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Washington StateBoard of Pharmacy

DRUG DIVERSION(and other despicable wrongdoing)

Richard D. Morrison, PharmacistChief Investigator

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Presentation Overview

Diversion: Who? What? When? Where? How? Why? and DetectionView video tape of actual diversionAwareness and preventionPractitioner responsibilitiesA primer on counterfeit drugs

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Who diverts drugs?

Health care professionals

Patient abusers

Others

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What drugs are diverted?

Controlled substances

Legend drugs

OTC drugs

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When are drugs diverted?

When procedures are not followedWhen records are not reviewedWhen staff are too trusting or naïveDuring periods of “turmoil”During “slow” work shiftsAnytime!

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Where are drugs diverted?

Drugs are diverted from any site where they are stored, stocked, administered, prescribed, or dispensed!!

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How are drugs diverted?(A partial list!)

TheftRecord alterationPrescription forgeryFrom “wastage”Some for “you”… some for “me”Substitution

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Why are drugs diverted?

Known quality and potencyReadily obtained by prescriptionAccess in the work placeProduce desired effectsLarge market if traffickingThey are not “street” drugs

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So what’s the motivation?

GreedSelf-use (impairment)SympathyEmpathySexual gratificationVictimization (blackmail, duped)

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Detection

Prescriptions filled too frequentlyPrescriptions filled concurrentlyUnjustified over-prescribingSelf-prescribingPrescription alterationCoworker lifestyle changes

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Other methods?

Alteration or loss of recordsUnjustified purchasesDecline in profit marginsPatients without pain reliefLosses of drugs subject to abuseProduct tampering

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Investigation

Confirmation of suspicionsConfrontation of SuspectPost-confrontation issuesAnalysis

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Video Tape Presentation

Actual casesTime consumingBest evidenceA picture is truly worth a thousand words!

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Legal Issues

Administrative proceedingsCriminal chargesLaws typically violated:

Professional practice actsUniform Disciplinary ActUniform Controlled Substances ActLegend Drug Act

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Awareness & Prevention

Sound policiesCommon senseAdherence to rulesAppropriate security measuresRemain informed

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What else should I do?

Ask questions when in doubtRegular record reviewTrack stockLimit stock to levels of useRestrict access

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Is there more? (You bet!)

Promptly return/destroy outdatesDocument & return unclaimed prescriptions to stockMaintain close working relationshipsInvestigate unusual circumstancesRely on a code of ethics

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Practitioner Responsibilities

Become knowledgeableKnow that occasionally, trusted coworkers divertProceed carefullyFollow proceduresKeep an open mindMaintain confidentiality

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Give me more hints!

Be an astute observerRecognize legal and ethical responsibilitiesNotify appropriate agenciesKeep accurate notesUse restraintPreserve evidence

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Anything else?? (Yep!)

Eliminate SuspectsRecognize records are often alteredResolution takes timeReport lossesTrust intuition

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Counterfeit Drugs

Old problem – new “drivers” & “twists”Formerly… most were limited to unwitting purchases overseasNow… Internet access and infiltration of drug distribution systemVictims are patients and companies

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Give me some examples?

Fake medicationsDiluted (to side-step red flags)ExpiredBogus labels

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Which drugs are targeted?

High cost and specialty drugs (Procrit, Serostim, Nutropin, Neupogen, etc.)

Widely prescribed medications (Celebrex, Lipitor, etc.)

“Lifestyle” drugs, i.e., Viagra

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Counterfeit Authentic32

Some important points:

Petty criminals to organized crimeVery profitableSophisticated methodsDifficult to detect and trackPer FDA, 10% of drugs worldwide are counterfeit (some countries 50%!)

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How does it happen?

Manufacturer to major wholesaler (AmeriSource Bergen, McKesson & Cardinal)

Secondary wholesalers (price driven… as bulk, overstock, etc.)

Wholesalers sell to each other (makes tracking more difficult)

Re-packagers (more tracking problems)

Secondary/re-packager to major wholesaler

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What adds to the problem?Rogue Internet sitesOverwhelmed Customs workersPolitical concernsLax or un-enforced regulationsDifferential pricingEase in obtaining licenses

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What’s being done?

Increased investigative effortsStiffer penalties (FDA)High-tech tracking & packagingIncreased border surveillanceGreater wholesaler oversightHealth practitioner awareness

Websites may look legitimate, but often sell unapproved or counterfeit drugs from around the world

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Questions and Answers