NIOSH has retitled and reorganized the List in response to comments received. documents in the last year, 422 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. on NARA's archives.gov. 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. Comment: While NIOSH describes several Bradford Hill criteria[6] NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. documents in the last year, 9 Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. The new iteration is now referred to as draft Procedures throughout this notice. In mice, doses near the maximum recommended human dose lead to increased neonatal death. You will receive an e-mail containing your requested General Chapter downloads after submission. NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. on NIOSH will begin the reevaluation process for any request to add or remove a drug that provides some new supporting evidence by searching for additional hazard identification (toxicity) and hazard characterization information about the drug that is relevant to the criteria set out in the NIOSH definition of a hazardous drug. Federal Register provide legal notice to the public and judicial notice 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. 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. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. These can be useful Comment: NIOSH should conduct or commission a meta-analysis or systematic review, [i]n the absence of published literature synthesizing the body of clinical knowledge about a specific drug. Of the 275 drugs identified during that timeframe, two had special handling information specified by the manufacturer (MSHI) and were automatically placed on the List. What additional information would improve the usefulness of this table and why? Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. Federal Register. Throughout the healthcare landscape, people are asking, "What is USP 800?" As such, the use of animal studies to evaluate the hazardous nature of a drug should be explicitly stated.. The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. documents in the last year, 153 As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. NIOSH response: It is NIOSH practice to respond to all stakeholder and public comments and peer reviews in a Federal Register notice or in a document posted in the relevant NIOSH docket, to maintain a transparent and thorough administrative record. 05/01/2023, 244 The NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, A. Is the information threshold scientifically sound? This table of contents is a navigational tool, processed from the Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020: Summary of Changes, C. NIOSH List of Hazardous Drugs in Healthcare Settings, 2020Title, Reorganization, and Removals, IV. Which unique ingredient identifier is the most useful for users of the List? Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. . Four independent peer reviewers and 55 public commenters offered input on the draft Policy and Procedures; their substantive comments are summarized below, followed by NIOSH responses. Comment: Add a new category for drugs that sublime and offer information about proper handling, including the conditions under which sublimation (transition of a solid substance to a gas) happens as well as the need to filter and exhaust the work area where such drugs are used. 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.
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