Detection and characterization of micro-organisms linked to unsealed drugs sold in Ihiagwa community, Owerri, Imo State, Nigeria

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Abstract

The contamination of pharmaceutical products by micro-organisms poses a significant risk to public health. This study was conducted to detect and characterize micro-organisms associated with unsealed drugs sold in Ihiagwa community in Owerri, Imo State, Nigeria. A variety of microbiological techniques were employed to analyse samples from unsealed drug containers. The identification process involved morphological, biochemical and sugar utilization methods, aiding in the accurate determination of microbial species. Microbial contamination was observed in 42 (84 %) out of 50 samples, with contaminants including bacteria and fungi. The range of contamination is between 1.2±0.01×10 3  and 2.3±0.02×10 3  c.f.u. ml −1 for viable count, 0.1±0.02×10 2  and 0.3±0.01×10 2  c.f.u. g −1 for coliform count and 0.2±0.01×10 1  and 0.5±0.01×10 1  c.f.u. g −1 for fungi count. The identified microbes were Staphylococcus aureus , Escherichia coli , Pseudomonas aeruginosa , Candida albicans and Aspergillus niger . The most common bacterial isolate was S. aureus (51.8 %), while C. albicans (73.3 %) was the most prevalent fungus. Among the pharmacies and healthcare facilities examined, the Uchems pharmacy had the highest proportion of bacterial isolates (37 %), followed by the Stepwise pharmacy (22.2 %), while the lowest proportion was found at the Roseline Health Clinic (7.4 %). The identification of potentially harmful micro-organisms in these unsealed drug container samples emphasizes the importance of stringent quality control measures and improved handling, storage and packaging practices to ensure product safety and efficacy, especially among pharmacetical dealers.

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  1. Editor's Comments to Author Thank you for addressing the raised concerns by the reviewers and myself. I just have two minor things to correct- there seems to be a typo n l268 severed where I think you mean served? And in l 286 "hand-cloves" do you gloves?

  2. You will need to provide more details in the method section as specified in detail by the reviewers, such as giving more details regarding the samples you analysed and also describe in more detail what aseptic sample collection entailed (how exactly was this done). How many different pharmacies/health care facilities were analysed, how many samples were taken per site and per container, etc. ? What are the exact steps for the identification of the isolates obtained? In the methods it is only described very vaguely. More detail is required here. Is contamination a problem in all sites/samples? Is there a certain pattern observable? Do all sites handle their drug containers the same way? What are the guidelines/rules, are these being followed? Table 2 it says yeasts, but later you also say you found an Aspergillus, which is not a yeast, please correct this. Could you be more specific in the quality control measures, do any of these exist? Are there national/local guidelines that need to be adhered to? The manuscript shows some redundancies that need to be addressed as detailed by the reviewer.

  3. Comments to Author

    Dear Author The Manuscript Title: Detection and Characterization of Microorganisms Linked to Unsealed drugs Sold in Ihiagwa Community, Owerri, Imo State, is a well written piece on this important topic of contamination of unsealed drugs especially in communities of low economical power. Although the situation is very obvious as in other adjacent areas but definitely needs to be brought into highlight. Having mentioned that , i would like to comment that the content of the manuscript is not new nor it is able to enhance our current knowledge of the situation. The quality of the material and methods is quite out dated and poorly defined. Please note the following 1. There is a bit of repetitive comments in line 51-52, 89-90. 2. Material : Nothing has been mentioned about if the drugs came in sealed packs and were opened up later at the facility for storage or they were received in the same unsealed conditions. The conditions of storage and processing is not defined. 3. Line no 133-134 : seems incomplete with missing information : and 0.2 x10 ......of what count ?? 4. Line 141 : Microorganisms isolated from lower leg ulcer patients ? seems copy paste error. 5. Line 197 : most commonly isolated organisms from this study included bacteria and fungi : have you tested for any other organisms like viruses / parasites ? 6. 205 : please italicize all the names of microorganisms 7. Discussion part : Is there any routine screening / environmental or personal in place for the drug storage area.? Any hand hygiene Audit for the staff ? 8. It will be valuable information to see what kind of patients were being severed from these dispensaries. Were there any issues reported previously ? 9. There is no mention about the economic restrains which is the biggest setback leading to these sort of scenarios.

    Please rate the manuscript for methodological rigour

    Poor

    Please rate the quality of the presentation and structure of the manuscript

    Satisfactory

    To what extent are the conclusions supported by the data?

    Strongly support

    Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?

    No

    Is there a potential financial or other conflict of interest between yourself and the author(s)?

    No

    If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?

    Yes

  4. Comments to Author

    Dear author I am writing to you about your paper (Detection and Characterization of Microorganisms Linked to Unsealed drugs Sold in Ihiagwa Community, Owerri, Imo State) I have some questions and notes that need your explanations. 1- Line 26-27 (The range of contamination is between 1.2 × 103 to 2.3 × 103 cfu/ml for viable count, 0.1 × 102 to 0.3 × 102 cfu/g for coliform count and 0.2 × 101 to 0.5 × 101 cfu/g), what did you mean by the last range? It is not clear for me as first range was about viable count and the second was for coliforms. 2- Line 102 (Samples were collected from unsealed drug containers) please explain what type of container, is it container for pills, capsule or syrup? You also must know the pharmaceutical company name and origin beside the vendor of each drug to trace the source of contamination. 3- Line 110-112 (Eswab samples were vortexed, and 90 μL of eluate was used for culture inoculation per plate/test condition (Sukhum et al., 2022). About 100 μL of the 
vortexed sample was used for culturing), how can you do 8 culture plates, for each 
you used 90 μL, however you mention only 100 μL use for culture? 4- Line 136 (A total of 50 unsealed drug samples comprising of paracetamol, chloroquine) 
it is not clear did you take drug samples or drug container sample sawabs? 5- Line 141(from lower leg ulcer patients are represented in Tables) what do you mean? Your sample from drug containers or patients? 6- Please revise your references and make sure that its suitable to the idea you discussed 


    Please rate the manuscript for methodological rigour

    Poor

    Please rate the quality of the presentation and structure of the manuscript

    Poor

    To what extent are the conclusions supported by the data?

    Partially support

    Do you have any concerns of possible image manipulation, plagiarism or any other unethical practices?

    No

    Is there a potential financial or other conflict of interest between yourself and the author(s)?

    No

    If this manuscript involves human and/or animal work, have the subjects been treated in an ethical manner and the authors complied with the appropriate guidelines?

    Yes