The new iteration is now referred to as draft Procedures throughout this notice. Comment. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? 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. Federal Register. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. To view the notice and related materials, visit http://www.regulations.govexternal icon and enter CDC-2020-0046 in the search field and click Search., Comments will be accepted until 11:59 p.m. when determining the potential for adverse health effects of hazardous drugs in healthcare workers. A new peer review was not conducted. Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. Peer review comment: A statement about the evaluation procedures in the draft Policy and Procedures indicates that NIOSH would only consider human studies. documents in the last year, 825 Document Drafting Handbook electronic version on GPOs govinfo.gov. List of Hazardous Drugs. The agency has updated its List of Hazardous Drugs in Healthcare Settings for 2020 as well as its procedures for developing the list. It is scheduled to be re-reviewed for the next update to the, This oncolytic viral therapy product is outside the scope of NIOSH's definition of a hazardous drug because it is approved by FDA's Center for Biologics Evaluation and Research. documents in the last year, 494 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. 04/30/2020 at 8:45 am. 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. 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.. documents in the last year. Public Comment Summaries and NIOSH Responses, B. Therefore, when antineoplastic drugs are grouped, as they were in earlier versions of Table 1, drugs that required different levels of protection were grouped together (non-cytotoxic drugs with cytotoxic drugs). 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. documents in the last year, 19 should verify the contents of the documents against a final, official . All relevant comments received will be posted without change to www.regulations.gov,, including any personal information provided. The new list format will allow organizations more flexibility for certain drugs when implementing USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings. NIOSH response: NIOSH views peer review and public comment as two distinct, often complementary, tools in ensuring both quality and transparency in influential scientific information products. NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. Comment: Hazardous drugs should also be identified by UNII code (the unique ingredient identifier used by FDA and USP) on the List. Please provide any additional studies or scientific information related to the use of a medical surveillance program as an additional approach to protect workers in healthcare settings. Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. . Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. 6. legal research should verify their results against an official edition of NIOSH identified a sample list of hazardous drugs. 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. 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. This chapter alone is not sufficient for a comprehensive approach to safe handling of hazardous drugs . Moreover, USP <800>requires the use of personal protective equipment for Table 1 drugs, which may delay care or undermine patient safety. The USP <800> requirements standardizing the safe handling of hazardous drugs went into effect December 1, 2019. NIOSH defines HDs as the following: Handling hazardous drugs under USP General Chapter <800> | McKesson 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. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. 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. 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. Which unique ingredient identifier is the most useful for users of the List? NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. Centers for Disease Control and Prevention. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. Commenters included pharmacists, professional organizations and associations, pharmaceutical manufacturers, medical centers and/or health systems, individuals who provided their names but not their affiliations, a company that provides risk assessments, a drug database, an insurance company, a medical school professor, a neurologist, and an anonymous commenter. NIOSH response: The majority of drug evaluations are based on information provided in the drug package insert; NIOSH relies on the quality of science Start Printed Page 25442generated by a drug manufacturer, subsequently reviewed by FDA during the drug approval process, and then published in the drug package insert. In addition, there are no reports of teratogenicity, developmental toxicity, embryo-fetal toxicity, lethality, or reduced growth in clinical trials conducted in humans, or in real world use since FDA approval in 2015. <800> Hazardous DrugsHandling in Healthcare Settings - USP-NF 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. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? 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. 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. The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. Although assessing specific controls for specific exposure situations is beyond the scope of the List, information about the use of respiratory protection in the handling of hazardous drugs is found in the draft risk management document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is available in the docket for this activity. 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. 05/01/2023, 858 Please include the URL of the site in the Subject line of your email request that you would like to access. headings within the legal text of Federal Register documents. USP <800> requires an assessment of risk, which is a consideration of the type of HD, dosage form, risk of exposure, packaging, and manipulation. 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. In the February 2018 Request for Comment, NIOSH requested comment on a draft Policy and Procedures for developing the List. 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. 7. 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. NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. 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. . Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. 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. 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. For more information on other compounding chaptersclick here. 05/01/2023, 244 See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. documents in the last year, 37 The NIOSH definition of a "hazardous" drug is a drug that is: Approved for use in humans11 by the FDA's Center for Drug Evaluation and Research (CDER);12 Not otherwise regulated by the U.S. Nuclear Regulatory Commission;13 and Either: hospital. The subsequent description of a site risk Start Printed Page 25441assessment does not seem appropriate here. In addition, having an algorithm to determine the strength of a paper will also aid in minimizing any potential inter- and intra-reviewer differences. Antineoplastic & Other Hazardous Drugs in Healthcare, 2016 | NIOSH - CDC Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. 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. Hazardous Drugs: Procedures for Developing the NIOSH List of Hazardous No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab.