While not on the New York Times Bestseller List, "USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations"is a must-read for all compounding pharmacists. It took effect on Jan. 1, 2004.
While not on the New York Times Bestseller List, "USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations" is a must-read for all compounding pharmacists. It took effect on Jan. 1, 2004.
The document details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings where sterile preparations are compounded. The settings include hospitals, community pharmacies, physician practices, infusion clinics, home care organizations, long-term care facilities, and satellite pharmacy locations.
JCAHO began including elements of Chapter 797 standards in its surveys on July 1, 2004. Experts say that if health facilities are not yet compliant with these standards, there are various steps they can take and tools they can use to achieve this goal.
Steven Aragona, R.Ph., director of pharmacy at Hackensack University Medical Center, Hackensack, N.J., said one challenge is to help pharmacists understand the regulations and what issues need to be addressed. "We understand about wanting to keep IV mixtures clean, but many pharmacy schools have not addressed some of the things that are included in 797," he said.
Driving home the importance of proper scrubbing and gowning to hospital employees was at the top of Aragona's action plan. "We're hitting them very hard on the importance of hand washing-not just hand washing when you go into a room, but every time you think you break aseptic technique," he said.
Aragona also stressed that it is beneficial for a hospital to have a training program through which R.Ph.s can convey to the environmental services staff precisely what takes place in a clean room and why the room must be kept clean. "We realized that if we can't create in people's minds an expectation of what that room should look like and that it needs to be kept clean at all times, we would be fighting a losing battle," he said. He suggested that hospitals consider having environmental services dedicate specific cleaning equipment for the clean room so that dirt and grime from another area would not end up there.
Noting that Hackensack recently hired a staff developer, Aragona said, "The way we orient people has to undergo a change. Most pharmacists or techs learned to make IVs on the job. Now, when someone joins our staff, we give them a lecture on aseptic technique."
McElhiney echoed Aragona's sentiments concerning the importance of training the housekeeping staff to follow rigorous clean room guidelines. "That was a challenge. You don't see the housekeeping staff all the time. Many times they clean at night so you don't see what they do," she said. The new regulations have also inspired McElhiney and Aragona to become more meticulous when it comes to testing their staff.
Aragona said Hackensack Medical Center is considering making its annual testing much more complicated by requiring its staff to prepare an admixture that involves the addition of more than one drug. The medical center is also considering having a system in place in which only those who are preapproved can prepare compounded drugs.