Disposal of Unused or Expired Drugs Attorneys General Education Program Public Policy Conference THE PHARMACEUTICAL INDUSTRY: ECONOMICS, REGULATION, AND LEGAL ISSUES May 4, 2012

Pharmaceuticals In Water  Results of human health assessments indicate that residues of pharmaceuticals in water present no appreciable risk to human health  Concentrations of pharmaceuticals in typical environmental settings are not high enough to cause the effects that can be observed in experimental settings.  The science underpinning measuring aquatic life impacts is still under active development (PhRMA members are participating).

Pharmaceuticals in Water  General Agreement: The vast majority of pharmaceuticals enter the water from excretion following patient use

A Product Stewardship Approach to the Unused Medicine Issue (general public) 1. Don’t generate the waste in the first place 2. Reuse 3. Recycle 4. Dispose Patient safety dictates that any medicine dispensed to the general public that goes unused be disposed

Disposal Impact on Pharmaceuticals in Water Assumes 10% of medicine is unused Household trash  15% incinerated  Impact on PIE Take back for incineration  20% participation*  Impact on PIE Patient Use 99.2% Unused 0.8% Patient Use 99.2% Unused 0.8% Patient Use 99.3% Unused 0.7% Patient Use 99.3% Unused 0.7% Drain disposal

Fate of Pharmaceuticals in Landfills  The acceptability of MSW landfills for unused medicine disposal is supported by studies of landfill leachate by US Geological Survey and EPA. – Inside EPA - “tentative results from EPA and other studies indicate that very little pharmaceutical components end up in leachate.” – A US Geological Survey study (Barnes et. al. 2004) analyzed (parts per trillion) leachate from a landfill for 76 compounds, 30 of which were pharmaceuticals. Only one pharmaceutical compound was found  PhRMA Study in the Society of Environmental Toxicology and Chemistry’s Journal “Integrated Environmental Assessment and Management”. – “disposal of unused medications in municipal solid waste landfills effectively eliminates the unused medicine contribution of APIs to surface waters”  Maine Department of Environmental Protection Paper Preliminary Characterization of the Pharmaceutical Content of Municipal Solid Waste Landfill Leachate from three landfills in Maine – The pharmaceutical concentrations in landfill Maine DEP reported are consistent with the predicted leachate concentrations developed in the PhRMA’study research and corroborate that disposal of unused medicine in household trash effectively removes the unused medicine component of pharmaceuticals in water.

University of Michigan Study - Life Cycle Comparison of Environmental Emissions from Unused Pharmaceutical Disposal Options Environmental Science & Technology Journal

University of Michigan Study  “As a result, we recommend trash disposal for unused pharmaceuticals. A 100% trash disposal program would have similar API emissions to a 50% take-back program, while also having significantly lower non-API emissions, lower financial costs, higher convenience, and higher compliance rates” Property of GlaxoSmithKline

A Product Stewardship Approach to the Unused Medicine Issue 1. Don’t generate the waste in the first place 2. Reuse 3. Recycle 4. Dispose Patient safety dictates that any medicine dispensed to the general public that goes unused be disposed

Source Reduction – first in the hierarchy  Educate patients to take all medicine as directed.  Educate patients & health care professionals on how to address the reasons why medicines go unused - Reason sited most often – The medication has been changed –side effects –not solving the problem. – The patient feels they no longer need the medication (patient adherence) – The medicine has expired (especially OTC)

Recommendations for Residential Unused Medicine Disposal  Household trash disposal is environmentally acceptable and meets all DEA & EPA requirements.  The scientific data does not support the need to develop new programs to take back & incinerate unused medicine  People that don’t feel comfortable with household trash disposal should be encouraged to take advantage of existing programs & infrastructure – Household hazardous waste collection – Law enforcement evidence disposal programs

Property of GlaxoSmithKline