Moving from USP 797 to USP 800 Patricia Cook RPh, B.S. HACP, GRCP - PowerPoint PPT Presentation

Moving from USP 797 to USP 800 Patricia Cook RPh, B.S. HACP, GRCP

2 USP Chapter 800 Learning Objectives 1. Cite and locate the document that defines the components and expectations of USP Chapter 800 2. Identify 2 major components of USP Chapter 800 3. Recognize the latest timeline for compliance

3 Today’s Program Outline 1. History of the USP 2. Review of the Journey 3. Overview of Evolution: USP 795; 797 and 800 4. Review and Timeline of USP 800‐ Who, What, When Where and Why • Key Terminology • Key Components • Timelines • Action Planning

4 Who is the USP? • The United States Pharmacopeia: An not‐for‐profit science driven organization dedicated to the establishment of standards designed to ensure the quality, safety, and benefit of medicines and foods. • Set the Gold Standards for medicinals, biologicals, medical equipment, food supplements and food ingredients. • Not a Government Agency ‐ but their standards are recognized and adhered to in over 140 countries including the United States

5 The USP Journey Past and Present USP 800 • USP 797 sets the standard for USP 795: • sets the standard for the delivery Handling of Hazardous • sets standards for of sterile compounds Drugs compounding of NON‐ • Designed to deliver quality • Sets standards for safe STERILE Drugs/Products preparations that are free from handling of hazardous contaminants and are consistent in drugs to minimize the intended identity, strength and risk of exposure to potency. healthcare personnel, patients and the environment.

6 USP 795…. Highlights • Introduced around 2013 • Established Good Compounding Practices for non‐sterile compounds • Oral suspensions, ointments/creams • Training Requirements • Equipment and Environmental Requirements

7 USP 797…. Highlights • Developed in 2004. Last revised 2008. • Far Reaching – applicable to all settings where the compounding of sterile preparations occurs. • Established Risk levels for compounded products • Simple ‐ Moderate ‐ Complex and Immediate Use • Birth of Beyond Use Dating

8 USP 800 Highlights • Developed in 2013 and 2016 • Establishes standards for handling hazardous drugs at every point of the drug distribution process. • Focuses on the management of Hazardous Drugs from both a Worker Safety Perspective and Environmental Perspective. • Far reaching applications‐ applicable to all settings involved in the procurement, compounding, administration and disposal of hazardous drugs. • Multiple Go‐Live dates

9 Important to note: USP 800 does not replace USP 795 or USP 797. It continues the spectrum and focuses on the people involved in the medication process involving those medications classified as hazardous or whose classification has not been determined yet.

10 Revised Timeline: • Revised September 2017 • Original date: July 2018 • New Date: December 1, 2019 • Revised 797 and new 800 requirements effective December 1, 2019 • Revisions to 797 will be announced Fall 2018

11 USP 800 A Summary Review

12 Major Components of USP 800 The Math Inventory + Risk Assessment + Engineering Controls + Training/Competency + Personal Protective Equipment + Work Practices = Reduced Exposure Risk

13 Major Components of USP 800 Reduce Exposure Risk – WHEN? • The management cycle: Receiving Transport Storage Process Process Process Administration Disposal Preparation Process Process Process

14 Major Components of USP 800 Reduce Exposure Where? Organizational Assessment Physician Receiving Practices Department Other Pharmacy Outpatient Locations ??? Infusion Emergency Oncology Department Inpatient Unit Ambulatory Locations

15 USP 800 Components The Inventory and NIOSH

16 Inventory The NIOSH List • NIOSH : National Institute for Occupational Safety and Health • Component of the CDC • USP 800 ‐ Uses the NIOSH List of Hazardous drugs as it’s foundation. • List is NOT limited to Anti‐neoplastics drugs. List of criteria for inclusion available on website at https://www.cdc.gov/niosh/docs/2016‐161/default.html • Currently about 40 active pharmaceutical ingredients listed

17 Inventory Your List • Use the NIOSH list to develop your organization’s inventory • Establish a process to review the inventory annually and each time a new active pharmaceutical ingredient or formulation is released • Maintain this inventory

18 USP 800 Components Risk Assessment & Risk Mitigation

19 Always Risk No Choice • All USP 800 containment strategies must be used in the following: • Whenever manipulating anti‐neoplastic drugs ( Chemo drugs) • When compounding with any NIOSH drug • When the results of the risk assessment are not available

20 Assessing Risk and Mitigation Considerations • Type of Drug: Antineoplastic, non‐antineoplastic, reproductive risk only • Dosage Form: Tablet, Capsule, liquid etc. • Risk of Exposure • Does the product require repackaging? • Does the repackaging require product manipulation?

21 When ? When there is RISK Risk Assessment • Based upon Risk Assessment – determine what containment strategies and work practices will be required. Maintain records of Risk assessment and mitigation strategies. • Each mitigation strategy should consider each of the risk reduction interventions: • Use a Biocontainment Safety Cabinet ( a/k/a Hood) ? • Use Personal Protective Equipment? What kind? • Impervious Gown? Chemo rated gloves? Double vinyl gloves? • Review and reassess your risk assessments every 12 months.

22 USP 800 Components Physical Facility & Engineering Controls

23 Physical Plant Requirements Non‐Negotiables Compounding Environment: • Primary Engineering Control‐ Containment Ventilated Enclosure – a/k/a HOOD • Must create an set type of environment • Vented to the outside • Hood must never be turned off. • Secondary Engineering Control – the room that contains the PEC ( Hood) • Must be a Separate Room with Fixed Walls • Constant Negative Pressure Environment • Vented to the outside • Set # of air exchanges per hour • Air flow must continuously circulate

24 Physical Plant Requirements Drug Storage • Separate dedicated storage and preparation spaces • Eliminates the current exception that allows compounding of small amounts of HD products in non‐HD designed spaces • ALL Hazardous Drugs must be stored in a Negative Pressure Environment • Even those requiring refrigeration • Repackaging of oral products requires use of a primary engineering control device • Cannot compound IV’s and Oral products at the same time. • Once repackaged, can be stored in individual plastic dosage bags ( to limit risk of exposure) and stored in a clearly identifiable bin in your normal storage location.

25 USP 800 Components Training & Competency

26 Training and Competency Each Task – Each discipline involved • Develop based upon Overall Facility Scope Assessment Results • Each person assigned to conduct a task or duty involving a hazardous drug needs training and competency.

27 Personal Protective Equipment Each Task – Each discipline involved • Personal protective equipment (PPE) refers to protective clothing, helmets, goggles, gloves, face shields, eye protections, masks or other garments or equipment designed to protect the wearer's body from injury or infection • Each PPE product has various specifications. • Align the PPE requirements with the task. Goal: Sufficient coverage without over burdening the user. • Include details of the PPE requirements on the risk assessment. BE SPECIFIC! • Ensure staff are trained and competent on how to DON and DOFF PPE.

28 USP 800 Components Work Practices

29 Work Practices – Policy & Procedure Accountability • Reduce the results of your risk assessments and mitigation strategies into POLICY. • Convert policy into easy to understand Staff Education Resources • Easily Accessible to Staff in Easy to Use Format • Wall Poster • Index Card System • Teach the to the WHY, then the HOW.

30 USP 800 Components Quality Control & Surveillance

31 Environmental Quality Controls Performance Improvement and Quality Assurance • USP 800 sets forth specific Environmental monitoring. • Also sets forth specific Assessment and Reassessment activities for medical surveillance of staff involved in these processes. • Ensure an operational reporting process for reporting all exposures.

32 Tips for Success Summary • Partnering with your Pharmacy Leadership team is essential. • Ensure that the key stakeholders assume • the lead in the development of the action plan and required processes • Serve as subject matter experts • Represent the key disciplines involved in this body of work • Hardwire this team into your PI/Quality Reporting process • Periodic status updates • Ongoing monitoring results