Up and Away with Opioids

Transcription

1 Up and Away with Opioids id A clinical discussion about use and abuse Presented by: Michael Giusani, R.Ph. Clinical Pharmacist RJ Health Systems (a partner of ScripNet) Michael Seise, PharmD Clinical Pharmacist Healthesystems September 19, 2012

2 Agenda / Summary Overview 1 2 The Problem and What s at Stake Clinical Discussion Top Drugs, Dosing, Addiction,Dependence Evidence Based Medicine Appropriate Use of Opioids Case Studies Real World Examples 3 Roundtable What is Your State Doing to Address these Issues? 4 Solutions: What You Can Do in Your Workers Comp Program Slide 2

3 The Problem 19% of work comp spend is attributable to drugs Narcotics are 34% of that drug spend 423% increase for opioids for back pain in the past 10 years The longer a claim remains open, the costlier it becomes Insurance companies increasing retention levels or not underwriting new business Prescription drug overdose deaths have surpassed deaths due to heroine and cocaine addictions This is a public health emergency! - Dr. Gary Franklin, Med. Director at WA Department of Labor Slide 3

4 What s at Stake? Dependence Addiction Overdose Death Lost productivity die a day of prescription drug overdose Not just a work comp issue Slide 4

5 The Top 10 Drugs for Workers Compensation in 2011 Drug Name Rank % Total Rx % Total Billed Oxycontin 1 21% 2.1% 92% 9.2% Lidoderm 2 1.8% 4.9% Vicodin * % 4.6% Lyrica 4 2.8% 4.4% Percocet * 5 4.9% 4.1% Celebrex 6 2.5% 3.5% Neurontin * 7 3.5% 3.5% Cymbalta 8 1.9% 3.3% Duragesic * 9 10% 1.0% 32% 3.2% Opana ER % 2.3% TOTALS 36.0% 43.0% Slide 5 *Aggregate of brand & generic

6 Opioid Use in Workers Compensation Short-Acting Opioids Morphine (MSIR ) Oxycodone (Roxicodone ) Oxycodone w APAP* (Percocet ) Hydrocodone w APAP* (Vicodin ) Oxymorphone (Opana ) Tapentadol (Nucynta ) Long-Acting Opioids Morphine (MS Contin ) Oxycodone (Oxycontin ) Fentanyl (Duragesic Patch ) Hydromorphone (Exalgo ) Oxymorphone (Opana ER ) Methadone (Dolophine ) *APAP is Acetaminophen Slide 6

7 Opioids & Morphine Equivalent Dosage (MED) Comparisons What is MED and how do the strengths of opioids differ? 2012 Healthesystems The MED scale presented represents approximations of doses compared to a standard reference, morphine. It is not intended to imply exact dose conversions. Route of administration for comparison is oral. Other routes of administration and differences in dosages could significantly change the estimation. Slide 7

8 Dosing Threshold for Selected Opioids Name of Opioid Codeine Fentanyl Transdermal Hydrocodone Hydromorphone Methadone Morphine Oxycodone Oxymorphone Recommended Starting Dose for Opioid-naïve Patients 30mg q 4 6 hours Use only in opioid-tolerant patients who have been taking 60mg MED daily for a week or longer 5-10mg q 4 6 hours 2mg q 4 6 hours 2.5-5mg BID TID Immediate-release: 10mg q 4 hours; Sustained release 15mg q12h Immediate-release: 5mg q 4 6 hours; Sustained release: 10mg q12h Immediate-release: 5 10mg q 4 6 hours ; Sustained release: 10mgq12h Slide 8

9 Drug Tolerance Tolerance A state of adaptation in which exposure to a drug induces changes that result in diminution of one or more of the drug s effects over time Slide 9

10 Characteristics of Substance Dependence 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 l of the drug and/or administration of an antagonist. Psychological Dependence Is a subjective sense of need for a specific substance for it s positive effects or to avoid negative effects associated with its abstinence. Slide 10

11 Characteristics of Substance Dependence Addiction A primary chronic neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Slide 11

12 Appropriate Use of Opioids

13 BLUF* Clinical trials and current guidelines question the long-term effectiveness of opioids. Prescribing decisions made early in the course of therapy often have profound implications. Without monitoring, patients are unlikely to be adherent to prescribed therapy. * Bottom Line Up Front Slide 13

14 By the Numbers: the Rise in RX Drug Abuse Four-fold increase in opioid prescribing in past decade Benzodiazepines and opioids represent 8 of top 10 meds most abused For first time in nearly a century, auto accidents are no longer the leading cause of accidental death 7 million people p regularly use RX drugs for non-medical purposes p RX painkillers prescribed in 2010 enough to medicate every American adult around-the-clock for a month Drug abusers cost healthcare system 8 times more than non-abusers Slide 14

15 How Do Patients Contribute? 72% of patients admit to not disposing of leftover opioid meds Nearly half of opioid patients did not follow prescribed therapy More than three quarters (77%) of patients do not understand instructions given to them In study (n 1,000,000), 75% of urine drug tests found to have abnormal result Slide 15

16 What Can be Learned from Opioid RCTs (Randomized Controlled Trials)? Short-term (1 to 6 months) High drop out rates due to adverse effects, lack of efficacy (up to 60%) Patients with SUD or mental health disorders excluded (limits generalizability) No long-term study of safety or maintenance of pain efficacy Prospective studies suggest opioid TX may retard functional recovery Slide 16

17 What the Guidelines Say VA/DoD Management of Opioid Therapy for Chronic Pain (May 2010) Use of opioids in chronic pain is controversial, [stemming] from the limited evidence regarding the long-term benefits and hazards associated with daily use. COT should be goal-directed ; therapy should be weaned if treatment goals not met Pain reduction shouldn t be sole measure of treatment efficacy Slide 17

18 What the Guidelines Say According to: (ACOEM) American College of Occupational and Environmental Medicine Opioids do not consistently and reliably relieve pain and can decrease quality of life and functional status t Opioid use is the most important factor impeding recovery of function in patients referred to pain clinics The use of opioids during the sub-acute and chronic phases of injury, especially in absence of an objectively identifiable pain generator, cannot be recommended. Slide 18

19 Recommendations for Opioid Use Based on Official Disability Guidelines (ODG) Establish a treatment plan Steps to take before initiating opioids Initiating opioids On-going management When to discontinue opioids When to continue opioids Have alternatives been tried? Is the patient likely to improve with opioid therapy? Screened for addiction risk? Are red flags present? Evaluate for neuropathic pain; trial of non-opioid analgesics; goal setting with patient; baseline pain and functional assessment; informed consent and pain management agreement (optional) Intermittent pain: short-acting opioid. Continuous pain: long-acting opioid. Change one drug at a time; initiate prophylaxis treatment of constipation Monitor adherence (urinalysis, pill count); document improvement in pain and functional assessment; 4 A s Hyperalgesia; no overall improvement; decrease in functioning; resolution of pain; illegal activity Patient has improved pain and function; return to work Slide 19

20 What Predicts Chronic Opioid Use? Opioid users using treatment > 90 days are 700% more likely to be using after 400 days Breakdown of opioid users (percent of overdoses): 80% with MED 100mg, one prescriber (20%) 10% with high doses (MED 100mg), one prescriber (40%) 10% with high doses, multiple prescribers (40%) 76% of drug abusers receive meds from someone else What is the risk of addiction with opioid use? Slide 20

21 Who are some of the key stakeholders? Claim Resolution Claimant PBM Clinical Pharmacist Claims Professional Prescribing Physician(s) Employer Proactive Strategy Collaboration and communication is key. Early intervention There is no single silver bullet answer Additional tools include: Urine drug screen Pill counts Pain contracts Nurse intervention Peer to Peer physician reviews Slide 21

22 Sample Case Study Claimant case overview: Age: Patient Profile 32 years old Accident Overview Accident Year: 2007 Sex: Male Occupation: Construction worker Accident Description: Injured his back falling off scaffolding from a height of 5 feet. Slide 22

23 Drug Treatment Timeline Placeholder Acute Chronic 1 to 3 Months 24 Months 36 Months 60 Months Hydrocodone/APAP (Vicodin eq.) Ibuprofen (NSAID) Prevacid (PPI) Oxycodone IR Hydrocodone/APAP Ibuprofen/Prevacid Fioricet (for headaches) Flexeril (muscle relaxant) Oxycontin Opana Prevacid Gabapentin Ambien Amitriptyline Soma Sentry AM & PM Theracodophen Exalgo Opana Cymbalta Amitriptyline Trazodone Imitrex Xanax Soma Ambien Slide 23

24 What indicators were missed? Placeholder Acute Chronic MED > 400mg (Morphine Equivalent Dose) Slide 24 1 to 3 Months 24 Months 36 Months 60 Months Hydrocodone/APAP (Vicodin eq.) Ibuprofen (NSAID) Prevacid (PPI) Duplicate therapy by different prescribers 190mg MED (Morphine Equivalent Dose) Oxycodone IR Hydrocodone/APAP Ibuprofen/Prevacid Fioricet (for headaches) Flexeril (muscle relaxant) PPI continued w/o indication Medical Foods Oxycontin Opana Prevacid Gabapentin Ambien Interacting Medications Amitriptyline Soma Sentry AM & PM Theracodophen Masking symptoms of serotonin syndrome? Exalgo Opana Cymbalta Amitriptyline Trazodone Imitrex Xanax Soma Ambien Multiple Brand Drugs

25 Case Study #2 Brief History 41 Year old male in construction industry Back injury Diagnosis: - Mild degenerative disease at L4-L5; AND L5 - S1 Slide 25

26 Case Study #2 Prescription Regimen Current Medications Oxycontin 80mg Q8h Oxycontin 20mg Q8h Oxydocone 15mg 1-2 Q4H(8/day) Gabapentin 300mg 4 TID Lyrica 300mg 1 BID Tizanidine 2mg 1-2 HS PRN Baclofen 10mg 1 BID Naproxen 500mg 1 BID Savella 50 Mg Ck Dose Senekot 8 6mg 2 BID Prochlorperazine 10mg, 1-2 X/day Multivitamin, 1 Tab QD Omeprazole 20mg QD Doxazosin 4mg QD Cymbalta 60mg 2 Caps HS Zyprexa 10mg QD Pharmacologic Concerns Therapeutic Duplicaton of : Savella & Cymbalta Tizanidine & Baclofen Gabapentin & Lyrica High Dose Chronic Use of Opioid Analgesics High Doses of Opioids Risk of Respiratory Depression Savella, Lyrica & Gabapentin Efficacy Slide 26

27 Pharmacologic Approach Based on Best Practice Guidelines Weaning and Discontinuation of: Oxycontin & Oxycodone Senna (Senokot) Lyrica, Savella & Gabapentin Baclofen Continue: Tizanidine Naproxen (or a different NSAID) Omeprazole Add: Tricyclic Antidepressant i.e. Amitriptyline Slide 27

28 Case Study Outcome/Success Reduction of CNS side effects Elimination of hyperalgesia effect Increased compliance Return to Work Slide 28

29 State Roundtable Discussion Share what your state is doing to address prescription drug use - Regulations? - Statutory changes? - Proposed Bills? - Proven results from your own work comp program? - Prescription Drug Monitoring Program? - Pharmacy or Medical Board involvement? Slide 29

30 What Can You Do? Questions to ask your providers: PBM How can the following program parameters be applied: Tighter or closed formulary Time sensitivity for filling scripts 7 or 14 day fill max without prior auth. on Schedule II drugs Limit to 90 days No Oxycontin / Oxycodone on first fill new injuries Limit on physician office dispensing Use of evidence based guidelines: ACOEM/ODG Prescriber intervention / outreach programs Claims Administration What processes are in place to help early detection of inappropriate drug utilization? Utilization Review How are evidence based guidelines incorporated into drug regimen reviews? Slide 30

31 Slide 31 Any Questions?

32 References 1. Return To Work Guidelines, 2012 Official Disability Guidelines, 17 th edition. Integrated with Treatment Guidelines. ODG Treatment in Workers Comp, 10 th edition. Work Loss Data Institute Washington State Agency Medical Directors Group. Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain update American College of Occupational and Environmental Medicine. ACOEM Guidelines for Chronic Use of Opioids Chou, R. et.al. Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. Journal Pain First Script Drug Trends. Drug Utilization and Spending Trends in Workers Compensation Coventry Workers Comp Services Slide 32