adverse drug reaction

Abstract Introduction: Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries.

Abstract Purpose: Active surveillance pharmacovigilance systems better estimate the burden of adverse events (AEs) and can generate useful information on risk factors of AEs for more effective medicine use, especially in conjunction with introduction of new medicines and/or changes in treatment guidelines.

The objective of this study was to assess the prevalence, profile and outcome of adverse events (AEs) associated with treatment of drug-resistant tuberculosis (DR-TB) and explore possible influences of HIV disease on the occurrence of adverse events. Data were collected from treatment records of all patients treated for DR-TB at the study facility between January 2008 and February 2010. A total of 141 adverse events of varying severity were experienced in 90% (53/59) of patients.The TB/HIV co-infection rate was 53%. The prevalence of gastrointestinal tract adverse events was 64%, tinnitus 45%, joint pain 28% and decreased hearing 25%. Abdominal pains, rash, nausea, decreased hearing and joint pain were more common in HIV infected than in HIV uninfected patients.

Sleeping sickness (human African trypanosomiasis [HAT]) is a neglected tropical disease with limited treatment options that currently require parenteral administration. In previous studies, orally administered pafuramidine was well tolerated in healthy patients (for up to 21 days) and stage 1 HAT patients (for up to 10 days), and demonstrated efficacy comparable to pentamidine. This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. The overall cure rate at 12 months was 89% in the pafuramidine group and 95% in the pentamidine group; pafuramidine was non-inferior to pentamidine as the upper bound of the 95% confidence interval did not exceed 15%. The safety profile of pafuramidine was superior to pentamidine; however, 3 patients in the pafuramidine group had glomerulonephritis or nephropathy approximately 8 weeks post-treatment. Two of these events were judged as possibly related to pafuramidine. Despite good tolerability observed in preceding studies, the development program for pafuramidine was discontinued due to delayed post-treatment toxicity.

The aim of this study was to assess the incidence and nature of adverse drug events (ADEs) in hospitalized children at a teaching hospital in Ethiopia. We studied 600 children hospitalized at Jimma University Specialized Hospital between 1 February and 1 May 2011. Fifty-eight ADEs were identified, with an incidence of 9.2 per 100 admissions, 1.7 per 1000 medication doses and 9.4 per 1000 patient-days. One-third of ADEs were preventable; 91% caused temporary harms and 9% resulted in permanent harm/death. A strategy to prevent ADEs, including education of nurses and physicians, is of paramount importance.

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