SAFE HANDLING AND
ADMINISTRATION OF MEDICINES
POLICY
Issue
History
April 2007
Issue
Version
Third Issue
Purpose of Issue/Description of Change
Planned update incorporating new national
guidance
Named Responsible Officer:-
Approved by
Medicines Governance Pharmacist
Provider Services
Governance Group
Planned
Review Date
December
2012
Date
December
2010
(Supported by Service Improvement Unit)
Policy:- General Policy
Impact Assessment Screening
- 5/1/11
Full Impact Assessment
Required No
No. 11
Key Performance Indicators
1. The number of medicine management incidents reported as per the incident reporting
policy.
2. The number of incidents reported involving the disposal of controlled drugs.
3. Auditing of standard operating procedures by Service Heads and the Medicines
Management Team.
Safe Handling and Administration of Medicines Policy
SAFE HANDLING AND ADMINISTRATION OF MEDICINES POLICY
Contents
1.
1.1
1.2
1.3
1.4
1.5
1.6
1.7
Introduction
Aim of the Safe Handling and Administration of Medicines Policy
Policy Outcome
Target Group
Cross Reference to Related NHS Wirral Policies
Definitions
Classification of Medicines and Related Preparations
Designated Roles to Clarify Clinical Responsibility
2.
Standard Operating Procedures
3.
3.1
3.2
Ordering of Medicines (Procurement / Acquisition)
Ordering of Medicines from Wirral University Teaching Hospital NHS Foundation Trust
(WUTH)
Additions or Deletions of Medicines from the Pharmacy Supplies Order Form
4.
Receipt of Medicines
5.
Transport of Medicines
6.
6.1
6.2
6.2.1
6.3
6.4
6.4.1
Storage of Medicines
Safe Storage of Medicines within Departments
Security of Medicines and Related Stationery within Departments
Lost Prescriptions
Medical Gases
Inflammable Liquids
Alcohol Gel
7.
7.1
7.2
7.3
Prescribing and Dispensing of Medicines
Prescribing Responsibilities
Dispensing of Prescriptions
Verbal Orders
8.
8.1
8.2
8.3
8.4
Administration
Consent
Principles for the Safe Administration of Medicines
Incident Reporting in the Event of a Medication Error
Self Administration
9.
Disposal of Pharmaceutical Waste
10.
10.1
10.2
10.3
10.3.1
Controlled Drugs (CDs)
Ordering of CDs from WUTH
Receipt of CDs from WUTH
Storage of CDs
Storage in Departments
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10.3.2
10.3.3
10.4
10.5
10.5.1
10.5.2
10.6
10.7
10.7.1
10.7.2
10.7.3
Storage in Doctors‟ Bags
Storage in Patients‟ Homes
CD Stock Reconciliation
Procedure for Missing CDs
Procedure for Missing CDs in Departments
Procedure for Missing CDs in Community Nursing
Administration of CDs
Disposal of CDs
Disposal of Expired Stock CDs from Departments
Disposal of Patient Returned CDs from a Patient‟s Home (Not Care Home)
Disposal of CDs from Care Homes
11.
11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
11.9
11.10
11.12
Patient Group Directions (PGDs)
Definition
Legal Framework for PGDs
Peer Review for PGDs
PGDs Safety Concerns
Developing New PGDs within NHS Wirral
Who Can Administer from a PGD
Signatures Required for NHS Wirral
Antibiotics
What cannot be Included in a PGD
Minimum Contents of a PGD
Updating a PGD
12.
12.1
12.2
12.3
12.4
12.4.1
12.5
12.6
Unlicensed Medicines
Responsibility of Prescribers
Responsibility of Supplying Pharmacist (Community or Hospital)
Responsibility of NHS Wirral Medicines Management Team
NHS Wirral Staff involved in Administering Unlicensed Medicines
Complementary or Alternative Medicines
Wirral Drug and Therapeutics Committee
Definition of “Off Label Medicines”
13.
Training and Medicines Information
14.
14.1
14.2
14.3
14.4
14.5
14.6
Adverse Drug Reaction Reporting and Yellow Card Scheme
Who Can Report?
What Should be Reported?
Areas of Special Interest
Where to Find a Yellow Card
Patient Details
Copy of Yellow Card in Patients‟ Notes
15.
15.1
15.2
Drug Alerts
Medicines and Healthcare Products Regulation Drug Alerts
National Patient Safety Agency Alerts and Rapid Response Reports
16.
Monitoring
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17.
Archiving and Document Retrieval
18.
Consultation
19.
Ratification
References:
Appendix 1 NHS Wirral Clinic and Departments Pharmacy Request Form
Appendix 2 Example of Audit Tool for Assessing Compliance with Departmental SOPs
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Safe Handling and Administration of Medicines Policy
1.
Introduction
NHS Wirral is required to establish, maintain, document and audit safe and effective systems
for the handling of medicines via:
Compliance with current legislation.
Adherence to guidelines for the administration and handling of medicines issued by
individual professional bodies and all related NHS documents.
Management of the risks to patients and staff arising from the use of medicines.
1.1
Aim of the Policy
It is the responsibility of the Head of Medicines Management to ensure systems are
implemented to ensure medicines are managed safely and securely throughout NHS Wirral to
meet patients‟ needs.
The aim of this policy is therefore to inform all health professionals and other NHS Wirral
employed staff of the correct procedures for the safe handling, ordering, storage,
transportation, administration and disposal of medicines and related preparations.
This policy only considers the processes associated with the physical handling of medicines.
It is not intended to give guidance on the prescribing of medicines by doctors or other
authorised prescribers. However, general advice on the prescribing of unlicensed medicines is
included.
1.2
Policy Outcome
NHS Wirral employed staff (including self-employed staff contracted to work within
NHS Wirral Provider Services) will follow best practice when dealing with medicines.
NHS Wirral employed staff will follow all relevant NHS guidance and Medicines Act
legislation.
NHS Wirral employed staff will adhere to the safe management of all medicines and
related products, therefore minimising the risk of errors associated with medicines.
This policy will act as a reference source for independent contractors, supporting
compliance with, Regulation 13 of the Health and Social Care Act 2008.
1.3
Target Group
This Policy is intended to be used as a resource for all NHS Wirral Provider Services
employed staff that have any involvement with the handling of medicines and related products.
1.4
Cross Reference to Related NHS Wirral Documents
Non Medical Prescribing Procedure
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Consent Policy
Incident Reporting Policy
Syringe Driver Procedure
Management of Healthcare waste policy
Guidance on the Prescribing and Use of Unlicensed and Off Label Medicines
Standard Operating Procedures for each department dealing with medicines
1.5
Definitions
The Medicine Trail:
The medicine trail covers all the potential activities that are associated with a medical product,
from the initiation of the patient treatment through a prescription or a patient group direction, to
the administration and the disposal of any waste material.
As this is a multistage process there is a need to introduce controlled links between the
relevant stages. These links must be included to ensure full consideration of all aspects of the
safe use of medicines throughout the trail.
Initiation of Treatment:
A patient‟s treatment must be initiated through a formal process. This may be by a doctor or
other authorised prescriber‟s prescription or may be through an approved patient group
direction. (See Section 11, Patient Group Directions.)
Procurement /Acquisition of Medicines:
This is the process through which a medicine is acquired for use in treating a patient.
Receipt of Medicines:
The formal activities, undertaken when medicines are received by the organisation from an
external source or transferred from one department to another. Procedures must be in place
to ensure product identity, quantity and quality.
Safe Storage of Medicines:
Medicines must be stored in a secure manner and in conditions that will not affect their
potency. Procedures must be in place to ensure compliance with the manufacturer‟s storage
recommendations and any legislation covering for example the storage of controlled drugs.
Administration or Supply of Medicines:
The activities undertaken when a medicine is administered to a patient or given to the patient
for administration at a later date. Procedures must be in place to ensure the right patient is
given the right medicine at the right time.
Removal/ Disposal of Surplus/Waste Medicines from Departments:
The activities associated with the removal and disposal of medicines that are no longer
required or no longer suitable for their intended use.
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Appropriate records should be made for a complete audit trail as outlined in each department‟s
standard operating procedure.
Standard Operating Procedures:
Each department that deals with medicines is required to produce a standard operating
procedure (SOP) for any activity undertaken throughout the medicines trail.
Patient Group Direction:
A Patient Group Direction (PGD) is a specific written instruction for the supply and
administration of a named medicine to a group of patients in an identified clinical situation. See
Section 11.6 for the professional groups who can be authorised to administer or supply
medicines using a PGD
Patient Specific Direction:
A Patient Specific Direction (PSD) is a written instruction from a qualified and registered
prescriber for a medicine including the dose, route and frequency or appliance to be supplied
or administered to a named patient.
Definition of a Medicine:
Any substance or combination of substances presented for treating or preventing disease.
Any substance or combination of substances which may be administered with a view to
making a medical diagnosis or restoring, correcting or modifying physiological or psychological
functions.
1.6
Classification of Medicines and Related Preparations
For the purpose of this policy, medicines are classified as follows:Controlled Drugs - those which come within the Misuse of Drugs Act (1971) and subsequent
regulations
Licensed Medicines - all medicines, oral, external, prescription only, pharmacy medicines,
general sales list medicines, or controlled drugs with a valid Marketing Authorisation for use
within the UK.
Unlicensed Medicines - any medicine that has not been granted a valid Marketing
Authorisation for use within the UK
Non-medicines - classified into the following groups
Surface disinfectants
Urine testing and other reagents
Medical gases
Medicines Act 1968
Classifies medicines into three main categories
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Prescription-Only Medicines (POM)
These are medicines, which may only be supplied or administered to a patient:- On the instruction of an authorised prescriber such as a doctor, dentist, nurse or
pharmacist prescriber in the form of a prescription.
- Or under the direction of an authorised patient specific direction or a patient group
direction.
Pharmacy-Only Medicines (P)
These medicines can be purchased from a registered primary care pharmacy, provided the
pharmacist supervises the sale.
General Sale List Medicines (GSL)
These medicines need neither a prescription nor the supervision of a pharmacist and can
be obtained from retail outlets.
1.7
Designated Roles to Clarify Clinical Responsibilities
Department
For the purpose of this document a department incorporates any community clinic, primary
care centre, Walk-In Centre, GP Out of Hours, intermediate service or clinical service.
Practitioner
Practitioner in this context is a term used to describe a qualified nurse, medical practitioner,
pharmacist or other authorised employee.
Practitioner in Charge
This is the senior practitioner appointed in charge of a department. The Practitioner in Charge
is responsible for ensuring the audit and maintenance of safe systems for the handling of
medicines within their department.
Assigned Practitioner in Charge
The senior practitioner on duty for the department for that shift/day.
Designated Practitioner
Any registered practitioner whom NHS Wirral has formally identified as competent and
appropriate to perform a specific medicines related function.
Health Service Authorised Employee
A member of staff who has been trained and authorised by NHS Wirral to undertake specific
duties in relation to medicines.
Accountability for ensuring safe practice remains with the registered health professional who
has delegated the task. A record needs to be held of the training the authorised employee has
received and their specific competencies, e.g. assistant practitioners in the community or
clinic clerks in a department.
Community Practitioner Nurse Prescribers
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A registered nurse who has completed a nationally recognised nurse prescribing course which
has been recorded with the Nursing and Midwifery Council.
These nurses can prescribe from a limited list of preparations. This list comprises of a range
of medicines, dressings and appliances suitable for use in a community setting.
Non Medical Independent Prescribers
Health professionals who are qualified to prescribe any licensed medicine (including some
controlled drugs for specific medical conditions) and are registered with Provider Services and
authorised by the Service Manager within the non medical prescriber‟s clinical competency.
The list of prescribable controlled drugs is available in the Drug Tariff (part XVIIB) and in the
current edition of the BNF.
Pharmacist Prescriber
A pharmacist registered with the General Pharmaceutical Council with an annotation signifying
their status as a qualified supplementary or independent prescriber.
All prescribers are accountable for their own actions, and must be aware of the limits of their
skills, knowledge and competence. Prescribers must also ensure there is an allocated budget
prior to initiating any prescribing.
Local Security Management Specialist
The person employed by NHS Wirral to investigate any breaches of security and report
through the governance structure to the board. The Local Security Management Specialist is
the person responsible for liasing with the police where necessary.
Medicines Management Team
The Medicines Management Team is a team of NHS Wirral employed pharmacists,
prescribing support technicians and administrative support staff who:
Work with a range of healthcare professionals to promote high quality, cost-effective
prescribing to improve patient care.
Provide information and support to all NHS Wirral employed and staff to ensure safe
handling and administration of medicines.
Head of Medicines Management
The Head of Medicines Management is accountable for ensuring processes are in place
across NHS Wirral for safe prescribing, handling and administration of medicines throughout
NHS Wirral by employed or contracted staff and commissioned services.
Medicines Governance Pharmacist
The Medicines Governance Pharmacist is responsible for relevant policy development and
provision of support to practitioners in charge of departments in auditing and maintaining safe
systems for the management of medicines within their departments.
Prescribing Adviser with Responsibility for Governance
The Prescribing Adviser with Responsibility for Governance reports to the Head of Medicines
Management and line manages the Medicines Governance Pharmacist.
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2.
Standard Operating Procedures
Each department that deals with medicines is required to produce a standard operating
procedure (SOP) for any activity undertaken throughout the medicines trail. The Practitioner in
Charge is responsible for writing the SOPs for their department, using the NHS Wirral
approved standard template. The Medicines Governance Pharmacist will provide advice in
finalising the document before ratification.
The Practitioner in Charge is also responsible for auditing compliance with their departmental
SOPs.
SOPs must be comprehensive, reproducible and unambiguous and must indicate who is
authorised to perform the relevant tasks. The SOPs must specify any equipment, facilities and
data associated with the process.
The Practitioner in Charge, the Medicines Governance Pharmacist and the Prescribing
Adviser with Responsibility for Governance will formally approve SOPs. SOPs will only be fully
operational when formal approval has been given.
SOPs will be subject to routine updating and review. A record of such reviews will be
maintained by the Medicines Management Team. A copy of the SOPs will be available to any
member of staff at the location at which they are used. The master copies will be held by the
Medicines Management Team. All SOPs will be dated and the date of review included.
Refer to Appendix 2 for an example of an audit tool that can be adapted for assessing
compliance with departmental SOPs.
Further advice on the contents of SOPs can be found in the revised Duthie Report March
2005. “The Safe and Secure Handling of Medicines, A Team Approach”.
3.
Ordering of Medicines
(Procurement/Acquisition of Medicines)
3.1
Ordering of Medicines from Wirral University Teaching Hospital NHS
Foundation Trust (WUTH)
The Practitioner in Charge is responsible for ensuring there is a robust audit trail of all
medicines received into their department, administered or supplied to patients, or
appropriately destroyed.
Medicines and related preparations should be ordered from WUTH pharmacy
department.
A Designated Practitioner is responsible for ordering medicines from WUTH for the
purpose of maintaining clinic stocks.
A WUTH “Pharmacy Supplies Order Form” must always be completed.
The form needs to be signed by a named Designated Senior Nurse / Designated
Practitioner. The clerical staff within the clinic or department can only sign for the
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ordering of medicines, if there are no health professionals on site or if this task has
been specifically delegated to them by a named health professional.
3.2
Additions or Deletions of Medicines from the Pharmacy Supplies Order Form
The Practitioner in Charge is responsible for requesting a regular review of the stock
medicines listed on the Pharmacy Supplies Order Form, by contacting the Medicines
Governance Pharmacist or the Senior Prescribing Support Technician, Medicines
Management Team.
Requests for additions or deletions of medicines from the Pharmacy Supplies Order
Form must be made by the Practitioner in Charge, who must complete a Pharmacy
Stock Amendment Request form (Refer to appendix 1).
Request forms must then be forwarded electronically or by FAX to the Senior
Prescribing Support Technician, Medicines Management Team. (Fax number 0151
643 5442)
The appropriateness of the request will be considered and if agreed, the request form
will be signed by an authorised member of the Medicines Management Team. (Usually
the Medicines Governance Pharmacist or where appropriate the Senior Prescribing
Support Technician.)
The authorised request form will then be forwarded to WUTH pharmacy department for
the amendment to the Pharmacy Supplies Order Form to be actioned.
WUTH pharmacy department will then send the updated form to the Senior
Prescribing Support Technician Medicines Management Team for the amendments to
be checked.
An updated amended Pharmacy Supplies Order Form will then be sent to the
Practitioner in Charge.
The Practitioner in charge of the department will be responsible for removing the
expired pharmacy supplies order form from circulation.
4.
Receipt of Medicines
On receipt of medicines from WUTH it is the Designated Practitioner‟s responsibility to
check the order is correct, received in good condition and with a reasonable shelf life.
The Designated Practitioner must notify WUTH if there are any discrepancies in the
order.
The Designated Practitioner must also report any discrepancies to the Practitioner in
Charge.
A written, signed and dated record must be maintained of stock received into the
department.
Order forms and delivery records must be kept for a period of two years as a record
that the supply was complete.
Vaccines and any other medication requiring refrigeration must be placed immediately
in a refrigerator specifically designated for the storage of medicines. The cold chain
must be maintained.
Medications not requiring refrigeration must be stored in a locked cupboard.
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Written records, signed and dated, of medication appropriately destroyed must also be
kept for a period of two years to maintain an audit trail. (See section 9)
Samples of medicines from pharmaceutical company representatives must not be
accepted for administration to patients and therefore must not be stored on NHS Wirral
premises.
5.
Transport of Medicines
NHS Wirral employed staff should not collect dispensed medicines from community
pharmacies, except in justifiable exceptional circumstances. In such cases a risk
assessment should be undertaken and any risks managed accordingly.
Patients/carers should collect dispensed medicines themselves. Where this is not
possible, the majority of local pharmacies operate a delivery service.
There will be specific situations were NHS Wirral employed staff are required to
transport medicines to clinic, these activities will be described in standard operating
procedures (SOPs) specific to individual departments.
Samples of medicines from pharmaceutical company representatives must not be
carried by NHS Wirral employed staff in the course of their work.
6.
Storage of Medicines
6.1
Safe Storage of Medicines within Departments
The recommended temperature for storing medicines will be indicated on the container
issued by the manufacturer.
Medicines that do not require storage in a refrigerator are usually stored at
temperatures up to 25ºC. Cupboards used to store medicines must therefore not be
located near radiators or hot water pipes or in areas of high humidity.
The room used to store medicines must be monitored with a room thermometer. When
temperatures exceed 25ºC advice must be requested from NHS Wirral Medicines
Management Team 0151 643 5319, as to whether the medicines stored in the room
are fit for purpose. Any advice given must be documented for audit purposes.
Medicines requiring storage in a refrigerator must be stored in a lockable fridge
manufactured specifically for the storage of medicines. Medicine fridges must be
monitored and temperatures recorded each working day with maximum minimum
thermometers to ensure temperatures are maintained between 2 and 8ºC. When
temperatures fall outside this recommended temperature range advice must be
requested from NHS Wirral Medicines Management Team as to whether the
medicines are fit for purpose. Any advice given must be documented for audit
purposes. Nursing staff are reminded to follow the SOP for the Safe Storage of
Vaccines.
Refrigerators and cupboards designated for the storage of medicines and
pharmaceutical supplies must on no account be used for the storage of food, valuables
or other items.
Cupboards designated for medicines must be lockable and the designated area ideally
should not be accessible to the public.
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Refrigerators and cupboards designated for the storage of medicines and
pharmaceutical supplies must be kept locked and the keys kept within a designated
safe place, ideally held personally by the Assigned Practitioner in Charge. The
Assigned Practitioner in Charge is responsible at all times for the safekeeping of all
medicines in their department.
The keys for the medicines cupboard must be kept on one key ring solely for this
purpose and clearly identified.
The Practitioner in Charge must immediately report any breaches of security to the
Local Security Management Specialist, an incident form must be completed.
All medicines to be taken orally and those for external use, must be stored separately in
locked cupboards, reserved solely for medicinal products. It is acceptable for
medicines to be taken orally and external products to be stored on separate shelves in
the same cupboard.
Disinfectants and reagents must be stored separately.
No samples of medicines or dressings will be left in clinics to be used by patients.
Where premises are shared by a number of clinics, each clinic is responsible for its
own stock and this stock must be stored separately.
At community bases where a number of Designated Practitioners may require access
to the medicines cupboard at different times, a secure system must be agreed between
the Designated Practitioners at the base. This system must be outlined in a standard
operating procedure.
Stock must be rotated to ensure that the stock with the shortest expiry date is used
first.
There must be no part-used pharmaceuticals, such as creams or ointments, kept in
any medicines cupboards. This is because communal use of such products has
resulted in outbreaks of infections such as MRSA and it is also an illegal practice to
administer pharmaceuticals to any person for whom they were not prescribed.
6.2
Security of Medicines and Related Stationery within Departments
The security of medicines and related stationery will be audited regularly by the
Practitioner in Charge and periodically by the Medicines Governance Pharmacist or a
delegated member of NHS Wirral Medicines Management Team.
The Pharmacy Supplies Order Form must be regarded as controlled stationery and
kept under lock and key and only accessible to authorised staff.
It should be possible to audit the process and account for all movements of stock and
to identity any inappropriate losses.
Staff in any supervisory position must be aware of the signs that may indicate abuse or
diversion of medicines (e.g. changes in an individual‟s behaviour such as lack of
concentration, unexplained absences from work, “odd behaviour”, loss of stock,
excessive ordering.) Appropriate action must then be taken.
The security of prescription forms is the responsibility of the prescriber. Under no
circumstances should blank prescription forms be pre signed before use. The
prescription form must only be produced when needed and never left unattended.
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Prescription pads must not be left on view and must be kept in a designated lockable
place, i.e. locked file, drawers or cupboard.
A record of prescription form serial numbers must be maintained to ensure a robust
audit trail.
All prescribers should follow the relevant SOP for Safe Handling of Prescription Forms
for their service.
6.2.1 Lost Prescriptions
In the event of a lost or stolen prescription, all prescribers should follow the relevant
SOP for Safe Handling of Prescription Forms for their service.
Incidents involving the loss, theft or misuse of prescription forms must be reported
immediately to the Head of Medicines Management on 0151 643 5319.
Outside office hours the police should be contacted directly on 0151 777 5856 or the
main police switchboard on 0151 709 6010.
All details of the incident should be recorded on the Missing/Lost/Stolen NHS
Prescription Form(s) Notification Form. Medicines Management keep copies of this
document.
An Incident Form should also be completed and sent to NHS Wirral Governance
Team.
The Head of Medicines Management will liaise with the police, the Local Security
Management Specialist and the Local Counter Fraud Specialist and report the incident
to Central Operations Mersey, who will alert all pharmacies and the Prescription Pricing
Division, providing as much information about serial numbers as possible.
The prescriber will be advised to write all prescriptions in a particular colour for the next
2 months.
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6.3
Medical Gases
Practitioners that use medical gases in the course of their duties must be fully trained and
aware of related risks such as fire and manual handling. They must ensure that they follow
their departmental SOPs for the handling of medical gases. In addition the following
precautions must also be observed:The number of cylinders held as stock in any department should be as small as
possible.
Cylinders must be firmly secured at all times to prevent them falling over.
They should be stored under cover, preferably inside and not subjected to extremes of
heat.
Naked lights must not be allowed within the immediate vicinity of a cylinder.
No oil or grease should be applied to the cylinder or tap connector, therefore ensure
hands are clean before handling cylinders. In particular ensure hands are adequately
dried after the use of alcohol gel.
Segregate full and empty cylinders and separate the different gases within the store
Have warning notices posted prohibiting smoking and naked lights within the vicinity of
the store.
Allow for a strict rotation of full cylinders to enable the cylinders with the oldest filling
date to be used first.
The storage should be designed to prevent unauthorised access and to protect
cylinders from theft.
Excessive force or any tools must not be used to open or close a cylinder valve.
Cylinders with damaged valves and defective equipment must be labelled appropriately
and withdrawn from use.
0
Allow for Entonox cylinders to be stored at above 10 C for 24 hours before use. Where
this is not feasible, it is important to consult the Entonox Medical Gas Data Sheet for
further information.
Notify the emergency services of the location and contents of the medical gas cylinder
store. Contact suppliers for more specialist advice where necessary.
There is a service level agreement between NHS Wirral and EBME WUTH for the service and
repair of medical devices, this includes flow meters and oxygen regulators, each department
must ensure these medical devices are serviced on a regular basis and should a problem
arise between services to contact Electro Biomedical Engineering (EBME) Tel No: 678 5111
ext 2194.
6.4
Flammable Liquids
Flammable liquids are issued from WUTH pharmacy and labelled “flammable”.
COSHH data sheets must be available for all flammable liquids kept on the premises.
The data sheets must be kept in a central point available to all staff.
To reduce the risk of combustion or explosion:- Keep stock levels to a minimum.
- Avoid spillage.
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-
Keep bottle closed. Replace the screw cap immediately after use.
Keep well away from naked flame or electrical apparatus.
Do not store in a refrigerator.
Store all flammable liquids in a locked metal cupboard that displays an appropriate
hazard notice.
6.4.1 Alcohol Gel
It should be noted that alcohol gel is also a highly flammable substance; the above precautions
must be followed.
If nursing staff need to store alcohol gel in their car it must not be stored anywhere where it
would be subject to direct sunlight. Alcohol gel must therefore be stored in nursing bags,
pockets and/or in the boot of the car.
7.
Prescribing and Dispensing of Medicines
7.1.
Prescribing Responsibilities
Medicines will only be prescribed by suitably trained and qualified healthcare professionals
(e.g. medical practitioner or authorised non-medical prescriber) according to the terms of their
qualification (e.g. within a limited formulary), and acting within their skills, knowledge and
competence.
Prescribers must also ensure there is an allocated budget prior to initiating any prescribing.
See section 1.7 for roles and responsibilities of nurse and pharmacist prescribers.
7.2.
Dispensing of Prescriptions
NHS Wirral does not operate a dispensing service, so any medicines will normally be
dispensed by an external supplier.
Prescriptions must be dispensed by a qualified pharmacist from a suitably registered
pharmacy.
The only exception will be for certain departments such as Sexual Health Services, Wirral
Walk-In Centres, or GP Out of Hours Service, where appropriately labelled medicines may be
supplied directly to patients. The medicines or prepacks must be ordered via WUTH
pharmacy department from a licensed supplier and must be labelled with directions and all
legally required information.
Prepacks will be given to patients to fulfil a prescription or under the conditions of a patient
group direction or patient specific direction.
If a member of NHS Wirral staff has a query relating to a specific medication, e.g.
product/dose, labelling instructions, quantity supplied, they should contact the dispensing
pharmacist or prescriber for clarification.
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7.3.
Verbal orders
The use of verbal orders for administration of medication is not supported by NHS Wirral and
must not be carried out by NHS Wirral employees.
8.
Administration of Medicines
8.1
Consent
Valid consent must be obtained before starting any treatment including the administration of
medicines.
For consent to be valid it must be given voluntarily by an appropriately informed person.
No-one can give consent on behalf of an incompetent adult; however such patients can be
treated if the treatment would be in their best interest.
Refer to NHS Wirral Consent Policy for further details.
8.2
Principles of Safe Administration of Medicines
In exercising professional accountability, in the best interests of the patients, staff
who are authorised to administer medicines must:Be certain of the identity of the patient to whom the medicine is to be administered.
Ascertain that the prescribed dose has not already been given.
Know the therapeutic uses of the medicine to be administered, its normal dosage, side
effects, precautions and contra-indications.
Where it is appropriate for a care plan to be in place, know the current contents of the
patient‟s care plan.
Check that the prescription, patient group direction or the label on a medicine
dispensed by a pharmacist, is clearly written and unambiguous with clear information
on:- The name of medication.
- The dosage.
- The name of the patient for whom the medicine is prescribed (In the case of patient
group directions the name of the patient will not be documented on the actual PGD).
- Frequency of administration.
- Route of administration.
- In the case of PGDs ensure that all conditions are fully met (It is therefore essential
that practitioners have a copy of the relevant PGD with them during administration or
supply and they refer directly to it ).
- Have considered the dosage, method of administration, route and timing of the
administration in the context of the patient and co-existing therapies.
Check the expiry date of the medication to be administered.
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Check that the patient is not allergic to the medication before administering it.
Administer or withhold in the context of the patient‟s condition (e.g. digoxin is not
usually given to patients if their pulse is below 60)
Contact the doctor or another authorised prescriber without delay where contraindications to the prescribed medication are discovered, where the patient develops a
reaction to the medication, or where assessment of the patient indicates that the
medication is no longer suitable.
Make a clear, accurate and immediate record of all medicines administered,
intentionally withheld or refused by the patient, ensuring that any written entries
including the signature are clear and legible together with the date of administration.
Where medication is not given the reason for not doing so must be recorded.
When supervising a student nurse in the administration of medicines, clearly
countersign the signature of the student.
Certain medicines such as cytotoxics or warfarin require special consideration, in the
event of NHS Provider Services being requested to administer these medications,
departmental SOPs must be followed.
When using syringes there is a risk of „wrong route‟ errors if the correct syringe is not
used. When administering oral or enteral doses ensure that an appropriate purple
coloured oral/ enteral syringe is used.
When administering insulin ensure that an insulin syringe or commercial insulin pen is
used. This is essential, because the use of intravenous syringes to administer insulin
has lead to incidences of overdose.
When administering medication via the intravenous route, two appropriately trained
staff members are required to check the medication to be administered (one of whom
must be a registered nurse who then administers the intravenous medication)
To reduce the risks of missed medications, a team management system should be in
place, for example Community Nursing have an approved system of maintaining a team
diary for safe work allocation.
8.3
Incident Reporting in the Event of a Medication Error
It is widely acknowledged that errors or near misses may occur. To build a safer NHS for
patients all healthcare organisations are being encouraged to develop a culture of openness.
Reporting medication errors is essential if underlying problems are to be addressed. Errors
can be due to many factors, which can include:-
Poor communication within the clinical team
Lack of supervision
Lack of competence
Insufficient training
System failures
Poor record keeping
Everyone can learn from mistakes. A fair blame approach to medication errors will contribute
to Continuing Professional Development and a safer environment of care for patients.
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When an error occurs the following steps must be taken:
Make sure the patient is safe and if necessary call emergency services or the Medical
Practitioner as dictated by clinical need.
Record any advice given, ensuring suggested monitoring arrangements are followed
and documented.
Ensure any evidence relating to the error is retained and not tampered with. (Evidence
will include any relevant documentation, the remaining medication administered and
any packaging or administration equipment.)
Inform line manager immediately who will refer to the, “Being Open” policy, to support
communication with patients and / or carers.
Inform the General Practitioner or other Medical Practitioner with clinical responsibility.
Complete an incident form and fax on the same day to Practitioner in Charge/ Manager.
Hard copy to follow in the post.
Discuss with line manager and clinical team to identify future prevention systems.
In certain circumstances, at the weekend or out of hours, the line manager may need to
inform the manager on call if there are critical implications.
All completed incident forms must be sent to the Governance Team who will record the
incident and forward a copy of the incident to the Head of Medicines Management and
the Service Improvement Unit.
If an incident involving Provider Staff has caused patient harm, the Service
Improvement Unit, will appoint a root cause analysis (RCA) lead within 2 working days.
The Medicines Management Team will provide expert medicines information to inform
this process as required. The investigation will be completed within 28 days.
Recommendations will be considered including reviewing any related policies or
procedures.
RCA Leads ensure any remedial actions following incidents will be followed up and
implemented.
Where there is a need for early action, for example for any incident involving controlled
drugs, oxygen or where a pharmacy dispensing error is suspected, the Head of
Medicines Management (who is also the Accountable Officer for Controlled Drugs)
must also be contacted immediately).
If a medication error has occurred within a patient‟s home, the healthcare professional
who discovered the error must also ensure that systems are in place to monitor the
patient‟s condition appropriately over the following 24 hours. The GP should be
informed at the earliest opportunity and an action plan drafted that defines what service
will be responsible for monitoring the patient and keeping other key healthcare
professionals updated. An incident form should also be completed
For staff members who require legal advice from NHS Wirral following an incident, it is
essential that they seek guidance from their immediate line manager.
NB
In cases where there has been a ‘near miss’, it is important to report as an incident as the
systems for administering medications may need to be altered. This system is a proactive
way of preventing the incident from actually occurring.
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For further details refer to NHS Wirral Incident Reporting Policy
8.4
Self Administration
It is a patient‟s right to self-administer their own medicines if willing and able to do so.
However, some patients have difficulty managing their medicines safely and sometimes
NHS Wirral staff are the only people to see these patients and, therefore, can highlight
the need for help.
To self administer, the patient needs to be at Level Three, as defined by the Nursing
and Midwifery Council 2010. “The patient accepts full responsibility for the storage and
administration of the medicinal products” and the level should be documented in the
patient‟s records.
Practitioners should be aware that the Mental Capacity Act 2005 requires all those
working with potentially incapacitated people to assess the individual‟s capacity at a
particular moment about a particular decision.
Any change in the patient‟s condition would necessitate a review of their self
administration status
Patients unable to self-administer medication
NHS Wirral employees caring for or managing patients who are self-administering
medication should be aware of factors affecting patients‟ ability to self-medicate.
Self-administration from dispensed containers may not be possible for some patients.
In such cases the advice of a community pharmacist or the patient‟s GP must be
sought. The most appropriate form of help can then be identified.
If a patient requires a compliance aid such as monitored dose container, this must be
dispensed, labelled and sealed by a pharmacist. If there is a delay in allocating a
pharmacist to fill a compliance aid, NHS Wirral staff must inform the patient that NHS
Wirral staff are unable to fill compliance aids because of the risk of error. This
information must be clearly documented in the patient‟s record.
9.
Disposal of Pharmaceutical Waste
Pharmaceutical Waste can be divided into three broad groups:
Pharmaceutical Hazardous (cytotoxic and cytostatic)
Pharmaceutical Non-Hazardous (non-cytotoxic and non-cytostatic)
Or not pharmaceutically active and possessing no hazardous properties e.g. sodium
chloride or glucose solutions
The disposal of pharmaceutical waste must be outlined in SOPs specific to each
department.
Pharmaceutical hazardous waste must be disposed of in clearly labelled purple lidded
waste containers for incineration, ensuring bins are not overfilled.
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Pharmaceutical non-hazardous waste must be disposed of in clearly labelled yellowlidded waste containers for incineration, ensuring bins are not overfilled.
For information on the classification and labelling of pharmaceutical waste, refer to the
Management of Healthcare Waste Policy or alternatively seek the advice of the
Medicines Governance Pharmacist.
Written records, signed and dated of medication disposed of, must be kept for a period
of two years to maintain an audit trail.
Patients‟ medication remains the property of the patient. Carers should be encouraged
to return any unused medication to their community pharmacy.
Community
pharmacies may operate a pick up as well as a delivery service for housebound
patients.
NHS Wirral employees must not remove medicines from the patient‟s home.
For disposal of Controlled Drugs see section 10.
10.
Controlled Drugs (CDs)
10.1
Ordering of CDs from WUTH
Certain departments such as GP Out of Hours, Minor Injuries VCH and Leasowe
Primary Care Centre are able to order stock CDs from WUTH Pharmacy.
The responsibility for ordering, receipt and storage of CDs is with the Assigned
Practitioner in charge of the department who must also be a registered doctor.
CDs can only be ordered from WUTH by submitting a requisition from the official
Controlled Drugs Requisition Book. Ordering is restricted to an Assigned Practitioner
in charge. All Assigned Practitioners who may order CDs must provide WUTH with
specimen signatures.
10.2
Receipt of CDs from WUTH
All CDs must be delivered to departments in a secure container or picked up directly
from WUTH Pharmacy by a Designated Practitioner with an identification badge.
Where appropriate a porter may deliver CDs in a secure container. The porter must
sign a Drugs Delivery Record Sheet. A Designated Practitioner must receive the
package and sign the Drugs Delivery Record Sheet. The Designated Practitioner is
signing for receipt of a secure pharmacy container. The designated practitioner must
be a registered nurse or a doctor.
A Designated Practitioner must check the amount delivered against the requisition.
Any discrepancy must be reported immediately to WUTH. If correct the Designated
Practitioner must sign the Requisition. The Designated Practitioner must enter the
new stock into the CD Register on the appropriate page, witnessed by another
Designated Practitioner or Authorised Employee who must verify the stock level and
sign the CD Register. The medicines must then be immediately locked away.
For controlled drugs received into stock the following details must be recorded in the
CD register:
1. The date on which the CD was received
2. The name of the pharmacy who supplied the CD
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3. The quantity received
4. The name, form and strength of the CD
Where sealed packs of Controlled Drugs are supplied with tamper evident seals there
is no requirement to open these packs for stock checking purposes.
Registers and requisition books for Controlled Drugs are controlled stationery and
obtainable only from WUTH Pharmacy. Requisition books should be locked away.
Orders and records must be in permanent ink and must be retained for a minimum of
two years from the last entry in the book.
10.3
Storage of CDs
10.3.1 Storage of CDs in Departments
CDs must be stored in a locked, controlled drug cabinet that complies with The Misuse
of Drugs (Safe Custody) Regulations 1973. Access must be limited to Designated
Practitioners who must also be registered nurses or doctors.
Stocks of CDs should be kept to a minimum.
High strength opiates must not be stored alongside lower strength products due to
known risks from selection errors.
CDs must be kept in the container issued by the supplying pharmacy.
10.3.2 Storage of CDs in Doctor’s Bags
Where doctors are visiting patients in their own homes, there are occasions when CDs
may need to be transported in a “doctor‟s bag”. A “doctor‟s bag” is a locked bag or
case which should be kept locked at all times, except when in immediate use.
If CDs are stored in a “doctor‟s bag” the details on storage, security and documentation
must be outlined in an approved standard operating procedure.
10.3.3 Storage of CDs in Patients’ Homes
There is no legislation covering how patients should store CDs in their own homes.
Community nursing staff however should encourage self medicating patients to store
their medicines in a secure location, away from sources of direct heat or high humidity.
Consideration must also be given to ensuring vulnerable persons such as children do
not have access to the medicines.
CDs are medicines of potential abuse, storage should therefore be out of sight of
visitors to the patient‟s home, whilst maintaining access to visiting nursing staff.
As there may be several different nursing staff visiting a particular patient, it is
advisable for all the patient‟s medicines to be stored in one area known by all visiting
nurses.
Controlled drugs administered only by community nursing services should be stored in
Envo packs, sealed with a numbered tag, to aid stock control and provide evidence of
potential tampering.
All advice given to patients or carers on the storage of CDs must be recorded in the
patient‟s record.
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10.4 CD Stock Reconciliation
Any department stocking CDs must perform a stock reconciliation. The accountability for
maintaining the correct balance of CD stock lies with the Practitioner in Charge who may
delegate this task to an Assigned Practitioner in Charge. Controlled drug stock reconciliation
should be performed at each shift change, or at least every working day.
Although community nurses are not involved in the ordering of controlled drugs which are
prescribed for patients and administered in the patient‟s own home, community nurses are
required to keep a running balance of the amount of these prescribed controlled drugs stored
within the patient‟s home.
10.5 Procedure for Missing CDs
10.5.1 Procedure for Missing CDs in Departments
In the event of any discrepancy in the amount of CDs stocked within a department the
Appointed Practitioner in Charge must immediately investigate the discrepancy.
Double check the count, ensuring all medication has been checked in the
manufacturer‟s packaging.
Contact the Practitioner in Charge to report the discrepancy.
In addition to completing the incident form, inform the Accountable Officer for
Controlled Drugs (the Head of Medicines Management) ideally via email or failing that
by telephone on the day of the incident.
Refer to NHS Wirral incident reporting policy for further details
If the loss cannot be resolved satisfactorily the Local Security Management Specialist
must be informed.
10.5.2 Procedure for Missing CDs in Community Nursing
In the event of any discrepancy in CDs the Designated Practitioner must immediately
investigate the loss.
Double check the count, ensuring all medication has been checked in the
manufacturer‟s packaging.
Check with the patient / carer to determine if any further information is available.
The nurse must record the incident in the patient‟s records and on the medication
chart, including the date, time and signature.
Contact the surgery to check the GP has not administered or removed controlled drugs
from the patient‟s home. This action must also be recorded in the patient‟s notes.
Contact the nurses who had previously visited to ensure there was no drug
discrepancy at the last visit.
Contact the line manger to report discrepancy.
All of the above must be reported with a completed incident form which is to be faxed to
both the Community Nursing Manager and the Accountable Officer for Controlled
Drugs.
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The Accountable Officer for Controlled Drugs (the Head of Medicines Management)
must be informed ideally via email or failing that, via telephone on the day of the
incident.
Refer to NHS Wirral incident reporting policy for further details.
If the loss cannot be resolved satisfactorily the Local Security Management Specialist
must be informed.
10.6
Administration of CDs
Dosages and frequencies for all controlled drugs should be written in full by the
prescriber, to aid correct administration. Particular care must be taken to ensure clarity
of dosage instructions where syringe drivers are being used.
Two appropriately trained staff members (one of whom must be a registered nurse) are
required to be present when setting up and re-priming a syringe driver, refer to the
NHS Wirral Graseby MS26 Syringe Driver Procedure for the Administration of
Palliative Medicines for full details.
There have been cases reported locally where carers who are healthcare professionals
have sought involvement in administration of parental opiates. If the community
nursing team is involved in the package of care, the Practitioner in Charge should
complete a risk assessment, refer to the “Clinical Protocol for Self-Administration of
Medicines and Administration of Medicines Supported by Family/Informal Carers of
Patients in Community Nursing” for further details.
Patients who have not previously received parental opiates must be observed by the
designated practitioner for any signs of adverse effects for a minimum of 15 minutes
after administration.
The patient or carers must be advised to contact the team, if there is deterioration in
the patient‟s condition. Out of hours and weekend cover contact details must be left
with the patient and/or carers.
Refer to Section 8.2 to follow the principles of safe administration of medicines
10.7
Disposal of CDs
Those healthcare professionals and service providers required by law to maintain a CD
register are not allowed to destroy controlled drugs from their stock without the destruction
being witnessed by an authorised person.
People authorised to witness the destruction of CDs include, Police Constables, Primary Care
Trust Chief Pharmacists or Prescribing Advisers who have been authorised by the
Accountable Officer. The Accountable Officer will not undertake destruction, as one of the
criteria for Accountable Officer is their independence from day to day management of
controlled drugs.
10.7.1 Disposal of Expired Stock CDs from Departments
When stock controlled drugs become expired they should be clearly marked as, “date expired“
and segregated from other stock to prevent them from being used in error. The destruction of
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the stock must either be witnessed by an authorised person using appropriate controlled drug
destruction kits, “Doop Kits” (with the destruction documented and witnessed in the CD
register) or if supplied by WUTH, they can be removed by a WUTH Pharmacist and signed
out of the register and countersigned by a Designated Practitioner. The WUTH Pharmacist
must then return the expired stock to WUTH pharmacy for appropriate destruction by an
authorised person.
10.7.2 Disposal of Patient-Returned CDs from a Patient’s Home (Not Care Home)
These are CDs that have been prescribed for, and dispensed to, a named patient and then no
longer needed. They do not have to be destroyed by a person who is authorised to destroy
stock controlled drugs.
CDs used in a community setting are the responsibility of the patient for whom they were
prescribed. However, if community nurses have been involved with the administration of these
drugs they should also take the responsibility for ensuring the safe disposal of any unwanted
CDs at the end of a course of treatment or on the death of the patient.
Ideally the patient‟s carer or patient should be encouraged to return CDs to the pharmacy that
originally dispensed them. Although all community/hospital pharmacists should accept,
“patient-returned” CDs for destruction, even if they did not originally dispense them.
CDs must not be removed from a patient‟s home by community nurses.
CDs may be destroyed in a patient‟s home provided all the following criteria are met:
Permission to destroy the CDs is granted by the patient or carer.
Where a patient has died, the practitioner can determine that the CDs will not be
required by the coroner.
If it is considered to be a risk to leave the patient or carer to dispose of the CDs, then
the CDs should be destroyed in the patient‟s home in the presence of a witness. The
witness may be, another appropriately trained staff member, the patient, or a
carer/relative of the patient.
Check the stock of the drugs for disposal against the last entry on the drug record
sheet to ensure that no discrepancy has occurred. If a discrepancy in the drug count
is noted, follow the Controlled Drug Discrepancy Action Plan.
Obtain a controlled drug destruction kit (Doop Kit) and follow the instructions provided
with the kit. This is the only method of destruction that should be used. Drugs must
not be disposed of via the sink or toilet.
For the disposal of transdermal opioid patches, fold adhesive sides in on themselves
and place in Doop Kit.
The used Doop Kit must be returned to the community pharmacy for appropriate
disposal. The return of the used Doop Kit must then be documented in the patient‟s
notes.
Record on the “Nurses Medication Stock Sheet” the drug name, the form, the strength,
the amount destroyed and the method of destruction. It must then be signed, dated
and timed by both the trained nurse and the witness. The designation of the nurse(s)
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and the relationship of the witness to the patient (if not witnessed by another member
of the nursing team) must also be documented. The sheet must then be filed in the
nursing records.
The “Nurses Medication Stock Sheet” must then be retained for 7 years if it contains
details of CD disposal.
If permission to destroy is refused, the GP must be informed and situation discussed
with the line manager, documenting all actions taken to risk assess the situation. The
organisations „Accountable Officer‟ must be informed as soon as possible. The refusal
must be recorded in the care plan and on the medication sheet.
10.7.3 Disposal of CDs from Care Homes.
Care homes are inspected by the Care Quality Commission and as such have to abide
by national minimum standards. Each care home should have a controlled drug
register and store controlled drugs in a controlled drug cabinet.
When community nurses are involved in administering controlled drugs in a care home
setting, the controlled drug register belonging to the care home together with the
medication administration record chart must be signed by the community nurses.
Medication that is no longer required must not be removed by community nursing staff.
Community nurses must document in their records that the medication is to be retained
by the care home.
An appropriately trained care home employee will take full responsibility for ensuring
the appropriate destruction of the controlled drugs.
If the patient has died, all the patient‟s medication must be kept in the care home for a
minimum period of 7 days.
11.
Patient Group Directions (PGDs)
11.1
Definition
A Patient Group Direction (PGD) is a specific written instruction for the supply and
administration of a named medicine to a group of patients in an identified clinical situation.
The majority of clinical care should be provided on an individual, patient specific basis. The
supply and administration of medicines under PGD must therefore be reserved for those
limited situations where they offer advantages for patient care without compromising patient
safety.
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It is essential that practitioners have a copy of the PGD to refer to when supplying or
administering medication, this will ensure the practitioner will be able to check that all the
conditions of the PGD are fully met for that individual.
11.2 Legal Framework for PGDs (Health Service Circular 2000/026)
Healthcare organisations need to ensure that any current or new patient group directions
comply with legal requirements and the guidance set out in the above circular. Failure to
comply with the legal requirements could result in a criminal prosecution under the Medicines
Act.
11.3 Peer Review for PGDs
The Provider Services Medicines Management Group for Nursing and Allied Health
Professionals will peer review all PGDs for provider services.
Each Practitioner in Charge is responsible for adhering to local and national NHS policy
governing this process. To ensure consistency in format there is a standard PGD layout for
use within NHS Wirral services.
11.4
PGD Safety Concerns
The NHS Executive recommendations state that safety concerns must be a priority, notably it
was specified that:
Security, storage and labelling arrangements must be in place for any medicine
administered or issued via a PGD.
Medicines must be supplied in packs produced by a pharmacist.
There must be secure recording and monitoring systems so that in-coming and outgoing stock may be reconciled on a patient-by-patient basis.
Names of those providing treatment, patient identifiers and medicines provided must all
be recorded.
Provision must comply with, section 20 regulations of the Health and Social Care Act
2008. Medicines Management and European Community Labelling and Leaflet
directive 92/27.
Medicine use is consistent with their Summary of Product Characteristics and any
relevant NHS guidance.
11.5
Developing New PGDs within NHS Wirral
Approval from the Practitioner in Charge of a department and the Provider Services
Medicines Management Group for Nursing and Allied Health Professionals is needed
before developing new PGDs.
There must be an identified budget to meet costs of new PGDs. If there is no existing
budget this should be discussed with the Head of Medicines Management and
finalised with both the Practitioner in Charge and the Deputy Director of Finance.
Health records must be consistent with current DoH guidance and NHS Wirral‟s
Health Records Policy
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Storage of medicines must comply with NHS Wirral policy and section 20 regulations
of the Health and Social Care Act 2008.
Safety concerns as listed earlier must be adhered to.
Clinical expertise for developing PGDs will come from the service developing the PGD
in partnership with the Medicines Governance Pharmacist.
11.6
Who Can Administer from a PGD
The qualified practitioners who may supply or administer medicines under a Patient Group
Direction are Nurses, Midwives, Health Visitors, Optometrists, Pharmacists, Chiropodists,
Radiographers, Orthoptists, Physiotherapists, Ambulance Paramedics, Dental Hygienists and
Dental Therapists. They can only do so as named individuals.
11.7
Required Signatures for NHS Wirral
The Patient Group Directions must be signed by the Clinical Governance Lead. In addition a
senior doctor (or, if appropriate a dentist) and a senior pharmacist, both of whom should have
been involved in developing the direction with a member of the professional group expected to
supply medicines under the direction.
PGD Developed By
Pharmacist
Department /Service
Lead
Authorisation
Medical Director
Senior Partner (or
delegate)- for GP
Signature:
Name:
Position:
Date:
Signature:
Date:
Name:
Position: Medical Director (Provider Services)
Clinical Governance
Lead
Lead Pharmacist
Name:
Position: Medicines Governance Pharmacist
Signature:
Name:
Position
Signature:
Name:
Position: Prescribing Adviser
Date:
Signature:
Name:
Position:
Date:
Date:
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employed nurses
only
Signature:
Walk-In Centres
PGD Developed By
Pharmacist
Department/ Service
Lead
Name:
Position: Medicines Governance Pharmacist
Signature:
Date:
Name:
Position: Nurse Consultant/Clinical Co-ordinator
Wirral Walk-In Centres
Signature:
Authorisation
Medical Director
Date:
Name:
Position: Medical Adviser Wirral Walk-In Centres
Clinical Governance
Lead
Lead Pharmacist
Date:
Signature:
Name:
Position:
Date:
Signature:
Name:
Position: Prescribing Adviser
Date:
Signature:
Date:
Responsibility for signing PGDs can be delegated e.g. in cases of prolonged sick leave etc.
The Chair of the Provider Services Medicines Management Group for Nursing and Allied
Health Professionals must be informed and any change in signatories must also be agreed
with an Executive Director, preferably a Medical Director.
Signatures of Qualified Practitioners
The individual qualified practitioners who are to follow the PGDs must sign to agree to comply
with the PGD, a copy of this must also be kept on file.
11.8
Antibiotics
Particular caution must be exercised in any decision to draw up Patient Group Directions
relating to antibiotics. A WUTH Consultant Microbiologist must be involved in drawing up any
such direction and the NHS Wirral Provider Services Medicines Management Group for
Nursing and Allied Health Professionals must ensure that such directions are consistent with
local policies and subject to regular external audit.
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11.9 What cannot be included in a Patient Group Direction
The following should not normally be included in a Patient Group Direction:New drugs under intensive monitoring and subject to special adverse reaction
reporting requirements (Black Triangle Scheme).
Unlicensed medicines.
Medicines used outside their licensed indications (except when such use is
supported by best clinical practice).
Medicines being used in clinical trials.
11.10 Minimum Contents of a Patient Group Direction
The law specifies that each Patient Group Direction must contain the following:
A description of the medicine(s) to which the direction applies.
The clinical condition or situation to which the direction applies.
A description of those patients included and those excluded from treatment under the
direction.
A description of the circumstances in which further advice should be sought from a
doctor (or dentist, as appropriate) and arrangements for referral.
Details of appropriate dosage and maximum total dosage, quantity, pharmaceutical
form and strength, route and frequency of administration, and minimum or maximum
period over which the medicine should be administered.
Details of any necessary follow-up action and the circumstances.
Relevant warnings, including potential adverse reactions.
The date the direction comes into force and the date it expires.
Class of health professional who may supply or administer the medicine.
Signature of a doctor or dentist, as appropriate, and a pharmacist.
Signature of the Trust‟s Clinical Governance lead.
A statement of the records to be kept for audit purposes.
Patient Group Directions should be reviewed every two years.
Further guidance is contained in HSC 2000/026 Patient Group Directions (England only)
11.11 Updating of PGDs
NHS Wirral PGDs are held electronically by the NHS Wirral Medicines Management
Team. The original signed copies are also held by the Medicines Management Team.
The Medicines Governance Pharmacist, together with Practitioner in Charge are
responsible for reviewing PGDs every two years. There will be a staggered approach
to the review of PGDs to manage capacity.
The Practitioners in Charge are to consult with the Medicines Governance Pharmacist
at least three months before expiry date to allow time to amend any necessary
changes.
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For any changes, clearly indicate reference source or rationale for change.
Allow time to obtain necessary signatures to ensure PGD is valid and adheres to DoH
guidance.
Plan for practitioners‟ signatures to be obtained for all those authorised to use the
PGD, keeping a copy on file.
Paper/electronic copies of outdated PGDs must be kept on file for eight years, PGDs
relating to children must be kept for 25 years.
12.
Unlicensed Medicines
An unlicensed medicine is the term used to refer to a medicine that does not have a Valid
Marketing Authorisation for use in the UK.
If an unlicensed medicine is administered to a patient, the liability rests with the prescriber
rather than the manufacturer.
Unlicensed medicinal products are only to be used when no pharmaceutically equivalent
licensed product or suitable alternative licensed product is available for use at the time the
patient requires it.
Refer to the NHS Wirral document, “Guidance on the Prescribing and Use of Unlicensed and
“Off-label” medicines” available on the NHS Wirral website for full details.
Complementary and alternative medicines, such as homeopathy and herbal medicines without
a valid Marketing Authority for use in the UK are also classified as unlicensed medicines.
12.1
Responsibilities of Prescribers
Prescribers of unlicensed products carry their own responsibility and are professionally
accountable for their judgement in so doing. Prescribers are responsible for the patient‟s
welfare and in the case of adverse events they maybe called upon to justify their actions.
Following amendments to the Medicines for Human Use Regulations 2009, independent
nurse or pharmacist non-medical prescribers are now permitted to prescribe unlicensed
medicines. However, non-medical prescribers should only prescribe unlicensed medicines in
justifiable exceptional and approved circumstances for example, justified by current best
practice (e.g. national NHS guidance)
12.2
Responsibility of Supplying Pharmacist (Community or Hospital)
Supplying pharmacists are responsible for ensuring that prescribers are always aware that a
medicine they have requested is only available as an unlicensed product.
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Pharmacists will share the responsibility as the purchaser of the product, particularly when
this involves specifying the product to be purchased. Pharmacists are responsible for
ensuring that the manufacturer holds the appropriate licence to manufacture and that the
product complies with the product specification.
12.3
Responsibilities of NHS Wirral Medicines Management Team
When an unlicensed medicine is to be prescribed or administered for the first time, there
needs to be critical, evidence based evaluation for its use. The Locality Prescribing Adviser is
responsible for assessing the evidence and challenging its use.
12.4
NHS Wirral Staff Involved in Administering Unlicensed Medicines
In exceptional circumstances NHS Wirral staff may be requested to administer unlicensed
medicines. Staff must contact their senior manager (or on call manager) who must establish
the medicine is clinically appropriate by contacting the Medicines Management Information
Service on 0151 643 5338 or internal extension 1026 who will direct the inquiry to the most
appropriate specialist pharmacist. All evaluation, advice and risk assessments must be
appropriately documented. Out of hours medicines advice can be obtained from the referring
prescriber or the General Practitioner „Out of Hours‟ Service.
In addition it is also the responsibility of each individual registered nurse to satisfy themselves
that the medicine may be administered safely and wherever possible, that there is acceptable
evidence for the intended use of the unlicensed medicine.
If a medicine is unlicensed, it should only be administered to a patient against a patientspecific prescription and not against a patient group direction.
However, medication which is licensed but outside its licensed indications may be in
exceptional circumstances administered under a patient group direction, if such use is clearly
described and justified by current best practice (e.g. national NHS guidance).
Prior to administration of unlicensed medicines staff involved in administration should ensure
they have appropriate informed consent.
12.4.1 Complimentary and Alternative Medicines
In the case of complementary and alternative medicines, such as homeopathy and herbal
remedies, practitioners who administer such medicines to patients must have successfully
undertaken training and have the role of administrating these medicines outlined in their job
description and be competent to practice the administration of the particular medicine.
Practitioners must also ensure that they have sufficient indemnity insurance and they must
check with their line manager that the administration of these medicines will be covered by
NHS Wirral‟s vicarious liability.
12.5
Wirral Drug and Therapeutics Committee
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The Wirral Drug and Therapeutics Committee is responsible for the approval for use of all
medicines prescribed in primary care and WUTH. However in the case of an urgent clinical
need, the Locality Prescribing Adviser may authorise use of a new unlicensed medicine,
subject to formal ratification at the next Wirral Drug and Therapeutics Committee.
12.6
Definition of “Off -Label Medicines”
The Summary of Product Characteristics (SPC) lists:
Indications, dose ranges, methods of administration and age restrictions as granted by the
Marketing Authorisation for each medicine licensed for use within the UK.
Any use not in accordance with the SPC is considered “off-label”, or an unlicensed use.
This policy also applies to products used outside their Marketing Authorisation “off label use”.
13.
Training and Medicines Information
The British National Formulary is the main source of reference for medicines. It describes the
preparations likely to be prescribed and summarises the relevant legislation regarding
prescriptions and controlled drugs. All health professionals involved in the administration of
medications are responsible for familiarising themselves with the formulary. The Nurse
Prescribers Formulary (incorporated in the British National Formulary) provides information of
special relevance to Nurse Prescribers.
A copy of the British National Formulary (BNF), within 12 months of date of issue will be
available in each department. The most current version of the BNF is available on the internet.
www.bnf.org
The expert on all aspects of medicines and medicines related legislation is the pharmacist who
should be consulted whenever necessary.
NHS Wirral Medicines Information Service is staffed by pharmacists during normal office
hours and can be contacted on 0151 643 5338 or alternatively on internal extension 1026.
All staff are encouraged to identify their Continuing Professional Development (CPD) needs
regarding their own competency level in the safe use of medicines according to the needs of
their role.
Staff and managers have joint responsibility to highlight training needs in regard to the
safe storage and administration of medicines and highlight these needs in annual
appraisals and management supervision as required.
All staff must adhere to NHS Wirral policy. Health Care Professionals are also
accountable to their own Professional Bodies to promote safe practice for patients and
for their own Continuing Professional Development.
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Staff are responsible for reading and acting within the Safe Handling and
Administration of Medicines Policy and for any departmental SOPs regarding
medicines.
A feedback form is available in the front of the Policy File for all staff to comment or
make suggestions for changes when the policy is due to be reviewed. This will be a
valuable feedback loop to promote best practice within NHS Wirral.
In addition NHS Wirral will provide training on medicines management specific to the
requirements of individual departments, for example community nurses are required to attend,
medicines management training every two years.
14.
Adverse Drug Reaction Reporting and Yellow Card Scheme
The Yellow Card Scheme for spontaneous reporting of suspected adverse drug reactions
(ADRs) was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for
routine monitoring of medicines. Adverse Drug Reactions should be reported to the Medicines
and Healthcare products Regulatory Agency (MHRA) by completing a yellow card.
14.1
Who Can Report?
Until recently adverse drug reaction reporting using the yellow card scheme was only available
to healthcare professionals such as doctors, pharmacists, coroners and nurses. In October
2005 the Yellow Card Scheme was extended to patients and their carers.
14.2
What Should be Reported?
An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the
administration of a drug or combination of drugs under normal conditions of use that is
suspected to be related to the drug.
For intensively monitored medicines (identified by ▼) report all suspected reactions.
For established drugs and herbal remedies report all serious adverse reactions in adults;
report all serious and minor reactions in children (under 18).
Serious reactions include those that are:
Fatal
Life threatening
Disabling
Incapacitating
Result in or prolonged hospitalisation
And / or are medically significant
Congenital abnormalities
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If in doubt about the seriousness of a reaction please report it.
14.3
Areas of Special Interest
Although all adverse reactions with medicines are monitored there are a number of areas of
particular interest, as listed below:
Children
The elderly
Delayed drug effects
Congenital abnormalities
Herbal remedies – it is important to monitor all herbal products to ensure their safety. It
would be helpful to report the ingredients, source or supplier.
14.4
Where to find a Yellow Card
A paper version of the Yellow Card is included in:
British National Formulary
Nurse Prescriber Formulary
Monthly Index of Medical Specialities (MIMS)
Alternatively down load a copy from the MHRA web site http://medicines.mhra.gov.uk
14.5
Patient Details
The following patient details should be included on the yellow card: the patient‟s initials, age,
sex, weight if known, and a local identification number. The patient‟s initials and a local
identification number will help identify the patient in any future correspondence. Do not
identify the patient by date of birth or name of patient to ensure confidentiality agreements
between the health care professional and the patient are not breached.
14.6
Copy of Yellow Card in Patient’s Notes
It is vital that a copy of the Yellow Card Report is included in the patient‟s notes. It is
recommended that a copy be sent to the GP for future reference and to the Medicines
Management Team, so that a central record can be kept and monitored.
15.
Medicine Alerts
15.1
Medicines and Healthcare Products Regulation Drug Alerts
Medicines and Healthcare Products Regulatory Agency (MHRA) Drug Alerts are cascaded
directly to Community Pharmacists throughout Wirral.
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Community Pharmacists are responsible for ensuring that the advised action is taken which
may necessitate the removal of the affected pharmaceuticals from pharmacy stock.
MHRA Drug Alerts are also cascaded directly to WUTH. Departments will be notified by
WUTH if they have been issued with a medicine that has been mentioned in an Alert.
Arrangements must be made to liase with WUTH by checking batch numbers and arranging
for the removal of affected medicines.
NHS Wirral Medicine Management Team holds a copy of all MHRA Drug Alerts.
Where relevant, information will also be shared with the Chair of the Provider Services
Medicines Management Group.
15.2
National Patient Safety Agency Alerts and Rapid Response Reports
NHS Wirral responds to National Patient Safety Agency (NPSA) alerts and rapid response
reports involving medication and treatments provided by NHS Wirral. Action plans to monitor
compliance are produced by liaising with relevant services. Evidence of compliance for
Provider Services is documented in the Provider Services Medicines Management Group for
Nursing and Allied Health Professionals. Completed action plans also documented by NHS
Wirral Governance Department.
16.
Monitoring
Compliance to this policy is monitored by using the key performance indicators at the front of
this document.
17.
Archiving and Document Retrieval
To conform to the requirements of DOH 2006- Records Management, NHS Code of Practice,
hard and/or electronic copies of previous versions of this document will be held by the
Medicines Management Team for the required 10 year period. All previous copies held by
staff members will be retrieved and destroyed on the issue of future amended and updated
versions of this document.
18.
Consultation
For consultation purposes this document is forwarded to the Provider Services Medicines
Management Group for Nursing and Allied Health Professionals and the Clinical Policy and
Procedures Group for review and discussion and with relevant stakeholders
19.
Ratification
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This document goes to the Provider Services Governance Group for approval.
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References
Health and Social Care Act 2008 (Regulated Activities) Regulations 2009
Care Quality Commission (Registration) Regulations 2009
Department of Health (2005) Medicines Matter. March
Department of Health (2006) Improving Patient’s Access to Medicines. April
Department of Health (2007) Safer Management of Controlled Drugs: Guidance on
Standard Operating Procedures for Controlled Drugs. January
Royal Pharmaceutical Society (2005) A revision of the Duthie Report (1988) The Safe
and Secure Handling of Medicines. (March)
Nursing and Midwifery Council (2010) Standards for Medicines Management
Nursing and Midwifery Council (2006) Standards of Proficiency for Nurse and Midwife
Prescribers. April
Health Service Circular 1998/062 Guidance for Doctors and Pharmacy Contractors
Health Service Circular 2000/026 Patient Group Directions (England only)
Medicines and Healthcare Products Regulatory Agency http://medicines.mhra.gov.uk.
National Prescribing Centre (2001) Maintaining Competency in Prescribing – An
outline framework to help nurse prescribers. November
National Prescribing Centre (2009) A guide to good practice in the management of
controlled drugs in primary care (England.) December
Department of Health (2001) 12 Key Points on Consent: the Law in England August
National Patient Safety Agency (2010) Reducing harm from omitted and delayed
medicines in hospital. RRR 009
National Patient Safety Agency (2010) Safer administration of insulin RRR013
National Patient Safety Agency (2010) Reducing treatment dose errors with low
molecular weight heparins RRR014
National Patient Safety Agency (2007) Alert No 20 Promoting Safer Use of Injectables
28 March
National Patient Safety Agency (2007) Alert No 19 Promoting Safer Measurement and
Administration of Liquid Medicines via Oral and Enteral Routes 28 March
National Patient Safety Agency (2007) Alert No 18 Actions that can make
Anticoagulant Therapy Safer 28 March
National Patient Safety Agency (2006) Safer Practice Notice 12 May
National Patient Safety Agency (2006) Safer Practice Notice 1 June
Department of Health (2006) Environment and sustainability Health Technical
Memorandum 07-01: Safe management of healthcare waste November
Appendix 1
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Pharmacy Department
Pharmacy Stock Amendment Request Form
Circle the organisation requesting the amendment:
NHS Wirral
St John’s Hospice
CCO
Claire House
Provide the details of the specific area requiring amendment:
Clinic/Ward/Department:
Contact Name:
Contact Tel No:
Provide details of the amendment required:
One Off Supply
Addition to stock Delete from stock
list
list
Provide details of the drug/s:
Drug name
Form
Strength
New stock list
Pack size
Quantity
(use approved name)
Delete existing
stock list
Comments
(NB: If request for a pre-labelled
pack – state directions required)
Reasons for the Request:
Request Authorised by :
Clinic/Ward/Department
Manager
Senior Pharmacist approval
Sign:
Print name:
Date:
Sign:
Print name:
Date:
Please forward the completed form to: Gerardine Draper, Senior Technician, Medicines
Management Team, OMH Tel No: 0151 643 5319 or ext 1156 / Fax No. 0151 643 5442
WUTH use only:
Processed by
Checked by
Contact informed by
Sign:
Print name:
Date:
Sign:
Print name:
Date:
Sign:
Print name:
Date:
Comments
Appendix 2
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An Example of an Audit Tool for Assessing Compliance with Departmental SOPs
Name of Service
Standard Operating Procedure Audited
Response
1
2
3
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
Comment
Are all staff involved in handling medicines
aware of Safe Handling and Administration of
Medicines Policy?
Are all staff aware of departmental SOPs?
Is there evidence that departmental SOPs are
followed in practice?
Check whether all orders are signed by the
authorised signatory for a given period
Is there documentary evidence medicines are
checked and signed for on receipt into
department?
Check whether delivery notes have been kept
for two years
Check whether temperatures have been
recorded daily where medicines are stored
Do staff know what to do in the event of
temperatures exceeding 25°C?
Are there any medicines that require storage
between 2 and 8°C?
If yes check whether maximum and minimum
temperatures have been recorded?
Do staff know what to do in the event of
temperatures going outside the recommended
temperature range?
Check whether any of the stored medicines
have gone out of date and these have not been
previously detected
Check whether all medicines are stored
separately from other products
Check whether areas where medicines are
stored are appropriately secure
Are medicines related stationery kept in locked
cupboard (s)?
Are medicines disposed of appropriately?
What evidence of disposal records is available?
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