Introduction to Pharmacy Law Flashcards

1
Q

List four different types of law

A

1) statute law
2) common law
3) public law
4) civil law

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2
Q

What is statute law? (3)

A

Statute law - the 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

(proposals for new legislations are called bills. before a bill is proposed, government will usually signal its intentions with a white paper. Often preceded by a discussion document - green paper)

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3
Q

Outline common law (3)

A

1) developed from the decisions of senior judges in the courts
2) relate to specific circumstances when legislation dose not exist/apply
3) e.g a pharmacist has a common law duty of care to their patients and the public

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4
Q

What is public law? (2)

A

Can either be statute law or common law , it involves the state or government.
Includes:
1) criminal law that defines the boundaries of acceptable conduct . Violating criminal law is an offence against society and is punishable by the state e.g theft
2) administrative law, controls how public bodies and individuals, including the NHS and community pharmacy contractors and pharmacists should operate. E.g NHS dispensing contract terms of service

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5
Q

Outline criminal law (4)

A

1) A crime is an act in violation of criminal law made with criminal intent.
2) in England and Wales the crown prosecution service makes decisions to prosecute someone alleged to have committed and offence.
3) The MHRA- government agency responsible for enforcing medicines legislation in the UK. Able to prosecute on cases such as unlawful manufacture, supply or promotion of medicines
4) GPhC can also prosecute for certain types of provisions of medicines offences

(Not allowed to advertise POMs on TV)

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6
Q

Define civil law (3)

A

1) concerned with disputes between individuals or organisations regarding duties, rights and obligations e.g. Property, law of contract, negligence and defamation
2) a wrongful act committed against another person
3) in healthcare - breach d confidence, defamation and negligence

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7
Q

With regards to civil law , outline what negligence is and how someone can prove it. (3)

A

Negligence- owe a legal duty of care and is a breach of that duty leading to loss or damage
E.g supplying the wrong drug to the patient resulting in harm or a doctor prescribing an overdose and the pharmacist dispenses it ( both to blame)

in order to establish negligence must prove:

1) duty - that a duty was owed to the patient in the particular situation
2) breach- that the. Professional breached this duty in failing to conform to the standards of care required by law
3) causation - that the patient suffered harm as a result of the defendants actions

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8
Q

Outline EU law (4)

A

1) much of the UK law needs to comply with EU law
2) EU court can make regulations which are compulsory and directly applicable to all EU member states
3) EU court issues directives which specify the objectives to be reached by each state. It is up to each state as to how to amend its law to comply with the directive
4) UK- most common means of incorporating directives in to law is as statutory instruments

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9
Q

Outline professional law (4)

A

1) law allowing disciplining of health professionals
2) the GPhC is constituted in statutory law (pharmacy order 2010)
3) pharmacist and pharmacy technicians order 2007 gives GPhC the power to discipline pharmacists
4) “standard of care” is the yardstick to judge in a professional tribunal if a pharmacist if guilty of professional misconduct . These standards are principally found in the GPhC professional code of conduct.

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10
Q

Outline the human rights act 1998 (3)

A

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
3) key human rights in relation to healthcare include:
- the right to life
- the right to liberty
- a fair trial
- respect for private and family life
- freedom of thought, conscience and religion
- prohibition of torture or inhuman or degrading treatment of punishment

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11
Q

Explain the following: indictable offences , summary offences and triable- either way offences (3)

A

1) indictable offences- are more serious crimes and are tried in the crown court by a judge and jury
2) summary offences- are less serious and tried in magistrates court
3) triable- either way offences -are those, under certain circumstances, are triable as summary or indictable offences.

E.g violating the medicines act by selling a P medicine in the absence of a pharmacist is a criminal offence and is triable either way. (Either a fine or imprisonment or both)

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12
Q

Picture

A

Picture

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13
Q

Describe the different criminal penalties (6)

A

1) discharges- the most lenient sentence available to a criminal court
- for minor offences
- absolute or conditional discharges
2) fines - most common
3) community orders e.g. Community service or supervision, alcohol or drug treatment orders
4) custodial sentences (prison)
5) ancillary orders may also be imposed e.g ASBO, ban from driving
6) warnings and cautions

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14
Q

1) What is the ‘notifiable occupations scheme’? (2)

2) What happens once a conviction is ‘spent’?

A

1i) Professions and occupations which may carry specialist trust or responsibility, and includes pharmacists
ii) The police have a duty to share with the GPhC convictions or other relevant information relating to pharmacists
2) Once a conviction becomes ‘spent’ it does not need to be disclosed e.g In a job application. However pharmacists are not entitled to withhold information about previous convictions even before registration as a pharmacist. Failure to disclose convictions can result in a fitness to practice investigation.

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15
Q

List the different types of law pharmacists should be aware of (10)

A

1) human medicines regulations 2012 and medicines act 1968
2) veterinary Medicinal products directive 2001
3) the misuse of drugs act 1971
4) data protection act 1998
5) environmental protection act 1990
6) poisons act 1972
7) denatured alcohol regulations 2005 , control of substances hazardous to health regulations 2002 (COSHH)
8) human rights act 2000
9) GPhC code of conduct, ethics and performance
10) GPhC guidances

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16
Q

Outline the medicines act 1968 (3)

A

1) first comprehensive licensing system for medicines in the UK
2) act of parliament that governs control of medicines for human use, which included the manufacture, importation, sale and supply of medicinal products
3) the medicine act used to cover veterinary medicines but these are now under veterinary medicines regulations

17
Q

What is the human medicines regulations 2012 (4)

A

Replaces medicines act 1968 and 200 statutory instruments repealing obsolete law and contributing to the governments drive for burden reduction.

1) true human medicines regulations 2012 sets out a comprehensive regime for the authorisation of medical products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising ; and for pharmacovigilance
2) incentive by MHRA to consolidate UK medicines legislation
3) there are 17 parts of the human medicines regulations 2012
4) “medicines legislation” includes the 1968 act and the 2012 regulations

18
Q

Outline which statutory warnings the human medicines regulations 2012 relate too. (7)

A

1) over the counter products
2) membership of review panels
3) health professionals exemptions
4) provisions for patient group directions
5) pharmacist-instigated changes to prescriptions
6) repeal of section 10 of the medicines act 1968 which permitted pharmacy businesses to undertake limited wholesale dealing without a license.
7) introduces a strengthened, clarified and more proportionate regime for pharmacovigilance in the EU market.

The human medicines regulation will cover everything that relates to medicines for human use- manufacturing, distributing, safety , efficacy , quality, clinical trials, imports and exports, packaging , containers, leaflets, sale and supply, registration, advertising , pharmacovigilance , publication of the British pharmacopeia, borderline products, regulation for sale and supply

19
Q

Outline the role of the:

1) MHRA (6)
2) and the GPhC (2)

in the enforcement of medicines legislation.

A

1) MHRA:
- licensing of medicinal product
- manufacturing
- wholesale dealing
- advertising and promotion of medicines
- import and export
- clinical trials

2) GPhC:
- registration, operation and inspections of premises
- all aspects of retail sale and supply ~ control and supervision , quality, labelling and packaging