Medication errors safety signals COVID-19-related Moroccan Pv database

Abstract

On March 23, 2020, the Moroccan Ministry of Health issued a circular authorizing the off label use of hydroxychloroquine or chloroquine in combination with azythromycin as first-line treatment for all COVID-19 patients. The aim of this study is to detect, assess and manage safety signals from individual cardiovascular adverse events (AE) reported. Methods: During the COVID19 pandemic, pharmacovigilance surveillance was based on spontaneous targeted notification in all health facilities. Newsletters with a suitable reporting form were sent and reporting of AEs was mandatory. The AEs collected were analyzed for causality assessment using the WHO method and the Preventavility method was used to detect any preventable ADR. Safety signals were detected and analyzed using a qualitative pharmacovigilance method. Results: As of December 31, 2020, a total of 527 adverse events have been reported to the NPC related to Hydroxychloroquine or Chloroquine among the Covid 19 patients. We received 09 cases of preventable AEs related to medication error including one drug interaction for 3 cases, dose errors for 5 cases and one case with both errors, these cases have been validated ad managed as safety signals. Discussion and conclusion: The detected signal concerned the QT prolongation, hypokalaemia and arrythmias, due to high dose of azithromycin and to drug interactions with hypokalaemic drugs. The signal was analyzed and validated during the technical committee, and recommendations were established to avoid the occurrence of similar cases.