31-01-22 - Use of Medicines Flashcards
Learning Outcomes
- List aims of medicine regulation
- Understand the significance of prescribing medicines unlicenced or off-label
- List the legal categories of medicines in the UK
- Summarise general principles of safe and legal prescribing
- Summarise the routes available to report adverse events involving medicines
- Explain the role of evidence based guidelines
- Explain the role of medicine formularies
What is Pharmacokinetics?
What is Pharmacodynamics?
- Pharmacokinetics is what the body does to a drug
- The movement into, through and out of the body
- ADME – absorption, distribution, metabolism, and excretion of the drug
- Pharmacodynamics is what a drug does to the body
- How a drug interacts with receptors and chemicals in the body
What is the MHRA?
What are the 4 roles of the MHRA?
- The MHRA are the Medicines and Healthcare products Regulatory Agency
- Roles of the MHRA:
1) Approvals and licences meds in the UK
• Issues clinical trial authorisations and marketing authorisations
2) Has power to withdraw meds from the market
3) Monitors safety
4) Issues manufacturers and wholesale dealers’ licences
What marketing authorisations are issues by the MHRA?
What are the 2 purposes of this authorisation?
- The MHRA issues marketing authorisations in the form of the label/product license
- The label/ product license:
1) Ensures medicine meets the standard of safety, quality, and efficacy
2) Specifies what sort of conditions and patients the medicines is licences for
What can it mean if medicine is unlicensed or off label?
- If medicine is unlicenced, there is no marketing authorisation, and the medicine may include special formulations for only a small group of people, imported drugs, and chemicals e.g most of paediatric medicine is unlicensed
- If medicine is off label, it has a marketing authorisation, but prescribed out with the terms of license (different dose, age of patient, indication, route)
What 6 points have to be considered by prescribers when prescribing unlicensed medication?
• 6 points have to be considered by prescribers when prescribing unlicensed medication?
1) When prescribing unlicensed medication, there is increased prescriber responsibility
2) They must ensure the patient is aware the medicine is being used out with a licence (label)
3) Ensure sufficient evidence for use
4) Benefits outweigh the risk?
5) Ensure adequate monitoring and follow up
6) Document and justify reasons for prescribing
What are the aims of the Misuse of the Drugs Act 1971?
How does it group drugs?
- The misuse of Drugs act aims to prevent misuse of potentially dangerous drugs by applying penalties to their manufacture, supply or possession
- Drugs are separated into 3 categories – How harmful would this drug be if it were misused?
What is the misuse of Drugs Regulations 2001?
What are the 5 schedules of controlled drugs?
- The misuse of Drugs Regulations 2001 specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs CDs
- Schedules of controlled drugs (CDs):
1) Schedule 1 – Lysergide
2) Schedule 2 – Opiates
3) Schedule 3 – Benzodiazepines
4) Schedule 4 – Anabolic Steroids
5) Schedule 5 – Codeine
What are the 3 legal categories of medicine specified by Human Medicines Regulations 2012?
• 3 legal categories of medicine specified by Human Medicines Regulations 2012:
1) General Sale List (GSL)
• Can be sold in registered pharmacies, but also in other retail outlets that can ‘close as to exclude the public’
• E.g paracetamol (pack sizes 16 or 32)
• Over the counter (OTC)
2) Pharmacy (P) only
• Solid from registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist
• Pharmacy medicines – not for self-selection
• Over the counter (OTC)
• Additional legal/professional considerations
• Check for contra-indications, and give appropriate advice
3) 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, indication or marketing authorisation)
• An increasing number of medicines reclassified POM to P – improving access to medicines with safety of pharmacists
What are 6 general principles of legal, safe, and effective prescribing?
• 6 general principles of legal, safe, and effective prescribing:
1) Prescriber is responsible for prescriptions signed for?
2) Must be able to explain and justify your decision to prescribe, including if unlicensed/off-label use
3) Work within limits of competence
4) Keep up to date
5) Take account of the evidence-based, clinical guidelines
6) Report adverse events
What are 8 legal considerations of prescription writing?
• 8 legal considerations of prescription writing:
1) Signed in by ink by appropriate practitioners
2) On proper stationary
3) Name and address of patient
4) Address of e.g GP practise
5) Dated
6) If patient is under 12, specify age
7) Name of drug, strength, quantity, dose, frequency
8) Controlled drugs
What are the 5Rs pf safe prescribing?
What 4 other things are important?
How do you write a prescription?
• 5Rs of safe prescribing:
1) Right patient
2) Right drug
3) Right dose
4) Right route
5) Right time
• And also important:
1) Legible
2) Unambiguous
3) No abbreviations
4) No Latin
- Specify formulation and strength
- Total amount in words and figures
- Specify dose
What does the MHRA yellow Card Scheme involve?
What are Black Triangle Drugs?
What are MHRA drug alerts for?
- The MHRA Yellow Car Scheme involves reporting suspected adverse reactions to any therapeutic agent
- Black triangle Drugs are newly licensed medicines that require intense monitoring
- MHRA drug alerts are used to communicate problems to all healthcare professionals
What are 2 bodies responsible for UK guidelines?
- SIGN – Scottish Intercollegiate Network
* NICE – National Institute for health and Clinical Excellence (England)
