1 an evaluation of unused medicine disposal options on wastewater treatment plant influents douglas...

32
1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer Inc. James Jahnke - Schering-Plough Corporation Fourth Annual Unused Drug Return Conference October 31 – November 1, 2007 Portland, Maine

Upload: ciera-coolidge

Post on 14-Dec-2015

217 views

Category:

Documents


3 download

TRANSCRIPT

Page 1: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

1

An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents

Douglas S. Finan – GlaxoSmithKlineMatthew D. Garamone - Pfizer Inc.

James Jahnke - Schering-Plough Corporation

Fourth Annual Unused Drug Return ConferenceOctober 31 – November 1, 2007

Portland, Maine

Page 2: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

2

12.11.2005

Effluent alters sexuality of fishEffluent alters sexuality of fish

By Tony Davis

Some Background on PIE

n 1999, USGS National Reconnaissance of Emerging Contaminants sampled a network of 139 streams across 30 states for the

presence of pharmaceuticals nonprescription drugs were found with the greatest frequency,

followed by antibiotics, reproductive hormones, and other prescriptions drugs

concentrations were very low (i.e., part per trillion level)

C ente r fo r D rug E va lua tion and R e sea rchC ente r fo r D rug E va lua tion and R e sea rch

Lots of PressMany interested stakeholders

Page 3: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

3

Some Background on PhRMA - The research based pharmaceutical industry is working to understand PIE

n PhRMA is committed to applying the same level of scientific rigor to PIE that we apply in other areas of our business

n We have developed working groups around PIE subjectsn Fate and Transportn Human Healthn Environmental Risk Assessmentn Hormonesn Unused Medicinesn Treatmentn Communications

Page 4: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

4

Some Background on Unused Medicine Disposal

n In the past patients were told that drain disposal was the safest way to dispose of unused medicines.

n Publications on PIE identified unused medicine disposal as a driver for detection of pharmaceutical compounds in surface waters

n Several cities & towns have sponsored unused medicines take- back events

n Some states such as Maine and California have introduced legislation designed to encourage the development of pharmaceutical take-back programs

n In 2007 ONDCP/EPA/FDA issue Federal Guidelines on the Proper Disposal of Prescription Drugs

n In 2007 a bill was introduced in the US Congress directing EPA to study pharmaceutical take back programs

Page 5: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

5

PRINCIPAL PATHWAYS FOR PHARMACEUTICALS INTO THE ENVIRONMENT

WWTP

Landfill

Incineration

What is the Impact of Unused Medicine Disposal on WWTPs?

Page 6: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

6

Objectives

n Determine the impact on WWTP influent concentrations if active pharmaceutical ingredients (API) if:n all patient unused medicine was flushedn all patient unused medicine was placed in household trashn all patient unused medicine was taken back for incineration.

n Compare estimated API influent concentrations currently with those anticipated if take back programs were widely available and implemented.

n Identify next steps and additional data that are needed to answer the question: What is the best way to dispose of unused medicine?

Page 7: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

7

OBJECTIVE 1

Determine the impact on WWTP influent concentrations if active pharmaceutical ingredients (API) if:

n all patient unused medicine was flushedn all patient unused medicine was placed in household trashn all patient unused medicine was taken back for incineration.

Page 8: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

8

First, How Much Medicine Given to Patients Goes Unused?

n No definitive answer yet

n What do we know - from peer reviewed literature

n LTCF 6.7% unused based on financial data

n LTCF 13.1% unused based on financial data

n General public 2.3% unused based on financial data

n General Public 3% unused based on unit counts

n For our analysis, it was assumed that 10% of medicine purchased by the patient is unused.

Page 9: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

9

Next, What Compounds Should be Studied

n What have been detected (USGS etc.)

n What data are available

n Other studies

n Identified twenty-four APIs representing a range of prescription drugs in terms of sales and physical-chemical properties

Acetaminophen Diltiazem Ibuprofen Ranitidine

Albuterol Sulfate Doxycycline Lincomycin Sulfamethoxazole

Cimetidine Enalaprilat Metformin Sulfathiazole

Ciprofloxacin Erythromycin-H2O Norfloxacin Tetracycline

Codeine Fluoxetine Oxytetracycline Trimethoprim

Digoxin Gemfibrozil Paroxetine metabolite Warfarin

Page 10: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

10

n Estimating influent mass for each API from Patient Usen Annual Sales Data converted to Kgs of API (Tischler, L. In Press)n % of sales that goes unused (assumed 10%)n Loss by human metabolism (Tischler, L. In Press)n Influent Amount (Kg) = Sales*(0.90)*(1-Metabolism%)

n Estimating influent concentration for each APIn U.S. FDA method for estimating aquatic conc. (FDA, 1998) Uses

• Kg/yr of API

• Annual liters of wastewater entering WWTPs = 4.431x1013

(FDA, 1998)n Influent Conc. μg/l=

Estimating WWTP Influent Concentrations From Patient Use

API (kg/yr) 4.431x1013 (l/yr)

* 1x109 (μg/kg)

Page 11: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

11

Estimated API Concentrations From Patient Use(also influent concentration if all unused medicine is taken back for incineration)

APIAPI

kg/year10% Unused API kg/year

API used by patients

Loss by Human

Metabolism (%)

Patient Use API to WWTP kg/year

POTW influent

μg/l

Acetaminophen 5,691,120 569,112 5,122,008 10% 4,609,807 104.03Albuterol Sulfate 3,569 357 3,212 72% 899 0.02Cimetidine 49,980 4,998 44,982 52% 21,591 0.49Ciprofloxacin 85,440 8,544 76,896 11% 68,437 1.54Codeine 15,095 1,510 13,586 10% 12,227 0.28Digoxin 229 23 206 16% 173 0.00Diltiazem 149,296 14,930 134,366 96% 5,375 0.12Doxycycline 32,784 3,278 29,506 0% 29,506 0.67Enalaprilat 772 77 695 10% 625 0.01Erythromycin-H2O 64,283 6,428 57,855 0% 57,855 1.31Fluoxetine 12,434 1,243 11,191 90% 1,119 0.03Gemfibrozil 231,530 23,153 208,377 24% 158,367 3.57Ibuprofen 1,035,229 103,523 931,706 78% 204,975 4.63Lincomycin 328 33 296 0% 296 0.01Metformin 1,597,887 159,789 1,438,098 0% 1,438,098 32.45Norfloxacin 2,700 270 2,430 7% 2,260 0.05Oxytetracycline 31 3 28 0% 28 0.00Paroxetine metabolite 19,474 1,947 17,527 0% 17,527 0.40Ranitidine 100,417 10,042 90,375 6% 84,952 1.92Sulfamethoxazole 314,389 31,439 282,950 88% 33,954 0.77Sulfathiazole 483 48 435 15% 369 0.01Tetracycline 68,569 6,857 61,712 0% 61,712 1.39Trimethoprim 64,450 6,445 58,005 15% 49,304 1.11Warfarin 3,999 400 3,599 92% 288 0.01

Page 12: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

12

n Drain Disposal = Annual mass of API from patient use plus mass of the 10% of sales that goes unused and total flow to WWTPs.

n Take Back Programs = patient use concentrations since it is assumed that all take back would be incinerated.

n Household Trash – annual mass of API from patient use plus amount of medicines in landfill leachate for 10% unused (Tischler, L. In Press) and total flow to WWTPs.n Tischler’s Method

• Estimate concentration of API in landfill leachate• Estimate leachate volume (assume all leachate sent to WWTPs)• Estimate mass of API in leachate• Assumed all medicine unpackaged & immediately available for leaching• Fate in landfill incorporates three loss mechanisms

n Partitioning to solids (based on Kp)n Anaerobic degradationn Hydrolysis

Comparing Influent Concentrations of Disposal Methods

Page 13: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

13

Estimated API Concentrations From Patient Use and 100% Sewer Disposal of Unused Medicine

API

Patient Use API

to WWTP kg/year

Flushed API Mass

(kg/yr) 10% of Sold

Total kg/year to

WWTP

POTW influent

μg/l

Acetaminophen 4,609,807 569,112 5,178,919 116.88Albuterol Sulfate 899 357 1,256 0.03Cimetidine 21,591 4,998 26,589 0.60Ciprofloxacin 68,437 8,544 76,981 1.74Codeine 12,227 1,510 13,737 0.31Digoxin 173 23 196 0.00Diltiazem 5,375 14,930 20,304 0.46Doxycycline 29,506 3,278 32,784 0.74Enalaprilat 625 77 702 0.02Erythromycin-H2O 57,855 6,428 64,283 1.45Fluoxetine 1,119 1,243 2,362 0.05Gemfibrozil 158,367 23,153 181,520 4.10Ibuprofen 204,975 103,523 308,498 6.96Lincomycin 296 33 328 0.01Metformin 1,438,098 159,789 1,597,887 36.06Norfloxacin 2,260 270 2,530 0.06Oxytetracycline 28 3 31 0.00Paroxetine metabolite 17,527 1,947 19,474 0.44Ranitidine 84,952 10,042 94,994 2.14Sulfamethoxazole 33,954 31,439 65,393 1.48Sulfathiazole 369 48 418 0.01Tetracycline 61,712 6,857 68,569 1.55Trimethoprim 49,304 6,445 55,749 1.26Warfarin 288 400 688 0.02

In this scenario, on average, 21% of influent load is due to unused medicine disposal to the sewer.

79% of influent load is due to patients taking medicines

Page 14: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

14

Estimated API Concentrations From Patient Use and 100% Household Trash Landfill Disposal of Unused Medicine

API

Patient Use API

to WWTP kg/year

10% Unused API kg/year

Leachate API Mass (kg/yr) sorption efficiency 0.5

(Tischler, 2007)

Total kg/year to

WWTP

POTW influent

μg/l

Acetaminophen 4,609,807 569,112 64.0 4,609,871 104.03Albuterol Sulfate 899 357 1.6 901 0.02Cimetidine 21,591 4,998 0.3 21,592 0.49Ciprofloxacin 68,437 8,544 85.4 68,523 1.55Codeine 12,227 1,510 3.5 12,231 0.28Digoxin 173 23 0.0 173 0.00Diltiazem 5,375 14,930 0.2 5,375 0.12Doxycycline 29,506 3,278 37.1 29,543 0.67Enalaprilat 625 77 77.2 702 0.02Erythromycin-H2O 57,855 6,428 0.0 57,855 1.31Fluoxetine 1,119 1,243 0.0 1,119 0.03Gemfibrozil 158,367 23,153 83.4 158,450 3.58Ibuprofen 204,975 103,523 432.6 205,408 4.64Lincomycin 296 33 0.0 296 0.01Metformin 1,438,098 159,789 65.0 1,438,163 32.46Norfloxacin 2,260 270 270.0 2,530 0.06Oxytetracycline 28 3 0.0 28 0.00Paroxetine metabolite 17,527 1,947 0.0 17,527 0.40Ranitidine 84,952 10,042 3.3 84,956 1.92Sulfamethoxazole 33,954 31,439 0.7 33,955 0.77Sulfathiazole 369 48 0.0 370 0.01Tetracycline 61,712 6,857 3.6 61,716 1.39Trimethoprim 49,304 6,445 0.0 49,304 1.11Warfarin 288 400 0.0 288 0.01

On average, 0.9% Influent Load is due to unused medicine disposal to landfill.

99.1% of influent load is due to patients taking medicines

Page 15: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

15

Comparison

n Sewer Disposal – Average = 0.9 μg/l

n Landfill Disposal – Average = 0.001 μg/l

n Take Back – No Change

Max = 12.8 μg/l

Min = 0.005 μg/l

Max = 0.01 μg/l

Min = <0.0000001 μg/l

n Influent Concentration Changes in μg/l From Unused Disposal

Max = 74%

Min = 10%

Max = 11%

Min = 0.0%

n Sewer Disposal – Average = 21%

n Landfill Disposal – Average = 0.9%

n Take Back – 0.0%

n % Influent Load From Unused

Page 16: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

16

Comparison Chart

% Influent Load From Unused

APISewer

DisposalTrash

DisposalTake Back

Sewer Disposal

Trash Disposal

Take BackSewer

DisposalTrash

DisposalTake Back

Acetaminophen 116.88 104.03 104.03 10.99% 0.00% n/a 12.8436 0.0014 n/aAlbuterol Sulfate 0.03 0.02 0.02 28.41% 0.18% n/a 0.0081 0.0000 n/aCimetidine 0.60 0.49 0.49 18.80% 0.00% n/a 0.1128 0.0000 n/aCiprofloxacin 1.74 1.55 1.54 11.10% 0.12% n/a 0.1928 0.0019 n/aCodeine 0.31 0.28 0.28 10.99% 0.03% n/a 0.0341 0.0001 n/aDigoxin 0.00 0.00 0.00 11.68% 0.00% n/a 0.0005 0.0000 n/aDiltiazem 0.46 0.12 0.12 73.53% 0.00% n/a 0.3369 0.0000 n/aDoxycycline 0.74 0.67 0.67 10.00% 0.13% n/a 0.0740 0.0008 n/aEnalaprilat 0.02 0.02 0.01 10.99% 10.99% n/a 0.0017 0.0017 n/aErythromycin-H2O 1.45 1.31 1.31 10.00% 0.00% n/a 0.1451 0.0000 n/aFluoxetine 0.05 0.03 0.03 52.63% 0.00% n/a 0.0281 0.0000 n/aGemfibrozil 4.10 3.58 3.57 12.76% 0.05% n/a 0.5225 0.0019 n/aIbuprofen 6.96 4.64 4.63 33.56% 0.21% n/a 2.3363 0.0098 n/aLincomycin 0.01 0.01 0.01 10.00% 0.00% n/a 0.0007 0.0000 n/aMetformin 36.06 32.46 32.45 10.00% 0.00% n/a 3.6061 0.0015 n/aNorfloxacin 0.06 0.06 0.05 10.67% 10.67% n/a 0.0061 0.0061 n/aOxytetracycline 0.00 0.00 0.00 10.00% 0.01% n/a 0.0001 0.0000 n/aParoxetine metabolite 0.44 0.40 0.40 10.00% 0.00% n/a 0.0439 0.0000 n/aRanitidine 2.14 1.92 1.92 10.57% 0.00% n/a 0.2266 0.0001 n/aSulfamethoxazole 1.48 0.77 0.77 48.08% 0.00% n/a 0.7095 0.0000 n/aSulfathiazole 0.01 0.01 0.01 11.56% 0.00% n/a 0.0011 0.0000 n/aTetracycline 1.55 1.39 1.39 10.00% 0.01% n/a 0.1547 0.0001 n/aTrimethoprim 1.26 1.11 1.11 11.56% 0.00% n/a 0.1454 0.0000 n/aWarfarin 0.02 0.01 0.01 58.14% 0.00% n/a 0.0090 0.0000 n/a

Average 20.67% 0.93% n/a 0.897 0.001 n/a

WWTP Influent Concentrations μg/lInfluent Concentration Change

From Unused in μg/l

Page 17: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

17

OBJECTIVE 2

Compare estimated API influent concentrations currently with those anticipated if take back programs were widely available and implemented.

Page 18: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

18

What Do Patients Currently Do With Their Unused Medicine

n Household Trash = 45% to 55%

n Drain Disposal = 20% to 35%

n Take Back or Household Hazardous Waste = 1% to 8%

n Other:n Give it to other peoplen Store itn Always take it all

n We will use the upper bound

n 15% of household trash in the US is incinerated

Page 19: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

19

Current State - Average 10% Influent Contribution From Unused

APIAPI

kg/yearUnused API

kg/year

8% HHW Incinerated API Mass

(kg/yr)

35% To Sewer API

Mass (kg/yr)

55% To Trash with 15% of Trash Incinerated

Leachate API Mass (kg/yr)

Patient Use API

to WWTP kg/year

Total kg/year to

WWTP

POTW influent

μg/l

% of Influent

Load From

Unused

Acetaminophen 5,691,120 569,112 0.0 199,189.2 29.9 4,609,807 4,809,026 108.53 4.14%Albuterol Sulfate 3,569 357 0.0 124.9 0.8 899 1,025 0.02 12.26%Cimetidine 49,980 4,998 0.0 1,749.3 0.1 21,591 23,341 0.53 7.50%Ciprofloxacin 85,440 8,544 0.0 2,990.4 39.9 68,437 71,468 1.61 4.24%Codeine 15,095 1,510 0.0 528.3 1.7 12,227 12,757 0.29 4.15%Digoxin 229 23 0.0 8.0 0.0 173 181 0.00 4.43%Diltiazem 149,296 14,930 0.0 5,225.4 0.1 5,375 10,600 0.24 49.30%Doxycycline 32,784 3,278 0.0 1,147.4 17.3 29,506 30,670 0.69 3.80%Enalaprilat 772 77 0.0 27.0 36.1 625 688 0.02 9.17%Erythromycin-H2O 64,283 6,428 0.0 2,249.9 0.0 57,855 60,105 1.36 3.74%Fluoxetine 12,434 1,243 0.0 435.2 0.0 1,119 1,554 0.04 28.00%Gemfibrozil 231,530 23,153 0.0 8,103.6 39.0 158,367 166,509 3.76 4.89%Ibuprofen 1,035,229 103,523 0.0 36,233.0 202.2 204,975 241,411 5.45 15.09%Lincomycin 328 33 0.0 11.5 0.0 296 307 0.01 3.74%Metformin 1,597,887 159,789 0.0 55,926.0 30.4 1,438,098 1,494,055 33.72 3.75%Norfloxacin 2,700 270 0.0 94.5 126.2 2,260 2,481 0.06 8.90%Oxytetracycline 31 3 0.0 1.1 0.0 28 29 0.00 3.75%Paroxetine metabolite 19,474 1,947 0.0 681.6 0.0 17,527 18,208 0.41 3.74%Ranitidine 100,417 10,042 0.0 3,514.6 1.5 84,952 88,469 2.00 3.97%Sulfamethoxazole 314,389 31,439 0.0 11,003.6 0.3 33,954 44,958 1.01 24.48%Sulfathiazole 483 48 0.0 16.9 0.0 369 386 0.01 4.38%Tetracycline 68,569 6,857 0.0 2,399.9 1.7 61,712 64,114 1.45 3.75%Trimethoprim 64,450 6,445 0.0 2,255.8 0.0 49,304 51,560 1.16 4.38%Warfarin 3,999 400 0.0 140.0 0.0 288 428 0.01 32.71%

Page 20: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

20

What Kind of Participation Can We Expect In Take Back Programs

n US unused medicine take back pilots - 1%

n European unused medicine take back programs – 50%

n Canada – 20%

n Other US take back or mail back programsn Dry Cell Batteries – 3%n Car Batteries – 90%n Electronic Equip – 15%n Plastic Shopping Bags – 3%n Household Hazardous Waste – 3%n Curbside Recycling – 80%

n We use 20% participation for a US program and assume that the rest is disposed of in the trash

Page 21: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

21

Future State with Mature Take Back - Average 0.7% Influent Contribution From Unused

APIAPI

kg/yearUnused API

kg/year

20% Take Back

Incinerated API Mass

(kg/yr)

80% To Trash with 15% of Trash Incinerated

Leachate API Mass (kg/yr)

Patient Use API

to WWTP kg/year

Total kg/year to

WWTP

POTW influent

μg/l

% of Influent

Load From

Unused

Acetaminophen 5,691,120 569,112 0.0 43.5 4,609,807 4,609,851 104.03 0.00%Albuterol Sulfate 3,569 357 0.0 1.1 899 900 0.02 0.12%Cimetidine 49,980 4,998 0.0 0.2 21,591 21,591 0.49 0.00%Ciprofloxacin 85,440 8,544 0.0 58.1 68,437 68,495 1.55 0.08%Codeine 15,095 1,510 0.0 2.4 12,227 12,230 0.28 0.02%Digoxin 229 23 0.0 0.0 173 173 0.00 0.00%Diltiazem 149,296 14,930 0.0 0.1 5,375 5,375 0.12 0.00%Doxycycline 32,784 3,278 0.0 25.2 29,506 29,531 0.67 0.09%Enalaprilat 772 77 0.0 52.5 625 678 0.02 7.74%Erythromycin-H2O 64,283 6,428 0.0 0.0 57,855 57,855 1.31 0.00%Fluoxetine 12,434 1,243 0.0 0.0 1,119 1,119 0.03 0.00%Gemfibrozil 231,530 23,153 0.0 56.7 158,367 158,423 3.58 0.04%Ibuprofen 1,035,229 103,523 0.0 294.2 204,975 205,270 4.63 0.14%Lincomycin 328 33 0.0 0.0 296 296 0.01 0.00%Metformin 1,597,887 159,789 0.0 44.2 1,438,098 1,438,142 32.46 0.00%Norfloxacin 2,700 270 0.0 183.6 2,260 2,444 0.06 7.51%Oxytetracycline 31 3 0.0 0.0 28 28 0.00 0.01%Paroxetine metabolite 19,474 1,947 0.0 0.0 17,527 17,527 0.40 0.00%Ranitidine 100,417 10,042 0.0 2.2 84,952 84,955 1.92 0.00%Sulfamethoxazole 314,389 31,439 0.0 0.5 33,954 33,954 0.77 0.00%Sulfathiazole 483 48 0.0 0.0 369 369 0.01 0.00%Tetracycline 68,569 6,857 0.0 2.4 61,712 61,715 1.39 0.00%Trimethoprim 64,450 6,445 0.0 0.0 49,304 49,304 1.11 0.00%Warfarin 3,999 400 0.0 0.0 288 288 0.01 0.00%

Page 22: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

22

Comparison Of Present and Potential Future States

n Average Estimated Influent Difference Between Take Back and Household Trash Disposal is:

n Concentration - 0.2 parts per trillion

n Percent of Influent Load From Unused 0.15%

Average % of Influent Load From Unused

Average Influent Concentration Change From Current in μg/l

Current 10.34%Take Back 0.66% 0.8966%Household Trash 0.81% 0.8968%* 15% of household trash is incinerated

*

Page 23: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

23

Comparison of Chart

% Influent Load From Unused

API CurrentTrash - 15% incinerated

20% Take Back

CurrentTrash - 15% incinerated

20% Take Back

Trash - 15% incinerated

20% Take Back

Acetaminophen 116.88 104.03 104.03 4.14% 0.00% 0.00% 12.8424 12.8426 0.0002Albuterol Sulfate 0.03 0.02 0.02 12.26% 0.15% 0.12% 0.0080 0.0080 0.0000Cimetidine 0.60 0.49 0.49 7.50% 0.00% 0.00% 0.1128 0.1128 0.0000Ciprofloxacin 1.74 1.55 1.55 4.24% 0.11% 0.08% 0.1912 0.1915 0.0003Codeine 0.31 0.28 0.28 4.15% 0.02% 0.02% 0.0340 0.0340 0.0000Digoxin 0.00 0.00 0.00 4.43% 0.00% 0.00% 0.0005 0.0005 0.0000Diltiazem 0.46 0.12 0.12 49.30% 0.00% 0.00% 0.3369 0.3369 0.0000Doxycycline 0.74 0.67 0.67 3.80% 0.11% 0.09% 0.0733 0.0734 0.0001Enalaprilat 0.02 0.02 0.02 9.17% 9.50% 7.74% 0.0003 0.0006 0.0003Erythromycin-H2O 1.45 1.31 1.31 3.74% 0.00% 0.00% 0.1451 0.1451 0.0000Fluoxetine 0.05 0.03 0.03 28.00% 0.00% 0.00% 0.0281 0.0281 0.0000Gemfibrozil 4.10 3.58 3.58 4.89% 0.04% 0.04% 0.5209 0.5212 0.0003Ibuprofen 6.96 4.63 4.63 15.09% 0.18% 0.14% 2.3280 2.3296 0.0017Lincomycin 0.01 0.01 0.01 3.74% 0.00% 0.00% 0.0007 0.0007 0.0000Metformin 36.06 32.46 32.46 3.75% 0.00% 0.00% 3.6048 3.6051 0.0002Norfloxacin 0.06 0.06 0.06 8.90% 9.22% 7.51% 0.0009 0.0019 0.0010Oxytetracycline 0.00 0.00 0.00 3.75% 0.01% 0.01% 0.0001 0.0001 0.0000Paroxetine metabolite 0.44 0.40 0.40 3.74% 0.00% 0.00% 0.0439 0.0439 0.0000Ranitidine 2.14 1.92 1.92 3.97% 0.00% 0.00% 0.2266 0.2266 0.0000Sulfamethoxazole 1.48 0.77 0.77 24.48% 0.00% 0.00% 0.7095 0.7095 0.0000Sulfathiazole 0.01 0.01 0.01 4.38% 0.00% 0.00% 0.0011 0.0011 0.0000Tetracycline 1.55 1.39 1.39 3.75% 0.00% 0.00% 0.1547 0.1547 0.0000Trimethoprim 1.26 1.11 1.11 4.38% 0.00% 0.00% 0.1454 0.1454 0.0000Warfarin 0.02 0.01 0.01 32.71% 0.00% 0.00% 0.0090 0.0090 0.0000

Average 10.34% 0.81% 0.66% 0.89659 0.89677 0.0002

WWTP Influent Concentrations μg/lInfluent Concentration Change

From Current in μg/lTack Back /

Trash Difference

in μg/l

Page 24: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

24

OBJECTIVE 3

Identify next steps and additional data that are needed to answer the question: What is the best way to dispose of unused medicine?

Page 25: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

25

Some Data Gaps

n Amount of Unused Medicine

n Long Term Care Facilities may help answer this question

n Coroner's offices may also have some data

n Better data collection during pilots

n Confirmation of landfill leachate estimations

n Actual sampling of leachate

n Take Back Participation

n Work with pilots to understand participation rates

Page 26: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

26

Evaluation of Other Environmental Drivers Needed

n Carbon Footprint and Climate Change

n Air Emissions

n Repackaging

n Groundwater Contamination

n Considering a Lifecycle Assessment of Take Back and Trash Disposal

Page 27: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

27

We Need to Understand the Drug Abuse & Poisoning IssueWhere Does It Occur?

Landfill

Incineration

Take Back

Household Trash

Mail Back

Household Hazardous Waste

Page 28: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

28

We Need to Understand Why Medicine Goes Unused

n From Patient Surveysn Adverse Effectsn Condition Resolvedn Excess suppliesn Medication expiredn Medication or dosage changedn Non-adherence - Perceived Ineffectiven Patient left (hospitalized, transferred, died)

n Over Prescribing

n Insurance Company Practices

Page 29: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

29

SUMMARY & QUESTIONS

Page 30: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

30

Summary

n Even with current disposal practices, drain disposal of unused medicines is very unlikely to contribute more than 10% of the APIs found in WWTP influents.

n Either household trash disposal or take back programs can reduce the unused medicine contribution of APIs in WWTP influent to < 1%

n Drain disposal of unused medicine should be discouragedn It is likely that there would be little effect (less than a 1 part per

trillion) on WWTP API influent concentrations as a result of implementing unused medicine take back programs compared to household trash disposal.

n More information is needed before the “best way to dispose of unused medicine” can be determinedn the other environmental impacts of landfill and incineration

disposal of unused medicinesn where in the unused medicine physical flow drug abuse and

poisoning occur

Page 31: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

31

Page 32: 1 An Evaluation of Unused Medicine Disposal Options On Wastewater Treatment Plant Influents Douglas S. Finan – GlaxoSmithKline Matthew D. Garamone - Pfizer

32

References

n What happens to expired medications? A survey of community medication disposal, Kuspis DA, Krenzelok EP, Veterinary and human toxicology, 2/1/1996, 38(1), 1

n Patient Practices and Beliefs Concerning Disposal of Medications, Seehusen DA, Edwards J, Journal of the American Board of Family Medicine, 11/1/2006, Vol. 19 No. 6, 2

n Medication destruction and waste measurement and management in long-term care facilities, Paone RP, Vogenberg FR, Caporello E, Rutkowski J, Parent R, Fachetti F, The Consultant Pharmacist, 1/1/1996, Vol. 11, 3

n The Disposition of Unused Medications in Nursing Facilities Study, Unpublished report prepared for the Ohio Department of Job & Family

n The Cost of Medication Waste, Bolvin M, Canada Pharm Journal, 5/1/1997, , 5

n The economic impact of Wasted Prescription Medication in an outpatient Population of Older Adults, Morgan TM, The Journal of Family Practice, 9/1/2001, Vol. 50 No. 9, 6

n Household Disposal of Pharmaceuticals as a Pathway for Aquatic Contamination in the United Kingdom, Bound JP, Voulvoulis N, Environmental Health Perspectives - available at http://dx.doi.org, 8/9/2005,

n Reasons why medicines are returned to Swedish pharmacies unused, Ekedhal ABE, Pharm World Science (2006) - DOI 10.1007/s11096-006-9055-1, 1/13/2007, Vol.

n Washington Citizens for Resource Conservation - a Soundstats Report, Unpublished, 1/1/2006, , 9

n An investigation of returned medicines in primary care, Langley CA, Marriott JF, Mackridge A, Daniszewsi R,, Pharm World Sci (2005), 1/1/2005, Vol. 27, 10

n Drugs up in smoke: a study of caseated drugs in Sweden, Isacson D, Olofsson C, Pharm World Sci 1999, 1/1/1999, Vol. 21(2), 11

n Report on San Francisco Bay Area's Safe Medicine Disposal Days, Unpublished available at - , http://www.baywise.info/disposaldays/SFBAY_SafeMeds_Report_August2006.pdf

n Three Years' Experience with a Medidump Program Operating from a Suburban Community Hospital, Stuchbery P, Australian Journal Of Hospital Pharmacy 1988, 1/1/1988, Vol. 18 No. 4, 13

n Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), July 1998, Available at: http://www.fda.gov/cder/guidance/1730fnl.pdf

n Potential Contribution of Unused Medicines to Environmental Concentrations of Pharmaceuticals, Tischler, L., September 2007, In Press

n Municipal Solid Waste in the United States 2005 Facts and Figures, US EPA, October 2006, EPA-530-F-06-039