On February 1, 2016, The United States Pharmacopeial Convention (USP) published an important new standard as part of a suite of healthcare quality standards included in the United States Pharmacopeia–National Formulary (USP–NF).
The new general chapter, <800> Hazardous Drugs – Handling in Healthcare Settings, has been developed to help protect personnel and patients, and reduce the risk of residual exposure in healthcare settings. The standard applies to all healthcare personnel (i.e., physicians, nurses, veterinarians, pharmacists and technicians) and all healthcare facilities where hazardous drugs are handled or manipulated, including their storage and distribution — with a goal of preventing and/or limiting exposure.
“Healthcare workers are on the frontline of protecting patients and consumers from the risks of hazardous drugs but are also themselves at risk,” noted Jaap Venema, Ph.D., executive vice-president and chief science officer of USP. “Each year, approximately 8 million healthcare workers in the US are potentially exposed to hazardous drugs. Practitioners are frequently unaware of the scope of the risk or the measures that should be taken to reduce such risk. The new standard defines processes intended to minimize exposure to hazardous drugs in healthcare settings, thereby protecting healthcare workers as well as patients.”
The standard was developed by the USP Compounding Expert Committee with input from an expert panel of medical and industry experts who provided guidance in best practices, alternative techniques, engineering controls, and other elements needed when handling hazardous drugs in healthcare settings. The standard builds upon several previous publications, including the NIOSH Alert – Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings; ASHP Guidelines on Handling Hazardous Drugs; the Oncology Nursing Society (ONS) Safe Handling of Hazardous Drugs; and OSHA Guidelines.
The USP Compounding Expert Committee recognized that it may take healthcare facilities additional time to comply with the new standard and therefore approved an extended official implementation date of July 1, 2018. With the extended date, healthcare facilities have more than two years to conform to the new requirements.
For more information on the chapter see Frequently Asked Questions. General Chapter <800> was published on February 1, 2016 in the First Supplement to USP 39–NF 34. General Chapter <800> was published in the First Supplement to USP 39–NF 34, and is available for purchase through a subscription to the USP Compounding Compendium or USP-NF.