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Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System

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Abstract

Background

Antibiotics are commonly used in both outpatient and inpatient settings and are responsible for the majority of adverse drug reaction (ADR) reports. We aimed to characterize spontaneously reported ADRs associated with antibiotics and assessing the preventability of these ADRs in a Vietnamese setting.

Materials and Methods

We conducted a retrospective descriptive study based on ADRs related to antibiotics spontaneously reported by healthcare workers to the National Pharmacovigilance Database of Vietnam (NPDV) between June 2018 and May 2019. The characteristics of included reports were descriptively analyzed. The preventability of reported ADRs was assessed using a standardized preventability scale. We identified the leading causes and described the characteristics associated with preventable ADRs (pADRs).

Results

We included 6385 antibiotic-related reports from a total of 12,056 reports submitted to the NPDV during the study period. Beta-lactam antibiotics, mostly broad-spectrum with parenteral route, were suspected in the majority cases. The most commonly reported pADRs were allergic reactions, mostly classified under skin and subcutaneous tissue disorders. Of all included cases, 537 cases (8.4%) were deemed as associated with pADRs. Major causes of pADRs include potentially inappropriate prescribing (352/537, 65.5%) and re-administration of antibiotics causing prior allergy/allergies (99/537, 18.4%). The majority of pADRs involved the use of beta-lactam antibiotics with inappropriate indications.

Conclusion

ADRs related to antibiotic use represent more than half of ADRs spontaneously reported in Vietnam. Approximately one in every ten reported cases is associated with pADRs. The majority pADRs can be prevented through simple improvement in antibiotic prescribing practices.

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Data Availability

The datasets generated and/or analyzed in this study are not publicly available due to data protection law in Vietnam but might be available from the corresponding author on reasonable request.

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Acknowledgements

We would like to thank Ms. Susan Luu and Ms. Ho Hong Ngoc from the WHO country office in Vietnam for constructive discussions to conceptualize study.

Funding

This study was funded by WHO (Project WPVNM1814680; Award No: 65763). The funders had no role in the design and conduct of the study; the analysis and interpretation of the data; the preparation; the review or approval of the manuscript. No other associations or activities might appear to have influenced the work that was presented.

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Authors and Affiliations

  1. National Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam

    Ha N. Tran, Tien N. T. Nguyen, Ngan T. K. Tran, Ly T. Nguyen, Hoa D. Vu & Anh H. Nguyen

  2. PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and, PharmaTox Strategic Research Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway

    Nhung T. H. Trinh

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  1. Ha N. Tran
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Contributions

HDV and AHN conceptualized the research question and reviewed drafts of the manuscript. All authors co-developed the analysis plan. TNTN, HNT, NKT, LTN conducted the data analysis and contributed to the manuscript preparation. HNT and NTHT drafted the manuscript. All authors read and approved the final version of the manuscript.

Corresponding author

Correspondence to Anh H. Nguyen.

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Conflict of interest

The authors have no conflict of interest to declare. We affirm that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of any organization or company.

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Tran, H.N., Nguyen, T.N.T., Tran, N.T.K. et al. Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System. Ther Innov Regul Sci 57, 1104–1112 (2023). https://doi.org/10.1007/s43441-023-00552-y

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