. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. 2020 NBA Draft results: Picks 1-60. documents in the last year, 1471 NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. NIOSH also sought comment on a draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (Policy and Procedures). NIOSH Docket Number 233-C, CDC-2020-0046. NIOSH has determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for users. By Connor TH, MacKenzieBA, DeBordDG, Trout DB, O’Callaghan JP, OvesenJL, Whittaker C. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safe ty and Health, DHHS (NIOSH) Publication Number 2020 -xxx on Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. This count refers to the total comment/submissions received on this document as reported by Regulations.gov. 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. relative risk, odds ratios, etc. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. The fact that FDA has requirements for reporting of relevant safety related data supports the NIOSH presumption that a lack of information on an endpoint indicates a lack of concern for a specific type of hazard. are not part of the published document itself. These markup elements allow the user to see how the document follows the In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. For some of these drugs, no drug-specific data were available in the package inserts to support warnings in the inserts regarding developmental or reproductive effects; for other drugs, the toxic effects occurred at doses higher than human recommended doses. These tools are designed to help you understand the official document As cancer therapy has changed from primarily cytotoxic drugs to non-cytotoxic and targeted therapies, there is sometimes a mismatch in general recommendations for safe handling and the hazardous nature of the drugs. [3] 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. Are there any issues not considered by the charge questions that should be addressed. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. Data evaluation submitted to the docket by the manufacturer demonstrates that interferon beta-1b is not causally associated with spontaneous abortion or with any “patterns or signals suggesting pregnancy outcomes.” Research on Start Printed Page 25447populations who have received interferon beta-1b throughout pregnancy have demonstrated no difference in spontaneous abortions or birth weight compared to population comparators. Until the ACFR grants it official status, the XML Docket ID: CDC-2020-0046. No labeling change has ever resulted in the removal of a drug from the List, but labeling changes that demonstrate a lack of evidence of toxicity would be dealt with in the regular List updates. The rationale for placing interferon beta-1b on the List is that information from the package insert indicated reproductive toxicity: spontaneous abortion in human clinical trials. . Polypeptides of this size and larger have been shown to have bioavailability through relevant routes of exposure. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. In this Issue, Documents This site displays a prototype of a “Web 2.0” version of the daily 12/02/2020, 137 A look at the full Draft board, which includes official and reported trades from the 2020 NBA Draft. The draft Procedures document is now focused on NIOSH's procedure for identifying hazardous drugs and no longer discusses managing the risk of exposure. 6. . Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. 4th Edition, (Burlington, MA: Jones & Bartlett). As such, they should be moved from Table 1 to another place on the List. and includes the following questions. 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. The inclusion of MSHI makes such drugs automatically hazardous under the NIOSH definition and thus, the extensive review process is not required. 3. b. In that case, important criteria for animal studies include strength of association; consistency between studies; relevance of the model system and routes of exposure; the duration, reversibility, and recoverability of the observed effects; and concordance of those effects with effects in humans. If so, perhaps this could be referenced with a footnote.”. The Federal Register Notice for the Draft of the 2020 NIOSH List of Hazardous Drugs is now available. 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. Additionally, peer reviews provide the Agency with a review of its science; peer reviewers and their credentials are identified in the NIOSH Peer Review Agenda.Start Printed Page 25445, Commenters: NIOSH should identify the criteria used to evaluate study quality and strength, and describe how they are used to critically appraise the quality and risk of bias and other limitations of individual studies; arbitrate conflicting information; and synthesize the totality of animal and human studies data in support of, or opposition to, the listing of a drug as “hazardous.”. 12/02/2020, 382 We’ve made big changes to make the eCFR easier to use. The other 273 were screened and the information available for 44 drugs suggested one or more toxic effects; those drugs were evaluated by NIOSH and shared with peer reviewers and stakeholders. . NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. 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. A new peer review was not conducted. Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? NIOSH did not take into account the real risk of occupational exposure or the mechanism of action of this relatively large molecule. This document has been published in the Federal Register. NIOSH Peer Review Agenda, https://www.cdc.gov/​niosh/​review/​peer/​isi/​healthsafetyrisks.html. Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. documents in the last year, 235 1. Therefore, when drugs are grouped by their function (i.e., antineoplastic), as they were in earlier versions of Table 1, drugs that required different protective measures were grouped together (non-cytotoxic drugs with cytotoxic drugs). Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? 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… If a meta-analysis or systematic review is warranted for a reevaluation, NIOSH would consider these criteria on a case-by-case basis. to the courts under 44 U.S.C. This information is not part of the official Federal Register document. 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). Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). 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 (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. 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. 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. Information about the application of the List can be found in the introduction of the draft Managing Hazardous Drug Exposures: Information for Healthcare Settings. . In mice, doses near the maximum recommended human dose lead to increased neonatal death. Learn more here. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? documents in the last year, 108 1. Most importantly, the definition of the term “hazardous drug” would now acknowledge that “hazard characterization” is an important factor for drugs under consideration. This prototype edition of the on Comment. One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH. . 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. documents in the last year, by the State Department Peer-reviewed, published studies are usually not available and therefore evaluating the quality of studies is not typically possible. Please provide feedback on the overall document: a. These changes now reflected in the draft Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (draft Procedures) include the clarification of some language and streamlining the procedures NIOSH uses to determine the hazard potential of a specific drug. 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. In humans receiving 400 mg/day or higher developmental effects consistent with animal data have been observed and epidemiological data suggest a risk of spontaneous abortions and congenital abnormalities in infants whose mothers were treated with 150 mg/day fluconazole. Comment: Hazardous drugs should also be identified by UNII code (the unique ingredient identifier used by FDA and USP) on the List. In February 2018, NIOSH proposed adding 21 drugs (including one class of drugs) to the List. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. NIOSH is adding text to clarify the agency's intent. Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adenomas in mice. has no substantive legal effect. The subsequent description of a site risk Start Printed Page 25441assessment does not seem appropriate here. Register, and does not replace the official print version or the official NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. NIOSH response: As presented in the 2018 FRN, daratumumab and dinutuximab were reviewed and did not meet the NIOSH criteria for a hazardous drug because the available information about each drug's toxicity was insufficient to support placement on the List. NIOSH has determined that exenatide extended-release caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats. Comment: While NIOSH describes several Bradford Hill criteria [6] 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. include documents scheduled for later issues, at the request Comment: Providing sufficient information to rebut a NIOSH determination to add or not add a drug to the List is difficult for healthcare organizations. Therefore, NIOSH has regrouped the tables by hazard. Seven commenters expressed concern about the impact of USP <800> on the NIOSH List, and, in turn, the effect on small pharmacies that compound pharmaceutical drugs. NIOSH appreciates that a timelier List might be helpful and is working toward that end. 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. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. These drugs should be placed on the List because of their teratogenic and/or reproductive effects or the rationale for not proposing their placement on the List should be further explained. The draft Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is in the docket for this activity, is intended to assist employers in establishing their own hazardous drugs management procedures specific to their workplace. NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. Comment: Monoclonal antibodies (i.e., therapeutic proteins) are of such a large molecular weight that they do not pose a realistic risk to healthcare workers. Moreover, caution should be taken when making determinations about potentially hazardous drugs because causality is not necessarily demonstrated by a strong association just as absence of causality is not necessarily demonstrated by weak associations; associations that demonstrate a monotonic trend in health outcome frequency (steadily increasing or decreasing without ever changing direction) are not necessarily causal if a confounding factor demonstrates a dose-response relationship with the health outcome; and prior beliefs should not be allowed to cloud judgment with regard to plausibility. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. Risks associated with how and how often a hazardous drug is used in a particular setting, and evaluation of exposure factors for all occupational exposures is beyond the scope of the List. Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information. Comment: The drugs ibrutinib and blinatumomab, both antineoplastic monoclonal antibodies, are treated inconsistently in the February 2018 FRN. Although assessing specific controls for specific exposure situations is beyond the scope of the List, information about the use of respiratory protection in the handling of hazardous drugs is found in the draft risk management document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is available in the docket for this activity. 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. The documents are the “NIOSH List of Hazardous Drugs in Healthcare Settings,” “Managing Hazardous Drug Exposures: Information for Healthcare Settings” and “Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare … In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. documents in the last year, 746 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. See https://www.cdc.gov/​niosh/​topics/​hazdrug/​peer-review-plan.html for the peer review plan for the draft Policy and Procedures. 25442 (May 1, 2020). Comment: Olaparib should not be placed on the List because the risk to direct occupational healthcare worker exposure is anticipated to be minimal when handling intact olaparib capsules. rendition of the daily Federal Register on FederalRegister.gov does not This drug is scheduled to be reviewed for the next, Because drugs sold over the counter are not contemplated in this activity, this drug has not been and will not be reviewed for placement on the, This drug was reviewed by NIOSH and presented in the 2018 FRN; the available information shows a toxic effect that does not meet the NIOSH definition of hazardous drug. when determining the potential for adverse health effects of hazardous drugs in healthcare workers. that agencies use to create their documents. 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niosh list 2020 draft

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