NIOSH has determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for users. 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. As many HDs are also hazards that are identified in the revised HCS, the requirements of the HCS must also be met [29 CFR 1910.1200] (OSHA, 2012b). USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH) released the long-awaited proposed “NIOSH List of Hazardous Drugs in Healthcare Settings, 2020”, as well as “Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings” and “Managing Hazardous Drug Exposures: Information for Healthcare Settings” in the Federal … Comment: While NIOSH describes several Bradford Hill criteria [6] used to evaluate information from human studies in footnote 44 of the draft Policy and Procedures, no rationale is offered to explain why many of the original nine Bradford Hill criteria are not used. Program 60 HazDrug--OMPA 2 (m) "Hazardous Drug Safety and Health Plan"Local Command Instructions Enter local instruction number in space provided--must be reviewed and updated (as needed) annually for a Yes response. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. 1. NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. Relevant information about this document from Regulations.gov provides additional context. See USP, FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings, https://www.usp.org/​frequently-asked-questions/​hazardous-drugs-handling-healthcare-settings. 02/12/2021, 152 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. Comment: Exenatide should not be placed on the List. Federal Register. 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. The two drugs with MSHI that were placed on the List and the 20 drugs and one drug class proposed for placement on the List were identified in the February 14, 2018 notice, along with NIOSH's rationale for each proposed addition. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? These tools are designed to help you understand the official document 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. If you are using public inspection listings for legal research, you Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. 1503 & 1507. This prototype edition of the documents in the last year, 776 Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. from 11 agencies, updated on 8:45 AM on Friday, February 12, 2021, 93 documents Healthcare Settings Managing Hazardous Drug Exposures: Information for ... Cytotoxic drugs are hazardous substances, as defined by the Control of Substances Hazardous to Health Regulations 2002 (COSHH). This count refers to the total comment/submissions received on this document as reported by Regulations.gov. Connor TH, Lawson C, Polovich M, McDiarmid M [2014]. Please provide feedback on the overall document: a. 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. Changes to the List structure would place all drugs that meet the NIOSH definition of a hazardous drug and contain MSHI in the package insert and/or are classified by the National Toxicology Program (NTP) as “known to be a human carcinogen,” or classified by the International Agency for Research on Cancer (IARC) as “carcinogenic” or “probably carcinogenic” on Table 1. This repetition of headings to form internal navigation links The package insert also cites gefitinib as exhibiting teratogenicity. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. NIOSH list of hazardous drugs in healthcare settings 2020. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. .”. 4. In that case, NIOSH may consider it to be appropriately grouped with carcinogenic drugs, although it would not necessarily meet the criteria for an occupational carcinogen according to the NIOSH Chemical Carcinogen Policy. Chemicals are classified as non-hazardous or hazardous. During the 1970s, evidence came to light indicating health care workers may be at risk of harmful effects from antineoplastic drugs as a result of occupational exposure. are not part of the published document itself. In this Issue, Documents From my perspective, as a minimum, this should include porters, ward aides and unit clerks.”. documents in the last year, 223 . 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. on A Notice by the Centers for Disease Control and Prevention on 05/01/2020. 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 … 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. [FR Doc. Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. The agency intends to review the toxicity and the hazards related to occupational exposure to botulinum toxins, and seeks additional studies, data, and expert opinions to evaluate the class of drug more fully. If a meta-analysis or systematic review is warranted for a reevaluation, NIOSH would consider these criteria on a case-by-case basis. Peer review comment: NIOSH should mention “some other common healthcare job categories that are likely to be exposed . 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. Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. 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. Hazardous Drug Exposures in Health Care | NIOSH | CDC Occupational and environmental health nurses can play a key role in the implementation of the U.S. Pharmacopeial (USP) <800> guidelines to protect the health and safety of all workers who handle hazardous drugs. 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. Hazardous drugs can be found across all healthcare settings, such as hospitals, pharmacies, physicians’ offices, skilled nursing facilities, and outpatient surgical centers. were derived. PURPOSE. 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.”. 2. on Independent peer reviewers are being consulted as well; their charge is available on the NIOSH website [9] The definition of a hazardous drug in the draft Procedures recognizes that the molecular properties of a drug, such as the molecular weight, may substantially limit the potential for adverse health effects. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the 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… This information is not part of the official Federal Register document. NIOSH response: As presented in the 2018 FRN, daratumumab and dinutuximab were reviewed and did not meet the NIOSH criteria for a hazardous drug because the available information about each drug's toxicity was insufficient to support placement on the List. Significant peer review and public comments on the draft Policy and Procedures are summarized and answered below in Section II; public comments on specific drugs are summarized and answered below in Section III. Comment: Osimertinib should not be placed on the List. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. 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. Please provide any additional studies or scientific information that evaluate or validate engineering, work practice or administrative controls to reduce exposures to hazardous drugs in healthcare settings. USP added clarification about the application of chapter <800> to hazardous drugs, which can be found on its FAQ page.[4]. Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. 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. 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. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. 5. 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. Register (ACFR) issues a regulation granting it official legal status. 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. Hazardous Drugs: Handling in Health Care Settings Hazardous Drugs: Handling in Health Care Settings Is there a scientific justification for them? the current document as it appeared on Public Inspection on 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. 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. 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. NIOSH seeks feedback on three new draft documents that address hazardous drugs in healthcare settings. On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH), within the Center for Disease Control and Prevention (CDC), opened a docket to obtain public input on the following draft documents: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, … 4. NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (includes drugs proposed for new placement on the 2020 list) Managing Hazardous Drug Exposures: Information for Healthcare Settings; In addition to general feedback, NIOSH is seeking comments specifically on … 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. documents in the last year, 312 . Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on the List. The List should also indicate that hazardous drugs that do not sublime may be exhausted through a HEPA filter back into the work area. . 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. documents in the last year, by the Federal Trade Commission Only official editions of the documents in the last year, 38 Cited studies in the package insert also demonstrate impaired fertility in rats. … The draft Policy and Procedures document was developed to formalize the methodology NIOSH uses to guide the addition of hazardous drugs to the List and create a process for requesting the removal from or placement of drugs on the List. Respiratory Protection Guidance for Hazardous Drug Handling (800)HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS 1. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. . USP <800> Hazardous Drugs – Handling in Health Care was published on February 1, 2016 with an implementation date of December 1, 2019. In embryo-fetal development studies of dihydroergotamine mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses approximately 0.4-1.2 times the exposures in humans receiving the maximum recommended daily dose of 4 mg or greater. 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. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. 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. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. 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 list further tools to aid employers to protect workers. documents in the last year, by the International Trade Administration Guidelines on Handling Hazardous Drugs in 2006.3-5 The 2006 guidelines were created to harmonize with the National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings issued in 2004.6 The ASHP 2006 HD guidelines were current to 2005. 3. 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. Accordingly, NIOSH proposes to place dihydroergotamine on the List. Therefore, all recombinant therapeutic proteins should be excluded from the List unless “science-based or product-specific circumstances dictate otherwise.”. The companion document, “Managing Hazardous Drug Exposures: Information for Healthcare Settings,” takes information that in the 2016 list was under “Table 5: Personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings” to create a “new, comprehensive document on risk management strategies,” according to the NIOSH proposal.