Clean Med Final05 19 09

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  • 1. Developing Long-TermStewardship forPharmaceuticalsClean MedMay 19, 2009Virginia ThompsonOffice of Environmental InnovationUS EPA Region 3

2. Whos Responsible for Pharms inthe 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 andtoxic endpoints More questions than answers abouteffects of pharmaceuticals on aquaticspecies & human health 5. A Changing Landscape. Historically: Sensitive monitoring equipment detectspharms at low levels in streams &drinking water Recent guidance: Increasing interest in preventingwaste of medications and thusdisposalusing a variety ofstewardship approaches 6. Regulatory and LegalConcerns regardingPharmaceuticalsCatherine Woods, EsquireAssociate CounselSenior Director, Corporate ComplianceexcelleRx, 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 toxicmedications or accidental poisoning 8. Stakeholders Government Insurance Healthcare CompaniesFacilitiesPharmaceuticalNon-profit IndustryOrganizationsPharmaceuticalWasteReverse AcademiaDistributorshipsPatient- Pharmacies Consumers 9. Oversight The Authorities DEAProfessional Boards & US EPA Regulatory AgenciesState & Local(e.g. DEP, Police Dept.,Water Dept., Sanitation 10. The Closed Loop Fine For Facilities But What About Home Care? Wholesalers, Pharmacies,ManufacturersDistributors Institutions Mfg. Return 3 partyrd 3rd partyprocessorsprocessorsIncinerator 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 prescriptionswere purchased. Over 80% of elderly individuals take morethan one drug daily. 50% of the elderly take three or more drugs daily2. In 2007, an estimated 1 billion dollars worth ofunused 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, 2008A health study shows ..The 2007 Risk Behavior Survey shows about 25 percent of westernNorth Carolina high school students said they have used prescription medicine such asOxycontin and Percocet for recreational use.New Addiction on Campus:Raiding the Medicine CabinetBy ELIZABETH BERNSTEINMarch 25, 2008; Page D1Parents have long worried whether their kids at college are drinkingtoo much or getting stoned. But alcohol and marijuana arent theonly substances they should be concerned about: In recent years, agrowing number of young people have begun abusing prescriptionopiates.. 16. Prescription for disasterAbuse of meds on the riseMarch 29, 2008Chris Lavender Staff Writer Prescription drug abusers often dont realize that theirbehavior could lead to fatal consequences. Like the nation,Eastern North Carolina is seeing an increase in prescriptiondrug abuse cases.According to the 2008 U.S. Department of Justice NationalDrug Threat Assessment report, "parents are less likely totalk to their children about the dangers of prescription drugabuse than they are about heroin, cocaine, crack, marijuana,or alcohol abuse."According to Partnership Attitude Tracking Study data for2006, 81.5 percent of parents perceive abuse of prescriptiondrugs to be a growing problem among teenagers, yet only36.2 percent of parents discuss with their children thedangers of using prescription drugs to get high. Some Walgreens stop carrying popular painkiller3/14 12:35 pmTAMPA BAY -- The ABC Action News Investigators have discovered that one of theTampa Bay areas largest drugstore chains has made a major policy change.Some Walgreens stores are not carrying Oxycontin, the widely used and often addictivepainkiller.The company wouldnt say which stores or how many are not carrying the drug, but ABCAction News investigative reporter Matthew Schwartz found two of the stores, both inPasco County. One is on Little Road in Port Richey, the other is on U.S. 19 in New PortRichey.Both stores were recently robbed of Oxycontin at gunpoint. Signs are posted on the frontdoors at the stores, stating that Oxycontin will be available to customers by mail, sentfrom 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 StatesLaws and Regulations Different states, local municipalitiesmay have different laws,regulations, guidelines or programsrelating to medication wastedisposal DEA regional offices (e.g. MI v. PA) BOP BON Local wastewater/sewage regulations 19. Reverse Pharmaceutical DistributionMary Hendrickson,RPh,MBA Director of Quality & Regulatory AffairsCapital Returns, Inc. / Genco Pharmaceutical Services Mary.Hendrickson@gencopharma.com Confidential 20. Reverse Distribution the basics Expired, unused, recalled medications primarily frombusiness 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 notsold.Confidential 21. Reverse Distribution the basicsManufacturers Strategic Nationalat a Dis trib Stockpileu sD ti o nrn tu Re ReverseWholesalers Distributorste asWnti oDibusp risten Di seIncinerators Chains,MailOrder IndependentPharmacies Confidential 22. Reverse Distribution Now Millions of pounds of product sent to incineration. Appropriate segregation, disposal, regulatory reporting Trend towards greater compliancePharmacies use technologyto evaluate their pharmaceutical product forwaste determination. Confidential 23. Consumer Pharmaceutical Waste Now Reverse distributors typically not an option forconsumers. Exception patient level recalls. Accepted national solution not in place Regulatory restrictions considerations: Controlled Substance Act State distributor license State specific regulations: environmentalConfidential 24. Capital Returns / Genco Pharmaceutical ServicesCompletes Pilot Project for ConsumerPharmaceutical 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 sendmeds back. Provide zip code to qualify for program. Education provided on what can/cannot be sentback. Upon receipt, medications are inventoried andsegregated by waste streamthen sent to incineration. Confidential 26. Excerpt of education provided toconsumers 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 inreverse 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 PAJulie Becker, Ph.D., MPH andTeresa Mndez-Quigley, MSW, LSWWomens Health & Environmental Networko2008 Sustainable Health Care Partner from Region III US EPAo2006 Champion for Change Award from Hospitals for a Healthy Environment (H2E)o2005 US EPA Childrens Environmental Health Recognition Awardo2004 Champion for Change Award from H2Eo2003 Governors 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 lecturesBreast Cancer and the EnvironmentNot too pretty: The Ugly Side of Beauty 31. Pilot in Southeastern PA Funded by EPA Region 3, PhiladelphiaWater Department and Society ofWomen 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 medicationsby preventing disposal into waterthrough flushing; 2) pilot mail-in programs before ME+WI 32. Pilot : Part 1- Senior Center Information Session: Preventing Medicinesfrom Getting into the Water: The Problem & PilotSolution- Tools to identify what medications can bedisposed of and safer disposal methods- Medication safety- Materials for Mailing Meds for Disposal Mail-In Assistance Program- Individual counseling withPharmacists &pharmacy students- Mailers for non-controlledsubstances- Narcotics Task Forcein case of controlledsubstances- Medications mailed back to reverse distributor 33. Results from Part 1: Senior Center ProgramInformation Sessions (n=2) 85+No. attending mail-in assistance 24 programAmount of drugs for mail-in12.12 lbsNumber of Controlled Substances6Number of Non-controlled Substances 114Main reason for turning in medications: Expired and unusedMost common medications: over-the-counter analgesics andcold medicines. Other popular medications included cholesterol-lowering drugs, antibiotics, and digestive aides/ GI drugs 34. Pilot : Part 2- Aging-in-PlaceNursing AssistanceIn-service Session for Nurse (RN) Management - Preventing Medicines from Getting into theWater- The Problem & Pilot Solution - Educational materials for RNs on safer disposal practices for medications2) 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 weremailed to reverse distributor forcounting 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 Substances38 No. of Pills Collected>5000Main reasons for turning in medications: Doctor ordered new medicationMost common medications: antidepressants, anti-convulsants,cholesterol-lowering drugs, over-the-counter analgesics and cold medicines.Other popular medications included high-blood pressure, antibiotics, and digestiveaides/ 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 publicagencies& private sector States differ from Federal regardingRCRA waste Manufacturers need to assumeresponsibility for safer disposal practices Healthcare and insurance need to revisedispensing of medications Risk Communication 38. Common Ground:Addressing the Challenges,Finding SolutionsJulie Becker,Mary Hendrickson,Virginia Thompson,Catherine WoodsCleanMed 2009Chicago 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 substancesUntil 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, comprehensiveprogram that covers controlledand non-controlled substances Other countries haveseveral models,but regardless,this can be done 43. Upstream Approaches:Education Training of stakeholders Prescribers (doctors, nursepractitioners, physician assistants) Dispensers (pharmacists) Payers (Insurers and Government) Consumer Advocacy Students in professional schools Law enforcement 44. Pay drives policy Payers needto change policiesthat encouragesmaller amountsof medicationsprescribed No more mega-level of over-the-counter analgesics or otherhigh-volume non-prescriptionmedications sold at stores 45. Success breeds success:Modeling Practices Using the laboratories ofdemocracy:the States Need to modeladditional practicesthat test sourcereduction withevaluation andcost data MnTap Voucherprogram 46. Healthcare ReformThe lifecycle of pharmaceuticalsneed to be part of healthcarereform, from determiningwhich ones to use,to prescribing, dispensingand reimbursement,to safe, legal,environmentallyresponsible disposal(ideally non-incineration!)