Assessment of Microbial Contamination in Over-the-Counter (OTC) Drugs: A Review
Adebayo Kabirat Adedoyin
*
Department of Microbiology, Faculty of Biological sciences, Imo State University, Nigeria.
Taiwo Bakare-Abidola
Department of Environmental Science, Georgia Southern University, USA.
Esther Chigbaziru Nwojiji
Department of Microbiology and Parasitology of David Umahi Federal University of Health Sciences Uburu Ebonyi State, Nigeria.
Iyiola Aanuoluwa Temitayo
Department of Biochemistry, Federal University of Technology, Minna, Nigeria.
Iyiola Emmanuel Bukola
Department of Microbiology, University of Ilorin, Nigeria.
*Author to whom correspondence should be addressed.
Abstract
This review aims to assess the extent of microbial contamination in over-the-counter (OTC) drugs, highlighting the importance of quality control in the pharmaceutical industry. Microbial contamination in OTC drugs poses significant risks to public health, particularly as these products are widely available for self-administration without healthcare supervision. It explores the common sources of contamination, including manufacturing practices, storage conditions, and packaging materials. The review further examines regulatory guidelines from organizations such as the WHO, USP, and BP, which set acceptable microbial limits for pharmaceuticals. A comprehensive search was conducted across multiple databases, including PubMed, Google Scholar, ScienceDirect, and JSTOR. Various microbial testing methods, including traditional techniques such as Total Viable Count (TVC) and newer rapid testing methods, are discussed as tools for ensuring the microbiological safety of OTC products. Additionally, the review addresses case studies of contaminated OTC drugs, identifying factors contributing to contamination and their public health impact. Finally, emerging technologies and strategies for minimizing microbial contamination are explored, with a focus on advancements in filtration, nanotechnology, and regulatory enforcement. The review concludes by emphasizing the need for stringent quality control measures, robust microbial testing, and continued innovation to safeguard public health and improve the safety of OTC drugs.
Keywords: Microbial contamination, over-the-counter drugs, quality control, pharmaceutical safety, microbial testing, Good Manufacturing Practices (GMP), OTC drug contamination