The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients

Farmacovigilância: perfil e notificações das reações adversas a medicamentos em hospital de ensino

“…During the period under study, only 4% of the notifications were via SNs. However, we must take into account that, even so, SNs are more assertive in identifying ADRs than AS, represent the classic method of identifying these problems and are extremely relevant for effective patient safety 4,7,11,12,22,26,30,35 .…”

“…In this period, 2 pharmacovigilance triggers stood out, RM1 (antiallergy) and RM2 (anticoagulant antidotes), with PVVs of 9% and 3%, respectively. A study with ADR triggers in pediatric patients 11 showed higher predictability of antiallergics (dexchlorpheniramine, loratadine and promethazine) with a 38% PPV index. The use of anticoagulant antidotes (protamine and Vitamin K) as triggers was also reported as an important ADR trigger with a relative yield of The very low presence of other professionals in the SNs is worrying, especially the lack of notifications by professionals closely linked to the medications and trained to identify potential ADRs.…”

“…RE7 (Ion exchange resin/Sorcal), RE9 (Positive test for C. difficile in feces) and RME 5 (Naloxone) were either not notified or did not find any ADE during the period (Figure 2). The PPV values 11 , which correspond to the number of confirmed ADRs among the suspected ones found by the trigger, can be seen in Table 2. An interesting fact can be observed: as it is not possible to search for specific words within one or several medical records in the TASY® electronic system, the RP19 trigger cannot be used within our AS since, as this service comprises all hospital wards, reading all the medical charts on a daily basis is inconceivable.…”

“…Even acting on the factors that generate underreporting in order to combat them, other reliable ways to generate these data are required 29 . In this premise, the use of trigger tools or trackers has spread, which can be considered data or information related to the patients that serve as a warning and which, in this case, can assist in the detection of potential ADRs and, in combination with SNs, create a more efficient system 4,11,30,32 .…”

“…Patient safety has been a recurrent subject of discussion 1-9 , especially after institution of the National Patient Safety Program (Programa Nacional de Segurança do Paciente, PNSP) by Ordinance No. 529/2013 10 , which encompasses pharmacovigilance and the practice of reporting adverse events as measures that certify safety of the health system users, competencies and knowledge desired in the training of future professionals in the area 5,9,11 . It is to be noted that quality of the service, as well as patient safety, is responsibility of all professionals with whom patients come into contact 12 .…”