Introduction to Pharmacy Law Flashcards by Jimmy Salon

Main Laws that you will need to know or be aware of?

Human Medicines Regulations 2012
Medicines Act 1968
Veterinary Medicines Regulations 2014
The Misuse of Drug Act 1971
Data Protection Act 1988
Environmental Protection Act 1990
The Deregulation Act 2015
Poisons Act 1972
Denatured alcohol regulations 2005: control of substances hazardous to health regulations 2002 (COSHH)
Human Rights Act 1998
Equality Act 2010

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What are the different types of law relevant to pharmacy?

Statute Law
Common Law
Public Law
Civil Law

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What is Statute Law?

Body of principles and rules laid down in statutes (between states and citizens).

1) it Is an act of parliament
- can be public or private acts
- pharmacy only affected by public acts of Parliament e.g poisons act, misuse of drugs act
2) acts are usually called primary legislation
3) statutory instruments are secondary legislation

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Public Law

Involves the state or government (can be either statute law or common law).
Includes:
- Criminal law
- Administrative law

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Criminal Law

In England and Wales the crown prosecution service makes decisions to prosecute someone alleged to have committed an offence.

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What is a crime?

An act of violation of criminal law made with criminal intent

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What is administrative law?

Controls how public bodies and individuals should operate.
Includes the NHS and community pharmacy operators.

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Examples of administrative law in pharmacy

NHS dispensing contract
Terms of service

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What is professional Law?

Law allowing discipline of eg. health professionals
GPhc is constituted in statutory law
Pharmacist and pharmacy technicians order 2007 gives GPhC the power to discipline pharmacists and technicians

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What is “Standard of care”?

A way to judge in a professional tribunal if a pharmacist is guilty of professional misconduct

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Common law

1) developed from the decisions of senior judges in the courts
2) relate to specific circumstances when legislation does not exist/apply

e.g a pharmacist has a common law duty of care to their patients and the public

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Civil Law

Concerned with disputes between individuals or organisations regarding duties, rights and obligations.
E.g. property, law of contract, negligence

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What is a tort?

A wrongful act committed against another person, intentional or not.

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Examples of tort in pharmacy practice

Breach of confidence
Defamation
Negligence

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Negligence

Owe a legal duty of care
Negligence is a breach of that duty leading to loss or damage.

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Examples of negligence

Supplying the wrong drug to the patient resulting in harm
A doctor prescribing an overdose and the pharmacist dispenses it ( both to blame)

What is involved proving negligence?

Duty: That a duty was owed to the patient in the particular situation
Breach: that the professional breached this duty in failing to conform to the standard of care required by law
Causation: that the patient suffered harm as a result of the defendants actions

What Year did The Human Rights Act come out?

1998

Human Rights Act 1998

1) Applies to public authorities and private bodies
2) All UK laws must be interpreted to respect and protect the human rights of all UK citizens

Examples of Articles in the Human rights act relevant to pharmacy

Article 2: Right to life
Article 3: The right not to be tortured or treated in an inhumane or degrading way
Article 5: Right to liberty and security
Article 6: Right to a fair trial
Article 8: Right to privacy
Article 10: Freedom of thought, conscience and religion

The Courts- Tribunals

NHS tribunals who administer administrative law
Power to enforce rests with administrative body rather than police or criminal courts
Other tribunals include employment and education law
FTP panels of the GPHc are a form of professional tribunal

Criminal courts

Magistrates Court: hears less serious criminal cases, can’t impose sentences of imprisonment > 12 months
Crown Court: Hears cases and appeals from magistrate’s court, has greater powers of sentencing, deals with minor and serious crimes
Divisional Court: Queens Bench Division
Court of Appeal: Criminal Division
Supreme Court: Highest Court in /England

Civil courts

County Court- 1 Judge, no jury. smalls comes of money eg. personal injury, discrimination
High Court- hears more major cases of negligence, also appeals for pharmacists
Court of Appeal
Supreme Court

Types of Offences

Indictable Offences: More serious crimes and are tried in the Crown Court by a judge or jury
Summary Offences: Less serious and are tried in the magistrates courts
Triable-either-way offences: those that are under the circumstances are triable as summary OR indictable offences (or both)

What is an example of a triable-either-way-offence?

- Violating HMR - e.g. selling a P med in the absence of a pharmacist, would be a criminal offence and is triable either way (either a fine or imprisonment or both)

Criminal Penalties (Sentencing)

1) Discharges: most lenient sentence available to criminal court for minor offences 2) Fines; most common 3) Community Orders: eg. Community service or supervision, alcohol or drug treatment orders 4) Custodial sentences i.e prison 4) Warning/Cautions eg. by police

What is the notifiable occupations scheme?

Relates to professions and occupations that carry special trust or responsibility - includes pharmacists

What happens after a conviction?

- After certain time period, specific convictions are described as spent - Once it becomes spent, individuals are not normally required to disclose it e.g. job application - Pharmacists are however not entitled to withhold info about previous convictions - failure to disclose the convictions when applying for a job or seeking registration can result in a fitness to practice investigation

What is the medicines act 1968?

- It is an act of parliament that governs the control of medicines for human use - Includes the manufacture, importation, sale and supply of medicinal products

What is the Human Medicines Regulations 2012?

Incentive by MHRA to consolidate UK medicines legislations - Sets out a comprehensive regime for the authorisation of med products

What does the term medicines legislation mean?

Used to include 1968 act and 2012 regulations

What does the Human Medicines Regulations 2012 cover?

- Definition of a medicinal product - Licensing system * Safety and efficacy * Quality * *Manufacturing * *Distribution - Exemptions to requirements for marketing authorisations - Sale/Supply/Exemptions of non prescription items (GSL and P) - Sale/supply/exemptions of POM - Sale of med to the public at a distance (falsified medicines) - Import and export of med products - Clinical trials - Containers, packaging, labelling, leaflets - Regulation for Sale and Supply * Certification of homeopathic med products * Traditional herbal registration - Borderline products - Advertising - Publication of BP - Pharmacovigilance - Enforcement

What is MHRA?

Government agency responsible for enforcing medicines legislations in the UK - Able to bring criminal prosecutions in cases such as unlawful manufacture, supply or promotion of meds - GPhC can also prosecute for certain offences of medicines provision

Outline the role of the MHRA

Medicines and Healthcare products Regulatory Agency - licensing of med - manufacturing - wholesaler dealing - advertising and promotion of meds - import and export - clinical trials

Outline the role of the GPhC

- Registration, operation and inspection of premises - all aspects of retail sale and supply of med * Control and supervision * Quality, labelling and packaging

What is a medical device?

Any instrument, apparatus, appliance, software, material or other article, whether used solo or in common, to be used specifically for diagnosis or therapeutic purpose or both and necessary for its proper application - Includes; IUD, dental fillings, CL, non-medicated dressings - Medical Device Regulations 2002: Obligations on manufacturers to ensure that the devices are safe and fit for their intended purposes, then given CE mark

CE marking Significance

- The letters 'CE' - To place device on the market - Mandatory - Means the manufacturer is satisfied that the product agrees with essential requirements in legislation - In UK, MHRA administers and enforces legislation