The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare. An entity must maintain a list of HDs, which must include any items on the current NIOSH list that the entity handles. The entity’s list must be reviewed at least every 12 months. Whenever a new agent or dosage form is used, it should be reviewed against the entity’s list. The NIOSH list of antineoplastic and other HDs provides the criteria used to identify HDs. These criteria must be used to identify HDs that enter the market after the most recent version of the NIOSH list, or that the entity handles as an investigational drug. If the information available on a drug is deemed insufficient to make an informed decision, consider the drug hazardous until more information is available.
RESPONSIBILITIES OF PERSONNEL HANDLING HAZARDOUS DRUGS
Each entity must have a designated person who is qualified and trained to be responsible for developing and implementing appropriate procedures; overseeing entity compliance with this chapter and other applicable laws, regulations, and standards;
ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas. The designated person must thoroughly understand the rationale for risk-prevention policies, risks to themselves and others, risks of noncompliance that may compromise safety, and the responsibility to report potentially hazardous situations to the management team. The designated person must also be responsible for the oversight of monitoring the facility and maintaining reports of
testing/sampling performed in facilities, and acting on the results. All personnel who handle HDs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment. (Feb 2016 / USP Compounding Compendium Physical Tests / Hazardous Drugs 285)
Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 10.6.1.1 by Becky Burgess (apecmpg3z) on Thu Feb 04 09:35:55 EST 2016
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