niosh list 2020 draft
, 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). 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. Register (ACFR) issues a regulation granting it official legal status. See USP, FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings, https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. Because the way cancer is treated therapeutically has changed, and the classes of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic or genotoxic. Table 2 would now contain drugs that meet one or more of the NIOSH hazardous drug criteria and may be developmental and/or reproductive developmental toxins but are not drugs which have MSHI or are classified as carcinogens or probable carcinogens by NTP or IARC. For example, monoclonal antibodies “are too large to be absorbed through skin contact, and if ingested, they would be destroyed by digestion; if inhaled, the pulmonary system would prevent absorption. Animal data on the developmental effects of fluconazole suggest developmental changes in rats at doses less than the equivalent maximum human recommended dose of 400 mg/day. As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. 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. 8. 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. This criterion is typically only used when toxicity information specific to the drug under evaluation is insufficient or unavailable but is available for the chemical analog. 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. From an occupational hygiene perspective, if there is no existing occupational exposure limit or threshold limit value for a chemical hazard, the best practice is to ensure that worker exposure to the chemical remains As Low As Reasonably Achievable (ALARA). 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. Please describe what you found to be most or least effective and why. Accordingly, NIOSH proposes to place exenatide on the List. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. Document Drafting Handbook . NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the “Application” section is removed. NIOSH response: NIOSH has determined that teratogenicity occurred in rats at doses approximately 0.3 percent of therapeutic doses in humans. 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.”. The drugs pose the greatest risk to healthcare workers, “based on a combination of volatility and dose-related toxic potential of those vapors.”. Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. 3. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. May 2020. 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: 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. 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. NIOSH has determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for users. 12/02/2020, 297 It is not an official legal edition of the Federal corresponding official PDF file on govinfo.gov. 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. Hormonal agents that are classified by NTP as “known to be a human carcinogen” or by IARC as “carcinogenic” or “probably carcinogenic” will be identified in Table 1. Register, and does not replace the official print version or the official on 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. 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. 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 … 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. As such, the use of animal studies to evaluate the hazardous nature of a drug should be explicitly stated.”. Because drugs with MSHI are automatically placed on the List and are not subject to public or peer review, polatuzumab vedotin was added to the 2016 List in September 2019 and will appear in the 2020 List. It hopes to use research to … Is the information threshold scientifically sound? NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. and includes the following questions. NIOSH has formalized the methodology NIOSH uses to guide the addition of drugs to or removal of drugs from the List, in a document entitled Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures).1 As stated in the Procedures, NIOSH defines a hazardous drug as a drug that is: 1 NIOSH . regulatory information on FederalRegister.gov with the objective of the Federal Register. Requests to Add, Remove, or Move a Drug between Tables of the List Public Comment Summaries and NIOSH Responses, B. 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). documents in the last year, 302 In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. 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). Listen to ASHPOfficial episodes free, on demand. . Is there a scientific justification for them? 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). publication in the future. on Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. Open for Comment, Economic Sanctions & Foreign Assets Control, Threatened Species Status for Whitebark Pine, Animal and Plant Health Inspection Service, Organization and functions (Government agencies), Addressing the Threat From Securities Investments That Finance Communist Chinese Military Companies, Establishing the President's Advisory 1776 Commission, Centers for Disease Control and Prevention, II. Peer review comment: NIOSH should clarify “how the threshold dosages (10 mg/day or 1 mg/kg/day) for defining organ toxicity at 'low doses' . NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. 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. NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. 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. Each document posted on the site includes a link to the No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. Peer review comment: NIOSH should list further tools to aid employers to protect workers. Cited studies in the package insert also demonstrate impaired fertility in rats. when determining the potential for adverse health effects of hazardous drugs in healthcare workers. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. The documents posted on this site are XML renditions of published Federal On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. to the courts under 44 U.S.C. daily Federal Register on FederalRegister.gov will remain an unofficial Therefore, NIOSH has regrouped the tables by hazard. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. documents in the last year, 1471 documents in the last year, by the Fish and Wildlife Service Comments are invited on any topic related to the procedures and drugs identified in this notice, including three draft documents: (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 identified in this notice as being proposed for placement on the List; and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. . This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. The Public Inspection page may also 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. NIOSH response: NIOSH is reorganizing and streamlining the document to make it more easily understood and to move information on site risk assessment to a separate draft document, Managing Hazardous Drug Exposures: Information for Healthcare Settings. 2. 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. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. Comment: The List should identify those hazardous drugs that are both cytotoxic and cytostatic as well as volatile. 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. 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. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. Include relevant publications if available. 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. If new information becomes available about any of these drugs, NIOSH will reevaluate them in a future update to the List. . 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. Links to the draft documents can be found here.  Darbepoetin alfa should not be placed on the List. The Procedures should state “that this list is [a] hazard identification and not a risk assessment exercise. NIOSH Docket Number 233-C, CDC-2020-0046. It is scheduled to be re-reviewed for the next update to the, This oncolytic viral therapy product is outside the scope of NIOSH's definition of a hazardous drug because it is approved by FDA's Center for Biologics Evaluation and Research. 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. NIOSH response: The NIOSH List is adopted, endorsed, and/or referenced by a number of non-governmental organizations, including the American Society of Health-System Pharmacists (ASHP), The Joint Commission, and the Oncology Nursing Society. Because Start Printed Page 25443Table 1 includes drugs identified as antineoplastic, NIOSH should clarify the rationale and intent of Table 1, since drugs used as antineoplastics, but which are not cytotoxic or genotoxic, as traditional antineoplastics are, have been included. NIOSH response: The rationale for proposing the placement of each drug to the List is provided in the Federal Register notice preceding the final List publication.  Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. Comment: Exenatide should not be placed on the List. A new peer review was not conducted. 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. 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. 12/02/2020, 865 NIOSH list of hazardous drugs in healthcare settings 2020. 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. Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information. Docket Folder Summary View all documents and comments in this Docket . The package insert also cites gefitinib as exhibiting teratogenicity. 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.”. Therefore, NIOSH no longer proposes to place osimertinib on the List. 6. Furthermore, some drugs carry multiple American Hospital Formulary Service (AHFS) code classifications and are not solely used as antineoplastic drugs. 1. 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.”. Many of the drugs currently used to fight cancer function differently than those previously used. 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. documents in the last year. Only when a labeling change results in the addition of MSHI to a package insert will NIOSH automatically consider the drug to be a hazardous drug and add it to the List. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. electronic version on GPO’s govinfo.gov. A Notice by the Centers for Disease Control and Prevention on 05/01/2020. Public Comment Summaries and NIOSH Responses, III. 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). documents in the last year, by the Centers for Medicare & Medicaid Services 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. 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. If emailing please type “508 Accommodation PR#9342” without quotes in the subject line of the email. Until the ACFR grants it official status, the XML Accordingly, drugs that sublime should be handled using risk management strategies relevant to the conditions of use. 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. Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. 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. 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 … The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. edition of the Federal Register. If so, perhaps this could be referenced with a footnote.”. Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. Comment: Hazardous drugs should also be identified by UNII code (the unique ingredient identifier used by FDA and USP) on the List. 04/30/2020 at 8:45 am. These can be useful 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. 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. 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. 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. 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. 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. 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.”. 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, 929 To view the notice and related materials, visit http://www.regulations.govexternal icon and enter CDC-2020-0046 in the search field and click “Search.”. 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. Public comments on the draft Policy and Procedures and the drugs proposed for placement on the List and peer review summaries on specific drugs proposed for placement on the List are available in dockets CDC-2018-0004 and NIOSH-233-B. 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.
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