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1 Protecting the Protecting the Ecosystem from Ecosystem from Improperly Disposed Improperly Disposed Pharmaceuticals Pharmaceuticals John M. Polimeni John M. Polimeni Assistant Professor of Assistant Professor of Economics Economics Albany College of Albany College of Pharmacy Pharmacy

1 Protecting the Ecosystem from Improperly Disposed Pharmaceuticals John M. Polimeni Assistant Professor of Economics Albany College of Pharmacy

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Page 1: 1 Protecting the Ecosystem from Improperly Disposed Pharmaceuticals John M. Polimeni Assistant Professor of Economics Albany College of Pharmacy

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Protecting the Protecting the Ecosystem from Ecosystem from

Improperly Disposed Improperly Disposed PharmaceuticalsPharmaceuticals

John M. PolimeniJohn M. Polimeni

Assistant Professor of Assistant Professor of EconomicsEconomics

Albany College of PharmacyAlbany College of Pharmacy

Page 2: 1 Protecting the Ecosystem from Improperly Disposed Pharmaceuticals John M. Polimeni Assistant Professor of Economics Albany College of Pharmacy

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What do all these What do all these products have in products have in

common?common?

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OutlineOutline

PurposePurpose Overview of PPCPs and veterinary Overview of PPCPs and veterinary

medicines in the water supplymedicines in the water supply Possible solutionsPossible solutions Discussion and questionsDiscussion and questions

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PurposePurpose

Fate of PPCPs and veterinary Fate of PPCPs and veterinary medicines in the environmentmedicines in the environment

Prevalence of PPCPs and veterinary Prevalence of PPCPs and veterinary medicines in the environmentmedicines in the environment

Human and environmental health Human and environmental health implicationsimplications

To identify possible solutionsTo identify possible solutions

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The ProblemThe Problem

Pharmaceutical & Personal Care Pharmaceutical & Personal Care Products (PPCPs) and Veterinary Products (PPCPs) and Veterinary Medicines are in our groundwater Medicines are in our groundwater supplysupply

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HistoryHistory 1977 - first identification of drugs in 1977 - first identification of drugs in

the water system in a Missouri the water system in a Missouri Sewage Treatment Plant (STP)Sewage Treatment Plant (STP)

~1990’s - researchers in the US and ~1990’s - researchers in the US and Europe started to investigate problemEurope started to investigate problem

~1998 - media’s discovery of topic~1998 - media’s discovery of topic

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Pharmaceuticals and Personal Care

Products

PharmaceuticalsPersonal Care

Products

Cosmetics

Shampoo

Detergent

Others

Prescription DrugsOver The Counter

Drugs

Antibiotics

Hormones

Others

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Modes of EntryModes of Entry

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Prevalence in the Prevalence in the EnvironmentEnvironment

As shown on the previous diagram As shown on the previous diagram effluents eventually make it into the effluents eventually make it into the groundwatergroundwater

Global problemGlobal problem High percentages of pharmaceuticals can High percentages of pharmaceuticals can

be excreted without being metabolizedbe excreted without being metabolized

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TriclosanTriclosan One of the most frequently found One of the most frequently found

compounds in USGS stream compounds in USGS stream reconnaissance reconnaissance

An antimicrobial preservative found in:An antimicrobial preservative found in:– Hand soapHand soap– Dish-washing productsDish-washing products– Laundry detergents and softenersLaundry detergents and softeners– Plastics (e.g., toys, cutting boards)Plastics (e.g., toys, cutting boards)– ToothpasteToothpaste– Deodorants and antiperspirantsDeodorants and antiperspirants– CosmeticsCosmetics– Hair conditionersHair conditioners– PesticidesPesticides

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Impacts of TriclosanImpacts of Triclosan Affects algae coloniesAffects algae colonies Bioaccumulates in fish at levels thousands Bioaccumulates in fish at levels thousands

times greater than levels found in watertimes greater than levels found in water Swiss study found it in breast milkSwiss study found it in breast milk Degrades to harmful compounds like methyl Degrades to harmful compounds like methyl

triclosan, dioxins, chloroform, and other triclosan, dioxins, chloroform, and other chlorinated compounds.chlorinated compounds.

City of Palo Alto, CA has a ban City of Palo Alto, CA has a ban – Triclosan free soaps in all city soap dispensersTriclosan free soaps in all city soap dispensers

Pushes in San Jose and Denver for same banPushes in San Jose and Denver for same ban

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What’s the Big Deal?What’s the Big Deal?

Only traces were found in these samples, Only traces were found in these samples, so why is this a concern?so why is this a concern?

Properties of PPCPs and veterinary Properties of PPCPs and veterinary medicinesmedicines

Antibiotic ResistanceAntibiotic Resistance Hormones and hormone-regulatorsHormones and hormone-regulators GenotoxinsGenotoxins

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AntibioticsAntibiotics

A unique caseA unique case Resistance does not require large Resistance does not require large

dosagesdosages A natural function of the environmentA natural function of the environment Increased use has led to more Increased use has led to more

harmful and stronger bacteriaharmful and stronger bacteria Serious public health threat - MRSASerious public health threat - MRSA

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Antibiotic ResistanceAntibiotic Resistance

Found inFound in

– River and coastal areasRiver and coastal areas– Domestic sewageDomestic sewage– Surface water and sedimentsSurface water and sediments– LakesLakes– Sewage polluted ocean waterSewage polluted ocean water– Drinking waterDrinking water

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Concentration vs Time Concentration vs Time DependantDependant

Shortening the duration of antibiotic therapy Shortening the duration of antibiotic therapy will decrease resistance… will decrease resistance… – Some antibiotics concentration dependantSome antibiotics concentration dependant– Some antibiotics time dependantSome antibiotics time dependant

Shortening duration MAY decrease Shortening duration MAY decrease contamination in the environment and contamination in the environment and therefore decrease resistance theretherefore decrease resistance there

If make duration too short in humans you WILL If make duration too short in humans you WILL increase resistance in those patientsincrease resistance in those patients

This is why the pharmacist always says to finish This is why the pharmacist always says to finish taking your antibiotics until they are gone, even taking your antibiotics until they are gone, even if you start to feel better!if you start to feel better!

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Hormones and Hormone-Hormones and Hormone-Regulating Drugs Regulating Drugs

Can cause major environmental Can cause major environmental damagedamage

Need only a few nanograms per liter – Need only a few nanograms per liter – 1,000 times less concentrated than 1,000 times less concentrated than the µg/l that has been found in the µg/l that has been found in samplessamples

Estradiol – alters reproductive tissues Estradiol – alters reproductive tissues in fishin fish

Endocrine disruptorsEndocrine disruptors

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Reports focus on substances known or Reports focus on substances known or suspected to act on sex hormone receptors and suspected to act on sex hormone receptors and pathwayspathways– Estrogen receptor most studied Estrogen receptor most studied

Estrogen receptor agonistsEstrogen receptor agonists– Methoxychlor (pesticide)Methoxychlor (pesticide)– PCB’sPCB’s– Bisphenol A (from polycarbonate plastic production)Bisphenol A (from polycarbonate plastic production)– Pharmaceutical estrogensPharmaceutical estrogens– Phytoestrogens from plantsPhytoestrogens from plants

Estrogen receptor antagonistsEstrogen receptor antagonists– Vinclozolin (fungicide)Vinclozolin (fungicide)– DDT metabolitesDDT metabolites– Phthalates (found in makeup, shampoo, soaps, Phthalates (found in makeup, shampoo, soaps,

plastics, paints, and some pesticides)plastics, paints, and some pesticides)

Endocrine Disrupting Endocrine Disrupting ChemicalsChemicals

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Daily articles about environmental impactsDaily articles about environmental impacts Reproductive and developmental abnormalities Reproductive and developmental abnormalities

found in birds, frogs, seals, polar bears, marine found in birds, frogs, seals, polar bears, marine mollusks, alligators, fish, and DOZENS more mollusks, alligators, fish, and DOZENS more speciesspecies

Report in Report in Pure and Applied ChemistryPure and Applied Chemistry from from 2003 suggested over 200 species of animals 2003 suggested over 200 species of animals have been / suspected affected by these have been / suspected affected by these chemicalschemicals

Current testing methods Current testing methods – Hard to decipher the different EDC from one anotherHard to decipher the different EDC from one another– Hard to pinpoint what is actually thereHard to pinpoint what is actually there

Endocrine Disrupting Endocrine Disrupting ChemicalsChemicals

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Pharmaceutical EstrogensPharmaceutical Estrogens All hormonal therapies are FDA Category All hormonal therapies are FDA Category

X in pregnancyX in pregnancy– Evidence of fetal risk in humans, no benefit Evidence of fetal risk in humans, no benefit

from use can be identifiedfrom use can be identified– Other substances in Category X for Other substances in Category X for

pregnancypregnancy AlcoholAlcohol TobaccoTobacco

Risks of estrogen exposureRisks of estrogen exposure– Congenital heart defectsCongenital heart defects– Limb malformationsLimb malformations– Virilization = male characteristicsVirilization = male characteristics

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GenotoxicityGenotoxicity

Correlated to CancerCorrelated to Cancer Highly toxicHighly toxic Damages cellular DNADamages cellular DNA Antineoplastics – carcinogenic, Antineoplastics – carcinogenic,

mutagenic, embryotoxic, or mutagenic, embryotoxic, or teratogenicteratogenic

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PPCPs and the Environment?PPCPs and the Environment?

Yes! Remember, where do many Yes! Remember, where do many PPCPs come from?PPCPs come from?

Perhaps no greater illustration of the Perhaps no greater illustration of the connection between the environment connection between the environment and human healthand human health

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What Can Be Done?What Can Be Done?

Let the market solve the problemLet the market solve the problem Upgrade sewage treatment plantsUpgrade sewage treatment plants Use regulatory oversightUse regulatory oversight

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Regulatory AlternativesRegulatory Alternatives

Day ProgramDay Program Mail ProgramMail Program Take-back ProgramTake-back Program

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Take-back ProgramTake-back Program

Arguably the most successful Arguably the most successful initiativeinitiative

Voluntary programVoluntary program 11stst one – November 1996 in British one – November 1996 in British

ColumbiaColumbia Only for retail customersOnly for retail customers Huge SuccessHuge Success

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Take-Back ProgramTake-Back Program

The Australian RUMThe Australian RUM July 1998July 1998 Community pharmaciesCommunity pharmacies Consumer awareness programsConsumer awareness programs $750,000 annual cost$750,000 annual cost

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Take-Back ProgramTake-Back Program

The EU – 11 countries involvedThe EU – 11 countries involved 5 are sponsored by the 5 are sponsored by the

pharmaceutical industrypharmaceutical industry 6 are community pharmacies 6 are community pharmacies

collaborating with waste collection collaborating with waste collection companiescompanies

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Take-Back ProgramTake-Back Program

The United StatesThe United States Vary in useVary in use No permanent programsNo permanent programs

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Other Solutions?Other Solutions?

Deposit programDeposit program

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Deposit ProgramDeposit Program

Medication deposit system:Medication deposit system:– Consumers pay deposit on medication Consumers pay deposit on medication

container container – Receive deposit refund upon container’s Receive deposit refund upon container’s

returnreturn Returned medications collected for disposal Returned medications collected for disposal

as hazardous wasteas hazardous waste Medication container recycledMedication container recycled

Venue: Venue: – Community Pharmacies Community Pharmacies

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Deposit ProgramDeposit Program Model based upon: Model based upon:

– Recyclable goods Recyclable goods – Consumer behavior patterns Consumer behavior patterns

Deposit system maximizes participationDeposit system maximizes participation

– Financial incentiveFinancial incentive Increases medication returnIncreases medication return Initiates medication container recyclingInitiates medication container recycling

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Deposit ProgramDeposit Program

– LimitationsLimitations

Consumer resistanceConsumer resistance

Agricultural agentsAgricultural agents

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Deposit Program AnalysisDeposit Program Analysis

Consumers pay depositConsumers pay deposit Receive refund upon returnReceive refund upon return Those who find it too inconvenient will Those who find it too inconvenient will

not participatenot participate Uncollected deposits entice producers to Uncollected deposits entice producers to

participateparticipate Goal to maximize medication return to Goal to maximize medication return to

decrease PPCP pollutiondecrease PPCP pollution Limitation of consumer resistanceLimitation of consumer resistance

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Other SolutionsOther Solutions

Are there other possible solutions to Are there other possible solutions to the problem?the problem?

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QuestionsQuestions