The 2013 USP Compliance Study

The results of the 2013 USP Chapter <797> Compliance Study show hospital pharmacies continue to struggle with USP Chapter <797> compliance. While a majority of respondents believe USP <797> is a valuable standard of practice that should be implemented, financial/budgetary restrictions and physical plant limitations are considered to be the primary barriers to adoption of all the guidelines.

The national study of sterile compounding practices has been conducted for the last three years by Pharmacy Purchasing & Products Magazine in partnership with CriticalPoint, LLC. The 2013 study included 1,045 participants, 76 percent from hospital pharmacies. In addition to the questions that measured compliance to 36 specific domains, participants were asked to provide feedback regarding the drivers and barriers to adoption of the USP <797> guidelines.

Differential Pressure Compliance Lags
One of the areas that received low scores on the survey is airflows and pressure differential monitoring. USP <797> has specific requirements for pressure differential monitoring, maintenance and documentation. Yet when study participants were asked the following question, only 56.6 percent gave an affirmative answer:

“There is evidence that mechanisms exist to report excursions, repair defects, and document actions taken as a result of any out of limit pressure/airflow condition until resolution.”

The number of respondents in compliance is up from 49.8 percent in 2011, but is down from the 2012 results of 59.8 percent.

Monitoring airflows is a fairly simple way to decrease the incidence of airborne contaminants in sterile processing areas. Continuous monitoring with audible, visual and email notification capabilities can detect changes in pressure differentials as soon as they occur and automatically alert the proper personnel to take action. Pharmacy personnel do not have to take manual readings several times a day and can concentrate on more valuable tasks. If pressure differential excursions do occur, they are immediately detected, reported and documented in complete compliance with USP Chapter <797>. Compare the features of SNS Differential Pressure Monitoring to the requirements of USP <797> and other regulatory agencies »

Visit the Pharmacy Purchasing & Products website to read the full results of the 2013 USP <797> Compliance Study »

To access the free Gap Analysis tools and receive a free action plan to improve your USP <797> compliance, visit CriticalPoint, LLC »

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