NHS FIFE
Unlicensed or Off Label Medicine Request
INTRODUCTION
This form should be completed by the prescriber / supporting pharmacist for EACH request to use an
unlicensed medicine for individuals or groups of patients where there is no approved protocol for its’ use,
or for the off label use of medicines where the risk has been assessed as high as specified in the Code of
Practice – Medicines F5-8)
https://intranet.fife.scot.nhs.uk/atoz/index.cfm?fuseaction=policy.display&objectid=045B2635-C1B141C9-38E01489042FE200
Unlicensed medicines are defined as all medicines with no Marketing Authorisation for ANY formulation
or indication in the United Kingdom. Off label use of medicines is where licensed medicines are used out
with the terms of their Marketing Authorisation.
For those unlicensed / off-label medicines prescribed in hospital and intended for use on a long-term
basis, it is essential that arrangements are made for the continuing prescribing, monitoring and supply
prior to the patient’s discharge, including making contact with the patients community pharmacist, where
appropriate.
General practitioners must not be expected to prescribe unlicensed medicines, but may do so if they feel
it appropriate for their patient, after discussion with the Consultant.
General practitioners may be asked to prescribe off-label medicines, but should be given sufficient
information to do this safely.
The consultant is responsible for ensuring that the relevant General Practitioner is given sufficient
information about the product.
The prescriber must take full responsibility for the use of the unlicensed medicine.
An appropriate clinical risk assessment should be carried out whenever a clinician wishes to use an
unlicensed medicine / off label medicine, with consideration being given to the evidence base for the
medicine, the risks / benefits to the patient or patient group in the proposed setting and peer group
opinion.
The decision to use an unlicensed medicine MUST reflect clinical need and should not be made for
economic reasons.
The patient must be informed and consent to receiving an unlicensed medicine and this must be
documented in the patient’s medical records.
Section 9 of the Medicines Act 1968 permits the use of an unlicensed medicine on a named patient basis.
A Doctor prescribing an unlicensed medicine does so entirely on his/her own responsibility. Prescribing of
an unlicensed medicine may have medico-legal implications.
Pharmacy will take all possible steps to ensure the quality and safety of the unlicensed medicine but this
cannot be guaranteed.
Author: David Mitchell, Principal Pharmacist, Victoria Hospital
Date: September 14
Review date September 16
SECTION 1 :
PRODUCT DETAILS
Drug Form, Name and Dose
Patient’s Name and CHI
Clinical Indication for Use
Outcome of Risk Assessment
High
No of patients per annum
Cost
SECTION 2 :
Intermediate
Low
per annum / Course of treatment
REQUESTING CONSULTANT / SUPPORTING PHARMACIST
Consultant
Pharmacist
Ward / Department
SECTION 3 :
APPROVAL
Approval by Clinical Director (Signature)
Divisional General Manager notified
SECTION 4 :
Y / N
CLINICAL EVIDENCE FOR UNLICENSED MEDICINE (attach relevant references)
Provide a summary of the key evidence for the use of this medicine
SECTION 5 :
PLACE IN THERAPY / ALTERNATIVE TREATMENT OPTIONS
Explain why the unlicensed medicine would be the best option. What are the advantages of this medicine
compared to other medicines licensed for this indication?
Author: David Mitchell, Principal Pharmacist, Victoria Hospital
Date: September 14
Review date September 16
SECTION 6 :
SERVICE IMPLICATIONS e.g. specialist assessment, monitoring requirements.
RETURN FORM TO PHARMACY DEPARTMENT
Author: David Mitchell, Principal Pharmacist, Victoria Hospital
Date: September 14
Review date September 16
Risk Assessment for Off Label Use
Medicine is not licensed
for this indication
Off Label Use
Risk Assessment
Medicine is not licensed
for any indication or
formulation in the UK.
Unlicensed Medicine
High Risk
Only evidence for use is based on :
•Phase I Clinical Trial Data
•Case Reports in established Journals
Route of Administration
•Intrathecal
•Epidural
Intermediate Risk
Only evidence for use is based on :
•Phase II/III Clinical Trial Data
Reported incidence of significant damage due to side effects
•High risk of life threatening or disabling side effects / toxicity
•Teratogenic
•Carcinogenic
•Requires ongoing monitoring e.g. full blood count, LFTs etc.
Type of Agent
•Cytotoxic
•Biological agent
Low Risk
Well established medicine for use in specific indication.
Does not fall into above categories
Low / Intermediate Risk
High Risk
< £2,500
> £2,500
Prescribe
Author: David Mitchell, Principal Pharmacist, Victoria Hospital
Complete Unlicensed
Medicine Request and
Forward to Pharmacy
Requires approval from
Clinical Director
> £2,500
< £2,500
Notify Divisional
General Manager
Prescribe
Date: September 14
Review date September 16