B1: The legal + Ethical Basis of Pharmacy Flashcards
Duty of ___ + duty of___ is included in ___
Care
Confidentiality
Civil
2 main types of law
Statute
- criminal
- administrative
- professional
Civil
- common law
Criminal law controls + duties
Between the state and its
citizens
Controlled by:
- Acts (1°legislation) Regulations
- Statutory Instruments (2°legislation)
Administrative law controls + duties
Between public bodies, their
servants and clients
Controlled by:
- Directions
- NHS Law, Town-Planning
- Law
Professional law controls + duties
Between state (as proxy for
patients) and health
professional
- controlled by GPhC Regulatory
Requirements
Civil law controls + duties
Between citizens
Between professionals and their clients
Tort - non-contractual civil wrong
- Negligence
- Breach of confidentiality
- Defamation
Controlled by:
- precedents in courts
Criminal law sanctions + penalties
Prosecutions, fines, imprisonments
Administrative sanctions + penalties
Loss of remuneration, contract, promotion, job
Professional sanctions + penalties
Removal from Register
Civil sanctions + penalties
Payment of compensation
Referral to professional or administrative route
Examples of statute law
Medicines Act 1968
Misuse of Drugs Act 1971
Poisons Act 1972
Health and Safety at Work Act 1974
Examples of civil law
The Pharmacy Order 2010
Human Medicines Regulations 2012
Main legislation affecting pharmacy
- Medicines Act 1968
- Human Medicines Regulations 2012
- Poisons Act 1972 (controls non-medicinal poisons)
- Misuse of Drugs Act 1971
- Pharmacy Order 2010
When can information be disclosed
1) with consent of patient
2) without consent of individual
What circumstances can information be shared without consent
- need to know basis
- statutory requirements (by law)
- –notifications, obligations (birth, death, illness)
- — persons with legal right (court order, healthcare obligator - GPhC, GMC)
- public interest
Valid consent
Given voluntarily by an appropriately informed person
who has the capacity to consent to the intervention.
What obtaining consent means
- Moral function
- Clinical function - gain patient’s trust, cooperation,
confidence, etc. - Legal function – provide justification for care; protect
HCPs from criminal / civil claims - Cannot assume you know patient’s best interests; it is
their decision
Confidentiality
Pharmacists have a duty of confidentiality = ethical requirement
- Data protection act 1998
- Human rights act 1998
Medicines Act 1998
To control the safety, quality and efficacy of
medicinal products for human use. It controls /
controlled:
- Which medicines can be marketed
- Medicines manufacture, sale and supply
- Labelling and description
- Sales promotion
Administration of Human Medicines Regulations 2012
Advisory bodies are Commission on Human Medicines (CHM) + British pharmacopoeia
CHM
- advises health ministers on executing regulations
- advises MHRA (licensing authority)
- commission membership
- receives advice from various committees (Advisory Board for the Registration of Homeopathic Products, Herbal Medicines Advisory Committee, Independent review panel for advertising, Ad hoc committees, Sub-committees)
BP comission
- prepares BP + other compendia
- lists approved drug names
Licensing of Human Medicines Regulations 2012
Licensing body = Medicines and Healthcare Products Regulatory Agency (MHRA)
License is required for:
- Human use medicines
- animal administration medicines
A medicine is:
- medicinal product
- medicinal purpose
Marketing authorisation
- Allows medicinal product to exist, be obtained, supplied, etc.
- Places restrictions on products