Impact of United States Pharmacopeia chapter 797: results of a national survey. 2006

Timothy A Candy, and Philip J Schneider, and Craig A Pedersen
The Ohio State University (OSU), USA.

OBJECTIVE The initial response of the pharmacy profession to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied. METHODS A stratified random sample of 600 hospital pharmacy directors across the nation were surveyed by mail. RESULTS A total of 251 surveys (41.8%) were returned. Larger hospitals (> or =200 staffed beds) were more likely than smaller hospitals (<200 staffed beds) to have read USP chapter 797 (80.0% versus 45.8%, respectively) and have a copy of the chapter (94.6% versus 78.0%, respectively). Overall, respondents felt that chapter 797 would negatively affect workload and pharmacy's ability to provide sterile preparations in a timely manner. Conversely, respondents replied that the new standard would have a positive effect on the quality of care provided by the hospital. Overall, 45.3% of respondents reported plans to build a clean-room, and 21.7% reported plans to obtain new equipment to comply with chapter 797. Furthermore, 42.3% of respondents had decreased the quantity of high-risk compounding. Respondents also reported that their pharmacy's budget had increased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. CONCLUSIONS USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall.

UI MeSH Term Description Entries
D010602 Pharmacopoeias as Topic Works about authoritative treatises on drugs and preparations, their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity, and dosage, chemical tests for determining identity and purity, etc. Formulary, National,National Formulary,Formularies, National,National Formularies
D010607 Pharmacy Service, Hospital Hospital department responsible for the receiving, storing, and distribution of pharmaceutical supplies. Clinical Pharmacy Service,Hospital Pharmacy Service,Pharmacy Service, Clinical,Hospital Pharmaceutic Service,Hospital Pharmaceutical Service,Hospital Pharmacy Services,Pharmaceutic Service, Hospital,Pharmaceutical Service, Hospital,Service, Clinical Pharmacy,Service, Hospital Pharmaceutic,Service, Hospital Pharmaceutical,Service, Hospital Pharmacy,Clinical Pharmacy Services,Hospital Pharmaceutic Services,Hospital Pharmaceutical Services,Pharmaceutic Services, Hospital,Pharmaceutical Services, Hospital,Pharmacy Services, Clinical,Pharmacy Services, Hospital,Services, Clinical Pharmacy,Services, Hospital Pharmaceutic,Services, Hospital Pharmaceutical,Services, Hospital Pharmacy
D004339 Drug Compounding The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814). Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, Drug
D004340 Drug Contamination The presence of organisms, or any foreign material that makes a drug preparation impure. Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D013242 Sterilization The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D040841 Resource Allocation Societal or individual decisions about the equitable distribution of available resources. Allocation of Resources,Allocative Efficiency,Allocation, Resource,Efficiency, Allocative,Resources Allocation

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