Request for a Medicine to Be Added to the Fife Joint Formulary

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-C1B1-41C9- 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 Intermediate Low

No of patients per annum Cost per annum / Course of treatment

SECTION 2 : REQUESTING CONSULTANT / SUPPORTING PHARMACIST

Consultant Pharmacist

Ward / Department

SECTION 3 : APPROVAL

Approval by Clinical Director (Signature)

Divisional General Manager notified Y / N

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 licensed for this indication?

SECTION 6 : SERVICE IMPLICATIONS e.g. specialist assessment, monitoring requirements.

Review date September 16 RETURN FORM TO PHARMACY DEPARTMENT

Review date September 16 Risk Assessment for Off Label Use Medicine is not licensed Medicine is not licensed for this indication High Risk for any indication or Only evidence for use is based on : Off Label Use •Phase I Clinical Trial Data formulation in the UK. •Case Reports in established Journals Unlicensed Medicine 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 Risk Assessment •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

Complete Unlicensed Low / Intermediate Risk High Risk Medicine Request and Forward to Pharmacy Requires approval from Clinical Director

< £2,500 > £2,500

> £2,500 < £2,500

Notify Divisional Prescribe Prescribe General Manager

Review date September 16