The use of medicines

Question 1

What are the aims of medicine regulation?

Answer 1

• To ensure medicines have required quality safety and efficacy
• To ensure medicines are appropriately manufactured stored, distributed and dispensed
• Allows detection of illegal manufacturing and trade
• Provides health professionals/patients with information to enable safe use of medicines
• Ensures promotion and advertising is fair
• Provides framework to allow access to new medicines

Question 2

What is medicine regulator of the UK?

Answer 2

Medicines and Healthcare products regulatory agency (MHRA)

Question 3

What does MHRA do?

Answer 3

• Approves and licences meds in UK - issues Clinical Trial Authorisations and Marketing Authorisations
• Has power to withdraw meds from the market
• Monitors safety
• Issues manufacturers and wholesale dealers licences

Question 4

What are marketing authorisations?

Answer 4

• Ensure medicine meets the standards of safety quality and efficacy
• The terms of this specifies what sort of conditions and patients the medicine is licenced for as described in the summary of product characteristics (SmPC)

Question 5

What is unlicenced medicines?

Answer 5

No marketing authorisation, includes “Special/Bespoke” formulations, imported drugs, chemicals

Question 6

What is the off-label medicine?

Answer 6

No marketing authorisation, includes “Special/Bespoke” formulations, imported drugs, chemicals

Question 7

What is the significance of prescriber beware?

Answer 7

• The increased prescriber responsibility
• Ensure patient aware the medicine is being used off label
• Ensure sufficient evidence for use
• Benefits outweigh risk
• Ensure adequate monitoring and follow up - reviewing the need for the medicine
• Document and justify reasons for prescribing

Question 8

What is the medicine Act 1968?

Answer 8

Provided legal framework regarding the control of medicines in the UK

Question 9

What is the misuse of drugs 1971?

Answer 9

Aims to prevent to prevent the misuse of potentially dangerous drugs by applying penalties to their manufacture supply or possession
Separated drugs into Class A,B,C

Question 11

Describe Class B drugs

Answer 11

• Cannabis, mephedrone
• Possession 5 years and fine
• Supply up to: 14 years and fine

Question 12

Describe C drugs

Question 13

What is the Misuse of drug regulations 2001

Answer 13

To allow for possession and supply of controlled drugs for legitimate purposes

Question 14

What is the Human Medicine Regulations 2012?

Answer 14

Simplified set of rules introduced pharmacovigilance requirements