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.
2.
3.
4.
Don’t generate the waste in the first place
Reuse
Recycle
Dispose
Patient safety dictates that any medicine
dispensed to the general public that goes
unused be disposed
Disposal Impact on Pharmaceuticals in Water
Unused
12%
Drain disposal
Human Use
88%
Household trash
Take back for incineration
u 15% incinerated
u Impact on PIE
Unused
0.8%
Patient Use
99.2%
Assumes 10% of medicine is unused
u20% participation*
uImpact on PIE
Unused
0.7%
Patient Use
99.3%
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”
Percentage Increase
300
250
200
150
100
50
0
API in water from
household trash
Other environmental
emissions from take back
Property of GlaxoSmithKline
A Product Stewardship Approach to the Unused
Medicine Issue
1.
2.
3.
4.
Don’t generate the waste in the first place
Reuse
Recycle
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