Section C of the draft Procedures, which includes the evaluation criteria, would be expanded to include new clauses 4 and 5 to allow NIOSH to consider additional factors beyond the intrinsic toxicity of the drug molecule in determining whether to place the drug on the List. The 60-day window for public comments is May 1st, 2020 – June 1st, 2020. NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. If the latter is the case, could a sentence be added to clarify that?”. 02/12/2021, 835 All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. 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. are not part of the published document itself. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. Urofollitropin AHFS Class: Ovulation stimulator. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? provide legal notice to the public or judicial notice to the courts. Comment: Monoclonal antibodies do not have a cytotoxic mechanism of action and, as such, do not pose the same level of occupational risk or toxicity as conventional antineoplastic drugs. Please describe what you found to be most or least effective and why. the material on FederalRegister.gov is accurately displayed, consistent with 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.”. As a result, drugs that required different protective measures were grouped together. In this Issue, Documents Comment: Hazardous drugs should also be identified by UNII code (the unique ingredient identifier used by FDA and USP) on the List. Washington — NIOSH has extended until July 30 the comment period on three draft documents pertaining to hazardous drugs in health care. The public comment period for the NIOSH List of Hazardous Drugs in Healthcare Settings for 2020, Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, and Managing Hazardous Drug Exposures: Information for Healthcare Settings will be open until June 30, 2020. 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. from 36 agencies. Please provide specific examples. publication in the future. Blinatumomab continues to be proposed for placement and other monoclonal antibodies that have properties meeting the NIOSH definition of a hazardous drug will remain on the List. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. 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. NIOSH also invites comments specifically on the following questions related to this activity: 1. 5. What additional information would improve its usefulness and why? 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. . 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. Document Drafting Handbook NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. For complete information about, and access to, our official publications consumed worldwide. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. 4. of hazardous drug exposure in the workplace was moved to the draft NIOSH document Managing Hazardous Drug Exposures: Information for Healthcare Settings. 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. 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. 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. These services can occur in a variety of work settings, including hospitals, clinics, dental offices, out-patient surgery centers, birthing centers, emergency medical care, home healthcare… Accordingly, NIOSH continues to propose placing ivabradine on the List. Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. 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. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. As cancer therapy has changed from primarily cytotoxic drugs to non-cytotoxic and targeted therapies, there is sometimes a mismatch in general recommendations for safe handling and the hazardous nature of the drugs. “Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals.”. Only when a labeling change results in the addition of MSHI to a package insert will NIOSH automatically consider the drug to be a hazardous drug and add it to the List. NIOSH response: While some drugs may have low bioavailability by relevant routes of exposure due to molecular weight, other factors in the characterization of the hazard are considered as well. 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. Based on input from the public and stakeholders, including conflicting evidence about the hazards posed by botulinum toxins to workers, NIOSH is not currently proposing that botulinum toxins be added to the list. See draft Procedures footnote 18, “Properties of a drug molecule that may limit adverse effects in healthcare workers are typically chemical, physical and structural properties that affect its absorption (ability to enter the cells of the body), distribution, metabolism, and/or elimination e.g., chemical structure, molecular weight or mass.”. 7. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Respiratory Protection Guidance for Hazardous Drug Handling (800)HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS 1. Federal Register provide legal notice to the public and judicial notice NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. 1503 & 1507. These tools are designed to help you understand the official document Peer review comment: Some paragraphs in the section entitled, “Evidence of Health Effects in Workers from Handling Hazardous Drugs” do not belong in the scientific approach section and should be moved to be part of section B “Systematic and Sequential Methodology” section. Thus, neither was proposed for placement on the List in the February 2018 FRN. Drawing conclusions from a methodologically flawed paper can lead to misclassification of a drug. From my perspective, as a minimum, this should include porters, ward aides and unit clerks.”. documents in the last year, 26 As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). 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. “Many of the drugs currently used to fight cancer function differently than those previously used,” the Federal Register notice reads. 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. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. 2616 Lexington Road, Suite #2 ! 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. 6. 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. . better and aid in comparing the online edition to the print edition. Which of the following events marked the beginning of the most outstanding improvements in public health? a. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. 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 … c. What information is redundant, incorrect, missing, or not needed? 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. NIOSH does not review drugs that are not yet approved for use in humans. 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. Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. TIP No. Both drugs should be placed on the List because information available in the respective package inserts indicates that both drugs may cause teratogenic effects. Also available for comments are the “NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings” and “Managing Hazardous Drug Exposures: Information for Healthcare Settings”. 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. Darbepoetin alfa should not be placed on the List. 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. Peer Review Summaries and NIOSH Responses, Identifying, Screening, Evaluating, and Reviewing a Drug for Placement on the, Reconsideration (Reevaluation) of NIOSH Decisions to Place and Remove Drugs, B. 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.”. NIOSH seeks feedback on three new draft documents that address hazardous drugs in healthcare settings. 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. See https://www.cdc.gov/​niosh/​docs/​2016-161/​default.html for all drugs with special handling information added to the 2016 List. the document speaks to the need for individual healthcare workplaces to create their own lists of hazardous drugs, but this places the burden of regulation on these institutions themselves, or more likely individuals within these institutions. We’ve made big changes to make the eCFR easier to use. 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. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. Aschengrau A, Seage GR [2018], Essentials of Epidemiology in Public Health. Is the information threshold scientifically sound? 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). Not refining the List to identify real risks of occupational exposure could lead to “overwarning” for drugs that present little or no workplace risk. NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. 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. 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 … Comment. Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. 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. It would presumably be courteous to respond to any party that has provided comments for consideration.”. documents in the last year, by the National Institutes of Health Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. 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. .”. Hazardous Drugs – Handling in Healthcare Settings, on 1 February 2016. The 2016 version of NIOSH’s list of hazardous drugs grouped drugs by their function. The Public Inspection page may also documents in the last year, 223 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. NIOSH response: NIOSH is reorganizing and streamlining the document to make it more easily understood and to move information on site risk assessment to a separate draft document, Managing Hazardous Drug Exposures: Information for Healthcare Settings. Consequently, these drugs are all administered by injection. Because many of the antineoplastic drugs are genotoxic by nature, biomarkers for genotoxic agents have been used to monitor worker exposure to these drugs. 2. Comment: Interferon beta-1b should not be placed on the List, or, in the alternative, it should only be placed on Table 3. Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? fax 1.859.624.3580 www.nlmnet.org Note: NAILM reserves the right to withdrawn contact hour credit for this material without notice Tools for Policy Development: Recommendations for handling linens exposed to hazardous drugs Is there a scientific justification for them? 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, … Hazardous Drugs: Handling in Health Care Settings Comment: The drugs ibrutinib and blinatumomab, both antineoplastic monoclonal antibodies, are treated inconsistently in the February 2018 FRN. b. 02/12/2021, 152 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 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 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 … Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. Chemicals are classified as non-hazardous or hazardous. NIOSH previously proposed an entire class of drug, botulinum toxins, for placement on the list. See USP, FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings, https://www.usp.org/​frequently-asked-questions/​hazardous-drugs-handling-healthcare-settings. Comment: Ivabradine should not be placed on the List. Moreover, USP <800>requires the use of personal protective equipment for Table 1 drugs, which may delay care or undermine patient safety. . Where HDs are used in the workplace, sound practice dictates that employers develop a written Hazardous Drug Safety and Health Plan. 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. One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH. Washington — NIOSH is asking for stakeholder comment on three draft documents pertaining to hazardous drugs in health care settings. NAILM ! b. 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. Therefore, all recombinant therapeutic proteins should be excluded from the List unless “science-based or product-specific circumstances dictate otherwise.”. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. From my perspective, as a minimum, this . Please provide any additional studies or scientific information that support or validate evidence-based strategies or approaches for controlling exposures to hazardous drugs that are different from those that NIOSH has proposed. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. 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. . of the issuing agency. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. 3141 Fairview Park Drive | Suite 777 | Falls Church, VA 22042 | +1 703-849-8888. 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. Accordingly, NIOSH proposes to place exenatide on the List. Links to the draft documents can be found here. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. “'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.' to the courts under 44 U.S.C. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. It is not an official legal edition of the Federal documents in the last year, by the Federal Trade Commission The documents posted on this site are XML renditions of published Federal NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. Comment 1: The “Update of NIOSH Hazardous Drug List (Appendix A) for the NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings (April 6, 2009)”, on the NIOSH web site, explains why some drugs have been included and others excluded, and the selection and evaluation process. 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. 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. Information for travelers returning from countries with level 3 travel health notices. 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.
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