The Use of Medicines Flashcards
What are the aims of medicine regulation?
• 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 adverting is fair
• Provides framework to allow access to new medicines
What is the UK medicine regulator?
MHRA - Medicines and Healthcare Products Regulatory Agency
What does the Medicines and Healthcare Products Regulatory Agency do?
- Approves and licences medicines in UK – issues Clinical Trial Authorisations and Marketing Authorisations
- Has power to withdraw medicines from the market
- Monitors safety
- Issues manufacturers and wholesale dealers licences.
What do the marketing authorisations provided by the MHRA do?
- 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)
What are unlicensed medicines?
no UK Marketing Authorisation, includes ‘Special’ formulations, imported drugs, chemicals
What are off-label or off-license medicines?
has a Marketing Authorisation
but prescribed out-with the terms of licence (different dose, age of patient, indication, route, contra-indication)
What responsibilities does the prescriber have when prescribing off-licence or unlicensed medicine?
• Increased prescriber responsibility
• Ensure patient aware the medicine is being used out-with licence or if
it does not have a licence at all in UK
• Ensure sufficient evidence for use
• Benefits outweigh risk?
• Ensure adequate monitoring and follow-up
• Document and justify reasons for prescribing
What are the four pieces of UK medicine legislation?
- Medicine Act 1968
- Misuse of Drugs Act 1971
- Misuse of Drugs Regulations 2001
- Human Medicines Regulations 2012
What does the Medicine Act 1968 do?
Provided legal framework regarding control of medicines in UK.
What does the Misuse of Drugs Act 1971 do?
prohibits activities around certain drugs
• Aim - to prevent misuse of potentially dangerous drugs by applying penalties to their manufacture, supply or possession
• Separated controlled drugs into 3 classes
What does the Misuse of Drugs Regulations 2001 do?
to allow for possession & supply of “controlled drugs” for legitimate purposes.
- Specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs (CDs)
- 5 Schedules of CDs
- E.g. lysergide (sch 1), opiates (sch 2), some benzodiazepines (sch 3), anabolic steroids (sch 4), codeine (sch 5)
What does the Human Medicines Regulations 2012 do?
simplified set of rules, introduced pharmacovigilance requirements
- Consolidated and modernised set of rules in line with EU laws
- Information on labelling of medicines and patient group directions
- Reduced regulatory burden
- Clearer pharmacovigilance routes
What are the three classes defined in the Misuse of Drugs Act 1971?
- Class A – cocaine, diamorphine (heroin), morphine, magic mushrooms
- Class B – cannabis, codeine, ketamine
- Class C – anabolic steroids, benzodiazepines, tramadol
What is the punishment for possession/supply of class A drugs?
Possession - 7 years + fine
Supply - Life + fine
What is the punishment for possession/supply of class B drugs?
Possession - 5 years + fine
Supply - 14 years + fine
