Pain Treatment and Prescription Drug Abuse Cathy Carlson, PhD, APN, FNP-BC Aaron Gilson, MS, MSSW, PhD Conflict of Interest Disclosure • Authors Conflicts of Interest; – C. Carlson, No Conflict of Interest – A. Gilson, No Conflict of Interest True Disclosure: WE ARE ONLY RESPONSIBLE FOR WHAT WE SAY……. NOT WHAT THE GOVERNMENT DOES!!! Opioid Rx per 100 People per Year by State MI = 107 CDC. (2012). Opioid painkiller prescribing infographic. Retrieved from http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html The Problem…. Deaths involving prescription opioid analgesics now outnumber deaths from heroin and cocaine combined Overdose Deaths Involving Opioid Analgesics, Cocaine, & Heroin: U. S. 1999-2013 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Opioid Analgesics** Cocaine Heroin Center for Disease Control & Prevention. (2014). Release of 2013 multiple cause of death data file. Retrieved from http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf The Problem…… Death involving prescription drug abuse is one of the most prevalent public health epidemics, outpacing deaths from traffic fatalities 2013: Statistics on Death in the U.S. Death Determinations Drug Overdoses Numbers of Deaths 43,982 Prescription Drug Overdoses 22,767 Overdoses involving Opioids 16,235 (71.3%) Overdoses involving Benzodiazapines MVA 6,973 (30.6%) 33,804 Center for Disease Control & Prevention. (2014). Release of 2013 multiple cause of death data file. Retrieved from http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf Past Month Nonmedical Use of Psychotherapeutic Drugs Aged 12 or Older, 2002-2014 Percent Using in the Past Month 2.5 2 1.9 2.1 2 1.8 2.1 1.9 2.1 1.9 2 1.9 1.7 1.7 1.6 1.5 1 0.8 0.8 0.6 0.6 0.5 0.2 0.1 0.7 0.7 0.5 0.5 0.1 0.1 0.7 0.6 0.2 0.7 0.7 0.4 0.4 0.1 0.1 0.8 0.5 0.1 0.9 0.7 0.4 0.4 0.1 0.1 0.8 0.5 0.6 0.5 0.1 0.1 0.7 0.6 0.1 0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Pain Relievers Tranquilizers Stimulants Sedatives U.S. Department of Health and Human Services. (2014). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. Retrieved from http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.htm#idtextanchor001 Non-Medical Use of Rx Opioids What is “non-medical use” of prescription opioids? Considering the Spectrum of Non-Medical Use of Rx Opioids Misuse (intentional) e.g., - recreational use for psychic effects - decide to increase dose for pain control - suicidal gesture or attempt Concurrent use of illicit drugs or Undisclosed Rx medication use Misuse Use involving (unintentional) aberrant behaviors e.g., e.g., - sharing with others - forging/altering prescriptions - unknowingly taking - going to multiple doctors larger amounts - stealing drugs than directed - inadvertent poisoning Opioid Dependence Abuse (“Addiction”) “Substance Use Disorder” The Problem… Nonmedical users of pain relievers most often get the drug from family and friends How Different Nonmedical Users of Pain Relievers Get Their Drugs Law Enforcement Definition of Drug Diversion “Diversion” is the transfer of a drug from a licit to an illicit channel of distribution or use. 1. DRUG CONTROL SYSTEM (lawful distribution) W H O L E S A L E R E T A I L U L T I M A T E U S E R 2. PRIMARY DIVERSION (unlawful; supplies some abusers and re-distribution) Manufacturers and Distributors Theft from manufacturers and distributors* (Common Carriers) Theft in transit * •Pharmacies •Hospitals/Clinics •Internet w/Rx •Practitioners Prescribers Dispensers •Nursing homes •Hospices •Theft from hospitals* Pharmacies/robbery* Employee/customer Pilferage * Patients (Lawful medical use) Theft of Rx/forgery •Script docs/pill mills •Inappropriate prescribing •Doctor shopping •Patient sells or gives •Theft from home •Theft from patient •Improper disposal (“Prescribed”) Medical Use PPSG, 2007 * = Amounts reported by law on DEA Form 106 International smuggling Internet sales without Rx Non-medical use ●Misuse Unintentional (sharing with others) Intentional (suicide attempt) ●Aberrant behaviors (forging/altering Rx) ●“Substance Use Disorders” (abuse & addiction) Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013. “Prescription medication” ≠ Prescribed medication Essential to determine whether valid prescription was involved Association Between Overdose/ Deaths and “Prescribing” Factors to Consider Hall et al. (2008) Dunn et al. (2010) Gomes et al. (2011a) Gomes et al. (2011b) Bonhert et al. (2011) Paulozzi et al. (2012) Diversion (i.e., no prescription found) Doctor-shopping (i.e., diversion) Motivations?? Non-medical routes of administration Co-morbidities (e.g., substance use history) Poly-pharmacy Previous overdose episodes Legitimate Little clinical information Patients? Not a linear effect Not causal Methadone Controlled Substances Act (CSA) First enacted in 1970 to regulate the manufacture, importation, possession, use, and distribution of certain substances DEA is responsible for interpreting and enforcing the CSA, although DHHS has a number of supporting responsibilities Federal Drug Control Responsibility (CSA) “Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people…the illegal importation, manufacture, distribution, and possession and improper use of controlled substances have substantial and detrimental effect on the health and general welfare of the American people…the United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.” 21 USC § 801 Principle of Policy Change Balance Opioids can be effective, are indispensable Must be available to relieve pain and suffering Opioids have a potential for abuse Must be controlled “Controlled substance” label does not change medical value of medications Efforts to prevent abuse must not interfere with medical practice and patient care PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014. Imperative to Achieve Balance U.S. Sources Department of Health and Human Services (DHHS) Food and Drug Administration (FDA) National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) Center for Disease Control & Prevention (CDC) National Cancer Institute (NCI) Substance Abuse and Mental Health Services Administration (SAMHSA) Drug Enforcement Administration (DEA) Office of National Drug Control Policy (ONDCP) Institute of Medicine (IOM) American Medical Association (AMA) American Cancer Society (ACS) Federation of State Medical Boards (FSMB) National Association of Attorneys General (NAAG) Law Enforcement on the Principle of Balance “…the prevention of drug abuse is an important societal goal that can and should be pursued without hindering proper patient care…” U.S. Drug Enforcement Administration 2001 Joint Policy Statement Still Awake??? Update: What is Happening at the Federal Level…. 1. Legislative and Regulatory Mandates 2. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) Requests/Rulings 3. Office of National Drug Control Policy (ONDCP) - White House Initiatives Legislative and Regulatory Mandates Food and Drug Administration Safety and Innovation Act (FDASIA) Signed into law on July 9, 2012, expanded the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health. An amendment to the Act: Section 1139 “Scheduling of Hydrocodone” • Required FDA to hold a public meeting • Solicit advice and recommendations to assist in conducting a scientific and medical evaluation and scheduling recommendation to DEA regarding drug products containing hydrocodone, combined with other analgesics, or as an antitussive FDA. (2014). Food and Drug Administration Safety and Innovation Act (FDASIA). Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmen tstotheFDCAct/FDASIA/ Hydrocodone Rescheduling: Yesterday’s Solutions for Today’s Problem (Barber, L. (2013, Nov 19). DEA Chronicles • Hydrocodone combination products were officially rescheduled, 8.22.2014 • Effective 10.6.2014 New Rule Effect • Need a new written prescription for each 30 day supply • May write up to 90 day supply (multiple prescriptions – with instructions indicating earliest date when pharmacy may fill each) • May fax prescription, but patient must have written prescription to obtain Rx from pharmacy • May call in for an emergency – Only for amount needed to cover emergency – Need written prescription within 7 days Wide Availability Leads to Leftovers • Utah post-op patients reported: – Most received hydrocodone (63%) – 67% had leftover medication – 92% received no disposal instructions – 91% kept the extra medication at home • Will rescheduling change this data? (Bates et al, 2011; Webster, 2013) Beware of Unintended Consequences “supply reduction … in the absence of demand reduction and harm reduction could paradoxically increase overdoses.” Albert et al., 2011, Project Lazarus: Community-based overdose prevention in rural North Carolina, Pain Medicine, 12, p. S83 Unintended Consequences • There was a large increase in the number of the opioid prescriptions from 2002-2010 • Followed by a slight decrease in the number of opioid prescriptions during 2011-2013 • The rates of opioid diversion and abuse and opioid related deaths followed a similar pattern of a large increase during the years of 2002-2010 followed by a slight decrease during 2011-2013 • Findings suggest that the U.S. may be making progress in controlling the diversion and abuse of prescription opioids and decreasing opioid related deaths • Abuse of heroin and the number of deaths from heroin has tripled during the years of 2011-2013 Dart, R. C., Surratt, H. L., Cicero, T. J., Parrino, M. W., Severtson, S. G., Bucher-Bartelson, B., & Green, J. L. (2015). Trends in opioid analgesic abuse and mortality in the United States. New England Journal of Medicine, 372(3), 241-248 FDA Requests/Rulings Oxycodone extended-release capsules with abuse deterrent properties (Xtampza ER) close to being approved by FDA (approved by advisory committees 9.11.2015) Hydrocodone bitartrate extended-release capsules (Zohydro ER) approved 10.25.2013 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” issued 4.1.2015 Hydrocodone bitartrate with abuse deterrent properties (Hysingla ER) approved 11.20.2014 Combination products with greater than 325 mg of acetaminophen per unit were voluntarily withdrawn by the manufacturers at FDA’s request • Effective 01.01.2014 Naloxone hydrochloride auto-injection (Evzio) approved 04.03.2014 Oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER) approved 07.23.2013 Office of National Drug Control Policy (ONDCP) National Drug Control Strategy 2014 1. Emphasizing prevention over incarceration 2. Training health care professionals to intervene early before addiction develops 3. Expanding access to treatment 4. Taking a "smart on crime" approach to drug enforcement 5. Giving a voice to Americans in recovery Office of National Drug Control Policy (ONDCP) Epidemic: Responding to America’s Prescription Drug Abuse Crisis 2011 1. Education – parents, youth, patients, & HCP 2. Tracking & Monitoring 3. Proper medication disposal 4. Enforcement Prescription Drug Monitoring Programs (PDMPs) Where When Why What All states but 4 (3 of the 4 have legislation) Most states established PDMPs to address the prescription drug abuse problem beginning in 2005 To reduce prescription drug abuse and diversion Statewide electronic databases • Collect, monitor, and reports electronically transmitted dispensing data on controlled substances Who Authorized healthcare professionals • Physicians (known as prescribers) • Pharmacists (known as dispensers) • Other authorized HCPs PDMP Value PDMPs contain useful information • Identify patients who are potentially abusing or diverting prescription drugs • Inform clinical decisions regarding controlled substances The issue is how to make this information more available to three key groups of clinical decisionmakers: • HCP practices • Emergency departments • Pharmacies PDMP Usage PDMPs are not used as much as desired because of issues with awareness and system registration Members of the care team supporting prescribers and dispensers often are not permitted access to PDMP systems The use of standalone Web portals and unsolicited reports do not adequately support clinical practices and workflows There is a lack of system-level access and standards among PDMPs, EHRs, and pharmacy systems. The business and health IT landscape increasingly contains third‐party intermediaries which currently lack optimized business agreements to adequately protect information Prescription Drug Overdose: Prevention for States CDC plans to give 16 states annual awards between $750,000 and $1 million to advance prevention in four key areas: • Enhancing and Maximizing State Prescription Drug Monitoring Programs (PDMPs) • Implementing Community or Insurer/Health Systems Interventions • Conducting Policy Evaluations • Developing and Implementing Rapid Response Projects Arizona, California, Illinois, Kentucky, Nebraska, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Utah, Vermont, and Wisconsin State Successes CDC. (2014). Opioid painkiller prescribing infographic. Retrieved from http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 • S. 480 – 2014 – Assigned to a congressional committee on 2.12.2015 • 1% chance of being enacted. • H.R. 1725 – Passed the House – To the Senate – 44% chance of being enacted We Cannot Bury Our Heads in the Sand and Not Act Promote Government and Society Actions – Require comprehensive prescriber education on opioid pharmacology and management-including risks, benefits, and alternatives – Advocate for increased access and funding for mental health treatment services, including substance use disorder treatment – Advocate for increased research funding for pain management and substance use disorder treatment – Develop safe, convenient and environmentally friendly medication disposal programs – Expand Prescription Drug Monitoring Program features • Support expanded access for all health professionals to PDMP websites • Support interstate/national sharing of information • Simplify and standardize state requirements for account registration Institutes of Medicine. (2011). Relieving pain in America: A blueprint for transforming prevention, care, education, and research. Retrieved from http://www.nap.edu/catalog.php?record_id=13172 HCP Actions to Decrease Risks Associated with Opioid RX • Conduct a thorough history and physical exam including the patient’s medical, psychiatric, and social history that also ascertains any substance use disorder • Obtain records from other providers treating the patient with pain • Facilitate interdisciplinary management (including specialist referrals) of comorbid conditions, including psychiatric and substance use disorders/conditions that may affect risk with opioid use (i.e., OSA, obesity, depression, PTSD, anxiety) • Utilize multimodal pharmacologic treatment, combining non-opioids with opioids • Initiate opioid therapy as a trial with the understanding if it decreases pain and increases function it may be maintained CDC.(2013). Common Elements in Guidelines for prescribing opioids for chronic pain. Retrieved from http://www.cdc.gov/homeandrecreationalsafety/pdf/Common_Elements_in_Guidelines_for_Prescribing_Opioidsa.pdf HCP Actions Cont… • • Start opioid therapy on lowest effective dose. Recommend pain specialist referral with higher doses of opioids (Some guidelines cite 90-100 mg morphine sulfate equivalents [Nuckols, Anderson, Popescu, Diamant, Doyle, Di Capua, & Chou, 2014]) Use Pain Management Universal Precautions regularly to monitor and manage potential risks with chronic opioid use (Gourlay, Heit, & Almahrezi, 2005): – Employ regular risk evaluations for all patients on opioids – Implement written Pain/Opioid treatment agreements – Determine opioid adjustments on outcomes of the 5 ‘A’s: Analgesia, activity, adverse effects, aberrant behavior, and affect – Employ intermittent adherence monitoring measures as indicated, including: • Urine drug testing • Pill counts • State prescription monitoring program (PMP) websites – Plan for safe opioid tapering when discontinuing therapy Nuckols, T. K., Anderson, L. Popescu, I. Diamant, A. L., Doyle, B., Di Capua, P., & Chou, R. (2014). Opioid prescribing: A systematic review and critical appraisal of guidelines for chronic pain. Annals of Internal Medicine, 160(1), 38-47. Gourlay, D. L., Heit, H. A., & Almahrezi, A. (2005). Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain. Pain Medicine, 6(2), 107-112. Let’s Change from Federal to State Why State Policies are Important Authorize healthcare practice, medical use of drugs Define unprofessional conduct, and prohibit unauthorized distribution of controlled substances Restrict prescriptive practices Policies can also… Recognize value of controlled substances and pain management Encourage pain management Address barriers (e.g., concern about regulatory scrutiny) Recognizing Types of State Policy Legislation Regulatory Policy (Statutes) (Regulations or Guidelines/Policy Statements) Practice Acts Controlled Substances Act Legislature (members of legislative committees) Past sponsors of related bills Healthcare Regulations Boards Executive Director (with Nursing, focus on license-specific division) Entity Governing Controlled Substances Policy Change/Adoption Add language that promotes safe and effective pain relief and palliative care Repeal or avoid potential barriers Severe restrictions Archaic terminology Ambiguous requirements Content and clarity of policy is essential Unintended consequences Example – Prescription Monitoring Programs PPSG. Achieving balance in state pain policy: A progress report card (CY 2013). 2014. (+) Criteria: Policy Language Enhance Pain Management 1. Controlled substances necessary for public health 2. Pain management is general healthcare practice 3. Medical use of opioids is legitimate professional practice 4. Pain management is encouraged 5. Addresses practitioners’ concerns about regulatory scrutiny 6. Prescription amount is insufficient to determine legitimacy 7. Addiction not confused with physical dependence/tolerance 8. Other positive language Category A: Issues related to healthcare professionals Category B: Issues related to patients Category C: Regulatory or policy issues (-) Criteria: Policy Language Impede Pain Management 9. Opioids are relegated as last resort 10. Opioids are outside legitimate practice 11. Addiction is confused with physical dependence/tolerance 12. Medical decisions are unduly restricted 13. Prescription validity is restricted 14. Additional undue prescription requirements 15. Other restrictive language 16. Ambiguous language Category A: Arbitrary standards for legitimate prescribing Category B: Unclear intent contributing to misinterpretation Category C: Conflicting or inconsistent policies or provisions Why a Progress Report Card? Simplifies complex evaluation Single index of quality to compare states Positive context for critical evaluation Simplifies measurement of progress Supports goal-setting Increases visibility of the need to improve pain policy Distribution of Grades 2006, 2012, & 2013 Number of States 25 2006 2012 2013 20 15 10 5 0 F D D+ C C+ B B+ A PPSG. Achieving balance in state pain policy: A progress report card (CY 2013). 2014. National Council of State Boards of Nursing 2008 Policy: Report of Disciplinary Resources Committee (September, 2008, pp. 114-324) Pain Management Policies (n=49) WA VT ME ND MT MN OR NH ID SD MI WY AK IL WV KS VA MO KY NC TN OK AR NM SC MS TX HI DE MD IN CO AZ NJ OH UT CA RI CT PA IA NE NV MA NY WI AL GA LA FL DC Nursing Regulatory Pain Policy (n=27) WA VT ME ND MT MN OR NH ID SD MI WY VA MO KY NC TN OK AR NM SC MS TX HI DE MD IN WV KS AZ NJ OH IL CO CA CT PA UT AK RI IA NE NV MA NY WI AL GA LA FL DC APN Prescribing Authority 2010, 2012, & 2013 25 20 Number of States 2010 2012 2013 15 10 5 0 No Rx authority MD involvement + limits MD Independent involvement Rx authority PPSG. Achieving balance in state pain policy: A progress report card (CY 2013). 2014. Independent Prescribing Authority (23 states) Alaska Arizona Colorado Connecticut DC Hawaii Idaho Iowa Maine Maryland Minnesota Mississippi Montana Nevada New Hampshire New Mexico North Dakota Oregon Rhode Island Vermont Virginia Washington Wyoming Prescribing Requires Formal Physician Involvement (12 states) California Delaware Indiana Kansas Massachusetts Nebraska New Jersey New York Tennessee Texas Utah Wisconsin Prescribing Requires Formal Physician Involvement/Other Limits (8 states) Illinois Kentucky Louisiana Michigan North Carolina Ohio Pennsylvania South Dakota PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014. No Prescribing Authority (8 states) Alabama Arkansas* Florida Georgia* Missouri* Oklahoma* South Carolina* West Virginia* * No prescribing authority for Schedule II medications only PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014. Potential Policy Barriers to Nursing Pain Practice Prescribing authority is prohibited Formal physician involvement (??) Additional requirements/limitations Supply limits (e.g., 24 hours, 72 hours, 7 days, 30 days) Not for chronic pain (including cancer pain) Ambiguous language Recent, not widespread, regulatory guidance PPSG. Achieving balance in federal and state pain policy: A guide to evaluation (CY 2013). 2014. Ways to Improve Practice Related to Pain Management “Multidisciplinary” (team approach) Reimbursement Research to inform practice Integrating PDMP with EMR Harmonizing both professional and regulatory guidance Increasing use of risk identification and mitigation strategies States with “Pill Mill” Activity (n=46) WA VT ME ND MT MN OR NH ID SD PA IA NE IL WV KS AZ VA MO KY NC TN OK AR NM SC MS TX HI AL GA LA FL Assessed via Internet search, September 14, 2015 DE MD IN CO CA RI CT NJ OH UT AK 2 MI WY NV MA NY WI DC What We Can Do to Engage at the State Level Engage with existing initiative Established network with policy-makers • Supportive of pain management issues • Sponsors • “Cue-givers” (Matthews & Stimson, 1975) Multidisciplinary Anticipate other policy implications Relevant initiatives becoming more prevalent Gilson, Joranson, & Maurer. Improving state pain policies: Recent progress and continuing opportunities. CA: A Cancer Journal for Clinicians. 2007;57:341-353. What We Can Do to Engage at the State Level State Pain Policy Advocacy Network (SPPAN) • State Legislation and Regulations Tracking • http://sppan.aapainmanage.org ACS Cancer Action Network • Quality of Life/Access to Care Initiatives • http://www.acscan.org U.S. Pain Foundation • Pain Advocacy Efforts (e.g., PDMPs, Federal) • http://uspainfoundation.org/uspain-advocacyefforts.html Questions???