The 25th Annual Region VI Pretreatment
Association Workshop
Addison, Texas
August 3-6, 2009
A MODERN MAN-MADE PANDEMIC
Stevan Gressitt, MD
Medical Director, Office of Adult Mental Health Services
Department of Health and Human Service, State of Maine
Matthew Mireles, PhD, MPH
President and CEO, Community Medical Foundation for Patient Safety
Almost 40% of accidental
poisoning occurs in
grandparents’ homes1
Source: Minnesota Poison Control, 2004
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Medication
errors and
overdoses can
occur among
seniors2
Source: CMFPS 2008
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80% of streams and
waterways have traces of
pharmaceuticals3
Source: US Geological Survey, 2002
Traces of pharmaceuticals
found in drinking water of
at least 46 million
Americans4
Source: Associated Press, 2008
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5
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Prescription drug
arrest is 39% of all
arrests; between 2003
and 2008, 250%
increase in prescription
drug arrests7
Source: Maine Drug Enforcement
Agency (2008)
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19% or 4.5 million
U.S. teens abuse
prescription meds—
pharming6
Source: Partnership for Drug
American (2005)
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600 tons of
expired,
damaged, or
inappropriate
medicines were
donated posttsunami, 20048
Source: PSF-CI 2005
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Contrary to WHO
guidelines and
standards,
70% of donated
medicines were
labeled in
languages other
than English or
Indonesian8
Source: PSF-CI 2005
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“Indonesia…has
become a
dumping ground
for western
countries.” It
cost $250(US) to
incinerate one
ton of waste8
Source: PSF-CI 2005
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Most unwanted
medicines are
usually flushed
down the sink or
toilet, but drug
take-back
programs are now
available to
intercept these
wasted meds2
40%-50% of
prescription
medicines are
wasted, never
used by patients2
Source: CMFPS 2008
Source: CMFPS 2008
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Total count of pills, capsules, and tablets = 74,696
Generic Name (Top 10)
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Metoprolol
Lisinopril
Ibuprofen
Aspirin
Acetaminophen-hydrocodone*
Metformin
Tramadol
Furosemide
Naproxen
Warfarin
Count by Pill
2400 (3.21%)
1972 (2.64%)
1751 (2.34%)
1639 (2.19%)
1370 (1.83%)
1334 (1.79%)
1284 (1.72%)
1136 (1.52%)
1133 (1.52%)
1091 (1.46%)
*Indicates product’s classification as a controlled substance defined by the Controlled
Substances Act of 1974.
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The Second Tsunami
A Documentary by Pharmaciens San Frontieres
(Pharmacists Without Borders)
“Donated medicines have created
more problems than benefits.”
PSF-CI 2005
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Drug/Law
Enforcement
Environmental
Protection
Patient Safety
Medical
Practice
Patients/
Consumers
Public Safety
and Policy
Consumer
Protection
Academia and
Research
Others
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The study of
epidemiology and
pretreatment
program (Title 40
CFR Part 403)9
overlap in purpose
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Term introduced in 1999
Includes any products used for personal health
or cosmetic reasons or used for the purpose of
enhancing growth or health of livestock
Sources: human activity, illicit drugs, vet drug
use, agribusiness, residues from drug
manufacturing, residues from hospitals
Concerns: PPCP are present in our water;
treatment plants not equipped to remove
them; risk to human is unknown.
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US pop accounts for 5% of world’s pop
Global production of pharmaceutical products
annually is $600 billion (US)11
US consumption of these products is 50% 0r
about $300 billion (US) worth of drugs11
US consumption growth rate is fastest
compared to those of other countries due to
more demand (aging population, more
prescription, etc.)
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Adverse effects on aquatic life
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
Continual exposure
Multi-generational exposures
High conc in untreated water
Possible low dose effects
Examples

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

Salmon—1 ppb to diazinon distrupts olfactory reception
Calcium-channel blockers inhibit sperm activity
Flathead minnow—5 ppt of 17α-ethinylestradiol, feminiz.
Anti-epileptics are potential human neuroteratogens
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No adverse effect or causality has been
documented
Chronic low-dose exposure being monitored
Suspected possible link to
 Low sperm count in males
 Outbreaks of neural tube defects (spinal bifida)
 Early menstrual development in girls
 Emergence of extreme drug-resistant microbes
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
2002 Maine Benzodiazepine Study Group

2003 LD1826 enabling house bill, drug take-back

2004 The National Unused and Expired Medicines Registry
created to systematically collect UEM data

2006 LD411 secured funds for drug take-back
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2007 The Athens Declaration

2007 First federal guidelines for consumer drug disposal

2007 Annual Survey of Drug Take-Back Programs launched

2008 National Directory of Drug Take-Back
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Based on framework of Community of
Competence™
Standardized data collection protocol (instrument
and coding): consensus on 5 basic variables
Main purpose is research
Designed and administered by Community Medical
Foundation for Patient Safety
Based in Houston, Texas
Data submission: written form, mail in, fax, and
online (web-based)
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The central component of the Get Rid of Unused
Pharmaceuticals (GROUP) Campaign
Classification and coding protocol based on
existing systems:
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Therapeutic class: DAWN (SAMHSA, DHHS)
Drug characteristics: FDA NDC Directory
Cost (AWP): Red Book
Environmental risk/hazard class: JANUS Info
Demographic profile: US Census 2000 (zip code)
Occupational exposure hazard: OSHA
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DATE
ZIP CODE
SOURCE REASON
DRUG
DRUG
QUANTITY
NAME STRENGTH
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SIDE
EFFECTS
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UNKNOWN
321, 3%
OTC
Medicine
4341, 37%
Prescription
Medicine
7022, 60%
n = 11684 UEMs
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RESPIRATORY
AGENTS, 1137,
10%
TOPICAL
AGENTS, 1267,
11%
PSYCHOTHERAPEUTIC
AGENTS, 1240,
11%
NUTRITIONAL
PRODUCTS,
GASTRO888, 8%
INTESTINAL
AGENTS, 1089,
9%
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OTHERS, 2613,
22%
ANTIINFECTIVES,
801, 7%
CARDIOVASCULAR
AGENTS, 843,
7%
CNS AGENTS,
1806, 15%
n = 11684 UEMs
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No Risk
78 (1%)
Insignificant
Risk
1867 (16%)
Low Risk
406 (3%)
Risk cannot
be excluded
1754 (15%)
Moderate
Risk
189 (2%)
Missing Risk
Datum
7291 (62%)
High Risk
99 (1%)
n = 11684 UEMs
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Harzard=1
35 (0%)
Harzard=2
269 (2%)
Hazard=0
4 (0%)
Harzard=3
445 (4%)
Harzard=4
1072 (9%)
Harzard=5
407 (4%)
Harzard=6
950 (8%)
Missing Environ
Hazard Data
7805 (67%)
Harzard=7
6 (0%)
Harzard=8
Harzard=9 360 (3%)
331 (3%)
n = 11684 UEMs
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Non-Pill
$168,860.64
n=3062: mean=$55.15, SD=$167.43, range 0:$3,217.33
$388,352.28
Pill
n=8622: mean=$45.04, SD=$135.62, range 0:$4,851.54
TOTAL ESTIMATED COST OF WASTE = $557,212.92 (US Dollars)
Precise cost of waste is between $724,376.80 and $891,540.67
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Est. Total
Packsize
Est. Quantity
Returned
691,656 Pills
352,916 Pills
TOTAL ESTIMATED PROPORTION OF WASTE = 51.02%
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US pop accounts for 5% of world’s pop
Global production of pharmaceutical products
annually is $600 billion (US)
US consumption of these products is 50% ($300
billion (US) worth of drugs)
flushing $150 billion worth
of medicines down the drain?
 Are we
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“If all medicines in the world were thrown
into the sea, it would be all the better
for mankind and all the worse for the
fishes.“
Oliver Wendell Holmes, Sr., 1842
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1. Minnesota Poison Control System. Are you a hazardous to your grandchildren, 2004.
Available: http://www.mnpoison.org/index.asp?pageID=198.
2. Mireles MC, Miller JA, Smith EA. The national directory of drug take-back and disposal
programs. Community Medical Foundation for Patient Safety, 2008.
3. US Geological Survey. What’s in the water? USGS releases first nationwide look at
pharmaceuticals, hormones and other organic contaminants in U.S. streams, 2002.
Available: http://www.toxics.usgs.gov/regional/emc.html
4. Associated Press. 46 million in U.S. have drugs in drinking water. September 11, 2008.
Available: http://www.msnbc.msn.com/id/26662637/
5. Daughton CG. Pharmaceuticals and personal care products (PPCPs) as environmental
pollutants: Pollution from personal actions, activities, and behaviors. Las Vegas, NV: U.S.
Environmental Protection Agency, comp. 2005 (webpage)
6. Partnership for a Drug-Free America. Latest teen drug trends, 2005. Available:
http://drugfree/org/Portal/DrugIssue/Research/Teens_2005/Generation_Rx...
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7.
Gressitt S, Kaye L, Crittenden J, Boehme S, Mireles M. Maine unused medicine mail back pilot
summary. Position paper presented at the 4th International Symposium on Environment,
Athens, Greece, May 21-24, 2009.
8.
Pharmaciens San Frontieres-Comite International. Improper international drug donation:
Case study of Indonesia. PSF-CI, 2005.
9.
U.S. Environmental Protection Agency. Introduction to the National Pretreatment Program.
U.S.EPA, Office of Wastewater Management (4203); EPA-833-B-98-002, February 1999.
10. U.S. Environmental Protection Agency. Frequent questions: Pharmaceutical and personal
care products (PPCPs), March 26, 2009. Available: http://www.epa.gov/ppcp/faq.html
11. All Associates Group. Pharmaceutical industry white paper. Document Systems: Dimensions
for the future, First Edition. All Associates Group, Inc., Raleigh, NC, November 2002.
12. Mireles MC, Miller JA, Smith EA. The National Unused and Expired Medicines Registry.
Position paper, Community Medical Foundation for Patient Safety, March 9, 2009.
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The 25th Annual Region VI Pretreatment
Association Workshop
Addison, Texas
August 3-6, 2009
A MODERN MAN-MADE PANDEMIC
For More Information, contact…
Stevan Gressitt, MD
Medical Director, Office of Adult Mental Health Services
Department of Health and Human Service, State of Maine
stevan.gressitt@maine.gov (207)287-4273
Matthew Mireles, PhD, MPH
President and CEO, Community Medical Foundation for Patient Safety
mcmireles@communityofcompetence.com (832)778-7777