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John A. Armitstead, MS, RPh, FASHPDirector of Pharmacy Services
University of Kentucky HealthCare Assistant Dean for Medical Center Pharmacy Services
University of Kentucky College of Pharmacy
Learning Objectives
Determine how “green” is your pharmacy Identify steps in identifying ways to minimize
the pharmaceutical impact on the environment
Counsel consumers on how to discard unwanted pharmaceuticals
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Case Example What is the Problem? Examining the types of wastes generated by
hospitals gives us an understanding of just how environmentally unfriendly health care is today. As an example, consider Nebraska Methodist Hospital (NMH), a 440-licensed-bed, not-for-profit facility located in Omaha In 2007 NMH generatedlocated in Omaha. In 2007, NMH generated approximately 125 tons of waste.
Case Example What is the Problem? Nebraska Methodist Hospital (NMH), 125 tons of
waste, broke out as follows: 80 tons of regular “brown” waste
(landfill-bound)
14 tons of “red and yellow” waste (biohazardous medical/hazardous to the incinerator) (biohazardous medical/hazardous to the incinerator)
15 tons of cardboard waste
16 tons of HIPAA document waste (shredded and sent to the landfill)
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HIPAA – Health Insurance Portability and Accountability Act
PHI (Protected Health Information) Individually identifiable health information
Control of Information/Destruction/Shredding
RCRA – Resource Conservation and Recovery Act The Resource Conservation and Recovery Act (RCRA), enacted in 1976, is
a Federal law of the United States contained in 42 U.S.C. §§6901-6992k. It is usually pronounced as "rick-rah" or "Wreck-rah." RCRA is the Unites States' primary law governing the disposal of solid and hazardous waste. Congress passed RCRA on October 21, 1976, to address the increasing problems the nation faced from our growing volume of municipal and industrial waste. g g pRCRA, which amended the Solid Waste Disposal Act of 1965, set national goals for: Protecting human health and the environment from the potential hazards of waste
disposal.
Conserving energy and natural resources.
Reducing the amount of waste generated.
Ensuring that wastes are managed in an environmentally-sound manner.
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Waste Management Team PharmacyPharmacy Nursing
Oncology, Cardiac Care, Med/Surg, ED, OR
Environmental Health and Safety Officer Housekeeping/Environmental Services Hospital Administration Hospital Administration
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Goals of the Waste Management TeamE l t t ti f li i k d t ti l hEvaluate current practice for compliance risk and potential harm
to staff.Evaluate hazardous drugs and chemicals inventory.– Chemo drugs– Drugs meeting definition of hazardous waste– Acids, bases, etc.Identify best practices and benchmark institutions.Identify best practices and benchmark institutions.Perform gap analysis of current practices to the best practices.– Identify process gaps and compare to recommendations and
regulations– Categorize gap points into High/Low risk, High/Low cost
impact
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UKH Inventory AnalysisPharmE® Inventory Analysis
Summary of Results
Fed Hazard2774%
PharmENon Hazardous
6457
Summary of Results
Fed Haz PharmE Hazardous
87011%
85%
PharmE Hazardous
Non Hazardous
UKH Inventory Analysis
Excel Columns Waste Classification Description
Product Strength Drug NameDescription
Waste Stream Description Product Label Name Primary EPA Code Reason Chemo OSHA NIOSH Alert Additional Reason Secondary EPA Code Original Key
Drug Name Categorized Categorized Information Categorized Additional Information Waste Classification Code Waste Stream Code Report Group Code Report Group Description Facility Date Reviewed Original File Original Sequence Original Key
Original NDC Additional Code Report NDC Medispan Database Status Manufacturer DEA Code Product Form Full Product Name
Original Sequence Original Generic Name Original Brand Name Original Manufacturer Original Package Size Original Strength Original Form Label/eMAR Comment
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UKH Inventory Analysis
90%
100% Non Hazardous
30%
40%
50%
60%
70%
80%
90% PharmE Hazardous
Fed Haz
0%
10%
20%
Percent by Category
1000
1200
Non Hazardous
PharmE Hazardous
Fed Haz
UKH Inventory Analysis
200
400
600
800
0
200
Products by Category
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1000
1200
Non Hazardous
PharmE Hazardous
Fed Haz
UKH Inventory Analysis
200
400
600
800
0
200
Products by Category
UKH Inventory Analysis
Taking a Look at Two Categories Antineoplastic Agents (N=295)Antineoplastic Agents (N 295)
28 Federal Hazardous Agents 245 Pharm E Hazardous Agents 22 Non-Hazardous Agents
Endocrine and Metabolic Drugs (N=636)g ( ) 42 Federal Hazard Agents 163 Pharm E Hazardous Agents 431 Non-Hazardous Agents
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UKH Inventory Analysis
Taking a Look at The AntiNeoplastics (N=295)
Product Label Name
DEXRAZOXANE INJ 250MG(N 295) 28 Federal Hazardous Agents 245 Pharm E Hazardous Agents 22 Non-Hazardous Agents
DEXRAZOXANE INJ 500MG
ELITEK INJ 1.5MG
ELITEK INJ 7.5MG
ETHYOL INJ 500MG
ETHYOL INJ 500MG
LEUCOVOR CA INJ 350MG
LEUCOVOR CA INJ 350MG
LEUCOVOR CA TAB 25MG
LEUCOVOR CA TAB 25MG
LEUCOVOR CA TAB 5MG
LEUCOVOR CA TAB 5MG
LEUCOVORIN INJ 200MG
LEUCOVORIN INJ 200MG
LEUCOVORIN INJ 350MG
MESNA INJ 1GM
MESNA INJ 1GM
MESNA INJ 1GM
MESNA INJ 1GM
MESNA INJ 1GM
MESNEX TAB 400MG
ZINECARD INJ 500MG
Pharmaceutical Waste Streams
Biohazard InfectiousWaste (Regulated
Blood products, sharps, items contaminated with liquid bloodWaste (Regulated
Medical Waste)contaminated with liquid blood,
etc.
Trace Chemo Waste Containers
RCRA empty chemotherapy vials, syringes, IVs, tubing,
gowns, gloves, etc.
RCRA Hazardous Waste Containers
Bulk chemo in vials, unused IV’s, P, U. toxic & ignitable DOvertly contaminated gowns, glove,
chemo spill clean up materials
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Approximate Cost of Disposing of Regulated Waste
$0.40/pound $4.00/pound $40.00/pound
Segregation of waste is essential for cost and generator status of facility
Points of Pharmaceutical Waste Points of Pharmaceutical Waste GenerationGeneration
Hospital Pharmacy LocationsCentral Pharmacy 2nd FloorCentral Pharmacy - 2nd FloorPediatric Satellite Pharmacy - 4th FloorOR Satellite Pharmacy - 2nd Floor
Kentucky Clinic Pharmacy LocationsSupport - BasementKentucky Clinic Pharmacy - 1st FloorPediatric Oncology - 2nd Floor
Markey Cancer Center Pharmacy2nd Floor Whitney Hendrickson Bld.
Hospital Patient Care Areas Hospital Patient Care AreasInpatientOutpatient
Markey Cancer Center Patient Care AreasInpatientOutpatient
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How is Pharmaceutical Waste GeneratedHow is Pharmaceutical Waste Generated
IV Preparation
General CompoundingGeneral Compounding
Spills/Breakage
Partially Used Vials/Syringes
Discontinued, Unused Preparations
Unused Repacks (Unit Dose)
Discontinued In-dated Pharmaceuticals
Patients’ Personal Medications
Outdated Pharmaceuticals
Discarded Drugs That Become Discarded Drugs That Become RCRA Hazardous WasteRCRA Hazardous Waste
P-Listed Waste Sole active ingredient
U-Listed Waste Sole active ingredient
Characteristic WasteIgnitability Ignitability
Toxicity Corrosivity Reactivity
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Examples of P and U-Listed Pharmaceutical Waste Generated at the University
Arsenic Trioxide P012 Epinephrine P042 Nicotine P075 Nitroglycerin P081 Physostigmine P204University Physostigmine P204 Warfarin >0.3% P001
Chloral Hydrate U034 Chlorambucil U035 Cyclophosphamide U058 Daunomycin U059 Diethylstibestrol U089 Lindane U129 Methphalan U150Methphalan U150 Mitomycin C U010 Phenol U188 Reserpine U200 Selenium Sulfide U205 Streptozotocin U206 Uracil Mustard U237 Warfarin <0.3 % U248
P-Listed Waste P-listed wastes possess “extremely hazardous properties”
that make them lethal in very small quantities (45 FR 33116). They are noted as acutely hazardous wastes.) y y
Technically, containers that have held P-listed wastes are not “RCRA empty” unless they are triple rinsed and the rinsate discarded as hazardous waste.
Only 1 quart of P-listed wastes may be accumulated in Satellite Accumulation Areas.
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U-Listed Waste U-Listed wastes meet the listing criteria of
federal and state regulations which identify various factors that could render a waste various factors that could render a waste “toxic.”
Containers that have held U-listed wastes are “RCRA empty” when all of the waste has been removed that can be removed and
No more than 1 inch of residue remains on the b tt f th t i bottom of the container or
No more than 3% by weight of the total capacity of the container remains in the container.
Characteristic ofIgnitability
Aqueous Solution Aqueous Solution containing 24% alcohol or more by volume & flash point<140° F.
Hazardous Waste Number: D001
Rubbing Alcoholg
Topical Preparation
Injections
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A l ti h i H
Characteristic of Corrosivity
An aqueous solution having a pH < or = 2 or > or = to 12.5
Examples: Primarily compounding chemicals
Glacial Acetic Acid Sodium Hydroxide
Hazardous waste number: D002
Characteristic of Toxicity
Approximately 40 chemicals which
Examples of potentially toxic pharmaceuticals:
Arsenic Cadmium
pp ymeet specific leaching concentrations
•Barium•Mercury
Chloroform Chromium Lindane
•Selenium•Silver
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Heavy Metals: Selenium,
Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity
,Chromium and Silver
Preservatives: thimerosal & m-cresol
Compliance Monitoring• Be prepared in case the EPA or state agencies arrive at p p g
your facility.
• Promote waste minimization efforts whenever possible.
• Perform random audits to determine compliance.
– Check and verify staff knowledge of program details
– Check waste containers (discarded appropriately)
– Track quantities of waste (type/location)
– Track costs
• Document entire process and results of Q/A audits for use with state and federal agencies.
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How to Dispose of For Consumers
Unused Medicines
http://www.fda.gov/consumer/updates/drug_disposal062308.html
How to Dispose of Unused Medicines
Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so. p y y
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How to Dispose of Unused Medicines
If no instructions are given throw the drugs If no instructions are given, throw the drugs in the household trash, but first: Take them out of their original containers and
mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children
d t d i bl t l h and pets and unrecognizable to people who may intentionally go through your trash.
Put them in a sealable bag, empty can or other container to prevent the medication from leaking or breaking out of a garbage bag.
How to Dispose of Unused Medicines Take advantage of community drug take-back
programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government's household trash and recycling service (see blue pages in phone book) to see if a take-back program is available in your community.
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How to Dispose of Unused Medicines Before throwing out a medicine container, scratch
out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.
Do not give medications to friends. Doctors prescribe d b d ' ifi t ddrugs based on a person's specific symptoms and medical history. A drug that works for you could be dangerous for someone else.
When in doubt about proper disposal, talk to your pharmacist.
Proper Disposal of Prescription DrugsOffice of National Drug Control Policy - February 2007Policy February 2007
Federal Guidelines: 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 container such as empty cans or sealable bags will further ensure the drugs are not diverted.
www.WhiteHouseDrugPolicy.gov
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Proper Disposal of Prescription DrugsOffice of National Drug Control Policy - February 2007
F d l G id li Federal Guidelines: Flush prescription drugs down the toilet only if the
label or accompanying patient information specifically instructs doing so (see next slide).
Take advantage of community pharmaceutical take-back programs that allow the public to bring unused drugs to a central location for proper disposaldrugs to a central location for proper disposal.
Some communities have pharmaceutical take-back programs or community solid-waste programs that allow the public to bring unused drugs to a central location for proper disposal. Where these exist, they are a good way to dispose of unused pharmaceuticals.
www.WhiteHouseDrugPolicy.gov
The FDA advises that the following drugs be flushed down the toilet instead of thrown in the trash: Actiq (fentanyl citrate) Daytrana Transdermal Patch (methylphenidate)Daytrana Transdermal Patch (methylphenidate) Duragesic Transdermal System (fentanyl) OxyContin Tablets (oxycodone) Avinza Capsules (morphine sulfate) Baraclude Tablets (entecavir) Reyataz Capsules (atazanavir sulfate) Tequin Tablets (gatifloxacin) Zerit for Oral Solution (stavudine)
Proper Disposal of Prescription DrugsOffice of National Drug Control Policy February 2007
Meperidine HCl Tablets Percocet (Oxycodone and Acetaminophen) Xyrem (Sodium Oxybate) Fentora (fentanyl buccal tablet)
Note: Patients should always refer to printed material accompanying their medication for specific instructions.
www.WhiteHouseDrugPolicy.gov
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ASHP Position Statement Safe Disposal of Patients’ Home Medications (0614) Safe Disposal of Patients’ Home Medications (0614) Source: Council on Professional Affairs To minimize the patient safety consequences and public health
impact of inappropriate disposal of patients’ home medications by working collaboratively with other interested organizations to1. Develop models for patient-oriented medication disposal
programs that will minimize accidental poisoning, drug diversion and potential environmental impactdiversion, and potential environmental impact
2. Advocate that the pharmaceutical industry and regulatory bodies support the development and implementation of such models, and
3. Educate health professionals, regulatory bodies, and the public regarding safe disposal of unused home medications.
How Green is Your Pharmacy? Pharmaceutical Waste Management Gap Toolg p
Have you read the current regulations on hazardous drugs and waste?
Has your pharmacy completed a RCRA risk assessment, including a comprehensive flow charting process?
Has your pharmacy conducted a gap analysis?
Does your pharmacy have a formal educational process?y p y p
Has your pharmacy completed a comprehensive RCRA hazardous material inventory classification process?
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How Green is Your Pharmacy? Pharmaceutical Waste Management Gap ToolPharmaceutical Waste Management Gap Tool
Do you have a formal multidisciplinary team to oversee the management of hazardous drug waste?
Does your pharmacy have a system for alerting all employees?
Does your pharmacy segregate hazardous drugs?
Does your pharmacy currently segregate pharmacy waste?
How Green is Your Pharmacy? Pharmaceutical Waste Management Gap ToolPharmaceutical Waste Management Gap Tool
Are you properly segregating trace and bulk chemo waste?
Have you assessed drugs stocked for P-listed, U-listed, and RCRA characteristic drugs?
Are you using a reverse distributor for unopened unused pharmacy waste?unopened, unused pharmacy waste?
Is your contracted incinerator vendor for P-listed and U-listed waste US-EPA/RCRA certified?
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