Abstract
Introduction: Infection risk from the misuse of multi-dose medicinal products is a seriousproblem which affects final consumer health and may impact on thereputation of pharmaceutical companies adversely.Objectives:The current study aimed to trace the most important contributing factors in the infection transfer through the application of two selected types of medicinal topical creamsfor the treatment of skin disease conditions.Methods: One type of the product that was subjected to the present study is anti-psoriatic while the other is steroidal anti-inflammatory antimicrobial creams that were packed in Aluminum tubes with orifice diameter of 0.173 cm2, approximately. The simulation study – conducted on these topical creams - integrated preservative efficacy test (PET) with dose-response model of infection to demonstrate the probability of infection that could occur due to unintentional transmission of pathogenic bacteria to damaged or injured skin of the patient.Results:The studied model showed that although both products possessed antimicrobial power activity against standard strain microorganisms, yet the critical factor is the hygienic control of hands and fingers during application of the cream on the affected area.Conclusion:The medicinal products itself were little affected by microbial contamination when they were enclosed in their primary packaging materials as was observed by the in-use study. However, the most important part was that portion of the product that was transferred to the patient skin. From the simulation study, it was expected that the situation could be aggravated if the hyiegenic practice was underestimated by hospital staff.
Highlights
Infection risk from the misuse of multi-dose medicinal products is a serious problem which affects final consumer health and may impact on the reputation of pharmaceutical companies adversely
It was expected that the situation could be aggravated if the hygienic practice was underestimated with hospital staffs
Pharmacopeial guidelines are clear in stressing in microbiological testing of total aerobic microbial count (TAMC) and total yeast mold count (TYMC), and both Staphylococcus aureus and P. aeruginosa should be strictly absent from the topical cream products
Summary
Infection risk from the misuse of multi-dose medicinal products is a serious problem which affects final consumer health and may impact on the reputation of pharmaceutical companies adversely. Multi-dose packaged products, especially those utilized by more than one individual, are liable to microbial intrusion, in the healthcare centers, and there are reports of disease episodes from the use of such items. Pseudomonas aeruginosa is considered one of the most problematic nosocomial pathogen due to its ability to disseminate through medicinal products, even those with antimicrobial properties (Denyer and Baird, 2007). Pharmacopeial guidelines are clear in stressing in microbiological testing of total aerobic microbial count (TAMC) and total yeast mold count (TYMC), and both Staphylococcus aureus and P. aeruginosa should be strictly absent from the topical cream products. Topical creams possess high water activity (aw) of value about 0.97 which may encourage their spoilage if they were not well preserved (Clontz, 2009)
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