Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. 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. 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 . Two drugs included in the 2018 FRN, inotuzumab ozogamicin and trabectedin, have MSHI and are automatically added to the 2016 List. should verify the contents of the documents against a final, official Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? 9. The goal of the standard is to help protect health - care workers from the risks associated with handling hazardous drugs. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Usp 800 | Usp NIOSH response: A systematic review is a significant undertaking requiring the prior publication or dissemination of multiple studies relating to a specific drug. . . 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. 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: FDA-approved drugs should be reviewed in real time or NIOSH should provide off-cycle updates to the List. documents in the last year, 24 This information is not part of the official Federal Register document. NIOSH response: A drug may be removed from the List based on either a written request from an interested party or a change to the package insert. 1503 & 1507. 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. 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 draft Procedures reflects peer review and public comment; the list of drugs proposed for placement on the List has been updated based on the revised draft Procedures. What structural or format changes could be made to improve the utility of this table? You can review and change the way we collect information below. In mice, doses near the maximum recommended human dose lead to increased neonatal death. Please provide specific examples. For complete information about, and access to, our official publications 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. 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] NIOSH Finalizes Procedures for Developing Hazardous Drug List Please refer to the current edition of the USP-NF for official text. documents in the last year, 887 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. NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. This feature is not available for this document. 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. Centers for Disease Control and Prevention. 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. Comment: While NIOSH describes several Bradford Hill criteria[6] NIOSH also sought comment on a draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (Policy and Procedures). Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. 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.. 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. 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.. This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. and III.B: bevacizumab, botulinum toxins, darbepoetin alfa, interferon beta-1b, osimertinib, trastuzumab, and triazolam. 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 . documents in the last year, 494 [3] USP <800> Public comment: Several commenters offered suggestions on the document's use of USP <800>. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. The new risk management document is available for review in the docket for this activity. It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. 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. the Federal Register. by the Securities and Exchange Commission If available, NIOSH would give preference to them over animal and in vitro studies. NIOSH response: FDA-approved drugs generally have a reasonable body of toxicity information because the manufacturers are required by FDA to provide this information to ensure patient safety when seeking approval for their drugs. Therefore, in accordance with the draft Procedures some monoclonal antibodies may not meet the NIOSH definition of the term hazardous drug. Because the list of drugs proposed for placement on the List has been updated based on the draft Procedures, the monoclonal antibodies bevacizumab and trastuzumab are no longer proposed for placement on the List. NIOSH response: NIOSH relies on a range of knowledge, experience, and skills to evaluate drugs for placement on the List, including but not limited to pharmacology, toxicology, medicine, and risk evaluation. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? 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. Public Comment Summaries and NIOSH Responses, B. PDF NIOSH Procedures for Hazardous Drugs draft - CDC 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. 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.
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