Pharmacy OneSource Blog

Lessons Learned from Patient Care Studies that Impact Sterile Compounding

Posted on 11/20/15

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The American Journal of Infection Control released two articles of interest in November (officially published in December) that raise important issues for compounding pharmacists. The first article published by David Koenig and colleagues1 studied the efficiency of transfer of Staphylococcus aureus between gloves and non-porous fomites.

An intriguing result from this study was that transfer of S. aureus to gloves was the highest with metal (stainless steel), followed by plastic. While glove to glove transfer occurred, it is less likely to transfer bacteria than metal or plastic. This finding has potential implications for the compounding pharmacist in the primary engineering control who has many opportunities for touch contact with metal surfaces and/or plastics.

It is important to maintain a state of control at all times, even though the gloves worn (and possibly sleeves) are presumed sterile. Any surface or device not adequately disinfected or sterilized found in the primary engineering control (containment hood) or its immediate surroundings in the clean room could serve as a potential reservoir to transfer microorganisms to gloved hands. This transfer could potentially contaminate the sterile compounded preparation if proper aseptic technique is not strictly observed at all times.

The second article from AJIC by Florian Heid and colleagues2 studied the microbial contamination of anesthetic syringes due to different handling practices. With no surprise to anyone, the researchers found that skin contact with the syringes was the major source of the contamination. The overall contamination rate for the three study group of syringes was 21.3%.

Coagulase-negative Staphylococci was the main organism isolated followed by aerobic spore formers. An Aspergillus species was identified in one case. Unfortunately, the impact of complying with hand hygiene protocols or the donning of gloves was not assessed in this study. Therefore it is hard to draw conclusions on this observed contamination of anesthetic syringes to the sterile compounding environment, where proper hand hygiene and the donning of sterile gloves (possibly sterile sleeves), gowns, hair coverings, and masks are utilized while compounding sterile preparations.

For me, the most intriguing data in this study were the different types of drugs and their varied contamination rates. The highest contamination rate occurred with the opioids, sufentanil (38.1%) and piritramid (33.3%), as well as the sedative, propofol (32.4%). Syringes containing the muscle relaxant atracurium showed a lower rate (12.0%). This observation raises an excellent point that organisms demonstrate various growth rates with certain drugs serving as growth medium. These findings are very relevant to the compounding pharmacist, as the difference in contamination rate phenomenon would raise an issue of patient safety if any of these drugs were compounded outside the commercial pharmaceutical industry setting, which must strictly adhere to the FDA Good Manufacturing Practices with direct oversight by the FDA regarding their compliance.

Have you recently evaluated your sterile compounding practices by direct observation in regards to performing proper hand hygiene and donning required personal protective equipment (PPE) in the pharmacy clean room? Direct observation is the best means to assess processes, especially complex tasks with multiple steps.

References:

  1. Transfer efficiency of Staphylococcus aureus between nitrile exam gloves and nonporous fomites, David W. Koenig PhD, Cindy Korir-Morrison PhD, Douglas R. Hoffman MS, AJIC 2015: 1-2
  2. Microbial contamination of anesthetic syringes in relation to different handling habits, Florian Heid MD, PhD, Carolin Bender MD, Hendrik Gervais MD, PhD, Joachim Schmeck MD, PhD, Wolfgang Kohnen PhD, Rüdiger Noppens MD, PhD, AJIC 2015: e1-e3.

 

Topics: Sterile Compounding

About the Author

Keith H. St. John, MT(ASCP), MS, CIC has served as an Infection Preventionist for the past 30 years, including over 17 years of managing Infection Prevention and Control programs and personnel at major tertiary teaching institutions that include pediatric as well as adult hospital settings. Keith is a clinical microbiologist by training and is certified in Infection Control & Epidemiology (CIC). Keith’s rich professional experience includes: Past President of the Certification board of Infection Control & Epidemiology (CBIC); publications in medical and infection control journals; presentation at national and regional conferences; and former faculty associate at Temple Dental and Medical School. Mr. St. John is also a former member of APIC’s Governmental Affairs Committee, Education Committee, Practice Guidance Council and Research Foundation. He has served APIC as Chapter President & Board member, Editorial Board and reviewer for AJIC, APIC Text Revision Task Force (x2) and Pharmacy chapter co-author. Keith has been a volunteer member of the United States Pharmacopeia Convention Expert Compounding Committee since 2005, sharing his expertise on the revision of USP Chapter <797>, Pharmaceutical Compounding – Sterile Preparations. In addition to APIC, he is an active member of the Healthcare Infection Society (UK) and the Society for Health Epidemiology of America (SHEA). Keith received his Master’s of Science degree in Clinical Microbiology from Thomas Jefferson University in Philadelphia and his Bachelor of Science degree in Medical Technology from the University of Delaware.