As expected, a slew of regulatory updates and new standards will define 2017. Notably, behind each regulation is the expectation of ensuing process changes that will drive patient care improvements. To enable this, sophisticated policies and procedures must be developed; simply reading a regulation synopsis and adopting a new checklist will not suffice.

While it can be beneficial to network and visit other pharmacies when considering any operational or process change, a well-known adage has stood the test of time: If you have seen one hospital pharmacy, you have seen one hospital pharmacy. As such, implementing new regulations requires an understanding of their intent. Thus, pharmacy management must develop and nurture expertise in a broad range of subspecialties—from HVAC functionality, to environmental monitoring timelines, to recognizing the risks that accompany the use of oral chemotherapy.

Consider these questions: Does it make sense for your facility to take advantage of the exception in USP <800> that allows for the mixing of hazardous and non-hazardous drugs in the same room under very specific circumstances? Where in your compounding complex are floor drains allowed? How often should spill tests be conducted in your receiving area? Which staff members should be covered under the employee medical surveillance program? What products need to be traceable at the lot level?

This is just a sampling of the working knowledge now expected of pharmacy management, and the implications can seem overwhelming. Fortunately, PP&P will continue to engage pharmacy and regulatory experts as this new year unfolds and provide the solutions you need to attain not only operational goals, but something even more valuable—peace of mind.

All the best,

R. Mitchell Halvorsen
Publisher

Correction: An error occurred in the December 2016 print version of the article titled USP <800> Requirements for Engineering Controls. The article stated, “It is critical to note that horizontal laminar flow hoods/laminar airflow workbenches (LAFWs) and containment aseptic isolators (CAIs) must never be used for compounding HDs due to their lack of safety controls necessary for operator protection.” The statement should have read, “It is critical to note that horizontal laminar flow hoods/laminar airflow workbenches (LAFWs) and compounding aseptic isolators (CAIs) must never be used for compounding HDs due to their lack of safety controls necessary for operator protection.” PP&P regrets the error.

Regulations impacting 2017 practices include, but are not limited to, the following:

• USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings
• Update to USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations
• New chemotherapy administration safety standards from the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS), including standards for pediatric oncology➢
• Ongoing implementation of requirements related to FDA’s Drug Supply Chain Security Act (DSCSA)