Prescribing Controlled Drugs: A Slippery Boundary Slope

1
PrescribingControlled DrugsA Slippery Boundary
Slope

• Theodore V. Parran, M.D.
• Associate Clinical Professor of Medicine
• Case Western Reserve UniversitySchool of Medicine

2
Prescribing Controlled DrugsA Question of Balance

• The under-prescribing of controlled drugs for
  acute, chronic and malignant pain, and anxiety is
  extremely widespread and contributes to
  significant patient morbidity.

1988 AMA/White House Symposium
3
Prescribing Controlled DrugsMagnitude of the
Problem

• Routine under-treatment of malignant pain
• Post-operative and acute pain mismanagement
• Under-diagnosis and treatment of anxiety
• Common fear of creating addiction with
  prescription
• Avoidance of controlled prescribing unless
  pushed
• Growing part of Q/A problems

4
Prescribing Controlled DrugsA Question of
Ballance

• The over prescribing of controlled drugs
  contributes to societal substance abuse,
  iatrogenic dependence, increased morbidity, and a
  risk management nightmare.

1988 AMA/White House Symposium
5
Prescribing Controlled DrugsMagnitude of the
Problem

• 1 cause of physician investigations by state
  boards
• 1 cause for actions taken against physician
  licenses
• 2 behind cocaine for national street
  value(ahead of heroin and marijuana)
• Growing proportion of risk management problems

6
Number of U.S. Treatment Admissions and Emergency
Department Mentions for Narcotic Painkillers,
1995-2002
7
Number of new non-medical users of therapeutics
(NSDUH, 2002)
8
TEDS Rural vs Urban

• Admissions for treatment of narcotic painkillers
• 155 increase from 1992-2002
• Greatest increase in rural areas (269), smallest
  in large central metro areas (58)
• 15 fall in admissions for injection users
• Increase in rural inhalant abuse from 2-12

9
Prescribing Controlled DrugsA Question of Balance

• The drugs
• The doctors
• The patients
• Strategies for balance

10
Prescription Drug Abuse The DRUGSEUPHORIA
PRODUCERS BRAIN REWARDERS

• All EPDs-BRDs have abuse and dependence producing
  potential
• Very diverse types or classes of medications
• Single common direct or indirect pharmacologic
  effect
• Produce an acute surge of dopamine from the
  mid-brain to the pre-frontal cortex
• Experience a quick sense of euphoria

11
Prescription Drug AbuseThe Drugs

• All EPD-BRDs require a DEA to be prescribed
• Some drugs of abuse do not
• Soma
• Ephedrine
• Fioricet
• Nubain (nalbuphine)
• Ultram (tramadol)

12
Prescription Drug AbuseThe Drugs

• All DEA requiring drugs are abused locally,
  have a street value, and are sought by some
  patients

13
Prescription Drug AbuseThe Drugs

• Street value depends on the dopamine surge
• Onset of actionfast
• Intensity of effecthigh
• Duration of actionshort
• Potential route of administrationIV/pulmonary
• Trade name generic
• Cost of illicit equivalent

14
Prescription Drug AbuseThe Drugs

• Heroin opioid analgesics II, III, or V
• Cocaine stimulants (diet, ADHD, narcolepsy)II
  or IV
• Alcohol sedative hypnotics (benzos,
  barbs,misc) IV

15
Prescription Drug AbuseThe Drugs
DEA schedule classification II high
abuse/dependence potential(opioid, analgesics,
amphetamines) III lower abuse/dependence
potential(compounded opioid analgesics) IV low
er abuse/dependence potential(sedative
hypnotics, some stimulants) V minimal
abuse/dependence potential
16
Prescription Drug AbuseThe Drugs
Shopping ListOpioids
Methadone 30 mg 50
Hydromorphone 4 mg 45
Morphine 30 mg 15
Meperidine 100 mg 10
Oxycodone 5 mg 7
Codeine 30 mg 2
Propoxyphene 100 mg 50
17
Prescription Drug AbuseThe Drugs
Shopping ListSedative Hypnotics
Alprazolam 1 mg 5-7
Diazepam 10 mg 4-5
Lorazepam 2 mg 23
Oxazepam 30 mg 50
Clonazepam 0.5 mg 4-5
18
Prescription Drug AbuseThe Drugs

• Controlled drugs to avoid prescribing
• Side effect
• meperidine, propoxyphene, butalbital
• Narrow toxic/therapeutic
• secobarbital, pentobarbital, meprobamate,
  ethchlorvynol
• Lack of efficacy
• carisoprodol (Soma), propoxyphene
• Regulatory environment
• ? diet medications (State by State)

19
Prescription Drug AbuseDrugs to Avoid
Alternatives

• ALTERNATIVES
• Meperidine any other CII medication!
• Butalbital DHE / compazine / tramadol / etc
• Sedative Hypnotics any benzodiazepine
• Soma baclofen / skelaxin / flexeril / etc
• Propoxyphene other opioids / NSAIDS (cox I or
  II) / acetaminophen / tramadol

20
Prescribing Controlled DrugsThe Doctors

• Physicians report feeling under-prepared in
• DDx (differential diagnosis) and management of
  acute v. chronic v. malignant pain
• DDx and management of anxiety v. depression
• DDx and management of insomnia
• DDx and management of chemical dependence
• Opioid pharmacology
• Benzodiazepine pharmacology

21
Prescribing Controlled DrugsThe Doctors

• The AMA has described mechanisms by which
  physicians become involved in RxDA the 4-Ds
  1
• Dated
• Duped
• Disabled
• Dishonest
• Defiant

22
Prescribing Controlled DrugsThe Doctors

• Beyond the 4 Ds 1 the CWRU experience
• Medication mania
• Confrontation phobia
• Hypertrophied enabling

23
Prescribing Controlled DrugsThe Doctors

• Pitfalls
• I just dont prescribe any controlled drugs in
  my practice
• If patients abuse their medications, that is
  their problem not mine
• I only prescribe controlled drugs in extreme
  situations, and only if pushed

24
Prescribing Controlled DrugsThe Patients

• Use other than prescribedcommon
• Over useunknown
• Doctor shoppinguncommon
• Scamsuncommon BUT memorable!

25
Prescribing Controlled Drugs assess for
addiction prior to long term RX

• Perform an AUDIT and CAGE.
• Ask family or sig. other the f-CAGE.
• Consider one or more toxicology tests.
• Inquire of prior physicians re use of controlled
  prescriptions (f-CAGE).
• If history of current or prior addiction, ever
  abused opioids?
• This IDs the patients level of RISK re Cont.
  drug RX

26
Prescribing Controlled DrugsThe Patients

• Doctor shopping
• Talk with family members
• Computerized medical/prescription records
• Collaboration with pharmacies
• State Pharmacy Board Web-sites

27
Diagnosing Aberrant Dr-Pt Relationships

• Assess Behavior
• The HEART SINK Patient interview
• Differential Diagnosis
• Borderline personality disorder
• Somatiform disorder
• Addiction / pseudo-addiction
• Family disturbances
• Criminal intent a true capitalist!

Passik SD, et al. Oncology. 199812517-22. Porten
oy RK, Savage SR. J Pain Symptom Manage.
199714S27-35. Passik SD, Weinreb HJ. Adv Ther.
20001770-83. Portenoy RK, Payne R. In
Substance Abuse A Comprehensive Textbook. 3rd
Edition. Baltimore, MD Williams Wilkins
1997563-89.
28
Prescription Drug AbuseScams

• Strategies to increase frequency, number, potency
  of controlled prescriptions
• Efforts to increase drug supply by
  stressing/pressuring the doctor-patient
  relationship
• You know Dad I really love you Dad!
• You know Doc I really love you Doc!

29
Prescription Drug AbuseScams 1

• Spilled the bottle
• The dog ate it
• Lost the prescription
• Washed in laundry
• Medications stolen
• Left somewhere
• The Pharmacist shorted me

30
Prescription Drug AbuseScams 2

• Lost my luggage
• No generics
• Multiple medication sensitivities
• Allergic to Kappa agonists
• This cough calls for...
• Its the only thing that works
• House burned down

31
Prescription Drug AbuseScams 3

• Physician heal thyself
• Oh, by the way
• You are the only one who understands...
• Rx lifting/altering
• Late calls/cross coverage
• John Hancock/Dear Doctor

32
Dealing with ScamsPrinciples

• Cops v. Docs attitudes
• No offense but...
• Learn to recognize common scams
• Just say no and mean it say no when you mean
  no and yes when you mean yes
• Avoid being coy when no becomes yes
• Turn the tables

33
Prescribing Controlled DrugsSolutions

• Improve skills to identify chemical dependence
• Approach affected patients as if they have a
  relative, if not absolute, contraindication to
  controlled prescriptions
• Aggressively pursue skills in DDx and management
  of
• Acute vs chronic pain
• Anxiety vs depression
• Insomnia

34
Prescribing DrugsSolutions (contd)

• Carefully document in progress note the
  rationale, diagnosis, anticipated time course,
  and symptom endpoint when initiating a controlled
  drug prescription
• Consider a prescription refill flow chart
• Establish a cross coverage prescription policy

35
Prescribing Controlled DrugsSolutions (contd)

• Know the pharmacology and abuse potential of all
  drugs prescribed
• Medical letter, AHFS PDR, industry reps
• Careful prescription writing and management
  habits
• Recognize and deal with scams

36
Prescribing Controlled DrugsA Question of Balance

• Implementing RxDA solutions can
• Increase comfort with prescribing controlled
  drugs
• Markedly decrease inappropriate prescribing
• Achieve better balanced and improved patient care

37
Prescribing Chronic Opioids in Chronic
PainRelieve sufferingAvoid addictionLimit
liability

• Ted Parran Jr. MD FACP
• Associate Clinical Professor of Medicine
• CWRU School of Medicine
• Cleveland, Ohio
• tvp_at_case.edu

38
Chronic intractable pain the clinical challenge

• Be aware of the Heart Sink patient.
• Remain within your area of expertise.
• Stay grounded in you role.
• FIRST.DO NO HARM
• THEN..
• CURE SOMETIMES
• COMFORT ALWAYS

39
Chronic Opioid therapyTo Prescribe or Not To
Prescribe that is the Question!

• How do you decide when you are considering
  chronic controlled drug prescribing?
• Indications patient specific and disease
  specific
• Contraindications history of, or current
  addictive disease

40
CASE Mr. Smith
41
Indications for possible chronic opioids THE
FIVE QUESTIONS

• Is there a clear diagnosis?
• Is there documentation of an adequate w/u?
• Is there impairment of function?
• Has non-opioid multi modal therapy failed?
• R/O contraindications to opioid therapy?
• Begin opioid therapyDocument! Monitor!
• Avoid poly-pharmacy

42
Contraindications to chronic opioid prescribing

• Allergy to opioid medications relative
• Current addiction to opioids ?absolute
• Past addiction to opioids ?absolute
• Current /past addiction, opioids never involved
  relative, ??absolute if cocaine
• Severe COPD relative

43
Chronic pain management ruling out addiction

• Perform an AUDIT and CAGE.
• Ask family or sig. other the f-CAGE.
• Perform one or more toxicology tests.
• Inquire of prior physicians re use of controlled
  prescriptions (f-CAGE).
• If history of current or prior addiction, ever
  abused opioids?
• Query Pharmacy Board web-site

44
Screening for Addiction the CAGE and the
f-CAGE

• CAGE Cut down on use? Comments by friends and
  family about use that have annoyed you?
  Embarrassed bashful or guilty re behaviors when
  using? Eye-openers to get started in the
  mornings?
• F-CAGE Ask the patients significant other the
  CAGE about the patients use of alcohol, drugs or
  controlled prescriptions.

45
TERMS

• Tolerance The development of a need to take
  increasing doses of a medication to obtain the
  same effect tachyphylaxsis is the term used when
  this process happens quickly.
• Dependence The development of substance
  specific symptoms of withdrawal after the abrupt
  stopping of a medication these symptoms can be
  physiological only (i.e., absence of
  psychological or behavioral maladaptive patterns).

46
TERMS

• Addiction The development of a maladaptive
  pattern of medication use that leads to
  clinically significant impairment or distress in
  personal or occupational roles. This syndrome
  also includes a great deal of time used to obtain
  the medication, use the medication, or recover
  from its effects loss of control over medication
  use continuation of medication use after medical
  or psychological adverse effects have occurred.

47
Terms

• Pseudo-addiction
• Patients with severe unrelieved pain can become
  intensely focused on obtaining relief, and can
  mimic aspects of drug seeking behavior.
• This behavior should resolve when adequate pain
  relief is provided, without evidence of loss of
  control, escalation, binging, etc.

48
Tips for the prescribing of chronic opioids

• Factor in tolerance (already on opioids).
• Start low/go slow (not already on opioids).
• Slow release, long acting preparations.
• Fixed dosing, avoid prns.
• Avoid opioids for breakthrough pain.
• Avoid poly-pharmacy involving controlled drugs!!!

49
Tips for prescribing chronic opioids (continued)

• Factor in tolerance physical/pain/euphoria
• Low Slow - use equi-analgesic tables
• Methadone 21 41 MSmethadone
• Use T½ for fixed dose intervals hold the line
• T½ for pain may NOT be T½ resp. depression
• Titrate AFTER steady state (5 X T½) minimum and
  most safe after full physical tolerance (15 X T½)

50
Tips for prescribing chronic opioids

• Tolerance minimizing is a tx. goal
• Malignant v. chronic pain model
• Differential tolerance to pain relieving v.
  euphoria producing v. other effects
• Change in tolerance to pain effects may be more
  related to peaks and troughs.
• Take home points
• LA/SR maintains pain efficacy
• IR meds may drive tolerance cycle

51
Tips for prescribing of chronic opioids

• Breakthrough pain (BTP)
• Malignant Pain v. Chronic Pain NOT same
• Chronic pain tx goal?
• Several week period of SR/LA opioid titration
  with short acting opioid for prn BTP
• THEN eliminate short acting opioid
• Use PRN aceta / nsaids / tramadol for BTP
• Keep pain log re day/wk with BTP retitrate

52
CASE Mr. Smith

• Work-up
• Titration
• RXing

53
Documentation when initiating a chronic opioid
treatment plan

• Identify a clear diagnosis.
• Document an adequate work-up.
• Ensure that non-opioid therapy failed or is not
  appropriate (tx. rationale).
• Identify anticipated outcome (tx. goal).
• Strongly consider an Opioid Informed Consent
  Form.
• Consult a physician with expertise in the organ
  system involved?

54
Monitoring strategy when prescribing chronic
opioids

• Document functional improvement.
• Titrate opioids to improved function.
• Monitor medications (pill counts).
• Avoid non-planned escalation.
• Monitor for scams (chr. cont. drug consent)
• Perform occasional toxicology tests.
• Document, document, document!

55
Monitoring Utilizing an Office Team Approach

• Chronic Controlled Drug Flow Sheet
• Dose
• Refills
• Toxicology testing / results (quarterly)
• Corroboration phone calls (quarterly)
• Pharmacy Board web-site query (twice yearly)
• Referrals / Studies
• etc

56
Diagnosing Aberrant Dr-Pt Relationships

• Assess Behavior
• The HEART SINK Patient interview
• Differential Diagnosis
• Borderline personality disorder
• Somatiform disorder
• Addiction / pseudo-addiction with controlled drug
  RX
• Family disturbances
• Criminal intent a true capitalist!

Passik SD, et al. Oncology. 199812517-22. Porten
oy RK, Savage SR. J Pain Symptom Manage.
199714S27-35. Passik SD, Weinreb HJ. Adv Ther.
20001770-83. Portenoy RK, Payne R. In
Substance Abuse A Comprehensive Textbook. 3rd
Edition. Baltimore, MD Williams Wilkins
1997563-89.
57
Prescription Drug AbuseScams

• Strategies to increase frequency, number, potency
  of controlled prescriptions
• Efforts to increase drug supply by
  stressing/pressuring the doctor-patient
  relationship
• You know Dad I really love you Dad!
• You know Doc I really love you Doc!

58
Prescription Drug AbuseScams 1

• Spilled the bottle
• The dog ate it
• Lost the prescription
• Washed in laundry
• Medications stolen
• Left somewhere
• The Pharmacist shorted me

59
Prescription Drug AbuseScams 2

• Lost my luggage
• No generics
• Multiple medication sensitivities
• Allergic to Kappa agonists
• This cough calls for...
• Its the only thing that works
• House burned down

60
Prescription Drug AbuseScams 3

• Physician heal thyself
• Oh, by the way
• You are the only one who understands...
• Rx lifting/altering
• Late calls/cross coverage
• John Hancock/Dear Doctor

61
Dealing with ScamsPrinciples

• Cops v. Docs attitudes
• No offense but...
• Learn to recognize common scams
• Just say no and mean it say no when you mean
  no and yes when you mean yes
• Avoid being coy when no becomes yes
• Turn the tables

62
Pain Patient on Chronic Opioids

New Physician
Are chronic opioids appropriate?
YES!
UNSURE
NO
Physical Dependence vs Addiction Chemical
dependence screening Toxicology tests Pill
counts Monitor for scams Reassess for
appropriateness
Educate patient on need to discontinue
opioids Emergency? ie overdoses selling
meds altering Rx NO! 3-month self
taper (document in chart) OK 10-week structured
taper OK Discontinue opioids at end of
structured taper
Redocument Diagnosis Work-up Treatment
goal Functional status Monitor Progress Pill
counts Function Refill flow chart Occasional
urine toxicology Adjust medications Watch for
scams
YES!
Discontinue opioids Instruct patient on
withdrawal symptoms Tell to go to ER if
withdrawal symptoms
63
Opioid w/d treatment options

• Gradual self taper over three months
• 10 week structured taper
• Abrupt discontinuation and detoxification
• Methadone
• Clonidine
• Buprenorphine
• Tramadol
• non-emergency patient with a legitimate pain
  diagnosis.

64
Emergency contraindications to continued
controlled drug prescribing(above all, first do
no harm)

• Altering a prescription FELONY
• Selling Rx. drugs DRUG DEALING
• Accidental/intentional overdose DEATH
• Threatening staff EXTORTION
• Too many scams OUT OF CONTROL

65
Emergency contraindications to continued
controlled drug prescribing(above all, first do
no harm)

• What is a physician to do?
• 1) Identify the contraindicated behavior.
• 2) Show where agreement was broken.
• 3) State that prescribing is inappropriate.
• 4) Educate about withdrawal symptoms.
• 5) Instruct to go to the E.R. if withdrawal.
• 6) Offer care with out Rx, and/or referral.

66
Signs and symptoms of opioid withdrawal

• HEENT, CV, GI, MS, Neuro/Psych.
• HEENT- dilated pupils, lacrimation, rhinorrhea,
  yawning
• CV- tachycardia, hypertension
• GI- nausea, vomiting, diarrhea, abd. cramps
• MS- piloerection, diaphoresis, myalgias,
  arthralgias, bone pains
• N/P-insomnia, anxiety, headache, dysphoria

67
CASE Mr. Smith

• Good response
• Iffy response
• Problematic response

68
Chronic intractable pain the clinical challenge

• Be aware of the Heart Sink patient.
• Remain within your area of expertise.
• Stay grounded in you role.
• FIRST.DO NO HARM
• THEN..
• CURE SOMETIMES
• COMFORT ALWAYS