Medicolegal Aspects of Disclosure of Side Effects of Biologic Drugs in Rheumatology: A Pilot Study

Abstract

Background: Management of rheumatoid arthritis is complicated due to different disease presentations and the multiplicity of drugs. Although most patients are informed about the risks of treatment, there remain possible side-effects, which patients are not informed about to avoid the 'information dump.’ Rheumatologists have to balance what they believe is essential to tell patients versus what reasonable patients believe they need to know to make an informed consent. Objectives: To determine differences in information that the physicians give, regarding the possible side effects of treatment options for rheumatoid arthritis, and what the patients actually want to know. Methods: To conduct this pilot study, a questionnaire was devised to assess what patients and prescribing rheumatologists, from the Gulf Cooperative Council, consider important for being informed about, including the possible adverse events with biologic drugs in rheumatoid arthritis. Results: A total of 20 patients and 13 physicians completed the questionnaire. Physicians routinely discussed the increased risk of infections (100%), skin rashes at injection sites (92%),falling white blood cell counts, and alterations in liver enzymes (84%). Patients were less interested in learning about infections (72%) and more interested in learning about rare complications, such as an increased risk of heart failure and cancer (81%), which doctors were less likely to discuss. Conclusions: There is a discordance between what doctors inform patients about and what patients want to know regarding the risks of biologic therapy in rheumatoid arthritis. This information gap can have a significant legal implications in routine practice if a patient develops a rare side effect of which they have not been informed. We propose a solution of both verbal and signed informed consent to bridge the gap.