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News of unclean facilities and lax safety standards at the New England Compounding Center in Framingham has cast a public spotlight on compounding — a critical, but not widely known, sector of the pharmaceutical industry. To learn more about compounding, its role in cancer treatment, and its use at Dana-Farber, DFCI Online spoke recently with Sylvia Bartel, RPh, MHP, the Institute's vice president of Pharmacy Services.
It's the preparation of sterile products used to treat patients intravenously. Such medications could be chemotherapy agents, antiemetics (which prevent nausea and vomiting), support medications, or vaccines.
Yes. The dose of chemotherapy a patient receives is based on his or her height, weight, and individual health circumstances. Because those factors vary from patient to patient and visit to visit, we prepare patient-specific doses on-site.
In general, they're chemotherapy agents and biotherapies (drugs that stimulate the body's immune system defenses) that treat a patient's cancer. We also prepare antiemetics, as well as intravenous fluid solutions that could contain potassium or magnesium to prevent the depletion of these nutrients in patients receiving chemotherapy.
The only products we've purchased from the New England Compounding Center are two topical solutions (agents applied to tissue) used in gynecologic procedures.
We have numerous safeguards to ensure the proper preparation of sterile products. We train and monitor our staff in correct preparation techniques. We routinely test staff members' sterile technique and the work environment for microbial growth. We've implemented a series of quality-control checks and report regularly to the Institute's Infection Control Committee.
We follow USP 797, a set of regulations developed by the United States Pharmacopeial Convention, a scientific organization that sets standards for the purity of medicines. The standards govern the preparation of sterile products in "clean rooms" where dust and foreign matter is kept below certain levels. Products are prepared within biological safety cabinets within the clean rooms. Before entering a clean room, the staff washes their hands and put on special clothing, much like that used in an operating room. Clean rooms undergo specific cleaning procedures on a daily, weekly, and monthly basis, and we routinely test surfaces from to ensure there is no microbial growth.