Ethics and Professionalism Flashcards
What is error?
planned actions ≠ desired outcome
What is harm? What are the 3 types of iatrogenic harm?
medical care ≈ unintended physical or psychosocial injury ≈ monitoring, treatment or fatality
1) Clinical Harm
2) Social Harm
3) Cultural Harm
Why does harm happen?
Failure in: People, Activity or Environment
- People: training, skills, competence, fatigue, stress, needs and psychosocial contact
- Activity: staffing, time pressure, complexity, volume, tools and technology
- Environment: teamwork, staff levels, leadership, financial, standards, policy and physical environment
What is the Fundamental Attribution Error?
tendency to over-emphasise dispositional, or personality-based explanations for behaviours observed in others while under-emphasising situational explanations
What is quality?
multi-dimensional framework capturing six domains: effectiveness, efficiency, equity, safety, timeliness, patient-centerdness ≈ standard measured against a criteria ≈ degree of excellence of something
What are the benefits of reporting?
List 4 benefits.
Maintains trust in the profession; part of candor; reduces future harm at individual and systems level; learn from mistakes; important for the safety + piece of mind of the patient and their family; integrity + trust \+ Trust + Candor + Reduces future harm at individual and systems level \+ Learn from mistakes \+ Safety + Integrity + Beneficence
What are the ethical and professional benefits of being open when things go wrong?
Ethical: J, B, C, NM
Professional:
- Honesty
- Integrity
- Transparency
- Trust
- Reflection
- Reduce future harm
- Teaching example
- Improve services
What are ethics?
Ethics, or moral philosophy, is the study of how to live: values, principles and rules
List the 4 domains of the publication GMC Good Medical Practice.
- Knowledge, skills and performance
- Safety + Quality
- Communication
- Trust
List 3 common moral theories.
- Consequentialism
- Deontology
- Virtue ethics
What are the 4 principles of medical ethics?
- Autonomy
- Non-maleficence
- Beneficence
- Justice
(5. Confidentiality)
What is the doctrine of double effect? What is the four criteria for this?
Moral distinction between intending harm and foreseeing harm - it is not permissible to deliberately cause harm but it is permissible to cause harm through a beneficial effect (described as the harm being a foreseen but unintended side effect of the beneficial effect)
- Good: action must be good, independent of its consequences - good effect (regardless of consequences)
- Right intention: bad effect can be foreseen, the agent must intend only the good effect - right intention for good effect
- Bad effect only a side effect of intended good effect: bad effect must not be a means to the good effect - cannot achieve good through bad
- Good > bad: good effect must outweigh, or compensate for, the bad effect - good effect > bad effect
List the aims of medicine regulation.
- Quality, safety + efficacy - Appropriate manufacturing, storage, distribution + dispensed - Detect illegal manufacturing + trade - Provide healthcare professionals + patients with info to enable safe use of medicines - Ensure promotion + advertising is fair - Framework to allow access to new medicines
What are the UK medicine regulators and what do they do?
MHRA:
- approve + licence medicines in UK
- monitor safety
- power to withdraw medicines from market
Medicines Inspectorate:
1. Issues manufacturers + wholesale dealers licences (Medicines Inspectorate - part of MHRA)
What guidance does the MHRA give regarding drugs?
Market Authorisations (‘the label’ / ‘product licence’) - the terms of this specifies what sort of conditions and patients the medicine is licensed for as described in the Summary of Product Characteristics (SmPC).
What two categories of drugs should you be aware of as a prescriber?
Unlicensed drugs + Off-label drugs;
1. Unlicensed = no UK Marketing Authorisation - including special/bespoke formulations, imported drugs, chemicals
2. Off-label = marketing authorisation but prescribed without terms of licence (different dose, age of patient, indication, route, contra-indication)
List the ramifications of unlicensed drugs from the prescriber’s perspective.
- Increased responsibility
- Patient aware: ensure patient is aware medicine is without license (label)
- Evidence: ensure sufficient evidence for use
- Benefits > risk
- Adequate monitoring + follow-up
- Document + justify reasons for prescribing
List some of the key UK Medicine Legislations.
- Medicine Act 1968 - Legal framework for medicines control in UK
- Misuse of Drugs Act 1971 - prohibits activities of certain drugs
3. Misuse of Drugs Regulations 2001 - possession and supply of controlled drugs for legitimate purposes - Human Medicines Regulations 2012 - set of rules introduced pharmacovigilance requirements
What is the aim of the Misuse of Drugs Act 1971 and how did it stratify drugs?
Aims to prevent misuse of potentially dangerous drugs by stratifying them into three classes and applying penalties to their manufacture, supply or possession.
Class A: Cocaine, Heroin, Magic mushrooms
- Possession: 7 years + fine
- Supply: Life + fine
Class B: Cannabis, Mepherdrone
- Possession: 5 years + fine
- Supply: 14 + fine
Class C: Steroids, benzodiazepines
- Possession: 2 years + fine
- Supply: 14 + fine
List the 3 legal categories of medicines.
- GSL = General Sales List (= Over the Counter) - sold in pharmacies + retail outlets e.g. paracetamol
2. P = Pharmacy Only - registered pharmacy premises by pharmacist or supervised by pharmacist - OTC + P medicines with additional legal/professional considerations; check for contra-indications + advice for patients
- POM = Prescription Only Medicine - written by “appropriate practitioner” before sale or supply; may have more than one category of classification (dependent on formulation, strength, quantity, indication or marketing authorisation); Increasing number of medicines re-classified from POM to P to improve access to medicines with safety net of pharmacists
List 4 appropriate practitioners.
- Doctor
- Dentist
- Nurse independent prescriber
- Pharmacist independent prescriber
- Community practitioner nurse
- Optometrist
List the 5 R’s in medicine regarding prescribing.
- Right patient
- Right drug
3. Right dose - Right route
- Right time;
What is pharmacovigilance?
Post-market surveillance with:
1) MHRA Yellow Card Scheme (reports suspected adverse reactions to any therapeutic agents, devices, fake drugs)
2) Black triangle drugs (newly licences medicines requiring intensive monitoring)
3) MHRA Drug Alerts (communicate problems to all healthcare professionals - sign up)
What is the role of medicine formularies?
produce a list of prescription drugs used by practitioners to identify drugs which offer the greatest overall value in terms of safety, efficacy and cost which should be up to date and evidence based