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Background <p>Pharmacovigilance (PV) plays a critical role in monitoring and evaluating adverse drug reactions (ADRs) to ensure the safety of marketed medical products. This study aimed to assess the quality of ADR reports submitted to the national PV center of Nepal by comparing pre- and post-training periods, and to identify factors associated with ADR reporting quality.</p> Methods <p>A retrospective analysis of ADR reports submitted to the national PV center was conducted over a three year period. Reports from January 2020 to November 2022 were classified as the pre-training phase while reports from December 2022 to April 2023 consitituted the post-training phase. In December 2022, the research team developed and implemented a capacity building plan that included a two-day training program for regional PV center contact persons, consisting of pharmacists and other health care professionals (HCPs) responsible for submitting ADR reorts through the VigiFlow system. The quality of ADR reports was assessed using the validated Adverse Drug Report Quality Algorithm (AQUA-12) tool. Statistical analysis was performed using Microsoft Excel and R.</p> Results <p>A total of 86 reports were evaluated, 57 from the pre-training phase and 29 from the post-training phase. Overall, 35% (<i>n</i> = 30) of the reports were classified as high quality according to the AQUA-12 criteria. Prior to the training, only 16% (<i>n</i> = 9) met the high quality level whereas this proportion increased to 72% (<i>n</i> = 21) following the training. This improvement in ADR reporting quality was statistically significant (<i>p</i> = 0.000; <i>p</i> &lt; 0.05).</p> Conclusion <p>The training significantly improved the quality of ADR reports, underscoring the value of continuous quality improvement within PV systems. Targeted programs for health care professionals, particularly pharmacists and regulatory authority personnel, are essential to strengthen ADR reporting quality and enhancing patient safety.</p>

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Quality of adverse drug reaction reports submitted to the national pharmacovigilance center of Nepal: a pre- and post-training evaluation

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Sushil Nepal,
  • Shyam Shah,
  • Narayan Prasad Dhakal,
  • Umanga Tripathee,
  • Santusta Adhikari,
  • Sunil Shrestha,
  • Birna Trap,
  • Tamara Hafner,
  • Andy Stergachis

摘要

Background

Pharmacovigilance (PV) plays a critical role in monitoring and evaluating adverse drug reactions (ADRs) to ensure the safety of marketed medical products. This study aimed to assess the quality of ADR reports submitted to the national PV center of Nepal by comparing pre- and post-training periods, and to identify factors associated with ADR reporting quality.

Methods

A retrospective analysis of ADR reports submitted to the national PV center was conducted over a three year period. Reports from January 2020 to November 2022 were classified as the pre-training phase while reports from December 2022 to April 2023 consitituted the post-training phase. In December 2022, the research team developed and implemented a capacity building plan that included a two-day training program for regional PV center contact persons, consisting of pharmacists and other health care professionals (HCPs) responsible for submitting ADR reorts through the VigiFlow system. The quality of ADR reports was assessed using the validated Adverse Drug Report Quality Algorithm (AQUA-12) tool. Statistical analysis was performed using Microsoft Excel and R.

Results

A total of 86 reports were evaluated, 57 from the pre-training phase and 29 from the post-training phase. Overall, 35% (n = 30) of the reports were classified as high quality according to the AQUA-12 criteria. Prior to the training, only 16% (n = 9) met the high quality level whereas this proportion increased to 72% (n = 21) following the training. This improvement in ADR reporting quality was statistically significant (p = 0.000; p < 0.05).

Conclusion

The training significantly improved the quality of ADR reports, underscoring the value of continuous quality improvement within PV systems. Targeted programs for health care professionals, particularly pharmacists and regulatory authority personnel, are essential to strengthen ADR reporting quality and enhancing patient safety.