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

Consumer Drug ReturnsRegulatory Challenges, Proposed Solutions

Joanie BurnsWisconsin Department of Natural

Resources

Mary Hendrickson,RPh,MBACapital Returns, Inc.

AgendaReview of drug distributionRegulatory challengesWisconsin initiativesProposed solutions

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.

SummaryDEA closed distribution system leaves out the consumer

and the millions of pharmaceuticals they never end up using.

Current system (s) are not sustainableRequirements are contributing to poor environmental

practicesWorkable alternatives exist