Prescription Drug Abuse Crises - HCCA Official Site...– Insomnia or AntiInsomnia or Anti-Anxiety medications Anxiety medications • ZolpidemZolpidem 154.9% increase 154.9% increase

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Prescription Drug Abuse CrisesPrescription Drug Abuse Crises

Outline

1. Past and Current Trends re: RX Abuse

2. Diversion Methods

3. Regulatory Reporting Requirements

4. Q/A

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1970s

1980s

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The 1990sOXYCODONE

OxyContinOxycodone/APAP

Hydrocodone

Alprazolam

Oxycodone 30 mg

Carisoprodol

OxyContin 80mg

Today and Beyond

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Prescription Drug Abuse

More Americans abuse prescription drugs than the

number of:

Cocaine, Hallucinogen, Heroin, and Inhalant abusers

COMBINED!!!

Current Current Users Users -- 20092009

METHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINE: : : : : : : : 502,000502,000502,000502,000502,000502,000502,000502,000METHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINE: : : : : : : : 502,000502,000502,000502,000502,000502,000502,000502,000

ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million(8.7% of population)ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million(8.7% of population)MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA: 16.7 million16.7 million16.7 million16.7 million16.7 million16.7 million16.7 million16.7 millionMARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA: 16.7 million16.7 million16.7 million16.7 million16.7 million16.7 million16.7 million16.7 millionCOCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE: 1.6 million1.6 million1.6 million1.6 million1.6 million1.6 million1.6 million1.6 millionCOCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE: 1.6 million1.6 million1.6 million1.6 million1.6 million1.6 million1.6 million1.6 millionPSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS: 7 million7 million7 million7 million7 million7 million7 million7 millionPSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS: 7 million7 million7 million7 million7 million7 million7 million7 million

HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: 213,000213,000213,000213,000213,000213,000213,000213,000HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: 213,000213,000213,000213,000213,000213,000213,000213,000METHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINEMETHAMPHETAMINE: : : : : : : : 502,000502,000502,000502,000502,000502,000502,000502,000

ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:ANY ILLICIT DRUG:21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million21.8 million(8.7% of population)MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA:MARIJUANA: 16.7 million16.7 million16.7 million16.7 million16.7 million16.7 million16.7 million16.7 millionCOCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE:COCAINE: 1.6 million1.6 million1.6 million1.6 million1.6 million1.6 million1.6 million1.6 millionPSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC PSYCHOTHERAPEUTIC DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS:DRUGS: 7 million7 million7 million7 million7 million7 million7 million7 million

HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: HEROIN: 213,000213,000213,000213,000213,000213,000213,000213,000Source: 2009 NSDUH, released September 2010

8.7%

9.8%

12%

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5

0

1000000

2000000

3000000

4000000

5000000

6000000

7000000

8000000

9000000

2004 2007 2008 2009

Sedatives

Stimulants

Anti-Anxiety

Narcotic Pain Relievers

2 million

Scope and Extent of ProblemScope and Extent of Problem

5.3 million

1.3 million

.37 million

Source: 2004, 2007, 2008, 2009 National Survey on Drug Use and Health

Past Year Initiates for Specific Drugs Persons

Aged 12 or Older 2009

0

500

1,000

1,500

2,000

2,500

Numbers in the ThousandsNumbers in the Thousands

Avg. 6,027 persons per day

initiating with pain relievers

Source: 2009 NSDUH survey

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Number of Forensic CasesNumber of Forensic Cases

20012001--20092009

-

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

2001 2002 2003 2004 2005 2006 2007 2008 2009

Number of Cases

Years

Methadone

Oxycodone

Hydrocodone

Percent IncreasePercent Increase

MethadoneMethadone-- 281%281%

OxycodoneOxycodone-- 330%330%

HydrocodoneHydrocodone-- 314%314%

Source: NFLIS State & Local Laboratories

Emergency Room Data 2004Emergency Room Data 2004--20092009

•• Increase of 98.4%Increase of 98.4%: ER visits attributable to pharmaceuticals : ER visits attributable to pharmaceuticals (627,291 to 1,244,679)(627,291 to 1,244,679)

–– No Significant Change: ER visits attributable to cocaine, heroin, marijuana, or No Significant Change: ER visits attributable to cocaine, heroin, marijuana, or methamphetamine methamphetamine

•• Rx Drugs most frequently implicated:Rx Drugs most frequently implicated:–– Opiates/Opiates/OpioidsOpioids pain relievers pain relievers

•• Oxycodone products 242.2% increaseOxycodone products 242.2% increase

•• Hydrocodone products 124.5% increaseHydrocodone products 124.5% increase

•• FentanylFentanyl products 117.5% increaseproducts 117.5% increase

–– Insomnia or AntiInsomnia or Anti--Anxiety medications Anxiety medications

•• ZolpidemZolpidem 154.9% increase 154.9% increase

•• AlprazolamAlprazolam 148.3% increase148.3% increase

•• ClonazepamClonazepam 114.8% increase114.8% increase

–– CarisoprodolCarisoprodol 100.6% increase100.6% increase

– For patients aged 20 and younger misuse/abuse of pharmaceuticals increased 45.4%

– For patients aged 20 and older the increase was 111%SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, December 28, 2010

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--100100

00

100100

200200

300300

400400

500500

% I

ncr

ease

All poisoning All poisoning

deathsdeaths

MethadoneMethadone

Other opioidOther opioid

Other synthetic Other synthetic

narcoticsnarcotics

CocaineCocaine

% Increase in Poisoning Deaths in the U.S. % Increase in Poisoning Deaths in the U.S.

2000 2000 -- 20052005

Source: CDC

Hennepin Drug Overdose Deaths

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Teens and Their Attitudes

�� 2 in 5 teens believe that Rx 2 in 5 teens believe that Rx meds are “much safer” than meds are “much safer” than illegal drugsillegal drugs

�� 31% teens believe there’s 31% teens believe there’s “nothing wrong” with using “nothing wrong” with using Rx meds without a Rx meds without a prescription “once in a prescription “once in a while”while”

�� Nearly 3 in 10 teens believe Nearly 3 in 10 teens believe Rx pain relievers are not Rx pain relievers are not addictiveaddictive

Source: Partnership for Drug Free America

Teens and Their Attitudes Teens and Their Attitudes

�� 56% believe that Rx drugs 56% believe that Rx drugs are easier to get than are easier to get than illegal drugsillegal drugs

�� 62% believe that teens get 62% believe that teens get Rx drugs from their own Rx drugs from their own family’s medicine cabinet family’s medicine cabinet –– for FREEfor FREE

Source: 2009 NSDUH & Partnership for Drug Free America

�� Every day 2,100 teens use Every day 2,100 teens use Rx drugs to get high for the Rx drugs to get high for the first timefirst time

�� 60% of teens who have 60% of teens who have abused Rx painkillers did so abused Rx painkillers did so before the age of 15before the age of 15

�� 1 in 7 teens admit to abusing 1 in 7 teens admit to abusing Rx drugs to get high in the Rx drugs to get high in the past yearpast year

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Parents and Their Attitudes(Fairfax school presentation)

•• Parents are still not discussing the risks of abusing Parents are still not discussing the risks of abusing prescription and overprescription and over--thethe--counter medicinescounter medicines

–– Increase in parent / teen discussions about the risks of illegal Increase in parent / teen discussions about the risks of illegal drugs, drugs, but not prescription drugsbut not prescription drugs

–– Parents have a misperception of Rx drugs too.Parents have a misperception of Rx drugs too.

–– Only 24% of teens report that their parents talked with them Only 24% of teens report that their parents talked with them about the dangers of prescription drugs or use of about the dangers of prescription drugs or use of medications outside of a doctor’s supervisionmedications outside of a doctor’s supervision

–– Just 18% of teens say their parents discuss the risks of Just 18% of teens say their parents discuss the risks of abusing overabusing over--thethe--counter (OTC) cough medicinecounter (OTC) cough medicine

SOURCE: 2008 Partnership Attitude and Tracking Study (PATS) Released FEB 2009

“Chasing the Dragon”

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Top Five Prescription Drugs Sold in the U.S. Top Five Prescription Drugs Sold in the U.S. (2004(2004--2009)2009)

0

20000000

40000000

60000000

80000000

100000000

120000000

140000000

2004 2005 2006 2007 2008 2009

Hydrocodone

Lipitor

Amoxicillin

Lisinopril

Hydrochlorothiazide

Simvastatin

Atenolol

Levothyroxine

Azithromycin

128,200,000

1. Pain reliever

2. Cholesterol

3. Antibiotic

4. Blood pressure

5. Diuretic

6. Cholesterol

7. Heart disease

(By Number of Prescriptions Sold)(By Number of Prescriptions Sold)

93,680,000 101,639,000 109,652,000 117,200,000 121,266,000

Source: Verispan / IMS

Oxymorphone HydromorphoneHydromorphone

OpanaOpana

MeperidineMeperidine

MorphineMorphine

CodeineCodeine PropoxyphenePropoxyphene

Other NarcoticsOther Narcotics

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�� FentanylFentanyl PatchesPatches

�� FentanylFentanyl Citrate dispensed in a Citrate dispensed in a berry flavored lollipopberry flavored lollipop--type unit type unit

�� FentanylFentanyl is 100 times more potent is 100 times more potent than morphinethan morphine

�� Intended to be used for chronic Intended to be used for chronic cancer pain & only for people cancer pain & only for people who are tolerant to prescription who are tolerant to prescription opioid (narcotic) pain medicinesopioid (narcotic) pain medicines

�� Abused for its intense euphoric Abused for its intense euphoric effectseffectsActiq®

FentanylFentanyl

FentoraFentora®®

AlprazolamAlprazolam

ClonazepamClonazepam

DiazepamDiazepam

LorazepamLorazepam

MidazolamMidazolam

TriazolamTriazolam

TemazepamTemazepam

FlunitrazepamFlunitrazepam

Benzodiazepines

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Methods of DiversionMethods of Diversion

•• Practitioners / PharmacistsPractitioners / Pharmacists–– Illegal distributionIllegal distribution

–– Self abuseSelf abuse

–– Trading drugs for sexTrading drugs for sex

•• Employee pilferageEmployee pilferage–– HospitalsHospitals

–– Practitioners’ officesPractitioners’ offices

–– Nursing homesNursing homes

–– Retail pharmaciesRetail pharmacies

–– Manufacturing / distribution Manufacturing / distribution facilitiesfacilities

•• Pharmacy / Other TheftPharmacy / Other Theft–– Armed robberyArmed robbery

–– Burglary (Night BreakBurglary (Night Break--ins)ins)

–– In Transit Loss (Hijacking)In Transit Loss (Hijacking)

–– SmurfingSmurfing

•• Patients / Drug SeekersPatients / Drug Seekers–– Drug ringsDrug rings

–– DoctorDoctor--shoppingshopping

–– Forged / fraudulent / altered Forged / fraudulent / altered prescriptionsprescriptions

•• The medicine cabinet / The medicine cabinet / obituariesobituaries

•• The Internet The Internet

•• Pain ClinicsPain Clinics

Pain Clinic "Customers"

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Reporting Requirements

• Theft or Loss: Must notify DEA within “one

business day,” 21 CFR § 1301.74(c)

• Complete and submit DEA Form 106 after

notification

• What is a significant loss?

Theft or Significant Loss

• (1) The actual quantity of controlled substances lost in relation to the type of business;

• (2) The specific controlled substances lost;

• (3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;

• (4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,

• (5) Whether the specific controlled substances are likely candidates for diversion;

• (6) Local trends and other indicators of the diversion potential of the missing controlled substance.

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How can you help?

• Practice “due diligence”

• Use Prescription Monitoring Programs

• Regular contact with law enforcement and

regulatory boards

Questions?