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TRANSCRIPT
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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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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?