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The Proper Place for Pharmacy Waste

The Proper Place for Pharmacy Waste. Keeping pharmaceuticals out of our waterways. K-State’s Pollution Prevention Institute (PPI). PPI staff operate Small Business Environmental Assistance Program or SBEAP Program services are Site visits Hotline Workshops Newsletters

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The Proper Place for Pharmacy Waste

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  1. The Proper Place for Pharmacy Waste Keeping pharmaceuticals out of our waterways

  2. K-State’s Pollution Prevention Institute (PPI) • PPI staff operate Small Business Environmental Assistance Program or SBEAP • Program services are • Site visits • Hotline • Workshops • Newsletters • Multimedia (cover air permits, haz waste, and water regulations, integrating pollution prevention) • Free • Confidential • H2E Champion www.sbeap.org 800-578-8898

  3. Pharmacy waste management • Supported by Bureau of Water at KDHE • Target audience is LTC facilities • Research, outreach and technical assistance • Hotline 800-578-8898 • Site visits • Seeking professional input for solutions www.sbeap.org 800-578-8898

  4. Web cast objectives • Understand the environmental impacts related to pharmacy waste management. • Identify practices that contribute to the problem. • Alternative pharmacy waste management requirements and/or the best management practices. • Identify available resources related to pharmaceutical waste management questions. www.sbeap.org 800-578-8898

  5. Pharmacy waste management, an emerging issue • The water connection • Becky Gagnon-Lewis • Why is this an issue? • What pharmaceuticals are regulated RCRA • Hierarchy of Rx waste management • Resources • Questions and answers www.sbeap.org 800-578-8898

  6. Pharmaceuticals – emerging contaminants in the wastewater utility Synthetic or naturally occurring chemicals or microorganisms Not commonly monitored in the environment Potential to enter the environment and cause known or suspected adverse ecological and/or human health effects May be new chemicals OR Release may have occurred for a long time, but only recently recognized as a potential problem OR New use of existing chemicals www.sbeap.org 800-578-8898

  7. Pharmaceuticals, Hormones, and other emerging contaminants study in US Streams Study • One or more of the following chemicals were found in over 80% of the streams sampled downstream of WWTPs • 17alpha Ethynyl Estradiol (16%) - Median concentration 73 ng/l -(Effects at as low as 1 ng/l may result in feminization of male fish) • Acetaminophen (24%) • Steroids and hormones (16%) • Diltiazem (blood pressure medication) (13%) • Codeine (11%) • Antibiotics and antimicrobials (10%) • Ibuprofen (10%) www.sbeap.org 800-578-8898

  8. Risks associated with pharmaceutical disposal down the drain • Wastewater Plants are biological processes designed to treat domestic human waste - cannot treat or remove pharmaceutical chemicals • May kill beneficial bacteria responsible for breaking down waste in sewage plants and damage septic systems; contaminate water and aquatic life in surrounding environment OR • Pass through the treatment plant and enter the receiving stream aquatic environment www.sbeap.org 800-578-8898

  9. Why should we care? • Increasing Attention to Emerging Contaminants, particularly pharmaceuticals • Media • Public • Non-Governmental Organizations • Potential Impacts to Organisms at low concentrations • Persistence in the Environment – Bioaccumulation • Chronic Toxicity • Endocrine Disruption • Regulatory Control? www.sbeap.org 800-578-8898

  10. Potential regulatory control • Pharmaceutical Manufacturers already regulated by EPA Effluent Guidelines • 2008 EPA Effluent Guideline Study • Proposed Guidelines may include discharge restrictions for Health care facilities http://www.epa.gov/EPA-WATER/2007/October/Day-30/w21310.pdf www.sbeap.org 800-578-8898

  11. What is the concern? • Drugs are designed to be biologically active • Life-long trace level exposures • Impact on aquatic life • Exposure (minute concentration) through our drinking water sources • Action: prevention…is key www.sbeap.org 800-578-8898

  12. Never down the drain www.sbeap.org 800-578-8898

  13. What practices are harmful? • Any drain disposal practices need to be eliminated • Direct conduit to the our rivers and water bodies • Eliminate land filling when possible • What about DEA restrictions on controlled substances? www.sbeap.org 800-578-8898

  14. NEW KDHE Guidance • New technical guidance document at http://www.kdheks.gov/waste/guidance/sw07-01.pdf • For residents and non-regulated hazardous waste generators, like nursing homes • Hospital are generally regulated under RCRA • KS Board of pharmacy has similar guidance on their Web site at http://www.kansas.gov/pharmacy/faq.html www.sbeap.org 800-578-8898

  15. Waste management hierarchy New KDHE guidance • Waste minimization • Reverse distribution • Collection events or programs • Incineration* • Hazardous waste landfill • Render non-recoverable and landfill • Sanitary sewer (last resort option for disposal) www.sbeap.org 800-578-8898

  16. Emerging issue for healthcare • Hospitals, larger sources, just now beginning to recognize this as an issue • EPA is beginning to inspect them • Most are considered regulated under the hazardous waste regulations (RCRA) • Hospitals for a Healthy Environment Workshop and Trade Show • Dec 6, 2007 in KC, Kansas www.sbeap.org 800-578-8898

  17. What types of pharmaceuticals are RCRA hazardous or regulated wastes? The reason we administer these drugs in controlled measures, is the same reason we need to managed them carefully when discarded

  18. What is RCRA • Resource Conservation Recovery Act • Hazardous waste regulation • Generator has cradle to grave responsibility • Most LTC facilities do not fall into the regulatory category of generators, so they have options for land filling RCRA wastes • Caution facilities linked to hospitals www.sbeap.org 800-578-8898

  19. Categories of RCRA Hazardous Wastes • Listed Wastes • U-listed – toxic • P-listed - acutely hazardous • Characteristic Wastes • Specific measurable properties • Ignitable • Corrosive • Reactive • Toxic www.sbeap.org 800-578-8898

  20. P-Listed Wastes • P-Listed Wastes • Sole active ingredient • Unused – drug has not been given to a patient • Empty Containers • Must be triple rinsed to be RCRC empty • Rinsate managed as hazardous waste • Rinsing generally not practical for pharmaceutical waste • Generally easier to manage container as hazardous waste www.sbeap.org 800-578-8898

  21. Examples of P-Listed Pharmaceutical Waste • Arsenic trioxide P012 • Epinephrine (non-salts) P042 • Nicotine P075 • Nitroglycerin* P081 • Phentermine (CIV) P046 • Physostigmine P204 • Physostigmine Salicylate P188 • Warfarin >0.3% P001 * Excluded from the P list federally and in a number of states if in final dosage forms, including Kansas www.sbeap.org 800-578-8898

  22. Chloral Hydrate(CIV) U034 Chlorambucil * U035 Cyclophosphamide* U058 Daunomycin* U059 Diethylstilbestrol* U089 Melphalan* U150 Mitomycin C * U010 Streptozotocin U206 Lindane U129 Saccharin U202 Selenium Sulfide U205 Uracil Mustard* U237 Warfarin<0.3% U248 Examples of U-listed Pharmaceutical Waste* *Chemotherapy agents www.sbeap.org 800-578-8898

  23. Characteristic Hazardous Waste • Ignitable • Aqueous solutions with 24% or more alcohol and a flashpoint less than 140°F • Non-aqueous drug formulations with flashpoint less than 140° F • Strong oxidizers • Potassium permanganate and silver nitrate • Compressed gases www.sbeap.org 800-578-8898

  24. Characteristic Hazardous Waste • Corrosive • pH of less than or equal to 2 (highly acidic) • pH greater than or equal to 12.5 (highly basic) • Reactive • Toxic • 10 of the 40 Toxicity Characteristic (TC) chemicals and heavy metals are found in drug formulations • Silver, barium or other metals compounds www.sbeap.org 800-578-8898

  25. Regulated levels • Based on monthly waste generation • P-Listed waste regulated at 2.2 lbs/month • Others regulated at 55 lbs/month • Categories of generators in KS • SQG • KSG • EPAG www.sbeap.org 800-578-8898

  26. Are long-term care facilities regulated under RCRA? • Most LTC facilities do not generate enough hazardous waste total to be regulated hazardous waste generators. • Most are non-regulated SQGs. • SQG have disposal options • Reverse distribution, collection programs, the landfill and only as a last resort (with written approval), the sewer. www.sbeap.org 800-578-8898

  27. SQGs in Sedgwick County • Can use the Household Hazardous Waste program services • Contact 316-6607464 in Sedgwick county • Can not take controlled substances www.sbeap.org 800-578-8898

  28. Pharm waste regulators • KDHE under RCRA • Just detailed regulatory level • Kansas Department on Aging • Board of Pharmacy • Concurs with KDHE and DEA guidelines • Drug Enforcement Agency • Judy Williams, DEA contact for BOP • 21 CFR 1307.21 www.sbeap.org 800-578-8898

  29. Code of Federal Regulations • DISPOSAL OF CONTROLLED SUBSTANCES • Section 1307.21 Procedure for disposing of controlled substances. • (a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance. The request should be made as follows: • (1) If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area; or … www.sbeap.org 800-578-8898

  30. Can a long term care facility (LTCF) return a resident’s unused controlled substance medication to a pharmacy? • Answer: No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., resident of a LTCF). Most long term care facilities are not licensed by their respective state to handle controlled substances and therefore are not registered with DEA. Long term care facilities act in a custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal. • http://www.deadiversion.usdoj.gov/faq/general.htm#5 www.sbeap.org 800-578-8898

  31. Can an individual return their controlled substance prescription medication to a pharmacy? • Answer: No. An individual patient may not return their unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return their controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e. individual patient). • The CFR does have a provision for an individual to return their unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred. • An individual may dispose of their own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications. www.sbeap.org 800-578-8898

  32. Controlled substances disposal • Non-RCRA or KDHE regulated • DEA approval of land fill option • BOP approval of land fill option • Kansas Department on Aging www.sbeap.org 800-578-8898

  33. Pharmacy Services Caryl Gill, RN, BSN Kansas Department on Aging December 13, 2007 www.sbeap.org 800-578-8898

  34. Pharmacy ServicesCFR 483.60, F425 • Pharmaceutical Services • A facility must provide pharmaceutical services to meet the needs of each resident. • What constitutes Pharmaceutical Services • Definition of Disposition • Services of a licensed pharmacist • Procedures addressing the disposition of medications www.sbeap.org 800-578-8898

  35. State Regulations • Accountability and disposition • KAR 28-39-156 (f)-Nursing Facilities • KAR 28-39-156 (f)(3) Role of the pharmacist-Nursing Facilities • KAR 28-39-247(f)(5)-Assisted Living and Residential Health Care • KAR 28-39-436 (f)(5)-Home Plus • KAR 28-39-282(f)(5)-Adult Day Care www.sbeap.org 800-578-8898

  36. http://www.kslegislature.org/supplemental/2008/SN2578.pdf www.sbeap.org 800-578-8898

  37. http://www.kansas.gov/pharmacy/Newsletters/March2006.pdf www.sbeap.org 800-578-8898

  38. Waste minimization opportunities • Use return processors • Ask “what is being wasted?” • Shelf life > 1 year • Minimize samples that might expire • Work with doctors and suppliers to control inventory and decrease waste • Eliminate drain disposal practices www.sbeap.org 800-578-8898

  39. Spread the word to others • Nurses • Safety committees • Pharmacy – set policy and training • Patients • Share guidance or posters www.sbeap.org 800-578-8898

  40. www.sbeap.org 800-578-8898

  41. Resources • HERC pharmacy waste guidance http://www.hercenter.org/hazmat/pharma.cfm • Blue print http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf • Pharmaceutical waste webpage: • http://www.h2e-online.org/hazmat/pharma.html • BOP newsletters - http://www.kansas.gov/pharmacy/Newsletters/March2006.pdf • Your pharmacist www.sbeap.org 800-578-8898

  42. Kansas resource • Pollution Prevention Institute • Technical assistance • Confidential • Free • 800-578-8898 – ask for Nancy • Question and Answer period – operator assisted www.sbeap.org 800-578-8898

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