Enhancing Pharmacovigilance in Pharmaceutical Companies: A Comparative Study of Electronic Reporting Before and After Implementation.

IF 0.7 Q4 PHARMACOLOGY & PHARMACY

Current drug safety Pub Date : 2025-06-30 DOI:10.2174/0115748863339571250610103928

Ghita Meknassi Salime, Nihal Bhirich, Abdelghani Asraoui, Moulay El Hassan El Karimi, Younes Rahali, Houda Sefiani

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引用次数: 0

Abstract

Background: Since 2016, Moroccan pharmaceutical companies have been required to report adverse effects linked to their medicines. Initially, reports were submitted using the CIOMS form, sent by normal mail to le Centre Antipoison et de Pharmacovigilance du Maroc, then using XML files in ICH E2B format, sent electronically. In 2021, a "vigiflow e-reporting for industry" standardized online reporting system was implemented. The primary objective of this study was to evaluate the pharmaceutical companies' use of electronic reporting. Secondarily, the study aimed to assess the quality of adverse drug reaction reports by comparing completeness scores across the three reporting means.

Methods: All individual case safety reports sent by pharmaceutical companies from January 1, 2019, to December 31, 2023, were extracted from Vigibase®. A quantitative and qualitative analysis was conducted, and a statistical comparison of data was performed using p-values. VigiGrade completeness score was calculated for a sample size selected.

Results: The highest number of reports were from E-reporting (50%), followed by CIOMS (29%) and E2B (21%). Between 2019 and 2021, CIOMS and E2B notifications decreased along with reporting laboratories. However, after 2021, electronic reporting increased steadily alongside reporting companies. Comparing vigiGrade completeness score across reporting means revealed no statistically significant differences (p = 0.094 > 0.05).

Conclusion: Electronic reporting shows quantitative effectiveness and consistent quality. Its adoption remains limited and requires continuous strengthening, particularly through increased awareness among pharmaceutical companies.

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提高制药公司的药物警惕性：电子报告实施前后的比较研究。

背景：自2016年以来，摩洛哥制药公司被要求报告与其药品相关的不良反应。最初，报告使用CIOMS表格提交，通过普通邮件发送到摩洛哥防毒和药物警戒中心，然后使用ICH E2B格式的XML文件以电子方式发送。2021年实施“维流行业电子报告”标准化在线报告系统。本研究的主要目的是评估制药公司使用电子报告。其次，本研究旨在通过比较三种报告方法的完整性评分来评估药物不良反应报告的质量。方法：从Vigibase®中提取2019年1月1日至2023年12月31日期间制药公司发送的所有病例安全性报告。进行定量和定性分析，并采用p值对数据进行统计比较。对选定的样本量计算vigiggrade完整性评分。结果：电子报告最多（50%），其次是CIOMS（29%）和E2B（21%）。在2019年至2021年期间，CIOMS和E2B通知随着报告实验室的减少而减少。然而，在2021年之后，电子报告与报告公司一起稳步增长。比较不同报告手段的vigiggrade完整性评分，差异无统计学意义（p = 0.094 bb0 0.05）。结论：电子报告具有定量有效性和质量一致性。它的采用仍然有限，需要不断加强，特别是通过提高制药公司的认识。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current drug safety PHARMACOLOGY & PHARMACY-

CiteScore

2.10

自引率

0.00%

发文量

112

期刊介绍： Current Drug Safety publishes frontier articles on all the latest advances on drug safety. The journal aims to publish the highest quality research articles, reviews and case reports in the field. Topics covered include: adverse effects of individual drugs and drug classes, management of adverse effects, pharmacovigilance and pharmacoepidemiology of new and existing drugs, post-marketing surveillance. The journal is essential reading for all researchers and clinicians involved in drug safety.