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Reasons for Concerns GreenPharmEdu.org
Reasons for concern: Environmental Drug Abuse- A rising concern Teens Internet  Child and Pet accidental ingestion Chemo Concerns
Environmental Large quantities of PPCPs can enter the environment after use by individuals or domestic animals. Sewage systems are not equipped for PPCP removal. Currently, there are no municipal sewage treatment plants that are engineered specifically for PPCP removal or for other unregulated contaminants.  Effective removal of PPCPs from treatment plants varies based on the type of chemical and on the individual sewage treatment facilities. The number of PPCPs are growing. In addition to antibiotics and steroids, over 100 individual PPCPs have been identified (as of 2007) in environmental samples and drinking water.
Environmental cont. The risks are uncertain.  The risks posed to aquatic organisms, and to humans are unknown, largely because the concentrations are so low.  While the major concerns have been the resistance to antibiotics and disruption of aquatic endocrine systems (the system of glands that produce hormones that help control the body's metabolic activity) by natural and synthetic sex steroids, many other PPCPs have unknown consequences.  There are no known human health effects from such low-level exposures in drinking water, but special scenarios (one example being fetal exposure to low levels of medications that a mother would ordinarily be avoiding) require more investigation.
Environmental cont. Studies have shown that pharmaceuticals are present in some of our nation's waterbodies. Further research suggests that there may be some ecological harm when certain drugs are present.  To date, no evidence has been found of human health effects from PPCPs in the environment.
Environmental cont. According to the EPA, previous studies have documented that wastewater from sewage treatment plants contains a variety of pharmaceuticals and other organic-wastewater contaminants.  As a result, increased attention is being given to the use of reclaimed water as a potential source for such contaminants in the environment.
Environmental cont. The EPA website refers to an article written by United States Geological Survey (USGS) scientists.  This article states that pharmaceuticals have been found in soil that had been irrigated with reclaimed water. According to the study, published in the International Journal of Environmental Toxicology and Chemistry, titled “Presence and distribution of wastewater-derived pharmaceuticals in soil irrigated with reclaimed water”, found that reclaimed-water irrigation results in soil pharmaceutical concentrations that vary through the irrigation season and that some compounds persist for months after irrigation. (6)  This persistent contamination of the soils in which food is grown leads to more uncertainty of the risks to human and wildlife.
Drug Abuse Per the National Survey on Drug Use and Health: In 2000, 3.8 million Americans abused prescription drugs compared with 6.9 million in 2007; an 82% increase. The Centers for Disease Control and Prevention (CDC) reports in Reuters Health (February 8, 2007) that unintentional deaths due to drug poisoning, primarily with prescription drugs, increased 68.3 percent between 1999 and 2004.
Drug Abuse cont. Drug poisoning is second only to motor vehicle crashes as a cause of death from unintentional injury in the U.S. The CDC’s Injury Center reports on its website that among people 35 to 54 years old, unintentional poisoning caused more deaths than motor vehicle crashes.  The Injury Center also reports that in 2006, unintentional poisoning caused over 700,000 emergency department visits, with almost 25 percent of those resulting in hospitalization or transfer to another facility.
Teen Drug Abuse Abuse of prescription and Over-the-counter (OTC) medications by teens is an emerging issue. For many teens, using prescription or over-the-counter medications is their first introduction to getting high. Until recently, teens began their drug use with marijuana.  Millions of teens are using very powerful pain medications to get high.  Some of these are the same medications doctors use to treat pain in terminal cancer patients
Teen Drug Abuse cont. Many teens obtain illegal drugs, particularly prescription drugs, from their families, friends, or relatives.  Since prescription drugs are widely available in the home, teens often do not have to go far to find ways to get high.  Other teens turn to the Internet for prescription drugs, and the world wide web plays a big role in providing information and advice to teens.
Drug Abuse: Internet Some pharmacies operating on the Internet are legal, and some are not.  Some of the legal Internet pharmacies have voluntarily sought certification as “Verified Internet Pharmacy Practice Sites” (VIPPS®) from the National Association of Boards of Pharmacies.  “Rogue” pharmacies pretend to be authentic by operating websites that advertise powerful drugs without a prescription or with the “approval” of a “doctor” working for the drug trafficking network.
Drug Abuse: Reporting Confidential reports by dialing toll free 1-877-RxAbuse (1-877-792-2873) around the clock, 365 days per year.  The hotline will be staffed by bilingual operators employed by DEA.  This is a toll-free call from Mexico as well.
Drug Abuse: Prevention Dispose of your prescription drugs when they are no longer needed. Federal guidelines recommend ways to do this: Take unused, unneeded or expired prescription drugs out of their original containers and throw them in the trash.  Mixing prescription drugs with an undesirable substance, such as used coffee grounds or kitty litter, and putting them in impermeable, non-descript containers, such as empty cans or sealable bags, will further ensure the drugs are not diverted.
Child and Pet accidental ingestion While the FDA suggests certain medications that are especially toxic if accidentally ingested be flushed when expired or of no use, a website called Smart Disposal (http://www.smarxtdisposal.net/ ) suggests otherwise.   Smart Disposal is a collaborative effort between the US Fish and Wildlife Service, American Pharmacists Association (APhA), and Pharmaceutical Research and Manufacturers of America (PhRMA).   They suggest disposing of unused and expired pharmaceuticals, including pet prescriptions, in a plastic bag, adding water and something unpalatable, such as kitty litter or coffee grounds and finally disposing of it in the trash.   Drug take-back programs are also mentioned as an alternative.  This will be addressed later in this module.
“Not” Smart Disposal When pills are simply thrown in the trash without additional steps and precautions, it can lead to unintended exposure to people or animals: People may go through the trash to obtain unused medications or personal information found on discarded prescription bottles, also called "dumpster diving"  Additionally, if trash is not securely closed, scavenging animals may accidentally eat discarded medicines along with food items they find in the garbage or at a landfill.  Also, trash occasionally spills, allowing loose pills to reach the environment where they could pose a risk to fish and wildlife.
Smart Disposal Both Smart Disposal and FDA’s Director of Pharmacy Affairs recommend extra steps to secure personal information.   This includes removal of personal information from medication containers by scratching out or removing label.  For you tree huggers, you can then recycle the bottles.
Chemo Concerns (1) Occupational exposure to anti-neoplastic agents has been well-documented, especially direct exposure involved in the compounding,  preparation,  administration,  and disposal  of these highly toxic chemicals.
Chemo Concerns (2) Human excretion of chemotherapeutic agents presents unique concerns of unintended exposure to pharmaceuticals. Potential for subsequent incidental exposures for others and higher risks than for other drugs because of the extreme cytotoxicity and mutagenicity of oncolytics. Of the many routes of exposure, however, the excretion of residues via sweat (and breathing) of patients is least understood.  Excretion of chemotherapeutics via sweat is well established, but its overall significance as a secondary route of exposure for others is not.  Excretion via sweat also plays a role in the development of hypersensitivity to certain other drugs since it ensures skin contact with drugs not intended for dermal application.
Chemo Concerns (3) Research provides strong indirect evidence that sweat conveys chemotherapeutics outside the body.  These studies have focused on occupational exposure, where bedding becomes contaminated and serves as a route of exposure for healthcare workers Especially those working outside hospitals, such as homecare providers; workers in laundry facilities were noted as having the potential for higher exposures to antineoplastics than oncology nurses during the handling of bed sheets.
Chemo Concerns (4) The trend towards dermal application of drugs is likely to increase the probability of drugs being introduced into the environment from bathing to discarding the used delivery devices which contain very high levels of residues. For recent literature regarding PPCPs in our environment and risk, please see the U.S. Environmental Protection Agency website: http://www.epa.gov/ppcp/lit.html

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2.3. Evidence for Ecotoxicity (Ruhoy)2.3. Evidence for Ecotoxicity (Ruhoy)
2.3. Evidence for Ecotoxicity (Ruhoy)
 
5.5. State Regulations and Guidance (Batz)
5.5. State Regulations and Guidance (Batz)5.5. State Regulations and Guidance (Batz)
5.5. State Regulations and Guidance (Batz)
 
5.4. Federal Regulations (Batz)
5.4. Federal Regulations (Batz)5.4. Federal Regulations (Batz)
5.4. Federal Regulations (Batz)
 
5.6. Conclusion (Batz)
5.6. Conclusion (Batz)5.6. Conclusion (Batz)
5.6. Conclusion (Batz)
 
5.1. Introduction (Batz)
5.1. Introduction (Batz)5.1. Introduction (Batz)
5.1. Introduction (Batz)
 
2.6. Reducing Unused Pharmaceuticals: Conclusion (Ruhoy)
2.6. Reducing Unused Pharmaceuticals: Conclusion (Ruhoy)2.6. Reducing Unused Pharmaceuticals: Conclusion (Ruhoy)
2.6. Reducing Unused Pharmaceuticals: Conclusion (Ruhoy)
 
2.4. Environmental Impact of Disposal (Ruhoy)
2.4. Environmental Impact of Disposal (Ruhoy)2.4. Environmental Impact of Disposal (Ruhoy)
2.4. Environmental Impact of Disposal (Ruhoy)
 
2.2. Significance of Long-Term Exposure to Multiple APIs (Ruhoy)
2.2. Significance of Long-Term Exposure to Multiple APIs (Ruhoy)2.2. Significance of Long-Term Exposure to Multiple APIs (Ruhoy)
2.2. Significance of Long-Term Exposure to Multiple APIs (Ruhoy)
 
2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introductio...
2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introductio...2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introductio...
2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introductio...
 
2.5. PharmEcoVigilance (Ruhoy)
2.5. PharmEcoVigilance (Ruhoy)2.5. PharmEcoVigilance (Ruhoy)
2.5. PharmEcoVigilance (Ruhoy)
 

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5.2. Reason for Concern (Batz)

  • 1. Reasons for Concerns GreenPharmEdu.org
  • 2. Reasons for concern: Environmental Drug Abuse- A rising concern Teens Internet Child and Pet accidental ingestion Chemo Concerns
  • 3. Environmental Large quantities of PPCPs can enter the environment after use by individuals or domestic animals. Sewage systems are not equipped for PPCP removal. Currently, there are no municipal sewage treatment plants that are engineered specifically for PPCP removal or for other unregulated contaminants. Effective removal of PPCPs from treatment plants varies based on the type of chemical and on the individual sewage treatment facilities. The number of PPCPs are growing. In addition to antibiotics and steroids, over 100 individual PPCPs have been identified (as of 2007) in environmental samples and drinking water.
  • 4. Environmental cont. The risks are uncertain. The risks posed to aquatic organisms, and to humans are unknown, largely because the concentrations are so low. While the major concerns have been the resistance to antibiotics and disruption of aquatic endocrine systems (the system of glands that produce hormones that help control the body's metabolic activity) by natural and synthetic sex steroids, many other PPCPs have unknown consequences. There are no known human health effects from such low-level exposures in drinking water, but special scenarios (one example being fetal exposure to low levels of medications that a mother would ordinarily be avoiding) require more investigation.
  • 5. Environmental cont. Studies have shown that pharmaceuticals are present in some of our nation's waterbodies. Further research suggests that there may be some ecological harm when certain drugs are present. To date, no evidence has been found of human health effects from PPCPs in the environment.
  • 6. Environmental cont. According to the EPA, previous studies have documented that wastewater from sewage treatment plants contains a variety of pharmaceuticals and other organic-wastewater contaminants. As a result, increased attention is being given to the use of reclaimed water as a potential source for such contaminants in the environment.
  • 7. Environmental cont. The EPA website refers to an article written by United States Geological Survey (USGS) scientists. This article states that pharmaceuticals have been found in soil that had been irrigated with reclaimed water. According to the study, published in the International Journal of Environmental Toxicology and Chemistry, titled “Presence and distribution of wastewater-derived pharmaceuticals in soil irrigated with reclaimed water”, found that reclaimed-water irrigation results in soil pharmaceutical concentrations that vary through the irrigation season and that some compounds persist for months after irrigation. (6) This persistent contamination of the soils in which food is grown leads to more uncertainty of the risks to human and wildlife.
  • 8. Drug Abuse Per the National Survey on Drug Use and Health: In 2000, 3.8 million Americans abused prescription drugs compared with 6.9 million in 2007; an 82% increase. The Centers for Disease Control and Prevention (CDC) reports in Reuters Health (February 8, 2007) that unintentional deaths due to drug poisoning, primarily with prescription drugs, increased 68.3 percent between 1999 and 2004.
  • 9. Drug Abuse cont. Drug poisoning is second only to motor vehicle crashes as a cause of death from unintentional injury in the U.S. The CDC’s Injury Center reports on its website that among people 35 to 54 years old, unintentional poisoning caused more deaths than motor vehicle crashes. The Injury Center also reports that in 2006, unintentional poisoning caused over 700,000 emergency department visits, with almost 25 percent of those resulting in hospitalization or transfer to another facility.
  • 10. Teen Drug Abuse Abuse of prescription and Over-the-counter (OTC) medications by teens is an emerging issue. For many teens, using prescription or over-the-counter medications is their first introduction to getting high. Until recently, teens began their drug use with marijuana. Millions of teens are using very powerful pain medications to get high. Some of these are the same medications doctors use to treat pain in terminal cancer patients
  • 11. Teen Drug Abuse cont. Many teens obtain illegal drugs, particularly prescription drugs, from their families, friends, or relatives. Since prescription drugs are widely available in the home, teens often do not have to go far to find ways to get high. Other teens turn to the Internet for prescription drugs, and the world wide web plays a big role in providing information and advice to teens.
  • 12. Drug Abuse: Internet Some pharmacies operating on the Internet are legal, and some are not. Some of the legal Internet pharmacies have voluntarily sought certification as “Verified Internet Pharmacy Practice Sites” (VIPPS®) from the National Association of Boards of Pharmacies. “Rogue” pharmacies pretend to be authentic by operating websites that advertise powerful drugs without a prescription or with the “approval” of a “doctor” working for the drug trafficking network.
  • 13. Drug Abuse: Reporting Confidential reports by dialing toll free 1-877-RxAbuse (1-877-792-2873) around the clock, 365 days per year. The hotline will be staffed by bilingual operators employed by DEA. This is a toll-free call from Mexico as well.
  • 14. Drug Abuse: Prevention Dispose of your prescription drugs when they are no longer needed. Federal guidelines recommend ways to do this: Take unused, unneeded or expired prescription drugs out of their original containers and throw them in the trash. Mixing prescription drugs with an undesirable substance, such as used coffee grounds or kitty litter, and putting them in impermeable, non-descript containers, such as empty cans or sealable bags, will further ensure the drugs are not diverted.
  • 15. Child and Pet accidental ingestion While the FDA suggests certain medications that are especially toxic if accidentally ingested be flushed when expired or of no use, a website called Smart Disposal (http://www.smarxtdisposal.net/ ) suggests otherwise. Smart Disposal is a collaborative effort between the US Fish and Wildlife Service, American Pharmacists Association (APhA), and Pharmaceutical Research and Manufacturers of America (PhRMA). They suggest disposing of unused and expired pharmaceuticals, including pet prescriptions, in a plastic bag, adding water and something unpalatable, such as kitty litter or coffee grounds and finally disposing of it in the trash. Drug take-back programs are also mentioned as an alternative. This will be addressed later in this module.
  • 16. “Not” Smart Disposal When pills are simply thrown in the trash without additional steps and precautions, it can lead to unintended exposure to people or animals: People may go through the trash to obtain unused medications or personal information found on discarded prescription bottles, also called "dumpster diving" Additionally, if trash is not securely closed, scavenging animals may accidentally eat discarded medicines along with food items they find in the garbage or at a landfill. Also, trash occasionally spills, allowing loose pills to reach the environment where they could pose a risk to fish and wildlife.
  • 17. Smart Disposal Both Smart Disposal and FDA’s Director of Pharmacy Affairs recommend extra steps to secure personal information. This includes removal of personal information from medication containers by scratching out or removing label. For you tree huggers, you can then recycle the bottles.
  • 18. Chemo Concerns (1) Occupational exposure to anti-neoplastic agents has been well-documented, especially direct exposure involved in the compounding, preparation, administration, and disposal of these highly toxic chemicals.
  • 19. Chemo Concerns (2) Human excretion of chemotherapeutic agents presents unique concerns of unintended exposure to pharmaceuticals. Potential for subsequent incidental exposures for others and higher risks than for other drugs because of the extreme cytotoxicity and mutagenicity of oncolytics. Of the many routes of exposure, however, the excretion of residues via sweat (and breathing) of patients is least understood. Excretion of chemotherapeutics via sweat is well established, but its overall significance as a secondary route of exposure for others is not. Excretion via sweat also plays a role in the development of hypersensitivity to certain other drugs since it ensures skin contact with drugs not intended for dermal application.
  • 20. Chemo Concerns (3) Research provides strong indirect evidence that sweat conveys chemotherapeutics outside the body. These studies have focused on occupational exposure, where bedding becomes contaminated and serves as a route of exposure for healthcare workers Especially those working outside hospitals, such as homecare providers; workers in laundry facilities were noted as having the potential for higher exposures to antineoplastics than oncology nurses during the handling of bed sheets.
  • 21. Chemo Concerns (4) The trend towards dermal application of drugs is likely to increase the probability of drugs being introduced into the environment from bathing to discarding the used delivery devices which contain very high levels of residues. For recent literature regarding PPCPs in our environment and risk, please see the U.S. Environmental Protection Agency website: http://www.epa.gov/ppcp/lit.html