Pharmacy OneSource Blog

What is Proposed USP 800 and Why It Should Matter to You

Posted on 11/24/14

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According to the Centers for Disease Control (CDC), about eight million healthcare workers are possibly exposed to hazardous drugs (HDs) each year.1 The impact of this exposure on long-term health is a matter of both concern and controversy. On the one hand, no incontrovertible links have been found between HD exposure and serious health risks (e.g. cancer, reproductive disease, and chromosomal abnormalities). On the other hand, hundreds of studies have been published that discuss HD exposure, and two 2010 studies published in the Journal of Occupational and Environmental Medicine2 raised the concern level among agencies that oversee healthcare practices.

In March 2014, the U.S. Pharmacopeia (USP) posted its proposed new chapter, USP 800, that specifically addresses the handling of compounded HDs in healthcare settings; public comments were accepted through July 31.3 The HDs are referenced in the new NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014. USP 800’s intent is “to protect personnel and the environment when handling HDs. This includes but is not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs, and includes both sterile and nonsterile products and preparations.”

Even though a section of the current USP Chapter 797 does address hazardous drugs sterile compounding, the level of detail is suboptimal, which was the catalyst to draft a new enforceable chapter. Furthermore, USP 797 only addresses the preparation of compounded medications, not the administration of these medications to patients. USP 800 is comprehensive in its level of detail regarding the storage, preparation, and administration of hazardous drugs. The publication of the new NIOSH List this year was also timely regarding this new USP Chapter, as it provides more clarity on what determines a drug to be “hazardous” in light of new evidenced-based science.

USP 800 will apply to all personnel who compound HDs and all places where they are prepared, including pharmacies, hospitals and other healthcare institutions, physicians’ practice facilities, patient clinics, veterinarians’ offices and other locations/facilities where HDs are stored, transported and administered.

One of the most consequential – and controversial – statements of USP 800 is that “there is no acceptable level of personnel exposure to HDs.”  It requires any entity involved in the compounding of HDs to provide containment to “as low a limit as reasonably achievable (ALARA)”. The acronym ALARA is a concept that comes from radiation safety principles. Applying ALARA to HD compounding has generated concern from the pharmacy community about costs, practicality, and the impact on patient access to anticancer preparations.

This and other concerns that were submitted to USP as comments from various stakeholders will be addressed and responded to by the USP Expert Compounding Committee prior to publication in the National Formulary. The final Chapter has not yet been published, but we recommend that you become familiar with USP Chapter 800 standards so you and your organization are better prepared regarding these safety concerns when handling hazardous drugs.

What is your opinion of proposed USP 800?

References:

1.CDC website. Workplace Safety & Health Topics. http://www.cdc.gov/niosh/topics/hazdrug/

2.Power, Luci A., MS, RPh, Kastango, Eric S., MBA, RPh, et al. Understanding the New Proposed USP Chapter <800>. Pharmacy Purchasing & Products. June 2014, Vol. 11 No. 6. Page 6.

3.USP website General Chapter 800. http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf

4.Association of Community Cancer Centers http://www.accc-cancer.org/

5. National Community Pharmacists Association http://www.ncpanet.org/

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Topics: Sterile Compounding

About the Author

Cathy Thompson, MBA Cathy is a Biomedical Engineer with an MBA by education and has spent the majority of her career in the healthcare industry marketing both medical devices and IT applications.