PORTSMOUTH HOSPITALS NHS TRUST
CLINICAL POLICIES
Section 3.47
PHT POLICY FOR THE USE OF
UNLICENSED MEDICINAL PRODUCTS
TITLE
REFERENCE
NUMBER
MANAGER /
COMMITTEE
RESPONSIBLE
3.47
Trust Chief Executive is responsible for ensuring compliance with current UK
medicines legislation.
Jeff Watling is Director of Pharmacy and Medicines Management, PHT and is
responsible for compliance with medicines legislation, and the implementation of
safe systems of work.
DATE ISSUED
26.06.2006
VERSION
1
REVIEW DATE
JUNE 2009
AUTHOR
Mel Stevens, Principal Pharmacist
Equality Impact
Assessment has been
applied to this policy
Mel Stevens, Principal Pharmacist
RATIFIED BY
PROFESSIONAL ADVISORY COMMITTEE – JUNE 2006
CONTENTS:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Introduction / Background
Status
Purpose
Scope
Definitions
Processes
Duties and Responsibilities
Training
Associated Documentation
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1. Introduction / Background
The majority of medicines supplied against a prescription or sold in the UK are manufactured and sold
under the terms of a Product Licence, within the meaning of the Medicines Act, 1968. The licensing
process subjects products to rigorous assessments of quality, safety and efficacy. Medicinal products that
do not have a licence, for any reason, may not have not undergone such scrutiny, and may therefore
carry a higher level of risk to patients.
Wherever possible licensed products will be the preferred choice, but there are many occasions where
the use of an unlicensed medicinal product is entirely appropriate and in the patients’ best interests.
Prescribers should fully understand the legal, ethical and practical implications of prescribing unlicensed
medicines.
Robust systems should be in place for whole process involving unlicensed medicines. i.e. approval of
clinical appropriateness; ordering and procurement; evaluation of the sources of these medicines and the
manufacturers’ quality systems; evaluation of the product for satisfactory quality; quarantine, approval
and release when in house quality control is required.
2. Status: Clinical Policy
3. Purpose
The purposes of this Policy are to:
 ensure the Trust is acting in accordance with the Medicines Act, 1968 regarding the use of
unlicensed medicines,
 safeguard patients against the risk of harm and minimise the likelihood of claims resulting from the
consequences of using unlicensed products.
 make clear the responsibilities of the Trust and its employees, when dealing with unlicensed
medicines.
4. Scope
This policy applies to
 Doctors and dentists who prescribe unlicensed medicines in the course of their duties
and
 Pharmacists and pharmacy staff involved in the ordering, procurement, pharmaceutical
evaluation/quality control, and supply of unlicensed medicines.
5. Definitions
Medicinal Product
Any substance or combination of substances presented for the purpose of treating or preventing disease
in human beings, or administered with a view to making a medical diagnosis or modifying physiological
functions.
Licensed Medicinal product
The majority of medicines sold to or prescribed for patients in the UK have a Product Licence (PL) issued
by the Medicines and Healthcare Products Regulatory Authority (MHRA), or a pan-EU Marketing
Authorization issued by EMEA (European Medicines Agency). The manufacturer is required to
demonstrate to the regulatory body the safety, efficacy and quality of the product when used for the
treatment of a stated range of indications in a defined patient group.
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Unlicensed Medicines: Medicines which are not the subject of a UK Product Licence or EU Marketing
Authorization.
Unlicensed medicines can be grouped as follows:


Specials - Unlicensed medicines which are obtainable from UK commercial suppliers or from NHS
pharmaceutical manufacturing units, under a Manufacturer’s Licence (Specials), issued by the
MHRA.
Medicines licensed for use and prepared commercially in other countries, but which are not licensed
for use in the UK. These can be imported and provided on a Named patient basis.
Technically, the following are also “unlicensed”, but are not considered by this policy, which is concerned
with the handling of unlicensed products rather than unlicensed use.
 Extemporaneous preparations - Medicines prepared for a specific patient in accordance with a
prescriber’s instructions. This is usually a one-off dispensing of a compounded product against an
individual prescription. When dispensed in a registered pharmacy, no Manufacturer’s Licence is
necessary. Products of this type are prepared under “Section 10 exemption” of the Medicines Act.

Repackaging and Over-labelling - a licensed medicine which has either been repackaged from its
original primary packing into a different container or over-labelled in its original pack is rendered
unlicensed. For instance,
 Integrity of Sterile products must be maintained
 Non-sterile products (e.g. tablets, syrups) are commonly decanted and it is pharmacist’s
responsibility to ensure that a suitable container is used so that the product is not adversely
affected by the change of primary pack.
 Small batches (e.g. TTO pre-packs) may be infrequently prepared prior to issue under the
supervision of a pharmacist as a section 10 exemption.
 Larger scale pre-packing is performed under a Manufacturers Specials licence.

Off licence indications – Use of a licensed medicinal product outside the terms of the product
licence.
UK
PL
MHRA
EMEA
DPC
GP
BP
BNF
WLS
United Kingdom of Great Britain and Northern Ireland
Product Licence
Medicines and Healthcare products Regulatory Agency
European Medicines Evaluation Agency
Drug Purchasing Centre
General Practitioner
British Pharmacopoeia
British National Formulary
Wessex Laboratory Services
The terms “must” or “may only” are used to indicate a legal requirement, “should” indicates Trust Policy
recommendations.
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6. Processes
6.1
PRESCRIBING UNLICENSED MEDICINES
Unlicensed medicines may only be used when;



There is not a suitable licensed alternative
It is accepted best current clinical practice. Clinical appraisal and approval of the therapy by
Formulary & Medicines Group and the Area Prescribing Committee, permits inclusion in the District
Prescribing Formulary for routine treatments. The principle also applies to one-off individual
prescriptions, which must be approved via the established process.
The prescriber has completed a “request and declaration” form for unlicensed use of medicines
acknowledging the unlicensed status of the treatment and declaring that they take full responsibility
for the use of this medicine for an individual patient or group of patients.
Patient-specific requests from a consultant for a product not listed in the Catalogue of Approved
Unlicensed Medicinal Products (see below) must be submitted for consideration to the Medical Director or
Chair of Formulary & Medicines Group, ensuring the requested details are complete, and authorised in
the same way as other non-formulary drug use.
All therapeutic prescribing of unlicensed medicinal products will be reported to the Formulary & Medicines
Group. The Formulary & Medicines Group will review the use of Specials and Named Patient medicines
in their annual report.
The prescriber should document in the patient’s medical notes the advantages and disadvantages of
choice of an unlicensed agent, ideally including reference to the evidence base and their experience. A
note should also be made of why other licensed medicines have not been prescribed or if they have
previously been tried. Consideration should be given to the need for a second opinion.
The prescriber should explain to the patient/carer that the medicine is not licensed for use, and the
intended benefits and risks of taking the medicine.
The prescriber should obtain and record the patient’s consent before prescribing (See 6.3 below)
The screening pharmacist (i.e. ward pharmacist for in-patients or dispensary pharmacist for outpatients)
should make sure that the prescriber is aware that the medicine is unlicensed and ask him/her to
complete form PHPSF 22.004 –Request and Declaration Form for an Unlicensed Medicine to be Supplied
including a countersignature of the consultant. The prescription should be screened as per usual Work
Instruction (PHPSWI 22.001 Screening prescriptions)
Nurse Independent Prescribers and Pharmacist Independent Prescribers cannot prescribe unlicensed
medicines, but are able to prescribe licensed medicines for uses outside their licensed indications within
their area of expertise and competence. They should only prescribe ‘off-label’ where it is accepted as
appropriate clinical practice and must accept legal responsibility for doing so.
Bespoke procurement and dispensing arrangements should be made in consultation with the Pharmacy
Dispensary (see 6.4 below).
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6.2
SYSTEM FOR APPROVAL AND SPECIFICATION OF UNLICENSED MEDICINAL
PRODUCTS
Unlicensed medicinal products in routine therapeutic use will be listed in a designated section of the
District Prescribing Formulary.
A database cataloguing all unlicensed medicinal products supplied by pharmacy will be developed and
available on the intranet. Information included will be the product specification, supplier particulars,
licence status, approved indications, restricted prescriber(s) or specialty and formulary status.
The list will be developed and maintained by the Formulary Pharmacist, in conjunction with the
Dispensary Managers.
Newly purchased products will require quality assurance evaluation (See 6.8 below).
6.3
CONSENT
Informed consent should be obtained for all treatments as appropriate to the circumstances.
Patients should be made aware that the treatment they have been prescribed is unlicensed and provided
with adequate information on the anticipated benefits and possible side-effects. Patients should also be
made aware that because of the nature of the medicine involved it may be a condition of the supply
process that their name is provided to the supplier. To do so without the patient’s consent would breach
confidentiality. The patient can be reassured that all parties (stores personnel, the company etc.) are
bound to maintain confidentiality consistent with data protection rules.
The prescriber should obtain and record the patient’s agreement to treatment before prescribing.
Written consent is not required if the use is conventional and straightforward e.g. it is listed in the BNF,
adult or paediatric formularies or the District Prescribing Formulary.
Written consent is mandatory for some treatments; special documentation and/or registration may be
required (e.g. thalidomide).
In situations where the use of unlicensed medicinal products is unconventional or might confer risks,
consideration should be given to obtaining consent in writing.
If this is not possible (i.e. where a patient lacks capacity) then where possible the situation should be
discussed with a senior colleague. It is only in an emergency situation due to necessity when prompt
action is clinically indicated, that a doctor may act without consent. Individual clinical judgement should be
used to determine whether or not to obtain verbal or written consent. In either case the action and
rationale should be documented clearly in the patient’s medical notes as being in the best interests of the
patient.
Please refer to Consent Policy for further guidance on obtaining consent.
6.4
PROCUREMENT OF APPROVED UNLICENSED MEDICINAL PRODUCTS
Once authorised on clinical/formulary grounds for purchase, a product appearing in the Catalogue of
Approved Unlicensed Medicinal Products may be ordered.
See 6.8 below for route of approval of a new product/supplier and subsequent inclusion in the catalogue.
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The screening pharmacist, in possession of a valid prescription, should make a copy of the completed
form and proceed to initiate an order as per Work Instruction PHPS WI 16.002 Ordering pharmaceutical
stock. Any specific arrangements made with the prescriber and/or patient regarding supply, expected
arrival, collection, contact details etc should be noted with this paperwork.
6.5
DISPENSING, STORAGE AND RECORD-KEEPING
Unlicensed medicinal products are dispensed as per usual procedures according to current recognised
departmental Work Instructions.
Named patient and special product items are stored in designated shelf locations in each dispensary.
JAC pharmacy computer system will highlight that the product is unlicensed.
The dispensary log of issues PHPSF 05.008 - Unlicensed Drugs (Named Patient and Specials) Record of
Supplies. will be completed. The following details should be fully documented by the dispenser, and the
page left with the items for final checking.
 Date
 Patient’s name
 Consultant’s name
 Ward or clinic
 Quantity supplied
 Batch number(s)
 Expiry date
The forms will be stored in a Yellow lever arch file called “Unlicensed Drugs (Named Patient and
Specials)” which is kept in each dispensary.
These records are legally required to be kept for 5 years. In practice they will be stored in the pharmacy
archive system and retained for 8 years.
6.5
ADMINISTRATION OF UNLICENSED MEDICINES
Staff administering unlicensed medicines should be aware of their unlicensed status and the
responsibilities of prescribers, pharmacists and nurses in the use of these products. See section 7 below.
By definition unlicensed medicines are not permitted to be supplied or administered under Patient Group
Directions, apart from in exceptional and justified circumstances. Refer to the Patient Group Directions
Steering Group for advice.
6.7
CONTINUATION OF SUPPLY
If treatment with an unlicensed medicine is required to continue on discharge the clinician should inform
the GP. A letter, information sheet and any supply details should be provided. It should be noted that the
GP is under no obligation to continue the prescribing of unlicensed medicinal products. Agreement can
usually be reached to best serve the patient’s interests. An associated agreed shared care guideline for
therapeutic use is helpful to support this.
Some products are only available from hospital pharmacy and not from a community pharmacy (local
chemist). In this case, the prescriber will be informed that they will need to prescribe the whole course of
treatment.
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6.8
APPROVAL PROCUREMENT AND QUALITY ASSURANCE OF UNLICENSED MEDICINAL
PRODUCTS NOT PREVIOUSLY PURCHASED
A monograph for the electronic database that is the Catalogue of Approved Unlicensed Medicinal
Products should be drawn up. Details of the product specification, approved indications, authorised
prescribers (named or specialty), source, supplier should be submitted to the Formulary Pharmacist.
On the delivery of first purchase of a new Unlicensed Medicinal product the item will be quarantined
awaiting release. All or part of the consignment will be sent to Wessex Laboratory Services (Quality
Control) who are required to evaluate the product assess it against any certificate of analysis
On passing quality control evaluation as satisfactory for use, the product can be released for use and the
details added to the Catalogue.
7. DUTIES AND RESPONSIBILITIES
7.1 The Prescriber
The prescriber has a duty to act in accordance with a responsible body of medical opinion.
It is the responsibility of the prescriber to:
 be aware of when a medicine he/she is prescribing does not have a product licence, and to be aware
of the extra responsibility and liability that this carries
 document this by completing form PHPSF 22.004 Request and declaration for supply of Unlicensed
Medicinal Product, which needs to be countersigned by a consultant.
 make the specification for an unlicensed medicinal product clear to the pharmacist.
 be aware of when he/she is prescribing a licensed medicine outside the scope of its Product Licence
and to be aware of the extra responsibility and liability this carries.
 explain to the patient/carer that the medicine is not licensed for use, the reason for this and the
intended benefits and risks of taking the medicine.
 warn the patient about potential side-effects.
 obtain informed consent to treatment
 document the advantages and disadvantages of prescribing an unlicensed agent
 monitor and follow up treatment
 notify the patient’s GP
7.2 The Pharmacist(s)
Pharmacists have a duty to act in accordance with a responsible body of pharmaceutical opinion and a
duty of care to ensure that any supply is made in the best interests of the patient.
It is the responsibility of the screening pharmacist (ward pharmacist for inpatients or dispensary
pharmacist for outpatients), to:
 ensure that the prescriber is made aware in cases where a medicine prescribed is available only as
an unlicensed product.
 ensure that form PHPSF 22.004 is duly completed before a product is ordered or supplied to a
patient.
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Additionally,
 Even though the prescriber may sign a declaration accepting full responsibility for any adverse
effects, potential liability may be shared between the pharmacist and prescriber, depending upon the
facts in each case.
 The pharmacist should make sure that the patient is aware that a medicine is unlicensed, without
undermining the patient’s confidence in either the prescriber or the prescribed medicine.
It is the responsibility of the ordering pharmacy staff to:






If the product is listed in the Catalogue of Approved Unlicensed Medicinal Products it may be ordered
from the approved supplier. (Note: Named Patient products are routinely ordered only once a week)
To negotiate the likely lead time for supply and inform the relevant pharmacist dealing with the
prescription, or dispensary manager, so that the patient can be kept informed.
Follow the steps given in the procurement decision tree (PHPS WI 16.002 Ordering pharmaceutical
stock), in order to determine a suitable supplier. Refer to the relevant pharmacist dealing with the
prescription, or dispensary manager, if alternatives need to be considered.
To receive (see PHPSWI 16.001 Receipt of Pharmaceutical Stock) and quarantine non-approved
unlicensed medicines on receipt, pending evaluation.
To organise independent prospective quality control tests to the product.
To receive the results of quality control tests from Wessex Laboratory Services and, if satisfactory, to
formally approve the medicines for use and release them from quarantine for dispensing.
7.3 The Nurse
Nurses have a duty to act in accordance with a responsible body of nursing opinion.
It is the responsibility of the nurse to:
 be aware of when a medicine he/she is administering does not have a product licence,
 confirm that the patient is aware of the unlicensed status of the medicine,
 obtain informed consent for administration
 be satisfied that there is sufficient information to administer the drug safely and, wherever possible,
that there is acceptable evidence for the use of that product for the intended indication.
7.4 Liability
Licensed Medicines Used Outside The Terms of their Product Licence:
Under the rules of “strict liability” under the Consumer Protection Act, 1987, the Trust can transfer liability
to the manufacturer of a product which causes harm. However, this is true only when the product has
been used within the terms of its design specification. For a licensed medicine, this means the terms of its
Product Licence. Therefore, if a licensed medicine is used to treat clinical conditions or persons outside of
its licensed indications, the Trust could not pass on the liability to the pharmaceutical company unless the
product was defective, faulty or of poor quality.
Unlicensed Medicines:
If the substance being used to treat the patient does not have a Product Licence or EU Marketing
Authorisation, responsibility for any consequences of its use rests with the prescriber (provided that it was
prepared in accordance with his/her specification) or with the pharmacist if the medicine does not comply
with the prescriber’s specification.
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Should any clinical negligence claim arise, with regard to NHS patients, it would be brought against the
Trust and would be handled through the NHS Litigation Authority’s Clinical Negligence Scheme for Trusts
(CNST). Any liability will be dependent upon the facts of the case and whether the product is/was used in
accordance of a responsible body of opinion.
8. TRAINING
Education and training for all existing pharmacists will be via a briefing in the pharmacy newsletter and
email notification at issue of this policy and the associated Work Instructions.
Training on this policy for new pharmacists and other relevant pharmacy staff will be included in their
induction package.
9. ASSOCIATED DOCUMENTATION







Royal Pharmaceutical Society of Great Britain: Professional Standards Fact Sheet 5: The use of
unlicensed medicines in pharmacy.
Royal Pharmaceutical Society of Great Britain: Medicines, Ethics and Practice Guidance (29), July
2005
Medicines Act, 1968
MHRA Guidance Note No 14. The supply of unlicensed relevant medicinal products for individual
patients. May 2005.
Trust Clinical Governance Committee: Policy for Gaining Informed Consent
Pharmacy ISO Work Instructions and Forms as referred to in the Processes above
NMC Guidelines for Administration of Medicines, 2004
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