USE OF CLOSED-SYSTEM TRANSFER DEVICES TO REDUCE DRUG WASTE

To recognize that a growing body of evidence supports the ability of specific closed-system transfer devices (CSTDs) to maintain sterility beyond the in-use time currently recommended by United States Pharmacopeia Chapter 797, when those CSTDs are used with aseptic technique and following current sterile compounding standards; further,

To foster additional research on and develop standards and best practices for use of CSTDs for drug vial optimization; further,

To educate healthcare professionals, especially pharmacists and pharmacy technicians, about standards and best practices for use of CSTDs in drug vial optimization.

Rationale

A 2016 study estimated that the U.S. may spend close to $2 billion on oncology drug products that are discarded because they come in vials in which the volume of drug product exceeds what is needed for most doses. Considerable savings are gained when the leftover contents of those vials are used. One practice that has shown promise in optimizing use of leftover drug product is the use of closed-system transfer devices (CSTDs) to facilitate the transfer of drug product from one reservoir to another. CSTDs prevent the release of hazardous drugs during compounding and administration and have primarily been used throughout the medication-use process to minimize healthcare workers’ exposure to hazardous drugs. Some CSTDs use a mechanical barrier that can also prevent the ingress of environmental contaminants, which has prompted study of their ability to safely prolong the sterility of drug product in vials. A growing number of studies have been generating data that indicate specific CSTDs have the possibility of maintaining sterility and extending in-use time when used under sterile conditions defined by United States Pharmacopeia Chapter 797. Although some CSTDs have an FDA-approved indication for use to prevent microbial ingress with studied dwell times of up to 168 hours when maintained in an ISO Class 5 environment using proper aseptic technique, they do not have an explicit indication for extending the in-use time of drug products. Until the data from the studies can be validated and applied, standard-setting entities and regulators will not permit this practice. ASHP therefore advocates that the existing evidence that supports the ability of properly used CSTDs to maintain sterility and extend in-use times be recognized, and encourages research and development of guidance by standard-setting entities and regulators regarding safe use of CSTDs for drug vial optimization.