B1 Introduction and classification of medicines Flashcards
what is the difference between law and ethics?
- law is legally enforced
- ethics are not punishable by law but more based upon society and morals
what kind of products MUST be sold as POM?
certain types of medications such as eye ointments and injections
describe GSL medicines
- reasonably safe to be sold without the supervision of a pharmacist
- doesn’t need anything on the box to identify it as a GSL
- a medicine is a GSL if the marketing authorisation states it is and if it’s not a P or POM
what are the conditions for GSL sale?
- place where sold must be able to be closed to exclude the general public
- must have a UK marketing authorisation
- must have been made up in a container elsewhere and not altered (if the pharmacist opens the box and changes it, it changes from a GSL to a P)
what are the restrictions on the sale of P medicines?
- P are generally stronger or have more side effects
- person selling must lawfully be conducting a retail pharmacy business
- product must be sold or offered for sale on premises which are a registered pharmacy
- seller must be, or act under the supervision of, a pharmacist
what must P medicines have on their packaging?
P
what legal classification medicines are OTC?
GSL and P
when may pharmacists sell POMs?
under the authority of prescription from an appropriate practitioner or via an exemption
who may be an appropriate practitioner to prescribe a POM?
- doctor
- dentist
- community nurse prescribers
- supplementary prescriber
- independent prescriber
what features do/can POMs have?
- listed in POM order
- hold MA as a POM
- for parenteral administration
- emit radiation on administration
- cyanogenic
- controlled drugs
- non-effervescent products containing aloxiprin, aspirin or paracetamol
- contain ephedrine, its salts or pseudoephedrine
- products without an MA meeting certain criteria
what must be on a POM packaging?
POM
which products are exempt from POM status?
- pseudoephedrine and ephedrine
what are the conditions around who can administer POMs?
- no one can administer a medicine parenterally unless to themselves or unless they’re a practitioner or under the direction of a practitioner
- UNLESS in an emergency and saving a life
what are controlled drugs?
- drugs which are or appear likely to be misused
- often painkillers or opioids
what does the Misuse of Drugs Act 1971/Regulations 2001 restrict?
restricts production, obtaining, supply, offer to supply, cultivation and possession of controlled drugs
