The inaugural USP Chapter <797> Compliance Study was published in the October 2011 issue of Pharmacy Purchasing & Products and is available online at www.pppmag.com/ComplianceStudy . The comprehensive results from this survey not only provide data to measure the success of pharmacies’ efforts in complying with sterile compounding requirements, but also offer access to the tools necessary to continually improve sterile compounding practices. Though deciphering
differences in overall compliance scores based on certain variables was not one of the stated purposes of the USP <797> Compliance Study, upon review and analysis it was observed that statistically significant differences existed in compliance scores based upon state regulatory status.
These differences are important and should be of interest to the National Boards of Pharmacy (NABP). Although it has been eight years since USP Chapter <797> became the official standard for sterile compounding practices in the United States, not all states require compliance with the Chapter. Analysis of the study data also identified some other interesting, though not necessarily statistically significant, relationships between overall compliance scores and certain other variables, such as equipment use, inspection findings, compounding volume, and hospital size.
The laws defining each state’s sterile compounding regulations can be categorized according to three status levels: no reference, indirect, and direct (See Table 1). No reference status (red) indicates states without laws or regulations that reference sterile compounding or parenteral nutrition practices in any way. The indirect status level (yellow) indicates that the laws and regulations of those states do not specifically cite <797>, but regulations are in place addressing sterile compounding or parenteral nutrition. States with direct status (green) either require compliance with <797> or have harmonized their laws and regulations with the chapter. Table 1 summarizes that status of the states in 2011: there were five no reference, 29 indirect, and 17 direct states.
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Comparing Results by State Status
To quantify the results from the USP <797> Compliance Study by the status level of the respondents’ states, the data was grouped according to state status. The results are summarized in Table 2. All statistical testing of overall compliance scores were exploratory in nature. Therefore, adjustments for multiple comparisons were not made. Independent t-tests were used to compare differences in overall compliance scores between the three groups (none, indirect, and direct) defined by the amount of state regulation of sterile compounding. The Satterthwaite formula for degrees of freedom was used when two groups had unequal variances.
differences in overall compliance scores based on certain variables was not one of the stated purposes of the USP <797> Compliance Study, upon review and analysis it was observed that statistically significant differences existed in compliance scores based upon state regulatory status.
These differences are important and should be of interest to the National Boards of Pharmacy (NABP). Although it has been eight years since USP Chapter <797> became the official standard for sterile compounding practices in the United States, not all states require compliance with the Chapter. Analysis of the study data also identified some other interesting, though not necessarily statistically significant, relationships between overall compliance scores and certain other variables, such as equipment use, inspection findings, compounding volume, and hospital size.
The laws defining each state’s sterile compounding regulations can be categorized according to three status levels: no reference, indirect, and direct (See Table 1). No reference status (red) indicates states without laws or regulations that reference sterile compounding or parenteral nutrition practices in any way. The indirect status level (yellow) indicates that the laws and regulations of those states do not specifically cite <797>, but regulations are in place addressing sterile compounding or parenteral nutrition. States with direct status (green) either require compliance with <797> or have harmonized their laws and regulations with the chapter. Table 1 summarizes that status of the states in 2011: there were five no reference, 29 indirect, and 17 direct states.
To view chart click here.
Comparing Results by State Status
To quantify the results from the USP <797> Compliance Study by the status level of the respondents’ states, the data was grouped according to state status. The results are summarized in Table 2. All statistical testing of overall compliance scores were exploratory in nature. Therefore, adjustments for multiple comparisons were not made. Independent t-tests were used to compare differences in overall compliance scores between the three groups (none, indirect, and direct) defined by the amount of state regulation of sterile compounding. The Satterthwaite formula for degrees of freedom was used when two groups had unequal variances.
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