Law and Ethics Flashcards
What is morality?
The values, ideals, beliefs, attitudes and characteristics which are important to us
They are usually inherited from our family, community and culture
What are ethics?
A branch of philosophy that is concerned with “what should I do”
A process of reflection in which people’s decisions are shaped by their values, principles and purposes rather than unthinking habits, social conventions or self-interest.
What is law?
establishes minimum standards of behaviour that everyone must meet
defined legal aspects of practice, rights of patients and duties of healthcare professionals
What are professional standards?
moral and legal dimensions
must aim for the maximum
- be as professional as possible
What are the ethical principles?
autonomy
- self-governance and respect for persons
- must have the capacity to think, decide and freely/independently
non-maleficence
- not doing harm
- must do our best to not harm patients intentionally or unintentionally
beneficence
- provide good
- must provide people with the best care
justice
- fairness
- all patients must be treated equally
What are the ethical rules?
veracity = truthfulness
- must maintain a relationship based on honesty with the patient
privacy
- have the right to restrict access to information about yourself/themselves
confidentiality
- must have the right to restrict information you have shared with others
fidelity
- must keep your promises and fulfil your agreements
- must act in the best interest of the patient
What is Statute Law?
Statute Law
- is an act of parliament
- introduced by the House of Commons or House of Lords
- goes through and parliament and is given royal assent by the monarch
What are the types of Statute Law?
Criminal Law
Administrative Law
Professional Law
What is Criminal Law?
defines criminal offences, regulates the apprehension, charging, trial of suspected persons and fixes the penalties and modes of treatment of the convicted offender
has agency that prevents and investigates the crime
has agency which prosecutes the offenders
has agency which provides the method of punishment for the convicted offender
What is Professional Law?
underpins the powers of professional regulatory bodies
- underpins the power to maintain fitness to practice of healthcare professionals
Regulatory Body - General Pharmaceutical Council
What is Administrative Law?
regulates the activity of public bodies
- NHS
What is Civil Law?
concerns the relationships between individuals and the conduct of human relationships
- regulates relationships between individuals
protects and enforces these rights by allowing the in conceived party to sue/seek damages or compensation from the party they believed to have infringed on their rights
What is Common Law?
body of legal rules made by judges as they issue rulings on cases
- are not acts of parliament
What is the Medicines Act? When was it formed?
is a Statute Law formed in 1968
- introduced in response to the thalidomide tragedy
- defines a medicinal product
set up a process of licensing for all products for which a medicinal claim is made
a prescriptive legislation
- it makes it unlawful to sell or supply any medicinal products unless in a circumstance when an exemption exists
comes under criminal law
What is a medicinal product according to the Medicines Act?
substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans
What is the Human Medicines Regulation? When was it formed?
a law which
- repealed, revoked or re-enacted most existing UK legislation regulating the authorisation, sale and supply of medicinal products
What is the MHRA? When was it created? What is it responsible for?
Medicines and Healthcare Products Regulatory Agency
- created in 1989
is a government agency responsible for the control of medicines within the UK
What is the purpose to the MRHA?
evaluates the information obtained from the various phases of clinical trials and assesses quality, safety and efficacy of all marketed medicines
provides issues marketing authorisation/licensing
- allows advertisement
does post marketing surveillance
What types of medicines are subject to additional monitoring? How are they identified sources of information?
a medicine which
- contains a new active substance
- is a biological medicine
- has been given a conditional approval or approved under exceptional circumstance
identified by black triangles
- BNF, MIMS, SPC
What type of reactions should and should not be reported on the Yellow Card Scheme?
for established drugs report
- only serious or unusual reactions be reported for established drugs
- any reaction that is fatal, life-threatening, disabling, incapacitating or which results in or prolongs hospitalisation should be reported, even if well recognised
for new drugs
- all reactions should be reported for new drugs
should not be reported
- minor and expected reactions for established drugs
What are actions taken by the MRHA when a medicine is reported on the Yellow Card Scheme?
The MRHA
- publishes the findings and advice to prescribers in Drug Safety Update
- withdraws drugs from the market
- amends product licences
- publish warnings in the BNF to highlight particular aspects of drug safety
Why are reporting rates on the Yellow Card Scheme low?
- the reaction not considered severe enough
- concern over potential legal implications
- the reaction may be predictable or expected
- ignorance of how to report an ADR
- time constraints
- lack of feedback following previous reports
- failure to identify the presence of an ADR
