Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey

PLoS Negl Trop Dis. 2014 Dec 4;8(12):e3345. doi: 10.1371/journal.pntd.0003345. eCollection 2014 Dec.

Abstract

Background: The presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia.

Methods/principal findings: A multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality.

Conclusions/significance: This study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Albendazole / standards
  • Animals
  • Anthelmintics / pharmacology
  • Anthelmintics / standards*
  • Ethiopia / epidemiology
  • Giardiasis / drug therapy*
  • Helminthiasis / drug therapy*
  • Humans
  • Mebendazole / standards
  • Prevalence
  • Soil / parasitology*
  • Surveys and Questionnaires
  • Tinidazole / standards

Substances

  • Anthelmintics
  • Soil
  • Tinidazole
  • Mebendazole
  • Albendazole

Grant support

This study was supported by Jimma University (http://www.ju.edu.et). SS and ZM are supported by the Infectious Diseases and Epidemiology Project within Institutional University Cooperation Programme (Jimma University) of VLIR (http://www.iucju.ugent.be). BL is a postdoctoral fellow of FWO (Grant number FWO12/PDO/099). MD is supported by the Institute for the Promotion of Innovation through Science and Technology in Flanders (IWT-Vlaanderen) (No. 101529) while EW is supported by the Special Research Fund of Ghent University (Grant number BOF 01J22510). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.