Unlicensed Medicines Flashcards
What are Unlicensed Medicines?
Those medicinal products without a UK Marketing Authorisation as issued by MHRA – Licensed products may be identified by PL or MA followed by number
- The Law requires that only licensed medicines should be made available and supplied.
what is a Marketing Authorisation ?
a guarantee of the quality, safety and efficacy of a medicine when used in accordance with the Summary of Product Characteristics.
which act governs the sale and supply of medicinal products for human use
Human Medicines Regulations 2012 and Medicines Act 1968
- Medicines cannot be placed on the market without authorisation
which act provides an exemption from the need for a marketing authorisation of a medicinal product in response to an unsolicited order?
1) Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product which is supplied: in response to an unsolicited order
2) manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber
what is meant by off-label?
Using a Licensed Medicinal Product outside what is written in the Summary of Product Characteristics.
- e.g. Age, Dose, Condition
outline MHRA Guidance Note 14
How to interpret Human Medicines Regulations 2012
1) Use of Unlicensed Medicine only justified when there is no licensed medicine which fully meets patient’s clinical needs– not cost, convenience or operational.
2) All in supply chain aware of medicine status
3) Records of supply to be kept for 5 years
with regards to unlicensed medicines, who is responsible for the product that is handed to the patient?
1) Responsibility for the product lies with the prescriber and with the pharmacist
2) Need to be sure giving best quality product to the patient-where patient is put at least risk
when might you need to give an unlicensed medicine?
Clinical need established
1) Intolerant to excipient
2) Unable to swallow solid dose formulation
describe the hierarchy of risk for unlicensed medicines
1) UK licensed medicine: Undergone rigorous assessment for Quality, safety and efficacy
2) Off label use of UK licensed medicine
3) Imported product licensed in country of origin - Standards equivalent to UK?
4) UK manufactured product made in MHRA licensed facilities
5) Extemporaneously dispensed medicine
6) Imported product not licensed in country of origin
7) Food supplement/cosmetics
what is a Certificate of analysis ?
1) Variation – detail – relevance to product
2) What is being tested and why? Use the European Pharmacopoeia/British Pharmacopoeia as a guide.
3) Process and product checks
what is a Certificate of conformity?
Usually only states complies with specification – only useful if you know the specification.
what is an Extemporaneously prepared medicine and comment on its safety and efficacy
1) Medicines made in a pharmacy under the supervision of a pharmacist.
2) No end product testing.
3) Quality –professional responsibility
4) Safety and Efficacy not formally tested no information
outline the issues with the use of Imported product not licensed in country of origin
1) Need to establish quality
2) Safety and Efficacy not formally tested
outline the issues with the use of Food supplement /cosmetic?
1) Need to establish quality
2) Safety and efficacy not formally tested
discuss the use of UK manufactured product made in licensed facilities
1) identified by MS followed by number- register on MHRA website
2) Quality: Premises suitable -checked by MHRA –licensed for product type.
- Audits may be available.
- Product formula and method of production can be confirmed.
- Final product testing may be done and confirmed by means of certificate of analysis
3) Safety and Efficacy – not formally tested – usually no SPC or equivalent/information for patients
