Six commenters were critical of the methodology NIOSH described for adding drugs to the List and asked that NIOSH clarify the language in certain sections of the draft Policy and Procedures. In February 2018, NIOSH proposed adding 21 drugs (including one class of drugs) to the List. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. Accordingly, NIOSH continues to propose placing ivabradine on the List. However, after consideration of input from the public and stakeholders, NIOSH has decided to review the toxicity and the hazards related to occupational exposure to botulinum toxins. Centers for Disease Control and Prevention. 05/01/2023, 244 the material on FederalRegister.gov is accurately displayed, consistent with The OFR/GPO partnership is committed to presenting accurate and reliable In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. Data on the developmental effects of itraconazole and ketoconazole suggest developmental toxicity has only been observed in doses greater than the maximum human recommended dose. rendition of the daily Federal Register on FederalRegister.gov does not . Register, and does not replace the official print version or the official Comment: Osimertinib should not be placed on the List. 9. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. Under the draft Procedures, NIOSH's rationale, including a description of any meta-analysis or systematic review if performed, and final determination would be described in a notice published in the Federal Register. regulatory information on FederalRegister.gov with the objective of See https://www.cdc.gov/niosh/docs/2016-161/default.html for all drugs with special handling information added to the 2016 List. documents in the last year, 422 The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose. Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from Table 1. . electronic version on GPOs govinfo.gov. In mice, doses near the maximum recommended human dose lead to increased neonatal death. 04/30/2020 at 8:45 am. Relevant information about this document from Regulations.gov provides additional context. This site displays a prototype of a Web 2.0 version of the daily documents in the last year, 669 . Those monoclonal antibodies that are not directly cytotoxic or conjugated with a cytotoxic agent should be moved from Table 1 to another place on the List. What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? Although rare, NIOSH notes any labeling changes that could affect the status of a drug that has been previously classified as hazardous. 3. Comment: Interferon beta-1b should not be placed on the List, or, in the alternative, it should only be placed on Table 3. Answer: The NIOSH list is not intended to rank hazards. General Chapter <800> was published on February 1, 2016. After review, NIOSH now finds that the information in the package insert for this drug does not support a determination that it presents a hazard to healthcare workers and is no longer proposing to place it on the List. The Public Inspection page NIOSH response: The List is updated any time NIOSH is aware that a drug manufacturer has added special handling information to the patient information for a specific drug. the current document as it appeared on Public Inspection on Comment: Eight drugs were approved by FDA prior to December 2015, but do not appear on the 2016 List and were not proposed for placement on the List in the February 2018 FRN. the official SGML-based PDF version on govinfo.gov, those relying on it for The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. All relevant comments received will be posted without change to www.regulations.gov,, including any personal information provided. In light of these changes, NIOSH proposes a new List structure, described in the preamble to the List, which is available for review in the docket for this activity. However, the remaining parts of the draft policy and procedures mentions that animal studies should be reviewed . The List now comprises only two tables: Table 1: Drugs that contain MSHI in the package insert and/or meet the NIOSH definition of a hazardous drug and are classified by NTP as known to be a human carcinogen, or classified by IARC as carcinogenic or probably carcinogenic., Table 2: Drugs that meet the NIOSH definition of a hazardous drug, but do not have MSHI and are not classified by NTP as known to be a human carcinogen, or classified by IARC as carcinogenic or probably carcinogenic.. You will receive an e-mail containing your requested General Chapter downloads after submission. 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. Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. 2020-09332 Filed 4-30-20; 8:45 am], updated on 4:15 PM on Monday, May 1, 2023, updated on 8:45 AM on Monday, May 1, 2023. b. Comment: Hazardous drugs should also be identified by UNII code (the unique ingredient identifier used by FDA and USP) on the List. Peer review comment: NIOSH should mention some other common healthcare job categories that are likely to be exposed . documents in the last year, 1407 Accordingly, NIOSH proposes to place dihydroergotamine on the List. The FDA requirements for tested and reported endpoints generally overlap with the NIOSH definition of a hazardous drug. Comment: It is unclear how NIOSH interprets evidence of increasing progression or severity with increased dose, and how the value for low dose was derived. Peer review comment: NIOSH should add administrative controls when discussing engineering controls, personal protective equipment, and other steps to manage the risk of exposure, because of their significance in the well-accepted hierarchy of controls for minimizing exposure to workplace hazards.. used to evaluate information from human studies in footnote 44 of the draft Policy and Procedures, no rationale is offered to explain why many of the original nine Bradford Hill criteria are not used. NIOSH response: A drug may be considered a hazardous drug but not a chemical carcinogen if, for example, a drug manufacturer includes a carcinogenicity warning in the drug's package insert but the evidence for carcinogenicity has not been reviewed by the International Agency for Research on Cancer (IARC); the National Toxicology Program (NTP), within the U.S. Department of Health and Human Services; the U.S. Environmental Protection Agency (EPA); or independently by NIOSH. that agencies use to create their documents. should verify the contents of the documents against a final, official The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. Centers for Disease Control and Prevention, HHS. In addition, having an algorithm to determine the strength of a paper will also aid in minimizing any potential inter- and intra-reviewer differences. Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020: Summary of Changes, C. NIOSH List of Hazardous Drugs in Healthcare Settings, 2020Title, Reorganization, and Removals, IV. This text is a courtesy copy of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings, intended to be used as an informational tool and resource only. Comments must be received by June 30, 2020. Seven commenters asked questions and offered suggestions about the procedures themselves. NIOSH carefully considered all of the peer reviews and public comments and determined that significant, substantial changes should be made to the draft Policy and Procedures, the list of drugs proposed for placement on the List, and also to the organization of the List itself. Although there is currently some guidance in the footnotes, it may be worthwhile to consider a more detailed evaluation process of relevant studies and place it in a more prominent location in the document or possibly as an Appendix.. Changes to the List structure would place all drugs that meet the NIOSH definition of a hazardous drug and contain MSHI in the package insert and/or are classified by the National Toxicology Program (NTP) as known to be a human carcinogen, or classified by the International Agency for Research on Cancer (IARC) as carcinogenic or probably carcinogenic on Table 1. 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 In a Federal Register notice (FRN) published on February 14, 2018 (83 FR 6563), NIOSH invited the public to participate in the development of the List and the procedures used to develop the List by submitting written views, opinions, recommendations, and/or data. See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. Because the way cancer is treated therapeutically has changed, and the types of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. If available, NIOSH would give preference to them over animal and in vitro studies. NIOSH response: A systematic review is a significant undertaking requiring the prior publication or dissemination of multiple studies relating to a specific drug. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? Peer Review Summaries and NIOSH Responses, Identifying, Screening, Evaluating, and Reviewing a Drug for Placement on the, Reconsideration (Reevaluation) of NIOSH Decisions to Place and Remove Drugs, B. Cited studies in the package insert also demonstrate impaired fertility in rats. Blinatumomab continues to be proposed for placement and other monoclonal antibodies that have properties meeting the NIOSH definition of a hazardous drug will remain on the List. corresponding official PDF file on govinfo.gov. to the courts under 44 U.S.C. . 1. Therefore, when antineoplastic drugs are grouped, as they were in earlier versions of Table 1, drugs that required different levels of protection were grouped together (non-cytotoxic drugs with cytotoxic drugs). CDC twenty four seven. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. NIOSH response: The daily therapeutic dose at which serious organ toxicity, developmental toxicity, or reproductive toxicity occurs (10 mg/day in human adults and 1 mg/kg per day in laboratory animals) has long been used by the pharmaceutical industry to develop occupational exposure limits (OELs) of less than 10 g/m[3] after applying appropriate uncertainty factors. NIOSH response: NIOSH views peer review and public comment as two distinct, often complementary, tools in ensuring both quality and transparency in influential scientific information products. 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 (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List), including those drugs proposed for placement on the 2020 List, and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. Are these standard or commonly accepted definitions of 'low dose' exposure? Antineoplastic cytotoxic medications, anesthetic agents, anti-viral agents, and others, have been identified as hazardous. Carcinogenicity: Cited studies demonstrated an increased incidence of various oncologic presentations (hepatocellular adenoma/carcinoma, interstitial cell hyperplasia, and uterine endometrial adenocarcinoma), in multiple animal species (rat and mice) at exposure lower than human doses (0.7-1.4 fold in rats and 0.3-0.7 fold in mice compared to a human dosing). In my opinion, a review of any animal studies should be conducted as they may offer insight regarding the potential risk posed by a drug. ASHP submitted comments in response to the 2020 draft documents in support of this new format. When studies are available for review of a drug being considered for placement on the List or for the reevaluation of a drug already on the List, quality may be evaluated by NIOSH scientists and independent peer reviewers on a case-by-case basis. Comment: Monoclonal antibodies do not have a cytotoxic mechanism of action and, as such, do not pose the same level of occupational risk or toxicity as conventional antineoplastic drugs. Therefore, NIOSH no longer proposes to place osimertinib on the List. I wonder whether the current regulatory climate permits NIOSH any level of control over the handling of drugs in this category.. The Public Inspection page may also Polypeptides of this size and larger have been shown to have bioavailability through relevant routes of exposure. NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. As discussed extensively in the notice published February 14, 2018, NIOSH identified 275 potentially hazardous drugs between January 2014 and December 2015 (83 FR 6563). Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Most were concerned . Section C of the draft Procedures, which includes the evaluation criteria, would be expanded to include new clauses 4 and 5 to allow NIOSH to consider additional factors beyond the intrinsic toxicity of the drug molecule in determining whether to place the drug on the List. documents in the last year, 825 Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adenomas in mice. The ordering of the tables in the List implies risk stratification; USP <800> supports this impression by requiring heightened handling requirements for Table 1 drugs. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. on NARA's archives.gov. documents in the last year, 84 This table of contents is a navigational tool, processed from the One additional drug, polatuzumab vedotin, was approved by FDA's Center for Drug Evaluation and Research in July/August 2019 and its package insert includes MSHI provided by the drug's manufacturer. 2. on Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH.
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