Enhance in the Incidence of Side Effects Reported to a New Regional Pharmacovigilance Center in Morocco, Between 2020 and 2021

Background/Introduction: Since the creation of the regional pharmacovigilance center within the IbnSina University Hospital Center (UHC), a pharmacist has been dedicated to this activity, responsible for establishing work procedures, calculating accountability and redaction responses to the notifiers. Thus, the collaboration between the medical services and this regional center to improve the pharmacovigilance system within the UHC. This resulted in an increase in notifications qualitatively and quantitatively Objective/Aim: Study the impact of setting up a regional center in the UHC, by comparing the incidence of skin adverse reaction notifications between 2020 and 2021. Methods: A retrospective analysis was performed for the clinical presentation, imputability (French method), severity, evolution, skin adverse reactions reported to the regional center between January 2020 and mid-June 2021. Results: During the study period, 23 cases were skin adverse reactions (50 and 75% of notifications, in 2020 and 2021 respectively). Using the Medical Dictionary for Regulated Activities (MedDRA) to present the results, up to June 16, 2021, 12 cases were notified, while in the whole of 2020 only 11 cases were notified. There is an increase of 109.09% in just 6 months. The most frequent clinical presentation was, during 2020 and 2021 respectively, maculopapular rash (rash and exanthema) (90.9%, 75%) followed by pruritus (9.1%), (8.33%) and only in 2021 maculopapular lesions (16.66%), with a female preponderance (54.54%) in 2020 and (58.33%) in 2021. The time to onset between skin side effects and drug treatment has revealed that they can develop within a few hours to 14 days in 2020 and up to 9 months of treatment in 2021. The groups of causal drugs common to 2020 and 2021, respectively, were antimicrobials (45.45-25%), uricemic agents (27.27-8.3%), antiepileptics (9-25%), antineoplastics (9-8.3%). In addition, nitrated vasodilators (9%) in 2020 and in 2021, 4-aminoquinolines (8.3%), antidiarrheals (8.3%). The majority of drugs in 2020 and 2021 respectively were administered orally (54.54%), (66.66%), followed by injectables (18.18%), (33.33%), in 2020 (9%) by transdermal route. Polypharmacy was observed in (54.54%) of cases in 2020 versus (83.33%) in 2021, with up to 7 drugs per patient. The imputability (score of I0 to I6), for the majority of skin adverse reactions, was greater than I4, sometimes attainment I6. Conclusion: The occurrence of skin side effects increas