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
Download Presentation The PPT/PDF document "An Evaluation of Unused Medicine Disposa..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
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 occurSlide31Slide32
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