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An Evaluation of Unused Medicine Disposal Options On Wastew An Evaluation of Unused Medicine Disposal Options On Wastew

An Evaluation of Unused Medicine Disposal Options On Wastew - PowerPoint Presentation

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An Evaluation of Unused Medicine Disposal Options On Wastew - PPT Presentation

Douglas S Finan GlaxoSmithKline Matthew D Garamone Pfizer Inc James Jahnke ScheringPlough Corporation Fourth Annual Unused Drug Return Conference October 31 November 1 2007 Portland Maine ID: 314876

medicine unused influent disposal unused medicine disposal influent patient household api trash concentrations medicines landfill data programs average wwtp

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Slide1

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 Conference

October 31 – November 1, 2007

Portland, MaineSlide2

Some Background on PIE

1999, USGS National Reconnaissance of Emerging Contaminantssampled 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)

Lots of Press

Many interested stakeholdersSlide3

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

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

We have developed working groups around PIE subjects

Fate and Transport

Human Health

Environmental Risk AssessmentHormones

Unused MedicinesTreatmentCommunicationsSlide4

Some Background on Unused Medicine Disposal

In the past patients were told that drain disposal was the safest way to dispose of unused medicines.Publications on PIE identified unused medicine disposal as a driver for detection of pharmaceutical compounds in surface watersSeveral cities & towns have sponsored unused medicines take- back eventsSome states such as Maine and California have introduced legislation designed to encourage the development of pharmaceutical take-back programsIn 2007 ONDCP/EPA/FDA issue Federal Guidelines on the Proper Disposal of Prescription Drugs

In 2007 a bill was introduced in the US Congress directing EPA to study pharmaceutical take back programsSlide5

PRINCIPAL PATHWAYS FOR PHARMACEUTICALS INTO THE ENVIRONMENT

WWTP

Landfill

Incineration

What is the Impact of Unused Medicine Disposal on WWTPs?Slide6

Objectives

Determine the impact on WWTP influent concentrations if active pharmaceutical ingredients (API) if:all patient unused medicine was flushedall patient unused medicine was placed in household trashall patient unused medicine was taken back for incineration.Compare estimated API influent concentrations currently with those anticipated if take back programs were widely available and implemented.

Identify next steps and additional data that are needed to answer the question: What is the best way to dispose of unused medicine?Slide7

OBJECTIVE 1

Determine the impact on WWTP influent concentrations if active pharmaceutical ingredients (API) if: all patient unused medicine was flushed all patient unused medicine was placed in household trash

all patient unused medicine was taken back for incineration.Slide8

First, How Much Medicine Given to Patients Goes Unused?

No definitive answer yetWhat do we know - from peer reviewed literatureLTCF 6.7% unused based on financial data LTCF 13.1% unused based on financial dataGeneral public 2.3% unused based on financial data

General Public 3% unused based on unit counts

For our analysis, it was assumed that 10% of medicine purchased by the patient is unused.Slide9

Next, What Compounds Should be Studied

What have been detected (USGS etc.)What data are availableOther studiesIdentified 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 Slide10

Estimating influent mass for each API from Patient UseAnnual Sales Data converted to Kgs of API (Tischler, L. In Press)

% of sales that goes unused (assumed 10%)Loss by human metabolism (Tischler, L. In Press)Influent Amount (Kg) = Sales*(0.90)*(1-Metabolism%)Estimating influent concentration for each APIU.S. FDA method for estimating aquatic conc. (FDA, 1998) UsesKg/yr of API

Annual liters of wastewater entering WWTPs = 4.431x10

13

(FDA, 1998)

Influent Conc. μg/l=

Estimating WWTP Influent Concentrations From Patient Use

API

(kg/yr)

4.431x10

13

(l/yr)

* 1x10

9

(

μ

g/kg)Slide11

Estimated API Concentrations From Patient Use(also influent concentration if all unused medicine is taken back for incineration)Slide12

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

Take Back Programs = patient use concentrations since it is assumed that all take back would be incinerated.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.Tischler’s MethodEstimate concentration of API in landfill leachateEstimate 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

Partitioning to solids (based on Kp)Anaerobic degradation

HydrolysisComparing Influent Concentrations of Disposal Methods Slide13

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

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 medicinesSlide14

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

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 Slide15

Comparison

Sewer Disposal – Average = 0.9 μg/lLandfill Disposal – Average = 0.001 μg/lTake Back – No Change

Max = 12.8

μ

g/l

Min = 0.005

μg/lMax = 0.01 μg/l

Min = <0.0000001 μg/l

Influent Concentration Changes in

μ

g/l From Unused Disposal

Max = 74%

Min = 10%

Max = 11%

Min = 0.0%

Sewer Disposal – Average = 21%

Landfill Disposal – Average = 0.9%

Take Back – 0.0%

% Influent Load From UnusedSlide16

Comparison Chart Slide17

OBJECTIVE 2

Compare estimated API influent concentrations currently with those anticipated if take back programs were widely available and implemented.Slide18

What Do Patients Currently Do With Their Unused MedicineHousehold Trash = 45% to 55%

Drain Disposal = 20% to 35%Take Back or Household Hazardous Waste = 1% to 8%Other:Give it to other peopleStore itAlways take it allWe will use the upper bound15% of household trash in the US is incineratedSlide19

Current State - Average 10% Influent Contribution From UnusedSlide20

What Kind of Participation Can We Expect In Take Back Programs

US unused medicine take back pilots - 1%European unused medicine take back programs – 50%Canada – 20%Other US take back or mail back programsDry Cell Batteries – 3%Car Batteries – 90%

Electronic Equip – 15%

Plastic Shopping Bags – 3%

Household Hazardous Waste – 3%

Curbside Recycling – 80%We use 20% participation for a US program and assume that the rest is disposed of in the trashSlide21

Future State with Mature Take Back - Average 0.7% Influent Contribution From UnusedSlide22

Comparison Of Present and Potential Future States

Average Estimated Influent Difference Between Take Back and Household Trash Disposal is: Concentration - 0.2 parts per trillion Percent of Influent Load From Unused 0.15%

* 15% of household trash is incinerated

*Slide23

Comparison of ChartSlide24

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?Slide25

Some Data GapsAmount of Unused Medicine

Long Term Care Facilities may help answer this questionCoroner's offices may also have some dataBetter data collection during pilotsConfirmation of landfill leachate estimationsActual sampling of leachateTake Back ParticipationWork with pilots to understand participation ratesSlide26

Evaluation of Other Environmental Drivers NeededCarbon Footprint and Climate Change

Air EmissionsRepackaging Groundwater ContaminationConsidering a Lifecycle Assessment of Take Back and Trash DisposalSlide27

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

Landfill

Incineration

Take Back

Household Trash

Mail Back

Household Hazardous WasteSlide28

We Need to Understand Why Medicine Goes Unused

From Patient SurveysAdverse EffectsCondition ResolvedExcess suppliesMedication expiredMedication or dosage changedNon-adherence - Perceived Ineffective

Patient left (hospitalized, transferred, died)

Over Prescribing

Insurance Company PracticesSlide29

SUMMARY & QUESTIONSSlide30

Summary

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.Either household trash disposal or take back programs can reduce the unused medicine contribution of APIs in WWTP influent to < 1%Drain disposal of unused medicine should be discouragedIt 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.

More information is needed before the “best way to dispose of unused medicine” can be determined

the other environmental impacts of landfill and incineration disposal of unused medicines

where in the unused medicine physical flow drug abuse and poisoning occurSlide31
Slide32

References

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

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

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

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

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,

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

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, 10Drugs 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

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

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

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

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

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