Pharmacovigilance of the Covid19 therapeutic protocol: Experience of the Hassan II University Hospital of Fez, Morocco and analysis of national and international data

Abstract

Faced with the pandemic related to the dissemination of the new Coronavirus and the health emergency, Morocco decided to treat patients with Covid-19 with Hydroxychloroquine (HCQ) or Chloroquine (CQ), associated with Azithromycin (AZM) according to a standardized therapeutic scheme, an off-label indication that required pharmacovigilance monitoring to ensure the safety of treated patients. Objective. To present the experience of the Hassan II University Hospital of Fez concerning the management of adverse events of the Covid19 therapeutic protocol. A notification form was made available to the nursing staff to be filled in for any adverse reaction (ADR) observed after the treatment was taken. A daily collection and in-depth analysis was performed. We present the results of the analysis of the data collected in our training between April 21 and August 22, 2020, discussing them with data from national and international databases. 102 ADR cases were collected out of 915 patients hospitalized at the UHC for Covid19 during this period with a prevalence of 11%. 23 patients had underlying defects. The incriminating protocol contained CQ in 55.8% and HCQ in 44.2%. The mean age of the patients was 40.83±17.1 years (18 to 86 years) with a M/F sex ratio of 0.92. The mean time to onset was 3 days (range 1-6 days). The most noted ADRs were digestive, cardiac and neurological. 14 cases were severe (one QT prolongation), 6 of which required transfer to an intensive care unit. The course of action adopted was the restoration of corrective treatment with 12 cases of treatment discontinuation and 8 cases of switching to 2nd line treatment.