Learning Objectives 10/1/2008

John A. Armitstead, MS, RPh, FASHP Director of Pharmacy Services University of Kentucky HealthCare Assistant Dean for Medical Center Pharmacy Services

University of Kentucky College of Pharmacy

Learning Objectives

the pharmaceutical impact on the environment

 Counsel consumers on how to discard

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 generated located 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

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 lawof the United Statescontained 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 p RCRA, 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.

Waste Management Team

 PharmacyPharmacy  Nursing

 Oncology, Cardiac Care, Med/Surg, ED, OR

 Environmental Health and Safety Officer  Housekeeping/Environmental Services  Hospital Administration

Goals of the Waste

Management Team

E l t t ti f li i k d t ti l h

Evaluate 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

UKH Inventory Analysis

Summary of Results Fed Hazard 277 4% PharmE Non Hazardous 6457 Summary of Results

Fed Haz _PharmE

Hazardous 870 11% 85% PharmE Hazardous Non Hazardous

UKH Inventory Analysis

Excel Columns

 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

UKH Inventory Analysis

UKH Inventory Analysis

200 400 600 800 0 200 Products by Category

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

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 Infectious

Waste (Regulated contaminated with liquid bloodBlood products, sharps, items

Waste (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 D Overtly contaminated gowns, glove,

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

Generation

Generation

 Hospital Pharmacy Locations

Central Pharmacy 2nd_Floor

Central Pharmacy - 2nd_Floor

Pediatric Satellite Pharmacy - 4th_Floor

OR Satellite Pharmacy - 2nd_Floor

 Kentucky Clinic Pharmacy Locations

Support - Basement

Kentucky Clinic Pharmacy - 1st_Floor

Pediatric Oncology - 2nd_Floor

 Markey Cancer Center Pharmacy

2nd_{Floor Whitney Hendrickson Bld.}

 Hospital Patient Care Areas

 Hospital Patient Care Areas

Inpatient Outpatient

 Markey Cancer Center Patient Care Areas

Inpatient Outpatient

How is Pharmaceutical Waste Generated

How 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 Waste

RCRA Hazardous Waste

 P-Listed Waste

 Sole active ingredient

 U-Listed Waste

 Sole active ingredient

 Characteristic Waste Ignitability  Ignitability  Toxicity  Corrosivity  Reactivity

Examples of P and U-Listed Pharmaceutical Waste Generated at the University  Arsenic Trioxide P012  Epinephrine P042  Nicotine P075  Nitroglycerin P081  Physostigmine P204 University Physostigmine P204  Warfarin >0.3% P001

 Chloral Hydrate U034

 Chlorambucil U035

 Cyclophosphamide U058

 Daunomycin U059

 Diethylstibestrol U089

 Lindane U129

 MethphalanMethphalan U150U150

 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.

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 of

Ignitability

 Aqueous Solution  Aqueous Solution

containing 24% alcohol or more by volume & flash point<140° F.  Hazardous Waste Number: D001  Rubbing Alcoholg  Topical Preparation  Injections

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 y

meet specific leaching concentrations

•Barium •Mercury  Chloroform  Chromium  Lindane •Selenium •Silver

Heavy Metals: Selenium,

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.

How to Dispose of

For Consumers

Unused Medicines

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

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.

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 d

drugs 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

Drugs

Office of National Drug Control

Policy - February 2007

Policy February 2007

 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.

Drugs

Office 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 disposal

drugs 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 Drugs Office 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.

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 to

1. Develop models for patient-oriented medication disposal programs that will minimize accidental poisoning, drug diversion and potential environmental impact

diversion, 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?

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-P-listed waste US-EPA/RCRA certified?