Pharmacy in Practice

Reprinted with the permission of Medicom (UK) Ltd.

Consent

Voluntary agreement; permission; compliance [1]

Pharmacy in Practice 1997:7:37-44.

Make sure consent is informed

The Case

Mrs J., an elderly lady, walked into the pharmacy supported by her husband, who was carrying a prescription. The pharmacist took the form and saw that it was a request for the supply of 14 ampoules for the VENEPUN study. He took the form into the trials dispensary, randomised the patient according to the protocol, and returned with the labelled ampoules for Mrs J to take home.

"Is the nurse coming to visit you at home to give you these ?", he asked.

"Oh, yes, they're all so kind. Dr M. is giving me a new treatment for my legs. I've got to have an injection every day for fourteen days".

"It's not very convenient, but she's got terribly painful vasculitis", her husband added, "so she jumped at the chance to try a new treatment".

"A new treatment ?", the pharmacist repeated. "Could you just wait a moment". He returned to the dispensary and confirmed that the VENEPUN study was a double-blind, randomised comparison of a new intravenous prostaglandin analogue versus saline placebo. "Dr M. did explain that this was a study, didn't she ?", he asked Mrs J. on his return.

"Oh yes, she was very helpful. She said it was a new kind of treatment, and worth a try".

"And Dr M. did say that you were going to be treated ?".

"Of course she did. Or maybe it was the nurse who spoke to me....to be honest, I can't really remember".

"Did you sign a form or anything before they prescribed this for you ?".

"Funny you say that. She asked me read something then sign a piece of paper, saying I had to do that before I could have this new drug. Why do you ask ?".

"Was it a patient information sheet she gave you ?".

"I don't know. The writing was too small for me to read. It just said something about this new treatment being helpful for people with my condition. What's the matter with you ?".

"These are injections", Mr J. said, looking worried. "If they are going to help my wife then what's wrong with that?".

"Did Dr M. tell you that this study involves the use of a placebo ?".

"What's one of those ?", Mrs J. asked, to which the pharmacist replied......

Editorial Comment

Our second case raises issues which are becoming increasingly common as pharmacy departments become more heavily involved in the organisation and management of clinical trials. It is well accepted that the doctor-patient relationship which exists during a standard clinical consultation is changed in those cases where a patient enters a clinical trial. In the former situation, a medical practitioner will prescribe whatever treatment they consider the most appropriate, and this will be expected by the patient. However, when a practitioner asks a patient to enter a randomised, controlled clinical trial, they will be prescribing one of at least two, or possibly more, alternative therapies. This may also involve the use of a placebo. In such cases, the medical practitioner is manifestly not prescribing what they consider the best treatment, but are instead offering the trial volunteer a choice on the basis that no one treatment on offer is already demonstrably better than another or is better than a placebo. The 'patient' is now a 'trial volunteer', and the clinical relationship has been changed.

The need for patients to be 'informed' that they are in a study is an area which is addressed by Elena Grant, regional drug information pharmacist in the West Midlands :

Trial designs should conform to accepted standards and patients should be able to make informed decisions about participation. Essential components of "informed consent" are an explanation that the subject will be participating in a research procedure, that entry is optional and withdrawal at any time is their right, the nature of the study and the likely effects of treatment (positive and negative). Use of placebo in the study should be explained. Unlike the USA, the term "informed consent" does not carry a specific legal meaning in the UK.

Several bodies have published guidelines on clinical trials which refer to "informed consent" (e.g. ABPI and the Royal College of Physicians). This subject is one which is usually overseen by Local Research Ethics Committees (LRECs) which the Dept. of Health has recommended should be established by each Health Authority.

There is no single preferred method of obtaining and recording consent that is appropriate to all research and patient groups. Consent checklists for investigators have been adopted by some Health Authority LRECs. Alternatives to signed consent forms are "witnessed consent" where a third party witnesses the consultation and confirms in writing that adequate explanation has been given and consent freely given, or obtaining a signature on a simple form to say that information has been provided. LRECs should decide the most appropriate method for the study and patient groups. (A bibliography of some of the main reference works relevant to this area is attached to the end of this article).

Most pharmacists would agree that these rules contain a lot of common sense, but obtaining consent is still one of the most difficult area faced by practitioners, patient volunteers and LRECs. The Very Reverend John Allen, Provost of Wakefield, Vice-Chairman of Wakefield Health Authority and Chairman of Wakefield LREC provides a useful insight into the practicalities of being asked to participate in a study, and of the importance of pharmaceutical representation on LRECs when matters such as consent are raised :

The case of Mrs J. raises so many issues of concern that I am sure that the pharmacist ought also to consult the physician concerned before proceeding. On the face of it, there are issues concerning the design of the trial, the actions of the GP and the practice nurse, and the role of the LREC. Presumably this was a multi-centre trial, sponsored by one of the major pharmaceutical companies. We are not told about the relevant inclusion and exclusion criteria, but at least they should have excluded anyone unable to give informed consent; and possibly anyone in the physical state of Mrs J. Additionally, patient information sheets and patient consent forms must be provided in large enough print, and simple enough English, for every potential patient to understand.

No trial can involve deceiving a patient. If the nurse or GP actually told Mrs J. that she was definitely going to try a new treatment, rather than that she might be going to try it, then that is deception; and in any case invalidates the trial. We know already that a large number of people, who receive placebo, report beneficial effects even when there is no form of suggestion involved. Here a susceptible old lady is told that she will benefit, so she will expect to benefit.

The reported actions of the GP practice concerned raise questions as to their suitability as local investigators for this trial. LREC's do not have the resources to monitor the conduct of trials. They rely on others. But a pharmacist is normally a member of the LREC, and the local pharmacist has access through him. Incidents like this help to inform future decisions. There is a move afoot to centralise approval of multi-centre trials, but this case demonstrates how important it is that LRECs should continue to have responsibility for approving the local investigators in a trial.

The role of the pharmacist in cases such as this can be very difficult. On the one hand we have a duty towards the medical practitioner of supplying drugs to their patients in a professional manner. On the other hand, we also have a duty of care towards the patient, such that we must provide information and advice when requested to do so. Faced with apparent ignorance, as in this case, should the pharmacist intervene ? Rabbi Julia Neuberger, Chairman of Camden and Islington Community Health Services NHS Trust in London, has written extensively on ethical issues and on the condict of LRECs. Her views favour patient autonomy :

It is a standard rule that patients entered into a randomised controlled trial must understand what that means. If there is any question that they do not, or cannot, understand, then it is unethical to enter them into such a study unless there are particular circumstances which justify the exception, such as patients with Alzheimer's disease. In the case of Mrs J therefore, the GP would have had to take considerable trouble in explaining to her, in making sure an information sheet was available to her in large print and that her husband understood what is involved, before consent was even sought. It is unacceptable for her to have thought she was getting a new treatment that was 'worth a try' when it was a trial, and she might be going into the placebo arm.

If someone like Mrs J. is to be entered into such a study, she needs to understand what a placebo is, be content that she might be receiving it, and have some sense that being part of the study is worth it to her for her own and for altruistic motives. This is not possible if she does not understand.

It is also unacceptable for her to be exposed to injections which could be very painful (given how painful her condition already was) unless there was arguably an advantage to her in doing so. That might be so if she could get the new treatment (if it emerged as useful), and she had tried it in the short term. But unless there was to be provision for early licensing to named patients, there is little justification for putting a patient in considerable pain into a trial. As an elderly person, she personally has little to gain.

The pharmacist seems to me to be in an arguably difficult position. If the GP has already put Mrs J into the study, should the pharmacist interfere? If it becomes clear to the pharmacist that Mrs J does not understand, then it seems to me that the pharmacist has no choice, but at the very least should ask Mrs J to go back to her GP, or, preferably, telephone the GP him or herself to express concern. If, throughout the service, we advocate the use of informed consent, and particularly in studies of any kind, then it must be right for one NHS professional to point out such a problem to another.

This case has highlighted several important issues, which anyone involved in clinical trials needs to address, as it can be anticipated that issues of patient consent are going to become increasingly important. For example, in relation to different treatment options, the so-called 'Bolam test' is currently applied by the British courts in matters of consent (which we summarise as 'medical practitoners need only tell patients of the most likely side effects of treatment that would also be mentioned by a group of their peers'). However, the Australian courts, which generally comply with Britisah case law, have overturned this principal2 in favour of full disclosure (which we summarise as 'medical practitoners should tell their patients of any and all potential side effects of a proposed treatment'). It can be anticipated that similar considerations might also apply to randomised controlled clinical trials.

Pharmacists have potentially a great deal to offer in this area as patient advocates. We do not generally stand to benefit personally from the conduct of a clinical trial, we are well-informed regarding alternative treatment strategies and, as a profession, we are investing a great deal of time and effort into improving our communication skills.

Is this a challenge that we should take on board ?

References

[1] - The Oxford Encyclopaedic English Dictionary (Eds. Hawkins, J.M. Allen, R.). Oxford University Press, Oxford (1991).

[2] - Kirby, M. Patients rights - Why the Australian courts have rejected 'Bolam'. Journal of Medical Ethics 1995;21:5-8.

Bibliography

Research involving patients. Royal College of Physicians, London, 1990.

Guidelines on the practice of ethics committees in medical research involving human subjects. Royal College of Physicians, London, 1990.

Guidelines on good clinical research practice. The Association of the British Pharmaceutical Industry, London, 1988.4.

Neuberger J. Ethics and Health Care. The role of research ethics committees in the United Kingdom. Research report No. 13., Kings Fund Institute, 1992.

Department of Health : Local Research Ethics Committees, 1991.

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