By Patricia C. Kienle, RPh, MPA, FASHP
Director of Accreditation and Medication Safety, Cardinal Health Innovative Delivery Solutions; Chair of USP’s Expert Panel on General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings
Approximately eight million U.S. healthcare workers are potentially exposed to hazardous drugs each year. Among those most at risk are the pharmacists, technicians, and nurses who prepare treatments containing hazardous drugs and the clinicians who administer them. Today, hazardous drugs are increasingly compounded (mixed and tailored to a patient’s specific needs) and delivered in a variety of facilities, including outpatient clinics, hospitals, and doctor’s offices that may not be designed or set-up to provide exposure protection for their employees, their patients and the environment.
The link between exposure to antineoplastic agents (chemotherapy drugs) and cancer in otherwise healthy healthcare workers, for example, has since been confirmed by multiple studies, and in September, 2004, the Centers for Disease Control’s National Institute for Occupational Safety and Health (NIOSH) issued an alert warning of the dangers of exposure to antineoplastic and other hazardous drugs. Yet, despite their efforts and the efforts of groups like the American Society of Health-System Pharmacists (ASHP) and the Oncology Nursing Society (ONS) to develop and promote voluntary guidelines, healthcare workers continue to be exposed to hazardous drugs.
In addition to antineoplastic drugs, NIOSH’s hazardous drugs list includes some commonly used and widely available drugs, such as antivirals, antibiotics, hormones and antipsychotics. Because many of these drugs are not perceived as hazardous, handling practices for these products may be even more casual. But the risks associated with repeat exposure remain potentially serious.
Consistent standards for the handling of hazardous drugs in healthcare settings can help minimize exposure to healthcare workers, avoid unintended and repeated exposures, and reduce the potential for adverse consequences. That’s the purpose of USP’s General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which was published on February 1, 2016 both in the United States Pharmacopeia–National Formulary (USP–NF) and the USP Compounding Compendium.
Before the publication of the new General Chapter <800> standard, all information on handling hazardous drugs was contained in USP’s General Chapter <797> Pharmaceutical Compounding—Sterile Preparations and <795> Pharmaceutical Compounding—Nonsterile Preparations. The new standard improves on the existing information and aligns with NIOSH’s Alert, as well as with guidances on handling hazardous drugs from the Occupational Safety and Health Administration (OSHA), NIOSH, ASHP and ONS.
In drafting and developing the new general chapter, USP convened both an expert committee and an advisory expert panel. Selected for their expertise, these individuals included experts practicing in healthcare settings, medical schools, research organizations, as well as federal agencies. These experts serve USP individually, not any outside interest, including those of their employers.
In addition to our volunteer experts, a key component to the USP standard development process is public input. The development of General Chapter <800> started in 2010 and went through two rounds of public comments before its final published version.
Many of the existing guidelines in use today are voluntary and vary depending on job function, type of facility, geographic area or even the type of patient. Development of this new general chapter helps ensure the safe handling of hazardous drugs and helps minimize exposure to healthcare workers throughout the healthcare setting. It provides an adoptable standard for state and federal regulatory agencies, and other institutions and organizations.
Recognizing that it may take healthcare facilities additional time to meet the requirements of the new standard, the official implementation period for General Chapter <800> has been extended until July 1, 2018. With the extended date, facilities and practices have more than two years to conform to the new chapter.