Rather, it provides hospital and health system leadership with a high-level overview of issues your organization should consider moving forward. The standards not only cover compounding and manipulations but also receipt, dispensing, administration, patient care activities, spills, transport and waste. The agency has also retitled and reorganized the document. USP <800> Hazardous Drugs Risk Readiness Checklist 3 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. the USP <800> Hazardous Drug-Handling in Healthcare Settings standard. 1. Yet, the regulatory bodies will be surveying on the current versions, with a … 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. 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 2021 PRISONS Health and Wellness Services Policies and Procedures III. Animal, Plant, Fish) may require special country importation requirements. 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 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. Personnel Training 10. General Chapter <800> was published on February 1, 2016. ONS & HOPA 2020. Types of Exposure 4. USP <800> Hazardous Drugs—Handling in Healthcare Settings . In 2008, USP <797> Pharmaceutical Compounding – Sterile Preparations was updated to include a specific section for hazardous drug (HD) preparation to resolve conflicts with the NIOSH Alert. Hazardous drugs, like antineoplastics, save lives but also pose an exposure risk to those transporting, mixing, and delivering them. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, Promoting the Quality of Medicines Plus (PQM+) Program, Compounded Preparations Monographs (CPMs), 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, 2019 – Official date for General Chapter <800>, February 1, 2016 – Publication Date of General Chapter <800>. Thus, the <800> requirements for antineoplastic HDs will continue to apply to antineoplastic drugs in … endstream endobj 461 0 obj <> endobj 462 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 11/Tabs/S/Type/Page>> endobj 463 0 obj <>stream 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. USP 800 summary. … j �b`m�E�X,� ���\�,�8���� �-�gLo�~2��Sf�>G��Ufc��t�$�M����Œ�F����l1\3�d4Ȓd�������)�tFv�������.�H3Q9��g`�6�����P ��c ��� �����!�X��U�1������` ���8 What Drugs are Considered Hazardous, and Relevant to USP <800… 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. Late Breaking HD News Items . Free Download USP GC <800> Get the HazRx® Mobile App  GC <800> Infographic. The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. USP 800 was published on February 1, 2016 and originally planned for implementation in December, 2019, but implementation has been delayed. Click on any product description to access the SDS and the USP Certificate, if available. Sixteen drugs have been added to NIOSH’s 2020 list, including three for which the manufacturers have provided special handling information. USP <800> defines processes intended to minimize the exposure to hazardous drugs in healthcare settings. Define “hazardous drug” and identify groups of hazardous drugs. According to Dr Yarrington, achieving a USP 800–compliant facility is the biggest and most expensive challenge. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. June 26, 2020 – Revision Bulletin published to clarify the term ‘antineoplastic’ for the purpose of Chapter <800> December 1, 2019 – Official date for General Chapter <800> May 31, 2019 – Revision Bulletin published to confirm the official date of USP General Chapter <800> February 1, 2016 – Publication Date of General Chapter <800> BY: SUPERVISING INSPECTOR CHRISTINE ACOSTA APRIL 16, 2019 . Facilities and Engineering Controls 6. It was created by the United States Pharmacopeia Convention. Hazardous Drugs like antineoplastics save lives but also pose a handling risk to those transporting, mixing and delivering them. This may delay care or undermine patient safety. 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. USP based its list of HDs on information provided by The National Institute for Occupational Safety and Health (NIOSH), the federal agency responsible for researching workplace safety, and for making recommendations for preventing work-related injury and illness. 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. USP Chapter 800 has a defined strategy of control for hazardous drugs, but an assess-and-stratify-risk approach may also be appropriate in certain situations. For those hazardous drugs not on Table 1, you should perform an AoR. 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. During this appeals process, USP <800> will be “informational and not compendial applicable. A commercial product ... 2020, pharmacies will not be able to compound peptides due to some new FDA policies. For more information on other compounding chapters click here. USP <800> Checklist for Hospital and Health System Leadership. 4 Explain the requirements for a hazard communication program and personnel training. 01�T�dpy������� ���H��g���f���o���0�p00�ċ��$K��,r����zI��"��Vμ��zĘTp7� qG�q;N*�$v ED�~lT$���zi�� �Y��3�~}��¸�� Introduction and Scope 2. LIST OF HAZARDOUS DRUGS Christina Kim • IT IS ADVISEABLE TO PERFORM AN ASSESSMENT OF RISK (AOR) OF ALL DRUGS ON YOUR HAZARDOUS DRUG LIST • Why? With USP <800> it’s time to also focus on your safety, as well as the safety of those around you. 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. Hazardous Drug Excreta. Developing and Maintaining a List of Hazardous Drugs - USP <800> Section 2 Create a hazardous drug and substance list by: Identifying all drugs stocked or likely to be stocked that appear on the NIOSH List 2016 (Source 2 above) Add additional hazardous or dangerous substances, e.g. “USP is a pharmacy-centric, nonprofit organization that sets standards for quality … This list is not exhaustive of all requirements. 482 0 obj <>/Filter/FlateDecode/ID[<997A18F16D48759ED0E55790B2D1F296>]/Index[460 37]/Info 459 0 R/Length 108/Prev 477007/Root 461 0 R/Size 497/Type/XRef/W[1 3 1]>>stream Respiratory Protection. Hazard Communication Program . USP 800 – protect employees who may be exposed to Hazardous Drugs during their daily routines. • Oral solids requiring repackaging: Single pair of chemotherapy gloves. The list is entitled “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings". The hazardous drug list was updated in 2010, 2012, 2014, 2016 and 2018, and the 2020 list is currently in draft form. strong acids or bases, toxic cleaning agents, etc., as desired. It is produced and promulgated by the US Pharmacopeia, a non-profit NGO that sets standards which are adopted by many governmental enforcement agencies. To reach compliance, you need to ensure you are using the correct PPE to minimize exposure to hazardous drugs. May be tubed and placed in Pyxis • Personal protective equipment not required for dispensing prepackaged intact drug product not requiring manipulation. Section 2 of USP <800>: LIST OF HAZARDOUS DRUGS The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other HDs used in healthcare. Check out part one of our comprehensive USP 800 article HERE. 800-243-0127 November 2020 II Catapres (clonidine hydrochloride,USP) 0.1 mg 0597000601 An extraneous peak was observed for dissolution testing. Editor's note: This article was written by A.J. %%EOF 2 Describe which drugs must adhere to USP 800 requirements and which are subject to a risk assessment. HD Spills. Latest USP <800> Guidance: Postponement of 795 and 797. In response to employee concerns, the U.S. Pharmacopeia established a standard that drives the safe handling of hazardous drugs. ardous drug list (NIOSH 2010 and 2012), NIOSH had previously recommended standard precau-tions (universal precautions) be taken in handling hazardous drugs. Handling Hazardous Drugs. USP Drug Classification Expert Volunteers. According to ONS member Seth Eisenberg, RN, ADN, OCN®, BMTCN®, professional practice coordinator of infusion services at Seattle Cancer Care Alliance in Washington, USP’s new chapter addresses the issue. ����x#���0$�2:���A D70�u����`QV�(�rH� L��Ie� "�"*n`��j � dCP���H��$�v1���H Closed System Transfer Devices Click button for late-breaking news or updated information on the topic of hazardous drug safety. Additionally, USP 800 requires the use of PPE by institutional personnel when handling drugs on the List. Browse and register for courses and webinars offered around the world. Guidelines for safe handling have existed for years, yet dedicated safe-handling standards that were enforceable on a state level were still needed. 4 Furthermore, if a new drug enters the market or is used on an investigational basis, NIOSH criteria must be applied to determine whether a drug is hazardous. <800> Hazardous Drugs—Handling in Healthcare Settings Type of Posting Revision Bulletin Posting Date 31–May–2019 (updated 27–Sep–2019) Official Date 01–Dec–2019 Expert Committee Compounding Reason for Revision Compliance (official date) In accordance with the Rules and Procedures of the 2015–2020 Council of Experts, USP revised the official date of Hazardous Drugs… Given the addition of new drug formulations and drugs in tablet and/or capsule form to the list, no single approach can cover the diverse potential occupational exposures to the drugs. For the 2020-2025 cycle, a new USP Drug Classification Subcommittee was formed to continue the work. The United States Pharmacopeia (USP) General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings outlines safe handling practices to promote patient safety, worker safety, and environmental protection. An entity must maintain a list of HDs, which must include any items on the current NIOSH list that the entity handles. These include abacavir, carbamazepine, divalproex, estradiol, and spironolactone. USP <800> only applies to pharmacies – These occupational safety standards apply to any healthcare facility where hazardous drugs exist. USP <800> requires covered workplaces to maintain an internal list of HDs used in their facilities, and review that list at … 3 Design an appropriate floor plan that would meet the requirements for hazardous drug compounding. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. List environmental controls and personal protective equipment required by USP <800>. 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>. CriticalPoint uses a best practice strategy of: Everything on Table 1 should utilize USP 800 standards and strategies. 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 call USP Customer Service at 1-800-227-8772 or 301-881-0666 to order. The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. This list is not exhaustive of all requirements. Note: General Chapter <800> is informational and not compendially applicable. Additions to the List present wide-reaching implications for pharmacies that compound since USP 800 incorporates the List by reference. USP <800> – formally known as 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. 9. h�b```���B cc`a���$����d The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. Wipe Testing & Deactivation. Start with obtaining a copy of both USP <800> and the NIOSH list of HDs. 1 Not only does it dictate millions of dollars of renovations, but also unveils the true risks of handling HDs. • HDs on the NIOSH List that must follow containment requirements of USP <800> regardless of AOR include • Any HD API Five drugs have been removed. ASSESSMENT OF RISK FORM. endstream endobj startxref The USP’s drug standards are enforceable in the U.S. by the FDA, and these standards are used in more than 140 countries, providing guidance to scientists and practitioners as they develop a… 2/13/2020 1 © 2018 Array Architects Inc. | 1 Presented by: Kristy Venrick - Array Architects / Advisors Pharmacies: USP <800> Compliance and Hazardous Drugs f���M�S9�v�7���3�~��$ Every facility should have a designated person responsible for developing and overseeing a hazardous drug safety program, so establish who that will be. Effective December 1, 2019, this standard is referred to as the USP General Chapter <800> standard, or simply USP <800>. Sixteen drugs have been added to NIOSH’s 2020 list, including three for which the manufacturers have provided special handling information. Know your exposure to hazardous drugs with the <800>HazRx™ Mobile App. It was updated in 2010 and 2012. Storage containment should be considered so that any spills, falls, or breaks remain locally isolated. 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 2021 PRISONS Health and Wellness Services Policies and Procedures (k) USP – United States Pharmacopeia, the reference that sets quality, purity, strength, and According to ONS member Seth Eisenberg, RN, ADN, OCN®, BMTCN®, professional practice coordinator of infusion services at Seattle Cancer Care Alliance in Washington, USP’s new chapter addresses the issue. Sign up for Healthcare Quality Standards Updates and stay current on our work in compounding, Medicare Model Guidelines, pictograms, medication safety and labeling and more. This list of hazardous drugs was first published in September 2004. USP’s standard on the safe handling of hazardous drugs (HD), General Chapter <800>, became official on December 1, 2019. 1 List … USP provides Safety Data Sheets (SDS) for all Reference Standards and USP Certificates for some Reference Standards. Guidelines for safe handling have existed for years, yet dedicated safe-handling standards that were enforceable on a state level were still needed. List of Hazardous Drugs 3. 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. USP <800> Majors Points1,5. USP 800 becomes official December 1, 2019 of this year. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. Know your exposure to hazardous drugs with the USP HazRx® mobile app. 5 List the SOPs that are required for a pharmacy compounding hazardous drugs Pharmacy Technician . 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 <800> requires covered workplaces to maintain an internal list of HDs used in their facilities, and review that list at least every 12 months. Sarasota Memorial Hospital Hazardous Drug List PHARMACY Handling Categories Category A1 (Low Risk): Primarily oral solids that are not anti-neoplastics. Certain Material Origins (i.e. Recommendations labeled with “should” are not required and not enforced by the Pharmacy Practice Act Rules. Personal Protective Equipment 8. 2015-2020 Resolutions ... USP General Chapter <800> Hazardous Drugs: Sections . We also have a great webinar on USP 800 that you can watch HERE. Monoclonal Antibodies . Here's how the 2020 NIOSH update, and its effect on USP 800, could impact your practice. The NIOSH list prevents exposure to hazardous drugs in healthcare workers. 795> Pharmaceutical Compounding – Nonsterile Preparations Reprinted from USP42-NF37 (last revised 2014) 797> Pharmaceutical Compounding – Sterile Preparations Reprinted from USP42-NF37 (last revised 2008) 800> Hazardous Drugs – Handling in Healthcare Settings (Informational) 825> Radiopharmaceuticals – Preparations, Compounding, Dispensing, and Repackaging as published … DRUG INVENTORY FORM. Five drugs have been removed. USP <800> defines HDs according to the criteria established in the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. 2016 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings remains the most current list until NIOSH finalizes and publishes the 2020 list. USP <800> requires each entity to maintain a list of hazardous drugs that is reviewed annually to include all NIOSH medications the entity uses. While USP <797> focused on protecting sterile products, the new USP <800> focuses on protecting people – specifically healthcare workers and patients. Key Resources. The agency has also retitled and reorganized the document. hޤV[O�@�+��Ƹs� 1&�Z5�^�����؎�,�4�����Pk�vC����}=��ˆ뻄s�$\�+•��#. Many organizations are or will soon be fully compliant with the 2019 USP revisions.

Sample Job Interview Question And Answer For Fresh Graduate, Chime Ssi Payment Schedule 2021, Plan B Burger Salad, Flytanium Lucha Scales, Akkineni Nagarjuna Net Worth In Rupees, Dcs F18 Harm Not Working, Pearson Physics Textbook Answers Pdf,