Pharmaceutical standards focus on safety in handling hazardous drugs

The United States Pharmacopeia (USP) Convention's Chapter 800, "Hazardous Drugs-Handling in Healthcare Settings" standards become effective December 1, 2019, and provide detailed specifications for the handling of hazardous drugs in order to protect pharmacy staff from health risks associated with harmful chemicals.

By Tom Brown, Don Burroughs, Cassey Franco, Dan Koenigshofer, April Vacca November 1, 2018

The United States Pharmacopeia (USP) Convention’s Chapter 800, “Hazardous Drugs-Handling in Healthcare Settings,” is set to become effective December 1, 2019. The new standards provide detailed specifications for the handling of hazardous drugs in order to protect pharmacy staff from health risks associated with harmful chemicals. Hazardous drugs, such as antineoplastic drugs used in chemotherapy, are identified by the National Institute for Occupational Safety and Health (NIOSH) based upon criteria that includes carcinogenicity and toxicity. Pharmacies that handle these hazardous drugs are primarily regulated by the State Boards of Pharmacy, and may also be inspected by the U.S. Food & Drug Administration.

As a result of the imminent USP 800 chapter, many pharmacies in hospitals and cancer clinic settings require substantial modification to comply with the safety requirements. The authoritative new standards address the sequence and types of spaces required; appropriate finishes for floors, counters, and ceilings; necessary components such as a sink and emergency eyewash station; and environmental controls, including negative pressure spaces for unpacking and compounding the drugs. In many cases, pharmacies will need to expand or reconfigure their space in order to accommodate the prescribed spaces.

Creating a safe process: Unpack, prepare, and store

Pharmacists and hospital facility administrators must focus on three primary functions in the handling of hazardous drugs in order to comply with USP 800: unpacking, preparation (compounding), and storage.

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Third, USP 800 calls for separate storage of hazardous drugs in an externally ventilated, negative pressure room, with a minimum of 12 ACH. This may require the conversion of an existing space into a storage area that meets the USP requirements.

Pharmacy automation: Dispensing robots and conveyor systems

Dispensing robots and conveyor systems now play a critical role in the reduction of errors; staff efficiency; and how drugs are stored, filled, and delivered. Robots enable technicians and pharmacists to spend less time manually finding prescriptions and more time with patients. Although not suitable for compounding drugs, these intelligent systems free up space and streamline operations through efficient retrieval and dispensation, and by storing drugs within the robot rather than on static shelves. While retrofitting pharmacy spaces to meet USP 800 requirements, pharmacists and facility administrators may want to explore options to incorporate this technology.

Other technology measures that must be addressed include security, an important concern in the protection of controlled substances. Security gates, cameras, card readers, access-controlled cabinets, and staff lockers with glass fronts are all part of necessary pharmacy security measures.

Resources regarding the new standards

While many hospital pharmacists are aware of the pending new standards, facility managers and administrators may be interested in learning more about the implications as they apply to the physical space. The American Society of Health System Pharmacists (ASHP) is one important source, with a number of articles posted to update hospital and clinic staff on the regulations. More information can also be found on the USP website under “Compounding Standards.” These new standards are an important step forward in protecting the health and safety of pharmacy staff as they unpack, prepare, and store hazardous drugs.


This article originally appeared on Dewberry’s blog. Dewberry is a CFE Media content partner.

Original content can be found at www.dewberry.com.