Transcript Patients and other “end users”

Consumer Drug Returns
Regulatory Challenges, Proposed Solutions
Joanie Burns
Wisconsin Department of Natural
Resources
Mary Hendrickson,RPh,MBA
Capital Returns, Inc.
Agenda
 Review of drug distribution
 Regulatory challenges
 Wisconsin initiatives
 Proposed solutions
Process Overview
Reverse
Distributors
Incinerators
Direct accounts only
Manufacturers
Wholesaler returns
Wholesalers
Debit memo information
Chains
Hospitals
Independents
Retail/Institutional Pharmacies, LTC,
Other indirect customer, etc.
Process Overview
Manufacturers
Reverse
Distributors
Incinerators
Wholesalers
Chains
MailOrder
Independent
Retail Pharmacies
Distribution
Consumer/Patients
Long Term Care
Facilities
Schools
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.
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
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?
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?
Controlled substances and law enforcement
What are the issues?
Public Safety
versus
Environmental Considerations
Controlled substances and law enforcement
What are the issues?
 WI law enforcement survey
 Waste Management 101
 Logistics
 Costs
 Schedule I controlled substances
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
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
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.
Proposed Logistics:
 Unused pharmaceutical product sent back to a reverse
distributor.
 Mail back program
Reverse
Distributors
Manufacturers
Patients,
LTC Facilities,
Schools
Wholesalers
Dispense
Incinerators
Chains
MailOrder
Independent
Retail Pharmacies
Adapted by permission from Capital Returns, Inc.
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.
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