B1: The legal + Ethical Basis of Pharmacy Flashcards

1
Q

Duty of ___ + duty of___ is included in ___

A

Care
Confidentiality
Civil

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

2 main types of law

A

Statute

  • criminal
  • administrative
  • professional

Civil
- common law

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Criminal law controls + duties

A

Between the state and its
citizens

Controlled by:

  • Acts (1°legislation) Regulations
  • Statutory Instruments (2°legislation)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Administrative law controls + duties

A

Between public bodies, their
servants and clients

Controlled by:

  • Directions
  • NHS Law, Town-Planning
  • Law
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Professional law controls + duties

A

Between state (as proxy for
patients) and health
professional

  • controlled by GPhC Regulatory
    Requirements
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Civil law controls + duties

A

Between citizens
Between professionals and their clients

Tort - non-contractual civil wrong

  • Negligence
  • Breach of confidentiality
  • Defamation

Controlled by:
- precedents in courts

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Criminal law sanctions + penalties

A

Prosecutions, fines, imprisonments

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Administrative sanctions + penalties

A

Loss of remuneration, contract, promotion, job

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Professional sanctions + penalties

A

Removal from Register

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Civil sanctions + penalties

A

Payment of compensation

Referral to professional or administrative route

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Examples of statute law

A

Medicines Act 1968
Misuse of Drugs Act 1971
Poisons Act 1972
Health and Safety at Work Act 1974

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Examples of civil law

A

The Pharmacy Order 2010

Human Medicines Regulations 2012

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Main legislation affecting pharmacy

A
  • Medicines Act 1968
  • Human Medicines Regulations 2012
  • Poisons Act 1972 (controls non-medicinal poisons)
  • Misuse of Drugs Act 1971
  • Pharmacy Order 2010
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

When can information be disclosed

A

1) with consent of patient

2) without consent of individual

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What circumstances can information be shared without consent

A
  • need to know basis
  • statutory requirements (by law)
  • –notifications, obligations (birth, death, illness)
  • — persons with legal right (court order, healthcare obligator - GPhC, GMC)
  • public interest
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Valid consent

A

Given voluntarily by an appropriately informed person

who has the capacity to consent to the intervention.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What obtaining consent means

A
  • Moral function
  • Clinical function - gain patient’s trust, cooperation,
    confidence, etc.
  • Legal function – provide justification for care; protect
    HCPs from criminal / civil claims
  • Cannot assume you know patient’s best interests; it is
    their decision
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Confidentiality

A

Pharmacists have a duty of confidentiality = ethical requirement

  • Data protection act 1998
  • Human rights act 1998
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Medicines Act 1998

A

To control the safety, quality and efficacy of
medicinal products for human use. It controls /
controlled:
- Which medicines can be marketed
- Medicines manufacture, sale and supply
- Labelling and description
- Sales promotion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Administration of Human Medicines Regulations 2012

A

Advisory bodies are Commission on Human Medicines (CHM) + British pharmacopoeia

CHM

  • advises health ministers on executing regulations
  • advises MHRA (licensing authority)
  • commission membership
  • receives advice from various committees (Advisory Board for the Registration of Homeopathic Products, Herbal Medicines Advisory Committee, Independent review panel for advertising, Ad hoc committees, Sub-committees)

BP comission

  • prepares BP + other compendia
  • lists approved drug names
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Licensing of Human Medicines Regulations 2012

A
Licensing body = Medicines and Healthcare Products
Regulatory Agency (MHRA)

License is required for:

  • Human use medicines
  • animal administration medicines

A medicine is:

  • medicinal product
  • medicinal purpose

Marketing authorisation

  • Allows medicinal product to exist, be obtained, supplied, etc.
  • Places restrictions on products
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What is a ‘Retail Pharmacy Business’

A

A business which consists of the retail sale of medicines
other than GSL
- Where this is not part of a professional practice of a
practitioner (i.e. doctor/dentist/vet)

23
Q

Who owns a ‘Retail Pharmacy Business’ (RPB)

A

pharmacist
partnership of pharmacists
- All partners must be registered pharmacists (in England)
‘body corporate’
- Must appoint superintendent pharmacist
‘representative’ of a pharmacist may carry on in certain circumstances
- i.e. if pharmacist died / bankrupt / become mentally unwell

24
Q

Features of a registered pharmacy

A

Registered with GPhC
Annual return of premises to register
- anyone who owns a RPB must complete an annual renewal declaring
— address details, ownership, superintendent
—activities taking place in pharmacy
—pay retention fee
GPhC standards for registered premises

25
Q

NHS Community Pharmacy Contract

A

Services which must/may be provided by pharmacies
- enforced + controlled by NHS england (local area teams, clinical commissioning groups (CCGs), local authorities)
- Pharmaceutical Services Negotiating Committee (PSNC)
negotiates terms (reimbursement)
- Prescription Pricing Division of the NHS Business Services Authority (Provides reimbursement, Drug Tariff)
- 3 tiers of service

26
Q

3 tiers of service of NHS community pharmacy contract

A

Essential services
Advanced services
Locally commissioned services

27
Q

Essential services

A
  • Dispensing and repeat dispensing
  • Signposting
  • Supply of appliances
  • Waste management (disposal)
  • Public Health
  • Support for self-care
  • Clinical Governance
28
Q

Advanced services

A
  • Medicines Use Review
  • Appliance Use Review
  • Flu vaccination
  • New Medicines Service
  • Stoma Appliance Customisation
29
Q

Locally commissioned services

A
  • Substance misuse
  • Out of hours services
  • Smoking cessation
  • Emergency contraception
  • Minor Ailments schemes
30
Q

Classes of human medicines

A
  • General Sale List medicines (GSL)
  • Pharmacy medicines (P)
  • Prescription Only Medicines (POM)
31
Q

Pack size limits of OTC sale

A

Aspirin + paracetamol = maximum of 16 GSL / 32 P

32
Q

How many OTC pack sizes of paracetamol/aspirin can a person buy at one time

A

OTC is between 16 or 32 dose units so has to be less than 100 non-effervescent tablets or capsules can be sold.

However there is no legal restriction limits for effervescent dosage forms.

33
Q

GSL medicine regulations

A

Can be sold/supplied with reasonable safety without a pharmacist’s supervision

Conditions:

  • the place where sold must be able to close to exclude public.
  • includes herbal homeopathic products
  • Pharmacy only (PO) medicines
  • excludes types of human products
34
Q

Products not for general sale

A
  • anthelmintics
  • for parenteral administration
  • eye ointments
  • enemas
  • for irrigation of wounds or of the bladder, vagina or
    rectum
  • preparations of aloxiprin or aspirin for administration
    wholly or mainly to children
35
Q

Identifying a GSL

A

Does not need anything on the box to identify it as a GSL

Product is GSL if it has a marketing authorisation and is not a P/POM medicine

36
Q

Regulations of Pharmacy medicines

A

P medicines shall not be sold, offered or exposed for sale by
retail, by any person unless:
1. That person is lawfully conducting a retail pharmacy
business
2. The product is sold, offered or exposed for sale, or supplied
on premises which are a registered pharmacy
3. The person is, or acts under the supervision of, a
pharmacist

37
Q

Identifying a P medicine

A

Must have P in a box on manufacturer’s original packaging

38
Q

What are OTC medicines + what controls OTC

A

OTC = GSL + P meds

  1. Terms of a MA may prevent distribution to nonpharmacy
    outlets (PO)
  2. MA specifies legal category
  3. Regulations impose restrictive conditions e.g. pack sizes
39
Q

POM regulations

A

Sold or supplied in accordance with a

Appropriate practitioner:
- doctor
- dentist
- nurse prescriber, supplementary prescriber, independent
prescriber
40
Q

Identify a POM

A

POM medicines must have the letters POM in a box on the manufacturer’s original packaging

41
Q

Exemptions from POM status

A
  1. Specifically licensed products
  2. High dilution products
  3. Pack sizes of certain products
  4. Certain controlled drugs at low dose
  5. Pseudoephedrine and ephedrine
42
Q

Examples of specifically licensed products exempt from POM status

A

Ketoconazole + Cimetidine

43
Q

Why is pseudoephedrine + ephedrine base exempt from POM status

A

May sell or supply (without Rx) to one person in a single
transaction:
- up to 720mg pseudoephedrine salts
- up to 180mg ephedrine base / salts
May supply more than one product containing only one
drug
May not supply both drugs, even within limits

44
Q

Administration of POMs

A

No one can administer a medicine parenterally other
than to themselves, unless they are a practitioner or
acting under the direction of a practitioner

  • list of medicines exempt from this restriction when trying to save a life in an emergency
45
Q

Controlled drugs

A

Concerns drugs which are being, or appear likely to be
misused

  • Restricts production, supply, offer to supply, possession
    and cultivation of controlled drugs

Schedules determine the controls of the drugs

  • Schedule 1: no medicinal use
  • Schedule 2, 3 & 4: POMs
  • Schedule 5: POM or P
46
Q

Responsible pharmacist

A

Every pharmacy must have a named RP

  • Only one RP at pharmacy at any given time
  • Pharmacist can only be RP for one pharmacy at a given time

RP is responsible for:

  • establishment, maintenance and review of SOPs
  • formal record of who is RP in charge at a particular time
  • clear display of name and registration number of current RP
  • compliance with condition concerning absence of RP
47
Q

Why law and ethics change

A

Politics operates at all levels
Cultures and morals change
New circumstances arise
▫ New roles - pharmacist prescribing
▫ New ways of assisted conception/ delay dying
▫ New IT possibilities - records/transfer of data
▫ New diagnostic methods – genetic profiles
▫ Organ transplants – hands, face? head?

48
Q

The fundamental bioethical principles

A

Autonomy
Beneficience
Non-maleficence
Justice

49
Q

Autonomy

A
  • Right to self governance, self rule, self-determination
  • Capacity to think and decide and to act on the basis of such thought and decision
  • Informed consent is key to autonomy; principle of ‘respect for persons’
  • Respect autonomy in allowing patients to make their own decisions
  • A person’s autonomy can be restricted by certain circumstances
50
Q

Beneficence

A

• Duty to promote the health and welfare of the
patient, not merely to avoid harm
• Requires positive action, to always act in the best
interest of the patient
• A primary goal of health care providers
• May conflict with the principle of autonomy – balance, best interest of patient

51
Q

Non-maleficence

A

• Duty not to harm anyone
• Commitment to protection of patients from harm
• Need for competence; duty of care
• Non-maleficence?
▫ Withdrawing or withholding life sustaining treatment
▫ Treatment of terminally ill patients
▫ Provision of futile treatment

52
Q

Justice

A

Acting on the basis of fair adjudication between competing interests
Equality and justice
▫ Treat equals equally
▫ Treat unequals unequally in proportion to morally relevant inequalities
Requires that morally defensible differences
among people be used to decide who
gets what

53
Q

What is professional Judgement

A
  • Knows the rules
  • Analyses the problem
  • Applies principles
  • Adds in experience
  • Exercises pragmatism
  • Synthesises a “good” solution
  • Able to justify the decision