Background Failure on the part of doctors to fully inform their patients of possible side affect of medications is the cause for 10% of all malpractice lawsuits and 40% of Rheumatology lawsuits in United States of America (USA) (1,3). What constitutes a risk is controversial;in one court case a 1% risk of hearing loss required disclosure whereas in another case a 1.5% risk of visual loss did not (2). Currently there is a divide in the United States concerning how physicians are expected to inform their patients. There are two main legal rules up for consideration, the Medical Practice Standard (MPS) (follows the ideology that information should be given at the discretion of physicians) and the Reasonable Person Standard (RPS)(maintains that it is a physician's duty to give their patients all the information that they might want).
Objectives To develop a standard format for rheumatologists when discussing the risks of prescription drugs with their patients which would fulfill all legal standards.
Methods We sent a questionnaire to thirteen rheumatologists who are considered key opinion leaders in the Middle East countries. They were asked “Do you routinely tell your patients in lay terminology about the following side effects of biological drugs?” They were then asked to check all those items that were routinely discussed out of twelve possible side effects that were derived from the American College of Rheumatology patient information leaflet. This questionnaire was also given to twenty patients taking biological drugs asking what side effects they would like to know about. Those items that were selected by at least fifty percent of the doctors were deemed the MPS and by fifty percent of the patients were made the RPS.
Results See table.
Conclusions There is a significant discordance between what patients want to know and what their doctors inform them of. To resolve this issue in our practice we have adopted a protocol of informing patients of side effects, giving them a ACR patient information leaflet, and having them sign a consent form. We believe that this will lead to better understanding and compliance from patients and lower risks of litigation.
Department of Health Education and Welfare: Report of the Secretary's Commission on Medical Malpractice (DHEW publication (OS) 73-89) U.S. Government Printing Office: Washington, DC, 1973.
Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965] and Yeats v. Hearms, 393 P.2d 982 [Kan. 1964].
Studdert DM, Mello MM, Brennan TA. Medical malpractice. N Engl J Med. 2004;350(3):283-292.
Disclosure of Interest None declared