law vs ethics and legislation

Question 1

describe what constitutes law in the UK

Answer 1

→ law is a system of rules, that regulate all aspects of human affairs and relationships

→ involves concepts of: rights, rules, duties, regulations, authority, morality, settling

→ dynamic system. eg. modern laws against online comments

Question 2

what are ethics

Answer 2

→ moral principles that govern our behaviour or actions: what is good for an individual versus society

→ professional bodies often have a code of ethics (expectations of members) e.g/AKA standards for pharmacy professionals

Question 3

Compare the difference between law and ethics

Answer 3

→ ethics = grey, law = black and white

→ ethics are based on our moral principles: each person has their own views based on our experiences.

Question 4

compare the difference between Civil Law and Criminal Law

Answer 4

→ CRIMINAL LAW: incidents governed by the relationship between the individual and rest of community (state)

→  CIVIL LAW: incidents governed by the law that concerns relationships between individuals

Question 5

criminal traits

Answer 5

State v defendant
Public action
Apprehension & disposition
Magistrate court (magistrate)
Crown court (jury)

Question 6

civil traits

Answer 6

Plaintiff v defendant
Private action
Compensation & restitution of wrongdoing
County court
High court

Question 7

Describe how negligence applies to pharmacy

Answer 7

→ healthcare workers = duty of care, so if breached, can be found negligent.

duty of care relates to advice, information, supply, servicing any intervention

so many standards and guidance on patient care e.g. Gphc

Question 8

legal tests for negligence:

Answer 8

• harm must be forseeable
• there must be a sufficiently proximate relationship between the parties
• it must be just & reasonable to expect the duty

Question 9

proving causation: when can it be difficult to prove?

Answer 9

its difficult to prove is there is a terminal care patient, or multiple morbidity

Question 10

when can proving causation cannot be sustained?

Answer 10

it cannot be sustained if the patient did not actually receive medication
- people tend to make ex gratia (termination) payments (morally obligated) but theres no admission of liability

Question 11

what is professional indemnity:

Answer 11

• when the employers liability extends to those harmed by the employees actions:
• this doesn’t extend to: self employed locums, consultants, employment disuputes
• pharmacists must have adequate professional indemnity insurance in place (usually covered by the employer)

Question 12

what is vicarious liability?

Answer 12

when something is exercised by one person on behalf of another

• e.g if carrying out employers requirements, or in accordance with their specification

However, must follow the systems and standard operating procedures for your employer.

Question 13

why is vicarious liability key in a pharmacy context?

Answer 13

because this means that if a pharmacist or pharmacy technician makes a mistake (like dispensing the wrong medication), the pharmacy owner can also be held liable for any resulting harm.

Question 14

what are the 3 types of paper in the UK legislative process?

Answer 14

green → white → bill

Question 15

Explain the UK legislative process

Answer 15

green paper
white paper
bill

Question 16

what happens in green paper

Answer 16

consultative documents
set out the government intent
what the government might do

Question 17

what happens in white paper

Answer 17

firm proposals
what the government will do, given acceptances of parliament

Question 18

what happens in the bill

Answer 18

the legislative process for enacting legislation
- bill then goes to the house of commons
- then house of lord

Question 19

Pharmacy legislation covers some topics like:

Answer 19

• procurement of medicines, ingredients & related products
  
  • dispensing & supply of medicinal products
  • ownership of pharmacies
  • prescribing of medications
  • sale & supply of poisons & chemicals
  • supply for animal use

Question 20

examples of current legislation include?

Answer 20

• pharmacy order 2010
• misuse of drugs act 1971 & regulations

Question 21

what is the pharmacy order 2010

Answer 21

• created the gphc, and separated it from the rps, with gphc = regulation, rps = leadership
• registration, education, standards, and fitness to practise for pharmacists and pharmacy technicians.

Question 22

what is the misuse of drugs act 1971

Answer 22

divides drugs into classes, penalties for each one, allows police to search and arrest for harmful drugs e.g. heroin - class A

Question 23

how are meds governed in the eu

Answer 23

Medicines are governed by EU regulations and directives, which member states must implement.

Question 24

Have knowledge of Medicines Regulations in UK

• what are the 2 key acts?

Answer 24

• the human medicines regulations 2012
  
  • the medicines act 1968

Question 25

what does the human medicines regulations 2012 regulate and do

Answer 25

regulate the licensing, safety, and efficacy of human medicines in the UK. They establish the framework for marketing authorisation, categorise medicines (POM, P, GSL), and set standards for pharmacovigilance, advertising, and clinical trials, ensuring that all medicines are safe and effective for public use.

Question 26

what does the medicines act 1968 govern

Answer 26

the control and regulation of medicines in the UK.

Question 27

what does the medicines act 1968 establish and define etc what else does it do

Answer 27

It establishes the Medicines and Healthcare products Regulatory Agency (MHRA), defines categories of medicines, mandates safety and efficacy requirements, regulates advertising, and sets forth strict guidelines for the handling of controlled substances. It ensures that pharmaceuticals are properly tested, approved, and used.

Question 28

what does the Human Rights Act 1998 do

Answer 28

The HRA allows individuals to bring cases regarding breaches of their rights under the ECHR in UK courts.

Question 29

why was the human medicines regulations act of 2012 enacted

Answer 29

to consolidate and update previous legislation concerning the regulation of medicines in the UK, ensuring compliance with EU directives and enhancing public health protection.

Question 30

role of the MHRA

Answer 30

tldr: labelling, packaging & advertising of medicinal products for sale - have the responsibility for the regulation of medicines and medical devices + can advise what is and isn’t e.g is a toothpaste cosmetic or medicine (whitening versus preventing sensitivity) - in accordance with European Community’s medicinal products directive and UK law -> key to distinguish between medicinal and cosmetic products as meds are subject to regulations to ensure safety, quality and efficacy

Question 31

Explain the role of the:

Answer 31

- register of pharmacy premises - disciplinary control of pharmaceutical profession - sale and supply of medicinal products - restriction of titles

Question 32

Explain the role of the EMA (decentralised European medicines agency)

Answer 32

- responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU - the agency provides the EU with scientific advice on any question relating to the evaluation of the quality, safety, efficacy of products - responsible for coordinating the evaluation, supervision and pharmacovigilance of medicinal products in the EU

Question 33

Explain the role of the: CHM - commission on human medicines

Answer 33

- Give advice on the safety, quality, and efficacy of medicinal products. - Promote the collection and investigation of Adverse Drug Reaction (ADR) reporting - Advise the licensing authority - To advise Health Ministers and the Licensing Authority (LA) on matters relating to human medicinal products (except for herbals & homeopathics) - To consider licensing applications - To consider representations made by applicants or license or Marketing Authorisation holders - To promote collection & investigation of information relating to Adverse Drug Reactions (ADRs) – Yellow Card Scheme

Question 34

why do we have regulations:

Answer 34

illegal to manufacture/sell/supply/ export products without marketing authorisation

Question 35

Explain the term ‘marketing authorisation’ in relation to medicines

Answer 35

To receive a marketing authorisation the licensing authority must give particular consideration to the safety, quality and efficacy of the products

Question 36

How to get a Marketing Authorisation?

Answer 36

- Manufacturers must apply to the licensing agency - Licensing Agency must be satisfied that it is safe can take up to years to write, need so much information:

Question 37

a full application for marketing authorisation must include

Answer 37

- the summary of product characteristics - the pharmaceutical form: its composition, use etc - reports of experimental/biological/clinical trials and studies any adverse reactions reported - where the product is made abroad + details of its manufacture, assembly etc

Question 38

what article allows an exemption to marketing authorisation

Answer 38

Article 126a allows for a product to be used in the UK without a UK marketing authorisation in an emergency situation

Question 39

where must the product be licensed to allow article 126a

Answer 39

- Product must be licensed in another EU state and be imported from there under the 2001 directive - This is where placing the product on the market is justifiable for public health reasons (e.g. an epidemic)

Question 40

what rule is used in the EU about generic vs branded meds

Answer 40

8+2+1

Question 41

what does the 8 refer to in the 8+2+1 rule

Answer 41

After 8 years, the data relating to the product can be used

Question 42

what does the 2 refer to in the 8+2+1 rule

Answer 42

– A generic product cannot be marketed for a further 2 years

Question 43

what does the 1refer to in the 8+2+1 rule

Answer 43

A one year extension is given if the original product has therapeutic indications which are of ‘significant clinical benefit’ over other remedies

Question 44

why do pharmaceutical companies invest billions in clinical trials and research to bring a product to market

Answer 44

Rewarded with “Market Exclusivity”