hazardous drugs. 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) Accordingly, NIOSH continues to propose placing ivabradine on the List. Comment: Interferon beta-1b should not be placed on the List, or, in the alternative, it should only be placed on Table 3. . NIOSH Peer Review Agenda, https://www.cdc.gov/niosh/review/peer/isi/healthsafetyrisks.html. Comments must be received by June 30, 2020. Risk Management for Hazardous Drugs in Healthcare Settings, 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. publication in the future. Docket 233-C: List of Hazardous Drugs in Healthcare Settings, 2020 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. 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. were derived. As such, they should be moved from Table 1 to another place on the List. Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. 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. documents in the last year, 84 More information and documentation can be found in our Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. [1], Fifty-seven submissions were received in docket CDC-2018-0004 (NIOSH-233-B) from 55 commenters (one commenter sent three separate submissions to the docket). 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. on FederalRegister.gov 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. . NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. NIOSH response: Because the draft Procedures document only addresses NIOSH's procedure for identifying hazardous drugs, the Application section is removed. However, rather than identifying job-specific titles, the document focuses on workplace activities. The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient. Many of the drugs currently used to fight cancer function differently than those previously used. 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 . The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. 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. 05/01/2023, 39 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. The USP <800> requirements standardizing the safe handling of hazardous drugs went into effect December 1, 2019. Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? 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. 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. . whereas public comment, including stakeholder review, often provides NIOSH with crucial feedback on how a project or publication may impact the interests of employees, stakeholder organizations, or other parties. Most importantly, the definition of the term hazardous drug would now acknowledge that hazard characterization is an important factor for drugs under consideration. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Interested parties are invited to participate in this activity by submitting Start Printed Page 25440written views, opinions, recommendations, and/or data. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. The agency has updated its List of Hazardous Drugs in Healthcare Settings for 2020 as well as its procedures for developing the list. Review their work plan and past meeting summaries. 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. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. 4. 05/01/2023, 244 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). documents in the last year, by the Food and Drug Administration They help us to know which pages are the most and least popular and see how visitors move around the site. The draft Procedures considers the toxicity criteria in the definition of a hazardous drug to identify the hazard and some intrinsic molecular properties to characterize the hazard[5] In identifying HDs, USP <800> Hazardous Drugs - Handling in Healthcare Settings requires use of the most current version of the list of such drugs maintained by the CDC's National Institute for Occupational Safety and Health (NIOSH). 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. 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). Therefore, all recombinant therapeutic proteins should be excluded from the List unless science-based or product-specific circumstances dictate otherwise.. when determining the potential for adverse health effects of hazardous drugs in healthcare workers. The new iteration is now referred to as draft Procedures throughout this notice. 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. NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. 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. 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. No labeling change has ever resulted in the removal of a drug from the List, but labeling changes that demonstrate a lack of evidence of toxicity would be dealt with in the regular List updates. 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. 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.. 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. USP General Chapter <800> AHazardous Drugs Handling in Healthcare Settings USP first published General Chapter <800> in February 2016, with the official date anticipated for December 2019. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. . The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick Therefore, in accordance with the draft Procedures some monoclonal antibodies may not meet the NIOSH definition of the term hazardous drug. Because the list of drugs proposed for placement on the List has been updated based on the draft Procedures, the monoclonal antibodies bevacizumab and trastuzumab are no longer proposed for placement on the List. 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. 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. USP 800 For Pharmacists & Healthcare Workers | Stericycle This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. 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. Table 2 would now contain drugs that meet one or more of the NIOSH hazardous drug criteria and may be developmental and/or reproductive developmental toxins but are not drugs which have MSHI or are classified as carcinogens or probable carcinogens by NTP or IARC. For the purposes of this chapter, the term antineoplastic only refers to antineoplastic drugs included in Table 1 of the most current NIOSH list. 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.. 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. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. NIOSH response: For reevaluation of a listed drug, NIOSH does not require requestors to provide a complete analysis of the available evidence. Please provide feedback on the overall document: a. NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. Information about the application of the List can be found in the introduction of the draft Managing Hazardous Drug Exposures: Information for Healthcare Settings. 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. that agencies use to create their 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 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. Cookies used to make website functionality more relevant to you. 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. 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. Seven commenters expressed concern about the impact of USP <800> on the NIOSH List, and, in turn, the effect on small pharmacies that compound pharmaceutical drugs. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. are not part of the published document itself. <800> Hazardous DrugsHandling in Healthcare Settings - USP-NF 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. This feature is not available for this document. Comments are invited on any topic related to the procedures and drugs identified in this notice, including three 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, 2020 (List), including those drugs identified in this notice as being proposed for placement on the List; and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. 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. Centers for Disease Control and Prevention, HHS. NIOSH defines HDs as the following: ET on July 30, 2020 All relevant comments received will be posted without change to www.regulations.gov,, including any personal information provided. 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. 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). Comment: The List should identify those hazardous drugs that are both cytotoxic and cytostatic as well as volatile. 2. The List should also indicate that hazardous drugs that do not sublime may be exhausted through a HEPA filter back into the work area. However, NIOSH did not independently evaluate triazolam. Peer review comment: NIOSH did not include a mechanism to place investigational drugs on the List. This criterion is typically only used when toxicity information specific to the drug under evaluation is insufficient or unavailable but is available for the chemical analog. NIOSH response: NIOSH has determined that teratogenicity occurred in rats at doses approximately 0.3 percent of therapeutic doses in humans. 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 g/m[3] after applying appropriate uncertainty factors. For some of these drugs, no drug-specific data were available in the package inserts to support warnings in the inserts regarding developmental or reproductive effects; for other drugs, the toxic effects occurred at doses higher than human recommended doses. 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. 6. 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. documents in the last year, 37 establishing the XML-based Federal Register as an ACFR-sanctioned One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH. Relevant information about this document from Regulations.gov provides additional context. Peer review comment: It may be inappropriate for NIOSH not to place drugs on the List when NIOSH has determined there is insufficient information to support the placement. 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. . NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. . Cited studies in the package insert also demonstrate impaired fertility in rats. 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. NIOSH also conducted a peer review, with four independent reviewers, of the draft Policy and Procedures.[2]. Independent peer reviewers are being consulted as well; their charge is available on the NIOSH website[9] Comment: Azole antifungal drugs are being treated inconsistently. This text is a courtesy copy of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings, intended to be used as an informational tool and resource only. documents in the last year, 887 Federal Register. 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 comment: NIOSH should clarify whether a drug may be removed from the List based on changes to the package insert, or if written requests from interested parties to the NIOSH Director are the only mechanism for consideration of a drug for deletion from the List (the reconsideration process as described). Is the information threshold scientifically sound? . Proposed Location Table 2: No MSHI, not classified as known or probable carcinogen by NTP or IARC. 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. The Procedures should state that this list is [a] hazard identification and not a risk assessment exercise. 7. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on 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). 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.
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