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Practice, Law, Ethics > Law & Ethics e-book > Flashcards

Law & Ethics e-book Flashcards

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1
Q

Law is defined as:

A

“The system of rules which a particular country or community recognises as regulating the actions of its members and which it may enforce by the imposition of penalties.”

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2
Q

Law can be classified in many ways, but the main classes are:

A
  • Common law – which is based on case law
  • Roman law – which is based on code
  • Civil law – disputes between people
  • Criminal law – enforcement of behaviour
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3
Q

the route to the creation of law is summarised as:

A

green paper -> white paper -> bill -> act of parliament

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4
Q

what are green, white papers, bill and act of parliament.

A

Green papers are Government consultations that may lead to legislation, with White papers being proposals for new legislation. At the Bill stage the proposal is presented for debate in Parliament, prior to the Act of Parliament being written and given Royal Ascension to become law.

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5
Q

As it stands, the UK Parliament’s role in Europe is to:

A
  • Scrutinise EU draft legislation
  • Change UK law to reflect agreed EU legislation and treaties
  • Hold the UK Government to account on its EU policies and negotiating positions in EU institutions
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6
Q

Precedent

A

Precedent is law made through cases. Precedent follows two fundamental principles; that all court cases should be treated alike, and when a decision has been made in a case, similar cases should follow the same pattern. Where there is no similar previous case, the Judge creates the precedent with the decision they reach in their case. An example of the application of precedent is Montgomery v Lanarkshire Health Board (2015), which is covered in the ‘Consent’ section of this eBook.

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7
Q

Human Rights Act 1998

A

Human rights are the basic rights and freedoms that belong to every person in the world.
The concept of “human rights” originates from the Magna Carta in 1215, and has developed worldwide ever since (British Institute of Human Rights, 2018). Rights conferred by the Act affecting healthcare include:
• Right to life
• Right to freedom of thought and expression
• Right to liberty and security
• Right to receive a fair trial
• Right to respect for private and family life, to home and correspondence
• Prohibition on slavery and forced labour
• Prohibition of torture, inhuman or degrading treatment or punishment

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8
Q

Freedom of Information Act 2000

A

The Freedom of Information (FOI) Act 2000 governs public access to information about public authorities in the UK, such as the NHS, Government departments and local
authorities. Under the Act, the public can access this information in one of two ways:
• The public authority publishing information about their activities, as required under the Act
• Where the member of the public requests this information from the public authority
The aim of the Act was to increase the public’s trust in public authorities through being more open about how these authorities use their funding (which comes from taxation) and the activities that they carry out however, information does not have to be disclosed if there is a good reason not to. If you work for a public authority, you have two duties under the Act:
• To proactively publish the information required by the Act
• To respond to requests for information
The FOI Act does not give the power for a member of the public to request access to information about themselves that is held by the public authority – such a request would
come under the Data Protection Act 1998.

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9
Q

Health & Safety at Work Act 1974

A

The Health & Safety at Work Act (HASAWA) 1974 is the main piece of legislation relating to occupational health and safety. This Act sets out the duties required of employers and employees in the workplace.

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10
Q

Information Governance

A 
There are a number of pieces of legislation that govern the collection, storage and sharing of patient information, and what is actually considered to be ‘confidential’ information. The handling of this information is known as “information governance”. The main pieces of legislation are:
• Data Protection Act 1998
• General Data Protection Regulation (EU) 2016/679
• Human Rights Act 1998
• NHS Act 2006
• Health & Social Care Act 2012
• Freedom of Information Act 2000
• Access to Health Records Act 1990

As a pharmacist, the way in which you process and handle patient data will also be governed by the GPhC Guidance on Confidentiality and NHS Information Governance requirements.

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11
Q

Data Protection Act 1998

A

the UK Government introduced the Data Protection Bill 2017 to the House of Lords in September 2017. Once this has passed through the relevant steps to becoming legislation, an updated Data Protection Act will be published. As it stands at present, the DPA 1998 confers rights of access to personal information to the subject of that information and regulates the processing of personal information; ‘processing’ is anything done to/with information from its creation to destruction and only
applies to live subjects.

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12
Q

NHS Information Governance

A

The Department of Health produces an ‘Information Governance Toolkit’, which can be used to assess compliance with IG policies and standards – this is currently under review due to the upcoming changes in legislation around the processing of data. Until this has been updated an interim guide has been published, known as “Data Security Awareness Level 1”, which is an annual training requirement for NHS workers and contractors.

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13
Q

Caldicott Guardians

A

All NHS providers and contractors, as well as local authorities providing social services, are required to appoint a Caldicott Guardian – this is person who is accountable for maintaining the confidentiality and appropriate storage and use of patient information.

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14
Q

Civil Law & Tort

A

Civil law is “the system of law concerned with private relations between members of a community rather than criminal, military, or religious affairs” (OED, 2017). With civil law a pharmacist could break the law through an act of negligence, which is when damage occurs due to a failure to take care. Negligence is an example of tort law, which is the area of law surrounding civil responsibilities that people have to one another. Other examples of torts include:
• Nuisance
• Defamation
• Trespass upon the person

Negligence that is so severe as to be dealt with under criminal law is termed “grossnegligence”.

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15
Q

As a pharmacist, you have professional accountability for your actions and omissions through:

A
  • The judicial system – through criminal and civil law
  • Professional regulation – traditionally professional misconduct and Fitness to Practise (FtP)
  • Disciplinary procedures by your employer or the NHS
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16
Q

Professional Negligence - For negligence to occur, three criteria must be met:

A
  1. The person owes a duty of care to anyone who can reasonably be foreseen as likely to suffer harm
  2. A breach of this duty of care has occurred
  3. Damage has been caused to the plaintiff
17
Q

Demonstrable Duty of Care

A

For criterion 1 to occur, it is must be proved that there is a causal link between the damage to the plaintiff and the breach of the duty of care, and that the damage was not too remote e.g. that it could be reasonably foreseen.

18
Q

Nature of Duty of Care

A

The requirement for a duty of care applies to both acts and omissions; it is therefore possible to be liable if you fail to do something as much as it would if you did something that led to harm of your patient

19
Q

Standard of Care

A

The duty of care expected of a health professional is measured against the level of competence that an average member of the same profession is required to possess; reliance is placed upon the specialist skills and knowledge associated with the role, and this doctrine
takes account of seniority and position.

20
Q

Trespass - There are five trespass torts:

A
  • Assault – putting a person in fear of an immediate battery. It is usually accompanied by battery as a matter of course
  • Battery – the infliction of unlawful personal force upon another. ‘Force’ includes light touching, and is unlawful if the person upon whom it is exerted has not provided consent to it
  • False imprisonment
  • Trespass to goods
  • Trespass to property
21
Q

False Imprisonment - The tort of false imprisonment and the Mental Capacity Act 2005 govern the conditions under which a person can legally be ‘deprived of their liberty’. The Act contains safeguards to:

A
  • Protect people’s human rights in circumstances where they cannot consent to their care or treatment
  • Ensure that people are only deprived of their rights if it is in their best interest and if there is no other form of treatment that could give them the care they need
  • Make sure that those providing care are responsible for their actions.
22
Q

The five statutory principles of the Mental Capacity Act 2005 are:

A
  1. A person must be assumed to have capacity unless it is established that they lack capacity
  2. A person is not to be treated as unable to make a decision unless all practicable steps to help them to do so have been taken without success
  3. A person is not to be treated as unable to make a decision merely because they make an unwise decision
  4. An act done, or decision made, on behalf of a person who lacks capacity, must be done or made in their best interests
  5. Before the act is done, or the decision is made, regard must be had to whether the purpose of the act or the decision can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action
23
Q

Consent to treatment requires three key elements, these being:

A
  • Sufficient information is given
  • The consent is voluntary
  • The patient has the capacity to understand that info

Sufficient information is given
Patients need sufficient information before they can decide whether to give their consent; if the patient is not offered as much information as they reasonably need to make their decision, and in a form they can understand, their consent may not be valid.

Voluntary consent
Consent must be given voluntarily i.e. not under any form of duress or undue influence from health professionals, family or friends.

Capacity
There are three factors to consider when judging a patient’s capacity:
• Can they understand and retain the information provided?
• Can they weigh that evidence?
• Can they reach a conclusion based on the evidence?
Patients also need to be able to communicate their decision.

24
Q

Mental Capacity Act 2005

A

This Act provides a framework to empower and protect people who may lack capacity to make some decisions for themselves. It makes clear who can take decisions, in which situations, and how they should go about this. Anyone who works with or cares for an adult who lacks capacity must:
• Comply with the Act when making decisions or acting for that person
• Ensure those who lack capacity are empowered to make as many decisions for themselves as possible
• Make sure that any decision made on the patient’s behalf is made in their best interests
Key principles from the Act:
1. Every adult has the right to make his or her own decisions and must be assumed to have capacity to make them unless it is proved otherwise
2. A person must be given all practicable help before anyone treats them as not being able to make their own decisions
3. Just because an individual makes what might be seen as an unwise decision, they should not be treated as lacking capacity to make that decision
4. Anything done or any decision made on behalf of a person who lacks capacity must be done in their best interests
5. Anything done for or on behalf of a person who lacks capacity should be the least restrictive of their basic rights and freedoms

25
Q

Gillick Competency

A

The Gillick competency and Fraser guidelines are applied to help balance children’s rights and wishes with our responsibility to keep children safe from harm.
The case of Gillick (Gillick v West Norfolk, 1984) looked specifically at whether doctors should be able to give contraceptive advice or treatment to under 16-year-olds without parental consent. But since then, they have been more widely used to help assess whether a child has the maturity to make their own decisions and to understand the implications of those decisions.

26
Q

Fraser guidelines – EHC in under 16s

A

The Fraser guidelines refer to the guidelines set out by Lord Fraser in his judgement of the Gillick case in the House of Lords (1985), which apply specifically to contraceptive advice. Lord Fraser stated that a doctor could proceed to give advice and treatment provided he is satisfied in the following criteria:
• The young person understands the advice and has sufficient maturity to understand what is involved
• You could not persuade the young person to inform their parents, nor allow you to inform them
• The young person would be very likely to begin, or continue having sexual intercourse with or without contraceptive treatment
• Without contraceptive advice or treatment, the young person’s physical or mental health would suffer
• It would be in the young person’s best interest to give such advice or treatment without parental consent

27
Q

Covert administration of medicines - Covert administration occurs when a

A

Covert administration occurs when a drug is administered to a patient without them knowing and without consent, such as mixing it with food. Covert administration should be:
• A last resort – only implemented when there is no viable alternative
• Medicine specific – the need must be identified for each medicine prescribed
• Time limited – it should be used for as short a time as possible, and the need should be reviewed regularly
The decision-making process should be:
• In the best interests of the patient – due consideration should be given to the holistic impact on the patient’s health and well-being
• Transparent – it must be easy to follow and clearly documented
• Inclusive – involving discussion and consultation with appropriate advocated for the patient. It must not be a decision taken alone

28
Q

The legal requirements of the role of RP relate to:

A
  • Displaying a notice that gives the details of who the RP is
  • Making and keeping records
  • Pharmacy procedures
  • RP absence from the pharmacy
29
Q

Pharmacy record. As a minimum the record should show:

A

The pharmacy record may be kept in writing, electronically or in both forms, and must be retained for 5 years.

As a minimum the record should show:
• The name and registration number of the RP
• The date and time at which they became and ceased to be the responsible pharmacist
• The date and start/end times of any absence from the premises by the RP

If a mistake is made in the pharmacy record, you must make an amendment and sign and date this.

30
Q

Pharmacy procedures - Under RP regulations all pharmacies must have procedures (SOPs) in place covering:

A
  • Safe and effective management of medicinal products
  • The circumstances in which non-pharmacist staff may give advice about medicinal products
  • Which members of staff are competent to do which task
  • What to do if the RP is absent
  • Arrangements which are to apply if the RP is no longer on the pharmacy premises
  • What to do when there is a changeover of RP
  • Complaints procedure – the procedure to be followed if an incident occurs which may indicate that the pharmacy business in not running in a safe and effective manner
  • How changes to the pharmacy procedures are to be notified to the staff
  • Records which need to be kept
31
Q

Absence

A

RPs are allowed to be absent from the pharmacy for a maximum of 2 hours in a 24 cycle from midnight to midnight and they must remain contactable and able to return to the pharmacy with ‘reasonable’ promptness. If unable to do so, they must nominate a contactable pharmacist. If there is more than one RP over the course of the 24 hour cycle, the total period of absence for all RPs must not exceed 2 hours.
The activities that can be performed in the pharmacy in the absence of the RP differ based on whether there is an appointed RP or if there is an RP appointed but they are absent:
• No RP = no sale or supply of GSL, P or POM medicines
• RP present = sale and supply of medicines permitted
• RP absent for under 2 hours = GSL medicines can be sold but no P or POM medicines to be supplied
During the RP’s absence the pharmacy team can continue the dispensing (assembly) process, accuracy check (Accredited Checking Technician only) however they cannot sell or supply POM or P medicines.

32
Q

Revalidation

A

“A framework of assurance to demonstrate a registrant’s commitment to develop their skills and knowledge to demonstrate safe and effective pharmacy practice”.

Revalidation is expected to be rolled out in phases across 2018. As part of the process, registrants will be required to submit:
• Four CPD entries – two of which must be planned learning activities
• One peer discussion
• One reflective account

33
Q

Peer Discussion

A

“A learning and development activity that encourages you to engage with others in your reflection on learning and practice.”

An effective peer discussion requires the pharmacy professional to:
• Decide on an appropriate peer
• Share relevant information to guide the discussion
• Have the discussion and respond to it in a reflective way

34
Q

Fitness to Practise - Pharmacy professionals

A

“…They can demonstrate the skills, knowledge, character and health required to do their job safely and effectively”.
Impairment of fitness to practise include:
• FtP or disciplinary proceedings from another regulatory body
• Issues connected with academic or training career
• Police caution, conviction or other criminal proceedings
• Health issues

During the yearly registration renewal process pharmacy professionals are required to complete a fitness to practice declaration. They are also required to inform the GPhC within 7 days if there is any change to their fitness to practice – e.g. if they receive punishment for committing a crime.

35
Q

Sanctions - If a pharmacy professional’s fitness to practice is impaired the GPhC can:

A
  • Issue a warning
  • Impose conditions
  • Suspend the pharmacy professional
  • Remove the pharmacy professional from the register

FtP Process
• Stage 1 – Concern received
• Stage 2 – Initial inquiries and investigation
• Stage 3 – Investigating committee
• Stage 4 – Fitness to Practice committee
• Appeal

Practice, Law, Ethics (8 decks)

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