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

Abstract

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. AbstractWhat 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. K E Y W O R D Sconsumers, FAERS, pharmacovigilance

Characteristics and completeness of spontaneous reports by reporter's role in Germany: An analysis of the EudraVigilance database using the example of opioid‐associated abuse, dependence, or withdrawal

“…Consumers' reports were surprisingly complete, especially with respect to indication. Good reporting was also found by a US study which concluded that consumers may be more meticulous and eager to report all information compared with HCPs since the latter are often under time pressure 5 …”

“…This tendency was also observed in VigiBase where (overall and in Germany) pharmacists' reports were less often well‐documented than those by physicians 4 . This is in contrast to other studies where pharmacists provided the most complete information for concomitant drugs/the ADR's outcome 11 and the drug's indication, respectively 5 . German pharmacists lack knowledge of indication/medical history since these are not (generally) mandatory on the prescription forms.…”

“…In the WHO's VigiBase the completeness varied substantially between reporters with physicians filing the highest proportion of well‐documented reports (24%) 4 . A recent study based on the United States (US) Food and Drug Administration adverse event reporting system (FAERS) found that the completeness of indication(s) was far higher in reports filed by consumers than in those by physicians and other HCPs 5 . Further, consumers tended to report concomitant drugs more completely than pharmacists, physicians, and other HCPs 5 .…”

Variation in adverse drug events of opioids in the United States

“…The FAERS database might have over-represented the selected opioids because of duplicates, incomplete results, non-verifiable data, and uncertainty in adverse effect causalities (Veronin et al, 2019). In this case, most of the opioid ADE reports were from patients, with one-third being from medical professionals, which may contribute to the heterogenous quality of reports because of differing report behaviors between healthcare professionals and customers (Toki and Ono, 2020). The FAERS database is specifically populated by both mandatory (manufacturers of drugs) and voluntary (healthcare professionals, consumers, family members, etc.)…”

Analysis of Adverse Drug Events of Opioids in the United States

“…The ADEs could also have been underreported since FAERs is a voluntary database submitted by healthcare professionals and others. In this case, most of the opioid ADEs reports were mainly from patients with a one-third from medical professionals which may contribute to heterogenous quality of reports because of differing report behaviors between healthcare professionals and customers (Toki & Ono 2020). Furthermore, since ARCOS does not differentiate formulations and generic vs brand names for the opioids, the proportion of ADEs and opioid counts may need to be further investigated.…”