LEGAL AND ETHICAL ISSUES IN MEDICINES INFORMATION

Janet WestPrincipal Pharmacist, Medicines InformationGlasgowJanuary 2009

Acknowledgements: Maggie Fitzgerald, Michael Currie

“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 no right answerRecognise that there is often no 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?