law & ethics Flashcards
describe what constitutes law in the UK
→ 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
law is defined as a what system
→ dynamic system. eg. modern laws against online comments
what are ethics
→ 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
- Compare the difference between law and ethics
→ ethics = grey, law = black and white
→ ethics are based on our moral principles: each person has their own views based on our experiences.
compare the difference between Civil Law and
Criminal Law
→ 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
Criminal law traits
State v defendant
Public action
Apprehension & disposition
Magistrate court (magistrate) or Crown court (jury)
civil law traits
Plaintiff v defendant
Private action
Compensation & restitution of wrongdoing
County court
High court
Describe how negligence applies to pharmacy
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
legal tests for negligence:
- harm must be forseeable
- there must be a sufficiently proximate relationship between the parties
- it must be just & reasonable to expect the duty
proving causation in pharmacy
its difficult to prove is there is a terminal care patient, or multiple morbidity
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
what’s professional indemnity:
- 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)
when can vicarious liability (exercised by one person on behalf of another) happen
- 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.
In a pharmacy context, 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.
Pharmacy legislation covers some topics like what?
- 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
examples of current law legislation
- pharmacy order 2010
- misuse of drugs act 1971 & regulations
what is ‘green paper’
- consultative documents
- set out the governments intents and what they might do
UK legislative process order
green paper -> white paper -> bill
what is ‘white paper’
- firm proposals
- what the government will do, given acceptance of parliament
what is a ‘bill’
- the legislative process for enacting legislation
- the bill then goes to the house of commons
- then the House of Lords
what does the human medicines regulations 2012 do
- 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.
what does the the medicines act 1968 do
- governs the control and regulation of medicines in the UK. 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.
Describe the complexities of defining what constitutes a medicine:
Cross-Border Regulations: What is classified as a medicine in one country may not be in another, affecting the availability and legality of certain products.
Functional Classification
The function and claims made about a product heavily influence its classification as a medicine. For example:
- Health Claims: Products that claim to prevent or treat illness are more likely to be classified as medicines.
- Nutraceuticals and Dietary Supplements: These may claim health benefits but often skirt the definition of a medicine, leading to regulatory challenges.
Be able to describe the 2012 Human Medicines Regulations - what is it?
just read through this its ok
Overview of Human Medicines Regulations 2012
1. Purpose:
- The HMR 2012 were enacted to consolidate and update previous legislation concerning the regulation of medicines in the UK, ensuring compliance with EU directives and enhancing public health protection.
2. Key Provisions:
-
Licensing of Medicines:Medicines must be authorized before they can be marketed. This includes:
- Marketing Authorization (MA):Required for all medicines, ensuring safety, quality, and efficacy.
- Different Pathways:There are routes for centralized, decentralized, and national authorizations.
-
Categories of Medicines:The regulations define various categories:
- Prescription-Only Medicines (POM):Must be prescribed by a qualified healthcare professional.
- Pharmacy Medicines (P):Can be obtained from a pharmacy without a prescription but under pharmacist supervision.
- General Sales List (GSL):Can be sold without professional supervision.
3. Pharmacovigilance:
- HMR 2012 emphasizes the importance of monitoring the safety of medicines post-marketing, including:
- Reporting adverse drug reactions (ADRs).
- Ensuring that effective measures are in place for ongoing safety assessments.
4. Clinical Trials:
- The regulations include provisions related to clinical trials, ensuring that they are conducted ethically and that participant safety is prioritized.
5. Advertising and Promotion:
- HMR 2012 regulates the advertising of medicines to ensure that it is not misleading and that it does not encourage inappropriate use.
6. Pharmaceutical Quality:
- The regulations set out standards for Good Manufacturing Practice (GMP), requiring that medicines meet specific quality standards before they can be marketed.
7. Specific Provisions:
- The regulations include provisions for controlled drugs and outline the responsibilities of healthcare professionals in the supply and administration of medicines.
Explain the role of the:
MHRA:
- 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
- tldr: labelling, packaging & advertising of medicinal products for sale
→ i’s key to distinguish between medicinal and cosmetic products as meds are subject to regulations to ensure safety, quality and efficacy
Explain the role of the:
GPhC:
- register of pharmacy premises
- disciplinary control of pharmaceutical profession
- sale and supply of medicinal products
- restriction of titles
Explain the role of the:
EMA (decentralised European medicines agency)
- 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
Explain the role of the:
CHM (commission on human meds)
- 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
why do we have regulations?
to make it illegal to manufacture/sell/supply/ export products without marketing authorisation
Explain the term ‘marketing authorisation’ in relation to medicines - what does it mean to have it
To receive a marketing authorisation the licensing authority must give particular consideration to the safety, quality and efficacy of the products
How to get a Marketing Authorisation?
- 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
what might a full application to get a marketing authorisation include:
- summary of product characteristics
- pharmaceutical form and use
- reports of trials
- any reactions reported
- where the product is made, manufactured etc
what is the exemption to when ur not allowed a marketing authorisation called e.g. what article
article 126a
what does article 126a allow
for a product to be used in the
UK without a UK marketing authorisation in an emergency situation
where does a product have to be licensed for article 126a to apply to it
- 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)
what’s the difference between generic and branded medicines
- Pharmaceutical companies invest billions in clinical trials and research to bring a product to market
- Rewarded with “Market Exclusivity”
- This is now governed in the EU by the 8+2+1 rule
– After 8 years, the data relating to the product can be used
– A generic product cannot be marketed for a further 2 years
– A one year extension is given if the original product has therapeutic indications which are of ‘significant clinical benefit’ over other remedies
what is a parallel import (PI)
a legitimately produced medicinal product
which is imported into one member state from another. Prices can vary, and shortages can occur
Explain the term pharmacovigilance
Pharmacovigilance is the continued surveillance of a medicinal product once it is on the market
what role do pharmacists play in pharmacovigilance
The Yellow Card Scheme and Black Triangle Drugs
- reporting suspected adverse reactions
- using the bnf
what’s the yellow card scheme and why is it good
Yellow cards for reporting adverse events
what are black triangle medicines
- Medicines that are being monitored particularly closely by regulatory authorities in the European Union (EU) are described as being under ‘additional monitoring’.
