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Original Research

Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

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Pages 115-121 | Published online: 02 Feb 2016
 

Abstract

Background

Adverse drug reactions (ADRs) have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system.

Methods

Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261) completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history.

Results

Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found between rheumatology patients with and without neurological comorbidities regarding their awareness of ADRs. The majority of patients reported ADRs of cytotoxic drugs. The most reported ADRs were moderate gastrointestinal discomforts.

Conclusion

We may draw a profile of rheumatological patients willing to report ADRs: 1) The majority of them suffer from systemic inflammatory diseases and are slightly more prone to neurological comorbidities. 2) They are predominantly aware of their diagnosis but less able to identify the drugs that may cause their ADRs. 3) They tend to report mainly moderate gastrointestinal ADRs; that is, other cohorts of patients and other types of ADRs remain mainly undetected in such a reporting, which could represent a bias. Counseling and education of patients as well as developing a network for online communication might improve patients’ reporting of potential ADRs.

Acknowledgments

This study was supported by the Scientific Research Grant from Ministry of Science of Montenegro (No 01-1370) and by the Scientific Research Grant from the Ministry of Education and Science of Serbia (No OI 175046). This paper was proofread and edited by teaching assistant Danka Sinadinovic, Faculty of Medicine, University of Belgrade (Department of Humanities). We would like to thank Mrs Snežana Slavković for technical support during this study.

Disclosure

The authors report no conflicts of interest in this work.