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  • Law Enforcement Track:Lessons from the Supply Side Presenters:Anglica Meinhofer, MS, Graduate Student, Department of Economics, Brown UniversityKyle Simon, MS, Director of Policy and Advocacy, Center for Lawful Access and Abuse Deterrence (CLAAD)Stacey L. Worthy, JD, Associate Attorney, DCBA Law and PolicyModerator: Frank Rapier, Executive Director, Appalachia High Intensity Drug Trafficking Area (HIDTA)

  • DisclosuresAnglica Meinhofer, MS, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.Stacey L. Worthy, JD, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.Kyle Simon, MS, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.Frank Rapier has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

  • DisclosuresAll planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.The following planners/managers have the following to disclose:Kelly Clark Employment: Publicis Touchpoint Solutions; Consultant: Grunenthal USRobert DuPont Employment: Bensinger, DuPont & Associates-Prescription Drug Research CenterCarla Saunders Speakers bureau: Abbott Nutrition

  • Learning ObjectivesEvaluate the impact of Rx drug supply-side interventions caused by enforcement and legislative interventions in FloridaContrast the impacts of Rx drug and illicit drug supply-side interventions.Describe the problem of Rx drug fraud, abuse and related issues.Outline strategies for protecting consumers from black-market Rx drugs.

  • Law Enforcement Track: Lessons from the Supply Side Anglica MeinhoferPh.D. Candidate, Brown UniversityAre We Fighting the Right War? Estimating the Effect of Prescription Drug Supply-SideInterventions

  • Disclosure StatementAnglica Meinhofer, Ph.D. Candidate, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

  • Learning Objectives Evaluate the impact of Rx drug supply-side interventions caused by enforcement and legislative interventions in Florida.

    Contrast the impacts of Rx drug and illicit drug supply-side interventions.

    Describe the problem of Rx drug fraud, abuse and related issues.

    Outline strategies for protecting consumers from black-market Rx drugs.

  • MotivationAfter marijuana, prescription drugs are the most abused controlled substances in the United States (NSDUH, 2013)

    Overdose deaths involving opioid pain relievers (OPR) increased by 313% from 4,030 in 1999 to 16,651 in 2010 (CDC, 2013)

    OPR deaths now exceed those involving heroin and cocaine combined (CDC, 2011)

  • MotivationOPR abuse imposes considerable societal costs

    In 2007 these costs amounted to $55.7 billion (Birnbaum et al., 2011)46% workplace45% health care9% criminal justice

  • Overview Can interventions that aim to reduce drug availability by targeting the supply-chain be effective against prescription drug abuse?

  • Broader Questions Why should the use of controlled substances be regulated?

    How should the use of controlled substances be regulated?

  • Why should the use of controlled substances be regulated?Market Failures

    Externalities (e.g. Neonatal Abstinence Syndrome)

    Imperfect information (e.g. Risk perception)

    Internalities (e.g. Time inconsistent preferences)

  • How should the use of controlled substances be regulated?Controlled Substances Act (1970)Register with the Drug Enforcement AdministrationKeep records of inventories and transactions involving controlled substancesDivide substances into five schedulesCurrent accepted use in medical treatmentAbuse potentialLikelihood of dependence when abused

  • How should the use of controlled substances be regulated?

  • InterventionsRevoking or suspending a supplier's prescription drug dispensing privilege

  • Questions of InterestCan supply-side interventions reduce drug availability?

    Can supply-side interventions improve public health?

    What mechanisms reinforce or offset supply-side interventions effectiveness?

  • Meanwhile, in Florida...Once the epicenter of the prescription drug abuse epidemic

    Oxycodone was the drug on demand (in 2009, 44% of all oxycodone 30mg products were distributed to Florida, DEA 2012)

    Practitioners operating from rogue pain management clinics or pill mills" were the main source of diversion

  • Meanwhile, in Florida...Source: ARCOS

  • InterventionsBy mid 2010 and throughout 2011, the state of Florida implemented a series of supply-side interventions to address prescription drug abuseEnforcement: Operation Pill NationLegislative: Dispensing Practitioner LawsSB 2272 (Oct. 2010): Can dispense up to 72-hour supply of CS II-VHB 7095 (July 2011): Cannot dispense CS II-III

    *Note: Prescription Drug Monitoring Program; Changes in Oxycontin formulation

  • Interventions

  • InterventionsSource: DEA

  • Data Sources Total Quantities (DEAs Automation of Reports and Consolidated Orders System)

    Street Prices (StreetRx.com & Bluelight.org)

    Overdose Deaths (Floridas Medical Examiners Commission)

    Pain Clinic & Pharmacy Licensure (Florida Department of Health)

  • Contributions Explore supply-side interventions in a new context: the case of prescription drugs Previous studies analyzed the effects of supply-side interventions on illicit drug availability Results have been somewhat mixed, with most finding no effects and others finding modest or temporary effects Previous findings may not generalize to controlled prescription drugs Accepted use in medical treatmentLegally produced, prescribed and dispensedRetail suppliers include healthcare providers End-consumer includes legitimate users

  • Contributions Study a particular type of supply-side intervention that consists of revoking a suppliers prescription drug dispensing privilege

    Rely on novel, high frequency administrative data, and a quasi-experimental research design

    Tie drug availability to health outcomes

    Foreshadow potential threats and benefits of re-scheduling/legalizing controlled substances

  • Preliminary ResultsPost-period begins after Q3 2010Difference in differences type of approachDivide drugs into groups based on their relation to Oxycodone OxycodoneComplements (Alprazolam, Diazepam) Substitutes (Hydrocodone, Hydromorphone, Morphine, Oxymorphone, Codeine) NTP (Methadone, Buprenorphine) Stimulants (Amphetamines)Illegal drugs (Heroin, Marijuana, Cocaine)

  • Total Quantities

  • Street Prices Source: Bluelight, StreetRx

  • Total Quantities by Provider - Practitioners

  • Total Quantities by Provider - Pharmacies

  • Total Quantities by Provider - Hospitals

  • Pain Clinic Closures

  • Pharmacy Openings

  • Total Deaths

  • Total Deaths

  • Conclusions PRELIMINARY FINDINGS suggest that in the context of prescription drugs: Supply-side interventions reduced drug availability and increased street prices No evidence of a supply recoverySupply-side interventions reduced drug abuse/ improved public health (despite substitution to other drugs) Some suppliers changed their behavior in response to the interventions and according to economic incentives

  • Lessons from the Supply SideStacey Worthy & Kyle Simon

  • Disclosure StatementStacey L. Worthy has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.Kyle Simon has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

  • Disclosure StatementThe Center for Lawful Access and Abuse Deterrence (CLAAD) receives funding from businesses in the health care industry that share CLAADs mission to reduce prescription drug fraud, diversion, misuse, and abuse while advancing consumer access to high-quality health care. CLAADs funders include pharmaceutical companies, treatment centers, and laboratories.CLAAD is managed by DCBA Law & Policy (DCBA). DCBA also provides legal and policy counsel to professionals and businesses whose activities align with CLAADs mission. To avoid conflicts of interest, DCBA adheres to the District of Columbia Rules of Professional Conduct 1.7-1.9.

  • Learning ObjectivesDescribe Rx drug fraud, abuse, and related issuesOutline strategies for protecting consumers from black market Rx drugs

  • PreviewOverview of the issuesTerminology, introduction to the Rx epidemic and biologicsRecent examples of diversionParallels to the Rx abuse epidemicFederal and state laws, issues, and policiesRecommendationsConclusion

  • Terminology Policy meeting: Washington, DC, 10/24/1518 organizationsBlack marketCounterfeits DivertedGray market FDA-approved drugsReimported foreign counterparts of FDA-approved drugsFDCA terms: misbranded, non-FDA-approved, adulterated

  • Prescription Drug