NIOSH has published for comment the long-awaited revised 2020 Hazardous Drug List along with information for managing hazardous drug exposure and the NIOSH procedures for developing the list. CDC twenty four seven. 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. 1. These three drugs do not appear below because they are not subject to public comment. documents in the last year, 22 Accordingly, NIOSH proposes to place olaparib on the List. for better understanding how a document is structured but 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. Because the organizations that may endorse the evaluation criteria may change, NIOSH declines to identify them in the Procedures document. Centers for Disease Control and Prevention, HHS. 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. 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. . As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. documents in the last year, by the State Department The individuals and organizations who commented on this issue felt that USP's use of the NIOSH List raises the List to the level of a regulatory action, and should include only antineoplastic drugs on Table 1. documents in the last year, 10 . 6. Reg. NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. documents in the last year, 34 Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. 2 Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information, 85 Fed. After review, NIOSH now finds that the information in the package insert for this drug does not support a determination that it presents a hazard to healthcare workers and is no longer proposing to place it on the List. NIOSH has published for comment the long awaited revised 2020 Hazardous Drug List along with information for managing hazardous drug exposure and the NIOSH procedures for developing the list. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Comment: Exenatide should not be placed on the List. The 60-day window for public comments is May 1st, 2020 – June 1st, 2020. Botulinum toxins do not meet the criteria for placement on the List; abotulinumtoxinA and rimabotulinumtoxinB did not have labeling changes during the search period January 2014 through December 2015, and changes to the labels for onabotulinumtoxinA and incobotulinumtoxinA do not meet the criteria for organ toxicity at low doses or teratogenicity or other developmental toxicity. 12/02/2020, 40 Are there other information sources that should be included? Three commenters offered opinions on the timeliness of the List, which NIOSH has attempted to publish every 2 years since 2010. 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. On October 15, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to … 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. NIOSH did not take into account the real risk of occupational exposure or the mechanism of action of this relatively large molecule. 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… 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. Public comments on the draft Policy and Procedures and the drugs proposed for placement on the List and peer review summaries on specific drugs proposed for placement on the List are available in dockets CDC-2018-0004 and NIOSH-233-B. regulatory information on FederalRegister.gov with the objective of Is the threshold of information required to move from the screening process to the full evaluation process clearly described? 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. 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 μg/m after applying appropriate uncertainty factors. NIOSH response: A systematic review is a significant undertaking requiring the prior publication or dissemination of multiple studies relating to a specific drug. The new iteration is now referred to as “draft Procedures” throughout this notice. See USP, FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings, https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. Sixteen drugs have been added to NIOSH’s 2020 list, including three for which the manufacturers have provided special handling information. To learn more about the list visit … and services, go to NIOSH is proposing to regroup the drugs by hazards. NIOSH response: Only a few of the drugs on the List are known to have an appreciable vapor pressure; reliable information concerning the vapor pressure of most drugs can be difficult to identify. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. (NIOSH) uses to determine whether a drug 2 meets the criteria in the NIOSH definition of a hazardous drug. This site displays a prototype of a “Web 2.0” version of the daily Please include the URL of the site in the Subject line of your email request that you would like to access. Both drugs should be placed on the List because information available in the respective package inserts indicates that both drugs may cause teratogenic effects. 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. Reproductive toxicity: The package insert contains MSHI stating, “Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients” due to the risk of transmission of talimogene laherparepvec and herpetic infection. . Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. 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.”. documents in the last year, 344 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. 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.
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