Uses of Medicine Flashcards
What are the aims of medicine regulation ?
• To ensure medicines have required quality, safety and efficacy
• To ensure medicines are appropriately manufactured, stored, distributed and dispensed
• Allowsdetectionofillegalmanufacturingandtrade
• Provides health professionals/patients with information
to enable safe use of medicines
• Ensures promotion and adverting is fair
• Provides framework to allow access to new medicines
What is the meaning of off-label and licence medicine ?
Off-label medicine : has a marketing authorisation
but prescribed outwith the terms of licence (different dose, age of patient, indication, route, contra-indication)
Off-licence medicine : no Marketing Authorisation, includes “Special/Bespoke” formulations, imported drugs, chemicals
What are the legal categories of medicine in the UK according to the Misuse of Drugs Act 1971 ? Give 2 examples for each.
Class A– cocaine, heroin
Class B– cannabis, mephedrone
Class C– anabolic steroids, benzodiazepines
What are the legal categories of medicine in the UK based on, according to the Misuse of Drugs Act 1971?
How harmful would this drug be if it were misused?
What are the punishments for possession and supply of class A, B, and C drugs respectively ?
Class A: POSSESSION: 7 years + fine SUPPLY: Life + fine
Class B: POSSESSION: 5 years + fine SUPPLY: 14 years + fine
Class C: 2 years + fine SUPPLY: 14 years + fine
What does the Misuse of Drugs Regulation (2001) do ?
Specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs (CDs)
Divides Controlled Drugs into 5 Schedules
Give an example of a controlled drug in each schedule according to the Misuse of Drugs Regulation (2001).
Schedule 1: Lysergide Schedule 2: Some opiates Schedule 3: Some benzodiazepines Schedule 4: Anabolic steroids Schedule 5: Codeine
What are the 3 legal categories of medicine according to the Human Medicines Regulations 2012 ?
General Sale List (GSL)
Pharmacy Only (P)
Prescription Only Medicine (POM)
What are general sale list medicines ? Give an example.
Can be sold in registered pharmacies but also in other retail outlets that can ‘close so as to exclude the public’.
Paracetamol
What are Pharmacy Only Medicines ?
Sold from registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.
Which of the 3 legal categories of medicine according to the Human Medicines Regulations 2012 are considered over-the-counter medications ?
General Sale List Medicines and Pharmacy Only Medicines
What are some considerations to be taken by a pharmacist before giving a Pharmacy Only medicine ?
Check for contra-indications, and give appropriate advice
What are prescription only medicines ?
Written by an “appropriate practitioner” before it can be sold or supplied
How may some medicines have more than one category of classification ?
Depending on formulation, strength, quantity, indication or marketing authorisation
Give examples of ‘appropriate practitioner’ which can prescribe POMs, in the UK.
- doctor
- dentist
- supplementary prescriber
- nurse independent prescriber
- pharmacist independent prescriber
- EEA and Swiss doctors and dentists (limited)
- community practitioner nurses (limited)
- optometrist independent prescribers (limited)
What does the GMC Good Medical Practice 2013 say about prescribing medicines ?
Says prescriber should report adverse drug reactions, medical device incidents and other patient safety incidents
What are some general principles of legal, safe, and effective prescribing ?
- Prescriber is responsible for prescriptions signed for
- Must be able to explain and justify your decision to prescribe, including if “unlicenced” /”off-label” use.
- Work within limits of competence
- Keep up to date
- Take account of evidence-based, clinical guidelines
- Report adverse events
What are some legal considerations of prescription writing ?
- Signed in ink by appropriate practitioner
- On proper stationary
- Name and address of patient
- Address of eg. GP practice
- Dated
- If patient under 12, specify age
- Name of drug, strength, quantity, dose, frequency
What are some specific precautions taken when prescribing controlled drugs ?
- Some schedules limited to supply of up to 30 days’ treatment.
- Specify formulation and strength
- Total amount in words and figures
- Specify dose
What are the 5 Rs of medicine safety ?
- Right patient
- Right drug
- Right dose
- Right route
- Right time
What are some routes available to report adverse events involving medicines ?
- MHRA Yellow Card Scheme
– report suspected adverse reactions to any
therapeutic agent
2 .“Black triangle” drugs
– newly licenced medicines that require intensive monitoring
- MHRA Drug Alerts
– to communicate problems to all healthcare professionals
Why is it important to Report any errors OR near misses in prescribing ?
- Improves medicine safety
- To share the learning, look for trends, target areas of concern.
Give examples of local, and national Medicine incident reporting systems.
Local: “DATIX” – NHS Fife reporting system
National: National Reporting and Learning System
Where do evidence based guidelines come from ?
From a systematic review of literature
What is the aim of evidence based guidelines ?
Recommend management and treatment options for specific conditions
What are the pros of evidence based guidelines ?
- Support practitioners
- Maximise efficacy
- Reduces variation in practice
- Maximise safety
- Advise on best value
What are examples of UK bodies publishing guidelines ?
NICE (National Institute for Health and Clinical Excellence)
SIGN (Scottish Intercollegiate Network)
What are medicine formularies and what is their role ?
A list of prescription drugs
Used by practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost
What is the NHS Fife Formulary ? Is it still allowed to prescribe outwith the formulary ?
List of medicines which are approved to be prescribed by hospitals and primary care in Fife
Non-formulary prescribing strongly discouraged
