NIOSH response: NIOSH reviews the relevant data on a drug when a label change is made, not just the data relating to the label change. . 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. 6. 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. See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. Reproductive toxicity/teratogenicity: The FDA classifies lapatinib as pregnancy category D indicating positive evidence of human fetal risk. NIOSH response: While some drugs may have low bioavailability by relevant routes of exposure due to molecular weight, other factors in the characterization of the hazard are considered as well. 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. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. documents in the last year, 1407 Because drugs with MSHI are automatically placed on the List and are not subject to public or peer review, polatuzumab vedotin was added to the 2016 List in September 2019 and will appear in the 2020 List. NIOSH is adding text in footnote 16 of the draft Procedures to clarify and emphasize the derivation. documents in the last year, 29 Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. 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. Peer review comment: NIOSH should clarify how the threshold dosages (10 mg/day or 1 mg/kg/day) for defining organ toxicity at 'low doses' . 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.. 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 should include the professional qualifications of the NIOSH staff who perform these evaluations. Comment: NIOSH should identify those drugs that pose a realistic risk to healthcare workers by considering such occupation exposure factors as drug type (e.g., small molecule, biologic), stability, dosage form, and route of exposure, and then evaluating them against the toxicity criteria. 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] NIOSH response: It is NIOSH practice to respond to all stakeholder and public comments and peer reviews in a Federal Register notice or in a document posted in the relevant NIOSH docket, to maintain a transparent and thorough administrative record. Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. The chapter describes containment requirements only for HD Active Pharmaceutical Ingredients (APIs) and antineoplastic drugs requiring manipulation. . Federal Register provide legal notice to the public and judicial notice 1. 05/01/2023, 858 The draft Procedures is in the docket for this activity. 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). 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. In that case, NIOSH may consider it to be appropriately grouped with carcinogenic drugs, although it would not necessarily meet the criteria for an occupational carcinogen according to the NIOSH Chemical Carcinogen Policy. Document Drafting Handbook If you are using public inspection listings for legal research, you Specifically, whether NIOSH conducts categorical regression analyses to evaluate dose-response data for severity. NIOSH will begin the reevaluation process for any request to add or remove a drug that provides some new supporting evidence by searching for additional hazard identification (toxicity) and hazard characterization information about the drug that is relevant to the criteria set out in the NIOSH definition of a hazardous drug. Comment. However, the lack of 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. Is the reconsideration process for addition or deletion of a drug to/from the hazardous drug list adequately described? provide legal notice to the public or judicial notice to the courts. NIOSH encourages public comment on these questions. 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. . The hazards of the drugs in Table 1 will relate to carcinogenicity or some other identified hazard by the manufacturer, usually genotoxicity/cytotoxicity. 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. This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. Not allowing public commenters to review peer reviews before submitting their own comments to the docket is in conflict with the principle of transparency established in the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664, Jan. 14, 2005). The OFR/GPO partnership is committed to presenting accurate and reliable 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. . Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? 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. 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. Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. Blinatumomab continues to be proposed for placement and other monoclonal antibodies that have properties meeting the NIOSH definition of a hazardous drug will remain on the List. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. 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. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. 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. However, after consideration of input from the public and stakeholders, NIOSH has decided to review the toxicity and the hazards related to occupational exposure to botulinum toxins. It is not an official legal edition of the Federal The large molecular size limits dermal absorption and aerosolization. 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. Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. No animal studies have been performed regarding developmental effects of daratumumab or dinutuximab. 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. Please provide feedback on the overall document: a. 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. 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. 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. 2. If you have any questions regarding hazardous drugs please submit them to Email CDC-INFO or call 1-800-CDC-INFO (800-232-4636), TTY: 888-232-6348) NIOSH response: Sublimation depends on the drug form and is not an inherent toxicity property of the drug. 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. 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. NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. Significant peer review and public comments on the draft Policy and Procedures are summarized and answered below in Section II; public comments on specific drugs are summarized and answered below in Section III. The documents posted on this site are XML renditions of published Federal Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. NIOSH response: The List is about 4 years behind the introduction of new drugs when it is periodically updated because there are several steps in the review process. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. A Notice by the Centers for Disease Control and Prevention on 05/01/2020. The new iteration is now referred to as draft Procedures throughout this notice. 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. 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. While some large molecular weight drugs may have low bioavailability by relevant routes of exposure, other factors in the characterization of the hazard are considered as well. The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. Comment: What is the mechanism for evaluating investigational new drugs (i.e., drugs used in preclinical and clinical research but not yet FDA-approved)? Cookies used to make website functionality more relevant to you. In that case, important criteria for animal studies include strength of association; consistency between studies; relevance of the model system and routes of exposure; the duration, reversibility, and recoverability of the observed effects; and concordance of those effects with effects in humans. Accordingly, NIOSH primarily uses information available in the package inserts to make determinations about whether to place a drug on the List. In 1981, after over 10 years of conformational research, the U.S. National Institute of Occupational Safety and Health (NIOSH) issued Recommendations for Safe Handling of Injectable Antineoplastic Drug Products, which recognized inhalation and direct skin contact as high-risk routes of exposure and recommended the use of Class II biosafety On the contrary, if a party submits a written request for reconsideration, NIOSH will be responding in these instances. Federal Register. However, the remaining parts of the draft policy and procedures mentions that animal studies should be reviewed . Comment: Prior to USP <800>, the NIOSH List was considered a precautionary recommendation. But the USP <800> standards are too restrictive and overreaching, and the chapter's incorporation into state law places facilities at legal risk if they fail to comply. 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. 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 . For a USP chapter numbered below 1000 to become compendially required, it needs to either be referenced in General Notices, a monograph or another general chapter numbered below <1000>. Answer: The NIOSH list is not intended to rank hazards. 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. 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. 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. Only when a labeling change results in the addition of MSHI to a package insert will NIOSH automatically consider the drug to be a hazardous drug and add it to the List. NIOSH response: There are several methods for identifying active pharmaceutical ingredient compounds, including Chemical Abstract Service Registry number (CAS) and UNII. It would presumably be courteous to respond to any party that has provided comments for consideration.. 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. Accordingly, NIOSH is not proposing to place these two drugs on the List. 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. The strategies used to manage the risk should match the hazard. Carcinogenicity: Cited studies demonstrated an increased incidence of various oncologic presentations (hepatocellular adenoma/carcinoma, interstitial cell hyperplasia, and uterine endometrial adenocarcinoma), in multiple animal species (rat and mice) at exposure lower than human doses (0.7-1.4 fold in rats and 0.3-0.7 fold in mice compared to a human dosing). informational resource until the Administrative Committee of the Federal NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. USP <800> Public comment: Several commenters offered suggestions on the document's use of USP <800>. NIOSH considered peer review and public comment received in response to the February 2018 FRN, and significantly revised the draft Policy and Procedures; that document is now called Procedures. In mice, doses near the maximum recommended human dose lead to increased neonatal death. . NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. 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. [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). Furthermore, some drugs carry multiple AHFS code classifications and are not just antineoplastic drugs. better and aid in comparing the online edition to the print edition. 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. Three commenters offered opinions on the timeliness of the List, which NIOSH has attempted to publish every 2 years since 2010. There seems to be no mechanism in place for labeling investigational (i.e., non-FDA approved drugs used in preclinical and clinical research prior to submission of an NDA [new drug approval]) drugs as potential human health hazards. 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. Comment: Ivabradine should not be placed on the List. Peer review comment: NIOSH should list further tools to aid employers to protect workers. As discussed later in this notice, NIOSH has revised the draft Policy and Procedures based on peer reviews and public comments.
Believing Without Seeing Activity,
Worst High School Basketball Team,
Articles B