Peer review comment: NIOSH should clarify whether a drug may be removed from the List based on changes to the package insert, or if written requests from interested parties to the NIOSH Director are the only mechanism for consideration of a drug for deletion from the List (the reconsideration process as described). A new peer review was not conducted. The draft Procedures document is now focused on NIOSH's procedure for identifying hazardous drugs and no longer discusses managing the risk of exposure. Not refining the List to identify real risks of occupational exposure could lead to overwarning for drugs that present little or no workplace risk. What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? documents in the last year, 1471 Accordingly, NIOSH proposes to place olaparib on the List. 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. 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. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. NIOSH must add criteria for animal studies to include the recovery/reversibility of adverse effects and the pharmacological relevance of the test species. 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. The purpose of the <800> chapter is to describe practice and quality standards for handling hazardous drugs (HD) in . on 05/01/2023, 244 Please include the URL of the site in the Subject line of your email request that you would like to access. Under the draft Procedures, NIOSH's rationale, including a description of any meta-analysis or systematic review if performed, and final determination would be described in a notice published in the Federal Register. The manufacturer or any other stakeholder is invited to comment on the sufficiency of the explanation of the basis for adding a drug to the List. General Chapter <800> was published on February 1, 2016. documents in the last year, 24 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. ET on July 30, 2020. 8. 2. Moreover, USP <800>requires the use of personal protective equipment for Table 1 drugs, which may delay care or undermine patient safety. November 02, 2020 USP 800 For Pharmacists & Healthcare Workers An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. Open for Comment. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. NIOSH also invites comments specifically on the following questions related to this activity: 1. Register, and does not replace the official print version or the official What changes could be made to improve the utility of the information? Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. Of the 275 drugs identified during that timeframe, two had special handling information specified by the manufacturer (MSHI) and were automatically placed on the List. The value for low dose should be drug-specific and a function of several factors such as normal therapeutic doses, body weight, and length of exposure. The subsequent description of a site risk Start Printed Page 25441assessment does not seem appropriate here. NIOSH response: While some drugs may have low bioavailability by relevant routes of exposure due to molecular weight, other factors in the characterization of the hazard are considered as well. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. As such, they should be moved from Table 1 to another place on the List. '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.' NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. 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 relevant publications if available. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. This document has been published in the Federal Register. Although rare, NIOSH notes any labeling changes that could affect the status of a drug that has been previously classified as hazardous. Comment: Triazolam should not be placed on the List. Comment: NIOSH indicated that two drugsdaratumumab and dinutuximabdemonstrated insufficient toxicity information available to meet the NIOSH definition of a hazardous drug. NIOSH may conduct a meta-analysis or systematic review when reevaluating the placement of a drug already on the List, if the available evidence warrants such a review. 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. . Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. Comment: The methodology used to develop the list of drugs proposed for placement on the List was not the same as the methodology used in previous years. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. For complete information about, and access to, our official publications NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. 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. 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. NIOSH encourages public input on the question of which ingredient identifier may be the most useful for the List. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. 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. documents in the last year, 29 No new information has been reported that would meet the NIOSH criteria for a hazardous drug. 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. Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. The 13 drugs proposed for placement on the List are presented for public comment in the table below, along with the rationale for their placement on the List. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? The drug's mechanism of action does not indicate DNA damage. Comment: Bacillus Calmette-Guerin (BCG) should be removed from the List. 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. Centers for Disease Control and Prevention. It would presumably be courteous to respond to any party that has provided comments for consideration.. You can review and change the way we collect information below. Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adenomas in mice. [7] No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. The list was compiled from information provided by four institutions that had generated lists of haz- . Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. 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), including those drugs proposed for placement on the 2020 List, and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List. Agenda About USP <800> Potential Risks . NIOSH defines HDs as the following: Are there other information sources that should be included? 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. USP <800> requires an assessment of risk, which is a consideration of the type of HD, dosage form, risk of exposure, packaging, and manipulation. After considering the peer and stakeholder reviews, NIOSH determined that 20 drugs and one class of drugs exhibit toxicity that meets the NIOSH definition of a hazardous drug and proposed them for placement on the List. 04/30/2020 at 8:45 am. 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. Significant peer review and public comments on the draft Policy and Procedures are summarized and answered below in Section II; public comments on specific drugs are summarized and answered below in Section III. This feature is not available for this document. hazardous drugs. documents in the last year, 9 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. All three draft documents are available in the docket for this activity. This PDF is 05/01/2023, 258 documents in the last year, 125 NIOSH has requested public comments on three draft documents: (1) the 2020 List of Hazardous Drugs; (2) Procedures for Developing the NIOSH List ("the List") of Hazardous Drugs; and (3) Managing Hazardous Drug Exposures For Health Care Settings available here . Comment: Monoclonal antibodies do not have a cytotoxic mechanism of action and, as such, do not pose the same level of occupational risk or toxicity as conventional antineoplastic drugs. NIOSH identified a sample list of hazardous drugs. offers a preview of documents scheduled to appear in the next day's Peer review comment: NIOSH did not include a mechanism to place investigational drugs on the 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. 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. 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. 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. . 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. documents in the last year, 1407 Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. 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 response: It is NIOSH practice to respond to all stakeholder and public comments and peer reviews in a Federal Register notice or in a document posted in the relevant NIOSH docket, to maintain a transparent and thorough administrative record. the current document as it appeared on Public Inspection on documents in the last year, 153 The two drugs with MSHI that were placed on the List and the 20 drugs and one drug class proposed for placement on the List were identified in the February 14, 2018 notice, along with NIOSH's rationale for each proposed addition. 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). This clearly infers human studies only. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress. This prototype edition of the Drugs are placed on the List based on their intrinsic properties. The USP <800> requirements standardizing the safe handling of hazardous drugs went into effect December 1, 2019. Written comments, identified by CDC-2020-0046 and docket number NIOSH-233-C, may be submitted by any of the following methods: 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. were derived. Therefore, all recombinant therapeutic proteins should be excluded from the List unless science-based or product-specific circumstances dictate otherwise.. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. Public Comment Summaries and NIOSH Responses, III. 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. 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. 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. 3. 05/01/2023, 39 The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. 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). NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the Application section is removed. The current List created by NIOSH requires an extensive review process that does not readily allow more frequent publication. The hazards of the drugs in Table 1 will relate to carcinogenicity or some other identified hazard by the manufacturer, usually genotoxicity/cytotoxicity. 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. edition of the Federal Register. 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. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. 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. Relevant information about this document from Regulations.gov provides additional context. by the Securities and Exchange Commission NIOSH appreciates that a timelier List might be helpful and is working toward that end. NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. Similar questions were raised about animal studies. . USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. Many of the drugs currently used to fight cancer function differently than those previously used. .. CN-20-058-00 Please provide feedback on the overall document: a. 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. For a USP chapter numbered below 1000 to become compendially required, it needs to either be referenced in General Notices, a monograph or another general chapter numbered below <1000>. 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 Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. USP General Chapter(s)800> Hazardous Drugs - Handling in Healthcare Settings (Informational)825> Radiopharmaceuticals - Preparations, Compounding, Dispensing, and Repackaging as published June 1, 2019 (Informational) First Name Last Name OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. 6. 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. If you have any questions regarding hazardous drugs please submit them to Email CDC-INFO or call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348) Please provide information about your professional experience, if any, of implementing control strategies for exposures to hazardous drugs in healthcare or similar settings. Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs?
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