Regulation and classification of medicines

What are the three classes of medicinal products ?

What regulations detail the three classes of medicinal products?

Human Medicines Regulations 2012

What regulation are veterinary medicines classified under?

Veterinary Medicines Regulation

Can pharmacists refuse to sell or supply medicines?

Yes, they can use their own professional judgement if they have a good reason

What does GSL medicines stand for?

general sales list

What are GSL medicines?

Medications found at various locations (supermarkets, petrol stations etc.) that can be ‘self selected’, they have very little restrictions on them, they are the lowest risk category and have a well establised saftey profile

What are the regulations/laws/rules around the purchasing of GSL medicines?

They can only be purchased from a registered pharmacy if a ‘responsible pharmacist’ is in place, can be purchased at other retail outlets that are ‘closed to exclude the public’ (e.g. supermarkets, vending machines, petrol stations, etc.) where a pharmacist is not required for the sale or supply.

What does P medicines stand for?

Pharmacy only medicines

What are P medicines?

can only be sold by a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist, they must not be accessible to the public by self selection - they must interact with a pharmacy professional before you are able to access them, there are specific regulations that are related to specific medicines

What does OTC medicines stand for?

over the counter medicines

What are GSL and P medicines collectively known as?

OTC medicines

What are OTC medicines also known as?

non-prescription medicines

What does POM stand for?

prescription only medicines

What are POMs?

medicines that require a legal prescription from an appropriate prescriber to supply the medicine, has to be for a specific person for a specific reason, to supply a responsible pharmacist must be present on the premises

Where can you find the list of appropriate prescribers?

the MEP

Why would a medicine be a POM?

they require supervision for safe use: monitoring requirements, prone to misuse, new product, parenteral use

Can drugs only have one classification? explain

No, they have different classifications based on the pack size and formulation

What is the legal limit of the quantity of OTC effervescent tablets, powders, granules and liquids that can be sold to a person at any one time?

no legal limit, down to the professional’s judgement, this is because it is much harder to consume large amounts of liquids than large amounts of tablets so they are less prone to misuse

Why would a medicine be downgraded (reclassified)?

it provides pharmacists with a larger range of medicines select from to treat patients, there may be growing confidence in a medicinal product

Why would a medicine be upgraded (reclassified)?

if there are concerns, the restrictions could relate to: maximum strength, route of administration, purpose of use or use in a specified group of people, particular pharmaceutical form, maximum quantity that can be sold or supplied.

What are the benefits of increasing availability to medicines OTC?

quick relief of the disorder, individual self-care/ autonomy, rapid and convenient access

What are the barriers to increasing availability to medicines OTC?

side effect profile - individual’s side effects will not have the follow up of care, possibility of misdiagnosis and delay to treatment, potential for harm from incorrect use - not monitored in the same way

What has to happen for a medicine to change classification?

based on evaluation of evidence focusing on the risk to the public, these risks are managed by limiting the dose/strength or the pack size available

What is the underlying principle in changing the classification of drugs?

to maximise timely access to effective medicines, while minimising risk of harm from inappropriate use

What are the signs of possible misuse?

lack of symptoms, rehearsed answers, inpatient or aggressive, opportunistic, specific products, paraphernalia, quantities, frequency

What are the responsibilities around misuse?

appropriate supervision by a pharmacist or trained pharmacy staff should identify and handle potential cases of misuse

What are the restrictions on solid dose OTC codeine and dihydrocodeine?

Only can be given for short term treatment of acute, moderate pain not relived by paracetamol, ibuprofen or aspirin alone. Cannot be given for cold, flu, cough, sore throat or minor pain. More than 32 units in a pack including effervescent tablets) are POMs. Labelling/ Patient information leaflet requirements.

What are the requirements for labelling and the patients information leaflet for solid dose OTC codeine and dihydrocodeine?

Packaging must state: can cause addiction, for three days use only. The patients information leaflet and packaging must state the indication and that it can cause addiction or headache if used for more than three days, the patients information leaflet needs to include information on how to recognise the signs of addiction

What are the responsibilities of the pharmacist and pharmacy team when selling solid dose OTC codeine and dihydrocodeine?

asking appropriate questions prior to supply of OTC sale and ensure referral when required to manage long-term pain. they should also look for signs of addiction

What are pseudoephedrine and ephedrine used in (legally)?

decongestant pharmacy medicines

Why are there restrictions with selling OTC medicines that contain pseudoephedrine and ephedrine?

there is a potential for them to be misused in the illicit production of methylamphetamine (crystal meth) which is a class A controlled drug

What are the restrictions on selling OTC medicines that contain pseudoephedrine and ephedrine?

it’s unlawful to sell or supply any pseudoephedrine product alongside an ephedrine product at the same time without a prescription, can’t supply a product or combination of products that contains 720mg of pseudoephedrine or 180mg of ephedrine at any one time without a prescription, sales or supplies should either be made personally by the pharmacist or by pharmacy staff who have been trained and know when it is necessary to refer to the pharmacist

What are the three methods of emergency contraception?

copper intrauterine device, oral ulipristal acetate and oral levonorgestrel

What are the practice points relating to oral emergency contraception?

they are licenced as a P for unprotected sexual intercourse or failure of the contraceptive method depending on certain time periods. over 16s (if a P). can provide advanced supply - assess that the patient is competent, that they are not going to misuse the drug, and that it is clinically appropriate. be aware of religous or moral beliefs

When are paracetamol and aspirin non effervescent tablets classed as a GSL?

where there are only 16 tablets in a pack, non-pharmacy retailers are limited to 2 packs

When are paracetamol and aspirin non effervescent tablets classed as a P?

when there are 32 tablets in a pack, you cannot supply anymore than 100

How many paracetamol or aspirin non effervescent tablets can you supply without a prescription (in practice)?

96

Why are there restrictions on the amount of paracetamol and aspirin non effervescent tablets that can be supplied?

they are prone to misuse

What are the legal limits on the quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time?

none - use professional judgement to decide the appropriate quantity to supply - this is because it is harder to misuse