USP <800> Majors Points1,5. Recommendations labeled with “should” are not required and not enforced by the Pharmacy Practice Act Rules. USP <800> defines HDs according to the criteria established in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. Any antineoplastic hazardous drug on the NIOSH list requiring hazardous drug manipulation must follow USP <800> with exceptions of any recommendation with the term “should”. With USP <800> it’s time to also focus on your safety, as well as the safety of those around you. • It is one of a number of compounding-related chapters in USP-NF. Hazardous drugs possess which of these characteristics: a. Genotoxicity b. Carcinogenicity c. Teratogenicity d. All of the above 3. The USP’s drug standards are enforceable in the U.S. by the FDA, and these standards are used in more than 140 countries, providing guidance to scientists and practitioners as they develop a… •Review the history and content of USP Chapter <800> and the NIOSH List of Antineoplastics and Other Hazardous Drugs in HealthCare Settings •Describe the process to construct a hazardous drug (HD) list and perform an assessment of risk •Define the key engineering controls required for compliance Consult the NIOSH list of hazardous drugs. Expected to become official on December 1, 2019, USP Chapter <800> Hazardous Drugs – Handling in the Healthcare Setting (www.usp.org) will then become enforceable federal standards that must be followed in all healthcare facilities, including veterinary facilities. • The USP chapter that contains guidelines for hazardous drug handling. USP 800, Section 2, states: The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare. Today, the USP compendium contains thousands of chapters that set standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. Handling Hazardous Drugs Medications that are on the Hazardous drug list are to be labeled, stored … Large portions of USP 800 may be used Vote was 16 to 4 with 4 absent (3 nonvoting members) No votes: adopt USP 800 with a waiver process Will be presented at the November 8, 2017 Board meeting. Exceptions are final dosage forms if only counted or repackaged, or for specific dosage forms based on an assessment of risk. At present, most commercially available hazardous drugs in the United States arrive at health care facilities in a form that requires manipulation by pharmacists prior to administration to a patient, as evidenced by the extensive list of opportunities for exposure detailed in USP General Chapter <800>. USP <800> does not replace USP <797> for sterile compounding or USP <795> for non-sterile compounding, but rather provides additional guidelines for hazardous drugs. Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive, and women who are pregnant or breastfeeding, such as clomiphene, clonazepam, dutasteride, and finasteride. Poster: Understanding USP <800> Who does this impact in healthcare and what do they need to do? Document review of the list annually . USP 800-Hazardous Drug Handling in Healthcare Settings. The SOPs must be reviewed at least every 12 months by the designated person, and the review must be documented. Implementing USP <800> standards may take additional time and costs, but the protection you’re providing for yourself, your extended team, and your patients is priceless. The Kentucky Board of Pharmacy may Identify the drugs and dosage forms you handle 3. USP 800 Hazardous Drugs – New List Published USP 800 governs the handling of hazardous drugs. For hazardous drugs used in the healthcare setting, these tasks will be performed in the ... Duke University Health System Hazardous Drug List . USP 800 has 18 sections across 20 pages, here’s the CliffsNotes version Section 1: Introduction. The USP 800 initiative uses a comprehensive hazardous drug list that was developed by: a. NIOSH b. OSHA c. CDC d. TJC 2. The list is entitled “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings”. Your Hazardous Drug List 1. Review the NIOSH list of hazardous drugs 2. Perform an Assessment of Risk 4. Kastango recommended healthcare organizations that handle hazardous drugs should take the following steps to achieve USP 800 compliance: Make a hazardous drug list: Which drugs you have on formulary will inform your strategy. Only sterile HDs may be stored within a sterile compounding area. The list of hazardous drugs referred to in USP 800 is the list published by the National Institute for Occupational Safety and Health (NIOSH). The way you prepare and handle hazardous drugs in the pharmacy impacts more than your health. An entity must maintain a list of HDs, which must include any items on the current NIOSH list that the entity handles. This section describes the purpose of the chapter and what areas must be covered by the entity (the pharmacy) which we will go into in the subsequent sections. This module is intended for all healthcare personnel who may have contact with hazardous drugs including: Pharmacists, Pharmacy Technicians, Nurses, Nurse Aids, Physicians, Physician Assistants, Home Healthcare Workers, EVS Team, Facilities Maintenance, Transporters..etc USP <800> defines processes intended to minimize the exposure to hazardous drugs in healthcare settings. First, any pharmacy that has any type of HD, as identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, needs to comply with USP <800>. C808CP0 rev 00 000. consumed worldwide. USP <800> will be required 13 USP <800> Requirements An Overview 14 USP <800> Requirements • Create a facility-specific list of hazardous drugs that is accessible by all staff • List must be: • Reviewed annually • Updated when newly-approved HDs are incorporated into the practice setting 15 Hazardous Drug List: That changed when USP 800 Hazardous Drugs – Handling in Healthcare Settings was published in 20165 with an anticipated enforceable date of December 20196. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. HDs cannot be stored on the floor. other containment primary engineering control (C-PEC) as defined in USP 800 whenever feasible. “This impacts everyone in healthcare – anyone who may potentially handle a hazardous drug. Section 2: List of Hazardous … the USP <800> Hazardous Drug-Handling in Healthcare Settings standard. USP 800 dictates a clear separation for the storage of non-hazardous and hazardous drugs. Why USP <800>? Read Online Usp Chapter 800 Hazardous Drugs Handling In Healthcare An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) will update the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. The facility’s list must be reviewed every year and after the introduction of new drugs. Revision Bulletin Official: July 1, 2020 (800)HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS 1. Page 2 of 9 TX II-24 Title USP <800> Hazardous Drugs-Handling in Healthcare Settings Section TX II-24 Issue Date September 22, 2020 Supersedes Date November 2019 Next Review Date September … Assessment of risk: Not all drugs need to be handled by USP 800. Review risk of exposure, packaging, and manipulation … USP 800 calls for the SOPs to be created and maintained for the safe handling of hazardous drugs in all situations hazardous drugs are used throughout a facility. Hazardous drugs are classified by the U.S. Department of Health & Human Services using the NIOSH standards, and, therefore, must be included on your list as you identify and inventory USP <800> Hazardous Drugs in your pharmacy. 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> Hazardous Drugs – Handling in Healthcare Settings Links For Supplemental Resources Information on USP General Chapter <800> USP General Chapter <800> FAQs USP General Chapter <800> Education Courses Sign up for USP updates Authorized reprint for individual use only. USP <800> standards are designed to protect you and your extended team from pharmacy through to nursing. Chapters < 1000 are requirements and legally enforceable Chapters > 1000 are recommendations USP <800>: Hazardous Drugs—Handling in Healthcare Settings 4 • … Some USP 795 and 797 facilities store both hazardous and non-hazardous products in a shared positive pressure environment. List of Hazardous Drugs (HDs) Rationale: All requirements of <800> must be followed for drugs on NIOSH list if they are APIs or antineoplastic HDs requiring manipulation. This includes compounding pharmacies, retail pharmacies, long-term care pharmacies, hospital/clinical pharmacies, patient treatment facilities, veterinary clinics, and any other … Such tasks would include reconstitution of powders or crushing of tablets. Hazardous Drugs like antineoplastics save lives but also pose a handling risk to those transporting, mixing and delivering them. [email protected]). USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings NIOSH defines criteria and identifies hazardous drugs (HD) USP develops the standards for handling these HDs to minimize the risk to public health. These include abacavir, carbamazepine, divalproex, estradiol, and spironolactone. USP <800> requires covered workplaces to maintain an internal list of HDs used in their facilities, and review that list … Essentially USP <800> sets the framework for creating Standard Operating Procedures for each facility for how they need to handle these drugs. Whenever a new HD or dosage form is introduced in the workplace, it should be reviewed against your internal list using the NIOSH list criteria. Usp Chapter 800 Hazardous Drugs USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. USP 800 – formally known as the USP General Chapter 800 Hazardous Drugs — Handling in Healthcare Settings – is a set of standards regarding the safe handling of hazardous drugs in any healthcare setting. USP 800 RN Module Post Test 1. But what drugs does USP 800 define as hazardous? • Does not replace USP795 or USP797 • Since it is below 1000 in the USP chapters it is enforceable by regulatory bodies. USP <800> requires covered workplaces to maintain an internal list of hazardous drugs (HDs) used in their facilities and review that list at least every 12 months. 9/19/2017 4 USP Chapter 800 Task Force Recommendation: Task Force to continue meeting to write Kentucky hazardous drug regulation. HAZARDOUS DRUG SAFETY and USP <800> Seth Eisenberg RN, OCN®, BMTCN® Professional Practice Coordinator, Infusion Services Seattle Cancer Care Alliance Seattle, WA PSONS March2018 HAZARDOUS DRUG DEFINITION •Defined by NIOSH as having any of the following characteristics: •Carcinogenicity •Teratogenicity or other developmental toxicity USP 800> Hazardous Drug List The USP 800 hazardous drugs list for each facility can be compiled by comparing all medications handled and compounded to the NIOSH list of antineoplastic and other HDs.

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