B1: The legal + Ethical Basis of Pharmacy Flashcards Preview

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Flashcards in B1: The legal + Ethical Basis of Pharmacy Deck (53):
1

Duty of ___ + duty of___ is included in ___

Care
Confidentiality
Civil

2

2 main types of law

Statute
- criminal
- administrative
- professional

Civil
- common law

3

Criminal law controls + duties

Between the state and its
citizens

Controlled by:
- Acts (1°legislation) Regulations
- Statutory Instruments (2°legislation)

4

Administrative law controls + duties

Between public bodies, their
servants and clients

Controlled by:
- Directions
- NHS Law, Town-Planning
- Law

5

Professional law controls + duties

Between state (as proxy for
patients) and health
professional

- controlled by GPhC Regulatory
Requirements

6

Civil law controls + duties

Between citizens
Between professionals and their clients

Tort - non-contractual civil wrong
- Negligence
- Breach of confidentiality
- Defamation

Controlled by:
- precedents in courts

7

Criminal law sanctions + penalties

Prosecutions, fines, imprisonments

8

Administrative sanctions + penalties

Loss of remuneration, contract, promotion, job

9

Professional sanctions + penalties

Removal from Register

10

Civil sanctions + penalties

Payment of compensation
Referral to professional or administrative route

11

Examples of statute law

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

12

Examples of civil law

The Pharmacy Order 2010
Human Medicines Regulations 2012

13

Main legislation affecting pharmacy

- Medicines Act 1968
- Human Medicines Regulations 2012
- Poisons Act 1972 (controls non-medicinal poisons)
- Misuse of Drugs Act 1971
- Pharmacy Order 2010

14

When can information be disclosed

1) with consent of patient
2) without consent of individual

15

What circumstances can information be shared without consent

- 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

16

Valid consent

Given voluntarily by an appropriately informed person
who has the capacity to consent to the intervention.

17

What obtaining consent means

- 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

18

Confidentiality

Pharmacists have a duty of confidentiality = ethical requirement
- Data protection act 1998
- Human rights act 1998

19

Medicines Act 1998

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

20

Administration of Human Medicines Regulations 2012

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

21

Licensing of Human Medicines Regulations 2012

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

22

What is a 'Retail Pharmacy Business'

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

Who owns a 'Retail Pharmacy Business' (RPB)

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

Features of a registered pharmacy

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

NHS Community Pharmacy Contract

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

3 tiers of service of NHS community pharmacy contract

Essential services
Advanced services
Locally commissioned services

27

Essential services

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

28

Advanced services

- Medicines Use Review
- Appliance Use Review
- Flu vaccination
- New Medicines Service
- Stoma Appliance Customisation

29

Locally commissioned services

- Substance misuse
- Out of hours services
- Smoking cessation
- Emergency contraception
- Minor Ailments schemes

30

Classes of human medicines

- General Sale List medicines (GSL)
- Pharmacy medicines (P)
- Prescription Only Medicines (POM)

31

Pack size limits of OTC sale

Aspirin + paracetamol = maximum of 16 GSL / 32 P

32

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

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

GSL medicine regulations

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

Products not for general sale

- 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

Identifying a GSL

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

Regulations of Pharmacy medicines

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

Identifying a P medicine

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

38

What are OTC medicines + what controls OTC

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

POM regulations

Sold or supplied in accordance with a

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

40

Identify a POM

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

41

Exemptions from POM status

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

Examples of specifically licensed products exempt from POM status

Ketoconazole + Cimetidine

43

Why is pseudoephedrine + ephedrine base exempt from POM status

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

Administration of POMs

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

Controlled drugs

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

Responsible pharmacist

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

Why law and ethics change

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

The fundamental bioethical principles

Autonomy
Beneficience
Non-maleficence
Justice

49

Autonomy

- 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

Beneficence

• 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

Non-maleficence

• 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

Justice

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

What is professional Judgement

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