Uses of medicines Flashcards
What percentage of drugs are thought to be fake?
10%
What are the aims of medicine regulations?
- To make sure drugs meet required safety, efficacy and quality
- Ensure they are properly manufactured, stored, distributed and dispensed
- Allow detection of illegal manufacturing and trade
- Provides health professional/ patients with information to enable safe uses of medicines
- Ensures promotions and advertising is fair
- Provides framework to allow access to new medicines
What is the UK medicine regulator? What is its role?
MHRA- medicine and healthcare regulatory agency
• Approves and licences meds in the uk and issues clinical trial and marketing authorisations
• Has the power to withdraw medicines form the market
• Monitors safety
• Issues marketing authorisations
What is a marketing authorisation?
- Known as ‘the label’ or ‘the product licence’
* Terms specify what sort of conditions and patients the medicine is licensed for
If a drug is unlicensed, what does this mean?
- No marketing authorisation
* Special/bespoke formulations, imported drugs, chemicals
If a drug is off market, what does this mean?
- Has a marketing authorisation but is prescribed out of the terms of license
- Different dose, age, indication route, contra indication
What needs to be taken into account if prescribing an unlicensed drug?
- Does the benefit outweigh the risk
- Is there evidence for the drug
- There is an increased prescriber responsibility
- The patient needs to be aware that the drug is being prescribed off license
- Adequate monitoring and follow up will be necessary
- The reasons and justifications for prescribing the drug must be recorded
What UK legislation is in place regarding the use of drugs?
- Medicine act 1968
- Missuse of Drugs act 1971
- Misuse of Drugs Regulations 2001
- Human medicines regulations 2012
What is the Misuse of drugs act?
- Classified drugs into A, B or C class
* Tried to prevent the misuse of potentially dangerous drugs
Give four drugs in A class
- Heroin
- Cocaine
- Magic mushrooms
- Methadone
Give two drugs in B class
- Cannabis
* Mephedrone
Give two drugs in C class
- Anabolic steroids
* Benzodiazepines
What was the purpose of the Human Medicines Regulations act?
- Consolidate and modernise
- Information on labelling and patient group directions
- Reduce the regulatory burden
- Provide clearer pharmacovigilance routes
What are the 3 legal categories of medicines?
- General Sales Lists- over the counter drugs that patients can choose themselves e.g. paracetamol
- Pharmacy only drugs - Sold in a registered pharmacy by a pharmacist, not for public selection
- Prescription only medicine - Appropriate practitioner needs to prescribe
What is the Shipman effect?
- An effect brought about by the serial killings by Dr Shipman as a result of the prescription of drugs
- Cultural change
- Improved the safeguarding and monitoring of doctors practices
- Encouraged the move from single to multiple Dr GP practices
- Revalidation/ Approval - clinicians need to provide proof that they are up to date and fit to practice
