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

Mary.Hendrickson@gencopharma.com

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!)