NHS FIFE
Unlicensed Medicine Request /

INTRODUCTION

This form should be completed by the prescriber / supporting pharmacist for all requests to use an unlicensed medicine for individuals or groups of patients.

Requests should be for medicines which can be obtained but are not licensed within the United Kingdom.

The prescriber must take full responsibility for the use of the unlicensed medicine.

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.

SECTION 1 : REQUESTING CONSULTANT / SUPPORTING PHARMACIST
Consultant / Pharmacist
Ward / Department
Request supported by Clinical Director, General Manager or Management Accountant / Y / N
SECTION 2 : PRODUCT DETAILS
Drug Form, Name and Dose
Indication for Use
No of patients per annum / Cost per annum / Course of treatment
SECTION 3 : RESTRICTIONS
Suitable for prescribing in Primary Care ð / Specialist / Consultant Use Only ð
Initiation restricted to Specialist ð / Hospital Use Only ð
To be used in accordance with protocol (attach copy) ð
SECTION 4 : 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 for this indication.
SECTION 6 : SERVICE IMPLICATIONS e.g. specialist assessment, monitoring requirements.

RETURN FORM TO PHARMACY DEPARTMENT

Unlicensed Medicine Request