1 Competing epidemics: pain and Prescription drug abuseBrian A. Rosenberg, MD Interventional Pain Mgmt Bone & Joint – Wausau, WI

2 disclosures

3 Albert Schweitzer, Theologian/Medical Missionary“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

4 Don’t die of boredom!!!! Agenda Definitions Epidemiology of Rx AbuseImpact of Rx Abuse Contributing Factors to Rx Abuse Reducing Rx Abuse Don’t die of boredom!!!!

5 Pain Words Can Hurt Definitions

6 PAIN “Pain is whatever the patient says it is, existing whenever he says it does.” - (McCaffery, 1979)

7 !!!PAIN!!!

8 PAIN “An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” - IASP

9 PAIN Consistent pain assessment tools (VAS, 5th vital sign)Include patient report

10 Measuring Pain =

11 The face of pain

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15 “I know an addict when I see one…”

16 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

17 DEPENDENCE

18 DEPENDENCE

19 dependence

20 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

21 TOLERANCE

22 Addiction A chronic biopsychosocial disease characterized by impaired control over drug use, compulsive use, continued use despite harm and craving.

24 PseudoAddiction A drug-seeking behavior that simulates true addiction, which occurs in patients with pain who are receiving inadequate pain control.

25 Pseudoaddiction Undertreated pain conditionPatient exhibits seeking behavior These behaviors extinguish with therapeutic doses

26 Oligoanalgesia Inadequate pain management“There is oligo-evidence for oligoanalgesia.” Green SM, Ann Emerg Med ;

27 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.

28 NOCEBO Latin for "I shall harm”A harmless substance that creates harmful effects in a patient who takes it.

29 Psychogenic vs. PsychosomaticOf or pertaining to a physical disorder that is caused by or notably influenced by emotional factors. Psychogenic Pain not due to an identifiable, somatic origin and that may reflect psychologic factors.

30 C.O.A.T. Chronic Opioid Analgesic Therapy

31 Diversion Medications prescribed end up out of the patient’s possession Lost Stolen Shared Sold

32 User vs Abuser User Abuser Improved quality of lifeTakes to treat illness Improved quality of life Control – Cooperates with prescriber, abuser controls his own regimen Pattern –stable and does not include nonmedical drugs 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

33 Identifying the Abuser

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35 Consequences of inadequate analgesiaUnnecessary 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;

36 Problems with C.O.A.T. Cognitive effects Sleep/Resp DisordersGastrointestinal Effects Endocrine Effects Cardiac Effects Opioid hyperalgesia and pronociceptive effects

37 Cognitive effects Memory Deficits/Poor concentration Sleep DisturbanceFatigue Delirium Decreased alertness/Coma Emotional distress/Mood disturbance

38 Gastrointestinal effectsNausea/Vomiting Anorexia and Weight Loss Opioid Induced Constipation Not responsive to conventional laxatives in half of patients Can lead to bowel obstruction

39 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

40 Cardiac Effects Bradycardia Vasodilation Edema Hypotension SyncopeSome (methadone and buprenorphine) prolong QTc causing arrhythmia Above effects are magnified when combined with other medications (benzos)

41 Opioid hyperalgesia Same nature as dependence and toleranceIncrease in pain receptor/Opioid receptor desensitization Increased spinal dynorphin, descending central facilitation, and activation of pronociceptive glutamate

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44 Epidemiology

45 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

46 Epidemiology Decline in use of some illicit drugs in US while Rx abuse increases Misconception that prescription drugs are safe Relatively cheap Widely available

47 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

48 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

49 Epidemiology Lifetime incidence of nonmedical use of Rx meds:Pain Relievers = 13% Tranquilizers = 9% Sedatives = 4%

50 Epidemiology 2005 student survey (compared to 1995)Much less illicit drug use (33% lower in 8th, 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

51 Epidemiology 2004 physician surveyFound 43% physicians don’t routinely ask about drug abuse (except alcohol) 1/3 did not obtain patient’s previous records before Rxing controlled meds

52 Impact

53 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

54 Impact Increased scrutiny of prescriptions for controlled drugsIncreasing 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

55 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

56 Contributing Factors To abuse

57 Contributing Factors to abuseDrug Patient Clinician

58 Blame the Drug Brain rewarding (Not “Brain affecting”)Formerly withdrawal suspected to be correlated

59 BLAME THE DRUG Four major classes: StimulantsCocaine, methamphetamine, nicotine, caffeine, Rx’d stimulants Sedative-hypnotics EtOH, Benzos, Barbiturates, other hypnotics Opioids Heroin, Rx Opioids “Other” Psychedelics, dissociative anesthetics, cannabinoids, hallucinogens

60 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

61 Blame the Drug Availability also yields higher abuse potentialClinicians 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

62 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

63 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

64 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

65 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

66 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

67 Blame the Clinician The Six D’s Dated – lack up-to-date knowledgeDeceived – 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

68 Blame the Clinician Prescribing prior to obtaining complete recordConcomitantly 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

69 Rise of the Rx Rx opiate deaths surpass heroin and cocaine combined- CDC, 2011;

70 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;

71 Reducing Abuse

72 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.

73 Reducing Abuse

74 Reducing abuse – Better DrugsLower risk of addiction Pain relief without dopamine surge Lower risk of abuse Abuse deterrents Lower risk of diversion Lower quantity Injectables

75 Reducing Abuse – better drugsControlled-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)

76 Reducing abuse - Better PatientsEducation Reasonable goals Alternatives Accountability

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79 Reducing Abuse – Better patientsEducation of staff in their role as patient advocates Educate PATIENT in role as patient advocate Educate FAMILIES/FRIENDS in role as patient advocate

80 Patient with History of AddictionRisk 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

81 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

82 Dealing with Drug Abusing PatientWorking 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

83 Dealing with Drug Abusing PatientImmediate cessation of prescription if: Unsafe, out of control behaviors Altering or selling Overdose (Accidental or otherwise) Bingeing Doctor shopping Threatening staff

84 Cessation of TreatmentCease 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

85 Cessation of Treatment - ControversySupplying 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

86 Ethical ConsiderationsClinician/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

87 BETTER CLINICIANS

88 Better Clinicians

89 Alternative TherapiesMedications Alternatives TCA’s Na Channel Blockers Ca Channel Blockers Muscle Relaxers NSAIDS Antidepressants Anticonvulsants Topicals (Lidocaine, Menthol, Capsaicin) Potentiation Acupuncture Injections (Facet, ESI, etc…) Physical/Occupational Therapy Hypnosis Counseling Guided Imagery TENS unit Neuromodulation (SCS)

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91 Responsible Prescribing

92 Reducing Abuse – Better CliniciansOpiate agreements Urine drug screens Pill counts Board of Pharmacy Prescription Monitoring Program (BOP/PMP)

93 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

94 The New Patient Patient assessment Careful drug selectionClear communication of treatment plan Minimizing potential for Rx alteration Monitoring response to treatment Maintain clear/accurate records Be knowledgeable about legal/regulatory requirements

95 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

96 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.

97 Drug Selection Efficacy and Safety come first Prior responseMetabolism and excretion Comorbidities Likelihood of compliance Potential for interaction Cost Formulary availability

98 Drug Selection Dependence-producing potential of drugIs 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

99 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

100 Communicating Treatment PlanStress 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

101 Communicating the Treatment PlanPain 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)

102 Prescriptions Date Name and address of patientName, address and DEA registration of physician Number of clinician Signature Name and quantity of drug Directions Refill information

103 Prescriptions DEA number should not be preprintedForms should be tamper-resistant Spelling out quantity limits tampering Electronic prescribing with direct transmission to pharmacy may prevent transcription errors, avert tampering

104 Prescriptions Forged Rx’s often begins with a legitimate Rx formSeekers 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

105 Monitoring the PatientSubjective Symptom response – Patient log Side effects Objective Signs of intoxication/abuse Body weight Pulse Temp BP Urine/Serum levels

106 Documentation Accurate and up-to-date recordsH&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

107 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

108 Golden Rules of PrescribingScreen 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

109 Golden Rules of PrescribingDo 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

110 Conclusion Rx abuse is a major and increasing problemStems 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

111 Questions?