pharmaceutical waste update on handling · pdf filepharmaceutical waste why do we care about...

PHARMACEUTICAL WASTEUPDATE ON HANDLING AND DISPOSALUPDATE ON HANDLING AND DISPOSAL

Pharmaceutical WasteWhy Do We Care About It?

•To comply with Federal, State and Local laws & regulations

T l ith Th J i t C i i t d d•To comply with The Joint Commission standards

•To protect patients & staff•To protect patients & staff

•To protect the environmentp

OVERVIEW OF PROGRAM

•What is RX waste? – Generation, types, where?•Current state of regulations and legislation•Current state of regulations and legislation•Current state of waste disposal

•Healthcare – hospitals•Healthcare – other•Home generated waste

•DEA Opportunities•Healthcare disposal•Home generated wastes

•Best management practices•Best management practices• In healthcare•Home generated

WHAT IS RX WASTE??

Pharmaceutical waste is a drug that is generated:• When the decision is made to discard an pharmaceutical

d t it i l bl f i t d dproduct, it is no longer usable for intended purpose• To be discarded for other reasons – contamination and

expiration• Can be a hazardous waste non hazardous waste• Can be a hazardous waste, non-hazardous waste,

controlled substance• In healthcare setting or in the home

WHAT IS RX WASTE??

In healthcare it can become waste where pharmaceuticals are prepared, used or dispensed to patients• Hospital Pharmacies (30%)p ( )• Inpatient and Out-Patient Care Areas (70%)

Types of Pharmaceutical Waste in Patient Care Areas:Types of Pharmaceutical Waste in Patient Care Areas:• Partial vials (safety caps removed)• Un-dispensed,

pre-instilled IV’spre-instilled IV s• Hospital repacks • Pre-filled syringes• Partial syringes• Partial syringes• Discontinued meds• Un-administered meds

Patient prescriptions• Patient prescriptions• Physician RX samples

WHAT IS RX WASTE??

Non-HazardousCompatible Hazardous RX 6%

HAZARDOUS RX WASTE

Non-Compatibles/Inhalers 2%•Aerosols & Inhalers•Oxidizers/Corrosives

p

92 % of WASTE

Oxidizers/CorrosivesNON-RCRA Controlled Substances

•5% of total formulary

Compatible Hazardous Waste Rx waste that CAN be placed in the same

y

•Less than 1% hazardous

Compatible Hazardous Waste – Rx waste that CAN be placed in the same container without danger of a chemical reaction

Non-Compatible Hazardous Waste – Rx waste that CANNOT be placed in the same container with other Rx waste because it may cause a dangerous chemical reaction

Non-Hazardous Waste – Typically not regulated

WHAT IS RX WASTE??

Waste Generation Locations

Ph

Characteristic Hazardous• Lantus

H l

RMW –Non-Hazardous

Abb ki• Pharmacy• Oncology - Chemo• All Other Patient Care Areas

• Humalog• Humulin N&R• Novalog • Flovent

• Abbokinase• Recombivax

Dual Waste –Areas Medication Dispense Station Med Carts

o e• Taxol

P – ListedEpinephrine*

Dual Waste Hazardous• Regulated medical

waste with RCRA h d d Med Carts

Med Rooms Soiled Utility Room

• Epinephrine* • Coumadin/Warfarin***

U – Listed

hazardous drug

Non - Compatible• Chemotherapy drugs• Cytoxan • Mutamycin

p• Silver Nitrate• Glycopyrrolate

* State Specific

CURRENT STATE OF REGS AND LEGS

Agencies involved in Rx waste regulation:Agencies involved in Rx waste regulation:

• State Regulatory Agencies All of you!• State Regulatory Agencies – All of you!• Environment Protection Agency (EPA)Resource Conservation and Recovery Act (RCRA)

• Department of Transportation (DOT) • Drug Enforcement Agency (DEA)• Publicly Owned Treatment Works (POTW)•State Board of Pharmacies • The Joint Commission (TJC)


FEDERAL LEGISLATIVE UPDATE• Drug Free Water Act 2009 – H.R. 276 and Water Quality Investment Act of 2009 – HR 1262• January 2009• Task force on proper disposal of unused pharmaceuticals • Primarily through Water Department

• Secure and Responsible Drug Disposal Act of 2009 HR 1395• March 5, 2009• Amend the controlled substances act to identify a way for ultimate

di luser disposal• Safe Drug Disposal Act of 2009 HR 1191

• February 25, 2009A d t ll d b t t t id f d t il d di l f• Amend controlled substances act to provide for detailed disposal of state controlled take back disposal programs


FEDERAL REGULATORY UPDATE• EPA• Water:

Sent for public comment last year survey for hospitals – No surveyResearch driven

Task force regarding proper disposal of unused drugsRelease info fall 2009; BMP to be released fall 2010Release info fall 2009; BMP to be released fall 2010

They are researching and visiting with all healthcare typesStericycle Baltimore visit – Sept 2009

• Office of resource Conservation and recovery (Solid and Hazardous Waste)

Proposed Universal Waste Rule – Possible mid to late 2011Issues relating to state adoption transportation packaging etcIssues relating to state adoption, transportation, packaging etc.Does not account for non hazardous or wastes not defined as

hazardous waste under RCRADoes not appear to have BMP built inWill not likely be applicable for home generated wastesControlled substances still remain a challenge


STATE LEGISLATIVE UPDATE

MAIN AREAS OF LEGISLATIVE ACTIVITY AT•MAIN AREAS OF LEGISLATIVE ACTIVITY AT STATE LEVEL:•Home Generated Pharmaceutical Waste DisposalHome Generated Pharmaceutical Waste Disposal and Take Back Programs

•No Flush Campaigns•Water Studies


STATE LEGISLATIVE UPDATE•NO FLUSH CAMPAIGNS AND WATER STUDIES

•CA – no official legislation but major issue individual POTWs• IL – Passed no flush but for solids only (CS and liquids not included)

•TX passed investigation and will do stakeholder meetings and study - Study to end in June and final report to legislation at the end of the year

•MA and NJ – investigation legislation is still pending•KY, MD, MN – Failed•NY – Major action taken in the water shed by AG officeNY Major action taken in the water shed by AG office•No Flush - Seen more localized with POTWs in other states•Can be a major problem with the hospitals

N l ti t th DEA i id tifi dNo resolution to the DEA issues identifiedHospital witness wasting


STATE LEGISLATIVE UPDATE•Home Generated Pharmaceutical Waste Disposal and Take Back Programs• States currently still active: DE, IL, MA, ME, MI, MN, NH, NY, RI,• Failed: FL, KY, ME, MO, MD, OR, WA, WV, VT , , , , , , , ,• Passed awaiting action: ID, MN, NH• Some components of programs:

Manufacturers responsible for the cost regardless of original manufacturer

Retail facilities responsible for program administrationOutreach requirements – web, phone, posters, invoices, packagingViolation for non compliance ability to reject plans or refuse plansViolation for non-compliance, ability to reject plans, or refuse plans

• Most in stalled mode, some are introduced on both house and senate.

Funding main problemFunding main problem


• STATE REGULATIONS:• CA – requires RX waste to be over classified as RMW and sent for

incineration if they meet the CA hazardous definition Some exceptionsincineration if they meet the CA hazardous definition. Some exceptions made for flushing

• MN – requires proper management of wastes that fall under the MN Lethal d fi iti S ti d f t ll d b t fl hidefinition. Some exceptions are made for controlled substance flushing

• WA – interim enforcement rule – healthcare has options for disposing and utilizing alternative management methods provided materials are g g pincinerated.

• FL – Universal waste rule

• MI – Universal waste rule

• NY – AG using RCRA regulations and regulatory authority discretion toNY AG using RCRA regulations and regulatory authority discretion to enforce for non hazardous drug disposal requirements

CURRENT STATE OF WASTE DISPOSAL

What Happens to Rx Waste Today?


Compatible – Rx waste that CAN be placed in the sameCAN be placed in the same container without danger of a chemical reaction

Non-Compatible – Rx waste pthat CANNOT be placed in the same container with other Rx waste because it may cause a dangerous chemical reactionreaction

Controlled Substances –Retuned to pharmacy (for inventory control and return toinventory control and return to reverse distributor) or witness wasted to sewer


•Waste is generated on different Units•Waste must be identified and determined how a healthcare facility•Waste must be identified and determined how a healthcare facility is going to manage these materials – drug coding and sorting

•Provide a program and containers

•Reasons for non compliance:•Training issues•Time limitation•Controlled substances•Containment and storageCo ta e t a d sto age

•Currently most hospitals good at P and U identification and segregation but have not done full categorization of full formularysegregation but have not done full categorization of full formulary


• HEALTHCARE• Hospitals -

Mix of waste disposal from solid waste, collection and segregation, all hazardous waste, red bag, and flushing

• Clinical careMostly disposal via red bag and flushing

• Nursing homes, hospices, etc.Mostly disposal via red bag, solid waste and flushing

• HOME• Flushing, solid waste • Special waste instructions – unrecognizable or undesirable and solid waste

• Take back programs where available

CURRENT STATE OF DISPOSAL

RISK TO HEALTHCARE FOR COMPLIANCE • Hazardous waste determinations not done or incorrect•• Labeling of hazardous waste not done or incorrect• Throwing HW down the drain - POTW• Improper disposal of chemotherapy drugs• Inadequate training for employees in HW management• Not conducting proper weekly inspections of HW storage• No or inadequate HW manifests• Improper management of expired pharmaceuticals• Lack of emergency contingency plan• DEA Registration risk

JOINT COMMISSION INSPECTIONS

“Identification and Management of Regulated Hazardous Waste” – EPA Region 2

DEA OPPORTUNITIES

• Controlled Substances in Healthcare• DEA regulated materials – registrant to registrant transfer only• DEA does not have a definition for waste as part of the statute• Options for unused controlled substances:

Controlled substances from the floors should be witness wasted at the floor level through flushing as directed by the manufacturer’s packaging instructions and using the Form 41 for Destruction

Controlled substances should be brought back down to the hospital pharmacy and documented to be transferred to a reversepharmacy and documented to be transferred to a reverse distributor for final disposition using the 222 Inventory Form

• DEA does not consider the sharps containers, regulated medical waste or solid waste containers as a method of treatment or witness wasting.solid waste containers as a method of treatment or witness wasting.

• DEA does not define irreclaimable or irretrievable as a method of destruction.

• Many healthcare facilities are required to obtain POTW variances to flushy q

DEA OPPORTUNITIES

•Controlled Substances in the Home•Considered an issue for both environmental reasons as well as for diversion control

•Take back programs are not allowed to take controlled substances due to current statutory requirementsy q

• Patients look for ways to return all drugs and are not aware which drugs are considered controlled substances

• Registrants cannot accept CS from “ultimate user”•Home generated RX – 5-10% controlled substances (some studies showed higher)

•Bills in congress must be passed for DEA to change the statuteBills in congress must be passed for DEA to change the statute•Many programs continuing •Mailback option difficult – DEA is not in full supportMany are still flushing or putting into undesirable materials to•Many are still flushing or putting into undesirable materials to solid waste

BEST MANAGEMENT PRACTICES

•HEALTHCARE:• Identification of RX waste – hazardous/non-hazardous;• Identification of RX waste – hazardous/non-hazardous; continuous inventory maintenance

• Identification of regulations from individual statesDetermine program and method of compliance•Determine program and method of compliance

PHARMACY CODESCOLOR CODESSTICKERS


HEALTHCARE:•Education – create simple methods for compliance for•Education – create simple methods for compliance for employees and train, train, train (and retrain!) – Example:

Color-Coded ContainersNon- Hazardous Waste (Blue)Compatible Hazardous (Black)Non- Compatible Hazardous (Black)CS - Units send back to pharmacy in baggie/tray

• Implement program and track accumulation•Ensure continued compliance with program – dedicated resource

• Identify best management options for controlled substances

HOSPITALS REALLY DO WANT TO DO THE RIGHT THING!!!


•HOME• Continue working with DEA and legislators to push to get g g p gstatute changed!

•Educate public to what are controlled substances so that those materials are clearly identified to stay out of take back y yprograms thus allowing take back programs for other drugs possible.•Coding, special labeling, warningg, p g, g


•REGULATORY•Study impact of “non-hazardous” drugs todayy p g y•Majority of the drugs found in the studies are not considered hazardous waste today

Steroids antibiotics hormones vitamin supplementsSteroids, antibiotics, hormones, vitamin supplements•EPA Federally has not kept up with the advances in drug manufacturing as it relates to classification

•Regulate segregation and enforce at generator level encourage•Regulate segregation and enforce at generator level – encourage training and reinforcement of hospital compliance policies

•Regulate disposal – today BMP for destruction is incineration (high temperature either municipal solid waste with air pollution controltemperature either municipal solid waste with air pollution control systems in place or regulated medical waste incinerators)

•Land filling could be an option provided liquids are controlled.

CONCLUSION

L t f t it f i t•Lots of opportunity for improvement•Compliance with RCRA improves as there is more awareness•Movement towards proper disposal of non-RCRA regulated materials properly

•Healthcare is wanting to do the right thing for their patients and the environment

•Generators of waste in the home are becoming more aware of proper disposal

•Conflicting regulations and statutory constraints continue to be g g ya challenge

•Regulatory focus will ensure continuation proper disposal

PHARMACEUTICAL WASTE UPDATE

QuestionsQuestions

Th k !!!Thank you!!!SELIN HOBOY

VP LEGISLATIVE AND REGULATORY AFFAIRSSTERICYCLE, INC

[email protected]

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