usp <800> hazardous drug list 2020

Because there is conflicting evidence about the hazard posed by botulinum toxins to the workers who handle these drugs, NIOSH is not proposing the placement of botulinum toxins on the List at this time and invites additional studies, data, and expert opinions pertinent to this issue in order to evaluate the botulinum toxins more fully. Accordingly, darbepoetin alfa is no longer proposed for placement on the 2020 List. Are these standard or commonly accepted definitions of 'low dose' exposure? . Should you have any questions, please contact Tiffany Chan, Associate Scientific Liaison, Healthcare Quality and Safety ( CompoundingSL@usp.org ). 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. USP 800> Hazardous Drugs-Handling in Healthcare Settings USP <800> Impact on Community Pharmacies Charles Lager RPh, MBA Thursday, April 8, 2021. 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. Seven commenters asked questions and offered suggestions about the procedures themselves. More information and documentation can be found in our The manufacturer or any other stakeholder is invited to comment on the sufficiency of the explanation of the basis for adding a drug to the List. NIOSH response: A drug may be considered a hazardous drug but not a chemical carcinogen if, for example, a drug manufacturer includes a carcinogenicity warning in the drug's package insert but the evidence for carcinogenicity has not been reviewed by the International Agency for Research on Cancer (IARC); the National Toxicology Program (NTP), within the U.S. Department of Health and Human Services; the U.S. Environmental Protection Agency (EPA); or independently by NIOSH. [FR Doc. The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. Are there any issues not considered by the charge questions that should be addressed. USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. 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. Similar questions were raised about animal studies. These three drugs do not appear below because they are not subject to public comment. NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. 2. 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. rendition of the daily Federal Register on FederalRegister.gov does not Comments must be received by June 30, 2020. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. Antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. 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. 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. hazardous drugs. NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. NIOSH response: Compilation of the List is a hazard identification and hazard characterization process, as described in the draft Procedures. Peer-reviewed, published studies are usually not available and therefore evaluating the quality of studies is not typically possible. Open for Comment. . 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. 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. 05/01/2023, 39 NIOSH Peer Review Agenda, https://www.cdc.gov/niosh/review/peer/isi/healthsafetyrisks.html. regulatory information on FederalRegister.gov with the objective of Answer: The NIOSH list is not intended to rank hazards. ASHP submitted comments in response to the 2020 draft documents in support of this new format. 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). 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. 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. 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 defines HDs as the following: Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. . This information is not part of the official Federal Register document. 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.. 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. 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. 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). The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. Peer review comment: A statement about the evaluation procedures in the draft Policy and Procedures indicates that NIOSH would only consider human studies. when determining the potential for adverse health effects of hazardous drugs in healthcare workers. Please provide any additional studies or scientific information that evaluate or validate engineering, work practice or administrative controls to reduce exposures to hazardous drugs in healthcare settings. Most were concerned . . Nine commenters expressed the sentiment that the List would be more useful if it identified drugs that pose a realistic risk to healthcare workers. The specific backgrounds of the professional staff engaged in the evaluation process may change over time, but NIOSH is committed to a high-quality process conducted by a team of professionals with the needed knowledge and experience. 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. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. of the issuing agency. Is the threshold of information required to move from the screening process to the full evaluation process clearly described? relative risk, odds ratios, etc. 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. Regardless of when the NIOSH 2020 list is finalized, the list states, "Drugs reviewed for this update were new drug approvals or received safety-related new warnings from FDA in the period between January 2014 and December 2015" 3 (emphasis added). This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Although there is currently some guidance in the footnotes, it may be worthwhile to consider a more detailed evaluation process of relevant studies and place it in a more prominent location in the document or possibly as an Appendix.. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. for better understanding how a document is structured but 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.. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. 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. . It is unclear why animal studies were not included as a source of evaluating potentially hazardous drugs. Comment: Azole antifungal drugs are being treated inconsistently. 7. 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. As such, the use of animal studies to evaluate the hazardous nature of a drug should be explicitly stated.. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. to the courts under 44 U.S.C. 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. Comment: Bacillus Calmette-Guerin (BCG) should be removed from the List. 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. 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. 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 last paragraph of this section is particularly confusing to the reader. 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. Those monoclonal antibodies that are not directly cytotoxic or conjugated with a cytotoxic agent should be moved from Table 1 to another place on the List. Antineoplastic cytotoxic medications, anesthetic agents, anti-viral agents, and others, have been identified as hazardous. In addition, darbepoetin alfa did not meet the NIOSH criteria for a hazardous drug based on any other toxicity endpoint. b. electronic version on GPOs govinfo.gov. It would presumably be courteous to respond to any party that has provided comments for consideration.. 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. 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. include documents scheduled for later issues, at the request Not refining the List to identify real risks of occupational exposure could lead to overwarning for drugs that present little or no workplace risk. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. If available, NIOSH would give preference to them over animal and in vitro studies. documents in the last year, 669 edition of the Federal Register. Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. 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. In accordance with the new structure, many of the hormonal agents on the 2016 List have been moved to Table 2. This prototype edition of the . 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. Independent peer reviewers are being consulted as well; their charge is available on the NIOSH website[9] Therefore, at this time NIOSH is no longer proposing to place the class of botulinum toxins on the 2020 List. 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. 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. In mice, doses near the maximum recommended human dose lead to increased neonatal death. Darbepoetin alfa should not be placed on the List. Consequently, these drugs are all administered by injection. documents in the last year, 1407 Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. 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. Comment: Triazolam should not be placed on the List. As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments. 04/30/2020 at 8:45 am. The USP <800> requirements standardizing the safe handling of hazardous drugs went into effect December 1, 2019. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. 1. 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. The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. 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. should verify the contents of the documents against a final, official NIOSH proposed an updated list in 2020, Ms. Kienle noted, which is not yet official. For complete information about, and access to, our official publications 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. 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. documents in the last year, by the International Trade Commission Each document posted on the site includes a link to the documents in the last year, 422 NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. Therefore, NIOSH has regrouped the tables by hazard. 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. 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 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. 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. USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. offers a preview of documents scheduled to appear in the next day's 3. NIOSH response: This refers to human genotoxicity studies, which are rarely available. USP <800> requires an assessment of risk, which is a consideration of the type of HD, dosage form, risk of exposure, packaging, and manipulation. Furthermore, some drugs carry multiple American Hospital Formulary Service (AHFS) code classifications and are not solely used as antineoplastic drugs. See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. Federal Register. Manufacturer recommendation: that females of reproduction potential use effective contraception during and for four months after completing therapy. The list was compiled from information provided by four institutions that had generated lists of haz- . 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. 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. NIOSH has requested public comments on three draft documents: (1) the 2020 List of Hazardous Drugs; (2) Procedures for Developing the NIOSH List ("the List") of Hazardous Drugs; and (3) Managing Hazardous Drug Exposures For Health Care Settings available here . 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. on 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). NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. Information about the application of the List can be found in the introduction of the draft Managing Hazardous Drug Exposures: Information for Healthcare Settings. The inclusion of MSHI makes such drugs automatically hazardous under the NIOSH definition and thus, the extensive review process is not required. Comment: The draft Policy and Procedures should provide the drug manufacturer with transparent documentation as to the basis of adding a drug to the List. Without a thorough understanding of the basis for adding a drug, the drug manufacturer may not be able to formulate a request for reconsideration of the drug. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. camp clark oregon wedding, franklin graham airplane,

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usp <800> hazardous drug list 2020

usp <800> hazardous drug list 2020

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