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.
Highlights
The use of medicines is an important aspect of many public health programmes (PHPs) that are designed to improve the health of a target population
The objective of this work is to demonstrate the various steps of successful model of integrating PV in Moroccan Tuberculosis Control Program (PV-MTCP)
Republic of Korea and India have the highest rate of notifications (4650 and 2960 ADRs, resp.) due to their high incidence (100-300 cases/105 inhabitants), Table 1.This increase of ADRs in period 2 was due to the effective integration of PV in the MTCP with awareness of the majority of anti-TB prescribers and involvement for spontaneous reporting of TB ADRs and feedback with practical procedures of ADRs management are regularly sent to anti-TB prescribers to motivate them to reporting ADRs
Summary
The use of medicines is an important aspect of many public health programmes (PHPs) that are designed to improve the health of a target population. Their cost to the health budget is between 6% in developed countries and 45% in some developing countries, but there are huge variations between both developed countries and developing countries [1]. Pharmacoeconomic studies on the costs of ADRs suggest that governments pay considerable amounts from their health budgets towards covering the costs associated with them. In a meta-analysis of 39 prospective studies from hospitals in the United States, it was shown that ADRs ranked from the fourth to sixth leading cause of death [2]
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