Use of Medicines

Question 1

what does the regulation of medicines ensure?

Answer 1

• drugs of required quality, safety and efficacy
• drugs are appropriately manufactured, stored, distributed and dispensed
• detects illegal manufacturing and trade
• health professionals/patients have information to enable safe use
• promotion and adverting is fair
• framework to allow access to new medicines

Question 2

what are the UK medicine regulators?

Answer 2

• medicines and healthcare products regulatory agency (MHRA)

- medicines inspectorate

Question 3

what is the role of the MHRA?

Answer 3

• approves and licences meds in UK: issues clinical trial authorisations and marketing authorisations
• has power to withdraw meds from market
• monitors safety

Question 4

what are unlicensed medicines?

Answer 4

have no marketing authorisation

Question 5

what are off-label medicines?

Answer 5

prescribed out with terms of marketing authorisation

Question 6

what are the 3 legal categories of medicines?

Answer 6

• GSL: general sales list
• P: pharmacy only
• POM: prescription only medicine

Question 7

what are GSL category medicines?

Answer 7

can be sold in registered pharmacies but also in other retail outlets that can ‘close so as to exclude the public’

e.g. paracetamol

Question 8

what are P category medicines?

Answer 8

• sold from registered pharmacy premises by a pharmacist or a person acting under supervision of one
• not for public self-selection

Question 9

what are POM category medicines?

Answer 9

• written by ‘appropriate practitioner’ before can be sold or supplied

Question 10

what are the legal considerations with prescription writing?

Answer 10

• signed in ink by appropriate practitioner
• on proper stationary
• name/address of patient
• address of e.g. GP practice
• dates
• if under 12, specify age
• name of drug, strength, dose, quantity, frequency

Question 11

what are the 5 R’s of medicine safety?

Answer 11

• Right patient
• Right drug
• Right dose
• Right route
• Right time

Question 12

what are the 5 schedules of controlled drugs?

Answer 12

1. lysergide
2. opiates
3. some benzodiazepines
4. anabolic steroids
5. codeine

Question 13

what is the MHRA yellow card scheme?

Answer 13

report suspected adverse reactions to any therapeutic agent

Question 14

what are black triangle drugs?

Answer 14

newly licensed medicines that require intensive monitoring