Introduction to Pharmacy Law

Question 1

What are the different types of law relevant for pharmacy?

Answer 1

• Statue Law

- Common Law

Question 2

What is Statue Law?

Answer 2

• It is an act of parliament
• Can be public or private acts
• Pharmacy only affected by public acts of parliament eg. Medicines act, Misuse of Drugs Act
• Acts are usually called Primary Legislation
• Statutory Instruments (Can be in the form of regulations or orders) are secondary legislations
• Proposals for new legislations are called bills
• Before a bill is proposed, gov will usually signal its intentions with a white paper
• Often preceded nay a discussion document: green paper

Question 3

Public Law

Answer 3

-Involves the state or government (Can be either statue law or common law):
Includes:
-Criminal law: defines the boundaries of acceptable conduct. Contravening criminal law means an offence against society and is punishable by state

Question 4

What is a crime?

Answer 4

-An act of violation of criminal law made with criminal intent

Question 5

Criminal Law

Answer 5

-Crown prosecution service makes decision to prosecute someone alleged to have committed an offence

Question 6

What is MHRA?

Answer 6

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 types of provisions of medicines offences

Question 7

What is administrative law?

Answer 7

Controls how public bodies and individuals, including the NHS and community pharmacy contractors should operate eg. NHS dispensing contract Terms of Service

Question 8

What is professional Law?

Answer 8

• Law allowing discipling 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

Question 9

What is “Standard of care”?

Answer 9

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

Question 10

Common law

Answer 10

• Common law related to duties and obligations between citizen and is built up of court judgements to create a body of decisions and precedents known as civil law
• Common law relates to specific circumstances when legislation does not exist or apply
• for example: a pharmacist has a common law duty of care to their patients and the public

Question 11

Civil Law

Answer 11

-Concerned with disputes between individuals or organisations regarding duties, rights and obligations. Eg. Property, law of contract, negligence

Question 12

What is a tort?

Answer 12

A wrongful act committed against another person, intentional or not

• It derives from the notion that citizens owe each other duties and responsibilities
• In healthcare practice- common are breach of confidence, defamation and negligence

Question 13

What occurs in a civil case?

Answer 13

Complaint makes an allegation that the actions of another person has caused them damage or injury
-complainant has to prove their case “on the balance of probabilities” i.e its more likely than not that the other person did cause the harm

Question 14

What is an example of negligence?

Answer 14

• Supplying the wrong drug to a patient who suffers harm as a result of that error
• a doctor prescribing too high of a dose and the pharmacist dispenses it

Question 15

What is involved proving negligence?

Answer 15

-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 (that was not too remote) as a result of the defendants actions

Question 16

What Year did The Human Rights Act come out?

Answer 16

1998

Question 17

What does the Human Rights Act 1998 incorporate?

Answer 17

• Requires all public bodies (like courts, police, local authorities, hospitals and publicly funded schools) and other bodies carrying out public functions to respect and protect your human rights
• All UK laws must be interpreted to respect and protect the human rights of all UK citizens
• Act sets out human rights in a series of ‘Articles’ Each article deals with a different right

Question 18

Examples of Articles

Answer 18

Article 2: Right to life
Article 6: Right to a fair trial
Article 5: Right to liberty and security

Question 19

The Courts- Criminal

Answer 19

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

Question 20

The Courts - Civil

Answer 20

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

Question 21

The Courts- Tribunals

Answer 21

• 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

Question 22

Types of Offences

Answer 22

• 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 indictable offences (or both)

Question 23

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

Answer 23

-Contravening the human medicines regulations such as when selling a pharmacy medicine from a registered pharmacy in the absence of a pharmacist, would be a criminal offence and is triable either way (either a fine or imprisonment or both)

Question 24

Criminal Penalties (Sentencing)

Answer 24

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

Question 25

What is the notifiable occupations scheme?

Answer 25

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

Question 26

What happens after a conviction?

Answer 26

- 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

Question 27

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

Answer 27

- 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 - Human Rights Act 1998 - Equality Act 2010

Question 28

What is the medicines act 1968?

Answer 28

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

Question 29

What is the Human Medicines Regulations 2012?

Answer 29

- The result of the initiative by the MHRA to consolidate the review UK medicines legislations - Sets out a comprehensive regime for the authorisation of med products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising, and for pharmacovigilance

Question 30

What does the term medicines legislation mean?

Answer 30

used to include 1968 act and 2012 regulations

Question 31

What does the Human Medicines Regulations cover?

Answer 31

- 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

Question 32

Enforcement of Med Legislation

Answer 32

MHRMA - licensing of med - manufacturing - wholesaler dealing - advertising and promotion of meds - import and export - clinical trials GPhC - Registration, operation and inspection of premises - all aspects of retail sale and supply of med * Control and supervision * Quality, labelling and packaging

Question 33

What is a medical device?

Answer 33

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

Question 34

CE marking Significance

Answer 34

- Allows for placing of device on market in any EC member state. It is a mandatory conformity mark and indicated that the manufacturer is satisfied that the product confirms to all relevant essential requirements in legislation - In uk, MHRA administers and enforces legislation