Community pharmacists’ challenges regarding adverse drug reaction reporting: a cross-sectional study

Abstract

Objective

The effectiveness of the national drug safety monitoring program directly depends on the active participation of healthcare professionals in reporting suspected adverse drug reactions (ADRs). The aim of the study was to explore community pharmacists’ comprehension of pharmacovigilance, their perspectives toward reporting ADRs and investigate the current practice of ADR reporting among pharmacists in Serbia.

Methods

This descriptive cross-sectional study was performed on a sample of pharmacists in Serbia between November 2019 and March 2020 using a pre-tested questionnaire distributed online. Eligible participants were community pharmacists in Serbia who were willing to participate in the study during the data collection period. Non-parametric statistical tests were performed in the analysis of knowledge, perspectives and ADR reporting. The validity and reliability of the survey were measured by exploratory factor analysis.

Results

The median knowledge score was 6 out of 10 (interquartile range 5–7, range 2–10). No significant differences in the knowledge scores of pharmacists were found based on weekly working hours (U = 24,805, p = .374), working experience (χ² = 4.011, DF = 2, p = .135), being a member of a professional organization (U = 24,312, p = .209), or highest level of pharmacy qualification obtained (χ² = 3.233, DF = 3, p = .506). Only 28.8% of pharmacists reported ADR at least once a year, while the majority of them have never reported any ADRs.

Conclusions

Despite the community pharmacists’ positive attitude toward adverse drug reporting and their role in the process, they show limited knowledge regarding the issue and highly prevalent under-reporting of ADRs. Educational programs are necessary to increase ADRs reporting.

Keywords:

• Pharmacovigilance
• adverse drug reaction reporting systems
• pharmacists
• knowledge
• Serbia

Transparency

Declaration of funding

This work was supported by the Provincial Secretariat for Higher Education and Scientific Research project No. 142-451-2621/2021-01.

Declarations of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors contributions

All authors contributed to this work. MPK was responsible for the study conception. MPK, AT and NS analyzed the data and contributed to interpreting and discussing the results. All authors contributed to discussing the results and writing the paper as well. All authors were responsible for revising this work critically for important intellectual content. All authors are accountable for all aspects of this work.

Acknowledgements

None.