About the Federal Register and III.B: bevacizumab, botulinum toxins, darbepoetin alfa, interferon beta-1b, osimertinib, trastuzumab, and triazolam. NIOSH should clarify the criteria described in the footnote and explain how evidence against these various criteria is evaluated, how each independent line of evidence is systematically and critically appraised, how the quality and risk of bias of individual studies is evaluated, how conflicting information is arbitrated, and how the totality of the data is synthesized. NIOSH will consider conducting a systematic review if such studies become available relating to the hazard that a specific drug may pose in healthcare settings. 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. This feature is not available for this document. In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. The draft Policy and Procedures document was developed to formalize the methodology NIOSH uses to guide the addition of hazardous drugs to the List and create a process for requesting the removal from or placement of drugs on the List. Centers for Disease Control and Prevention, HHS. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. Register documents. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 6. 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 NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH. On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. Ibrutinib was identified as a drug for which the available information shows a toxic effect that does not meet the NIOSH definition of a hazardous drug; blinatumomab was proposed for placement on the List on the basis of evidence which shows the drug is a neurotoxin at low doses. Accordingly, NIOSH proposes to place exenatide on the List. documents in the last year, 24 Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. Peer review comment: NIOSH should offer an example of why a drug identified as a hazardous drug because it poses as carcinogenic hazard might not be a classified as a carcinogen pursuant to the NIOSH Chemical Carcinogen Policy. documents in the last year, 887 Hazardous-Drugs-Lists-Where-to-Look - Pharmacy Practice News 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. Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? 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. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. Employing this same train of thought to the draft policy and procedures, it would, in my opinion, be a best practice to add the drug that has insufficient information to the List until suitable scientific evidence demonstrates that it should not be included.. USP Peer review comment: NIOSH should consider a more detailed process when evaluating study quality because [t]he issue related to the quality of a study and, in turn, the strength of data i.e. 3. Comment: Azole antifungal drugs are being treated inconsistently. As such, the use of animal studies to evaluate the hazardous nature of a drug should be explicitly stated.. NIOSH also invites comments specifically on the following questions related to this activity: 1. DRAFT - NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in II. [1], Fifty-seven submissions were received in docket CDC-2018-0004 (NIOSH-233-B) from 55 commenters (one commenter sent three separate submissions to the docket). 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. What additional information would improve its usefulness and why? NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the Application section is removed. NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. 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). CN-20-058-00 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. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. documents in the last year, 422 The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Animal studies, where available, are also used in our evaluations. Comment: Dihydroergotamine should not be placed on the List. The FDA requirements for tested and reported endpoints generally overlap with the NIOSH definition of a hazardous drug. In light of these changes, NIOSH proposes a new List structure, described in the preamble to the draft List, which is available for review in the docket for this activity. of the issuing agency. This drug was reviewed by NIOSH for a previous update to the, This drug was reviewed by NIOSH and presented in the 2018 FRN; it did not meet the criteria for a hazardous drug. If you are using public inspection listings for legal research, you 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. However, because NIOSH has reaffirmed in the draft Procedures that only those drugs approved by the FDA Center for Drug Evaluation and Research are included in the List, BCG is no longer included in the List. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Ensuring Your Hazardous Drug List and Assessment Of Risk Are USP <800 NIOSH Updates List of Hazardous Drugs in Healthcare Settings for 2020 A new peer review was not conducted. However, the remaining parts of the draft policy and procedures mentions that animal studies should be reviewed . documents in the last year, 1471 PDF 2017 - Usp It is unclear if NIOSH will conduct meta-analyses to test for consistency of results; how NIOSH will interpret evidence for, or absence of, concordance across species or between structural analogs of the drug; whether NIOSH will conduct categorical regression analyses to evaluate dose-response data; and how NIOSH evaluates routes of exposures. The Procedures should state that this list is [a] hazard identification and not a risk assessment exercise. Information about this document as published in the Federal Register. The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. Many of the drugs currently used to fight cancer function differently than those previously used. Comment: NIOSH indicated that 10 drugscetuximab, ibrutinib, ipilmumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinibdemonstrated available information that shows a toxic effect that does not meet the NIOSH definition of a hazardous drug. Accordingly, NIOSH primarily uses information available in the package inserts to make determinations about whether to place a drug on the List. . NIOSH response: A systematic review is a significant undertaking requiring the prior publication or dissemination of multiple studies relating to a specific drug. In that case, NIOSH may consider it to be appropriately grouped with carcinogenic drugs, although it would not necessarily meet the criteria for an occupational carcinogen according to the NIOSH Chemical Carcinogen Policy. hazardous drugs. 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. NIOSH appreciates that a timelier List might be helpful and is working toward that end. corresponding official PDF file on govinfo.gov. Similarly, small-molecule kinase inhibitors, such as afatinib, crizotinib, dabrafenib, and imatinib, act through a targeted mechanism of action and are not directly cytotoxic; they primarily pose a reproductive and teratogenic risk. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. documents in the last year, by the Energy Department From my perspective, as a minimum, this should include porters, ward aides and unit clerks.. to the courts under 44 U.S.C. Self-Regulatory Organizations; NYSE Arca, Inc. Economic Sanctions & Foreign Assets Control, Smoking Cessation and Related Indications, Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, Authority To Order the Ready Reserve of the Armed Forces to Active Duty To Address International Drug Trafficking, Revitalizing Our Nation's Commitment to Environmental Justice for All, Centers for Disease Control and Prevention, DRAFT - Managing Hazardous Drug Exposures: Information for Healthcare Settings, DRAFT - NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. that agencies use to create their documents. NIOSH response: NIOSH has determined that teratogenicity occurred in rats at doses approximately 0.3 percent of therapeutic doses in humans. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? documents in the last year, 125 are not part of the published document itself. Comment: Interferon beta-1b should not be placed on the List, or, in the alternative, it should only be placed on Table 3. In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. 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. 05/01/2023, 244 NIOSH created and periodically updates the List to assist employers in providing safe and healthful workplaces by offering a list of drugs that meet the NIOSH definition of a hazardous drug. Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. For example, three drugs were added to the 2016 List after it was initially published; they are identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 web page, https://www.cdc.gov/niosh/docs/2016-161/default.html. <800> Hazardous DrugsHandling in Healthcare Settings - USP-NF 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. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. Peer review comment: NIOSH's discussion of an employer-performed site-based risk assessment to control the risk of exposure is confusing when placed in a document describing NIOSH's hazard identification procedures. the Federal Register. NIOSH response: The manufacturer provided information indicating that multiple evaluations of pregnancy registries did not provide any signals suggesting negative pregnancy outcomes associated with interferon beta-1b. NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. NIOSH is seeking input from the public on the draft risk management strategies document and table to ensure that they contain accurate and helpful information. documents in the last year, 1407 Therefore, in accordance with the draft Procedures some monoclonal antibodies may not meet the NIOSH definition of the term hazardous drug. Because the list of drugs proposed for placement on the List has been updated based on the draft Procedures, the monoclonal antibodies bevacizumab and trastuzumab are no longer proposed for placement on the List. In February 2018, NIOSH proposed adding 21 drugs (including one class of drugs) to the List. If available, NIOSH would give preference to them over animal and in vitro studies. Comment: Add a new category for drugs that sublime and offer information about proper handling, including the conditions under which sublimation (transition of a solid substance to a gas) happens as well as the need to filter and exhaust the work area where such drugs are used. This table of contents is a navigational tool, processed from the offers a preview of documents scheduled to appear in the next day's In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. Federal Register :: Hazardous Drugs: Draft NIOSH List of Hazardous NIOSH response: NIOSH has determined that teratogenicity or other developmental toxicity after exposure to osimertinib were observed at doses higher than the maximum recommended human dose and reproductive effects at doses lower than the maximum recommended human doses were equivocal. CDC twenty four seven. Two reviewers had questions about the information thresholds required to evaluate drugs, and all reviewers had editorial suggestions for improving the clarity of the draft. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? 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. Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. Polypeptides of this size and larger have been shown to have bioavailability through relevant routes of exposure. The Public Inspection page In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. Most were concerned . . 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. The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick Federal Register provide legal notice to the public and judicial notice For example, NIOSH found that ibrutinib had developmental effects in animals but only at doses twice the maximum recommended human dose of 560 mg/day. The requestor need only provide some new information that is relevant to the issue of whether the drug does or does not meet the NIOSH definition of a hazardous drug or the decision to place a drug on a particular table in the List. USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. documents in the last year, by the Food and Drug Administration Procedures for deactivating, decontaminating and cleaning. The new iteration is now referred to as draft Procedures throughout this notice. Botulinum toxins do not meet the criteria for placement on the List; abotulinumtoxinA and rimabotulinumtoxinB did not have labeling changes during the search period January 2014 through December 2015, and changes to the labels for onabotulinumtoxinA and incobotulinumtoxinA do not meet the criteria for organ toxicity at low doses or teratogenicity or other developmental toxicity. The definition of a hazardous drug in the draft Procedures recognizes that the molecular properties of a drug, such as the molecular weight, may substantially limit the potential for adverse health effects. ET on July 30, 2020 Any additional information from any interested party that will assist with further reviews of the botulinum toxins will be reviewed for potential placement on the List in the future. 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. 6. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. The OFR/GPO partnership is committed to presenting accurate and reliable At this time, NIOSH has chosen not to list any of the identification numbers but is considering doing so in the future. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. the document speaks to the need for individual healthcare workplaces to create their own lists of hazardous drugs, but this places the burden of regulation on these institutions themselves, or more likely individuals within these institutions. Register, and does not replace the official print version or the official Accordingly, NIOSH proposes to place olaparib on the List. 05/01/2023, 39 PDF NIOSH List of Antineoplastic and Other Hazardous Drugs in - CDC The United States Pharmacopeia General Chapter <800> standards focus on controlling occupational exposure to hazardous drugs while also protecting patients. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. This PDF is The current List created by NIOSH requires an extensive review process that does not readily allow more frequent publication. USP's standard on the safe handling of hazardous drugs (HD), General Chapter <800>, became official on December 1, 2019. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies.
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