Antineoplastic cytotoxic medications, anesthetic agents, anti-viral agents, and others, have been identified as hazardous. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. For example, monoclonal antibodies are too large to be absorbed through skin contact, and if ingested, they would be destroyed by digestion; if inhaled, the pulmonary system would prevent absorption. NIOSH's definition of a hazardous drug only covers drugs approved by FDA's Center for Drug Evaluation and Research and is not considered for inclusion on the, Dihydroergotamine AHFS Class: 5-hydroxytryptamine (HT) receptor binder, Ivabradine AHFS Class: Hyperpolarization-activated cyclic nucleotide-gated (HCN) blocker. These markup elements allow the user to see how the document follows the Accordingly, NIOSH proposes to place dihydroergotamine on the List. relative risk, odds ratios, etc. 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. 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.. .. 4th Edition, (Burlington, MA: Jones & Bartlett). However, the lack of After review, NIOSH now finds that the information in the package insert for this drug does not support a determination that it presents a hazard to healthcare workers and is no longer proposing to place it on the List. In my opinion, a review of any animal studies should be conducted as they may offer insight regarding the potential risk posed by a drug. 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). In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. . 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. The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. This chapter alone is not sufficient for a comprehensive approach to safe handling of hazardous drugs . From an occupational hygiene perspective, if there is no existing occupational exposure limit or threshold limit value for a chemical hazard, the best practice is to ensure that worker exposure to the chemical remains As Low As Reasonably Achievable (ALARA). 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. Two reviewers had questions about the information thresholds required to evaluate drugs, and all reviewers had editorial suggestions for improving the clarity of the draft. 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. Comment: Dihydroergotamine should not be placed on the List. Furthermore, some drugs carry multiple American Hospital Formulary Service (AHFS) code classifications and are not solely used as antineoplastic drugs. The other 273 were screened and the information available for 44 drugs suggested one or more toxic effects; those drugs were evaluated by NIOSH and shared with peer reviewers and stakeholders. Please provide specific examples. 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. While the Bulletin recognizes the benefit of both forms of input to agencies, it provides agencies with broad discretion in determining how to implement peer review, including timing as it relates to public comment, if applicable. 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. 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. This PDF is The OFR/GPO partnership is committed to presenting accurate and reliable NIOSH response: NIOSH examines chemical analogs based on similarities in a drug's structure and toxicity profile compared with other drugs on the List. USP <800> Public comment: Several commenters offered suggestions on the document's use of USP <800>. 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. NIOSH response: A drug may be removed from the List based on either a written request from an interested party or a change to the package insert. In its place, NIOSH has developed a new, comprehensive document on risk management strategies entitled, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which includes a revision of this table on control approaches to safe handling of hazardous drugs. NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. 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. Data on the developmental effects of itraconazole and ketoconazole suggest developmental toxicity has only been observed in doses greater than the maximum human recommended dose. NIOSH also invites comments specifically on the following questions related to this activity: 1. [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). Both drugs should be placed on the List because information available in the respective package inserts indicates that both drugs may cause teratogenic effects. 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. Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. Drawing conclusions from a methodologically flawed paper can lead to misclassification of a drug. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Please provide information about your professional experience, if any, of implementing control strategies for exposures to hazardous drugs in healthcare or similar settings. In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. by the Securities and Exchange Commission NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. 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. 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 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). NIOSH has retitled and reorganized the List in response to comments received. daily Federal Register on FederalRegister.gov will remain an unofficial 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. The public comments have been organized into the following topic areas: organization of the List and impact of United States Pharmacopeia (USP) Compounding Compendium chapter <800> Hazardous DrugsHandling in Healthcare Settings; the nature of the Listexposure/hazard characterization; monoclonal antibodies; periodicity; methodology/process; criteria clarification; and editorial suggestions. b. 8. 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. See https://www.cdc.gov/niosh/docs/2016-161/default.html for all drugs with special handling information added to the 2016 List. 9. NIOSH's extensive review process only allows for periodic updates of hazardous drugs that do not have MSHI. Please refer to the current edition of the USP-NF for official text. General Chapter <800> was published on February 1, 2016. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. 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>. In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. The goals of these standards are to help increase awareness, provide uniform guidance to reduce the risk of managing hazardous drugs, and help reduce the risk posed to patients and the healthcare workforce. 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. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020. on In a Federal Register notice (FRN) published on February 14, 2018 (83 FR 6563), NIOSH invited the public to participate in the development of the List and the procedures used to develop the List by submitting written views, opinions, recommendations, and/or data. 6. 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. Publications Presenting Best Practices In Hazardous Drug Management 1,3,5-11: CDC/NIOSH: Managing Hazardous Drug Exposures: Information for Healthcare Settings (Draft, 2020) 1 ASCO Safe Handling of Hazardous Drugs: ASCO Standards (2019) 5 ONS/HOPA Ensuring Health Care Worker Safety When Handling Hazardous Drugs (2019) 6 USP General Chapter <800> (2019) 7 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 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. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? Of the 275 drugs identified during that timeframe, two had special handling information specified by the manufacturer (MSHI) and were automatically placed on the List. USP 800> Hazardous Drugs-Handling in Healthcare Settings USP <800> Impact on Community Pharmacies Charles Lager RPh, MBA Thursday, April 8, 2021. [3] Throughout the healthcare landscape, people are asking, "What is USP 800?" Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, Managing Hazardous Drug Exposures: Information for Healthcare Settings, National Institute for Occupational Safety and Health, U.S. Department of Health & Human Services. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. 7. From my perspective, as a minimum, this should include porters, ward aides and unit clerks.. 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.. A pharmacy's list of hazardous drugs should be reviewed ever 12 months with a document review, when a new agent or dosage form is added, or if storage, preparation, or administration of the hazardous drug will not meet USP <800> standards and an assessment of risk must be done. Table 1. This drug is scheduled to be reviewed for the next, Because drugs sold over the counter are not contemplated in this activity, this drug has not been and will not be reviewed for placement on the, This drug was reviewed by NIOSH and presented in the 2018 FRN; the available information shows a toxic effect that does not meet the NIOSH definition of hazardous drug. Additionally, peer reviews provide the Agency with a review of its science; peer reviewers and their credentials are identified in the NIOSH Peer Review Agenda.Start Printed Page 25445, Commenters: NIOSH should identify the criteria used to evaluate study quality and strength, and describe how they are used to critically appraise the quality and risk of bias and other limitations of individual studies; arbitrate conflicting information; and synthesize the totality of animal and human studies data in support of, or opposition to, the listing of a drug as hazardous.. 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. Register, and does not replace the official print version or the official on ET on July 30, 2020 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. As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. The 13 drugs proposed for placement on the List are presented for public comment in the table below, along with the rationale for their placement on the List. In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. 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. documents in the last year, 1008 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. 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. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. Aschengrau A, Seage GR [2018], Essentials of Epidemiology in Public Health. provide legal notice to the public or judicial notice to the courts. 2. Each document posted on the site includes a link to the 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. . If available, NIOSH would give preference to them over animal and in vitro studies. Please include the URL of the site in the Subject line of your email request that you would like to access. 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. 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. 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. documents in the last year, 931 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). 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. All information these cookies collect is aggregated and therefore anonymous. 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. Comment: Olaparib should not be placed on the List because the risk to direct occupational healthcare worker exposure is anticipated to be minimal when handling intact olaparib capsules. Free Download USP GC <800>Register for live webcastGC <800> Infographic. the material on FederalRegister.gov is accurately displayed, consistent with NIOSH should provide the rationale for not proposing their placement on the List. Because the way cancer is treated therapeutically has changed, and the classes of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic or genotoxic. In light of these changes, NIOSH proposes a new List structure, described in the preamble to the List, which is available for review in the docket for this activity. documents in the last year, 887 For complete information about, and access to, our official publications This site displays a prototype of a Web 2.0 version of the daily Three commenters offered opinions on the timeliness of the List, which NIOSH has attempted to publish every 2 years since 2010. 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. Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. Moreover, NIOSH is not properly weighing the low therapeutic index of the drug against the relatively low risk of handling the drug by healthcare workers who are knowledgeable about safe handling. NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. Thus, neither was proposed for placement on the List in the February 2018 FRN. The Public Inspection page may also If new information becomes available about any of these drugs, NIOSH will reevaluate them in a future update to the List. Federal Register. 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. These cookies may also be used for advertising purposes by these third parties. establishing the XML-based Federal Register as an ACFR-sanctioned NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. 04/30/2020 at 8:45 am. 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. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. 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. 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. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. 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. Please provide feedback on the overall document: a. Answer: The NIOSH list is not intended to rank hazards. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. 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. 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. So, any drugs that were approved after 2015, other than those 10 drugs added on March 23, 2022, must be evaluated by your pharmacy as . documents in the last year, 825 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. documents in the last year, by the Food and Drug Administration If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. NIOSH encourages public comment on these questions. The current List created by NIOSH requires an extensive review process that does not readily allow more frequent publication. [7] 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. 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. 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). For the purposes of this chapter, the term antineoplastic only refers to antineoplastic drugs included in Table 1 of the most current NIOSH list. Four independent peer reviewers and 55 public commenters offered input on the draft Policy and Procedures; their substantive comments are summarized below, followed by NIOSH responses. Under the draft Procedures, NIOSH's rationale, including a description of any meta-analysis or systematic review if performed, and final determination would be described in a notice published in the Federal Register. 4. November 02, 2020 USP 800 For Pharmacists & Healthcare Workers An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. 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). You will be subject to the destination website's privacy policy when you follow the link. The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient. 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). CDC twenty four seven. 2020-09332 Filed 4-30-20; 8:45 am], updated on 4:15 PM on Monday, May 1, 2023, updated on 8:45 AM on Monday, May 1, 2023. 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.
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