Transcript Legal and Ethical Issues in Medicines Information

Bridget Rankin
Principal Pharmacist, Medicines Information
Maidstone & Tunbridge Wells NHS Trust
July 2009
Acknowledgements: Maggie Fitzgerald, Michael Currie, Janet West
“There is
no moral precept that
does not have something
inconvenient about it.”
Denis Diderot, 1713-1784
 Consider how to identify and deal with
legal and ethical problems that may be
encountered when providing a
Medicines Information service
 Define commonly used legal and ethical
concepts in the context of MI
 Identify situations where legal or ethical
considerations may come into play
 Explain how legal and ethical
considerations can influence the outcome
of a situation
 Discuss how such situations can be dealt
with effectively
 Relevant legal definitions
 Important legislation
 Ethical frameworks
 Professional code of conduct
 Where to get further guidance
 Crossword puzzle
 How legal and ethical considerations
interact and how they may ‘clash’
 Is a health professional’s position
vulnerable?
 Do you have any particular issue that
you would like to discuss during this
session?
 Medical (or health care) law is a branch of
law
 It covers health care professionals (including
institutes) and patients
 Encompasses many areas of law, such as tort
law, criminal law, public and administrative
law, and family law
 Problems that arise in medical law always
include an ethical issue
 Laws can originate from two sources:
 Common (case) law – cases tried in courts of
law, giving rise to rulings that set precedents
 Statutory law (legislation) – issued by the
Government, normally as an Act of Parliament
 Law may be further divided into:
 Public law or private law
 Criminal or civil law
 The Data Protection Act 1998
 The Copyright, Designs and Patents Act
1988 (amended by the Copyright and
Related Rights Regulations 2003)
 The Access to Health Records Act 1990
 The Access to Medical Reports Act 1988
 The Freedom of Information Act 2000
 A person may be considered negligent
if their conduct falls short of what a
reasonable person would be expected
to do in order to protect another from a
foreseeable risk of harm
 Do you see any obstacles to applying
this definition?
 Does this simply mean that you could
be negligent simply by not
concentrating?
 According to English Law, in order to prove
negligence the prosecution has to
demonstrate that:
 There was a duty of care to the affected
party, and
 That duty of care was breached, and
 The breach resulted in the injury or
damage.
 The Paisley Snail (or Donoghue v Stevenson)
 What is duty of care?
 How do we exercise it?
 To whom do we owe it?
 “A person is not negligent if they acted in
accordance with accepted practice at the
time as decided by a responsible body of
competent professional opinion.”
 Consider:
 Which of the three aspects of negligence
might this principle be used in (the
“Bolam test”)?
 Negligence cases are normally tried as civil
cases
 If a case is sufficiently serious, the plaintiff
may attempt to sue under criminal law for
gross negligence
 This is negligence of a greater degree, if it
can be demonstrated that the defendant is
guilty of reckless indifference
 What circumstances might give rise to cases
of gross negligence?
 Expressly applies to:
 Living individuals, and
 Data that could be used to identify said
individuals
 Governs the way information about individuals is
held and handled
 It also gives individuals certain rights in relation to
said information
 The legislation is written so as to cover many
eventualities, several of which are relevant to the
provision of Medicines Information Services
 The Data Protection Principles state that personal
information should be:
 Fairly and lawfully processed
 Processed for limited purposes
 Adequate, relevant and not excessive
 Accurate and up-to-date
 Not kept for longer than necessary
 Processed in line with your rights
 Secure
 Not transferred to other countries without
permission
 Confidentiality concerns the keeping of
confidential information private, i.e. not sharing it
with those who are not entitled to have it
 How does this principle tie in with the Data
Protection Act?
 Where else is confidentiality enshrined?
 Hippocratic Oath
 Geneva Declaration
 The Caldicott Report
 Professional guidelines
 A breach of confidentiality is a serious issue
 Consider:
 What might the consequences be (to others / to
yourself / to your employer) if confidentiality is
breached?
 Under what circumstances might it be
appropriate to breach confidentiality?
 How might these circumstances arise during the
provision of Medicines Information services?
 The granting of permission before a
medicine is given, before a procedure is
carried out or before information is
divulged.
 What do you need to confirm before
consent is considered valid?
 How does this relate to Medicines
Information
 Copyright is the right granted by law to the creators of
literary, dramatic, musical or artistic works the ability
to control ways their work is used.
 The Act sets out specific actions that only the author
(or other copyright owner) may carry out, also known
as restricted acts.
 If a restricted act is carried out without the
authorisation of copyright owner, this is an
infringement of copyright and may be a civil or
criminal offence.
 Copying
 Distributing copies
 Renting or lending
 Performing or exhibiting
 Transmitting or broadcasting
 Adapting
 Asserting paternity
 Attribution
 Integrity
 Which of these are relevant to work in MI?
 The NHS, as a large organisation, has a license that
covers copying and scanning from magazines,
books, journals and other periodicals.
 A copy of the agreement is available at
www.cla.co.uk for you to inspect in your own time
 It is important that you become familiar with the
agreement and with what is allowed under it
 This Act gives the public right of access to
information pertaining to public bodies
 This includes the NHS
 FOI applies where the information is about a
public authority
 When might you be asked to provide an answer to
a query that falls under FOI?
 What can you do if you receive such a request?
 Refers to the principles or standards of
human conduct and the study of such
principles
 Broader than just deciding if a particular
action is right or wrong
 Whether a decision is ethical or unethical
depends very much on the ethics!
 How many different schools of ethical
thought do you know about?
 In medicine and (more broadly) bioethics, the
following principles apply:
 Beneficence
 Non-maleficence
 Autonomy
 Justice
 How are these principles used during ethical
decision-making in a healthcare setting?
 How might these principles conflict with each
other?
 Learn to recognise moral issues
 Gather all relevant information
 Identify and clarify the ethical problem(s)
 Analyse the problem by considering the various
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ethical theories or approaches
Explore the range of options or possible solutions
Make a decision
Implement and then reflect on your decision
Recognise that there is often no right answer
 Regulates the conduct of professionals in a
particular group
 Includes concepts such as…
 Accountability
 Character traits
 Ethical code
 Professional etiquette
 Responsibility
 Pharmacists are guided by the Code of Ethics for
Pharmacists and Pharmacy Technicians
 This is based on seven principles, all equally
weighted, designed to guide the work of
pharmacists and pharmacy technicians and to
support the decisions they make as they carry out
their professional responsibilities
 Pharmacists are expected to abide by these
principles – otherwise, their registration is at risk
 How legal and ethical considerations
interact and how they may ‘clash’
 Is a health professional’s position
vulnerable?
 Do you have any particular issue that you
would like to discuss during this session?
 How are those learning points going to
affect your day-to-day practice?