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The Pharmaceutical Journal
Vol 270 No 7244 p515-516
12 April 2003

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Agenda for 2003

What should we be teaching students about pharmacy law and ethics?

The APPLET — Advancing the Provision of Pharmacy Law and Ethics Teaching — project team has surveyed current provision of pharmacy law and ethics teaching and then sought the views of those currently involved in such teaching on an ideal future curriculum. This article from the project team reports on those views and invites contributions from those who are currently in practice


This article has been is submitted by the APPLET (Advancing the Provision of Pharmacy Law and Ethics Teaching) project team, whose members are

Professor Joy Wingfield, of Nottingham Pharmacy School
Dr Keith Wilson, of Aston Pharmacy School, Birmingham
Sandra Hall, of De Montfort Pharmacy School, Leicester

Correspondence to APPLET project manager Phil Whieldon
e-mail phil.whieldon@nottingham.ac.uk

The past decade has witnessed a shift in the ambitions of pharmacists away from the core role of dispensing towards more interesting and rewarding relationships and responsibilities with other health care providers and patients. This change reflects the strategic policy for the National Health Service set out in the NHS plan, with its emphasis upon the patient rather than the provider. Pharmacy education has a key role to prepare for practice and must anticipate the changing professional role. From foundations largely rooted in supply, undergraduate education has already accommodated significant quantities of material which would have been unrecognisable in the pharmacy course of 30 years ago: social and behavioural sciences, communication skills and, most recently, therapeutics, to prepare for new roles in prescribing and medicines management. The increasing patient focus of future practice raises the fundamental question as to whether development of teaching in pharmacy law and ethics has developed as quickly and to the same extent. Does such teaching equip future pharmacists for the sharp accountabilities now expected in health care practice, the heightened prospect of litigation and the ever expanding regulatory challenges of a risk averse society? Does it create "value literate" practitioners who are aware of, have an interest in, and can identify, discuss and "handle" value and ethical issues in pharmacy?

Panel 1: The Society syllabus

• Sale and supply of medicines, including evaluation and management of risk and provision of advice

• Licensing of medicines; consumer protection, including product liability and unlicensed medicines; legal classifications of medicines, including Controlled Drugs and their subclasses

• Duty of care to patients and the wider public; concept, scope and application of professional ethics; the Code of Ethics of the Society

• Codes, standards and systems of governance and practice; risk management and personal accountability

• Political and legal framework, requirements and processes relevant to pharmacy

The Royal Pharmaceutical Society sets an indicative syllabus in pharmacy law and ethics as part of its accreditation requirement for providers of undergraduate education. Although this allows significant flexibility for interpretation (Panel 1), its scope remains focused on the statutory controls for the supply of medicines coupled with a working knowledge of the Code of Ethics. Within individual schools of pharmacy, the syllabus will be supplemented by the particular interest or expertise of individual lecturers, but there is no consensus as to what an ideal core curriculum should cover or what areas are essential and what are simply "nice to know". Moreover, there is little experience within the profession as to how competence in ethical reasoning should be assessed, and limited scope for capturing the full range and complexity of legal and ethical aspects of practice dilemmas encountered in practice.

In 2002, a consortium of the schools in Nottingham, Aston and De Montfort (APPLET: Advancing the Provision of Pharmacy Law and Ethics Teaching) gained government funding (Higher Education Funding Council for England) to work with all the UK schools to identify good practice and novel approaches to the teaching of pharmacy law and ethics and, through this process, to secure an agreed curriculum and learning resources to assist lecturers and students alike. As a first step, APPLET surveyed current provision and then sought the views of those currently involved in teaching pharmacy law and ethics on an ideal curriculum. This article has two purposes:

• To report on those views

• To invite the views and contributions of those who are now in practice

Scope of the curriculum

Panel 2: Developing a national picture

What is being taught?

• Sale and supply of medicines

• Other law affecting pharmacy

• Professional discipline and code

• The National Health Service

• Decision-making processes

What resource needs have been identified?

• Validated problems and scenarios

• Validated examination questions and assessments

• Suggestions for guest lecturers

• Guidance to references

• Ways to introduce new thinking

Our first task was to ascertain broadly what is currently covered in pharmacy law and ethics teaching. Analysis of current curricula is limited by constant change and varying terminology, description and level of detail, making interpretation of documented material difficult and time consuming. APPLET used semistructured interviews with the key person accountable for teaching pharmacy law and ethics to develop a picture of what is being taught and to identify resource needs (Panel 2). As expected, it was clear that the Society's requirements are fully satisfied, but we found that teaching was not confined to a specific law or ethics module. Instead there was considerable integration with other material such as social science or clinical practice. Furthermore, problem-based learning, usually involving dispensing practicals and scenarios from practice, was the preferred approach to prepare students in pharmacy law and ethics.

APPLET then devised descriptions of what the widest possible curriculum in pharmacy law and ethics might conceivably contain, based in part on the consensus core curriculum in medical law and ethics devised for medical education. These descriptions were converted into a questionnaire that was sent to all known teachers in pharmacy law and ethics for their views. Such an exercise can only be theoretical. Nevertheless, the process was useful to create possible horizons for such teaching and then invite those currently teaching to identify priorities in a core curriculum. The questionnaire was in three parts:

• An assessment of how important to teachers each aspect was perceived to be to pharmacy undergraduate education

• An indication of the extent to which teachers believed educational support material in each aspect would be useful to them

• Questions to establish the profile of current teachers of pharmacy law and ethics

The response to our questionnaire was encouraging, with some schools providing two or more responses and only one school declining to return the questionnaire.

Priority areas

Three themes were suggested, with component topics described within them (Panel 3).

Panel 3: Suggested themes and topics

Theme 1: Legal concepts and systems of law

• Systems and types of health care law (eg, primary and secondary legislation, administrative NHS law, public health and professional law)

• European and human rights law

• The NHS variations in law between England, Scotland, Wales and Northern Ireland

• NHS rights and complaints mechanisms, duty of quality and governance

• Civil law (eg, tort, negligence, assault, breach of confidence, defamation, malpractice)

• Law on consent, confidentiality, capacity and mental disorder

• Law relating to medical research

Theme 2: Moral philosophy, schools of thought, concepts of health care law and ethics

• Principal schools of thought in Western philosophy, natural law, utilitarianism and virtue theory

• Values in health care and in pharmacy

• The nature of ethics, realism, relativism and other moral theories

• The scope of bioethics, health care ethics and medical ethics

• Four principles of biomedical ethics; business ethics and organisational values

• Influence of major religions and cultural norms on health care ethics and practice

Theme 3: Application of ethics to health care

• Human rights, autonomy, paternalism, trust, truthfulness and confidentiality

• Consent and capacity, mental disorder

• Life, death, dying, killing, reproduction, conception and abortion

• Impact of genetic information on health care; research governance

• Resource allocation and equity in health care


Panel 4: Priority areas

• Systems and types of health care law

• European and human rights law

• National Health Service quality, complaints and governance

• Values in health care and pharmacy

• Nature of ethics and moral theory

• Autonomy, trust, paternalism and truth

• Ethical aspects of consent, capacity and mental disorder

• Laws on consent, confidentiality, capacity and mental disorder

Space does not permit a detailed account of the questionnaire results but the eight priority areas in terms of importance and need for teaching resource are summarised in Panel 4. One striking feature of the response was that all possible topics for the curriculum were seen as important; none was rejected. This indicates wide support for the rationale behind the APPLET project and suggests there is a need to make more explicit the topics to be covered within an agreed curriculum. The APPLET project will extend the questionnaire approach to other stakeholders in the preparation of practising pharmacists: the students, other health professionals and pharmacy practitioners themselves.

The questionnaire also asked for other topics to include in the curriculum and resources needed. We found that current teachers would welcome resource to assist in their awareness and knowledge of authorities to turn to in each topic area such as text books, websites, published papers and named "experts".

The fourth theme in the questionnaire aimed to assess support for the creation of graded problems and scenarios to demonstrate rational defensible decision making, such as in:

• Simple conflicts of patients' interests versus budgets or financial drivers

• Dilemmas surrounding legal constraints and ethical imperatives

• Material to stimulate debate on the "big" ethical issues such as beginning and end of life, animal rights, pharmaceutical imperialism, etc

• Integrated problems covering clinical, legal and ethical issues and involving other care professionals such as nurses, doctors and social workers

Practising pharmacists can contribute

Current lecturers would welcome ideas and examples of practice situations which could be interpreted to meet the needs of pharmacy students. Also evident was a strong appreciation of the value attached to "problem-based learning"; law and ethics really only comes to life when illustrated by a practice context. Schools of pharmacy have implemented this approach for many years in relation to the application of statutory controls on the supply of medicines by simultaneous application to dispensing. For the wider concepts of law, such as consent or confidentiality, or to illustrate respect for autonomy or truth telling, lecturers need to draw on many examples from practice. At present, the publications or articles that have sought to capture and analyse "dilemmas" are few and would benefit greatly from expansion.

Pharmacists are not much given to ethical debate in public, with the notable exception of the reactions to the availability of emergency hormonal contraception as a pharmacy medicine. Perhaps because of the effectiveness of policing and the copious guidance provided by the Royal Pharmaceutical Society, little debate takes place on the interpretation of statutory controls on medicine supply (apart from supervision), to what extent they remain relevant some decades after their formulation and when one might have an overriding ethical obligation to the patient which transcends the law. Examples of real dispensing errors are powerful platforms for learning; they can be used to illustrate risk management, root cause analysis, principles of litigation, professional discipline and jurisprudence. Unfortunately, most of these areas are contentious, provoke strong emotions and are frequently dealt with and forgotten with relief rather than inviting further exposure.

APPLET would welcome practising pharmacists' contributions to the project. Preregistration trainees and recently qualified pharmacists in particular may recollect situations which challenged their legal or ethical knowledge, brought them into conflict with commercial imperatives or caused them to agonise over whose interests should take precedence in a difficult professional decision. Specialist practitioners in mental health, palliative care, neonatal care; primary care pharmacists who formulate prescribing advice or manage prescribing budgets; community pharmacists who undertake medicines management or review of medication in care homes — all these groups, and others we have not thought of, have experiences to share which could inform the teaching of pharmacy students in the application of law and ethics.

We do not need names and places, just the raw material to develop into teaching and learning resource. Those who can contribute their experiences can contact Phil Whieldon, the APPLET project manager (e-mail phil.whieldon@nottingham.ac.uk).


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