• Determine Risk Level of Compounding using Risk Level Assessment Checklist, Chapter <797> and professional judgment
• Perform Gap Analysis by comparing <797> requirements line by line with pharmacy operational procedures and facilities
• Develop action plan for <797> compliance from prioritized Gap Analysis
• Communicate results of Gap Analysis and Action Plan with pharmacy staff
• Implement non-facility requirements and revise Policies and Procedures for CSPs, then address changes needed for facility and equipment compliance
• Communicate action plan and demonstrated improvements in patient care with staff
• Evaluate use of alternative products and reassess workload demands for all compounding sites
• Document all measures of quality performance and communicate improvements in <797> compliance with staff, administration, and accreditation organizations
USP 797 - “pharmaceutical compounding – sterile preparations”, issued in January 2004, gives standards for the preparation of pharmaceutical compounds. These standards have been adopted by the Joint Commission for Accreditation of Healthcare Organizations (JCAHO)and are scheduled to be enforceable in January 2008.
Additional Resources-
Complete text of USP 797 and text of proposed revisions U.S. Pharmacopeia
1. Assess the hazards in the workplace.
• Evaluate the workplace to identify and assess hazards before anyone begins work with hazardous drugs.
• Regularly review the current inventory of hazardous drugs, equipment, and practices, seeking input from affected workers
• Conduct regular training reviews with all potentially exposed workers in workplaces where hazardous drugs are used.
2. Handle drugs safely.
• Implement a program for safely handling hazardous drugs at work and review this program annually on the basis of the workplace evaluation.
• Establish procedures and provide training for handling hazardous drugs safely, cleaning up spills, and using all equipment and PPE properly.
• Establish work practices related to both drug manipulation techniques and to general hygiene practices—such as not permitting eating or drinking in areas where drugs are handled, such as the pharmacy or the clinic.
3. Use and maintain equipment properly.
• Develop workplace procedures for using and maintaining all equipment that functions to reduce exposure—such as ventilated cabinets, closed system drug-transfer devices, needleless systems, and PPE.
The National Institute for Occupational Safety and Health alert, “Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Health Care Settings.” addresses the risks to health care workers handling hazardous materials.
