Med Regs 1 Flashcards
What are the main UK legislations relevant to pharmacy medications?
• The Medicines Act 1968
• The Misuse of Drugs Act 1971
• The Misuse of Drugs Regulations 2001
• The Human Medicines Regulation (HMR) 2012
• The Veterinary Medicines Regulations 2013
What are the 3 legal medicine classifications under the HMR 2012
• Prescription Only Medicines (POM)
• Pharmacy Medicines (P)
• General Sales List (GSL)
Who regulates medicines in the UK?
The Medicines and Healthcare Products Regulatory Agency (MHRA)
Define ‘Medicinal
product’
Any substance or combination of substances presented as having properties of preventing or treating disease in human beings
When can POMs be prescribed?
POMS generally can only be supplied when in receipt of a prescription from an appropriate prescriber:
- Doctors
- Dentists
- Supplementary/ Independent prescribers
(However there are circumstances where they can be supplied wout prescription)
What factors could make a medicine exempt from POM classification?
• Maximum strengths to be sold (codeine max strength 20mg)
• Maximum quantities to be sold
(paracetamol up to 100 tablets)
• Certain routes of administration
(diclofenac only available as gel/cream (topical preparation))
• Use in specified persons
(sildenafil for erectile dysfunction in males)
• Use for a specific purpose
(chloramphenicol eye drops for bacterial conjunctivitis)
What are Controlled Drugs (CDs)
• they are type of POM medication which require prescription to get
• governed by the Misuse of Drugs Regulations 2001
• Classified by schedules 1 to 5
When can P medicines be sold?
• Can only be sold from a registered pharmacy premises
• Can only be sold under supervision of a pharmacist
• Must not be accessible to the public for self-selection (most pharmacies although GPhC no longer prohibit this)
• There is no definitive list of P medicines but there are some medicines which can only be sold in a pharmacy
eg Paracetamol 500mg: pack size doesnt exceed 32, total quantity max 96 per person at a time
Why do P medicines have restrictions?
• Addiction
• overdose
• overuse
• delay in diagnosing a condition which may require a different treatment
• risk to certain patient groups
• side effects
• abuse- not being used for the intentional indication
• additional counselling and information required
What are the signs of possible misuse and what do you need to be cautious of?
• Nervous or guilty behaviour
• Lack of symptoms
• Rehearsed answers
• Impatient or aggressive
• Opportunistic- busy times or inexperienced staff
• Specific products
• Paraphernalia
• Large quantities or frequent requests
need to be cautious of unconscious bias
What should you do when dealing with pharmacy medicines?
• When asked for advice on treatment must:
- obtain sufficient info eg WWHAM questions
- provide advice on the use of products
• When asked for a product by name, procedures must allow intervention when needed
• Particular care is needed for children, elderly and other social groups
• Pharmacists must be personally involved where appropriate
What is a General Sales List (GSL) medicine?
• A product that is not a POM or P Medicine
• Can, with reasonable safety, be sold or supplied without the supervision of a pharmacist
• From registered pharmacies and other places that can ‘close to exclude the public’
(Some are categorised as this due to packaging size ie paracetamol 16 tablets)
Sometimes medicines change drug classes or fall within more than one. How can this happen?
Manufacturers can request this with supporting evidence
