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. documents in the last year, 83 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. 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. . . Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. Comments must be received by June 30, 2020. Access 200+ compounding-related standards, Know your exposure and download the HazRx Mobile App, USP Compounding and Hazardous Drugs Courses, Hazardous DrugsHandling in Healthcare Settings, Promoting the Quality of Medicines Plus (PQM+) Program, USP Monographs for Bulk Drug Substances and Other Ingredients, National Institute for Occupational Safety and Health (NIOSH), Revision Bulletin published to clarify the term antineoplastic for the purpose of Chapter <800>, Revision Bulletin published to confirm the official date of USP General Chapter <800>, Review their work plan and past meeting summaries, Sign up for USP Healthcare Quality & Safety Updates, The United States Pharmacopeial Convention, December 1, 2019Official date for General Chapter <800>, February 1, 2016 Publication Date of General Chapter <800>. Drugs are placed on the List based on their intrinsic properties. 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. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? All three draft documents are 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. Comment: The draft Policy and Procedures should provide the drug manufacturer with transparent documentation as to the basis of adding a drug to the List. Without a thorough understanding of the basis for adding a drug, the drug manufacturer may not be able to formulate a request for reconsideration of the drug. 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. Register (ACFR) issues a regulation granting it official legal status. . You will receive an e-mail containing your requested General Chapter downloads after submission. ET on July 30, 2020 Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. The NIOSH definition of a "hazardous" drug is a drug that is: Approved for use in humans11 by the FDA's Center for Drug Evaluation and Research (CDER);12 Not otherwise regulated by the U.S. Nuclear Regulatory Commission;13 and Either: hospital. 3. Table 1. This clearly infers human studies only. rendition of the daily Federal Register on FederalRegister.gov does not NIOSH should provide the rationale for not proposing their placement on the List. headings within the legal text of Federal Register documents. and includes the following questions. However, rather than identifying job-specific titles, the document focuses on workplace activities. 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. This table of contents is a navigational tool, processed from the The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab vedotin-tftv These tools are designed to help you understand the official document About the Federal Register USP's standard on the safe handling of hazardous drugs (HD), General Chapter <800>, became official on December 1, 2019. 2. Hazardous Drugs - Overview - Occupational Safety and Health Administration USP General Chapter <800> - McKesson Medical-Surgical Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. Is the information threshold scientifically sound? These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. 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. <800> Hazardous DrugsHandling in Healthcare Settings - USP-NF 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. 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. documents in the last year, 295 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. According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. 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. 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 Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings ( Procedures) establish the NIOSH definition of a hazardous drug and a methodology for evaluating chemical properties, pre-clinical information, and available clinical information about each drug. Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020: Summary of Changes, C. NIOSH List of Hazardous Drugs in Healthcare Settings, 2020Title, Reorganization, and Removals, IV. Accordingly, NIOSH primarily uses information available in the package inserts to make determinations about whether to place a drug on the List. On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List. The new list format will allow organizations more flexibility for certain drugs when implementing USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings. It is not an official legal edition of the Federal 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>. Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on the List. NIOSH response: The daily therapeutic dose at which serious organ toxicity, developmental toxicity, or reproductive toxicity occurs (10 mg/day in human adults and 1 mg/kg per day in laboratory animals) has long been used by the pharmaceutical industry to develop occupational exposure limits (OELs) of less than 10 g/m[3] after applying appropriate uncertainty factors. This repetition of headings to form internal navigation links 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. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. Accordingly, NIOSH proposes to place exenatide on the List. NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. 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. All relevant comments received will be posted without change to www.regulations.gov,, including any personal information provided. The size of the molecule limits dermal absorption and aerosolization. NIOSH response: This refers to human genotoxicity studies, which are rarely available. Thank you for taking the time to confirm your preferences. 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. Accordingly, drugs that sublime should be handled using risk management strategies relevant to the conditions of use. NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. the Federal Register. It is unclear if NIOSH will conduct meta-analyses to test for consistency of results; how NIOSH will interpret evidence for, or absence of, concordance across species or between structural analogs of the drug; whether NIOSH will conduct categorical regression analyses to evaluate dose-response data; and how NIOSH evaluates routes of exposures. The documents posted on this site are XML renditions of published Federal 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. . 05/01/2023, 258 NIOSH does not review drugs that are not yet approved for use in humans. NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. 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. 05/01/2023, 244 2020-09332 Filed 4-30-20; 8:45 am], updated on 4:15 PM on Monday, May 1, 2023, updated on 8:45 AM on Monday, May 1, 2023. Register documents. USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. 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. provide legal notice to the public or judicial notice to the courts. 4. 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. PDF USP General Chapter <800> Hazardous DrugsHandling in Healthcare Settings Federal Register :: Hazardous Drugs: Draft NIOSH List of Hazardous 05/01/2023, 858 It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. 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. 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. electronic version on GPOs govinfo.gov. Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226, telephone (513) 533-8132 (not a toll free number), email: bmackenzie@cdc.gov. . However, the lack of What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? Therefore, NIOSH no longer proposes to place osimertinib on the List. 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. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. Answer: The NIOSH list is not intended to rank hazards. 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. Relevant information about this document from Regulations.gov provides additional context. What changes could be made to improve the utility of the information? . Please refer to the current edition of the USP-NF for official text. 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. For this reason, NIOSH encourages individual healthcare settings to develop their own formulary-specific lists of hazardous drugs, which could include investigational drugs that have not yet been approved by FDA. The List now comprises only two tables: Table 1: Drugs that contain MSHI in the package insert and/or meet the NIOSH definition of a hazardous drug and are classified by NTP as known to be a human carcinogen, or classified by IARC as carcinogenic or probably carcinogenic., Table 2: Drugs that meet the NIOSH definition of a hazardous drug, but do not have MSHI and are not classified by NTP as known to be a human carcinogen, or classified by IARC as carcinogenic or probably carcinogenic.. NIOSH should consider whether reliance on the AHFS Class 10:00 (antineoplastic agents) alone is enough to necessitate Table 1 Start Printed Page 25449inclusion even if a drug does need to be on the NIOSH list.. 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 when determining the potential for adverse health effects of hazardous drugs in healthcare workers. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. 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. 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. Comment: NIOSH should conduct or commission a meta-analysis or systematic review, [i]n the absence of published literature synthesizing the body of clinical knowledge about a specific drug. 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. . Throughout the healthcare landscape, people are asking, "What is USP 800?" In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. 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. The requestor need only provide some new information that is relevant to the issue of whether the drug does or does not meet the NIOSH definition of a hazardous drug or the decision to place a drug on a particular table in the List. documents in the last year, 84 If available, NIOSH would give preference to them over animal and in vitro studies. 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. This document has been published in the Federal Register. The President of the United States manages the operations of the Executive branch of Government through Executive orders. It would presumably be courteous to respond to any party that has provided comments for consideration..
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