Darbepoetin alfa should not be placed on the List. developer tools pages. Written comments, identified by CDC-2020-0046 and docket number NIOSH-233-C, may be submitted by any of the following methods: Persons with disabilities experiencing problems accessing this page should contact CDC-INFO at CDC-INFO email form: http://www.cdc.gov/info/, 800-232-4636 or the TTY number at (888) 232-6348 and ask for a 508 Accommodation PR#9342. 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.. Therefore, at this time NIOSH is no longer proposing to place the class of botulinum toxins on the 2020 List. 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. 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. 6. 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 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.. documents in the last year, by the International Trade Commission In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. Two drugs included in the 2018 FRN, inotuzumab ozogamicin and trabectedin, have MSHI and are automatically added to the 2016 List. Please describe what you found to be most or least effective and why. should verify the contents of the documents against a final, official Accordingly, NIOSH proposes to place olaparib on the List. Peer review comment: NIOSH should add administrative controls when discussing engineering controls, personal protective equipment, and other steps to manage the risk of exposure, because of their significance in the well-accepted hierarchy of controls for minimizing exposure to workplace hazards.. 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. 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. NIOSH appreciates that a timelier List might be helpful and is working toward that end. Comments may be submitted, identified by docket numbers CDC-2020-0046 and NIOSH-233-C, by either of the following two methods: Instructions: All information received in response to this notice must include the agency name and the docket numbers (CDC-2020-0046; NIOSH-233-C). NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. All three draft documents are available in the docket for this activity. Although there is currently some guidance in the footnotes, it may be worthwhile to consider a more detailed evaluation process of relevant studies and place it in a more prominent location in the document or possibly as an Appendix.. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. Because Start Printed Page 25443Table 1 includes drugs identified as antineoplastic, NIOSH should clarify the rationale and intent of Table 1, since drugs used as antineoplastics, but which are not cytotoxic or genotoxic, as traditional antineoplastics are, have been included. and services, go to Peer review comment: A statement about the evaluation procedures in the draft Policy and Procedures indicates that NIOSH would only consider human studies. USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Genotoxicity has been noted in Chinese hamster ovary cells. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings is intended to formalize the methodology that NIOSH uses to add hazardous drugs to its list. Federal Register issue. is not clearly outlined with respect to the evaluation process. . If new information becomes available about any of these drugs, NIOSH will reevaluate them in a future update to the List. 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. provide legal notice to the public or judicial notice to the courts. In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. Drugs are placed on the List based on their intrinsic properties. 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. NIOSH response: For reevaluation of a listed drug, NIOSH does not require requestors to provide a complete analysis of the available evidence. NIOSH response: In response to input from peer reviewers and external comments and following scientific review, 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. 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. Is there a scientific justification for them? List of Hazardous Drugs. Comment: The language in the section titled Application indicates that the draft Policy and Procedures do not apply to healthcare workers who handle recombinant therapeutic proteins. . b. [8] NIOSH did not take into account the real risk of occupational exposure or the mechanism of action of this relatively large molecule. It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. . You can review and change the way we collect information below. documents in the last year, 887 NIOSH response: The majority of these evaluations are based on the information provided in the drug package insert; thus, NIOSH relies on the quality of science generated by a drug manufacturer, subsequently reviewed by FDA during the drug approval process, and then published in the drug package insert. Peer review comment: Following the 60-day period to allow for public and stakeholder consultations, it is unclear if NIOSH will be responding to any parties that have provided comments. Open for Comment. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. NIOSH should provide the rationale for not proposing their placement on the List. Peer-reviewed, published studies are usually not available and therefore evaluating the quality of studies is not typically possible. However, NIOSH did not independently evaluate triazolam. Independent peer reviewers are being consulted as well; their charge is available on the NIOSH website[9] Document Drafting Handbook For complete information about, and access to, our official publications Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. This feature is not available for this document. This repetition of headings to form internal navigation links Comment: The methodology used to develop the list of drugs proposed for placement on the List was not the same as the methodology used in previous years. These markup elements allow the user to see how the document follows the 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. If you are using public inspection listings for legal research, you What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? Self-Regulatory Organizations; NYSE Arca, Inc. Economic Sanctions & Foreign Assets Control, Smoking Cessation and Related Indications, Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, Authority To Order the Ready Reserve of the Armed Forces to Active Duty To Address International Drug Trafficking, Revitalizing Our Nation's Commitment to Environmental Justice for All, Centers for Disease Control and Prevention, DRAFT - Managing Hazardous Drug Exposures: Information for Healthcare Settings, DRAFT - NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. NIOSH response: BCG, a vaccine approved by the FDA Center for Biologics Evaluation and Research, was included in the original 2004 Alert and `grandfathered' into the List. Comment: Azole antifungal drugs are being treated inconsistently. The draft Policy and Procedures used to develop the drugs proposed for placement on the List in the February 2018 FRN described the methodology used by NIOSH since 2010. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. What changes could be made to improve the utility of the information? establishing the XML-based Federal Register as an ACFR-sanctioned Aschengrau A, Seage GR [2018], Essentials of Epidemiology in Public Health. on 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. 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: NIOSH has determined that teratogenicity or other developmental toxicity after exposure to osimertinib were observed at doses higher than the maximum recommended human dose and reproductive effects at doses lower than the maximum recommended human doses were equivocal. The rationale for placing interferon beta-1b on the List is that information from the package insert indicated reproductive toxicity: spontaneous abortion in human clinical trials. The Public Inspection page Comment: Dihydroergotamine should not be placed on the List. From my perspective, as a minimum, this should include porters, ward aides and unit clerks.. 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. Carcinogenicity/teratogenicity: Cited studies demonstrated an increased incidence of hepatocellular adenomas in mice. 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. 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. 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. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. USP General Chapter(s)800> Hazardous Drugs - Handling in Healthcare Settings (Informational)825> Radiopharmaceuticals - Preparations, Compounding, Dispensing, and Repackaging as published June 1, 2019 (Informational) First Name Last Name headings within the legal text of Federal Register documents. documents in the last year, 84 The NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, A. Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. 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. USP added clarification about the application of chapter <800> to hazardous drugs, which can be found on its FAQ page.[4]. 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. 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. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. 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. ET on July 30, 2020. If you have any questions regarding hazardous drugs please submit them to Email CDC-INFO or call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348) What additional information would improve the usefulness of this table and why? Note: General Chapter <800> is informational and not compendially applicable. Consequently, these drugs are all administered by injection. are not part of the published document itself. However, rather than identifying job-specific titles, the document focuses on workplace activities. Identify Hazardous Drugs (HDs) Start by closely reading the National Institute for Occupational Safety and Health's (NIOSH) 2020 list of HD to see which are classified as hazardous. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. NIOSH is seeking input from the public on the draft risk management strategies document and table to ensure that they contain accurate and helpful information. The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab vedotin-tftv [FR Doc. 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. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. has no substantive legal effect. The current List created by NIOSH requires an extensive review process that does not readily allow more frequent publication. 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. Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. 3. The drug's mechanism of action does not indicate DNA damage. NIOSH has determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for users. NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. 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. USP 800> Hazardous Drugs-Handling in Healthcare Settings USP <800> Impact on Community Pharmacies Charles Lager RPh, MBA Thursday, April 8, 2021. Any additional information from any interested party that will assist with further reviews of the botulinum toxins will be reviewed for potential placement on the List in the future. See https://www.cdc.gov/niosh/docs/2016-161/default.html for all drugs with special handling information added to the 2016 List. Furthermore, some drugs carry multiple American Hospital Formulary Service (AHFS) code classifications and are not solely used as antineoplastic drugs. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. These can be useful NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose. Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from Table 1. For example, NIOSH found that ibrutinib had developmental effects in animals but only at doses twice the maximum recommended human dose of 560 mg/day. Comment: Triazolam should not be placed on the List. documents in the last year, 125 Comment: NIOSH should clarify how close chemical analogs are identified, and whether NIOSH establishes site concordance across analogs and how evidence for and against the absence of concordance is interpreted. The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies. documents in the last year, 19 . In addition, having an algorithm to determine the strength of a paper will also aid in minimizing any potential inter- and intra-reviewer differences. New Documents 3. documents in the last year, 669 .. Therefore, NIOSH has regrouped the tables by hazard. Access 200+ compounding-related standards, Know your exposure and download the HazRx Mobile App, USP Compounding and Hazardous Drugs Courses, Hazardous DrugsHandling in Healthcare Settings, Promoting the Quality of Medicines Plus (PQM+) Program, USP Monographs for Bulk Drug Substances and Other Ingredients, National Institute for Occupational Safety and Health (NIOSH), Revision Bulletin published to clarify the term antineoplastic for the purpose of Chapter <800>, Revision Bulletin published to confirm the official date of USP General Chapter <800>, Review their work plan and past meeting summaries, Sign up for USP Healthcare Quality & Safety Updates, The United States Pharmacopeial Convention, December 1, 2019Official date for General Chapter <800>, February 1, 2016 Publication Date of General Chapter <800>. 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. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. 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). NIOSH Peer Review Agenda, https://www.cdc.gov/niosh/review/peer/isi/healthsafetyrisks.html. NIOSH response: The List is about 4 years behind the introduction of new drugs when it is periodically updated because there are several steps in the review process. NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. Are there other information sources that should be included? Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. NIOSH encourages public comment on these questions. 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. 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. About the Federal Register 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). Peer review comment: NIOSH should provide a more robust description of the evaluation criteria to include that these are shared across a number of other professional organizations and panels which also endorsed these same criteria.. It is unclear if NIOSH will conduct meta-analyses to test for consistency of results; how NIOSH will interpret evidence for, or absence of, concordance across species or between structural analogs of the drug; whether NIOSH will conduct categorical regression analyses to evaluate dose-response data; and how NIOSH evaluates routes of exposures. 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. Accordingly, NIOSH is not proposing to place these two drugs on the List. Relevant information about this document from Regulations.gov provides additional context. Manufacturer recommendation: that females of reproduction potential use effective contraception during and for four months after completing therapy. The President of the United States manages the operations of the Executive branch of Government through Executive orders. . Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? The goal of the standard is to help protect health - care workers from the risks associated with handling hazardous drugs. The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. on FederalRegister.gov documents in the last year, 9 The Public Inspection page may also 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. It is not an official legal edition of the Federal USP Chapters <797> and <800> New and Revised Compounding Standards February 7, 2020 USP Chapters <797> and <800> New and Revised Compounding Standards At A Glance At Issue The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. 2. 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. b. 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, 37 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. 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. 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. NIOSH also sought comment on a draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (Policy and Procedures). the Federal Register. See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List.
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