Unused Patient Medication Disposal

2 Concerns About Pharmaceutical Disposal Pharmaceuticals have been found in surface and ground sources of drinking water Minute concentrations of endocrine disruptors have been found in waste water treatment plant receiving waters –Having detrimental effects on aquatic species –May have an impact on human health

3 Sources of Pharmaceuticals in Waterways

4 Pharmaceuticals in the News Medical facilities making uncontrolled releases of controlled drugs into water By JEFF DONN | AP National Writer 12:36 PM EDT, September 14, 2008 MINNEAPOLIS (AP) _ In a frustrating quirk in government policy, the most tightly controlled drugs — like painkilling narcotics prone to abuse — are the ones that most often elude environmental regulation when they become waste.

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6 Unused patient medication in the U.S. Approximately 4 billion prescriptions are filled in the United States annually, and it has been estimated that as much as 35% of the dispensed medication goes unused, resulting in over 200 million pounds of pharmaceuticals which can adversely affect the environment if disposed of improperly. Improper disposal or diversion of unused medications increase the risk of accidental poisoning and drug abuse.

7 TakeAway ™ Envelope 10 & 20 Gallon TakeAway ™ Community Environmental Return System

8 Sharps RxTakeAway ® Capabilities: USPS – A Federal Agency takes custody of envelope Tracked, validated and measurable results Currently in use and in test programs Sustainable costs Production –Handled by licensed law enforcement officials –Securely stored (packaging is never opened) –Weight and date stamped –Witnessed and assured destruction Online data warehouse of production All products, except controls are returned from patients

9 Sharps ® TakeAway Customized Packaging: Costs included: –Packaging –Instructions –Tracking –Return postage –Security –Assured destruction Customization (TBD) Tamper evident packaging Police process the return Approved by

10 Sharps ® TakeAway Customized Packaging: 10 & 20 Gallon System –Packaging –Instructions –Tracking –Return UPS –Security –Assured destruction Customization (TBD) Tamper evident packaging Police process the return Approved by UPS Ideal for community and event returns programs

11 Tracking Capabilities: Secure, proprietary online data warehouse, unique for each client. –Outbound inventory –Returned inventory –Date of return –Condition of return –Weight of return –Current status of return (stored) –Date of destruction –7/24 access –Customized reporting available

12 Controls: Plant is registered by the DEA as a Reverse Distributor (I-V) Was approved by DEA (twice) – Currently approval is on hold pending a legislative change, vs the granted exception –Build out of cage/vault is completed –Staffed with licensed law enforcement Sharps has made comments for the current review taking place by the DEA Have congressional support for initiative Currently, packaging and/or IFU’s state “No Controls” No inventory is opened All inventory is tracked, incinerated and witnessed USPS agreement in place to allow for controls, once DEA grants permission

13 Success of Mailback Programs: Lessons Learned Dependent on extent of Public Relations Used in first fills/changes of script/recalls Patients will contribute to help lower costs Needs to be simple to drive participation and lower costs Significant public awareness exists of the need for a solution Rules on What Can Be Returned No Controlled Substances Each liquid, should be 4oz or less, placed in a individual plastic bag Envelopes sealed in original dispensed package Customizable via printing on envelope, IFU’s or program i.e. recall All packaging is serialized and tracked

14 Advantages of a Mailback System: Environmental –Participant does not have to drive to location ( also increases participation) –Uses existing logistics (USPS is at their home already, no additional footprint) –Eliminate truck to pick up and location personnel involvement Security and risk reduction –Patient can call USPS to pick up from home –Product is with a federal agency (diversion reduction) –Handled in plant by law enforcement –Assured and witnessed destruction –Packages - all are tracked/serialized –No possibility for re-dispensing or return for credit Frees pharmacy personnel to focus on patient care HIPAA compliant – patient opts in, packages not opened