The draft Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is in the docket for this activity, is intended to assist employers in establishing their own hazardous drugs management procedures specific to their workplace. If you are using public inspection listings for legal research, you Federal Register issue. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. The manufacturers of trabectedin (Yondelis), inotuzumab ozogamicin (Besponsa), polatuzumab vedotin (Polivy), enfortumab vedotin (Padcev), trastuzumab deruxtecan (Enhertu), sacituzumab govitecan (Trodelvy), loncastuximab tesirine (Zynlonta), melphalan flufenamide (Pepaxto), belantamab mafodotin (Blenrep), and tisotumab vedotin-tftv NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. Is there a scientific justification for them? Comment: The draft Policy and Procedures should include a methodology describing how NIOSH evaluates monoclonal antibodies. Comment: Ivabradine should not be placed on the List. 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.. This repetition of headings to form internal navigation links The updated USP <800> requirements include: Responsibilities of personnel handling hazardous drugs. 'When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug, including any studies cited in the package insert that are relevant to workers in a health care setting.' PDF NIOSH Procedures for Hazardous Drugs draft - CDC 5. 6. Ensuring Your Hazardous Drug List and Assessment Of Risk Are 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. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? For example, three drugs were added to the 2016 List after it was initially published; they are identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 web page, https://www.cdc.gov/niosh/docs/2016-161/default.html. This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. 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. Please provide any additional studies or scientific information that support or validate evidence-based strategies or approaches for controlling exposures to hazardous drugs that are different from those that NIOSH has proposed. [3] 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 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. 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. 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. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. documents in the last year, 24 documents in the last year, 29 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 response: The NIOSH List is adopted, endorsed, and/or referenced by a number of non-governmental organizations, including the American Society of Health-System Pharmacists (ASHP), The Joint Commission, and the Oncology Nursing Society. They help us to know which pages are the most and least popular and see how visitors move around the site. Usp 800 | Usp Procedures for deactivating, decontaminating and cleaning. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. to the courts under 44 U.S.C. The United States Pharmacopeia General Chapter <800> standards focus on controlling occupational exposure to hazardous drugs while also protecting patients. For the purposes of this chapter, the term antineoplastic only refers to antineoplastic drugs included in Table 1 of the most current NIOSH list. If available, NIOSH would give preference to them over animal and in vitro studies. 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. This PDF is 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. 7. 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: FDA-approved drugs should be reviewed in real time or NIOSH should provide off-cycle updates to the List. should verify the contents of the documents against a final, official 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. documents in the last year, 1407 NIOSH response: The reviewer has interpreted the NIOSH statement differently than what the agency intended. . NIOSH Finalizes Procedures for Developing Hazardous Drug List b. Hazardous Drug Exposures in Health Care | NIOSH | CDC The package insert also cites gefitinib as exhibiting teratogenicity. The drugs pose the greatest risk to healthcare workers, based on a combination of volatility and dose-related toxic potential of those vapors.. and includes the following questions. These hazardous medications are capable of causing serious effects including cancer, organ toxicity, fertility problems, genetic damage, and birth defects. documents in the last year, 125 . 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. NIOSH has determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for users. 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). Hazardous drugs: NIOSH update impact on pharmacy - Wolters Kluwer 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. NIOSH response: This refers to human genotoxicity studies, which are rarely available. 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. 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). Comment: The methodology used to develop the list of drugs proposed for placement on the List was not the same as the methodology used in previous years. Thank you for taking the time to confirm your preferences. Table 3 would be removed and the drugs formerly placed in that table placed into Table 1 or 2, accordingly. 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. . 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. NIOSH defines HDs as the following: The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. The Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings ( Procedures) establish the NIOSH definition of a hazardous drug and a methodology for evaluating chemical properties, pre-clinical information, and available clinical information about each drug. One additional drug, polatuzumab vedotin, was approved by FDA's Center for Drug Evaluation and Research in July/August 2019 and its package insert includes MSHI provided by the drug's manufacturer. A new peer review was not conducted. hazardous drugs. Comment: Osimertinib should not be placed on the List. 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. Employing this same train of thought to the draft policy and procedures, it would, in my opinion, be a best practice to add the drug that has insufficient information to the List until suitable scientific evidence demonstrates that it should not be included.. 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. However, rather than identifying job-specific titles, the document focuses on workplace activities. The NIOSH List of Hazardous Drugs in Healthcare Settings, 2020, A. Although the official list hasn't been updated since 2016, NIOSH did propose updates in 2020 which serves as a useful guide. 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 response: NIOSH concurs with commenters that the evidence of carcinogenicity for darbepoetin alfa in patients who did not already have cancer was insufficient to support a NIOSH finding of carcinogenicity. 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. Drawing conclusions from a methodologically flawed paper can lead to misclassification of a drug. 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. . CN-20-058-00 Relevant information about this document from Regulations.gov provides additional context. USP documents in the last year, 1008 In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. Comment: NIOSH should include the professional qualifications of the NIOSH staff who perform these evaluations. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. After considering the peer and stakeholder reviews, NIOSH determined that 20 drugs and one class of drugs exhibit toxicity that meets the NIOSH definition of a hazardous drug and proposed them for placement on the List. Seven commenters opposed the inclusion of biological drug products (monoclonal antibodies) on the List. 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. 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). rendition of the daily Federal Register on FederalRegister.gov does not 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. 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. NIOSH response: NIOSH has determined that reproductive effects were observed in pregnant rats at doses near the equivalent maximum recommended human dose. 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. 2. the Federal Register. In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. and services, go to Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. This document has been published in the Federal Register. 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. Each document posted on the site includes a link to the Handling hazardous drugs under USP General Chapter <800> | McKesson on 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. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. Comment: Triazolam should not be placed on the List. Because the way cancer is treated therapeutically has changed, and the types of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. USP 800 only states Table 1. From my perspective, as a minimum, this should include porters, ward aides and unit clerks.. All three draft documents are available in the docket for this activity. Therefore, when antineoplastic drugs are grouped as they were in earlier versions of Table 1 of the List, an appearance that these drugs pose the same hazard was inadvertently created (i.e., non-cytotoxic drugs with cytotoxic drugs). Three commenters offered opinions on the timeliness of the List, which NIOSH has attempted to publish every 2 years since 2010. This site displays a prototype of a Web 2.0 version of the daily Botulinum toxins do not meet the criteria for placement on the List; abotulinumtoxinA and rimabotulinumtoxinB did not have labeling changes during the search period January 2014 through December 2015, and changes to the labels for onabotulinumtoxinA and incobotulinumtoxinA do not meet the criteria for organ toxicity at low doses or teratogenicity or other developmental toxicity. Include relevant publications if available. 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. 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. Therefore, all recombinant therapeutic proteins should be excluded from the List unless science-based or product-specific circumstances dictate otherwise.. 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. USP General Chapter <800> - McKesson Medical-Surgical Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. NIOSH response: NIOSH uses the subset of Bradford Hill criteria which are most useful for evaluating human study results on hazardous drugs. 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. NIOSH response: The daily therapeutic dose at which serious organ toxicity, developmental toxicity, or reproductive toxicity occurs (10 mg/day in human adults and 1 mg/kg per day in laboratory animals) has long been used by the pharmaceutical industry to develop occupational exposure limits (OELs) of less than 10 g/m[3] after applying appropriate uncertainty factors. Federal Register. OELs in this range are typically established for potent or toxic drugs in the pharmaceutical industry. In mice, doses near the maximum recommended human dose lead to increased neonatal death. . Note: General Chapter <800> is informational and not compendially applicable. Comment: In the draft Policy and Procedures footnote 45, NIOSH lists criteria used to evaluate information from animal studies. 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. 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. 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 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. . documents in the last year, 153 In humans receiving 400 mg/day or higher developmental effects consistent with animal data have been observed and epidemiological data suggest a risk of spontaneous abortions and congenital abnormalities in infants whose mothers were treated with 150 mg/day fluconazole. Aschengrau A, Seage GR [2018], Essentials of Epidemiology in Public Health. . NIOSH is proposing to regroup the drugs by hazards. 4th Edition, (Burlington, MA: Jones & Bartlett). 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. Please provide information about your professional experience, if any, of implementing control strategies for exposures to hazardous drugs in healthcare or similar settings. Please describe what you found to be most or least effective and why. The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. NIOSH response: NIOSH views peer review and public comment as two distinct, often complementary, tools in ensuring both quality and transparency in influential scientific information products. on Teratogenicity: The package insert contains a warning of embryofetal toxicity when administered to pregnant women. 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. documents in the last year, 83 Use the PDF linked in the document sidebar for the official electronic format. 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. However, the lack of NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. Best-Practices-for-Monitoring-Hazardous-Drug-Surface-Contamination
Will Pepsico Stock Split In 2021,
Diana Ross Kids Father,
Scott Henderson Wme Email,
Articles U