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Managing Risk -Identifying Issues in   the Workplace       April 10-12, 2012Walt Disney World Swan Resort
Accepted Learning Objectives:1.  Identify the signs and symptoms of drug    addiction.2.  Describe the proper procedure fo...
Disclosure Statement•  Det. Ryan Buzzini has disclosed no   relevant, real or apparent personal or   professional financia...
“Doctors pour drugs, of which they knowlittle, for diseases, of which we know less,      Into patients—of which we know   ...
•  From 1991 to 2009, prescriptions for   opioid analgesics increased almost   threefold, to over 200 million.•  Overdoses...
Prescription opioid overdose is now the secondleading cause of accidental death in the U.S., killingmore people than heroi...
In Worker’s Compensation“The abuse of prescription opioids hasbecome a grave personal risk to injuredworkers, a disruptive...
•  Temporary disability payments are 3.5 times higher   when opioids are prescribed•  A study of 17 states found that many...
Drug Use Statistics•  80% of the world’s supply of opioids is   consumed in the US•  99% of the world’s supply of   hydroc...
Search Results:    “undertreatment of pain”April 15, 2011 “Despite Awareness,  Undertreated Cancer Pain Persists”July 5, 2...
Commonly Prescribed Drugs                       (from all payer types)        Atorvastatin         AmoxicillinHydrocodone ...
Drug Enforcement        Administration–  Bureau of Prohibition 1927-1930–  Bureau of Narcotics 1930-1968–  Bureau of Narco...
Role of the DEA–  Controlled Substances    •  Narcotics vs. Opioids    •  Illicit drugs    •  Diversion of prescription dr...
Controlled Substances•  Schedule II    –  Rx cannot be phoned or faxed to       pharmacy    –  Rx cannot be refilled•  Sch...
Schedule IIExamples•  Actiq (oral transmucosal fentanyl citrate,   OTFC)•  Avinza (morphine sulfate)•  Dolophine, Methados...
Schedule III and IV•  Darvocet N 100 (propoxyphene napsylate   and APAP)•  Tylenol #3 (codeine with acetaminophen)•  Vicod...
Schedule V•  Codeine containing cough syrups•  Certain paregoric formulations
Tolerance•  Tolerance is a state of adaptation in which   exposure to a drug induces changes that   result in a diminution...
Physical Dependence•  A state of adaptation that is manifested by   a drug class-specific withdrawal syndrome   that can b...
Addiction Concensus Medical Definition•  “A primary, chronic neurobiological   disease with genetic, psychosocial and   en...
Addictive Behaviors•  Addictive behaviors include one or more of   the following:   –  Impaired control over drug use   – ...
Opioid Effects:          Analgesia and Reward•  General                   •  Reinforcing effects   –  Analgesia           ...
Pseudoaddiction•  Behaviors that may occur when pain is   inadequately treated•  Patients may become focused on   obtainin...
Diversion•  The use of a legitimately prescribed   medication for illicit or illegitimate   purposes—perhaps with the inte...
Aberrant Behavior vs Abuse                                               Aberrant                                         ...
What about Schedule I?•  Highest potential for   abuse and   addiction•  No approved   medical use•  Cocaine (CS II)•  Her...
FDA Panel Votes Against  Requiring Prescriptions For    Medicines Containing     Dextromethorphan.NBC Nightly News (9/14) ...
Red Flags In Screening/Early             Therapy•  Little or no relief using opioid therapy in acute/sub-   acute phases• ...
Daily Equivalent Morphine      Dosage (MED)•  Computed utilizing dosages of all   opioid and opioid-containing   medicatio...
MED (cont.)National Council of Self-Insurers•  Early data show the 120 mg MED guideline has played a part in reducing inju...
Best Practices•  Full evaluation of medical history and physical   examination•  Determine the lowest effective dose•  Set...
Urine Drug Screening•  Start with baseline and   determine risk level with ORT,   then repeat randomly based on   level of...
Long Term Use?•  Routine use not recommended for chronic pain   syndromes•  Can be carefully prescribed for select patient...
Risk Reduction Strategies•  Treatment plan   with clearly   defined objectives•  Use a written Pain   Treatment   Agreemen...
Risk Reduction Strategies•  Use a risk screening   tool such as the   Current Opioid Misuse   Measure (COMM) to   assess h...
Evaluating Continued Use• Use 4 A’s of ongoing monitoring:Analgesia – Is there documented pain relief?Activities of daily ...
Other Standards to Maintain                •  Use of a                   pain diary                •  Continuing          ...
When To Stop TreatmentIndicators should be well documented and include:•  Level of function – if no overall improvement, s...
Risk Reduction is KeyCarefully balancing of benefits and risks is essential inthe treatment of injured workersFDA Actions•...
When Should Your PBM Take              Action?•    2 or more long-acting opioids•    Multiple pharmacies•    Multiple pres...
Principles of Chronic Opioid       Maintenance for Pain:•  Try aggressive rehabilitative approaches which aim to restore  ...
NY Times Headline July 23, 2010:      “FDA Panel Opposes Plan to Tighten Use of Painkillers”•  In actuality, the panel sup...
Risk Evaluation and Mitigation         Strategies (REMS)•  Effective March 25, 2008 as part of the Food and   Drug Adminis...
Three components to a REMS program•  Medication guide or patient package   insert•  Communication plan for healthcare   pr...
For drugs requiring ETASU:•  Dispense drugs through specific   distribution channels•  Require specific training or certif...
Update on Implementation of         Opioids REMS•  The central component of the Opioid REMS is an   education program for ...
Blueprint•  Prescribers should establish goals for   therapy and continuously evaluate   pain as well as functioning level...
PPAs–  PPAs are documents signed by both   prescriber and patient at the time an   opioid is prescribed. PPAs can help ens...
List of TIRF Medicines Available Only through the TIRF REMS Access Program•  ABSTRAL® (fentanyl) sublingual tablets•  ACTI...
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Managing Risk - Identifying Issues in the Workplace
National Rx Drug Abuse Summit 4-10-12

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  1. 1. Managing Risk -Identifying Issues in the Workplace April 10-12, 2012Walt Disney World Swan Resort
  2. 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. 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. 4. “Doctors pour drugs, of which they knowlittle, for diseases, of which we know less, Into patients—of which we know nothing.” —Voltaire
  5. 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. 6. Prescription opioid overdose is now the secondleading cause of accidental death in the U.S., killingmore people than heroin and cocaine combined.
  7. 7. In Worker’s Compensation“The abuse of prescription opioids hasbecome a grave personal risk to injuredworkers, a disruptive force in the lives ofthose close to claimants harmed by abuse,and a cost concern to other stakeholders inthe United States workers’ compensationsystem.” Joint statement of ACOEM and IAIABC
  8. 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. 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 USManchikanti, L. National Drug Control Policy and Prescription Drug Abuse: Facts and Fallacies. Pain Physician. 10:399-424, 2007.
  10. 10. Search Results: “undertreatment of pain”April 15, 2011 “Despite Awareness, Undertreated Cancer Pain Persists”July 5, 2011 “Pain Common but Undertreated”, www.medscape.comJuly 11, 2011 “Case Report: Undertreatment of Pain in a 40-Year- Old Woman”, Psychiatry WeeklyETC.
  11. 11. Commonly Prescribed Drugs (from all payer types) Atorvastatin AmoxicillinHydrocodone Comb. Oxycodone Comb.Propoxyphene Comb.Tramadol and Comb. Codeine Comb. Oxycodone Other Opioids Fentanyl Morphine Number of Prescriptions (in millions) IMS 2005
  12. 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. 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. 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. 15. Schedule IIExamples•  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. 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. 17. Schedule V•  Codeine containing cough syrups•  Certain paregoric formulations
  18. 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 drugs effects over time•  Tolerance develops at different rates, in different people, to different effects
  19. 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. 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 forthe Treatment of Pain. Available at: http://www.ampainsoc.org/advocacy/opioids2.htm.
  21. 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) –  CravingSavage SR, et al. J Pain Symptom Manage. 2003;26(1):655–667.[Evidence Level C]
  22. 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, vomitingClinical Manual Addiction Psychopharmacology, 2005.
  23. 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. 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. 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;
  26. 26. What about Schedule I?•  Highest potential for abuse and addiction•  No approved medical use•  Cocaine (CS II)•  Heroin•  Marijuana•  Methamphetamine
  27. 27. 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."
  28. 28. 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
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. Urine Drug Screening•  Start with baseline and determine risk level with ORT, then repeat randomly based on level of risk
  33. 33. 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
  34. 34. Risk Reduction Strategies•  Treatment plan with clearly defined objectives•  Use a written Pain Treatment Agreement to clarify proper medication practices and expectations for relief
  35. 35. 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
  36. 36. 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
  37. 37. Other Standards to Maintain •  Use of a pain diary •  Continuing UDS •  Documenta tion of misuse
  38. 38. When To Stop TreatmentIndicators 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
  39. 39. Risk Reduction is KeyCarefully balancing of benefits and risks is essential inthe treatment of injured workersFDA Actions• Focus on reducing overall risk with long-acting andextended-release opioids• REMS – require manufacturers to provide prescribertraining materials covering use, risks of misuse andpotential for abuse/addiction• Encouraging development of abuse deterrentformulations more difficult to alter in order to getimmediate release
  40. 40. 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
  41. 41. 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 documentationBallantyne JC and LaForge KS, Opioid dependence and addiction during opioid treatment of chronic pain, Pain. 2007;129:235-255.
  42. 42. 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.
  43. 43. 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.
  44. 44. 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.
  45. 45. 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
  46. 46. 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
  47. 47. 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/
  48. 48. 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
  49. 49. 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)
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