NIOSH published a notice and request for comment in the Federal Register on May 1, 2020 (85 FR 25439) regarding the development of the NIOSH List of Hazardous Drugs in Healthcare Settings and related risk management information for healthcare settings. Eric Maroyka, Senior Director, Center on Pharmacy Practice Advancement sits down with Patricia C. Kienle, MPA, BCSCP, FASHP, and Michael Ganio, Senior Director, Pharmacy Practice and Quality to discuss aspects of the draft The National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Healthcare Settings 2020. Cookies used to make website functionality more relevant to you. More information and documentation can be found in our Learn more here. 01/18/2023, 823 Until the ACFR grants it official status, the XML Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 01/18/2023, 284 You can review and change the way we collect information below. Title: NIOSH Update to the Hazardous Drug List (Appendix A), Purpose: To provide an update of the list of hazardous drugs in the Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, Primary Disciplines or Expertise Needed for Review: Pharmacy, Nursing, Pharmacology, Academic and Professional Credentials: Ph.D. The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab vedotin-tftv (Tivdak) recommend that they be handled as hazardous drugs. and services, go to Thank you for taking the time to confirm your preferences. by the Farm Credit System Insurance Corporation This should only be necessary once for each IP address you access the site from. %%EOF In the description of the 2020 Hazardous Drugs List Changes, NIOSH notes in the CAUTION on page 11 that the 2020 list addresses only those new drugs on the market between January 2014 and December 1See Connor, T., Mackenzie, B., and DeBord, D. (2012). If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. These cookies may also be used for advertising purposes by these third parties. to the courts under 44 U.S.C. A Notice by the Centers for Disease Control and Prevention on 06/19/2020. https://www.federalregister.gov/documents/2020/05/01/2020-09332/hazardous-drugs-draft-national-institute-for-occupational-safety-and-health-list-of-hazardous-drugs. 0000068481 00000 n documents in the last year, by the International Trade Commission 0000085885 00000 n You will be subject to the destination website's privacy policy when you follow the link. These cookies may also be used for advertising purposes by these third parties. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, /niosh/docket/review/docket233/pdf/CDC-2013-0007.pdf, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, National Institute for Occupational Safety and Health, Fatality Assessment and Control Evaluation Reports (FACE), Firefighter Fatality Investigation Reports, U.S. Department of Health & Human Services. Since that time, approximately 70 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. include documents scheduled for later issues, at the request hbbd```b``}" These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Recommended by: Scientific or professional association, Vernon Wilkes In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. Health care workers who prepare or administer hazardous drugs (e.g., those used for cancer therapy, and some antiviral drugs, hormone agents, and bioengineered drugs) or who work in areas where these drugs are used may be exposed to these agents in the workplace. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. 3566 0 obj <> endobj Biotechnology Industry Organization You will be subject to the destination website's privacy policy when you follow the link. The review process for the addition of the new listings is described in a Federal Register Noticepdf icon. Centers for Disease Control and Prevention. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Update to the Hazardous Drug List (Appendix A), National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health & Human Services. Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226; phone: (513) 533-8132 (not a toll-free number); email: bmackenzie@cdc.gov. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. This prototype edition of the hb```u| eaX@x(gCk)La&{3L0u_r+ They have looked into hazardous drugs that healthcare workers may be exposed to and categorized these compounds into three groups. the material on FederalRegister.gov is accurately displayed, consistent with 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings ("List"). Thank you for taking the time to confirm your preferences. This PDF is However NIOSH has always had some delay in time between new . better and aid in comparing the online edition to the print edition. When these documents are finalized they will be published to the NIOSH website. "Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals." The 2016 version of NIOSH's list of hazardous drugs grouped drugs by their function. 0000052457 00000 n The current update (2016) adds 34 drugs and includes a review of the 2004 list. documents in the last year, 876 The reviewers will be requested to take part in the following process: The reviewers will be required to sign a conflict of interest form and to provide their individual reviews to NIOSH. Recommended by: Scientific or professional association, S. Leigh Verbois HS>;z^ eJ_ER%!gPm5IWba4IEVl>tp?ms&/bYHLIJ:Y~KkA0&j%5* on FederalRegister.gov NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018 A Notice by the Centers for Disease Control and Prevention on 02/14/2018 Published Document AGENCY: Centers for Disease Control and Prevention, HHS. You may submit written comments, identified by docket numbers CDC-2020-0046 and NIOSH-233-C, by either of the following two methods: Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2020-0046; NIOSH-233-C]. CDC twenty four seven. 112 0 obj <> endobj While every effort has been made to ensure that Take part in a one-day public meeting in Washington, DC on August 28, 2007. 141 0 obj <>stream Document Drafting Handbook These can be useful The list was compiled from information provided by four institutions that had generated lists of hazardous drugs for their respective institutions, as well as a list from the Pharmaceutical Research and Manufacturers of America (PhRMA). While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. a hazardous drug. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. No attempt i8U Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services. Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. The 2016 list adds 34 drugs and includes a review of the 2004 list. 0000069655 00000 n The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016. Register, and does not replace the official print version or the official developer tools pages. endstream endobj 4763 0 obj <>/Metadata 93 0 R/Outlines 97 0 R/Pages 4760 0 R/StructTreeRoot 106 0 R/Type/Catalog/ViewerPreferences<>>> endobj 4764 0 obj <>/MediaBox[0 0 792 612]/Parent 4760 0 R/Resources<>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 4765 0 obj <>stream documents in the last year, by the Indian Affairs Bureau Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. We take your privacy seriously. 0000001505 00000 n electronic version on GPOs govinfo.gov. For additional information, see the package inserts for these drugs. Comments must be received by July 30, 2020. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. CDC twenty four seven. Pfizer Global Environment, Health, and Safety, PhRMA NIOSH requests public comment on the updated draft of the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, as well as the draft NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and the draft Managing Hazardous Drugs Exposures: Information for Healthcare Settings. Toxicology, Occupational Health, Industrial Hygiene, Reviewers Selected by: NIOSH, ASHP, ONS, ANA, VA, OSHA, FDA, PhRMA, and BIO, Public Nominations Requested for Reviewers: No, Opportunities for the Public to Comment: Yes, Peer Reviewers Provided with Public Comments Before Their Review: Yes, Cynthia Reilly Directorate of Standards and Guidance This notice announces the extension of the comment period until July 30, 2020. Submitted comments may not be available to be read until the agency has approved them. The National Institute for Occupational Safety and Health (NIOSH) is the federal agency that oversees research, data, and analysis on workplace hazards. The tables below provide the stakeholder reviews received regarding NIOSH's proposal to place or not place drugs on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List). Recommended by: Scientific or professional association, Bruce Naumann This notice announces the extension of the comment period until July 30, 2020. OSHA/DOL The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond. Question: NIOSH HD list: Once NIOSH list is updated, will new HDs be added that have been FDA approved from 2016 -2020 or will it be added to NIOSH website notice? on Qh+Q0' PUNGF)AEx8I$d,TDI "s}Rp$u}!ZIV;I@ A$! Merck & Co., Inc. 3607 0 obj <>stream 0000027413 00000 n 4762 0 obj <> endobj These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. 01/18/2023, 159 documents in the last year, by the Engineers Corps and the Environmental Protection Agency The National Institute for Occupational Safety and Health (NIOSH, / n a /) is the United States . hWn8>/xN"nZGm5"gC#RjF6XOC` documents in the last year, 480 Recommended by: NIOSH, Katie Slavin We take your privacy seriously. 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