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

2. 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

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

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

5. 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

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

7. 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

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

9. 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

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

11. 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)

12. 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

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

14. 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

15. 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

16. 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?

17. 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

18. 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?

19. Recommended Action Items to be Compliant
Read USP 800
Read OAC Rule:
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

20. Helpful USP 800 Resources NIOSH List OAC: 4729-16-11
OAC:
ASHP Chapter 800 Answer Book

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