Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

Abstract EN

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.