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New Emirates Medical Journal

Editor-in-Chief

ISSN (Print): -
ISSN (Online): 0250-6882

Research Article

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

Author(s): Ryan Basheer*, Souheil Moufarrej and Humeira Badsha

Volume 2 , Issue 1 , 2021

Published on: 21 April, 2020

Page: [25 - 30] Pages: 6

DOI: 10.2174/0250688201999200421153704

open access plus

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.

Objective: 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.

Conclusion: 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.

Keywords: Side effects, Biologics, Rheumatoid arthritis, Disclosure, Informed consent, Medicolegal.

[1]
Mckeown EJ. The ethical challenges in rheumatology. Curr Rev Musculoskelet Med 2015; 8(2): 107-12.
[http://dx.doi.org/10.1007/s12178-015-9263-1] [PMID: 25749485]
[2]
Townsend A, Adam P, Cox SM, Li LC. Everyday ethics and help-seeking in early rheumatoid arthritis. Chronic Illn 2010; 6(3): 171-82.
[http://dx.doi.org/10.1177/1742395309351963] [PMID: 20610465]
[3]
Marques Filho J. Informed consent in rheumatology care practice. Rev Bras Reumatol 2011; 51(2): 179-83.
[http://dx.doi.org/10.1590/S0482-50042011000200007] [PMID: 21584423]
[4]
Grady C, Cummings SR, Rowbotham MC, McConnell MV, Ashley EA, Kang G. Informed Consent. N Engl J Med 2017; 376(9): 856-67.
[http://dx.doi.org/10.1056/NEJMra1603773] [PMID: 28249147]
[5]
Wright SJ. What a rheumatologist should know about the law: I. Battery, breach of contract and negligence. Br J Rheumatol 1987; 26(2): 147-52.
[http://dx.doi.org/10.1093/rheumatology/26.2.147] [PMID: 3828667]
[6]
Fernandez Lynch H, Joffe S, Feldman EA. Informed consent and the role of the treating physician. N Engl J Med 2018; 378(25): 2433-8.
[http://dx.doi.org/10.1056/NEJMhle1800071] [PMID: 29924950]
[7]
Koh J, Goh E, Yu KS, Cho B, Yang JH. Discrepancy between participants’ understanding and desire to know in informed consent: are they informed about what they really want to know? J Med Ethics 2012; 38(2): 102-6.
[http://dx.doi.org/10.1136/jme.2010.040972] [PMID: 21708828]
[8]
Romain PL. Ethics: Investigators’ interests: what should trial participants be told? Nat Rev Rheumatol 2010; 6(2): 70-1.
[http://dx.doi.org/10.1038/nrrheum.2009.264] [PMID: 20125171]
[9]
Appelbaum PS, Anatchkova M, Albert K, Dunn LB, Lidz CW. Therapeutic misconception in research subjects: development and validation of a measure. Clin Trials 2012; 9(6): 748-61.
[http://dx.doi.org/10.1177/1740774512456455] [PMID: 22942217]
[10]
Muth CC. Conflict of Interest in Medicine. JAMA 2017; 317(17): 1812.
[http://dx.doi.org/10.1001/jama.2017.4044] [PMID: 28464142]
[11]
Duclos CW, Eichler M, Taylor L, et al. Patient perspectives of patient-provider communication after adverse events. Int J Qual Health Care 2005; 17(6): 479-86.
[http://dx.doi.org/10.1093/intqhc/mzi065] [PMID: 16037100]
[12]
Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA 1992; 267(10): 1359-63.
[http://dx.doi.org/10.1001/jama.1992.03480100065032] [PMID: 1740858]
[13]
Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology /European League Against Rheumatism collaborative initiative. Arthritis Rheum 2010; 62(9): 2569-81.
[http://dx.doi.org/10.1002/art.27584] [PMID: 20872595]
[14]
Greenblum J, Hubbard R. The common rule’s ‘reasonable person’ standard for informed consent. Bioethics 2019; 33(2): 274-7.
[http://dx.doi.org/10.1111/bioe.12544] [PMID: 30474124]
[15]
Colloca L. Nocebo effects can make you feel pain. Science 2017; 358(6359): 44.
[http://dx.doi.org/10.1126/science.aap8488] [PMID: 28983038]
[16]
Levinson W, Roter DL, Mullooly JP, Dull VT, Frankel RM. Physician-patient communication. The relationship with malpractice claims among primary care physicians and surgeons. JAMA 1997; 277(7): 553-9.
[http://dx.doi.org/10.1001/jama.1997.03540310051034] [PMID: 9032162]
[17]
Dodge AM, Fitzer SF. When good doctors get sued: A guide for defendant physicians involved in malpractice lawsuits. Book Partners, Inc. 2006.
[18]
Skolnik NS, Smith DR, Diamond J. Professional satisfaction and dissatisfaction of family physicians. J Fam Pract 1993; 37(3): 257-63.
[PMID: 8409877]
[19]
Salvarani C, Hunder GG. Giant cell arteritis with low erythrocyte sedimentation rate: frequency of occurence in a population-based study. Arthritis Rheum 2001; 45(2): 140-5.
[http://dx.doi.org/10.1002/1529-0131(200104)45:2<140::AID-ANR166>3.0.CO;2-2] [PMID: 11324777]
[20]
Studdert DM, Mello MM, Brennan TA. Medical malpractice. N Engl J Med 2004; 350(3): 283-92.
[http://dx.doi.org/10.1056/NEJMhpr035470] [PMID: 14724310]
[21]
Pope JE, Tingey DP, Arnold JM, Hong P, Ouimet JM, Krizova A. Are subjects satisfied with the informed consent process? A survey of research participants. J Rheumatol 2003; 30(4): 815-24.
[PMID: 12672205]
[22]
Wohlfahrt A, Campos A, Iversen MD, et al. Use of rheumatology-specific patient navigators to understand and reduce barriers to medication adherence: Analysis of qualitative findings. PLoS One 2018; 13(7)e0200886
[http://dx.doi.org/10.1371/journal.pone.0200886] [PMID: 30024938]
[23]
Safdar N, Abbo LM, Knobloch MJ, Seo SK. Research methods in healthcare epidemiology: Survey and qualitative research. Infect Control Hosp Epidemiol 2016; 37(11): 1272-7.
[http://dx.doi.org/10.1017/ice.2016.171] [PMID: 27514583]

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