PHARMACOVIGILANCE NOTIFICATIONS: INCONSISTENCIES IN THE SEARCH FOR INFORMATION

Introduction: Cancer treatment uses drugs that potentially induce, in certain circumstances, adverse events which are mostly predictable and minimized with the use of supportive drugs. ANVISA provides a notification panel on its website referring to suspected cases of adverse events caused by drugs Purpose The research aims at analyzing the notifications regarding drugs with onco-hematological indications present in ANVISA’s panel of pharmacovigilance notifications. Methodology: The work is classified as an observational study carried out between 2020 and 2022. The data were obtained from ANVISA’s website. Results: 211,190 notifications were identified. Of this total, 26,703 (11.22%) were related to drugs with onco-hematological indication, 9,725 (36.42%) had described batches and 16,978 (63.58%) had not. Of the notifications that were carried out with the completion of all the necessary information, only 82 (0.32%) were listed, of which 51 (62.19%) are of drugs for exclusive use in health services and 31 (38.81%) were oral medications. The panel presents Paclitaxel as the drug with the highest number of oncological indications, with 2,591 (9.70%) notifications, however, observing the 82 notifications, Paclitaxel had only 2 (2.44%) notifications. In this context, Ribociclib is the drug with the highest number of suspected cases, totaling 18 (21.95%) occurrences. Conclusion: ANVISA itself informs on its website that there is a lack of information in the panel as it does not control how the notifier feeds the notification form. Therefore, the present work brings an alert to the professionals who make the notifications to make it a more effective tool in terms of pharmacovigilance.