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,

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? 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 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 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 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?