Risk of Infection from Application of Two Types of Pharmaceutical Creams
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.
References
Ashour, M. S., Mansy, M. S., &Eissa, M. E. (2011). Microbiologicalenvironmental monitoring in pharmaceuticalfacility. Egypt Acad J Biolog Sci, 3(1), 63-74.
Clontz, L. (2009). Microbial limit and bioburden tests (1st ed.). Boca Raton: CRC Taylor & Francis.
Denyer, S. &Baird, R. (2007). Guide to microbiologicalcontrol in pharmaceuticals and medicaldevices (1st ed.). BocaRaton, Fla.: CRC Press.
Eissa, M. (2016). QuantitativeMicrobial Risk AssessmentofPharmaceuticalProducts. PDA JournalOfPharmaceutical Science And Technology. http://dx.doi.org/10.5731/pdajpst.2016.007047
Elder, D.P. &Crowley, P. (2012). AntimicrobialPreservatives Part One: Choosing a Preservative System. Americanpharmaceuticalreview.com. Retrieved 23 February 2017, fromhttp://www.americanpharmaceuticalreview.com/Featured-Articles/38886-Antimicrobial-Preservatives-Part-One-Choosing-a-Preservative-System/
Hazlett, L., Rosen, D., &Berk, R. (1978). MurineCorneal Response to Heat-InactivatedPseudomonasaeruginosa. OphthalmicResearch, 10(2), 73-81. http://dx.doi.org/10.1159/000264939
Kampf, G. &Kramer, A. (2004). Epidemiologic Background of Hand Hygiene and Evaluationofthe Most ImportantAgentsforScrubs and Rubs. ClinicalMicrobiologyReviews, 17(4), 863-893. http://dx.doi.org/10.1128/cmr.17.4.863-893.2004
Kowalski, W. (2012). HospitalAirborneInfectionControl CRC Press. BocaRaton.
Lawin-Brussel, C., Refojo, M., Leong, F., Hanninen, L., &Kenyon, K. (1993). EffectofPseudomonasaeruginosaConcentration in ExperimentalContactLens--RelatedMicrobial Keratitis. Cornea, 12(1), 10-18. http://dx.doi.org/10.1097/00003226-199301000-00003
Leggett, H., Cornwallis, C., &West, S. (2012). MechanismsofPathogenesis, Infective Dose and Virulence in HumanParasites. Plos Pathogens, 8(2), e1002512. http://dx.doi.org/10.1371/journal.ppat.1002512
Rose, J. & Haas, C. (1999). A risk assessment framework for the evaluation of skin infections and the potential impact of antibacterial soap washing. American Journal Of Infection Control, 27(6), S26-S33. http://dx.doi.org/10.1016/s0196-6553(99)70039-8
Todar, K. (2017). The Normal Bacterial Flora of Humans. Textbookofbacteriology.net. Retrieved 23 February 2017, from http://textbookofbacteriology.net/normalflora.html
United StatesPharmacopeia (2015a). Preservative challenge test chapter<51>. Thirty-eighthRevision, NationalFormulary, 33th ed. Rockville, MD: The United StatesPharmacopeialConvention Inc.
United StatesPharmacopeia (2015b). Microbiologicalexaminationof non-sterileproducts: microbialenumeration test<61>. Thirty-eighthRevision, NationalFormulary, 33th ed. Rockville, MD: The United StatesPharmacopeialConvention Inc.
United StatesPharmacopeia (2015c). Microbiologicalexaminationof non-sterileproducts: testsforspecifiedmicroorganisms<62>. Thirty-eighthRevision, NationalFormulary, 33th ed. Rockville, MD: The United StatesPharmacopeialConvention Inc.
Copyright information
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License (Creative Commons Attribution License 3.0 - CC BY 3.0) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
info@cbuni.cz, www.cbuni.cz, ojs.journals.cz