Approach to Use of Opioids in Patients with Low Back Pain

Transcription

1 Apprach t Use f Opiids in Patients with Lw Back Pain Rger Chu, MD, FACP Prfessr f Medicine Oregn Health & Science University Directr, the Pacific Nrthwest Evidence-based Practice Center 1

2 Cnflict f Interest Disclsure Research funding frm the American Pain Sciety and the Agency fr Healthcare Research and Quality Cnsultant with Wellpint Inc, Blue Crss Blue Shield, Palladian Health Authr ryalties frm UpTDate 2

3 Planning Cmmittee, Disclsures AAAP aims t prvide educatinal infrmatin that is balanced, independent, bjective and free f bias and based n evidence. In rder t reslve any identified Cnflicts f Interest, disclsure infrmatin frm all planners, faculty and anyne in the psitin t cntrl cntent is prvided during the planning prcess t ensure reslutin f any identified cnflicts. This disclsure infrmatin is listed belw: The fllwing develpers and planning cmmittee members have reprted that they have n cmmercial relatinships relevant t the cntent f this webinar t disclse: AAAP CME/CPD Cmmittee Members Dean Krahn, MD, Kevin Sevarin, MD, PhD, Tim Fng, MD, Rbert Milin, MD, Tm Ksten, MD, Jji Suzuki, MD; and AAAP Staff Kathryn Cates-Wessel, Miriam Giles, Sharn Jubert Frezza, and Justina Andnian. All faculty have been advised that any recmmendatins invlving clinical medicine must be based n evidence that is accepted within the prfessin f medicine as adequate justificatin fr their indicatins and cntraindicatins in the care f patients. All scientific research referred t, reprted, r used in the presentatin must cnfrm t the generally accepted standards f experimental design, data cllectin, and analysis. Speakers must infrm the learners if their presentatin will include discussin f unlabeled/investigatinal use f cmmercial prducts. 3

4 Target Audience The verarching gal f PCSS-O is t ffer evidence-based trainings n the safe and effective prescribing f piid medicatins in the treatment f pain and/r piid addictin. Our fcus is t reach prviders and/r prviders-intraining frm diverse healthcare prfessins including physicians, nurses, dentists, physician assistants, pharmacists, and prgram administratrs. 4

5 Educatinal Objectives At the cnclusin f this activity participants shuld be able t: List the benefits and harms f piids in patients with lw back pain. Summarize an evidence-based apprach in the use f piids fr lw back pain. 5

6 Case Mr. S. is a 57 year ld with LBP x 2 years, n specific inciting event N assciated leg pain r ther neurlgical symptms Pain slwly wrsening, t the pint f nt being able t walk mre than 2 t 3 blcks, rated 7/10 mst days Cntinues t glf mst weekends, but riding cart nw Wrking as an engineer X-rays shw lumbar disc degeneratin and facet jint arthrpathy Tried acetaminphen and NSAIDs and has undergne PT What d yu think abut trying an piid dc? 6

7 Backgrund Lw back pain is the 5 th mst cmmn reasn fr U.S. ffice visits, and the 2 nd mst cmmn symptmatic reasn Lifetime prevalence fr any LBP episde: 49% t 70% Pint prevalence: 12% t 30% Estimated >$100 billin dllars in ttal health care expenditures fr LBP in U.S. Pharmacy csts >20% f ttal health care expenditures Large indirect csts Lw back pain is the mst cmmn cause fr activity limitatins in persns under the age f 45 Kes BW et al. BMJ 2006;332:1430;Katz JN. J Bne Jint Surg Am 2006;88 (suppl 2):21;Martin BI et al. JAMA 2008;299:656 7

8 Prevalence f Chrnic LBP is Rising Percentage f Nrth Carlina adults with chrnic lw back pain Overall y y y y >=65 y Freburger JK. Arch Intern Med 2009;169:251

9 Opiid Prescribing Patterns Increased use f piids in patients with LBP Prescribing rates mre than dubled (108% increase) frm 1997 thrugh 2004 Increased prescribing resulted in 423% inflatin-adjusted increase in expenditures >50% f regular prescriptin piid users have LBP High prprtins f patients with LBP prescribed piids 42% in a prspective study f patients with wrk-related LBP 61% in large health maintenance rganizatin with LBP received piids, 19% chrnic use Marked practice variatins in piid prescribing rates fr LBP Dey RA et al. J Am Bard Fam Med 2009;22:62-8; Franklin GM et al. Clin J Pain 2009;25: ; Dey RA et al. J Am Bard Fam Med 2011; 24: ; Lu X et al. Spine 2004;29: ; Webster BS et al. Am J Ind Med 52;

10 Increasing Rates f Opiid Use 10 Dey RA et al. J Am Bard Fam Med 2009;22:62-8

11 Which Patients with LBP are Treated with Opiids? Variatins nt explained by differences in pain severity Factrs assciated with increased likelihd f piid prescribing: Greater psychlgic distress Prer health and unhealthy lifestyles Use f sedative-hypntics Similar factrs assciated with use f high-dse piids Data indicate use f piids related in part t presence f psychscial factrs that put patients at increased use fr adverse piid-related drug events 11 Dey RA et al. J Am Bard Fam Med 2011;24:717; Kbus AM et al. J Pain 2012;13:1131

12 Benefits f Opiid Therapy fr LBP Benefits fr chrnic LBP appear mderate at best Few randmized trials f patients specifically with chrnic LBP; results mixed, with sme studies shwing n clear benefits Fr chrnic pain in general, mre evidence, with benefits in randmized trials averaging 20-30% fr shrt-term (<12 weeks) pain relief; can we extraplate t LBP? N studies n lng-term benefits f piid therapy vs. n piid Effects n functin nt cnsistently demnstrated in randmized trials Sme bservatinal studies suggest piid use assciated with prer functinal utcmes N trials f piids fr acute LBP Opiid generally accepted as effective fr varius types f acute pain Chappar A et al. Cchrane Database System Rev 2013:CD004959;Martell BA et al. Ann Intern Med 2007;146:116; Franklin GM et al. Clin J Pain 2009;25:743; Furlan AD et al. CMAJ 2006;174:

13 Abuse Ptential f Opiids Estimates f abuse/misuse vary frm 4% t 26%, r higher Definitins incnsistent acrss studies and behavirs evaluated vary in seriusness Prly standardized methds t detect these utcmes Data frm efficacy trials underestimate risks due t patient selectin methds One study (n=801) based n standardized, detailed interviews f patients n chrnic piids 26% purpseful versedatin 39% increased dse withut prescriptin 8% btained extra piids frm ther dctrs 18% used fr purpses ther than pain 12% harded pain medicatins Fleming MF et al. J Pain 2007;7:573 13

14 Prescriptin Drug Overdses Large increases in prescriptin piid verdses natinally Overdse trends parallel piid prescribing trends 15,000 cases/year In sme states, piid-related verdse deaths exceed MVA s as mst cmmn cause f accidental death Exceed deaths frm herin and ccaine cmbined High prprtin f deaths ccur in patients prescribed piids fr chrnic pain, but als bserved in patients treated fr piid dependence 14

15 Opiid Pain Reliever (OPR) Overdse Deaths, Treatment Admissins, and Kilgrams Sld 15

16 Risk Factrs fr Overdse Higher-dse piid therapy Cncmitant use f CNS depressants (especially benzdiazepines) Recent initiatin f piids Multiple piid prescribers Significant mental health disrders Aberrant drug related behavirs Use f methadne Presence f significant medical cmrbidities Active r histry f substance abuse Dunn KM et al. Ann Intern Med 2010;152:85; Bhnert AS. JAMA 2011;305:1315; Gmes T et al. Arch Intern Med 2011;171:686; Braden JB et al. Arch Intern Med 2010;170:1425; Hall AJ et al. JAMA 2008;3000:

17 Other Harms Assciated with Opiids High rates f adverse events Cnstipatin, nausea, sedatin, and thers Hyperalgesia Paradxical increased sensitivity t pain Prevalence, risk factrs and clinical significance nt well understd Generally assciated with higher dses Hypgnadism Primarily based n crss-sectinal studies Clinical significance nt well understd Falls/fracture risk hu R et al. J Pain 2009;10:113 17

18 Use Opiids Only in the Cntext f an Overall LBP Management Plan Understand chrnic LBP as a cmplex bipsychscial cnditin Opiids alne d nt address psychscial cntributrs t pain Benefits f piids unlikely t exceed an average 20-30% reductin in pain (may be smaller) Be clear with patients that piids generally d nt eliminate pain, and are just part f a cmprehensive management plan Use piids in cnjunctin with therapies that address psychscial factrs Fr acute LBP, the natural histry is very favrable ~85% f patients imprve substantially in the first mnth Opiid use in acute LBP assciated with prer functinal utcmes and subsequent lng-term use Selective piid use fr acute severe pain n a time-limited basis, fr shrtterm symptmatic relief Gatchel RJ et al. Psychlgical Bulletin 2007;133:581;Franklin GM et al. Spine 2008;33:199; Webster BS et al. Spine 2007;32:

19 Management Apprach t LBP First-line medicatins: acetaminphen and NSAIDs Recent RCT shwed n benefits f acetaminphen fr acute LBP Secnd-line ptins: skeletal muscle relaxants (acute LBP) and antidepressants (chrnic LBP) Emphasis n self-care and imprving functin Advise patients t remain active Exercise therapy, interdisciplinary rehabilitatin Identify and address psychscial cntributrs t pain Depressin, anxiety, maladaptive cping behavirs (fear avidance, catastrphizing) Cgnitive behaviral therapy, functinal restratin, interdisciplinary rehabilitatin Cnsider ther nn-pharmaclgical therapies Spinal manipulatin, acupuncture, massage Reserve piids fr patients wh dn t respnd t first-line therapies, r selected cases with very severe symptms Chu R et al. Ann Intern Med 2007;147:478; Williams CM et al. Lancet (e-published 23 July 2014) 19

20 Will this Patient Develp Persistent Disabling LBP? Predictr Nnrganic signs 3.0 ( ) Maladaptive pain cping behavirs 2.5 ( ) Baseline functinal impairment 2.1 ( ) Psychiatric cmrbidities 2.2 ( ) Lw general health status 1.8 ( ) Psitive likelihd rati fr persistent disabling LBP at 1 year: median (range) Variables related t wrk envirnment, baseline pain, presence f radiculpathy Histry f prir LBP episdes, demgraphic variables (age, sex, verweight, smking, educatin) Arund 1.5 Nt predictive 20 Chu R and Shekelle P. JAMA 2010;303:

21 Targeting Patients at Risk fr Chrnicity STarT Back Trial 1573 UK patients with LBP (+/- radiculpathy) Randmized t stratified care based n prgnsis (lw, medium, r high-risk) r usual care Lw-risk interventin: educatinal vide and bklet Medium and high-risk interventins: referred fr psychlgically infrmed physitherapy (3 vs. 9 days f additinal training) Stratified care mre effective than usual care fr functin (1.8 pints at 4 mnths and 1.1 pts at 12 mnths); als cst effective STarT Back apprach being tested in the U.S. Hill JC et al. Lancet 2011;378:

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23 Scring the STarT Back Screening Tl Nte: Psych scre based n items 5-9 f STarT Back Screening Tl 23

24 Selecting Patients fr Opiid Therapy Risk assessment is critical befre using piids Helps infrm the decisin f whether t initiate piids Helps determine the intensity f fllw-up and mnitring Assessment f abuse ptential required in all patients cnsidered fr piids Strngest predictr is persnal r family histry f substance abuse The Opiid Risk Tl allws clinicians t categrize patients as lw, medium, r high risk fr aberrant drug-related behavirs based n a simple pint system Additinal validatin needed fr risk assessment instruments Avid piids in patients at high risk; cnsider alternatives in patients at medium risk; address identified risk factrs Als cnsider ptential benefits, and ther ptential harms (i.e. respiratry depressin in patients with sleep apnea) when making decisin t start piids Chu R et al. J Pain 2009;10:113; Chu R et al. J Pain 2009;10:131 24

25 Opiid Risk Tl (ORT) Administratin On initial visit Prir t piid therapy Scring 0-3: lw risk (6%) 4-7: mderate risk (28%) > 8: high risk (> 90%) 25 Webster LR et al. Pain Med. 2005;6:432.

26 Initiatin and Titratin f Opiids Initial curse f treatment shuld be viewed as a shrt-term, therapeutic trial The decisin t prceed (r cntinue) with COT shuld be a cnscius ne Determine achievable functinal gals in rder t assess benefits D nt cntinue COT in patients wh are nt benefitting Start at lw dses and titrate cautiusly, t reduce risk f accidental verdse Particular cautin with methadne (lng and unpredictable half-life) Chu R et al. J Pain 2009;10:113; Chu R et al. J Pain 2009;10:131 26

27 Set Functinal Treatment Gals Gals shuld be actinable, measurable, and achievable Regular assessments f whether patients are achieving treatment gals, in rder t guide treatment decisins Cnsider discntinuatin in patients nt making prgress twards meeting gals Nt achievable: I want t be pain-free. Actinable, measurable, and achievable: I want t be able t walk my dg 20 minutes a day, 4-5 times a week. Chu R et al. J Pain 2009;10:113; Chu R et al. J Pain 2009;10:131 27

28 Dse Escalatins Opiids fr chrnic pain ften prescribed with n ceiling dse Risk f verdse begins t increase at <50 mg mrphine equivalents/day, and cntinues t rise in dse-dependent fashin Very limited data n effectiveness f piids at higher dses Patients wh d nt respnd ften d nt appear t respnd at higher dses Only prescribe higher dses in patients with clear imprvements in pain and functin and with clse mnitring Cautin with use f > mg mrphine equivalents/day Slw dse increases, with fllw-up after changes Dunn et al. Ann Intern Med 2010;152:85; Bhnert et al. JAMA 2011;305:1315; Gmes et al. Arch Intern Med 2011;171:686 28

29 Dse-respnse relatinship fr piids and verdse 1. Chrt study (n=9940, 51 piid verdses, 6 fatal) Risk f piid verdse (vs. 1t <20 mg/day) >=100 mg/d: HR 8.9 (4.0-20) 50 -<100 mg/d: HR 3.7 ( ) 20-<50 mg/d: HR 1.4 ( ) 2. Case-cntrl study (VA, 750 cases) Risk f piid verdse-related death (vs. 1 t <20 mg/day) >=100 mg/d: HR 7.2 (4.8-11) 50-<100 mg/d: HR 4.6 ( ) 20-<50 mg/d: HR 1.9 ( ) 3. Nested case-cntrl study (Ontari, 498 cases) Risk f piid-related mrtality (vs. 1 t <20 mg/day) >=200 mg/d: OR 2.9 ( ) mg/d: OR 2.0 ( ) mg/d: OR 1.9 ( ) mg/d: OR 1.3 ( ) Dunn et al. Ann Intern Med 2010;152:85; Bhnert et al. JAMA 2011;305:1315; Gmes et al. Arch Intern Med 2011;171:686 29

30 Effects f Dse Limitatin Strategies In 2007, WA state implemented dsing plicy f <120 mg/day mrphine equivalents in wrkers cmpensatin After 2007, prprtin prescribed >120 mg/day decreased by 35% 50% decrease frm 2009 t 2010 in number f piid-related deaths Data bservatinal, subject t cnfunding and attributin bias Overdse trend based n a single year in published study, thugh trend maintained fr additinal year (persnal cmmunicatin with authr) ranklin GM et al, Am J Industrial Med 2012;55:325 30

31 Selectin f Opiids N evidence that lng-acting piids are safer r less prne t abuse than shrt-acting piids Lng-acting piids may result in fewer drug peaks assciated with euphria, but decreased risk f addictin r abuse has nt been demnstrated N evidence that rund-the-clck, scheduled dsing safer r less prne t abuse than PRN dsing Use f rund-the-clck, scheduled dsing may cntribute t develpment f tlerance and dse escalatins Recmmend initiatin with shrt-acting piids Safer in piid-naïve patients, easier t titrate dses Can transitin t lng-acting piids, but n cmpelling reasn t d s in patients withut aberrant behavirs and gd respnse n shrt-acting meds Chu R et al. J Pain 2009;10:113; Bhnert et al. JAMA 2011;305:

32 Risk Mitigatin Strategies Infrmed cnsent required in all patients Lng-term piid therapy management plan recmmended by guidelines Cmpnents include: Fllw-up expectatins, single prescriber and pharmacy, n early r ff-hur fill requests, expectatins fr mnitring, use f nn-piid therapies, functinal gals, indicatins fr tapering r discntinuatin Helps define expectatins as well as assist ther prviders wh see patient Fllw-up generally recmmended q3-6 mnths, may be mre frequent in high risk patients Cnsider dispensing weekly r biweekly rather than mnthly in higher risk patients Sme data suggesting shrter duratin between prescriptin refills (smaller amunts dispensed) assciated with shrter time ff wrk Chu R et al. J Pain 2009;10:113; Cifuentes M et al. JOEM 2012;54:491 32

33 Prescriptin Drug Mnitring Prgrams Available nw in almst all states Studies shw that use f PDMPs can identify cases f diversin, dctr shpping and flag unsafe prescribing practices Recent study fund decreased inapprpriate drug prescribing with use f a centralized prescribing system in Canada Effects n clinical utcmes (e.g., verdse) nt knwn Use variable and generally subptimal PDMPs vary in wh can access, infrmatin nt available acrss states, functinality variable Gugelman HM. JAMA 2011;306:2258; Drmuth CR et al. CMAJ 2012;184:E852 33

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35 Urine Drug Tests Diagnstic accuracy fr presence r absence f a drug at a defined cncentratin in the urine is well-established Very useful fr identifying use f nn-piid illicit drugs Must cnsider differential diagnsis when evaluating urine drug test results False-psitives r -negatives can ccur based n dse, differences in rates f metablism, crss-reactin, presence f uncmmn metablites Must understand metablic pathways f piids Diagnstic accuracy fr abuse/addictin nt well studied Always evaluate suspected aberrant behavirs, cnsider dse adjustments r discntinuatin fr serius and recurrent behavirs Chu R et al. J Pain 2009;10:113; Chu R et al. J Pain 2009;10:131 35

36 Opiid-deterrent Frmulatins Opiid-deterrent frmulatins recently apprved by FDA r underging FDA apprval prcess Designed t be tamper-resistant r c-frmulated with medicatins that reverse piid effects r prduce nxius side effects when tampered with Effectiveness fr reducing misuse/substance abuse and imprving clinical utcmes yet t be established Likely t be primarily effective in patients wh crush r inject ral piids May nt imprve safety related t accidental verdse frm ral ingestin Des nt remve the need t perfrm apprpriate risk assessment and mnitring when using piids Webster L. J Opiid Manage 2011;7:235 36

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38 Discntinuing Opiids r Restructuring Therapy Have an exit strategy when starting piids fr LBP Clear understanding f circumstances that will lead t discntinuatin Patients nt benefitting frm piids in terms f reduced pain AND imprved functin Patients experiencing harms r unable t safely manage piids Plan fr tapering piids and managing withdrawal Patients may require restructuring f therapy t safely cntinue piids Lwering dse Intensified mnitring Specialty cnsultatin Cntinue t manage patients fr pain with nn-piid therapies Interventins t address psychlgical cmrbidities and maladaptive cping Fcus n imprving functin Gurlay DL et al. J Addict Dis 2008;27:23 38

39 Opiids and Lw Back Pain Cnsider piids nly in the cntext f an verall pain management plan Opiids d nt address the psychscial cntributrs t pain Nt recmmended as first-line treatment Evidence n effectiveness fr LBP limited Average 20-30% imprvement in pain at best, limited data n imprvement in functin Ptential harms include addictin, abuse ptential, verdse Cnsider nly after perfrming risk assessment and with apprpriate mnitring Duratin-limited trial f therapy Dse-dependent verdse risks Unclear benefits f higher dses Cautin with dses > mg mrphine equivalents/day 39

40 Case Risk Assessment Mr. S. has n persnal r family histry f substance abuse N histry f depressin r ther psychlgical disrders N serius cmrbid cnditins that are cntraindicatins t piid therapy Opiid Risk Tl scre: 0 Urine drug test negative Assessed risk: Lw 40

41 Case Management Plan Set gal f walking 30 minutes 4 times a week Lnger term gal walking 9 hles f glf Lw-dse piid therapy (xycdne 5 mg twice daily) initiated At 4 week fllw-up, pain decreased frm 7/10 t 4/10 Able t walk minutes 4 times a week N signs f aberrant behavirs Plan: Cntinue piid therapy at the same, lw dse, fllw-up in 2 mnths 41

42 References Bhnert et al. JAMA 2011; 305: Braden JB et al. Arch Intern Med 2010; 170: Chappar A et al. Cchrane Database System Rev 2013: CD Chu R and Shekelle P. JAMA 2010; 303: Chu R et al. Ann Intern Med 2007; 147: 478. Chu R et al. J Pain 2009; 10: 113. Cifuentes M et al. JOEM 2012; 54: 491. Dey RA et al. J Am Bard Fam Med 2009; 22:

43 References Dey RA et al. J Am Bard Fam Med 2011; 24: Drmuth CR et al. CMAJ 2012; 184: E852. Dunn et al. Ann Intern Med 2010; 152: 85. Dunn KM et al. Ann Intern Med 2010; 152: 85. Fleming MF et al. J Pain 2007; 7: 573. Franklin GM et al, Am J Industrial Med 2012; 55: 325. Franklin GM et al. Clin J Pain 2009; 25: Franklin GM et al. Spine 2008; 33:

44 References Freburger JK. Arch Intern Med 2009; 169: 251. Furlan AD et al. CMAJ 2006; 174: Gatchel RJ et al. Psychlgical Bulletin 2007; 133: 581. Gmes et al. Arch Intern Med 2011; 171: 686. Gurlay DL et al. J Addict Dis 2008; 27: 23. Gugelman HM. JAMA 2011; 306: Hall AJ et al. JAMA 2008; 3000: Hill JC et al. Lancet 2011; 378:

45 References Katz JN. J Bne Jint Surg Am 2006; 88(suppl 2): 21. Kbus AM et al. J Pain 2012; 13: Kes BW et al. BMJ 2006; 332: Lu X et al. Spine 2004; 29: Martell BA et al. Ann Intern Med 2007; 146: 116. Martin BI et al. JAMA 2008; 299:

46 References Webster BS et al. Am J Ind Med 52; Webster BS et al. Spine 2007; 32: Webster L. J Opiid Manage 2011; 7: 235. Webster LR et al. Pain Med. 2005; 6: 432. Williams CM et al. Lancet (e-published 23 July 2014) 46

47 PCSS-O Clleague Supprt Prgram and Listserv PCSS-O Clleague Supprt Prgram is designed t ffer general infrmatin t health prfessinals seeking guidance in their clinical practice in prescribing piid medicatins. PCSS-O Mentrs cmprise a natinal netwrk f trained prviders with expertise in addictin medicine/psychiatry and pain management. Our mentring apprach allws every mentr/mentee relatinship t be unique and catered t the specific needs f bth parties. The mentring prgram is available at n cst t prviders. Fr mre infrmatin n requesting r becming a mentr visit: pcss-.rg/ask-clleague Listserv: A resurce that prvides an Expert f the Mnth wh will answer questins abut educatinal cntent that has been presented thrugh PCSS-O prject. T jin pcss-@aaap.rg. 47

48 PCSS-O is a cllabrative effrt led by American Academy f Addictin Psychiatry (AAAP) in partnership with: American Dental Assciatin (ADA), American Medical Assciatin (AMA), American Ostepathic Academy f Addictin Medicine (AOAAM), American Psychiatric Assciatin (APA), American Sciety fr Pain Management Nursing (ASPMN),and Internatinal Nurses Sciety n Addictins (IntNSA). Fr mre infrmatin visit: Fr questins pcss-@aaap.rg Funding fr this initiative was made pssible (in part) by Prviders Clinical Supprt System fr Opiid Therapies (grant n. 5H79TI023439) frm SAMHSA. The views expressed in written cnference materials r publicatins and by speakers and mderatrs d nt necessarily reflect the fficial plicies f the Department f Health and Human Services; nr des mentin f trade names, cmmercial practices, r rganizatins imply endrsement 48 by the U.S. Gvernment.