Prepare for Intense Inspections


April 2019 : State of Pharmacy Compounding - Vol. 16 No. 4 - Page #4

In its 12th year, PP&P’s State of Pharmacy Compounding survey establishes the current status of compounding practice in the US, while also examining the pressures faced by hospital pharmacy in the endeavor to achieve safe, compliant compounding practices. The results on the pages that follow illustrate the growth that has occurred, while also demonstrating the continual change that is driven by a constantly evolving regulatory focus.

The survey queries pharmacy directors on a wide range of compounding issues, from costs expended on cleanroom renovations and changes in utilization of outsourced compounding to the frequency of compounding errors and the reasons behind accreditation citations.

Survey responses are solicited via email, and this year a total of 363 responses were received, yielding a confidence interval of 4.97 (95% +/- 4.97) based on the total population of pharmacy directors nationwide. We purposely survey a random sampling of pharmacy directors, not just readers of PP&P, to ensure the data herein reflects trends across the entirety of health system practices.


More than 8 out of 10 hospital pharmacy directors rely on Pharmacy Purchasing & Products to provide guidance on <797> compliance.


Inspection Themes

Pharmacy inspections were markedly different this year in their intensity. Both state board and accreditation inspections have become more comprehensive as inspectors are highly prepared, thus requiring that pharmacy be equally prepared for any inspection.

Gone are the days when an inspector with limited pharmacy experience would review the cleanroom and ask two perfunctory questions about policies and procedures. Instead, pharmacy can expect well-trained inspectors to come prepared with 100-question surveys that cover a broad array of specific compounding practices. Surveyors are also more likely to make recommendations or even cite facilities.

Recent recommendations have often focused on documentation deficiencies and the need for physical layout improvements within the compounding complex. One commonly repeated recommendation is the need to install a line of demarcation in the anteroom. This is an easy-to-resolve issue that should be addressed immediately. Cleaning practices also received significant attention during inspections this year; ensure that cleaning logs are compliant prior to any inspection.

Inspections Drive Best Practices

As stressful as an inspection can be, it is important to recognize that facilities located in states that require <797> compliance boast higher rates of compliance and are more likely to have adopted best practices for compounding.

The lowest compliance rates are found in those organizations where pharmacy directors have indicated a general disinterest in <797>. In facilities where the pharmacy director is unaware as to whether their state board requires <797> compliance, cleanroom installation rates are well below average, documentation of cleaning is inconsistent, and environmental monitoring plans are often nonexistent. Apathy regarding <797> is intrinsically dangerous to patient safety. Just as <800> requires assigning a designated person to oversee all HD handling, consider assigning the same role for overseeing <797> compliance.

Budget Challenges

Renovation costs jumped significantly this year, with most facilities spending a minimum of $500,000, and often well over $1 million, on pharmacy renovations. Unfortunately, the impending December 1st deadline has not eased the budget process in many institutions. Most facilities continue to find it quite difficult to gain administration’s support for the pharmacy renovation budget.

Conclusion

In the coming year, compounding volumes are expected to increase in most facilities; virtually no pharmacy directors are projecting decreasing volumes. As such, a strong investment in automation and equipment must accompany the current investment in compliant practice to ensure the continued safety of our CSPs.


Deanne Halvorsen is the editorial director of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and MedicalLab Management. She can be reached at dhalvorsen@ridgewoodmedia.com.


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