prescription drug abuse and nasper1.6% bought on internet 0.1% other1 1.6% source where respondent...

Nick Reuter, DEA 19th Conference on Pharm Chem Div 1

1

Prescription Drug Abuse and NASPER19th National Conference on Pharmaceutical & Chemical Diversion

June 16, 2010St. Louis, MO



Nick ReuterDivision of Pharmacologic Therapy

Center for Substance Abuse TreatmentSubstance Abuse and Mental Health

Services Administration

Center for Substance Abuse TreatmentSubstance Abuse and Mental Health Services Administration

Overview

National Survey Trends –Rx Drug Abuse

Rx Drug Mortality Rx Drug Costs NASPER – Rx Monitoring Programs


Is prescription drug abuse a problem?

National Survey on Drug Use and Health – NSDUH, formerly national household survey.

Drug Abuse Warning Network –DAWN Emergency Department Medical Examiner

Monitoring the Future



NSDUH Design

Representative nationally and in each State

Civilian, noninstitutional population, age 12+

Face-to-face interview

Computer-assisted, self-administered

67,870 respondents in 2007

2008 data are comparable with 2002-2006, but not with data prior to 2002


2008 NSDUH Highlights

The 2008 survey showed that the overall level of current illicitdrug use has remained level at about 8 percent. (22 million)

National Survey Reveals Significant Decline in the Misuse of Prescription Drugs

Past month methamphetamine use among those aged 12 and older dropped sharply from approximately 529,000 people in 2007 to 314,000 in 2008.

Similarly, the level of current cocaine use among the populationaged 12 and older has decreased from 1.0 percent in 2006 to 0.7 percent in 2008.


NSDUH 2008

Despite many positive trends, the most recent NSDUH survey also reveals continuing problems and setbacks. For example there were significant increases in the rates of Ecstasy and LSD use among youth over past few years. The level of past year Ecstasy use in 2008 for youth was 1.4 percent – lower than the 2.2 percent in 2002, but higher than the lowest level of 1.0percent reported in 2005. Likewise, the 2008 level of past yearLSD among youth of 0.7 percent, while lower than the 2002 level of 1.3 percent in 2002, is significantly higher than the lowest use rate of 0.4 percent reported in 2006.

Treatment – 2008 NSDUH also continues to show a vast disparity between the number of number of people needing specialized treatment for a substance abuse problem and the number who actually receive it. According to the survey 23.1 million Americans need specialized treatment for a substance abuse problem, but only 2.3 million (or roughly 10 percent of them) get it.



Past Month Use of Selected Illicit Drugs among Persons aged 12 or Older: 2002-2008

Fig2.2

8.0

6.1

2.5

8.3 8.27.9 8.1 8.3

8.0

6.2 6.2 6.1 6.0 6.0 5.8

2.7 2.72.5 2.7 2.9+

2.8+

0.9 1.0+0.8 1.0+ 1.0+

0.80.70.40.5 0.4 0.4 0.4 0.4 0.40

1

2

3

4

5

6

7

8

9

2002 2003 2004 2005 2006 2007 2008

Illicit Drugs

Marijuana

CocaineHallucinogens

Psycho-therapeutics

Percent Using in Past Month

7+ Difference between this estimate and the 2008 estimate is statistically significant at the .05 level.


Past Month Illicit Drug Use among Persons Aged 12 or Older: 2007

Fig2.1

1 Illicit Drugs include marijuana/hashish, cocaine (including crack), heroin, hallucinogens, inhalants, or prescription-type psychotherapeutics used nonmedically.

Numbers in Millions

0.2

0.6

1.0

2.1

6.9

14.4

19.9

0 5 10 15 20 25

Heroin

Inhalants

Hallucinogens

Cocaine

Psychotherapeutics

Marijuana

Illicit Drugs

1


Past Month Nonmedical Use of Types of Psychotherapeutic Drugs among Persons Aged 12 or Older: 2002-2008

Fig2.3

1.9

0.7

0.4

0.1

2.12.1

1.91.8

2.01.9

0.70.8 0.8

0.7 0.7 0.7

0.6+ 0.6+

0.5+ 0.5+ 0.6+

0.40.1

0.2+

0.10.10.10.2+

0.0

0.5

1.0

1.5

2.0

2.5

2002 2003 2004 2005 2006 2007 2008

Pain Relievers

Tranquilizers

Sedatives

Stimulants

9


+ Difference between this estimate and the 2008 estimate is statistically significant at the .05 level.



Past Month Use of Selected Illicit Drugs among Youths Aged 12 to 17: 2002-2008

Fig2.5

9.3

6.7

2.9

11.6+

11.2+

10.6+

9.9 9.8 9.5

6.8 6.76.7

7.6+7.9+8.2+

4.0+ 4.0+

3.6+

3.3+ 3.3+ 3.3+

1.21.31.1

1.21.21.31.2

1.01.0 1.0 0.8 0.8 0.7+ 0.7+

0

2

4

6

8

10

12

14

2002 2003 2004 2005 2006 2007 2008

Illicit Drugs

Marijuana

InhalantsHallucinogens

Psycho-therapeutics

10




Past Month Use of Selected Illicit Drugs among Young Adults Aged 18 to 25: 2002-2008

Fig2.6

19.6

16.5

5.9

19.719.820.119.4

20.320.2

16.1 16.6 16.3 16.417.017.3

6.06.56.36.16.15.5

1.5

1.72.2+2.6+

2.1+2.2+2.0+

1.7

1.51.5 1.71.51.71.90

3

6

9

12

15

18

21

2002 2003 2004 2005 2006 2007 2008

Illicit Drugs

Marijuana

CocaineHallucinogens

Psycho-therapeutics

11




Past Month Nonmedical Use of Pain Relievers among Persons Aged 12 or Older, by Age: 2002-2007


2.7

4.6

1.6

2.72.73.0

3.2+3.2+

4.94.74.74.7

4.1+

1.51.31.2+1.31.3+

0

1

2

3

4

5

6

2002 2003 2004 2005 2006 2007

26 or Older

12 to 17

18 to 25




Figure 2.7 Past Month Illicit Drug Use among Adults Aged 50 to 59: 2002-2008


Source Where Pain Relievers Were Obtained for Most Recent Nonmedical Use among Past Year Users Aged 12 or Older: 2007-2008

Note: Totals may not sum to 100 percent because of rounding or because suppressed estimates are not shown.1The Other category includes the sources “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.” 14

Free from Friend/Relative

55.9%

Bought/Tookfrom Friend/Relative

14.3%

One Doctor18.0%

More than One Doctor

2.4%

Drug Dealer/ Stranger

4.3%

Bought on Internet

0.4% Other1

4.8%

One Doctor81.7%

Free from Friend/Relative

6.2%

Bought/Took from Friend/

Relative5.4%

More than One Doctor

3.4%

Drug Dealer/ Stranger

1.6%

Bought on Internet

0.1%Other1

1.6%

Source Where Respondent Obtained

Source Where Friend/Relative Obtained


re 5.1 Specific Drug Used When Initiating Illicit Drug Use among Past Year Initiates of Illicit Drugs Aged 12 or Older: 2



Figure 5.2 Past Year Initiates for Specific Illicit Drugs among Persons Aged 12 or Older: 2008


Past Year Initiates for Specific Illicit Drugs among Persons Aged 12 or Older: 2002-2007

Numbers in Thousands

2,0902,0632,1142,142

1,973

2,196

2,1472,1502,193

2,4222,456+

2,320

0

500

1,000

1,500

2,000

2,500

3,000

2002 2003 2004 2005 2006 2007

Pain Relievers

Marijuana



Drug Abuse Warning Network

Trends – 2004-2008


Center for Substance Abuse TreatmentSubstance Abuse and Mental Health Services AdministrationSource: SAMHSA / OAS

Trends in Nonmedical Use ED Visits –2004 compared to 2008 -DAWN

ED visits due to opioid pain medications increased 112% between 2004 and 2008

Benzodiazepines increased 89%

Antipsychotics increased 56%

Most visits involved more than one drug Interactions between drugs can have a cumulative effect

CNS depressants can reduce respiration, leading to unconsciousness and death


Trends for Opioid Non-medical Use ED Visits – 2004 - 2008

0

30,000

60,000

90,000

120,000

2004 2005 2006 2007 2008

Oxycodone Hydrocodone Methadone Unspec. opioids

Source: DAWN Estimates, 2009


Number of Drugs per ED visit – 2008

28%

25%

24%

10%

13%

40%

26%

17%

10%

7%

1 drug

2

3

4

5 +

Methadone (nonmedical use)

Hydrocodone (nonmedical use)

SAMHSA / OASSource: DAWN Estimates, 2009



Trends for Benzodiazepine Non-medical Use ED Visits, – 2004 - 2008

0

30,000

60,000

90,000

120,000

2004 2005 2006 2007 2008

alprazolam clonazepam lorazepam diazepam Unspec. benzos



Projected number of patients receiving a prescription for methadone in U.S. outpatient retail pharmacies

SDI, Vector One: National. Years 2002 - 2008. Extracted 3/09.

354,449

484,130

548,072

652,274

720,251 718,726742,944

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

2002 2003 2004 2005 2006 2007 2008

Years

Pat

ien

ts

Methadone


Total number of patients receiving a prescription for Subutex or Suboxone from U.S. outpatient retail pharmacies, Years 2003 - 2008

SDI Total Patient Tracker, Extracted 3/09

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

450,000

500,000

2003 2004 2005 2006 2007 2008

Years

Pa

tie

nts

SUBOXONE

SUBUTEX

File: TPT 2009-347 SAMHSA 3-6-09 Subutex Suboxone.xls


Center for Substance Abuse TreatmentSubstance Abuse and Mental Health Services AdministrationSAMHSA / OAS

Trends for Opioid NMUP ED Visits – 2004 - 2008

0

30,000

60,000

90,000

120,000

2004 2005 2006 2007 2008

Buprenorphine^

Fentanyl

Morphine

Hydromorphone


**Statis. significant difference from 2008

^Estimates suppressed (2004, 2005)

* **


Prescription Drugs and Overdose Deaths


Drug Overdose Deaths in the U.S.

Source: National Vital Statistics System as cited in CDC, Unintentional Drug Poisoning in the United States, Retrieved 3/19/10 from www.cdc.gov/HomeandRecreationalSafety/Poisoning/index.html

Drug overdose deaths in 2006 were second only to motor vehicle crash deaths among leading causes of unintentional injury death in the U.S.



Drug Overdose Deaths in the U.S.

Source: National Vital Statistics System as cited in CDC, Unintentional Drug Poisoning in the United States, Retrieved 3/19/10 from www.cdc.gov/HomeandRecreationalSafety/Poisoning/index.html


Drug Overdose Deaths in the U.S. States in the Appalachian region and the Southwest have the

highest overall drug overdose death rates.


Costs tied to illicit Rx Drug



GAO Study – Medicaid Fraud and Controlled Substances – Sept 2009 5 states – CA, IL, NY, NC, TX Findings – tens of thousands of beneficiaries involved

in fraud purchases. Doctor shopping – 65,000 beneficiaries filled CS rx

from 6 or more different prescribers. $63 million Prescriptions filled for debarred prescribers,

unregistered prescribers, dead beneficiaries. PMP’s not used required, some cases available. Recommendations One relates to doctor shopping, - DUR identify and

prevent doctor shopping.


Prescription Drug Increases

Since 1991……….

Stimulant prescriptions increased 7 fold

(5-35 million)

Opioid prescriptions increased 4 fold(40 million -180 million)


How can PDMPs Reduce Opioid Overdose Risk? – Dunn, et al, 2010, Annals of Internal Med

51 opioid-related overdoses were identified, including 6 deaths.

Compared with patients receiving 1 to 20 mg/d of opioids (0.2% annual overdose rate),

patients receiving 50 to 99 mg/d had a 3.7-fold increase in overdose risk (95% CI, 1.5 to 9.5) and a 0.7% annual overdose rate.

Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk (CI, 4.0 to 19.7) and a 1.8% annual overdose rate.



NASPER

National All Schedules Prescription Electronic Reporting

Act of 2005


NASPER - P.L. 109-191 – Intent

1. to foster the establishment or enhancementof State-administered controlled substance monitoring systems in order

2. to ensure that health care providers have access to accurate, timely prescription history information.

3. for assisting in the early identification of patients at risk for addiction. Early identification will lead to enhanced substance abuse treatment interventions.


Alliance Goals for PMPs

Education and information Public health initiatives Early intervention and prevention Investigations and enforcement Protection of confidentiality



How – Formula grant, annual

Establishes the authority for a grant program with the Secretary,

HHS, wherein a State may submit an application to

1. implement a new controlled substance prescription monitoring system, or

2. to make improvements upon an existing State controlled substance monitoring system.


How Much??

Authorizations, Future appropriations - $15 million, no appropriation until March 2009 ($2 million) –Authorization for appropriation ends 2010.

Minimum Amount – no less than 1% of the amount appropriated. ($20,000)

Additional Amounts = appropriated amount x number of pharmacies in the state/total

number of pharmacies in all approved states.


Who is Eligible-requirements

Law in effect and penalties for unauthorized disclosures.

D. To participate (1) The State shall require dispensers* to report to such State

each dispensing in the State of a controlled substance to an ultimate user not later than 1 week after the date of such dispensing.

(2) The State may exclude from the reporting requirement of this subsection— Direct administration to body of ultimate user Dispensing in quantity 48 hours or less Any other exclusion identified by the Secretary



Improve vs Establish/Implement

Improve – assurance of compliance or statement why not feasible or contrary to best interest

Establish/Implement – assurance of compliance only


2009 Appropriation - Process

Consult with States, other parties Propose minimum requirements solicit

comments - 04/29/09 9 comments received 6 States Alliance, NACDS, ASAP

SAMHSA Request For Grant App –7/27/09

13 applications received and approved Entire $2 million awarded


2009 Awards

$190,995Ohio*

$342,264New York *

$52,922Nevada

$79,246Mississippi

$193,362Michigan

$40,514Maine

$101,409Kentucky

$66,407Kansas *

$108,079Indiana

$188,843Illinois

$65,976Connecticut

$454,587California *

$115,396Alabama

AllotmentState



2010 Proposed Minimum Stds

April 14, 2010 Federal Register

1. Existing PMPs must adopt the 2007 version of the ASAP standard for electronic prescription formatting by September 30, 2011. Version 4.1, with commitment to change if legislation is required

2. Authentication requirements were proposed to bring PMPs into compliance with National Institute of Standards and Technology (NIST) 800-63. (a) A practitioner or dispenser (pharmacist) must submit a hard copy written,

signed, and notarized request every three years to the designated State agency, which in turn, verifies the information before providing a username and password to the practitioner. The request must include the practitioner's name and date of birth, a corresponding DEA registration number, and State medical license number.

Postpone for one year. 3. Sub Accounts - Proposed the authorization of one PMP sub-account

per prescriber, if permitted by State law. The dispenser would not be permitted to obtain sub accounts. Allow states to establish sub accounts, no limits, prescriber monitors


Unsolicited Disclosure Proposal

GAO Report “For PDMPs to be useful, health care providers and

pharmacies must use the data. Officials from the five selected states said that physician participation in the PDMP is not widespread and not required. In fact, one state did not have a Web-based PDMP; a health care provider has to put in a manual request to the agency to have a controlled substance report generated.”


Unsolicited Disc, Continued

Any individual that has filled six or more controlled substance prescriptions from six different prescribers, or six different dispensers in the State, within a six month period shall be the subject of a report from the prescription drug monitoring program to each prescriber.

Reports must be sent to at least ten percent of the registered prescribers in the State in one calendar year.



Unsolicited Reports, Cont

Privacy – content of report not specified, does not need to include PHI (Michigan, Louisiana)

Threshold – 6/6/1 month, or State applies alternate notification

system that reaches at least 5% of registered prescribers.


OTP Disclosure To PMP (1)

1200 Opioid Treatment Programs in the U.S.

270,000 patients in Tx Most OTPs dispense Schedule II

methadone or Schedule III buprenorphine beyond 48 hour supply.

Do State PMP laws require OTP reporting to PMPs?



42 CFR Part 2 prohibits federally assisted alcohol and drug treatment programs from disclosing “patient health information”

Information that would directly or indirectly reveal a person’s status as a patient or formal patient.

OTPs provide SA treatment and they are Federally assisted (licensure, OBOTs)




Disclosure only permitted if it falls under an “exception”

A. “Audit and Evaluation” Exception only for licensing/regulating

entities – PMPs do not regulate OTPs Only for audit/evaluation purposes –

not identify “doctor shoppers”



Evaluation/Audit – no further disclosure, only back to program.

OTP disclosure with patient consent? Not permitted if there is any possibility that

the information would be used to prosecute patient.

If there is no possibility to use information to prosecute, Consent would need to name all parties All parties would need to agree to disclose no

further.


OTP Disclosure To PMP (5)Central Registries

Can States require “Central Registries”to report to PMPs? Provision in 42 CFR Part 2 permits

disclosure to registry “to prevent multiple enrollments” in OTPs.

Regulations limit only for preventing multiple enrollments

Not the type of information PMPs contain (no amounts distributed)



Can OTPs request information from PMPs?

Physician (sub account) with account queries PMP about OTP patient. Encouraged by SAMHSA/CSAT Required by some States (WV) Becomes part of patient record.

Indirectly reveal a person’s status as a drug treatment program patient?


PMP’s Part of Solution

Expanded/enhanced PMP use Doctor Shopping Laws? Tennessee Pain Clinic Regulation at State Level


Rx Drug Abuse – Manufacturer Responsibilities

FDA – Risk Evaluation Mitigation Strategy

Schedule II sustained release opioids (includes methadone)

Stakeholders/public meetings, open comments – 2009

Physician, Consumer Education,



Summary

NSDUH – overall illicit use same (8%, 19 million) decreases in current Rx drug abuse 7 million, 2.5% population

Medication Assisted Treatment –Expanding

NASPER commitment to encourage uniform stds,

treatment Practitioner, consumer education cont.

56





Nick ReuterDivision of Pharmacologic Therapy

Center for Substance Abuse TreatmentSubstance Abuse and Mental Health

Services Administration

prescription drug abuse and nasper1.6% bought on internet 0.1% other1 1.6% source where respondent...

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