Abstract:
Purpose: Contamination of pharmaceuticals with microorganisms irrespective whether they
are harmful or nonpathogenic can bring about changes in physicochemical characteristics of
the medicines. Although sterility is not a requirement in official compendia for nonsterile pharmaceuticals,
bioburdens need to be within acceptable limits. Therefore, this study investigated
microbial contamination of 10 nonsterile pharmaceuticals frequently delivered to outpatients
by identifying and quantifying microbial contaminants and susceptibility pattern testing on the
microbes isolated.
Methods: The study was carried out at Amana Municipal Hospital in Dar es Salaam, Tanzania.
The protocol for the study involved structured selection of representative tablets, syrups, and
capsules from the hospital’s outpatient pharmacy. Constitutive microorganisms were elaborated
and enumerated using standard microbiologic procedures.
Results: Results showed that 50% of all tested products were heavily contaminated, and the
predominant contaminants comprised Klebsiella, Bacillus, and Candida species. Furthermore,
the results showed that the isolated Bacillus and Klebsiella species were resistant to Augmentin
®
and cloxacillin. The differences in means for cfu/mL and zones of inhibition among the microorganisms
isolated were considered significant at P , 0.05.
Conclusion: The nonsterile pharmaceuticals were presumably microbiologically contaminated
due to poor handling during dispensing, repackaging, and/or nonadherence to good manufacturing
practice. Therefore, training and educating the dispensers, as well as patients, on the proper
handling and use of medicines cannot be overemphasized, because these are key aspects in
controlling cross-contamination of medicines.