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 PPI staff operate Small Business Environmental Assistance Program or SBEAP Program services are Program services are –Site visits –Hotline –Workshops –Newsletters –Multimedia (cover air permits, haz waste, and water regulations, integrating pollution prevention) –Free –Confidential H2E Champion H2E Champion

Pharmacy waste management Supported by Bureau of Water at KDHE Supported by Bureau of Water at KDHE Target audience is LTC facilities Target audience is LTC facilities Research, outreach and technical assistance Research, outreach and technical assistance –Hotline –Site visits Seeking professional input for solutions Seeking professional input for solutions

Web cast objectives Understand the environmental impacts related to pharmacy waste management. Understand the environmental impacts related to pharmacy waste management. Identify practices that contribute to the problem. Identify practices that contribute to the problem. Alternative pharmacy waste management requirements and/or the best management practices. Alternative pharmacy waste management requirements and/or the best management practices. Identify available resources related to pharmaceutical waste management questions. Identify available resources related to pharmaceutical waste management questions.

Pharmacy waste management, an emerging issue The water connection The water connection –Becky Gagnon-Lewis Why is this an issue? Why is this an issue? What pharmaceuticals are regulated RCRA What pharmaceuticals are regulated RCRA Hierarchy of Rx waste management Hierarchy of Rx waste management Resources Resources Questions and answers Questions and answers

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

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

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 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 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 Pass through the treatment plant and enter the receiving stream aquatic environment

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

Potential regulatory control Pharmaceutical Manufacturers already regulated by EPA Effluent Guidelines Pharmaceutical Manufacturers already regulated by EPA Effluent Guidelines 2008 EPA Effluent Guideline Study 2008 EPA Effluent Guideline Study Proposed Guidelines may include discharge restrictions for Health care facilities Proposed Guidelines may include discharge restrictions for Health care facilities 30/w21310.pdf 30/w21310.pdf

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

Never down the drain

What practices are harmful? Any drain disposal practices need to be eliminated Any drain disposal practices need to be eliminated Direct conduit to the our rivers and water bodies Direct conduit to the our rivers and water bodies Eliminate land filling when possible Eliminate land filling when possible What about DEA restrictions on controlled substances? What about DEA restrictions on controlled substances?

NEW KDHE Guidance New technical guidance document at sw07-01.pdf New technical guidance document at sw07-01.pdf sw07-01.pdf 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 ml KS Board of pharmacy has similar guidance on their Web site at ml ml ml

Waste management hierarchy New KDHE guidance Waste minimization Waste minimization Reverse distribution Reverse distribution Collection events or programs Collection events or programs Incineration* Incineration* Hazardous waste landfill Hazardous waste landfill Render non-recoverable and landfill Render non-recoverable and landfill Sanitary sewer (last resort option for disposal) Sanitary sewer (last resort option for disposal)

Emerging issue for healthcare Hospitals, larger sources, just now beginning to recognize this as an issue 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 Dec 6, 2007 in KC, Kansas

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

What is RCRA Resource Conservation Recovery Act Resource Conservation Recovery Act Hazardous waste regulation Hazardous waste regulation Generator has cradle to grave responsibility 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 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

Categories of RCRA Hazardous Wastes Listed Wastes Listed Wastes –U-listed – toxic –P-listed - acutely hazardous Characteristic Wastes Characteristic Wastes –Specific measurable properties Ignitable Ignitable Corrosive Corrosive Reactive Reactive Toxic Toxic

P-Listed Wastes P-Listed Wastes P-Listed Wastes –Sole active ingredient –Unused – drug has not been given to a patient Empty Containers 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

Examples of P-Listed Pharmaceutical Waste Arsenic trioxideP012 Arsenic trioxideP012 Epinephrine (non-salts) P042 Epinephrine (non-salts) P042 NicotineP075 NicotineP075 Nitroglycerin*P081 Nitroglycerin*P081 Phentermine (CIV)P046 Phentermine (CIV)P046 Physostigmine P204 Physostigmine P204 Physostigmine SalicylateP188 Physostigmine SalicylateP188 Warfarin >0.3%P001 Warfarin >0.3%P001 * Excluded from the P list federally and in a number of states if in final dosage forms, including Kansas

Examples of U-listed Pharmaceutical Waste* Examples of U-listed Pharmaceutical Waste* Chloral Hydrate(CIV)U034 Chloral Hydrate(CIV)U034 Chlorambucil*U035 Chlorambucil*U035 Cyclophosphamide*U058 Cyclophosphamide*U058 Daunomycin*U059 Daunomycin*U059 Diethylstilbestrol*U089 Diethylstilbestrol*U089 Melphalan*U150 Melphalan*U150 Mitomycin C *U010 Mitomycin C *U010 StreptozotocinU206 StreptozotocinU206 LindaneU129 LindaneU129 SaccharinU202 SaccharinU202 Selenium SulfideU205 Selenium SulfideU205 Uracil Mustard*U237 Uracil Mustard*U237 Warfarin<0.3%U248 Warfarin<0.3%U248 *Chemotherapy agents

Characteristic Hazardous Waste Ignitable 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 Potassium permanganate and silver nitrate –Compressed gases

Characteristic Hazardous Waste Corrosive Corrosive –pH of less than or equal to 2 (highly acidic) –pH greater than or equal to 12.5 (highly basic) Reactive Reactive Toxic Toxic –10 of the 40 Toxicity Characteristic (TC) chemicals and heavy metals are found in drug formulations –Silver, barium or other metals compounds

Regulated levels Based on monthly waste generation Based on monthly waste generation P-Listed waste regulated at 2.2 lbs/month P-Listed waste regulated at 2.2 lbs/month Others regulated at 55 lbs/month Others regulated at 55 lbs/month Categories of generators in KS Categories of generators in KS –SQG –KSG –EPAG

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 LTC facilities do not generate enough hazardous waste total to be regulated hazardous waste generators. Most are non-regulated SQGs. Most are non-regulated SQGs. SQG have disposal options SQG have disposal options –Reverse distribution, collection programs, the landfill and only as a last resort (with written approval), the sewer.

SQGs in Sedgwick County Can use the Household Hazardous Waste program services Can use the Household Hazardous Waste program services –Contact in Sedgwick county Can not take controlled substances Can not take controlled substances

Pharm waste regulators KDHE under RCRA KDHE under RCRA –Just detailed regulatory level Kansas Department on Aging Kansas Department on Aging Board of Pharmacy Board of Pharmacy –Concurs with KDHE and DEA guidelines Drug Enforcement Agency Drug Enforcement Agency –Judy Williams, DEA contact for BOP –21 CFR

Code of Federal Regulations DISPOSAL OF CONTROLLED SUBSTANCES DISPOSAL OF CONTROLLED SUBSTANCES Section Procedure for disposing of controlled substances. Section 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: (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 … (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 …

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. 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

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). 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. 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. 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.

Controlled substances disposal Non-RCRA or KDHE regulated Non-RCRA or KDHE regulated DEA approval of land fill option DEA approval of land fill option BOP approval of land fill option BOP approval of land fill option Kansas Department on Aging Kansas Department on Aging

Pharmacy Services Caryl Gill, RN, BSN Kansas Department on Aging December 13, 2007

Pharmacy Services CFR , F425 Pharmaceutical Services Pharmaceutical Services A facility must provide pharmaceutical services to meet the needs of each resident. A facility must provide pharmaceutical services to meet the needs of each resident. What constitutes Pharmaceutical Services What constitutes Pharmaceutical Services Definition of Disposition Definition of Disposition Services of a licensed pharmacist Services of a licensed pharmacist Procedures addressing the disposition of medications Procedures addressing the disposition of medications

State Regulations Accountability and disposition Accountability and disposition KAR (f)-Nursing Facilities KAR (f)-Nursing Facilities KAR (f)(3) Role of the pharmacist-Nursing Facilities KAR (f)(3) Role of the pharmacist-Nursing Facilities KAR (f)(5)-Assisted Living and Residential Health Care KAR (f)(5)-Assisted Living and Residential Health Care KAR (f)(5)-Home Plus KAR (f)(5)-Home Plus KAR (f)(5)-Adult Day Care KAR (f)(5)-Adult Day Care

Waste minimization opportunities Use return processors Use return processors Ask “what is being wasted?” Ask “what is being wasted?” Shelf life > 1 year Shelf life > 1 year Minimize samples that might expire Minimize samples that might expire Work with doctors and suppliers to control inventory and decrease waste Work with doctors and suppliers to control inventory and decrease waste Eliminate drain disposal practices Eliminate drain disposal practices

Spread the word to others Nurses Nurses Safety committees Safety committees Pharmacy – set policy and training Pharmacy – set policy and training Patients Patients Share guidance or posters Share guidance or posters

Resources –HERC pharmacy waste guidance –Blue print online.org/docs/h2epharmablueprint41506.pdf online.org/docs/h2epharmablueprint41506.pdf online.org/docs/h2epharmablueprint41506.pdf –Pharmaceutical waste webpage: –BOP newsletters –Your pharmacist

Kansas resource Pollution Prevention Institute Pollution Prevention Institute Technical assistance Technical assistance –Confidential –Free – ask for Nancy – ask for Nancy Question and Answer period – operator assisted Question and Answer period – operator assisted