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PARE0018 The Dilemmas of Disclosure of Side Effects of Rheumatic Biological Drugs
  1. S. Moufarrej,
  2. R. Basheer,
  3. K. Thornely
  1. Middle East Arthritis Foundation, Dubai, United Arab Emirates

Abstract

Background Doctors face a dilemma when disclosing side effects of prescription drugs to patients. While generally, 6.3 to 17% of lawsuits are attributed to medication including side effects, 40% of rheumatology malpractice claims are attributed to drug related adverse effects [1–3]. On the other hand, the disclosure of treatment's adverse effects may increase such side effects in what is called the Nocebo effect. Arthritis patients who are more worrisome of the adverse effect of the medication are more likely to end up with such side effects [4].

Objectives To identify the gap between what rheumatology patients in the Middle East care to know about the side effects of their treatment and to what practicing rheumatologist in the region typically disclose to their patients. The second objective is to identify the most effective ways to disclose treatment information to rheumatology patients in the Middle East.

Methods Twenty rheumatology patients taking the biological drug completed a questionnaire identifying the side effects that they would like to be informed of out of the 12 possible ones listed in the American College of Rheumatology information leaflet. Similarly, thirteen practicing rheumatologist were also asked to identify the side effects that they normally inform their patients of on a routinely basis. The second step consisted of open-ended interviews of patients by the Patient Liaison Officer of the Middle East Arthritis Foundation revealing how they would like to be informed of the drugs they are prescribed.

Results There was a gap between what rheumatologists informed their patients and what patients wished to know (Figure 1). The research indicates that the surveyed patients wished for the information to be presented to them in a clear, concise manner, and to be provided in their own language. The surveyed patients desired for a support forum and expressed distinct preference to learning about their treatment from their physician in contrast to reading about it on the internet or in leaflets provided by pharmaceutical companies.

Figure 1.

Proportions of side effects disclosed by Rheumatologist practicing in the Middle East and those that Rheumatology patients find important.

Conclusions In order to reconcile the need to be transparent but prevent anxiety, Rheumatologists may omit disclosure of some drug side effects. There is a need though to emphasize patient-physician interaction when disclosing information. Modifications in the communication of treatment to Rheumatology patients in the Middle East will improve compliance and the outcomes.

References

  1. Boyle, D. J. What Gets a Good Rheumatologist Sued? Pitfalls to avoid and habits that protect you from malpractice suits. The Rheumatologist.

  2. Rothschild, J.M., Frederico, F.A., Ghandi, T. K., Kaushal, R., William, D. H., and Bates, D. W. (2002). Analysis of medication-related malpractice claims: causes, preventability, and costs. Arch Intern Med. 162(21):2414-20.

  3. Studdert, D. M., Mello, M. M., Gawande, A. A., Gandhi, T. K., Kachalia, A., Yoon, C., Puopolo, A. L., and Brennan, T. A. (2006). Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 354:2024-2033.

  4. Wells, R.E. (2012, March). To tell the truth, the whole truth, may do patients harm: The problem of the Nocebo effect for informed consent. Am J Bioeth; 12(3): 22-29.

Disclosure of Interest None declared

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