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COMPETING EPIDEMICS: PAIN AND PRESCRIPTION DRUG ABUSE Brian A. Rosenberg, MD Interventional Pain Mgmt Bone & Joint – Wausau, WI DISCLOSURES “We must all die. But that I can save a person from days of torture that is what I feel is my great and ever-new privilege. Pain is a more terrible lord of mankind than even death itself.” Albert Schweitzer, Theologian/Medical Missionary AGENDA • Definitions • Epidemiology of Rx Abuse • Impact of Rx Abuse • Contributing Factors to Rx Abuse • Reducing Rx Abuse Pain Words Can Hurt DEFINITIONS PAIN • “Pain is whatever the patient says it is, existing whenever he says it does.” - (McCaffery, 1979) !!!PAIN!!! www.chucknorrisfacts.com PAIN • “An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” - IASP PAIN • Consistent pain assessment tools (VAS, 5 th vital sign) • Include patient report MEASURING PAIN = THE FACE OF PAIN ADDICTION ADDICTION? “I know an addict when I see one…” • A maladaptive pattern of drug use marked by tolerance and a drug class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood levels of drug, or administration of an antagonist. DEPENDENCE DEPENDENCE DEPENDENCE DEPENDENCE • A state of adaptation in which exposure to a drug induces changes that result in diminution of one or more of the drug’s effects over time. TOLERANCE TOLERANCE ADDICTION • A chronic biopsychosocial disease characterized by impaired control over drug use, compulsive use, continued use despite harm and craving. ADDICTION PSEUDOADDICTION • A drug-seeking behavior that simulates true addiction, which occurs in patients with pain who are receiving inadequate pain control. PSEUDOADDICTION • Undertreated pain condition • Patient exhibits seeking behavior • These behaviors extinguish with therapeutic doses OLIGOANALGESIA • Inadequate pain management • “There is oligo-evidence for oligoanalgesia.” • Green SM, Ann Emerg Med. 2013; PLACEBO • Latin for “I shall please.” • Any therapy that is intentionally or knowingly used for its nonspecific, psychological or psychophysiological, therapeutic effect, or that is used for a presumed specific therapeutic effect on a patient, symptom, or illness but is without specific activity for the condition being treated. NOCEBO • Latin for "I shall harm” • A harmless substance that creates harmful effects in a patient who takes it. PSYCHOGENIC VS. PSYCHOSOMATIC Psychogenic • Pain not due to an identifiable, somatic origin and that may reflect psychologic factors. Psychosomatic • Of or pertaining to a physical disorder that is caused by or notably influenced by emotional factors. C.O.A.T. Chronic Opioid Analgesic Therapy Diversion • Medications prescribed end up out of the patient’s possession • Lost • Stolen • Shared • Sold USER VS ABUSER User • Takes to treat illness • Improved quality of life • Control – Cooperates with prescriber, abuser controls his own regimen • Pattern –stable and does not include nonmedical drugs Abuser • Uses for recreation (often in conjunction with other nonmedical drugs) • Consequences, deteriorated quality of life • Controls own regimen • Unstable, typically with polydrug abuse and excessive alcohol IDENTIFYING THE ABUSER CONSEQUENCES OF INADEQUATE ANALGESIA • Unnecessary suffering • Delayed healing • Functional disability • Increased length of hospitalization • Increased medical cost to patient and society • Inadequate pain management as a “medical error.” McNeill et al., J of Pain and Symptoms Management. 2004; PROBLEMS WITH C.O.A.T. • Cognitive effects • Sleep/Resp Disorders • Gastrointestinal Effects • Endocrine Effects • Cardiac Effects • Opioid hyperalgesia and pronociceptive effects COGNITIVE EFFECTS • Memory Deficits/Poor concentration • Sleep Disturbance • Fatigue • Delirium • Decreased alertness/Coma • Emotional distress/Mood disturbance GASTROINTESTINAL EFFECTS • Nausea/Vomiting • Anorexia and Weight Loss • Opioid Induced Constipation • Not responsive to conventional laxatives in half of patients • Can lead to bowel obstruction ENDOCRINE EFFECTS • Decreased testosterone, progesterone, estradiol – decreased libido • Amenorrhea • Reduced cortisol response to stress • Breast pain/gynecomastia • Hair loss • Infertility • Low bone density • Hot flushes/sweating • Reduced muscle mass CARDIAC EFFECTS • Bradycardia • Vasodilation • Edema • Hypotension • Syncope • Some (methadone and buprenorphine) prolong QTc causing arrhythmia • Above effects are magnified when combined with other medications (benzos) • Same nature as dependence and tolerance • Increase in pain receptor/Opioid receptor desensitization • Increased spinal dynorphin, descending central facilitation, and activation of pronociceptive glutamate Rx Drug Abuse EPIDEMIOLOGY EPIDEMIOLOGY • Prescriptions for opioid medications have increased annually since 1990 • Evolving attitudes toward opioids for chronic pain • Increasing prevalence of chronic pain in aging population • Prevalence of prescription abuse increasing faster than medical use EPIDEMIOLOGY • Decline in use of some illicit drugs in US while Rx abuse increases • Misconception that prescription drugs are safe • Relatively cheap • Widely available EPIDEMIOLOGY • Street value of controlled drugs comparable to cocaine, greater than heroin and MJ • Increasing demand • Increase production of counterfeit drugs • Internet has expanded global market • Over 300 sites on web search for “no prescription” sites EPIDEMIOLOGY • 1992 – 7.8 million persons in US used prescription medication for nonmedical reasons • 2003 – 15.1 million • 2006 – More Americans used Rx drugs nonmedically than used cocaine, heroin, hallucinogens, ecstasy and inhalants combined • Rx drugs second only to cannabis in frequency of use EPIDEMIOLOGY • Lifetime incidence of nonmedical use of Rx meds: • Pain Relievers = 13% • Tranquilizers = 9% • Sedatives = 4% EPIDEMIOLOGY • 2005 student survey (compared to 1995) • Much less illicit drug use (33% lower in 8 th, 10% lower in 12th) • Nonmedical Rx use much higher • 7.2% high school seniors used sedatives • 5.5% used oxycodone products • Obtained from friends and parents, often from physicians EPIDEMIOLOGY • 2004 physician survey • Found 43% physicians don’t routinely ask about drug abuse (except alcohol) • 1/3 did not obtain patient’s previous records before Rxing controlled meds IMPACT IMPACT • Dramatic increase in number of ED visits for accidental overdose • Increase in admissions to addiction programs for Rx opiates • Most pronounced in rural states IMPACT • Increased scrutiny of prescriptions for controlled drugs • Increasing public health attention • Laws internationally have now been written restricting certain agents to “appropriate diagnoses” and within the context of “appropriate medical care” • Regulations in place to identify shoppers • Produces new barriers to clinicians IMPACT • Clinicians now undertreating anxiety disorders, attention deficit/hyperactivity disorder and chronic pain • Substantial amount of controlled meds are prescribed appropriately, but used inappropriately, given away or sold • Now exists an “imbalance in controlled drug prescribing” • Simultaneous over- and under-prescribing • Debate between expanding or limiting access CONTRIBUTING FACTORS TO ABUSE CONTRIBUTING FACTORS TO ABUSE • Drug • Patient • Clinician BLAME THE DRUG • Brain rewarding (Not “Brain affecting”) • Formerly withdrawal suspected to be correlated BLAME THE DRUG Four major classes: Stimulants Cocaine, methamphetamine, nicotine, caffeine, Rx’d stimulants Sedative-hypnotics EtOH, Benzos, Barbiturates, other hypnotics Opioids Heroin, Rx Opioids “Other” Psychedelics, dissociative anesthetics, cannabinoids, hallucinogens BLAME THE DRUG • Drugs in 4 classes provoke acute dopamine release from ventral tegmental area and nucleus accumbens (midbrain) to the forebrain • Dopamine surge = brain reward • Higher dopamine surge, greater addiction risk • Street value determined by: • Rapid onset • Magnitude of dopamine surge • Route of administration • Purity • Trade name BLAME THE DRUG • Availability also yields higher abuse potential • Clinicians more willing to prescribe Sch.III (Now Tramadol, formerly Hydrocodone) • Oxycodone Rx’s increased dramatically in late 90’s • Internet sales contribute to abuse • Law enforcement closing US internet pharmacies, sanctioning MD’s • Offshore pharmacies have increased delivering substandard manufacture, inconsistent potency and even counterfeit drugs BLAME THE PATIENT • Quantitative and qualitative variation of dopamine surge with drug use between patients • Individuals susceptible to addiction have ‘abnormal’ brain response/reward creating persistent craving • Leads to escalation in dose/frequency despite consequences • Global dysfunction develops due to inability to prioritize pathologic relationship with drug vs. interpersonal relationships BLAME THE PATIENT • Patients vulnerable to addiction usually have succumbed to addiction to EtOH, tobacco or marijuana in late adolescence/early adulthood • Prescription for a drug does not CAUSE addiction, but it can complicate a pre-existing addiction BLAME THE PATIENT • Risk factors for addiction: • Current addiction or history of substance abuse • Nonmedical use of controlled substances (non-Rx’d routes) • Use of controlled substances for wrong reasons (e.g. sleep) • Younger age • Patients who work in health care • When they lose control, supply runs short: • Pressure the clinician for more • Pressure the clinician/pharmacist for early refills • Seek additional sources • DISHONESTY is a hallmark of addiction BLAME THE PATIENT • Those not vulnerable to addiction will not experience brain reward and will not misuse Rx’d meds • Patients and caretakers have disproportionate fear of addiction, however, leading to under-treatment • When prescribed ‘addictive’ drugs on long-term basis, physical dependence develops, but behavioral criteria for addiction are not met BLAME THE CLINICIAN • One of principal reasons for adverse action against physicians is “inappropriate or excessive prescribing of controlled drugs” • Most lack formal training in diagnosis and treatment of acute, chronic and malignant pain as well as anxiety, depression, insomnia and addiction • Clinicians report discomfort in managing these conditions • Clinicians fail to recognize aberrant behavior in their patients BLAME THE CLINICIAN • The Six D’s • Dated – lack up-to-date knowledge • Deceived – Misled by patients • Distracted – Time pressured • Defiant – Overestimate their expertise • Disabled – Have personal problems (Psych, medical, substance) • Dishonest – Prescribe for other than legitimate purposes ($$$) • Add’l factors are pathological enabling and confrontation phobia BLAME THE CLINICIAN • Prescribing prior to obtaining complete record • Concomitantly prescribing multiple controlled drugs • Prescribing for extended periods of time without reevaluating indications • Lack of monitoring to detect other substance abuse • Failure to communicate with colleagues • Continued prescribing despite aberrant behaviors RISE OF THE RX • Rx opiate deaths surpass heroin and cocaine combined - CDC, 2011; RISE OF THE RX • Among oxycontin addicts, 78% had never been prescribed the drug, and 78% had been treated for prior addiction. • 86% used the drug to get “high or buzzed.” - Carise D, Am J Psychiatry. 2007; REDUCING ABUSE REDUCING ABUSE The US government is: • Tracking prescription drug overdose trends to better understand the epidemic. • Educating health care providers and the public about prescription drug abuse and overdose. • Developing, evaluating and promoting programs and policies shown to prevent and treat prescription drug abuse and overdose, while making sure patients have access to safe, effective pain treatment. STATES CAN: • Start or improve prescription drug monitoring programs (PDMPs), which are electronic databases that track all prescriptions for painkillers in the state. • Use PDMP, Medicaid, and workers’ compensation data to identify improper prescribing of painkillers. • Set up programs for Medicaid, workers’ compensation programs, and state-run health plans that identify and address improper patient use of painkillers. • Pass, enforce and evaluate pill mill, doctor shopping and other laws to reduce prescription painkiller abuse. • Encourage professional licensing boards to take action against inappropriate prescribing. • Increase access to substance abuse treatment. REDUCING ABUSE REDUCING ABUSE – BETTER DRUGS • Lower risk of addiction • Pain relief without dopamine surge • Lower risk of abuse • Abuse deterrents • Lower risk of diversion • Lower quantity • Injectables REDUCING ABUSE – BETTER DRUGS • Controlled-release slows entry into brain, reduces abuse • Prodrugs produce slower onset of action, less activated if not taken orally • Compounding drug with antagonist activated by quantity (atropine) or nonmedical route (naloxone) REDUCING ABUSE - BETTER PATIENTS • Education • Reasonable goals • Alternatives • Accountability REDUCING ABUSE – BETTER PATIENTS • Education of staff in their role as patient advocates • Educate PATIENT in role as patient advocate • Educate FAMILIES/FRIENDS in role as patient advocate PATIENT WITH HISTORY OF ADDICTION • Risk of relapse depends on class of drug to be used, patient’s drug of choice • Former alcoholics have moderate risk for opioid or stimulant addiction, but high risk for sedative/hypnotic abuse • Former opiate addicts are at high risk for opioid analgesics, especially if used for long periods of time • In absence of urgency, pain/addiction consultation is warranted DRUG SEEKING • Early requests for refills- urgent unscheduled visits late in the day, lost/stolen Rx’s and pills, pharmacist shorted count • Multisourcing – Recruiting surrogates, multiple physicians/pharmacies, internet or illicit dealers • Intoxicated behavior – Slurred or disinhibited calls, presenting under the influence, frequent ER visits for falls, trauma or accidental overdose • Pressuring behaviors – begging, excessive compliments, breaching boundaries, solicitous implications, vague or overt threats to harm self or others DEALING WITH DRUG ABUSING PATIENT • Working with the patient and family • Referral to an addiction expert • Placement in a formal addiction treatment program • Long term participation in a 12 step mutual help program • Follow up of medical and psychiatric problems DEALING WITH DRUG ABUSING PATIENT • Immediate cessation of prescription if: • Unsafe, out of control behaviors • Altering or selling • Overdose (Accidental or otherwise) • Bingeing • Doctor shopping • Threatening staff CESSATION OF TREATMENT • Cease prescribing • Indicate that continued prescribing is not clinically supportable • Urge the patient to accept referral for medically supervised withdrawal • Educate patient about signs and symptoms of withdrawal • Urge patient to report to ED if symptoms occur CESSATION OF TREATMENT - CONTROVERSY • Supplying an abusing patient with a supply of drugs • Illegal? • Medically inadvisable? • May actually defer patient’s acceptance of need for treatment • Believing your patient • Desire to quit may be genuine • Patient’s expression of intent to quit may be ruse • Should nevertheless be referred to an addiction specialist ETHICAL CONSIDERATIONS • Clinician/patient relationship – TRUST • Patient autonomy vs. Clinician Beneficence • Informed consent and patient’s right to know • Obligations to relieve suffering when possible • “Do No Harm” (non-malfeasance) • Patient abandonment and obligation to treat BETTER CLINICIANS BETTER CLINICIANS ALTERNATIVE THERAPIES Medications Alternatives • TCA’s • Acupuncture • Na Channel Blockers • Injections (Facet, ESI, etc…) • Ca Channel Blockers • Muscle Relaxers • Physical/Occupational Therapy • NSAIDS • Hypnosis • Antidepressants • Counseling • Anticonvulsants • Guided Imagery • Topicals (Lidocaine, Menthol, Capsaicin) • TENS unit • Potentiation • Neuromodulation (SCS) RESPONSIBLE PRESCRIBING REDUCING ABUSE – BETTER CLINICIANS • Opiate agreements • Urine drug screens • Pill counts • Board of Pharmacy Prescription Monitoring Program (BOP/PMP) OPIATE AGREEMENT: “PAIN CONTRACT” • Rx to be obtained from a single clinician and single pharmacy when possible (Identify each in the agreement) • Take only as prescribed with limited latitude • Patients are responsible for arranging refills during regular office hours • Patient will stop all other controlled medications unless instructed to continue • Terms for violations indicating that prescribing may be stopped leading to gradual or abrupt discontinuation of therapy if it is deemed unsafe to continue THE NEW PATIENT • Patient assessment • Careful drug selection • Clear communication of treatment plan • Minimizing potential for Rx alteration • Monitoring response to treatment • Maintain clear/accurate records • Be knowledgeable about legal/regulatory requirements • In past 6 months have you taken any medications to help you calm down, keep from getting nervous/upset, raise your spirits or make you feel better? • Have you been taking any med to help you sleep? Have you used EtOH for this purpose? • Have you ever taken a med to help you with a drug/EtOH problem? • Have you ever taken a medication for a nervous stomach? • Have you taken a medication to give you more energy or to cut down your appetite? • Have you ever taken OTC cold preparations other than when you have a cold? Have you taken OTC diet pills? THE NEW PATIENT THE NEW PATIENT • Also determine who has been providing medical care in past, what drugs have been prescribed for what indications • Patient Consent/Agreement should be obtained and submitted to the record • In emergency situation, physician should Rx no more than one day’s supply and arrange for return visit (Photo ID should be obtained at minimum) • Limit quantities – only enough to meet patient’s needs until next appt. DRUG SELECTION • Efficacy and Safety come first • Prior response • Metabolism and excretion • Comorbidities • Likelihood of compliance • Potential for interaction • Cost • Formulary availability DRUG SELECTION • Dependence-producing potential of drug • Is there an alternative? • Are there effective adjuvants reducing requirement? • Determination of endpoint • Relief of symptoms is goal • Patients differ in tolerance/threshold • Drug abusers exaggerate/enhance symptoms • Using multiple psychoactive drugs to achieve complete relief can be risky DRUG SELECTION • Dose • Based on age, weight, severity of disease, loading dose and potential interaction • Timing of Administration • Bedtime dose to minimize sedative effects • Formulation and Route • Patch vs. tablet • Extended release vs. immediate COMMUNICATING TREATMENT PLAN • Stress that EVERY medication is part of plan • Monitor for efficacy, safety, compliance, and development of tolerance and communicate this to patient • NO treatment program should be left open-ended • Planned termination minimizes exposure and contains cost COMMUNICATING THE TREATMENT PLAN • Pain Consent • Risks vs. Benefits • Ethical and legal obligations • Potential for dependence and cognitive impairment • Possible adverse effects from interaction, including EtOH • Implications of opioids in pregnancy (dependent newborn) • Informs patient and encourages adherence • Limits potential for inadvertent or intentional misuse • Improves efficacy (at least enhances comfort among staff) PRESCRIPTIONS • Date • Name and address of patient • Name, address and DEA registration of physician • Number of clinician • Signature • Name and quantity of drug • Directions • Refill information PRESCRIPTIONS • DEA number should not be preprinted • Forms should be tamper-resistant • Spelling out quantity limits tampering • Electronic prescribing with direct transmission to pharmacy may prevent transcription errors, avert tampering • Forged Rx’s • often begins with a legitimate Rx form • Seekers are on the lookout for blank forms • May utilize names of retired, departed or deceased physicians • Lock Rx pads up, don’t leave them in exam rooms • Immediately report lost/stolen forms • Altered Rx’s • Pen with same color ink • Numerals easily altered, including refills • Spelled out can be altered as well PRESCRIPTIONS MONITORING THE PATIENT • Subjective • Symptom response – Patient log • Side effects • Objective • Signs of intoxication/abuse • Body weight • Pulse • Temp • BP • Urine/Serum levels DOCUMENTATION • Accurate and up-to-date records • H&P including history of all controlled drugs, illicit drugs, allergies, personal/family history of alcoholism/addiction, major depression or other psych disorder • Caution with records supplied by patient • Clearly outline individualized treatment plan and response • Use of Consultants with written report of consultation DOCUMENTATION • Prescription orders, whether written or telephone, should be charted including explicit instructions • Informed consent form • Evidence of monitoring visits (nurse visits) • Report of outcomes, regardless whether favorable GOLDEN RULES OF PRESCRIBING • Screen for history of abuse before and during treatment • Do not provide early refills • Do not prescribe on chronic basis in face of diagnostic insecurity – saying no early is better than later • Stay within your area of expertise, seek second opinions • Discontinue or revise regimen if patient shows “out-of-control” behavior GOLDEN RULES OF PRESCRIBING • Do not prescribe to self, family, friends or colleagues • Never prescribe without a medical record of doctor/patient relationship and legitimate medical purpose • Perform periodic toxicology • Become familiar with opioid, benzo and stimulant pharmacology and withdrawal management • Follow a structured monitoring strategy (Like DM, Anticoag) • Beware the “heart-sink” patient – screen and screen, refer CONCLUSION • Rx abuse is a major and increasing problem • Stems from 3P’s: Patients, Pills and Providers • Improving the problem means improving all 3 • Adhere to the golden rules to limit use and abuse • Educate Questions?