usp <800> hazardous drug list 2020

Comment: Dihydroergotamine should not be placed on the List. NIOSH response: NIOSH's rationale for proposing the placement of triazolam on the List was that it mimics the benzodiazepines which are included on the List because they are teratogenic or cause other developmental effects. 2020-N-0145 for ''Reporting Associated With Animal Drug and Animal Generic Drug User Fees.'' Received comments, those filed in a timely manner (see 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. 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. Until the ACFR grants it official status, the XML Register, and does not replace the official print version or the official 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. The new iteration is now referred to as draft Procedures throughout this notice. If available, NIOSH would give preference to them over animal and in vitro studies. 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. Comment: NIOSH indicated that two drugsdaratumumab and dinutuximabdemonstrated insufficient toxicity information available to meet the NIOSH definition of a hazardous drug. 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. Comment: Botulinum toxins, including abobotulinumtoxinA and onabotulinumtoxinA, should not be placed on the List. The Public Inspection page may also NIOSH also conducted a peer review, with four independent reviewers, of the draft Policy and Procedures.[2]. NIOSH response: Only a few of the drugs on the List are known to have an appreciable vapor pressure; reliable information concerning the vapor pressure of most drugs can be difficult to identify. 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. USP General Chapter <800 . NIOSH may consider molecular weight along with the other intrinsic molecular properties of a drug that affect the hazard a drug poses. 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. 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. 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. Relevant information about this document from Regulations.gov provides additional context. that agencies use to create their documents. 5. documents in the last year, 9 and includes the following questions. What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? informational resource until the Administrative Committee of the Federal If new information becomes available, NIOSH will reevaluate it in a future update to the, This drug was approved by FDA in 2017. by the Securities and Exchange Commission Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. 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. One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH. NIOSH must add criteria for animal studies to include the recovery/reversibility of adverse effects and the pharmacological relevance of the test species. In rats, exenatide administered during the period of organogenesis reduced fetal growth and produced skeletal ossification deficits at doses that approximate the maximum recommended human dose. These markup elements allow the user to see how the document follows the Comment: Eight drugs were approved by FDA prior to December 2015, but do not appear on the 2016 List and were not proposed for placement on the List in the February 2018 FRN. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. Please refer to the current edition of the USP-NF for official text. 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. 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. Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. Peer review comment: NIOSH's discussion of an employer-performed site-based risk assessment to control the risk of exposure is confusing when placed in a document describing NIOSH's hazard identification procedures. Darbepoetin alfa should not be placed on the List. If new information becomes available about any of these drugs, NIOSH will reevaluate them in a future update to the List. 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. Seven commenters opposed the inclusion of biological drug products (monoclonal antibodies) on the List. Accordingly, NIOSH proposes to place olaparib on the List. on NARA's archives.gov. Urofollitropin AHFS Class: Ovulation stimulator. 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. Throughout the healthcare landscape, people are asking, "What is USP 800?" 4. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. Comment: The List should identify those hazardous drugs that are both cytotoxic and cytostatic as well as volatile. 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. 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. See USP, FAQs: <800> Hazardous DrugsHandling in Healthcare Settings, https://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. Comment: Monoclonal antibodies (i.e., therapeutic proteins) are of such a large molecular weight that they do not pose a realistic risk to healthcare workers. NIOSH has provided its proposed recommendations and related information about controlling hazardous drugs in the Table of Control Approaches in Chapter 8. a. More than 12 billion doses of hazardous drugs are handled by US providers each year. Therefore, all recombinant therapeutic proteins should be excluded from the List unless science-based or product-specific circumstances dictate otherwise.. USP General Chapter(s)800> Hazardous Drugs - Handling in Healthcare Settings (Informational)825> Radiopharmaceuticals - Preparations, Compounding, Dispensing, and Repackaging as published June 1, 2019 (Informational) First Name Last Name documents in the last year, 19 Learn more here. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. In February 2018, NIOSH proposed adding 21 drugs (including one class of drugs) to the List. Please explain. In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. 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. Animal studies, where available, are also used in our evaluations. As such, the use of animal studies to evaluate the hazardous nature of a drug should be explicitly stated.. 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. publication in the future. USP <800> Hazardous Drugs Risk Readiness Checklist Implementation Date December 1, 2019 USP <800> Hazardous Drugs - Handling in Health Care was published on February 1, 2016 with an implementation date of December 1, 2019. It is not an official legal edition of the Federal Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? 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. In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. Federal Register provide legal notice to the public and judicial notice OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. provide legal notice to the public or judicial notice to the courts. . The draft Procedures is in the docket for this activity. documents in the last year, 422 If you are using public inspection listings for legal research, you 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. Drawing conclusions from a methodologically flawed paper can lead to misclassification of a drug. Comment: Bacillus Calmette-Guerin (BCG) should be removed from the List. The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. The new risk management document is available for review in the docket for this activity. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. If the latter is the case, could a sentence be added to clarify that?. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings, A. 04/30/2020 at 8:45 am. It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. CDC twenty four seven. ET on July 30, 2020 USP 800 only states Table 1. USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Register documents. This site displays a prototype of a Web 2.0 version of the daily NIOSH appreciates that a timelier List might be helpful and is working toward that end. 05/01/2023, 244 documents in the last year, 37 Thank you for taking the time to confirm your preferences. 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. You can review and change the way we collect information below. The draft Procedures document is now focused on NIOSH's procedure for identifying hazardous drugs and no longer discusses managing the risk of exposure. Is the set of information sources used for classifying drugs sufficient to identify relevant hazards? Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. Free Download USP GC <800>Register for live webcastGC <800> Infographic. NIOSH response: As presented in the 2018 FRN, NIOSH reviewed cetuximab, ibrutinib, ipilimumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib for placement on the List and, for each, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug. documents in the last year, by the Food and Drug Administration NIOSH encourages public input on the question of which ingredient identifier may be the most useful for the List. USP added clarification about the application of chapter <800> to hazardous drugs, which can be found on its FAQ page.[4]. of the issuing agency. This drug was reviewed by NIOSH for a previous update to the, This drug was reviewed by NIOSH and presented in the 2018 FRN; it did not meet the criteria for a hazardous drug. Thus, neither was proposed for placement on the List in the February 2018 FRN. 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. What structural or format changes could be made to improve the utility of this table? 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] The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress. The large molecular size limits dermal absorption and aerosolization. Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. Accordingly, NIOSH continues to propose placing ivabradine on the List. These drugs should be placed on the List because of their teratogenic and/or reproductive effects or the rationale for not proposing their placement on the List should be further explained. 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. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient. 3. documents in the last year, 83 The OFR/GPO partnership is committed to presenting accurate and reliable 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. In this Issue, Documents Peer review comment: A statement about the evaluation procedures in the draft Policy and Procedures indicates that NIOSH would only consider human studies. 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. Similar questions were raised about animal studies. 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. hazardous drugs. After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. 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. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. The requestor need only provide some new information that is relevant to the issue of whether the drug does or does not meet the NIOSH definition of a hazardous drug or the decision to place a drug on a particular table in the List. 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. NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. 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. Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. In mice, doses near the maximum recommended human dose lead to increased neonatal death. Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. The last paragraph of this section is particularly confusing to the reader. 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. This is because there is insufficient information to establish an exposure limit and, therefore, one should err on the side of caution and apply the ALARA principle. Register (ACFR) issues a regulation granting it official legal status. Comment: Ivabradine should not be placed on the List. . 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 language in the section titled Application indicates that the draft Policy and Procedures do not apply to healthcare workers who handle recombinant therapeutic proteins. Comment. Ibrutinib was identified as a drug for which the available information shows a toxic effect that does not meet the NIOSH definition of a hazardous drug; blinatumomab was proposed for placement on the List on the basis of evidence which shows the drug is a neurotoxin at low doses. 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. Risks associated with how and how often a hazardous drug is used in a particular setting, and evaluation of exposure factors for all occupational exposures is beyond the scope of the List. Additional changes to the List, including those drugs proposed for removal from the List, are described in detail in the draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, which is available for review in the docket for this activity. Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. However, NIOSH did not independently evaluate triazolam. It would presumably be courteous to respond to any party that has provided comments for consideration.. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. regulatory information on FederalRegister.gov with the objective of NIOSH encourages public comment on these questions. 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. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. 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. 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. 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. This PDF is NIOSH response: After scientific review and consideration of input from peer reviewers and public commenters, NIOSH is proposing a reorganization of the List. documents in the last year, 1008 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. NIOSH should provide the rationale for not proposing their placement on the List. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. should verify the contents of the documents against a final, official This table of contents is a navigational tool, processed from the [3] However, rather than identifying job-specific titles, the document focuses on workplace activities. 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. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. 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. Reproductive toxicity: Cited studies in the package insert demonstrated reproductive toxicity in male and female rates. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. 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). This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. 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.. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. 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 . Comment: The drugs ibrutinib and blinatumomab, both antineoplastic monoclonal antibodies, are treated inconsistently in the February 2018 FRN. c. What information is redundant, incorrect, missing, or not needed? 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. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. include documents scheduled for later issues, at the request 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>. NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. New Documents Sargent EV and Kirk GD [1988], Establishing Airborne Exposure Control Limits in the Pharmaceutical Industry, Am Ind Hyg Assoc J 49(6):309-13; Naumann BD and Sargent EV [1997], Setting Occupational Exposure Limits for Pharmaceuticals, Occup Med 12(1):67-80; Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L [2002], The Importance of Human Data in the Establishment of Occupational Exposure Limits, Hum Ecol Risk Assess 8(4):805-822.

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