1. Developing Long-Term
Stewardship for
Pharmaceuticals
Clean Med
May 19, 2009
Virginia Thompson
Office of Environmental Innovation
US EPA Region 3

2. Who’s Responsible for Pharms in
the Environment?
Pharm manufacturers?
 Government?
 Medical community?
 Individuals?
 Agriculture?
ANSWER:
(e) All of the above!
“There is no such thing as ZERO.”
--Shane Snyder, Southern Nevada Water Authority

3. PURPOSEFUL INADVERTENT

4. Primary Environmental Concerns
 Endocrine disruption
 Antimicrobial resistance
 Other priority modes of action and
toxic endpoints
 More questions than answers about
effects of pharmaceuticals on aquatic
species & human health

5. A Changing Landscape….
 Historically:
 Sensitive monitoring equipment detects
pharms at low levels in streams &
drinking water
 Recent guidance:
 Increasing interest in preventing
waste of medications and thus
disposal—using a variety of
stewardship approaches

6. Regulatory and Legal
Concerns regarding
Pharmaceuticals
Catherine Woods, Esquire
Associate Counsel
Senior Director, Corporate Compliance
excelleRx, Inc.
an Omnicare Company

7. The Concerns
 Diversion of controlled substances
 Contaminated water supply
 Negative impact on aquatic life
 Possible increased resistance to antibiotics
 Hormone disruption
 Unintentional exposure to possibly toxic
medications or accidental poisoning

8. Stakeholders
Government
Insurance Healthcare
Companies Facilities
Pharmaceutical Non-profit
Industry Organizations
Pharmaceutical
Waste
Reverse
Academia
Distributorships
Patient-
Pharmacies
Consumers

9. Oversight – The Authorities
DEA
Professional Boards &
US EPA
Regulatory Agencies
State & Local
(e.g. DEP, Police Dept.,
Water Dept., Sanitation

10. The Closed Loop – Fine For Facilities…
But What About Home Care?
Wholesalers,
Pharmacies,
Manufacturers Distributors
Institutions
Mfg. Return
3 party
rd 3rd party
processors processors
Incinerator

11. Federal Guidelines –
Individual Disposal of Rx Drugs

12. Q: How Many Drugs Are Out There?
 A: It Depends.
 N= 13,260 – First Data Bank Active Clinical Product
ID (criteria: drug, strength, dosage form)
 N= 24,154 – Orange Book (FDA approved drugs
under the Federal Food, Drug, and Cosmetic Act)
 N = 112,761 – First Databank Active NDC (criteria:
drug, strength, dosage form, package size,
manufacturer)

13. Q: How Many Drugs Are Wasted?
A: Too Many.
 In 2005, approximately 3.6 billion prescriptions
were purchased.
 Over 80% of elderly individuals take more
than one drug daily.
 50% of the elderly take three or more drugs
daily2.
 In 2007, an estimated 1 billion dollars worth of
unused medications was wasted3.

14. The Time To Act Is Now –
Our Watersheds

15. The Time To Act Is Now –
Our Children
Teens And Prescription Drug Abuse
March 24TH, 2008
A health study shows …..The 2007 Risk Behavior Survey shows about 25 percent of western
North Carolina high school students said they have used prescription medicine such as
Oxycontin and Percocet for recreational use.
New Addiction on Campus:
Raiding the Medicine Cabinet
By ELIZABETH BERNSTEIN
March 25, 2008; Page D1
Parents have long worried whether their kids at college are drinking
too much or getting stoned. But alcohol and marijuana aren't the
only substances they should be concerned about: In recent years, a
growing number of young people have begun abusing prescription
opiates…..

16. Prescription for disaster
Abuse of meds on the rise
March 29, 2008
Chris Lavender Staff Writer
Prescription drug abusers often don't realize that their
behavior could lead to fatal consequences. Like the nation,
Eastern North Carolina is seeing an increase in prescription
drug abuse cases.
According to the 2008 U.S. Department of Justice National
Drug Threat Assessment report, "parents are less likely to
talk to their children about the dangers of prescription drug
abuse than they are about heroin, cocaine, crack, marijuana,
or alcohol abuse."
According to Partnership Attitude Tracking Study data for
2006, 81.5 percent of parents perceive abuse of prescription
drugs to be a growing problem among teenagers, yet only
36.2 percent of parents discuss with their children the
dangers of using prescription drugs to get high….
Some Walgreens stop carrying popular painkiller
3/14 12:35 pm
TAMPA BAY -- The ABC Action News Investigators have discovered that one of the
Tampa Bay area's largest drugstore chains has made a major policy change.
Some Walgreens stores are not carrying Oxycontin, the widely used and often addictive
painkiller.
The company wouldn't say which stores or how many are not carrying the drug, but ABC
Action News investigative reporter Matthew Schwartz found two of the stores, both in
Pasco County. One is on Little Road in Port Richey, the other is on U.S. 19 in New Port
Richey.
Both stores were recently robbed of Oxycontin at gunpoint. Signs are posted on the front
doors at the stores, stating that Oxycontin will be available to customers by mail, sent
from a central location….

17. Impact Agencies –
Rules & Updates
 EPA
 RCRA
 Hazardous Waste
 Universal Waste
 P-List/U-List
 Proposed Rule: Amendment to the Universal Waste Rule:
Addition of Pharmaceuticals
 DEA
 Controlled Substances Act
 Advanced Notice of Proposed Rulemaking: Disposal of
Controlled Substances by Person Not Registered With the
Drug Enforcement Agency
 Congress
 HR 1191 (Inslee (D) WA, Moran (D) VA)
 HR 1359 (Stupak (D)MI, Smith (R)TX)

18. Understand Your State’s
Laws and Regulations
 Different states, local municipalities
may have different laws,
regulations, guidelines or programs
relating to medication waste
disposal
 DEA regional offices (e.g. MI v. PA)
 BOP
 BON
 Local wastewater/sewage regulations

19. Reverse Pharmaceutical Distribution
Mary Hendrickson,RPh,MBA
Director of Quality & Regulatory Affairs
Capital Returns, Inc. /
Genco Pharmaceutical Services
Mary.Hendrickson@gencopharma.com
Confidential

20. Reverse Distribution – the basics
 Expired, unused, recalled medications primarily from
business entities.
 Appropriate waste segregation & environmental disposal
 Regulatory reporting
 Manufacturers provide credit back to purchaser
 Promotes environmentally responsible disposal.
 Guarantees the purchaser is not left with the inventory if not
sold.
Confidential

21. Reverse Distribution – the basics
Manufacturers
Strategic
National
at
a
Dis
trib
Stockpile
u
sD ti o
n
rn
tu
Re
Reverse
Wholesalers
Distributors
te
as
W
n
ti o
Di
bu
sp
ri
st
en
Di
se
Incinerators Chains ,MailOrder Independent
Pharmacies
Confidential

22. Reverse Distribution Now
 Millions of pounds of product sent to incineration.
 Appropriate segregation, disposal, regulatory reporting
 Trend towards greater compliance
Pharmacies
use technology
to evaluate their
pharmaceutical
product for
waste
determination.
Confidential

23. Consumer Pharmaceutical Waste Now
 Reverse distributors typically not an option for
consumers.
 Exception patient level recalls.
 Accepted national solution not in place
 Regulatory restrictions considerations:
 Controlled Substance Act
 State distributor license
 State specific regulations: environmental
Confidential

24. Capital Returns / Genco Pharmaceutical Services
Completes Pilot Project for Consumer
Pharmaceutical Returns
 Two counties in Wisconsin.
 Available to all residents: free
 Funded through grant money.
 Easily accessible to all consumers.
 Utilized existing reverse distribution
infrastructure and systems.
Confidential

25. Logistics of the Pilot
 Consumers call 1-800-number to request to send
meds back.
 Provide zip code to qualify for program.
 Education provided on what can/cannot be sent
back.
 Upon receipt, medications are inventoried and
segregated by waste stream
then sent to incineration.
Confidential

26. Excerpt of education provided to
consumers of what could be returned:

27. Consumer Returns Pilot results:
 Number of consumer calls: 1730
 County specific:
 Waukesha 1378
 Winnebago 352
 Total number of items returned: 15164
 County specific:
 Waukesha 12322
 Winnebago 2842
 Participating households return
multiple medications

28. Looking forward in
reverse distribution:
 Business returns:
 Improvements in inventory management
 Considerations for re-distribution of product
when expiration date still good.
 Consumer returns:
 A national solution for a growing problem.

29. Pharmaceutical Stewardship:
Pilot in Southeastern PA
Julie Becker, Ph.D., MPH and
Teresa Méndez-Quigley, MSW, LSW
Women’s Health & Environmental Network
o2008 Sustainable Health Care Partner from Region III US EPA
o2006 Champion for Change Award from Hospitals for a Healthy Environment (H2E)
o2005 US EPA Children's Environmental Health Recognition Award
o2004 Champion for Change Award from H2E
o2003 Governor's Award for Environmental Excellence

30. Mission: championing
our health through
environmental action.
Programs
- Environmental Stewardship for Healthcare
“Mercury-Free Philly”
Waste Reduction
Healthy Food in Health Care
- Out of Harms Way: Greening Childcare
- Toxins in Our Midst: series of conferences
and lectures
Breast Cancer and the Environment
“Not too pretty: The Ugly Side of Beauty”

31. Pilot in Southeastern PA
 Funded by EPA Region 3, Philadelphia
Water Department and Society of
Women Environmental Professionals
 Partners include: WHEN,
Philadelphia Water Department,
Capital Returns, Philadelphia Senior Center, Mercy Life
Home Assistance Center, and University of the
Sciences of Philadelphia with cooperation from Thomas
Jefferson University School of Pharmacy and Hospira
 Spearheaded by WHEN
 Purpose: 1) source reduction of medications
by preventing disposal into water
through flushing;
2) pilot mail-in programs before ME+WI

32. Pilot : Part 1- Senior Center
• Information Session: “Preventing Medicines
from Getting into the Water: The Problem & Pilot
Solution”
- Tools to identify what medications can be
disposed of and safer disposal methods
- Medication safety
- Materials for Mailing Meds for Disposal
• Mail-In Assistance Program
- Individual counseling with
Pharmacists &
pharmacy students
- Mailers for non-controlled
substances
- Narcotics Task Force
in case of controlled
substances
- Medications mailed back to reverse distributor

33. Results from Part 1:
Senior Center Program
Information Sessions (n=2) 85+
No. attending mail-in assistance 24
program
Amount of drugs for mail-in 12.12 lbs
Number of Controlled Substances 6
Number of Non-controlled Substances 114
Main reason for turning in medications: Expired and unused
Most common medications: over-the-counter analgesics and
cold medicines. Other popular medications included cholesterol-
lowering drugs, antibiotics, and digestive aides/ GI drugs

34. Pilot : Part 2- Aging-in-Place
Nursing Assistance
• In-service Session for Nurse (RN)
Management
- “Preventing Medicines from Getting into the
Water- The Problem & Pilot Solution”
- Educational materials for RNs on safer disposal
practices for medications
2) Mail-In Assistance Program
For each new client, RN cleans out medicine
cabinet and removes all unused, expired or
unwanted non-controlled medications for mail-in
- Mailers for non-controlled substances
All medications from both parts were
mailed to reverse distributor for
counting and classification,
then sent to RCRA-level incinerator

35. Results from Part II:
Aging-in-Place Program
Number of nurses educated At least 10
Amount of drugs for mail-in 5 lbs
Value of drugs for disposal $3806
Number of Controlled Substances 0
No. of Non-controlled Substances 38
No. of Pills Collected >5000
Main reasons for turning in medications: Doctor ordered new medication
Most common medications: antidepressants, anti-convulsants,
cholesterol-lowering drugs, over-the-counter analgesics and cold medicines.
Other popular medications included high-blood pressure, antibiotics, and digestive
aides/ GI drugs

36. Next Steps:
Public health concerns
 Largest group of potential users of pharmaceuticals-
Baby Boomers are aging with 1or more chronic
diseases
 Children are becoming large scale users of
medications
(both legally and illegally through “Pharm Parties”)
 Need to enact the Precautionary
Principle
 An opportunity to work collaboratively
towards a common end

37. Challenges:
 DEA: What to do with controlled substances
 On-going funding
 Developing partnerships across public
agencies
& private sector
 States differ from Federal regarding
RCRA waste
 Manufacturers need to assume
responsibility for safer disposal practices
 Healthcare and insurance need to revise
dispensing of medications
 Risk Communication

38. Common Ground:
Addressing the Challenges,
Finding Solutions
Julie Becker,
Mary Hendrickson,
Virginia Thompson,
Catherine Woods
CleanMed 2009
Chicago IL

39. Solution Strategies
 Elephant in the Room:
Controlled substances
 Mind the gap: missing data
 Downstream Approaches:
Disposal practices
 Upstream Approaches: Education
 Pay drives policy
 Success breeds success:
Modeling practices
 Healthcare reform

40. Elephant in the Room:
Controlled substances
Until safe, environmentally responsible,
legal way to dispose
of controlled
substances is
addressed,
this will continue to
be the Achilles heel
of pharmaceutical
waste management

41. Mind the gap: missing data
 Data NEEDED and REQUIRED
 How much pharmaceuticals are not being
used and where does it go?
 EPA survey (national)
 EPA survey about soap usage with antimicrobial
ingredients
 Vulnerable populations:
 Long-term care facilities
 Hospice
 Geriatrics
 Pediatrics

42. Downstream Approaches:
Disposal practices
 Need a national, legal,
sustainable, comprehensive
program that covers controlled
and non-controlled substances
 Other countries have
several models,
but regardless,
this can be done

43. Upstream Approaches:
Education
 Training of stakeholders
 Prescribers (doctors, nurse
practitioners, physician assistants)
 Dispensers (pharmacists)
 Payers (Insurers and Government)
 Consumer Advocacy
 Students in professional schools
 Law enforcement

44. Pay drives policy
 Payers need
to change policies
that encourage
smaller amounts
of medications
prescribed
 No more mega-level of over-the-
counter analgesics or other
high-volume non-prescription
medications sold at stores

45. Success breeds success:
Modeling Practices
 Using the laboratories of
democracy:
the States
 Need to model
additional practices
that test source
reduction with
evaluation and
cost data
 MnTap Voucher
program

46. Healthcare Reform
The lifecycle of pharmaceuticals
need to be part of healthcare
reform, from determining
which ones to use,
to prescribing, dispensing
and reimbursement,
to safe, legal,
environmentally
responsible disposal
(ideally non-incineration!)