1 csat’s view of prescription drug misuse: problems and solutions comp conference october 28, 2009...

1

CSAT’s View of Prescription Drug Misuse: Problems and

SolutionsCOMP ConferenceOctober 28, 2009

CSAT’s View of Prescription Drug Misuse: Problems and

SolutionsCOMP ConferenceOctober 28, 2009

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 NASPER Medication Assisted Treatment Buprenorphine Diversion


Substance Abuse and Mental Health Services Administration/CSAT

SAMHSA’s Mission: • To build resilience and facilitate recovery for

people with or at risk for substance abuse and mental illness.

Center for Substance Abuse Treatment (CSAT) Mission:

• To improve the health of the nation by bringing effective alcohol and drug treatment to every community.


SAMHSA’s Role in Fighting SAMHSA’s Role in Fighting Drug Misuse and AbuseDrug Misuse and Abuse

• At a policy level, SAMHSA works to ensure that science, rather than ideology or anecdote, forms the foundation for the Nation's addiction treatment system.

• SAMHSA and its component Centers serve health professionals and the public by disseminating scientifically sound, clinically relevant information on best practices in the treatment of addictive disorders, and working to enhance public acceptance of that treatment.


We Face Multiple We Face Multiple ChallengesChallenges Reaching those in need of services

Providing adequate resources

Developing culturally-appropriate, evidence-based interventions

Building and sustaining a qualified workforce

Integrating substance use disorder

services into the public health paradigm


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 2007 data are comparable with 2002-

2006, but not with data prior to 2002


Illicit Drug Use


2008 NSDUH Highlights

New National Survey Reveals Significant Decline in the Misuse of Prescription Drugs + Sharp decline also continues for methamphetamine use

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

The misuse of prescription drugs decreased significantly between 2007 and 2008 among those aged 12 and older, including among adolescents,

Progress has been made in curbing other types of the illicit drug use. For example, 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 population aged 12 and older has decreased from 1.0 percent in 2006 to 0.7 percent in 2008.


NSDUH 2008 -2

Promising results from the latest survey also were also found for the most part among youth (12 to 17 year olds).

a significant decline in overall past month illicit drug use, from 11.6 percent in 2002 to 9.3 percent in 2008. Although the rate of current marijuana use among youth has remained level at about 6.7 percent over the past few years there have been significant decreases in the current use of alcohol, cigarettes and non-medical use of prescription drugs since 2007. Non-medical use of prescription drugs dropped from 3.3 percent in 2007 to 2.9 percent in 2008.

Historically, young adults have had the highest rates of substance abuse, and for most types of illicit substance abuse the levels have remained steady over the past year. However, over the past three years there has been a steady drop in the rate of heavy alcohol use by full time college students aged 18 to 22 – from a high of 19.5 percent in 2005 to 16.3 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 1.0 percent reported in 2005. Likewise, the 2008 level of past year LSD 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

12+ 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

14


+ 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

15




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

16




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.” 19

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


Figure 5.1 Specific Drug Used When Initiating Illicit Drug Use among Past Year Initiates of Illicit Drugs Aged 12 or Older: 2008


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



Dependence on or Abuse of Specific Illicit Drugs in the Past Year among Persons Aged 12 or Older: 2008


NASPER

National All Schedules Prescription Electronic Reporting

Act of 2005


NASPER - P.L. 109-191 – Intent

1. to foster the establishment or enhancement of 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.


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)

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.


Drug Diversion

States, after consultation with stakeholders :

Shall establish a program to notify practitioners, dispensers with info to help identify and prevent unlawful distribution, and

May notify drug diversion investigators.


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


Unsolicited Disclosures

Proposed minimum standard – “The threshold for notifying

prescribers and dispensers is when an individual has filled five or more controlled substance prescriptions from five different prescribers, or five different dispensers in the State, within a six month period.”


Unsolicited Disclosures (2)

Applications for NASPER grants must include proposals for unsolicited notifications, or alternative proposals that demonstrate that information and analysis from the PMP is being used to reduce prescription drug misuse and diversion, or being used to direct individuals to treatment.


2009 Awards

State Allotment

Alabama $115,396

California * $454,587

Connecticut $65,976

Illinois $188,843

Indiana $108,079

Kansas * $66,407

Kentucky $101,409

Maine $40,514

Michigan $193,362

Mississippi $79,246

Nevada $52,922

New York * $342,264

Ohio* $190,995


S-754- Methadone Treatmentand Protection Act of 2009 (1)

(1) in subsection (d)(1), by inserting ‘‘(including prescribers of methadone)’’ after ‘‘dispensers’’;

(2) Subject to the requirements of section 543, the State shall, at the request of a Federal, State, or local officer whose duties include enforcing laws relating to drugs, provide to such officer information from the database relating to an individual who is the subject of an active drug-related investigation conducted by the officer’s employing government entity.

(3)APPROPRIATIONS.—There is authorized to be appropriated, and there is appropriated, to carry out this section $25,000,000 for each of fiscal years 2010 through 2014.


S-754- Methadone Treatmentand Protection Act of 2009 (2)

As a condition for receiving funds under section 399O, each State shall require that any individual who signs a death certificate where an opioid drug is detected in the body of the deceased, or where such drug is otherwise associated with the death, report such death to the Administrator by submitting a Model Opioid Treatment Program Mortality Report

Such report shall be submitted to the Administrator on or before the later of

(A) 90 days after the date of signing the ‘‘(B) as soon as practicable after the date

26 on which the necessary postmortem and toxicology reports become available to such individual, as required by the Secretary.


PMPs – Intervention and Prevention

Physician Education – Prescribing practices Identifying dependence addiction Intervention

Screening and referral Treatment


Education Update: “Clinical Challenges in Prescribing Controlled Drugs”

To date, 21 courses in 18 states have been completed by the program. 2007: New York and Ohio. 2008: California, Connecticut, Idaho, Indiana,

Massachusetts, North Carolina, Virginia, Washington State, West Virginia, Florida, Illinois, Main, Nevada, and Vermont.

2009: Phoenix, AZ; Springfield, IL, Michigan, Alaska, Maryland, California, Utah

For information: http://www.dpt.samhsa.gov/providers/prescribingcourses.aspx

An online version is expected to be available in June 2009 through the CSAT website, as well as other sites that offer continuing medical education (CME) credits.


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,


Prescription Drug Abuse, PMPs Part of Solution

Expanded/enhanced Prescription Drug Monitoring Programs

Doctor Shopping Laws Pain Clinic Laws


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.


Medication Assisted Treatment

Methadone Buprenorphine


OTP Demographics

1,195 OTPs in 47 states, DC, Puerto Rico and the Virgin Islands as of July 1, 2008 3 States are without an OTP Significant growth in treatment capacity

since 2001

Approximately 260,000 patients in OTP maintenance treatment or detoxification

42

Active Opioid Treatment Programs by State as of June 2008 (1,192)

=Bottom 6 States

=Top 5 States


Increases and Decreases in Methadone PatientsSource NSSATS 2007

US - 2002 – 2007 (260,000) – 16% increase

WV – 2000% Vermont 480% NH – 393% Indiana – 230% Colorado – (39%) New York – (15%) California – (10%)


OTP Characteristics Treatment capacity – average 208 patients Mean size—253 patients Range—20 to 2,000 patients Public/Non-profit—approximately 52% For-Profit—approximately 48% Typical pt: white male, 26-50 years old 75% treated for heroin addiction; 25% addicted to opioid

prescription medications Less than 1% are treated with buprenorphine Mean years in treatment: 6.3 Mean length, current treatment episode: 25.9 months Less than one/third of patients without insurance

Of patients with insurance, two-thirds covered for OTP treatment.


Education Update: Opioid Treatment Training

CSAT is planning to conduct 8-9 trainings in 2009 for health professionals working in OTPs.

Priority states are: North Carolina Nevada Pennsylvania Kentucky/West Virginia Texas/Oklahoma

Training will be live, with materials then being converted for use in Webinars.


Methadone Mortality Update: Methadone Mortality Update: GAO ReportGAO Report

Purpose: Review Federal and State oversight and identify selected efforts to prevent methadone abuse and overdose deaths that focused on education, safety, and monitoring.

Looked at five States: FL – unk KY – 10% (source opioid treatment) ME – unk NM – 39% WV – 11%


GAO Report

“Although information on methadone associated deaths is limited, available data suggest that methadone’s growing use for pain management has made more of the drug available thus contributing to the rise in methadone associated deaths”


Methadone Mortality

CDC – NCHS The number of poisoning deaths

involving methadone increased nearly sevenfold from almost 790 in 1999 to almost 5,420 in 2006, which is the most rapid increase among opioid analgesics and other narcotics involved in poisoning deaths


Increase in Methadone Deaths

Prescriptions for Methadone have increased 700% from 1998-2006

Between 1999-2005, an increase of 468% according to CDC.


West Virginia Study

1999-2004 nation’s largest increase in unintentional drug overdoses (55%)

Most common drug was Methadone involved in 40% of all deaths

Risk factors for prescription drug deaths included: being male, low education, and poverty


West Virginia Study

Contributory drugs involved in unintentional overdoses were highest with psychotherapeutic drugs (48.8%)

Most common was benzodiazepines (42.4%)

Particularly: Diazepam (22.4%) Alprazolam (18.3%) Other Benzo’s (1.7%)


Methadone Mortality Update: Methadone Mortality Update: Importance of Submitting Importance of Submitting Methadone Mortality ReportsMethadone Mortality Reports

November 2008 – SAMHSA received OMB approval allowing OTPs to voluntarily report mortality data on patients who – at the time of death – were receiving medication-assisted treatment (methadone or buprenorphine). Via filing Opioid Treatment Program (OTP)

Mortality Reporting Form These reports provide SAMHSA with information

that contributes to providing better risk management assistance for OTPs and their patients to reduce the number of preventable deaths.

Information from reports also helps SAMHSA to define areas that will benefit from the development of appropriate educational tools.


SAMHSA’s Data Collection

Mortality Reports Submitted 203

Females 64 31.5%

Males 126 62.1%

Patient 35 or Younger 24 11.8%

Patient Older than 35 161 79.3%

States Reporting 22 44.0%


Cause of DeathCount PercentUnknown/Undetermined 52 27.4%Liver Disease 38 20.0%Cardiovascular 21 11.1%Cancer 17 8.9%COPD 13 6.8%Diabetes 11 5.8%Overdose 10 5.3%Motor Vehicle Accident 6 3.7%Suicide 7 3.7%Trauma 5 2.6%Kidney Disease 3 1.6%Seizures 3 1.6%HIV/AIDS 2 1.1%Homicide 1 0.5%


Methadone Mortality

Preliminary trends 2008, 2009 reports FL medical examiner RADARS Poison Control Decreases in methadone mortality Increases oxycodone, hydrocodone,

cocaine Heroin Mortality Levamisole in Cocaine


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


Methadone Treatment and Methadone Treatment and Protection Act of 2009 Protection Act of 2009 (S.754)(S.754)

Findings Federal oversight of methadone inadequate Legislation necessary to increase oversight,

reduce methadone mortality Provisions

Consumer education grants Mandates 16 hours Physician Training Moratorium on 40 mg diskettes for TH Standards commission sets benchmarks for

reducing methadone abuse, standards for dosing. Mandates mortality reporting from OTPs, some ME Opioid Death registry Periodic Reports


Methadone Mortality Update:Methadone Mortality Update:Florida Medical Examiner StudyFlorida Medical Examiner Study

Uniform standards and case definitions have been developed to address variations in the way drug-associated deaths are classified and reported.

Florida Medical Examiner (ME) study: Uses the standardized system for classifying and

reporting methadone-related deaths through an online model, real time surveillance system for rapid reporting.

Preliminary data will be examined at a meeting in mid-2009 that will include representatives from:

National Association of Medical Examiners (NAME) Society of Forensic Toxicologists (SOFT), and The American Academy of Forensic Sciences (AAFS)


Methadone Mortality Update: Methadone Mortality Update: Patient Safety Initiative MeetingPatient Safety Initiative Meeting

CSAT meeting on Patient Safety Education Initiative – scheduled for April 26, 2009

Meeting purpose: Identify strategies to address accidental

ingestion of methadone, as well as diversion Participants include:

Representatives from CSAT State representatives Patient advocates

Participants were asked to come with identified patient safety concerns and issues – and what actions, if any, were taken to address or alleviate those concerns.


Buprenorphine Treatment

Office-Based Opioid Treatment (OBOT)

Drug Addiction Treatment Act of 2000

18,000 Certified Physicians 500,000 patients in 2008


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


Increasing Buprenorphine Diversion


DAWN 2006

Oxycodone/combinations – 64,888 visits Hydrocodone/combinations – 57,550 visits Methadone 45,130 Heroin 17,310 Fentanyl/combinations – 16,012 visits Hydromorphone/combinations – 6,780

Buprenorphine/combinations - 4,440 DAWN estimates for 2004 and 2005 could not be

published for buprenorphine because the estimates for buprenorphine were too imprecise for publication.

Source Drug Abuse Warning Network, National Estimate, 2006


Suboxone Abuse – Monte, et al.

2008 ethnographic study of Suboxone diversion and abuse in Central MA and VT.

The authors interviewed 49 individuals aware of Suboxone

100% had diverted B/N to modulate opiate withdrawal symptoms arising from

attempted “self-detoxification,” insufficient funds to purchase preferred illicit opioids, or inability to find a preferred source of drugs.

A substantial proportion of participants (30; 61%) obtained the drug from an individual holding a legitimate prescription, either as a gift or by purchase.

The remaining participants(19; 39%) purchased from heroin dealers.


Suboxone Abuse – Monte, et al.-2

The availability of diverted B/N may delay entry into formal drug treatment programs.

Lack of access to waivered B/N providers also may also contribute to B/N diversion.

Clinicians should carefully review their prescribing and patient monitoring practices.


Proposed Rule – Bup in OTP

Would permit buprenorphine products to be dispensed without adherence to the take-home schedule

Comments period closed Aug 19 Evaluating Comments – publicly

available at www.regulations.gov


Buprenorphine - Future

Abuse increases, but mortality remains low

Originator “Orphan Product” exclusivity expired October 8.

Generic single entity buprenorphine approved October 8


Summary

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

NASPER commitment to encourage uniform stds,

treatment Practitioner, consumer education

cont.

70

COMP Annual ConferenceOctober 28. 2009Los Angeles, CA

COMP Annual ConferenceOctober 28. 2009Los Angeles, CA

Nick ReuterDivision of Pharmacologic Therapy

Center for Substance Abuse TreatmentSubstance Abuse and Mental Health

Services Administrationwww.samhsa.gov/statistics

1 csat’s view of prescription drug misuse: problems and solutions comp conference october 28, 2009...

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