LES RÉACTIONS LOCALES LIÉES AU VACCIN BCG

To evaluate the frequency and severity of associated local reactions to BCG a retrospective study was conducted on the notified in Moroccan Centre Anti Poison and Pharmacovigilance. During this period, 295 cases have been reported following vaccination with BCG local natureMales were the most concerned with 57%. Infants are much more represented (61%) than other age groups. The most local reactions are observed: becegites (37%), abscesses (20%), rash (16%), ulcers (15%), and fistula (12%). Accompanying signs of these local reactions are usually represented by a fever (6%) and lymphadenopathy (2%). BCG was injected intradermally in 87% of cases, followed by the intramuscular route (8%) and the subcutaneous route in 5% of cases. According to the classification of severity of the WHO ART, these reactions were severe in 18% of cases, moderate in 69% and severe in 14% of cases. The relation of cause and effect between BCG vaccination and the occurrence of local reactions is well established with 46% of probable cases and 7% of cases while some is possible in 46%, and excluded in 1%. The outcome was favorable in 85%, 14% recovered with sequelae and 1% was fatal

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

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

Lessons learned from a cluster of immunization errors in newborns

Background: Vaccines are safe and effective, but adverse reactions can occur. Immunization errors (IEs) are one of the types of adverse events following immunization. The Moroccan Pharmacovigilance Centre (MPC) received a cluster of IEs from a maternity university hospital (MUH) regarding six newborns who were inadvertently administered rocuronium instead of hepatitis B (HepB) vaccine. The newborns experienced respiratory distress and one had a fatal outcome. Objectives: The study aimed to describe the investigation findings, the underlying causes, and contributing factors of the IEs cluster, and proposed risk minimization actions. Design: We carried out a descriptive analysis of the cluster of IEs related to the HepB vaccine reported to the MPC. Methods: An investigation was conducted by the Ministry of Health according to the World Health Organization guidance. The root cause analysis was performed to identify underlying causes and contributing factors that lead to IE occurrence. Results: The cluster analysis showed that the main contributing factors were the look-alike rocuronium and HepB vaccine packaging, the first-time running HepB vaccination for newborns in the MUH, the lack of a full-time pharmacist, and the unsafe storage of rocuronium and vaccines. The administration of Sugammadex to the newborns followed by their transfer to the neonatal care unit resulted in the recovery of five of the six newborns. Proposed recommendations included (1) raising awareness of healthcare professionals to the risk related to look-alike medications, (2) training nurses to ensure vaccination to implement procedures related to immunization practices, (3) nomination of a full-time pharmacist, (4) reassessment of the safety of drug storage and dispensing at the hospital pharmacy, particularly for high-alert medications. Conclusion: Reporting IEs, particularly serious ones, allows us to identify causes and contributing factors that led to their occurrence. Lessons learned from errors are key to take risk minimization actions to improve vaccine safety worldwide

Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

). The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month ( < 10 −3 ). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period ( = 10 −4 ), and 40.9% of cases in the first period were serious against 15.8% in second period ( = 0.003). Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs

Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010–October 2012; period 2: October 2012–December 2013). The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P<10-3). The average age was 40.7±17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (P=10-4), and 40.9% of cases in the first period were serious against 15.8% in second period (P=0.003). Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs