Needle Disposal Presentation

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    Coalition for SafeCommunity Needle Disposal

    Removing

    Home Generated Sharps from

    Household Waste

    October 2009

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    Purpose of Presentation

    Understand the current and future sharps disposalproblem in the U.S.

    Recognize that removing needles from the household

    trash is a shared responsibility among all stakeholdersinvolved: waste, sharps manufacturers,pharmaceutical, retailers/pharmacies, PBMs, insurancecompanies and patients.

    Introduce you to existing programs and solutions forsafe needle disposal

    Help you identify what would be the most effective

    approach for your community

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    Sharps Outside of Medical Facilities9 million Americans self inject prescription drugs.

    1 in 12 homes in the U.S. houses a self-injector.

    3 billion needle injections occur yearly outside of medicalfacilities.

    2 billion from patients treating their own diseases the other 1

    billion injections are illicit drugs users43% of Consumers do not use containers Throw regularHousehold Trash.

    20% - Use a sharps or biohazard container- Few take to adisposal facility.

    12 % - Use coffee cans, soda bottles, detergent bottles, milkcartons

    10 % - Plastic or glass containers, metal can, wrap in bag.

    Most sharps end up in the municipal waste stream!* Data Source: 2007 Roper Diabetes Study

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    Sharps Outside of Medical Facilities

    Insulin Syringes = 1,425,000,000 unitsPen Needles = 786,000,000 units

    Lancets = Over 900 million annually.

    About 15-17% of the above are obtained via mailpharmacies

    The injection category (home uses) - (pen needles andsyringes) are growing about 11-12% on an annual basis.

    Other items not included are sharps via home infusion(catheters, cannulas, infusion sets, etc)

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    Improper Disposal: Many Forms/Locations

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    Why Billions of Needles?

    Older population.

    Increase in incidence of chronic illnesses.

    Patient care pushed out of medical facilities.

    Pharmaceutical industry pipeline of injectable drugsdeveloped and marketed to treat chronic illnesses.

    21 million Americans have diabetes and incidence willincrease 165% over 50 years.

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    And The Problem Will Only Get Worse

    Need

    leUsers

    Needle

    s

    Waste

    Sticks

    1x

    2x

    3x

    4x

    Today 10-20 Years

    Demographics

    Diseases

    Self-Injectable Treatments

    Unchecked, a number of factors willconspire to exponentially increaseneedle use/waste/sticks and their

    personal/social/economicconsequences.

    Unless We Work Together on Solutions

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    Whos Impacted?

    Household residents (family members, guests, pets)

    General population in public venues

    (airports, casinos, hotels, parks, restaurants, stadiums, stores)

    Workers in various service industries Environmental Services (janitorial, recycling, waste disposal,

    water treatment)

    Hospitality (hotels, theme parks, stadiums, casinos, airports) Retail (stores, restaurants)

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    Reaction to Needles in Public Waste

    Needles in public waste are of unknown origin

    Needles of unknown origin must be considered aspotentially dangerous infectious material

    Needles in public waste create exposure to accidentalneedle-stick injuries

    Needles discarded by self-injectors have historically

    been non-regulated by state and federal legislationgenerators

    Due to increasing visibility of public health safety issue,state and federal legislation is emerging

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    Cost Impact of Accidental Needle Sticks

    Physical/emotional trauma to individual

    Loss of work productivity and income

    Cost of diagnostic testing and treatment

    Transmission of pathogenic diseases

    Life altering illnesses (HIV, HEP B & C)

    Life-long consumption of medical care

    Lawsuits, litigation and settlements

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    Manufacturers of Home Care Injectibles

    Arthritis: Humira and Enbrel (Abbott, Amgen)

    Diabetes: Insulin, Byetta, Symlin and Diagnostic (Eli Lilly,Sanofi-Aventis, Novo Nordisk, Lifescan, Roche Diagnostics, Abbott , Bayer)

    Hepatitis C & B/HIV: Interferon, Retrovir (Roche, Schering-Plough)

    Growth Hormones: Nutropin, Humatrop, Tev-Tropin, Genotropin, Saizen,

    Norditropin (Genentech, Pfizer, Gate, Serono, Novo)

    Infertility: FSH, HCG, and HMG (Serono, Organon, Ferring)

    Migraine: Imitrex (GlaxoSmithKline)

    Multiple Sclerosis: Interferon (Serono, Teva, Biogen, Berlex-Schering AG)

    Osteoporosis: Forteo (Eli Lilly)

    Psoriasis: Raptiva, Amevive (Genentech, Biogen)

    Others : Vitamin B12, Allergies, Blood Thinning, Veterinary Care

    In Development: Hundreds of designer drugs in the pipeline

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    Solving the Problem

    Gaining attention of industry, public and Federalagencies.

    Development of grass-roots community disposalprograms.

    Evolving State and Federal legislation.

    Initiating help from Product Stewardship Institute todevelop safe disposal solution from industry

    stakeholders.

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    Coalition Agenda

    Advocate to all 50 States to create legislation re-writingnon-regulated medical waste regulations

    Advocate development of reimbursement strategies

    Advocate to industry stakeholders to develop needledisposal solutions for all self-injecting drugs

    With the help of PSI (Product Stewardship Institute)

    determine nationwide disposal solution including costresponsibility.

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    Reimbursement Strategies

    Medicare Reimbursement Bills S. 1312 and H.R. 2976

    On June 19, 2009, Senator Johnny Isakson (R-GA) andRepresentative Mike Castle (R-DE) introduced S. 1312 and H.R.2976, respectively. The bills are Federal Medicare Part D Bills thatwill provide coverage for sharps containers, home needle

    destruction devices, and a sharps-by-mail or similar programbecause these are supplies associated with the injection of insulin.

    Co-sponsorship by Senator Ted Kaufman (D-DE) andRepresentatives Diane DeGette ( D-CO) and Mark Kirk (R-IL) and

    is anticipated by Xavier Bacerra (D-CA) all chairpersons of thediabetes caucus.

    In September 2008, the CBO provided Senator Isaksons officewith a score of a similar bill. With that information in hand,potential sponsors can now see a cost associated with these bills.

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    Medicare Part D Bill Language

    SECTION 1. SHORT TITLE.

    This Act may be cited as the Medicare Safe Needle Disposal Coverage Actof 2010.

    SEC. 2. COVERAGE OF CONTAINMENT, REMOVAL, DECONTAMINATIONAND DISPOSAL OF HOME-GENERATED NEEDLES, SYRINGES, [AND

    OTHER SHARPS]THROUGH A SHARPS CONTAINER,DECONTAMINATION/DESTRUCTION DEVICE, AND SHARPS-BY-MAILPROGRAM OR SIMILAR PROGRAM UNDER MEDICARE PART D.

    (d) IN GENERAL.Section 1860D2(e)(1)(B) of the Social Security Act (42U.S.C. 1395w102(e)(1)(B)) is amended by insert ing after regulations ofthe Secretary the following: and including devices approved for home

    use by the Food and Drug Administration for the safe and effectiveremoval, through a a sharps container, decontamination and disposal ofneedles, a sharps-by-mail or similar program.

    (e) (b) EFFECTIVE DATE.The amendment made by subsection (a) shalltake effect on January 1, 2010.

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    State Needle Disposal Legislation

    Legislationremoving needles

    from MSW

    States interestedin introducing

    legislation

    States with nolegislation but

    alternativedisposal solutions

    States still usingformer EPA

    recommendations(household trash)

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    State Legislative Progress

    Current State Legislation(Ultimately removing needles from the household garbage)

    Passed: California, Massachusetts, New Jersey, Louisiana,Mississippi, Wisconsin, Oregon

    Pending: New Hampshire, Pennsylvania

    Considering Legislation in 2009/2010: Texas,Tennessee, Florida, DC, New York, Maine, New Jersey

    Considering Policy Changes: Rhode Island

    Waiting on results of Massachusetts: Alabama, Georgia

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    Current Legislation

    CaliforniaAB 283: Very broad product stewardship bill thatincludes more than just needle disposal. Has a greatdeal of opposition. Probably wont pass this year.

    SB 486: This bill requires manufacturers to let the stateknow what they are doing to support the safemanagement of home-generated sharps. Passed andsigned by Gov. Oct. 11.

    AB 501: A bill that was vetoed by Governor last yearbut will most likely be re-introduced this year. Theformer bill required pharma manufacturers the issuedpre-filled syringes to provide either a sharps containerwith information to the closest disposal or a sharps bymail program. No cost to the patient. New bill ispromising to include all sharps, not just pre-filled.

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    Current Legislation

    Minnesota

    H.F. No. 1372: Every box of 90 or more syringes sold bysharps retailers must be accompanied by a free sharpsdisposal container that has adequate capacity to contain thesharps purchased. Sharps containers must be provided bythe sharps manufacturers to the sharps retailers at no cost.The disposal of these containers is not clear in thelegislation. This creates a HUGE problem for the patient.This bill only contains the sharps but doesnt solve the

    problem of disposal.

    Status: This bill was killed in the house.

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    Current Legislation

    Unfunded Mandates Already PassedLA: SB 226: Passed in 2007. Requires that Dept ofPublic Health enforce the rules. The new rule is noperson should knowingly place needles in thehousehold trash. The act shall be effective Sept. 1,

    2009.

    Status: NOTHING has been done to address this billby the state. Currently only one person in DPHassigned to issue no time or resources. Will

    present extended producer responsibility options toLA as it develops in MA.

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    Current Legislation

    Unfunded Mandates Already PassedNJ: AB 1852: Passed in 2006. A board from eachcounty shall prepare and adopt a sharps disposalcomponent as an amendment to the solid wastemanagement plan required by the Solid Waste

    Management Act. NO money was appropriated,therefore no county has implemented a program.The DPH has successfully added more hospitalsaround the state to accept sharps from thecommunity.

    Status: Met with Rep. Conoway Chairman ofHealth Committee and discussing legislation similar toFederal Medicare Bill requiring insurance companiesto cover needle disposal products to NJ patients.

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    Current Legislation

    Unfunded Mandates Already PassedMS: SB 2730: Passed in 2008. Requires the DEQ todevelop and implement a program for the disposal ofhome-generated medical sharps. The departmentshall also develop and implement a state-wideeducation program to promote the publics safe

    disposal of home-generated medical sharps. Theprogram shall be developed no later than July 1, 2009and implemented no later than Jan. 2010.

    Status: MS DEQ and the MS Diabetes Associationdeveloped and implemented a state-wide program thatincludes drop-offs at 90 participating pharmacies andfire stations, 3 local medical waste haulers pick-up thewaste free of charge and BD donated 3000 safe clipsfor home bound patients. Huge educational campaignwas also developed.

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    Current Legislation

    Unfunded Mandates Already PassedMA: Bill was a syringe access bill that included safedisposal of all sharps. The responsibility to implement theprogram fell into the hands of the DPH. There was nomoney available. Many communities in the state haveimplemented various programs, but overall the state hasnot developed a state-wide needle disposal program. The

    MA DPH and the Solid Waste divisions have been veryactive in the PSI Needle Disposal meetings. MA hasagreed to be a model state and is working with PSI todevelop a program that is a shared responsibilityprogram. The program should be developed by Jan. 2010and implemented by July 2010.

    Status: Coalition working with Produce Stewardship Instituteto develop a financially sustainable program using a sharedresponsibility approach. A meeting was held July 20 todiscuss WM proposal for needle disposal program (seeattachment).

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    Current Legislation

    New Hampshire H.B. 1502 :(a) No person shall place any needles, syringes, or other

    medical instruments that are capable of puncturing the skinfor the delivery of medication in any container used for the

    collection of solid waste, recyclable materials, constructionand demolition debris, or compost.

    (c) Any person who disburses, within this state, needles,syringes, or other medical instruments that are capable ofpuncturing the skin for the delivery of medication shall

    participate in a take-back disposalprogram for needles,syringes, and other similar medical instruments which isapproved by the department.

    Status: Committee for Review.

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    Current Legislation

    Pennsylvania H.B. 594:DEP will develop and implement a statewide program for thesafe, convenient and cost-effective disposal of homegenerated medical sharps. The program may provide for avariety of methods of disposal including:

    1. use of mail-back programs

    2. community-based drop-off sites3. municipal HHW drop-off sites4. special curb-side pick-up service, or5. home needle destruction devices

    The program shall include an educational componentdesigned to inform the public about safe disposal of home-

    generated medical sharps and to promote the public's use ofthe program for disposal of home-generated medical sharps.Status: Removed from table May 6, 2009 and re-committed to

    Appropriations May 6, 2009. Currently passed in House and isSenate Health and Welfare Committee. Coalition will sendletter of support to members.

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    Current Legislation

    MaineWorking with citizen in Maine to identify the bestlegislation for the state. Maine does not passunfunded mandates so we need to develop a

    program and a solution.

    Citizen is active with American Legion and hasbefriended leaders in the Maine legislation andgovernment. He is setting up meetings in August to

    meet with leaders to work on legislation for next year.

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    Other Legislation

    Texas:

    At this time Rep England would like to present a needledisposal resolution. If there are programs in place theRep England will introduce those programs at the timethe Resolution is read, as well as have a briefing todiscuss the issue of safe needle disposal.

    Because there is not a solution in place that is financiallysustainable he does not want to introduce legislation thisyear that will put the financial responsibility on thepatient, not in this current economy.

    Alabama, Florida, Tennessee:All states have expressed interest, but waiting to see ifsolutions result from MA efforts.

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    State Legislation

    Wisconsin and OregonMedical waste is medical waste it does not matter where

    it is generated. It must be treated the same in a hospitalor at home.

    Wisconsin: Most counties provide patients with a disposalsolution using local hospitals, pharmacies, clinics, etc. asdrop-off sites for sharps containers. Most programsaccept the needles in any puncture resistant container.The cost to the county to provide this service topatients is so much cheaper that the cost of treating oneneedle stick injury to my employee, says the WasteManager for Madison, Wisconsin.

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    Types of Needle Disposal Programs

    Community-Centric Needle Disposal Programs- Drop Box Collection Sites- Residential Special Waste Pick-Up- Household Hazardous Waste Programs

    - Syringe Exchange Programs

    Patient-Centric Needle Disposal Programs- Disposal by Mail Programs- In-Home Individual Disposal Products(needle destruction devices)

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    INDIVIDUAL HOME MAIL BACKCOSTS/ SHARPS CONTAINER

    COST

    SHARPS CONTAINER $2.00PACKAGING $3.00SHIPPING TO CONSUMER $2.00RETURN POSTAGE $6.50DOCUMENTATION $1.00TREATMENT/DISPOSAL $3.50

    TOTAL / PKG $18.00

    RETAIL PRICE RANGE $25 - $50

    INDIVIDUAL MAIL-BACK

    COMPONENTS

    COMMUNITY CENTRIC

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    COMMUNITY CENTRICMAIL-BACKER SHIPPER - 20 UNIT

    COSTS/ SHARPS CONTAINERCOMMUNITY CENTRIC SHIPPER MAIL-BACK

    CHARGES

    SHARPS CONTAINER @20 UNITS $60.00AGGREGRATED SHIPPER BOX* $3.00AGGREGATED MAILER @20 UNITS $57.00Mailer includes USPS postage(transportation), disposal &documentation*HD PE

    TOTAL / PKG @ 20 UNITS $120.00COST / PKG $6.00

    COMPONENTS

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    COMMUNITY CENTRIC KIOSK-20MODEL COSTS

    UNITSCOMMUNITY CENTRIC KIOSK PICK-UP 20

    COST

    SHARPS CONTAINER @20 UNITS $40.00

    KIOSK (MONTHLY RENTAL) $600.00

    AGGREGATED TUB @20 UNITS $100.00Pick-up includes transportation, disposal &

    documentation

    KIOSK (PURCHASE) $1,000.00

    RENTAL

    TOTAL / PKG @ 20 UNITS $740.00

    COST / PKG $37.00

    PURCHASE

    KIOSK AMORTIZED 12 MONTHS @ 20 UNITS $223.33

    COST / PKG $11.17

    COMPONENTS

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    COMMUNITY CENTRIC KIOSK-40MODEL COSTS

    UNITS

    COMMUNITY CENTRIC KIOSK PICK-UP ONLY 40

    COMPONENTS COST

    SHARPS CONTAINER @40 UNITS $80.00

    KIOSK (MONTHLY RENTAL) $600.00

    AGGREGATED TUB @40 UNITS $150.00

    Pick-up includes transportation, disposal &

    documentation

    KIOSK (PURCHASE) $1,000.00

    RENTALTOTAL / PKG @ 40 UNITS $830.00

    COST / PKG $20.75

    PURCHASE

    KIOSK AMORTIZED 12 MONTHS @ 40 UNITS $313.33

    COST / PKG $7.83

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    Rhode Island Community-based Program

    Program Specifics

    5.3 Years5,009,106 poundsof needles collected58% collected at CVS Locations

    Site LocationsPharmaciesFire and Police Stations

    Healthcare Agencies (hospitals, clinics, nursing homes,doctor offices, etc.)Government BuildingsTransfer Stations

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    Options for Site Funding

    Pharmaceutical Company re-imbursement

    Town funding (i.e.-San Francisco is increasingresidential disposal fees by .5% to cover sharpsdisposal.)

    Charge a collection fee at point of purchase ($5.00co-pay)

    Sponsorship on Kiosk

    Local Hospital Funding

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    Household Hazardous Waste Option

    Pulaski County, Arkansas (Little Rock)

    Pulaski County Residents can obtain a free containerfrom a participating pharmacy (provided by the countyWaste Department)

    When the container is full, residents return it to oneof five public works facilities (household hazardouswaste facilities) in the county at no cost.

    Annual cost for disposal is virtually nothing becausethe needles are disposed of as hazardous waste notmedical waste.

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    Hospital Disposal Program

    Riverview Hospital Wisconsin Rapids, WI

    Sharps Smartwas implemented to help sharps usersfollow the state law.

    Self-injectors bring their filled sharps or householdcontainer to the hospital lobby where it is disposed ina large kiosk open 24/7.

    Maintaining the program costs about $2500 per yearand is paid for by the Hospital Foundation.

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    Economic Cost of Diabetes

    2007, the diagnosed population reached 17.5million, costs do not reflect undiagnosed

    The total cost reached $174 billion up

    $116 billion in direct medical expenditures$58 billion in indirect reduced productivity

    Cost per Patient = $11,744/yr

    2.3 times non-diabetes

    1 in 5 health care dollars are spent on a personwith diabetes

    Diabetes Supplies Account for Only 4% of the

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    Diabetes Supplies Account for Only 4% of the$4,579 Pharmacy Spend for Insulin Users

    Pharm acy Spend by Average Diabetes Patient

    9%

    4%

    20%

    61%

    6%

    Insulin

    Diabetes Supplies

    Diabetic Oral Agents

    Other Prescriptions

    Other equipment/supplies

    Diabetes Suppliesincludes injection devices

    & BGM Test Strips

    Independent Analysis Conducted by Lewin Group, April, 2008

    Note: does not include OTC Spend

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    How the Coalition Can Help You

    Introduce the community to existing programs andsolutions

    Introduce you to businesses that offer safe disposal

    solutions

    Help educate the public and developeducational/informational materials

    Encourage reimbursement at Federal Level

    Coalition for Safe

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    Coalition for SafeCommunity Needle Disposal

    Contact:

    Jenny Schumann800-643-1643

    [email protected]

    mailto:[email protected]:[email protected]