After the revamp of USP 797 in 2008, pharmacies found themselves, once again, confused about the guidelines and just what they exactly meant. This confusion resulted in less pharmacy and hospital compliance to USP797 clean rooms and the operations within. In 2011, the United States Pharmacopeia developed a survey to evaluate compliance rates and issues regarding the ability to comply to USP797. The results of which, they hoped, would provide a baseline from which to measure progress. USP repeated this survey in 2012 and found improvement in certain areas when compared with 2011 results.
With a 7.3 percent response rate, only 950 registered for the survey of which 412 actually participated. This was a drop in participants by 64 percent from the previous year. Limited to only the United States, participants whose results were taken into account answered at least 95 percent of the questions asked. The vast majority of respondents participated to measure their own level of compliance and to act further where needed. Ninety-five percent of survey respondents believe that USP 797 has had an effect on patient safety. When asked about delays in complying more than half indicated that they were concentrated more on another standard of practice that should be implemented, while another 20 percent were more concerned with regulatory body sanctions.
Financial restrictions were pointed to as the biggest challenge in achieving compliance. Pharmacies were also faced with physical plant limitations regarding modular cleanrooms. Time required in planning, constructing and implementing changes to include a cleanroom were also to be considered a challenge.
As more pharmacies look further into USP797 cleanrooms and their level of compliance, TCA will be here to help educate and clear up some of the questions regarding modular clean rooms and how to comply. Call us at 970-203-0516 for further information or to schedule a consultation.