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
What are the 4 UK Medicine legislation acts ?
- Medicine Act 1968 - Provided legal framework regarding control of medicines in the UK
- Misuse of Drugs Act 1971 - prohibits activities around certain drugs
- Misuse of Drugs regulations 2001 - to allows for possession & supply of ‘controlled drugs’ for legitimate purposes
- Human Medicines Regulations 2012 - simplified set of rules, introduced pharmacovigilance requirements
What was the aim of the Misuse of Drugs Act 1971 ?
Aim - to prevent the misuse of potentially dangerous drugs by applying penalties to their manufacturer, supply or possession
Separated controlled drugs into 3 classes
What are the 3 classes of controlled drugs and the penalties for possession of them and supplying them?
Class A - Cocaine, Heroin, Methadone, Magic Mushrooms
Possession penalty - 7 years + a fine
Supply penalty - Life + a fine
Class B - Cannabis, Mephedrone
Possession penalty - 5 years + a fine
Supply penalty - 14 years + a fine
Class C - Anabolic steroids, benzodiazepines
Possession penalty - 2 years + a fine
Supply penalty - 14 years + a fine
What is a common argument and controversy with legal drugs?
Just because a drug is legal to supply doesn’t mean it is safe
E.g - Alcohol, Nicotine, Legal highs (chemicals, plant food, pond cleaners, bath salts), Gases, Glues, Aerosols
The drugs aren’t included in the Misuse of Drugs Act 1971 and argued.
What was the aim of the Misuse of Drugs Regulations 2001 ?
- Specifies import, export, production, supply, possession, prescribing, record keeping activities for controlled drugs (CD’s)
- 5 schedules of controlled drugs
E.g Lysergide (schedule 1), Opiates (schedule 2), some benzodiazepines (schedule 3), anabolic steroids (schedule 4), codeine (schedule 5)
Why does the Misuse of Drugs Regulations 2001 act matter to me?
- Legal prescribing and monitoring matters!
- Be aware of drug misuse
- Emphasises importance of early review if these drugs are started
What did the Human Medicines Regulations in 2012 do?
- Consolidated and modernised a set of rules in line with EU laws
- Info on labelling of meds and patient group directions
- Reduced regulatory burden
- Clearer pharmacovigilance routes
What are the features of drugs in the General sale list (GSL)?
These drugs 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 sizes 16 or 32) - limited
- “Over-the-counter” – OTC
What are the features of drugs that are Pharmacy only (P) ?
These drugs are 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
- “Over-the-counter” (OTC)
- Additional legal/professional considerations
- Check for contra-indications, and give appropriate advice
Have to speak to pharmacist or assistant to see if someone should get the drug or not
What 2 types of drugs are referred to as “Over-the-counter” (OTC) drugs?
General sale list (GSL) and Pharmacy only (P)
Over £2 billion are spent on these drugs a year in the UK alone
What should you remember to ask a patient when taking a drug history?
If they are taking any over the counter (OTC) medication as well?
What are the features of drugs that are 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
Who are the “appropriate practitioners considered in Prescription Only medicine (POM)?
- 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’s Good Medical Practice 2013 include and recommend?
The GMC’s Good Medical Practice 2013;
- Describes what is expected of all registered doctors
- Includes good practice in prescribing and managing medicines and devices
- Says prescriber should report adverse drug reactions, medical device incidents and other patient safety incidents
What legal considerations should be taken into account when writing prescriptions?
- Singed in only Ink by appropriate practitioner (NO PENCIL)
- On proper stationary
- Name and address of patient
- Address of GP practice
- Dated
- If patient under 12, specify age
- Name of drug, strength, quantity, dose, frequency
- Controlled drugs
What are special about the prescription of controlled drugs?
- Some controlled drugs schedules are limited to a supply of up to 30 days treatment
- Specify formulation and strength
- Total amount in words and figures
- Specify dose
What are the 5R’s of medicine prescribing safety?
- Right patient
- Right drug
- Right dose
- Right route
- Right time
What other factors should be taken into account to help prescriptions?
- Make legible
- Unambiguous
- No abbreviations
- No Latin
What are some sound-a-likes/look-a-like issues?
Recent cases, fatal outcomes due to. being wrongly prescribed, dispensed or administered
E.g;
- Risperidone (antipsychotic) instead of Rpinerole (Parkinson’s med)
- Propanolol (Beta-blocker for Angina) instead of Prednisolone (Steroid)
What is Pharmacovigilance and what is done in it?
Pharmacovigilance is post marketing surveillance
MHRA Yellow card scheme;
- Report suspected adverse reactions to any therapeutic agents, devices, fake drugs
“Black triangle” drugs;
- Newly licensed medicines that require intensive monitoring (SPC drugs - new medicine)
MHRA drug alerts are used to communicate problems to all healthcare professionals
Who makes the UK guidelines for medications ?
SIGN - Scottish intercollegiate Guideline Network
NICE - National institute for health and clinical excellence (England)
Who publishes the UK national formularies?
BNF
What does the Scottish Medicines Consortium (SMC) do?
- Independent, multi-professional
- Analyses health benefits of meds
- Compares to other treatments
- Questions if its good value for money?
- Question if it should be used by NHS Scotland ?
(England uses NICE for this)
What local health board formulary do we use and what do they do?
NHS Fife Formulary;
- List of medicines which are approved to be prescribed by hospitals and primary care in Fife
- Non-formulary prescribing strongly discouraged
What does PRN mean?
Take when needed
