B4. Medicines regulation, ethical principles and professional judgement

Question 1

Describe medicines act 1968

Answer 1

-purpose: to control the safety, quality and efficacy of medicinal products for human use
-legalisation following thalidomide tragedy causing lage replacement by HMR but parts still remain: registration and conduct of pharmacies, clinical trials, administration of radioactive medicinal products

Question 2

What is the human medicines regulations (HMR) 2012?

Answer 2

the main legislation in the UK covering the manufacture, importation, distribution, advertising, labelling, sale and supply of medical products for human use and pharmacovigilance (the monitoring of the effect and safety of medical drugs (one note)

Question 3

what are the advisory bodies of the administration of human medicines regulations?

Answer 3

-commission on human medicines (CHM)
-British Pharmacopoeia Commission (BPC)

Question 4

Describe the commission on human medicines (CHM)

Answer 4

-Advisory body reporting to government ministers on: safety, quality, efficacy of medicinal products; ADR reporting; legal classification of medicines
-Advises on executing the Regulations (annual report to Government)
-Advises MHRA (licensing authority)
-Receives advice from various sub-committees
-Rules on commission membership

Question 5

What is the British Pharmacopoeia Commission (BPC)?

Answer 5

-Provides official standards for pharmaceutical substances and medicinal
products
-Prepares BP, other compendia, and lists of approved (non-proprietary) drug
names

Question 6

what are the four fundamental bioethical principles?

Answer 6

-autonomy
-beneficence
-non-maleficence
-justice

Question 7

what does it mean to have a respect for autonomy?

Answer 7

-Obtaining informed consent and maintaining confidentiality are key
activities that respect autonomy
-Being open and honest about diagnoses / keeping appointments
-Allowing patients to make their own decisions
-A person’s autonomy can be restricted by certain circumstances

Question 8

What does it mean to have respect for beneficence?

Answer 8

-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 health care providers
-May conflict with the principle of autonomy –
balance, best interest of patient

Question 9

What does it mean to have respect for non- maleficence?

Answer 9

-Duty not to harm anyone (includes doing nothing where this is harmful)
-Commitment to protect patients from harm
-Need for competence (up to date education and training)
-Legal “Duty of Care” (prosecutions under Civil Law for medical negligence)

Question 10

what does non- maleficence conflict with?

Answer 10

-Withdrawing or withholding life sustaining treatment
-Treatment of terminally ill patients
-Provision of futile treatment
-Medical research
-Side effects

Question 11

What does it mean to have respect for justice?

Answer 11

-Making fair (just) decisions
-Opposite of discrimination
-Equality and justice
-Treat equals equally
-Treat unequals unequally in proportion to morally relevant inequalities
-Distributive justice
-Acting on the basis of fair adjudication between competing interests (most in need)
-Requires morally defensible differences between people be used to distribute
scarce resources
-Rights-based justice
-Right to privacy / right to care / right to be treated same as others in same situation