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>. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. Therefore, all recombinant therapeutic proteins should be excluded from the List unless science-based or product-specific circumstances dictate otherwise.. 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. 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. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. on FederalRegister.gov Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. Two very similar drugs may have substantially different toxicities and at different doses. 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.. 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. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. USP <800> Hazardous Drugs Risk Readiness Checklist Implementation Date December 1, 2019 USP <800> Hazardous Drugs - Handling in Health Care was published on February 1, 2016 with an implementation date of December 1, 2019. Urofollitropin AHFS Class: Ovulation stimulator. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. 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. NIOSH did not take into account the real risk of occupational exposure or the mechanism of action of this relatively large molecule. 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. Animal studies, where available, are also used in our evaluations. .. PDF NIOSH List of Antineoplastic and Other Hazardous Drugs in - CDC 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. In embryo-fetal development studies of dihydroergotamine mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses approximately 0.4-1.2 times the exposures in humans receiving the maximum recommended daily dose of 4 mg or greater. b. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. are not part of the published document itself. The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. 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.. In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? documents in the last year, 931 About the Federal Register 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). The Procedures should state that this list is [a] hazard identification and not a risk assessment exercise. 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. This information is not part of the official Federal Register document. NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. 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. A Notice by the Centers for Disease Control and Prevention on 05/01/2020. headings within the legal text of Federal Register documents. '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.' Thank you for taking the time to confirm your preferences. Comment: Azole antifungal drugs are being treated inconsistently. [1], 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). 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. Centers for Disease Control and Prevention, HHS. If so, perhaps this could be referenced with a footnote.. 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. You can review and change the way we collect information below. . Docket 233-C: List of Hazardous Drugs in Healthcare Settings, 2020 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. In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List. on documents in the last year, 825 The ordering of the tables in the List implies risk stratification; USP <800> supports this impression by requiring heightened handling requirements for Table 1 drugs. 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. Should you have any questions, please contact Tiffany Chan, Associate Scientific Liaison, Healthcare Quality and Safety ( CompoundingSL@usp.org ). NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. The agency has updated its List of Hazardous Drugs in Healthcare Settings for 2020 as well as its procedures for developing the list. More information and documentation can be found in our On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. Moreover, USP <800>requires the use of personal protective equipment for Table 1 drugs, which may delay care or undermine patient safety. . relative risk, odds ratios, etc. 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. 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. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? Federal Register issue. Because there is conflicting evidence about the hazard posed by botulinum toxins to the workers who handle these drugs, NIOSH is not proposing the placement of botulinum toxins on the List at this time and invites additional studies, data, and expert opinions pertinent to this issue in order to evaluate the botulinum toxins more fully. The USP <800> requirements standardizing the safe handling of hazardous drugs went into effect December 1, 2019. Hazardous Drugs: Procedures for Developing the NIOSH List of Hazardous used to evaluate information from human studies in footnote 44 of the draft Policy and Procedures, no rationale is offered to explain why many of the original nine Bradford Hill criteria are not used. The purpose of the <800> chapter is to describe practice and quality standards for handling hazardous drugs (HD) in .