medicnes regulation, ethics & professional judgement

What areas do the human medicines regulations 2012 cover ?

• licensing

• manufacturing

• wholesaling

• pharmacovigilance

• packaging and labelling

• advertising

• British pharmacopoeia

• enforcement

What is pharmacovigilance?

monitoring and reporting adverse drug reactions

what is the legal consequence of breaching HMR 2012?

usually a criminal offence

What is the role of the commission on human medicines (CHM) ?

a committee that advises government and MHRA on safety, quality, efficacy of medicines, ADRs and legal classification

What is the role of British pharmacopoeia commission?

sets official standards for pharmaceutical substances and medicinal products and prepares the British Pharmacopoeia

Who is the licensing and enforcement authority for medicines?

medicines and healthcare products regulatory agency (MHRA)

Where do morals come from?

personal moral philosophy, healthcare ethics, professional standards, law and societal values

why do morals change over time?

political influences, cultural change, new technologies, new professional roles and new medical possibilities

What is the Hippocratic Oath?

An ancient ethical code guiding professional conduct in medicine

Name three commitments of the Hippocratic oath?

• prescribe beneficial treatments

• avoid harm

• maintain exemplary professional and personal conduct

What are the four bioethical principles?

Autonomy

Beneficence

Non- maleficence

Justice

Autonomy

respecting a person’s right to make informed decisions about their own care

Beneficience

The duty to act in the best interests of the patient and promote their welfare

non-maleficence

the duty to avoid causing harm

when might non-maleficence be challenged?

end-of-life car, withholding treatment, side effects, medicinal research

justice

a fair, non-sicriminatory decision making

What is distributive justice?

fair allocation of limited healthcare resources based on need

What is rights-based justice?

Respecting rights such as privacy, access to care and equal treatment

What are the key ingredients of professional judgement?

knowledge of rules, analysis, ethical principles, experience , pragmatism, justification

First step in ethical decision-making

identify ethical dilemma or professional issue

why should decisions be recorded?

for accountability, transparency, and legal protection