Managing Risk - Identifying Issues in the Workplace National Rx Drug Abuse Summit 4-10-12

1. Managing Risk -
Identifying Issues in
the Workplace
April 10-12, 2012
Walt Disney World Swan Resort

2. Accepted Learning Objectives:
1. Identify the signs and symptoms of drug
addiction.
2. Describe the proper procedure for
employers to take when they suspect
substance abuse in their employees.
3. Explain the potential liabilities faced by
employers who do not address
substance abuse issues within the
workplace.

3. Disclosure Statement
• Det. Ryan Buzzini has disclosed no
relevant, real or apparent personal or
professional financial relationships.
• Phil Walls has disclosed that he will
discuss the off-label use of drugs such
as Actiq and Fentora that create a
high risk environment for developing
addiction.

4. “Doctors pour drugs, of which they know
little, for diseases, of which we know less,
Into patients—of which we know
nothing.”
—Voltaire

5. • From 1991 to 2009, prescriptions for
opioid analgesics increased almost
threefold, to over 200 million.
• Overdoses attributed to prescription
painkillers killed nearly 15,000 people
in the U.S. in 2008, more than three
times as many as in 1999.

6. Prescription opioid overdose is now the second
leading cause of accidental death in the U.S., killing
more people than heroin and cocaine combined.

7. In Worker’s Compensation
“The abuse of prescription opioids has
become a grave personal risk to injured
workers, a disruptive force in the lives of
those close to claimants harmed by abuse,
and a cost concern to other stakeholders in
the United States workers’ compensation
system.”
Joint statement of ACOEM and IAIABC

8. • Temporary disability payments are 3.5 times higher
when opioids are prescribed
• A study of 17 states found that many physicians
who prescribed narcotics to injured workers were
not using recommended tools to monitor use, abuse
and diversion

9. Drug Use Statistics
• 80% of the world’s supply of opioids is
consumed in the US
• 99% of the world’s supply of
hydrocodone is consumed in the US
• 2/3 of the world’s supply of illicit
substances are consumed in the US
Manchikanti, L. National Drug Control Policy and Prescription
Drug Abuse: Facts and Fallacies. Pain Physician. 10:399-424,
2007.

10. Search Results:
“undertreatment of pain”
April 15, 2011 “Despite Awareness,
Undertreated Cancer Pain Persists”
July 5, 2011 “Pain Common but
Undertreated”, www.medscape.com
July 11, 2011 “Case Report:
Undertreatment of Pain in a 40-Year-
Old Woman”, Psychiatry Weekly
ETC.

11. Commonly Prescribed Drugs
(from all payer types)
Atorvastatin
Amoxicillin
Hydrocodone Comb.
Oxycodone Comb.
Propoxyphene Comb.
Tramadol and Comb.
Codeine Comb.
Oxycodone
Other Opioids
Fentanyl
Morphine
Number of Prescriptions (in millions) IMS 2005

12. Drug Enforcement
Administration
– Bureau of Prohibition 1927-1930
– Bureau of Narcotics 1930-1968
– Bureau of Narcotics and Dangerous Drugs
(BNDD) 1968-1973
– Drug Enforcement Administration 1973

13. Role of the DEA
– Controlled Substances
• Narcotics vs. Opioids
• Illicit drugs
• Diversion of prescription drugs
– Schedules – level based on potential for
abuse and addiction
– Addiction vs. Tolerance

14. Controlled Substances
• Schedule II
– Rx cannot be phoned or faxed to
pharmacy
– Rx cannot be refilled
• Schedule III, IV and V
– Rx may be phoned or faxed to pharmacy.
Fax must originate from doctor’s office.
– Rx may be refilled if authorized by MD up
to 5 times within 6 months of the date Rx
was ‘written’ (all other prescriptions expire
after 12 months).

15. Schedule II
Examples
• Actiq (oral transmucosal fentanyl citrate,
OTFC)
• Avinza (morphine sulfate)
• Dolophine, Methadose (methadone)
• Duragesic (fentanyl patches)
• Embeda (morphine sulfate and naltrexone)
• Fentora (OTFC)
• Kadian (morphine sulfate)
• OxyContin (oxycodone)

16. Schedule III and IV
• Darvocet N 100 (propoxyphene napsylate
and APAP)
• Tylenol #3 (codeine with acetaminophen)
• Vicodin/Lortab/Lorcet (hydrocodone with
APAP)
• Talwin (pentazocine with naloxone)
• Ativan (lorazepam)
• Klonopin (clonazepam)
• Valium (diazepam)
• Xanax (alprazolam)

17. Schedule V
• Codeine containing cough syrups
• Certain paregoric formulations

18. Tolerance
• Tolerance is a state of adaptation in which
exposure to a drug induces changes that
result in a diminution of one or more of the
drug's effects over time
• Tolerance develops at different rates, in
different people, to different effects

19. Physical Dependence
• A state of adaptation that is manifested by
a drug class-specific withdrawal syndrome
that can be produced by abrupt cessation,
rapid dose reduction, decreasing blood
level of the drug, and/or administration of
an antagonist

20. Addiction
Concensus Medical Definition
• “A primary, chronic neurobiological
disease with genetic, psychosocial and
environmental factors influencing its
development and manifestation”
From AAPM, APS, ASAM Definitions Related to the Use of Opioids for
the Treatment of Pain. Available at: http://www.ampainsoc.org/
advocacy/opioids2.htm.

21. Addictive Behaviors
• Addictive behaviors include one or more of
the following:
– Impaired control over drug use
– Compulsive use
– Continued use despite harm (physical,
mental, and/or social)
– Craving
Savage SR, et al. J Pain Symptom Manage. 2003;26(1):655–667.
[Evidence Level C]

22. Opioid Effects:
Analgesia and Reward
• General • Reinforcing effects
– Analgesia
- Reduce anxiety
– Altered mood
– Decreased anxiety - Decrease boredom
– Respiratory depression
– (-) GI motility - Decrease aggression
– Cough suppression
- Increase self-esteem
– Miosis
– Pruritus, nausea,
vomiting
Clinical Manual Addiction
Psychopharmacology, 2005.

23. Pseudoaddiction
• Behaviors that may occur when pain is
inadequately treated
• Patients may become focused on
obtaining medications
• May seem to be drug-seeking
• Behaviors resolve when pain is
appropriately treated

24. Diversion
• The use of a legitimately prescribed
medication for illicit or illegitimate
purposes—perhaps with the intent to sell
or distribute
• Examples
– Stolen, altered, or forged prescriptions
– Trading for profit on medication from others
– Scams

25. Aberrant Behavior vs Abuse
Aberrant
Behavior: 40%
Abuse:
20%
Addiction:
2%–5%
Total Pain Population
Webster LR, et al. Pain Med. 2005;6:432–442.
Webster LR, Webster RM. Pain Med. 2005;6:432–442;

27. What about Schedule I?
• Highest potential for
abuse and
addiction
• No approved
medical use
• Cocaine (CS II)
• Heroin
• Marijuana
• Methamphetamine

28. FDA Panel Votes Against
Requiring Prescriptions For
Medicines Containing
Dextromethorphan.
NBC Nightly News (9/14) reported that in "a decision
that surprised some people late this afternoon," and
"despite an alarming number of teenagers who are
using common over-the-counter medicines to get
high," a FDA panel "considering whether or not to
recommend a prescription to buy them has
decided that it is not a good idea for now."

29. Red Flags In Screening/Early
Therapy
• Little or no relief using opioid therapy in acute/sub-
acute phases
• Diagnosis identified as one that hasn’t been shown
to have good success using opioids, i.e.
unidentifiable pain or pain associated with
physiological factors
• Patient request of opioid medication, with
inconsistencies in history, presentation, behaviors or
physical findings
• Inappropriate use of opioids within first 30 days of
therapy

30. Daily Equivalent Morphine
Dosage (MED)
• Computed utilizing dosages of all
opioid and opioid-containing
medication taken during a 24-hour
period
• 120 mg MED threshold as an indicator
of risk
• Patients receiving 100 mg or more per
day MED had a 9-fold increase in
overdose risk – most were medically
serious, 12% were fatal

31. MED (cont.)
National Council of Self-Insurers
• Early data show the 120 mg MED
guideline has played a part in
reducing injured-worker deaths
caused by the dramatic rise in opioid
prescribing

32. Best Practices
• Full evaluation of medical history and physical
examination
• Determine the lowest effective dose
• Set and agree upon goals. Use Pain Treatment
Agreement
• Use Step Therapy approach
• Actively monitor with Urine Drug Screening (UDS)
The purpose of UDS is to reveal not only the
presence of illicit substances, but also the
absence of the prescribed medication
• Stop use if pain is not at least partially relieved

33. Urine Drug Screening
• Start with baseline and
determine risk level with ORT,
then repeat randomly based on
level of risk

34. Long Term Use?
• Routine use not recommended for chronic pain
syndromes
• Can be carefully prescribed for select patients who
have not responded to other therapies
• Can be effective if improvement can be
documented in:
reduced pain
better quality of life
functional improvement
appropriate medication use
minimal side effects
• Periodically re-assess benefit-risk ratio

35. Risk Reduction Strategies
• Treatment plan
with clearly
defined objectives
• Use a written Pain
Treatment
Agreement to
clarify proper
medication
practices and
expectations for
relief

36. Risk Reduction Strategies
• Use a risk screening
tool such as the
Current Opioid Misuse
Measure (COMM) to
assess how medication
is being used
• Monitor compliance
with periodic Urine
Drug Screening
• Periodically decrease
dosage and try
alternate therapies to
reduce potential for
abuse or dependence

37. Evaluating Continued Use
• Use 4 A’s of ongoing monitoring:
Analgesia – Is there documented pain relief?
Activities of daily living – Normal function returning, not
just a patient-reported decrease in pain?
Adverse side effects – Are they minimal and tolerable?
Aberrant drug-taking behaviors – Are there “red flags”?
• Return to work?
• Prescriptions obtained from a single practitioner
• Prescriptions filled by a single pharmacy

38. Other Standards to Maintain
• Use of a
pain diary
• Continuing
UDS
• Documenta
tion of
misuse

39. When To Stop Treatment
Indicators should be well documented and include:
• Level of function – if no overall improvement, stop
therapy
• Continuing pain with intolerable adverse effects –
side effects may outweigh benefits
• Serious non-adherence in the way the patient takes
medication or in the manner it’s obtained
• Evidence of diversion, forgery, stealing or motor
vehicle accident related to opioids or other illicit
drugs
• Repeated violations of medication contract or
evidence of abuse/addiction

40. Risk Reduction is Key
Carefully balancing of benefits and risks is essential in
the treatment of injured workers
FDA Actions
• Focus on reducing overall risk with long-acting and
extended-release opioids
• REMS – require manufacturers to provide prescriber
training materials covering use, risks of misuse and
potential for abuse/addiction
• Encouraging development of abuse deterrent
formulations more difficult to alter in order to get
immediate release

41. When Should Your PBM Take
Action?
• 2 or more long-acting opioids
• Multiple pharmacies
• Multiple prescribers
• High dose opioids
• Opioid prescription for known substance abuser
• Injectable opioids for non-cancer patents
• Frequent physician changes within same specialty
• Prescribing patterns outside of pain management
or REMS guidelines

42. Principles of Chronic Opioid
Maintenance for Pain:
• Try aggressive rehabilitative approaches which aim to restore
function and reduce reliance on medications
• Ensure other treatment options have been maximized
• Consider opioid therapy as an adjunct; sole opioid therapy is
rarely successful
• Base regimen on long-acting opioids
• Ensure careful and regular follow-up
• Be prepared to wean and discontinue if treatment goals are
not met
• Careful evaluation of patient/Maintain good documentation
Ballantyne JC and LaForge KS, Opioid dependence and
addiction during opioid treatment of chronic pain, Pain.
2007;129:235-255.

43. NY Times Headline July 23, 2010:
“FDA Panel Opposes Plan to Tighten Use of Painkillers”
• In actuality, the panel supports restricting the use of
opioids
• The rejection was because the panel did not think
REMS for opioids was strong enough to actually
control the use of these drugs
• The panel voted 25 to 10 against the FDA plan, with
the primary reason for dissension being that the
plan did not require training for physicians that
prescribe these drugs.

44. Risk Evaluation and Mitigation
Strategies (REMS)
• Effective March 25, 2008 as part of the Food and
Drug Administration Amendments Act of 2007
• Provides the FDA with the authority to order REMS
for any drug or biological with significant toxicity
levels or demonstrable risk factors. Not limited to
opioids.
• REMS should ensure that the benefits of a drug
outweigh the risks.

45. Three components to a REMS program
• Medication guide or patient package
insert
• Communication plan for healthcare
providers
• Elements to assure safe use (ETASU)
Note: Not all drugs require all three
components.

46. For drugs requiring ETASU:
• Dispense drugs through specific
distribution channels
• Require specific training or certification
in order to prescribe
• Develop registry for patients
• Mandatory time sensitive reports of
patient responses to treatment

47. Update on Implementation of
Opioids REMS
• The central component of the Opioid REMS is an
education program for prescribers so that LA/ER
opioid drugs can be prescribed and used safely.
FDA expects the training to be conducted by
accredited, independent continuing education
(CE) providers.
• On November 4, 2011, FDA announced the
availability for public comment of a draft "Blueprint."
http://www.fda.gov/drugs/drugsafety/informationbydrugclass/
ucm163647.htm

48. Blueprint
• Prescribers should establish goals for
therapy and continuously evaluate
pain as well as functioning level and
quality of life.
• Prescribers should be aware of the
existence of Patient Provider
Agreements (PPAs), although FDA is
not requiring their use.
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/

49. PPAs
– PPAs are documents signed by both
prescriber and patient at the time an
opioid is prescribed. PPAs can help ensure
patients understand the goals of
treatment, the risks, and how to use the
medications safely.
• Utilizing PDMPs to identify potential abuse
where available
• Understanding the role of drug testing and
performing drug screens as indicated
• Screening and referring for substance abuse
treatment when indicated

50. List of TIRF Medicines Available Only
through the TIRF REMS Access Program
• ABSTRAL® (fentanyl) sublingual tablets
• ACTIQ® (fentanyl citrate) oral
transmucosal lozenge
• FENTORA® (fentanyl citrate) buccal
tablet
• LAZANDA® (fentanyl) nasal spray
• ONSOLIS® (fentanyl buccal soluble
film)