Trends in Rx Drug Abuse Dr. Andrew Kolodny Chairman, Department of Psychiatry, Maimonides Medical Center Tess Benham Program Manager, Na?onal Safety Council Hon. Sherry L. Green, JD Chief Execu?ve Oﬃcer, Na?onal Alliance for Model State Drug Laws
Learning Objec?ves 1. Iden?fy recent increasing trends in the misuse and abuse of prescrip?on drugs. 2. Evaluate the state laws and regula?ons that exist on a state level across the country. 3. Outline ini?a?ves that can be taken back and implemented in your state.
Disclosure Statement • Andrew Kolodny has no ﬁnancial rela?onships with proprietary en??es that produce health care goods and services. • Tess Benham has no ﬁnancial rela?onships with proprietary en??es that produce health care goods and services. • Sherry Green has no ﬁnancial rela?onships with proprietary en??es that produce health care goods and services.
Overview of the Opioid AddicAon Epidemic April 2 – 4, 2013 Omni Orlando Resort at ChampionsGate
Presenta?on Outline I. Past opioid epidemics II. Current epidemic III. Reasons for the current epidemic IV. The chronic pain controversy V. Strategies to control the epidemic
Rates of ED visits for nonmedical use of selected opioid analgesics increased significantly in the US 40 35 2004 2005 2006 2007 2008ED visits per 100,000 population 30 25 20 * 15 * * * * 10 * 5 * * 0 * * Fentanyl Hydrocodone Hydromorphone Methadone Morphine Oxycodone * Indicates a rate that was significantly less than the rate in 2008. Note: Drug types include combination products , e.g, combinations of oxycodone and aspirin. 13
Unintentional Drug Overdose Deaths United States, 1970–2007 38,329 drug overdose deaths in 2010 Cocaine Heroin YearNational Vital Statistics System, http://wonder.cdc.gov
Drug Overdose Deaths by Major Drug Type, United States, 1999–2010 Opioids Heroin Cocaine Benzodiazepines 18,000 16,000 14,000 12,000 Number of Deaths 10,000 8,000 6,000 4,000 2,000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 YearCDC, National Center for Health Statistics, National Vital Statistics System, CDC Wonder. Updated with 2010 mortality data.
Primary non-‐heroin opiates/syntheAcs admission rates, by State (per 100,000 populaAon aged 12 and over) 17
Primary non-‐heroin opiates/syntheAcs admission rates, by State (per 100,000 populaAon aged 12 and over) 18
Primary non-‐heroin opiates/syntheAcs admission rates, by State (per 100,000 populaAon aged 12 and over) 19
Primary non-‐heroin opiates/syntheAcs admission rates, by State (per 100,000 populaAon aged 12 and over) 20
Primary non-‐heroin opiates/syntheAcs admission rates, by State (per 100,000 populaAon aged 12 and over) 21
Primary non-‐heroin opiates/syntheAcs admission rates, by State (per 100,000 populaAon aged 12 and over) 22
UnintenAonal overdose deaths involving opioid analgesics parallel per capita sales of opioid analgesics in morphine equivalents by year, U.S., 1997-‐2007 * Number of Opioid sales (mg/ Deaths person) Source: Na?onal Vital Sta?s?cs System, mul?ple cause of death dataset, and DEA ARCOS * 2007 opioid sales ﬁgure is preliminary.
Dollars Spent Marketing OxyContin (1996-2001)Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion andEfforts to Address the Problem.” 27
Industry-funded organizationscampaigned for greater use of opioids• Pain Patient Groups• Professional Societies• The Joint Commission• The Federation of State Medical Boards 28
Industry-funded “education” emphasizes:• Opioid addiction is rare in pain patients.• Physicians are needlessly allowing patients to suffer because of “opiophobia.”• Opioids are safe and effective for chronic pain.• Opioid therapy can be easily discontinued. 29
“Only four cases of addiction among11,882 patients treated with opioids”Porter J, Jick H. Addiction rare in patients treatedwith narcotics. N Engl J Med. 1980 Jan 10;302(2):123Cited 677 times (Google Scholar) 30
I think that after 20 years of a failedexperiment that there are not many peoplesupporting this except for the die-hards andthe pharmaceutical industry.Jane C. Ballantyne, MD FRCAProfessor, Univ. of Washington Source: New York Times, April 9, 2012. Tightening the Lid on Pain Prescriptions .
The Emperor’s New Paradigm:Patient Selection, Risk Stratification & Monitoring 34
Urine Tox Results in Chronic Pain PaAents on Opioid Therapy Source: Couto JE, Goldfarb NI, Leider HL, Romney MC, Sharma S. High rates of inappropriate drug use in the chronic pain popula?on. Popul Health Manag. 2009;12(4):185–190. 35
Controlling the epidemic: A Three-‐pronged Approach • Primary Preven?on-‐ prevent new cases of opioid addic?on. • Secondary Preven?on-‐ provide people who are addicted with eﬀec?ve treatment. • Supply control-‐ collaborate with law enforcement, DEA and OPMC to over-‐prescribing and black-‐market availability. 36
Opioid manufacturers continue to advertise opioids assafe and effective for chronic pain.
Controlling the Epidemic: Potential Interventions• Opioid Label Changes• Hydrocodone Up-scheduling• Prescription Drug Monitoring Programs• Tamper-Resistant Formulations
This is a false dichotomy Aberrant drug use behaviors are common in pain patients 63% admitted to using opioids for purposes other than pain192% of opioid OD decedentswere Pain Patients prescribed opioids for Drug Abuserschronic pain. 35% met DSM V criteria for addiction21. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample ReceivingDaily Opioid Therapy. J Pain 2007;8:573-582.2. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients:comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194.3. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description ofDecedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.
Please visit www.supportPROP.org Follow us on Twi[er @supportPROP 40
Trends in Prescrip?on Drug Abuse April 2 – 4, 2013 Omni Orlando Resort at ChampionsGate
Who is NSC? Our Mission: The Na?onal Safety Council saves lives by preven?ng injuries and deaths at work, in homes and communi?es, and on the roads through leadership, research, educa?on and advocacy.
Opportuni?es for Ac?on • Build State Capacity to Address Rx Drug Overdoses • Increase Access and U?liza?on of Prescrip?on Monitoring Programs (PMPs) • Support Responsible Opioid Prescribing • Advocate for Overdose Educa?on Programs
Increase Access and U?liza?on of (PMPs) • Allow authorized delegates • Move to real-‐?me data collec?on intervals • Share PMP data with other states • Proac?ve alerts
Support Responsible Prescribing • Deter forma?on of pill mills • Provide guidance and educa?on on responsible prescribing of controlled substances • Increase u?liza?on of PMPs by prescribers and dispensers
Overdose Educa?on Programs • Provide overdose educa?on • Naloxone distribu?on • Good Samaritan laws
Ques?ons Tess Benham Na?onal Safety Council firstname.lastname@example.org
Snapshot of Laws, RegulaAons and Policies on: State PrescripAon Drug Monitoring Programs (PMPS) State RegulaAon of Pain Clinics State Prescribing PracAces for the Treatment of Non-‐Cancer Pain April 2 – 4, 2013 Omni Orlando Resort at ChampionsGate
Who is NAMSDL? • 501 (c)(3) nonproﬁt corpora?on • Successor to the President’s Commission on Model State Drug Laws • 19 ½ years • Funded by Congress • Provides legisla?ve and policy services on drug and alcohol laws to a variety of stakeholders at the state and local level
State PrescripAon Drug Monitoring Programs (PMPS) – InformaAon Tools • PMP-‐ statewide electronic database that collects designated data on prescrip?on controlled substances and some?mes drugs of concern 49 states with PMP laws 44 states with opera?onal programs
InformaAon Tools Cont… • 12 common categories of recommenda?ons by 6 en??es PMP Center of Excellence at Brandeis University School of Medicine and Public Health at University of Wisconsin-‐Madison Mitre Corpora?on, Oﬃce of Na?onal Coordinator for Health Informa?on Technology and the Substance Abuse and Mental Health Services Administra?on NAMSDL Alliance of States with PMPS American Cancer Society
InformaAon Tools Cont… • Increase use of PMP as health care tool • Frequency of dispenser repor?ng Real ?me – OK Daily/24 hours – 5 states: DE, KS, MN, ND, WV Weekly/7 Days – 31 states: AL, AZ, AR, CA, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MA, MS, MT, NV, NH, NM, NC, OH, OR, SD, TN, TX, UT, VT, VA, WA, WY Twice monthly – 4 states: CO, CT, MI, NJ Monthly – 5 states: AK, NY, PA, RI, SC
InformaAon Tools Cont… • Expand categories of authorized users Delegates or authorized agents of prescribers/dispensers – 21 states: DE, ID, IN, IA, KS, KY, ME, MD, MA, MN, MT, NM, NY, ND, OH, SD, TN, UT, VA, WA, WV Mental health/substance abuse professionals, peer review/ quality improvement commirees – 7 states: IN, KS, MD, ND, SD, TN, UT
InformaAon Tools Cont… • Mandatory use of PMP by prescribers 13 states 4 -‐ Limited circumstances: CO, LA, OK, NC 2 -‐ If prescriber believes pa?ent wants prescrip?on for non-‐medical purpose: NV, DE 6 -‐ Upon the ini?a?on of designated circumstances, such as ini?al prescribing or dispensing of speciﬁed substances, and periodically thereaser: KY, NM, NY, OH, TN, WV 1 -‐ Department of Health to promulgate regula?ons outlining when prescribers have to use the PMP prior to seeing a new pa?ent: MA
InformaAon Tools Cont… • Proac?ve or unsolicited alerts/reports 42 states: AL, AK, AZ, AR, CA, CT, DE, FL, HI, ID, IL, IN, KS, KY, LA, ME, MA, MI, MS, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY • Interstate sharing Other state PMPs – 20 states: AL, AR, DE, HI, IL, KS, ME, MD, MA, MS, MT, NV, NH, NC, OR, RI, SD, UT, VA, WI Authorized users in other states – 8 states: AK, CA, CO, ID, IA, MN, TX, WY Both – 15 states: AZ, CT, IN, KY, LA, MI, NJ, NM, NY, ND, OH, SC, TN, WA, WV
State RegulaAon of Pain Clinics • 8 states as of 12/31/2012 have adopted pain clinic regula?on acts: FL, KY, LA, MS, OH, TN, TX, WV • 14 common components • Deﬁni?on of “pain clinic” Publically or privately owned facility Majority of pa?ents on a monthly basis prescribed or dispensed speciﬁed substances as part of treatment for pain
State RegulaAon Cont… • Registra?on, cer?ﬁca?on or licensure Exemp?ons: long-‐term care, nursing homes, hospice facili?es, state operated facili?es • Clinic owners must hold certain licenses/board cer?ﬁca?ons Physician with unrestricted license to prac?ce Board cer?ﬁca?on by American Board of Pain Medicine or American Board of Interven?onal Pain Physicians Subspecialty in pain management, hospice or pallia?ve care Comple?on of residency or fellowship in pain medicine
State RegulaAon Cont… • Restric?ons on prescribing or dispensing controlled substances Louisiana – limits prescrip?ons to non-‐reﬁllable 30 day supply Florida – document reason for prescribing more than 72 hour dose of controlled substances for treatment of pain West Virginia – limits dispensing of controlled substances to 72 hour supply
State RegulaAon Cont… • Requirement to access a state’s PMP • Enforcement experience Reduc?on of “pill mills” Unintended consequences – some claims that legi?mate pa?ents having diﬃculty accessing pain medica?ons Some “pill mill” operators re-‐labeled themselves as wellness clinics or weight loss centers
Prescribing of Controlled Substances for the Treatment of Non-‐Cancer Pain • Policies, guidelines, rules, strategies, and guides Federa?on of State Medical Boards Utah Department of Health Journal of Pain Washington State American Society of Interven?onal Pain Physicians U.S. Food and Drug Administra?on (FDA) Dr. Scor Fishman – “Responsible Opioid Prescribing: A Physician’s Guide”
Prescribing Cont… • 7 commonly recommended prescribing prac?ces • Educa?on on designated topics: pain management, prescribing of controlled substances, addic?on and addic?on treatment, use of the state’s PMP Statute or regula?on -‐ 14 states: AR, CA, FL, GA, KY, MA, MI, NM, OH, OR, TN, TX, UT, WA Medical board policy -‐ 4 states: MI, MN, MT, VA
Prescribing Cont… • Physical exam and/or screening for substance abuse and addic?on Statute or regula?on -‐ 25 states + D.C.: AL, AR, DE, DC, FL, GA, IA, KY, LA, ME, MN, MS, NV, NH, NJ, NM, OH, OK, OR, RI, TN, TX, UT, VA, WA, WV Medical board policy -‐ 39 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NC, OH, OK, OR, PA, RI, SC, SD, UT, VA, WA, WV, WI, WY
Prescribing Cont… • Treatment plan, including informed consent, with periodic review; treatment agreement with provider/ pa?ent responsibili?es Statute or regula?on -‐ 25 states + D.C.: AL, AR, DE, DC, FL, GA, IA, KY, LA, ME, MN, MS, NV, NH, NJ, NM, OH, OK, OR, RI, TN, TX, UT, VA, WA, WV Medical board policy -‐ 41 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, UT, VA, WA, WV, WI, WY
Prescribing Cont… • Use of the state PMP Statute or regula?on -‐ 5 states: KY, LA, NM, TN, WV Medical board policy -‐ 2 states: NC, WA • Referral to specialists for addi?onal evalua?on and treatment, or steps to take for suspected abuse or diversion Statute or regula?on -‐ 22 states + D.C.: AL, CA, DE, DC, FL, GA, IA, KY, LA, ME, MS, NE, NH, NJ, NM, OH, OK, OR, TN, TX, UT, VA, WA Medical board policy -‐ 38 states: AL, AZ, CA, CO, CT, DE, FL, HI, ID, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NC, OH, OK, OR, PA, RI, SC, SD, UT, VA, WA, WV, WI, WY
Prescribing Cont… • Restric?ons on Schedule II controlled substances, including opioids Statute or regula?on -‐ 45 states + D.C.: AL, AZ, AR, CA, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY Medical board policy: 2 states – UT, WA
Prescribing Cont… • Complete and accurate medical records Statute or regula?on -‐ 27 states + D.C.: AL, AR, CA, DE, DC, FL, GA, IA, KY, LA, ME, MS, MO, NV, NH, NJ, NM, ND, OH, OK, OR, RI, TN, TX, UT, VA, WA, WV Medical board policy -‐ 41 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, UT, VA, WA, WV, WI, WY
Prescribing Cont… • Implementa?on of recommended prac?ces – facilita?on of the use of legi?mate pain management prac?ces Integrated, interdisciplinary approach that promotes referrals to specialists and the use of alterna?ves and adjuncts to controlled substances Use of opioids for chronic pain must be associated with documented func?onal outcomes
Prescribing Cont… Restric?ons on dispensing by prescribers Support in payment systems for referrals to specialists, including qualiﬁed pain management and addic?on treatment professionals. e.g., reimbursement for psychological/psychiatric evalua?ons for high risk pa?ents Mandated referral to a pain management specialist if the pa?ent is receiving a certain dosage of opioids
NAMSDL CONTACT INFORMATION Sherry L. Green WEBSITE: www.namsdl.org Chief Execu?ve Oﬃcer Sarah Kelsey NAMSDL Headquarters Oﬃce Legisla?ve Arorney 215 Lincoln Ave., Suite 201 NAMSDL Santa Fe, NM 87501 1598 Gray Fox Trail Phone: 703-‐836-‐7496 Charloresville, VA 22901 Cell: 703-‐801-‐8350 Phone: 703-‐836-‐6100, Fax: 505-‐820-‐1750 Ext. 119 Email: email@example.com Email: firstname.lastname@example.org Heather Gray Research Arorney Kevin Smith NAMSDL Government Aﬀairs Coordinator 9841 Cedar Glade NAMSDL Memphis, TN 38016 113 Manchester Ave. Phone: 703-‐836-‐6100, Earlville, IA 52041 ext. 114 Phone: 703-‐836-‐6100, Email: email@example.com Ext. 118 Cell: 563-‐929-‐0519 Email: firstname.lastname@example.org