Active search for pharmacovigilance Analysis in a private hospital of Distrito Federal (DF) during the first semester of 2021

Abstract

Objective: The objective of this study was to document an active search of pharmacovigilance during the first six months of 2021 in a private hospital of Distrito Federal (DF) using trigger tools. It was also to establish the profile of active search and adverse drug reactions (ADR) by sector. Method: The active search and notifications of possible ADR were identified and analyzed through pharmaceutical evolutions and ADR forms filled during the period, which were stratified according to the Naranjo\Karch’s and Lasagna’s algorithm. Descriptive statistics were used as estimates of absolute equancy, relative frequency and positive predictive value (PPV). Results: In the first period of 2021, 83 active pharmacovigilance searches were made, with the highest number of records in the first two months. ADR notifications remained between 2 to 4 notifications per month (2.5 ± 1.5) and represented 18,07% of the total search performed. The amount, profile of trigger tools and the ADR identified were different between the hospital sectors studied. The trigger tools with the highest number of active searches were: vitamin K, within 38 records (45,78%); protamine, within 25 records (33,73%) and naloxone, within 9 records (10,84%). The trigger tools that were able to identify possible ADR were: protamine (n = 7; 46,67%); vitamin K (n = 5; 33,33%) and naloxone (n = 3; 20%). The global positive predictive value (PPV) was 0.18. Naloxona showed the best performance (PPV = 0,33), followed by protamine (PPV = 0,25) and vitamin K (PPV = 0,13). Conclusion: The obtained data allowed us to observe that the results surpassed some variations according to the studied sector. Therefore, we intend to collect more information to improve the pharmacovigilance service according to the sector and area to guarantee safety for the inpatients.