were derived. All relevant comments received will be posted without change to www.regulations.gov,, including any personal information provided. This feature is not available for this document. 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. In my opinion, a review of any animal studies should be conducted as they may offer insight regarding the potential risk posed by a drug. on NARA's archives.gov. by the Securities and Exchange Commission offers a preview of documents scheduled to appear in the next day's Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. [7] Comment: While NIOSH describes several Bradford Hill criteria[6] . The agency has updated its List of Hazardous Drugs in Healthcare Settings for 2020 as well as its procedures for developing the list. Which unique ingredient identifier is the most useful for users of 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. for better understanding how a document is structured but documents in the last year, 669 Please refer to the current edition of the USP-NF for official text. Comment: NIOSH indicated that two drugsdaratumumab and dinutuximabdemonstrated insufficient toxicity information available to meet the NIOSH definition of a hazardous drug. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. regulatory information on FederalRegister.gov with the objective of The new risk management document is available for review in the docket for this activity. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. 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. Publications Presenting Best Practices In Hazardous Drug Management 1,3,5-11: CDC/NIOSH: Managing Hazardous Drug Exposures: Information for Healthcare Settings (Draft, 2020) 1 ASCO Safe Handling of Hazardous Drugs: ASCO Standards (2019) 5 ONS/HOPA Ensuring Health Care Worker Safety When Handling Hazardous Drugs (2019) 6 USP General Chapter <800> (2019) 7 informational resource until the Administrative Committee of the Federal 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. Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. 8. NIOSH has determined that exenatide extended-release caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? Two very similar drugs may have substantially different toxicities and at different doses. 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. 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. NIOSH response: NIOSH concurs with commenters that the evidence of carcinogenicity for darbepoetin alfa in patients who did not already have cancer was insufficient to support a NIOSH finding of carcinogenicity. This document has been published in the Federal Register. The new list format will allow organizations more flexibility for certain drugs when implementing USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings. Animal studies, where available, are also used in our evaluations. NIOSH also conducted a peer review, with four independent reviewers, of the draft Policy and Procedures.[2]. However, the lack of In that case, important criteria for animal studies include strength of association; consistency between studies; relevance of the model system and routes of exposure; the duration, reversibility, and recoverability of the observed effects; and concordance of those effects with effects in humans. Information about this document as published in the Federal Register. In 1981, after over 10 years of conformational research, the U.S. National Institute of Occupational Safety and Health (NIOSH) issued Recommendations for Safe Handling of Injectable Antineoplastic Drug Products, which recognized inhalation and direct skin contact as high-risk routes of exposure and recommended the use of Class II biosafety Public Comment Summaries and NIOSH Responses, B. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. NIOSH response: The List is updated any time NIOSH is aware that a drug manufacturer has added special handling information to the patient information for a specific drug. Peer review comment: NIOSH's discussion of an employer-performed site-based risk assessment to control the risk of exposure is confusing when placed in a document describing NIOSH's hazard identification procedures. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. publication in the future. legal research should verify their results against an official edition of Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. Fluconazole meets the NIOSH criteria for a hazardous drug while the other two, ketoconazol and itraconazole, do not. 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. 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. 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. documents in the last year. While every effort has been made to ensure that This table of contents is a navigational tool, processed from the The value for low dose should be drug-specific and a function of several factors such as normal therapeutic doses, body weight, and length of exposure. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. List of Hazardous Drugs. The size of the molecule limits dermal absorption and aerosolization. However, because NIOSH has reaffirmed in the draft Procedures that only those drugs approved by the FDA Center for Drug Evaluation and Research are included in the List, BCG is no longer included in the List. 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. . These tools are designed to help you understand the official document Although such drugs are not in widespread clinical use, personnel in academic and research-oriented facilities are potentially at risk from exposure to these drugs. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. NIOSH response: A drug may be considered a hazardous drug but not a chemical carcinogen if, for example, a drug manufacturer includes a carcinogenicity warning in the drug's package insert but the evidence for carcinogenicity has not been reviewed by the International Agency for Research on Cancer (IARC); the National Toxicology Program (NTP), within the U.S. Department of Health and Human Services; the U.S. Environmental Protection Agency (EPA); or independently by NIOSH. 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. Review their work plan and past meeting summaries. documents in the last year, 494 The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. In addition, having an algorithm to determine the strength of a paper will also aid in minimizing any potential inter- and intra-reviewer differences. Because the way cancer is treated therapeutically has changed, and the types of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. NIOSH should clarify the criteria described in the footnote and explain how evidence against these various criteria is evaluated, how each independent line of evidence is systematically and critically appraised, how the quality and risk of bias of individual studies is evaluated, how conflicting information is arbitrated, and how the totality of the data is synthesized. The drugs and rationales for each of them include the following: NIOSH response: Each of these drugs has either been previously reviewed and found not to meet the NIOSH definition of a hazardous drug, falls outside the scope of the List, or is slated for review in the future. Thus, neither was proposed for placement on the List in the February 2018 FRN. 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. In this Issue, Documents [3] 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. Comment: Triazolam should not be placed on the List. For this reason, NIOSH encourages individual healthcare settings to develop their own formulary-specific lists of hazardous drugs, which could include investigational drugs that have not yet been approved by FDA. DRAFT - NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in II. Comments must be received by June 30, 2020. and services, go to Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. There seems to be no mechanism in place for labeling investigational (i.e., non-FDA approved drugs used in preclinical and clinical research prior to submission of an NDA [new drug approval]) drugs as potential human health hazards. documents in the last year, 125 At this time, NIOSH has chosen not to list any of the identification numbers but is considering doing so in the future. 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. 7. These changes now reflected in the draft Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (draft Procedures) include the clarification of some language and streamlining the procedures NIOSH uses to determine the hazard potential of a specific drug. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Ibrutinib was identified as a drug for which the available information shows a toxic effect that does not meet the NIOSH definition of a hazardous drug; blinatumomab was proposed for placement on the List on the basis of evidence which shows the drug is a neurotoxin at low doses. The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient. 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. Because the way cancer is treated therapeutically has changed, and the classes of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic or genotoxic. Two commenters offered editorial suggestions for clarifying language in the draft; although the comments are not summarized here, changes were made to the revised draft Procedures as appropriate.Start Printed Page 25446. 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 . Although rare, NIOSH notes any labeling changes that could affect the status of a drug that has been previously classified as hazardous. 6. documents in the last year, by the International Trade Commission Data on the developmental effects of itraconazole and ketoconazole suggest developmental toxicity has only been observed in doses greater than the maximum human recommended dose. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled. 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. NIOSH response: NIOSH's rationale for proposing the placement of triazolam on the List was that it mimics the benzodiazepines which are included on the List because they are teratogenic or cause other developmental effects. electronic version on GPOs govinfo.gov. 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. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. NIOSH does not review drugs that are not yet approved for use in humans. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. Therefore, when antineoplastic drugs are grouped as they were in earlier versions of Table 1 of the List, an appearance that these drugs pose the same hazard was inadvertently created (i.e., non-cytotoxic drugs with cytotoxic drugs). establishing the XML-based Federal Register as an ACFR-sanctioned NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. You will receive an e-mail containing your requested General Chapter downloads after submission. Therefore, when drugs are grouped by their function (i.e., antineoplastic), as they were in earlier versions of Table 1, drugs that required different protective measures were grouped together (non-cytotoxic drugs with cytotoxic drugs). include documents scheduled for later issues, at the request . The public comments have been organized into the following topic areas: organization of the List and impact of United States Pharmacopeia (USP) Compounding Compendium chapter <800> Hazardous DrugsHandling in Healthcare Settings; the nature of the Listexposure/hazard characterization; monoclonal antibodies; periodicity; methodology/process; criteria clarification; and editorial suggestions. NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. 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. libby gates macphee, steakhouses in west des moines, nadiya hussain rainbow cardigan,
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