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Environmental Impact of Disposal GreenPharmEdu.org
Environmental Impact of Disposal APIs enter the environment by three primary routes: Excretion (primarily via urine and secondarily via feces) comprises continual low-level contributions from multitudes of people Bathing releases APIs from medications applied directly to the skin and excreted via sweat * Disposalof leftover, unwanted medications represents acute but transient and episodic contributions from fewer people Disposalis the best route for pollution prevention / source control measures ,[object Object]
Proper disposal is greatly complicated by the conflict between the need to protect public safety (e.g., from drug diversion) and the need to minimize environmental exposure* DaughtonCG and Ruhoy IS. "Environmental Footprint of Pharmaceuticals: The Significance of Factors Beyond Direct Excretion to Sewers," Environmental Toxicology & Chemistry 2009, 28(12):2495-2521; doi:10.1897/08-382.1; available: http://www3.interscience.wiley.com/cgi-bin/fulltext/123234136/PDFSTART
Environmental Concerns Treatment and prevention of disease, together with improved quality of life, are highly visible aspects of a global pharmaceutical industry with sales in 2007 exceeding $700 Billion. Medicines are designed to have biological effects in small doses Non-target organisms can be exposed Possible subtle effects in aquatic organisms at very low concentrations (as low as ng/L or parts per trillion [ppt]) There are thousands of chemically distinct APIs in medicines Potential for synergistic effects with other medicines and/or other contaminants
Environmental Concerns Pharmaceutical Facility Waste Streams In IndiaThe levels of the most abundant API (ciprofloxacin) reached 31 mg/L (31 ppm)  at a waste treatment facility, orders of magnitude higher than had ever been reportedLarsson et al. 2007 “Health facilities flush estimated 250 Million pounds of drugs a year” USA Today, Sept. 2008
Effects Ecological Sex ratios Feminization Behavioral/Social Neurological Growth Human Effects Largely unknown Food chain Antibiotic resistance Unintended Exposure in Vulnerable Populations Faeroe Island Statement FDA – environmental risk assessment
Factors influencing Drug Consumption Ruhoy IS and Daughton CG "Beyond the Medicine Cabinet: An Analysis of Where and Why Medications Accumulate," Environ. Internat., 2008, 34(8):1157-1169; doi:10.1016/j.envint.2008.05.002; available: www.epa.gov/nerlesd1/bios/daughton/EnvInt2008.pdf
8 Pharmaceutical Accumulation Consumer Homes Both human and animal medicine Physician Offices and Clinics Samples and in-office procedure use Veterinarian Offices Animal Shelters Dental Offices Hospitals Long-Term and Chronic Care Facilities Decedent Homes Donations Schools (confiscation and health care offices) Military Bases Shelters Dialysis Centers Transfusion Centers First Responder Services First-Aid Kits Border Check Points Customs (airline and freight) Confined Animal Feeding Operations (CAFOs) Agriculture Aquaculture Zoos Clan Labs Cemeteries Cruise Ships Prisons and Jails Humanitarian Organizations
Accumulation and Disposal of Pharmaceuticals Ruhoy IS and Daughton CG "Beyond the Medicine Cabinet: An Analysis of Where and Why Medications Accumulate," Environ. Internat., 2008, 34(8):1157-1169; doi:10.1016/j.envint.2008.05.002; available: www.epa.gov/nerlesd1/bios/daughton/EnvInt2008.pdf
10 Major Unknown What fractions of drug residues occurring in the ambient environment result from discarding leftover drugs? No studies provided objective data from well-defined populations to support any type of conclusion Data are needed on the types, quantities, and frequencies with which drugs accumulate as household waste

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2.4. Environmental Impact of Disposal (Ruhoy)

  • 1. Environmental Impact of Disposal GreenPharmEdu.org
  • 2.
  • 3. Proper disposal is greatly complicated by the conflict between the need to protect public safety (e.g., from drug diversion) and the need to minimize environmental exposure* DaughtonCG and Ruhoy IS. "Environmental Footprint of Pharmaceuticals: The Significance of Factors Beyond Direct Excretion to Sewers," Environmental Toxicology & Chemistry 2009, 28(12):2495-2521; doi:10.1897/08-382.1; available: http://www3.interscience.wiley.com/cgi-bin/fulltext/123234136/PDFSTART
  • 4.
  • 5. Environmental Concerns Treatment and prevention of disease, together with improved quality of life, are highly visible aspects of a global pharmaceutical industry with sales in 2007 exceeding $700 Billion. Medicines are designed to have biological effects in small doses Non-target organisms can be exposed Possible subtle effects in aquatic organisms at very low concentrations (as low as ng/L or parts per trillion [ppt]) There are thousands of chemically distinct APIs in medicines Potential for synergistic effects with other medicines and/or other contaminants
  • 6. Environmental Concerns Pharmaceutical Facility Waste Streams In IndiaThe levels of the most abundant API (ciprofloxacin) reached 31 mg/L (31 ppm) at a waste treatment facility, orders of magnitude higher than had ever been reportedLarsson et al. 2007 “Health facilities flush estimated 250 Million pounds of drugs a year” USA Today, Sept. 2008
  • 7. Effects Ecological Sex ratios Feminization Behavioral/Social Neurological Growth Human Effects Largely unknown Food chain Antibiotic resistance Unintended Exposure in Vulnerable Populations Faeroe Island Statement FDA – environmental risk assessment
  • 8. Factors influencing Drug Consumption Ruhoy IS and Daughton CG "Beyond the Medicine Cabinet: An Analysis of Where and Why Medications Accumulate," Environ. Internat., 2008, 34(8):1157-1169; doi:10.1016/j.envint.2008.05.002; available: www.epa.gov/nerlesd1/bios/daughton/EnvInt2008.pdf
  • 9. 8 Pharmaceutical Accumulation Consumer Homes Both human and animal medicine Physician Offices and Clinics Samples and in-office procedure use Veterinarian Offices Animal Shelters Dental Offices Hospitals Long-Term and Chronic Care Facilities Decedent Homes Donations Schools (confiscation and health care offices) Military Bases Shelters Dialysis Centers Transfusion Centers First Responder Services First-Aid Kits Border Check Points Customs (airline and freight) Confined Animal Feeding Operations (CAFOs) Agriculture Aquaculture Zoos Clan Labs Cemeteries Cruise Ships Prisons and Jails Humanitarian Organizations
  • 10. Accumulation and Disposal of Pharmaceuticals Ruhoy IS and Daughton CG "Beyond the Medicine Cabinet: An Analysis of Where and Why Medications Accumulate," Environ. Internat., 2008, 34(8):1157-1169; doi:10.1016/j.envint.2008.05.002; available: www.epa.gov/nerlesd1/bios/daughton/EnvInt2008.pdf
  • 11. 10 Major Unknown What fractions of drug residues occurring in the ambient environment result from discarding leftover drugs? No studies provided objective data from well-defined populations to support any type of conclusion Data are needed on the types, quantities, and frequencies with which drugs accumulate as household waste
  • 12. Summary of API Masses Disposed to Sewerage by a Coroner Office during a 12-Month Period: Categorized by Therapeutic Class Ruhoy IS and Daughton CG "Beyond the Medicine Cabinet: An Analysis of Where and Why Medications Accumulate," Environ. Internat., 2008, 34(8):1157-1169; doi:10.1016/j.envint.2008.05.002; available: www.epa.gov/nerlesd1/bios/daughton/EnvInt2008.pdf