The Use of Medicines Flashcards
List aims of medicine regulation
To ensure :
- Medicines have required quality, safety and efficacy
- Medicines are appropriately manufactured, stored, distributes and dispensed
- Promotion and advertising is fair
What does medicine regulation allow ?
Detection of illegal manufacturing and trade.
What does health regulation provide ?
Health professionals/patients with information to enable the safe use of medicines.
Framework to allow access to new medicines
What % of medicines in the world are counterfeit ?
Up to 10% of medicines in the world are counterfeit.
State the Medicine Regulator in the UK
MHRA - Medicines and Healthcare products regulatory agency
What is the function of the MHRA ?
Approves and Licences meds in the UK - issues clinical trial authorisations and marketing authorisations
Describe the role of MHRA
What does MHRA have the power to do ?
Has the power to withdraw meds from the market
Monitors safety
Issues manufacturers and wholesale dealers licenses.
What are marketing authorisations ?
Granted for a period of 5 years.
Ensures that the medicine meets the standards of safety, quality and efficacy.
What is the Summary of Product Characteristics ?
The terms which specifies what sort of conditions and patients the medicine is licensed for.
SmPC
Summary of product characteristics
Where can you find the SmPC ?
Electronic Medicines Compendium
Describe unlicensed medicines
No marketing authorisation, includes “special/bespoke” formulations, imported drugs, chemicals.
“special/bespoke formulations “
Crushing a tablet
(tablet is the licensed form not crushed form)
Describe off-label medicines
Has a marketing authorisation but prescribed outwith the terms of licence.
(different dose, age of patient, indication, route, contra-indication)
Off-label medications
Using a licensed medicine for an indication thats not on the summary of product characteristics.
Understand the significance of prescribing medicines unlicensed or off-label
There is an increased prescriber responsibility.
You must document and justify reasons for prescribing
Benefits outweigh risk ?
When prescribing unlicensed or off-label medicines, what are some things you need to ensure ?
Ensure :
- Sufficient evidence for use
- Adequate monitoring and follow-up
- Patient is aware the medicine being used is outwith license (“label”)
Describe off-label thalidomide use
Marked as a sedative - became over-the counter
Resulted in tragedy - caused malformation of limbs and other developmental problems
Medicine Act 1968
Provided legal framework regarding control of medicines in the UK
Misuse of Drugs Act 1971
Prohibits activities around certain drugs
Aim of the misuse of drugs act 1971
To prevent misuse of potentially dangerous drugs by applying penalties to their manufacture, supply or possession.
Separated drugs into 3 classes
Class A drugs examples
Cocaine, Heroin, Methadone, Magic Mushrooms
Consequences for possessing/supplying Class A drugs
Possession : 7 years + fine
Supply : Life + Fine
Class B drugs examples
Cannabis, Mephedrone
Consequences for possessing/supplying Class B drugs
Possession : 5 Years + fine
Supply : 14 years + fine
Class C drugs examples
Anabolic steroids, Benzodiazepines
Consequences for possessing/supplying Class C drugs
Possession : 2 years + fine
Supply : 14 years + fine
Misuse of Drugs Regulations 2001
To allow the possession and supply of controlled drugs for legitimate purposes
Describe the misuse of drugs regulations
State the schedules of controlled drug
5 Schedules of Controlled Drug :
- Lysergide
- Opiates
- Some benzodiazepines
- Anabolic steroids
- Codeine
Human Medicines Regulations 2012
Simplified set of rules, introduced pharmacovigilance requirements.
Describe human medicines regulations 2012
Information on labelling of medicines and patient group directions.
Controversies of drugs
Just because a drug is legal to supply and use doesn’t mean it is safe.
FRANK
Honest information about drugs
State the 3 legal categories of medicines in the UK
GSL
P
POM
GSL
General Sales List
P
Pharmacy Only
POM
Prescription only medicine
Describe General Sale List
Can be sold in registered pharmacies but also in other retail outlets :
e.g. paracetamol
- over the counter
Describe pharmacy only medicines
Not for public self-selection
Additional legal/professional considerations
Check for contra-indications, and give appropriate advice.
Describe prescription only medicine
Written by an “appropriate practitioner” before it can be sold/supplied
An increasing number of medicines are reclassified from POM to P - improving access to medicines with safety net of pharmacists.
Who are appropriate practitioners ?
Doctor
Dentist
Supplementary Prescriber
Nurse independent practitioner
Pharmacist independent prescriber
Describe the GMC 2013
Describe what is expected of all registered doctors
Summarise general principles of safe and legal prescribing
Prescriber is responsible for prescriptions signed for
Must be able to explain and justify your decision to prescribe, including if unlicensed/off-label use.
General principles of safe and legal prescribing (in terms of prescriber)
Keep up to date
Report adverse events
Work within limits of competence
Take account of evidence-based, clinical guidelines
Legal considerations of prescription writing
Name and Address of patient
If patient is under 12, specify age
Name of drug, strength, quantity, dose, frequency
Describe controlled drugs
Valid for 28 days from the appropriate date
Specify formulation and strength
Total amount in words and figures
State the 5 R’s of medicine safety
Right patient
Right drug
Right dose
Right route
Right time
State some important parts of safe prescribing
Legible writing
Unambiguous
No abbreviations
No latin
Summarise the routes available to report adverse events involving medicines
MHRA Yellow Card Scheme
MHRA Drug Alerts
MHRA yellow card scheme
Report suspected adverse reactions to any therapeutic agent
“Black triangle” drugs
Newly licensed drugs that require intensive monitoring
MHRA Drug Alerts
To communicate problems to al healthcare professionals
Why use incident reporting systems ?
Improves medicine safety
TO share the learning, look for trends, target areas of concern.
Explain the role of evidence based guidelines
Maximise safety and efficacy
Reduce variation in practice
Advise on best value
Support practitioners
What are evidence based guidelines ?
Result of a systematic review of literature by multi-disciplinary teams.
What do evidence based clinical guidelines do ?
Recommend management and treatment options for specific conditions
UK Guidelines
SIGN - Scottish
NICE - English
Explain the role of medicine formularies
A list of prescription drugs used by practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost.
Individual country medicine advice
(SMC)
Independent, multi-professional
Analyses health benefits of meds
Compares to other treatment
