Hazardous drugs can be found across all healthcare settings, such as hospitals, pharmacies, physicians’ offices, skilled nursing facilities, and outpatient surgical centers.
The purpose of USP<800> is to provide quality standards for handling hazardous drugs in the health care environment. 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 the standards which apply to all healthcare personnel who receive, store, prepare, administer, transport or who are involved with clean-up/spill management of hazardous drugs. The goal of USP<800> is to protect the health and safety of healthcare workers and patients who may be exposed to hazardous drugs and the environment. Under the hierarchy of controls [elimination, substitution, engineering controls, administrative controls, personal protective equipment (PPE)] which is a is a method of identifying and ranking safeguards to protect workers from hazards; elimination is the most effective and PPE would be the least effective. Yet, in the healthcare environment, after elimination, substitution and the implementation of engineering and administrative controls, PPE is a reasonable and last line of defense for employees handling hazardous drugs.
Under USP<800>, the facility must conduct an Assessment of Risk if complete containment practices will not be followed for all hazardous drugs.
The Assessment of Risk requires:
1) An annual review of the organization’s Hazardous Drug list.
2) An evaluation of each drug, dosage form, type of hazardous drug, packaging, and level of manipulation
3) Operationalizing control measures (i.e., containment strategies, administrative rules or workplace practices) to reduce the risk of exposure to the hazardous drugs for your personnel; the use of PPE is a workplace practice.
4) Document and record your controls and PPE decisions.
This may seem like a daunting and time-consuming task. However, by partnering with a company dedicated to providing this information for your organizations and assisting in meeting recommendations for compliance under USP<800> Assessment of Risk, you can rest easy knowing your organization will be in good hands.
PharmEcology®
Sources: (USP General Chapter 800, North Carolina Board of Pharmacy). sources: (USP General Chapter 800, North Carolina Board of Pharmacy).
Identifying Hazard Control Options: The Hierarchy of Controls
https://www.osha.gov/sites/default/files/Hierarchy_of_Controls_02.01.23_form_508_2.pdf ; A PRODUCT OF OSHA’S RECOMMENDED PRACTICES FOR SAFETY & HEALTH PROGRAMS | https://www.osha.gov/safety-management
PharmEcology provides a one-stop solution to help your organization identify, segregate, manage, and dispose of pharmaceutical waste in a compliant and cost-effective manner. We now offer a unique Assessment of Risk customized to your inventory as required by USP <800>.
