Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Jan 31:26:48.
doi: 10.11604/pamj.2017.26.48.7394. eCollection 2017.

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

Driss Soussi Tanani  1 , Samira Serragui  2 , Sanae Hammi  3 , Latifa Ait Moussa  4 , Abdelmajid Soulaymani  5 , Rachida Soulaymani  4 , Yahia Cherrah  2
Affiliations

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

Driss Soussi Tanani et al. Pan Afr Med J. .

Abstract

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.

Keywords: Pharmacovigilance; adverse drug reactions; antituberculosis drugs.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
National Reporting System of anti-TB ADRs
Figure 2
Figure 2
Comparison of average times to onset of cutaneous, hepatic and neurological ADRs
Figure 3
Figure 3
Management of anti-TB drugs induced hepatotoxicity in Morocco
See this image and copyright information in PMC

References

    1. The safety of medicines in public health programmes:pharmacovigilance an essential tool. WHO; 2006. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharma....
    1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients: a meta-analysis of prospective studies. Journal of the AmericanMedical Association. 1998 Apr 15;279(15):1200–5. - PubMed
    1. Pirmohamed M, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. British Medical Journal. 2004 Jul 3;329(7456):15–9. - PMC - PubMed
    1. Safety monitoring of medicinal products- WHO Guidelines for setting up andrunning a pharmacovigilance centre. Stora Torget 3, Uppsala, Sweden: The Uppsala Monitoring Centre; 2000.
    1. Soussi Tanani D, Tebaa A, Benkirane R, et al. Pharmacovigilance and Moroccan Tuberculosis Public Program:Current Situation. Tuberculosis Research and Treatment. 2014:6 pages. Article ID 626797. - PMC - PubMed

Substances