The Use of Medicines 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
• 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 framework to allow access to new medicines
What is the UK medicine regulator?
MHRA - Medicines and Healthcare Products Regulatory Agency
What does the Medicines and Healthcare Products Regulatory Agency do?
- Approves and licences medicines in UK – issues Clinical Trial Authorisations and Marketing Authorisations
- Has power to withdraw medicines from the market
- Monitors safety
- Issues manufacturers and wholesale dealers licences.
What do the marketing authorisations provided by the MHRA do?
- Ensure medicine meets the standards of safety, quality and efficacy.
- The terms of this specifies what sort of conditions and patients the medicine is licenced for, as described in the Summary of Product Characteristics (SmPC)
What are unlicensed medicines?
no UK Marketing Authorisation, includes ‘Special’ formulations, imported drugs, chemicals
What are off-label or off-license medicines?
has a Marketing Authorisation
but prescribed out-with the terms of licence (different dose, age of patient, indication, route, contra-indication)
What responsibilities does the prescriber have when prescribing off-licence or unlicensed medicine?
• Increased prescriber responsibility
• Ensure patient aware the medicine is being used out-with licence or if
it does not have a licence at all in UK
• Ensure sufficient evidence for use
• Benefits outweigh risk?
• Ensure adequate monitoring and follow-up
• Document and justify reasons for prescribing
What are the four pieces of UK medicine legislation?
- Medicine Act 1968
- Misuse of Drugs Act 1971
- Misuse of Drugs Regulations 2001
- Human Medicines Regulations 2012
What does the Medicine Act 1968 do?
Provided legal framework regarding control of medicines in UK.
What does the Misuse of Drugs Act 1971 do?
prohibits activities around certain drugs
• Aim - to prevent misuse of potentially dangerous drugs by applying penalties to their manufacture, supply or possession
• Separated controlled drugs into 3 classes
What does the Misuse of Drugs Regulations 2001 do?
to allow for possession & supply of “controlled drugs” for legitimate purposes.
- Specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs (CDs)
- 5 Schedules of CDs
- E.g. lysergide (sch 1), opiates (sch 2), some benzodiazepines (sch 3), anabolic steroids (sch 4), codeine (sch 5)
What does the Human Medicines Regulations 2012 do?
simplified set of rules, introduced pharmacovigilance requirements
- Consolidated and modernised set of rules in line with EU laws
- Information on labelling of medicines and patient group directions
- Reduced regulatory burden
- Clearer pharmacovigilance routes
What are the three classes defined in the Misuse of Drugs Act 1971?
- Class A – cocaine, diamorphine (heroin), morphine, magic mushrooms
- Class B – cannabis, codeine, ketamine
- Class C – anabolic steroids, benzodiazepines, tramadol
What is the punishment for possession/supply of class A drugs?
Possession - 7 years + fine
Supply - Life + fine
What is the punishment for possession/supply of class B drugs?
Possession - 5 years + fine
Supply - 14 years + fine
What is the punishment for possession/supply of class C drugs?
Possession - 2 years + fine
Supply - 14 years + fine
What are the 3 legal categories of medicines in the UK?
GSL - General Sales List
P - Pharmacy Only
POM - Prescription Only Medicine
What are GSL medicines?
General Sale List (GSL)
Can be sold in registered pharmacies but also in other retail outlets that can ‘close so as to exclude the public’.
• E.g. Paracetamol (pack size 16)
• Over-the-counter (OTC)
What are P medicines?
Pharmacy (P) Only
Sold from registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.
• “P” medicines - not for public self-selection
• Additional legal/professional considerations
• Check for contra-indications, and give appropriate advice
What are POM medicines
Prescription Only Medicine (POM)
• Written by an “appropriate practitioner” before it can be sold or supplied.
• Some medicines may have more than one category of classification (depending on formulation, strength, quantity, indication or marketing authorisation).
• An increasing number of medicines reclassified from POM to P – improving access to medicines with safety net of Pharmacists.
What are appropriate practitioners as defined by the Human Medicines Regulations 2012?
- 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 are the general principles of legal, safe, and effective prescribing as set out by GMC Good Medical Practice 2013
• 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
• Take account of evidence-based, clinical guidelines
• Report adverse events
What are the legal considerations of prescription writing?
- Signed in ink by appropriate practitioner
- On proper stationary
- Name and address of patient
- Address of GP practice/hospital
- Dated
- If patient under 12, specify age
- Name of drug, strength, quantity, dose, frequency
- Controlled drugs
What are the legal considerations of prescription writing for controlled drugs?
- Some schedules limited to supply of up to 30 days of 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 other shizzle should be considered when writing prescriptions?
- Legible
- Unambiguous
- No abbreviations
- No Latin please (BD, QDS, T.DS)
Give some examples of sound alikes/look alike medicines
Risperidone (antipsychotic) instead of Ropinerole (Parkinson medicine)
Propranolol (beta-blocker for angina) instead of Prednisolone (steroid)
What pharmacovigilance post marketing surveillance schemes are there?
• MHRA Yellow Card Scheme
– report suspected adverse reactions to any therapeutic
agents, devices, fake drugs
• “Black triangle” drugs
– newly licenced medicines that require intensive monitoring
• MHRA Drug Alerts
– to communicate problems to all healthcare professionals – sign up!
What are the UK guidelines for drugs?
- SIGN – Scottish Intercollegiate Guideline Network
- NICE - National Institute for Health and Clinical Excellence (England)
- Dept for Health, Social Services and Public Safety (Northern Ireland)
- All-Wales Medicine Strategy Group (Wales)
What is 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
• Should be up to date and evidence based
What is the UK medicine formulary?
British National Formulary
• Book – 6 monthly
• Online always up to date, use your Athens log on – see Library Staff
• BNF App – allow for updates
What formularies other than the British National Formulary may be used?
Individual Country medicine advice:
e.g. Scottish Medicines Consortium (SMC)
Local Health Board Formularies
e.g. NHS Fife Formulary
Your Formulary
