Stakeholder Comments . Brookfield, Wis. As of June 15, 2020, the National Institute for Occupational Safety and Health (NIOSH) has received 23 separate comments on its much-awaited document, "NIOSH List of Hazardous Drugs in Healthcare Settings, 2020.". 2018, 2020, 2021, 2022 Alberta Health Services (Pharmacy Services, Health Professions Strategy and Practice and Workplace Health and Safety) and Covenant Health (Pharmacy Services) . The list of hazardous drugs referred to in USP 800 is the list published by the National Institute for Occupational Safety and Health (NIOSH). 3. . NIOSH Pocket Guide to Chemical Hazards 3rd Printing. The committee reviewed 73 new drug approvals and 198 drugs with new warnings. Description. Revision 12/2021. Nearly 507,000 documents were downloaded from the NIOSH website in 2021. Additionally, all investigational drugs will be handled as . The list was compiled from information provided by four institutions that had generated lists of haz- . Skip directly to site content Skip directly to page options Skip directly to A-Z link. It is included on the current NIOSH List in Table 1 2. 2022. Peer reviewers provided comments on each drug screened and evaluated by NIOSH, as described in the Federal Register notice published in NIOSH Docket 233-B. ardous drug list (NIOSH 2010 and 2012), NIOSH had previously recommended standard precau-tions (universal precautions) be taken in handling NIOSH List of Hazardous Drugs in Healthcare Settings 2020; and Managing Hazardous Drug Exposures, . The peer reviewers' comments in the tables below are organized by drug. See BC Cancer Provincial Pharmacy Directive VI-80 Hazardous Drug List (currently under . A change in hazardous drug content (18 hazardous drugs have been added, and 5 hazardous drugs have been removed). NIOSH evaluates each drug on an individual basis and does not group drugs into classes. If you have any questions regarding hazardous drugs please submit them to Email CDC-INFO or call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348) In Fall 2021, Wanda will begin her Master Jurisprudence in Health Law and Policy at Texas A&M University. Because investigational drugs are not fully or partially approved by FDA-CDER, they may not have been reviewed for safe . 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). The NIOSH Docket is a repository of NIOSH policy products (documents, policy responses, testimony, and other types of NIOSH policy statements) and related materials. Designed specifically for Retail, LTC, and Non-Sterile Pharmacies. NIOSH Docket Office. LIST OF HAZARDOUS DRUGS The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare. NIOSH Update: National Safety Stand-Down to Prevent Falls in Construction. 3. DHHS (NIOSH) Publication No. . 5. Drugs to be evaluated include new Food and Drug Administration (FDA) approvals and existing drugs with new FDA warnings, usually black box warnings . The document also describes the process for requesting drugs' removal from or placement on the list. Appendix A of the Alert, NIOSH identified a sample list of hazardous drugs. Are antineoplastic drugs hazardous? 2. 6 NIOSH Hazardous Drug List Antineoplastic Agents-89 Hormonal Agents-21 Biological Agents-8 Antiviral Agents-7 Immunosuppressant Agents-5 Antibiotics-1 Vaccines-1 (NIOSH, 2004) NIOSH Hazardous Drug List Original hazardous drug list (2004) Utilized existing lists from 4 organizations List generated by the Pharmaceutical Research and Manufacturers of Congress passed the Occupational Safety and Health Act of 1970 that created NIOSH "to assure so far as possible every working man and woman in the Nation safe and healthful working conditions.". PP&P 's 2021 USP <800> survey noted that 23% of institutions handling investigational drugs currently take this approach. It was updated in 2010 and 2012. Acetone liquid N/ABlack EPA Repiratory precaution: for all compounding and administration of hazardous liquids/solutions that have inhalation potential, plus cutting or crushing of oral tablets Acitretin Blue Trash Yellow NIOSH Ventilation : for the compounding or preparation of all hazardous drugs USP and NIOSH in limbo. Appendix A: Duke University Health System Hazardous Drug List Appendix B: Safe Handling Procedures for Preparing Hazardous Drugs . The proposed NIOSH List 2020 reflects; 1.A change in format (5 tables in NIOSH List 2016 to 2 tables in NIOSH List 2020), 2. NIOSH's list of Hazardous Drugs is located here. 2. NIOSH has developed an extensive review process in order to continuously update its list of hazardous drugs. Hazardous Medication List PPE Chart. The list is entitled "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings". In 2021 we will celebrate the 50th anniversary of the National Institute for Occupational Safety and Health (NIOSH). MS-C-34. "NIOSH received comments from more than 180 individual commenters in the public comments. Videos. the national institute for occupational safety and health (niosh) of the centers for disease control and prevention (cdc), in the department of health and human services announces that the following draft documents are available for public comment: (1) niosh procedures for developing the niosh list of hazardous drugs in healthcare settings Will meet USP <800>, OSHA, and EPA requirements and can be used for any spill including bodily fluids. Centers for Disease Control and Prevention. NIOSH List A hazardous drug is identified by one or more of these criteria: Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity A new drug that has a structure and toxicity profile that mimics an existing hazardous drug 8 Columbus Regional Healthcare System Hazardous Drug Inventory List 2022 Table 1 - Drugs having MSHI in the PI and/or meet the NIOSH definition of a hazardous drug and are classified by the NTP as known to be a human carcinogen or probably carcinogenic are in Red. Title USP <800> Hazardous Drugs-Handling in Healthcare Settings Section TX II-24 Issue Date September 22, 2020 . Additionally, some of the . 2016-161 (Supersedes 2014-138). The BC Cancer Hazardous Drug List will be made available in each BC Cancer Regional Centre Pharmacy. The format for the 2014 list was revised to include three groups of hazardous drugs: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; and (3) Drugs with reproductive effects. The NIOSH List of Antineoplastics and Other Hazardous Drugs, 2016 update, is still the current finalized list. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020 list. alcohols (ethanol, methanol, isopropanol etc) > 24% methyl methacrylate (if not solidified) hydrogen peroxide chloroprep (if ampoule is not broken) collodian acetone anesthesia gases/liquids vidrape (if not completely used) barium sulfate (unused, non-dispensed or expired) sulfuric, nitric, phosphoric and acetic acids chloroform foramaldehyde September 2016. NIOSH also provides criteria used to identify new HDs that become available after the most current NIOSH list has been published. The new drafts, entitled the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 ( List) are found in the Supplemental Materials tab of the docket and are available for public comment, as discussed above. 1. Stakeholders provided comments on each drug . Non-chemotherapy drugs that meet one or more of the NIOSH criteria for a hazardous drug. 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 . September 2021 PRISONS Health and Wellness Services Policies and Procedures III . NIOSH Update: NIOSH honors staff, partners, and collaborators at 2022 Science and Service Awards ceremony. Certified Equipment List. NIOSH has developed an extensive review process in order to continuously update its list of hazardous drugs. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs. Hazardous Drug List. Many organizations are or will soon be fully compliant with the 2019 USP revisions. Hazardous drugs include those used for cancer chemotherapy, some antiviral drugs, hormones, and bioengineered drugs. . Facility NIOSH List of Hazardous Medications . Work precautions for handling hazardous drugs highlighted by NIOSH, OSHA, Joint Commission. Remember NIOSH hazardous drugs must be safely handled and disposed of; but, they are not necessarily disposed of as RCRA hazardous waste. USP General Chapter <800> Hazardous DrugsHandling in Healthcare Settings. 2. Pharmacy & Hazardous Drug Spill Kit. The top five most downloaded documents were: 1. Defines standard processes and staff guidance for safe practices during these activities. NIOSH is currently responding to all those comments and making the appropriate changes to the documents. CDC twenty four seven. 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. Department of Health and Human Services. We have a total of 283 videos there, and in 2021 they were viewed 300,000 times. 1. TO DATE: The NIOSH Hazardous Drug List 2016 is the official list The NIOSH Hazardous Drug 2020 is in final revision The NIOSH Hazardous Drug List 2020 ONLY reviews drugs up through 2015 SO, Pharmacy Buyers have an opportunity to assist in identifying hazardous drugs as they are purchased, especially new drugs 2021 GreatWorks LLC 7 8 This includes drugs that exhibit one or more of the following characteristics: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or having a structure and toxicity profile . NIOSH classifies hazardous drugs as those that exhibit any of the following 6 characteristics in humans or animals: Carcinogenicity. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 2. The National Institute for Occupational Safety and Health (NIOSH) recently released the updated list of hazardous drugs, bringing the total to well over 100 Date of Approval: March 22, 2021. In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. For the first time, a Spanish language blog was among the top five most-viewed blog . Reproductive toxicity. Proposed Additions to the NIOSH Hazardous Drug List 2018 . ASHP is pleased to submit comments . Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings is intended to formalize the methodology that NIOSH uses to add hazardous drugs to its list. Under the NIOSH Procedures, a drug may be removed from the NIOSH HD List based on either (1) written request from an interested party or (2) a change to the packet insert. 1090 Tusculum Avenue. The comments range from short paragraphs to relatively lengthy entries. Hazard Recognition. PP&P 's 2021 USP <800> survey noted that 23% of institutions handling investigational drugs currently take this approach. Teratogenicity/other developmental toxicity. This list of hazardous drugs was first published in September 2004. LIST OF COMMON HAZARDOUS DRUGS (HDS) This Appendix is taken verbatim from the NIOSH List of and Other Hazardous Drugs in Healthcare Settings, 2016, DHHS (NIOSH) Publication No. American Society of Hospital Pharmacists. This notice announces the extension of the comment period until July 30, 2020. Cincinnati, OH 45226-1998. 4 The NIOSH On January 30, 2019, ASA submitted detailed petitions that followed NIOSH procedures to remove drugs the national institute for occupational safety and health (niosh) of the centers for disease control and prevention (cdc), in the department of health and human services announced that the following draft documents were available for public comment: (1) niosh procedures for developing the niosh list of hazardous drugs in healthcare settings Drugs to be evaluated include new Food and Drug Administration (FDA) approvals and existing drugs with new FDA warnings, usually black box warnings . NIOSH Pocket Guide to Chemical Hazards 3rd Printing 3. Exposures to hazardous drugs can cause both acute and chronic health effects such as rashes, adverse reproductive outcomes . Cancer chemotherapy, antivirals, and hormone therapies are only some of drugs listed in the 2016 NIOSH list. ramucivumab rasburicase rituximab natalizumab Annual Review Completion Date December 15, 2021 Steven Williams, RPh . NIOSH Update: Workers Memorial Day 2022: Statement by NIOSH Director John Howard, M.D. In 2020, NIOSH posted 88 new blog posts. WASHINGTON - Hospital and health care employers were reminded today that hazardous drugs such as antineoplastic drugs can pose serious job-related health risks to workers if proper precautions are not used in handling the drugs. 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. This Revision Bulletin will not result in any The entity's list must be reviewed at least every 12 months. In addition to many of these drugs being cytotoxic, the majority are hazardous to males . This list is not all-inclusive and represents an assessment of some, but not all, marketed drugs at a fixed point in time. A change in placement of hazardous drugs on specific tables. Thus, the <800> requirements for antineoplastic HDs will continue to apply to antineoplastic drugs in Table 1 of the 2016 NIOSH list. Table 1: Table 1 now includes drugs that meet the NIOSH definition of a hazardous drug and contain MSHI in the package insert; and/or are classified by the NTP . the new drafts, entitled the procedures for developing the niosh list of hazardous drugs in healthcare settings (procedures) and the niosh list of hazardous drugs in healthcare settings, 2020 (list) are found in the supplemental materials tab of the docket and are available for public comment, as discussed above. RE: Docket CDC-20180004, Docket Number NIOSH- 233B for "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018; Request for Comment". Waste Management Sustainability Services. Antineoplastic drugs, also known as chemotherapy, cytotoxic and oncology drugs, are used to treat cancer, as well as arthritis, The list was compiled from information provided by four institutions that have generated lists of hazardous drugs for their respective facilities and by the Pharmaceutical Research and Manufacturers of America (PhRMA) from the American Hospital Formulary . 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