The Use of Medicines Flashcards
List 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 the framework to allow access to new medicines
What are the 2 categories of drugs that can be prescribed?
Unlicenced - No UK Marketing Authorisation, includes “special/bespoke” formulation, imported drugs, chemicals
Off-label or off-licence - Has a marketing authorisation but is prescribed outwith the terms of licence (different dose, age of patient, indication, route, contra-indication) - Common in paediatrics as companies can’t do trials on children so they can’t apply for a Childs licence
List the 3 legal categories of medicines in the UK
GSL - General sales list
P - Pharmacy only
POM - Prescription only medicine
Summarise general principles of safe and legal prescribing
- The prescriber is responsible for prescriptions signed for
- Must be able to explain and justify your decision to prescribe, including if “unlicensed”/”off-label” use
- Work within limits of competence
- Keep up to date (drugs come on and off the market everyday)
- Take account of evidence-based, clinical guidelines
- Report adverse events
Summarise the routes available to report adverse events involving medicines
You should report any errors or near misses in prescribing, dispensing, administration, and monitoring of medicines because;
- It improves medicine safety
- It shares the learning, we can look for trends and target areas of concern
Locally - DATIX (incident reporting system used in NHS Fife)
National - National reporting and learning system (England and Wales)
Explain the role of evidence based guidelines
- Results of a systematic review of literature by multi-disciplinary teams
- Recommend management and treatment options for specific conditions
- Support practitioners
- Maximise efficacy
- Reduces variation in practice
- Maximise safety
- Advise on best value
- Reduces postcode prescribing
Explain the role of medicine formularies
- A list of prescription drugs used any practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost
- Should be up to date and evidence based
What has been put in place to prevent people buying counterfeit drugs over the internet?
A green flag with a white cross in the middle saying “click to verify if this website is operating legally”
Each medication now has a unique number and barcode to prevent counterfeit
Who’s the main Medicine regulator in the UK?
MHRA
What is the role of the MRHA?
The Medicines and Healthcare products Regulatory Agency (MHRA);
- Approve and license meds in the UK - issues clinical trails
- Has the power to withdraw meds from the market
- Monitors safety
- Issues manufacturers and wholesale dealers licenses
What does the MRHA do with “the label”/”product licence”?
They;
- Ensure medicine meets the standard of safety, quality and efficacy
- The terms of this specifies what sort of conditions and patients the medicine is licensed for, as described in the Summary of Product Charateristics
What is the SmPC and what can you find in it?
Summary of product characteristics
The SmPC is used by healthcare professionals, such as doctors, nurses and pharmacists, and explains how to use and prescribe a medicine. SmPCs are written and updated by pharmaceutical companies and are based on their research and product knowledge
For every 5 years a drug is on the market what does the company need to apply for?
A new SmPC licence.
What the issue with most new drugs?
They cannot be tested on a wide enough scale of people so they aren’t properly trialed until they come to the market
What must the drug prescriber be aware of before prescribing Unlicenced/off licence drugs ?
- Increased prescriber responsibility
- Ensure the patient is aware the medicine is being used outwith licence (“label) or is it does not at all have a licence in the UK
- Ensure sufficient evident for use
- Benefits outweigh risk?
- Ensure adequate monitoring and follow-up
- Document and justify reasons for prescribing
Commonly used in psychiatry and palliative care
Should ask other peer if this medication is justified to prescribe in the patients case
What happened with Off-label/licence Thalidomide use?
Thalidomide was initially marketed as a sedative for sleep, however women started using is off-licence to treat morning sickness and this lead to malformation of limbs and neurological issues in children
It is now back on the market to treat leprosy and melanoma cancers
