Thursday, 13 August 2015

Continuing Gaps in High-Risk Sterile Compounding Practices


Hospital and health-system pharmacists must ensure that both internal sterile compounding staff and external sterile compounding facilities meet high standards of practice to ensure patient safety, according to an article and accompanying editorial in the August 1 issue of AJHP. A national certification or credential to verify competence in sterile compounding personnel may be needed to achieve this goal on a broad scale, according to the editorial.

PRESS RELEASE

Ongoing, chronic national drug shortages are forcing hospitals to seek other sources for medications that meet patients’ clinical needs, including external compounding facilities. The AJHP editorial urges pharmacy managers and directors to ensure that the proper risk mitigation procedures are in place if they conduct their own compounding or outsource to a compounding facility. Pharmacy leaders also should evaluate the risks and benefits associated with switching to another commercially available product.

The editorial, which accompanies a practice report, “Laboratory Replication of Filtration Procedures Associated with Serratia Marcescens Bloodstream Infections in Patients Receiving Compounded Amino Acid Solutions,” recommends that administrators ensure the credibility of external compounding facilities before contracting with them.

The practice report details a March 2011 high-fatality outbreak of Serratia marcescens bloodstream infections at six Alabama hospitals among patients who had received total parenteral nutrition (TPN). Because the 15% amino acid solution used in the TPN was part of a national drug shortage, the hospitals had contracted with a compounding pharmacy to prepare and filter-sterilize their supplies.

Once the outbreak occurred, personnel from the Alabama Department of Public Health and the Centers for Disease Control and Prevention found a number of problems with the way the solution had been compounded. They identified deviations from USP chapter 797 standards, including the following:
  • The compounded solution was allowed to sit for up to 48 hours before filtration.
  • There was no use of a prefilter before use of the sterilizing filter, despite excessive particulate matter in the solution.
  • Sterilizing filters were changed during filtration slowdown or clogging without replacing the entire tubing set.
  • Insufficient volumes of postfiltration solution were used during sterility testing.

The investigating team also discovered that harmful bacteria were able to pass through 0.2- and 0.22-µm filters intended for sterilization of the amino acid solution. However, the bacteria did not pass through 0.2-µm filters when a USP-recommended 0.5-µm prefilter was used.

The creation of USP chapter 797 — a set of regulations that governs a wide range of pharmacy policies and procedures, including compounded sterile preparations — has reduced instances of preparation contamination, but many gaps still remain, according to the article authors.

The findings by study authors Heather Moulton-Meissner, Ph.D.; Judith Noble-Wang, Ph.D.; LCDR Neil Gupta, USPHS, M.D.; LCDR Susan Hocevar, USPHS, M.D.; CDR Alex Kallen, USPHS, M.D.; and Matthew Arduino, Dr.P.H., are critically important for patient safety, according to AJHP Editor in Chief Daniel Cobaugh, Pharm.D., FAACT, DABAT.

“Choosing to use an outside sterile compounding facility can reduce a pharmacist’s ability to directly ensure competence and diligence in preparing the medication,” Dr. Cobaugh said. “Pharmacists must be vigilant and knowledgeable when evaluating both the facility and the compounding processes that are used to ensure that risks are minimized.”

The editorial, authored by Ross W. Thompson, B.S.Pharm., M.S., FASHP, director of Pharmacy Services at Tufts Medical Center, and Caryn Belisle, B.S.Pharm., M.B.A., director of Pharmacy Regulatory Compliance, Quality, and Safety at Brigham and Women’s Hospital, notes that the pharmacy profession has no universal standard for establishing sterile compounding credentials or competency. The editorial goes on to state that “perhaps the time has come for the pharmacy profession to develop a nationally recognized certification or other credential to validate the expertise in the practice of sterile compounding.” 

Posted by Tim Sandle