Is it time for national compounding certification?

A national certification system for sterile compounding may be needed for hospitals, according to an article and accompanying editorial in the August 1 issue of AJHP.

Quality assurance in a post-NECC world

The risks associated with sterile compounding are increasing as chronic national drug shortages force hospitals to seek other sources for medications that meet patients’ clinical needs, including external compounding facilities.

Safeguarding the U.S. drug supply

“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,” wrote Ross W. Thompson, BS Pharm, director of Pharmacy Services at Tufts Medical Center, and Caryn Belisle, BS Pharm, director of Pharmacy Regulatory Compliance, Quality, and Safety at Brigham and Women’s Hospital, in the editorial.

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.

In addition, health-system administrators should ensure the credibility of external compounding facilities before contracting with them. “Choosing to use an outside sterile compounding facility can reduce a pharmacist’s ability to directly ensure competence and diligence in preparing the medication,” said AJHP Editor-in-Chief Daniel Cobaugh, PharmD, FAACT, DABAT. “Pharmacists must be vigilant and knowledgeable when evaluating both the facility and the compounding processes that are used to ensure that risks are minimized.”

Deadly bloodstream infections

The editorial is accompanied by a practice report, “Laboratory Replication of Filtration Procedures Associated with Serratia Marcescens Bloodstream Infections in Patients Receiving Compounded Amino Acid Solutions,” which 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 percent 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,” the American Society of Health-System Pharmacists (ASHP) said in a statement.

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, including:

·      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.

·      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.