Posted on January 6, 2016
The work involved in complying with proposed USP Chapter 800 Hazardous Drugs: Handling in Health Settings means that hospitals should start preparing now.
USP 800 will help fill the gap to protect pharmacy personnel and other healthcare workers who come in contact with hazardous drugs. It will be an enforceable chapter like USP Chapters 795 and 797, but will be wider in scope than other compounding chapters as it applies to both sterile and nonsterile compounding.
The chapter will require every facility to maintain a list of antineoplastic and other hazardous drugs it uses, including all the drugs on the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs, and update the list anytime a new dosage or agent is added. It also outlines the responsibilities of personnel and specifies the personnel protective equipment required for handling hazardous drugs. The chapter establishes requirements for receiving, storing, compounding and administering hazardous drugs, for cleaning and ensuring environmental controls, and for medical surveillance of individuals who may come in contact with hazardous drugs.
On January 13, join Patricia C. Kienle, RPh, MPA, FASHP and Eric S. Kastango, MBA, BSPharm, FASHP in a webinar that will review the main requirements of proposed USP 800 and actions facilities can do now to prepare. The presenters will provide practical tips to assure compliance with the proposed chapter. The webinar will cover changes in facilities, use of personal protective equipment, personnel training, and environmental monitoring. In addition, the presenters will discuss the links between USP Chapters 795, 797, and 800 and how the new chapter will likely affect the previous ones, particularly in terms of storage and compounding requirements.
Patricia C. Kienle, RPh, MPA, FASHP is the Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions. Her experience includes serving on the ASHP Board of Directors and as an ASHP Fellow. She is a current member of the USP Expert Committee on Compounding, and chair of the Subcommittee and Expert Panel on Hazardous Drugs. She was named Pharmacist of the Year by the Pennsylvania Society of Health-System Pharmacists and received the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management. She has also served on the on the Board of Governors of the National Patient Safety Foundation. In addition to authoring multiple guides and videos dealing with sterile compounding, Patti is a frequent presenter to professional groups, with special interests in promoting medication safety, compounding sterile preparations, accreditation and regulatory issues.
Eric S. Kastango, M.B.A., B.S.Pharm., FASHP is president of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company. Eric received a coveted ISMP Cheers Award in 2015 for his work related to sterile compounding safety. He is one of four recipients of the 2013 Outstanding Service Award from the Massachusetts Society of Health-System Pharmacists and the 2014 recipient of the NABP Henry Cade Memorial Award that recognized his efforts and assistance to the states and NABP to address the compounding tragedy that occurred in 2012.