Opiate Narcotic Prescriptions in Pain Medicine

1. Opiate Narcotic Prescriptions in Pain Medicine Balancing Compassion with Reason MLWhitworth, MD

2. Balancing Compassion with Reason Duplicate script pad with the copy kept on the chart Write for a maximum number per day No night, weekend, holiday, or lost script refills No refills without being seen by a physician or NP Scan the arrest records of the local newspaper Drug screen mandatory and random Don’t discharge patients, simply change their therapy to non-narcotic Report all diversion, telephone calls regarding diversion, etc. to the police Never accept old records directly from a patient

3. More reasoning Absolute consequences for deviation from the narcotic agreement If UDS is + for opiates you are not prescribing, is - for opiates you are prescribing, or is positive for illicit drugs, recommend a substance abuse treatment center and discontinue narcotics….KNOW YOUR UDS LIMITATIONS Require the patient to obtain a lockbox at home and have the patient obtain a labeled days supply bottle Strongly consider the use of a NP: they pay for themselves many times over Policies should be inflexible and known to the patient before prescribing narcotics Incorporate a consent form for narcotic treatment into the policy to be signed by the patient

4. Narcotic Analgesics in Chronic Pain: Basic Principles Abuse potential is very high: adequate screening and monitoring are mandatory May be appropriate for patients when used in conjunction with other therapies Should not be used as a sole agent of pain relief NO TOLERANCE RULES Once more than 3 dosings of a short acting med is reached, consider conversion to a longer acting drug

5. Chronic Pain Patient Substance Abuse Rates 34% abuse rate in chronic pain population Clin J Pain 1997 Jun;13(2):150-5 Prescription opiate abuse is seen in 24-33% of chronic non-cancer pain patients J Gen Intern Med 2002 Mar;17(3):173-9 Use of opioid medications for chronic noncancer pain syndromes in primary care. Prescription narcotic abuse is seen in 25% of a chronic pain clinic population Pain Physician 2001 July 24% of spinal cord injury patients report abusing prescription abusable drugs Int J Addict 1992 Mar;27(3):301-16 50% of chronic headache patients had abuse of narcotics over a 3 year period."Patients used medications inappropriately, received them from more than one physician, tried to fill prescriptions early, or claimed to lose them and requested more than prescribed.” Neurology. 2004;62:1687-1694

6. Pros and Cons of Opiate Prescribing Opiates provide a bridge between short term interventional nociceptive origin therapies Vast majority have no substance abuse issues Provides better function Systemic approach to a systemic disease Habituation, substance abuse, overdose, diversion are real issues Chronic pain population is often indistinguishable from drug abuse population Monitoring and compliance require significant resources

8. Opiates Should Rarely Be Used as the Sole Agent to Treat Chronic Pain Tolerance considerations Lack of addressing other important receptors/systems Amplifies psychological dependence on narcotics Functional rehabilitation Injection therapy Neuromodulation Psychological aberrancies Secondary Gain

9. Therapies Used in Conjunction with Narcotics Spinal diagnostics including precision spinal injection diagnosis and therapy Implanted intrathecal opiates/SCS Minimally Invasive spine surgery: Endoscopic spine surgery Opiate Assessment and Management Non-narcotic Therapies Psychological Intervention Functional Rehabiliation

10. Models of Narcotic Use in Current Pain Practice No narcotics....go see your family doctor Minimal narcotics only around procedure times Short term narcotics during course of interventional treatment Long term narcotics prescribing with interventionalist providing such Long term narcotics with psychology, PT, and social work involvement (University)

11. Permissiveness in Prescribing Opiates Promulgated by early 1990s pain physicians No well constructed studies at the time to evaluate chronic pain abuse potential Early studies did not objectively evaluate substance abuse: relied on self-eval AAPM, APS, FSMB Statements JCAHO Standards for Pain 2001 Patients Bills of Rights State Pain Laws Forums and Internet Associations

12. License to Drug Patients Freely Very aggressive marketing by some manufacturers for off label uses Unlimited marketing of medications direct to patients and to many physician groups. Emphasis on safety of the drugs rather than on monitoring of patients or abuse potential Neophyte pain physicians deluded into believing non sequitur drug studies

13. . Evidence of diversion include selling prescription narcotic drugs, forgery in order to obtain prescription narcotics, stealing or borrowing drugs from another person. Substance abuse and addiction are catagorized by obtaining narcotics from a non-medical source, obtaining narcotics from overseas pharmacies through the mail, injecting oral formulations, multiple episodes of prescription loss or theft, concurrent abuse of illicit drugs, multiple dose escalations despite warnings against this behavior, repeated episodes of gross impairment or dishevelment, obtaining narcotics chronically from multiple medical providers simultaneously, concurrent use of alcohol with chronic narcotic therapy, non-iatrogenic overdose resulting in intubation, DUI, obtundation, ICU admission, or endangerment of a family member or society through their actions. Second line indicators include histrionic behavior, drug hoarding, aggressive complaining, requesting specific drugs, unsanctioned drug dose escalation once or twice, occasional mild impairment, or unapproved use of a drug to treat other symptoms.

14. Rule #1 Prescribing in a Balanced Pain Management Program:Lay Down the Rules for Narcotic Prescribing Before Treatment Begins

15. Narcotic Rules..Patient Should Sign a Statement They Understand These Rules (Our Policy is Included as a Modifiable Word Document on this CD) Refills only during scheduled appointments No mailed prescriptions or prescriptions called in to pharmacies Patient is completely responsible for acquisition and safekeeping of the medications Diversion or extortion will be reported to the police Overuse of narcotics is not tolerated by our practice No doctor shopping, no lying about present or past history Reasons for withdrawal or modifications spelled out

16. Rule #2: Never Violate Rule Number 1

17. Rule #3: Narcotics Should Only Very Rarely Be Used as the Sole Active Treatment Modality

18. Rule #4: The Use of Interventional Techniques Must Be With The Understanding That Increasing Opiates Will Not Be Possible Immediately After A Procedure

21. The Interplay Between Illicit Drugs, Alcohol, Tobacco and Prescription Drug Abuse: Risk Factors The patient who takes illicit drugs or who engages in alcohol abuse is very high risk for prescription drug abuse Patients with these disorders will rarely tell the truth regarding the presence of these issues Past substance abusers try to hide their substance abuse by withholding medical information or by altering records

22. Should Patients Who Unwilling to Follow Federal and State Laws Regarding Illicit Drugs Be Prescribed Narcotics?What makes us believe these patients will follow our rules regarding narcotics?

23. US Illicit Drug Use Past Month in 2003

24. In 2003, there were 22 million Americans who met criteria for needing treatment for drugs or alcohol but only 1.9 million received treatment

25. Of the 20+ million Who Met Criteria for Needing Treatment for Drug/Alcohol Abuse, 95% did Not Think Treatment Needed

26. Reasons Given for Not Seeking Treatment for Drug or Alcohol Abuse

27. Lifetime Prescription Narcotic Non Medical Substance Abuse

28. Mental Illness Has a Direct Correlation to Alcohol and Drug Abuse

29. US Illicit Drug Use vs EmploymentNSDUH 2003

30. Alcohol Abuse in Americans 2003

31. % DUI Alcohol vs Age 2003

32. Drug Abuse vs. Race 2003

33. Reality Check 4.9% of the population age 12 and older will have abused prescription narcotics in the past year, half of these have abused prescription narcotics in the past month. The claims of 0.1% or less abuse of prescription narcotics are ludicrous

34. % of Population Engaging in Substance Abuse Past Year (US 2003)

35. % of Population Engaging in Substance Abuse Past Year sans Marijuana (US 2003)

36. Is Smoking One Indicator of Potential Prescription or Illicit Drug Abuse? Smoking is a form of legalized drug addiction with associated addictive behaviors 23% of the population smokes daily (US) Smoking has a definite association with degenerative disc disease and low back pain in numerous studies 69% of my pain population smoke compared with 28% for the state. Patients averaged 17 years of smoking before the onset of chronic pain

38. J Addict Dis 2002;21(2):35-54 To smoke or not to smoke: impact on disability, quality of life, and illicit drug use in baseline polydrug users. Stable everyday smoking was strongly associated with increased probability of positive urine tests for illicit drug use. Smoking, but not illicit drug use, was associated with increased disability and higher disability scores on SF-36

39. A population-based study of cigarette smoking among illicit drug users in the United States. Addiction 2002 Jul;97(7):861-9 Seventy-one per cent of recent illicit drug users smoked cigarettes at least once in the past month. Their adjusted odds of being a smoker were much greater than for the general population (OR = 3.07, P < 0.0001). Odds of being a smoker were higher for poly- versus monodrug users (OR = 2.35, P=0.0020) and rose with increased drug use (OR = 1.36, P=0.0374).

40. Narcotic Abuse vs Dependence Dependence on narcotics for medical purposes is no more abuse than a diabetic who depends on insulin for treatment of their condition Tolerance, esp. at higher doses of narcotics, is a frequent outcome of opiate prescribing but is not abuse Abuse is a behavioral issue in which the patient has lost control of the drugs

41. Substance Abuse Characteristics Denial is the patients first and often consistent response to concerns regarding abuse, even when incontrovertible evidence is presented Family members will often recognize a problem with abuse long before the patient or physician

42. RED FLAGS Patients come from hundreds of miles often from several states to see you for primarily narcotics while bypassing many other pain physicians. You are NOT that good of a physician to warrant that type of treatment...it is not exclusively available by you, and therefore you must question the patient motives.

43. RED FLAGS Initial Visit-Do NOT Treat with Narcotics No available prior medical records Will not divulge name or sign information release for prior physician’s records Refuses all psychological, physical therapy evaluations and interventional techniques Needle track marks, skin pop marks History of selling narcotics, forging prescriptions, manufacture of methamphetamine or other illegal drugs

44. RED FLAGS- Established Patient. Withdraw Narcotics Immediately Multiple lost/stolen scripts or medications Positive drug screen for cocaine, methamphetamines, schedule II drugs not prescribed Negative drug screen for prescribed controlled release medication Multiple physicians routinely prescribing opiates Diversion or sale or prescription alteration

45. Yellow Flags-Place On Watch List Frequent telephone number and address changes Asks for specific brand name Multiple “allergies” or side effects cornering the physician into few choices Fails to keep one appointment or fails to call in advance with a legitimate excuse if the appointment was interventional Lost or stolen script or drug x 1 Concerns expressed by other MD, PT, etc.

46. Yellow Flags: Change Therapy Increase frequency of visits and concommittantly lower the quantity of narcotics prescribed with each visit when patient is having trouble controlling drug, has exhibited sedation or being “zoned” in the office or to family, or when there is a history of past drug abuse Calls from family or friends regarding sale of narcotics should prompt a call to the local police and increase frequency of visits

47. Narcotic Pre-prescribing Questionare to Predict AbuseAnesthesiology News in March 1999, predicts with an accuracy of 92%, the probable presence of narcotic addiction. 1.Does the patient believe that he/she is addicted to opioid narcotics? 2.Does the referring physician believe that the patient is addicted to opioid analgesics? 3.Does the patient have more than one prescription provider, (including doctors, dentists, and emergency room physicians? 4.Is there a pattern of the patient calling in for early refills of prescriptions? 5.Is there a pattern of increasing dosage or frequency?

48. Narcotic Abuse Screening Questions 6.Does the patient report using narcotics for symptoms other than those for which the drugs have been prescribed, (anxiety, insomnia or depression)? 7.Does the patient save/hoard unused medication or have partial bottles of narcotics at home? 8.Does the patient report supplanting narcotics with alcohol, cocaine or psychotropic drugs like carisprodol, (Soma), or benzodiazipines? 9.Does the patient have requests for favorite drugs or routes of administration? 10.Is there a pattern of the patient making frequent emergency room visits for pain control?

49. Narcotic Abuse Screening Questions 11.Has any medical professional limited care or expressed concern about addiction and refused further prescriptions? 12.Have family members expressed concern about the patient abusing narcotics? 13.Is there a family member interacting with the patient with overly concern about pain or withdrawal preventing stopping the use of opioids. 14.Have family members or friends obtained opioids for the patient? 15.Has the patient ever taken drugs prescribed for family members or friends?

50. Narcotic Abuse Screening Questions 16.Does the patient have a history of drug or substance abuse? 17.Has opioid detoxification been attempted in the past? 18.Does the patient report the necessity for regularly spaced doses of narcotics over extended periods of time? An opioid addict/substance abuser will answer negative to all the above, therefore you must EXAMINE PRIOR MEDICAL RECORDS

51. Narcotic Addicts vs Pain Patients in a Methadone Treatment ProgramJ Pain Symptom Manage 2000 Jan;19(1):53-62 Pain patients reported significantly more health problems (P < 0.001), psychiatric disturbance (P < 0.05), prescription and nonprescription medication use (P < 0.001), and greater belief that they were undertreated (P <0.001); 44% of those with pain believed that opioids prescribed for their pain had led to an addiction problem. Narcotic addicts reported they used alcohol or narcotics to make them feel normal

52. Why require my patients to undergo drug screening since there hasn’t been a problem with drug abuse in my practice?

53. Answer: Because there statistically is a substance abuse problem in the medical practice of a pain physician. We cannot hope to serve as stewards of prescription narcotics unless we look at narcotic abuse.

54. Myths and Facts Myth: “I believe my patients when they say they hurt therefore I do not feel the need to perform drug monitoring of their urine” Fact: Not all patients really have chronic pain and even those who do will lie to their physicians about substance abuse. 111 patients in a pain practice; random drug screens; 50.5% had other non-prescribed narcotics, illicit drugs, or alcohol; 25% had negative screen for drugs prescribed. J Pain Symptom Manage 2000 Jan;19(1):40-4

55. Clin J Pain 2002 Jul-Aug;18(4 Suppl):S76-82 Role of urine toxicology testing in the management of chronic opioid therapy. Katz, et al. Self-report of drug use, prescribed or otherwise, among patients with chronic pain treated with opioids is often unreliable. Patients may inaccurately report use of prescribed medications, fail to report use of nonprescribed medications or medications prescribed by other physicians, or fail to report use of illicit drugs. Urine toxicology testing may reveal the presence of illicit drugs, such as heroin or cocaine, or controlled substances not prescribed by the physician ordering the test

56. Myths and Facts about Opiates Myth: Patients should be given whatever dose necessary to achieve pain relief Fact: Rapid tolerance develops dependent on the dose given: 100% pain relief may mean rapid development of tolerance GenPharmacol1991;22(6):1033-42

61. Other Myths Regarding Prescription Opiates Myth-Patients in pain have a 9 times higher suicide rate compared with the normal population, and therefore the physician has an obligation to give narcotics to relieve the pain. Fact- Since the incidence of pain increases with age, it would follow that the suicide rate would increase with age, yet it does not. Also, there is no medical evidence of such a large suicide rate in pain patients

64. Suicide and Chronic Pain In a study of elderly patient suicide, 76% were known to suffer from depression, 34% from poor physical health Int J Geriatr Psychiatry. 2002 Mar;17(3):261-9. A study of 204 chronic pain patients revealed 50% had inadequately treated pain, 50% had contemplated suicide, 44% used less medication than prescribed J Pain Symptom Manage 1994 Jul;9(5):312-8 These results imply that inadequate narcotic availability was not a reason for suicide and that depression is the single major factor in suicide (not lack of narcotics).

65. More Myths and Facts Myth: The patient who complains of pain and exhibits increased drug seeking behavior when given opiate narcotics has pseudoaddiction phenomenon. Fact: Several animal studies demonstrate increased sensitivity over baseline when given chronic morphine, methadone, or fentanyl. This is termed “narcotic induced hyperalgesia”

66. Opiate Induced Hyperalgesia Several animal studies demonstrate hyperalgesia with chronic opiate dosing J Neurosci 2002 Sep 15;22(18):8312-23, Anesthesiology. 2000 Feb;92(2):465-72 Anesthesiology. 2002 Feb;96(2):381-91 Clinical studies confirm this effect Drug Alcohol Depend 2001 Jul 1;63(2):139-46, Effect can be blocked by NMDA antagonists Neuroplasticity can induce permanent changes with opiate administration Closely related to tolerance and dependence

67. Opiate Induced Mu and NMDA Receptor Activation: Clinical Effect is Summation of These

68. Clinical Correlates: The higher the dose used, the more narcotic induced hyperalgesia will occur and the more withdrawal symptoms will predominate once the mu activity wanes What we see as “drug seeking behavior” or “substance abuse” may be due to our lack of understanding of the clinical effect of the drug pharmacokinetically

70. Oxcodone Plasma Levels After a Single Dose Oxycontin 80mg:The Truth behind Oxycontin when Plotted Correctly Linear:Linear Scale

71. Significant Opiate Side Effects Hypersomnolence causing automobile crashes and cigarette induced fires Hypotension from nausea and vomiting Slurred Speech, inability to understand or control usage of narcotics Overdose resulting in Death, anoxic brain damage, or intubation with protracted ICU stay. In the year 2000-2001, Oxycontin produced deaths from 32 states exceeded 400 people

72. Issues of Concern to Physicians Drug Diversion by patients: The use of a narcotic for a non-medical purpose, sale, or trade of a narcotic. Opiate narcotic abuse: Federal law precludes further prescribing of opiates once addiction has been identified Illicit substance use: Some medical boards take the position that physicians knowingly continuing to prescribe narcotics for pain control to those using illegal drugs are in violation of medical standards of care

73. The Wages of Sin: Or How to Become a Drug Pusher with MD After Your Name Inadequate initial patient evaluation Inadequate patient follow up Failure to monitor patients for addiction Large numbers of patients who are being treated only with narcotics Treating addicts with narcotics unless the patient is enrolled in a drug treatment program

74. National Standard Used by the DEA: FSMB Guidelines Adopted 1998 by FSMB Ratified by 43 state medical boards or codified into law Endorsed by the DEA 1998, NASCSA, JASON, several other organizations Indiana is one of only 7 states which has no policy or regulations on the prescriptions of opiates for pain management. The ISMA opposes the consideration of adoption of guidelines (2002)

75. FSMB Guidelines 1. Evaluation of the Patient: A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

76. FSMB Guidelines 2. Treatment Plan: The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of eachpatient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

77. FSMB Guidelines 3. Informed Consent and Agreement for Treatment The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient’s surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including urine/serum medication levels screening when requested; number and frequency of all prescription refills; and reasons for which drug therapy may be discontinued (i.e., violation of agreement).

78. FSMB Guidelines 4. Periodic Review: At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician’s evaluation of progress toward stated treatment objectives, such as improvement in patient’s pain intensity and improved physical and/or psychosocial function, i.e., ability to work, need of health care resources, activities of daily living and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans.

79. FSMB Guidelines 5. Consultation: The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangement pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with or referral to an expert in the management of such patients.

80. FSMB Guidelines 6. Medical Records: The physician should keep accurate and complete records to include the medical history and physical examination; diagnostic, therapeutic and laboratory results; evaluations and consultations; treatment objectives; discussion of risks and benefits; treatments; medications (including date, type, dosage and quantity prescribed); instructions and agreements; and periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review.

81. FSMB Guidelines 7. Compliance With Controlled Substances Laws and Regulations: To prescribe, dispense or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.

82. Punitive Actions Against Physicians Most punitive actions are taken by state medical boards against physicians The DEA often refers cases to the medical boards if there is substandard care being rendered without a systematic evidence of widespread diversion or abuse by a given physician DEA concentrates on diversion cases, tips from law enforcement, undercover agents The absolute amounts of drugs prescribed are usually not a significant factor in and of themselves

83. Key Features in Recent DEA Cases Against Physicians Drug mills with very short visit times (inadequate follow up), failure to monitor or address addiction, inadequate records, reputation as a drug mill, undercover cameras during physician encounter Large prescription amounts or frequent large prescriptions for the same patient in conjunction with one of the above

84. 2001-2003 7 doctors in Eastern Kentucky pleaded guilty or were convicted of felonies for prescribing without a legitimate medical reason: David Proctor pleaded guilty April 29,2003 Joseph Tally, MD North Carolina was charged with 24 counts of prescribing without adequate exams or records in 2002 Dr. Franklin J. Sutherland, 46, was convicted of 430 counts of prescribing narcotics without legitimate medical purpose and faced life imprisonment in Virginia 2001 Hurowitz MD in Virgina gave up his practice after years of legal battles of federal and state authorities because of his narcotic prescribing (2002) Frank Fisher, MD California was convicted of manslaughter in 1999 for prescribing narcotics to 5 people who overdosed and died Dudley Hall, MD Bridgeport, CT charged with 36 counts of overprescribing James Graves, MD of Florida was convicted of 4 counts of manslaughter for overprescribing Oxycontin in 2001

85. Medical Responsibility Physicians prescribing potent opiate narcotics have the same duty to monitor their patients as do physicians treating diabetes or those on prophylactic coumadin. Pain centers, with their potentially much higher prescribing levels of opiates may engender a lower threshhold for substance abuse criteria than would a typical primary care physician office because the potential consequences of abuse in such a situation are much worse.

86. Strong Indicators of Diversion (Felony-Must be Reported) Prescription alteration- contact police Stolen scripts-contact police Patient family state patient is selling-contact police or sheriff Anonymous tips patient is selling-still must contact police

87. Strong Indicators of Substance Abuse Lost or stolen scripts when patient is aware of clinic rules and patient is insistent on receiving refills UDS: Any positive illicit drug, any positive narcotic you are not prescribing, negative for drugs you are prescribing (Assumes GC-MS analysis) Injection of oral preparations, crushing Oxycontin for oral use, snorting oral preparations Unsanctioned escalation of narcotics Calls on nights and weekends for drug refills Using multiple physicians to obtain narcotics Obvious withdrawal sx, dark glasses, extremely anxious

88. Russell Portenoy “The difference between a patient with opioid addiction and a patient who is dependent on opioids for chronic pain is simple. The opioid-dependent patient with chronic pain has improved function with his use of the drugs and the patient with opioid addiction does not.” “The presence of pain does not mean a deficit of narcotics”