Prescription Drug Abuse: Prevention and Treatment Across the Continuum of Care

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Prescription Drug Abuse: Prevention and Treatment Across the Continuum of Care Scott P. Novak, Ph.D. Senior Research Scientist RTI International RTI International is a trade name of Research Triangle Institute. www.rti.org

Funding Disclosure/Conflict of Interest Dr. Novak has received contracts earned through competitive bids with the following companies: Eli Lilly and Company Shire Pharmaceuticals King Pharmaceuticals Pfizer Endo Pharmaceuticals Purdue Pharma Funding for this presentation--nida (R01-030427, Novak, PI) and Substance Abuse and Mental Health Services Administration (SAMHSA)

Co-Authors: Co-Authors and Collaborators Sara L. Calvin, MS RTI International Cristie Glasheen, Ph.D. RTI International Nathanial Katz, M.D. Tufts Medical School Collaborators: Deborah Galvin, Ph.D., CSAP-SAMSHA Deepa Avula, M.S., CSAT-SAMHSA Georgia Karuntzos, Ph.D. RTI International Ted Miller, Ph.D., PIRE Sandra Lapham, M.D., PIRE Mark Edlund, M.D., RTI International

Focus of Today s Symposium: Challenges for Addiction Health Services Research 1) Definition of the Problem 2) Surveillance Strategies to Identify High-Risk consumers

Prescription Drug Availability is Increasing

Health Care Consequences and Costs Trends in Emergency Department (ED) Visits Involving the Nonmedical Use of Narcotic Pain Relievers: 2004 to 2008 Total Societal Costs: $55.7B $5.10 $25.60 Productivity Loss Healthcare $25 Criminal Justice Mean annual health care costs: $12,000-20,000 Opioid dependent $1,000-$8,000 Non-Opioid dependent

Federal Response Issued May 2011 Includes guidance on Federal agency roles and responsibilities (NIDA, CDC, SAMHSA, DEA, FDA, DOJ, DOD, DOJ) Office of National Drug Control Policy April 2011 Prevention and Treatment Goals *Establish best practice guidelines *New medications with lower abuse liability *Prescriber and patient education programs

Pharmaceutical Industry Requirements Issued January 2010 Includes guidance on Preclinical screening Chemistry and manufacturing Animal Behavioral Pharmacology Pharmacokinetic/ Pharmacodynamic Studies Human Abuse Potential Studies Related Pharmacology studies Postmarketing Experience/PMP Labeling & Drug Scheduling Physician and consumer education programs

#1) Definition of the Problem Nonmedical Use: Defined as any illicit use of a prescription substance, regardless of motivations for use (e.g., euphoria or self-treatment) and acquisition (own prescription versus illicit possession)

The use of a prescription medication in a way not intended by the prescribing doctor. Prescription drug abuse includes everything from taking a friend's prescription painkiller for your backache to snorting ground-up pills to get high. Definition of the Problem Drug Abuse*: Nonmedical use of a drug, repeatedly, or even sporadically, for the positive psychoactive effects it produces. An exposure resulting from the intentional improper or incorrect use of a substance where the victim was likely attempting to achieve a euphoric or psychotropic effect. All recreational use of substances for any effect is included.

Definition of the Problem Drug Misuse: The use of a drug outside label directions or in a way other than prescribed or directed by a healthcare practitioner. An exposure resulting from the intentional improper or incorrect use of a substance for reasons other than the pursuit of a psychotropic or euphoric effect. The use of a medication (with therapeutic intent) other than as directed or as indicated, whether willful or unintentional, and whether harm results or not.

Other Key Definitions Florida Pain Clinic Retail Pharmacy Diversion: The inten(onal removal of a medica(on from legi(mate distribu(on and dispensing channels. Disordered Use: Diagnos(c classifica(on of a substance use problem DSM abuse/ dependence Non- Disordered Use: Do not meet criteria for Disordered Use

Drug Typologies Therapeutic Class: The pharmacological properties and/or medical indication for a drug (e.g., pain reliever, sedative/hypnotic, anti-depressant) Drug Schedule: Rating based on Drug Enforcement and individual state criteria for abuse liability of a given drug. DEA scheduling determines: (a) who can prescribe; (b) number that can be prescribed; (c ) number of refills; (d) written versus Eprescribing. Currently 5 levels of DEA scheduling, ranging from Schedule I Illicit drugs with accepted no medical value (e.g., LSD) to Schedule V over the counter medications (e.g., aspirin) Formulation: Immediate release (IR) versus extended release (ER/CR) Active Pharmaceutical Ingredient (API): Primary chemical (oxycodone, oxycodone with aspirin, hydrocodone) Abuse/Tamper: Altering a product (crushing/snorting) with the intent to abuse via an alternative route of administration that maximizes desired physiological response (OxyContin OC/OP)

Substance Abuse Treatment Data: Abuse 30 Days Prior to Admission Substance Number of clients Valid % 5/1/11-5/31/11 % Oral as Indicated % Other by Tampering Heroin 4866 5.4% 1.1% 98.9% Morphine 448 0.7% 52.9% 47.1% Diluadid 232 0.4% 40.0% 60.0% Demerol 61 0.1% 77.8% 22.2% Percocet 1278 2.0% 79.1% 20.9% Darvon 85 0.1% 92.3% 7.7% Codeine alone Tylenol 2,3,4 w/ codeine Oxycontin/ Oxycodone Total 9,240 386 0.6% 86.5% 13.5% 342 0.5% 90.0% 10.0% 1542 2.4% 55.0% 45.0%

#2: National Surveillance Systems for Rx Abuse are Lacking Product specificity TEDS DAWN- Live NSDUH HMO/ ADMN NHIS/MEP PMPs X X X Consumption Freq None Freq Dose Freq None Motivation X X X X X X Timeliness X X X X Data Collection Client Tx Staff Person Tx Staff Person Report Risk Factors Med Low High Med Med Low-Med Health Care Utilization X X Call to action: More data are needed on therapeutic class/product, motivations (abuse/misuse), individual risk and protective factors, and interactions with health care system

Data Visualization and Geographic Mapping (RTI Analyst) Data Sources: Product Supply NSDUH/TEDS (State) Other data sources (RADARS, Drug Arrest, Media Tracking) Unit of Analysis: Nation State Zip Code Use of Signal Processing to detect early patterns of abuse Model forecasting to estimate cost-benefit ratios based on possible intervention scenarios/ market changes

Identifying Patterns of Nonmedical Use Difference between High Risk areas and High Prevalence Areas: Rural: High Risk, Low Prev Urban: Low Risk, High Prev Nonmedical Prescription Pain Reliever Use 2008-2009 NSDUH Substate Estimates

9000 Past Year Nonmedical Prescription Drug Use and Meeting Criteria for Dependence or Abuse of Nonmedical Prescription Drugs, by Age and Year: 2005-2009 NSDUHs (per 100,000) 8000 7000 6000 5000 4000 3000 2000 1000 0 12-17 18+ 12-17 18+ 12-17 18+ 12-17 18+ 12-17 18+ 2005 2006 2007 2008 2009 Past Year NMPD Dependence or Abuse Past Year NMPD Use

Past Year Substance Use Disorder among Persons Receiving Drug Treatment in the Past Year, by Age and Year: 2005-2009 NSDUHs (In Percent) 60.0% 40.0% 20.0% 0.0% 12-17 18+ 12-17 18+ 12-17 18+ 12-17 18+ 12-17 18+ 2005 2006 2007 2008 2009 NMPD Use Disorder No NMDP Disorder, but Alcohol or Illicit Drug Use Disorder

Past Year Substance Use Disorders Among Persons Aged 18 or Older Receiving Past Year Drug Treatment, by Year: 2005-2009 NSDUHs 8.0% 6.0% 4.0% 2.0% 0.0% 2005 2006 2007 2008 2009 NMPD Use Disorder Only NMPD and Alcohol Use Disorder, No Other Illicit Drug Use Disorder NMPD and Other Illicit Drug Use Disorder, No Alcohol Use Disorder NMPD, Alcohol, and Illicit Drug Use Disorder

Who are the High-Risk Targets for Intervention? Youth (approximately 10% reported any NMPD in past year) Injection drug users: 90% of IDUs report cooccurring NMPD Pain Patients (20% report chronic pain, 30% NMPD) Military:??? Unemployed (in labor force) Myths: College students use 1-2 times often stimulants for studying Elderly initiation rates less than 1%, mostly due to continued use from middle adulthood

Past-Year Pain Reliever NMU among Levels of Pain No Pain Moderate Pain High Pain % % % Any NMU 1.39 2.45 2.73 Non-disordered NMU 1.18 1.89 1.99 Disordered NMU 0.21 0.56 0.75 Source: 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions

18 Prevalence of Past Year Opioid Use Among Adults Age 18-64 by Employment Status and Quarter for 2005-2009 16 14 12 10 8 6 4 2 0 Percent Endorsed Past Year Opioid Use Employed Full Time Employed Part Time Unemployed Not in Labor Force 2005 2006 2007 2008 2009 Year and Quarter

Prevalence of Past Year Stimulant Use Among Adults Age 18-64 by Employment Status and Quarter for 2005-2009 9 8 7 6 5 4 3 2 1 0 Percent Endorsed Pasy Year Stimulant Use Employed Full Time Employed Part Time Unemployed Not in Labor Force 2005 2006 2007 2008 2009 Year and Quarter

10 Prevalence of Past Year Sedative or Tranquilizer Use Among Adults Age 18-64 by Employment Status and Quarter for 2005-2009 9 8 7 6 5 4 3 2 1 0 Percent Endorsed Past Year Sedative or Tranquilizer Use Employed Full Time Employed Part Time Unemployed Not in Labor Force 2005 2006 2007 2008 2009 Year and Quarter

Recommend Opportunities for Intervention Middle/High School Health care providers- Pain Specialists Drug treatment Employer Unemployment Military Primary Prevention Pain.EDU/Provider education Identify poly/drug users, motivations for use Reduce health care costs/csap-samhsa Gaps in health care coverage Wounded Warrier

Contact Scott P. Novak, Ph.D. 919.541.7129 snovak@rti.org