. Completed sheets should be passed to Team Leader for filing when complete

or at the end of each month.


Officer, Community Resuscitation Manager or NWAS Clinical Quality Team upon

request.





D1.1 HART: Mass Casualty Vehicle Check Daily/Weekly requirements

SOP Title: Medicine Management including

requisition and stock checks

Reference Number: D1.1



Version Number & Date: D1.1 December 2014

Supersedes: D1.0 September (2012)




Date Obsolete:


OBJECTIVES

To comply with Department of Health instructions for the use of Mass

Casualty Vehicles within HART

Ensure that the management of vehicle stocks is in accordance with best practice guidelines

and compliant with legislation whilst providing assurance that NWAS will have sufficient

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

event of a mass casualty incident.

Provide assurance to NWAS and DH relating to compliance with medicines

management of Mass Casualty Vehicles.

SCOPE

HART Mass Casualty Vehicles





PROCEDURE

The designated HART operative will be required to perform and record the daily and weekly

vehicle checks recommended by the National Ambulance Pharmacists Network (Appendix

1). Designated HART operatives include:

Manchester: HART Team Leader

Liverpool: HART Team Leader

Preston: Nominated Service Delivery Personnel for daily vehicle checks. Weekly

checks to be performed by designated HART operative / nominated member of the

Resilience team

DAILY CHECKS

Controlled Drugs Locker

1. Check the locker is sealed with a numbered security tag.

2. Record the number of the security tag on the daily check form record.

If the numbered tag has been broken or is different to the tag attached at the last

check report this immediately to the HART Operations Manager

General Medicines Netting

1. Check the netting is sealed with a numbered security tag.

2. Record the number of the security tag on the daily check form record.

If the numbered tag has been broken or is different to the tag attached at the last

check report this immediately to the HART Operations Manager

Refrigerator Temperature Monitoring

Refrigerator temperatures monitored and recorded (see SOP D.2.1 HART Daily Refrigerator

Monitoring)





WEEKLY CHECKS

Controlled Drugs Locker

The Controlled Drugs Locker must be checked by the HART Team Leader / designated

Resilience Team member (Preston) and a witness.

1. The numbered security tag in situ must be removed and the locker opened.

2. A visual count of the number of sealed boxes in the locker must be performed,

witnessed and recorded on the daily / weekly vehicle check form.

3. Both staff must sign the form.

4. The Controlled Drugs Locker should be closed and a new security tag attached to

secure the locker.

5. A new security number should be recorded on the tag.

6. Record the number on the form, sign and date it.

Any discrepancies / evidence of tampering with the security tags should be immediately

reported to the HART Operations Manager.

HART Operations Manager should report this to the Medicines Performance Facilitator as

soon as possible for investigation.


system under incident type ‘Clinical Incident’ referencing in category type ‘Controlled

Drugs’ and also included in the station level AO report each month.

Maintaining Roadworthiness

The vehicle must be driven for a minimum journey of 20 miles each week. The mileage

must:

be recorded after the journey on the weekly check form to evidence this

The HART Team Leader / Resilience Team member (Preston) should ensure that the

mileage has increased by a minimum of 20 miles since the last weekly check was

performed.

Note: All records of daily / weekly vehicle checks must be retained and filed for audit

/inspection for a period of 2 years from the last date of entry.





D2.1: HART: Mass Casualty Vehicle Refrigerator Monitoring

SOP Title: Vehicle Refrigerator Monitoring Reference Number: D2.1



Version Number & Date: D2.1 December 2014

Supersedes: D2.0 September (2012)




Date Obsolete:


OBJECTIVES

To comply with Department of Health instructions for the use of Mass

Casualty Vehicles within HART

Ensure that the management of vehicle stocks is in accordance with best practice guidelines

and compliant with legislation whilst providing assurance that NWAS will have sufficient

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

event of a mass casualty incident.

SCOPE

HART Mass Casualty Vehicles





PROCEDURE

The designated HART operative will be required to perform and record the daily refrigerator

monitoring in accordance with DH recommendations. Designated HART operatives include:

Manchester: HART Team Leader

Liverpool: HART Team Leader

Preston: Nominated Service Delivery Personnel for daily vehicle checks. Weekly

checks to be performed by designated HART operative / nominated member of the

Resilience team

DAILY REFRIGERATOR MONITORING

On the daily check form record the:

date,

time,

current minimum and

maximum temperatures

The temperatures recorded must fall within the range of 2˚C – 8˚C.

If the temperature is recorded outside of this range make an entry on the daily check

form and notify the HART Operations Manager.

HART Operations Manager should report this to the Medicines Performance

Facilitator as soon as possible for advice.





E1.1: Commercial Courier: Deliveries of Pharmaceutical Supplies from Lancashire Teaching

Hospitals NHS Trust

SOP Title: Deliveries of Pharmaceutical supplies

from Lancashire Teaching Hospitals

NHS Trust

Reference Number: E1.1



Version Number & Date: E1.1 December 2014

Supersedes: E1.0 September (2012)




Date Obsolete:


OBJECTIVES

To ensure the:

security, safe handling, quality and integrity of the pharmaceutical supplies being

delivered from Lancashire Teaching Hospital NHS Foundation Trust to designated

sites in accordance with current Service Level Agreements

Courier deliveries are in accordance with best practice guidance and current

legislation

To ensure the safety of courier drivers during transit and comply with correct

regulations for waste disposal in the event of breakages

SCOPE

All deliveries made by the Trust as part of the contracted courier service provided by

Transport Services Team, Preston from Lancashire Teaching Hospitals NHS Trust to various

sites across the North West of England including health centres, GP surgeries, and

Hospitals.





PROCEDURE:

Only couriers employed by NWAS Transport Logistics Team are authorised to transport

consignments of pharmaceutical supplies to named establishments in accordance with

existing service level agreements.

All couriers to have received full vetting procedures including enhanced DBS checks before

being authorised to act as a pharmacy courier.

Schedule and route of deliveries are to be agreed by Transport Supervisor prior to collection

and delivery.

All pharmaceutical supplies must be supplied in tamper evident packaging and

transported with packaging remaining intact.

COLLECTION PROCESS:

1. On arrival at the collection site the courier must check the items to be collected

against the completed delivery log.

Packages sealed in tamper-evident packaging: the Courier must sign and log

the time on the delivery log.

Packages not sealed in tamper-evident packaging must not be accepted for

delivery until they are sealed by the pharmacy staff.

2. Any refrigerated items must be supplied in an appropriate cool container and the

cold chain procedures should be followed during transit.

In the event of an unexpected delay to the delivery schedule the receiving unit

should be informed of the extended period that the item has been in transit. The

notification allows the opportunity to assess the storage temperature of the

refrigerated supplies on receipt.

Any items being carried in accordance with the cold chain should be prioritised for

delivery.

3. All consignments must be promptly secured in the transit vehicle.

All transit vehicles must be fitted with slam lock doors.





DELIVERY PROCESS:

1. On arrival at the destination point the driver must ensure that the full delivery is

signed for on the driver’s delivery log.

2. The driver should collect any previous delivery boxes / packaging to be returned to

the pharmacy – to be returned to the pharmacy on the next scheduled visit.

SPILLAGE PROCEDURE:

In the event of any spillages during transit the driver must contact the pharmacy for

details of the products in transit.

All spills should be dealt with using the Hazardous spill kits (located in each transit vehicle).

If any items are identified as cytotoxic the procedure E3.1 Courier Transportation of

Cytotoxic Materials must be followed.

NB: The drivers delivery log should be retained for governance purposes to ensure an audit

trail is available for the carriage of pharmaceutical supplies.





E2.1: Commercial courier: Delivery of General and Controlled Drugs to Prisons

SOP Title: Delivery of General and Controlled

Drugs to Prisons









Date Obsolete:


OBJECTIVES

To ensure the;

safe delivery of all general pharmaceutical and Controlled Drugs (CDs) to

courier contracted Prison sites is in accordance with best practice guidance

and legislation

NWAS couriers will have the correct items collected and delivered in

accordance with the terms of the service agreement

courier drivers are aware of correct safe and legal procedure for non- delivery

of consignment

See Appendix 2 for list of current contracted HMP sites

SCOPE

All general pharmaceutical and CD deliveries made by the Trust as part of the

contracted courier service provided by Transport Services Team, Preston to various HMP

sites across the North West of England.





PROCEDURE:


consignments of pharmaceutical supplies and Controlled Drugs to named HMP

establishments in accordance with pre-agreed schedules of delivery.

All couriers must have received full HMP vetting procedures including enhanced DBS checks

before being authorised to act as a pharmacy prison courier.

Schedule and route of deliveries are to be agreed by Transport Supervisor prior to collection

and delivery.

N.B: Consider using alternate routes where possible to avoid predictability of route

and time of delivery.

COLLECTION PROCESS:

On arrival at the HMP pharmacy site a photographic NWAS Trust identification badge must

be presented and clearance authorised before the courier will be allowed into the prison

compound.

The courier will undergo a full body search in the ‘airlock’. All mobile phones and vehicle

keys must be handed to HMP staff prior to entry being authorised.

The Courier and vehicle are escorted to a ‘sterile area’ until an HMP staff member is

available to escort the courier to the pharmacy collection point.

1. The courier driver must sign the delivery log for acceptance of all general

pharmaceutical stock to be delivered to the Prison site(s).

2. The HMP pharmacist will complete and sign any CD requisition records to confirm

the controlled drugs delivery contents. See Appendix 2 for copy of CD Requisition

Record.





3. The Courier will make a visual confirmation of the contents of the consignment

against the CD Requisition record.

Any discrepancies must be immediately reported to the pharmacy staff and

rectified before signing for the acceptance of the delivery.

Couriers should not be made aware of the contents of the consignment only

the requirements of the load i.e. controlled drugs/cytotoxic drugs/radioactive drugs

etc.

4. The Courier will counter sign the CD Requisition record to confirm the contents of

the consignment.

5. The consignment is loaded into the courier’s vehicle under observation from security

at all times. The vehicle doors are locked under observation (slam lock).

6. The courier will be escorted back to the ‘airlock’ for a final body search before being

released from HMP Pharmacy complex control.

TRANSPORTATION PROCESS

Couriers should be alert and aware of surroundings and any potentially threatening activity.

If the courier feels under threat at any time throughout the delivery:

the route must be diverted to the nearest police station and reported directly to the

Transport Supervisor and to the Police

1. The vehicle must remain locked at all times

2. The vehicle must not carry any signage to indicate that controlled drugs are being

carried.

3. Under no circumstances will any unscheduled or unnecessary stops be made en-

route.

In the event of breakdown or untoward roadside incident a ‘High Consequence’ load signage

must be displayed.





DELIVERY PROCESS

On arrival at the HMP site:

General Pharmaceutical Supplies Delivery

1. The courier must deliver any general pharmaceutical supplies to the gatehouse.

2. The driver should hand over the driver’s delivery log with the order.

o At some prison sites the gatehouse staff will sign for the order.

o At sites where this does not happen, the delivery log should be handed over

with the delivery for the healthcare staff to sign and return to the driver on

the next scheduled delivery.

Controlled Drug Supplies Delivery

1. The courier must present to the gatehouse and inform them of the delivery of

controlled drugs.

2. The drugs need to be delivered to the authorised health care personnel / pharmacy

for acceptance of the delivery. The courier now falls under the controls and SOPs of

the HMP establishment for the delivery of controlled drugs.

A signature must be obtained for the acceptance of the delivery.

In the event that the controlled drugs cannot be accepted for delivery:

1. The HMP pharmacy must be contacted immediately to notify them of the problem

with the delivery.

During normal opening hours HMP pharmacy must be contacted directly.

See appendix 2 for pharmacy contact details.

Outside of normal opening hours the On Call HMP pharmacist must be

contacted to return to HMP pharmacy receive the undelivered consignment.

2. The consignment must be returned immediately to the supplying HMP pharmacy.

HMP pharmacy is legally obliged to accept the return of the controlled drugs back onto

their site following a failed delivery.





In the event that the delivery cannot be made AND cannot be returned to HMP pharmacy:

1. The vehicle must be driven to Preston Ambulance Station (secured by CCTV and

manned 24 hours a day); where it will be kept locked and secured overnight.

2. The transit vehicle must be locked

3. The transit vehicle key must be secured in the designated courier CD key cabinet.

4. The Operational Manager, Senior Paramedic and or Assistant Operation Manager

must be contacted to inform them of the presence of the vehicle.

5. The Transport Supervisor must be contacted and informed of the location of the

vehicle and consignment.

6. An Incident Reporting Form should be completed in accordance with the NWAS

Incident Reporting Policy

7. An attempt to deliver the CD consignment must be made the following day.

All failed deliveries must be reported via the Datix online incident reporting system under

incident type ‘Clinical Incident’ referencing in category type ‘Controlled Drugs’ and also

included in the station level AO report each month.





E3.1: Commercial Courier: Transportation of Cytotoxic Pharmaceuticals

SOP Title: Transportation of Cytotoxic

Pharmaceuticals









Date Obsolete:


OBJECTIVES

To ensure the

safe delivery of all cytotoxic pharmaceuticals

delivery is in accordance with best practice guidance and legislation and

NWAS couriers will have the correct handling procedures and training to deal with

spillages.

SCOPE

All cytotoxic pharmaceuticals deliveries made by the Trust as part of the contracted courier

service provided by Transport Services Team, Preston from Lancashire Teaching Hospitals

NHS Trust to various sites across the North West of England.





PROCEDURE:


consignments of cytotoxic pharmaceuticals.

All couriers must receive full training on:

the handling of cytotoxic pharmaceuticals prior to commencing deliveries, and

the use of the Spill kit Cytotoxic single use pack in the event of a spillage during

transportation (follow the printed instructions inside the Spill kit).

All vehicles transporting cytotoxic pharmaceuticals must have a Spill kit Cytotoxic single use

pack on board the vehicle at all times.

Following a spillage of cytotoxic pharmaceuticals:

1. Dispose the spillage - following the instructions provided for cytotoxic waste.

2. Report the incident to the Transport Supervisor and to the supplying pharmacy.

3. Continue with the remainder of the delivery as scheduled.

7. An IRF should be completed in accordance with the Trust Incident Reporting

Policy and a copy forwarded to the Medicines Performance Facilitator.

medicine management procedures toolkit

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