1. Pharmacy Benefits Management www.pbm.va.gov Hazardous Drug Management VA Pharmacy Informatics Conference Pleasanton, CA Aug 2-5, 2011 George H. Knight, RPh. VISN 2 Pharmacy Executive PBM Manager Syracuse, NY 1

2. Overview of Today’s Discussion  Why review VAMC Pharmaceutical Management Practices and Why Now?  Pharmaceutical Management Objectives and Goals  Program Milestones and Timeline  What is meant by “hazardous pharmaceutical”?  Hazardous Pharmaceutical Handling and Use  Issues and Challenges * Warfarin containers  Leading Practices * Labeling * Containers  Recommendations Pharmacy Benefits Management www.pbm.va.gov 2

3. Why review Pharmaceutical Management Practices and Why Now?  Heightened levels of scrutiny in recent years by Federal and state environmental regulators on the management of pharmaceutical products and waste at health care facilities  To answer the overarching question, “Does VA have a well-developed pharmaceutical management program in place?  To proactively identify and address gaps in VA’s current pharmaceutical waste management practices  To share leading practices and lessons learned with the field Pharmacy Benefits Management www.pbm.va.gov 3

4. Goals and Objectives of the VHA Pharmaceutical Management Program  The Pharmaceutical Management Program was initiated to:  Maximize the efficiency of pharmaceutical management and waste management policies and procedures within VA;  Promote and implement best practices for the handling and administering of pharmaceuticals (both hazardous and non- hazardous) in compliance with Federal regulations and VA and VHA policy; and  Promote the protection of the environment and VA staff, through well-defined and properly implemented pharmaceutical waste management processes. Pharmacy Benefits Management www.pbm.va.gov 4

5. Pharmaceutical Management Program Timeline and Milestones Dec 08 Project “Kickoff” Meeting Universal Waste Rule (UWR) Response (Feb 09) Jun 09 Draft Baseline Report (Mar 09) Pilot Site Visit Assessor’s Guide (May 09) Conducted 2 Pilot Site Visits (Jul 09) Finalized Assessor’s Guide (Oct 09) Conducted 9 Site Visits (Sept 09 – Mar 10) Summary Site Visit Report (May 10) Draft Guidance Document (Jun 10) Jan 09 Final Baseline Report (Nov 09) Maryland VAHCS (Jul) Phoenix VAHCS (Nov) Sierra Nevada VAHCS (Nov) Greater LA VAHCS (Jan) Bay Pines VAHCS (Feb) Richmond VAMC (Jul) Lexington VAMC (Sept) Manchester VAMC (Nov) Roseburg VAMC (Jan) Charleston VAMC (Feb) Detroit VAMC (Mar) Nov 09Sep 09Jul 09Jan 10Mar 10Feb 10 Pharmacy Benefits Management www.pbm.va.gov5 Final Guidance Document (Feb 11) Final VACO Summary (Feb 11) EPA Letter (Mar 11) Coumadin Fact Sheet (Mar 11) Pharmaceutical Management Training Program (Jun 11)

6. What is meant by “hazardous pharmaceutical”?  For the purpose of today’s discussion, it is important to understand that there are two commonly confused working definitions of hazardous pharmaceuticals:  Occupational Safety & Health Administration/ National Institute of Occupational Safety & Health OSHA/NIOSH Hazardous (adverse health effects) Pharmaceuticals Carcinogenic, Corrosive, Toxic or Highly Toxic, Irritant, or Sensitizer  Resource Conservation & Recovery Act (Environmental Impact) RCRA Hazardous (waste) Pharmaceuticals Listed Hazardous Waste (P- and U-listed) Characteristic Hazardous Waste (Ignitability, Corrosivity, Reactivity, and Toxicity) D - Listed Pharmacy Benefits Management www.pbm.va.gov 6

7. Categories of RCRA Hazardous Wastes  P-Listed  Acutely Hazardous  Sole Active Ingredient – Unused  Empty – Only if Triple Rinsed Rinse Solution is Hazardous Manage Un-rinsed Containers as Hazardous (Vials) Pharmacy Benefits Management www.pbm.va.gov 7

8. Categories of RCRA Hazardous Wastes  P-Listed  Arsenic Trioxide (Chemotherapy)  Epinephrine (Excluded if in used syringe; may be discarded as regulated medical waste) ** not EPI salts ** except MN  Nicotine (Patch backing but not wrappers)  Warfarin >0.3% (all Rx dosages)  Nitroglycerine (Excluded federally and some states if in final dosage form)  Phentermine (1 of 3 controlled substances) Pharmacy Benefits Management www.pbm.va.gov 8

9. Categories of RCRA Hazardous Wastes  U-Listed  Toxic – not as hazardous as “P”  Sole Active Ingredient – Unused  Empty Containers All contents have been removed through normal means and <3% by weight remains = not hazardous Residues removed from containers must be managed as hazardous waste Pharmacy Benefits Management www.pbm.va.gov 9

10. Categories of RCRA Hazardous Wastes  U-Listed  Chloral Hydrate & Paraldehyde  Chlorambucil  Cyclophosphamide  Warfarin <0.3% (all Rx dosages exceed this percentage)  Selenium Sulfide (Selsun Blue) Pharmacy Benefits Management www.pbm.va.gov 10

11. Categories of RCRA Hazardous Wastes  Characteristic (D-Listed): Pharmaceutical, chemical formulations not on P-List or U-List, which exhibit one or more of the following characteristics:  Ignitability (nitroglycerine inj.)  Toxicity (M-Cresol or thimerosal as a preservative – fluvax)  Corrosivity (Zephiran solution 1:750)  Reactivity (no examples on VANF) Pharmacy Benefits Management www.pbm.va.gov 11

12. Pharmaceutical Waste Management Issues and Challenges identified through VAMC site visits  Lack of guidance on hazardous waste identification and segregation beyond the Pharmacy (e.g., Patient Care Wards, Oncology)  Lack of containers for the accumulation of pharmaceutical hazardous waste at or near the point of generation (e.g., Patient Care Wards, Oncology)  Commingling of P-listed with U-listed and characteristic hazardous wastes in a single container in the Pharmacy satellite accumulation area  Expired drugs that are potentially hazardous waste (e.g., repackaged Coumadin, flu vaccine, insulin) returned to VAMC Pharmacy from CBOC  Reports and online tools from Reverse Distributors not fully leveraged  Proper management of empty Coumadin stock bottles due to varying regulatory interpretations (hazardous or non-hazardous waste?) Pharmacy Benefits Management www.pbm.va.gov 12

13. Pharmaceutical Handling and Use : Issues and challenges identified through VAMC site visits  Lack of “OSHA/NIOSH” Hazardous Drug List  Absence of Written Hazardous Drug Programs  Omission of pharmaceuticals from Hazard Communication Programs  Limited participation in medical surveillance programs  Limited Safety and Health Training on pharmaceutical waste disposal procedures  Limited availability of Industrial Hygienist (IH) support to perform Job Hazard Analyses (JHA) and develop employee exposure control procedures  Absence of “Standard Precautions” for handling and use of all pharmaceuticals (hazardous, “non-hazardous”, and controlled)  Establishment of VHA policies for safety and health regarding exposure to pharmaceuticals Pharmacy Benefits Management www.pbm.va.gov 13

14. Pharmaceutical Handling and Use : Leading practices identified through VAMC site visits  Radiopharmaceutical Management  All eleven facilities visited were determined to be effectively managing radiopharmaceuticals  Documented and fully implemented Chemotherapy Training, Handling and Use Procedures  Labeling  Container Implementation Pharmacy Benefits Management www.pbm.va.gov 14

15. Pharmaceutical Waste Management Recommendations based on environmental scan and VAMC site visits  Waste Identification and Segregation  Provide guidance or tools to assist staff with proper waste identification (e.g., stickers, labels, posters, BCMA)  Provide containers for the management of hazardous pharmaceutical waste to the medication or patient care rooms on the wards  Until a VAMC receives documentation from the state hazardous waste regulatory authority that dictates otherwise, empty stock bottles or containers of Coumadin ® or warfarin should be managed as acute hazardous waste (P001)  Hazardous Waste Accumulation  Pharmacy should have at least two separate containers for the accumulation of hazardous pharmaceutical waste; one container should be dedicated for P-listed waste only Pharmacy Benefits Management www.pbm.va.gov 15

16. Pharmaceutical Waste Management Leading Practices identified through site visits  pharmaceuticals as they enter Pharmacy to identify those that should be managed as hazardous waste Use of colored stickers on  Containers at Satellite Accumulation Areas clearly labeled to indicate what hazardous waste should be placed therein (P-listed, U-listed, characteristic) Pharmacy Benefits Management www.pbm.va.gov 16

17. Pharmaceutical Waste Management Leading Practices identified through site visits  Appropriate containers available for any given hazardous waste category (P- listed, U-listed, characteristic)  Training provided to nursing staff regarding pharmaceutical hazardous waste identification and segregation  Providing containers for the management of non-hazardous pharmaceuticals, trace chemotherapy and bulk chemotherapy waste Hazardous Waste (Bulk Chemotherapy) Non-Hazardous Pharmaceutical Waste Trace Chemotherapy Waste Acute Hazardous Waste Pharmacy Benefits Management www.pbm.va.gov 17

18. Pharmaceutical Waste Management Recommendations based on environmental scan and VAMC site visits ( continued)  Expired Drugs at CBOCs  Drugs that become hazardous waste upon expiration should be managed as waste from CBOC or returned to VAMC Pharmacy before expiration  Reverse Distribution  Use the data made available in reports and tools from Reverse Distributor to identify those drugs that are consistently wasted and divert them from the reverse distribution channel and manage them as waste from Pharmacy  Remove those drugs that have sole active ingredients on the P- or U- list or that exhibit a hazardous characteristic from the non-hazardous drugs, prior to adding to the reverse distribution holding area Pharmacy Benefits Management www.pbm.va.gov 18

19. Pharmaceutical Handling & Use: Recommendations based on environmental scan and VAMC site visits  VHA Formulary Review  VHA facilities need to identify (list) pharmaceuticals in the formulary that are hazardous chemicals (or hazardous drugs) for OSHA compliance.  A national level review should be conducted to identify drugs against both OSHA’s definition of “hazardous chemical“ and the Environmental Protection Agency’s (EPA) definition of “hazardous waste.”  Local Policies/Practices  Facilities should develop and implement an action plan with milestones for each of the elements of the recommended VHA hazardous drug management policy.  Facilities should report the implementation status of each of the elements and progress should be monitored yearly using the Annual Workplace Evaluation (AWE).  VHA should add hazardous drug management as an annual mandatory review item in the AWE. Pharmacy Benefits Management www.pbm.va.gov 19

20. Pharmaceutical Handling & Use: Recommendations based on environmental scan and VAMC site visits (continued)  Hazardous Drug Communication Program  A National Hazardous Drug HAZCOM Plan should be developed and implemented consistently across the VHA and should incorporate the requirements of the HAZCOM rule.  “Fact Sheets” for each hazardous drug or drug class could be developed. These fact sheets would convey essential information such as physical state, summary health hazard information and required engineering controls, administrative controls, and PPE.  Training  Personnel should be trained on the proper use and handling of hazardous drugs.  A HAZCOM training module should be developed at the national level and included in LMS. The training should educate personnel on hazardous drug topics. Pharmacy Benefits Management www.pbm.va.gov 20

21. Pharmaceutical Handling and Use: Recommendations based on environmental scan and VAMC site visits ( continued)  Medical Surveillance and Recordkeeping  An action plan with milestones should be required of all facilities that have not effectively implemented medical surveillance.  Goals should be established for identifying and successfully inviting or recruiting employees who handle hazardous drugs into program.  Work with NIOSH to conduct health hazard evaluations of processes that are known to create potential long-term, low-level exposures to hazardous drugs or exposures to drugs with synergistic effects.  Hazard/Exposure Controls  Standard precautions should be developed for the use and handling of pharmaceuticals similar to the universal precautions used for bloodborne pathogen control (i.e., using gloves whenever contact with drugs or drug residues is expected, using eye protection when sprays or splashes are possible, and reinforcing hand and workplace hygiene practices when working with or around pharmaceuticals). Pharmacy Benefits Management www.pbm.va.gov 21

22. Waste Management: Should empty Coumadin ® stock bottles be managed as hazardous waste?  State interpretations vary significantly  Kentucky: The wrappers or vials that held P-listed drugs (e.g., warfarin or nicotine patches) are considered P-listed hazardous waste  Michigan: Vials that do not meet the empty pharmaceutical container rule and had contained drugs on the “P” hazardous waste list in must be managed as either a universal waste or hazardous waste unless the vial had been triple rinsed  Washington: Any container that held a warfarin tablet that is administered would not carry the RCRA listed waste codes since the tablet is removed as a product  In the Universal Waste Proposed Rule, Federal EPA states that “[i]f a chemical is listed on the P-list, then its container must also be managed as a hazardous waste, unless it has been declared ‘‘RCRA empty’’ via triple- rinsing.” (73 FR 73520; December 2, 2008)  It is VHA’ s position that until a VAMC receives documentation from the state hazardous waste regulatory authority that dictates otherwise, empty stock bottles or containers of Coumadin® or warfarin should be deemed to have contained P001 waste. Pharmacy Benefits Management www.pbm.va.gov 22

23. Waste Management: Should empty Coumadin ® stock bottles be managed as hazardous waste? (continued)  VHA has developed a fact sheet entitled, Proper Management of Empty Coumadin ® Containers that addresses:  What is “RCRA-empty”?  Interpretations Regarding Empty Coumadin ® Bottles  VHA Position on Empty Coumadin ® Containers  Counting the Weight of the Container  VHA is requesting an opinion letter from EPA regarding:  Should empty Coumadin ® stock bottles be managed as hazardous waste?  Is the weight of the Coumadin ® stock bottle or only the warfarin residue therein counted toward the monthly generator status and/or quantity limits at a satellite accumulation area? Pharmacy Benefits Management www.pbm.va.gov 23

24. Acknowledgements to: The Pharmaceuticals Management Task Group Paul Carnes Chief of Pharmacy Lebanon, PA Donald Horning Environmental Protection Manager Long Beach, CA George Knight VISN 2 Pharmacy/PBM Manager Syracuse, NY William Kulas VISN 1 Environmental Protection Manager Augusta, ME Jody McClarin National GEMS Program Manager St. Louis, MO Pamela Russell Industrial Hygiene Manager, Engineering Minneapolis, MN Jack Staudt Environmental Engineer Washington, DC Vaiyapuri Subramaniam Associate Chief Consultant, Pharmacy Benefits Management Washington, DC Robert Van Arsdale Pharmacy Chief Columbia, MO Booz Allen Hamilton Steve Buchanan Senior Associate McLean, VA Janet Gagnon Senior Associate Rockville, MD Timothy Killian Associate McLean, VA Tom Pape Associate Rockville, MD Veterans Health Administration Pharmacy Benefits Management www.pbm.va.gov 24

25. Questions? Pharmacy Benefits Management www.pbm.va.gov25