Uses of medicines Flashcards
Why do we need medicine regulation?
To ensure that medicines have the right quality, safety and efficacy. It also ensures that medicines are appropriately manufactured, stored, distributed and dispensed.
It is intended to help detect the illegal manufacturing and trade of medicines.
The regulations also provides health care professionals and patients with information to enable the safe use of medicines.
Also ensure that promotion and advertising of medicines is fair and provide a framework to allow patients safe access to new medicines
What is the name of the UK regulators?
Medicines and Healthcare products Regulatory Agency (MHRA)
What does the MHRA do?
- 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
What are unlicenced medicines?
Medicines with no marketing authorisation, includes “special/bespoke” formulations’ imported drugs, chemicals
What are off-label medicines?
Medicines that have a marketing authorisation but prescribed outwith the terms of licence (different dose, age of patient, indication, route, contra indication
What does the medicine act 1968 do?
Provide legal framework regarding control of medicines in UK
What does the misuse of drugs act 1971 do?
Prohibits activities around certain drugs
What does the misuse of drugs regulations 2001 do?
Allows for possession and supply of ‘controlled drugs’ for legitimate purposes
What is the human medicines regulations 2012?
Simplified set of rules, introduced pharmacovigilance requirements
How many classes of contolled drugs were created in the misuse of drugs act 1971?
3 - A, B and C
What are some examples of Class A drugs and what are the criminal charges if found to be involved with them?
- Cocaine, heroin, methadone, magic mushrooms
- Possession charge: up to 7 years + fine
- Supply charge: up to life + fine
What are some examples of class B drugs and what are the criminal charges if found to be involved with them?
- Cannabis, mephedrone
- Possession charge: up to 5 years + fine
- Supply charge: up to 14 years + fine
What are some examples of class C drugs and what are the criminal charges if found to be involved with them?
- Anabolic steroids, benzodiazepines
- Possession charge: up to 2 years + fine
- Supply charge: up to 14 years + fine
What does the misuse of drugs regulations 2001 specifically address?
-Specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs (CDs)
What is an example of each of the 5 schedules of CDs?
- Schedule 1 - Lysergide
- Schedule 2 - Opiates
- Schedule 3 - some benzodiazepines
- Schedule 4 - Anabolic steroids
- Schedule 5 - Codeine
