USP 800 Lisa Lasita, PharmD, MBA Director of Pharmacy Oncology Hematology Care, Inc Kyle T. Brown, CPhT Infusion & Spec. Retail Purchaser Zangmeister Center

Agenda Review OHC’s and Zangmeister’s pharmacy operations Quick review of the standards Steps to take to meet the standards OHC’s progress and pain points Zangmeister’s progress and pain points

OHC 12 locations that operate under a physician dispensing license 1 licensed retail pharmacy 24 Medical Oncologists 11 Radiation Oncologists 3 Gynecologic Oncologists

Zangmeister One all-encompassing site Specialty Retail Pharmacy 14 Medical Oncologists 1 Gynecologic Oncologists Radiology Department Accessible Radiation Oncology

United States Pharmacopeia 800 New Official Compliance Date December 1, 2019 Ohio has its own set of rules that went into effect May 1, 2016 for hazardous drugs compounded by a prescriber Main goal: Protect employees, and patients, during the transport, storage, preparation, dispensing, and administration

Becoming Compliant Form a multidisciplinary team Assign 1 person to be the project lead Perform a gap analysis Develop an action plan

Gap Analysis Divide and conquer amongst team Physical requirements Hoods Facilities: Receipt/Storage of drug Personal Protective Equipment (PPE) Closed System Transfer Devices Hood: Deactivation/Cleaning/ Decontamination/Disinfecting

Action Plan Address each gap individually Update policies and procedures Educate/Train Staff Include a cost analysis Must include a timeline

Hazardous Drug List Start with NIOSH list You can expand the hazardous drug list to meet your organizations needs We revised 3 times as staff had questions/opinions Need a plan for evaluating new drugs Need to update hazardous drug list annually

Closed System Transfer Devices (CSTD) Must be used during administration Should be used while compounding Trial 2-3 devices Complete a cost analysis

PPE This was a big gap for us that required additional training as staff was resistant Garbing technique is important to minimize exposure. Consider Annual Garbing Competency Compounding: Gown, gloves (double), shoe covers, bouffant, mask, eye protection Handling/Receiving: Full Garb Spill: Full garb plus N-95 approved respiratory protection Administration: Gown, gloves (double)

N-95 Approved Respiratory Protection Need to get staff FIT tested Need to select and then stock all sizes of the N-95 approved masks Need to FIT test staff annually and keep list Work with PPE vendor for FIT test supplies

How OHC has tackled USP 800 4 person team including Nursing Pharmacy Facilities/Building Gap analysis completed Cost analysis completed Action plan put together

OHC’s Action Items Update policies and procedures for the following: PPE Cleaning/Disinfecting/Decontaminating etc. Label Requirement Beyond use date of 12 hours Educate/Train staff on updates Create hazardous drug list Trial and select CSTD FIT test employees

OHC’s Action Items This is by far our biggest challenge Need a plan for each building in regards to: HVAC: Positive and negative pressure C-PEC: External venting C-SEC: Hazardous vs non-hazardous areas Storage/Receipt Designated receiving area Separate refrigerators Separate drug storage cabinets This is by far our biggest challenge

OHC’s Next Steps Engage team Revisit plan and gap analysis Retrain if gaps still exist Finalize building plans/physical requirements Need to make sure building plans are part of the 5 and 10 year strategic plan Cost to get all buildings compliant? Evaluate centralized mixing, is it feasible?

How Zangmeister Accomplished USP 800 Building was constructed to be USP 797 compliant Identify where your strengths and weaknesses lie Make a point person Divide out action points into similar areas of change Phase in change in increments Build upon existing SOP, stage mock audits, HD spill drill and evaluate

Purchasing Tips Define items for change and addition Work closely with your Medical Supply Co rep- use this free resource Bid out current catalog’s purchase volume Leverage volume, entirety, and future USP items Focus on CSTD and other high spend/high frequency items Wipes- HD clean, Peridox, etc dwell time Should we do a chemo surface test?

Recommended Action Items to be Compliant Read USP 800 Read OAC Rule: 4729-16-11 Identify team members Complete gap analysis Create an action plan Define hazardous drug list Evaluate/Update policies and procedures Evaluate HVAC, PEC, SEC, and PPE Evaluate and choose a CSTD Create and/or update training program

Helpful USP 800 Resources NIOSH List OAC: 4729-16-11 https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf https://www.cdc.gov/niosh/topics/hazdrug/default.html OAC: 4729-16-11 http://codes.ohio.gov/oac/4729-16-11 ASHP Chapter 800 Answer Book https://store.ashp.org/Default.aspx?TabID=251&productId=557160751

Questions lisa.lasita@usoncology.com kbrown@zangcenter.com