Bending the Curve of Opioid Misuse and Abuse

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1 Bending the Curve of Opioid Misuse and Abuse November 5,

2 About Helios Helios, the new name for Progressive Medical and PMSI, is bringing the focus of workers compensation and auto-no fault pharmacy benefit management, ancillary services, and Settlement Solutions back to where it belongs the injured party. Along with this new name comes a passion and intensity on delivering value beyond just the transactional savings for which we excel. To learn how our creative and innovative tools, expertise, and industry leadership can help your business shine, visit 2

3 Today s Webinar The presentation will last one hour All attendee phones are muted, but you can ask questions using the chat box on the right side of your screen. If we are unable to answer your question during the presentation, we will respond to you via shortly following the webinar There is no CE available for this webinar The slide deck will be ed out to all registrants of this webinar At the end of today s webinar, we ask that you complete a short survey to let us know if the information shared today was helpful and what information you d like us to cover in the future 3

4 Your Presenters Brian Allen, VP Government Affairs Matt Foster, PharmD Clinical Pharmacy Manager Kevin Tribout Exec. Director Government Affairs 4

5 OPIOID UTILIZATION 5

6 Opioid Utilization Opioid analgesic usage maintains a significant presence both on individual claims and as a whole in workers compensation 2013 Top Therapeutic Classes as a Percentage of Total Spend 31% Group Health: Average national share of opioid analgesics to all prescriptions hovers around 25% Source: Progressive Medical and PMSI 2014 Drug Trend Report 6

7 Opioid Utilization 2013 Top Long-Acting Opioid Analgesics ranked by Total Opioid Spend Oxycodone (OxyContin ) 43% Fentanyl TD Patch (Duragesic ) Morphine ER (Kadian, MS Contin ) Oxymorphone ER (Opana ER) Hydromorphone (Exalgo ) Tramadol SR (Ultram, Ryzolt ) Morphine ER (Avinza ) Buenorphine TD Patch (Butrans ) Tapentadol ER (Nucynta ) Methadone 17% 13% 10% 4% 4% 3% 3% 2% 1% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Source: Progressive Medical and PMSI 2014 Drug Trend Report 7

8 Why Is This a Concern in Workers Compensation? Most patients enter the workers compensation system due to physical injury, which often requires treatment for pain Most common injuries include: Sprains, strains Burns Lacerations, punctures Treatment of pain is a major issue in workers compensation The longer the claim remains open, the greater the likelihood opioids will be used to treat chronic pain 8

9 Use of Medications by Class in Workers Compensation 9

10 INJURED WORKER ACTIONS THAT HINDER OPIOID MANAGEMENT 10

11 Injured Worker Actions That Hinder Opioid Management Doctor/Pharmacy Shopping Pill Mills Beating the Urine Drug Test Rent-a-Pill Operations Forged Prescriptions 11

12 Epidemiology of Overuse Sources: Centers for Disease Control and Prevention (CDC) 12

13 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 who aren't so diligent in their prescribing practices Shoppers often work in groups and track where they had successes and failures 13

14 Pill Mills Accept cash only No physical exam performed No medical records or X-rays 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 14

15 Beating the Urine Test 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 15

16 Rent-a-Pill Operations When prescribers demand a claimant submit to drug counts (random or not), claimant must bring in their prescription bottles. The quantity remaining should match up to the prescribed dose. Example: An injured worker is prescribed 60 OxyContin tablets with the dosage of one pill twice a day The prescription is dispensed on 2/15 The injured worker is asked to bring in the bottle for a pill count at their office visit on 2/28 Rent-a-Pill: Rent-a-Pill operations have supplies of various products and from multiple manufacturers so your pills look alike. The injured worker can pay a fee to rent the pills needed for their upcoming office visit. 2/28 minus 2/15 = 13 days x 2 tabs/day = 26 should be gone The bottle should have 34 (+/- one) remaining 16

17 Forged Prescriptions There are multiple ways to create and edit prescription pads online Replace prescriber s phone number with another number Cut the pad down to the correct size John Smith 123 Main Street OxyContin tabs 10 mg 2x daily For demonstration only 11/5/2014 2/19/1965 Dr. Example 17

18 CLINICAL TOOLS FOR OPIOID MANAGEMENT 18

19 Clinical Tools for Opioid Management Formularies Treatment Agreements Documentation of Care PDMPs Drug Testing Prescribing Control 19

20 Formularies A formulary is a list of medications that may or may not require prior authorization before being prescribed and/or dispensed by a pharmacy Several states have implemented workers compensation formularies, with variable success. Texas: Official Disability Guidelines (ODG)-based closed formulary legislated for all nonsubscribers; N drugs require pre-authorization, all other medications may undergo retrospective UR for relatedness/appropriateness to claim. Compounded medications are allowed as long as no N drug ingredients. Oklahoma: ODG-based closed formulary, but voluntary; Y drugs are authorized, N drugs require authorization. All compounded medications require authorization, regardless of ingredients. Ohio: State-based workers compensation formulary Wyoming: State-based workers compensation formulary Washington: Preferred Drug List (PDL), Formulary, and Treatment Guidelines PBM based: General, injury based 20

21 Opioid Treatment Agreements An important obligation between the prescribing physician and patient Limitations of opioid use in controlling the pain in question Possible side effects of long-term use Risks of opioid dependency Importance of therapy and other activities to relieve the symptoms of the injury Patient s responsibilities, including full disclosure of all substances being taken and participation in urine drug screens as required by adopted treatment protocols Renew annually with any patient on the continued use of opioids 21

22 Documentation Example Justify the Treatment Plan Define the role of all medications Treatment plan for current and future medications Plan for follow-up 22

23 Inappropriate Follow Through Notes state drug test is negative for all medications, BUT the prescriber still writes a prescription for Percocet and Duragesic. If it isn t in the patient, where is it, exactly? What do you expect of that next drug screen? Do pharmacy records support these results?! 23

24 Prescription Drug Monitoring Programs (PDMPs) Support access to legitimate medical use of controlled substances Identify, deter, or prevent drug abuse and diversion Facilitate and encourage the identification, intervention with, and treatment of persons addicted to prescription medications Inform public health initiatives through outlining use and abuse trends Educate individuals about PDMPs and the use, abuse, and diversion of and addiction to prescription medications Challenges and Opportunities: Often understaffed and underfunded in state budgets (California and Florida) Needs better interaction across state borders and include PBMs Delaware and New Jersey just implemented a sharing pact 24

25 PDMP Results 2011 Pain Medicine Journal Drug overdoses increased in states with or without PDMPs Minimal impact on reducing drug overdoses and opioid consumption States lacked funds and efforts sparse Often underfunded at state level and understaffed Data is there but is it used properly? PDMPs need to recognize role of pharmacist and PBM in viewing data 25

26 Prescription Drug Monitoring Programs WA VT ME AK OR CA NV ID UT AZ MT WY CO NM ND MN WI SD IA NE IL KS MO OK AR MS TX LA NY MI PA IN OH WV VA KY NC TN SC AL GA FL N H MA RI CT NJ D MD E DC HI Operational PDMP (Prescription Drug Monitoring Program) Enacted Legislation, but PDMP not yet operational No PDMP Data Reflects published state statutes/regulations on PDMP Operations Current as of Sept

27 PDMP: Access to Information WA VT ME AK OR CA NV ID AZ UT MT WY CO NM ND MN SD IA NE KS OK TX MO WI IL AR MS LA MI 2 OH IN KY TN AL NY PA WV VA NC 1 SC GA FL NH RI CT NJ DE MD DC HI To prescribers, pharmacists, law enforcement and licensing entities (21) To prescribers, pharmacists and law enforcement only (4) To prescribers, pharmacists and licensing entities only (2) To prescribers and pharmacists only (5) To law enforcement and licensing entities only (3) To prescribers only (3) To prescribers and law enforcement only (1) Law enforcement only (2) Licensing entities only (1) Practitioners and licensing entities only (1) 1 North Carolina provides unsolicited reports to the Attorney General who has the discretion to forward the information to law enforcement. 2 Michigan sends alerts to physicians when a patient surpasses the threshold but does not send the actual report. Accessed Oct

28 Drug Testing Testing of biological specimens for the presence of medications and drug metabolites Urine Blood Saliva Hair Types of urine drug tests In Provider s Office (Point of Care) Screening Laboratory Testing 32.08% 67.2% Did not detect the prescribed medication(s) Detected an illicit substance Detected a Non- Prescriber Drug Screening (Immunoassay) Consistent Results Inconsistent Results Confirmatory Testing (High Performance Chromatography/Mass Spectrometry) 28

29 Tips for Physicians to Control Prescribing Securing Prescriptions Keep control of prescription pads Limit the ability of employees to have access privileges to prescription pads and office dispensing machines Patient Activities to Be Aware Of 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 Traveling long distance to see doctor Puppeteering (bring in family member and direct choice of medications) 29

30 PHARMACEUTICAL INDUSTRY ACTIONS FOR OPIOID MANAGEMENT 30

31 Pharmaceutical Industry Actions for Opioid Management Abuse Deterrent Formulations Reformulations REMS 31

32 Crush Resistant Formulations Crush resistant formulations have a harder shell Opana ER (hydromorphone) Zohydro ER (hydrocodone) It is still possible to crush into a powder and abuse the opioid as an injection or inhalation instead of the intended time release dose; a generic version of Opana ER is available that is not crush resistant Zohydro, a single agent form of hydrocodone was approved in 2013 without any abuse deterrent properties, creating a public outcry of having another opioid available that could be easily abused Hydrocodone is the same opioid as found in Vicodin, Lortab, and Norco, but without the acetaminophen that limited its abuse potential due to liver toxicity There are efforts underway to ban at a state-based level 32

33 Effect of Abuse Deterrent Opioids Abuse deterrent formulation of OxyContin decreased the rate of abuse of OxyContin However, there was an increase in the use of other opioids Even more disturbing was the increase in the rise of heroin use coinciding with the decrease in OxyContin use Source: N Engl J Med 2012; 367:

34 Risk Evaluation and Mitigation Strategy (REMS) September 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 34

35 TREATMENT GUIDELINES

36 Workers Compensation Drug Utilization Controls WA VT ME AK CA OR NV ID AZ UT MT WY CO NM ND MN SD IA NE KS OK TX MO WI IL AR MS LA MI OH IN KY TN AL NY PA WV VA NC SC GA N H MA RI CT NJ DE MD DC FL HI WC Treatment Guidelines WC Treatment Guidelines as well as PDL/State WC Specific Formulary WC Treatment Guidelines and WC Closed Formulary None Data Reflects most current published jurisdictional medical treatment guidelines (prescription drug usage specifically) for workers compensation Current as of Sept

37 State Opioid Rules WA VT ME AK OR CA NV ID AZ UT MT WY CO NM ND MN WI SD IA NE IL KS MO OK AR MS TX LA MI OH IN KY TN AL NY PA WV VA NC SC GA FL NH MA RI CT NJ DE MD DC HI Preauthorization by employer for pain management program Requires step process for prescription opioids Requires preauthorization on some opioids Requires further action for long-term opioid use States either studying or pending regulations No rules or pending regulations 37

38 Use of Services Recommended by Guidelines for Chronic Opioid Management Prescribers still underutilize recommended monitoring parameters when prescribing opioids in chronic pain 25-State Median Range for State between 20 th and 80 th Percentile Range for all 25 States for Each Measure Minimum Maximum Minimum Maximum % of cases that had urine drug testing 2008/ % 11% 28% 3% 37% 2010/ % 14% 36% 6% 42% % of cases that had psychological evaluations 2008/2010 6% 4% 10% 2% 31% 2010/2012 5% 4% 9% 2% 32% % of cases that had psychological treatments/reports 2008/2010 5% 2% 8% 1% 18% 2010/2012 4% 3% 8% 1% 14% % of cases that had active physical medicine 2008/ % 84% 89% 80% 90% 2010/ % 85% 91% 75% 96% Wang, Dongchun. Longer-term use of opioids, 2 nd edition. WCRI May

39 PUBLIC POLICY ACTIONS AND RESULTS

40 Regulation and Legislation Regulation Arizona to initiate a pilot program on opioid usage Massachusetts moving to prohibit prescribing and dispensing of Zohydro Ohio has a state-based workers compensation formulary Wyoming has a state-based workers compensation formulary DEA Reclassifies all HCPs as Schedule II medications (Impact at state level) Reclassified Tramadol as a Schedule IV medication Impact to PDMP reporting Legislation California SB 809 Saves PDMP Program from budget cuts Kentucky HB 1 Requires reporting to state PDMP within one day Restricts office dispensing of CII and CIII HCPs to 48 hours Louisiana SB 618 Reclassifies Carisprodol as Schedule II medication Oklahoma HB 1783 Restricts refills on all HCPs Tennessee SB 1663 Prohibits office dispensing of opioids/benzodiazepines (30 days) West Virginia HB 4208 Reclassifies all HCPs as Schedule II medications 40

41 Delaware Preferred Drug List Preferred and non-preferred drugs Proof of non-preferred drug usage and written justification (state format) for all preferred drugs Prior written authorization OxyContin, Oxycodone ER, Actiq and transmucosal Fentanyl 41

42 Oklahoma Closed Formulary Adopted closed formulary Effective February 1, 2014 Utilizes ODG Drug Appendix A to classify drugs Requires pre-authorization for all N drugs, compounded medications, and experimental drugs 42

43 New York I-Stop Expanded PDMP reporting and access requirements for prescribing doctors and pharmacies Prompted a real-time PDMP reporting/viewing and shortened days for reporting Required eprescribing of prescriptions and eventual eprescribing of narcotics Rescheduled all HCPs to Schedule II from Schedule III controlled substance 43

44 New York I-Stop Rx for Hydrocodone w/no substitutes 7.9% No change in prescribing 68.0% No change in prescribing 68.0% Decrease in Hydrocodone 0.9% Increase in Hydrocodone 7.5% Switched to NSAIDs 3.5% Switched to Oxycodone 2.9% Switched to Tramadol 1.6% Switched to other Opioids 2.6% Switched to many medications 5.2% 44

45 Washington Preferred Drug List and Outpatient Drug Formulary Preferred Drug List (PDL) State Preferred Drug List from which Dept of L&I uses a subset for WC Non-preferred medications generally require prior-authorization Outpatient Drug Formulary Formulary developed by P&T Committee Medications are permitted or require prior authorization; medications not prior authorized can be denied 45

46 Texas Closed Formulary New claims impacted in 2011 and legacy claims in 2013 Official Disability Guidelines (ODG) Drug Appendix A classifies drugs N drugs deemed not medically necessary (front line usage) Usage of N drugs require prospective utilization review for medical necessity 46

47 Positive Results: Texas Closed Formulary Share of N-Drug Cost in the Total Cost by Claim Type by Service Month 47

48 Positive Results From Florida MMWR July 4, 2014 / 63(26);

49 SUMMARY AND LOOKING AHEAD

50 Summary Opioids are an 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 opioid prescribing Pharmaceutical options for treating pain in high-risk patients Prescribers must be aware of issues of inappropriate use of opioids 50

51 Controlling Opioids Treatment Guidelines Pain Specific Prescribing Specific Comprehensive Addiction Monitoring/Treatment More Systematic and Coordinated UDM Structured Weaning Programs 51

52 Prescription Drug Monitoring Programs (PDMPs) Missouri joins the rest of the country Movement to mandatory participation by providers Mandatory review of database prior to prescribing or dispensing Mandatory entry of prescriptions following prescribing or dispensing More aggressive investigation/enforcement Law enforcement more engaged in tracking patterns More scrutiny on prescribers and dispensers Individuals with multiple entries National database sharing State compacts or national database 52

53 Evolution of PDMPs Real-Time Data Entry and Sharing Automated Lookup 53

54 State Imposed Formularies Closed Formularies Limited, Drug Specific, Formularies Advantages/Disadvantages Want to learn more? Controlling Utilization Through Formularies Wednesday, December 3, 2014, 2:00 pm 3:00 pm ET 54

55 Thank You! Questions? A link to the slide deck will be sent out to all of today s registrants in an Visit us at NWCDC Booth #1223 Visit to register for our upcoming webinar: Controlling Utilization Through Formularies Wednesday, December 3, 2014, 2:00 pm 3:00 pm ET Please take our short survey 55

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