With the recently published USP Chapter 800 standards for hazardous drug compounding and the proposed USP Chapter 797 revisions under review by the USP Compounding Expert Committee, those involved in hazardous drug and other sterile compounding should expect more focus on quality assurance and control.1 Pharmacists must build a case to secure the proper resources will be needed to meet the changing standards.
Pharmacies will need to ensure staff is knowledgeable to perform more frequent personnel and environmental testing, along with improved dedication to training and meaningful competencies. According to Eric S. Kastango, MBA, RPh, FASHP, pharmacy executives and managers must "take the time to explain the rationales behind compounding safety and detail the potential return on investment to those who hold the purse strings."
Pharmacies must take a collaborative approach with the C-suite, risk management, legal, medicine, nursing, environmental services and others to garner support and funding. A key component in building support is the importance of quality costs. Investing money on equipment, supplies, training and technology can actually help the pharmacy recoup dollars later by reducing compounding waste and managing patient risk.
Kastango recommends that pharmacies should first establish how well they comply with current standards by performing a gap analysis to determine current state of compliance. Identifying the gaps in sterile compounding compliance and then further understanding why these gaps are present will help the pharmacy drive an action plan. This action plan will not only work to close the current gaps but will also help anticipate future needs so that the pharmacy can secure the proper leadership support to obtain the resources needed and comply with these evolving standards.
- Kastango, E. “The Upcoming USP <797> Revision.” Pharmacy Purchasing & Products. April 2016, Vol. 13 (4). http://www.pppmag.com/article/1844