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Comparative Study
. 2020 Jun;45(3):462-469.
doi: 10.1111/jcpt.13086. Epub 2019 Nov 25.

Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports

Tadashi Toki  1 , Shunsuke Ono  1
Affiliations
Comparative Study

Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports

Tadashi Toki et al. J Clin Pharm Ther. 2020 Jun.

Abstract

What is known and objective: The objectives of this study were to explore completeness of direct adverse event (AE) reports from consumers and healthcare professionals (HCPs), and to discuss the reasons completeness varied among reporters with different occupations.

Methods: We used a total of 5475 direct AE reports to the United States (US) Food and Drug Administration (FDA) from the first and second quarters of 2016 and assessed completeness of basic information (eg, patient sex, age, weight) and information relevant to AEs (eg, suspect and concomitant drugs). Logistic regression analysis was conducted to evaluate the associations between report completeness and reporting backgrounds.

Results and discussion: The completeness of AE reports from consumers was generally greater than that of reports from HCPs. Completeness of specific items varied among different occupations, which may reflect accessibility to, and/or availability of, relevant information for each type of reporter. There was a clear association between the proportion of 'known' ADRs in a report and completeness, suggesting that consumers and HCPs are likely to consult labelling information when reporting AEs.

What is new and conclusion: The quality of AE reports seemed to depend on information costs accrued to potential reporters. Researchers should consider the impact of database heterogeneity and possible sample selection bias when using spontaneous AE reports as a sample of events in the United States.

Keywords: FAERS; consumers; pharmacovigilance.

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Conflict of interest statement

Tadashi Toki was employed by Daiichi Sankyo Co. Ltd during the study period. Shunsuke Ono declares no conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of data selection. To evaluate the impact of candidate factors such as previous drug information (eg, known ADRs and duration on market) on reporting rates of reporters, 5475 direct reports that met 4 criteria were identified. Filters 1 and 2 were required to determine if AEs were known ADRs of the primary suspect drug. Filter 3 was used to calculate the duration after drug approval in the United States. Filter 4 was used to calculate time‐to‐report
See this image and copyright information in PMC

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