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Controlled Substance Management or

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Title: Controlled Substance Management or


1
Controlled Substance Management orDoctor I need
Oxy
  • Tony Tommasello, Ph.D.
  • University of Maryland School of Pharmacy
  • Office of Substance Abuse Studies
  • 410 706-7513
  • atommase_at_rx.umaryland.edu

2
Program Objectives
  • At the end of this program participants will be
    better able to
  • Screen for substance abuse
  • Assess the severity of a patients involvement
    with alcohol or illicit drugs
  • Determine the legitimacy of a patients 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 18
    - 25 (NHSDA, 1999)

6
Heroin Price Falls, Purity Increases1980 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 www.samhsa.gov/oas/2k3/pain/dawnpain.pdf
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 2003.
http//www.samhsa.gov/oas/2k3/pain/DAWNpain.pdf
11
Teen Abuse of Rx DrugsNational 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
    persons 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 18S91-S98. available at
    http//www.medsch.wisc.edu/painpolicy/

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

23
(No Transcript)
24
The Memory of Drugs
Amygdalanot lit up
Amygdalaactivated
Front of Brain
Back of Brain
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
Physical dependence (common)
Addiction (lt3)
Brushwood et al. (2002) Pharmacists
Responsibilities in Manageing Opioids A Resource
APhA Special Report American Pharmacists
Association.
33
SummaryDifferentiating factors
  • Motivation for use
  • Route of administration
  • Frequency of use and dose
  • Pseudo-addiction?
  • Continued use despite problems

34
Types of Pain
  • Nociceptive
  • 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 patients 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
Morphine Hydromorphone Methadone Levorphanol Fenta
nyl 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. 1996.
41
Patient Centered Treatment Goals
  • What would you like to do that you cant do
    because of your pain?
  • Id like to be able to do my needlework
  • Id 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 patientsTwo 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
  • Chronic
  • Acute

Gourlay et al. (2005) Pain Medicine 6(2)
107-112
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
  • Dont 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),
107-112.
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 Rare Rare Absent Rare Unusual Rare Usually No Usually (break through pain) Common Common Common Common Common Frequent Common Not usually Yes No
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
    18S91-S98. available at http//www.medsch.wisc.ed
    u/painpolicy/

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),
107-112.
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
  • Patients fear and staff reluctance may conspire
    to under-medicate
  • A patients 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) 05-4048 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),
107-112.
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
  • Dont negotiate
  • Refer to substance abuse and pain services
  • Disclose plan for prescription abuse (Pain
    management contract)

57
Drug Diverter Not a patientMedico-legal
nightmare
  • Do a thorough pain assessment
  • Document, document, document
  • First time patients who request specific agents
  • Abide by pain management ladder dont 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 Pharmacists Dilemma To fill or not to fill

Therapeutically Appropriate
Yes No
Yes OK Dispense Resolve problem (dose, route interaction)
No Resolve document problem Dont dispense
Legally Valid
61
Corresponding Responsibility Rule21 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 High abuse potential Accepted medical uses Morphine, hydromorphone, methadone, oxycodone, cocaine, amphetamines
III Less abuse potential than I and II Accepted medical uses Opioid combined with non-opioids, anabolic steroids, buprenorphine
IV Less abuse potential than III Accepted medical uses Benzos, Chloral hydrate, phenobarb, fenfluramine.
V Less abuse potential than IV Accepted medical uses 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 PrescriptionSchedule 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 physicians 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. 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) 05-4048 Rockville, Md.
75
Guidelines for Methadone Patients
  • Dont expect the patients methadone maintenance
    dose to provide analgesia
  • Continue patients 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 ClassificationsAcute 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 ClassificationsChronic
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 ClassificationsChronic
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 ClassificationsMalignant 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 drivers 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

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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 patients ability to
    make balanced decision and other complications of
    unrelieved pain

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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

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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

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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

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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

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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

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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

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PharmacotherapyGeneral 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/neuropathi
    c etiology
  • Anticipate, prevent, and treat predictable SEs
  • Constipation

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

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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.

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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 1997-202. J.
    Pain and Symptom Management 28(2)
  • Websites of interest http//www.medsch.wisc.edu/p
    ainpolicy/
  • http//www.deadiversion.usdoj.gov/
  • Brushwood DB (2002) The Pharmacists 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)
    107-112.

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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) 05-4048 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) 04-3939
    Rockville, Md

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