Medication Disposal as a S Source for Drugs as f D Environmental - PowerPoint PPT Presentation

Medication Disposal as a S Source for Drugs as f D Environmental Contaminants Ilene S. Ruhoy, MD U.S. EPA Student Volunteer ORD NERL L ORD, NERL, Las Vegas V Office of Research and Development June, 2007 National Exposure Research Laboratory, Las Vegas, NV

U.S. EPA Office of Research and Development Seminar presented for: presented for: U.S. EPA Office of Water Office of Science and Technology Emerging Contaminants Team at: at: U.S. EPA Ariel Rios South NETI Training Room 6226 Washington, DC W hi t DC 20 June 2007 citation: Ruhoy IS “Medication Disposal as a Source for Drugs as Environmental Contaminants,” U.S. EPA Office of Research and Development Seminar, presented for 33 U.S. EPA Office of Water, Office of Science and Technology, Emerging Contaminants Team, 20 June 2007, Washington, DC.

Affiliations: Ilene S. Ruhoy, MD • EPA Student Volunteer at ORD’s National Exposure Research Laboratory (NERL), Environmental Sciences Division, Las Vegas; mentored by Dr Christian Daughton Vegas; mentored by Dr. Christian Daughton • UNLV Doctoral student , Department of Environmental Studies, Greenspun College of Urban Affairs (Chaired by Prof. David Hassenzahl; committee members: Christian Daughton PhD EPA; Hassenzahl; committee members: Christian Daughton, PhD, EPA; Christopher Williamson, PhD, ONDCP; Shawn Gerstenberger, PhD, UNLV School of Public Health; Chad Cross, PhD, UNLV S h School of Public Health) l f P bli H lth) • As an MD , serve on faculty at Touro University School of Osteopathic Medicine (Henderson, NV) as Assistant Professor of Clinical and Basic Sciences 1

EPA Notice Although this work was reviewed by EPA and approved for publication it may not and approved for publication, it may not necessarily reflect official Agency policy. 2

Outline • Overview of issues surrounding drug disposal • Key, unresolved questions Key, unresolved questions • Overview of research on drug disposal at NERL-Las Vegas. (Summary of Proposed APM under Water Quality MYP) • Future Plans • To obtain feedback from Program Offices and Regions in order to make research responsive to Agency needs order to make research responsive to Agency needs. 3

Drug Disposal • Pharmaceutical Waste • Take-back events and programs Take back events and programs • Controlled Substances Act (CSA) • Stakeholders & Beneficiaries: Stakeholders & Beneficiaries: EPA, DEA, ONDCP, FDA, USFWS, state and local governments, municipal water districts, pharmacy & pharmaceutical industries, healthcare industry, insurance industry 4

Environmental Impact of Disposal • Pharmaceuticals owe their origins in the environment to their worldwide, universal, frequent, and highly dispersed but cumulative usage by multitudes of individuals but cumulative usage by multitudes of individuals • Occurrence of pharmaceuticals in the environment mirrors the intimate, inseparable, and immediate connection p between the actions and activities of individuals and their environment • Proper disposal is greatly complicated by the inherent, di l i l li d b h i h fundamental conflict between the need to protect public safety and the need to minimize aquatic (and terrestrial) exposure 5

Major Unknown • What fractions of drug residues occurring in the ambient environment result from discarding leftover drugs? –No studies exist that provide objective data from well- defined populations to support any type of conclusion defined populations to support any type of conclusion. • To gauge the significance of leftover drugs as potential pollutants, data are needed on the types, quantities, and p , yp , q , frequencies with which drugs accumulate as household waste. 6

Pharmaceutical Accumulation Pharmaceutical Accumulation • Pharmaceuticals designed for both humans and animals often accumulate beyond the time of their intended use • Numerous factors play roles in the accumulation of drugs by end-users –Consumers, health care professionals, physicians, C h l h f i l h i i patients, veterinarians, farmers, humanitarian relief workers –Factors include expiry, non-adherence, over-prescribing, or excessive purchase 7

Accumulation and Disposal of Pharmaceuticals Coroner IS Ruhoy & CG Daughton U.S. EPA-Las Vegas 15 December 2006 15 December 2006 Decedent Unusable Donations In-Patient Clan Labs Abandoned Cruise Ship Pharmacies D Donations ti Out-Patient Clinics Nurses Offices Medicine Cabinet Internet Consumer Abusers (e.g., "pharming") Pharmacies Take-Backs & Collection Manufacturers Events Drug Dentists Controlled Sharing Controlled Substances Black Susbtances Market NOTE: This diagram NOTE: This diagram Reverse Distributors st buto s Physicians Physicians Physician Law is for EPA internal Samples Enforcement Diversion use only. Do not Illegal Via Pets distribute or cite Hospitals Hospice Transporter In-practice Use without consent from ith t t f the authors. Pharmaceutical Representatives Veterinarians LTCFs Distributors CAFOs Points of Accumulation Accumulation Ambulances Vendors Discard to sewerage 8 Discard to trash/landfill Agriculture First Aid Kits Zoos (farners) Incineration

Pharmaceutical Accumulation Pharmaceutical Accumulation • Consumer Homes • First Responder Services – Both human and animal medicine • First-Aid Kits • Physician Offices y • Border Check Points – Samples and in-office procedure • Customs (airline and freight) use • Confined Animal Feeding Operations • Veterinarian Offices (CAFOs) • Dental Offices • Dental Offices • Agriculture • Agriculture • Hospitals • Aquaculture • Long-Term Care Facilities • Zoos • Donations • Clan Labs • Schools (confiscation and health care offices) • Cemeteries • Cruise Ships 9

Pharmaceutical Accumulation • Accumulate for varied reasons l f i d –NON-COMPLIANCE/NON-ADHERENCE • Reduced ability to treat • Reduced ability to treat –INEFFICIENCES IN DISTRIBUTION AND PRESCRIBING –CONSUMER OVER-PURCHASING • Wal-Mart –EXPIRED 10

Pharmaceutical Prescriptions in the US - 2005 • Top Ten # of prescriptions written (X1000) –Hydrocodone/APAP 101,639 –Lipitor 63,219 –Amoxicillin 52,104 –Lisinopril Lisinopril 47,829 47,829 –HCTZ 42,757 –Atenolol 42,001 –Zithromax Zith 38 110 38,110 –Furosemide 34,782 –Alprazolam 34,230 –Toprol-XL 33,598 11

New Approach to Mining Data for Types and Quantities of Disposed Drugs † y g • Medications collected and disposed of by coroner offices are potentially a large source of drugs in the p y g g environment • But arguably even more important, inventories of medications provide information regarding the di i id i f i di h categories and dosage amounts of medications disposed disposed † from unpublished dissertation research of I. Ruhoy 2006. 12

New Approach to Mining Data for Types and Quantities of Disposed Drugs † Types and Quantities of Disposed Drugs • Understanding the categories and quantities of drugs disposed can help assess potential impacts on both the disposed can help assess potential impacts on both the environment and human health – environmental scientists to better target APIs (active pharmaceutical ingredients) for monitoring purposes g ) g p p – assessment of risk to human health from chronic and/or acute exposures (e.g., imprudent consumption of leftover drugs) – health care practitioners to address inefficient prescribing practices and patient non compliance and patient non-compliance – policymakers (including those in the insurance industry) to begin to understand and confront the growing issue of wasted and discarded medications. – Ultimate Objective: No Leftover Drugs 13 † from unpublished dissertation research of I. Ruhoy 2006.

New Approach to Mining Data for Types and Quantities of Disposed Drugs † • Coroner cases are those in which the decedent died alone or when there C h i hi h h d d di d l h h were unusual circumstances regarding the death – Standard definition of coroner cases as used nationally – Population demographics from which coroner cases are derived do not differ from the general population • Coroner inventory is the only ready source of accurate data that: – Indicates what types of drugs accumulate – Indicates which drugs may result in disposal – Indicates what categories of drugs are actually disposed of (by the Indicates what categories of drugs are actually disposed of (by the coroner) – Encompasses all medication – OTC and prescription † from unpublished dissertation research of I. Ruhoy 2006. 14

DISPOSAL New Data † Clark County Coroner • Based on Clark County Coroner Cases for 13 month period (January 2005 – January 2006) • Population: 3 million people • 1,623 cases reviewed – Approximately 325,000 pills/tablets/capsules disposed into sewage system • Controlled substances/Non-controlled substances – Greater than 102,000,000 mg (102 kg) of APIs disposed into the environment • 92% flushed into sewage system • 7% trash disposal • 1% incinerated † from unpublished dissertation research of I. Ruhoy 2006. 15