In our days, tuberculosis, whet ever its localization, became a curable disease. The cornerstone is a 6 month course of isoniazid, rifampicine and pyrazinamide. All of the three first line antituberculosis drugs may induce hepatic damage which may have negative consequences for treatment outcome. Several risk factors were associated with the development of antituberculosis- drug-induced hepatotoxicity (ATDH). A retrospective study was conducted from July 2014 to March 2015 regarding all therapeutic drug-monitoring requests sent to the Laboratory of Poison Control and Pharmacovigilance Centre of Morocco. 142 patients diagnosed with active tuberculosis were included in study. Plasma peak levels of isoniazid, rifampicin and pyrazinamide were analyzed in plasma samples after 2 to 3 hours of administration of anti-tuberculosis treatment. Logistic regression was used to identify the ATDH risk factors. The incidence of ATDH was found 24.6% (35 patients out of 142). Intergroup differences in the plasma levels were statistically significant for isoniazid (p=0.036). ATDH was found to be associated with combined form of anti-TB drugs (p=0.002, COR=13.1, AOR= 13.5) and plasma concentration of INH superior to 2mg/l (p=0.045, COR=1.3, AOR= 1.4).age, gender, alcohol intake and smoking status were not significantly associated with ATDH. The finding of 24.6% incidence of hepatotoxicity is extremely high. Many factors can be associated with the development of ATDH such as genetic factors, combined forms of treatment and plasma peak levels.

Objective: High concentrations of antituberculosis (anti-TB) drugs can be associated with many adverse drug reactions (ADRs). The objective of this study was to examine the plasma concentrations of rifampicin (RMP) and isoniazid (INH) in patients with and without ADRs. Methods: Concentration monitoring data of patients treated with anti-TB drugs were retrospectively analyzed from 2009 to 2011. RMP and INH plasma concentrations were measured 2 and 3 h after drug administration respectively using high-performance liquid chromatography. Results: A total of 54 out of 120 patients have experienced ADRs to anti-TB drugs. The median concentrations [interquartile range (IQR)] obtained in patients with and without ADRs were 6.7 mg/l (3.7–9.9) and 5.6 mg/l (2.9–8.6) (p = 0.56) for RMP and 4.3 mg/l (2.3–5.3) and 3.1 mg/l (1.7–4.8) (p = 0.04) for INH, respectively. Related median doses (IQR) were 8.7 mg/kg (8.0–10.0) and 8.6 mg/kg (6.5–9.9) (p = 0.42) for RMP and 4.8 mg/kg (4.3–5.0) and 4.0 mg/kg (2.8–5) (p < 0.01) for INH, respectively. Concentrations above the expected range in patients with and without ADRs were not reached for RMP, but were 76% and 65% for INH, respectively. Correlation between concentrations and doses has not been established for RMP or INH. In addition, high INH concentrations showed no association with sex, age, liver injury or renal or diabetes. Conclusions: High INH concentrations were common in patients with and without ADRs whereas RMP concentrations were low or within the normal range in most patients. Further studies are required to assess the association between high INH concentrations and the occurrence of ADRs.

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.

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.

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IntroductionLe suivi thérapeutique pharmacologique (STP) des médicaments antiépileptiques (MAE) est un outil très utilisé dans la gestion de l'épilepsie. Au Maroc, ce dosage est réalisé au Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM) depuis Avril 1995.MéthodesIl s'agit d'une étude rétrospective s'étalant sur 20 ans. Elle concerne le STP du Phénobarbital (PB), de la Carbamazépine (CBZ) et de l'Acide Valproique (AVP).RésultatsLe STP des 3 MAE représentaient 58,85% de l'ensemble des demandes de STP reçue par le CAPM. Le dosage du PB était classé en première position suivi par celui de la CBZ et enfin par l'AVP. La faible demande de STP au Maroc pouvait être expliquée par le faible nombre de neurologues auquel s'ajoutaient des facteurs sociaux. Grâce à son prix très accessible par les patients, le PB est le MAE le plus prescrit dans notre pays expliquant ainsi la demande élevée de son dosage. Quant aux motifs de STP des 3 MAE, ils étaient essentiellement liés à l'âge, à l'apparition d'effets indésirables, à l'association de MAE ou dans le cas de vérification de l'observance des malades.ConclusionDes efforts sont à fournir pour promouvoir l'intérêt du STP des MAE dans la prise en charge de l'épilepsie au Maroc.

To date, the occurrence of adverse events following immunization after COVID-19 vaccine is rare, and their report is still very poor; however, causality assessment is conducted to identify the associated cause, if they occur. In this case report, we present a case of an association of three cutaneous manifestations (maculopapular exanthem with enanthem, site injection reaction, and rosacea exacerbation) occurring three days after taking the first dose of AstraZeneca AZD1222 vaccine.

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