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How-to Guide forDRUG TAKE-BACK:Managing a Pharmacy-Based Collection Program for Leftover Household PharmaceuticalsWHAT’S INSIDE? Best practices for running a drug take-back program Regulatory instructions for handling controlled substances Collection systems and vendor options Cost information and funding options Strategies for promoting your programWHO WAS THIS GUIDE DESIGNED TO HELP? Pharmacists and pharmacy managers Anyone else interested in safe drug disposal including:ü Local leadersü Government officialsü Healthcare providersü Drug abuse prevention and recovery networksü Waste managersü Environmental advocatesü Rural communitiesPrepared by the Product Stewardship Institute, Inc. in collaboration with theNew York Product Stewardship Council with funding from the Rural Utilities ServicesUnited States Department of Agriculture.3
PRODUCT STEWARDSHIP INSTITUTEThe Product Stewardship Institute (PSI) is a national, membership-based nonprofit committedto reducing the health, safety, and environmental impacts of consumer products across theirlifecycle with a strong focus on sustainable end-of-life management. Headquartered in Boston,Massachusetts, we take a unique product stewardship approach to solving waste managementproblems by mediating stakeholder dialogues and encouraging producer responsibility. Witha membership base comprised of 47 state governments and hundreds of local governmentagencies, as well as partnerships with more than 110 companies, organizations, academicinstitutions, and non-U.S. governments, we work to design, implement, evaluate, strengthen, andpromote both legislative and voluntary product stewardship initiatives across North America.NEW YORK PRODUCT STEWARDSHIP COUNCILThe New York Product Stewardship Council (NYPSC) works to implement the principles of productstewardship in New York State and nationally by providing leadership, guidance, and resources(including policies, evaluations, and educational tools) to individuals, organizations, institutions,local governments, the state legislature, elected officials, and manufacturers. NYPSC educatesthese stakeholders about the benefits of product stewardship and provides a forum for theexchange of information regarding existing policies and programs.This material is based on work supported under a grant by the Rural Utilities Service, United StatesDepartment of Agriculture. Any opinions, findings, and conclusions or recommendations expressedin this material are solely the responsibility of the authors and do not necessarily represent theofficial views of the Rural Utilities Service.ACKNOWLEDGMENTSThis How-to Guide was developed by the Product Stewardship Institute, Inc. and the New YorkProduct Stewardship Council (the Project Team) for the United States Department of AgricultureRural Development Office. The Project Team would like to thank the many individuals in New YorkState who contributed their time and provided valuable insights towards this project, includingthose from the Development Authority of the North Country, Oneida-Herkimer Solid WasteAuthority, Mountain View Prevention Services, Upstate New York Poison Center, Center for FamilyLife and Recovery, Sims Municipal Recycling, the Vernon Police Department, Lewis County PublicHealth Agency, Oneida County Health Department, Citizens Campaign for the Environment,and the New York Department of Environmental Conservation Region 6 Office. Many of theseorganizations provided on-the-ground assistance and were instrumental in identifying potentialpharmaceutical collection locations in the county. The Project Team is also grateful to the fivepharmacies that volunteered to be collection locations for this project. Finally, the Project Teamwould like to acknowledge Cornell University’s Survey Research Institute for conducting the publicawareness survey for this project.PROJECT CONTACTFor more information, please contact Vivian Fuhrman, associate for policy and programs at theProduct Stewardship Institute, at (617) 236–4771 or vivian@productstewardship.us.People with disabilities who require these materials in a different format or other specialaccommodations should contact Amanda Nicholson at amanda@productstewardship.us or at (617)236-4833.4
CONTENTSTABLE of CONTENTSINTRODUCTION.6Why Was This Guide Created?.6What’s the Problem? .7What’s the Solution? .7What are the Benefits of Pharmacy Collection? .8SO YOU WANT TO START A DRUG TAKE-BACK PROGRAM:PHARMACY IMPLEMENTATION GUIDE.91.2.3.4.5.6.Comply with Federal Regulations. 10Modifying your DEA Registration: a Step-by-Step Process.10DOT Special Permit: How to Comply.12How to Apply for Party Status to a DOT Special Permit.13Choose the Right Collection System. 14Choosing a Reverse Distributor.14Choosing a Receptacle.15Mail-Back Envelopes.15Determine a Funding Source. 16Legislated Programs .16Voluntary Programs.16Set up the Program. 17Receptacle Installation .17Log, Liner, Signs, and Mail-back.17Operate the Program. 18Educate and Train Your Employees.18Monitor Your Receptacle.19Replace Full Liners .19Order New Liners.19Spread the Word. 20In-Pharmacy Advertising.20Outreach in the Community.21CASE STUDY: DRUG TAKE-BACK IN RURAL NY.26Choosing our Reverse Distributor.26Selecting our Products and Services.27Yearly Costs Associated with our Pilot Program.28Collection Success .29The Power of Community Outreach .30APPENDICES .32Appendix A. Sample: Submission for Party Status to DOT Special Permit.32Appendix B. Matrix for Choosing a Vendor.33Appendix C. FAQ Document for Running a Pharmacy Drug Take-Back Program.35Appendix D. Sample Press Release.36ENDNOTES.385
INTRODUCTIINTRODUCTIONWHY WAS THIS GUIDE CREATED?Project BackgroundAlthough the number of drug take-back programs continues to increase across the country, onlya small fraction of the U.S. population has access to these programs, and many existing collectionlocations do not accept controlled substances. As a result, residents who want to remove unwantedpharmaceuticals from their homes often flush medicines down the drain or throw them out withthe household trash—both of which can lead to water contamination and adverse environmentalimpacts. The absence of safe and convenient drug disposal options also contributes to prolongedstorage of unwanted medicines in the home where they can lead to accidental poisonings andprescription drug abuse, especially among teens.In 2014, the U.S. Drug Enforcement Administration (DEA) issued a new policy allowing pharmacies tocollect controlled substances, such as prescription painkillers, for disposal. This guide offers step-bystep guidance to help pharmacies provide this critical service to their communities. It also providesvaluable information for government officials, community groups, and others interested in promotingpharmacy-based drug take-back.From October 2015 through September 2016, the Product Stewardship Institute and the New YorkProduct Stewardship Council promoted the collection of pharmaceuticals through a pilot projectin Oneida and Lewis Counties, New York. Thanks to funding from the United States Departmentof Agriculture, the two organizations helped five pharmacies set up safe and convenient collectionprograms for leftover— unwanted and expired— household medications in rural areas. Theinformation presented throughoutthis guide was gathered throughexperience with this and other takeback projects. This guide can help youset up a drug take-back program inany pharmacy, regardless of location.6
IONWHAT’S THE PROBLEM?WHAT’S THE SOLUTION?Prescription Drug Abuse Epidemic:Take-Back Programs for Safe Drug DisposalOne U.S. citizen dies every 14 minutes froma drug overdose,i leading to 100 deaths perday across the country.ii Today, unintentionalprescription opioid overdose kills moreAmericans than cocaine andheroin combined,iii and drugabuse has surpassed motorvehicle accidents as the leadingcause of injury death.ivFederal and state governmentshave declared this publichealth threat an epidemic.vStoring unwanted and expiredmedications in the homeincreases the risk of misuse,and places children, seniors,and pets at risk for accidentalpoisoning.Many Americans wonder how to properly ridtheir home of unwanted and expired drugs.Drug take-back programs that accept bothover-the-counter and prescription drugs —including controlled substances — provide asafe and convenient disposal option for leftoverhousehold medications. State and federalgovernment agencies — as well as the FederalDrug Administration (FDA), EnvironmentalProtection Agency (EPA), and other federal offices— promote take-back as the preferred strategyin preventing drug abuse and environmentalcontamination. To learn more, view PSI’s October2015 webinar, “A Quest for Convenience: DrugTake-Back at Retail Pharmacies.”Environmental Contamination:When drugs are disposed of in the garbage,poured down the drain, or flushed, they endup in the environment, potentially harmingaquatic ecosystems.vi Even if they enter thesewage system first, pharmaceutical compoundsreach wastewater treatment plants that arenot designed to remove them before beingreleased into the environment. Concern abouttheir presence in the drinking water supplyviicontinues to grow. A 2002 study conducted bythe U.S. Geological Survey found that 80 percentof streams tested across the country werecontaminated with at least one pharmaceutical,personal care product, or other organicwastewater contaminant.viiiTypes of Drug Take-Back Programs:On-Site Receptacles: Pharmacies, police stations,and a short list of other locations can voluntarilyset up a drug collection kiosk for consumers tosafely dispose of their controlled (schedule II-V)and non-controlled substances. On-site collectionis the safest and most convenient method forconsumers to dispose of unwanted medications.Mail-Back: Mail-back programs are a commonalternative or supplement to on-site collectionreceptacles. A pharmacy may offer prepaid mailback envelopes to customers to purchase or forfree.Collection Events: Federal, state, tribal, or locallaw enforcement can host periodic take-backdays when residents can drop off their leftoverpharmaceuticals at a designated location duringa specific window of time.Community organizations,municipalities, and otherEach year, over 1 billion worth of leftover drugsgroups can partner with lawenforcement to hold such aare thrown in the trash, flushed, or relegated tocollection event.medicine cabinets. These disposal strategies leavethe door open for accidental poisonings, drugabuse, and contamination of our waterways.7
WHAT ARE THE BENEFITS OF PHARMACY COLLECTION?Pharmacies are an ideal location for drug take-back kiosks. In many other countries, thepharmaceutical industry collaborates with government to offer drug disposal services at a wide arrayof participating pharmacies. These long-running programs provide safe drug disposal options toentire populations and play a pivotal role in protecting community health and the environment.How Does Becoming a Collection Site Benefit Your Pharmacy? Community Leadership: Highlight your pharmacy as a pillar of the community and show youare committed to the health and well-being of every resident. Customer Interaction: Demonstrate your expertise and value to the community when youanswer questions about safe medication disposal. Increased Foot Traffic: Community members enter your store to return unwanted or expiredmedications, increasing sales opportunities. Customer Loyalty: Customers will appreciate your efforts to provide this helpful service. Thisencourages their loyalty and their future business.How Does Becoming a Collection Site Benefit Your Community?8 Convenience: Residents already visit your pharmacy to pick up their prescriptions; offering adrug collection kiosk makes it as easy for residents to drop off unwanted drugs as it is to pickthem up. Education: Pharmacists are trusted health care professionals and are, therefore, the idealcandidates for conveying the environmental health and safety benefits of drug take-backprograms. Environmental Health: These programs prevent pharmaceuticals from entering waterways,where they can harm the aquatic ecosystem and potentially contaminate drinking water. Public Health and Safety: Collecting leftover drugs for disposal provides a safe alternative toleaving them in the medicine cabinet where they are at risk of being abused or misused.
STARTHEREPharmacy Implementation Guide*So You Want to Start a DRUG TAKE-BACK PROGRAM:It’s easy to start a drug take-back programthat collects both controlled and noncontrolled substances. Create a program atyour pharmacy in 6 simple steps:COMPLY WITH FEDERAL REGULATIONS1CHOOSE THE RIGHT COLLECTION SYSTEM2DETERMINE A FUNDING SOURCE3SET UP THE PROGRAM4OPERATE THE PROGRAM5SPREAD THE WORD6Ithaca, NY* New information on safe drug disposal is becoming available regularly. Visit the Product Stewardship Institute’sPharmaceuticals webpage and the U.S. DEA National Take-Back Initiative webpage for updates and additional resources. Besure to check your state laws and contact your state’s pharmacy board before launching a take-back program as pharmacybased programs are still prohibited in a limited number of states: AK, CT, HI, MN, MO, & MS (as of Sept. 2016).9
1)GUIDECOMPLY WITH FEDERAL REGULATIONS*Modifying Your DEA Registration: a Step-by-Step ProcessYou must modify your DEA registration in order to collect controlled substances through an on-sitetake-back program. This is a free and simple online process that takes just minutes. Registering as acollection site does not commit you to collect pharmaceuticals; it simply allows your pharmacy theoption.Follow these easy ation Support”CLICK“Registration forDisposal of ControlledSubstances.”C* This process and website may change over time. With questions,call (800) 882-9539 or email DEA.Registration.Help@usdoj.gov andinclude the name on your Registration and your DEA Number.10ENTERyour logininformation, all foundon your existingDEA registrationcertificate.
SELECTyour collectionmethod: collectionreceptacle, mail-backprogram, or both.(For information onthese options, seeSection 2: “Choosethe Right CollectionSystem.”)SIGNand certifyyour collectorstatus registrationelectronically.SAVEand printa copy of yournew registrationcertificate.DEF11
Drug EnforcementAdministration’s (DEA’s) FinalRule on Collection of ControlledSubstancesDOT Special Permit: How to Comply*Why was the U.S. Department ofTransportation (DOT) special permitcreated?Per the final DEA rule (see box on the right), pharmaciesaccepting controlled substances in their drug take-backreceptacle are not allowed to inspect the collectedmaterial to determine whether it contained anything thatwould be considered hazardous materials. Because thehazardous nature of the content is unknown, the Pipelineand Hazardous Materials Safety Administration of the DOTwould normally require specific protocol to be followedto ensure the safe transportation of these collectedpharmaceuticals. The shipping container would have toadhere to DOT specifications for the hazardous materialsthat may be present in the container, and the containerwould have to be marked accordingly for transportation tothe treatment facility. This is burdensome and was not theintention of the DEA.The DEA enforces regulations andlaws concerning the manufactureand distribution of controlledsubstances. The DEA issued adrug take-back policy in 2014permitting more types of businessto collect controlled substancesin an effort to increase collectionlocations and convenience, andencourage safe drug disposal.The rule allows manufacturers,distributors, reverse distributors,narcotics treatment programs, retailpharmacies, and hospitals/clinicswith an on-site pharmacy to modifytheir registration with the DEA tomaintain on-site drug collectionreceptacles and mail-back programsthat accept controlled substances.In order to assure compliance with the DOT and DEA, theDOT approved a Special Permit, SP 20255, for shipment ofmaterials collected through take-back programs using receptacles. The permit exempts collectors(e.g., reverse distributors) and shippers (e.g., pharmacies) from havingto ship the collected contents of a take-back program receptacle as ifit was hazardous material.More informationon this specialpermit, including arecorded webinar andpresentation slides, afull copy of SP 20255,and the samplesubmission for partystatus can be foundon the PSI website.12How long does the process take?If not using a vendor with its own DOT Special Permit, pharmacieswill need to apply for “party status” in order to be considered oneof a group/class of business eligible for this exemption under anapproved special permit 20255. This process takes just 5-10 minutesonce you have all of the information you need. It can take anywherefrom one day to three weeks for the DOT to process an applicationafter you submit by email. Upon party status approval, DOT providesan authorization letter via email as proof of compliance under a specialpermit.* The information and process described here was put into place to help thoseparticipating in take-back programs comply with federal regulations, but the processmay change. Contact the DOT at (202) 366-4535 or specialpermits@dot.gov with anyquestions.
How to apply for party status to a DOT special permit:Note that a reverse distributor may have received their own unique special permit from DOT whichwill not require the pharmacy to apply for the “party status” Special Permit 20255. If you are usingsuch a vendor, you will NOT need to apply for party status to SP 20255. Check with your vendorbefore proceeding with SP 20255 below.A. Using a sample party status application (see Appendix A), fill out your company informationwhere indicated in red.Recommended: Run through the DOT Party Status list.pdfB. Place application on your company’s letterhead.Recommended: Save application as a PDF file.C. Submit the PDF application file as an attachment tospecialpermits@dot.gov.Recommended: Include an informative email subject line (e.g.,“Submission for party status to a special permit for INSERTPHARMACY NAME ”).D. You will receive an automatic email confirmation that submission wasreceived.E. Once processed, you will receive an email indicating you have beenapproved with an attached Authorization letter for your records.HELPFUL HINT:D-U-N-S stands for“Data UniversalNumbering System.”It is a nine-digitnumber (completelyseparate from yourDEA registrationnumber) issued byDunn & Bradstreet. Formore information, visitwww.dnb.com/dunsnumber.html.13
2)GUIDECHOOSE THE RIGHT COLLECTION SYSTEMOnly authorized reverse distributors can transport — or use a commoncarrier to transport— collected materials for destruction. Some of thesevendors also provide collection containers. Begin by selecting a reversedistributor, and if needed, select a separate receptacle provider.HELPFUL HINTIf your reversedistributor does noprovide on-sitecollection receptaccontact a separatereceptacle vendor.Choosing a Reverse DistributorConsult the vendor matrix in Appendix B to help you select a reverse distributor that meetsyour pharmacy’s specific needs. In doing so, consider the following about each vendor:14TRANSPORT OFCOLLECTED MATERIALSWhat is the system for transporting collected materials? Willthis company pick up materials collected in inner liners, or is thepharmacy responsible for shipping pre-paid full liners throughcommon carrier?ADDITIONAL SERVICESDoes the reverse distribution company also offer collectionreceptacles? (See Choosing a Receptacle chart in the section below).Do they offer mail-back envelopes? What educational material andsignage comes with this option?DATA TRACKINGIs there an online system to track collection quantities? Find outwhether the company provides tools for easily analyzing andreporting collection results. This is important to tracking theperformance of a program and provides content to promote yourpharmacy’s contribution to the community’s health and environment.CUSTOMER SUPPORTCan customer service be reached when it is most convenient for yourbusiness? Does their website answer your most important questions?REGULATORYCOMPLIANCEDoes the company prioritize regulatory compliance? Make sure theycan answer questions about how they keep their system and servicesup to date with regulations. Numerous state Boards of Pharmacyhave additional regulations to which the pharmacy must comply.CONTRACT TERMSSome companies require a pharmacy to sign a contract for aminimum number of years and assess a fee for early contracttermination. Weigh the risks and benefits of signing a longer contract,and negotiate terms with the company if needed.COLLECTION SCHEDULEDoes the company offer flexible collection options to meet yourbusiness needs and budget? For example, do they offer multiplecollection schedules with a range of prices? Do they offer a fixed, prescheduled option? Your arrangement with a vendor will require lessmaintenance if services are pre-scheduled, but this may give you lessflexibility to change services as needed, or may cost more to adjust.COSTDoes the company offer pricing options that provide the features youneed? Make sure these fall within your budget.
T:otcles,Choosing a ReceptacleCollection receptacles include a tamper-proof outer shell that can be locked, an innerliner composed of a box made of cardboard or other sturdy material, and layers of plasticthat can be sealed for shipping. It should be able to be affixed to the wall or the floor.Consider the following when selecting a receptacle:Ithaca, NYSECURITYDoes the receptacle meet DEA performance standards (e.g., tamper-proof, with adual lock, with a lockable access slot, able to affix to wall/floor)?MATERIALIs the receptacle sturdy? Metal containers are recommended as they meet theDEA’s standard for strength. Make sure it comes with liners that can be shippedaccording to DOT packaging requirements specified in any relevant specialpermits.SIZEAre there different receptacle dimensions available? Consider where you willplace the receptacle and how much space it requires on the floor or counter.VISIBILITYCan you easily tell when the receptacle liner is full? A receptacle with atranslucent viewing pane allows you to see how full the liner is without unlocking(it does not reveal the contents) but may compromise the receptacle security.Check with the vendor for testing specifications.OUTREACHDoes the company provide promotional material? Make sure signage is largeenough to be read and includes what content is permissible and what isprohibited (by the DEA as well as any applicable local, state, and federal laws).RENTAL ORPURCHASEDoes the company provide receptacles for rent, for purchase, or both? Considerwhether your collection program is intended to be short-term or permanent.Some companies charge a removal fee for rented receptacles.COSTHow much does the receptacle cost? Decide which receptacle characteristics aremost important to you and choose a vendor that offers these at the lowest cost.(See “Choosing a Vendor” matrix in Appendix B.)Mail-Back EnvelopesSome vendors also sell certified mail-back envelopes, which a pharmacycan sell to customers, or provide “prepaid” as a free community service.This option allows residents to dispose of their leftover drugs by placingthem in the envelope and shipping them directly to a destruction facility. Make sure the mail-back envelopes are prepaid and preaddressedto the onsite destruction facility of the reverse distributor (a DEAregistered collector) as is required by the DEA rule. Mail-back envelopes can be used as a supplement to an on-sitereceptacle. They help serve populations that do not or cannotregularly visit the pharmacy. Order mail-back envelopes on a regular schedule or as needed.HELPFUL HINT:Bulk envelopepurchases tend tocome at a discountedprice. Purchase a smallnumber of mail-backenvelopes to assesscommunity interestfirst, and invest in abulk order if demand ishigh.15
3)GUIDEVoluntary government drug take-back receptacle in Boise, IDDETERMINE A FUNDING SOURCELegislated ProgramsVoluntary ProgramsExtended producer responsibility (EPR)laws require pharmaceutical companies tofinance — and often to manage — drug takeback programs. They may also require a specificlevel of convenience, public education, andparticipation by certain collection sites likepharmacies, usually required to be paid for bypharmaceutical companies. Countries includingBelgium, France, Hungary, Portugal, Spain,Mexico, Brazil, Columbia, and many Canadianprovinces have thriving EPR programs thatleverage the private sector’s expertise andefficiency.Government: Many police departments andsheriff’s offices host pharmaceutical collectionboxes and/or support one-day communitycollection events. The DEA sponsors periodicnationwide take-back events, although the longterm fate of this funding is tenuous. Ultimately,the cost of any government effort is borne bytaxpayers.In the U.S., after years of costly pharmaceuticalcollection programs paid for by taxpayers,an increasing number of local and stategovernments are supporting EPR legislation toprovide a more sustainable funding source. Asof September 2016, there are over a dozen suchlaws in effect in the U.S., including two at thestate level (Massachusetts and Vermont) and11 at the local level (9 in California and two inWashington state). Similar legislation is underconsideration across the country at the local,state, and federal levels.Retailers: Sometimes pharmacies — especiallylarge chains — fund their own take-backprograms. For example, in 2016 Walgreensbegan installing medication disposal kiosks inmore than 500 of its drugstores (mostly just the24 hour locations) in 39 states and WashingtonD.C. The same year, Benzer Pharmacy launchedits RxTakeBack program (in conjunction withPharmaLink) at select Florida locations. YellowJug Old Drugs, a non-profit organization,provides low-cost take-back services in manyretail pharmacies, which are paid for by eachpharmacy. (See “Choosing a Vendor” matrixin Appendix B for more information on theseand other reverse distributors and collectionservices.)
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Product Stewardship Institute? Non-profit founded in 2000 Memberships 47 States 200 Local governments Partnerships (75 ) Companies Organizations Universities Non-US Governments Board of Directors: 7 states, 4 local agencies Multi-stakeholder product stewardship network October 13, 2011 4
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