NHS FORTH VALLEY
UNLICENSED MEDICINE TREATMENT REQUEST
How to complete this form:
 This form should be completed by the requesting clinician/ clinical pharmacist where a medicine that does not contain a UK
product licence is being considered for use OR is an Expanded Access Medication.
All sections of the form must be completed, and agreement to prescribe obtained prior to prescribing/requesting the
medicine to ensure that delays in treatment are minimised.
What to do with the form once complete:
 The requesting consultant should send the completed form to Medicines Information, Pharmacy Department. Where the
treatment cost ≥ £10,000 per patient per annum or treatment cost for estimated total number of patients exceeds £50,000,
the form will be forwarded to the Exceptions Committee for consideration.

SECTION 1:
PRESCRIBER, PATIENT & MEDICINE DETAILS
Patient Details:
Attach addressograph or use patient CHI number and
postcode
CHI Number:
Ward/
department/
practice:

 
Postcode:
Name of Prescriber:
(print clearly in
capitals)
Contact
number:
Medicine name and
formulation requested
Indication:
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SECTION 2a
Details of the Unlicensed Medicine (ULM) and the
Clinical Evidence supporting this request.
(To be completed by the clinical pharmacist/the prescriber)
This request is for:
Please tick box
A - Prescribing of an Unlicensed Medicine
B - Prescribing of a medicine from a completed
Clinical Trial


Product
Name:………………………………………………….................………………………………….
Proprietary Name (if
applicable)……………………………………………………………..:……..………
Pharmaceutical Form:
……………………………………………………………………………………….
Strength:
……………………………….………………….…………………………………………………..
Manufacturer: (if
known)…………...……………………….………………………………………………..
Dose and frequency:
……………………………..……………..……………………………………………
Route:
………………………………………..…….………………………………………………………….
.
Length of
treatment:………………………………………..…………………………………………………
Cost of each treatment course per
patient:………………………………………………………………..
Estimated number of
patients:………………………………………………………………………………
Section 2b Clinical Evidence supporting this request
A practitioner prescribing an unlicensed medicine or a licensed medicine for an unlicensed
condition does so under his/her own responsibility. Consequently, he/she carries the
burden of the patient’s welfare and may be called upon to justify their actions. A
pharmacist will share the responsibility in situations where they have been involved in the
procurement and purchase of an unlicensed medicine, where this involves specifying the
product or if their actions/omissions have contributed to harm. Pharmacists will not be held
accountable for “off label” use. Clinicians must make patients aware of the unlicensed
nature of the treatment and gain their consent before use. This should be documented in
the patient’s clinical notes.
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It is the responsibility of the requesting clinician to demonstrate the clinical case for the
individual patient, such that the following criteria are satisfied:
•
demonstrate that the patient’s potential response to treatment with the unlicensed
medicine outweighs the risk of using an unlicensed product.
and
•
clearly describe the arrangements to monitor and review the patient’s response to
the medicine.
Is there any clinical evidence for prescribing this medicine? Y/N (delete as
appropriate)
(Please attach evidence to this form)
What are the risks to the patient not receiving this medicine?
…………………………………….
What special precautions / monitoring is required whilst the patient is receiving this
medicine?
……………………………………………………………………………………………………..
What are the reported side effects / toxicity of this medicine?
………………………………………
SECTION 3
Final Approval Process
(To be completed by the requesting Consultant/
Clinical Pharmacist and AMD.)
Name of Consultant:
Name of Clinical Pharmacist:
………………………….……………
…….
……………………………………
…….
Signature of Consultant:
Signature of Clinical
Pharmacist:
………………………………………
……..
……………………………………
…….
Unit/Speciality
……………………………….………
…….
Date: ……………………….
Date: ………………………….
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Name of Associate Medical Director
…………………………
Signature of Associate Medical Director
…………
… … … … … … … … … … Date … … …
NOTE:
For treatments costing < £10,000 per patient per annum, the AMD is responsible for
alerting the General Manager and Finance if the cost or the demand for use will have
significant impact on budgeting.
For treatments costing ≥ £10,000 per patient per annum or >£50,000 per annum for
the total potential number of patients, the AMD is responsible for considering the
use on clinical grounds but the request must be forwarded to the Exceptions Panel
for final approval before prescribing. In this instance the completed form must be
sent to the Medicines Information Pharmacist for processing through the
exceptions pathway.
In some cases the AMD may wish to refer approval of the use of this medicine to the
Chair of the Drug and Therapeutics Committee.
PLEASE FORWARD THE COMPLETED FORM TO -The Medicines Information
Pharmacist.
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