Legal Classification Of Medicines Flashcards
Define the term medicinal product (2)
1) Any substance or combination of substances presented as having properties of preventing or treating diseases in human beings
2) Any substance or combination of substances that may be used by or administered to human beings with a view to:
i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action
ii) making a medical diagnosis
What is the MHRA and what do they do? (2)
1) the medicines and healthcare products regulatory agency operates a system of licensing medicines
2) medicines which meet the standards of safety, quality, and efficacy are granted a marketing authorisation which is necessary before they can be prescribed or sold .
Outline the 3 legal statuses a product might have (3)
1) POM- prescription only medicine
2) P- in a pharmacy without prescription, under the supervision of pharmacists
3) GSL- on general sale - can be sold in general retail outlets without the supervision of a pharmacist
Outline what a GSL is (3)
General sales list:
1) a GSL product is defined as a product that is not a prescription only medicine or pharmacy medicine, but is a product that:
- is covered by an authorisation that the product is to be available on general sale
- is covered by an EU marketing authorisation and is not classified as a POM; the licensing authority has determined it should be available on general sale.
What is a pharmacy only (PO) medicine?
A medicinal product that is licensed as GSL- however the manufacturer has restricted the sale or supply through pharmacies only.
E.g fybogel
Explain when a GSL is not a GSL (6)
When the product is:
1) For use as an anthelmintic (destroys worms)
2) for parenteral ( injected) administration
3) for use as an eye ointment
4) for use as an enema
5) for use wholly or mainly for irrigation of wounds or for the bladder, vagina or rectum
6) for administration wholly or mainly to children being a preperation of aloxiprin or aspirin
Explain where a GSL product can be sold. (3)
1) can be sold in registered pharmacies but also in other retail outlets that can close so as to exclude the public
2) supermarkets, newsagents, petrol stations
3) in a pharmacy GSL can only be sold when a pharmacist has assumed the role of responsible pharmacist, however, the pharmacist may be physically absent for a limited period of time while remaining responsible, thus permitting sale of GSL medicines during this absence.
- can still sell GSL up to 2 hours after the pharmacist leaves when he has signed in
Outline what a pharmacy medicine (P) is (3)
1) any medicinal product which is not a POM or a medicinal product classified as GSL is a pharmacy medicine.
2) all medicines which are covered by a MA- specifying the product is to be available from a pharmacy
3) medicines made by pharmacists (extemps) - products existed as GSL but decanted into smaller bottles by pharmacists so medicine becomes pharmacy only
What does MHRA stand for
Medicines and healthcare products regulatory agency
Explain what a POM is (6)
a medicinal product that is listed in part 1 of schedule 1 of the prescription only medicines (human use) order SI 1997.
1) available only on prescription
2) covered by EU marketing authorisation and classified as a POM
3) controlled drug: ( unless classified as a P or GSL by order of MA)
4) cyanogenic substances (except for external use)
5) contain aloxiprin, asprin, or paracetamol (unless classified as P or GSL by MA)
6) substances that generate or emit radiation
Outline the sale and supply of P-meds
Retail sales or supplies of pharmacy medicines must:
1) be made by a person conducting a retail pharmacy business
- at a registered pharmacy
- by or under the supervision of a registered pharmacist
(can’t sell when pharmacist is not present)
List three places where you can find the classification of a medicine (3)
1) BNF
2) MHRA
3) electronic medicines compendium (eMC)
