Controlled Substance Management or “Doctor I need Oxy” Tony Tommasello, Ph.D. University of Maryland School of Pharmacy Office of Substance Abuse Studies 410 706-7513 atommase@rx.umaryland.edu Program Objectives * At the end of this program participants will be better able to: * Screen for substance abuse * Assess the severity of a patient’s involvement with alcohol or illicit drugs * Determine the legitimacy of a patient’s request for opioid analgesics * Justify and document the decision to prescribe or refuse to prescribe CDS Lawnmower Addict Enduring pain to avoid relapse E.P. is a 40 y.o. married male with 4 children, He has been in opioid addiction recovery for over 9 years. I received a tearful midnight call from his wife stating the E.P. was lying in bed in a fetal position, moaning in pain and refusing to take opioid analgesics after incurring a back injury while wrestling with his son who is a star member of the high school wrestling team. His goal is to never relapse to active opioid addiction. Scope of the Public Health Problem * An estimated 2.4 million people have used heroin at some time in their lives (NHSDA, 1998) * During 1996 through 1998, an estimated 471,000 persons used heroin for the first time. Of them, 25% were under age 18 and another 47% were age 18 - 25 (NHSDA, 1999) Heroin Price Falls, Purity Increases 1980 through 1998 What about abuse? * According to the National Institute on Drug Abuse (NIDA), in 1999 Four million Americans reported current use of prescription drugs for non-medical purposes * The most dramatic increases were found among the 12 to 25 year olds * Oxycontin® and Ritalin® were among the most cited abused medications Oxycontin 80mg sustained release tablet Number of U.S. Narcotic Analgesic-Related ED Visits, 1994-2001 Narcotic Abuse Taxes ED Resources * In 2001 there were an estimated 90,232 ED visits, a 117% increase since 1994 * “Dependence” was the most frequently mentioned motive for abuse (44% of cases) * Between 2000 and 2001 Oxycodone mentions increased 70% and accounted for 53.7% of the overall increase in narcotic abuse cases during that year. Teen Abuse of Rx Drugs National figures Access to treatment is limited * Of the estimated 810,000 opioid dependent persons in the U.S. only 170,000 maintenance treatment slots exist. The Journey Matters Therapeutic drug use: * Drug use to treat or diagnose illness. Almost everyone has taken a drug at one time or another because they were sick. * A direct and reliable drug effect is expected. Antibiotics kill bacteria regardless of the sick person’s belief in the medicine. The drug is a known entity. * There are rules. The prescription tells: what to take, how much to take, and when to take it. A person who violates the rules must own the consequences. Social Drug Use * Drugs are used to increase social interactions. * Rules are vague or non-existent. * Drug supply is uncertain * Most cases of addiction result from social drug use that gets out of control. A Basic Distinction * High seeking = Pain relief seeking * “Because 6 to 15% of the U.S. population abuses drugs, the history of pain management is marked by the undertreatment [of pain in] the other 85 to 94%.” Passik SD quoted in: Gilson AM and Joranson DE (2002) U.S. Policies Relevant to the Prescribing of Opioid Analgesics for the Treatment of Pain in Patients with Addiction Disease Clinical Journal of Pain 18:S91-S98. available at http://www.medsch.wisc.edu/painpolicy/ Pain Statistics * Most common reason that people seek medical care * 50 million Americans are partially or totally disabled due to pain * Annual cost to U.S. society estimated to exceed $100 billion * 50-80% of patients with pain report that their pain is inadequately managed * Risk of undertreatment is increased among those with a history of substance abuse Addiction Defined * Addiction is compulsive use with loss of control and continued use despite adverse consequences. Elements of Compulsivity: * Constant thought of drug acquisition * Anticipation of opportunities to use * Defer other priorities of life * Unable to resist desire to use Aspects of Loss of Control * Inability to use in moderation consistently * Easier to abstain completely * Frequent episodes of excessive use Continued use despite problems * Loss associated with use * Multiple crisis not seen as drug-related * Sincere promises to self and others to quit Signs of Psychological Dependence * Carrying Drugs * Using Drugs alone * Stockpiling Drugs * Concern over supply * Changing friends * Finding excuses to use * Using at inappropriate times * Willingness to take increasing risks DSM IV: Substance Dependence * 3 of following in 12 month period: * Tolerance * Withdrawal * Difficulty cutting down (loss of control) * Time spent drug seeking (compulsive use) * Decrease in activities * Continued use despite knowledge of persistent physical or psychological problems Addiction Characteristics * First priority is drug acquisition and use * Negative consequences occur in order * 1) Interpersonal relationships suffer * 2) Productivity declines * 3) Self-Esteem plummets * 4) Health problems emerge or worsen * Note: Legal problems can occur at any time. Why Treatment ? * Dysfunctional lifestyle of opioid addiction makes treatment a desired alternative * Oral methadone and buprenorphine sublingual tablets are approved for both medical withdrawal and medical maintenance Addictive Behaviors * Selling prescription drugs * Prescription forgery * Stealing drug from others * Injecting oral formulations * Buying drugs on the street * Resistance to change therapy despite evidence of adverse effects from the drug Pseudo-addiction * Drug-seeking behavior misidentified by health providers as addictive behavior, when it is actually relief-seeking behavior * Behaviors resembling those of drug addiction disappear when patient is given adequate doses of analgesia Pseudoaddiction Behaviors * Complaints for more drug * Hoarding drug during pain free periods * Specific drug requests * Openly seeking other sources of help * Occasional unsanctioned dose increases * Resistance to change in therapy Ambiguous Behaviors * Complaints for more drug * Hoarding drug during pain free periods * Specific drug requests * Openly seeking other sources of help * Occasional unsanctioned dose increases * Resistance to change in therapy Principles Summary Differentiating factors * Motivation for use * Route of administration * Frequency of use and dose * Pseudo-addiction? * Continued use despite problems Types of Pain * Nociceptive * Pain resulting from actual or potential tissue damage * Results from ongoing activation of primary afferent nociceptive neurons by noxious stimuli * Neuropathic * Results from a disturbance in function or pathologic change in a neuron * Can be peripheral or central Pain Characteristics Non-Verbal Signs of Pain * Aggressive behavior * Changes in daily activities * Facial expression * Bodily movements * Vocal * Mood * Physical Assessment Values * Change in vital signs Symptom Analysis * Precipitating events * Palliating events * Quality * Severity * Pain location and radiation * Temporal relationships * Associated symptoms * Previous treatments and their effects Pain Scales Pain Assessment * Accept the patient’s description * Thorough assessment of each pain * History, examination, investigation * Assess impact of pain on ADLs and functional status * Assess other factors that influence pain * Physical, psychological, social, cultural, spiritual * Reassessment WHO-Step Ladder Patient Centered Treatment Goals * “What would you like to do that you can’t do because of your pain?” * “I’d like to be able to do my needlework” * “I’d like to walk to the bathroom – alone” * “I want to sleep through the night” * “I want to go back to work” * “I want to be able to play with my children” With Uncontrolled Pain … Four kinds of patients Two kinds of pain * No History of Abuse (Group 1)* * Substance abuser in the past (Group 2)* * Addict in recovery including opioid maintenance patient * Active substance abuser (Group 3)* * Nociceptive pain * Acute * Chronic * Somatic * Visceral * Neuropathic pain * Chronic * Acute The CAGE Screen * Have you ever felt the need to Cut Down on your drinking * Have you ever been Annoyed by criticism of your drinking * Have you ever felt Guilty about your drinking * Have you ever needed an Eye Opener to get going in the morning. Toxicology Screening Tests Purposes * To identify surreptitious use * To monitor known users Clinical Examples * Prenatal Care * Impaired Professionals * Trauma/ER Legitimate patient with no Hx of addiction (Group 1*) * Manage pain (analgesic ladder) * Recognize low addiction risk * Differentiate physical dependence from addiction * Don’t mistake pain relief seeking for drug seeking - pseudoaddiction Pain Management and Addiction * Misconception: Therapeutic use of opioids is commonly associated with substance abuse or addiction * Reality: In patients with no history of substance abuse the risk of addiction following therapeutic use appears to be less than 3% Clinical Features Distinguishing Opioid Use in Patients With Pain Versus Patients Who Are Addicted to Opioids (TIP 40) Patient populations under-treated for pain * Elderly * Minorities * Children * Terminally ill patients with HIV/AIDS * Chronic non-cancer pain * Perceived as high addiction risk * Gilson AM and Joranson DE (2002) U.S. Policies Relevant to the Prescribing of Opioid Analgesics for the Treatment of Pain in Patients with Addiction Disease Clinical Journal of Pain 18:S91-S98. available at http://www.medsch.wisc.edu/painpolicy/ Addict in solid recovery (Group 2*) * May refuse adequate pain pharmacotherapy * Use of buprenorphine * Suggest increased support group work while on analgesic pharmacotherapy * Conduct urine or saliva screens for unauthorized substances * Utilize pain management contract * Misconception: it is illegal to prescribe or dispense opioids for a patient with a history of substance abuse * Reality: It is not illegal and the regulatory agencies do not intend to restrict appropriate therapeutic use Management Guideline for Recovering Addicts * Relapse prevention: “Relapse occurs most often when practitioners are unaware of their patients’ opioid addiction history” (TIP43 p174) * Education regarding the need for drug * Patient’s fear and staff reluctance may conspire to under-medicate * “A patient’s previous drug of abuse should not be prescribed for pain treatment” (TIP 43 p176) Undiagnosed substance abuse or addiction – active users (Group 3*) * Screen all patients for substance use disorders with CAGE * Ask * Make pain management contingent on thorough assessment and treatment if warranted * Utilize pain management contract Management Guidelines for High Risk (Group 2) and Active User (Group 3) * Identify and treat underlying medical problem(s). * Use appropriate drug, dose, and route * Employ non-opioids when possible * Recognize abuse behaviors * Don’t negotiate * Refer to substance abuse and pain services * Disclose plan for prescription abuse (Pain management contract) Drug Diverter – Not a patient Medico-legal nightmare * Do a thorough pain assessment * Document, document, document * First time patients who request specific agents * Abide by pain management ladder – don’t trade off good medical practice for convenience Policy Barriers to Effective Pain Management * Lack of training or expertise by healthcare practitioners and limited access to pain specialists * Regulatory steps to prevent drug diversion may also impede pain management (Electronic CDS prescriptions) * Perceived risk by physicians that sanctions may be imposed by regulatory boards for over prescribing opioids for non-malignant conditions (Chilling Effect) * Poor communication Federal Food Drug Cosmetic Act and the Controlled Substances Act The Pharmacist’s Dilemma To fill or not to fill Corresponding Responsibility Rule 21 CFR 1306.04 * A prescription for a CDS to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of CDS is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly filling such a purported prescription as well as the person issuing it shall be subject to the penalties provided for violations of the provisions of law relating to CDS. Federal CDS schedules CDS Requirements Model Prescription Schedule II medication Red Flags for Prescription Forgery * The prescription is “too legible” * Standard abbreviations are not used * The prescription appears to be photocopied * More that one ink color or handwriting used * Erasure marks visible * Paper appears to have been wet. (acetone) * Odd combinations of medications * Someone other than the patient presents the prescription for dispensing\ Prescription Drug Monitoring Programs * Electronic PDMP passed in 2006 Maryland general session (SB 333 & HB 1287) and was vetoed by Gov. Ehrlich on May 26, 2006. * As of April 2005, 22 states already adopted electronic PDMPs * Of the various PDMP approaches (serial Rx, triplicate) electronic systems are the least intrusive and “chilling” on prescribing practices. Federation of State Medical Boards * “The board will judge the validity of prescribing on the physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing” * Evaluation of patient, treatment plan, informed consent and agreement for treatment, periodic review, consultation,medical records, compliance with regulations Case: Acute Pain * Patient with hx of heroin addiction who is currently receiving buprenorphine sublingual tablets (Suboxone®) comes to Acute Care Center with compound fracture of the right femur. Case: Acute Pain - Issues * Ability to control pain in patient receiving chronic partial antagonist therapy * Risk of relapse * Uncontrolled pain may delay/impair rehabilitation and recovery Case: Acute Pain- Strategies * Non-pharmacologic and non-opioid interventions should be optimized first * Engage patient in strategies that have aided in their recovery as soon as possible * Consult addiction medicine specialist * When opioids are necessary, use long-acting, slower onset formulations when possible * Must D/C buprenorphine in order to obtain full agonist effect of mu agonists. Examples of Nonpharmacologic Interventions for Pain * Cognitive-Behavioral * education/instruction * relaxation * imagery * music distraction * biofeedback * Physical Agents * heat or cold compress * massage, exercise, immobilization * transcutaneous electrical nerve stimulation Case: Acute Pain- Strategies * Begin tapering of opioids as soon as possible but gradually to avoid any withdrawal symptoms * Treat relapse if it occurs * Re-start buprenorphine therapy Misconception regarding pain management with opioids * Misconception: patients on methadone maintenance therapy should not be experiencing pain * Reality: “Reluctance to provide adequate pain treatment to patients on medication assisted therapy usually is based on the mistaken belief that a maintenance dose of opioid addiction treatment medication also relieves acute pain” (TIP43 p174) Guidelines for Methadone Patients * Don’t expect the patient’s methadone maintenance dose to provide analgesia * Continue patient’s maintenance dose * Add analgesic (opioid and otherwise) starting with usual doses * Anticipate tolerance and the need for higher dose requirement Sample Adult Screening Protocol * Transition: Stresses and ways of coping * “Do you use tobacco?” (if so, “Are you interested in quitting?”) “Do you drink alcohol?” * “Have you ever experimented with any drugs?” * Ask CAGE or CAGE-AID questions * Ask Q/F questions on alcohol Usually takes less than one minute Review of Pain Classifications Acute Pain * Warning that tissue injury (or disease) has occurred * Subsides as healing takes place (usually less than 3 months) * Often accompanied by autonomic responses – tachycardia, tachypnea, hypertension, diaphoresis, mydriasis * Goal: relieve pain and allow healing to occur ? CURE * evidence supports that pain relief may hasten healing following many types of injuries Review of Pain Classifications Chronic Nonmalignant Pain * May initially be elicited by injury but may persist long after healing has taken place and change in characteristics and location * May occur following injury, chronic disease, or have no definable cause * Examples: diabetic neuropathy, radicular or low back pain * Typically persists for months to years and may be continuous (persistent) or cyclic (chronic) * Goal: relief and management as cycles occur Review of Pain Classifications Chronic Nonmalignant Pain * Not associated with autonomic responses * Frequently associated with depression, anxiety, fear, sleep disorders, anorexia, disability * Likely to develop physical dependence and tolerance to analgesics * Use of opioids has been controversial but becoming more widely accepted in specific circumstances * Evidence that functionality improves * Cognitive and motor impairment are not problems associated with chronic use * Goal: relief and rehabilitation (not cure) Review of Pain Classifications Malignant Pain * Associated with cancer or some similar progressive, ultimately fatal disease * Frequently worsens in intensity and spreads to other areas of the body as the disease progresses * Not associated with autonomic responses * Frequently associated with depression, anxiety, fear, sleep disorders, complications of the cancer and other symptoms including hiccups, cough, chronic nausea, shortness of breath, myoclonus, delirium as patient enters final days to weeks of life * Physical dependence is assumed and patients usually require higher and higher doses of opioids due to tolerance and disease progression * Goal: relief, maintain function, quality of life, palliative care American Academy of Pain Medicine and American Pain Society Joint Statement 1997 * Good medical practice for patients receiving chronic opioid therapy involves: * Complete patient evaluation including coexisting diseases and conditions * Treatment plan: inform patient of risks and benefits of opioids and conditions for prescribing. * Consultation with specialists * Periodic review of efficacy, AEs, functional status, QOL, medication misuse * Thorough documentation The VIGIL System * Verification: that the pt. can take the medication responsibly and that the Rx is genuine * Identification: driver’s license or other ID * Generalization: establish the general parameters of the provider-pt relationship * Interpretation: the decision to dispense is made * Legalization: ensuring adherence to legal requirements for treatment Case: Chronic Nonmalignant Pain * Patient with diabetic neuropathy, degenerative spinal disease, and history of cocaine (nasal) dependence. Pain described as shooting up right leg, dysesthesias, burning and numbness in both feet. Recurrent diabetic foot ulcers that required amputation of several toes. Frequently misses work due to pain. Receiving maximum doses of gabapentin and SSRI. Previously has failed trials of imipramine and carbamazepine. A trial of oxycodone 10 mg Q 4 H improves pain significantly, however his clinician feels that he should decide whether he wants to take the risk of addiction. Case: Chronic Nonmalignant Pain- Issues * Past substance abuse places him at greater risk for opioid abuse and dependence (10-25%) * Patient seeking medical attention has a right to treatments that he may benefit from * Clinicians have ethical responsibility to intervene and relieve suffering (beneficence) but should exercise knowledge, skills and experience in making intervention decisions * Clinicians should not knowingly cause unwanted injury or suffering * Inadequate treatment of pain has been found to be criminal negligence and malpractice in courts Case: Chronic Nonmalignant Pain- Issues * If patient is impaired, does he have the capacity to understand risks and make judgment? * Determining etiology and pathophysiology of chronic pain syndromes if often difficult * Chronic pain is often complicated by depression and anxiety which may limit patient’s ability to make balanced decision and other complications of unrelieved pain Case: Chronic Nonmalignant Pain- Issues * Unrelieved or undertreated pain may: * provoke drug abuse in patients with substance abuse * prevent patient from fulfilling responsibilities that impact others – salary, benefits Case: Chronic Nonmalignant Pain- Strategies * Non-opioid strategies should be evaluated prior to initiation of opioids including co-analgesics * Individuals caring for patient should be experienced in chronic pain, substance abuse and use of opioids in patients with history of substance abuse Case: Chronic Nonmalignant Pain- Strategies * When opioids are considered: * Patient should be informed (in writing) of potential risks and benefits and conditions of treatment and given opportunity to accept or reject opioid trial * Pain Management contract Case: Chronic Nonmalignant Pain- Strategies * Special monitoring and clear limits regarding opioid use should be set (to avoid secondary harm of substance abuse) * Prescriptions are for fixed amounts, clinicians should see patients more frequently than other patients * Single pharmacies * Pharmacy will not accept opioid prescriptions from other than contracted prescriber * Inappropriate behavior, accelerated use of opioids etc will result in screening Case: Chronic Nonmalignant Pain- Strategies * Treatment goals should be clearly established – pain relief, function, quality of life * Pain should be adequately treated using standardized guidelines (including use of breakthrough medications) – may lead to pseudoaddiction or abuse * Opioid doses in patients with history of substance abuse frequently are higher than “typical” doses * Underdosing may provoke or exacerbate abuse Case: Chronic Nonmalignant Pain- Strategies * Due to prior history of abuse, patient should connect (if not already) with AA or NA, etc or formal treatment program – some clinicians may require participation for prescriptions Pharmacotherapy General Principles * Around-the-clock dosing and long-acting formulations for continuous pain * As-needed immediate-release analgesic supplementation for breakthrough pain * Observe for end-of-dose failure * Incident pain “prophylaxis” * Spontaneous pain suggestive of visceral/neuropathic etiology * Anticipate, prevent, and treat predictable SEs * Constipation Conclusions * There is no easy formula for dealing with this common yet complex area of patient care * Engage addiction specialists sooner rather than later Conclusions * Consider referral to pain management specialist when standard approaches fail and discomfort sets in – before the situation has escalated out of control. * Employ the assistance and cooperation of a competent pharmacist who maintains a patient centered pharmacy practice. Recommended Readings and Websites * Gilson AM and Joranson DE. (2002) U.S. Policies Relevant to the Prescribing of Opioid Analgesices for the Treatment of Pain in Patients with Addictive Disease Clin J Pain 18: S91-S98. * Brushwood DB, Finley R, Giglio JG and Heit HA (2002) APhA Special Report: Pharmacists’ Responsibilities in Managing Opioids: A Resource. (American Pharmacists Assocition) * Gilson AM, Ryan KM, Joranson DE and Dahl JL (2004) A Reassessment of Trends in the Medical Use and Abuse of Opioid Analgesics and Implications for Diversion Control: 1997-202. J. Pain and Symptom Management 28(2) * Websites of interest: http://www.medsch.wisc.edu/painpolicy/ * http://www.deadiversion.usdoj.gov/ * Brushwood DB (2002): The Pharmacist’s Duty to Dispense Legally Prescribed and Therapeutically Appropriate Opioid Analgesics. Pharmacy Times January 2002 C.E. program. * Gourlay DL et al. (2005) Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain. Pain Medicine 6(2) 107-112. Recommended Readings and Websites * TIP 43 Center for Substance Abuse Treatment. (2005) Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs DHHS Publication No. (SMA) 05-4048 Rockville, Md * TIP 40 Center for Substance Abuse Treatment. (2004) Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction DHHS Publication No. (SMA) 04-3939 Rockville, Md