Download This Item - Kettering General Hospital

Affiliated Teaching Hospital
Index No: MM0000
MEDICINES CODE
Version:
1
Date ratified:
14 September 2016
Ratified by:
(Name of Committee)
Name of originator/author, job title and
department:
Medicines Management Committee
Director Lead (Trust-wide policies)
Associate Medical Director (local
Policies)
Clinical Management Team /
Directorate Applicable to
Name of responsible committee for the
policy:
Date issued for publication:
Duane McLean
Chief Pharmacist and Accountable
Officer for Controlled Drugs
Medical Director
Trustwide
Medicines Management Committee
September 2016
Review date:
June 2019
Expiry date:
(Date 3 months following review date)
Equality impact assessed by:
(name, job title and department)
Date impact assessed:
September 2019
CQC Fundamental Standards
Regulation 12: Safe Care and Treatment
MM0000 Medicines Code v1
Page 1 of 113
Duane McLean, Chief Pharmacist
August 2016
Chairman: Graham Foster JP
1
Chief Executive: David Sissling
CONTRIBUTION LIST
Individuals involved in developing the document
Name
Duane McLean
Karen Favell
Sue Hussain
Designation
Chief Pharmacist
Deputy Chief Pharmacist - Clinical Excellence
Deputy Chief Pharmacist - QIPP
Circulated to the following individuals for consultation
Name
Dhiren Bharkhada
Karen Moody
Naomi Fleming
Anthony Bartlett
Anusha Patel
Scott Hillery
Janice Wright
Robin Lee
Beverley Bone
Eilish Crowson
Designation
Pharmacist Advanced Cancer Services
Pharmacist Team Manager Medicine
Pharmacist Advanced Micro and Infectious Diseases
Pharmacist Advanced Informatics/Medicines Information
Pharmacist Advanced Pharmacist
Technician Team Manager Production
Technician Team Manager Dispensary and Stores
Consultant ENT Surgeon and Chair of MMC
Acute Pain Service Matron
Head of Midwifery and Business Unit Director, Women &
Children
Marie Sharpe
Lead Nurse – Practice Development
Diane Postle
Deputy Director of Nursing
Senior Nurse representatives via Matrons’ Forum
Consultant members of the Medicines Management Committee, New
Medicines Group and Medication Safety Group
MM0000 Medicines Code
Page 2 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
MM0000
Index No.
Approval and Authorisation
Completion of the following signature blocks signifies the review and approval of this process.
Name
Job Title
Mr Robin Lee
Chair of MMC
Signature
Date
14 September
2016
Local Committee approval (where applicable)
Name of Committee
Name of
Chairperson
Date of
Approval
Medicines Management
Mr Robin Lee
14 September
2016
Change History
Version
Date
Author
Reason
1
September 2016
Duane McLean
Amalgamation of several
Trust policies into one
overarching Medicines
Code*
*Trust policies superseded by the introduction of Medicines Code:

MM5 Patient Self-Administration of Medicines Policy

MM11 Policy for Use of Unlicensed and ‘Off Label’ Medicines for Adults and
Children

MM14 Medicines Reconciliation Policy for Adults

MM16 Intravenous Medication Preparation and Administration

MM19 Prescribing Medicines Policy

MM28 Controlled Drugs Policy

MM29 Secure management of FP10s in clinics, wards and departments

MM32 Procedure for the Disposal of Medicines in Clinical Areas

MM36 The Security and Storage of Medicines in Clinical Areas

MM49 Preparation and Administration of Medicines in Clinical Areas

MM50 Procedures for the Development, Authorisation, Use and Review of
Patient Group Directions
MM0000 Medicines Code
Page 3 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
Impact Assessment
Undertaken by
Date
Duane McLean, Chief Pharmacist
August 2016
A translation service is available for this policy. The Interpretation/Translation
Policy, Guidance for Staff (I55) is located on the library intranet under Trust wide
policies.
MM0000 Medicines Code
Page 4 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
CONTENTS PAGE
1.
INTRODUCTION
9
2.
SCOPE
10
3.
AIM
10
4.
RESPONSIBILITIES
11
5.
DEFINITIONS
12
6.
DOCUMENT CONTENT - MEDICINES CODE
1.
ORDERING AND RECEIPT OF MEDICINES
18
1.1 Key principles
1.2 Responsibilities
1.3 Risk assessment
1.4 Components of safety
1.5 Ordering of medicines
1.6 Unlicensed medicines
1.7 Home delivered medicines
1.8 Receipt of medicines into Pharmacy
1.9 Receipt of unlicensed medicines into Pharmacy
1.10 Receipt of home delivered medicines
1.11 Receipt of medicines into clinical areas from
Pharmacy
2.
STORAGE AND SECURITY OF MEDICINES
23
2.1 Key principles
2.2 Responsibilities
2.3 Medicines keys
2.4 Storage locations
2.5 Fluid warmers
2.6 Temperature monitoring
2.7 Refrigerated storage
2.8 Stock maintenance
2.9 Return of medicines
2.10 Disposal of medicines
2.11 Ward and department closures
MM0000 Medicines Code
Page 5 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.12 Audit, assurance and accountability
3.
MEDICINES RECONCILIATION
34
3.1 Medicines reconciliation checklist
3.2 Medicines reconciliation process
4.
PRESCRIBING
37
4.1 Who can prescribe
4.2 General principles of prescribing
4.3 Range of medicines to prescribe
4.4 Verbal orders
4.5 Inpatient prescribing
4.6 Allergies or sensitivities
4.7 Prescribing for all medicines
4.8 Prescribing for intravenous medicines
5.
PREPARATION OF MEDICINES
49
5.1 Responsibilities
5.2 Key principles
5.3 General principles
5.4 Ward preparation
5.5 Use of oral syringes
5.6 Insulin syringes
6.
CHECKING OF MEDICINES
55
6.1 Key principles
6.2 General procedures
6.3 Prescription validation and optimisation
7.
ADMINISTRATION OF MEDICINES
59
7.1 Key principles
7.2 When administering medicines steps to follow
7.3 Patients’ own medicines
7.4 Delay or omission of medicines
7.5 Omission codes
8.
SELF-ADMINISTRATION OF MEDICINES
67
8.1 Who can self-administer
8.2 Assessment of patients
MM0000 Medicines Code
Page 6 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
9.
SUPPLY OF MEDICINES TO PATIENTS
70
9.1 Key principles
9.2 Key standards
9.3 General procedures
10. DISPOSAL OF PHARMACEUTICAL WASTE
71
10.1 Key principles
10.2 General procedures
11. PATIENT GROUP DIRECTIONS
74
11.1 Key principles
11.2 Development, authorisation and review
11.3 Using a PGD
12. CONTROLLED DRUGS
77
12.1 Key principles
12.2 Key standards
12.3 Accountability for CDs
12.4 Ordering of CDs
12.5 Receipt of CDs
12.6 Obtaining CDs out-of-hours
12.7 Transport of CDs
12.8 Transfer of CDs
12.9 Storage and security of CDs
12.10 Storage and security of TTAs including CDs
12.11 Loss of CD cupboard keys/replacement lock
12.12 Patients’ own CDs
12.13 Prescribing of CDs
12.14 Preparation and administration of CDs
12.15 CDs issued directly to medical staff
12.16 Documentation and record keeping for CDs
12.17 Disposal or return of CDs
12.18 Stock checks of CDs
12.19 Abusable medicines
12.20 Illicit substances
12.21 CD stationery
MM0000 Medicines Code
Page 7 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
13. UNLICENSED AND OFF LABEL MEDICINES
104
13.1 When can unlicensed medicines to used
13.2 Unlicensed prescribing for children
13.3 Prescribing in Critical Care
13.4 Prescribing in Haematology or Oncology
13.5 Prescribers
14. FP10 PRESCRIPTION FORMS
108
14.1 Key principles
14.2 Ordering FP10 prescription forms from
Pharmacy
14.3 Returning FP10 forms
14.4 Secure storage and safekeeping of FP10
prescription forms when not in use
14.5 Secure management of FP10 prescription forms
‘in-use’
14.6 Unused and/or ‘spoilt’ FP10 prescription forms
14.7 Procedure for missing or unaccounted-for FP10
prescription forms
14.8 Prescribing on FP10 prescription pads
14.9 Monitoring, compliance and effectiveness
7.
TRAINING
15
8.
MONITORING COMPLIANCE AND EFFECTIVENESS
16
9.
PROCESS FOR IMPLEMENTATION AND
DISSEMINATION
16
10.
DOCUMENT REVIEWS AND UPDATES
16
11.
REFERENCES
16
12.
EQUALITY IMPACT ASSESSMENT
16
13.
APPENDICES
16
MM0000 Medicines Code
Page 8 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
1.0
INTRODUCTION
Medicines management encompasses a range of activities intended to improve
the way that medicines are selected, procured, prescribed, dispensed, and
administered.
The Royal Pharmaceutical Society Professional Standards for Hospital Pharmacy
Services requires hospitals to have a policy, procedures and guidelines to ensure
the safe use of medicines across the organisation. It is a requirement for
Registration by the Care Quality Commission (CQC) that registered staff protect
patients against the risks associated with unsafe use of medicines. Appropriate
arrangements should be in place for obtaining, recording, handling, using, safe
keeping, safe administration and disposal of medicines used for regulated activity.
This policy lays out the key principles for the control of medicines to be followed at
every stage of the medicines use process (procurement, storage, prescribing,
preparation, dispensing, administration and disposal). Finally it includes the roles
of the medicines management committees including the Northamptonshire
Prescribing Advisory Group.
Clinical Business Units may then develop local policies within this framework in
consultation with the Medicines Management Groups for Kettering General
Hospital (KGH). The local policy should be approved by the Medicines
Management Committee, Associate Medical Director and Head of Nursing or
other suitable group.
KGH NHS Foundation Trust endeavours to reflect the needs and preferences of
patients, their families and their carers. Patients, with their families and carers,
where appropriate, will be involved in and consulted on all decisions about their
care and treatment.
KGH NHS Foundation Trust also commits to:
MM0000 Medicines Code
Page 9 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling

Make decisions in a clear and transparent way, so that patients and
the public can understand how services are planned and delivered.

Make the transition as smooth as possible when patients are referred
between services, and to include patients in relevant discussions.
Patients have the right to medicines and treatments that have been recommended
by the National Institute for Clinical Excellence for use in the NHS, provided that
the prescriber considers that they are clinically appropriate, and the patient meets
the criteria specified.
Patients have the right to be involved in discussions and decisions about their
healthcare and to be given information to enable them to do this.
2.0 SCOPE
This document applies to all areas of the Trust where medicines are used and to
all employees involved in the medicines use process. Employees include those
who are employed through external agencies, students, locums and bank staff.
3.0 AIM
Medicines are the most frequent therapeutic intervention made within the NHS
with potential for error at every stage of the medicines use process. Errors in
medicines management expose patients to unnecessary risk and harm, poor
patient experience, unnecessary expenditure and loss of reputation.
The aim of this policy and procedures is to define safe, high quality processes for
medicines use. Through following these processes and learning from mistakes,
patient safety will be improved.
The Medicines Code is presented as a series of chapters covering all aspects of
the medicines use process and applies to all medical, nursing, pharmacy and
allied health professions involved in medicines management activities. It applies
to all staff employed by the Kettering General Hospital NHS Foundation Trust and
those contracted to work on a sessional basis.
MM0000 Medicines Code
Page 10 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.0 RESPONSIBILITIES
Integrated Governance Committee is responsible for assuring the Trust Board
that policy and procedures meet statutory and best practice requirements, to
safeguard patient care.
Quality Governance Steering Group is responsible for ensuring prescribing and
medicines management are evidence-based and relevant policy and procedures
are consistently applied across the organisation to deliver high standards of care.
Any risks identified, which cannot be mitigated will be owned by this committee
and documented on the Risk Register.
Medicines Management Committee is responsible for the safe, clinical and costeffective use of medicines in the Trust. This multi-disciplinary committee promotes
evidence based prescribing, is responsible for development and audit of policy
and procedures for the safe use of medicines.
New Medicines Group this multi-disciplinary committee promotes evidence
based prescribing, reviews requests for new medicines and manages the hospital
and joint area prescribing formularies.
Medication Safety Group this multi-disciplinary committee reviews medication
incidents and develops action plans to improve medicines use within the Trust.
Clinical Business Units have responsibility in managing performance related to
all aspects of medicines use within their areas.
The Medical Director and Director of Nursing have overall responsibility for
ensuring adherence to this policy and procedures.
The Chief Pharmacist is accountable for ensuring the requisite processes are in
place and for monitoring overall compliance with this policy.
MM0000 Medicines Code
Page 11 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
The Chief Pharmacist is accountable to the Department of Health, with the Chief
Executive, Medical Director and Director of Nursing and Midwifery for the safe,
appropriate and effective use of medicines within the Trust. The Chief Pharmacist
provides specialist expertise and, delegated from the Chief Executive, has
corporate responsibility across the Trust for all aspects of medicines management
including associated controls assurance standards and other DoH and SHA
performance management arrangements that are applicable.
Heads of Nursing are responsible for medicines practice in within their area
Matrons are accountable for ensuring that the systems associated with medicines
management are followed and that the security of medicines on the ward is
maintained.
Clinicians and Practitioners
All clinicians and practitioners (of all health professions) are responsible for
following these legislative and best practice standards for medicines use in order
to deliver safe and effective patient care.
5.0 DEFINITIONS
5.1 Staff Definitions
Accountable Officer
Officer in a health care organisation who is
responsible for the safe management of
controlled drugs, as required by Controlled
Drugs (Supervision and Management of Use)
Regulations 2006.
Appointed Practitioner
The senior registered practitioner with overall
responsibility for the safe and secure handling
of medicines for a ward or department e.g.
Lead Nurse, Theatre Manager or their deputy.
Assigned Practitioner
A healthcare practitioner assigned to a
particular task.
Assistant Practitioner
A non-registered healthcare practitioner with
specific extended roles and competencies
MM0000 Medicines Code
Page 12 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
Designated Practitioner
The senior registered practitioner in charge of a
ward or department at a particular time/shift.
Medical Practitioner
Any doctor registered to practice in the UK as
an independent medical prescriber.
Non-Medical Prescriber
A registered non-medical practitioner who has
completed the necessary training and
registration to prescribe medicines:

Supplementary
A member of an approved healthcare
profession who can prescribe medicines for a
named patient as part of a written clinical
management plan, agreed with the patient and
an independent medical prescriber.

Independent
A nurse or pharmacist who has undertaken
formal non-medical prescribing training and
assessment and is registered as a prescriber
with their professional body.
Physicians Associate
Registered practitioner
Physician associates are dependent
practitioners with a generalist medical
education, who work alongside doctors..
A state regulated and registered practitioner
who is listed on a professional practice register.
This does NOT include voluntary registration.
Responsible Pharmacist The lead pharmacist for a Clinical Business
Unit or Department, or their deputy, who is
responsible for the safe preparation and supply
of a pharmaceutical product.
Responsible Officer
The person accountable for medication
homecare for Homecare services.
5.2 Process Definitions
Administer
To introduce a medicine into a patient by
means of enteral (oral) or parenteral (injection)
route or by external application.
Controlled Drug (CD)
The drugs listed in schedules 1-5 of the Misuse
of Drugs Regulations 2001 (as amended,
which are subject to varying controls on
prescribing, storage, handling and disposal).
MM0000 Medicines Code
Page 13 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
Dispense
To make up or supply a medicine for a patient
(usually a prescription only medicine) together
will all the necessary technical, clinical and
professional checks. Medicines are dispensed
under the supervision of a pharmacist.
Homecare Medicines
Homecare medicine delivery service can be
described as being a service that delivers
ongoing medicine supplies and, where
necessary, associated care, initiated by the
hospital prescriber, direct to the patient’s home
with their consent.
Licensed Medicine
A medicine that has been granted a marketing
authorisation (MA) (previously known as a
product licence PL), and can be ‘placed on the
market’ in the UK for the treatment of medical
conditions as defined in its MA or PL (i.e. its
licensed indications).
Medicine
Any substance or combination of substances
administered to human beings for the purpose
of investigating or treating disease.
Medicines Code
Kettering General Hospital Policy and
Procedures for medicines
Medicines Management
A broad term describing activities that promote
the safe, clinical and cost-effective use of
medicines.
Medicines use process
The process of procuring, storing, prescribing,
dispensing, preparing and administering
medicines and disposing of pharmaceutical
waste.
Medicines Reconciliation The process of identifying an accurate list of a
person's current medicines and comparing
them with the current list in use, recognising
any discrepancies, and documenting any
changes
Off Label Use
Use of a medicine for a clinical indication or in
a way that is not covered by the licence.
Patient Group Direction
Specific written instruction for supply &
administration of a named medicine in a
defined clinical situation signed by a doctor or
MM0000 Medicines Code
Page 14 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
dentist and authorised by an appropriate
healthcare body.
Pharmacy Validation
The clinical pharmacy process of reviewing a
prescribed medicine for clinical
appropriateness in terms of drug, dose and
frequency as well as for prescription clarity,
completeness and safety.
Prescribe
To authorise in writing the supply of a
medicine. Prescription only medicines (POM)
can only be prescribed by a registered medical
or non-medical prescriber.
Prescription
A written authorisation to supply or administer
a medicine.
POM
A medicine included in the Prescription Only
Medicines (Human Use) Order 1997 of the
Medicines Act.
Registered
A health professional who is part of state
regulated profession and named on the
designated register.
Supply
To provide a medicine to a patient or carer for
the purpose of administration or selfadministration.
Unlicensed Medicine
A medicine is one that does not have a MA and
therefore does not have a licence for use in the
UK. This may be because the product is
awaiting the granting of a licence in the UK, or
it is undergoing clinical trials, or is only
manufactured for export or has been withdrawn
from the UK market.
6.0 DOCUMENT CONTENT - see from p18 to end
7.0 TRAINING
All clinical staff will have medicines management training at induction.
Assessments of competence to prepare and administer medications are required.
MM0000 Medicines Code
Page 15 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
8.0 MONITORING COMPLIANCE AND EFFECTIVENESS
Audit Schedule:
 Prescribing standards (3 per year)
 Controlled drugs storage (quarterly)
 Medicines security (quarterly)
 Patient Group Directions (annually)
 Unlicensed medicines (annually)
 Medicines Safety Thermometer (monthly)
9.0 PROCESS FOR IMPLEMENTATION AND DISSEMINATION
Dissemination and implementation will be through the Quality Governance
Steering Group and Medicines Management representatives, Lead Nursing
structure, Matrons Forum, CBU governance structures and ward meetings.
Further communications will be issued through the Leadership Brief and
Pharmacy Matters publication.
10.0 DOCUMENT REVIEWS AND UPDATES
This document will be reviewed every three years at a minimum.
11.0 REFERENCES
Royal Pharmaceutical Society of Great Britain, “The Safe and Secure Handling of
Medicines: A Team Approach,” Royal Pharmaceutical Society of Great Britain,
2005.
12.0 EQUALITY IMPACT ASSESSMENT
The Trust takes its obligations under Equality Legislation very seriously and aims to
provide fair and equitable treatment to, and value diversity in, its staff, patients and
visitors. In doing so it aims to ensure that its actions and working practices comply
with both the spirit and intention of the Human Rights Act (1998) and the Equality Act
(2010) which relates to the protected characteristics of age, disability, gender
reassignment, marriage & civil partnerships, pregnancy & maternity, race, religion or
belief, sex and sexual orientation. The Trust will also carry out its functions in a
manner that reduce the inequalities of outcome, which may result from socioeconomic disadvantage.
13.0 APPENDICES
1.
2.
3.
Prescribing Audit Tool
Self Administration of Medicines Assessment Tool
Self Administration of Medicines Consent Form
MM0000 Medicines Code
Page 16 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Patient Group Directions (PGD) Proposal
Patient Group Directions (PGD) Proposal Form
Patient Group Directions (PGD) Development and Submission
Patient Group Directions (PGD) Pre-Approval Form
Controlled drug cupboard lock/key replacement
Controlled drug TTA prescription
Controlled drug returns/destruction
Sample Ward CD Record Book
Sample Theatre CD Record Book
Request to use an unlicensed or off-label medicine
'Special' medicines patient information leaflet‘
KGH FP10 Prescription Order Form
http://www.nhsbsa.nhs.uk/Documents/SecurityManagement/Security_of_pre
scription_forms_guidance_Updated_August_2013.pdf
MM0000 Medicines Code
Page 17 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
1. ORDERING AND RECEIPT OF MEDICINES
Medicines must be procured to ensure that the right medicine is available in the
right quantity and quality, at the right time for the right patient. In order to achieve
this, medicines must be ordered and received through the Pharmacy Department.
1.1.
Key Principles
1.1.1.
The use of all medicines carries the risk of a patient safety
incident (such as inappropriate reconstitution or administration) as
well as the more usually considered adverse events such as side
effects.
1.1.2.
These risks can and should be minimised. To enable this it is
essential that all risks are identified and assessed and action
taken to minimise the possibility of a patient safety incident.
1.1.3.
Part of this process is to ensure that the procurement of
medicines provides so far as is possible medicines which are of
suitable quality, and are safe in use i.e. prescribing, dispensing,
preparation, administration and disposal. Moreover it is essential
that the procurement process assesses the capabilities of the
upstream supply chain to ensure products are genuine, stored
correctly and available when required.
1.1.4.
Licensed medicines should be used in preference to unlicensed
medication, however there maybe circumstances where the
licensed product is deemed to present a significant clinical risk
and it may be safer to use and unlicensed product or
formulations.
1.2.
Responsibilities
1.2.1.
The Trust Chief Pharmacist has the delegated responsibility for
the procurement of medicines.
1.2.2.
Authority to procure certain specific products may be delegated
elsewhere (e.g. medical gases, which may be purchased by
Estates/Facilities).
MM0000 Medicines Code
Page 18 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
1.3.
Risk Assessment
1.3.1.
Where new medicines, presentations of formulations of medicines
are added to the Trust medicines formulary, a risk assessment
should be undertaken by staff with a full understanding of the
purpose and end use of the product being procured.
1.3.2.
Risks should be identified and minimised, reporting systems
should be available and acted upon, and if normal sources are not
available (e.g. in a shortage situation) then alternatives need to be
assessed in the light of the increased risk they may present to
patients.
1.3.3.
If a product is assessed locally as a high risk of causing a patient
safety incident this should be reported to regional Quality
Assurance (QA) and procurement specialists. These lists can then
form the basis of discussion with the manufacturers about
possible changes in presentation.
1.4.
Components of Safety
1.4.1.
Risk assessment should take account of the following factors.
1.4.1.1.
Quality of Products.
1.4.1.2.
Design and Use of Products (e.g. ready-to-use and ready-toadminister products).
1.5.
1.4.1.3.
Labelling and Packaging of Products.
1.4.1.4.
Source of Products and Materials.
1.4.1.5.
Treatment of Product within Supply Chain.
Ordering of medicines
1.5.1.
Ordering of medicines is carried out by the Pharmacy Purchasing
Office (during office hours).
1.5.2.
Orders for medicines should be transmitted to suppliers
electronically to reduce the risk of errors.
1.5.3.
Out of hours, in cases of emergency, where a medicine is
required that is not available in the Pharmacy Department, the
MM0000 Medicines Code
Page 19 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
oncall pharmacist may order the medicine from a wholesaler or
another hospital or other usual supplier. In this case, the order will
be placed by telephone and the details passed to the Pharmacy
Purchasing Office on the next working day.
1.6.
Unlicensed Medicines
1.6.1.
Unlicensed medicines should be procured in accordance with the
Unlicensed Medicines Policy.
1.6.2.
The Pharmacy Department is responsible for the specification of
an unlicensed medicine, and with ensuring that the product
supplied meets the specification and is of acceptable quality.
1.7.
Home Delivered Medicines
1.7.1.
All supplies of home delivered medicines should be ordered in
conjunction with the Pharmacy Department.
1.7.2.
The prescription for a home delivered medicine constitutes an
order.
1.7.3.
All homecare prescriptions require a professional check by a
registered member of the pharmacy team, initial prescriptions or
where doses and frequency have been amended should,
whenever possible be professionally checked by a pharmacist.
1.7.3.1.
Where the prescription is a continuation of a previously
commenced therapy and which remains unchanged for
dose, frequency and duration a competent registered
pharmacy technician may provide the clinical screen.
1.8.
Receipt of Medicines into Pharmacy
1.8.1.
All medicines received into stock in the Pharmacy Department
must be recorded on the pharmacy computer system.
1.8.2.
The receipt process involves the following checks:
1.8.2.1.
The physical condition of the packs supplied is checked,
including the temperature at which they are delivered.
MM0000 Medicines Code
Page 20 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
1.8.2.2.
The quantity supplied is checked.
1.8.2.3.
The expiry dates are checked.
1.8.2.4.
The product received is checked against the delivery note
supplied with it to ensure that the supplier has correctly
described what has been supplied.
1.8.3.
Medicines received are placed into secure storage within the
Pharmacy Department.
1.9.
Receipt of Unlicensed Medicines into Pharmacy
1.9.1.
Upon receipt, unlicensed medicines are put into bonded storage.
1.9.2.
Following the checks listed above, and a further check to ensure
that the product received meets the original specification, the
product is approved for release by a suitably trained and
designated person.
1.10.
Receipt of Home Delivered Medicines
1.10.1.
Patients receiving their medicines by home delivery should be
asked to sign the delivery note supplied with their medicines.
1.10.2.
A copy of the signed delivery note is then sent to the Pharmacy
Department by the homecare company (the supplier).
1.10.3.
It should be a condition of contract with a homecare company that
no payments will be made for home delivered medicines unless a
signed delivery note is received for them.
1.11.
Receipt of medicines in clinical areas from pharmacy
1.11.1.
Member(s) of staff receiving sealed bags or boxes of medicines
from pharmacy or the pharmacy porter will be required to show a
KGH photo identity badge.
1.11.2.
All sealed units MUST be signed for, if being collected by a nonregistered member of healthcare staff the name of the appointed
practitioner for the clinical area MUST be provided.
MM0000 Medicines Code
Page 21 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
1.11.3.
A delivery note shall accompany each delivery of stock
medicines.
1.11.4.
Discrepancies shall be notified to the pharmacy department as
soon as possible.
1.11.5.
Medicines should be unpacked as soon as possible after delivery
and stored in the appropriate location, ensuring the stock is
rotated to use the shortest dated stock first.
1.11.6.
Staff in receipt of drugs requiring refrigeration must ensure that
they are placed immediately into the medicines fridge to maintain
the cold chain.
1.11.7.
For the receipt of controlled drugs refer to section 12.5.
MM0000 Medicines Code
Page 22 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2. STORAGE AND SECURITY OF MEDICINES
The safe and secure storage of medicines is a statutory requirement under the
Medicines Act, and requires a team approach to ensure this and reduce the risk of
misuse, tampering or diversion.
Medicines MUST always be locked away when not in use and responsibility for
this, and their safe and appropriate use, is the responsibility of the registered
practitioner in charge of a ward or department during each shift who holds the
medicines keys.
Stock medicines MUST be stored in their original container for easy identification,
at the correct storage temperature. Controlled Drugs are subject to additional
specific security requirements (refer to section on Controlled Drugs).
2.1.
Key Principles
ALWAYS…
 Ensure medicines are locked away when not in use for safety and security.
 Keep medicines in their original labelled container (for easier identification).
 Segregate different strengths of the same medicine to prevent misselection.
 Store medicines (including vaccines) at the correct temperature; check
fridge temperatures are in normal range 2-8°C daily; take action if out of
range.
 Reorder stock medicines (during day-time hours) before you run out.
 Lock away medicines as soon as these are received from Pharmacy or
patients.
 Use the oldest (short expiry date) stock first.
 Return medicines to Pharmacy that you will not use (only part-used,
damaged or expired items should be put in the pharmacy returns box).
 Ensure the treatment room door is kept closed and locked when not in use.
MM0000 Medicines Code
Page 23 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
 Store concentrated potassium solutions (e.g. strong potassium chloride
injection) in the Controlled Drug cupboard; dilute before administration.
NEVER…
 Leave medicines unattended in patient/public areas e.g. at nursing station,
or when the patient is absent, or incapable of managing their medicines.
 Throw away a patient’s own medicines unless these are no longer required.
 Put refrigerated stock in the Pharmacy returns box (leave these in the
fridge).
 Mix different packs of medicines together even if they look the same.
 Throw away external packaging or information leaflets, until finished.
 Keep excess stock (leads to increased wastage and risk of mis-selection).
 Remove labels from dispensed medicines.
 Supply stock or unlabelled (or incompletely labelled) medicines on
discharge.
WHERE POSSIBLE…
Use up one container or strip of medicines first, before starting another.
Store patient’s named medicines in their bedside locker for selfadministration.
Regularly check stock to ensure it is in date, and rotate older stock to the
front of the cupboard.
2.2.
Responsibilities
2.2.1.
The Chief Pharmacist, in consultation with appropriate medical
and senior nursing staff, is responsible for establishing and
maintaining a system for the secure storage of medicines in all
clinical areas at Kettering General Hospital NHS Foundation
Trust.
MM0000 Medicines Code
Page 24 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.2.2.
The appointed Nurse-in-Charge/Matron shall be accountable for
ensuring that the system is followed and that the security of
medicines on the ward is maintained.
2.2.3.
The accountability for the security of the medicines cupboard
keys, and all the medicines held on the ward, remains with the
Nurse–in-Charge/Matron even if he/she delegates this
responsibility.
2.2.4.
Responsibility for the security and safe use of medicines lies with
the registered practitioner in charge of a ward or department
during each shift.
2.2.5.
The registered practitioner in charge of a ward or department
must satisfy themselves that medicines are secured and used
appropriately during their shift.
2.2.6.
The appointed practitioner in charge of a ward or department, in
conjunction with the Pharmacy team are responsible for ensuring
stock levels and demand for medicines reflect normal clinical
practice.
2.2.7.
Excessive use of medicines must be investigated promptly; any
suspicion of tampering, misuse or diversion of medicines must be
reported to the Chief Pharmacist or their deputy immediately.
2.3.
Medicine Keys
2.3.1.
Ward and clinical areas will be issued with a maximum of 3 sets of
keys.
2.3.2.
Additional sets of keys over and above the standard can be
obtained by agreement of the Medicines Management Committee
upon demonstration of clinical need and risk management
processes to ensure medicine security.
2.3.3.
Medicine keys MUST be held by the registered practitioner
working on the ward or department for each shift.
2.3.4.
The registered practitioner in charge may only assign keys to
another registered practitioner for the purpose of supplying a
medicine to fulfil a prescription, or for stock management.
MM0000 Medicines Code
Page 25 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.3.5.
A system of signing for the keys at handover must be adhered to.
A log book must be maintained in the clinical area containing the
date, the time and the signature of the nurse accepting the keys.
2.3.6.
ALWAYS confirm staff identity and NEVER give keys to
unauthorised staff.
2.3.7.
Medicine keys MUST be kept separate from other ward or
personal keys.
2.3.8.
Controlled Drug keys MUST be kept separate from all other
medicine keys and only given to registered staff who are
authorised and have legitimate reason to access the CD
cupboard (see section on Controlled Drugs).
2.3.9.
Three sets of medicines keys may be held by ward or department
teams on duty.
2.3.9.1.
Spare keys will be retained securely within the Pharmacy
Department.
2.3.9.2.
Additional sets of keys over and above the standard can be
obtained by agreement of the Medicines Management
Committee upon demonstration of clinical need and risk
management processes to ensure medicine security.
2.3.10.
If keys cannot be found, it is the responsibility of the ‘nurse in
charge’ to make every effort to find them as soon as possible,
including contacting staff who have just gone off duty and
arranging returns of any keys they have inadvertently taken
home, as a matter of urgency.
2.3.11.
Ensure all stock is secured and access to the clinical room is
restricted.
2.3.12.
In the event the keys cannot be found, the nurse in charge must
contact the Pharmacy Department and seek authorisation from
the Chief Pharmacist (or nominated deputy) for a replacement key
and to consider the need to replace locks.
2.3.12.1. In out of hours situations contact the oncall pharmacist.
2.3.13.
All incidents involving lost keys should be reported on Datix.
2.3.14.
Loss of Controlled Drug Cupboard Keys should be managed as
described in section 12.11.
MM0000 Medicines Code
Page 26 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.4.
Storage Locations
2.4.1.
Medicines MUST always be locked away.
2.4.2.
Storage locations, racking, cupboards and security must meet the
requirements of BS 2881:1989 (security level 1) for medicines
and be approved by the Chief Pharmacist or their deputy.
2.4.3.
Medicine should be stored within a secure clinical room in general
wards and departments, the door MUST be closed and locked at
all times when not in use; ALL staff have a responsibility for
ensuring this.
2.4.4.
Internal Medicines (tablets, capsules, liquid medicines and
injections) MUST be stored separately from external medicines
(topical creams etc).
2.4.5.
Schedule 2 (and some schedule 3) Controlled Drugs MUST
always be locked in a separate Controlled Drug Cabinet (see
section 12 Controlled Drugs).
2.4.6.
Intravenous fluids and diluents for injection (including plastic
ampoules of water for injections and Sodium Chloride 0.9%w/v
injection) MUST be stored off of the floor and may be stored on
clean open racking or shelving within a locked clinical room.
2.4.7.
Reagents, disinfectants and antiseptic preparations should be
stored in a separate cupboard which meets of BS 2881:1989
(security level 1) specifications.
2.4.8.
Volatile substances including flammable liquids, gases and
aerosols must be stored in a separate locked cabinet that has
been certified for this use by a Fire Safety Officer.
2.4.9.
If drug trolleys are used for medicine administration rounds these
MUST be locked when not in use and stored in a locked clinical
room.
2.4.10.
Small bedside cabinets may be used to lock away patient’s own
medicines on wards (see section 8 on self-administration of
medicines).
MM0000 Medicines Code
Page 27 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.4.11.
Medicines for clinical emergencies (e.g. CPR boxes) should be
stored on the resuscitation trolley where they are readily
accessible. They are held in a tamper evident box (the seal
should be checked daily), and once used returned to Pharmacy
for immediate replacement. Outside of Pharmacy hours
replacement boxes/rolls can be found in the emergency drug
cupboards.
2.5.
Fluid warmers
2.5.1.
It is recognised practice for certain intravenous fluids to be
warmed to body temperature prior to administration in designated
fluid warming devices.
2.5.2.
Intravenous infusion bags (e.g. sodium chloride 0.9%, glucose
5%, Hartmann’s, Gelofusine®) may be stored in a fluid warmer for
up to 20 days (bag size 500mL and above) or 10 days (bag size
less than 500mL). The outer protective layer should not be
removed.
2.5.3.
Intravenous fluids must only be warmed in designated fluid
warming equipment.
2.5.4.
Once removed from the warmer, bags may be used within the
normal shelf life of the product, however they must not be
returned to the warmer.
2.5.5.
Infusion bags that have had medicines added to them must not be
warmed.
2.6.
Temperature Monitoring
2.6.1.
Where medicines are stored the temperature should not exceed
25°C.
2.6.2.
For all medicine storage areas, the ambient room temperature
should be recorded daily using a maximum/minimum thermometer
(these are available from Pharmacy Stores, with instructions for
use).
MM0000 Medicines Code
Page 28 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.6.3.
If in areas where medicines are stored the temperature exceeds
25°C, medicines issued as ward stock will have a reduced expiry
date in line with NHS Quality Control recommendations. These
will be: -
2.6.3.1. 12 months for storage in areas up to temperatures of 30°C
2.6.3.2. 6 months for storage in areas up to temperatures of 35°C.
2.6.4.
Where the temperature rises above 35°C for longer than 24
hours, contact Pharmacy Medicines Information for further advice.
2.7.
Refrigerated storage
2.7.1.
A locked, pharmaceutical grade refrigerator must be used for
medicines that require storage between 2-8 degrees centigrade,
with an integral digital temperature display and audible alarm for
high/low temperature.
2.7.2.
Food or specimens must NEVER be stored in the medicines
refrigerator.
2.7.3.
The temperature of medicines refrigerators MUST be checked
daily and recorded on the ‘temperature monitoring chart’.
2.7.4.
Where temperatures fall outside of the specified temperature
range the following actions MUST be taken:-
2.7.4.1. Contact Estates to check the integrity of the refrigerator.
2.7.4.2. Contact the Pharmacy Medicines Information to ensure that
medicines remain fit for use (in out of hours contact the oncall
pharmacist.)
2.7.5.
Refrigerators should be kept clean, tidy, frost-free and not overfilled. Particular care should be taken to ensure temperature labile
products such as vaccines are not frozen.
2.7.6.
Where a product has been stored incorrectly, do not use until
advice has been obtained from the Pharmacy Department to
ensure it remains fit for use.
MM0000 Medicines Code
Page 29 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.8.
Stock Maintenance
2.8.1.
Common medicines, as well as those required for urgent or
emergency treatment are stocked in wards and departments
throughout the hospital.
2.8.2.
Medicines MUST be retained in their original packaging to help
with positive identification; do not remove blister strips from outer
packaging.
2.8.3.
Different strengths of the same medicine MUST be separated to
reduce the risk of mis-selection. NEVER mix different packs of
medicines together, even if they look the same.
2.8.4.
The registered practitioner in charge of a ward or department is
responsible for the safe use and security of stock medicines
during a shift.
2.8.5.
Stock usage should be checked regularly during shifts and at
handover.
2.8.6.
Rotate stock to ensure the oldest stock is used first and only one
strip or pack is used at a time to facilitate recycling of unused
stock.
2.8.7.
Regular stock maintenance and top-ups are conducted by
pharmacy staff.
2.8.8.
Always reorder stock before you run out and in normal working
hours.
2.8.9.
Stock medicines received from Pharmacy MUST be signed for,
and locked away, as soon as possible, by a registered practitioner
on the ward or department. The registered practitioner takes
responsibility for the secure storage of medicines.
2.8.10.
Excessive stock usage or ad-hoc orders must be reported to the
registered practitioner in charge of the ward and department, and
senior pharmacy logistics manager, to investigate.
2.8.11.
Stock lists are reviewed annually by the appointed practitioner in
charge and the CBU lead pharmacist to ensure stock medicines
and demand reflect normal clinical practice.
MM0000 Medicines Code
Page 30 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.8.12.
Any changes in clinical practice must be notified to the
responsible pharmacist so that stock levels of relevant medicines
can be adjusted.
2.8.13.
Stock levels of Controlled Drugs and other potentially abusable
medicines are reviewed quarterly, and regular reports of
medicines use provided to the appointed practitioner in charge,
and the responsible pharmacist, to confirm that use reflects
legitimate clinical practice.
2.8.14.
Registered practitioners should satisfy themselves that stock is
only used for the purpose intended and should report any
suspicious behaviour or loss of medicines to the appointed
practitioner in charge and complete a datix incident report.
2.8.15.
Any suspicion of tampering, misuse or diversion of medicines
must be reported to the Chief Pharmacist or their deputy
immediately.
2.9.
Return of medicines
2.9.1.
Excessive medicines stock or medicines that are no longer
required should be returned to Pharmacy for recycling or safe
disposal (as below).
2.9.2.
Unwanted solid dose medicines (e.g. tablets and capsules)
should be returned in their original packaging, by placing these in
the green pharmacy bins within the locked clinical room.
2.9.3.
Refrigerated items for return, should be left within the locked
medicine fridge, but separated from stock that is in date and being
used. Pharmacy should be notified on the next working that items
require removal, using the pharmacy communication diary.
2.9.4.
Controlled Drugs for return MUST be left locked in the CD
cupboard. Refer to Section 12.17 on Controlled Drugs for secure
return to Pharmacy.
2.9.5.
Patients’ own medicines that are no longer required should be
disposed of with the patient’s permission (see section 7.3 on
Patients’ own medicines).
MM0000 Medicines Code
Page 31 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.10.
Disposal of medicines
2.10.1.
Some part-used or expired aqueous (water-based) medicines, in
normal clinical quantities, may be disposed of in wards and
departments.
2.10.2.
Small quantities (e.g. part-used ampoule or syringe) may be
placed in a clinical sharps bin.
2.10.3.
Larger quantities (e.g. part-used infusion bag) should be emptied
down the foul sewer with plenty of water.
2.10.4.
Controlled drugs must NOT be disposed of down the foul sewer,
refer to section 12.17Error! Reference source not found. on
Controlled Drugs for specific guidance for safe ward disposal.
2.10.5.
Medicines returned to Pharmacy for destruction will be disposed
of in accordance with current Trust waste management policy and
procedures.
2.11.
Ward and department closures
2.11.1.
The safe and secure storage of medicines must be maintained
even when wards or departments are closed, and remain the
responsibility of the appointed practitioner in charge.
2.11.2.
Where wards or departments are routinely closed for short
periods (e.g. weekends), medicines stock (including controlled
drugs) may be retained.
2.11.3.
The keys for all medicine cupboards MUST be stored securely in
a designated area within a locked key safe during periods of
routine closure.
2.11.4.
Where wards or departments are closed for longer periods
(greater than 2 weeks) then all medicines stock MUST be
returned to Pharmacy, by arrangement.
2.11.5.
Medicine keys will be retained by the appointed practitioner in
charge.
MM0000 Medicines Code
Page 32 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
2.12.
Audit, Assurance and Accountability
2.12.1.
The Appointed practitioner in charge of a ward or department
should satisfy themselves that medicines are stored securely and
used safely.
2.12.2.
Compliance with standards for medicines security (doors to
clinical rooms, medicine cupboards and medicine fridges are
locked when not in use) are reported monthly using the Trust
Ward Assurance tool. Note ALL medicine cupboards, medicine
fridges and the clinical room door must be locked to meet the
standard.
2.12.3.
Pharmacy undertakes a rolling audit of compliance against
standards, providing regular assurance reports to Medicines
Management, CBU Governance and Trust Governance
Committees.
2.12.4.
Where standards are not met, registered staff in charge of wards
and departments will be held to account by Professional Leads/
Managers within their Division.
2.12.5.
Where failure to secure medicines results in misuse or diversion,
staff involved may be subject to professional or Trust disciplinary
action. Where misuse or diversion involves Controlled Drugs, this
could result in criminal prosecution.
MM0000 Medicines Code
Page 33 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
3. MEDICINES RECONCILIATION
Medicines reconciliation (MR), as defined by the Institute for Healthcare
Improvement, is the process of identifying an accurate list of a person's current
medicines and comparing them with the current list in use, recognising any
discrepancies, and documenting any changes, The term 'medicines' also includes
over‑the‑counter or complementary medicines, and any discrepancies should be
resolved with all reasons documented within the medical notes.
It encompasses two elements, firstly obtaining an accurate medication history and
secondly reconciling the history with the in-patient prescription ensuring all
differences are intended:

Collection of the medication history from a variety of sources – This
involves taking a medication history and gathering relevant information
about the patient’s medicines.
The medication history should be collected from the most recent and
reliable sources, ideally this will be the patient’s summary care record.
Where possible, information should be cross-checked and verified. The
person recording the information should always record the date that the
information was obtained and the source of the information.

Checking that medicines prescribed on admission for the patient are
correct – This involves ensuring that the medicines, doses and
formulations that are prescribed for the patient are correct and that
discrepancies are identified and understood as intentional or unintentional.
Discrepancies need to be communicated and unintentional changes
addressed.
MM0000 Medicines Code
Page 34 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
3.1.
Medicines Reconciliation Checklist
This checklist may be used as a guide when taking and documenting
a patient’s medication history.
1. Any known allergies or drug intolerances and nature of the
reaction.
2. A complete list of all of the medicines currently being taken by the
patient.
3. Dose, frequency, formulation and route of all the medicines listed.
4.














5.
Specific medication you may want to ask about include:Inhalers
Eye drops
Topical Preparations
Once weekly medications
Injections
OTC medicines
Oral contraceptives
Hormone replacement therapy
Nebulisers
Home oxygen
Herbal remedies
Insulin, including the type of device
Any medicines delivered to the home
Any medicines which have recently started or been stopped
Additional information for specific drugs e.g. indication for warfarin
or corticosteroids, day of week of administration for once weekly
medication (bisphosphonates, methotrexate).
6. Medication management in own home e.g. Dosette® boxes, district
nurses, family support.
7. Source/s used to obtain full medicines reconciliation.
8. Name, signature and date of practitioner carrying out medicines
reconciliation.
3.2.
Medicines Reconciliation Process
3.2.1.
Medicines reconciliation should be carried out for all patients by
the admitting practitioner as part of the clerking process within 6
hours of admission.
3.2.2.
Documentation of medication history should always be made in
the patient medical record, noting sources used and dated and
signed by the admitting healthcare professional.
MM0000 Medicines Code
Page 35 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
3.2.3.
This information may be obtained from multiple sources including
the patient/carer, their labelled medicines (patient’s own drugs),
the GP admission letter, a repeat prescription slip, Medicines
Administration Records or following discussion with the GP
practice, or nursing/care home.
3.2.4.
Where possible two or more sources should be used to verify the
information, and MUST be used where the patient or their carers
have communication difficulties (e.g. language, cognitive
difficulties).
3.2.5.
A prescription chart (a list of medicines to be administered) should
be written for the patient by the admitting healthcare professional.
3.2.6.
Intentional medication changes should always be documented in
the patient’s medical record giving reasons for the change. These
can also be documented in the appropriate section of the
prescription chart.
3.2.7.
Unintentional discrepancies highlighted by other healthcare
professionals or the patient, should be appropriately prioritised
and resolved.
3.2.8.
A member of the Pharmacy team should be involved in MR as
soon as possible after the admission of an adult patient.
3.2.9.
The prescription chart should be signed and dated by the member
of the Pharmacy team to confirm completion of medication history;
this includes pharmacists, accredited pharmacy technicians and
accredited pre-registration pharmacists.
3.2.10.
Reconciliation of this medication history with the prescription chart
should ideally be completed by a pharmacist within 24 hours of
the patient’s admission and will be completed within 72 hours for
patients admitted at the weekend.
3.2.11.
If there are concerns about the reliability or accuracy of the
medication history, a member of the Pharmacy team should be
contacted to help resolve these.
3.2.12.
All medication changes and reasons for the changes should be
documented on the discharge or transfer letter.
MM0000 Medicines Code
Page 36 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4. PRESCRIBING
In this section “prescriber” means any practitioner legally authorised to prescribe
under the Medicines Act 1968 or subsequent amendments. Thus this policy
applies equally and fully to both medical and non-medical practitioner prescribing.
All KGH prescribers have a responsibility to ensure that a copy of their usual
signature is held in the Pharmacy Record of Prescribers’ Signatures.
KGH assures accuracy and appropriateness of prescribing via the various staffing
(prescribing, nursing, pharmacy) involved in the management of patients. The
clinical pharmacy services assess the accuracy of all prescribing documentation
through regular prescription review.
Assurance on prescribing accuracy is provided through regular audit (Appendix 1)
from the Pharmacy team.
4.1.
Who can Prescribe
There are two categories of prescribers within KGH. These are:
4.1.1.
Independent prescribers - professionals who are responsible for
the initial assessment of the patient and for devising the broad
treatment plan, with the authority to prescribe the medicines
required as part of that plan. This includes medical staff, dentists
and authorised nurse and pharmacist prescribers who have
successfully completed an independent prescribing course.
4.1.1.1. nurse and pharmacist independent prescribers are able to
prescribe any medicine for any medical condition within their
competence, including any controlled drug in Schedule 2, 3, 4
or 5 of the MDR 2002 Regulations, as amended.
MM0000 Medicines Code
Page 37 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.1.1.2. optometrist Independent Prescribers can prescribe any
licensed medicine for ocular conditions affecting the eye and
surrounding tissue, but cannot prescribe any controlled drugs.
4.1.1.3. physiotherapists and podiatrists or chiropodists can prescribe
any licensed medicine provided it falls within their individual
area of competence and respective scope of practice as
independent prescribers, but cannot prescribe any controlled
drugs.
4.1.2.
Supplementary prescribers - professionals who are authorised
to prescribe certain medicines for patients whose condition has
been diagnosed or assessed by an independent prescriber, which
in this situation must be a medical practitioner, within an agreed
clinical management plan (CMP). Professionals who can
undertake supplementary prescribing are nurses, pharmacists
and certain allied health professionals (chiropodists/podiatrists,
physiotherapists, optometrists and radiographers). Supplementary
and Independent prescribers must be registered as such with the
relevant regulatory body and any activity carried out by them must
have Trust approval and authorisation.
Where a nurse or a pharmacist is the supplementary prescriber, a
CMP may include any medicine prescribable at NHS expense,
this includes controlled drugs, unlicensed and off label medicines.
The use of a medicine off label must have the joint agreement of
both prescribers and the status of the medicines should be
recorded in the CMP.
Allied health professional supplementary prescribers are not
allowed to prescribe controlled drugs.
4.1.3.
The Trust considers the following as a guide to good practice for
non-medical prescribers:
MM0000 Medicines Code
Page 38 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.1.3.1.
Ensure you have notified your professional registration body
about your prescribing qualification.
4.1.3.2.
Ensure your job description includes a reference to nonmedical prescribing in your role.
4.1.3.3.
Adhere to the principles of good prescribing in the policy for
prescribing medicines.
4.1.3.4.
Use the appropriate approved stationary for prescribing. This
could be KGH internal prescribing forms and charts or FP10
(HNC) forms which patients may choose to have dispensed at
a community pharmacy or the hospital pharmacy.
4.1.3.5.
4.2.
Never prescribe for someone who is not one of your patients.
General Prescribing Principles
4.2.1.
The Trust does not support prescribers prescribing for themselves
(privately or otherwise) or for family/friends to which the prescriber
may have close personal contact
Ref: GMC Guidance for Doctors - Prescribing Guidance - Need and
Objectivity: http://www.gmc-uk.org/guidance/ethical_guidance/14318.asp
4.2.2.
Registered medical and non-medical prescribers are permitted to
prescribe within their scope of competence and current
legislation.
4.2.3.
The person who signs a prescription is responsible for its
accuracy and the appropriateness for the patient it is prescribed
for.
4.2.4.
Prescribers must make themselves familiar with the BNF and the
processes involved in writing a legally correct prescription. All
non-medical prescribers are required to follow the relevant NonMedical Prescribing Policy.
4.2.5.
Medicines must be prescribed on official Trust prescription
stationary.
MM0000 Medicines Code
Page 39 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.2.6.
Medicines should be prescribed only when they are necessary,
and in all cases the benefit of administering the medicine should
be considered in relation to the risk involved.
4.2.7.
Treatment options must be carefully discussed with the patient to
ensure that the patient is willing and able to take the medicine as
prescribed. In particular, the patient should be helped to
distinguish the possible adverse effects of prescribed drugs from
the likely outcomes of the untreated medical disorder.
4.2.8.
If the beneficial effects of the medicine are likely to be delayed,
the patient should be advised of this.
4.2.9.
Prescribers must listen to patients, take account of their views,
and respond honestly to any questions asked. Information must
be presented in a format that can be understood.
4.2.10.
Treatment and care should take into account a patient’s individual
needs and preferences.
4.2.11.
Good communication, supported by evidence-based information,
is essential.
4.2.12.
Healthcare professionals have a duty under the Disability
Discrimination Act (2005) to make adjustments to ensure that all
people have the same opportunity for good health.
4.2.13.
Healthcare professionals should follow the code of practice that
accompanies the Mental Capacity Act (2005) if concerned about
patient capacity.
4.3.
Range of Medicines to Prescribe
4.3.1.
Only medicines that have been approved for use by the New
Medicines Group in the Trust prescribing formulary,
Northamptonshire Prescribing Advisory Group, or within an
Individual Funding Request may be prescribed.
4.3.2.
KGH and Nene CCG will ensure that all prescribing clinicians are
aware of the Trust formulary and the Northamptonshire Medicines
Formulary and Traffic Light system.
MM0000 Medicines Code
Page 40 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.3.3.
The Traffic light system provides a framework for defining where
clinical and therefore prescribing responsibility should lie through
categorisation of individual drugs (http://nww.pathfinderrf.northants.nhs.uk/nene/therapeutics/traffic-light-drugs/).
4.3.4.
Medicines that are classified as 'red' on the Traffic Light list are
considered not suitable for prescribing in primary care and so
clinicians should not approach primary care prescribers to
prescribe these.
4.3.5.
This also applies to “double red” as these medicines are not
recommended for use in the Northamptonshire Health Community
because of lack of evidence of clinical effectiveness, cost
prioritisation or concerns over safety.
4.3.6.
“Amber” medicines are initiated in secondary care with the
potential to transfer to the GP, with their prior agreement, under a
shared care agreement. Care should only be transferred when all
of the approved shared care agreement requirements for that
medicine have been met. Documents associated with shared care
can be found http://nww.pathfinderrf.northants.nhs.uk/nene/therapeutics/traffic-light-drugs/
4.3.7.
If hospital clinicians wish to prescribe medicines that are not
currently included on the formulary or supported for specialist
prescribing by the New Medicines Group (NMG) they should
submit a request to the New Medicines Group (NMG) for
evaluation and possible inclusion in the formulary.
4.4.
Verbal Orders
4.4.1.
Verbal orders are not acceptable at KGH with the exception of
those drugs used in life threatening situations such as cardiac
arrest or where the prescriber is scrubbed for an aseptic
procedure (e.g. in theatre).
4.4.2.
Verbal orders are given to a registered nurse by a medical
practitioner when they are in the same room.
MM0000 Medicines Code
Page 41 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.4.3.
Verbal orders must be restricted to medicines commonly
prescribed on the ward/department and be used only in an
emergency situation.
4.4.4.
The person accepting a verbal order must repeat the name of the
patient and prescription back to the prescriber and get a second
person who is present to confirm the details of the verbal
instruction with the prescriber.
4.4.5.
The instruction is entered on to the “once only” section of the
prescription. It is identified as a verbal instruction and the name of
the doctor/bleep entered into the signatory box or added as a note
to the electronic prescription the identity of the person making the
entry should also be made apparent on the prescription chart.
4.4.6.
The medical practitioner must countersign any verbal instruction
within 12 hours and cannot delegate this to another individual.
4.4.7.
Controlled drugs must never be given or prescribed as a verbal
order.
4.4.8.
A Pharmacist may receive verbal authority from the original
prescriber to alter or rectify a prescription item for example,
following an intervention. If using paper charts all alterations must
be endorsed “PC” and the name of the prescriber stated and the
prescription should be signed and dated by the Pharmacist. The
Pharmacist must read the alteration or addition back to the
prescriber who must then confirm it.
4.5.
Inpatient Prescribing
4.5.1.
The inpatient prescribing documentation
4.5.1.1.
The standard prescribing documentation must be used for all
inpatients across the Trust unless there is an authorised
alternative in use, such as the surgical short stay chart.
4.5.1.2.
Authorised alternatives are only valid for use in the clinical
area specified on the document. When patients are
transferred to another clinical area with an authorised
alternative in use (e.g. ward to intensive care), prescriptions
MM0000 Medicines Code
Page 42 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
must be rewritten onto the prescribing documentation in use
for that particular clinical area.
4.5.1.3.
The registered prescriber must complete all the required
details, sign and date for the prescription to be valid. The
prescriber should make every effort to check other records
before adding new medicines (eg A&E ‘cas card’) to prevent
inadvertent overdose.
4.5.1.4.
Where additional specialised documents are used to support
the prescribing of specific drugs (e.g. aminophylline, insulin or
warfarin) these should be referred to on the inpatient
prescription chart.
4.5.2.
General Instructions for prescribers who must
4.5.2.1.
Write in Black indelible ink if prescribing on paper
prescriptions.
4.5.2.2.
Complete all patient identifiable information, to include name,
address, date of birth, hospital and NHS numbers. (Preprinted labels are encouraged).
4.5.2.3.
Document patient’s current drug history in the patient’s
casenotes.
4.5.2.4.
Document known drug hypersensitivities in the section
allocated for Drug Allergy/Sensitivities.
4.5.2.5.
Document the weight (in kilograms) of the patient on the
prescription.
4.5.2.6.
Inform the registered nurse-in-charge whenever new
prescriptions are written, in order that supplies can be
obtained at appropriate times.
4.5.2.7.
Specify the indication for any antimicrobial prescribed.
4.5.2.8.
Specify course length/ finish date on the prescription where
required.
4.5.2.9.
Sign and date all prescriptions
THE PRESCRIBER MUST SIGN THE PRESCRIPTION
LEGIBLY i.e. it should be recognisable to pharmacy staff and
the health professional responsible for administering the
MM0000 Medicines Code
Page 43 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
medicine to the patient. The prescriber should print his/her
name and bleep number at least once on the prescription, to
facilitate ease of contact if a query arises.
4.6.
Allergies or Sensitivities
4.6.1.
All prescribers are responsible for entering/checking any known
allergy information, including complementary/alternative
medicines and latex, in the allergy section of the prescription
before prescribing any medications on the prescription chart.
4.6.2.
This information must be transferred to subsequent prescription
charts.
4.6.3.
It is not acceptable to leave the allergy box blank. State “None
Known” or “NKA” or “NKDA” if there is no known (drug) allergy
4.6.4.
Where the patient has identified an allergy, the nature of this
allergy must be ascertained and documented in the allergy box.
i.e. Penicillin – anaphylaxis.
4.6.5.
Whether an allergy has been identified or not, the allergy box
must be initialled and dated by the prescriber. The information
must also be clearly stated in the patient’s notes.
4.6.6.
Registered nurses, midwives, pharmacists and pharmacy
technicians are authorised to complete the allergy box of a
prescription chart but should state qualifications after their
signature. This is not just the responsibility of medical staff.
4.6.7.
All staff MUST always clarify the allergy status of the patient
before dispensing or administering a medicine. The registered
prescriber must enter all known allergies/sensitivities in the
relevant section of the prescribing documentation before
prescribing any medicines.
MM0000 Medicines Code
Page 44 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.7.
Prescribing for All Medicines
4.7.1.
Name and form of medication
4.7.1.1.
The name of the medicine must be written in block capitals.
Abbreviations (e.g. ISMN) and chemical formulae (e.g.
FeSO4) are not acceptable. Approved names must be used.
This will normally be the generic name except for:
4.7.1.2.
a compound preparation, e.g. Seretide.
4.7.1.3.
a preparation with specific pharmacokinetic properties, e.g. a
specific slow release preparation where the BNF states that
prescribing should be by brand.
4.7.1.4.
Solid dose oral forms of medication will be given unless
another form or route is indicated. For liquids and topical
preparations the strength and form must be stated, wherever
possible.
4.7.2.
Dose of Medicine
4.7.2.1.
The dose must be expressed in metric units avoiding decimal
places.
4.7.2.2.
Do not use decimal points that are unnecessary e.g. 3mg not
3.0mg.
4.7.2.3.
Where use of a decimal point is unavoidable a zero should be
written in front of the decimal point where there is no other
figure e.g. 0.5ml not .5ml.
4.7.2.4.
The word “micrograms” and “nanograms” must be written in
full and not abbreviated to mcg or μg or ng to avoid confusion
with milligrams (mg).
4.7.2.5.
“g” is a permitted abbreviation for gram.
4.7.2.6.
“mg “ is a permitted abbreviation for milligram.
4.7.2.7.
Only standard liquid preparations that cannot be expressed
by concentration e.g. 5mg in 5ml, should be prescribed as
volume alone e.g. lactulose. Other preparations must be
prescribed by weight or units e.g. amoxicillin syrup 500mg or
colecalciferol 1000units.
MM0000 Medicines Code
Page 45 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.7.2.8.
The word unit must be written in full rather than abbreviated to
“U” or “IU”.
4.7.2.9.
The blood unit symbol ‫ ּס‬must not be used as an abbreviation
for prescribing units of medicines as it can frequently be
confused with a “0” (zero) and may lead to 10 times the dose
of insulin or heparin being administered in error.
4.7.2.10. Roman numerals or other symbols, for example ”ii” are also
the cause of medication errors and must not be used. If there
is no obvious or practical tablet/capsule strength e.g. senna,
the number of tablets to be administered should be expressed
in numbers e.g. “2” tabs not “ii”.
4.7.3.
Route of Administration
4.7.3.1.
The route must be specified. The following abbreviations are
permitted:
IV
Intravenous
PR
Per Rectum
IM
Intramuscular
PV
Per Vagina
INH
Inhalation
ID
Intradermal
SC
Subcutaneous
ORAL, O or
By Mouth
PO
SL
Sublingual
TOP
Topical
NG
Nasogastric
NJ
Nasojejunal tube
PEG
Percutaneous
PEJ
Percutaneous
NEB
4.7.3.2.
endoscopic
endoscopic
gastrostomy
jejunostomy
tube
tube
Nedbulised
Buccal
Buccal
Other instructions must be written in full to avoid confusion
e.g. intrathecal preparations used for the eye, ear and nose
indications must state in full the intended site of application
i.e. “Right Eye”.
MM0000 Medicines Code
Page 46 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.7.3.3.
The practice of writing more than one route of administration,
for example “O/IM” in the same box should be avoided and
separate prescriptions should be written out for each route
stating either/or. This is because there are a number of
medicines that have very different pharmacokinetic profiles
and hence doses and routes are not always safely
interchangeably and can lead to over or under dosing. In
addition there is the risk that both routes may be used
simultaneously. The registered prescriber must specify the
time of medicine administration.
4.7.4.
Times of Administration.
4.7.4.1.
The Prescriber must specify the time at which the medicines
is to be administered.
4.7.4.2.
If the medicine is to be administered at non-standard times or
is a once only dose the prescriber should communicate this to
the registered nurse-in charge for the shift.
4.7.5.
Duration of Treatment
4.7.5.1.
Where a defined course is required the length of course must
be indicated at the time of prescribing.
4.7.5.2.
Prescriptions for antibiotics should normally be written for a
limited period with an automatic stop on the prescription made
5 days after initiation of therapy. (please refer to the Trust
Antimicrobial Policy).
4.8.
Prescribing for Intravenous Medicines
4.8.1.
Intravenous fluids must be prescribed on the IV fluid chart or
appropriate section of the prescription. The prescription must
state the name, strength and volume of the fluid, any additives
required, the duration or rate of administration and should be
signed by the prescriber. All additions to fluids other than
electrolytes must also be prescribed on the prescription chart.
MM0000 Medicines Code
Page 47 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
4.8.2.
Medicines to be given intravenously as discrete bolus injections
must be prescribed on the standard prescription chart following
the requirements in Section 4.8.
4.8.3.
Medicines to be given by intravenous infusion or as additives to
intravenous fluids must be prescribed on the appropriate section
of the prescription chart stating in addition in the ‘medicine’ box,
the infusion fluid, volume and duration of administration.
4.8.4.
Where specialist prescription forms are used, e.g. gentamicin,
reference should be made to this in the main inpatient prescription
chart.
MM0000 Medicines Code
Page 48 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
5. PREPARATION OF MEDICINES
The preparation and administration of medicines is a high risk activity and prone
to error. Over 60% of errors reported to the National Patient Safety Agency occur
during preparation and administration. Kettering General Hospital promotes the
principles outlined by the National Patient Safety Agency 2007 Promoting safer
use of injectable medicines, with the aim of reducing the risk to patients, and
enhancing patient safety.
If in doubt, do not proceed; check with another member of the medical, nursing or
Pharmacy team.
Where possible and practicable practitioners should use the online injectable
medicines guide MEDUSA resource as the primary source of injectable medicines
information.
The Trust Pharmacy Department, current BNF, UCL Injectable Drug
Administration Guide, Electronic Database (where available) and medicine
information leaflet may also be used to provide this information.
5.1.
Responsibilities
5.1.1.
The practitioner in charge of the clinical area is responsible for
ensuring that standards for medicines preparation fall within the
requirements of this code.
5.1.2.
The suitably qualified health professional carrying out the
medicine preparation should understand the prescription and
should have knowledge of the common indications, side-effects
and dosages of the medicine prescribed.
5.1.3.
They should also be aware if there are any risks in handling or
administration of the medicine and whether any specific
equipment is required. Local procedures for handling high
risk/hazardous material should be referred to where appropriate.
MM0000 Medicines Code
Page 49 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
5.1.4.
It is the practitioner’s responsibility to ensure that information
sources used are current. If hard copies of information contained
on the electronic database are stored in files these should be up
to date and include published references.
5.1.5.
The Healthcare professional administering the medication will be
accountable for his/her practice in accordance with their
professional code of conduct and standards for administration of
medicines.
5.2.
Key Principles
5.2.1.
A Designated registered practitioner MUST prepare, check and
administer medicines to patients.
5.2.2.
Students (nurses, midwives and medical students) or other
professionals in training who are not yet registered must be under
the direct supervision of a registered practitioner who is then
responsible for the preparation, administration and
documentation.
5.2.3.
Advice MUST be sought by a practitioner if they are unsure about
any aspect of medicine preparation.
5.2.4.
Always check that medicines containers, outer wrappers and
seals are intact, and show no signs of damage or tampering,
before use.
5.2.5.
It is essential to ensure that the medicine to be administered is
compatible and stable within the diluent or intravenous fluid being
used.
5.2.6.
IV syringes must NOT be used to measure or administer oral
medicines.
5.2.7.
IV syringes must NOT be used to measure insulin doses.
5.2.8.
Medicines Must Never be added to:

Blood

Plasma

Blood products
MM0000 Medicines Code
Page 50 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
5.3.

Total Parental Nutrition (TPN)

Mannitol

Sodium Bicarbonate

Gelofusin
General Principles
5.3.1.
Only medicines that have been supplied by the Trust Pharmacy
service or patient’s own medicines that have been approved for
use should be administered to patients.
5.3.2.
Medicines MUST only be prepared, checked and administered to
a patient by a designated registered Practitioner. This includes:
5.3.2.1.
A practitioner in training, but only when under the direct
supervision of a Designated Practitioner who remains
responsible for ensuring that the correct procedure takes
place.
5.3.2.2.
It is acceptable to continue an already established infusion,
which has been instigated by another practitioner following
the principles, within this document, or medication prepared
within a pharmacy aseptic unit and clearly labelled for that
patient.
5.3.3.
Prescribed medicines should be administered within 60 minutes
either side of the prescribed time.
5.3.4.
Clinically urgent medicines (such as intravenous antibiotics)
should be prepared and administered within 30 minutes of the
prescribed time.
5.3.5.
Where urgently required medicines are not stocked in the
pharmacy, the prescriber should discuss the prescription directly
with a member of the Pharmacy team to confirm the prescription
and supply arrangements.
5.3.6.
All medicines must be labelled. Where a medicine is prepared in a
clinical area the prepared dose must also be labelled.
MM0000 Medicines Code
Page 51 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
5.4.
Ward Preparation
5.4.1.
Wherever possible medicines should be supplied from Pharmacy
in a ‘ready to administer form’, requiring no further manipulation,
calculation or dilution, prior to administration.
5.4.2.
In most cases, where more than three dosage units (i.e. three
tablets, ampoules, and vials) have to be administered as one
dose, this should be checked using the current BNF, and /or
confirmation should be sought from a Pharmacist. (This is not
always required where low strength dose units are commonly
used e.g. warfarin 1mg or prednisolone 5mg tablets.)
5.4.3.
Where medicine preparation is performed outside of the
Pharmacy Department, the following points must be observed:
5.4.3.1.
Read the prescription carefully. Determine the medicine
name, dose, diluent, route for administration and expiry date.
5.4.3.2.
If a dosage calculation is required, this information should be
included as part of the prescription either by the Prescriber or
the Pharmacist, or within an approved protocol/standard
operating procedure, so that the practitioner administering the
dose is clear about the actual amount to administer.
5.4.3.3.
Where a dose calculation is involved or where the medicine is
intended for intravenous administration, a second registered
practitioner MUST check the medicine preparation (and
administration see section 6.2
5.4.3.4.
If the Designated practitioner is unclear as to the correct
diluent or precise method for preparation, they MUST obtain
this information using an appropriate reference source or
discuss with a member of the Pharmacy team.
5.4.3.5.
An appropriate area should be identified where intravenous
medicines are to be prepared; where possible this area
should be separated from direct patient areas and enclosed
(all doors and windows should be closed). These precautions
reduce the risk of microbial contamination and interruptions,
which can lead to medication errors.
MM0000 Medicines Code
Page 52 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
5.4.4.
Intravenous medicines MUST be prepared using Aseptic NoTouch Technique (ANTT) in accordance with Trust policy and
procedures.
5.4.4.1.
ALWAYS CHECK that medicinal products are suitable for
use, have been stored correctly and show no evidence of
damage BEFORE use:
5.4.4.2.
Check packaging and seals have not been damaged and
show no sign of tampering. If in doubt, do NOT use and return
to pharmacy immediately.
5.4.4.3.
Check the product label is clear, within expiry date, and the
container and contents show no signs of decomposition (e.g.
colour change/precipitate in liquid injections).
5.4.4.4.
Check that any flexible plastic containers (e.g. infusions and
plastic ampoules) are not leaking by squeezing them. If
leaking, they must NOT be used and MUST be returned to
pharmacy immediately.
5.4.5.
All medicines MUST be labelled to identify the medicine, and
where appropriate the strength and total dose. Where medicines
are prepared outside Pharmacy:
5.4.5.1.
In critical care areas the Royal College of Anaesthetists
(RCOA) critical care labelling system is used to differentiate
products.
5.4.5.2.
In other areas, pre-printed syringe labels or blank labels for
infusions MUST be completed and applied during preparation
to differentiate products and prevent medication errors.
5.4.5.3.
The only exception to this is where a medicine is drawn up
and immediately administered to a patient by the same
member of staff, without putting down the product.
5.4.6.
Medicines prepared outside of pharmacy are for immediate use
and administration should commence as soon as practicable after
preparation has been completed, this should not exceed 60
minutes in advance of the anticipated time of requirement.
MM0000 Medicines Code
Page 53 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
5.5.
Use of oral syringes
5.5.1.
IV syringes MUST NOT be used to measure or administer oral
liquid medicines by mouth or enteral feeding tube.
5.5.2.
A medicine cup or 5ml spoon should be used to measure and
administer oral liquid medication except in the following situations
where a PURPLE oral/enteral syringe should be used:

The dose cannot be accurately measured using a 5ml spoon.

Administration via an enteral feeding tube.

Administration from a medicine cup or spoon is unsuitable e.g.
babies and young children.
5.5.3.
‘Press-in bungs’ are available for liquid medicine bottles to allow
easy removal of the dose using a PURPLE oral syringe.
5.5.4.
Once an oral syringe has been used to administer medication
directly to a patient or via an enteral feeding tube, it must NOT be
used to withdraw further doses of that or any other medication
from an original container, to reduce risk of cross-contamination.
5.5.5.
Used oral syringes that are contaminated with medicines must be
disposed of immediately, in a clinical sharps bin in accordance
with Trust waste disposal policy.
5.6.
Insulin syringes
5.6.1.
Patient doses of insulin must NEVER be measured using an
Intravenous syringe, which can lead to medication errors.
5.6.2.
Bespoke insulin syringes or insulin ‘pen’ devices MUST always be
used to measure insulin doses.
5.6.3.
Where appropriate diabetic patients should be encouraged to
manage and self-administer their own insulin, as part of the Trust
self-administration policy (see section 8).
5.6.4.
Insulin products MUST always be locked away in the patient’s
bedside locker and stock vials in a locked refrigerator.
MM0000 Medicines Code
Page 54 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
6. CHECKING OF MEDICINES
Checking is essential at all stages of the medicines use process. This involves
scrutiny and reconciliation of available information, to verify that the intended
medicine is prescribed, prepared and administered correctly.
The multi-professional hospital environment lends itself to second checking, which
is recommended for all medicines and considered essential for complex
medicines (including intravenous preparations and all medicines for children), to
safeguard patient care.
Assumptions must NOT be made; factual information MUST be used and all
checks made on an individual patient basis.
6.1.
Key Principles
6.1.1.
Practitioners MUST check any medicine activity that they
undertake.
6.1.2.
An accurate medication history MUST be recorded in the health
record.
6.1.3.
A second independent check MUST be made before the
administration of high risk medicines or medicines for children.
6.1.4.
‘Clinical’ checks MUST be carried out by competent registered
staff.
6.1.5.
Checkers MUST alert a designated practitioner if they are
concerned about correct identification, preparation or
administration of a medicine.
6.1.6.
Two sources MUST be used to reconcile medicines where
patients or their carers have communication difficulties.
6.1.7.
Appropriate checks are made for preparation and administration
of high risk medicines (e.g. IV medicines, cytotoxic chemotherapy
etc.)
MM0000 Medicines Code
Page 55 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
6.2.
General Procedures
6.2.1.
Checks should be carried out by a registered practitioner
undertaking any medicine activity, who is professionally
responsible for their own actions.
6.2.2.
It is considered best practice that a second independent check
occurs for all preparation and administration of all medicines.
Second independent checks MUST be undertaken for:
6.2.2.1.
Controlled drugs (Schedule 2)
6.2.2.2.
Paediatric medicines
6.2.2.3.
Intravenous medicines
6.2.2.4.
Cytotoxic chemotherapy
6.2.2.5.
Complex calculations for preparation or administration
6.2.2.6.
Epidural and intrathecal medications
6.2.3.
Checking should be undertaken in an unhurried manner, and
wherever possible in a calm environment, without interruptions.
6.2.4.
Checking involves careful triangulation of information from the
prescription, the product to be administered, with positive patient
identification, and should be carried out at the patient bedside
wherever possible.
6.2.5.
A systematic process should be adopted to allow independent
checking, avoiding use of verbal cues or prompts. The second
checker should independently check the prescription, product and
patient identification.
6.2.6.
Second checking may be conducted at two levels:
6.2.6.1.
A basic identification check, confirming the medicine, dose
and directions against those prescribed, and confirming
patient identify. This is the usual check performed, and
patients/carers, where appropriate, may participate in this
type of check.
6.2.6.2.
A ‘clinical’ second check confirming that the medicine, dose
and route are clinically appropriate for the patient, as well as
correctly identified. A ‘clinical’ second check can only be
carried out by another competent registered health
MM0000 Medicines Code
Page 56 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
professional. This is suitable for high risk medicines with a
wide dose range e.g. insulin, anticoagulants, opioid
analgesics.
6.2.6.3.
At Kettering General Hospital, second checks for preparation
and administration of all Intravenous medicines, Controlled
Drugs (Schedule 2), Paediatric or Cytotoxic drugs MUST be
completed by another competent registered health
professional.
6.2.7.
In all cases the registered practitioner who initiated the
prescription, preparation or administration of the medicine
remains professionally responsible and accountable for the
activity.
6.2.8.
Where a checker has concerns about the prescription, product or
patient identification they must STOP the medicine activity until
clarification can be sought; where necessary this should be
escalated to a more senior member of staff.
6.3.
Prescription Validation and Optimisation
6.3.1.
Prescription validation and optimisation involves medicines review
to ensure that all prescribed medicines are safe, clinically
appropriate for the patient and cost-effective, and that medicines
are available in a form and at the time they are needed.
6.3.2.
Medicines documented on admission should be compared with
those prescribed on the prescription chart, and any deviations
investigated to ensure these are clinically appropriate; reasons for
change should be documented in the health record.
6.3.3.
Pharmacists will routinely perform a clinical pharmacy validation
of new prescriptions to ensure these are clinically appropriate for
the patient, and will initial and date the prescription to
demonstrate this.
6.3.4.
Special emphasis will be placed on validating complex, high risk
and potentially toxic medicines that require higher levels of
MM0000 Medicines Code
Page 57 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
monitoring; continuing medicine treatment will be reviewed as
necessary.
6.3.5.
Recommendations to change prescribed medicines (medicine,
dose, route, frequency) will be documented on the prescription
chart or in the health record in addition to verbal communication
with the prescriber.
6.3.6.
Pharmacy staff will annotate prescriptions for clarity, and that
patient’s medicines are appropriate for use or have been ordered.
6.3.7.
Minor modification of a prescription to ensure that this can be
administered safely (e.g. appropriate form, route) will be
documented on the prescription chart, in accordance with the
pharmacy enabling policy..
6.3.8.
Prescriptions for high risk medicines should not be administered
until validated by a pharmacist e.g. cytotoxic chemotherapy,
including low dose methotrexate used in non-cancer indications
e.g. Rheumatology.
6.3.9.
Where medicines are given as a once weekly dose (such as low
dose methotrexate), this MUST be clearly specified in the special
directions box, on the medicine label, and in the administration
record, where the administration boxes MUST be crossed out
between doses that are due.
MM0000 Medicines Code
Page 58 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
7. ADMINISTRATION OF MEDICINES
The practitioner in charge of the clinical area is responsible for ensuring that
standards for medicines administration fall within the requirements of this code.
The suitably qualified health professional carrying out the medicine administration
check should understand the prescription and should have knowledge of the
common indications, side-effects and dosages of the medicine prescribed. They
should also be aware if there are any risks in handling or administration of the
medicine and whether any specific equipment is required. Local procedures for
handling high risk/hazardous material should be referred to where appropriate.
The Healthcare professional administering the medication will be accountable for
his/her practice in accordance with their professional code of conduct and standards
for administration of medicines and should hold a certificate of competency from
KGH in relation to the preparation and administration of parenteral therapies.
7.1.
Key Principles
ALWAYS…
 Ensure that written prescriptions are unambiguous, legible and complete (if in
doubt do not proceed until you have confirmed the prescription).
 Check medicines prior to administration to ensure they are correct, are
administered to the right patient and at the right time. Avoid delays.
 Witness administration of medicines where patients lack mental capacity.
 Wear ‘do not disturb’ tabard when undertaking medicines administration round.
 Confirm the identity of the patient prior to administration of a medicine.
 Check the patient does not have any documented allergy to the medicine.
 Check that medicines are in date and have been stored correctly.
 Ensure that medicines contained in a patient’s bedside medicines locker are
correctly labelled, and only used for the current ‘named’ patient.
 Document the administration of a medicine on the prescription chart.
MM0000 Medicines Code
Page 59 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
 Document the reason a medicine is omitted in the health record and take action
to obtain the medicine and/or escalate to a prescriber or pharmacist.
NEVER…


Administer medicines that you are unfamiliar with (ALWAYS check first).
Administer medicines that have NOT been authorised by a prescriber as a
written patient specific prescription, or under a Patient Group Direction.


Administer medicines on a verbal order (except in a medical emergency).
Omit medicines unless you are authorised to do so by a prescriber or pharmacist
(always document the reason clearly in the health record).



Administer medicines labelled for a named patient to another patient.
Sign for administering medicines prior to the patient taking the medicine.
Administer unlabelled IV medicines (unless you have just drawn these up).
WHERE POSSIBLE…
 Administer urgent medicines (e.g. IV antibiotics) as soon as possible.
 Involve patients in self-administering their own medicines. Regularly reassess
them during their stay and support them to take their medicines safely.
 Avoid disturbing staff when administering medicines.
 Provide, or ask a member of the ward pharmacy team to provide, further
information to the patient about their medicines or common side-effects.
7.2.
When administering medicines the following steps should be
followed
7.2.1.
Check the patient name and unique identifying number on the
prescription chart matches the patient’s wristband.
7.2.2.
Check administration is required and has not been previously
completed for this administration.
7.2.3.
Check the patient does not have a known allergy or contraindications
to the medicine.
MM0000 Medicines Code
Page 60 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
7.2.4.
Check you have the right drug, right dose, right time and right
indication.
7.2.4.1.
Look up any unfamiliar medicines in the BNF and ensure you
know the reason for giving the medicine, its usual dose and any
likely side-effects. If you are in doubt as to the suitability check
with the prescriber.
7.2.4.2.
Check the route is prescribed and correct.
7.2.4.3.
Check what is required - tablet/liquid/injection/inhaler.
7.2.4.4.
Check the strength of the medicine for administration matches
that prescribed.
7.2.4.5.
If the medicine has required preparation, check that it has been
prepared according to the SPC.
7.2.4.6.
7.2.5.
Check the expiry date of the medicine has not passed.
Documenting medicines administration
7.2.5.1.
The practitioner must sign or initial the appropriate box on the
prescription.
7.2.5.2.
Where a second checker has been required they must also sign
the prescription.
7.2.5.3.
Where additional information is required such as batch numbers
these must also be recorded on the prescription sheet.
7.3.
Patients’ Own Medicines
7.3.1.
Wherever possible patients’ own medicines, including Controlled
Drugs, should be used during their stay in hospital, to facilitate
continuity of care, self-administration (where appropriate) and to
reduce waste.
7.3.2.
A patient’s medicines that have been prescribed should be stored in
the patient’s locked medicines cabinet on the ward, along with other
named patient medicines supplied from Pharmacy for the same
patient.
MM0000 Medicines Code
Page 61 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
7.3.2.1.
Always ensure a patient’s medicines are transferred with the
patient and the bedside medicine cabinet is empty, before
putting in another patient’s medicines.
7.3.3.
Before a patient’s own medicines can be used in the hospital they
should be checked to ensure that they are clearly labelled and of
sufficient quality to be safely administered.
7.3.4.
Where labelled, medicines should include the following information:
7.3.4.1.
The name of the patient.
7.3.4.2.
Name and strength of the medicine.
7.3.4.3.
Method and frequency of administration.
7.3.4.4.
Date dispensed.
7.3.4.5.
Name and address of supplier.
7.3.5.
Where a brand name is used on the label, a member of Pharmacy
staff should annotate this against the approved name on the
prescription chart.
7.3.6.
The directions on the label MUST match those on the prescription
sheet (‘as directed’ is acceptable). If necessary these may be
relabelled by Pharmacy.
7.3.7.
If the medicine has no label, it must NOT be used unless it is clearly
identifiable and is within its expiry date (in practice usually within a
‘blister strip’); such medicines should be relabelled by the Pharmacy
before use.
7.3.8.
Overall appearance of bottle, label and medicine MUST be
acceptable; the container MUST be intact and clean, and the
medicine must NOT show any visible sign of deterioration, and be of
uniform appearance.
7.3.9.
Confirmation that the medicines have been stored correctly should
be checked before use.
7.3.10.
Sealed compliance aids (blister packs) may be used if they are
clearly labelled (or accompanied by a completed medicines
administration record (MAR) sheet). Before use, staff should satisfy
themselves that:
MM0000 Medicines Code
Page 62 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
7.3.10.1. All the medicines are prescribed. Where medicines have been
stopped or changed the sealed compliance aid must NOT be
used, and the medicines redispensed by Pharmacy.
7.3.10.2. Includes the patient’s name, date of birth (or alternative ID),
details of the medicine and strength, and name and address of
the pharmacy supplier.
7.3.10.3. The medicines appear to be in good condition, with no signs of
degradation.
7.3.11.
Compliance aids that are not sealed (i.e. have a removable lid
covering medicine compartments) and that can be filled by relatives
and carers must NOT be used.
7.3.12.
Where a compliance aid is required to assist a patient to take their
medicines this must be assessed by the ward pharmacy team and at
least 24 hours’ notice provided before discharge.
7.3.13.
Patients’ own medicines that do not meet these requirements, or are
no longer required, should usually be destroyed with the patient’s
permission.
7.3.13.1. Routine analgesics and other general sales medicines that are
not required in hospital e.g. paracetamol may be sent home with
the patient’s relatives, but patient’s prescription only medicines
that have been discontinued should be returned to Pharmacy for
destruction.
7.4.
Delay or Omission of Medicines
7.4.1.
All drugs should be given as soon as possible after administration
time. Due to risk of serious patient harm, prescribing, administration
and dispensing of critical medicines must never be unintentionally
omitted or delayed.
7.4.1.1.
Critical medicines include those used for resuscitation,
anaphylaxis, antidotes for reversal of drug toxicity (e.g.
naloxone), systemic therapy for prophylaxis or treatment (e.g.
antimicrobials, anticoagulants), and therapy for long-term
MM0000 Medicines Code
Page 63 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
conditions (e.g. insulin, anticonvulsants) or symptom
management (e.g. strong analgesia).
7.4.2.
Delay is defined as failure to administer a medicine within 60
minutes of the specified time. Critical medicines MUST be
administered within 30 minutes of prescribed time.
7.4.3.
Omission is defined as failure to prescribe a critical medicine in a
timely manner, failure to administer a dose before the next dose is
due, or failure to administer ‘once only’ medication, within 2 hours of
the prescribed time.
7.4.4.
Unintentional omission or delay of any critical medicines should be
reported as a medication error and recorded on DATIX.
7.4.5.
Prescribers MUST inform nursing staff when a ‘stat’ dose medicine
has been prescribed.
7.4.6.
For non-standard treatments, the prescriber should inform the
pharmacist to ensure the medicine is appropriate, available and can
be supplied in a timely manner.
7.4.7.
Nursing staff MUST communicate any medication delays/omissions
during patient handover/transfers of care. If a dose cannot be given
due to an unclear/illegible prescription, the prescriber should be
contacted to re-write the prescription/clarify instructions for
administration.
7.4.8.
Medical, nursing and pharmacy staff should routinely review the
administration section of the prescription chart as part of their daily
activities and query any omitted doses so these can be followed up
and appropriate action taken.
7.4.9.
If a medicine is not available on the ward ensure it is ordered from
Pharmacy as soon as possible.
7.4.10.
If Pharmacy is not open, refer to the medicines management website
to identify areas in the hospital that hold stock of the required
medicine. Should the medicine still not be available contact the
oncall pharmacist for advice and inform the relevant doctor to
ascertain whether any other action is required.
MM0000 Medicines Code
Page 64 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
7.4.11.
For patients who have swallowing difficulties the prescription must
be reviewed by a prescriber to identify alternative routes or
medications, additional information can be found in the Nil by
mouth and peri-operative medicines use guideline (MMG13).
7.5.
Omission codes
7.5.1.
If a medicine cannot be administered to the patient as prescribed,
the registered nurse responsible for administration must record the
time, the appropriate omission code and their initials on the
administration record of the prescription chart.
7.5.2.
An omission code should only be used ONCE per medicine by a
nurse and appropriate action taken. When a prescribed medicine
has not been given for two or more doses or when any dose of a
critical medicine has been omitted or significantly delayed, this
should be followed up. If necessary, the prescriber or pharmacist
must be advised and asked for further instructions.
7.5.3.
A record of action(s) undertaken for dose omissions must be
documented in the appropriate section of the patient’s inpatient
treatment chart.
7.5.4.
Where a prescribers wishes to withhold a medication(s) they should
mark a ‘X’ in the administration box for each dose they want to
withhold and document the reason for omission in the notes so
nursing staff have clear written instructions regarding any deviations
to prescribed doses.
7.5.5.
Omission codes used in Kettering General Hospital are shown in the
table overleaf, along with definitions, examples and appropriate
action(s) to be taken.
MM0000 Medicines Code
Page 65 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
Omission code
Definition and action to be taken
1
Patient not on
ward
Give dose when patient returns to ward unless next dose is due. If unsure,
ask pharmacist or prescriber for advice on timing of medication.
Infusion therapy should normally be continued when patients are off the ward
e.g. receiving a diagnostic test. Infusion therapy should only be temporarily
discontinued on written instructions of a prescriber.
Nursing staff to use this code when a medicine is omitted for clinical reasons
e.g. contra-indicated, adverse drug reaction. Reason for omission must be
documented and the prescriber informed so alternatives can be prescribed if
necessary.
For long term medicines or those continued on admission, always ask if the
patient has their own supply or if a relative/carer can bring in their supply from
home.
If not, order medication from pharmacy (contact ward services for stock
replenishment or ward pharmacist for non-stock items).
Speak to patient and ensure they understand what the medicine is for and
any implications of not taking the dose. (Contact medical/pharmacy staff for
advice if further information needed).
Where the patient is fully informed and has capacity to understand their
actions, this should be respected and medicine should not be administered.
Medication must not be disguised in food or drink as this constitutes
‘deception’ of the patient and breaches current NMC guidance.
Document the reason for refusal in the notes and inform prescriber if a patient
refuses a dose of a critical medicine or refuses multiple doses. Prescribers
should review the need for medication that a patient is continually refusing
and amend the prescription chart as appropriate.
Discuss with the prescriber or ward pharmacist, to have the prescription
clarified.
Doses should be given as soon as possible after the prescription has been
clarified unless the next dose is due. If unsure, ask pharmacist or prescriber
for advice on timing of medication.
Patients who are fasting prior to a diagnostic procedure or surgery should
receive all of their usual medicines as prescribed with a small amount of
water unless specifically informed to withhold by prescriber/anaesthetist.
Use this omission code when the patient is unable to take the dose for other
reasons e.g. if patient is too drowsy or is vomiting or has severe nausea.
Refer to specific Trust guidelines for ‘nil by mouth’ patients.
If patient has difficulty swallowing, contact Pharmacy for advice on alternative
formulations. Medicines should not be crushed for ease of administration
unless approved by Pharmacy.
Examples for when this code should be used are cannula not in situ/not
patent; NG tube is pulled out.
IV route – contact prescriber/Night Nurse Practitioner to request cannula
insertion. Contact the prescriber/pharmacist to consider alternative routes if
necessary.
Use this omission code if the reason does not fit within the above categories.
Appropriate action should be taken to ensure medicines are given as soon as
clinically appropriate and possible
2
Omitted for
clinical reasons
3
Medicine not
available
4
Patient refused
6
Incomplete or
illegible
prescription
7
Nil by Mouth
8
Route not
available
9
Other
documented
reason
MM0000 Medicines Code
Page 66 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
8. SELF-ADMINISTRATION OF MEDICINES
Self-administration of medicines (self-medication) occurs when an inpatient
administers one or more of their own medicines. This does NOT remove the Trust’s
duty of care to ensure medicines are stored and taken safely.
Nursing staff should assure themselves on a regular basis that the patient is taking
their medicines as prescribed.
8.1.
Who can Self Administer
8.1.1.
If a nurse or patient feels the patient/carer is suitable for selfadministration, then a SAM assessor or administrator should assess
the patient’s ability to safely self-administer their medicines using the
self-administration assessment tool (Appendix 2).
8.1.2.
It is important that the trained SAM assessor/administrator recognise
the limitations of the assessment (as patient competence may be
affected by a change in their condition or mental status).
8.2.
Assessment of Patients
8.2.1.
When assessing a patient, should the trained SAM assessor/
administrator in his or her professional judgment be at all unhappy
for a patient to self-administer then the patient will be excluded. The
reasons for exclusion should be documented in the patient’s case
notes.
8.2.2.
Those not suitable for self-administration include:
8.2.2.1.
Patients who are medically unstable.
8.2.2.2.
Patients who are confused, disorientated or have a significant
neurological deficit.
8.2.2.3.
Patients who refuse to participate in the self-administration of
medicines scheme.
8.2.2.4.
Patients on a mental health section.
8.2.2.5.
Patients expressing suicidal/self-harm feelings.
8.2.2.6.
Patients known to have a current drug/alcohol abuse problem.
MM0000 Medicines Code
Page 67 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
8.2.3.
Patients with a history of drug/alcohol abuse (but not a current issue)
should not necessarily be excluded. Self-medication for these
patients should be discussed with the medical team.
8.2.4.
The SAM assessment form should be filed in the patient’s health
record.
8.2.5.
Patient consent should be obtained and documented using the form
in Appendix 3.
8.2.6.
Patients should be assigned the appropriate level (see section 6.2),
and this should be re-assessed daily as the patient’s condition may
change.
8.2.7.
The SAM assessor or administrator must assess the patient’s ability
to manage their medicines daily in line with the Mental Capacity Act
2005.
8.2.8.
Patient’s own medicines that are suitable for use, or medicines that
have been dispensed from the hospital, may be used for selfadministration.
8.2.9.
All medicines used for self-administration MUST be clearly labelled.
8.2.10.
If the prescription is altered the patient should be advised of the
change and relevant medicines information provided. It may be
necessary to re-label medicines and change the level of selfadministration for a period.
8.2.11.
All medicines for self-administration MUST be locked in the
individual patient’s bedside medicine cabinet.
8.2.12.
When a patient is self-administering his or her own medicines, a
record MUST be made in the administration section of the
prescription sheet.
8.2.13.
Nursing staff should document on the inpatient treatment chart that
the patient is self-administering medications using the code 5.
8.2.14.
On transfer or discharge, the patient’s medicines MUST be removed
from the medicine cabinet and the key to the cabinet retained on the
ward.
MM0000 Medicines Code
Page 68 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
8.2.15.
Day case and outpatients can continue to take their medicines as
they would at home without an assessment, as long as there is no
clinical reason not to do so.
8.2.16.
Patients self-administering their medicines should be given an
information leaflet about the scheme and a ‘medicines Information
card’ to record relevant information about their medicines.
MM0000 Medicines Code
Page 69 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
9. SUPPLY OF MEDICINES TO P ATIENTS
9.1.
Key Principles
9.1.1.
POMs (Prescription only Medicines) MUST only be supplied against
a written prescription or PGD.
9.1.2.
PGDs (Patient Group Directions) MUST be approved by the
Medicines Management Group.
9.1.3.
Only staff authorised in law may supply medicines against a PGD.
9.1.4.
Supply and/or administration MUST be fully documented.
9.1.5.
Prescriptions that are rewritten or transcribed MUST be authorised.
9.2.
Key Standards
9.2.1.
All POMs are supplied against a written prescription or PGD.
9.2.2.
An approved PGD exists for all medicines supplied under PGD.
9.2.3.
A training record is retained for staff authorised to use PGDs.
9.3.
General Procedures
9.3.1.
Prescription only Medicines are only supplied or administered
against a valid written prescription (authorised by a registered
medical or non-medical prescriber), or against an authorised Patient
Group Direction.
9.3.2.
Prescription only medicines are only supplied under the supervision
of a registered doctor, nurse, midwife or pharmacist.
9.3.3.
Stock medicines are only used to administer doses to patients while
in hospital and must NOT be supplied to individual patients on
discharge.
9.3.4.
Medicines which the patient is to take home MUST be clearly
labelled with the patient’s name and the directions for use.
9.3.5.
Verbal messages must NOT be used to order or supply medicines
except in medical emergencies (see section 4.4).
9.3.6.
The sale and supply of medicines is subject to statutory
requirements of the Medicines Act and statutory instruments.
MM0000 Medicines Code
Page 70 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
10. DISPOSAL OF PHARMACEUTICAL WASTE
Pharmaceutical waste is classed as ‘special waste’. Healthcare professionals must
never dispose of medicines into the mains sewerage system i.e. sink or toilet.
10.1. Key Principles
10.1.1.
It must be disposed of by incineration, in approved containers, at
high degree temperatures in order to completely destroy all potent
substances.
10.1.2.
Prosecution will occur if such waste is consigned as anything other
than ‘special waste’ e.g. it is discovered in landfill tips, and it can be
traced back to the user.
10.1.3.
Cytotoxic and cytostatic medicines are classified as hazardous
waste and must be segregated from other pharmaceutical waste and
placed in the correct hazardous waste bin please refer to the Trust
Cytotoxic Chemotherapy Policy MM25.
10.1.4.
Disposal of controlled drugs is subject to special legislative controls
and procedures please refer to section12.17.
10.1.5.
Disposal of pharmaceutical waste must be in accordance with local
waste management policy. Refer to the policy for further information.
10.1.6.
A consignment note must accompany pharmaceutical waste
removed for incineration.
10.2. General Procedures
10.2.1.
Empty Containers
10.2.1.1. Empty medicine containers must be disposed of at ward /
department level. These should be placed in the appropriate
glass, plastic or household waste bin.
10.2.1.2. Liquid bottles must be rinsed with water, before placing into the
glass bin.
10.2.1.3. Ensure that patient names are obliterated from empty containers
before disposal
MM0000 Medicines Code
Page 71 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
10.2.2.
Tablets and Capsules
10.2.2.1. Any table or capsule removed from its original packaging and not
administered to the patient must be destroyed by placing it in the
yellow sharps bin.
10.2.2.2. Full and part used boxes of medicines, including loose blister
strips should be returned to pharmacy in the green Pharmacy
bins for processing.
10.2.3.
Glass vials and Pre-filled syringes
10.2.3.1. For part used ampoules the remaining drug should be emptied
into the yellow sharps bin before disposing of the glass container
in the same way.
10.2.3.2. Empty glass vials should be placed in the non-hazardous
pharmaceutical waste bin (blue).
10.2.3.3. Part used vials or pre-filled syringe must be placed directly in the
yellow sharps bin.
10.2.4.
Mixtures and syrups
10.2.4.1. Full and part used bottles of syrups and mixtures should be
returned to pharmacy in the green Pharmacy bin for processing.
10.2.5.
Medicated plasters and patches
10.2.5.1. Patches or plasters which remain in their outer container should
be returned to pharmacy in the green Pharmacy bin for
processing
10.2.5.2. Plasters or patches which have been removed from the patient
should be folded in half so any active surface is adhered to itself
and place in the yellow sharps bin.
10.2.6.
Inhalers and aerosols
10.2.6.1. Full and part used containers should be returned to pharmacy in
the green Pharmacy bin for processing
10.2.7.
Parenteral fluids and solutions for irrigation
10.2.7.1. Part used containers of simple fluids (sodium chloride,
potassium containing solutions, hartmanns and glucose) should
be emptied into a foul sewer and the outer container disposed of
in the yellow sharps bin.
MM0000 Medicines Code
Page 72 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
10.2.7.2. Where a pharmaceutically active substance has been added to a
fluid, the remainder should be disposed of in the yellow sharps
bin.
10.2.7.3. Full containers should be returned to pharmacy in the green
Pharmacy bin for processing.
MM0000 Medicines Code
Page 73 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
11. P ATIENT GROUP DIRECTIONS
The preferred way for patients to receive the medicines they need is for a prescriber
to provide care for an individual patient.
PGDs provide a legal framework that allows the supply and/or administration of a
specified medicine(s), by named, authorised, registered health professionals, to a
predefined group of patients needing prophylaxis or treatment for a condition
described in the PGD, without the need for a prescription or an instruction from a
prescriber. Using a PGD is not a form of prescribing. Supplying and/or administering
medicines under PGDs should be reserved for situations in which this offers an
advantage for patient care, without compromising patient safety.
The purpose of using a PGD is to:

deliver effective patient care that is appropriate in a pre-defined clinical
situation, without compromising patient safety.

offer a significant advantage to patient care by improving access to
appropriate medicines.

provide equity in the availability and quality of services when other options for
supplying and/or administering medicines are not available.

provide a safe legal framework to protect patients.

reduce delays in treatment.

maximise the use of the skills of a range of health professionals.
11.1. Key Principles
11.1.1.
The supply and/or administration of prescription-only medicines
(POMs) to patients within a PDG framework MUST follow an
assessment of patient need by an individual registered health
professional who is authorised to perform such an activity within
KGH.
11.1.2.
Only named registered professions are authorised to supply
medicines under PGD, these currently include nurses; midwives;
MM0000 Medicines Code
Page 74 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
health visitors; optometrists; pharmacists; chiropodists;
radiographers; orthoptists; physiotherapists; ambulance paramedics;
dieticians; occupational therapists; speech and language therapists;
prosthetists; orthotists; dental hygienists and dental therapists.
11.1.3.
PGDs are subject to legislation and the content must be prepared in
an approved format and authorised by a senior medical practitioner,
the Chief Pharmacist and approved by the Trust Medicines
Management Group (MMC).
11.1.4.
A PGD MUST include the following information:
11.1.4.1. Details of the condition and situation for which the PGD applies.
11.1.4.2. Details of any contra-indications or other exclusion criteria.
11.1.4.3. A description of the treatment available under the PGD.
11.1.4.4. Details of the staff authorised to take responsibility under the
PGD.
11.1.4.5. The management and monitoring of the PGD including an
annual audit of its use.
11.2. Development, Authorisation and Review of PGDs
11.2.1.
Recommendations for good practice have been developed by the
NICE Guidance Development Group (GDG), using relevant
legislation and guidance as the foundation for good practice.
11.2.2.
The procedure for considering the need for, and obtaining
agreement to develop a PGD is described in Appendix 4. The
template PGD Proposal Form (Appendix 5) must be completed and
submitted to support each application.
11.2.3.
The procedure for developing and submitting a PGD for approval
and authorisation is described in Appendix 6. The template CBU preapproval Form (Appendix 7) must be completed and submitted to
support each application.
MM0000 Medicines Code
Page 75 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
11.3. Using a PGD
11.3.1.
Individual registered staff who supply or administer medicines
against a PGD MUST be aware of the policy and procedures
pertaining to PGDs.
11.3.2.
The Appointed Practitioner in Charge of each ward or department is
responsible for ensuring that medicines are administered against a
written prescription or PGD, and for maintaining a record of
signatures authorising individual registered staff to use the PGD.
11.3.3.
A record of administration under PGD MUST be entered on the
patient’s prescription chart or health records as described in the
individual PGD and signed by the Designated Practitioner supplying
or administering the medicines under the PGD.
11.3.4.
Medicines must be supplied directly by the registered practitioner at
the time they are using a PGD, and cannot be delegated to someone
else.
11.3.5.
The Appointed Practitioner in Charge should review PGDs annually
to ensure these accurately reflect practice and are being used
appropriately.
11.3.6.
Staff using PGDs or protocols should have undertaken appropriate
training to demonstrate understanding and competence and will at all
times work within their scope of practice, professional guidance and
Trust policy and procedures.
MM0000 Medicines Code
Page 76 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12. CONTROLLED DRUGS
The Misuse of Drugs Act, 1971 controls certain classes of dangerous drugs, which
are listed and known as “Controlled Drugs”. Its main purpose is to prevent the
misuse of these drugs by imposing a total ban on the possession, supply,
manufacture or importation of Controlled Drugs, except as allowed by regulations.
The use of Controlled Drugs in medicine is regulated by the Misuse of Drugs
Regulations, 2001 (as amended). Separate regulations deal with the safe custody of
Controlled Drugs and their supply to substance misusers.
The 2001 Regulations set out a number of schedules, which classify Controlled
Drugs (CDs) according to different levels of control.
Storage and security requirements may be increased locally at the discretion and
direction of the Nursing Management in discussion with the Accountable Officer or
their nominated deputy.
12.1. Key Principles
12.1.1.
Controlled drugs are an important therapeutic intervention e.g. for
pain management, and, as such, must be readily accessible to
patients who require strong analgesia.
12.1.2.
Controlled drugs are subject to special legislative controls because
there is a potential for them to be abused or diverted, causing
possible harm.
12.1.3.
Designated healthcare staff are authorised in law, to be in
possession of controlled drugs for the purposes of supply,
administration or disposal in accordance with the above principles
12.1.4.
All preparation, administration and disposal of schedule 2 CDs
MUST be directly witnessed by another register Practitioner.
12.1.5.
Systematic documentation and checks MUST be maintained to
ensure the secure management of controlled drugs and demonstrate
this to the Accountable Officer.
MM0000 Medicines Code
Page 77 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.1.6.
All incidents MUST be investigated and reported to the Accountable
Officer or their deputy, and will be referred to the CD Intelligence
network as appropriate.
12.1.7.
Healthcare staff of all grades involved in the storage, prescribing,
supply, administration and disposal of CDs MUST adhere to this
policy.
12.1.8.
Failure to comply with these good practice standards and legislative
requirements could result in disciplinary action and / or criminal
prosecution.
12.2. Key Standards
12.2.1.
All Schedule 2 and some Schedule 3 CDs are locked in a CD
cupboard
12.2.2.
CDs subject to safe custody requirements must be physically
checked every day against register balances
12.2.3.
Prescriptions for CDs are prescribed on the correct KGH prescribing
stationary and comply with handwriting requirements
12.2.4.
Preparation and Administration of CDs that are subject to safe
custody requirements must be checked by a second registered
practitioner against a valid prescription
12.2.5.
Quarterly checks of the safe and secure management of CDs are
carried out by Pharmacy staff
12.2.6.
All unresolved CD errors are reported on datix incident report and
fully investigated
12.3. Accountability for CDs
12.3.1.
The Accountable Officer (Chief Pharmacist) is responsible for the
safe and secure management of CDs throughout the Trust, under
statutory provisions of the Health Act 2006.
12.3.2.
The appointed nurse, midwife or Operating Department Practitioner
(ODP) in overall charge of a ward or department is responsible for
the safe and appropriate management CDs in that area.
MM0000 Medicines Code
Page 78 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.3.3.
The designated nurse, midwife or ODP in charge can delegate
control of access (i.e. key-holding) to the CD cupboard to another
Assigned Practitioner, such as a registered nurse or ODP. However,
legal responsibility remains with the appointed nurse, midwife or
ODP in charge.
12.3.4.
All designated staff involved with the management of CDs
(prescribing, ordering, preparation, administration and disposal)
MUST submit a copy of their signature, area of work and
professional registration number to pharmacy for confidential use in
checking and validating written records.
12.4. Ordering of CDs
12.4.1.
Each ward or department will hold a stock of CDs agreed by the
designated nurse, midwife or ODP with the CBU Lead Pharmacist.
The stock list will reflect current usage, whilst minimising risks
associated with storage of multiple products and strengths. The
stock list will define drug, form, strength and quantity held.
12.4.2.
CDs may be ‘topped up’ against the defined stock list for each ward
and department by a pharmacist or pharmacy technician, who is
responsible for checking the stock balances in the Ward CD register
against the levels in the agreed stock list.
12.4.3.
Only one controlled drugs order book should be in use in a
ward/clinical area at any one time, for requisitioning controlled drugs
from pharmacy.
12.4.4.
Under no circumstances can controlled drugs be requisitioned from
another clinical area. Orders for controlled drugs must be written in
ink in the controlled drugs order book and must include the following
information:
12.4.4.1. hospital and ward/department
12.4.4.2. name of CD
12.4.4.3. strength or concentration
12.4.4.4. form (e.g. tablets, capsules, injection, ampoules)
12.4.4.5. total quantity required
MM0000 Medicines Code
Page 79 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.4.4.6. signature
12.4.4.7. printed name
12.4.4.8. designation
12.4.4.9. date
12.4.5.
CD requisitions MUST be written in the CD ward order book and
must be signed by a registered Nurse, Midwife or ODP who is an
authorised CD signatory.
12.4.6.
In certain circumstances, CD requisitions, for items other than those
on the CD stock list, may be prepared by a pharmacist or pharmacy
technician but MUST be signed by a registered Nurse, Midwife or
ODP who is an authorised CD signatory.
12.4.7.
Methadone for inpatient use is to be labelled with patient’s name.
Other CDs dispensed for in-patient use only are labelled ‘Temporary
Stock’ to differentiate these from patient’s own drugs / other stock
items.
12.4.8.
Stock CDs or those issued for inpatient use only must NEVER be
given to patients on discharge.
12.4.9.
CDs that may be taken home by the patient, must be supplied
against a valid discharge or outpatient prescription [see section
12.13.2 on Prescribing CDs for discharge and section 12.13.3
Prescribing CDs for outpatients].
12.4.10. A copy of the signature of each Designated Practitioner for the
purposes of ordering CDs must be available in the pharmacy
department for verification, and checked prior to the supply being
made.
12.5. Receipt of CDs
12.5.1.
Receipt of controlled drugs on to a ward/clinical area must be by a
Designated Practitioner.
12.5.2.
The Designated Practitioner must check that the numbered seal on
the delivery bag is intact and the bag has not been tampered with.
The entire contents of the delivery bag must immediately be
MM0000 Medicines Code
Page 80 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
checked, and signed as received, against the entry in the controlled
drugs order book.
12.5.3.
Although the quantity received should be checked, it is unnecessary
to break a tamper evident seal on a pack in order to check the
quantity.
12.5.4.
Once checked, the registered staff member must immediately enter
the received controlled drug(s) on to the appropriate page(s) of the
controlled drugs register.
12.5.5.
Any discrepancy should immediately be reported to Pharmacy.
12.6. Obtaining controlled drugs out-of-hours
12.6.1.
It is vital to maintain a robust audit trail for controlled drugs.
12.6.2.
During Pharmacy opening hours, controlled drugs must always be
ordered from Pharmacy.
12.6.3.
In exceptional circumstances when medication is required urgently
and Pharmacy is closed, controlled drugs sufficient for a single dose
only may be obtained from another ward. The registered staff
member must contact other areas in the following order:
- Another ward in their own CBU
- Another ward in a different CBU
- The Intensive Care Unit
12.6.4.
The registered staff member must take the patient’s prescription
chart to the area holding the required controlled drug and, with the
assistance of the controlled drugs keyholder in that area, prepare
and record a single dose for the patient. On return to the patient’s
ward, an independent check must be obtained from a second
registered nurse/midwife to ensure the controlled drug dose is
administered to the correct patient. For all other supplies of
controlled drugs, when Pharmacy is closed, the emergency duty
Pharmacist should be contacted.
MM0000 Medicines Code
Page 81 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.7. Transport of CDs
12.7.1.
A record of transport is required for Controlled Drugs. This should
include signatures from the Assigned Practitioner issuing the CD,
transporting the CD and receiving the CD in the ward or department.
12.7.2.
CDs subject to safe custody requirements MUST be transported in a
security sealed bag and Designated Practitioners are required to
sign the duplicate copy of the requisition when receiving this onto the
ward. These CDs must NOT be left unaccompanied and MUST be
handed directly to a Designated Practitioner for immediate storage in
the CD cupboard.
12.7.3.
Where CDs are collected from the pharmacy department, an
assigned practitioner will be required to sign for a sealed bag with
numbered tag.
12.7.4.
Positive ID and signature checks must be undertaken when
Controlled Drugs are issued directly by Pharmacy to Trust staff.
12.7.5.
Where an outpatient (or their relative or carer) collects CDs from the
pharmacy department, they are required to show proof of identity.
Where a healthcare professional, acting in their professional capacity
on behalf of the patient, collects CDs, they MUST show proof of
identity, and provide details of their name and address / place of
work.
12.8. Transfer of CDs
12.8.1.
A securely sealed CD transfer bag must be used to transport
patient’s own controlled drugs between wards, and when they are
discharged on transport e.g. by ambulance, and are unable to look
after their medicines.
12.8.2.
Where a patient is given their CDs directly on discharge and is able
to manage these safely and securely, then these may be placed with
other medicines in the patient’s medicines bag, which should not be
left unattended and stored safely at all times.
MM0000 Medicines Code
Page 82 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.8.3.
When a sealed CD transfer bag is used, the serial number must be
recorded in the issuing CD register and patient’s name, ward,
hospital (unit) number, and date of transfer should be completed on
the tear-off section and signed by the Designated Practitioner issuing
the CDs.
12.8.4.
The Assigned practitioner (e.g. Hospital porter, Ambulance crew)
must sign for receiving the sealed bag and transport this intact to the
receiving ward or patient’s home.
12.8.5.
The Designated Practitioner receiving the patient, checks the bag is
intact, signs the tear-off record on the CD transfer bag and records
the CDs and serial number in the ward CD register. The tear-off
record is retained by the person transporting the patient, as proof of
delivery.
12.8.6.
Where a patient is transferred to a residential or domiciliary setting,
the patient’s carer or adult representative receiving the sealed CD
transfer bag, signs the tear–off record, confirming the bag is intact,
and returns this to the person transporting the patient, as proof of
delivery.
12.9. Storage and Security of CDs
12.9.1.
Wards, Theatres or Departments must NOT store Controlled Drugs
unless there is an Appointed Practitioner in Charge responsible for
the secure storage and safe use of the Controlled Drugs.
12.9.2.
Controlled drugs (including patients’ own controlled drugs) must be
stored in a cupboard which conforms to British Standard reference
BS2881, or in a cupboard individually approved in advance by
Pharmacy. All cupboards for the storage of CDs MUST be secured
to a wall or the floor.
12.9.3.
The cupboard must be locked when not in active use. Access to the
cupboard must be restricted to those staff who can lawfully be in
possession of a controlled drug (e.g. registered nurse / midwife /
ODP, pharmacist, doctor, or a person acting under their direct
authority, e.g. pharmacy technician).
MM0000 Medicines Code
Page 83 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.9.4.
Locks for CD cupboards must NOT be common to any other lock in
the hospital. Two sets of keys should be held, one in use carried by
the Designated Practitioner, and a spare set locked away in a secure
key cabinet with access limited to the appointed nurse, midwife, or
ODP in charge of an area. A third set will be retained securely within
the Pharmacy Department.
12.9.5.
An accurate and current record of the named keyholder must be
maintained and updated at each shift change or other handover
period. The controlled drug cupboard keys must be kept separate (or
easily separable) from other drug cupboard keys.
12.9.6.
Keys may be handed to a staff member authorised to access the
controlled drug cupboard (as outlined above) but must be returned to
the authorised keyholder immediately after use.
12.9.7.
The controlled drug cupboard must only be used to store controlled
drugs and medicines to which special arrangements are attached,
e.g. midazolam, ketamine.
12.9.8.
Controlled Drug Order Books and Registers must be kept either in
the controlled drug cupboard or in an alternative secure storage
area.
12.9.9.
During any temporary closure of a ward/clinical area, arrangements
must be made in advance with Pharmacy to cover security of
controlled drug cupboard keys, and security arrangements for
controlled drugs, either on the existing ward/clinical area or in an
alternative location, during the period of the closure.
12.10. Storage and security of TTAs which include a controlled drug
12.10.1. There is no requirement to store in the controlled drug cupboard, or
record in the controlled drugs register, a controlled drug supplied to a
patient as part of their discharge medication (TTA), provided that the
patient is being discharged immediately.
12.10.2. However, if there is any delay between the controlled drug TTA
arriving on the ward and the patient leaving the ward, the nursing
staff must store the dispensed controlled drug in the controlled drug
MM0000 Medicines Code
Page 84 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
cupboard. This must be appropriately recorded in the patient’s own
controlled drugs register.
12.10.3. At the point of discharge, the controlled drug must be removed from
the controlled drug cupboard and the removal recorded in the
patient’s own controlled drugs register.
12.11. Loss of controlled drug cupboard keys/replacement controlled drugs
cupboard lock.
12.11.1. If CD keys go missing, every effort should be made to find or retrieve
the keys, as a matter of urgency e.g. by contacting staff who have
just gone off duty.
12.11.2. If the keys cannot be found the keyholder must inform the Nurse in
Charge, CBU Lead Nurse and the Controlled Drug Accountable
Officer (CDAO) and Local Security Management Specialist (LSMS)
as soon as possible. (If CDAO is unavailable, notify the Deputy Chief
Pharmacist for QiPPs or Clinical Excellence during opening hours.
For Out of hours notify Emergency Duty Pharmacist.) who will advise
any action to secure the CD stock and arrange supply of CDs for
urgent clinical use.
12.11.3. Out of Hours, a dose may be provided from another ward, as long as
this is fully documented in that ward’s CD register for the specific
patient and their location, and in accordance with a valid prescription
for that patient.
12.11.4. Replacement of locks MUST only be on the authority of the CDAO
(Chief Pharmacist) and the LSMS. Complete the ‘request form for
replacement of a key or lock’ (Appendix 8). (If CDAO is unavailable,
the Deputy Chief Pharmacist for QiPPs or Clinical Excellence during
opening hours or the oncall Pharmacist out of hours have delegated
authority to authorise this).
12.11.5. Both Pharmacy and Estates will maintain a log of all requests to
include date, reason for request, nurse in charge making request
and name of person/s authorising the replacement.
MM0000 Medicines Code
Page 85 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.11.6. Where access is restricted due to missing or lost keys a datix
incident report MUST be completed and forwarded to the CDAO.
12.11.7. Loss or theft of any controlled stationery which may be used to order
CDs should be reported immediately to the Responsible Pharmacist
and Accountable Officer. This includes ward CD order books,
registers, discharge and outpatient prescription forms, which MUST
be stored securely when not in use to prevent fraudulent use.
12.12. Patients’ Own CDs
12.12.1. The Trust encourages the use of patient’s own medicines that are
suitable for use, including controlled drugs. These remain the
property of the patient, but their secure storage is the responsibility
of the Trust.
12.12.2. Medicines labelled for a specific named patient must NOT be used to
treat another patient, and MUST be stored separately from stock
medicines.
12.12.3. Patients’ own CDs that are not prescribed during their stay should
not routinely be stored on the ward, but sent to pharmacy for
destruction, or returned home with a relative, where appropriate [see
section Return and Disposal].
12.12.4. For patients who have brought their own supply of CDs into hospital,
a record of the patient’s own CDs retained on the ward MUST be
entered into the ward Patient’s Own CD register and a record of
doses administered and running balance kept [see section
Documentation and Record Keeping].
12.13. Prescribing of CDs
The following registered staff are authorised to prescribe controlled drugs:

Doctors (FY1) can prescribe controlled drugs for inpatients and for TTAs,
but cannot prescribe controlled drugs for out-patients.

Supplementary prescribers where the controlled drug is included in the
clinical management plan.
MM0000 Medicines Code
Page 86 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling

Independent non-medical prescribers can prescribe some controlled
drugs within their competence.
Controlled drugs cannot be supplied against a prescription signed by a prescriber
whose signature is not already held in Pharmacy records.
12.13.1. Prescribing controlled drugs for in-patients
There are no special requirements for prescribing controlled drugs for in-patients.
Guidance provided in the Trust’s Prescribing Medicines Policy should be followed at
all times.
12.13.2. Prescribing controlled drugs for patients to take home (TTAs)
12.13.2.1. Controlled drug TTAs must be prescribed on the standard
Controlled Drugs TTA prescription form (Appendix 9).
12.13.2.2. Where different strengths or forms of the same controlled drug
are required, these should be treated as different controlled
drugs.
12.13.2.3. Prescriptions should be written for a maximum of 28 days’
supply.
12.13.2.4. Complete the minimum information required, detailed below, for
each separate controlled drug:

Patient name

Home address

Hospital number (a patient label is acceptable but must be
signed by the prescriber, across the edge of the label and
TTA form)

Form (e.g. tablets, patch, liquid) even if only one form

Drug name

Drug strength, including the units of the strength

Quantity, in both words and figures

Drug dose and frequency (if prescribed ‘when required’ eg
for breakthrough pain, a minimum interval for administration
MM0000 Medicines Code
Page 87 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
should be specified and a maximum total quantity to be
administered in 24 hours).
12.13.2.5. To authorise the prescription the prescriber must sign and date
the CD TTA prescription in the field provided, using their usual
signature, which must match the signature held in Pharmacy.
Whilst not a legal requirement, it may be helpful to include a
bleep number/contact number.
12.13.3. Prescribing controlled drugs for out-patients
12.13.3.1. Prescribing controlled drugs for out-patients follows the same
process as outlined above for the prescribing of controlled drugs
as TTAs, except that controlled drugs for out-patients must be
prescribed using one of the following prescribing documents:
12.13.3.2. F126 Out-Patient Prescription and Dietary Prescription Card.
12.13.3.3. KGH Controlled Drug Prescription Form for hospital dispensing
only.
12.13.4. Doctors prescribing controlled drugs for themselves or someone
close to them.
Guidance issued by the GMC states:
12.13.4.1. Doctors should, wherever possible, avoid treating themselves or
anyone with whom they have a close personal relationship and
should be registered with a GP outside their family.
12.13.4.2. Controlled drugs can present particular problems, occasionally
resulting in a loss of objectivity leading to drug misuse and
misconduct.
12.13.4.3. Doctors should not prescribe a controlled drug for themselves or
someone close to them unless:
12.13.4.3.1.
No other person with the legal right to prescribe is
available to assess the patient's clinical condition and to
prescribe without a delay which would put the patient's
life or health at risk, or cause the patient unacceptable
pain, and
MM0000 Medicines Code
Page 88 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.13.4.3.2.
That treatment is immediately necessary to:

Save life

Avoid serious deterioration in the patient's health, or

Alleviate otherwise uncontrollable pain.
12.13.4.4. The Trust foresees no situation within the hospital environment
where these are likely to occur, therefore doctors are not allowed
to prescribe controlled drugs for themselves or someone close
on FP10 forms.
12.13.4.5. If a pharmacist or doctor becomes aware of a practitioner
prescribing controlled drugs for family, friends, or themselves,
they must discuss the circumstances directly with the prescriber.
12.13.4.6. Prescribers who have issued such prescriptions should cooperate with enquiries made by other healthcare professionals
who wish to discuss the treatment.
12.13.4.7. Where there remains any concern about a prescription, the
person with the concern should make the Trust Accountable
Officer and Medical Director aware of it as soon as possible.
Ref: GMC Guidance for Doctors - Prescribing Guidance - Need and Objectivity:
Prescribing guidance: Need and objectivity.
12.13.5. Prescribing private prescriptions for controlled drugs
12.13.5.1. Kettering General Hospital Trust do not hold FP10cd forms and
hospital prescribers may not prescribe controlled drugs for
private patients.
12.13.5.2. The Pharmacy Department at KGHFT do not dispense private
prescriptions.
12.14. Preparation and Administration of CDs
Kettering General Hospital NHS Foundation Trust sets a standard of two registered
healthcare practitioners being involved in the administration of controlled drugs
(except in an emergency situation) so that an independent check is made on
administration.
MM0000 Medicines Code
Page 89 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.14.1. Controlled drugs can only be administered against a legal
prescription (see section 4.1) by an authorised member of staff (see
section 7 above).
12.14.2. The authorised staff member must be witnessed throughout the
selection, preparation and administration process.
12.14.3. Destruction and disposal of any surplus controlled drug following
administration, eg a part used ampoule, must also be witnessed.
12.14.4. An immediate record of the administration of the controlled drug
must be made in the controlled drugs register. This entry must be
made in indelible ink, must be chronological and must be
countersigned by the witness. The following information must be
included:

date and time of administration

name of patient

quantity administered

signature of person administering dose

signature of witness to administration

new stock balance
12.14.5. If a part vial or ampoule is administered, the amount administered
and the amount destroyed must both be recorded in the controlled
drug register.
12.14.6. In Critical Care, Theatre areas and Emergency Departments it may
not always be possible to directly witness administration, where
doses are administered incrementally by medical staff. Disposal of
any remaining dose or the syringe, vial or ampoule MUST be
witnessed (see section 12.15).
12.14.7. Failure to witness the administration and/or disposal of Controlled
Drugs is considered a breach of procedure and could result in
disciplinary action or criminal prosecution if evidence of theft or
diversion occurs. Such incidents may be reported to the professional
regulator.
MM0000 Medicines Code
Page 90 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.14.8. CDs will ONLY be booked out of the ward CD register for an
individual patient, prepared and administered in accordance with the
written authorisation of a qualified medical or non-medical prescriber
[see section on record keeping].
12.14.9. Registered healthcare practitioners may administer a CD as long as
they are acting in accordance with the written directions of a
registered prescriber.
12.14.10.
If administration of a controlled drug given by infusion is not
completed, the remainder should be destroyed on the ward/clinical
area and a record made on the appropriate page of the controlled
drugs register. (See section 12.17 disposal of controlled drugs on
wards/clinical areas). If, for any reason, an individual dose of a
prepared controlled drug cannot be administered, it should be
immediately destroyed and an entry made in the controlled drugs
register by the practitioner and witness.
12.14.10.1.
Residual volumes of patient controlled analgesia (PCAs),
maybe destroyed on the ward were the PCA is stopped which may
not be the theatre were prepared and administration commenced.
An appropriate record of witnessed destruction should be made in
the ward CD register.
12.14.11.
The reason for non-administration must be recorded (see
section 7.5).
12.14.12.
If any error is made in the controlled drugs register, the incorrect
entry must be bracketed, leaving the original entry clearly legible.
This must be signed, dated and witnessed by two registered
members of staff. The reason for the error must be recorded.
12.14.13.
Liquid paper correction fluid (eg Tippex®) must NEVER be used.
12.15. CDs issued directly to Medical Staff
12.15.1. In Critical Care, Theatre areas and the Emergency Department, CDs
are routinely issued to medical staff who then administer these to a
named patient in accordance with a written prescription. A bespoke
MM0000 Medicines Code
Page 91 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
CD register has been provided to record such issues, clearly identify
accountability of staff involved and document return or destruction of
remaining CDs.
12.15.2. It is the responsibility of the Designated Nurse or Operating
Department Practitioner (ODP), when issuing a CD, to document the
name of the Doctor / Anaesthetist and, where possible, the patient
name, in section B of the CD register
12.15.3. It is recognised that administration cannot be routinely witnessed by
a second practitioner in critical care areas. A record of administration
should be recorded by medical staff and compared with the quantity
remaining at the end of each patient procedure.
12.15.4. As staff may change over during a procedure or theatre session, the
medical staff who complete administration MUST confirm the amount
administered or to be destroyed, at the end of each patient
procedure, and sign for this in section C.
12.15.5. A registered Nurse or ODP MUST witness the destruction of a partused ampoule or syringe containing Controlled Drug or return of an
unused ampoule back into stock, and sign for this in section D.
12.15.6. Part-used quantities must be rendered irretrievable in accordance
with the section on Returns and Disposal of CDs.
12.15.7. Disposal of ampoules that are found broken, or are accidentally
dropped or spilled during a procedure MUST be documented AND
witnessed.
12.15.8. Witnessed destruction can be done at the end of each patient
procedure but MUST be completed at the end of each theatre
session.
12.15.9. The stock balance must be checked and witnessed at the end of
each theatre session, and at minimum once daily, and signed for in
section E.
12.15.10.
CDs should be issued for use in ONE patient only. National
guidelines on Controlled Drugs discourage the practice of sharing an
ampoule amongst several patients.
MM0000 Medicines Code
Page 92 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.15.11.
Quantities administered and/or wasted MUST be clearly
documented and signed by the Anaesthetist, at the end of each
patient procedure, and signed for in section C.
12.15.12.
Any part-used syringes or ampoules MUST be destroyed at the
end of the theatre session, and witnessed and documented in
section D of the register, before medical staff leave the theatre area
or department.
12.16. Documentation and Record Keeping for CDs
12.16.1. Each ward or department that holds supplies of CDs MUST keep a
record of schedule 2 CDs received and administered in a standard
bound ward CD register. Separate registers are held for ward stock,
syringe drivers, patients’ own CDs and CDs used in theatre or
emergency departments; registers are supplied from pharmacy on
written request via a requisition in the ward CD order book.
12.16.2. Ward and department CD registers MUST be kept locked away
when not in use, either in the CD cupboard or another locked
cupboard or drawer, to which access is restricted to the Designated
Practitioner, who holds the CD keys.
12.16.3. The ward CD register has separate pages for each drug, form and
strength, so that a running balance can be easily recorded. Entries
should be made in chronological order, in indelible ink.
12.16.4. Non-stock items received only for administration to an individual inpatient should be entered on the appropriate page for that drug, form
and strength, in the ward stock register.
12.16.5. All entries MUST be signed by the designated nurse, midwife or
ODP and should be witnessed preferably by second registered
nurse, midwife or ODP. If a second registered nurse, midwife or
ODP is not available, then the transaction can be witnessed by
another registered professional (e.g. doctor, pharmacist, pharmacy
technician).
MM0000 Medicines Code
Page 93 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.16.6. On reaching the end of a page in the ward CD register, the balance
should be transferred to another page. The new page number should
be added to the bottom of the finished page and the index updated.
As a matter of good practice this transfer may be witnessed.
12.16.7. If a mistake is made it should be bracketed so that the original entry
is still clearly legible, and corrections made. These should be signed,
dated and witnessed by a second registered nurse, midwife or other
registered professional.
12.16.8. On receipt of all schedule 2 CDs, the following details should be
recorded on the appropriate page in the relevant ward CD register:

Date of entry

Serial number of requisition

Quantity received

Name/signature of nurse/authorised person making
entry

Name/signature of witness

Balance in stock [see sections on checking and
reporting]
12.16.9. When recording CDs received from pharmacy, the number of units
received should be recorded in words not figures (e.g. ten, not 10) to
reduce the chance of entries being altered.
12.16.10.
After every administration, the physical stock balance of an
individual preparation should be confirmed to be correct and the
balance recorded in the ward or department CD register. The entry
should be signed and dated [see section 12.18 on checking and
reporting].
12.16.11.
On administration of all schedule 2 CDs, the following details
should be recorded on the appropriate page in the relevant ward CD
register:
MM0000 Medicines Code
Page 94 of 113

Date and time when dose administered

Name of patient

Quantity administered
Chairman: Graham Foster JP
Chief Executive: David Sissling

Name/signature of Designated Practitioner who
administered the dose

Name/signature of witness

Balance in stock [see sections on checking and
reporting]
12.16.12.
Any medicine prepared and not used, or only partly used, MUST
be destroyed in the presence of a second registered practitioner. An
entry MUST be made in the ward CD register and signed by both
parties [see next section on returns and disposal].
12.16.13.
CD records, including ward requisitions books and registers
MUST be kept for a period of at least two years from the last entry
being made. They should be securely stored in the ward or
department, and made available in the event of an investigation.
12.17. Disposal or return of CDS
12.17.1. Expired controlled drug stock
12.17.1.1. Wherever possible, stock rotation should be used to avoid expiry
dates being reached before use. However, if stock passes its
expiry date, it should be returned to Pharmacy together with a
completed Controlled Drug Returns/Destruction form (Appendix
10).
12.17.1.2. Expired stocks of controlled drugs must not be destroyed on the
ward/clinical area, but placed in an ‘out of date CD return bag’
and returned to the CD cupboard for collection.
12.17.1.3. Expired controlled drug stock can be handed to a pharmacist or
pharmacy technician for return to Pharmacy.
12.17.1.4. On receipt in Pharmacy, Section B of the Controlled Drug
Returns/Destruction form will be completed and a copy returned
to the relevant ward/clinical area. This document must be
retained in a safe place (Appendix 10)
12.17.2. Disposal and destruction of patients’ own controlled drugs (see also
Section 10.)
MM0000 Medicines Code
Page 95 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.17.2.1. Patients’ own controlled drugs are the personal property of the
patient. If a decision is taken that these controlled drugs are no
longer needed, consent must be obtained from the patient to
send the unwanted controlled drug to Pharmacy for destruction.
If consent is not forthcoming, the issue should be discussed with
the ward pharmacist.
12.17.2.2. The Trust reserves the right, for purposes of safeguard and
public interest, to retain such controlled drugs where the original
prescription has been cancelled or superseded.
12.17.2.3. Once consent has been obtained from the patient, the registered
staff member must complete the Controlled Drug
Returns/Destruction form (Appendix 10).
12.17.2.4. Patients’ own controlled drugs must not be destroyed on the
ward/clinical area, with the exception of part used vials,
ampoules or infusion bags or used patches, lozenges or other
novel delivery devices.
12.17.2.5. Patients’ own controlled drugs can be handed to a pharmacist or
pharmacy technician for return to Pharmacy.
12.17.2.6. On receipt in Pharmacy, Section B of the Controlled Drug
Returns/Destruction form will be completed and a copy returned
to the relevant ward/clinical area. This document must be
retained in a safe place.
12.17.3. Controlled drugs no longer required on the ward
12.17.3.1. If controlled drugs are no longer required on the ward (eg the
patient’s drug treatment has changed, patient has been
discharged or deceased), they should be returned to Pharmacy
as soon as possible, together with a completed Controlled Drugs
Destruction Form (Appendix 10).
12.17.3.2. For Wards or Departments who do not have a regular
Pharmacist visit, a Pharmacist can be asked to attend or a
Registered Nurse/Midwife, can complete the controlled drugs
register, a Controlled Drug Returns/Destruction Form, as in 9.1
above.
MM0000 Medicines Code
Page 96 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.17.4. Disposal of controlled drugs on wards/clinical areas
12.17.4.1. Small amounts of controlled drugs can be destroyed on
wards/clinical areas, including:

Doses which have been prepared for administration
but not administered

Partly used doses, vials, ampoules or infusion bags

Liquid preparations of controlled drugs, where less
than a dose remains

Disposal of broken/defective ampoules
12.17.4.2. All other controlled drugs must be returned to Pharmacy, (see
section 12.17).
12.17.4.3. If a controlled drug is prepared for administration (e.g. removed
from its original container in a way that it cannot be replaced) but
is not administered, it must be disposed of into the CD waste bin
(purple) in the presence of an authorised witness. The contents
of any ampoule or infusion bag opened, and not required, must
be emptied into the CD waste bin (purple). The drug must be
rendered irretrievable using denaturing gel/granules.
12.17.4.4. Liquid preparations for controlled drugs where less than a dose
remains this should be disposed of in the CD waste bin (purple),
in the presence of an authorised witness.
12.17.4.5. The authorised witness MUST provide the second check.
12.17.4.6. The reason for disposal must be recorded in the register and the
witness must only sign the register once the controlled drug has
been disposed of as outlined above.
12.17.4.7. Accidental breakage of ampoules, and other fragile containers,
has been known to occur from time to time. In this circumstance,
the drug should be disposed of in the CD waste bin (purple), in
the presence of an authorised witness.
12.17.4.8. The ampoule/s need to be accounted for so should be signed
out of the ward controlled drugs record book by two registered
practitioners, stating the reason.
MM0000 Medicines Code
Page 97 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.17.4.9. In cases of accidental breakage a datix incident should be
completed and made reference to in the controlled drugs book.
12.17.4.10.
If a CD medicine is found to be defective (e.g. ampoules
cracked, appears cloudy), the item/s should be marked ‘do not
use’ and retained in the controlled drugs cupboard and
Pharmacy contacted.
12.17.4.11.
Authorised witnesses MUST be involved in the disposal
of controlled drugs, this will be either:

A registered prescriber

A registered nurse/midwife

A registered pharmacist

A registered operating department practitioner
(ODP)

A pharmacy technician
12.18. Stock checks of CDs in ward/clinical areas and theatres
12.18.1. Frequency of stock checks must be agreed in advance with
Pharmacy and must be no less frequent than once daily.
12.18.2. Stock checks must be carried out by two registered healthcare
practitioners (nurses, midwives, operating department practitioners,
doctors, pharmacists, pharmacy technicians).
12.18.3. An effective stock check must include the removal of all the contents
of the controlled drug cupboard with each controlled drug replaced in
the controlled drug cupboard once it has been checked against the
relevant entry in the controlled drugs register.
12.18.4. Unopened packs with tamper evident seals should be left intact
during the stock checking process.
12.18.5. Stock balances of liquid controlled drugs should be checked by
visual inspection only, with balances confirmed on the completion of
each bottle.
MM0000 Medicines Code
Page 98 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.18.6. An end volume discrepancy greater than 5% must be reported to the
controlled drug keyholder immediately, every possible step should
be taken to identify the cause of the discrepancy.
12.18.7. As each controlled drug is checked, signatures of the primary
checker and the witness must be made against the final entry on the
relevant page in the controlled drugs Register.
12.18.8. It is permissible, but not mandatory, to record the date and time of
stock checks, together with names and signatures of the two
practitioners, in a separate record book.
12.18.9. Any discrepancies identified during the controlled drug stock check
must be reported to the controlled drug keyholder immediately.
12.18.10.
If any discrepancy in a Controlled Drug quantity is discovered,
every possible step should be taken to identify the cause of the
discrepancy and/or correct the errors/omission(s) in the Ward CDs
Record Book (sample page shown in Appendix 11) or the Theatre
CDs Record Book (sample page shown in Appendix 12). Flow
diagram of the procedure to follow when a discrepancy is discovered
in the Ward CDs Record Book.
12.18.11.
If the discrepancy cannot be resolved and/or corrected during
the shift having performed a preliminary investigation, the Clinical
Ward/ Department Manager should be informed. Out of hours the
Clinical Site Manager should be contacted and the matter reported to
the Accountable Officer or their nominated deputy the next working
day.
12.18.12.
If the balance is adjusted in the CD Record Book, this should be
carried out by making a separate entry.
12.18.13.
There should be no unexplained gaps in the running balance.
The corrected balance must be countersigned by a
Pharmacist/Pharmacy Technician.
12.18.14.
A datix report MUST be completed for each discrepancy with the
incident report referenced in the CD record book.
MM0000 Medicines Code
Page 99 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.18.15.
The Trust’s Accountable Officer for CDs should be informed in
the case of all major incidents or those where there is suspicion of
wider fraud/misuse.
12.18.16.
The Police must be informed of major or suspicious CD
Incidents at the discretion of the Accountable Officer in consultation
with the Local Security Management Specialist (LSMS) and the Trust
Policy for the Reporting and Management of Serious Incidents (S01)
followed.
12.18.17.
In addition, a quarterly controlled drug check must take place.
This will be arranged by Pharmacy at a mutually convenient time and
should be carried out jointly by a registered nurse/midwife/ODP and
a Pharmacy technician/pharmacist.
12.19. Abusable Medicines
12.19.1. In addition to Controlled Drugs, a number of prescription only
medicines are sometimes subject to misuse, abuse or diversion,
including common analgesics and some anaesthetic agents.
12.19.2. Abusable medicines MUST be stored in a locked medicines
cupboard, and key holders must satisfy themselves that these are
secured, and that requests to access stock are legitimate.
12.19.3. Regular usage reports are supplied by pharmacy and must be
reviewed by senior clinical staff in charge of wards and departments
to confirm that usage is within normal limits, and reflects current
clinical practice.
12.19.3.1. Pharmacy MUST be notified of any change in clinical practice so
that stock levels can be adjusted.
12.19.3.2. Ward and department managers MUST investigate any
deviation from expected use, and document the deviation and
investigation on a datix incident report, where this is not
adequately explained (e.g. by checking patient prescriptions)
MM0000 Medicines Code
Page 100 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.19.3.3. Unresolved deviations MUST be reported to the Responsible
Pharmacist, and where diversion or misuse is suspected, to the
Accountable Officer immediately.
12.19.3.4. Staff should be aware of the signs that might indicate abuse or
diversion of medicines (e.g. changes in an individual’s behaviour
such as lack of concentration, regular unexplained absences
from the work area, a change in character, or other ‘odd’
behaviour) and take appropriate action.
12.20. Illicit Substances
12.20.1. Patients and visitors will sometimes bring suspected illicit or
unknown substances into hospital. Staff are reminded to be vigilant
and report any suspicion to the senior registered practitioner in
charge.
12.20.2. Where these represent a small quantity ‘for personal use’, then the
patient should be asked to surrender these for destruction. Staff
have no automatic right to search a patient’s belongings and if
considered necessary consent must be obtained.
12.20.3. The suspected illicit substance should be stored in the CD cupboard
for retrieval by a pharmacist using the ‘Controlled Drug Return Form’
(Appendix 10), for subsequent witnessed destruction, by an
authorised witness.
12.20.4. The identity of the patient should NOT be documented for
confidentiality, but for documentation purposes, only the ward
location, a brief description of the suspected illicit substance (e.g.
small white tablets, off-white powder, ‘spliff’), and the names of the
registered Nurse and Pharmacist‘ handling the substance for
purpose of destruction’.
12.20.5. If a patient refuses to give up a suspected illicit substance, then staff
should refer to Local Security Management Specialist and may be
referred to the Police, as below.
MM0000 Medicines Code
Page 101 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.20.6. Where the quantity is large or there is evidence of a criminal act
taking place e.g. dealing on premises, then the Police may be called
to investigate. The Police must only be involved with the agreement
of the treating Consultant in charge of the patient’s care, and
express permission of the Trust Accountable Officer for Controlled
Drugs (Chief Pharmacist).
12.20.7. Illicit substances must NEVER be given back to a patient or their
carer, as this constitutes an act of criminal supply and may be
prosecuted under the Misuse of Drugs Act.
12.21. Controlled drug stationery
12.21.1. Controlled drug stationery includes:

controlled drug order books

controlled drug registers

controlled drug TTA prescription forms and returns
paperwork
12.21.2. Controlled drug stationery must be stored in a locked cupboard or
drawer at all times and access restricted to those authorised to use
or check it.
12.21.3. The controlled drug cupboard may be used to store controlled drug
stationery.
12.21.4. Controlled drug stationery may be ordered from Pharmacy using a
controlled drug stationery order form signed by a
nurse/midwife/operating department practitioner or pharmacist.
12.21.5. A record of signatures of staff authorised to order controlled drug
stationery will be held by Pharmacy.
12.21.6. The controlled drug stationery order must include the following:
MM0000 Medicines Code
Page 102 of 113

date

name of hospital and ward

signature of person ordering stationery

quantity and type of stationery ordered
Chairman: Graham Foster JP
Chief Executive: David Sissling
12.21.7. Loss or theft of any controlled drug stationery must be reported
immediately to the Designated Practitioner and within one working
day to the CMT Head of Nursing and Chief Pharmacist (who will
report to the Accountable Officer).
12.21.8. Completed controlled drug order books and registers must be
retained for at least two years after the date of the last entry.
MM0000 Medicines Code
Page 103 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
13. UNLICENSED AND O FF LABEL MEDICINES
In order to ensure that medicines are safe, effective and of appropriate quality, their
manufacture and sale or supply is controlled by national and EU legislation.
Accordingly, no medicinal product may be “placed on the market” unless a marketing
authorisation (formerly a product licence) has been granted.
However, in order to preserve prescribers’ clinical freedom, the legislation gives
some exemptions from full control. Thus, medicinal products that are not licensed
may be prescribed in order to fulfil special needs in individual patients, however, the
consequences of prescribing are the responsibility of the individual clinician.
13.1. When can unlicensed medicines be used within the Trust
13.1.1.
It is preferable that prescribers prescribe licensed medicines in
accordance with the terms of their licence, however it is recognised
that there may be instances where for clinical reasons that an
unlicensed medicine(s) are necessary to meet the needs of the
patient.
13.1.2.
Where a licensed medicine is available it is Trust policy to normally
prefer it to be chosen over off-licence or unlicensed medicines in
order to reduce risk to patients.
13.2. Unlicensed Prescribing for Children
13.2.1.
Customised formulations for individual children should be used only
when a patient has a clinical need that cannot be adequately met by
a licensed medicine.
13.2.2.
Guidance on unlicensed and off-label medicines use and doses in
paediatrics which is available in best practice publications, notably
the BNF for Children and other peer reviewed national or
international guidelines.
13.2.3.
Where doses prescribed do not correspond with the BNF for
Children, prescribers are asked to endorse the prescription with the
reference source used.
MM0000 Medicines Code
Page 104 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
13.2.4.
Where an unlicensed medicine is required for the first time the
Consultant requesting must complete a Declaration of Responsibility
for Prescribing Unlicensed and Off Label Medicines form and a
Formulary Application (Appendix 13) form unless the medicine is
being used in accordance with best practice publications.
13.2.5.
Following review by New Medicines Group, if the request is
approved the medicines will be added to the ‘list of unlicensed
medicines /medicines for unlicensed use approved within the trust’,
which will be maintained by NMG
13.3. Prescribing in Critical Care
13.3.1.
Prescribing medicines for ‘off-label’ use is not uncommon in critical
care areas.
13.3.2.
Where an unlicensed medicine is required for the first time the
Consultant requesting must complete a Declaration of Responsibility
for Prescribing Unlicensed and Off Label Medicines form and a
Formulary Application form unless the medicine is being used in
accordance with best practice publications.
13.3.3.
Following review by NMG if the request is approved the medicines
will be added to the ‘list of unlicensed medicines /medicines for
unlicensed use approved within the trust which will be maintained by
NMG
13.4. Prescribing in Haematology/oncology
13.4.1.
Prescribing in advance of a product license is not uncommon within
haematology/oncology specialties.
13.4.2.
Where an unlicensed medicine is prescribed for the first time the
consultant must complete a Declaration of Responsibility for
Prescribing Unlicensed and Off-label Medicines form.
13.4.3.
A full formulary application will be required unless the medicine is
being used in accordance with best practice publications (i.e.
guidelines/protocols approved by LNR cancer network).
MM0000 Medicines Code
Page 105 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
13.4.4.
Following review by NMG, if the request is approved the medicines
will be added to the ‘list of unlicensed medicines /medicines for
unlicensed use approved within the Trust’, which will be maintained
by NMG
13.4.5.
On occasion a clinician may be unaware that their intended use is
outside of the product license. This can happen frequently where a
class of drugs does not have the same licensed range of indications
e.g. the proton pump inhibitors, or in certain clinical conditions e.g.
prescribing during pregnancy. In any case of liability assessment this
would be the basis of defence i.e. that the peer group practice clearly
supported the prescriber.
13.5. Prescribers
13.5.1.
Prescribers should be current in their knowledge to be aware when
they prescribe an unlicensed medicine/licensed medicine in an
unlicensed way
13.5.2.
The clinical pharmacy team will assist in identifying these situations
where possible.
13.5.3.
Only Consultant medical staff are permitted to initiate the prescribing
of unlicensed or off-label medicines.
13.5.4.
Consultant medical staff prescribing an unlicensed or off-label
medicine which is already, or has previously been stocked within the
Trust will use the Declaration of Responsibility for Prescribing
Unlicensed and Off-Label Medicines form (Appendix 13) to confirm
to the Pharmacist that they understand the responsibilities of such
prescribing.
13.5.5.
When prescribing an unlicensed or off-label medicine new to the
Trust an application to use an unlicensed medicine/licensed
medicine in an unlicensed way MUST be submitted by the prescriber
to the New Medicines Group (Appendix 13). The application will be
subject to the same processes as an application for a licensed
medicine.
13.5.6.
In cases of urgent clinical need should be discussed with pharmacy.
MM0000 Medicines Code
Page 106 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
13.5.7.
Junior medical staff may only continue to prescribe unlicensed and
off-label medicines previously initiated within the Trust by a member
of the consultant medical staff.
13.5.8.
A prescriber will, whenever possible, ensure at the time of
prescribing, that the patient (or carer) knows that an unlicensed or
off-label medicine will be prescribed for them.
13.5.9.
It is important the patient understands what a ‘special’ medicine is
and a patient information leaflet (Appendix 14) to be provided to
assist with this. Please contact pharmacy for assistance if additional
information is required for patients who have protected
characteristics.
13.5.10. The prescriber MUST record this activity within the medical notes in
accordance with the Policy 130 Consent for treatment and
examination.
13.5.11. Where it is deemed appropriate for General Practitioners to assume
prescribing responsibility on discharge of the patient, information
must be provided regarding the licence status, prescribing advice
including dose any special monitoring requirements, and information
on availability and supply. Shared Care Agreements may be
required.
13.5.12. The GP may decline to take over the prescribing it is felt that this is
not in the best interest of the patient.
MM0000 Medicines Code
Page 107 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
14.
FP10 PRESCRIPTION FORMS
FP10 prescription forms are used to prescribe for patients, enabling the patient to
take the prescription to a community pharmacy to be dispensed. Unused blank
FP10 prescription forms are liable to fraudulent misuse if lost or stolen.
These forms are, therefore, designated by the NHS as “Controlled Stationery” and,
as such, are subject to close control to minimise the opportunity for misappropriation
and misuse.
FP10 prescription forms that cannot be accounted for must be investigated and
reported to the Accountable Officer or their deputy, with possible referral to the
Police
A national procedure exists for the reporting of missing FP10 prescriptions (the
Accountable Officer will initiate this - Appendix 16).
14.1.
Key Principles
14.1.1.
FP10 pads must be kept secure at all times.
14.1.2.
Only designated clinical areas are permitted to hold and use FP10
prescription forms.
14.1.3.
If a need to use this stationery is identified, approval must be
sought from Pharmacy to become a designated clinical area.
14.1.4.
The nurse/manager in charge of the clinical area is responsible for
the secure storage and use of FP10 prescription forms although the
day-to-day management of this task may be delegated with a
record maintained.
14.2. Ordering FP10 prescription forms from Pharmacy
14.2.1
Only authorised staff, whose signatures are registered with the
Pharmacy Department for the purpose are permitted to order FP10
prescription forms as follows:
14.2.1.1.
FP10 prescription forms can only be ordered on
the specific 3-section FP10 order form (Appendix 15), signed by an
authorised member of staff.
MM0000 Medicines Code
Page 108 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
14.2.1.2. A minimum of five working days’ notice is required, as forms
may need to be ordered from the supplier.
14.2.1.3. Pharmacy will supply the requested forms, completing section 2
of the order form with the serial number of the first and last form
in each pad supplied.
14.2.1.4. Prepared orders must be collected in person from Pharmacy
and signed for by an authorised member of staff as above.
14.2.1.5. Immediately upon receipt in the clinical area, the FP10
prescription pads should be entered into the FP10 log book and
stored in an approved locked cupboard/drawer.
14.3. Returning FP10 prescription forms
14.3.1.
FP10 prescription forms no longer required MUST be returned to
Pharmacy for secure disposal/re-use. They must not be disposed
of by wards/departments directly.
14.3.2.
The nurse in charge or other authorised member of staff must
contact the Pharmacy Department to make arrangements for the
return of the prescription forms to Pharmacy with the log book.
14.3.3.
A designated member of the Pharmacy staff and the designated
returning nurse will jointly check the forms against the logbook and
the logbook will be endorsed accordingly with both persons signing.
14.3.4.
Pharmacy will dispose of the returned forms or return them to stock
for re-issue.
14.4. Secure storage and safekeeping of FP10 prescription forms when not
in use
14.4.1.
FP10 prescription forms must be stored in a controlled drug
cupboard or other designated lockable cabinet/drawer approved in
writing by the Chief Pharmacist.
14.4.2.
The keys to this cupboard/drawer must be held only by the
designated FP10 keyholder when ‘in use’ (see 14.5), or by the
nurse in charge at other times.
MM0000 Medicines Code
Page 109 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
14.4.3.
The keys should not be passed to others when they request keys to
obtain other medicines. For clinical areas with restricted opening
hours, there must be designated storage for the medicines and
controlled drug/FP10 cupboard (see 14.4.1) keys approved by the
Chief Pharmacist.
14.4.4.
A log-book must be maintained of all FP10 prescriptions, detailing
each individual prescription form by serial number with space to
record the following details (as a minimum) when used:


14.4.4.1.
date used:
patient number
prescriber
An A5 notebook is recommended for use as a log book.
There is no specific pre-printed stationery available for this.
14.4.4.2.
The last digit in the serial number is a check-digit. For the
purposes of checking, if this digit is disregarded the forms
within a pad are numbered sequentially.
14.4.5.
During each working day, a reconciliation check of actual
prescription forms held against the log book must be performed by
two nurses to identify missing or unaccounted-for forms.
14.4.6.
A record of this check, and the nurses involved, should be recorded
in the log book.
14.4.7.
Any discrepancies between actual stock and log book must be
investigated immediately as detailed in 14.7 and reported via datix
to the Accountable Officer or their Deputy.
14.4.8.
Areas with high FP10 usage may find it necessary to perform this
reconciliation more frequently such as at each shift or clinic
change.
14.5. Secure management of FP10 prescription forms ‘in-use’
14.5.1.
The period for which FP10s will be considered to be in use is
dependent on the clinical area and the nature of the activity
performed.
MM0000 Medicines Code
Page 110 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
14.5.2.
A designated nurse must be authorised to control access to the
FP10 prescription forms during each shift/clinic, in the absence of
identification of another individual this will be the nurse in charge.
14.5.3.
At the start of the shift the designated nurse MUST sign the logbook to accept responsibility and keys for FP10 prescription forms.
14.5.4.
At the start of the shift two nurses (one MUST be the authorised
nurse) must undertake a reconciliation of prescription forms held
against the log book. This replaces the daily check specified above
and any discrepancies between actual stock and log book must be
investigated immediately as detailed in 14.7.
14.5.5.
Prescribers needing a FP10 prescription form will make a request
to the designated nurse who will obtain a form from the FP10
cupboard/drawer and issue it to the prescriber.
14.5.6.
FP10 prescription forms that are requested but subsequently not
required must be returned to the designated nurse as soon as
possible. Blank forms MUST NEVER be left unattended.
14.5.7.
At the time of issue, the designated nurse will be responsible for
recording the date, prescriber and patient details (as a minimum) in
the log book.
14.5.8.
At the end of the shift/clinic all FP10 forms must be returned to the
FP10 cupboard/drawer and the actual stock of FP10 forms must be
reconciled against the log book and any discrepancies investigated
immediately as detailed in 14.6.
14.5.9.
Handover of the FP10 keys to the nurse in charge or to the next
designated nurse must be recorded in the log book.
14.6. Unused and/or ‘spoilt’ FP10 prescription forms
14.6.1.
If a FP10 prescription form is returned to the designated nurse
unused (ie no longer required) he/she should endorse the logbook
appropriately and return the form to ‘stock’ for re-use.
14.6.2.
If an FP10 prescription form is “spoilt” eg prescribed incorrectly or
otherwise unintentionally made unusable:
14.6.2.1. The prescriber should return the form to the designated nurse
after clearly writing “SPOILT” and signing diagonally across the
MM0000 Medicines Code
Page 111 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
prescribing section of the form, and tearing the form in two or
otherwise rendering it irretrievable.
14.6.2.2. The designated nurse should endorse the logbook accordingly
and retain the two halves in the FP10 cupboard/drawer for return
to Pharmacy when FP10 forms are next ordered.
14.7. Procedure for missing or unaccounted-for FP10 prescription forms
14.7.1.
FP10 prescription forms that cannot be accounted for must be
investigated and reported to the Accountable Officer or their
deputy, with possible referral to the Police.
14.7.2.
The majority of ‘missing’ FP10 prescription forms are a result of
omitted recording or mis-recording of their use. This is the
responsibility of the designated keyholder at the time the
discrepancy is identified.
14.7.3.
The procedures detailed above are designed to ensure that
unaccounted-for FP10 prescription forms are identified at the
earliest opportunity. Increasing the likelihood of swift resolution of
the issue, whilst minimising the work required to resolve.
14.7.4.
All instances of missing/unaccounted-for FP10 forms must be
investigated and reported via datix as soon as they are identified.
14.7.5.
The ward/clinic manager should also be informed immediately, who
will take charge of the investigation.
14.7.6.
The Accountable Officer should be informed (via the on-call
pharmacist if necessary) before investigation commences, with
details of the loss, and may be able to offer advice to assist the
investigation additional to that outlined below.
14.7.7.
The investigation will vary according to clinical area but (until
resolved) should involve activities similar to:-
14.7.7.1. Physical check of all areas where the prescription pad may have
been in use, including clinic rooms, floors, desk drawers,
relevant casenotes and wastepaper bins, etc;
MM0000 Medicines Code
Page 112 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling
14.7.7.2. Check for corroborating entries in other parts of the healthcare
record e.g. relevant casenotes, to identify if usage has been
omitted in the log book;
14.7.7.3. Discussion with all nursing and medical staff on duty to identify
possible use or ’wasting’ of prescription forms unaccounted for in
the log book.
14.7.8.
If investigation resolves the issue, the logbook should be updated
appropriately and the nurse in charge must inform the Accountable
Officer (or on-call pharmacist if already informed of loss earlier) and
ensure that the incident is recorded via the Trust’s Datix incident
reporting system.
14.7.9.
If required the Accountable Officer will consult with the Trust
Security Officer in relation to police involvement who may
commence their own investigation.
14.7.10.
The Accountable Officer will initiate the NHS Protection procedure
for missing FP10 prescription forms if required (Appendix 16).
14.7.11.
Any further action will be led the Accountable Officer and/or Trust
Security Officer, or as a result of any police investigation.
14.8. Prescribing on FP10 prescription pads
14.8.1
When prescribing using an FP10 prescription form, the
prescriber should make a specific FP10 annotation in the
patient’s case notes. This is good practice and will assist any
investigation of ‘missing’ FP10 prescription forms.
14.8.2
For detailed prescribing guidance see Section 4. Prescribing.
14.9 Monitoring compliance and effectiveness
14.9.1
Monitoring compliance of the document will be the through the
quarterly medicines safety and security audits.
14.9.2
Reports from these audits will be submitted to the Medicines
Management Committee and subsequent action plans will be
implemented.
MM0000 Medicines Code
Page 113 of 113
Chairman: Graham Foster JP
Chief Executive: David Sissling