1. Consumer Drug Returns Regulatory Challenges, Proposed Solutions Joanie Burns Wisconsin Department of Natural Resources Mary Hendrickson,RPh,MBA Capital Returns, Inc.

2. Agenda Review of drug distribution Regulatory challenges Wisconsin initiatives Proposed solutions

3. Debit memo information Reporting Process Overview Distribution Wholesaler returns Pharmacy returns Distribution Direct accounts only Hospitals Independents Chains ManufacturersWholesalers Retail/Institutional Pharmacies, LTC, Other indirect customer, etc. Reverse Distributors Incinerators Creditable product Waste

4. Process Overview Distribution MailOrderIndependentChains Manufacturers Wholesalers Retail Pharmacies Reverse Distributors Incinerators Returns Data Waste Distribution Pharmacy Returns Consumer/PatientsSchools Long Term Care Facilities Distribution

5. Regulatory challenges with consumer returns Overall goal of the controlled substances act is to provide a closed distribution system. A DEA concern: diversion already occurs to some extent in spite of all precautions with the closed loop system. Goal: provide an environmentally safe system to return unused consumer pharmaceutical products while minimizing diversion, abuse, accidental poisonings and overdosing.

6. Patients and other “end users” Current best case scenario: material brought to a collection event or sent for other safe, environmentally sound management Considerations: Safety/diversion Patient confidentiality/HIPPA Staffing and participants Real world: no collection event or patient leaves it behind Nursing homes/other non-hospital healthcare facility Home (patient dies) School Pharmacy

7. Patients and other “end users” What are the issues? Nursing homes/other non-hospital healthcare facilities Flush policies Household or business? Waste or product? Home (patient dies) Family members Coroners and medical examiners School Pharmacy Waste or product?

8. Collection events Easiest scenario: all material sent for hazardous waste (HW) incineration Real world: non-controlled substances sent for HW incineration; controlled substances taken into possession by law enforcement What is law enforcement doing with it?

9. Controlled substances and law enforcement What are the issues? Public Safety versus Environmental Considerations

10. Controlled substances and law enforcement What are the issues? WI law enforcement survey Waste Management 101 Logistics Costs Schedule I controlled substances

11. Management of Controlled Substances Wisconsin’s “temporary fixes” Nursing homes/other non-hospital healthcare facilities DHFS guidance and “enforcement discretion” DNR/DHFS regulatory consensus Schools, coroners and medical examiners Outreach and education Practical application of law Law enforcement In-state infrastructure Dialogue

12. A proposed solution: Acceptance from non-registrants Potential ways this could work: In-pharmacy return “Hands off” collection e.g., secure box Kept separate from products/creditable materials generated by the pharmacy DEA registered waste companies Direct from collection events From law enforcement agencies Reverse distributors

13. A proposed solution: reverse distributors Reverse Distribution centralizes outdated drugs into a finite numbers of locations. Core competency is receipt, documentation, and proper disposal of outdated drugs. Outsourcing by pharmacies for processing outdated drugs: near 100%. Limited number of reverse distributor DEA registrants. Precedent with DEA already exists in the management of recalled controlled substances.

14. Proposed Logistics: Unused pharmaceutical product sent back to a reverse distributor. Mail back program Distribution MailOrderIndependentChains ManufacturersWholesalers Retail Pharmacies Reverse Distributors Incinerators Returns Data Waste Distribution Patients, LTC Facilities, Schools Dispense Adapted by permission from Capital Returns, Inc. Pharmacy Returns Returns

15. The benefits of a reverse distributor solution: Relevant data is recorded and retained by the RD as required by the CSA. Includes drug name, dosage, quantity, etc. All product sent for incineration Controlled substances sent through routine witness incineration. Unwanted, unused medications are removed from the “wrong” hands: accidental poisonings, overdose, etc. Data obtained could prove to be very beneficial: manufacturers, insurance providers.

16. Summary DEA closed distribution system leaves out the consumer and the millions of pharmaceuticals they never end up using. Current system (s) are not sustainable Requirements are contributing to poor environmental practices Workable alternatives exist