Consumer Drug ReturnsRegulatory Challenges, Proposed Solutions
Joanie BurnsWisconsin Department of Natural
Resources
Mary Hendrickson,RPh,MBACapital Returns, Inc.
Debit memo information
Reporting
Process Overview
Distributio
n
Wholesaler returns
Pharmacy returns
Distribution
Dir
ect
acco
un
ts o
nly
Hospitals IndependentsChains
Manufacturers
Wholesalers
Retail/Institutional Pharmacies, LTC, Other indirect customer, etc.
Reverse Distributors
Incinerators
Creditable pro
duct
Waste
Process Overview
Distributio
n
MailOrder IndependentChains
Manufacturers
Wholesalers
Retail Pharmacies
Reverse Distributors
Incinerators
Returns D
ata
Waste
DistributionPharm
acy Retu
rns
Consumer/Patients SchoolsLong Term Care
Facilities
Distrib
utio
n
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/diversionPatient confidentiality/HIPPAStaffing and participants
Real world: no collection event or patient leaves it behindNursing homes/other non-hospital healthcare facilityHome (patient dies)SchoolPharmacy
Patients and other “end users”What are the issues?
Nursing homes/other non-hospital healthcare facilitiesFlush policiesHousehold or business?Waste or product?
Home (patient dies)Family membersCoroners and medical examiners
School
PharmacyWaste 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 enforcementWhat are the issues?
Public Safety
versus
Environmental Considerations
Controlled substances and law enforcementWhat are the issues?
WI law enforcement survey
Waste Management 101
Logistics
Costs
Schedule I controlled substances
Management of Controlled SubstancesWisconsin’s “temporary fixes”
Nursing homes/other non-hospital healthcare facilitiesDHFS guidance and “enforcement discretion”DNR/DHFS regulatory consensus
Schools, coroners and medical examinersOutreach and educationPractical application of law
Law enforcementIn-state infrastructureDialogue
A proposed solution: Acceptance from non-registrants
Potential ways this could work:
In-pharmacy return“Hands off” collection e.g., secure boxKept separate from products/creditable materials
generated by the pharmacy
DEA registered waste companiesDirect from collection eventsFrom 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
Distributio
n
MailOrder IndependentChains
Manufacturers
Wholesalers
Retail Pharmacies
Reverse Distributors
Incinerators
Returns D
ata
Waste
Distribution
Patients, LTC Facilities,
Schools
Disp
en
se
Adapted by permission from Capital Returns, Inc.
Pharmacy R
eturn
s
Returns
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 incinerationControlled 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.