Licensed and Unlicensed Medicines Flashcards
What is the MHRA?
Medicines and Healthcare products Regulatory Agency (MHRA)
- UK medicines regulator
- assigns marketing authorisations (MA)
ensures the safety, efficacy and quality of medicines, medical devices and blood components for transfusion
- licensing body needs to know if the medicine works well with minimal harm to most people who will be taking it, if it’s acceptably safe, its impact on quality and length of life
What is the purpose of licensing?
guarantee that all those involved are answerable to their actions
- accountability
ensure that processes, supplies and quality can be thoroughly monitored
enable swift corrective action to be taken when needed
What is the post Brexit MHRA marketing authorisation route? What is its aim? Who in the MHRA is involved in the licensing process?
150-day assessment
- aim is to ensure availability of medicines for patients in the UK
the Commission on Human Medicines (CHM) reviews all information.
- will either recommend a licence be granted, accept the application subject to modifications, or reject the application with reasons
What are the types of MAs in the UK?
PL
- authorised for use in United Kingdom (Great Britain and Northern Ireland)
PLGB
- authorised for use in Great Britain only (England, Scotland and Wales only)
PLNI
- authorised for use in Northern Ireland only
What are the legal requirements on holders of MAs?
all new licensed medicines are required to comply with strict regulations on labelling
PILs must be provided
- each time a pharmacist makes a supply or sells a medicinal product a PIL must be present
- requirements do not extend to products which are not covered by a MA
= e.g. when extemporaneously prepared, or specials
What is Yellow Card Reporting?
the scheme collects information on suspected problems or incidents involving
- side effects (ADRs)
- medical device adverse incidents
- defective medicines
- counterfeit or fake medicines or medical devices
- safety concerns for e-cigarettes or their refill containers (e-liquids)
What is the difference between unlicensed and off label medicines?
unlicensed medicines
- do not have an MA and is not expected to have one within 2 years
off label medicines
- do have an MA but is used outside of the terms of its MA
= e.g. indication, dose, route, patient population
When can unlicensed and off label medicines be legally dispensed? What must be done when using them?
preparing or dispensing a medicinal product (off-label or without an MA) is allowed
- in accordance with a prescription given by a prescriber
- as long as the product has not been the subject of an advertisement
reasonable steps must be taken to ensure that the prescriber is aware that s/he is using a product outside its MA, or an unlicensed medicine, and what the possible consequences might be
should also bring to the attention of the patient that the product does not have an MA or is being used off-label
What are specials?
medicine manufactured by a specials manufacturer holding a Manufacturer’s Specials License (MS) in multiple quantities with end product analytical testing
special medicine produced by a specials manufacturer holding a MS as a bespoke medicine without end product analysis
Extemporaneously prepared medicine – unlicensed medicines made in a pharmacy (MS not required)
What are extemporaneously prepared medicines?
unlicensed medicines made in a pharmacy
- does not require a manufacturer’s specials license (MS)
What is the difference between a marketing authorisation (MA) and a manufacturer’s specials license (MS)?
MA
- meets all regulatory standards
- is tested and monitored for safety, efficacy and quality
MS
- guarantees sourcing of ingredients, product development, packaging, labelling and manufacturing are all to regulatory standards
- no formal assessment of product safety or efficacy
What is preferred specials or extemporaneously prepared products? Which is easier to use?
specials are preferred as quality can be ensured and safety can be enhanced
- are only supplied when there is no available licensed medicine which fully meets the patient’s clinical needs
extemporaneously prepared products have no guarantees on safety, quality or efficacy
specials are more difficult to procure
- are expensive on the NHS as they are manufactured outside of the UK
- GMP compliance is needed
What is the specials tariff? What is its purpose?
cuts out any opportunity to profit from supply chain mark-ups
- contractors will have to declare any discounts or rebates received
claims for out-of-pocket expenses limited to £20 per special
How can you ensure safety of specials?
try to procure from an appropriate source
- obtain a certificate of analysis or a certificate of conformity with every product
- try and use the same supplier if history of satisfaction)
certificate of analysis
- evidence that critical parameters have been confirmed regarding physical, chemical or microbiological properties
certificate of conformity
- signed statement by manufacturer that they believe the product complies with the purchaser’s specifications
What records must be kept for specials? How long must they be kept for?
a record of the purchase and supply of a special and the specification of the product agreed with the supplier
documentation to verify the specifications which should be obtained on delivery
- must include the batch number and expiry details of the product
patient details
source of product
quantity of each sale or supply
if ordered on a prescription - prescription details and date of dispensing
date the product was supplied
records must be kept for a minimum of 5 years in accordance to MHRA regulations
