Stephanie E. Hughes, P.E. (408)

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1 Stephanie E. Hughes, P.E. (408)

2 Learning Objectives Understand the environmental and social burdens of pharmaceutical waste Recognize the complexity of pharmaceutical pollution Distinguish between upstream and downstream solutions Learn how to minimize the risks associated with hospice pharmaceuticals Gain resources to advocate for proper medication disposal with hospice patients.

3 Your instructor and this presentation have been approved by the California Board of Registered Nurses All participants are eligible to obtain a certificate for 1.0 contact hour of continuing education

4 Certification of Completion Proper Disposal of Unwanted Medications 1.0 Contact Hour This is to certify that: First and Last Name Has completed the above educational training. Provider approved by the California Board of Registered Nursing, Provider #CEP for 1.0 Contact Hours. This certificate must be retained by the licensee for a period of four years after the course ends. Stephanie Hughes, Instructor Date

5 Today s Discussion Introduce myself and the funders of today s webinar Explore impacts and unintended consequences of unused pharmaceuticals Review a local inventory of unwanted pharmaceuticals Discuss upstream and downstream solutions What you can do to help families of hospice patients

6 About me, Stephanie Hughes Registered Chemical Engineer B.S. Chemical Engineering, University of Minnesota M.S. Chemical Engineering, Stanford M.S. Environmental Engineering, Stanford More than 20 years of experience in environmental engineering and water quality Consultant to wastewater agencies throughout California regarding pollutant source identification and pollution prevention Lecturer at Santa Clara University, Dept. of Environmental Studies and Science

7 Funding today s CHAPCA webinar:

8 Provides wastewater conveyance and treatment services to residential, industrial and commercial customers throughout unincorporated Sacramento County; the cities of Citrus Heights, Elk Grove, Folsom, Rancho Cordova, Sacramento and West Sacramento; and the communities of Courtland and Walnut Grove.

9 BAPPG represents Bay Area sewage treatment plants Serve 7 million people in 9-county Bay Area Treat domestic, commercial, and industrial wastewater Collaborate to conduct educational programs to ensure long-term stewardship of the San Francisco Bay Estuary.

10 39 wastewater treatment plants discharge into San Francisco Bay and treat 620,000,000 gallons of wastewater every day from homes, industry and businesses

11 In the USA, 16,000 wastewater treatment plants discharge into local water bodies and treat billions of gallons of wastewater every day from homes, industry and businesses

12 Treated wastewater is released into a local water body or recycled / reclaimed for irrigation and other purposes

13 1. Childhood poisoning 2. Theft, Abuse, Misuse 3. Excessive accumulation of unwanted drugs 4. Unintended environmental exposure 5. Inappropriate international donations

14 With increases in prescriptions and population, the issue will only grow Overall Population growth in the US between 1992 and 2003 Increased 13% Number of prescriptions written for noncontrolled drugs Increased 57% Number of prescriptions filled for controlled drugs Increased 154% National Center on Addiction and Substance Abuse at Columbia University (CASA)

15 1. Childhood Poisoning 2,500,000 human exposures in 2005 (AAPCC) 51% of all poisoning exposures were due to pharmaceuticals 41.6% involved children less than 6 years of age 14.9% involved minors aged 6 to 19 years 34 % involved adults over 20 years of age

16 2. Increased Abuse Number of people admitted to hospitals abusing controlled prescription drugs Increased 90% Among 12 to 17 year olds Increased 203% Among those greater than 18-years old Increase 78% From 1992 to 2003, based on a study from the National Center on Addiction and Substance Abuse at Columbia University (CASA)

17 Abuse and Misuse From 1992 to 2003 Teenage use of Alprazolam, oxycodone, and methylphenidate Increased 212% Teenager addicted to opioids, CNS depressants or stimulants Increased 15% Total # of Americans abusing controlled prescription drugs 15.1 million Exceeds the combined number abusing: cocaine (5.9 million), hallucinogens (4.0 million), inhalants (2.1 million), heroin (.3 million).

18 Prescription Drug Abuse County ME Substances involved in Substance Abuse Questions from Top 10 Categories Only Northern New England Poison Center's SASRS Database Count N = 68,792 Group Name Opioids Benzodiazepines/Benzodiazepine-like Non-Opioid Analgesics without sedatives (aspirin, Tylenol ) Unknown Drug Antidepressants Cardiovascular (Heart) Skeletal Muscle Relaxants Stimulants and Street Drugs Antibiotics and Other Anti-infectives, Vaccines Other Drug (Chemotherapy, Radiopharmaceuticals, Diagnostic, Hormones, Antidiabetic, Antithyroid) Year

19 Crime The Federal ONDCP recognizes the connection between the accumulation of medicines in the home and the potential for diversion and abuse. Hydrocodone and oxycodone are implicated in 28% of all drug related crime. Methylphenidate and dextromethorphan are implicated in 19% of all drug related crime.

20 3. Household Accumulations Number of Medications Respondent s Household Members Have Number of P or NP Meds Prescription Nonprescription % 11.7% % 13.0% % 15.6% % 12.6% % 23.8% % 23.3% Mean Std. Dev (3.8) (4.4) MEDICATION DISPOSAL SURVEY Report (2010)

21 4. Environmental Exposures Correlate to Endocrine Disruption and Toxicity Prozac and Luvox induce spawning in bivalves at significantly low concentrations Fluoxetine enhances the release of ovary-stimulating hormones in crayfish Diclofenac has been proven to be toxic to vultures, decimating populations in the Indian subcontinent due to its ubiquitous use in cattle

22 Primary Sex Characteristic Example: Testicular Cell Tissue normal male flounder intersex male flounder Matthiessen P, Allen YT, Allchin CR, Feist SW, Kirby MF, Law RJ, Scott AP, Thain JE, Thomas KV. (1998) Oestrogenic endocrine disruption in flounder (Platichthys flesus L.) from United Kingdom estuarine and marine waters. Science Series, Technical Report No Centre for Environment, Fisheries and Aquaculture Science]

23 Secondary Sex Characteristics Male Female Female with male characteristics Secondary sex characteristics may also be affected by EDCs. Above left is a male fathead minnow. Above middle is a female fathead minnow. Far right is a female minnow that developed male nose markings following exposure to androgenic EDCs. (Provided by G. Ankley, U.S. EPA, Duluth, MN)

24 More examples SSRIs elicit aggressive behavior in lobsters, causing subordinates to engage in fighting against the dominant member, and reducing the propensity to retreat induce spawning in shellfish Calcium channel blockers (lowers blood pressure) dramatically inhibit sperm activity in Atlantic croaker Clofibrate (lowers cholesterol) cause high production of estrogen in juvenile zebra fish at concentrations present in Chesapeake Bay

25 5. Inappropriate Humanitarian Drug Donations Armenia, ,000 tons of drugs and medical supplies worth US$ 55 million were sent. It took 50 people six months to gain a clear picture of the drugs that had been received. 8% had expired on arrival 4% were destroyed by frost Of the remaining 88% only 30% were easy to identify 42% were relevant for an emergency situation.

26 Inappropriate Humanitarian Drug Donations France, 1991 Pharmaciens Sans Frontières collected 4 million kg of unused drugs from 4,000 pharmacies Sorted in 88 centers around the country Only about 20% could be used for international aid programs Remaining 80% incinerated instead

27

28 Based on a Bay Area survey, these are the top medications needing disposal In 2009, surveyed 3 out of 126 Bay Area drop-off sites, and gathered 2 months of disposed material.

29

30

31 Medications by Sub-therapeutic Class Top Sub-therapeutic Class Therapeutic Class % Analgesics CNS 12.4% Bronchodilators Respiratory 12.4% Dermatological agents Topical 5.4% Cardiovascular agents NTA Cardiovascular 3.9% Antipsychotics Psychotherapeutic 3.8% Anxiolytics, sedatives, and hypnotics Psychotherapeutic 3.5% Antihistamine Respiratory 2.7% Nasal preparations Topical 2.3% Vitamins Nutritional 2.1% Antidepressants Psychotherapeutic 2.1% Laxatives Gastrointestinal 2.1% Minerals and electrolytes Nutritional 2.1% Respiratory agents NTA Respiratory 2.1% Ophthalmic preparations Topical 2%

32 Most Common Medications Returned

33 Powders 3% Injectables 4% Ointments 6% Inhalers 2% Suppositories 1% Patch 1% Dosage Form Liquids 26% Pills 57%

34 Expired? 21% Expired Not Expired 79%

35 Packaging is a HUGE part of the disposed volume What are the disposal implications?

36 Upstream vs. Downstream

37 What are upstream solutions? Manufacturer product stewardship Consider fate of products Pollution Prevention Controlling at the source

38 Cradle to Cradle Medicine In theory, waste occurs when the prescription isn t effective. If we get to the point where we have no leftover drugs, will that lead to improved therapeutic outcomes? Learning about what is unused will improve the quality of medical care

39 Medical staff are part of the UPSTREAM solution Moderate prescribing and dispensing patterns of p.r.n. medications. At discharge or transfer to another facility, give remaining medications to the patient or new facility to use. Single Dose electronic dispensing

40 What about downstream? What should one do with unwanted medications? Should we flush down the toilet or not? It depends

41 There are major concerns with flushing Sewage systems are not designed to remove these medicines from water 80 percent of US waterways contain measurable amounts of human medicines. Fish and other aquatic animals have shown adverse effects from pharmaceuticals and other chemicals

42 Wastewater treatment plants are designed to remove certain pollutants Examples: human waste, food waste, biodegradable soaps but not others, such as Pharmaceuticals Anti-bacterial soap Metals Pesticides

43 Meanwhile, due to potential single-dose toxicity, the FDA considers especially harmful drugs to be flushable Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are used by someone other than the person the medicine was prescribed for. For this reason, a few medicines have special disposal directions that indicate they should be flushed down the sink or toilet after the medicine is no longer needed.

44 The FDA recommends flushing these meds: Medicine Active Ingredient Abstral, tablets Actiq, oral transmucosal lozenge * Avinza, capsules (extended release) Buprenorphine Hydrochloride,, Naloxone Hydrochloride, tablets Butrans, transdermal patch system Daytrana, transdermal patch system Demerol, tablets and oral solution * Diastat/Diastat AcuDial, rectal gel Dilaudid, tablets and oral liquid* Dolophine Hydrochloride, tablets * Duragesic, patch (extended release) * Embeda, capsules (extended release) Fentanyl Fentanyl Citrate Morphine Sulfate Buprenorphine Hydrochloride, Naloxone Hydrochloride Buprenorphine Methylphenidate Meperidine Hydrochloride Diazepam Hydromorphone Hydrochloride Methadone Hydrochloride Fentanyl Morphine Sulfate; Naltrexone Hydrochloride

45 FDA s List, cont d (page 2 of 3) Medicine Active Ingredient Exalgo, tablets (extended release) Fentora, tablets (buccal) Kadian, capsules (extended release) Hydromorphone Hydrochloride Fentanyl Citrate Morphine Sulfate Methadone Hydrochloride, oral solution* Methadone Hydrochloride Methadose, tablets * Morphine Sulfate, tablets (immediate release) * Morphine Sulfate, oral solution * MS Contin, tablets (extended release) * Nucynta ER, tablets (extended release) Onsolis, soluble film (buccal) Opana, tablets (immediate release) Opana ER, tablets (extended release) Methadone Hydrochloride Morphine Sulfate Morphine Sulfate Morphine Sulfate Morphine Sulfate Fentanyl Citrate Oxymorphone Hydrochloride Oxymorphone Hydrochloride

46 FDA s List, cont d (page 3 of 3) Medicine Oxecta, tablets (immediate release) Oxycodone Hydrochloride, capsules Oxycodone Hydrochloride, oral solution Oxycontin, tablets (extended release) * Percocet, tablets * Active Ingredient Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Oxycodone Hydrochloride Acetaminophen; Oxycodone Hydrochloride Percodan, tablets * Suboxone Xyrem, oral solution Zubsolv, tablets Aspirin; Oxycodone Hydrochloride Buprenorphine Hydrochloride, Naloxone Hydrochloride Sodium Oxybate Buprenorphine Hydrochloride, Naloxone Hydrochloride *These medicines have generic versions available or are only available in generic formulations. List revised by FDA: November 2013

47 If we aren t flushing, what are we doing? Encourage families to collect unwanted or expired medications and bring to a local collection program These medications are incinerated Eliminates impact of drain disposal Eliminates impact of landfilling

48 Take-back programs are available throughout California and Nevada Photo: Michael Macor, The Chronicle / SF

49 Today I will share a number of resources with you: Sacramento/Yolo Counties San Francisco Bay Area Alameda, Sacramento, and Santa Clara Counties Southern California (Los Angeles, Orange County, Riverside, and San Diego) Southern Nevada

50 Earth911.com Type in medication or drugs along with zip code

51 Example for San Jose, 95126

52 Sacramento and Yolo Counties:

53 San Francisco Bay Area: Type in medication or drugs along with zip code

54 For Contra Costa, Sacramento, Santa Clara, and Yolo Counties, go to:

55 Programs in these counties are being managed by the California Product Stewardship Council thanks to government grants.

56 For Southern California:

57 Southern Nevada:

58

59 When advising patients and their families to collect pharmaceuticals Consolidate pills into one container Leave ointments and liquids in original container Dispose of vitamins in the garbage

60 What about controlled substances? The DEA has JUST modified their controlled substances regulations which should expand the collection options: Take-back programs Mail-back programs Collection receptacles

61 DEA s Final Rule on Disposal of Controlled Substances Published September 9, 2014 in the Federal Register Effective October 9, ex.html Google: DEA drug diversion

62 This one-page summary has been provided to all webinar participants

63 At the DEA Drug Diversion Site:

64 Hospice-specific language from the Federal Register

65 Continued

66 Long Term Care Facility Language

67 The future of pharmaceutical disposal? Many jurisdictions are seeking manufacturer-funded take-back programs Local efforts The County of Alameda King County (Seattle-area), Washington

68 The California Pharmaceutical Stewardship Bill If enacted, this would require pharmaceutical manufacturers to develop and manage pharmaceutical collection programs in California. Authored by Hannah-Beth Jackson, Santa Barbara

69 What else can you do? Hold and reduce! Hold medications during the acute hospitalization period of up to 10 days. Continue to examine prescribing patterns decrease quantities in the event of unexpected changes discontinue medications to help eliminate unused and wasted medications

70 As a hospice professional, you can: Reduce unused accumulations Understand proper medication disposal Know where local take back sites are located Provide information to patients and their families Photo: Michael Macor, The Chronicle / SF

71 Other efforts that you and your patients can help our waterways Eliminate the use of triclosan-containing antibacterial soaps and other products Do NOT flush any wipes ( flushable or otherwise)

72

73 Products Containing Triclosan Hand soap Dish-washing products Laundry detergents and softeners Plastics (e.g., toys, cutting boards) Toothpaste Deodorants and antiperspirants Cosmetics Hair conditioners Impregnated sponges Pesticides (as an inert ingredient)

74 Triclosan is in Our Environment U.S. Geological Society found triclosan in 57% of tested U.S. waterways Acutely and chronically toxic to aquatic organisms Bioaccumulates in fish and human tissue Found in human breast milk Degrades into other toxic (dioxin-like) compounds May provide false sense of security

75 May Create an Antibiotic Resistance in Bacteria Triclosan interferes with a specific bacterial enzyme Some antibiotics targets same enzyme Example: tuberculosis antibiotic Overuse of triclosan may lead to antibacterial resistance to some of our antibiotics Antiseptics (e.g., ethyl alcohol, peroxides) simply break open the cell wall, so cannot affect antibiotic resistance Use of ethyl alcohol or peroxides is fine!

76 Are These Antibacterial Products Necessary? American Medical Association No data exist to support their efficacy Mayo Clinic a false sense of security Center for Science in the Public Interest's project on antibiotic resistance never been shown to be superior, to my knowledge, to regular soap and water"

77 Alternatives?

78

79

80 What everyone can do! Commit to a healthy lifestyle Focus on prevention Dispose unwanted medications at take-back sites Purchase drugs in small amounts Ask for medications with low environmental impact All health providers should know what to do with unused medications Take them back!

81 Consider the environment as part of our overall health care system Treating the environment and healthcare as an integral system could greatly clarify where and how to invest resources to achieve optimal outcomes. Improvements in either can lead to collateral in improvements in the other. - Christian Daughton, PhD

82 Reducing pharmaceuticals entering the environment at all levels of healthcare delivery will have personal, social and environmental benefits

83 Acknowledgements Dr. Joel Kreisberg, DC Executive Director, Teleosis Institute

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