Academic journal article American Journal of Pharmaceutical Education

Parenterals Laboratory Course to Reduce Microbial Contamination Rates in Media Fill Tests Performed by Pharmacy Students

Academic journal article American Journal of Pharmaceutical Education

Parenterals Laboratory Course to Reduce Microbial Contamination Rates in Media Fill Tests Performed by Pharmacy Students

Article excerpt

Objectives. To evaluate microbial contamination rates of low- and medium-risk level media fill tests performed by pharmacy students near the beginning and end of a parenterals laboratory course in the second- professional year of a doctor of pharmacy (PharmD) program.

Methods. Students enrolled in a required parenterals laboratory class (N = 84) participated in this study. The aseptic technique procedures performed at the beginning of the course were identical to the procedures performed at the end of the course and included 3 low-risk level media-fill tests and a medium-risk level media-fill test. Single-strength trypticase-soy broth (TSB) was substituted for the drug and was used to detect microbial contamination for all manipulations.

Results. The baseline and end-of-course contamination rate was 21 of 504 syringes and 0 of 498 syringes, respectively (p < 0.001). Eighteen of 84 students at baseline and 0 of 83 students near the end of the course produced one or more contaminated syringes (p < 0.001). Of the 21 contaminated syringes at baseline, low-risk manipulations accounted for 14 and medium-risk manipulations accounted for 7. Of the low-risk procedures, the ampule produced the highest contamination rate (11 syringes), followed by the vial (2 syringes) and the reconstitution (1 syringe).

Conclusions. This study demonstrated a decreased rate of microbial contamination during the manipulation of parenteral products and a corresponding improvement in aseptic technique skills among pharmacy students enrolled in a parenterals laboratory course. The most sensitive tests for poor aseptic technique and bacterial contamination were medium-risk manipulations and low-risk manipulations involving an ampule.

Keywords: media fill tests, microbial contamination, USP Chapter 797, sterile products, aseptic technique, parenteral products

INTRODUCTION

The Parenterals Laboratory course teaching team at the Texas Tech University Health Sciences Center (TTUHSC) School of Pharmacy proposed a residency project designed to foster a data-driven assessment of the aseptic technique skills of second-professional year pharmacy students performing low- and medium-risk media-fill tests near the beginning and end of the parenterals course.

The importance of proper aseptic technique while manipulating parenteral products has been demonstrated in multiple studies conducted in the practice setting. (2-4) In one such study, contamination rates were compared between pharmacists and technicians. Each investigator prepared medium-risk intravenous (IV) admixtures according to United States Pharmacopeia (USP) chapter 797 guidelines in both a traditional practice site and a class 1000 cleanroom. TSB was substituted for the drug and the diluent and was used to detect contamination. Contamination rates did not significantly differ between the cleanroom and the traditional practice site (p = 1.0). There was, however, a significant difference in contamination rates, with pharmacists performing better than technician (p = 0.012). This emphasizes that the most important variable affecting contamination rates of sterile preparations was the aseptic technique of the investigator rather than the environment. (2)

A second study looked at bacterial contamination rates of an infusate in a simulation model of syringes prepared for continuous intravenous administration by nurses in the intensive care unit (ICU) compared with syringes prepared by pharmacy technicians working under standard aseptic conditions. (3) A difference in the rate of contamination was detected between syringes prepared from vials and syringes prepared from ampules, and in the rate of contamination between syringes prepared from ampules by ICU nurses and those prepared by pharmacy technicians (p < 0.001 for each, respectively). The syringes prepared from ampules by the ICU nurses had a median contamination rate of 22% while those prepared by pharmacy technicians had a median contamination rate of only 1%. …

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