USP 800 Implementation Tips

1. USP 800 Implementation Tips Joanna Robinson, PharmD, MS Inpatient Operations Manager jrobinson14@kumc.edu

2. Objectives • Describe how to develop a Hazardous Drug (HD) list • Develop a USP 800 Compliance Plan

3. USP 800 Overview • USP 800 is an enforceable standard aimed at minimizing the risk of hazardous drug exposure to healthcare personnel, patients and the environment • Employees must know which drugs are hazardous • Employees must understand the risks of hazardous drugs • Employees must know how they should keep themselves safe when handling hazardous drugs • Compliance deadline is December 1, 2019! • It’s not just chemotherapy • Must use the NIOSH Hazardous Drug List and have a plan for all drugs on this list

4. Before we jump in…

5. Two Paths to Compliance Complete Risk Assessments & Decide how WE want to handle Hazardous Drugs All NIOSH List Agents Must Follow USP <800> Requirements

6. Understanding what makes a drug “Hazardous” • NIOSH Hazardous Drug Criteria • NIOSH Hazardous Drug List

7. Understanding the Hazard • It’s important to know why the drug is hazardous • Case reports describe congenital anomalies in infants exposed to in utero maternal fluconazole during most or all of the first trimester • But we also must consider the dosage form and how we’re going to manipulate it at our institution. USP 800 allows us the flexibility to do this. • Priming tubing on IV fluconazole may lead to more employee exposure than opening a unit dose container to administer to a patient • Crushing a tablet of fluconazole may lead to more employee exposure than not crushing it • Preparing an IV fluconazole in a clean room may lead to more employee exposure than buying pre-made bags

8. Risk Assessments for Non-Antineoplastic Parenteral Dosage Forms • Parenteral Dosage Form Risk > Oral Dosage Form Risk Determine Alternative Safe Handling Treat like Chemotherapy = Full USP 800 Precautions • IRAC 2B or greater • Manufacturer does not require • Pregnancy Category C,D • Hazardous data is at therapeutic doses (Black box warnings) or in animals • IRAC Group 1 or 2A • Pregnancy Category X • Manufacturer Requires (MSHG)

9. IARC and Pregnancy Risk Classifications An agent is classified based on scientific evidence derived from human and experimental animal studies and from mechanistic and other relevant data FDA has decided to eliminate the pregnancy categories because they are often viewed as confusing and overly simplistic and don’t effectively communicate the risk a drug may have during pregnancy and lactation and in females and males of reproductive potential.

10. What is KU planning on doing?

11. KU HD Risk Levels • Communication about the hazardous risk level will be • In a MAR message • On the label (if there is a label) • Communication will be something like • “Level 1 Hazardous Drug” • Staff will need to know what they must do to protect themselves when handling a “Level 1 Hazardous Drug” • Education will be provided; Policies will be available • EMR will not tell them

12. KU HD Risk Levels: PPE and Safe Handling

13. The HD List

14. Assessment of Risk • Must consider (at a minimum): • Type of HD (antineoplastic, non-antineoplastic, reproductive risk) • Dosage form • Risk of exposure • Packaging • Manipulation • Must document what alternative containment strategies and/or work practices are being employed for specific dosage forms to minimize occupational exposure

15. KU Assessment of Risk • Export of all drug records from EMR • Ensured all dosage forms were captured • Foundation for AoR • Excel spreadsheet with columns for each consideration

16. USP 800 Compliance Plan

17. Compliance Plan 101 • Know your compliance gaps • Several gap analysis tools available: • ASHP (www.ashp.org) • Critical Point LLC (http://www.800gaptool.com/) • IJPC (https://compoundingtoday.com/Compliance/USPGap.cfm) • TJC (www.hazmedsafety.com)

18. Compliance Plan • Prioritize (and delegate) your tasks • Evaluate Effort vs. Impact • Buckets of work

19. Buckets of Work

20. HD Risk Level Implications • Risk Assessments determined that we will treat chloramphenicol, cidofovir, cyclosporine, dexrazoxane, ganciclovir, and inhaled ribavirin like chemotherapy • RNs cannot crush or open tablets / capsules of oral anti-neoplastic agents on the floor (must be manipulated per USP 800 requirements – in BSC) • Policies and Procedures will be written with HD Level 1 and Level 2 in mind • E.g. PPE for HD Level 1 will be as required by USP 800 whereas PPE for HD Level 2s will be decided internally based on risk assessment

21. HD Risk Level Implications • Antineoplastic drugs can not go through automatic packaging devices • Must be packaged in BSC • Once in final dosage form (unit dose), may be stored with other non-hazardous inventory • Pharmacy cannot draw up oral liquid anti-neoplastic agents outside of USP 800 requirements • Doses will be drawn up in BSC • Spill response team Haz Mat team + volunteers • Deployed for spills greater than 1L • Hazardous Drug Precautions PPE Cart • All PPE and cleaning products for inpatient on Level 1 HD

22. Remember…

23. Learning opportunities are endless!

24. USP 800 Implementation Tips Joanna Robinson, PharmD, MS Inpatient Operations Manager jrobinson14@kumc.edu