The President of the United States manages the operations of the Executive branch of Government through Executive orders. NIOSH Peer Review Agenda, https://www.cdc.gov/niosh/review/peer/isi/healthsafetyrisks.html. . 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. Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. The package insert also cites gefitinib as exhibiting teratogenicity. Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. Listen to ASHPOfficial episodes free, on demand. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. Moreover, USP <800>requires the use of personal protective equipment for Table 1 drugs, which may delay care or undermine patient safety. The following seven drugs that were proposed for placement on the List in the February 2018 FRN are no longer proposed for placement on the List, for the reasons discussed above in Sections II.B. NIOSH response: As presented in the 2018 FRN, NIOSH reviewed cetuximab, ibrutinib, ipilimumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib for placement on the List and, for each, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug. NIOSH response: Only a few of the drugs on the List are known to have an appreciable vapor pressure; reliable information concerning the vapor pressure of most drugs can be difficult to identify. offers a preview of documents scheduled to appear in the next day's The public comments have been organized into the following topic areas: organization of the List and impact of United States Pharmacopeia (USP) Compounding Compendium chapter <800> Hazardous Drugs—Handling in Healthcare Settings; the nature of the List—exposure/hazard characterization; monoclonal antibodies; periodicity; methodology/process; criteria clarification; and editorial suggestions. 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. This clearly infers human studies only. “'When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug, including any studies cited in the package insert that are relevant to workers in a health care setting.' Peer review comment: NIOSH should mention “some other common healthcare job categories that are likely to be exposed . NIOSH response: In streamlining the document to make it more focused on NIOSH's procedures for identifying hazardous drugs, information on controlling the risk of hazardous drug exposure in the workplace was moved to the draft NIOSH document Managing Hazardous Drug Exposures: Information for Healthcare Settings. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. NIOSH response: Although NIOSH typically reviews the FDA database on a monthly basis, the draft Procedures no longer specifies or indicates a frequency of database review to allow for flexibility in the event of unforeseen circumstances. 2. According to the reviewer, “[t]his approach may not be appropriate if indeed the purpose of the screening is to protect the health and well-being of workers who may be exposed to hazardous drugs. and includes the following questions. 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). Moreover, NIOSH is not properly weighing the low therapeutic index of the drug against the relatively low risk of handling the drug by healthcare workers who are knowledgeable about safe handling. Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. The available information does not demonstrate or support a determination that the drug meets the NIOSH definition of hazardous drug. . Centers for Disease Control and Prevention, HHS. Submitted comments may not be available to be read until the agency has approved them. 3. documents in the last year, 22 publication in the future. NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. of the issuing agency. 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.”. 2 Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information, 85 Fed. documents in the last year, 32 While the Bulletin recognizes the benefit of both forms of input to agencies, it provides agencies with broad discretion in determining how to implement peer review, including timing as it relates to public comment, if applicable. 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. Comment: NIOSH should identify those drugs that pose a realistic risk to healthcare workers by considering such occupation exposure factors as drug type (e.g., small molecule, biologic), stability, dosage form, and route of exposure, and then evaluating them against the toxicity criteria. Darbepoetin alfa should not be placed on the List. 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. Seven commenters asked questions and offered suggestions about the procedures themselves. Drugs are placed on the List based on their intrinsic properties. 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 Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. Therefore, when antineoplastic drugs are grouped as they were in earlier versions of Table 1 of the List, an appearance that these drugs pose the same hazard was inadvertently created (i.e., non-cytotoxic drugs with cytotoxic drugs). Docket ID: CDC-2020-0046. Include relevant publications if available. 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. NIOSH did not take into account the real risk of occupational exposure or the mechanism of action of this relatively large molecule. has no substantive legal effect. Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adenomas in mice. NIOSH encourages public comment on these questions. 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. 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. 2020-09332 Filed 4-30-20; 8:45 am], updated on 4:15 PM on Wednesday, December 2, 2020, updated on 8:45 AM on Wednesday, December 2, 2020. NIOSH response: NIOSH reviews the relevant data on a drug when a label change is made, not just the data relating to the label change. NIOSH response: In response to input from peer reviewers and external comments and following scientific review, NIOSH proposes a reorganization of the tables in the draft 2020 List in a manner that may address at least some of the concerns expressed. In this Issue, Documents 12/02/2020, 865 In addition, there are no reports of teratogenicity, developmental toxicity, embryo-fetal toxicity, lethality, or reduced growth in clinical trials conducted in humans, or in real world use since FDA approval in 2015. Therefore, all recombinant therapeutic proteins should be excluded from the List unless “science-based or product-specific circumstances dictate otherwise.”. 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. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. NIOSH must add criteria for animal studies to include the recovery/reversibility of adverse effects and the pharmacological relevance of the test species. B. NIOSH response: NIOSH relies on a range of knowledge, experience, and skills to evaluate drugs for placement on the List, including but not limited to pharmacology, toxicology, medicine, and risk evaluation. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. for better understanding how a document is structured but Not refining the List to identify real risks of occupational exposure could lead to “overwarning” for drugs that present little or no workplace risk. Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information. to the courts under 44 U.S.C. See USP, FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings, https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. documents in the last year, 235 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. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. Reg. . NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. All are open for a 60 day comment period. Therefore, NIOSH no longer proposes to place osimertinib on the List. Comment: Bacillus Calmette-Guerin (BCG) should be removed from the List. NIOSH response: BCG, a vaccine approved by the FDA Center for Biologics Evaluation and Research, was included in the original 2004 Alert and `grandfathered' into the List. Two drugs included in the 2018 FRN, inotuzumab ozogamicin and trabectedin, have MSHI and are automatically added to the 2016 List. These can be useful While every effort has been made to ensure that Four independent peer reviewers and 55 public commenters offered input on the draft Policy and Procedures; their substantive comments are summarized below, followed by NIOSH responses. 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. The Public Inspection page 4. What changes could be made to improve the utility of the information? Federal Register provide legal notice to the public and judicial notice Peer-reviewed, published studies are usually not available and therefore evaluating the quality of studies is not typically possible. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. 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. While some large molecular weight drugs may have low bioavailability by relevant routes of exposure, other factors in the characterization of the hazard are considered as well. 2. NIOSH considered peer review and public comment received in response to the February 2018 FRN, and significantly revised the draft Policy and Procedures; that document is now called Procedures. Independent peer reviewers are being consulted as well; their charge is available on the NIOSH website  Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. . The individuals and organizations who commented on this issue felt that USP's use of the NIOSH List raises the List to the level of a regulatory action, and should include only antineoplastic drugs on Table 1. Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. To learn more about the list visit … This is because there is insufficient information to establish an exposure limit and, therefore, one should err on the side of caution and apply the ALARA principle. In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. Peer review comment: A statement about the evaluation procedures in the draft Policy and Procedures indicates that NIOSH would only consider human studies. 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. 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. 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. The Federal Register Notice for the Draft of the 2020 NIOSH List of Hazardous Drugs is now available. 12/02/2020, 137 Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. If available, NIOSH would give preference to them over animal and in vitro studies. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. should verify the contents of the documents against a final, official legal research should verify their results against an official edition of NIOSH consulted four independent peer reviewers, who were asked to consider the following questions: Overall, the independent peer reviewers found the draft Policy and Procedures to be clearly written and supported by the available science and the reconsideration process (now referred to as “reevaluation”) to be adequate. These tools are designed to help you understand the official document In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on the List. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. See draft Procedures footnote 18, “Properties of a drug molecule that may limit adverse effects in healthcare workers are typically chemical, physical and structural properties that affect its absorption (ability to enter the cells of the body), distribution, metabolism, and/or elimination e.g., chemical structure, molecular weight or mass.”. What structural or format changes could be made to improve the utility of this table? Consequently, these drugs are all administered by injection. 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.
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