Med Waste Disposal Teleconference Final Jb Edit1 2009
1. Medication Waste In Hospice:
Appropriate Disposal Methods, Barriers,
and Solutions to a Growing Concern
Developed & Presented by:
Kate Woods, Esq.
Associate Counsel &
Sr. Director, Corporate Compliance
Terri L. Maxwell PhD, APRN
VP, Clinical Initiatives
Hospice Pharmacia
2. Disclaimer
• 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.
3. 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:
•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
4. excelleRx, Inc. is accredited by the American Council of Pharmaceutical
Education as a provider of continuing pharmaceutical education.
Requirements:
•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
5. Program 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).
7. 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)
8. 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.
9. The 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
13. Disposal by Flushing
STRENGTHS CONCERNS
• Fast • Contaminated water
supply
• Easy
• Negative impact on
• Effective
aquatic life
• Traditional
• Possible increased
• Controlled (immediately resistance to antibiotics
minimizes diversion risk)
• Hormone disruption
• Unintentional exposure to
possibly toxic medications
14. Two New Options
OPTIONS STRENGTHS WEAKNESSES
Community Take-Back •Disposal of drugs occurs •Limited
Programs in a regulated/controlled availability/accessibility
environment (but is growing)
•Reduces diversion risk Controlled Substances not
•Reduces potential for accepted
accidental poisoning •Time commitment
•Cost
Household Solid Waste •Limits diversion risk •Diversion risk still exists
Disposal •Reduces environmental •Release into
(with dilution and pollution exposure environment still occurs
masking of drugs prior to (landfill v. water •Time commitment
disposal) contamination) •Labor-intensive
15. Medications in Hospice:
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
16. Project 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
17. Project 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.
18. CS Medications Disposed of at the Time of Death
Table 1
Morphine Lorazepam Lorazepam Roxicodone Morphine Fentanyl
Conc tablets* liquid (mLs) liquid (mLs) long-acting patches*
(20 mg/mL) tablets*
# (%) of 104 (99%) 53 (50%) 15 (14%) 7 (7%) 3 (3%) 10 (10%)
Patients with
medication
remaining
Mean amount 31.8 18.7 26.5 54.6 83.7 5.7
disposed of
Minimum 2 4 10 4 38 2
Maximum 110 112 58 150 160 17
Total amount 3184 mLs 990 tablets 397 mLs 382 mLs 251 tablets 57 patches
disposed of
* Included multiple strengths
19. CS Medications Disposed of at the Time of Death
Table 1 (continued)
Oxycodone Oxyfast liquid Oxycodone Lorazepam gel Acetaminophen
tablets* (20mg/ml) extended- packets* with codeine
release tablets* (1 ml packets) liquid (mLs)
# (%) of 3 (3%) 1 (1%) 2 (2%) 2 (2%) 1 (1%)
Patients with
medication
remaining
Mean amount 30 22 45 37 473
disposed of
Minimum 10 22 30 25 473
Maximum 58 22 60 58 473
Total amount 90 tablets 22 mLs 90 tablets 74 gel packs 473 mLs
disposed of
* Included multiple strengths
20. Project 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
21. Rules 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.
22. Steps 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.
23. Considerations for Medication Disposal
Practices/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)
24. Federal, 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
25. Federal 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 at
http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf
{And a copy is located in HP’s Resource Manual (RM 5.4)}
26. The Federal Guidelines:
Proper 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)
28. Medication Destruction in Hospice:
Additional 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.
29. Stakeholders
Government
Insurance Healthcare
Companies Facilities
Pharmaceutical Non-profit
Industry Organizations
Pharmaceutical
Waste
Reverse
Academia
Distributorships
Patient-
Pharmacies
Consumers
30. Oversight – The Authorities
DEA
Professional Boards &
US EPA
Regulatory Agencies
State & Local
(e.g. DEP, Police Dept.,
Water Dept., Sanitation
31. Controlled 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)
32. Purposes 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
36. Scheduled 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
37. The Closed Loop –
Fine For LTC, But What About HomeCare?
Wholesalers,
Pharmacies,
Manufacturers Distributors
Institutions
Mfg. Return
3rd party 3rd party
processors processors
Incinerator
38. Disposing 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
42. Examples of Progressive States On The Issue of
Pharmaceutical Waste and/or Wasted Medications
Indiana
• 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”
43. 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
44. California
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.
45. Pennsylvania
• 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.
46. Rx 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.
47. 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
49. Scope 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
50. Don’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
51. Prior Planning: Forming Your Drug
Diversion Assessment & Policy Committee
Your Drug Diversion Assessment Committee
• Medical director
• Nurse administrator
• Pharmacist
• Social worker
• Clergy
• Field representative
• Legal department representative (internal/external)
53. Understand Your Hospice's Philosophy, Systems
and Tolerances
• Stakeholders • Employee factors
– Internal politics – Drug testing—routine?
– Community
– Law enforcement
• Internal vs. External
Diversion
• History of diversion
– Where are you located?
– Has this happened before?
54. Understanding and Responding to
Medication 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
55. Distribution 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;...”
56. The 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
57. Simple 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.”
58. Simple 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
59. 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
60. Some Considerations in Managing a
Diversion 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?
61. Prospective vs. Retrospective Approaches
• Monitoring
• On-going discrepancy review
• Post-incident analysis and second guessing
• Proactive Auditing v. Retrospective
62. When to Impact Diversion
• New start patient
– educating on destruction/disposal
• Limiting diversion after death or discharge
– patient owned meds
• General monitoring
63. Prospective…..
• Securing medications
– Adherence and access balance
• CoPs
– P&P
– Educating family and patient
• Educating nursing staff on potential warning signs
64. 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.
65. Additional 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”)
66. References
1. Garey KW, Johle ML, Behrman K, Neuhauser MM. Economic
consequences of unused medications in Houston, Texas. Ann
Pharmacother. 2004;38:1165-8.
3. Kuspis DA, Krenzelok EP. What happens to expired medications? A
survey of community medication disposal. Vet Hum Toxicol.
1996;38(1):48-9.
5. 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.
7. 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].
67. References
• NHPCO 2007 Facts and Figures
http://www.nhpco.org/files/public/Statistics_Research/NHPCO_facts-and-fig
3. 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].
5. Proper Disposal of Prescription Drugs. (2007). Drug Facts: Office of
National Drug Control Policy. Available:
http://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_dispo
sal.html [Accessed 28 Sept. 2007].
68. Thank You for Your Participation!
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
Editor's Notes
Before we begin, I’d like to take a minute to highlight that the information and the materials included in this presentation are intended for educational use. 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 be a focus on the Medication Use Guidelines and is intended for educational purposes.
In addition, excelleRx, Inc. is accredited by the American Council of Pharmaceutical Education as a provider of continuing pharmaceutical education.
A 2002 US Geological Survey study indicates that greater than 80% of US waterways tested contained trace contamination of medications. Diversion Illicit use of legitimately prescribed medications continues to increase. The practice of “pharming” among teens and young adults continues to grow 4 . Accidental poisoning
A 2006 survey of patient practices and beliefs concerning disposal of medications found that over 50% of patients threw away unused medication in the trash and about 35% flushed them down the toilet.
In home hospice care, common practice for disposing unused controlled substances is through the household water system by flushing them down the toilet or pouring them down the drain. Disposal through the sink or toilet also contributes to environmental concerns. While this practice may minimize risks of diversion, medications can leach into groundwater from septic tanks and sewers. Water treatment plants are not equipped to remove pharmaceutical contaminants from waste water. When the water is eventually reused, it may even cause unintentional harm to fish and wildlife and expose humans to chemicals found in the wasted medications.(2,3) A 2002 US Geological Survey study concluded that over 80% of the 139 US waterways tested contained traces of medications including acetaminophen, hormones, blood pressure medications, and antibiotics3. The environmental impact is unknown although there is a growing body of literature discussing the effects of medications on aquatic organisms.
Although flushing has its advantages: it’s fast, easy, effective and successful at minimizing diversion risk, it also has disadvantages: flushing contaminates the water supply and may have a negative effect on aquatic life, may increase resistance to antibiotics, result in hormone disruption and may unintentionally expose people to toxic medications. The health consequences of flushing medications are controversial and more research is needed to better understand this problem.
There are options other than flushing that hospices should be aware of. There are a limited, but growing number of community take-back programs that allow people to bring unused medications for destruction. The advantage of community take back programs include disposal of drugs in a regulated/controlled environment and a reduction in risk for accidental poisoning or diversion. However, controlled substances are not accepted and they require time to gather and drop off the medications and are costly to administer. Recently, many hospices are mixing kitty litter or coffee grounds with medications to dilute and mask them before disposing them in household waste receptacles. This method limits (but does not eliminate) diversion risk and reduces environmental water pollution, although landfill pollution is still an issue and medications can still seep into ground water. This method takes more time than flushing-which is a significant issue for busy hospice nurses.
We embarked on a study to better understand how much and what types of medications are left in the home at the time of death and how they are generally disposed of.
Initially, we had hoped to collect information about all types of medications, not just CIIs, but recording all leftover medications would have been too burdensome for the hospices nurses. Therefore, we decided to do a retrospective chart audit and record findings from narcotic waste destruction records. The types, quantities, and forms of disposed medications were analyzed for 105 patients who expired in their homes during a 3 month period from 5 participating hospices. We also asked clinical managers and hospice administrators how their nurses typically disposed of CIIs at the time of death.
The sample was comprised of typical hospice patients. Most were 65 yrs or older , men and women were equally represented and a little more than half had a diagnosis of cancer. Patients were enrolled in hospice on average 42 days. Nurses usually disposed of unused controlled substances by flushing.
The table on the next 2 slides lists all of the medications recorded in the narcotic destruction records, along with the number of patients having these medications, the average and range of remaining medications per patient, and the total amount wasted for all. At the time of death, patients commonly had CS in the home that required disposal by the hospice nurse. All but one patient had liquid concentrate morphine remaining, with amounts ranging from 2 to 110 mls, an average of 31.8 ml per patient, which is slightly more than a standard issued 30 mls bottle. Lorazepam (Ativan) was the next most common drug present, with close to 1000 tablets of different strengths and approximately 400 mls of liquid concentrate wasted. Three patients had long-acting morphine tablets (total 251 tablets) and two patients had oxycontin tablets (total 90 tablets) remaining. Ten of the 105 patients had unused fentanyl patches of varying strengths at the time of death.
This table illustrated the other medications that were recorded as destroyed on the narcotic destruction records. We had hoped to calculate an estimate of the costs of the medications destroyed, but the cost could not be determined because the doses of many of the medications were not recorded and cost varies by dose. Lastly, all 5 of the hospices reported that they flushed unused medications down the toilet as their primary method of disposal.
We concluded that the majority of patients had reasonable amounts of medications remaining at the time of death. However, when you view the amount of medication waste collectively over large numbers of hospice patients, the amount of unused medication is striking. Almost every patient had the equivalent of a 30 ml bottle of Roxanol left over- when totaling the amount of morphine concentrate for these 105 patients, over 3 liters of liquid morphine were disposed of, which represents 64,680 mg of morphine and represents approximately $2000 worth of medication. When considering the environmental and economic impact and potential for diversion of these medications, all hospices should actively take steps to try to reduce waste. The simplest approach is to assess patient supply prior to requesting refills. Especially when refilling PRN medications, check the patient’s supply before refilling through Xeris. Also, consider requesting a smaller quantity if the patient’s condition is noticeably failing. Let the pharmacist know if you expect the patient to expire in the next 24- 72 hours so that they dispense an amount based upon that rather than the typical 15 day supply.
The new Medicare CoPs have ushered in new requirements related to medication waste policies and procedures. When the new CoPs become active this December, hospices must have written policies and procedures for managing and disposing of drugs in patient’s home, the policy must be discussed with patient and family in a manner that they can understand, they must be provided with the policy and you must document in the clinical record that the policies and procedures were provided and discussed. Note: This standard was changed from discussing disposal policies at admission to when CII’s are ordered, however, most hospices are electing to do this as part of the admission process to help improve consistency in their practice. Providing the policy at admission is especially important if Comfort Paks containing morphine or other controlled substances are ordered upon admission.
If you haven’t pulled together your medication waste policy yet- don’t fret- Hospice Pharmacia has a number of resources that will help you. When creating or updating your policy, I suggest the following: 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. It’s important to remember that your policy must reflect local and state ordinances or regulations regarding disposal of household medications, since local regulations take precedence over federal guidelines. So if your community does not allow flushing of ANY medications, your policy should state that and procedures should be developed to dispose of medications in alternate ways. Educate your staff on the importance of following your policy, make sure that they realize that this is now a required standard in hospice. Lastly, carefully weigh the risk of diversion of certain drugs against any potential environmental impact. Err on the side of caution when determining how best to dispose of opioids and other controlled substances.
It is important to remember that local and state laws must be abided by, even if they conflict with the Federal Guidelines- so check your local and state laws when developing your policy. Also, remember, medications in the home are the property of the patient/family; if they refuse to dispose of the medication in the nurse’s presence, you cannot force them to do so, but it is important that you document the event!
When developing your medication destruction policy, start with the Federal Guidelines. However, states and local municipalities sometimes differ in their regulations or guidelines for medication disposal. Local regulations must be followed, even if they are different than the Federal guidelines. There are a number of additional helpful resources listed on this slide.
The Federal Guidelines for Medication Destruction were first introduced in 2007 as a resource for best practices in disposing of household medication waste. Although flushing is not recommended for most drugs, there is a list of controlled substances that are an exception. The website for the guidelines is listed on this slide and a copy is available in the HP Resource Manual.
The Federal Guidelines suggest removing drugs from original containers and mixing or diluting them with undesirable, but non-toxic substances such as kitty litter prior to disposal. Some controlled substances such as fentanyl patches should be flushed. Community take back programs should be taken advantage of when available.
This medication disposal decision tree has some suggested best practices for medication disposal practices. Again, check your local ordinances first. A copy of this algorithm is available in the HP Resource Manual.
There are many issues to consider when determining your Hospice policy on the destruction of unused medicines in the patient home. Nurses should not remove medications from the home and transport them, even for disposal purposes, Hospice must create a policy and procedure on medication destruction – more importantly, hospice should ensure that all staff follow the policy.
The issue of unused medications and their proper disposal has many components. There are numerous stakeholders involved in handling the problem of wasted medications and their disposal; they both affect and are affected by the issue of unused medications. Viable solutions for one area of healthcare or business practice may not make sense in another business model or practice setting. All stakeholders must work together in order to create a long term viable solution to the problem of unused and wasted medications.
Healthcare practitioners and individuals should be aware that there are numerous government agencies that have controlling authority over various parts of medication distribution, access, disposal, and compliance. Importantly, know that DEA has exclusive authority over the regulation of Controlled Substances.
The Controlled Substances Act (CSA) is a compilation of numerous laws enacted over a period of approximately 60 years.
The overarching objective of the CSA is to limit and/or control the use of Controlled Substances and to minimize the misuse, diversion, abuse, and illegal trafficking of Controlled Substances (CS).
In the past 10 years, the use of the top five major painkillers has doubled in the United States alone. With increased use, comes added need to control for potential misuse/abuse as well as wasted/unused medications.
Morphine is a legitimate medication for use in treating pain, particularly in the hospice and palliative care setting. It is important to recognize the value of its legitimate use by patients in severe pain while addressing ways to reduce waste and potential for diversion.
Like morphine, oxycodone is a legitimate medication for pain relief for use by hospice and palliative care patients as well as chronic pain patients. Efforts should be taken to ensure access to these medications for and by legitimate patients with appropriate prescriptions.
Medications are classified under the Controlled Substance Act based upon several factors, including: potential for abuse, scientific evidence of its effects, history of abuse, public health and dependency risks.
DEA registrants constitute a “closed loop” of organizations and healthcare providers who are issued DEA numbers for the manufacture, distribution, and destruction of Controlled Substances.
Individual end-user patient consumers are not part of this “closed loop” system. As such, once Controlled Substances have been dispensed according to prescription to an individual patient, they may not be returned to any of the DEA registrants that constitute the “closed loop”.
The Federal Guidelines for Proper Disposal of Prescription Drugs, issued in February 2008 are not a law or a regulation. They are suggested best practices issued after significant dialogue and discussion amongst various government agencies. They can be used as an appropriate starting place for determining best practices for creation of Hospice policy, but are not in and of themselves, the final rule on how to dispose of medications, especially Controlled Substances.
Numerous states throughout the US have begun to attempt to address the issue of unused and wasted medications. Proposed solutions includebut may not be limited to, take-back programs, disposal sites open to the public, and the enactment of regulations on unused medication returns to pharmacies. This map indicates some of the states that have begun attempting to address this issue.
The issue of unused medications and what to do with them is a complicated one. The following 3 states are examples of states that have taken a serious look at the issue and are attempting to address it. Indiana is a good example of a classic solution: some medications may be recycled under certain proscribed rules for use by indigent patients, but only when the medications have remained within the healthcare facility model. Medications previously dispensed to an end-user patient are not eligible for recycling under this program.
California is one of the “leader states” on attempting to resolve the issue of unused medications and their environmental impact. CA has community medication disposal drop-off sites, public awareness campaigns, and a recently enacted Senate Bill (SB 966) calling for pilot projects to allow consumers to drop off old prescriptions at retailers and public facilities within one year.
Like Indiana, Pennsylvania has enacted a Drug Repository Act, which allows for the return and reuse of certain cancer medications within the closed delivery system (hospitals, clinics, long term care facilities) for re-dispensing and use by indigent patients.
One relatively recent attempt by the Federal Government to further monitor the prescribing, dispensing, and use of Controlled Substances in an attempt to minimize their abuse/misuse and to control a steady supply of prescriptions.
When creating a hospice policy for the destruction of unused medication, it is helpful to understand some of the issues associated with prescription medications and controlled substances. 30-50% of illicit drug use in US revolves around pharmaceuticals. The legitimate practice of hospice care includes the use of medications regulated as Controlled Substances.
DEA pays close attention to Controlled Substances, especially the misuse or abuse of them in US. It estimates 22 million Americans as dependent or abusive of Controlled Substances. Tellingly, approximately 15 million individuals self-reported misuse or abuse of Controlled Substances in 2003.
Hospices should include staff members with diverse perspectives and areas of expertise when creating policy committees. Members may include: medical directors, nurse-administrators, pharmacists, visiting nurses, clergy or social workers, and legal representatives.
Address the issue of medication use and misuse across a broad spectrum. Look at several liability angles, including but not limited to: legal, financial, fraud and abuse, and accreditation viability.
Your hospice policy should be representative of your hospice’s philosophy, systems, and specific concerns. Areas of focus may include: history of internal and external diversion, geographic location, community issues or drug concerns, and internal desire or need for drug testing (routine, upon employment, or random are all possibilities).
Educate your staff on the penalties for the diversion and distribution of Controlled Substances.
An individual found guilty of illegally distributing a Controlled Substance can receive anywhere from 1 year prison sentence and a $100,000.00 dollar fine to 20 year prison sentence and a $1 Million dollar fine.
Likewise, criminal (illegal) possession of a Controlled Substance carries significant penalties.
An individual found guilty of criminal possession of a Controlled Substance may be imprisoned anywhere from 1 year to 3 years and can be responsible for the payment of fines (financial penalties) of anywhere from $1,000.00 to $5,000.00 dollars.
Always consider the applicable practice setting(s) when creating your hospice Medication Destruction Policy. There are similar and different considerations in the homecare versus the long-term and inpatient unit facilities. Look closely at daily usage and refill trends and consider what technology you have in place that may help your hospice control, track, and audit medication distribution, use, and waste.
Hospice should have a standard policy for what to do in the event of a known or suspected drug diversion. There may be variations of the policy dependent upon whether an incident is a confirmed or suspected diversion. Some questions to consider when creating your policy are: Are Controlled Substances involved? Is evidence concrete or circumstantial? Where did the alleged diversion occur (home care setting? LTC? IPU?) Is there any documented technology evidence to narrow focus to a small size of individuals (e.g. auditing capabilities in Pyxis Automated Dispensing Systems in IPU setting)? Is the diversion a recurring issue? Does the hospice need to complete a DEA 106 Loss or Theft Report?
It is a good idea to look at drug waste and diversion from both prospective and retrospective perspectives. It is always best to minimize waste and diversion potential prior to any occurrences. However, post-incident analysis can provide valuable insight into “gaps” or “holes” in a hospice policy and procedure and provide an opportunity to update hospice policy and enhance procedures to limit waste and diversion potential.
Hospices must educate patients on the importance of Controlled Substances, their value to patients in pain and their potential for abuse. Hospice should also provide education on means of disposal and how hospice may be available to help in this process.
Hospice can help deceased patients’ families with appropriate disposal of medications however, the medications belong to the deceased patient; they are neither the hospice’s property nor the family’s property. In the event of a dispute on disposal methods between hospice and family, hospice nurse should document in writing that hospice instructed/educated on potential for diversion and attempted to destroy; when possible nurse should have the refusing family member or caregiver acknowledge and sign the written document for hospice records.
Hospices are best prepared and best served when staff, patients, family and caregivers are informed and educated on the value of Controlled Substances and prescription medications for the treatment of pain as well as the potential for diversion and the importance of limiting wasted medication and diversion potential. Be proactive in approaching policy and procedure surrounding unused medication destruction. Once hospice has a policy and procedure in place, it is important to educate all staff and team members and to ensure continued compliance with the written policy and procedure. Hospice may consider quarterly or at least annual review of its policies, including this one in order to maintain an educated and compliant staff.
