B1: The legal + Ethical Basis of Pharmacy Flashcards
Duty of ___ + duty of___ is included in ___
Care
Confidentiality
Civil
2 main types of law
Statute
- criminal
- administrative
- professional
Civil
- common law
Criminal law controls + duties
Between the state and its
citizens
Controlled by:
- Acts (1°legislation) Regulations
- Statutory Instruments (2°legislation)
Administrative law controls + duties
Between public bodies, their
servants and clients
Controlled by:
- Directions
- NHS Law, Town-Planning
- Law
Professional law controls + duties
Between state (as proxy for
patients) and health
professional
- controlled by GPhC Regulatory
Requirements
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
Criminal law sanctions + penalties
Prosecutions, fines, imprisonments
Administrative sanctions + penalties
Loss of remuneration, contract, promotion, job
Professional sanctions + penalties
Removal from Register
Civil sanctions + penalties
Payment of compensation
Referral to professional or administrative route
Examples of statute law
Medicines Act 1968
Misuse of Drugs Act 1971
Poisons Act 1972
Health and Safety at Work Act 1974
Examples of civil law
The Pharmacy Order 2010
Human Medicines Regulations 2012
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
When can information be disclosed
1) with consent of patient
2) without consent of individual
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
Valid consent
Given voluntarily by an appropriately informed person
who has the capacity to consent to the intervention.
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
Confidentiality
Pharmacists have a duty of confidentiality = ethical requirement
- Data protection act 1998
- Human rights act 1998
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
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
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
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)
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
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
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
3 tiers of service of NHS community pharmacy contract
Essential services
Advanced services
Locally commissioned services
Essential services
- Dispensing and repeat dispensing
- Signposting
- Supply of appliances
- Waste management (disposal)
- Public Health
- Support for self-care
- Clinical Governance
Advanced services
- Medicines Use Review
- Appliance Use Review
- Flu vaccination
- New Medicines Service
- Stoma Appliance Customisation
Locally commissioned services
- Substance misuse
- Out of hours services
- Smoking cessation
- Emergency contraception
- Minor Ailments schemes
Classes of human medicines
- General Sale List medicines (GSL)
- Pharmacy medicines (P)
- Prescription Only Medicines (POM)
Pack size limits of OTC sale
Aspirin + paracetamol = maximum of 16 GSL / 32 P
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.
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
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
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
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
Identifying a P medicine
Must have P in a box on manufacturer’s original packaging
What are OTC medicines + what controls OTC
OTC = GSL + P meds
- Terms of a MA may prevent distribution to nonpharmacy
outlets (PO) - MA specifies legal category
- Regulations impose restrictive conditions e.g. pack sizes
POM regulations
Sold or supplied in accordance with a
Appropriate practitioner: - doctor - dentist - nurse prescriber, supplementary prescriber, independent prescriber
Identify a POM
POM medicines must have the letters POM in a box on the manufacturer’s original packaging
Exemptions from POM status
- Specifically licensed products
- High dilution products
- Pack sizes of certain products
- Certain controlled drugs at low dose
- Pseudoephedrine and ephedrine
Examples of specifically licensed products exempt from POM status
Ketoconazole + Cimetidine
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
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
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
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
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?
The fundamental bioethical principles
Autonomy
Beneficience
Non-maleficence
Justice
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
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
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
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
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
