B1. Intro to classification of meds Flashcards
what is a licence required for?
the sale, supply and administration of medicines and medical devices for human use
what is the licensing body?
the medicines and healthcare products regulatory agency (MHRA)
Describe marketing authorisation (MA)
-name given to the licence with full regulatory approval
-places restrictions on products
what is the classification of medicines controlled by?
human medicines regulations 2012: sale or supply of medicinal products
What are the different classes of medicine products?
-general sale list medicines (GSL)
-Pharmacy medicines (P)
-Prescription only medicines (POM)
Describe GSL medicinal products
-can be sold or supplied with reasonable safety without the supervision of a pharmacist
-includes some herbal and homeopathic products
-excludes certain types of products e.g eye ointments, injections
what are the conditions for GSL sale medicines?
-Place where sold or supplied must be able to close so as to exclude the public (proper shop)
-has a UK marketing authorisation (or equivalent for herbal and homeopathic)
-must have been made up in a container elsewhere and not altered
how do you identify a GSL medicine?
GSL medicine does not need anything on the box to identify it. Therefore product is GSL if it has a marketing authorisation (MA) and is not a P or POM medicine
Pharmacy (P) medicines definition?
neither a Prescription Only Medicine (POM) or GSL medicine
what are the restrictions on the sale and supply of Pharmacy (P) medicines?
may not be sold, supplied or offered for sale/supply unless:
1)person is lawfully conducting a retail pharmacy business
2)the product is sold, offered or exposed for sale, or supplied on premises which are a registered pharmacy
3)the person is, or acts under the supervision of a pharmacist
-products must not be accessible for self selection
how do you identify a Pharmacy medicine?
must have a P in a box somewhere on the original packaging
what are over the counter (OTC) medicines?
GSL+P medicines (non-prescription)
what laws and regulations control OTC medicines as a group?
-MA specifies legal category
-Regulations impose restrictive conditions e.g pack sizes
what is the maximum pack size for aspirin and paracetamol (non-effervescent) tablets or capsules in GSL and P medicines?
16 (GSL) and 32 (P)
-maximum quantity = 100 (96 in reality)
what are the conditions for prescription only medicines (POMs)?
A pharmacist may sell or supply a POM under the authority of a prescription from an appropriate practitioner, or via an exemption (patient specific directions, PSDs)
POM medicines are listed in the Prescription Only Medicines Order and/ or…
- Hold a marketing authorisation (MA) as a POM
- For parenteral administration
- Emit radiation on administration
- Cyanogenic (if not for external use)
- Controlled drugs, unless MA specifies P or GSL
- Non-effervescent products containing aloxiprin, aspirin or paracetamol, unless
MA specifies P or GSL - Contain ephedrine, its salts or pseudoephedrine, unless MA specifies P or GSL
- Products without a MA meeting certain criteria
How to identify a POM medicine?
letters POM on the original packaging
What products are exempt from POM status?
specifically licensed products sold within the terms of that licence e.g Hana (desogestrel) oral contraceptive
Up to how much pseudoephedrine salts and ephedrine base/ salts can you sell or supply to one person in a single transaction?
-up to 720mg pseudoephedrine salts
-up to 180mg ephedrine base/ salts
-you may not supply more than one product containing the same drug and may not supply both drugs, even within limits
who can administer POMs?
no one can administer parenterally (by injection), other than to themselves, unless they are a practitioner or acting under the direction of a practitioner
(exemptions during emergency)
Describe the controlled by misuse of drugs act 1971/ Regulations 2001
-concerns drugs which are likely to be misused
-restricts production, obtaining, supply, offer to supply, possession and cultivation of controlled drugs
-schedules determine the control of the drugs (one note)
