Critical Issues: Providing Relief and Preventing Abuse C. Scott Anthony, D.O. Tulsa Pain Consultants, Inc. Opioid Prescribing in Chronic Pain Legitimate practice Evidence of improved quality of life and functionality But… issues remain: Serious concerns about regulatory agencies Confusion and fear Skyrocketing abuse and diversion Federal and State Controlled Substance Law Analgesia Abuse Joint Statement of 21Health Organizations and the DEA Undertreatment of pain is a serious problem in the United States. Effective pain management is an integral and important aspect of quality medical care and pain should be treated aggressively Opioid analgesics, when used as recommended may be the most effective and only treatment option to manage pain Joint Statement of 21Health Organizations and the DEA In spite of regulatory controls, drug abusers obtain these medications by diverting them from legitimate channels: fraud, theft, forgery and dishonest physicians Drug abuse is a serious problem. Those who prescribe must be diligent to prevent diversion Focusing only on the abuse potential can lead to undertreatment of pain Opioid Diversion Public health and safety issue Methods: Theft, forgery of prescription Illegal sale of drugs and prescriptions Fraudulent patient contact with physicians Impaired, dishonest physicians What about the honest physician trying to help? Should we worry? National All Schedules Prescription Electronic Reporting (NASPER) Act 2005 Federal Law that provides for the establishment of a state monitoring system Electronic monitoring for Schedule II-IV drugs Requires dispensers to report to the state Each state develops an electronic database that is easily searchable by prescribers and dispensers Prevention of diversion and abuse Physicians Should Be Aware Pain and Policy Study Group FAQ Document in combination with the DEA Co-sponsored document released Aug. 2004 Removed from DEA website Oct. 2004 PPSG with significant concerns American College of Physicians voice concern National Association of Attorneys General express concern in letter to DEA DEA Concerns Outlined in the Federal Register (Nov. 2004) Multiple Schedule II prescriptions What constitutes a refill? Dealing with patients who knowingly abuse their medications Under no circumstances can a physician dispense with the knowledge… Concerns of family members Physicians should seriously consider any expressed concern… Recurring “Condemned Behavior” per the DEA Federal Register Inordinately large number of prescriptions Inordinately large quantity prescribed Known prescribing to drug addicts or dealers Prescribing inconsistent with legitimate medical practice Physician used “street slang” when discussing No logical relationship between drugs prescribed and treatment of the condition Legal Precedence United States vs. Morton Salt Co. It is a longstanding legal principle that the Government “can investigate merely on suspicion that the law is being violated, or even that it wants assurances that it is not” PPSG Response (Mar. 2005) DEA must reassure physicians that there are specific indicators of diversion that are not confused with appropriate prescribing Clarify clearly what constitutes “unlawful conduct” regarding prescribing Avoid sending messages of fear Embrace the commitment to a “balanced Federal policy” Drug Abuse Rapid escalation of epidemic proportion 7.3% of the population abuse illegal drugs Hydrocodone, oxycodone and methadone show >100% increase in abuse since 1994 Increases seen in: ER visits Health care costs Loss of productivity Non-Medical Use of Prescription Drugs 1992-2003: 94% increase 3rd most abused substances DAWN data 1992-2002: 154% increase in prescription drugs prescribed 90% increase in number of people admitting to use There indeed is a link between increase in prescribed drugs and abuse per the DAWN and CASA data Oxycodone Abuse 166% increase in abuse 1994-2000 ER visits for overdose up 100% since 1996 Multiple reasons Pharmacological Easy to obtain/street cost lower Abusers “knowledge” Potent high Concern about generic Oxycontin Hydrocodone Abuse 116% increase in abuse since 1994 Most commonly abused opioid Schedule III Phone-in prescriptions Less tracking Acetaminophen issues Methadone Abuse 140% increase since 1994 Significant problem in Oklahoma with marked increase in deaths Nationwide increase in deaths due to abuse Pharmacology Long, variable half-life Potent, difficult to convert, titrate Pain and Addiction Continued use despite adverse consequences Impaired control and compulsive use Preoccupation with obtaining drugs CAGE Questionaire Have you tried to Cut down? Do you get Annoyed with people discussing your use? Do you feel Guilty about using drugs? Do you need an Eye-opener? Pain and Drug Abuse Addiction and abuse are not the same Abuse as defined by the DSM-IV Overuse in cases of celebration, stress, anxiety, despair, ignorance or self medication Examples: “rational abuser” or “chemical coper” Multiple studies suggest abuse rate may be 3.2-28% of those with chronic pain Detecting Abuse Using opioids for psychological relief Using opioids when mad, sad, happy or glad Using opioids with other illicit drugs Using illegal means to obtain opioids Using opioids against medical advice (compulsive, overuse) Using opioids with alcohol “Doctor shopping” Using deception to obtain more opioids Important “Red Flags” at TPC Past substance abuse Nonfunctional Medicaid Disability Work comp Excessive opioid needs Dose escalations ER visits Asking for higher doses Multiple phone calls Deception or lying Doctor shopping Asking for specific opioids or Soma Current or prior use of illicit drugs Pharmacy concerns Intolerance to opioids Common Signs of a Drug Seeker or Abuser Physical signs Poor compliance Lost prescriptions Stolen prescriptions Funny stories No interest in workup Knowledge of opioids Lengthy travel to see you Appointments late in the day Night and weekend phone calls Manipulative Speak poorly of other physicians History of many doctors That “gut feeling” A Comparative Evaluation of Illicit Drug Use in Patients With or Without Controlled Substance Abuse in Pain Management Pain Physician, 2003;6:281-285 Methods Consecutive, double blind, clinical evaluation 150 patients Group I: 100 patients without signs of abuse Group II: 50 patients with signs of abuse All underwent urine drug screen to test for marijuana, methamphetamine, amphetamine and cocaine Results Group I (without signs of drug abuse) 10% positive for marijuana 4% positive for cocaine None positive for methamphetamine or amphetamine Group II (with signs of drug abuse) 22% positive for marijuana 12% positive for cocaine None for meth or amphetamine The Reality The national drive to eliminate under-treatment of pain and relieve suffering has given drug abusers and addicts an added advantage and opportunity to obtain opioids from physicians thus contributing to the risk of under treatment of those patients who would legitimately benefit from opioid therapy Essential Components of Pain Evaluation and Assessment Assess pain intensity and character Evaluate the psychosocial status of the patient Perform physical and neurological examination Perform a diagnostic evaluation to determine pathology, recurrence or progression Frequently reassess pain and side effects of treatment The Importance of Medical Records H&P, diagnostic studies and consultations Attempted treatment modalities Treatment objectives Informed consent Periodic review of treatment plan Record of prescribed medications Optimizing Management of Chronic Pain Goals to increase function and decrease pain To achieve goals a combination of pharmacological and non-pharmacological treatment is often required Opioid therapy alone is usually not sufficient Multidimensional approach works best Issues That Must Be Considered When Using Opioids Pain is subjective Only appropriate in well selected patients Some patients are focused on obtaining drugs rather than pain relief Most opioid abuse is a consequence of written prescriptions Detecting abuse is paramount Critical Issues When Using Opioids Well-defined goal Patient selection (disease state, age etc.) Address psychological and social support Case by case basis Trial of therapy Documentation and follow-up care Types of Chronic Pain Patients Type I Patients Type II Patients “chronic pain patients Poorly defined pain Multiple complaints Using opioids poorly Overlying psych issues Ongoing legal issues Unemployed or poor function Well defined etiology Appropriate pain mannerisms Few or no psych issues Functional Compliant with therapy Common Mistakes Continued escalation of medication with no improvement in function Opioids used in pain syndromes known to be poorly responsive Not addressing psychological issues Lenient with abuse behaviors Fear of converting to long acting medications Addressing Obvious Abuse WEAN! Treat withdrawal Contact other physicians and pharmacies Discharge letter 30 day supply of opioids? Remember: An abuser will always find drugs but do all you can to protect yourself The Opioid Contract Mandatory for patients on chronic opioids Surprisingly the majority of our patients agree and understand why we must do this Key points: No function = no opioids Lost, stolen, misplaced opioids One pharmacy Urine drug screens Privacy issues Urine Drug Screens Types Drug screen 9 OPGCMS Useful tool but not often used randomly Some studies suggest high incidence of abuse Not taking prescribed drug Taking opioids not prescribed Illicit drug use Informed Consent Malpractice lawsuits becoming more common “my doctor addicted me!” The informed consent discusses: Risk of addiction Risks of overuse and overdose Risks of side effects Key Points Thoroughly evaluate the pain complaint Consider psychological issues Consider opioids as a treatment of last resort Use a contract and informed consent Patients should demonstrate a high level of responsibility An accountability system must be in place Practice a zero-tolerance policy