Uses of medicines Flashcards
(20 cards)
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
What are the requirements for prescribing a drug?
- Prescriber is responsible for prescriptions signed for
- Must be able to justify and explain the reason for prescribing
- Must keep up to date
- Must be evidence based
- Need to report adverse effects
- Work within the limits of competence
What a practitioner legally do on a prescription?
- Sign it
- Complete on proper stationary
- Date it
- Provide the patients address and the address of the doctors practice/surgery
- Specify the age of the patient if they are under the age of 12
- Quote the name, dose, strength , frequency of the drug
What are the 5 rights of medicine?
- Right patient
- Right drug
- Right dose
- Right route
- Right time
What are the measures to ensure pharmacovigilance?
- MHRA yellow card scheme for reporting any adverse drug effects
- MHRA Drug alerts to communicate problems to all healthcare professionals
- Black triangle drugs, to ensure the close monitoring of newly licensed drugs
What are the medicine incident reporting systems for?
To report any errors or near misses in prescribing, dispensing, administering and monitoring medicines
