ASHP has issued broad recommendations to protect healthcare workers and patients from exposure to known carcinogens and other hazardous substances. The guidelines can be used to develop and implement safety programs that cover all aspects of the handling of hazardous drugs, from receipt to disposal.
Hazardous drugs guidelines revised by ASHP
ASHP has issued broad recommendations to protect healthcare workers and patients from exposure to known carcinogens and other hazardous substances. The guidelines can be used to develop and implement safety programs that cover all aspects of the handling of hazardous drugs, from receipt to disposal. They include work practices, including compounding, administration, and spill clean-up; use of personal protective equipment; hazardous waste containment and disposal; and staff training and demonstration of competence. The guidelines also include research findings and recommendations from expert bodies such as the National Institute for Occupational Safety & Health (NIOSH), the Occupational Safety & Health Administration, and the Oncology Nursing Society. The original guidance document, published in 1990, was one of the first sets of recommendations issued on handling hazardous drugs in the United States.
USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Free Download USP GC <800>
Get the HazRx® Mobile App GC <800> Infographic The
National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. USP General Chapter <800>
describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled. The
need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. While NIOSH defines criteria and identifies hazardous drugs,
USP developed standards for handling these hazardous drugs to minimize the risk to public health. The goals of these standards are to help increase awareness, provide uniform guidance to reduce the risk of managing hazardous drugs, and help reduce the risk posed to patients and the healthcare workforce.Developing USP General Chapter <800>
Public Health Need
USP Process
USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress.
The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. Review their work plan and past meeting summaries. General Chapter <800> was published on February 1, 2016.
Resources
- USP <800> Context for Implementation (published 11/26/2019)
- Compendial Applicability of USP <800> (published 11/18/2019)
- USP <800> FAQs
- USP <800> Commentary (published 02/01/2016)
- USP General Chapter Education Courses
- Sign up for USP Healthcare Quality & Safety Updates
- Other Publications
Thomas H. Connor Division of Applied Research and Technology
National Institute for Occupational Safety and Health
Cincinnati, Ohio, USA
The NIOSH criteria include : carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, organ toxicity at low doses, and drugs that mimic existing drugs in structure or toxicity. While the majority of the hazardous drugs are cytotoxic antineoplastic drugs, drugs from other classes are included.
NIOSH evaluates each drug on an individual basis and does not group drugs into classes. NIOSH has developed an extensive review process in order to continuously update its list of hazardous drugs. Drugs to be evaluated include new Food and Drug Administration (FDA) approvals and existing drugs with new FDA warnings, usually black box warnings.