NIOSH response: After scientific review and consideration of input from peer reviewers and public commenters, NIOSH is proposing a reorganization of the List. NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. Accordingly, NIOSH continues to propose placing ivabradine on the List. Comment: Eight drugs were approved by FDA prior to December 2015, but do not appear on the 2016 List and were not proposed for placement on the List in the February 2018 FRN. The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. 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. 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. 1. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? Fluconazole is included in the List on Table 3, but for two newer azole antifungals, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug (ketoconazole) and information does not demonstrate or support that the drug meets the NIOSH definition (itraconazole) in the FRN. Since its inception, it has been revised to keep up to date with drug development and evolution, and it is undergoing its most recent update. NIOSH response: NIOSH views peer review and public comment as two distinct, often complementary, tools in ensuring both quality and transparency in influential scientific information products. Peer review comment: NIOSH did not include a mechanism to place investigational drugs on the List. 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. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. For some of these drugs, no drug-specific data were available in the package inserts to support warnings in the inserts regarding developmental or reproductive effects; for other drugs, the toxic effects occurred at doses higher than human recommended doses. In its place, NIOSH has developed a new, comprehensive document on risk management strategies entitled, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which includes a revision of this table on control approaches to safe handling of hazardous drugs. ET on July 30, 2020. Accordingly, NIOSH is not proposing to place these two drugs on the List. 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. 6. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? offers a preview of documents scheduled to appear in the next day's NIOSH response: As presented in the 2018 FRN, NIOSH reviewed cetuximab, ibrutinib, ipilimumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib for placement on the List and, for each, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug. . Please describe what you found to be most or least effective and why. 05/01/2023, 858 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. 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. 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. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. USP 800 only states Table 1. Please provide any additional studies or scientific information that evaluate or validate engineering, work practice or administrative controls to reduce exposures to hazardous drugs in healthcare settings. Federal Register. The strategies used to manage the risk should match the hazard. Comment: NIOSH should identify those drugs that pose a realistic risk to healthcare workers by considering such occupation exposure factors as drug type (e.g., small molecule, biologic), stability, dosage form, and route of exposure, and then evaluating them against the toxicity criteria. developer tools pages. 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. Should you have any questions, please contact Tiffany Chan, Associate Scientific Liaison, Healthcare Quality and Safety ( CompoundingSL@usp.org ). USP Chapters <797> and <800> New and Revised Compounding Standards February 7, 2020 USP Chapters <797> and <800> New and Revised Compounding Standards At A Glance At Issue The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards. 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 . No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. 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. However, NIOSH did not independently evaluate triazolam. 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. on documents in the last year, by the Energy Department 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. better and aid in comparing the online edition to the print edition. The fact that FDA has requirements for reporting of relevant safety related data supports the NIOSH presumption that a lack of information on an endpoint indicates a lack of concern for a specific type of hazard. Relevant information about this document from Regulations.gov provides additional context. 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. 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. 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. 2020-N-0145 for ''Reporting Associated With Animal Drug and Animal Generic Drug User Fees.'' Received comments, those filed in a timely manner (see Polypeptides of this size and larger have been shown to have bioavailability through relevant routes of exposure. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? Employing this same train of thought to the draft policy and procedures, it would, in my opinion, be a best practice to add the drug that has insufficient information to the List until suitable scientific evidence demonstrates that it should not be included.. Peer review comment: Some paragraphs in the section entitled, Evidence of Health Effects in Workers from Handling Hazardous Drugs do not belong in the scientific approach section and should be moved to be part of section B Systematic and Sequential Methodology section. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. Comment: Bacillus Calmette-Guerin (BCG) should be removed from the List. NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. NIOSH considered peer review and public comment received in response to the February 2018 FRN, and significantly revised the draft Policy and Procedures; that document is now called Procedures. Comments must be received by June 30, 2020. The new list format will allow organizations more flexibility for certain drugs when implementing USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings. on 04/30/2020 at 8:45 am. .. The updated USP <800> requirements include: Responsibilities of personnel handling hazardous drugs. NIOSH encourages public input on the question of which ingredient identifier may be the most useful for the List. In addition, there are no reports of teratogenicity, developmental toxicity, embryo-fetal toxicity, lethality, or reduced growth in clinical trials conducted in humans, or in real world use since FDA approval in 2015. Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. 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. On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. Drugs are placed on the List based on their intrinsic properties. . The President of the United States manages the operations of the Executive branch of Government through Executive orders. 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. 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. While the Bulletin recognizes the benefit of both forms of input to agencies, it provides agencies with broad discretion in determining how to implement peer review, including timing as it relates to public comment, if applicable. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. . The new iteration is now referred to as draft Procedures throughout this notice. Peer review comment: Following the 60-day period to allow for public and stakeholder consultations, it is unclear if NIOSH will be responding to any parties that have provided comments. Please provide feedback on the overall document: a. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. 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. 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. Document page views are updated periodically throughout the day and are cumulative counts for this document. on NARA's archives.gov. Each document posted on the site includes a link to the [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). 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. Federal Register issue. What structural or format changes could be made to improve the utility of this table? If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. As stated in the OMB Final Information Quality Bulletin for Peer Review (Bulletin), [p]eer reviewers shall be charged with reviewing scientific and technical matters. Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 [PDF - 1 MB] Managing Hazardous Drug Exposures: Information for Healthcare Settings [PDF - 4 MB] Public Comment Period Comments will be accepted until 11:59 p.m. Centers for Disease Control and Prevention. These cookies may also be used for advertising purposes by these third parties. The new risk management document is available for review in the docket for this activity. and III.B: bevacizumab, botulinum toxins, darbepoetin alfa, interferon beta-1b, osimertinib, trastuzumab, and triazolam. NIOSH's definition of a hazardous drug only covers drugs approved by FDA's Center for Drug Evaluation and Research and is not considered for inclusion on the, Dihydroergotamine AHFS Class: 5-hydroxytryptamine (HT) receptor binder, Ivabradine AHFS Class: Hyperpolarization-activated cyclic nucleotide-gated (HCN) blocker. edition of the Federal Register. Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. 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. documents in the last year, 83 See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. 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. . Both drugs should be placed on the List because information available in the respective package inserts indicates that both drugs may cause teratogenic effects. Table 1. to the courts under 44 U.S.C. It would presumably be courteous to respond to any party that has provided comments for consideration.. Information about this document as published in the Federal Register. 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. 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. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. NIOSH appreciates that a timelier List might be helpful and is working toward that end. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. In humans receiving 400 mg/day or higher developmental effects consistent with animal data have been observed and epidemiological data suggest a risk of spontaneous abortions and congenital abnormalities in infants whose mothers were treated with 150 mg/day fluconazole. 05/01/2023, 244 Only official editions of the NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. This repetition of headings to form internal navigation links 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 list was compiled from information provided by four institutions that had generated lists of haz- . Cited studies in the package insert also demonstrate impaired fertility in rats. NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. NIOSH encourages public comment on these questions. The subsequent description of a site risk Start Printed Page 25441assessment does not seem appropriate here. USP 800> Hazardous Drugs-Handling in Healthcare Settings USP <800> Impact on Community Pharmacies Charles Lager RPh, MBA Thursday, April 8, 2021. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. 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.
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