Setting Up Drug Screening and Abuse Criteria in a Chronic Pain Patient Medical Practice

1. Setting Up Drug Screening and Abuse Criteria in a Chronic Pain Patient Medical Practice Algos Pain Research algosresearch.org

2. Why Prescribe Narcotics? Narcotics provide a central treatment for a central issue: chronic pain. Chronic pain is not simply nociceptive in nature. Long track record of efficacy Expands the treatments from �block jock� mentality of a technician to that of a physician Pain physicians should be the experts in narcotic prescribing and serve as a resource to other physicians when chronic pain requires treatment in doses and with regimens out of the realm of the PCP

3. I. Defining Substance Abuse and Diversion

4. Consequences of Substance Abuse in Chronic Pain Death by overdose: single or multiple drugs Physician may incur legal liability via wrongful death doctrines Injury to self or others via pharmacological intoxication Pain Center becomes a �target� for drug abusers Police are on alert regarding prescribing practices

5. Substance Abuse in Pain Patients which Poses a Risk to Themselves and Others Around Them Concurrent use of other narcotics not prescribed by the physician Concurrent use of illicit drugs Taking long acting medications on a prn basis in a manner which may be dangerous (route or dose schedule) Failure to take any significant amount of the drug at all but repeatedly obtaining prescriptions for such (diversion)

6. Legal Requirements Anyone who is a DEA registrant is required by law to report to law enforcement any scheduled drug diversion. This includes prescription alteration, obtaining drugs fraudulently, use in a manner not prescribed (eg. IV instead of oral), obtaining narcotics from other people. It is not a DEA requirement to report substance abuse

7. Investigate Prior to Prescribing Opiates Physical control over narcotics and prescriptions Behavioral control over narcotics Concurrent use of illicit drugs Past history of illicit drug use Past history of substance abuse Binge drinking Age, Smoking History

8. 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.

9. Without An Opiate Tracking System Statewide, Your Options for Monitoring are Limited Urine drug screens Random pill counts Calls to state police re: specific patient illicit drug use or sale or narcotic diversion Read the newspaper HIPAA waiver Pharmacy computer tracking/insurance computer tracking

10. New NASPER Law 2005 Not a national program- it is a small federal grant to states that plan on setting up their own program with substantial federal rules of operation Not mandatory Not mandatory to share information with more than one state May be used to track physician prescribing A feckless approach to a national problem

11. Abuse Rates of Prescription Opiates 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

14. Smoking and Substance Abuse

15. 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

16. 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

18. 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).

19. Age and Risk of Substance Abuse

20. US % Illicit Drug Abuse vs. Age2002 National Survey on Drug Use and Health

21. Employment Status in Substance Abuse

22. Illicit Drug Abuse 2002 (within past 30 days) 17.4% of unemployed are illicit drug abusers 8.2% full time employees abuse illicit drugs 4.7% drive under the influence of illicit drugs in past 12 months

23. Alcohol Abuse Facts

24. US Alcohol Use and Abuse 2002 71% of those >21 years old have used alcohol within the past 30 days 51% of those>12 have used alcohol in the past 30 days 22.9% have engaged in binge drinking at least once in the past 30 days 6.7% are heavy drinkers 14.2% admit to have been DUI in past 12 months (not necessarily convicted)

25. Strongest Indicator of Drug Abuse: Past History of Drug Abuse Obtain your own records from a referring or prior treating doctor�ask where the patient is currently receiving their prescriptions. Call the office yourself for records. If patient refuses to sign a release or there are no records available (even though patient is currently receiving medications), then tell the patient to go elsewhere.

26. Detecting Substance Abuse Pill counts if there is anything suspicious about the patient�s medication use. 48 hours to bring in pills or have patient take the pills to the local pharmacy for a pill count. Pharmacy chain/insurance use history of meds Targeted urine drug screens-info patient is using illicit drugs or is selling his drugs-must do this within 24 hours Random drug screens

27. 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

28. 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

29. II. Set Up Your Rules

30. Set Up Your Rules Determine abuse criteria in advance set up through opiate agreement with patient Strongly consider psychologist intervention in potential problem patients Consider a flag system or substance abuse point system BE SPECIFIC WITH YOUR PATIENTS AS TO WHAT CONSTITUTES ABUSE

31. Key Elements in Defining Your Rules

39. Ideal Rules for the Clinic�Patient MUST Receive a Copy of These or Acknowledge They Understand the Rules

40. Downloadable Modifiable Narcotic Agreement You May Use in Your Practice

41. III. The Wages of Sin: Implementing a Measured Response to Substance Abuse

42. One Point:Substance Abuse SystemAlgos Pain Research One point: calls in early for meds due to running out early with up to 25% overuse; lost or stolen script; non-emergent physician contact regarding opiates on nights or weekends; telephone report (anonymous) that patient is selling drugs (DRUG SCREEN AND PILL COUNT IMMEDIATELY) family report that patient is impaired (Pill count)

43. Two Points: Substance Abuse System Fails to show up for procedures or PT but shows up for opiate prescribing Telephone report (identified) that patient is selling drug (must call police) Marijuana in drug screen One time episode of multiple prescribers of narcotics Overuse of meds by 50% without physician authorization

44. Three Points: Substance Abuse System Police reports patient is selling drugs Overdose resulting in hospital admission Prescription alteration Cocaine, methamphetamines, heroin, etc in drug screen Refusal to take drug screen in allotted timeframe Chronically (>2 months) obtaining narcotics from multiple prescribers Hostile or threatening behavior in order to obtain narcotics (call police: extortion)

45. Consequences Substance Abuse System 3 points in a year: no narcotics for at least a year, then may re-institute with controlled monitoring with frequent follow-up and mandatory psychology visits. If overdose, then addictionology consult is necessary. 2 points: Written warning to patient 1 point: Verbal warning

47. IV. Drug Testing: An Essential Part of a Narcotic Prescribing Program

48. Goals of Random Drug Screens Truly random- patient does not know in advance of their selection for such Assures presence of prescribed drugs (this only works if on prn narcotic medications you specifically write �maximum _ tablets per day� or �max _/day� Assures patient is clear of illicit drugs or non-prescribed drugs

50. Types of Screening Tests Urine Blood Saliva Hair Nails EMIT Monoclonal antibodies HPLC/TLC GC/MS

51. Serum Testing Useful for screening for suicide drugs eg. Antidepressants, alcohol, benzodiazepines, salicylates, acetaminophen, and barbituates. Not useful for routine recreational drug testing nor for opiate detection. Performed by hospital labs stat Many cross reacting substances Quantitative values for opiates are useless since there is a wide normal range (4 fold) for most opiate concentrations given an identical dose

52. Urine Drug Screens are Preferred AM urine specimens concentrate drugs and are more likely to be positive than afternoon drug screens Cannot detect alcohol Quantities detected have little relationship to blood levels of the drug EMIT method is insensitive for hydrocodone/oxycodone, and may not pick up synthetics at all Monoclonal antibody tests are more accurate and have specific test strips available for oxycodone and methadone GC/MS (send out) is the most accurate and will detect any interfering substances

53. Drugs to be Screened in UDS Opiate alkaloids (morphine, codeine) Synthetic opiates Semisynthetic opiates Amphetamines esp. methamphetamine Benzodiazepines Cocaine THC MDMA (ecstacy)

54. Triggers for Drug Screens Report patient is selling their drugs Report patient is taking other narcotic drugs or illicit drugs from others Reports from police patient is a dealer or illicit drug user Hyperactivity/paranoia (methamphetamine, PCP) Excessive somnolence (suspect concurrent drug use) Random

55. Detection Time After Drug Use Methamphetamine up to 2-4 days Barbituates 2-4 days unless the barbituatate is phenobaribital (detectable up to 30 days) Benzodiazepines: up to 30 days Cocaine: up to 3 days Marijuana: 30 days chronic, 7 days acute Opiates 2-4 days except darvocet that may be detected up to 30 days later.

56. Cutoff Values Set by the lab in cases of TLC, liquid chromatography, or GC/MS Set by the manufacturer for EMIT and specific drug monoclonal antibody testing Cutoff values are the 50% thresh-hold of reactivity of the test. Some patients will react at values 25% lower than cutoff, but nearly all react at 25% above cutoff levels Cutoff values for opiates needs to be 300ng/ml

57. EMIT Technology Least expensive test�costs $2-5 in the office or $15-30 for the same test in a hospital Uses test strips Very sensitive for some drugs (eg. Marijuana) but not specific Many interferences and cross-reactants Unexpected positive or negative test should be followed by GC/MS or liquid chromatography

58. Limitations of EMIT screening Multiple interferences Overlap in detection 10-30 times higher concentration (vs. Morphine) needed of semisynthetics to be detected under opiate narcotic panel Synthetics (methadone, propoxyphene, meperidine are NOT detected on routine drug screening

59. EMIT Urine Interferences Rifampin, poppy seeds, codeine cough syrup cause positive urine opiate assays Ibuprofen causes false positive for marijuana Ephedra, diet pills, cough and cold and allergy OTC drugs cause false positive for methamphetamine Valerian causes false + for benzodiazepines

60. Monoclonal Antibody Single Strip Testing Much more accurate than other dipstick methods- costs $6-12 in the office 95-98% agreement with GC/MS Cutoff values may be set lower than with polyclonal antibody testing Useful for semi and completely synthetic opiates Few interferences-bleach or alum invalidates test

61. Distribution of Morphine Reactivity For the MOR Test Strip

62. MOR300 Test Strip Cutoffs

63. Embedded Test Strips-No handling of urine. 10 test panel kits cost around $11Includes methadone, darvocet, oxycodonerapidxams.com

64. TLC Testing

65. TLC-Thin Layer Chromatography Laboratory test not available in offices More accurate than EMIT or monoclonal strips TLC is less sensitive but more specific than dipstick methods TLC is used as a confirmatory test when EMIT or monoclonal technologies are positve

66. GC/MS and HPLC/MS Far more accurate and discriminating than other methods. Uses a chromatographic separation then mass spectrography detection of drugs Interfering chemicals are not a problem Must be sent out�turnaround is usually 1-2 days�not available in physician offices Expensive-physician cost is about $75 for opiate panel alone

67. Hybrid GC/MS, Enzyme Link Method: Obligatory GC/MS for opiates Confirmatory GC/MS for all other substances Cost to the patient: $100-200

68. Limits of Detection: Set by Lab or Agency SAMSHA THC: 50 ng/dl SAMSHA Cocaine: 150ng/dl SAMSHA Morphine: 2000ng/dl SAMSHA Amphetamines: 500ng/dl The limits of detection reported by the lab may need to be changed to fit the profile and sensitivity you require- the above are too high to detect routine prescription narcotic use

69. CPT Coding for UDS 80101 times the number of enzyme or antibody linked tests. For instance a 10 panel test would be coded 80101 x 10. 80102 is used for confirmatory testing (TLC, HPLC, etc) for each class of drug confirmed) The code 80100 is to be used for hospitals and labs for chromatographic testing

70. Medicare Reimbursement Code 80101 pays $19.24 per unit as a clinical lab fee. If multiple units are billed, the reimbursement is obviously increased. Check with your local Medicare carrier on appropriate coding

71. Saliva Testing The OratectTM Oral Fluids (Saliva) Drug Screen Test is a one-step chromatographic immunoassay device for the qualitative detection of amphetamine, morphine, phencyclidine, THC (marijuana), methamphetamine, cocaine, and their metabolites in saliva. Cost $22 Patient must give sample immediately, no excuses.

72. Hair Analysis Within 5 days, drugs appear in the hair and provide a history of the drug abused as the hair grows out. An accurate history of different drug use and amounts are obtainable up to 90 days Minimum amount hair needed: 50 strands=40 mg for analysis plus GC/MS comfirmation

73. Subterfuge Methods Washout Golden seal and other substances Donated or purchased urine Artificial Penis Denaturation or contamination of sample Time delay: afternoon samples are much less concentrated than AM samples

82. Methods to Assure Compliance with Testing Immediate drug test on demand Patient escorted to lab...no drinks, cannot leave escort until entering testing area Saliva testing. Patient gives saliva sample immediately. No running water in sample room...(some systems require water to add to system for detox of sample). Use blue dye in toilet tank.