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

2. 2 What do all these products have in common?

3. 3 Outline Purpose Purpose Overview of PPCPs and veterinary medicines in the water supply Overview of PPCPs and veterinary medicines in the water supply Possible solutions Possible solutions Discussion and questions Discussion and questions

4. 4 Purpose Fate of PPCPs and veterinary medicines in the environment Fate of PPCPs and veterinary medicines in the environment Prevalence of PPCPs and veterinary medicines in the environment Prevalence of PPCPs and veterinary medicines in the environment Human and environmental health implications Human and environmental health implications To identify possible solutions To identify possible solutions

5. 5 The Problem Pharmaceutical & Personal Care Products (PPCPs) and Veterinary Medicines are in our groundwater supply Pharmaceutical & Personal Care Products (PPCPs) and Veterinary Medicines are in our groundwater supply

6. 6 History 1977 - first identification of drugs in the water system in a Missouri Sewage Treatment Plant (STP) 1977 - first identification of drugs in the water system in a Missouri Sewage Treatment Plant (STP) ~1990’s - researchers in the US and Europe started to investigate problem ~1990’s - researchers in the US and Europe started to investigate problem ~1998 - media’s discovery of topic ~1998 - media’s discovery of topic

7. 7 Pharmaceuticals and Personal Care Products Pharmaceuticals Prescription Drugs Antibiotics Hormones Others Over The Counter Drugs Personal Care Products Cosmetics Shampoo Detergent Others

8. 8 Modes of Entry

9. 9 Prevalence in the Environment As shown on the previous diagram effluents eventually make it into the groundwater As shown on the previous diagram effluents eventually make it into the groundwater Global problem Global problem High percentages of pharmaceuticals can be excreted without being metabolized High percentages of pharmaceuticals can be excreted without being metabolized

10. 10 Triclosan One of the most frequently found compounds in USGS stream reconnaissance One of the most frequently found compounds in USGS stream reconnaissance An antimicrobial preservative found in: An antimicrobial preservative found in: –Hand soap –Dish-washing products –Laundry detergents and softeners –Plastics (e.g., toys, cutting boards) –Toothpaste –Deodorants and antiperspirants –Cosmetics –Hair conditioners –Pesticides

11. 11 Impacts of Triclosan Affects algae colonies Affects algae colonies Bioaccumulates in fish at levels thousands times greater than levels found in water Bioaccumulates in fish at levels thousands times greater than levels found in water Swiss study found it in breast milk Swiss study found it in breast milk Degrades to harmful compounds like methyl triclosan, dioxins, chloroform, and other chlorinated compounds. Degrades to harmful compounds like methyl triclosan, dioxins, chloroform, and other 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 dispensers Pushes in San Jose and Denver for same ban Pushes in San Jose and Denver for same ban

12. 12 What’s the Big Deal? Only traces were found in these samples, so why is this a concern? Only traces were found in these samples, so why is this a concern? Properties of PPCPs and veterinary medicines Properties of PPCPs and veterinary medicines Antibiotic Resistance Antibiotic Resistance Hormones and hormone-regulators Hormones and hormone-regulators Genotoxins Genotoxins

13. 13 Antibiotics A unique case A unique case Resistance does not require large dosages Resistance does not require large dosages A natural function of the environment A natural function of the environment Increased use has led to more harmful and stronger bacteria Increased use has led to more harmful and stronger bacteria Serious public health threat - MRSA Serious public health threat - MRSA

14. 14 Antibiotic Resistance Found in Found in –River and coastal areas –Domestic sewage –Surface water and sediments –Lakes –Sewage polluted ocean water –Drinking water

15. 15 Concentration vs Time Dependant Shortening the duration of antibiotic therapy will decrease resistance… Shortening the duration of antibiotic therapy will decrease resistance… –Some antibiotics concentration dependant –Some antibiotics time dependant Shortening duration MAY decrease contamination in the environment and therefore decrease resistance there Shortening duration MAY decrease contamination in the environment and therefore decrease resistance there If make duration too short in humans you WILL increase resistance in those patients If make duration too short in humans you WILL increase resistance in those patients This is why the pharmacist always says to finish taking your antibiotics until they are gone, even if you start to feel better! This is why the pharmacist always says to finish taking your antibiotics until they are gone, even if you start to feel better!

16. 16 Hormones and Hormone-Regulating Drugs Can cause major environmental damage Can cause major environmental damage Need only a few nanograms per liter – 1,000 times less concentrated than the µg/l that has been found in samples Need only a few nanograms per liter – 1,000 times less concentrated than the µg/l that has been found in samples Estradiol – alters reproductive tissues in fish Estradiol – alters reproductive tissues in fish Endocrine disruptors Endocrine disruptors

17. 17 Reports focus on substances known or suspected to act on sex hormone receptors and pathways Reports focus on substances known or suspected to act on sex hormone receptors and pathways –Estrogen receptor most studied Estrogen receptor agonists Estrogen receptor agonists –Methoxychlor (pesticide) –PCB’s –Bisphenol A (from polycarbonate plastic production) –Pharmaceutical estrogens –Phytoestrogens from plants Estrogen receptor antagonists Estrogen receptor antagonists –Vinclozolin (fungicide) –DDT metabolites –Phthalates (found in makeup, shampoo, soaps, plastics, paints, and some pesticides) Endocrine Disrupting Chemicals

18. 18 Daily articles about environmental impacts Daily articles about environmental impacts Reproductive and developmental abnormalities found in birds, frogs, seals, polar bears, marine mollusks, alligators, fish, and DOZENS more species Reproductive and developmental abnormalities found in birds, frogs, seals, polar bears, marine mollusks, alligators, fish, and DOZENS more species Report in Pure and Applied Chemistry from 2003 suggested over 200 species of animals have been / suspected affected by these chemicals Report in Pure and Applied Chemistry from 2003 suggested over 200 species of animals have been / suspected affected by these chemicals Current testing methods Current testing methods –Hard to decipher the different EDC from one another –Hard to pinpoint what is actually there Endocrine Disrupting Chemicals

19. 19 Pharmaceutical Estrogens All hormonal therapies are FDA Category X in pregnancy All hormonal therapies are FDA Category X in pregnancy –Evidence of fetal risk in humans, no benefit from use can be identified –Other substances in Category X for pregnancy  Alcohol  Tobacco Risks of estrogen exposure Risks of estrogen exposure –Congenital heart defects –Limb malformations –Virilization = male characteristics

20. 20 Genotoxicity Correlated to Cancer Correlated to Cancer Highly toxic Highly toxic Damages cellular DNA Damages cellular DNA Antineoplastics – carcinogenic, mutagenic, embryotoxic, or teratogenic Antineoplastics – carcinogenic, mutagenic, embryotoxic, or teratogenic

21. 21 PPCPs and the Environment? Yes! Remember, where do many PPCPs come from? Yes! Remember, where do many PPCPs come from? Perhaps no greater illustration of the connection between the environment and human health Perhaps no greater illustration of the connection between the environment and human health

22. 22 What Can Be Done? Let the market solve the problem Let the market solve the problem Upgrade sewage treatment plants Upgrade sewage treatment plants Use regulatory oversight Use regulatory oversight

23. 23 Regulatory Alternatives Day Program Day Program Mail Program Mail Program Take-back Program Take-back Program

24. 24 Take-back Program Arguably the most successful initiative Arguably the most successful initiative Voluntary program Voluntary program 1 st one – November 1996 in British Columbia 1 st one – November 1996 in British Columbia Only for retail customers Only for retail customers Huge Success Huge Success

25. 25 Take-Back Program The Australian RUM The Australian RUM July 1998 July 1998 Community pharmacies Community pharmacies Consumer awareness programs Consumer awareness programs $750,000 annual cost $750,000 annual cost

26. 26 Take-Back Program The EU – 11 countries involved The EU – 11 countries involved 5 are sponsored by the pharmaceutical industry 5 are sponsored by the pharmaceutical industry 6 are community pharmacies collaborating with waste collection companies 6 are community pharmacies collaborating with waste collection companies

27. 27 Take-Back Program The United States The United States Vary in use Vary in use No permanent programs No permanent programs

28. 28 Other Solutions? Deposit program Deposit program

29. 29 Deposit Program Medication deposit system: Medication deposit system: –Consumers pay deposit on medication container –Receive deposit refund upon container’s return  Returned medications collected for disposal as hazardous waste  Medication container recycled Venue: Venue: –Community Pharmacies

30. 30 Deposit Program Model based upon: Model based upon: –Recyclable goods –Consumer behavior patterns Deposit system maximizes participation Deposit system maximizes participation –Financial incentive  Increases medication return  Initiates medication container recycling

31. 31 Deposit Program –Limitations  Consumer resistance  Agricultural agents

32. 32 Deposit Program Analysis Consumers pay deposit Consumers pay deposit Receive refund upon return Receive refund upon return Those who find it too inconvenient will not participate Those who find it too inconvenient will not participate Uncollected deposits entice producers to participate Uncollected deposits entice producers to participate Goal to maximize medication return to decrease PPCP pollution Goal to maximize medication return to decrease PPCP pollution Limitation of consumer resistance Limitation of consumer resistance

33. 33 Other Solutions Are there other possible solutions to the problem? Are there other possible solutions to the problem?

34. 34 Questions