legal and ethical issues in medicines information michael currie, mrpharms medicines information...
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LEGAL AND ETHICAL ISSUES IN MEDICINES INFORMATION
Michael Currie, MRPharmSMedicines Information Pharmacist9th July 2008
Acknowledgements: Maggie Fitzgerald
“There is no moral precept that does not have something inconvenient about it.”
Denis Diderot, 1713-1784
Aim of the Session
Learn how to identify and deal with legal and ethical problems that may be encountered when providing a medicines information service
Session Objectives
By the end of the session, participants should be able to: 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
Session Outline
Relevant legal definitions Important legislation Ethical frameworks Professional code of conduct Where to get further guidance Crossword puzzle
Before we get started…
How do legal structures and ethical considerations interact?
In what ways is a health professional’s position vulnerable? How are those vulnerabilities addressed?
What do you not know at the start of this session that you would like to know by the end?
How are those learning points going to affect your day-to-day practice?
What is Medical Law?
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
Where do laws come from?
Laws can originate from two sources: Common (case) law – arises from cases as
they are tried in courts of law, giving rise to important 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
Statutory legislation that mayaffect the provision of MI services 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
When things go wrong… Professional Negligence 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
Consider: Do you see any obstacles to applying this
definition? Does this simply mean that you could be
negligent simply by not concentrating?
Proving Negligence
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) Consider:
What is duty of care? How do we exercise it? To whom do we owe it?
Bolam v Friern Hospital Committee 1957
“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”)?
Gross negligence
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?
The Data Protection Act 1998 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 Act 1998 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
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
Caldicott Principles
Breaching confidentiality
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?
Consent
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?
Copyright, Designs and Patents Act 1988 (as amended) 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.
Restricted acts underthe CDP Act 1998 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?Which of these are relevant to work in MI?
Copyright provisions for the NHS 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
Freedom of Information Act2000 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?
Ethics
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?
Some ethical theories
Some common theoriesexplained
Bioethical principles
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?
Hoe might these principles conflict with each other?
Framework for making ethical decisions Learn to recognise moral issues Gather all relevant information Identify and clarify the ethical problem(s) Analyse the problem by considering the
various 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 to right answerRecognise that there is often to right answer
What is a professional code of conduct? Regulates the conduct of professionals in
a particular group Includes concepts such as…
Accountability Character traits Ethical code Professional etiquette Responsibility
Professional code of conduct 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
Rounding off…
How do legal structures and ethical considerations interact?In what ways is a health professional’s position vulnerable? How are those vulnerabilities addressed?What did you not know at the start of this session that you now know?How are those learning points going to affect your day-to-day practice?