The cost of pharmacovigilance: a time and motion study of an adverse drug reaction program

Abstract

Objectives Adverse medication events are associated with a significant number of hospital admissions, and the appropriate recording of these events plays a vital role in medication safety. We set out to analyse the time and extrapolated cost in reporting adverse drug reactions (ADRs). Methods A time and motion study of the tasks involved in reviewing, assessing, reporting and communicating ADRs was done over a period of 2 months. Key findings We found a median of 69 min was needed in background work per ADR report. Conclusion The commitment involved in the support of this program is considerable and will encourage further refinement to streamline the process.

The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs

“…However, the management of spontaneous reporting of AEs is far from negligible in terms of time and resource costs. For example, a small study involving a single organization reported a median data ingestion time of 69 min per spontaneous report 4 . However, that estimate did not include costs accrued by multiple organizations handling the same report or sharing it with other organizations, while adhering to strict legal requirements 5 …”

“…For example, a small study involving a single organization reported a median data ingestion time of 69 min per spontaneous report. 4 However, that estimate did not include costs accrued by multiple organizations handling the same report or sharing it with other organizations, while adhering to strict legal requirements. 5 In 2021, GSK estimated a mean cost of US$33 per processed spontaneous report and similar estimations were seen across other pharmaceutical companies.…”

Developing A Deep Learning Natural Language Processing Algorithm For Automated Reporting Of Adverse Drug Reactions

“…However, using ADE codes for ADR detection is a relatively resource intensive process, with a large volume of ADE events and only a small subset of ADRs. Not all hospitals have the capacity to review all coded records to differentiate the ADRs [8]. Given coding for ADEs is performed by individuals not involved in clinical care, multiple opportunities for inconsistency in ADE reporting arise, including inter-coder variability [9], lack of context, knowledge, and time [2].…”

“…Although maintaining a comprehensive hospital-based pharmacovigilance program is relatively costly and time-intensive [8], reporting ADRs is an essential component of clinical practice because it contributes to our broader understanding of the safety and risk-benefit profile of medications [2]. Failure to recognise ADRs can lead to delays in changing post-marketing product label warnings and actioning changes [10].…”