Medication Waste In HospiceMedication Waste In Hospice:: Appropriate Disposal Methods, Barriers, Appropriate Disposal Methods, Barriers,

and Solutions to a Growing Concernand Solutions to a Growing Concern

Developed & Presented by:Kate Woods, Esq.

Associate Counsel & Sr. Director, Corporate Compliance

Terri L. Maxwell PhD, APRNVP, Clinical Initiatives

Hospice Pharmacia

DisclaimerDisclaimer

• This presentation is for educational purposes only. It is not intended as legal or professional advice. The author has expressly allowed excelleRx and its team members to present this material for educational purposes only. Any reproduction by Third Parties of this presentation or materials contained herein is prohibited in the absence of written permission obtained from the author.

• Review or discussion of any agent does not alter in any way the conditions for use contractually agreed upon and outlined in the Hospice Pharmacia Medication Use Guidelines.

• This program will not discuss nor focus on the Medication Use Guidelines and is intended for educational purposes.

excelleRx, Inc. is an accredited provider of continuing nursing education by PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on accreditation.

Requirements:Requirements:•Contact hours: 1.0

•Program number: 164-3-C-07-17

•Release date: 10/29/2008

•Expiration date: 11/16/2010

•Requirements for statement of credit:

–Participate in entire web-teleconference

–Submit post-test and pass with a score of 70% or higher.

•Statements of credit: Awarded within 6 to 8 weeks of the completion date.

•This program contains content that discusses the off-label use of various medications

•The program developer and presenter declare no conflicts of interest or relevant financial relationships

•Contact hours: 1.0

•UPN: 343-000-08-014-L04-P

•Release date: 10/29/2008

•Expiration date: 10/29/2011

•Requirements for statement of credit:

–Participate in entire web-teleconference

–Submit post-test and pass with a score of 70% or higher

•Statements of credit: Awarded within 6 to 8 weeks of the completion date.

•This program contains content that discusses the off-label use of various medications

•The program developer and presenter declare no conflicts of interest or relevant financial relationships

excelleRx, Inc. is accredited by the American Council of Pharmaceutical Education as a provider of continuing pharmaceutical education.

Requirements:Requirements:

Program ObjectivesProgram Objectives

• Describe issues related to medication waste, including its impact on the environment, healthcare costs and diversion concerns.

Review laws and regulations controlling pharmaceutical waste disposal mechanisms in the homecare setting.

• Describe findings from a pilot project that examined the amount and types of unused controlled substances at the time of death in home hospice.

• Provide examples of resources for proper medication disposal in hospice and discuss ways to become compliant with regulations related to medication waste in the revised Conditions of Participation (CoPs).

The Pill ProblemThe Pill ProblemThe Pill Problem

Q: How Many Drugs Are Out There?Q: How Many Drugs Are Out There?

• A: It Depends.

• N= 13,260 – First Data Bank Active Clinical Product ID (criteria: drug, strength, dosage form)

• N= 24,154 – Orange Book (FDA approved drugs under the Federal Food, Drug, and Cosmetic Act)

• N = 112,761 – First Databank Active NDC (criteria: drug, strength, dosage form, package size, manufacturer)

Medication Waste: How Big A Problem?Medication Waste: How Big A Problem?

• In 2005, approximately 3.6 billion prescriptions were purchased¹.

• Over 80% of elderly individuals take more than one drug daily.– 50% of the elderly take three or more drugs

daily2.

• In 2007, an estimated 1 billion dollars worth of unused medications was wasted3.

The ConcernsThe Concerns

• Diversion of controlled substances• Contaminated water supply• Negative impact on aquatic life• Possible increased resistance to antibiotics• Hormone disruption• Unintentional exposure to possibly toxic

medications or accidental poisoning

Where Do All of These Medications Go?Where Do All of These Medications Go?

Disposal PracticesDisposal Practices

The Longstanding Practice –The Longstanding Practice – Flushing or Throwing in the Trash Flushing or Throwing in the Trash

X

Disposal by Flushing Disposal by Flushing

STRENGTHS

• Fast

• Easy

• Effective

• Traditional

• Controlled (immediately minimizes diversion risk)

CONCERNS

• Contaminated water supply

• Negative impact on aquatic life

• Possible increased resistance to antibiotics

• Hormone disruption

• Unintentional exposure to possibly toxic medications

Two New Options Two New Options

OPTIONS STRENGTHS WEAKNESSESCommunity Take-Back Programs

•Disposal of drugs occurs in a regulated/controlled environment

•Reduces diversion risk

•Reduces potential for accidental poisoning

•Limited availability/accessibility (but is growing)

Controlled Substances not accepted

•Time commitment

•Cost

Household Solid Waste Disposal

(with dilution and masking of drugs prior to disposal)

•Limits diversion risk

•Reduces environmental pollution exposure (landfill v. water contamination)

•Diversion risk still exists

•Release into environment still occurs

•Time commitment

•Labor-intensive

Medications in Hospice:Medications in Hospice:What is left in the home when the patient dies?What is left in the home when the patient dies?

• Pilot study to describe the amount and types of unused controlled substances (CS) at the time of death in home hospice

• To describe ways that hospice nurses dispose of CS after patients expire

Project MethodsProject Methods

• Chart review– 105 home hospice patients who expired between April

and June in 2007

– 4 small hospices and 1 large hospice

– Medication waste data were obtained from narcotic waste destruction records

– Hospice administrators were interviewed to describe the most common practices of disposing controlled substances (CS) in their programs

Project FindingsProject Findings

• Characteristics of the patients– Mean age of the patients = 78, (range 44-103)

– Average LOS in hospice = 42 days (median 21)

• Most patients had unused medications at the time of death that required disposal (Table 1) – All but one patient had unused morphine concentrate (20mg/mL)

– Collectively, over 3 liters of morphine concentrate were destroyed

• Nurses typically disposed of unused controlled substances by flushing them down the toilet.

CS Medications Disposed of at the Time of DeathCS Medications Disposed of at the Time of Death

Table 1Morphine Conc

(20 mg/mL)

Lorazepam tablets*

Lorazepam liquid (mLs)

Roxicodone liquid (mLs)

Morphine long-acting tablets*

Fentanyl patches*

# (%) of Patients with medication remaining

104 (99%) 53 (50%) 15 (14%) 7 (7%) 3 (3%) 10 (10%)

Mean amount disposed of

31.8 18.7 26.5 54.6 83.7 5.7

Minimum 2 4 10 4 38 2

Maximum 110 112 58 150 160 17

Total amount disposed of

3184 mLs 990 tablets 397 mLs 382 mLs 251 tablets 57 patches

* Included multiple strengths

CS Medications Disposed of at the Time of DeathCS Medications Disposed of at the Time of Death

Table 1 (continued)Oxycodone tablets*

Oxyfast liquid (20mg/ml)

Oxycodone extended-release tablets*

Lorazepam gel packets*

(1 ml packets)

Acetaminophen with codeine liquid (mLs)

# (%) of Patients with medication remaining

3 (3%) 1 (1%) 2 (2%) 2 (2%) 1 (1%)

Mean amount disposed of

30 22 45 37 473

Minimum 10 22 30 25 473

Maximum 58 22 60 58 473

Total amount disposed of

90 tablets 22 mLs 90 tablets 74 gel packs 473 mLs

* Included multiple strengths

Project ConclusionsProject Conclusions

• The amount of CS remaining at the time of death was not excessive on an individual basis, but is significant when viewed collectively.

• Ways to decrease medication waste – Limit quantity dispensed or determine dispense

quantity based upon patient’s clinical condition and life expectancy

– Assess patient supply prior to requesting refills

Rules Regarding Medication Waste in HospiceRules Regarding Medication Waste in Hospice

The revised Medicare Conditions of Participation (CoPs) require hospices to have:

• Written policies and procedures for managing and disposing of controlled drugs in patient’s home, discussed with patient and family at the time when controlled drugs are first ordered.

• Must document in clinical record that these policies

and procedures were provided and discussed.

Steps for Hospices to TakeSteps for Hospices to Take

• Create or update your hospice’s Policy and Procedure on medication disposal.– Refer to HM 5. 4 in HP’s Resource Manual for a sample

policy and other resources– Check to see if your state or local municipality has its own

laws or regulations regarding disposal of household medications.

• Educate your staff on the importance of following your policy.

• Carefully weigh the risk of diversion of certain drugs against any potential environmental impact. Err on the side of caution.

Considerations for Medication Disposal Considerations for Medication Disposal Practices/PoliciesPractices/Policies

• Community commitment to “green” policies– Hospices have reported that the driving force for change to their

disposal policy was family requests or issues with flushing.

• Risk of diversion of certain medications or in certain communities

• Federal, state, and local laws (some regulations conflict)

Federal, State and Local Laws and RegulationsFederal, State and Local Laws and Regulations

• Start with the Federal Guidelines

• Different states, local municipalities may have different laws, regulations, guidelines or programs relating to medication waste disposal

• Helpful resources include your state’s:– DEA regional offices (e.g. MI v. PA)– Board of Pharmacy– Board of Nursing– Local wastewater/sewage regulations– EPA

Federal Guidelines for Medication DestructionFederal Guidelines for Medication Destruction

• Created in February 2007 as a resource for best practices in the disposal of household medication waste.

• Includes exceptions for disposal of controlled substances.

• The Federal Guidelines may be found athttp://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf

{And a copy is located in HP’s Resource Manual (RM 5.4)}

The Federal Guidelines: The Federal Guidelines: Proper Disposal of Prescription DrugsProper Disposal of Prescription Drugs

• Remove drugs from original containers

• Mix/dilute drugs with undesirable but non-toxic substances

– Suggestions include mixing unused medications with coffee grounds or kitty litter and other forms of dilution prior to disposal.

• Flush only in certain instances

• Take advantage of community pharmacy take-back programs (not for CS)

Medication Disposal Decision TreeMedication Disposal Decision Tree

Medication Destruction in Hospice: Medication Destruction in Hospice: Additional ConsiderationsAdditional Considerations

• Consider destruction timetables– Discontinuation of medication regimen– Patient discharge or passing

• Look for “Take Back” programs and provide info to caregivers about community medication disposal programs.

• Medications in the home are the property of the patient; if they refuse to dispose of the medication in the nurse’s presence, document!

• Nurses should NOT transport medications.

Stakeholders Stakeholders

Insurance Companies

PharmaceuticalIndustry

Academia

PharmaciesPatient-

Consumers

ReverseDistributorships

Non-profitOrganizations

HealthcareFacilities

Government

Pharmaceutical Waste

Oversight – The AuthoritiesOversight – The Authorities

DEA

US EPA

State & Local(e.g. DEP, Police Dept.,Water Dept., Sanitation

Professional Boards &Regulatory Agencies

Controlled Substances ActControlled Substances Act

• Harrison Narcotic Act of 1914

• Single Convention on Narcotic Drugs of 1961

• Convention on Psychotropic Substances of 1971

• Chemical Diversion Trafficking Act of 1988

• Methamphetamine Control Act of 1996

• Combat Methamphetamine Epidemic Act of 2005

• Codified in Code of Federal Regulations (21 CFR Ch. 13)

Purposes of Controlled Substances ActPurposes of Controlled Substances Act

• Control abused/addictive drugs– Classification through Schedules

• Create a “closed system” of distribution of controlled substances

• Regulate distribution of chemicals used in manufacture of illegal drugs

More Drugs Are Being Used- Including CIIs More Drugs Are Being Used- Including CIIs

Scheduled Drugs – Factors of ConsiderationScheduled Drugs – Factors of Consideration

• Actual or potential for abuse

• Scientific evidence/ current knowledge of effects

• History/current pattern of abuse

• Public health risk

• Dependence risks

• Status of substance as immediate precursor of substance already listed as controlled

The Closed Loop – The Closed Loop – Fine For LTC, But What About HomeCare?Fine For LTC, But What About HomeCare?

ManufacturersWholesalers, Distributors Pharmacies,

Institutions

Return3rd party

processors

Mfg.3rd party

processorsIncinerator

Disposing of Controlled SubstancesDisposing of Controlled Substances

• End users may NOT return medications to a DEA registrant

• Destruction must be “beyond reclamation”

• Community take back – law enforcement must be involved: DEA registrants may NOT accept CS at take back programs unless law enforcement is involved– “possession” of CS must pass to law enforcement

Action Needed To Be Taken!Action Needed To Be Taken!

What Did The Stakeholders Do?

Federal Guidelines – Federal Guidelines – Individual Disposal of Rx DrugsIndividual Disposal of Rx Drugs

The ProgressThe Progress

Examples of Progressive States On The Issue of Examples of Progressive States On The Issue of Pharmaceutical Waste and/or Wasted MedicationsPharmaceutical Waste and/or Wasted Medications

IndianaIndiana

• IC 25-26-20: Regional Drug Repository Program• A hospice can donate to a drug repository program,

organized by the BOP

• Organizations that are eligible to participate in the BOP’s program include pharmacies, wholesalers, hospitals and healthcare facilities

• A repository program can donate drugs to a nonprofit health clinic for distribution, without charge, to an individual, as long as the individual is not Medicaid-eligible or “eligible to participate in a program that provides a prescription drug benefit and is funded in whole or in part by the state”

Indiana (con’t)Indiana (con’t)

• IC 25-26-13-25: Regulation of Pharmacists and Pharmacies

• Requirements for eligible drugs for donation:– Patient was on hospice or resided in institutional facility– Properly stored– Drug was dispensed by the same pharmacy accepting the

return– Was dispensed in the mfr’s original sealed or unit-dosed

packages, or dispensing pharmacy packaged in multi-dose blister or unit dose packaging

– Returned unopened– Not expired– Unclear whether Controlled substances are/are not

allowed

CaliforniaCalifornia

California Awareness Project Aims to Divert Pharmaceuticals from Water Supply

State and local officials in California are joining forces with the US Environmental Protection Agency for a "No Drugs Down the Drain Week" October 4-11, 2008. The statewide campaign recommends that unused medications be dropped off at special collection sites or mixed with water, sealed, and tossed in the trash. The awareness week is a spin-off of Senate Bill (SB) 966, signed into law in 2007, which allocates funds for pilot projects allowing consumers to drop off old prescriptions at retailers and public facilities. The legislation requires the California Integrated Waste Management Board (CIWMB) to establish a model pharmaceutical take-back program for the state. The “No Drugs Down the Drain!” campaign is coordinating with the CIWMB so that data and lessons learned from the campaign can assist in the implementation of SB 966. More information about the campaign and alternative disposal methods is available on the Web site of No Drugs Down the Drain.

PennsylvaniaPennsylvania

• Cancer Drug Repository Act Passed

S.B. 638 has been signed into law by Governor Rendell.  This act permits entities that are part of a closed drug delivery system (hospitals, clinics, long term care facilities) to return certain cancer drugs to approved pharmacies for re-dispensing to indigent patients. The cancer drugs that are returned must still be in their original packaging and have an expiration date no sooner than six months after the date the cancer drug was restocked.  It will also allow drugs dispensed under a state medical assistance program to be accepted and dispensed.  No compensation will be allowed for returned drugs.  However, participating pharmacies may charge a handling fee (to be determined) under the program.  This voluntary cancer drug repository program will be carried out under the supervision of the State Board of Pharmacy.  The law takes effect in 60 days and the board shall develop regulations related to this within 90 days of the effective date of the law.  PPA originally raised some concerns about this bill which were addressed in the final form.

Rx monitoring - One Control MechanismRx monitoring - One Control Mechanism

• 35 states have legislation requiring prescription monitoring

• 26 states have currently operating programs

• 9 are in start-up phase– Alabama, Arizona, California, Colorado, Connecticut, Hawaii,

Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Mexico, New York, North Dakota, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia, and Wyoming. Currently, the state of Washington uses their program only for disciplinary purposes, however legislation has been introduced to expand the program statewide.

Rx Monitoring – Ok, But What Is It?Rx Monitoring – Ok, But What Is It?

• The National Alliance for Model State Drug Laws (NAMSDL) is a resource for governors, state legislators, attorneys general, drug and alcohol professionals, community leaders, the recovering community, and others striving for comprehensive, effective state drug and alcohol laws and policies(1)

• Stated purpose: to reduce abuse of controlled prescription medications

• Secondary purpose: reduce number of Rx issued; control a steady supply of Rx

http://www.natlalliance.org/prescription_drug.asp

Creating a Medication Diversion Creating a Medication Diversion Policy & ProcedurePolicy & Procedure

(That works for your hospice!)

Scope of the ProblemScope of the Problem

• Stressed out population

• 30% - 50% of nation’s illicit drug use involves pharmaceuticals

• Heightened access to controlled substance and other dangerous narcotics in hospice setting

Don’t Be a StatisticDon’t Be a Statistic

• 15.1 million– the number of people who admitted abusing controlled

substances/prescription drugs in 2003 (CASA)

• 2.4 million– the number of people reporting the use of prescription

pain relievers for non-medical/non-prescribed purposes

• 22 million – DEA estimate of the number of Americans who are

substance dependent or abusers

Prior Planning: Forming Your Drug Prior Planning: Forming Your Drug Diversion Assessment & Policy CommitteeDiversion Assessment & Policy Committee

Your Drug Diversion Assessment Committee• Medical director

• Nurse administrator

• Pharmacist

• Social worker

• Clergy

• Field representative

• Legal department representative (internal/external)

Potential LiabilitiesPotential Liabilities

• Legal liability

• Accreditation concerns

• Medicaid Audit

• Fraud—complicity

Understand Your Hospice's Philosophy, Systems Understand Your Hospice's Philosophy, Systems and Tolerancesand Tolerances

• Stakeholders– Internal politics– Community – Law enforcement

• History of diversion – Where are you located?– Has this happened before?

• Employee factors– Drug testing—routine?

• Internal vs. External Diversion

Understanding and Responding to Understanding and Responding to Medication DiversionMedication Diversion

• Proactively identify potential diversion opportunities

• What is your current policy and procedure? Is it effective? Is it balanced?

• Know CS schedule or type of medication(s) alleged in diversion

• Understand:– general risks associated with diversion – specific risks associated with the medication(s) alleged to

have been diverted– Hospice/Staff potential risks and liabilities

Distribution of CS - Maximum PenaltiesDistribution of CS - Maximum Penalties

• 21 USC CSA § 841(a)(1)– “Except as authorized by this subchapter, it shall be

unlawful for any person knowingly or intentionally to (1) manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance;...”

The Crime & The TimeThe Crime & The Time

• Schedule II – 20 years imprisonment/ $1 million fine/ supervised release (2-5 years)

• Schedule III – up to 5 years imprisonment/ $250,000.00 fine/ supervised release (2-5 years)

• Schedule IV – up to 3 years imprisonment/ $250,000.00 fine/ supervised release (up to 2 years)

• Schedule V – up to 1 year imprisonment/ $100,000.00

Simple Possession – Serious ConsequencesSimple Possession – Serious Consequences

• 21 USC – Controlled Substances Act (CSA) § 844.– “It shall be unlawful for any person knowingly or

intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, acting in the course of his (her) professional practice, or except as otherwise authorized by this subchapter or subchapter II of this chapter.”

Simple Possession –Criminal PenaltiesSimple Possession –Criminal Penalties

• 1st time - ~ 1yr imprisonment/ $1,000.00 minimum fine

• 2nd time - 15 days to 2 yrs imprisonment/ $2,500.00 minimum fine

• 3rd time – 90 days to 3 yrs imprisonment/ $5,000.00 minimum fine

• **additional fines include reasonable investigation and prosecution costs

Care Venue Considerations Care Venue Considerations

• Homecare– Expanded care setting, less ability to closely monitor and

audit– Trending & tracking

• Daily usage• Refills

• LTC/IPU– Storage– Diversification of duties (i.e. order/receive/stock

medications)– Audits and discrepancy resolution (24 hours)– Special systems

Some Considerations in Managing a Some Considerations in Managing a Diversion CaseDiversion Case

• Are controlled substance involved?• Practice setting where incident occurred?• Evidence – circumstantial or concrete?• Risk of sentinel event?• DEA 106 report filed?• Recurring issue?• Known diverter?

Prospective vs. Retrospective ApproachesProspective vs. Retrospective Approaches

• Monitoring

• On-going discrepancy review

• Post-incident analysis and second guessing

• Proactive Auditing v. Retrospective

When to Impact DiversionWhen to Impact Diversion

• New start patient – educating on destruction/disposal

• Limiting diversion after death or discharge– patient owned meds

• General monitoring

Prospective…..Prospective…..

• Securing medications– Adherence and access balance

• CoPs– P&P

– Educating family and patient

• Educating nursing staff on potential warning signs

Retrospective…..Retrospective…..

• Post Facto Auditing & Sanctions– Action taken upon missing medication report, sentinel event, other

direct evidence

– Law enforcement and reporting

– Employment file and report

* Don’t wait for bad things to happen - by the time medications are diverted, the most that can be done is to resolve the specific issue; hospices are best served when staff, patients, family, and caregivers are informed and educated on the issue of medication

waste and diversion.

Additional ResourcesAdditional Resources

General References

– DEA Website• http://www.usdoj.gov/dea/index.htm

– EPA Guidelines• http://www.epa.gov/epaoswer/osw/home.htm#medical

(“Around Your Home: Waste Reduction and Recycling”)

ReferencesReferences1. Garey KW, Johle ML, Behrman K, Neuhauser MM. Economic

consequences of unused medications in Houston, Texas. Ann Pharmacother. 2004;38:1165-8.

2. Kuspis DA, Krenzelok EP. What happens to expired medications? A survey of community medication disposal. Vet Hum Toxicol. 1996;38(1):48-9.

3. Daughton CG. Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. I. Rationale for and avenues toward a green pharmacy. Environ Health Perspect. 2003;111:757-74.

4. Substance Abuse and Mental Health Services Administration. (2007). Results from the 2005 National Survey on Drug Use and Health: National Findings (Office of Applied Studies). Department of Health and Human Services. Available at http://www.oas.samhsa.gov/nsduh/2k6nsduh/2k6Results.pdf. [Accessed 31 December 2007].

ReferencesReferences

5. NHPCO 2007 Facts and Figures http://www.nhpco.org/files/public/Statistics_Research/NHPCO_facts-and-figures_Nov2007.pdf

6. Poisoning in the United States: Fact Sheet. (2007). Centers for Disease Control and Prevention. Available: http://www.cdc.gov/ncipc/factsheets/poisoning.htm [Accessed 2 April 2008].

7. Proper Disposal of Prescription Drugs. (2007). Drug Facts: Office of National Drug Control Policy. Available: http://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_disposal.html [Accessed 28 Sept. 2007].

Questions/Comments?Questions/Comments?

Please contact:

Catherine J. Woods, JD

cwoods@excelleRx.com

215.282.1735

or

Terri Maxwell PhD, APRN

tmaxwell@excelleRx.com

215.282.1789

Thank You for Your Participation!Thank You for Your Participation!