Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit

Mário Rui Salvador, Cristina Monteiro, Luísa Pereira and Ana Paula Duarte
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Mário Rui Salvador: Public Health Unit, Local Health Unit of Guarda, 6301-858 Guarda, Portugal
Cristina Monteiro: Pharmacovigilance Unit of Beira Interior, Faculty of Health Sciences, University of Beira Interior, 6200-506 Covilha, Portugal
Luísa Pereira: Department of Mathematics, University of Beira Interior, 6201-001 Covilha, Portugal
Ana Paula Duarte: Pharmacovigilance Unit of Beira Interior, Faculty of Health Sciences, University of Beira Interior, 6200-506 Covilha, Portugal

IJERPH, 2022, vol. 19, issue 7, 1-8

Abstract: Spontaneous reports (SRs) of adverse drug reactions (ADRs) remain the basis of pharmacovigilance systems. The main objective of this study was to evaluate the quality of SRs received by the Pharmacovigilance Unit of Beira Interior, in Central Portugal. The second objective was to identify factors associated with complete SRs. SRs received between 1 January 2017 and 31 October 2019 were analyzed. SR information was classified as “mandatory” or “recommended” criteria. SR were then grouped into three categories (well, slightly, and poorly documented). Association between “well documented” SR and confounding variables was estimated using a multiple logistic regression model. The results showed 22.4% of SRs are “well documented”, and 41.2% are “poorly documented”. Most of the complete SRs correspond to non-serious ADRs (55.8%), with a negative association between complete SRs and serious ADRs (OR = 0.595, [95% CI 0.362–0.977], p = 0.040). There is also a significant association between complete SRs and e-mail notification (OR = 1.876, [95% CI 1.060–3.321], p = 0.002). The results highlight the small amount of SR documentation sent to pharmacovigilance systems. There is an association between non-serious ADRs and complete SRs. These results reinforce the need for training for notification of ADRs and that these SRs include as much information as possible for an effective drug risk management.

Keywords: adverse drug reactions; pharmacovigilance; spontaneous report; quality; public health (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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