SCWEA Meeting Charleston, SC Feb 27, 2011

1. SCWEA MeetingCharleston, SCFeb 27, 2011 Appropriate Opioid Management Matthew Foster, PharmD Clinical Pharmacy Manger, PMSI

2. Overview • Medication use for treatment of chronic pain • Adverse effects of narcotics (abuse/addiction) • Appropriate pain management for narcotics • Legislative efforts for appropriate pain management • Pharmaceutical industry efforts for appropriate pain management • Patient activities to subvert appropriate pain management monitoring

3. Top Injuries in Workers Compensation • Most patients enter the workers’ compensation system due to some type of physical injury • Physical injuries often require treatment for pain • Most common injuries include • Sprains, strains • Burns • Lacerations, punctures, amputations • Therefore, treatment of pain is major issue in workers compensation

4. Medication Management of Chronic Pain • Choice of initial agent dependent upon type of pain present • World Health Organization pain ladder commonly used • Opioid for moderate to severe pain +/- Non-Opioid +/- Adjuvant Increased or Persisting Pain • Opioid for mild to moderate pain +/- Non-Opioid +/- Adjuvant • Non-Opioid

5. Common Medications in Pain Management • Non-steroidal ant-inflammatory drugs (NSAIDs) • Ibuprofen (Motrin), Naproxen (Aleve), Celecoxib (Celebrex) • Narcotic Analgesics • Short-acting • Oxycodone-Acetaminophen (Percocet), hydrocodone-acetaminophen (Vicodin, Lortab), tramadol (Ultram) • Long-acting • Oxycodone (Oxycontin), fentanyl (Duragesic), Morphine (Kadian, Avinva, MS Contin, Embeda) • Topical Analgesics • Topical NSAIDs • Diclofenac (Voltaren Gel, Pennsaid, Flector patches) • Topical Anesthetics • Lidocaine patch (Lidoderm) • Adjuvants • Duloxetine (Cymbalta), Pregabalin (Lyrica)

6. Use of Narcotics and Other Drug Classes in the First Year after Injury • Early use of narcotics decreasing • Other medication classes being used to treat early injuries more commonly

7. Use of Medications by Class in Workers’ Comp • Early use decreased, but in those claimants needing continued treatment of chronic pain conditions, narcotic use INCREASES

8. Opioid Analgesics: Adverse Effects Physical Dependence • “…a state of adaptation that is manifested by a drug class-specific abstinence syndrome following abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist” • Also occurs in antihypertensives and steroids • Not a problem when dosage tapered during discontinuation Pseudo-addiction • “…patient behaviors that may occur when pain is under-treated” • NOT the same as addiction • May appear to be drug-seeking • Behaviors will subside when optimal pain control achieved

9. Opioid Analgesics: Adverse Effects Addiction • “…a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations” • “…impaired control over drug use, compulsive use, continued use despite harm and craving” • Prevalence uncertain in chronic pain patients • One study only occurred in about 2% of enrolled patients • Probably closer to general rate of additions in society (7-11%)

10. Prevalence of Narcotic use • Across the country, there is an increase in the number of ER visits due to non-medical use of narcotics • Up to 89% of abused prescription drugs are diverted from legally written prescriptions • In 1994-2004, there was a 550% increase in unintentional drug overdose mortality Problem isn’t just with narcotic prescribing, but with how they are used once in the hands of the public

11. Narcotics Prevalence in Society • Narcotics commonly used to treat pain • Issues with safety of NSAIDs (Vioxx, Bextra, etc) drove higher use of narcotics in treatment of injuries • Issues with safety of antiinflammatory drugs in elderly (cardiovascular complications) drove increase in use in elderly for treatment of pain • Even in animals…

12. What prescribers should be doing to conduct appropriate pain management • Enact treatment plans • Documentation of results of patient response • Continued maintenance of therapy and reassessment • Conduct pill counts to ensure compliance • Periodic monitoring through drug testing (urine or blood)

13. Taking control of your prescribing • Tips for doctors on how to avoid doctor shoppers and drug diverters • Keeping control of their prescription pads • Limit the ability of employees to have access privileges to prescription pads, office dispensing machines • Patient activities to watch out for • Patients allergic to everything but one specific drug • Patients with all the right answers about pain thresholds, while taking large quantities of pain medications • Cash patients • Travellers (live >50 miles away) • Puppeteering (bring in family member and direct choice of drugs)

14. Drug Testing • Testing methods available • Urine stand alone kits • Stand alone kits test for limited drugs, potential false positives • Kits only test for a limited set of drugs • Urine test alone can only test for recent use of a drug, not current use or compliance with therapy • Blood tests • Much more accurate; no false positives

15. Treatment plans and documentation • Example of documentation to justify the treatment plan • Define the role of all medications • Treatment plan of current and future medications • Plan for follow-up

16. Treatment Plans and Documentation • Example of a sheet to help the prescriber assess all aspects of narcotic management • Great tool, but only as good as the information it provides • What’s the plan?!!

17. Treatment Plans and Documenation • Example of documentation with inappropriate follow through • Notes state drug test is negative for all meds, BUT the prescriber still goes ahead and writes for Percocet and Duragesic • If it isn’t in the patient, where is it, exactly? • What do you expect of that next drug screen? • Did pharmacy records support these results?!

18. Treatment Plans and Documentation • Aside from the dates, can you make anything out of this?

19. What is being done Legislatively to ensure appropriate pain management • Prescription pads/ ePrescribing • Texas legislation for ODG formulary • NY Pain Guidelines • State Monitoring programs • FDA updates • Removal of propoxyphene products from the market • Dose limitations for acetaminophen products

20. Prescriptions • Prescription pads can be bought with tamper resistant technology • Security watermarks, colored backgrounds, etc • Still only as good as security to keep that pad out of patient’s hands! • ePrescribing • Securely send the prescription to the (registered) pharmacy of choice • Not valid for C-II prescriptions (yet)

21. Texas ODG Formulary • House Bill 7 mandated Texas enact a closed formulary system for workers’ compensation • Decision to use the Official Disability Guidelines (ODG) as the source for deciding what is allowed for treatment of injured workers

22. New York Treatment Guidelines • Implements new treatment guidelines for medical care – back, neck, shoulder and knee – based upon ACOEM national guidelines • Medical providers must adhere to treatment guidelines and recommendations; can deviate for emergency care if variance from guidelines is approved • Some treatments (even recommended by guidelines) require prior authorization; for prior authorization, providers must fill out a C-4 Authorization form • Treatment guidelines also contain recommendations for drug therapy and prescribing of medications by treating doctors • Aimed at length and legitimacy of narcotics and steroids • Sets optimum durations and steps for use of specific drugs

23. Prescription Drug Monitoring Program • Goals/Objectives of having a PDMP • Support access to legitimate medical use of controlled substances • Identify and deter or prevent drug abuse and diversion • Facilitate and encourage the identification, intervention with and treatment of persons addicted to RX drugs • Inform public health initiatives through outlining of use and abuse trends and • Educate individuals about PDMPs and the use, abuse and diversion of and addiction to RX drugs • Prescription information from pharmacies, outpatient clinics, prescriber offices sent to a central data store • Allow health care practitioners to get a snapshot of controlled substance use by their claimant

24. Scripts Rx (South Carolina)

25. FDA Propoxyphene Market Recall • Propoxyphene (Darvocet, Darvon) removed from Market November 2010 • Of those claimants receiving propoxyphene before the recall • 12% were acute injuries and most likely didn’t require further treatment • 50% switched to other short-acting opioids (Tylenol #3, Ultram, Vicodin, etc.) • 38% apparently did not continue on anything (but may be too early to tell)

26. Dose limits for Acetaminophen Products • Over next three years, FDA mandates that the acetaminophen component of combination products be limited to no more than 325 mg • Goal is to reduce potential toxicity of cumulative dose of acetaminophen exceeding 4 grams per day

27. What is being done by the industry to ensure appropriate pain management • Abuse resistant formulations • Reformulations of existing products • Oxycontin • REMS • New drugs/formulations for getting patients “detoxed” • Suboxone, Subutex

28. Abuse Resistant Formulations • Embeda • Sustained release morphine beads • Beads also contain naloxone pellets • When Embeda is crushed or chewed, pellets are opened releasing naloxone which counteracts effects of morphine and other narcotics • Acurox • “Oxycontin + niacin” • When crushed, release niacin (uncomfortable flushing reaction • Able to be mostly averted by taking an aspirin first

29. Oxycontin Reformulation • Oxycontin released version with “harder shell” • Went through FDA as a reformulation, not as an “abuse resistant” formulation • Crushed tablets are chunkier, and less able to be used for snorting or injecting • Also helps extend out Oxycontin patent for when generics will be possible in 2012

30. REMS (Risk Evaluation and Mitigation Strategy) • September 2007 - Food and Drug Administration Amendments Act (FDAAA) • REMS may be required at any stage of the product lifecycle • Manufacturer: • 120 days to submit REMS for a marketed drug • Must be part of NDA for new drug • FDA has issued an outline of specific elements that have to be included in the proposed document. • Medication guide • Communication plan • Elements to assure Safe use • Implementation plan • Timetable for submission of assessments.

31. Suboxone/Subutex • Buprenorphine (Subutex) and Buprenorphine-Naloxone (Suboxone) used in the outpatient management of narcotic dependence to “detoxify” a patient off of narcotics • Physicians with additional training can prescribe buprenorphine products in effort to wean a patient off of narcotics • Buprenorphine provides analgesic effects as well as blocks other narcotics effects • Allows outpatient management of narcotic addiction program, as opposed to inpatient treatment programs or methadone clinics • Goal is to get the patient completely off of narcotics, not just substitute one for another via medically supervised withdrawal • http://buprenorphine.samhsa.gov/

32. What are the patients doing to block efforts at appropriate pain management and monitoring strategies • Doctor shopping • Pain clinics/pill mills • Cheating urine drug tests • Rent a pill • Forged prescription pads

33. Doctor/Pharmacy Shopping • Going to different prescribers or pharmacies, under same or other identities, in order to get multiple prescriptions for narcotics • Able to obtain “legitimate” prescriptions, as well as find those doctors that aren't so diligent in their prescribing practices • Shoppers often work in groups • Track where they had successes and failures

34. Pill Mills • Prevalent in Florida, Texas • Signs of a pill mill: • Accept cash only • No physical exam is given • No medical records or x-rays are needed • You get to pick your own medicine, no questions asked • You are directed to "their" pharmacy • They treat pain with pills only • You get a set number of pills and they tell you a specific date to come back for more • They have security guards • There may be huge crowds of people waiting to see the doctor • Efforts under way to legislatively stop these from occurring

35. Beating the Urine Tests • Multiple commercial products available to attempt to mask results of urine tests • Availability of clean urine (synthetic or real!) • Don’t forget the delivery device! • Urinator, Wizzinator • Refusal for testing • Religious grounds, moral grounds, etc • Knowing the false positives for office based tests • Opioids -> fluroquinolone antibiotics (Levaquin) • Benzodiazepine -> oxaprozin (NSAID) • Amphetamines -> Vick’s inhaler

36. Rent a Pill • When prescribers demand claimant submit to drug counts (random or not), claimant must bring in their prescription bottles • Quantity left should match up to prescribed dose • Example • 60 Oxycontin, twice daily, dispensed 2/15; patient asked to bring in bottle for pill count at office visit on 2/28 • 2/28 minus 2/15 = 13 days x 2 tabs/day =26 should be gone • Bottle should have 34 (+/- one) remaining • Rent a Pill operations have supplies of various products and from multiple manufacturers (so your pills look alike) • Pay a fee to rent the pills for your office visit

37. Forging Prescriptions • With today’s technology, it isn’tdifficult to create a forged prescription pad • There are multiple avenues to create and edit your own prescription pads online • Replace prescribers phone number with another number • Cut the pad down to the correct size

38. Summary • Narcotics are still a very important tool in pain management, but must be prescribed and monitored appropriately • When inappropriate activity occurs, prescribers should take appropriate actions • Legislative efforts have been enacted to crack down on inappropriate narcotic prescribing • Pharmaceutical options for treating pain in high risk patients • Prescribers must be aware of issues of inappropriate use of narcotics Tomorrows lecture will get more into these issues of how insurers can work with their pharmacy benefit manager to uncover high risk and/or inappropriate use of narcotics

39. Narcotic diversion mug shots

40. Thank you, celebrities, for being positive role models!!