PL+E 2: Regulation and Classification of Medicines Flashcards
(17 cards)
What are the 3 classifications of human medicinal products under HMRA 2012?
POM, P, GSL
What does classification determine?
Sale and supply, how much health professional input is needed to diagnose and treat condition
In what instances might medicines be classified as more than one category?
Different formulations/strengths/quantities
Give an example of a medicine that has multiple classifications.
Paracetamol + aspirin non-effervescent tablets - 16 GSL, 32 P, 100 POM, effervescent have no limits
Qualities of ‘general sales list’ medicines.
Available as ‘self-selection’ from registered pharmacies (only when responsible pharmacist is in place) and retail outlets that can be ‘closed to public’ like supermarkets/petrol stations/vending machines, typically have well established safety profile, lowest risk category
Qualities of ‘pharmacy only’ medicines.
Can only be sold from registered pharmacy premises by pharmacist/person under supervision of pharmacist, not accessible to public by self-selection, must have discussion with pharmacist to get, might be regulations on products in this category
What two medicine classes are over the counter/non-prescription medicines?
GSL and P
Qualities of ‘prescription only medicines’.
Medicine that requires a prescription written by appropriate practitioner (MEP lists all), require supervision for safe use + monitoring, may be prone to misuse
Why might medicines be reclassified?
Pharmacists get larger range of medicines to select from to treat patients, don’t have to refer so save GP time, can ‘upgrade’ classification if concerns
What restrictions might be in place when a medicine is reclassified?
Maximum strength, route of administration, purpose of use/use in specified group of people, particular pharmaceutical form, maximum quantity that can be sold/supplied
What are the disadvantages of reclassifying medicines?
Side effect profile (having side effects with no appropriate follow up), possibility of misdiagnosis and delay to treatment, potential for harm from incorrect use
What are the 8 possible signs of misuse?
Lack of symptoms, rehearsed answers, inpatient/aggressive, opportunistic (wait till shop is busy or less experienced staff are in charge), specific products (e.g. asking for brands with ephedrine), paraphernalia (purchasing items that can be used to make meth), large quantities, frequently making requests
What are the indications for codeine/dihydrocodeine?
Solid dose OTC, short term treatment of acute moderate pain not relieved by paracetamol/ibuprofen/aspirin
What are the pack size limits on codeine/dihydrocodeine?
More than 32 units is a POM, including effervescent formulations
What information is on the labels/patient information leaflet for codeine/dihydrocodeine?
‘Can cause addiction, for three days use only’, PIL and packaging must state indication and that it can cause addiction/headache if used for more than 3 days, advised to only sell one pack of any medication containing these
What information should be noted for giving pseudoephedrine/ephedrine containing products?
Widely used in decongestants, potential misuse in illicit production of methylamphetamine, max supply is 720mg of pseudoephedrine or 180mg of ephedrine at any one time without prescription
What information should be noted for giving oral emergency contraception?
Three methods (copper intrauterine device, oral ulipristal acetate, oral levonorgestrel), medicines licensed as P, have to look at age of patient/advance supply/religious or moral beliefs
