Accordingly, NIOSH has determined that interferon beta-1b does not meet the criteria for a hazardous drug and is no longer proposing to place it on the List. Centers for Disease Control and Prevention, HHS. The other 273 were screened and the information available for 44 drugs suggested one or more toxic effects; those drugs were evaluated by NIOSH and shared with peer reviewers and stakeholders. by the Comptroller of the Currency, the Federal Reserve System, and the Federal Deposit Insurance Corporation Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. 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. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. NIOSH response: The rationale for proposing the placement of each drug to the List is provided in the Federal Register notice preceding the final List publication. Federal Register provide legal notice to the public and judicial notice Listen to ASHPOfficial episodes free, on demand. 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. Peer review comment: NIOSH should clarify “how the threshold dosages (10 mg/day or 1 mg/kg/day) for defining organ toxicity at 'low doses' . Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. Seven commenters asked questions and offered suggestions about the procedures themselves. to the courts under 44 U.S.C. 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. After considering the peer and stakeholder reviews, NIOSH determined that 20 drugs and one class of drugs exhibit toxicity that meets the NIOSH definition of a hazardous drug and proposed them for placement on the List. Register, and does not replace the official print version or the official NIOSH response: After scientific review and consideration of input from peer reviewers and public commenters, NIOSH is proposing a reorganization of the List. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. We're less than a week away from the 2020 NFL draft, which means it's time to unveil my annual list of favorite prospects at every position. 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. Peer review comment: NIOSH did not include a mechanism to place investigational drugs on the List. daily Federal Register on FederalRegister.gov will remain an unofficial 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. 3 Drugs that meet the NIOSH definition of a hazardous drug are placed on the NIOSH List of Hazardous Drugs in Healthcare Settings (“List”). Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. Accordingly, NIOSH proposes to place exenatide on the List. 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. b. Comment: Dihydroergotamine should not be placed on the List. A look at the full Draft board, which includes official and reported trades from the 2020 NBA Draft. 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[3] after applying appropriate uncertainty factors. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. 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. When studies are available for review of a drug being considered for placement on the List or for the reevaluation of a drug already on the List, quality may be evaluated by NIOSH scientists and independent peer reviewers on a case-by-case basis. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. NIOSH response: The manufacturer provided information indicating that multiple evaluations of pregnancy registries did not provide any signals suggesting negative pregnancy outcomes associated with interferon beta-1b. 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. offers a preview of documents scheduled to appear in the next day's A third draft document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, is intended to help employers establish workplace-specific management procedures for hazardous drugs. the current document as it appeared on Public Inspection on The drugs pose the greatest risk to healthcare workers, “based on a combination of volatility and dose-related toxic potential of those vapors.”. 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. The NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, A. 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. This document has been published in the Federal Register. The following seven drugs that were proposed for placement on the List in the February 2018 FRN are no longer proposed for placement on the List, for the reasons discussed above in Sections II.B. NIOSH's findings about each drug are as follows: Comment: The hormonal agents in Table 1 of the 2016 List that are exclusively reproductive risks, including estrogens (estrogen agonist-antagonists such as tamoxifen and antiestrogens such as anastrozole, exemestane, and letrozole), gonadotropins (leuprolide and triptorelin), antigonadotrophins (degarelix), and progestins (megestrol) should be moved to Table 2 or 3. rendition of the daily Federal Register on FederalRegister.gov does not Comment: The List should identify those hazardous drugs that are both cytotoxic and cytostatic as well as volatile. documents in the last year, 1001 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. NIOSH should consider whether reliance on the AHFS Class 10:00 (antineoplastic agents) alone “is enough to necessitate Table 1 Start Printed Page 25449inclusion even if a drug does need to be on the NIOSH list.”. The draft Procedures is in the docket for this activity. If the latter is the case, could a sentence be added to clarify that?”. In a Federal Register notice (FRN) published on February 14, 2018 (83 FR 6563), NIOSH invited the public to participate in the development of the List and the procedures used to develop the List by submitting written views, opinions, recommendations, and/or data. NIOSH appreciates that a timelier List might be helpful and is working toward that end. 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. Which unique ingredient identifier is the most useful for users of the List? Hormonal agents that are classified by NTP as “known to be a human carcinogen” or by IARC as “carcinogenic” or “probably carcinogenic” will be identified in Table 1. 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… Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. From my perspective, as a minimum, this should include porters, ward aides and unit clerks.”. The new drafts, entitled the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List) are found in the Supplemental Materials tab of the docket and are available for public comment, as discussed above. 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's extensive review process only allows for periodic updates of hazardous drugs that do not have MSHI. NIOSH carefully considered all of the peer reviews and public comments and determined that significant, substantial changes should be made to the draft Policy and Procedures, the list of drugs proposed for placement on the List, and also to the organization of the List itself. NIOSH will consider conducting a systematic review if such studies become available relating to the hazard that a specific drug may pose in healthcare settings. Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. The available information does not demonstrate or support a determination that the drug meets the NIOSH definition of hazardous drug. Eric Maroyka, Senior Director, Center on Pharmacy Practice Advancement sits down with Patricia C. Kienle, MPA, BCSCP, FASHP, and Michael Ganio, Senior Director, Pharmacy Practice and Quality to discuss aspects of the draft The National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Healthcare Settings 2020. include documents scheduled for later issues, at the request Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. Three commenters offered opinions on the timeliness of the List, which NIOSH has attempted to publish every 2 years since 2010. Similar questions were raised about animal studies. Register documents. 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 announced that the following draft documents were 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. Similarly, small-molecule kinase inhibitors, such as afatinib, crizotinib, dabrafenib, and imatinib, act through a targeted mechanism of action and are not directly cytotoxic; they primarily pose a reproductive and teratogenic risk. As such, they should be moved from Table 1 to another place on the List. for better understanding how a document is structured but documents in the last year, 1471 This clearly infers human studies only. Peer review comment: NIOSH should clarify a sentence concerning NIOSH's preference for human genotoxicity data which states: “If available, NIOSH gives preference to those studies. Are there other information sources that should be included? 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. 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. NIOSH encourages public comment on these questions. 3. What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? The package insert also cites gefitinib as exhibiting teratogenicity. Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. 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. Comment: NIOSH indicated that 10 drugs—cetuximab, ibrutinib, ipilmumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib—demonstrated available information that shows a toxic effect that does not meet the NIOSH definition of a hazardous drug. on However, after consideration of input from the public and stakeholders, NIOSH has decided to review the toxicity and the hazards related to occupational exposure to botulinum toxins. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. 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. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? Get the latest news and information on your favorite teams and prospects from CBSSports.com. documents in the last year, by the Fish and Wildlife Service . While every effort has been made to ensure that legal research should verify their results against an official edition of Please provide feedback on the overall document: a. 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. Fluconazole meets the NIOSH criteria for a hazardous drug while the other two, ketoconazol and itraconazole, do not. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. The draft Procedures document is now focused on NIOSH's procedure for identifying hazardous drugs and no longer discusses managing the risk of exposure. Centers for Disease Control and Prevention. the Federal Register. Docket ID: CDC-2020-0046. documents in the last year, 929 Moreover, USP <800>requires the use of personal protective equipment for Table 1 drugs, which may delay care or undermine patient safety. This repetition of headings to form internal navigation links Federal Register. According to a notice published in the May 1 Federal Register, the documents are “Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings”; “Managing Hazardous Drug Exposures: Information for Healthcare Settings”; and “NIOSH … on FederalRegister.gov . documents in the last year, 108 documents in the last year, 769 . Include relevant publications if available. These tools are designed to help you understand the official document Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. In light of these changes, NIOSH proposes a new List structure, described in the preamble to the List, which is available for review in the docket for this activity. 1503 & 1507. b. Information about this document as published in the Federal Register. For complete information about, and access to, our official publications As discussed extensively in the notice published February 14, 2018, NIOSH identified 275 potentially hazardous drugs between January 2014 and December 2015 (83 FR 6563). 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. were derived. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. documents in the last year, by the Animal and Plant Health Inspection Service The manufacturer or any other stakeholder is invited to comment on the sufficiency of the explanation of the basis for adding a drug to the List. “'When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug, including any studies cited in the package insert that are relevant to workers in a health care setting.' documents in the last year, 34 Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. 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. The last paragraph of this section is particularly confusing to the reader. Animal data on the developmental effects of fluconazole suggest developmental changes in rats at doses less than the equivalent maximum human recommended dose of 400 mg/day. NIOSH response: NIOSH reviews the relevant data on a drug when a label change is made, not just the data relating to the label change. 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.”. Although rare, NIOSH notes any labeling changes that could affect the status of a drug that has been previously classified as hazardous. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. The size of the molecule limits dermal absorption and aerosolization. Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226, telephone (513) 533-8132 (not a toll free number), email: bmackenzie@cdc.gov. . on better and aid in comparing the online edition to the print edition. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. The documents posted on this site are XML renditions of published Federal 7. 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. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. Regulations.gov will redirect users to beta.regulations.gov on Tuesdays and Thursdays for 24 hours starting at 8am ET. Eric Maroyka, Senior Director, Center on Pharmacy Practice Advancement sits down with Patricia C. Kienle, MPA, BCSCP, FASHP, and Michael Ganio, Senior Director, Pharmacy Practice and Quality to discuss aspects of the draft The National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Healthcare Settings 2020. As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. . If so, perhaps this could be referenced with a footnote.”. NIOSH created and periodically updates the List to assist employers in providing safe and healthful workplaces by offering a list of drugs that meet the NIOSH definition of a hazardous drug. In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. 2020 NBA Draft predictions including pick-by-pick analysis from CBS Sports NBA experts. NIOSH did not take into account the real risk of occupational exposure or the mechanism of action of this relatively large molecule. . Comment: Ivabradine should not be placed on the List. documents in the last year, by the Internal Revenue Service 4. Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on 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. See https://www.cdc.gov/​niosh/​docs/​2016-161/​default.html for all drugs with special handling information added to the 2016 List. 4th Edition, (Burlington, MA: Jones & Bartlett). It is not an official legal edition of the Federal 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. 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. The drug's mechanism of action does not indicate DNA damage. . This count refers to the total comment/submissions received on this document as reported by Regulations.gov. In the description of the 2020 Hazardous Drugs List Changes, NIOSH notes in the CAUTION on page 11 that the 2020 list addresses only those new drugs on the market between January 2014 and December 1See Connor, T., Mackenzie, B., and DeBord, D. … Each document posted on the site includes a link to the Risk Management for Hazardous Drugs in Healthcare Settings, Read the 86 public comments on this document, https://www.federalregister.gov/d/2020-09332, MODS: Government Publishing Office metadata, https://www.cdc.gov/​niosh/​docs/​2016-161/​default.html, https://www.cdc.gov/​niosh/​topics/​hazdrug/​peer-review-plan.html, https://www.usp.org/​frequently-asked-questions/​hazardous-drugs-handling-healthcare-settings, https://www.cdc.gov/​niosh/​review/​peer/​isi/​healthsafetyrisks.html. A Notice by the Centers for Disease Control and Prevention on 05/01/2020. Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. In this Issue, Documents 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. 1. This is because there is insufficient information to establish an exposure limit and, therefore, one should err on the side of caution and apply the ALARA principle. If available, NIOSH would give preference to them over animal and in vitro studies. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. Relevant information about this document from Regulations.gov provides additional context. 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.
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