In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List. What changes could be made to improve the utility of the information? NIOSH Finalizes Procedures for Developing Hazardous Drug List The Public Inspection page may also NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. PDF USP <800> USP 800> Hazardous Drugs-Handling in Healthcare Settings 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. . Most were concerned . USP 800 For Pharmacists & Healthcare Workers | Stericycle You will receive an e-mail containing your requested General Chapter downloads after submission. 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). 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. Although the official list hasn't been updated since 2016, NIOSH did propose updates in 2020 which serves as a useful guide. Please provide any additional studies or scientific information that support or validate evidence-based strategies or approaches for controlling exposures to hazardous drugs that are different from those that NIOSH has proposed. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. . The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. According to the reviewer, [t]his approach may not be appropriate if indeed the purpose of the screening is to protect the health and well-being of workers who may be exposed to hazardous drugs. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. Carcinogenicity: Cited studies demonstrated an increased incidence of various oncologic presentations (hepatocellular adenoma/carcinoma, interstitial cell hyperplasia, and uterine endometrial adenocarcinoma), in multiple animal species (rat and mice) at exposure lower than human doses (0.7-1.4 fold in rats and 0.3-0.7 fold in mice compared to a human dosing). 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. documents in the last year, 84 . when determining the potential for adverse health effects of hazardous drugs in healthcare workers. In response to peer reviews and public comments, 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. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? The current List created by NIOSH requires an extensive review process that does not readily allow more frequent publication. 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 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. 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. 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. Although rare, NIOSH notes any labeling changes that could affect the status of a drug that has been previously classified as hazardous. [3] NIOSH has determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for users. This document has been published in the Federal Register. documents in the last year, 422 Best-Practices-for-Monitoring-Hazardous-Drug-Surface-Contamination In addition, having an algorithm to determine the strength of a paper will also aid in minimizing any potential inter- and intra-reviewer differences. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. NIOSH must add criteria for animal studies to include the recovery/reversibility of adverse effects and the pharmacological relevance of the test species. NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. Please refer to the current edition of the USP-NF for official text. Please provide information about your professional experience, if any, of implementing control strategies for exposures to hazardous drugs in healthcare or similar settings. Please provide feedback on the overall document: a. NIOSH Updates List of Hazardous Drugs in Healthcare Settings for 2020 The List now comprises only two tables: Table 1: Drugs that contain MSHI in the package insert and/or meet the NIOSH definition of a hazardous drug and are classified by NTP as known to be a human carcinogen, or classified by IARC as carcinogenic or probably carcinogenic., Table 2: Drugs that meet the NIOSH definition of a hazardous drug, but do not have MSHI and are not classified by NTP as known to be a human carcinogen, or classified by IARC as carcinogenic or probably carcinogenic.. For complete information about, and access to, our official publications This site displays a prototype of a Web 2.0 version of the daily 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. The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick Moreover, caution should be taken when making determinations about potentially hazardous drugs because causality is not necessarily demonstrated by a strong association just as absence of causality is not necessarily demonstrated by weak associations; associations that demonstrate a monotonic trend in health outcome frequency (steadily increasing or decreasing without ever changing direction) are not necessarily causal if a confounding factor demonstrates a dose-response relationship with the health outcome; and prior beliefs should not be allowed to cloud judgment with regard to plausibility. Aschengrau A, Seage GR [2018], Essentials of Epidemiology in Public Health. The Procedures should state that this list is [a] hazard identification and not a risk assessment exercise. Data evaluation submitted to the docket by the manufacturer demonstrates that interferon beta-1b is not causally associated with spontaneous abortion or with any patterns or signals suggesting pregnancy outcomes. Research on Start Printed Page 25447populations who have received interferon beta-1b throughout pregnancy have demonstrated no difference in spontaneous abortions or birth weight compared to population comparators. Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. November 02, 2020 USP 800 For Pharmacists & Healthcare Workers An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. 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.. Table 1. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. The strategies used to manage the risk should match the hazard. NIOSH should provide the rationale for not proposing their placement on the List. documents in the last year, 204 Accordingly, NIOSH primarily uses information available in the package inserts to make determinations about whether to place a drug on the List. Comment: Ivabradine should not be placed on the List. In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. on 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. informational resource until the Administrative Committee of the Federal c. What information is redundant, incorrect, missing, or not needed? Please provide specific examples. . These drugs should be placed on the List because of their teratogenic and/or reproductive effects or the rationale for not proposing their placement on the List should be further explained. For example, three drugs were added to the 2016 List after it was initially published; they are identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 web page, https://www.cdc.gov/niosh/docs/2016-161/default.html. However, the lack of 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. 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. 2011; USP 2016, OSHA 2016]. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services.

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