A comparative study of active and passive adverse drug reaction reporting systems in terms of false reporting rate

Background: World Health Organisation Uppsala Monitoring Centre (WHO-UMC) was set up in 1968 to collect Adverse Drug Reactions (ADRs) periodically for all drugs across the globe. It identifies two main approaches to pharmacovigilance: active (intensive) and passive (spontaneous). However, very few studies are available to compare these two methods of adverse drug reaction reporting. Methods: A prospective observational study was done on 303 newly diagnosed patients with tuberculosis receiving directly observed therapy short-course (DOTS) in the Sawai Man Singh (SMS) Hospital, Jaipur between 1 January 2019 and 31 December 2019. They were randomly divided into groups A (150 patients) and B (153 patients). Group A patients were followed actively at fixed intervals of time for ADRs till next six months through electronic conversation or personal interview. Group B patients were required to report spontaneously for any ADRs to pharmacovigilance centre. After data collection causality assessment was done using the WHO-UMC scale to identify false reporting and finally results were analysed statistically by means of the t-test using Minitab 14 software Pennsylvania, USA. Results: 153 ADRs were reported in active and 39 in passive group. Hence the yield of ADR was four times more in active method. After causality assessment, 31 in group A and 12 in group B were found to be falsely related (unlikely) to antitubercular drugs. Two sample t-test revealed active method reported more false ADR (p = 0.005). Conclusion: Although active method of surveillance identifies more ADRs than passive method, it is also more prone to false reporting. Hence its benefits should be weighed against its cost before adopting it for countries with limited resources.

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Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

Journal of Pharmaceutical Policy and Practice ◽

10.1186/s40545-021-00298-8 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Zuzaan Zulzaga ◽

Erdenetuya Myagmarsuren ◽

Herman J. Woerdenbag ◽

Eugene P. van Puijenbroek

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Drug Safety ◽

Reporting System ◽

Adverse Drug Reaction Reporting ◽

Safety Data ◽

Regulatory System ◽

Basic Structure ◽

Reaction Reporting ◽

Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

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