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PPM > TBL 2 - INTRO TO ENGLISH LAW AND ETHICAL PRINCIPLES > Flashcards

TBL 2 - INTRO TO ENGLISH LAW AND ETHICAL PRINCIPLES Flashcards

1
Q

When were drug standards known and by who?

A

First known drug standards found in salemo medical edict of 1240 issued by Fredrick 11 of Sicily.

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2
Q

When was the apothecaries wares drugs and stuffs act passed?

A

Apothecaries wares drugs and stuffs act, passed in 1540 during Henry VIII’s reign.

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3
Q

When was modern medication regulations started?

A

Modern meds regulation started in 20th century - prompted by a series of drug-related incidents

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4
Q

In what event in the USA caused them to become more strict with the regulation of their medication?

A

In response to event in USA in 1937, where over 100 ppl died of poisoning when a Sulphonamides elixir (an antibiotic product) was prepared using diethylene glycol a solvent without any safety testing.

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5
Q

What was thalidomide originally intended for?

A

Thalidomide originally intended as a sedative or tranquilizer but was then prescribed for conditions like colds, flu and nausea and morning sickness in pregnant women.

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6
Q

What problem was caused by thalidomide?

A

Problem caused was severe birth defects in foetus.
Impact of development was linked to when pregnancy the drug taken effects occurred between 20 to 37 days after conception.

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7
Q

What are the 3 main changes that the thalidomide prompted?

A

One key change was that drugs intended for human use could no longer be approved purely based on animal testing.
Drug trials for substances marketed to pregnant women had to provide evidence that they were safe for use in pregnancy.
Prompted many countries to improve their classification/control of meds.
UK 1968 medicines act made distinction between POM, P AND GSL drugs (as thalidomide was an over-counter med)

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8
Q

What conditions is thalidomide used to treat?

A

Thalidomide used to treat leprosy, some aid-related conditions as a targeted cancer drug for treating cancers such as multiple myeloma.

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9
Q

What is the role of medicines act 1968?

A

medicines act 1968 was to control the safety, quality and efficacy of medicinal products.
Did this by means of a system of licenses and certificates.
Regulate process from the first clinical trials of meds through to the manufacture and supply of meds to the patient
Amended over 350 times

ACT REQURIES MEDICINE TO BE SAFE, EFFECTIVE AND AN APPROPRIATE QUALITY.

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10
Q

Why were the 1963 committee on safety of drugs created?

A

1963 committee on safety of drugs was created in UK which was followed by the introduction of yellow card scheme.

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11
Q

What is the role of the commission on human meds (CHM)?

A

CHM is an advisory, non-departmental public body which is sponsored by the Department of Health and Social Care.
The CHM provides advice to ministers on the safety, efficacy and quality of medicines.

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12
Q

What is the role of the committee for medicinal products (CHMP)?

A

It is the EMA’s committee responsible for human medicines; it plays a particularly vital role in the authorisation of medicines.

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13
Q

What is the role of the European medicines agency (EMA)?

A

The EMA’s role is to protect and promote human and animal health by evaluating and monitoring medicines within the European Union (EU) and the European Economic Area.

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14
Q

What is the role of the medicines and healthcare products regulatory agency?

A

The MHRA is responsible for regulating medicines, medical devices and blood components for transfusion in the UK.

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15
Q

What is the role of the Medicines Act 1968?

A

It governs the control of medicines for human use, which includes the manufacture and supply of medicines, and the manufacture and supply of (medicated) animal feeding stuffs.

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16
Q

What is the role of the human regulations 2012?

A

authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.

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17
Q

What is the role of the veterinary medicines regulations 2013?

A

authorization of medicinal products for animal use. Also, for the manufacture, import, distribution, sale and supply of those products.

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18
Q

What is the role of the Misuse of drugs regulation 2001?

A

allow for the lawful possession and supply of controlled (illegal) drugs for legitimate purposes. They cover prescribing, administering, safe custody, dispensing, record keeping, destruction and disposal of controlled drugs to prevent diversion for misuse.

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19
Q

What is the role of the Misuse of drugs regulation (safe custody) regulations 1973?

A

The Misuse of Drugs (Safe Custody) Regulations 1973 (‘the 1973 Regulations’) set out the minimum requirement for the safe custody of Schedule 2 controlled drugs (‘CDs’) (e.g. opiates) and some Schedule 3 CDs (e.g. temazepam) which carry the biggest risk of diversion.

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20
Q

What is the role of the Controlled drugs (supervision of management and use) regulations 2013?

A

required to appoint Controlled Drugs Accountable Officer (CDAOs) and set out who may be appointed to the CDAO role, under what circumstances they should be removed from this role and the registration requirements for all CDAOs (regulations 8–10).

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21
Q

What is the role of the medicines and medical devices act 2021?

A

A Bill to confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and the protection of health and safety, in relation to medical devices; and for connected purposes

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22
Q

What is the role of the health and care 2022?

A

aim to make it easier for health and care organisations to deliver joined-up care for people who rely on multiple different services, building on earlier recommendations by NHS England and NHS Improvement.

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23
Q

What is the role of the health care act 2006?

A

The Act covers smoke-free public places and workplaces; power to amend the minimum age of sale of tobacco; prevention and control of health care associated infections; management of controlled drugs in the NHS; provision of pharmacy and ophthalmic services

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24
Q

What is the role of data protection act 2018?

A

Everyone responsible for using personal data has to follow strict rules called ‘data protection principles’. They must make sure the information is: used fairly, lawfully and transparently.

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25
Q

What is the role of Access to Health Care Records Act 1998?

A

gave individuals the right of access, subject to certain exceptions, to health information recorded about themselves, and, in certain circumstances, about others, within manual records.

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26
Q

What is the role of Freedom of information act 2000?

A

provides public access to information held by public authorities. It does this in two ways: public authorities are obliged to publish certain information about their activities; and. members of the public are entitled to request information from public authorities.

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27
Q

What is the role of Health and social care act 2012

A

aims of the Act are to change how NHS care is commissioned through the greater involvement of clinicians and a new NHS Commissioning Board; to improve accountability and patient voice.

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28
Q

What is the role of the equality act 2010 and their protected classes?

A

The Equality Act 2010 legally protects people from discrimination in the workplace and in wider society.
Protected classes:
age, disability, gender reassignment, marriage or civil partnership (in employment only), pregnancy and maternity, race, religion or beliefs, sex and sexual orientation.

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29
Q

What is the role of the pharmacy order 2010?

A

set out the regulatory powers of the General Pharmaceutical Council in Great Britain and brought regulation of the pharmacy professions in Great Britain into line with other health professions

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30
Q

What is the role of the trades description act 1968?

A

offence for businesses or salespeople to sell a product or service based on misinformation

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31
Q

What 2 legislation are involved in statue law?

A

primary and secondary legislation.

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31
Q

What 2 legislation are involved in statue law?

A

primary and secondary legislation.

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32
Q

What are primary legislations?

A

Primary legalisation is the term used to describe the main laws passed by the legislative bodies in the UK, including UK parliament.

33
Q

What are examples of primary legislation?

A

An act of parliament example of primary legislation include medicines act 1968 and misuse of drugs act 1971.

34
Q

Which legislation cant be overturn?

A

Court of law cant overturn an act of parliament - parliament is sovereign so it is to say it is the ‘supreme legal authority in the UK which can create or end any law’

35
Q

When decisions are made by judges they become precedent what is precedent?

A

Decisions from judges should be on how it should be interpreted will be based on parliaments intention. - decisions become precedents.

Precedent - they will be followed in future cases.
Regulations take months as passes through all of the parliamentary processes

36
Q

What is a secondary legislation?

A

Secondary legislation is law caused by ministers or other bodies under powers given to them by an act of parliament, usually in the form of regulations or orders in council.
Known as statutory instruments (secondary legislation). - once been put into effect they have as much force in law as primary legislation.

37
Q

What is green paper?

A

First step in creating a new law or changing an existing law often a green paper.
Green paper is a consultation document put together by gov department.
GP not a statement of policy but to stimulate discussion by putting forward idea for future gov policy.
Anyone can comment on green paper available on department website.

38
Q

What is white paper?

A

WP allows gov to test public opinion and gather feedback before presenting a bill to parliament.
GP/WP together made up consultation process before a new piece of legislation is put before parliament

39
Q

What is the first step in the preliminary process?

A

Begins with monarchs speech.
Made every year at the opening of parliament and sets out gov proposals for legislation in coming year.

40
Q

What is a bill and what does it become?

A

Proposed new law is then presented to parliament known as a bill
Bill passes through stages in parliament before coming an Act of parliament.
Act of parliament known as statue, create new law or change an existing law.
All acts of parliament together made up the body of UK statute law.

41
Q

What is common law?

A

Common law (case law) is a body of law that has been built up over many years, based on the principle of the judicial precedent.

42
Q

What is judicial precedent?

A

judicial precedent: when a decisions has been made by a judge sitting in a court that decisions is binding in later cases where the facts are the same or similar.

43
Q

Who created crime and decided which crime were unacceptable in activities?

A

Crimes created by gov. Gov decides that certain activities are unacceptable in our society.
Parliament passes laws which make these unacceptable activities into criminal offences (crimes).

44
Q

What is the defination of a crime?

A

A crime happens when a person intentionally commits one of these activities or intentionally fails to do something required by criminal law.

45
Q

What is the 2 parts involved in crime and who would have to prove both of these parts in court?

A

Crime has 2 parts: THE CRIMINAL ACT/ THE CRIMINAL INTENT
Successful prosecution involves proving both action and intent

46
Q

What is strict/absolute liability?

A

For some offences intent is not important. Known as strict or absolute liability. e.g. speeding offence. Prosecution need to prove that person accused was driving and exceeded speed limit not prove they indented to drive at that speed.

47
Q

Who enforces criminal law and who prosecutes offenders?

A

Criminal law is enforced by the state, investigates crimes and detects offenders.
Usually police or can be another agency. e.g. MHRA has power to investigate some medicines offences such as illegal sale or supply of meds.
State prosecutes offenders, via crown prosecution service (CPS)

48
Q

The state prosecutes people accused of criminal offences in the criminal courts only prosecute if they believe (2 parts):

A

1) Have the reasonable chance of winning the case (there is sufficient evidence) and
2) It is in the public interest to do so.

49
Q

What is the standard of proof?

A

Standard of proof: Is the degree of which as party must prove its case to succeed.

50
Q

What is the burden of proof?

A

Burden of proof: requirement to satisfy that standard.

51
Q

Who does the burden of proof rest with in a criminal case?

A

In criminal case burden of proof rests with the prosecution to prove their case BEYOND RESONABLE DOUBT in court.

52
Q

What happens during serious cases?

A

Serious cases: decision made by 12-person jury

53
Q

What happens during less serious cases?

A

Less serious cases: panel of magistrates decides the outcome

54
Q

What is beyond reasonable doubt?

A

Beyond reasonable doubt: is the standard of proof required in a criminal court. ‘Beyond reasonable doubt’ means there are no other logical explanation can be deduced from the facts and evidence presented in court except that the defendant committed the crime.

55
Q

What happens after offender is convicted?

A

After conviction, court ill sentence offender with a suitable sanction e.g prison/fine.

56
Q

What is the purpose of a sanction (4 things)?

A

Purpose of a sanction in criminal law:
To punish offenders
To prevent them from re-offending
To deter others from committing the same offence
Rehabilitation or helping the offenders to move away from crime.

57
Q

What is the purpose of civil law?

A

Purpose of civil law is to regulate human relationships, protect individual rights and provide compensation when rights are infringed.

58
Q

What is civil law and what does it cover?

A

Civil law deals with relationships between individuals or companies. Covers wide range of matters such as contracts, libel (defemination), slander, trespass and negligence.

59
Q

In civil law who is the burden of proof on?

A

Civil case burden of proof is on the claimant.

60
Q

What must the claimant prove and what happens if they are successful?

A

Claimant must prove on the BALANCE OF PROBABILITES that the defendant is responsible for the problem.
Lower standard of proof than used in criminal law (beyond reasonable doubt)
If claimant successful, court can award compensation to take action to remedy the problem.

61
Q

What happens during civil law actions?

A

Civil law actions are taken by an individual (the claimant) who sues another person or body corporate (the defendant)

62
Q

What is the aim of civil law?

A

Aim to restore, as far as possible, the claimant to the position they would have been in had the incident that led to the case not occurred. Compensation is calculated on the basis.

63
Q

What does punitive/exemplary award mean?

A

An award made which is designed to punish defendant - known as PUNITIVE DAMAGES/EXEMPLARY AWARD

64
Q

What is a tort and what is the most common tort?

A

A tort is a civil wrong - most common tort is negligence

65
Q

For a claim of negligence to be successful under the law following elements must exists (4 things):

A

1) There must be a duty of care owned by the defendant to the claimant
2) The defendant must have breached that duty
3) The claimant must have suffered a loss or injury as a result of the breach
4) If breach of duty an causation is established, it is quantify the claim for compensation or damages.

66
Q

What is the bolem test?

A

For many years leading case in clinical negligence (formally medical negligence) was Bolam v Friern Barnet Hospital Management committee (1957).

67
Q

What is administrative law and what are their responsibilities ?

A

Administrative law part of civil law which creates and regulates public bodies such as NHS Authorities, hospital trusts and CCGs and regulates their activities.
Sets out responsibilities gives them the authority they need to take on those responsibilities e.g authority to employ ppl, own buildings and buy goods and service.

68
Q

What is a professional law?

A

Professional law gives regulatory bodies such as GPhC and GMC powers to register and discipline relevant healthcare professionals.
Class of law allows GPhC to remove pharmacist.
Pharmacy order 2010 which provides the GPhC with authority to discipline pharmacists

69
Q

What are the common themes found in fitness to practices investigation which GPhC carried out (4 things)?

A

1) Meds being prescribed to patients based on an online questionnaire alone, with no
direct interaction between either the patient or the GP.
2) Prescribing of high-risk meds or meds which require monitoring without adequate safeguarding.
3) prescribing of meds outside the prescribers scope of practice.
4) High volumes of prescriptions being issues by the prescriber in short periods of time

70
Q

Where are less serious criminal offences heard?

A

Criminal cases heard in magistrates court. Less serious offences (known as summary offences) such as most motoring offences or minor assaults.

Magistrates have a lower max penalties available than crown courts.

71
Q

Where are more serious criminal offences heard?

A

Serious cases passed in crown court heard in front of a jury. Serious cases range from theft, murder, rape and robbery.

72
Q

Where are civil cases heard and where are serious civil cases heard ?

A

Civil cases initially heard in county court or family court.
Serious civil cases passed in high court.
Both types of case appealed in a court of appeal.
Important cases which may set a precedent for the future may pass upwards to supreme court.

73
Q

When did the UK withdraw from the EU?

A

UK withdrew from EU on 31st Jan 2020.

74
Q

What is the 4 ethical principle?

A
  • Beneficence
    • Non-maleficence
    • Respect for autonomy
      • Justice
75
Q

What is the definition benefiance?

A

Considers balancing of benefits trtoeatments against risks and costs. Healthcare professional should act in a way that benefits the patient

76
Q

What is the definition for non-maleficence?

A

Avoiding causation of harm. Healthcare professional should not harm the patient. All treatments involves some harm even if its minimal, but harm must not be disproportionate to the benefits of the treatment.

77
Q

What is the definition for respect to autonomy?

A

Respecting the decision making capabilities of automatous person enabling induvial to make a reasoned informed choices.

78
Q

What is the definition for justice?

A

Distributing benefits, costs and risks fairly. The notion that patients in a similar position should be treated in a similar manner.

79
Q

What did ppl change there perspective on?

A
  • Driving under the influence
  • IVF
  • Heart transplants
  • Mitochondrial transplantation
80
Q

6 steps in RPS guidance on professional judgement…

A

1) Identify the ethical dilemma or professional issue
2) Gather all the relevant info and research the problem.
3) Identify all the possible solutions and gather further relevant info
4) weigh up the benefits and risks, advantages and disadvantages of each options
5) choose an option, ensuring that you justify your decision
6) Make a record of the decision making process.

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