The Emerging Epidemic of Prescription Drug Abuse Causes, Prevention

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The Emerging Epidemic of Prescription Drug Abuse
Causes, Prevention Treatment

• Friday, May 6,2005
• Hazelden Springbrook Conference
• Honolulu, Hawaii

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• Knowledge
• Skills and Tools
• Attitudes
• 3 components
• Cognitive
• Beliefs
• Affective
• Feelings emotion
• Conative
• Decision behavior

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Overview

• Pain Drug Abuse
• Prescription drug abuse
• Medication factors
• Patient factors
• Physician factors
• Prevention and Management of chronic pain and
  drug abuse

4
Changing Opioid Opinions

• The use of narcotics in terminal cases is to be
  condemnedmorphine use is an unpleasant
  experience undesirable side effects. Dominant
  on the list of these unfortunate effects is
  addiction.
• American Medical Association Consensus Paper,
  1940
• Reiderberg MM, Lancet 3471276, 1996. Barriers
  to controlling
• pain in patients with cancer.

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Opioid Opinions

• Morphine, Gods own medicine W.Osler M.D.
• We must all die. But that I can spare a person
  from days of torture, that is what I feel is my
  great and ever new privilege. Pain is a more
  terrible lord of mankind than even death itself.
  A. Schweitzer, M.D.
• Everything one does in life, even love, occurs
  in an express train racing toward death. To smoke
  opium is to get out of the train while it is
  still moving. It is to concern oneself with
  something other than life or death.Jean Cocteau

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Changing Opioid Opinions
JACHO Guidelines 2000

• Mandate pain assessment and treatment
• Nurse and physician education required
• Pain as the fifth vital sign

7

• Jury awards 1.5 million to San Francisco mans
  family
• ( June, 2001)

Judgment against physician for failing to provide
adequate pain medication to terminal cancer
patient.
8

• Physicians told not to feardiscipline for pain
  treatment

amednews.com The Newspaper for Americas
Physicians, June 16, 2003
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• Strong Opioid Consensus
• Use aggressively for severe acute pain
• Use aggressively for terminal pain (cancer, AIDS)
• Trial for severe CNMP
• clear diagnostic basis
• supportive objective findings
• disease has a record of response when other
  therapies ineffective ( i.e. arthritis,
  pancreatitis)
• Weak or No Opioid Consensus
• Use in less well-defined syndromes (CRPS, PPS,)
• Use in pain syndromes with moderate pain and
  complex psychosocial components ( FM, LBP)

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Reasons for Inadequate Analgesia

• Lack of suitable knowledge base
• Inhibitory influence of regulations
• Adherence to customary prescribing practice
• Cultural and societal barriers
• Unconscious bias towards certain groups
• Fear of drug abuse, dependency, addiction

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Addiction-phobia

• The public a strong negative attitude
• 87 fearful of becoming over reliant on pain
  medication
• 82 concerned about addiction, 41 believe
  physicians over prescribe
• 50 dont believe acute or chronic pain can be
  significantly relieved
• The Patients
• Reluctant to report pain and use analgesics,
  concerned with addiction, adverse effects,
  injections, tolerance, Good patients dont
  complain, pain is inevitable
• RNs estimate of addiction off by 500
• 76 believed 5of patients would become
  addicted after 3 months of continuous opioids
• Physicians
• Fear of regulatory scrutiny, reputation as drug
  doctor
• Adverse effects difficult to manage
• Scant education and thin pain network

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Addiction in Pain Patients The Facts

• 7 of 24,000 pain patients became addicted
• Friedman DP Perspectives on the medical sue of
  drugs of abuse. J. Pain Symptom Manage (Suppl
  1) S2-5, 1990
• 4 of 11,882 pain patients became addicted
• Porter J, Jick H Addiction rare in patients
  treated with narcotics, N Engl J Med 302123,
  1980
• 0 of 500 patients receiving heroin for pain
  became addicted
• Twycross RG Clinical experience with
  diamorphine in advanced malignant disease. Int J
  Clinical Pharmacol 9184-198, 1974
• 0 of 10,000 burn patients became addicted
• Perry, Heidrich, Pain 1982
• 300 CNMP pts opioid responsive, abuse - 4
• Taub A., In Kitahata LM, Collins, D. eds.
  Narcotic Analgesics in Anesthesiology. Balt. Md.
  Williams Wilkins, 1982129-208
• Iatrogenic addiction for persons with no history
  of addiction is less than 1
• Principles of Addiction Medicine, Second Edition.
  Grahm WG, Schultz TK, Editors. 1998 p914

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The Disconnect

• The rare patient who abuses or becomes addicted
  to prescription drugs may account for inordinate
  levels of concern, time and energy on the part of
  the physician and office staff.
• This sets the stage for not going down that
  road for legitimate pain patients. And the
  paradox of over-prescribing to substance
  abusers leads to under-prescribing for pain.

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The Emerging Epidemic of Prescription Drug Abuse

• Increased rates of non-medical use
• 8 of 12-17 year-olds in last year
• 15 of 18-19 year-olds in last year
• 12 of 18-25 year-olds in last year
• 2002 6.2 million Americans used prescription
  drugs non-medically

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Other Indicators of the Problem

• 72 of ED multi-drug related visits included a
  prescribed controlled drug (2001)
• 1994-2001 increase in ED drug visit mentions
• Hydrocodone 131
• Morphine 210
• Methadone 230
• Oxycodone 352
• Heroin, ice, cocaine and club drugs rank below
  non-medical use of prescribed drugs

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DEA Production Quotas,1990-2000

• Morphine 300
• Hydrocodone 500
• Hydromorphone 600
• Oxycodone 1200
• Fentanyl 1700

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Is this really a new problem?

• 1 in 200 Americans either cocaine or
  opium addicted
• 2003 hydrocodone 1 prescribed
  drug in America

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.poppy fields

• .

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.where poppies grow

• .

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Drug
2003 Rx
Revenue

• Hydrocodone 74-84M
• Lipitor 69M 6.7B
• Synthroid 49M
• Norvasc 36M
• Zoloft 33M 2.9B
• Toprol XL 30M
• Zocor 29M 4.9B
• Prevacid 28M 4B
• Amoxicillin 27M
• (Others in the top 130 Xanax, Ambien, Ativan,
  Klonipin, Soma
• Valium, oxycodone, Oxycontin, Darvocet, Ultracet,
  Concerta, Adderal)

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Prescribed Opioids In Hawaii(Source K. Kamita,
Chief, NED, State of Hawaii. 11/7/03)

• Drug
• APAP/hydrocodone
• Tussionex
• Endocet
• OxyContin
• Morphine sulfate
• Methadone

• Prescriptions
• 2,310,398
• 564,258
• 561,658
• 506,408
• 335,502
• 326,446

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Balance

• Pain and Symptom Relief vs. Abuse
• The majority of patients who misuse or abuse
  controlled substances have underlying substance
  abuse controlled substances are virtually never
  abused by a patient who lacks risk factors for
  chemical dependency.

Paradigm Shift Treat pain adequately, screen all
patients for substance abuse risk, and avoid
controlled substances in at risk patients.
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Pain

• ALL pain has 3 components
• Sensory
• Emotional
• Cognitive

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Types of Pain

• Acute less than 3 months duration
• Chronic more than 3 months duration
• Nociceptive somatic/visceral, intact pathways
• Neuropathic damage to neural structure
• Malignant(cancer) or Non-malignant
• CNMP Chronic Non-malignant Pain

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Physician Goals for Pain Rx

• Acute Pain
• Relieve pain, avoid AE until patient heals
• Malignant Pain
• Relieve pain, limit AE, until patient passes
• CNMP (chronic non-malignant pain)
• Reduce pain, improve function, reduce reliance on
  drugs, limit AE, teach/assist the patient to
  manage and live with their pain

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Common CNMP Co-Morbidities

• Anxiety Disorder ( 3 of 6)
• Restless/on edge
• Fatigue
• Difficulty concentrating
• Irritable
• Muscle tension
• Sleep disturbance
• Depression (5 of 9)
• Depressed mood
• Diminished interest or pleasure
• Insomnia or hypersomnia
• Psychomotor agitation or retardation
• Fatigue/loss of energy
• Diminished ability to think/concentrate /
  indecisiveness
• Thoughts of death
• Insomnia
• Primary or secondary
• Associated with anxiety and depression

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CNMP Treatment Modalities

• Non-pharmacologic
• Psychologic
• Pharmacologic
• Interventional
• Hygenic Ask your Grandmother

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CNMP Non-Pharmacologic Rx

• Thermal Modalities
• Ice, cold and hot packs, ultrasound,diathermy
• Peripheral Counter-stimulation
• TENS, Vibration, Topical aromatic applications
• Manual Therapies
• Massage, manipulation, myofascial release
• Active Movement
• Stretching, conditioning, strengthening, PT
• Orthotics
• Splints, braces, positioning aides (pillows,
  lifts)
• Any others? Your favorites?

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CNMP Psychologic Interventions

• Deep relaxation (and relaxation response,
  meditation)
• Biofeedback
• Cognitive-Behavioral Therapy
• Guided Imagery
• Treatment of associated mood disorder
• Family/relationship therapy
• Functional rehabilitation
• Any others? Favorites?

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CNMPInterventional Medicine

• Blocks Epidural, nerve, ganglion, celiac p.,
  sympathetic
• Spinal cord and peripheral nerve stimulators
• Intrathecal infusion pumps
• Trigger point and intra-articular injections
• Surgery Fusion, discetomy, other
• Botox
• Rhizotomy
• Etc., etc.
• Have you had success with these? Problems?

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CNMP Pharmacologic Rx

• Non-opioid, non-controlled
• Analgesics NSAIDs, acetaminophen
• Adjunctives antidepressants, anti-convulsants,
  corticosteroids, neuroleptics, NMDA Blockers,
  Alpha-2 adrenergic agonists, muscle relaxants,
  drugs for sympathetically maintained pain, oral
  local anesthetics, GABAergics, caffeine
• Topicals capsaicin, EMLA, Lidoderm, ketamine
• Your favorites from each class above?

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CNMP Controlled Drugs

• Opioids
• Morphine, hydrocodone, oxycodone, tramadol,
  codeine, propoxyphene, fentanyl, methadone, LAAM,
  butorphanol (Stadol), pentazocine (Talwin),
  naltrexone, naloxone, buprenorphine
  (Subutex/Suboxone)
• Sedative-Hypnotics
• Alcohol, Xanax, Valium, Klonipin, Ambien, Sonata,
  butalbital (Fioricet, Esgic), carisoprodol/meproba
  mate (Soma)
• Stimulants
• Adderal, Ritalin, Concerta, Medidate, Focalin,
  Dexedrine, Desoxyn,, Cylert

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All Controlled Substances

• Scheduled by DEA, FDA (why?)
• Increase dopamine activity
• Positive reinforcement
• Can cause compulsive self-administration
• Habit forming (dependence)
• Abuse potential (misuse, abuse, addiction)
• Significant risk of abuse if prescribed to a
  patient with underlying chemical dependency, or
  risk factors for CD

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Commonalities Licit and Illicit Drugs

• Psychoactive potential
• Cause acute psychomotor effects
• Reinforcement potential
• Decrease negative symptoms
• Increase positive symptoms
• Tolerance and withdrawal potential

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Factors Influencing Abuse Potential

• Rapid onset
• Xanax vs. Tranxene
• High potency/intensity
• Dilaudid vs. Darvocet
• Brief duration of action Actig vs. MS Contin
• Purity/Water soluble MS vs. Anexia
• High volatility (smokable)
• Brand name Vicodin vs. HC/APAP

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OpioidsIllicit vs. Prescription
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StimulantsIllicit vs. Prescription
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Sedative/HypnoticsOTC vs. Rx
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Definitions

• Dependence
• Tolerance
• Misuse
• Abuse
• Addiction
• Pseudo-addiction
• Detoxification vs. Medical Withdrawal
• Term-merge misuse, abuse, addiction

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Physical Dependence

• Neuroadaption, manifested by a withdrawal
  syndrome
• Withdrawal produced by
• abrupt cessation, rapid dose reduction,
  decreasing bioavailability, antagonist
• An expected occurrence with the continuous use
  of controlled substances for days.
• Does not indicate addiction, and is not directly
  related to the development of abuse or addiction

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Physical Dependence Therapeutic Dependence

• Therapeutic Dependence
• Patients taking opioid drugs for the relief of
  pain are using them therapeutically they do not
  seek psychic effects as do individuals who may
  misuse, abuse or take drugs addictively.
• Portenoy RK Opioid therapy for chronic
  non-malignant pain current status. In Fields
  HC. Liebeskind JC Progress in Pain Research and
  Management, Vol 1, pp247-287, Seattle, 1994, IASP
  Press
• Problems Arise
• when opioids are not tapered as pain resolves,
  or are inappropriately withheld

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Dependence

• May compel a patient to seek drugs for relief of
  withdrawal, even when pain has resolved. This
  does not indicate addiction.

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Tolerance

• Higher or more frequent dosing to achieve the
  initial effects of the drug, usually stabilizes
  quickly
• Neuroadaption to continuously administered
  opioids
• Occurrence variable, not always linked with
  dependence
• Tolerance to non-analgesic effects beneficial
• Analgesic tolerance rarely the cause for dose
  escalation
• Dose escalation usually indicates disease change
• Inreased pain sensitivity 2nd to opioids may be
  factor
• Tolerance does not imply addiction, and is not
  directly related to the development of abuse or
  addiction.

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Misuse, Abuse

• Misuse
• Using the medication for something for which it
  was not intended
• Abuse
• Recurrent or continued drug use leading to
  impairment/distress

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Misuse? Appropriate Care?

• 43 year-old woman with fibromyalgia, breast
  cancer in remission, she copes better with
  current meds. Works full time. No tobacco, no
  alcohol, married with 3 school-age children.
  NKDA. Meds Tamoxifen OTC NSAIDs
  SSRIKlonipin 1mg qhs and Vicodin 10/500 4/day x
  3 y.

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Addiction

• A primary, chronic, neurobiologic disease, with
  genetic, psychosocial, and environmental factors
  influencing its development and manifestations.
• Addiction is a brain disease, expressed as
  behaviors.

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Manifestations of Addiction

• Control
• Compulsion
• Consequences
• Continued Use
• Craving

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Maladaptive Behaviors

• Loss of control over drug use
• Inebriated at important family events
• Unable to take pain medications as directed
• Continuing preoccupation with drug use
• Works side job to pay for marijuana, cocaine
• Seeks extra meds despite adequate relief
• Adverse consequences
• Declining function despite analgesia
• All spheres of life decaying, pt. cant discern

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What Does Addiction Look Like?

• Non-medical use of drugs
• 6-15 of U.S. population (excluding nicotine)
• Patients often unable to discern negative impact
  on quality of life
• Denial, minimalization, rationalization, other
  defense mechanisms prominent
• Affective Component
• Poor relationship with self, others, life

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Pseudoaddiction

• Drug seeking behavior in patients who have not
  received effective treatment of pain.
• Also results from inadequate medical withdrawal
  from controlled substances
• Pre-occupation with obtaining meds reflects need
  to control pain or withdrawal
• Resolves with adequate pain or withdrawal Rx
• Differential Dx

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Physical Dependence or Addiction?

• Physical dependence is a normal physiologic
  response to the medical use of opioids
• Addiction involves the non-medical use of
  opioids, and a constellation of abnormal
  behaviors.

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Screening for Addiction

• DSM criteria inadequate for pain patients
• Simple Screening Tools
• Do you use____? How much? How often?
• CAGE (Cut down, Angry, Guilty, Eye-opener)
• CAGE AID
• Comprehensive Addictions Psychological
  Evaluation (Axis I, II) www.evinceassessment.com
• Referral to Substance Abuse Professional

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If you identifyabuse or addiction..

• Initiate a referral, or treatment
• Dont turn your head bad medicine
• Addiction is a serious and potentially fatal
  disease requiring prompt and appropriate
  treatment.

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Opioids 101 Definitions

• Opiate
• Any drug developed from opium or thebaine
  with morphine like qualities
• Opioid Inclusive term, including opiates brain
  neurotransmitters synthetic drugs with
  morphine like qualities ( i.e. fentanyl )
• Narcotic A legal term including licit and illicit
  drugs, not a useful term clinically

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Medical Uses of Opioids

• Pain
• Cough
• Diarrhea
• Anesthesia
• Pulmonary edema
• Maintenance of opioid addiction

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.morphine molecule

• .

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• .

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Mesolimbic Dopamine System and Drug Misuse

• Circuit 1
• LIKE
• Pleasure circuit
• Meso-accumbens
• Circuit 2
• WANT
• Desire and urge circuit
• Basolateral n. of amygdala
• Circuit 3
• Need
• Pathologic desire demand circuit
• Periaqueducal gray of brain stem

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Classes of Opioids

• Agonist Relieve pain and alter mood
• Natural opium, morphine, codeine
• Semi-synthetic hydrocodone, oxycodone, heroin
• Synthetic fentanyl, meperidine, methadone
• Antagonist Displace/block at receptor, no mood
  altering effect
• Naloxone, naltrexone
• Mixed Agonist and antagonist actions
• Butorphanol (Stadol), Pentazocine (Talwin),
  buprenorphine (Buprenex, Subutex, Suboxone)

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Buprenorphine

• Opioid agonist/antagonist. Low diversion risk.
• Replacing methadone in France, ? US
• Excellent safety profile, decades of experience
  as IM-IV-SL analgesic. MDs now Rx for pain.
• FDA approved for opioid detox or maintenance
• Formulated as Subutex, and Suboxone -naloxone
  added to deter IV use, diversion
• Being used in addiction,dependence,pain
• MDs can acquire DEA OK CME required

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Bup Diss curve
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Short-acting Vs. Long-acting opioids

• Diabetes short regular insulin
• long lente, ultra lente
• Pain short hydrocodone, morphine, etc.
• long continuous release ????
  
• long at the receptor methadone,
  buprenorpine, propoxyphene
• On-Off Phenomena disruption of physiologic
  systems secondary to fluctuating opioid levels

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Dosing in Chronic Pain

• Initial dose achieved within weeks, should be
  moderate ( up to 180mg MS equiv/day).
• Opioid responsiveness, ceiling doses vary
• Extreme caution for further increases
• Breakthru meds are not daily, continuous
• Higher doses not yet validated in literature
• opioid doses should be limited in order to
  maintain both efficacy and safety (NEJM)
• If dose escalation ongoing, reassess or wean

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Opioids Adverse Effects

• Sedation, Respiratory depression
• Nausea, vomiting, sweating, histamine S/S
• Constipation, miosis (no tolerance)
• Truncal rigidity
• Hypotension, inhibition of urinary void reflex
• GI effects decrease HCL, secretions, propulsive
  waves, sphincter of Oddi
• Tolerance, dependence, addiction (rarely)
• Cautions head injury, pregnancy, COPD, renal or
  hepatic disease
• ..complex problems in functioning or quality of
  life (NEJM)

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Opioid-Induced HormonalEffects

• HPA Axis
• (hypothalamic-pituitary-adrenal axis)
• progressive decline in plasma cortisol levels in
  adults

• HPG Axis
• (hypothalamic-pituitary-gonadal axis)
• prolactin increase
• LH decrease
• FSH decrease
• estrogen decrease
• testosterone decrease
• leads to
• decreased libido, aggression and drive
  amenorrhea, galactorrhea, testosterone depletion

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Problematic Opioids

• Toxicity Issues
• Meperidine (limited use for acute pain only)
• Propxyphene (delusions, confusion, seizures)
• Pentazocine
• Dosing Issue
• Methadone (prolonged, unpredictable half- life)
• Identity Issue
• Tramadol
• High Abuse/tolerance potential
• Oxycontin

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• C R oxycodone
• (Oxycontin)
• Initial dose release 37
• Peak 3 hours
• Duration 12 hours
• Delivery System easy to crush, cut, chew, heat
• Destruction results in IR dose

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Duragesic FDA Warning (9/04)

• False, Misleading Claims
• No evidence there is less abuse
• No evidence to support claim of less GI side
  effects
• Effectiveness for LPB based on uncontrolled study
• Disability improvement not substantiated

• Work, uninterrupted
• Life, uninterrupted
• Supports functionality
• Improves physical and social functioning
• Game, uninterrupted
• No substantial evidence supporting any of these.
• Game Interrupted?

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Concerns Opioids in CNMP

• Cognitive, psychomotor effects
• Changes in pain modulation
• Tolerance to analgesic effect
• Pain Reinforcement
• Use for non-pain purposes
• Risk of abuse, addiction

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Opioid Concerns

• Cognitive and psychomotor effects
• Very rarely persist after dose adaptation
• No higher incidence of trauma (excluding elderly)
• Physicians, skyscraper guys all OK
• Untreated pain may have more deliterious effects
• Individualize
• Potential changes in pain modulation
• Opioids induce changes in receptor
  structure/function
• Hyperalgesia, allodynia, lowered pain tolerance
• Unknown what have this at-risk pts may have
  less pain after discontinuing opioids

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Tolerance to Analgesic Effect

• Does not occur uniformly
• Not clear which factors related to its
  development
• Most increased opioid need relates to disease
  progression
• May be secondary to opioid induced abnormal pain
  sensitivity
• Tolerance unrelenting? (rare in pt. not
  at-risk)
• Trial of transition to another opioid
• Medical withdrawal, then alternative pain
  management approaches

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Opioids can increase pain!

• 30, of patients feel better after withdrawal
  from chronic opioids
• Can cause hyperalgesia, allodynia
• Prolonged use increases expression of dynorphin,
  associated with increased pain sensitivity

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Pain Reinforcement

• Opioids stimulate dopamine release
• Produce euphoria, or at least a sense of comfort
  in most people
• Opioid use thus reinforcing, opioids are freely
  self-administered by most animal species
• There can be a learned association between opioid
  taking and pain relief, which could perpetuate
  pain in the absence of opioid administration
• The experience of chronic pain is complex, shaped
  by a variety of cognitive, behavioral and
  psychological and other variables, all of which
  can be modulated with opioids neurophysiologically
  

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OpioidsUse for Non-Pain Purposes

• Non-pain symptom management
• Use may be conscious or unconscious
• Opioids can relieve distressing symptoms,
  including depression, anxiety, insomnia, PTSD,
  etc.
• Diversion
• All controlled substances have street value ()
• Prescription drugs can be traded for illicit
  drugs
• Maintaining Addiction
• Giving opioids to a pure addict is bad medicine
• Using opioids for an addict with legit pain is
  OK, risky
• Treat the pain, treat the addiction dont ignore
  the addiction

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Opioids Risk of Addiction

• Infrequent in persons without a personal or
  family history of drug abuse, or risk factors for
  drug abuse (less than 1)
• Chronic opioid therapy for chronic pain is
  relatively new, with few long term studies, so
  the risk cannot be stated conclusively
• In a patient not at-risk, it is reasonable to
  acknowledge a remote risk for addiction

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Opioid Withdrawal

• Acute
• Autonomic
• Rebound increased NE activity from locus
  coeruleus
• Increase BP, HR, peristalsis, diaphoresis, CNS
  irritability, etc.
• Affective
• Suppressed in the dopaminergic reward pathways
• Depression, anxiety, anhedonia, craving, anergia
• Protracted
• 3-6 months or longer
• Anxiety, insomnia, craving, cyclic changes in
  wgt, pupil size

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Acute Opioid Withdrawal

• 5-7 days in length
• Runny nose, sneezing,
• sweating, yawning,
• restless, insomnia
• Piloerection, twitching,
• myalgia, arthralgia,
• abdominal cramps
• Tachycardia,fever,
• hypertension,tachypnea,
• anorexia, diarrhea,
• vomiting, dehydration

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Protracted Opioid Withdrawal

• Anergia
• Ahedonia
• Sleep disturbance
• Emotional lability/dysphoria
• Stress incompetence
• Craving
• Can persist for months

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Detoxification vs. Medical Withdrawal

• Detoxification
• A term referring to the return of alcoholics
  and addicts to a drug free state with or without
  medical supervision
• Medical Withdrawal
• Is the medically supervised process of safely
  and comfortably taking a dependant person off
  controlled medications

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Unacceptable Behaviors- Detoxification Indicated

• Repeated unsanctioned dose escalation
• Borrowing, trading, buying street drugs
• Continued use of illicit drugs, at-risk EtOh
  use
• Recurrent unsubstantiated Rx losses, thefts
• Prescription forgery, multiple prescribers
• Intoxication, overdose
• Gross Non-compliance with treatment plan
• Please, no knee-jerk tapers, discontinuations!

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Detoxification OptionsFor Addiction - Cant
use Opioids!

• Detoxification the treatment that is not a
  treatment provides a drug free person with an
  addictive disease, not a disease free person!
• Ultra-Rapid Detox (with general anesthesia)
• Naltrexone induced, hospital setting
• Licensed methadone clinic (detox or maintenance)
• Symptomatic medications
• Clonidine, NSAID, Vistaril, Robaxin etc. high
  fail rate
• Subutex/Suboxone (detox or maintenance), need
  FDA/DEA OK
• Still need Rx for primary disease of addiction

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When is Medical Withdrawal Needed?

• Pain is subsiding or pain generator removed
• Contributing factors reduced
• Misuse, abuse,
• Insurance issues, cost issues
• Adverse effects physical, social etc.
• Not following Rx plan, change in Rx plan
• Accelerating tolerance, loss of control
• Cultural, personal issues
• Trial off opioids may improve pain !, (and life)

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Medical Withdrawal OptionsFor Dependence - Can
use opioids!

• 1. Taper by 50 every several days (weaning),
  without signs/symptoms of withdrawal
• Goodman Gilmans The Pharmacologic Basis of
  Therapeutics, Ninth Edition. McGraw-Hill 1996.
  P. 533
• Transition to longer acting analgesic
  (propoxyphene, methadone) and taper
• 3. Symptomatic Rx clonidine, NSAID,
  anti- anxiety/sleeper, muscle relaxant, etc.
• Buprenorphine safe, easy, effective
• Educate pt. on withdrawal before initiating
  opioids.

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Buprenorphine

• Useful for detoxification, medical withdrawal.
  Also used for pain.
• Orphan Drug in development 25 years at NIDA,
  private industry (Mr. Clean)
• FDA/DEA certificate needed requires special
  certification or 8 h Bup CME
• 15 Hawaii MDs certified, 3,000 in U.S.
• Available only since October, 2002

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Sedative Hypnotics

• Alcohol
• Most prominent and important drug in this class
• Benzodiazepines
• Xanax, Valium, Klonipin, Ativan, Ambien, Sonata
• Barbiturates
• Firoicet, Esgic (butalbital), Soma
• Older generation rarely used (Seconal, etc.)
• Cross-tolerance among all (GABA related)

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Benzodiazepines

• Rx for anxiety (8-9 of US) and insomnia (2.5)
• Intentional abuse is rare
• Short-term use causes little tolerance/withdrawal
• Tolerance/dependence/withdrawal after months
• Withdrawal vs. symptom re-emergence
• Most patients can maintain stable doses for years
• A subgroup of at-risk patients have problems
• No preference for BNZ in normal people (they
  choose placebo over BNZ)

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Sleep sedative meds can change the physiology
of sleep with subsequent tolerance to the
medication (Goodman Gilman)
96
APA Guidelines for BNZ Use

• Intermittent use preferable to daily use
• Risk of abuse increases in persons with hx of
  alcoholism or other drug abuse
• At-risk persons should rarely, if ever, be
  treated with BNZ on a chronic basis
• Insomnia rarely should be treated with medication
  except when produced by a short-term stressful
  situation

97
BNZ/Barb Withdrawal Rx

• Taper
• Substitute long-acting for short acting, then
  taper
• Use of Anti-epilepetics
• Symptom treatment

98
Stimulants in CNMP

• Very rarely indicated
• Caffeine is generally safe
• Consider specialty consultation before Rx

99
Provigil and FDA warning

• Minimized CNS effects and abuse potential
• Promoting for unapproved uses energy, fatigue,
  tiredness
• Actually produces psychoactive and euphoric
  effects and feelings similar to Ritalin
• false, lacking in fair balance, or otherwise
  misleading..

100
Solutions Drug factors Some drugs have such
high abuse potential, serious side effects, or
lack of clear therapeutic benefit, that they
should generally be prescribed rarely, if at all,
in CNMP

• High Abuse potential- amphetamine/methamphetamine
  /diet pills
• Problematic Side effects- propoxyphene,
  meperidine, butalbital
• Narrow Safety margins- barbiturates, including
  Soma (mebrobamate)
• Little Established Efficacy- propoxyphene,
  carisoprodol, butalbital, scheduled diet
  pills

101
Solutions Limit DrugsAvoid 2 or more controlled
drugs, from the same or different classes, for
the same pt.

• It is very rare for a single patient to meet
  diagnostic and symptomatic criteria to require
  concomitant Rx of 2 or more controlled drugs
• Natural history of substance abuse involves
  multiple drugs (poly-substance abuse/dependence
  is the norm in this group)
• Long-acting opioids with breakthrough meds use
  extreme caution, highly risky, set standards

102
How did this happen?

• Medication Factors
• Patient Factors
• Physician Factors

103
Patient Factors

• Probably 15 of patients are at-risk for
  prescription drug abuse/addiction
• Prevalence of prescription drug abuse varies
  widely among differing physician practices
• Practice patterns range from always encouraging
  Rx to always discouraging Rx
• Majority of patients wont be abusers same as
  with alcohol, tobaccogolf, gambling

104
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105
At-Risk PatientsWho are the abusers, or
potential abusers, and what do they look like?

• Genetically vulnerable (60/40)
• Vulnerable by history
• Past problems/consequences with any drugs
• Present problems with any drug (yes, even
  nicotine)
• Family history of substance abuse
• Mental Health Co-morbidity
• Poorly treated mood disorders (I.e.anxiety,
  depression, PTSD) Personality disorders
• Psychosocial and Environmental Problems (Axis IV)
• GAF Global Assessment of Functioning (Axis V)

106
At-risk Pt Controlled Rx

• Escalating use pattern
• Doctor shopping
• Manipulations to maintain/increase supply
• Tolerance, abuse, dependence, addiction
• Drug seeking behavior a poor term, not a dx,
  best summary over-reporting or extreme
  elaboration or intensification of symptoms which
  should logically (for the pt.) require increased
  doses of medication

107
Drug-Seeking Behaviors

• The result of the basic physiologic, pathologic
  and behavioral state of addiction .
• A progressive, continuing pre-occupation
  withobtaining, using, and recovering from the
  useof mood altering drugs, at the expense of
  other relationships and despite consequences

108
Drug-Seeking Behavior

• Over-reporting symptoms
• Multiple somatic complaints, vague symptom
  complexes
• Insistence on specific meds, refusal of generics
• Arguments about pharmacology
• Self-asserted high tolerance
• Flattery followed by Rx request, veiled threats
• Youre the only doctor that understands me,
• You gave this Rx to me before
• Multiple medical allergies/intolerances
• Demand for poly-pharmacy
• First visit request for controlled substances

109
Preoccupation with drug use

• Non-compliant with other treatment
  recommendations
• Misses other appointments, always arrives for
  opioid prescriptions
• Uses street drugs, involved in street culture
• Preference for short-acting or bolus dose
  medications
• Reports no relief with other medications or
  treatments
• Reports allergies or adverse effects from many
  other drugs

110
Loss of control

• Compulsive overuse, unable to take medication as
  prescribed
• Frequently runs out of medication despite dose
  agreement
• Frequently reports lost/stolen prescriptions
• Uses multiple pharmacies to fill Rx
• Solicits multiple prescribers

111
Doctor Shopping

• Using two or more unwitting physicians to acquire
  controlled substances
• On the decline, secondary to managed care,
  Electronic Monitoring by pharmacies and NED
• Pharmacists share professional and legal
  responsibility with MDs for the use of prescribed
  drugs nurture the relationship

112
Rare Drug Seeking Behaviors

• Prescription forgery, altering prescriptions
• Stealing prescription pads, xeroxing Rx
• Boundary violations friendship,
  flirtatiousness, sex, subtle intimidation

113
Manipulations

• Pt. generated pressure to prescribe in the face
  of clinical uncertainty
• Prescription reversal an initial MD no
  (refusal) to prescribe becomes a yes
  (willingness to prescribe)
• Distractions, diversions, lies
• Dr. X said he went to med school with you My
  depression is so much better, thank you Is this
  skin cancer? Lost my luggage Dog ate it stolen
  from the gym But you filled it before! the
  pharmacist shorted me pastries for you, your
  staff Just this one time Oh, by the way,
  Doctor.

114
Stop, Do Not Proceed!

• Vague sense of uneasiness about Dx or Rx
• If the patient engenders this in you, consider
  him/her to be drug seeking
• Pushed
• If you feel pushed about a symptom or controlled
  drug prescription, Stop, Regroup, get more data
  (other MDs, pharmacy, records), consultation

115
Turn the Tables..

• I am feeling uncomfortable about writing this
  prescription today that it is not clinically
  indicated. Because of this I am really concerned
  about your use of controlled substances, and
  alcohol or other drugs as well.

116
Furthermore

• these are the reasons I cannot prescribe this
• State this prescription would be
  inappropriate..
• Offer to make arrangements for referral, detox,
  withdrawal, ER directions, now
• Offer to continue care of the underlying problem
  once this issue is resolved

117
Absolute Exclusion Criteria for Chronic
Controlled Rx

• Inability to understand, follow instructions
• Aggressive,threatening,or violent behavior
• Imminently suicidal, OD
• Unrealistic expectations
• Unstable medical condition
• Overdose

118
Alternatives for the At-Risk Pt.

• Anxiety and anxiety-like symptoms
• Avoid BNZ use talk-therapy, Vistail tricyclics
  for sleep
• If BNZ unavoidable, exceedingly rare, short
  term (days) for clear exacerbation of symptoms,
  under close supervision
• Pain- severe, acute, self-limited (i.e.post-op)
  same guidelines as not-at-risk pt.
• Chronic Pain, cryptogenic pain
• Use non-controlled drugs, modalities exceedingly
  rare use of opioids for severe exacerbation,
  short term (hours/days)
• Insomnia, obesity, ADD, narcolepsy, fatigue
• Use of controlled substances in these patients
  extremely problematic
• Avoid controlled prescriptions and/or seek expert
  consultation

119
Doctor, how did this happen?

• How do physicians become enmeshed with
• over-prescribing or inappropriate prescribing
• to an at-risk patient?

120
Prescribing Opioids to Addicts

• 20 patients with chronic non-malignant pain and
  history of substance abuse
• 11 that did not abuse Rx, had active 12-step
  recovery, supportive family
• 9 that did abuse Rx abused early in trial
  no12-step Rx lost or stolen frequent, rapid
  dose increase calls/visits-no appt.
• Dunbar, Katz Pain and Symptom Manage. Vol. 11,
  No 2, pp 163-171, March 1996

121
Opioids in Co-Morbid Pain Addiction

• Highly structured environment/interactions
• Prohibit monitor alcohol, other drugs
• Marijuana ? must have use certificate
• Frequent visits (q week, then q 2 weeks)
• Referral for substance abuse Rx, 12-step
• Multidisciplinary support
• Spouse/Family involvement
• Addiction Medicine, Pain Medicine, or Pain
  Management consult periodically
• Collect medical records, document all encounters

122
Physician Factors

• Dated
• Duped
• Disabled
• Dysfunctional
• Dishonest
• Medication Mania
• Hypertrophied Enabling
• Confrontation Phobia

123
Dated Physicians

• Out-of-date in the diagnosis and treatment of
  chronic pain, anxiety, insomnia, or substance
  abuse
• It is ironic that these are are among the most
  common problems in the PCP office
• Limited or no medical school training in these
  areas, current CME via drug reps, samples, bad
  experiences
• Solution Courses like this, intensive courses
  elsewhere

124
Whats Your Source?

• Independent CMEcourses
• Independent journals, references and other texts
• Professional Groups
• (i.e. Amer. Acad. Pain Medicine)
• PDR, pharmaceutical sponsored events, trips,
• Drug reps, lunches, dinner
• Samples

125
Duped Physicians

• It is widely acknowledged fact that physicians
  are a caring, trusting group of professionals
  trying to help their patients in an open and
  honest relationship based on mutual trust
• Physicians have unwavering positive regard and
  empathy for the patient usually it is
  beneficial
• Anyone can get burned, when controlled
  substances are involved, special precautions are
  needed

126
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127
Duragesic sounded good..but

• FDA Warning Letter, 2004
• False and/or misleading claims
• Unsubstantiated claim effectiveness
• Abuse potential no evidence of less abuse
• Evidence insufficient to support Janssen
  efficacy, physical, social functioning claims
• Patent expires this year..

128
Disabled Physicians

• Medical or psychiatric disability, such as
  chemical dependency, depression, PD
• 11.4 of physicians used unsupervised BNZ in the
  last year
• 17.6 engaged in unsupervised use of opioids
  (although less likely to use tobacco, illicit
  drugs)
• Death may be the initial presentation in
  substance abusing physicians
• Physicians can become loose prescribers
• Refer to CPH (voluntary) or to RICO/BME if
  necessary

129
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130
Dishonest Physicians

• Script Docs
• In every geographic area of Hawaii, there are MDs
  who are willing to prescribe a controlled drug,
  or combinations of drugs, to almost anybody, for
  almost anything.
• Ease of medical justification
• Easy renumeration
• Reputation among abusers circulates rapidly
• Generally difficult to intervene, since any MD
  can legally write any Rx(s)

131
Mediation Mania

• Societal phenomenon
• Origins both in high efficacy of certain meds for
  certain conditions, and the profit-oriented
  pharmaceutical industry
• Very visible results over prescribing
  antibiotics and antibiotic resistance
  polypharmacy (especially in elderly), increased
  patient expectation and pressure to prescribe
• Difficult access/payment for referral,
  non-pharmacologic therapies

132
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133
The United States of Drugs
134
Medication Mania

• Remember
• It is never wise to prescribe potentially habit
• forming medications for vague clinical
• presentations or indications with poorly
• defined therapeutic end points.

135
Confrontation Phobia

• We all have learned and practice
  physician-patient relationship skills rapport
  building and empathy are essential to good
  medicine
• We have not been taught to say no, or limit
  setting skills. In fact we dont need these 90
  of the time.
• We as physicians feel acutely uncomfortable with
  conflict and inter-personal confrontation
• This plays into the hands of at-risk and
  chemically dependent patients, who will be
  skilled and effective in the art of confrontation

136
Hypertrophied EnablingI was only trying to
help!

• Physician instinct to do anything possible to
  enable patients to live at a higher level of
  function
• For at-risk patients, enabling with controlled Rx
  can result in blossoming/worsening/relapse of SA
• Abusing patients manipulate MDs to avoid the
  consequences of their chemical dependency
  (withdrawal, street dealing, shame) thus allowing
  the chemical dependency to progress and worsen.
• The patient has an abnormal relationship with the
  drug, you risk an abnormal relationship with the
  patient and the drug

137
Dysfunctional Physicians

• Influences from physicians family of origin and
  other life experiences may guide their medical
  problem solving and decision making.
• i.e. A physician who sees his/her role in the
  familyas peacekeeper and parent pleaser might
  prescribe a larger number of pills to an older
  patient in pain.

138
Must Have MD Solutions

• Clear Diagnosos
• Documentation and work-up
• No contraindications/Review of risk factors
• Failure of non-controlled meds, and
• multimodal therapies

139
MD Solutions

• Comprehensive H P
• Establish firmly that non-opioid Rx has failed
• Establish agreed upon goals for treatment
• Shared understanding between MD and Pt the true
  benefits, pitfalls of long-term opioids
• Involve a single prescribing MD and pharmacy
  whenever possible
• Ensure comprehensive follow-up
• Regular assessment of goal achievement,
  monitoring signs of abuse, adjunctive Rx whenever
  possible,, willingness to end opioid Rx if goals
  not met

140
Solutions MD factors

• New patient no controlled Rx at first visit
• record releases from MDs, hospitals, pharmacies
• pain questionnaire
• full Hx and AOD review
• consent for treatment
• controlled prescription agreement
• All patients Controlled prescription refill
  flow chart
• document at each visit pain, function, AE
• (consider pill counts, UDT give dose in
  office, family contact)
• Periodic consultations, opioid therapy review
• Screening tools Availability, proficiency

141
Solutions Guidelines, Forms

• Guidelines for Use of Controlled Substances (HMA,
  others)
• Forms in your syllabus
• Checklist for Long-term Opioid Therapy
• Initial Pain Assessment
• Initial Pain Assessment Tool
• Pain Patient History
• Consent for Chronic Opioid Therapy
• Agreement for Controlled Sustance Therapy
• Pain Management Logs
• Opioid Progress Report
• Follow-up Office Visit for Chronic Opioid Therapy

142
Bottom Line

• Always screen for personal and family history of
  past or present substance abuse, mental health
  illnesses. These are risk factors for
  prescription drug abuse that can help inform the
  physician in making the best treatment plan.

143
Guidelines for the Use of Controlled Substances
for the Treatment of PainAdopted by Hawaii
Medical Association, May 2003

• Patient Evaluation, indication for opioids use
• Written Treatment Plan
• Informed Consent , Agreement for Treatment
• Periodic Review
• Consultation
• Medical Records
• Compliance with Laws and Regulations

144
Best References

• 1. Pain Clinical Manual 2nd Edition
• Margo McCaffery, Chris Pasero1999, Mosby
• 2. Bonicas Management of Pain 3rd Edition
• J.D. Loeser et al. 2001, Lippincott Williams
  Wilkins
• 3. Principles Practices of Pain Medicine, 2nd
  Ed
• C.A. Warfield, Z.H. Bajwa. 2004, McGraw-Hill
• 4. Massachusetts General Hospital Handbook of
  Pain Management 2nd Edition McGraw-Hill. 2002,
  Lippcott
• Goodman Gilmans The Pharmacological Basis of
  Therapeutics 9th Edition. Multiple Editors.
  1996. McGraw-Hill
• Principles of Addiction Medicine 3rd Ed. 2002.
  ASAM
• Pain Addiction Common Threads 2000-2004. ASAM
• .

145
Web Sites

• American Society of Addiction Medicine,
  www.asam.org
• American Academy of Pain Management
• www.aapainmanage.org
• American Pain Society
• www.ampainsoc.org