National strategy for the integration of pharmacovigilance in the Moroccan TB Control Program.

Autor: Tanani DS; Department of Pharmacology, Faculty of Medicine and Pharmacy, University of Abdelmalek Essaadi Tanger 90100, Morocco., Serragui S; Department of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy, University of Mohamed V Rabat 10170, Morocco., Hammi S; Department of Pneumology, Faculty of Medicine and Pharmacy, University of Abdelmalek Essaadi Tanger 90100, Morocco., Moussa LA; Moroccan Anti Poison and Pharmacovigilance Center, Rabat 10170, Morocco., Soulaymani A; Laboratory of Genetics and Biometry, University Ibn Tofail, Kenitra 14000, Morocco., Soulaymani R; Moroccan Anti Poison and Pharmacovigilance Center, Rabat 10170, Morocco., Cherrah Y; Department of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy, University of Mohamed V Rabat 10170, Morocco.
Jazyk: angličtina
Zdroj: The Pan African medical journal [Pan Afr Med J] 2017 Jan 31; Vol. 26, pp. 48. Date of Electronic Publication: 2017 Jan 31 (Print Publication: 2017).
DOI: 10.11604/pamj.2017.26.48.7394
Abstrakt: The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). The integration of pharmacovigilance in MTCP was conducted in October 2012with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010-October2012; period 2: October 2012-December 2013). The detection of signals was based on the Information Component available inVigiMine. We used the SPSS version 10.0 and Med Calc version 7.3 for data analysis. 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 ), and40.9% of cases in the first period were serious against 15.8% in second period (P = 0.003). Nine signals were generated (hepaticenzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.
Competing Interests: The authors declare no competing interests.
Databáze: MEDLINE
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