Abstract:
Background: Sub-standard and counterfeit drug product use is serious public health issue in
developing countries like Ethiopia. Assuring access to quality, safe and effective drugs for the
public is great assignment for a regulatory body and related organization for effective health care
service and to prevents drug resistance and other problems related to substandard and falsified
drugs. The status of problems with the quality of medicines in Ethiopia where regulatory and
legal oversight are weak not clearly identified and quantified. A study of post market medicine
quality test results gives the level of post market medicine quality in the country.
Objective: To conduct a review on the quality data of post marketing surveillance of drug
products quality test reports in Ethiopian Food and Medicine Authority quality testing laboratory
starting from 2015 -2019 with respect to quality and safety of drug products imported,
manufactured and distributed to private and government health institutions in Ethiopia.
Methods: A retrospective data analysis of post market drug product quality test results that
tested by Ethiopian Food and Drug Authority Medicine Quality Testing Laboratory starting from
2015 to 2019 was conducted. Post market medicine quality test results for a total of 2093 drug
product samples were collected from quality assurance department archive and then quality test
parameter results were analyzed with respect study objective using Microsoft excel and version
20 SPSS software.
Results and conclusion: A total of 2093 medicine quality test results starting from 2015 till
2019 were analyzed. From these total post market quality test results, 95.5% of drug product
samples were meet required quality specification requirements but 4.5% of drug products were
not meet the required quality specification requirements. Ethiopia has less prevalence of
counterfeit and substandard drug substances from some other African and Asian countries and
the good thing is 0% of counterfeit drugs reported in the study.
......................................... Thesis available at ACIPH Library