Use of trigger tool to identify Adverse Drugs Events in dogs.

Beatriz Cristina De Oliveira Fonseca,Marcelo Rodrigues Martins,Paulo Henrique Jorge Da Cunha,Patrícia De Carvalho Matroianni,Marcela Forgerini,Nathalie De Lourdes Souza Dewulf,Leila Crystina Dias Zorzin,Ngela Ferreira Lopes

doi:10.29374/2527-2179.bjvm109720

Abstract

The highlight of the shortcomings in the regulation and surveillance of veterinary drugs in Brazil is the absence of a system to report adverse drug events (ADEs). The aim of this study was evaluate the use of triggers in dogs to detect ADEs by estimating the prevalence of ADE and identifying the possible triggers. We screened medical records for ADEs and degree of harm caused by an ADE, using known triggers, with the Global Trigger Tool: translated, adapted and validated for use in animal health. The triggers comprised two-fold increase in blood urea nitrogen or serum creatinine levels compared to baseline, administration of vitamin K, administration of diphenhydramine or promethazine, excessive sedation or hypotension, administration of an antiemetic, abrupt cessation of medication, or others. The association between the occurrence of ADEs and variables, such as age, race, duration of hospitalization, polypharmacy, and clinical outcome was evaluated. A total of 148 medical records were analyzed. The trigger tools identified the known triggers 109 times in 68 medical records. Additionally, 14 ADEs were identified; the prevalence of ADEs was 9.5%. Positive predictive values of the triggers were 12.8%, and “vitamin K administration” had the best performance. The duration of hospitalization (p-value = 0.030) and polypharmacy (p-value < 0.001) were associated with the occurrence of ADEs. Approximately 46% of the hospitalized dogs presented with at least one trigger. One out of five hospitalized dogs suffered from temporary harm due to an ADE. The duration of hospitalization and polypharmacy were found to be risk factors for ADEs in dogs.

Highlights

Despite the recent changes in pharmacovigilance and legislation to improve patient safety, the shortcomings in regulation and surveillance of veterinary drugs still exist in Brazil, even after the affiliation of Brazil with the International Conference of Harmonization (Varallo et al, 2019)
Prevalence studies, and data from previously reported cases world-wide showed the occurrence of adverse drug events (ADEs) in different animal species, primarily in companion animals (Mouiche et al, 2019; Müntener et al, 2019), that was related to the use of vaccines, antiparasitic drugs, antimicrobials, and non-steroidal anti-inflammatory drugs (Maddison, 1996; Woodward, 2005b; Müntener et al, 2017)
Among the 14 ADEs that were identified in our study population, we found a prevalence of 9.5%

Summary

Introduction

Despite the recent changes in pharmacovigilance and legislation to improve patient safety, the shortcomings in regulation and surveillance of veterinary drugs still exist in Brazil, even after the affiliation of Brazil with the International Conference of Harmonization (Varallo et al, 2019). The absence of a system to report adverse drug events (ADEs) in the field of animal health in Brazil is noteworthy. The Global Trigger Tool is an instrument widely used to actively screen for ADEs using known triggers. It measures the degree of harm caused by ADEs (Griffin & Resar, 2004; Griffin & Resar, 2009). Objective: Evaluate the use of triggers in dogs to detect ADEs by estimating the prevalence of ADE and identifying the possible triggers. Method: We screened medical records for ADEs and degree of harm caused by an ADE, using known triggers, with the Global Trigger Tool: translated, adapted and validated for use in animal health. The duration of hospitalization and polypharmacy were found to be risk factors for ADEs in dogs

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Discussion

Conclusion