The Pharmaceutical Journal
Vol 269 No 7214 p319-323
7 September 2002

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  Emergency hormonal contraception (EHC)
  Olanzapine
  Drug interactions
  Consent
  Tablet crushing
  Modernisation
  The Society

Letters to the Editor

Consent

Patient autonomy or avoidance of litigation?

From Ms V. L. Isitt, MRPharmS

In response to the letter "Should patients be informed" (PJ, 24 August, p248), I would like to make the following comments. In any discussion of "informed consent" it is necessary to consider its purpose. Is informed consent intended to allow the patient to make an "intelligent decision" about the treatment offered to him or her; a safeguard for patient autonomy and self-determination? Or is it simply an expression of the standard of the professional duty a doctor must discharge in order to avoid litigation? Medical law and practice are slowly following medical ethics in moving to the former from the latter.

Until recently, it was held that the level of disclosure could be determined by the medical profession, in that it should be "in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art".¹ It was not until 1990 that the idea that a patient could have an opinion about how much information was enough entered English law.² It was held that "... if there is a significant risk which would affect the judgement of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him- or herself as to what course he or she should adopt."

Whether information on the source of a product or the fact that it is unlicensed should be disclosed must therefore depend on the risk, as perceived by the patient. Withholding information that the patient would not understand or which might cause him or her distress ("therapeutic privilege") is still legal,³ but unfashionable. The General Medical Council guidelines on obtaining consent state: "You should not withhold information necessary for decision making unless you judge that disclosure of some relevant information would cause the patient serious harm. In this context, serious harm does not mean the patient would become upset or refuse to consent to treatment."⁴

It is well established in medical law that a competent patient may refuse treatment on any number of grounds. It is also well established in both law and ethics that a doctor, and by extension the whole health care team, must always act in the best interests of the patient. These interests may not be exclusively medical. If a patient's religious convictions are strong enough to cause him or her to refuse a certain treatment, it would be unethical for a doctor or pharmacist to withhold the information necessary to make that decision.

Valerie Isitt
Regulatory Consultant
Radlett,
Hertfordshire

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