301 Off label/unlicensed use Flashcards
Medicinal product
A substance or combination of substances presented as having properties, or used, to prevent, treat or diagnose a disease
Marketing authorisation
Permission to manufacture for sale a specific product
Licensed product
A specific medicinal product, licensed by a specific company, for which there is a marketing authorisation
SmPC - summary of product characteristics
Essential information about the product that forms part of the marketing authorisation
Authorised mode of use
How a licensed product can be used, as detailed in the SmPC
Off-label prescribing
Prescribing an authorised medicinal product in a way not described in the SMPC
Unlicensed product
A medicinal product that has no marketing authority (a.k.a specials)
Types of off label prescribing
- Not approved for intended indication
- Approved for intended indication but not in other respects
Examples of not approved for intended indication off-label
- Brand not approved but other brands are
- Drug not approved but other drugs in class are
- Med. not approved or any in class
- Med. approved and used in cases where indication assumed (not known)
Examples of approved for intended indication off-label
- Unapproved age group
- Unapproved dosage regime
- Unapproved route of administration
- Omission of therapy of drug mandated to be used with primary drug
- Omission of mandated monitoring
Reasons for using unlicensed medicines:
Specific groups
Specific therapeutic area
Specific patient factors
- Children & elderly
- Ophthalmic & dermatological
- Difficulty swallowing & enteral feeding
Responsibilities for prescribing unlicensed/off-label medicines
- Satisfied sufficient evidence of using med. with safety & efficacy
- Responsible for prescribing medicine, overseeing care, monitoring and follow-up
- Make clear, accurate legible record of all med. prescribed and when not following common practice, reasons for prescribing an unlicensed med.
Understanding patients experience & shared decision
Discuss use of unlicensed med.
Support patient/carer with practical issues, implications and keep them informed
Provide patient with PIL
How to identify a preparation and supplier with unlicensed use?
Different suppliers = different formulations
Potential problems with bioavailability
Follow local guideline
Conscious of price
Dispensing an unlicensed medicine
A special - produced by a licensed specials manufacturer
Extemporaneous dispensing
Manipulation of licensed medicine
Record keeping for unlicensed medicines
- 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)
Prescribing principles
- Establish optimal treatment for patient
- Understand patient experience & make shared decision
- Identify a preparation & supplier
- Monitor patient & review need for special
- Ensure effective governance
Considerations when dispensing an unlicensed medicine
- Identify licensed meds., ensure prescriber/patient aware, assess risk/benefit
- Ensure continuity, provide info for meds, available for advice
- Responsibility for quality, ensure continuity
- Continued need for unlicensed med, ADRs, record keeping
- Quality system, record keeping
Reimbursements for specials (part VIIIB)
Endorse SP for procurement fee
(Product variations included, minimum you will get paid & price paid for anything above minimum)
Specials that are not part VIIIB
(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
