and III.B: bevacizumab, botulinum toxins, darbepoetin alfa, interferon beta-1b, osimertinib, trastuzumab, and triazolam. 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. by the Comptroller of the Currency, the Federal Reserve System, and the Federal Deposit Insurance Corporation Comment: NIOSH should clarify how close chemical analogs are identified, and whether NIOSH establishes site concordance across analogs and how evidence for and against the absence of concordance is interpreted. 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. on NARA's archives.gov. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. Comment: Osimertinib should not be placed on the List. 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 NIOSH response: This refers to human genotoxicity studies, which are rarely available. 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. As part of the update process for the List of Hazardous Drugs in Healthcare Settings, 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, is seeking public comments on the draft documents through July 30, 2020. The drugs and rationales for each of them include the following: NIOSH response: Each of these drugs has either been previously reviewed and found not to meet the NIOSH definition of a hazardous drug, falls outside the scope of the List, or is slated for review in the future. If emailing please type “508 Accommodation PR#9342” without quotes in the subject line of the email. NIOSH is proposing to regroup the drugs by hazards. Information about this document as published in the Federal Register. NIOSH will begin the reevaluation process for any request to add or remove a drug that provides some new supporting evidence by searching for additional hazard identification (toxicity) and hazard characterization information about the drug that is relevant to the criteria set out in the NIOSH definition of a hazardous drug. . Please provide any additional studies or scientific information that support or validate the use of the NIOSH recommended control strategies or alternative strategies to control exposures to hazardous drugs. NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. 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. Comment: Prior to USP <800>, the NIOSH List was considered a “precautionary recommendation.” But the USP <800> standards are too restrictive and overreaching, and the chapter's incorporation into state law places facilities at legal risk if they fail to comply. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. Peer review comment: “Following the 60-day period to allow for public and stakeholder consultations, it is unclear if NIOSH will be responding to any parties that have provided comments. 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 … In response to peer reviews and public comments, 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. Links to the draft documents can be found here. The Procedures should state “that this list is [a] hazard identification and not a risk assessment exercise. NIOSH's findings about each drug are as follows: Comment: The hormonal agents in Table 1 of the 2016 List that are exclusively reproductive risks, including estrogens (estrogen agonist-antagonists such as tamoxifen and antiestrogens such as anastrozole, exemestane, and letrozole), gonadotropins (leuprolide and triptorelin), antigonadotrophins (degarelix), and progestins (megestrol) should be moved to Table 2 or 3. A look at the full Draft board, which includes official and reported trades from the 2020 NBA Draft. 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. Commenters included pharmacists, professional organizations and associations, pharmaceutical manufacturers, medical centers and/or health systems, individuals who provided their names but not their affiliations, a company that provides risk assessments, a drug database, an insurance company, a medical school professor, a neurologist, and an anonymous commenter. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. NIOSH encourages public input on the question of which ingredient identifier may be the most useful for the List. If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. The subsequent description of a site risk Start Printed Page 25441assessment does not seem appropriate here. on 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. Genotoxicity: Cited studies demonstrated genotoxicity in male rats at high doses (2 grams/kilogram). Accordingly, NIOSH has determined that interferon beta-1b does not meet the criteria for a hazardous drug and is no longer proposing to place it on the List. Most importantly, the definition of the term “hazardous drug” would now acknowledge that “hazard characterization” is an important factor for drugs under consideration. Peer review comment: Some paragraphs in the section entitled, “Evidence of Health Effects in Workers from Handling Hazardous Drugs” do not belong in the scientific approach section and should be moved to be part of section B “Systematic and Sequential Methodology” section. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. The Federal Docket folder of supporting information behind the NIOSH proposal includes not only a draft of the actual 2020 list and the document on managing drug exposures, but also a draft of the procedures NIOSH used to develop the 2020 list. The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies. 2020 NBA Draft results: Picks 1-60. Not allowing public commenters to review peer reviews before submitting their own comments to the docket is “in conflict with the principle of transparency” established in the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664, Jan. 14, 2005). NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. 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. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). .” whereas public comment, including stakeholder review, often provides NIOSH with crucial feedback on how a project or publication may impact the interests of employees, stakeholder organizations, or other parties. Therefore, NIOSH no longer proposes to place osimertinib on the List. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. That said, when NIOSH becomes aware of new drugs with MSHI, NIOSH identifies such drugs on the web page for the current List to immediately alert stakeholders. If the latter is the case, could a sentence be added to clarify that?”. In February 2018, NIOSH proposed adding 21 drugs (including one class of drugs) to the List. 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. 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. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services. This site displays a prototype of a “Web 2.0” version of the daily In its place, NIOSH has developed a new, comprehensive document on risk management strategies entitled, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which includes a revision of this table on control approaches to safe handling of hazardous drugs. NIOSH response: The majority of these evaluations are based on the information provided in the drug package insert; thus, NIOSH relies on the quality of science generated by a drug manufacturer, subsequently reviewed by FDA during the drug approval process, and then published in the drug package insert. documents in the last year, 10 documents in the last year, 929 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. NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. NIOSH appreciates that a timelier List might be helpful and is working toward that end. Independent peer reviewers are being consulted as well; their charge is available on the NIOSH website [9] USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on 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. Risk Management for Hazardous Drugs in Healthcare Settings, Read the 86 public comments on this document, https://www.federalregister.gov/d/2020-09332, MODS: Government Publishing Office metadata, https://www.cdc.gov/​niosh/​docs/​2016-161/​default.html, https://www.cdc.gov/​niosh/​topics/​hazdrug/​peer-review-plan.html, https://www.usp.org/​frequently-asked-questions/​hazardous-drugs-handling-healthcare-settings, https://www.cdc.gov/​niosh/​review/​peer/​isi/​healthsafetyrisks.html. Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. This count refers to the total comment/submissions received on this document as reported by Regulations.gov. These three drugs do not appear below because they are not subject to public comment. 4. It hopes to use research to … 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. 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.”. 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. Comment: The language in the section titled “Application” indicates that the draft Policy and Procedures do not apply to healthcare workers who handle recombinant therapeutic proteins. 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. 8. on Two commenters offered editorial suggestions for clarifying language in the draft; although the comments are not summarized here, changes were made to the revised draft Procedures as appropriate.Start Printed Page 25446. Use the PDF linked in the document sidebar for the official electronic format. 3. NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. 1503 & 1507. Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. About the Federal Register NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. 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. Until the ACFR grants it official status, the XML documents in the last year, by the Fish and Wildlife Service In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. NIOSH must add criteria for animal studies to include the recovery/reversibility of adverse effects and the pharmacological relevance of the test species. 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. 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. A Notice by the Centers for Disease Control and Prevention on 05/01/2020. 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. These can be useful The List should also indicate that hazardous drugs that do not sublime may be exhausted through a HEPA filter back into the work area. The draft Procedures is in the docket for this activity. 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. is not clearly outlined with respect to the evaluation process. Each document posted on the site includes a link to the Please note that all comments submitted through Beta, both d 12/02/2020, 40 Relevant information about this document from Regulations.gov provides additional context. There seems to be no “mechanism in place for labeling investigational (i.e., non-FDA approved drugs used in preclinical and clinical research prior to submission of an NDA [new drug approval]) drugs as potential human health hazards. Peer review comment: NIOSH should clarify a sentence concerning NIOSH's preference for human genotoxicity data which states: “If available, NIOSH gives preference to those studies. Comment: Dihydroergotamine should not be placed on the List. A third draft document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, is intended to help employers establish workplace-specific management procedures for hazardous drugs. 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. 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) uses to determine whether a drug 2 meets the criteria in the NIOSH definition of a hazardous drug. As stated in the OMB Final Information Quality Bulletin for Peer Review (Bulletin), “[p]eer reviewers shall be charged with reviewing scientific and technical matters. Please provide any additional studies or scientific information that support or validate evidence-based strategies or approaches for controlling exposures to hazardous drugs that are different from those that NIOSH has proposed. for better understanding how a document is structured but Darbepoetin alfa should not be placed on the List. [3] NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. Comment: Ivabradine should not be placed on the List. daily Federal Register on FederalRegister.gov will remain an unofficial Please provide specific examples. To learn more about the list visit … 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. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. USP added clarification about the application of chapter <800> to hazardous drugs, which can be found on its FAQ page.[4]. documents in the last year, 344 NIOSH response: The majority of drug evaluations are based on information provided in the drug package insert; NIOSH relies on the quality of science Start Printed Page 25442generated by a drug manufacturer, subsequently reviewed by FDA during the drug approval process, and then published in the drug package insert. 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. Comments may be submitted, identified by docket numbers CDC-2020-0046 and NIOSH-233-C, by either of the following two methods: Instructions: All information received in response to this notice must include the agency name and the docket numbers (CDC-2020-0046; NIOSH-233-C). NIOSH response: FDA-approved drugs generally have a reasonable body of toxicity information because the manufacturers are required by FDA to provide this information to ensure patient safety when seeking approval for their drugs. regulatory information on FederalRegister.gov with the objective of developer tools pages. Reproductive toxicity: The package insert contains MSHI stating, “Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients” due to the risk of transmission of talimogene laherparepvec and herpetic infection. 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. documents in the last year, 1471 According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. We’ve made big changes to make the eCFR easier to use. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. documents in the last year, by the Internal Revenue Service The draft Policy and Procedures used to develop the drugs proposed for placement on the List in the February 2018 FRN described the methodology used by NIOSH since 2010. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. NIOSH list of hazardous drugs in healthcare settings 2020. Is there a scientific justification for them? May 2020. NIOSH also invites comments specifically on the following questions related to this activity: 1. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. 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. 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. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. 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. NIOSH's extensive review process only allows for periodic updates of hazardous drugs that do not have MSHI. Get the latest news and information on your favorite teams and prospects from CBSSports.com. Comment: FDA-approved drugs should be reviewed in real time or NIOSH should provide “off-cycle” updates to the List. on Two very similar drugs may have substantially different toxicities and at different doses. The Federal Register Notice for the Draft of the 2020 NIOSH List of Hazardous Drugs is now available. Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. The new risk management document is available for review in the docket for this activity. legal research should verify their results against an official edition of Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. NIOSH response: NIOSH's rationale for proposing the placement of triazolam on the List was that it mimics the benzodiazepines which are included on the List because they are teratogenic or cause other developmental effects. In mice, doses near the maximum recommended human dose lead to increased neonatal death. In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. Therefore, NIOSH has regrouped the tables by hazard. In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. 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. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. NIOSH Peer Review Agenda, https://www.cdc.gov/​niosh/​review/​peer/​isi/​healthsafetyrisks.html. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. NIOSH has published for comment the long-awaited revised 2020 Hazardous Drug List along with information for managing hazardous drug exposure and the NIOSH procedures for developing the list. 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