a modern man-made pandemic the 25 th annual region vi pretreatment association workshop addison,...

A MODERN MAN-MADE A MODERN MAN-MADE PANDEMICPANDEMIC

The 25The 25thth Annual Region VI Pretreatment Annual Region VI Pretreatment Association WorkshopAssociation WorkshopAddison, TexasAddison, TexasAugust 3-6, 2009August 3-6, 2009

Stevan Gressitt, MDStevan Gressitt, MDMedical Director, Office of Adult Mental Health ServicesMedical Director, Office of Adult Mental Health ServicesDepartment of Health and Human Service, State of MaineDepartment of Health and Human Service, State of Maine

Matthew Mireles, PhD, MPHMatthew Mireles, PhD, MPHPresident and CEO, Community Medical Foundation for President and CEO, Community Medical Foundation for Patient SafetyPatient Safety

Almost 40% of accidental poisoning occurs in grandparents’ homes1

Source: Minnesota Poison Control, 2004

2Copyright 2009 CMFPS

Medication errors and overdoses can occur

among seniors2

Source: CMFPS 2008


Traces of pharmaceuticals found in drinking water of at least 46 million Americans4

Source: Associated Press, 2008

80% of streams and waterways have traces of pharmaceuticals3

Source: US Geological Survey, 2002



5

19% or 4.5 million U.S. teens abuse prescription meds—pharming6

Source: Partnership for Drug American (2005)

Prescription drug arrest is 39% of all arrests; between 2003 and 2008, 250% increase in prescription drug arrests7

Source: Maine Drug Enforcement Agency (2008)


600 tons of expired, damaged, or inappropriate medicines were donated post-tsunami, 20048 Source: PSF-CI 2005


Contrary to WHO guidelines and standards, 70% of donated medicines were labeled in languages other than English or Indonesian8

Source: PSF-CI 2005


“Indonesia…has become a dumping ground for western countries.” It cost $250(US) to incinerate one ton of waste8

Source: PSF-CI 20059Copyright 2009 CMFPS

40%-50% of prescription medicines are wasted, never used by patients2

Source: CMFPS 2008

Most unwanted medicines are usually flushed down the sink or toilet, but drug take-back programs are now available to intercept these wasted meds2 Source: CMFPS 2008


Total count of pills, capsules, and tablets = 74,696Total count of pills, capsules, and tablets = 74,696

Generic Name (Top 10)Generic Name (Top 10) Count by PillCount by Pill MetoprololMetoprolol 2400 (3.21%)2400 (3.21%) LisinoprilLisinopril 1972 (2.64%)1972 (2.64%) IbuprofenIbuprofen 1751 (2.34%)1751 (2.34%) AspirinAspirin 1639 (2.19%)1639 (2.19%) Acetaminophen-hydrocodone*Acetaminophen-hydrocodone* 1370 (1.83%)1370 (1.83%) MetforminMetformin 1334 (1.79%)1334 (1.79%) TramadolTramadol 1284 (1.72%)1284 (1.72%) FurosemideFurosemide 1136 (1.52%)1136 (1.52%) NaproxenNaproxen 1133 (1.52%)1133 (1.52%) WarfarinWarfarin 1091 (1.46%) 1091 (1.46%)

*Indicates product’s classification as a controlled substance defined by the Controlled Substances Act of 1974.


The Second TsunamiThe Second TsunamiA Documentary by Pharmaciens San A Documentary by Pharmaciens San

Frontieres (Pharmacists Without Frontieres (Pharmacists Without Borders)Borders)

““Donated medicines have created Donated medicines have created more problems than benefits.”more problems than benefits.”

PSF-CI 2005PSF-CI 2005


Copyright 2009 CMFPS 14

PatientsPatients//

ConsumConsumersers

MedicalMedicalPracticePractice

Drug/LawDrug/LawEnforcementEnforcement

Public Safety Public Safety and Policyand Policy

ConsumerConsumerProtectionProtection

Patient Patient SafetySafety

EnvironmentEnvironmentalal

ProtectionProtection

Academia Academia andand

ResearchResearchOthersOthers

The study of epidemiology and pretreatment program (Title 40 CFR Part 403)9 overlap in purpose


Term introduced in 1999Term introduced in 1999 Includes any products used for personal Includes any products used for personal

health or cosmetic reasons or used for health or cosmetic reasons or used for the purpose of enhancing growth or the purpose of enhancing growth or health of livestockhealth of livestock

SourcesSources: human activity, illicit drugs, vet : human activity, illicit drugs, vet drug use, agribusiness, residues from drug use, agribusiness, residues from drug manufacturing, residues from drug manufacturing, residues from hospitalshospitals

ConcernsConcerns: PPCP are present in our water; : PPCP are present in our water; treatment plants not equipped to remove treatment plants not equipped to remove them; risk to human is unknown.them; risk to human is unknown.


US pop accounts for US pop accounts for 5%5% of world’s pop of world’s pop Global production of pharmaceutical Global production of pharmaceutical

products annually is products annually is $600 billion $600 billion (US)(US)1111

US consumption of these products is US consumption of these products is 50%50% 0r about 0r about $300 billion $300 billion (US) worth (US) worth of drugsof drugs1111

US consumption growth rate is fastest US consumption growth rate is fastest compared to those of other countries compared to those of other countries due to more demand (aging population, due to more demand (aging population, more prescription, etc.)more prescription, etc.)


Adverse effects on aquatic lifeAdverse effects on aquatic life Continual exposureContinual exposure Multi-generational exposuresMulti-generational exposures High conc in untreated waterHigh conc in untreated water Possible low dose effectsPossible low dose effects

ExamplesExamples Salmon—1 ppb to Salmon—1 ppb to diazinondiazinon distrupts olfactory distrupts olfactory

receptionreception Calcium-channel blockers inhibit sperm activityCalcium-channel blockers inhibit sperm activity Flathead minnow—5 ppt of 17α-

ethinylestradiol, feminiz. Anti-epileptics are potential human Anti-epileptics are potential human

neuroteratogensneuroteratogens18Copyright 2009 CMFPS

No adverse effect or causality has No adverse effect or causality has been documentedbeen documented

Chronic low-dose exposure being Chronic low-dose exposure being monitoredmonitored

Suspected possible link toSuspected possible link to Low sperm count in malesLow sperm count in males Outbreaks of neural tube defects (spinal Outbreaks of neural tube defects (spinal

bifida)bifida) Early menstrual development in girlsEarly menstrual development in girls Emergence of extreme drug-resistant Emergence of extreme drug-resistant

microbesmicrobes19Copyright 2009 CMFPS

2002 Maine Benzodiazepine Study Group2002 Maine Benzodiazepine Study Group

2003 LD1826 enabling house bill, drug take-back2003 LD1826 enabling house bill, drug take-back

2004 The National Unused and Expired Medicines 2004 The National Unused and Expired Medicines Registry created to systematically collect UEM dataRegistry created to systematically collect UEM data

2006 LD411 secured funds for drug take-back2006 LD411 secured funds for drug take-back

2007 The Athens Declaration2007 The Athens Declaration

2007 First federal guidelines for consumer drug 2007 First federal guidelines for consumer drug disposaldisposal

2007 Annual Survey of Drug Take-Back Programs 2007 Annual Survey of Drug Take-Back Programs launchedlaunched

2008 National Directory of Drug Take-Back 2008 National Directory of Drug Take-Back 20Copyright 2009 CMFPS

Based on framework of Community of Based on framework of Community of Competence™Competence™

Standardized data collection protocol Standardized data collection protocol (instrument and coding): consensus on 5 (instrument and coding): consensus on 5 basic variablesbasic variables

Main purpose is researchMain purpose is research Designed and administered by Designed and administered by

Community Medical Foundation for Community Medical Foundation for Patient Safety Patient Safety

Based in Houston, TexasBased in Houston, Texas Data submission: written form, mail in, Data submission: written form, mail in,

fax, and online (web-based) fax, and online (web-based) 22Copyright 2009 CMFPS

The central component of the The central component of the Get Rid of Get Rid of Unused PharmaceuticalsUnused Pharmaceuticals (GROUP) (GROUP) CampaignCampaign

Classification and coding protocol based Classification and coding protocol based on existing systems:on existing systems: Therapeutic classTherapeutic class: DAWN (SAMHSA, DHHS): DAWN (SAMHSA, DHHS) Drug characteristicsDrug characteristics: FDA NDC Directory: FDA NDC Directory Cost (AWP): Cost (AWP): Red BookRed Book Environmental risk/hazard classEnvironmental risk/hazard class: JANUS Info: JANUS Info Demographic profileDemographic profile: US Census 2000 (zip : US Census 2000 (zip

code)code) Occupational exposure hazardOccupational exposure hazard: OSHA: OSHA 23Copyright 2009 CMFPS

ZIP CODE

DRUG NAME

DRUG STRENGT

H

QUANTITY

SOURCE REASON

DATE

SIDE EFFECTS


n = 11684 n = 11684 UEMsUEMs


TOTAL ESTIMATED COST OF WASTE =TOTAL ESTIMATED COST OF WASTE = $557,212.92 $557,212.92 ((US US Dollars)Dollars)

Precise cost of waste is between Precise cost of waste is between $724,376.80 $724,376.80 and and $891,540.67$891,540.67


n=8622: mean=$45.04, SD=$135.62, range 0:$4,851.54

n=3062: mean=$55.15, SD=$167.43, range 0:$3,217.33

TOTAL ESTIMATED PROPORTION OF WASTE = TOTAL ESTIMATED PROPORTION OF WASTE = 51.02%51.02%


US pop accounts for US pop accounts for 5%5% of world’s pop of world’s pop Global production of pharmaceutical Global production of pharmaceutical

products annually is products annually is $600 billion $600 billion (US)(US) US consumption of these products is US consumption of these products is

50%50% ($300 billion($300 billion (US) worth of drugs) (US) worth of drugs) Are we flushing Are we flushing $150 $150 billion billion worth of medicines down worth of medicines down the drain?the drain?


““If all medicines in the world If all medicines in the world were thrown into the sea, it were thrown into the sea, it would be all the better for would be all the better for mankind and all the worse mankind and all the worse for the fishes.“for the fishes.“

Oliver Wendell Holmes, Sr., 1842Oliver Wendell Holmes, Sr., 1842


1.1. Minnesota Poison Control System. Minnesota Poison Control System. Are you a hazardous to your grandchildrenAre you a hazardous to your grandchildren, , 2004. Available: 2004. Available: http://www.mnpoison.org/index.asp?pageID=198. .

2.2. Mireles MC, Miller JA, Smith EA. Mireles MC, Miller JA, Smith EA. The national directory of drug take-back and The national directory of drug take-back and disposal programs.disposal programs. Community Medical Foundation for Patient Safety, 2008. Community Medical Foundation for Patient Safety, 2008.

3.3. US Geological Survey. US Geological Survey. What’s in the water? USGS releases first nationwide What’s in the water? USGS releases first nationwide look at pharmaceuticals, hormones and other organic contaminants in U.S. look at pharmaceuticals, hormones and other organic contaminants in U.S. streamsstreams, 2002. Available: , 2002. Available: http://www.toxics.usgs.gov/regional/emc.html

4.4. Associated Press. Associated Press. 46 million in U.S. have drugs in drinking water46 million in U.S. have drugs in drinking water. September . September 11, 2008. Available: 11, 2008. Available: http://www.msnbc.msn.com/id/26662637/

5.5. Daughton CG. Daughton CG. Pharmaceuticals and personal care products (PPCPs) as Pharmaceuticals and personal care products (PPCPs) as environmental pollutants: Pollution from personal actions, activities, and environmental pollutants: Pollution from personal actions, activities, and behaviorsbehaviors. Las Vegas, NV: U.S. Environmental Protection Agency, comp. 2005 . Las Vegas, NV: U.S. Environmental Protection Agency, comp. 2005 (webpage)(webpage)

6.6. Partnership for a Drug-Free America. Partnership for a Drug-Free America. Latest teen drug trendsLatest teen drug trends, 2005. Available: , 2005. Available: http://drugfree/org/Portal/DrugIssue/Research/Teens_2005/Generation_Rx... ...


7.7. Gressitt S, Kaye L, Crittenden J, Boehme S, Mireles M. Gressitt S, Kaye L, Crittenden J, Boehme S, Mireles M. Maine unused medicine mail Maine unused medicine mail back pilot summary. Position paper back pilot summary. Position paper presented at the 4presented at the 4thth International Symposium International Symposium on Environment, Athens, Greece, May 21-24, 2009.on Environment, Athens, Greece, May 21-24, 2009.

8.8. Pharmaciens San Frontieres-Comite International. Pharmaciens San Frontieres-Comite International. Improper international drug Improper international drug donation: Case study of Indonesiadonation: Case study of Indonesia. PSF-CI, 2005. . PSF-CI, 2005.

9.9. U.S. Environmental Protection Agency. U.S. Environmental Protection Agency. Introduction to the National Pretreatment Introduction to the National Pretreatment Program. Program. U.S.EPA, Office of Wastewater Management (4203); EPA-833-B-98-002, U.S.EPA, Office of Wastewater Management (4203); EPA-833-B-98-002, February 1999.February 1999.

10.10. U.S. Environmental Protection Agency. Frequent questions: Pharmaceutical and U.S. Environmental Protection Agency. Frequent questions: Pharmaceutical and personal care products (PPCPs), March 26, 2009. Available: personal care products (PPCPs), March 26, 2009. Available: http://www.epa.gov/ppcp/faq.html

11.11. All Associates Group. All Associates Group. Pharmaceutical industry white paper. Document Systems: Pharmaceutical industry white paper. Document Systems: Dimensions for the future, Dimensions for the future, First Edition. All Associates Group, Inc., Raleigh, NC, First Edition. All Associates Group, Inc., Raleigh, NC, November 2002.November 2002.

12.12. Mireles MC, Miller JA, Smith EAMireles MC, Miller JA, Smith EA. The National Unused and Expired Medicines . The National Unused and Expired Medicines RegistryRegistry. Position paper, Community Medical Foundation for Patient Safety, March . Position paper, Community Medical Foundation for Patient Safety, March 9, 2009.9, 2009.


A MODERN MAN-MADE A MODERN MAN-MADE PANDEMICPANDEMIC

The 25The 25thth Annual Region VI Pretreatment Annual Region VI Pretreatment Association WorkshopAssociation WorkshopAddison, TexasAddison, TexasAugust 3-6, 2009August 3-6, 2009

For More Information, contact…For More Information, contact…

Stevan Gressitt, MDStevan Gressitt, MDMedical Director, Office of Adult Mental Health ServicesMedical Director, Office of Adult Mental Health ServicesDepartment of Health and Human Service, State of MaineDepartment of Health and Human Service, State of [email protected] (207)287-4273

Matthew Mireles, PhD, MPHMatthew Mireles, PhD, MPHPresident and CEO, Community Medical Foundation for President and CEO, Community Medical Foundation for Patient SafetyPatient [email protected] (832)778-7777 (832)778-7777

a modern man-made pandemic the 25 th annual region vi pretreatment association workshop addison,...

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