Developing Long-Term Stewardship for Pharmaceuticals
Clean MedMay 19, 2009
Virginia ThompsonOffice of Environmental InnovationUS EPA Region 3
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
PURPOSEFULPURPOSEFUL INADVERTENTINADVERTENT
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
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
Regulatory and Legal Concerns regarding Pharmaceuticals
Catherine Woods, EsquireAssociate Counsel
Senior Director, Corporate Compliance
excelleRx, Inc.an Omnicare Company
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
Stakeholders
Insurance Companies
PharmaceuticalIndustry
Academia
PharmaciesPatient-
Consumers
ReverseDistributorships
Non-profitOrganizations
HealthcareFacilities
Government
Pharmaceutical Waste
Oversight – The Authorities
DEA
US EPA
State & Local(e.g. DEP, Police Dept.,Water Dept., Sanitation
Professional Boards &Regulatory Agencies
The Closed Loop – Fine For Facilities… But What About Home Care?
ManufacturersWholesalers, Distributors Pharmacies,
Institutions
Return3rd party
processors
Mfg.3rd party
processorsIncinerator
Federal Guidelines – Individual Disposal of Rx Drugs
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)
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.
The Time To Act Is Now – Our Watersheds
The Time To Act Is Now – Our Children
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.
Teens And Prescription Drug AbuseMarch 24TH, 2008
New Addiction on Campus: Raiding the Medicine CabinetBy ELIZABETH BERNSTEINMarch 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…..
Prescription for disaster Abuse of meds on the riseMarch 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….
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)
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
Confidential
Reverse Pharmaceutical Distribution
Mary Hendrickson,RPh,MBADirector of Quality & Regulatory Affairs
Capital Returns, Inc. / Genco Pharmaceutical Services
Confidential
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
Reverse Distribution – the basics
Dis
trib
utio
n
,MailOrder IndependentChains
Manufacturers
Wholesalers
Pharmacies
Reverse Distributors
Incinerators
Returns D
ata
Waste
Distribution
Dispense
Strategic National
Stockpile
Confidential
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
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
Capital Returns / Genco Pharmaceutical Services Capital Returns / Genco Pharmaceutical Services Completes Pilot Project for Consumer Completes Pilot Project for Consumer Pharmaceutical ReturnsPharmaceutical Returns
Two counties in Wisconsin.Two counties in Wisconsin. Available to all residents: freeAvailable to all residents: free Funded through grant money.Funded through grant money. Easily accessible to all consumers.Easily accessible to all consumers. Utilized existing reverse distribution Utilized existing reverse distribution infrastructure and systems.infrastructure and systems.
Confidential
Logistics of the PilotLogistics of the Pilot Consumers call 1-800-number to request to send Consumers call 1-800-number to request to send
meds back. meds back. Provide zip code to qualify for program.Provide zip code to qualify for program. Education provided on what can/cannot be sent Education provided on what can/cannot be sent
back. back. Upon receipt, medications are inventoried and Upon receipt, medications are inventoried and
segregated by waste stream segregated by waste stream then sent to incineration. then sent to incineration.
Excerpt of education provided to consumers of what could be returned:
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
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.
Pharmaceutical Stewardship: Pharmaceutical Stewardship: Pilot in Southeastern PAPilot in Southeastern PA
Julie Becker, Ph.D., MPH and Teresa Méndez-Quigley, MSW, LSWWomen’s Health & Environmental Network
o2008 Sustainable Health Care Partner from Region III US EPAo2006 Champion for Change Award from Hospitals for a Healthy Environment (H2E)o2005 US EPA Children's Environmental Health Recognition Awardo2004 Champion for Change Award from H2Eo2003 Governor's Award for Environmental Excellence
Programs Programs - - Environmental Stewardship for Healthcare
“Mercury-Free Philly”Waste ReductionHealthy 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”
Mission:Mission: championing our health through environmental action.
Pilot in Southeastern PAPilot 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: Purpose: 1) source reduction of medications
by preventing disposal into water through flushing;
2) pilot mail-in programs before ME+WI
Pilot : Part 1- Senior CenterPilot : Part 1- Senior Center1)1) Information SessionInformation 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
2)2) Mail-In Assistance ProgramMail-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
Results from Part 1: Results from Part 1: Senior Center ProgramSenior Center Program
Information Sessions (n=2) 85+
No. attending mail-in assistance program
24
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: Main reason for turning in medications: Expired and Expired and unusedunusedMost common medications: over-the-counter Most common medications: over-the-counter analgesicsanalgesics and and cold medicinescold medicines.. Other popular medications included cholesterol- Other popular medications included cholesterol-lowering drugs, antibiotics, and digestive aides/ GI drugslowering drugs, antibiotics, and digestive aides/ GI drugs
All medications from both parts were mailed to reverse distributor for
counting and classification, then sent to RCRA-level incinerator
Pilot : Pilot : Part 2- - Aging-in-Place Nursing Assistance
1)1) In-service Session for Nurse (RN) In-service Session for Nurse (RN) ManagementManagement - “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 Program2) Mail-In Assistance ProgramFor 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
Results from Part II: Results from Part II: Aging-in-Place ProgramAging-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 SubstancesNo. of Pills Collected
38>5000
Main reasons for turning in medications: Main reasons for turning in medications: Doctor ordered new Doctor ordered new medicationmedicationMost common medications: Most common medications: antidepressants, anti-convulsantsantidepressants, anti-convulsants, , cholesterol-lowering drugs, over-the-counter analgesics and cold cholesterol-lowering drugs, over-the-counter analgesics and cold medicines.medicines. Other popular medications included high-blood pressure, antibiotics, Other popular medications included high-blood pressure, antibiotics, and digestive aides/ GI drugsand digestive aides/ GI drugs
Next Steps:Next Steps:
Public health concernsPublic 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
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
Challenges:Challenges:
Common Ground: Common Ground: Addressing the Challenges, Addressing the Challenges, Finding SolutionsFinding Solutions
Julie Becker, Mary Hendrickson, Virginia Thompson, Catherine Woods
CleanMed 2009Chicago IL
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
Elephant in the Room: Controlled substances
Until safe, environmentally responsible, legal way to disposeof controlled substances is addressed, this will continue to be the Achilles heel of pharmaceutical waste management
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
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
Upstream Approaches: Education
Training of stakeholdersPrescribers (doctors, nurse
practitioners, physician assistants)Dispensers (pharmacists)Payers (Insurers and Government)Consumer AdvocacyStudents in professional schoolsLaw enforcement
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
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 dataMnTap Voucher
program
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!)