1. Controlled Substance Management or “Doctor I need Oxy”
Tony Tommasello, Ph.D.
University of Maryland School of Pharmacy
Office of Substance Abuse Studies

2. 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

3. Lawnmower Addict
L.A. is a 42 Y.O. male who broke his ankle while mowing wet grass across an incline. After several surgical attempts including failed pinning operations, his foot is rotated 60 degrees out of alignment and he has chronic pain. Prior to this injury L.A. had a history of opioid addiction. He states that he is committed to recovery and participates in 12-step N.A. meetings but he abused his last oxycodone prescription and experienced a relapse. His goal is to achieve pain relief without relapse to opioid abuse.

4. 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.

5. 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 (NHSDA, 1999)

6. Heroin Price Falls, Purity Increases 1980 through 1998
Purity (% heroin)
Purity (% heroin)
Price in $US
Price in $US
Data from U.S. Department of Justice: Drug Enforcement Administration

7. 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

8. Oxycontin 80mg sustained release tablet

9. Number of U.S. Narcotic Analgesic-Related ED Visits, 1994-2001
Source:

10. 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.
Source: The DAWN report January

11. Teen Abuse of Rx Drugs National figures
Curran JJ: Prescription for Disaster – The growing problem of prescription drug abuse in Maryland. Sept 2005.

12. Access to treatment is limited
Of the estimated 810,000 opioid dependent persons in the U.S. only 170,000 maintenance treatment slots exist.

13. The Journey Matters

14. 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.

15. 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.

16. 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

17. 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

18. Addiction Defined
Addiction is compulsive use with loss of control and continued use despite adverse consequences.

19. Elements of Compulsivity:
Constant thought of drug acquisition
Anticipation of opportunities to use
Defer other priorities of life
Unable to resist desire to use

20. Aspects of Loss of Control
Inability to use in moderation consistently
Easier to abstain completely
Frequent episodes of excessive use

21. Continued use despite problems
Loss associated with use
Multiple crisis not seen as drug-related
Sincere promises to self and others to quit

22. 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

24. The Memory of Drugs Nature Video Cocaine Video Amygdala not lit up
Amygdala activated
Front of Brain
Back of Brain
Slide 10: The memory of drugs.
This slide demonstrates something really amazing—how just the mention of items associated with drug use may cause an addict to “crave” or desire drugs. This PET scan is part of a scientific study that compared recovering addicts, who had stopped using cocaine, with people who had no history of cocaine use. The study hoped to determine what parts of the brain are activated when drugs are craved.
For this study, brain scans were performed while subjects watched two videos. The first video, a nondrug presentation, showed nature images—mountains, rivers, animals, flowers, trees. The second video showed cocaine and drug paraphernalia, such as pipes, needles, matches, and other items familiar to addicts.
This is how the memory of drugs works: The yellow area on the upper part of the second image is the amygdala (a-mig-duh-luh), a part of the brain’s limbic system, which is critical for memory and responsible for evoking emotions. For an addict, when a drug craving occurs, the amygdala becomes active and a craving for cocaine is triggered.
So if it’s the middle of the night, raining, snowing, it doesn’t matter. This craving demands the drug immediately. Rational thoughts are dismissed by the uncontrollable desire for drugs. At this point, a basic change has occurred in the brain. The person is no longer in control. This changed brain makes it almost impossible for drug addicts to stay drug-free without professional help. Because addiction is a brain disease.
Photo courtesy of Anna Rose Childress, Ph.D.
Nature Video
Cocaine Video

25. 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

26. 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.

27. Why Treatment ?
Rewards
Negative consequences
Utility Theory
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

28. 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

29. 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

30. 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

31. 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

32. Principles Physical Dependence = Addiction
Pain Management with opioids
Addiction (<3%)*
Physical dependence (common)
* Brushwood et al. (2002) Pharmacists’ Responsibilities in Manageing Opioids: A Resource APhA Special Report American Pharmacists Association.

33. Summary Differentiating factors
Motivation for use
Route of administration
Frequency of use and dose
Pseudo-addiction?
Continued use despite problems

34. Types of Pain Nociceptive Neuropathic
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

35. Pain Characteristics

36. Non-Verbal Signs of Pain
Aggressive behavior
Changes in daily activities
Facial expression
Bodily movements
Vocal
Mood
Physical Assessment Values
Change in vital signs

37. Symptom Analysis Precipitating events Palliating events Quality
Severity
Pain location and radiation
Temporal relationships
Associated symptoms
Previous treatments and their effects

38. Pain Scales
Numerical Pain Scale
Faces Pain Scale

39. 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

40. WHO-Step Ladder Severe Moderate Mild Morphine Hydromorphone Methadone
Levorphanol
Fentanyl
Oxycodone
± Adjuvants
Moderate
APAP/Codeine
APAP/Hydrocodone
APAP/Oxycodone
APAP/Dihydrocodeine
Tramadol
± Adjuvants
Mild
Aspirin
Acetaminophen
NSAIDs
± Adjuvants
Adapted from: World Health Organization. Cancer Pain Relief

41. 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”

42. With Uncontrolled Pain …
Emotional Effects
Depression, anxiety, anger
Cognitive Effects
Somatic focus, helplessness, “catastrophization”
Behavioral Effects
Inacitvity, social/sexual dysfunction, poor sleep, loss of productivity
Physical Changes
Muscle tension, poor posture, circulatory impairment, obesity
Increased PAIN and Dysfunction
PAIN

43. 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
* Gourlay et al. (2005) Pain Medicine 6(2)

44. 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.

45. CAGE 4 yes/no questions (1 yes = positive) Administered by interview
Alcohol only
Screens for abuse and dependence
Add quantity and frequency questions to screen for at-risk drinking
Sens: 43% - 94% Spec: 78% - 96%

46. Toxicology Screening Tests
Qualitative results
Purposes
To identify surreptitious use
To monitor known users
Clinical Examples
Prenatal Care
Impaired Professionals
Trauma/ER

47. 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
* Gourlay DL et al. (2005) Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine 6(2),

48. Pain Management and Addiction
Confusion over the distinction between physical dependence (a state of adaptation that produces withdrawal signs upon abrupt drug discontinuation) and addiction (DSM-IV Substance Dependence) has confounded approaches to the patient in pain.

49. Misconception regarding pain management with opioids
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%

50. Clinical Features Distinguishing Opioid Use in Patients With Pain Versus Patients Who Are Addicted to Opioids (TIP 40)
Clinical features
Pain Pt.
Addicted Pt.
Compulsive drug use
Crave drug (when not in pain)
Obtain or purchase drugs from nonmedical sources
Procure drugs through illegal activities
Escalate opioid dose without medical instruction
Supplement with other opioid drugs
Demand specific opioid agent
Cease use when effective alternatives are available
Prefer specific routes of administration
Can regulate use according to supply
Rare
Absent
Unusual
Usually No
Usually (break through pain)
Common
Frequent
Not usually
Yes

51. 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

52. 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
* Gourlay DL et al. (2005) Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine 6(2),

53. Misconception regarding pain management with opioids
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

54. 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)
TIP 43 Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs DHHS Publication No. (SMA) Rockville, Md.

55. 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
* Gourlay DL et al. (2005) Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine 6(2),

56. 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)

57. 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

58. 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

59. Federal Food Drug Cosmetic Act and the Controlled Substances Act
CSA
FFDCA
“Pain specialists may treat a chronic pain patient currently enrolled in a narcotic treatment program with narcotics. The CSA does not set standards of medical practice. It is the responsibility of individual practitioners to treat patients according to their professional judgment for a legitimate medical purpose in accordance with generally acceptable medical standards.”
P. Good (2000) Chief; Liaison and Policy Section, Office of Diversion Control DEA.

60. The Pharmacist’s Dilemma To fill or not to fill
Therapeutically Appropriate
Yes No OK
Dispense
Resolve problem (dose, route interaction)
Resolve document problem
Don’t dispense
Legally Valid

61. 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.

62. Federal CDS schedules I High abuse potential
No current accepted medical use
May be used in research
Heroin, LSD, MDMA II
Accepted medical uses
Morphine, hydromorphone, methadone, oxycodone, cocaine, amphetamines
III
Less abuse potential than I and II
Opioid combined with non-opioids, anabolic steroids, buprenorphine IV
Less abuse potential than III
Benzos, Chloral hydrate, phenobarb, fenfluramine. V
Less abuse potential than IV
Antitussives with limited amounts of codeine

63. CDS Requirements II
Signed prescriptions*; no refills; prescriber must be registered with DEA
III & IV
Written, oral, or faxed prescription; refill 5 times in 6 months; prescriber must be registered with DEA V
Written, oral, or faxed prescription; refill as authorized; prescriber must be registered with DEA
* - Emergency prescriptions require follow up prescription, Fax may be used for home infusion/intravenous therapy, long term care facility, and hospice patients

64. Model Prescription Schedule II medication
Physician name, address, and DEA number
Ralph Amado, M.D.
3862 North Hampton Lane
Rudolph, PA 38216
AA620395
Patient:
Patient name and address
Roger Bacon
1063 Eastlight Dr.
Essex, PA 38604
Drug name and strength
Dosage form and quantity
Oxycontin 20mgs
Tablets #60 (sixty)
SIG: for pain take one tablets every 12 hours.
Refill x 0 (none)
Physician signature: Ralph Amado
Date issued: 4/18/06

65. 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\

66. 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.
Brushwood DB, Hahn KL and Rickert ED (2005) Pharmacists’ Responsibilities in Managing Opioids: 2005 update. American Pharmacists Association CE Monograph

67. 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

68. 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.

69. 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

70. 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.

71. 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

72. Mechanistic stratification of antineuralgic agents
Mechanistic stratification of antineuralgic agents. PNS = peripheral nervous system; CBZ = carbamazepine; OXC = oxcarbazepine; PHT = phenytoin; TPA = topiramate; LTG = lamotrigine; TCA = tricyclic antidepressant; NE = norepinephrine; SSRI = selective serotonin re-uptake inhibitor; SNRI = serotonin and norepinephrine re-uptake inhibitor; GBP = gabapentin; LVT = levetiracetam; NMDA = N-methyl-D-aspartate; NSAID = nonsteroidal anti-inflammatory drug.
Beydoun A. Neuropathic pain: from mechanisms to treatment strategies. [Journal Article] Journal of Pain & Symptom Management. 25(5 Suppl):S1-3, 2003

73. 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

74. 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)
TIP 43 Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs DHHS Publication No. (SMA) Rockville, Md.

75. 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

76. 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

77. For Especially Sensitive Situations
Ask about friends first
Ask about prior use first
Make normalizing statements before asking questions

78. 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

79. 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

80. 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)

81. 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

82. 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

83. 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
While this process takes time – most bona fide patients will accept or welcome it because it acknowledges their need for ongoing treatment with controlled substances and provides “rules” for safe conduct with these agents. Bogus “patients” will not be willing to meet these requirements.

84. 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.

85. 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

86. 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

87. 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

88. 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

89. 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

90. 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

91. 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

92. 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

93. 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

94. Conclusions
There is no easy formula for dealing with this common yet complex area of patient care
Engage addiction specialists sooner rather than later

95. 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.

96. 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: J. Pain and Symptom Management 28(2)
Websites of interest:
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)

97. 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) 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) Rockville, Md

98. You
DEA