. The available information does not demonstrate or support a determination that the drug meets the NIOSH definition of hazardous drug. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. See USP, FAQs: <800> Hazardous DrugsHandling in Healthcare Settings, https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. Comment: FDA-approved drugs should be reviewed in real time or NIOSH should provide off-cycle updates to the List. 4th Edition, (Burlington, MA: Jones & Bartlett). This clearly infers human studies only. Which unique ingredient identifier is the most useful for users of the List? Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. 2020-N-0145 for ''Reporting Associated With Animal Drug and Animal Generic Drug User Fees.'' Received comments, those filed in a timely manner (see NIOSH response: A systematic review is a significant undertaking requiring the prior publication or dissemination of multiple studies relating to a specific drug. to the courts under 44 U.S.C. Therefore, at this time NIOSH is no longer proposing to place the class of botulinum toxins on the 2020 List. Peer review comment: It may be inappropriate for NIOSH not to place drugs on the List when NIOSH has determined there is insufficient information to support the placement. include documents scheduled for later issues, at the request NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the Application section is removed. Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. documents in the last year, 84 While some large molecular weight drugs may have low bioavailability by relevant routes of exposure, other factors in the characterization of the hazard are considered as well. 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. Please explain. [7] 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. The last paragraph of this section is particularly confusing to the reader. NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. The package insert also cites gefitinib as exhibiting teratogenicity. Two very similar drugs may have substantially different toxicities and at different doses. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. documents in the last year, 422 About the Federal Register headings within the legal text of Federal Register documents. 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. 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 is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. 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. The list was compiled from information provided by four institutions that had generated lists of haz- . 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. The documents posted on this site are XML renditions of published Federal If the latter is the case, could a sentence be added to clarify that?. . This convention was prepared to implement USP General Chapter <800> on December 1, 2019, which would have been an enforceable standard for managing sterile and non-sterile hazardous . In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. informational resource until the Administrative Committee of the Federal On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. 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. 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. Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? 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). 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. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. Information about this document as published in the Federal Register. Polypeptides of this size and larger have been shown to have bioavailability through relevant routes of exposure. NIOSH encourages public input on the question of which ingredient identifier may be the most useful for the List. 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. 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. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. 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. Free Download USP GC <800>Register for live webcastGC <800> Infographic. Review their work plan and past meeting summaries. Are these standard or commonly accepted definitions of 'low dose' exposure? So, any drugs that were approved after 2015, other than those 10 drugs added on March 23, 2022, must be evaluated by your pharmacy as . Manufacturer recommendation: that females of reproduction potential use effective contraception during and for four months after completing therapy. Both drugs should be placed on the List because information available in the respective package inserts indicates that both drugs may cause teratogenic effects. better and aid in comparing the online edition to the print edition. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. 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. 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. on NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. 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. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. NIOSH response: The reviewer has interpreted the NIOSH statement differently than what the agency intended. Relevant information about this document from Regulations.gov provides additional context. 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. ASHP submitted comments in response to the 2020 draft documents in support of this new format. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. 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. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. 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. It is not an official legal edition of the Federal 05/01/2023, 858 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). 5. the current document as it appeared on Public Inspection on List of Hazardous Drugs. [8] Regardless of when the NIOSH 2020 list is finalized, the list states, "Drugs reviewed for this update were new drug approvals or received safety-related new warnings from FDA in the period between January 2014 and December 2015" 3 (emphasis added). Accordingly, drugs that sublime should be handled using risk management strategies relevant to the conditions of use. The United States Pharmacopeia General Chapter <800> standards focus on controlling occupational exposure to hazardous drugs while also protecting patients. [3] Is there a scientific justification for them? Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. We take your privacy seriously. Genotoxicity: Cited studies demonstrated genotoxicity in male rats at high doses (2 grams/kilogram). that agencies use to create their documents. NIOSH response: NIOSH reviews the relevant data on a drug when a label change is made, not just the data relating to the label change. NIOSH response: The manufacturer provided information indicating that multiple evaluations of pregnancy registries did not provide any signals suggesting negative pregnancy outcomes associated with interferon beta-1b. 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. 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. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. . The draft Procedures considers the toxicity criteria in the definition of a hazardous drug to identify the hazard and some intrinsic molecular properties to characterize the hazard[5] USP General Chapter <800 . USP added clarification about the application of chapter <800> to hazardous drugs, which can be found on its FAQ page.[4]. Centers for Disease Control and Prevention, HHS. Seven commenters opposed the inclusion of biological drug products (monoclonal antibodies) on the List. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. These changes now reflected in the draft Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (draft Procedures) include the clarification of some language and streamlining the procedures NIOSH uses to determine the hazard potential of a specific drug. 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. The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies. This text is a courtesy copy of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings, intended to be used as an informational tool and resource only. NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. In this Issue, Documents Peer review comment: NIOSH should provide a more robust description of the evaluation criteria to include that these are shared across a number of other professional organizations and panels which also endorsed these same criteria.. Furthermore, some drugs carry multiple American Hospital Formulary Service (AHFS) code classifications and are not solely used as antineoplastic drugs. 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' . Drawing conclusions from a methodologically flawed paper can lead to misclassification of a drug. Risk Management for Hazardous Drugs in Healthcare Settings, 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. ET on July 30, 2020 . . . NIOSH created and periodically updates the List to assist employers in providing safe and healthful workplaces by offering a list of drugs that meet the NIOSH definition of a hazardous drug. 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. NIOSH does not offer peer reviews for public comment for any scientific publications because the technical and scientific review conducted by independent peer reviewers are not NIOSH products. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. and services, go to
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