301 Off label/unlicensed use

Question 1

Medicinal product

Answer 1

A substance or combination of substances presented as having properties, or used, to prevent, treat or diagnose a disease

Question 2

Marketing authorisation

Answer 2

Permission to manufacture for sale a specific product

Question 3

Licensed product

Answer 3

A specific medicinal product, licensed by a specific company, for which there is a marketing authorisation

Question 4

SmPC - summary of product characteristics

Answer 4

Essential information about the product that forms part of the marketing authorisation

Question 5

Authorised mode of use

Answer 5

How a licensed product can be used, as detailed in the SmPC

Question 6

Off-label prescribing

Answer 6

Prescribing an authorised medicinal product in a way not described in the SMPC

Question 7

Unlicensed product

Answer 7

A medicinal product that has no marketing authority (a.k.a specials)

Question 8

Types of off label prescribing

Answer 8

1. Not approved for intended indication
2. Approved for intended indication but not in other respects

Question 9

Examples of not approved for intended indication off-label

Answer 9

1. Brand not approved but other brands are
2. Drug not approved but other drugs in class are
3. Med. not approved or any in class
4. Med. approved and used in cases where indication assumed (not known)

Question 10

Examples of approved for intended indication off-label

Answer 10

1. Unapproved age group
2. Unapproved dosage regime
3. Unapproved route of administration
4. Omission of therapy of drug mandated to be used with primary drug
5. Omission of mandated monitoring

Question 11

Reasons for using unlicensed medicines:
Specific groups
Specific therapeutic area
Specific patient factors

Answer 11

1. Children & elderly
2. Ophthalmic & dermatological
3. Difficulty swallowing & enteral feeding

Question 12

Responsibilities for prescribing unlicensed/off-label medicines

Answer 12

1. Satisfied sufficient evidence of using med. with safety & efficacy
2. Responsible for prescribing medicine, overseeing care, monitoring and follow-up
3. Make clear, accurate legible record of all med. prescribed and when not following common practice, reasons for prescribing an unlicensed med.

Question 13

Understanding patients experience & shared decision

Answer 13

Discuss use of unlicensed med.
Support patient/carer with practical issues, implications and keep them informed
Provide patient with PIL

Question 14

How to identify a preparation and supplier with unlicensed use?

Answer 14

Different suppliers = different formulations
Potential problems with bioavailability
Follow local guideline
Conscious of price

Question 15

Dispensing an unlicensed medicine

Answer 15

A special - produced by a licensed specials manufacturer
Extemporaneous dispensing
Manipulation of licensed medicine

Question 16

Record keeping for unlicensed medicines

Answer 16

• Source from which and date on which the special was obtained
• Person whom special was supplied to
• Quantity of supply
• Batch number from which supply was made
• Detailed any suspected ADR to product (current or subsequent)

Question 17

Prescribing principles

Answer 17

1. Establish optimal treatment for patient
2. Understand patient experience & make shared decision
3. Identify a preparation & supplier
4. Monitor patient & review need for special
5. Ensure effective governance

Question 18

Considerations when dispensing an unlicensed medicine

Answer 18

1. Identify licensed meds., ensure prescriber/patient aware, assess risk/benefit
2. Ensure continuity, provide info for meds, available for advice
3. Responsibility for quality, ensure continuity
4. Continued need for unlicensed med, ADRs, record keeping
5. Quality system, record keeping

Question 19

Reimbursements for specials (part VIIIB)

Answer 19

Endorse SP for procurement fee
(Product variations included, minimum you will get paid & price paid for anything above minimum)

Question 20

Specials that are not part VIIIB

Answer 20

(Produced for individual patient)
Endorse product details
1. Invoice price minus discount
2. Manufacturers MHRA license no.
3. Batch no.
Pack size
Endorse SP for endorsement fee