The Pharmaceutical Journal Vol 265 No 7107 p158-159
July 29, 2000 The Society

Guidance for pharmacists on working with the pharmaceutical industry

The Royal Pharmaceutical Society's Practice Committee has produced a guidance document to assist pharmacists whose involvement in prescribing issues brings them into closer contact with the pharmaceutical industry. The committee identified a need for such guidance partly because of comments from members and partly as a result of considering the changing interface between pharmacists and the pharmaceutical industry in the move towards a primary care-led National Health Service and the prospect of an increasing range of health professionals being given prescribing rights
A downloadable PDF version of the document is available on the Society's website (PDF 30K)

Recent changes in the National Health Service have led to many more pharmacists now undertaking roles in which they come into regular contact with the pharmaceutical industry. The involvement of pharmacists on the boards and subcommittees of primary care groups (PCGs) and trusts (PCTs), local health groups (LHGs) and local health care co-operatives (LHCCs) means that pharmacists can expect to be approached by representatives of the pharmaceutical industry wishing to discuss a wide range of subjects. This guidance is not intended to apply to pharmacists who are employed by, or carrying out remunerated work for, the pharmaceutical industry but to assist pharmacists working in other sectors who are likely to liaise with the industry.
Pharmaceutical industry representatives have regularly interacted with community pharmacists for product-specific and business-orientated discussions, and similarly have built good relationships with senior hospital and health authority pharmacists. However, the way in which health care is being delivered is changing rapidly and the need for greater prescribing support to PCGs, PCTs, LHGs, LHCCs and individual general practices has led to many more pharmacists in roles looking at treatment priorities, prescribing policy, formulary development and being involved with prescribing issues based on local health improvement programmes and specific problems in their locality. This interaction could increase further as pharmacists' involvement in independent or dependent prescribing, and in the production and use of patient group directions, develops in the future.
Recent Government White Papers place an obligation on those providing health services to work together with other agencies to improve the health of the population that they serve and the health services for that population.^1-3 Collaborative working with the pharmaceutical industry can have a number of benefits in the context of this obligation, which can include provision of information about products and therapeutic issues, educational activities, project support, provision of resources/materials/ equipment or expertise. It should also be remembered that industry has more information about its products than is held by any other source.

Conduct of meetings with representatives

Preparation It is good practice to see representatives by appointment, rather than on an ad hoc basis, with the purpose of the visit and who will be attending stated in advance.
This provides the opportunity to prepare for the meeting so that the time can be put to best use. Preparation may include background reading, discussion with colleagues on the desired outcome of the meeting, preparation of questions, etc. Pharmacists should check that they are receiving the same level of information from industry representatives, eg, on research evidence, as is being supplied to other local health professionals, eg, GPs.
It is also helpful to establish either prior to the meeting or at its start the length of time that is available for the discussions.

Critical appraisal and evaluation For most therapeutic areas, more than one pharmaceutical company will be involved in the supply of potential treatment options. In roles that include the provision of advice on the choice of therapeutic options it is important that the costs and benefits of all the available options are considered.
Credibility with colleagues and clinicians may be lost if an individual is seen to be biased towards a particular company or its products. In order to be able to reach informed decisions, pharmacists need to have discussions with representatives of several companies within a given therapeutic area. Decisions should be based on the best evidence and clinical practice available, ensuring patients' interests are also taken into account. It is advisable to document the reasoning behind decisions, particularly if recommending the use of one company's product rather than another's.
Pharmacists should have the skills to be able critically to appraise information that they are presented with by pharmaceutical companies. The Code of Ethics and Standards of Good Professional Practice require pharmacists to participate in continuing professional development to enable them competently to provide the professional services that they offer.⁴ Pharmacists should be confident to seek clarification of, or justification for, any claims or statements made by pharmaceutical representatives.

Hospitality, gifts and inducements Pharmacists must not ask for or accept fees for agreeing to meet representatives of the pharmaceutical industry. It is also inappropriate to ask for, or accept, any material gifts except those which are of insignificant value and relevant to the organisation. Examples of items that may be considered appropriate include pens, memo pads, diaries, calendars, etc.
Representatives organising educational meetings may offer to provide hospitality. This is generally considered to be acceptable if it is secondary to the purpose of the meeting, and the level of hospitality is appropriate and not out of proportion to the occasion. The costs should not exceed the level that the recipients would normally adopt if they were paying for themselves.
Obligations relating to the provision of inducements and hospitality are also placed on the pharmaceutical industry and health professionals by the Medicines (Advertising) Regulations.⁵

Commercial sponsorship

Pharmaceutical companies may offer to provide support for the business of an NHS organisation. Examples of the sort of initiatives that may be discussed include:

• Sponsorship of a local educational meeting
• Provision of doctors, nurses, pharmacists or technicians to carry out audit work
• Funding the costs of a post within the organisation
• Provision of free starter packs
• Provision of management and organisational development training
• Sponsorship of "health awareness" sessions for patients on particular disease states (non-product specific)

(a) Points to be considered In considering the development of any sponsorship arrangement with a pharmaceutical company, pharmacists should consider the importance of the particular area of work to the organisation. It is unlikely that the involvement of resources in an area that represents a low priority to the organisation will be seen as a good use of time and manpower.
Other issues that will need to be considered and agreed prior to entering into a sponsorship agreement include:

• That the intended benefit to patients or service users is clear
• Whether the arrangement will provide the best value services for the resources available
• That all parties are clear about the others' expectations of the arrangement
• The clinical and financial outcome measures to be used, and how they will be monitored
• Ownership of intellectual property resulting from the arrangement
• If appropriate, how the project will be managed and by whom
• That opt-out clauses are included so that either party can terminate the arrangement if it is not providing the desired outcomes or good value for money
• Confidentiality and access to patient-specific information
• Terms and conditions for employees, where relevant

Any sponsorship agreement must be legally robust. This may require advice to be sought from the legal advisers to the organisation. The confidentiality of NHS data is of paramount importance. The requirements of the Data Protection Act must be adhered to. Guidance has also been issued on the use of patient information within the NHS.⁶

Conduct and accountability Guidance issued by government health departments defines the expected standards of corporate governance for staff of the NHS.^7-9 The same principles apply to independent contractors working with NHS organisations.
In considering the development of any joint ventures it is important that such arrangements are seen to be open and transparent by all stakeholders. This is likely to require discussion of proposals at executive or board meetings of the organisation. Pharmacists should ensure that any potential conflicts of interest due to financial or commercial involvement with a pharmaceutical company or other interested party are openly declared and recorded.
Primary care groups, primary care trusts, NHS trusts and health authorities in England and Wales should have a register for recording sponsorship arrangements, which should be available to the public.

Codes of practice for the pharmaceutical industry

The Association of the British Pharmaceutical Industry regulates the conduct of the pharmaceutical industry in relation to the promotion of medicines to members of the health professions. The ABPI's code of practice¹⁰ is drawn up, and regularly revised, in consultation with the British Medical Association, the Royal Pharmaceutical Society and the Medicines Control Agency. It aims to ensure that the promotion of medicines is carried out in a responsible, ethical and professional manner.
The promotion of over-the-counter medicines to health professionals is covered by similar codes of practice issued by the Proprietary Association of Great Britain.^11,12

References

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