B4 Law and ethics: Medicines regulation, ethical principles & professional judgement Flashcards
what is the purpose of the Medicines Act 1968?
to control the safety, quality and efficacy of medicinal products for human use
state some topics covered in the Human Medicines Regulations 2012
- general provisions
- administration
- manufacturing and wholesaling
- pharmacovigilance
- dealings with medicinal products
- packaging and labelling
- advertising
- British Pharmacopoeia
- enforcement
- miscellaneous
what is the Commission on Human Medicines (CHM)?
- advisory body reporting to government ministers on safety, quality, efficacy of medicine products, ADR reporting, legal classification of medicines
- advises MHRA
- rules on commission membership
what is the British Pharmacopeia Commission (BPC)?
- provides official standards for pharmaceutical substances and medicines products
- prepares Bp, other compendia and lists of approved drug names
- used to be very prominent in pharmacy
why is the BPC less prominent in pharmacy now?
pharmacists aren’t manufacturing medicines as much anymore so it’s not used as much these days
what is the Hippocratic oath?
- ethical code attributed to the Ancient Greek Physician ‘Hippocrates’
- adopted as a guide for professional conduct by the medical profession through the ages
- still used in many medical school graduations
- quite a short pledge but the underpinnings live to our standards
what is the Hippocratic oath a pledge to do?
- prescribe only beneficial treatment, according to own ability and judgement
- refrain from causing harm and hurt
- live an exemplary personal and professional life
what are the 4 fundamental bioethical principles?
- autonomy
- beneficence
- non-maleficence
- justice
describe the bioethical principle of autonomy
- right to self-governance, self-rule and self-determination
- right to think and decide and to act on the basis of such thought and decision
- not to deceive or break promises
what is autonomy in healthcare?
- obtaining informed consent and maintaining confidentiality
- being open and honest about diagnoses
- allowing patients to make their own decisions
describe the bioethical principle of beneficence
- duty to promote the health and welfare of the patient, not merely to avoid harm
- requires positive action to always act in the best interest of the patient
- a primary goal of healthcare providers and professionals
- may conflict with autonomy
describe the bioethical principle of non-maleficence
- duty to not harm anyone
- commitment to protect patients from harm
- need for competence
what activities conflict non-maleficence?
- treatment of terminally ill patients
- provision of futile treatment
- medical research
- side effects
- withdrawing or withholding life sustaining treatment
describe the bioethical principle of justice
- making fair decisions
- treat equals equally and treat unequals unequally in proportion to morally relevant inequalities
what is distributive justice?
- acting on the basis of fair adjudication between competing interests (most in need)
- requires morally defensible differences between people being used to distribute scarce resources
- whose interests are the most important in a situation?
