Pennsylvania Guidelines n the Use f Opiids t Treat Chrnic Nncancer Pain Chrnic pain is a majr health prblem in the United States, ccurring with a pintprevalence f abut ne-third f the US ppulatin.(1) Mre wmen than men experience chrnic pain, and the prevalence f chrnic pain increases with age. The impact f pain n individuals and sciety is substantial. In a recent survey, individuals reprting frequent r persistent pain within the last 3 mnths reprted that their pain ften caused prblems with sleep and md, and 32% reprted nt being able t wrk.(2) The ecnmic impact f chrnic pain in the United States is staggering. A recent Institute f Medicine reprt estimated the annual cst in the United States was $560 t ver $600 billin, including healthcare csts ($261-300 billin) and lst prductivity ($297-336 billin).(3) Chrnic pain is best treated using an interdisciplinary, multi-mdal apprach. The treatment team ften includes the patient and his r her family, the primary care prvider, a physical therapist, a behaviral health prvider and ne r mre specialists. Patient utcmes are ptimized when several treatments are used in a crdinated manner. These treatments may include activating physical therapy, cgnitive-behaviral therapy, prper use f medicatins, and interventins when indicated. Reliance n nly ne medicatin r treatment mdality can lead t inadequate pain cntrl and increased risk f harm. Chrnic piid therapy is a cmmn treatment ptin fr chrnic pain, and its use has increased substantially ver the last 15 years, in spite f limited evidence f safety and lng-term efficacy in the general patient ppulatin. Prescriptin drug abuse has increased significantly ver the last 15 years, and this increase has been attributed in part t the increased use f piids t treat chrnic nncancer pain.(4) Abut 6.1 millin Americans abused r misused prescriptin drugs in 2011. Drug pisning deaths, the vast majrity f which invlve prescriptin drugs, surpassed traffic-related accidents as the leading cause f injury-related deaths in the United States in 2009.(5) Prescriptin piids are nw respnsible fr ver 16,000 deaths and 475,000 Emergency Department visits a year in the United States. These guidelines address the use f piids fr the treatment f chrnic nncancer pain. These guidelines d nt address the use f piids fr acute pain, nr d they address the use f piids fr the treatment f pain at the end-f-life. These guidelines are intended t help health care prviders imprve patient utcmes when prviding this treatment, including aviding ptential adverse utcmes assciated with the use f piids t treat pain. These guidelines are intended t supplement and nt replace the individual prescriber s clinical judgment. Additinal detailed infrmatin may be btained frm recently published evidence based guidelines.(6-8) Opiid analgesics may be necessary fr the relief f pain, but imprper use f piids pses a threat t the individual and t sciety. Prviders have a respnsibility t diagnse and treat pain using sund clinical judgment, and such treatment may include the prescribing f piids. Prviders als have a respnsibility t minimize the ptential fr the abuse and diversin f piids. Therefre, prviders shuld use prper safeguards t minimize the ptential fr abuse and diversin f piids. These guidelines suggest that health care prviders incrprate the fllwing key practices int their care f the patient receiving piids fr the treatment f chrnic nncancer pain: Final - Revised 15 May 2014 1
Befre initiating chrnic piid therapy, clinicians shuld cnduct and dcument a histry, including dcumentatin and verificatin f current medicatins, and a physical examinatin. Apprpriate testing shuld be cmpleted befre starting chrnic piid therapy. The initial evaluatin shuld include dcumentatin f the patient s psychiatric status and substance use histry. Clinicians shuld cnsider using a valid screening tl t determine the patient s risk fr aberrant drug-related behavir. Opiids shuld rarely be used as a sle treatment mdality. Rather, piids shuld be cnsidered as a treatment ptin within the cntext f multimdality therapy. Prviders shuld recgnize that high risk patients, including thse with significant psychiatric c-mrbidities, may require specialty care, and that chrnic piid therapy may nt be pssible absent needed specialty care. Patients at risk fr bstructive sleep apnea (OSA) are at increased risk fr harm with the use f chrnic piid therapy. Prviders shuld cnsider the use f a screening tl fr OSA, refer patients fr prper evaluatin and treatment when indicated, and seek t ensure patients with OSA are cmpliant with treatment. When starting chrnic piid therapy, the prvider shuld discuss the risks and ptential benefits assciated with treatment, s that the patient can make an infrmed decisin regarding treatment. Reasnable gals and expectatins fr treatment shuld be agreed upn, and the patient shuld understand the prcess fr hw the care will be prvided, including prper strage and dispsal f cntrlled substances. Prviders shuld practively review the necessity f peridic cmpliance checks that may include urine r saliva drug testing and pill cunts. Prviders may wish t dcument this discussin thrugh the use f an piid treatment agreement. Initial treatment with piids shuld be cnsidered by clinicians and patients as a therapeutic trial t determine whether chrnic piid therapy is apprpriate. Bth clinicians and patients shuld understand that chrnic piid therapy will nt be effective fr all patients, either due t lack f efficacy r the develpment f unacceptable adverse events, including aberrant drug-related behavir. Patient s piid selectin, initial dsing, and dse adjustments shuld be individualized accrding t the patient s health status, previus expsure t piids, respnse t treatment (including attainment f established treatment gals), and predicted r bserved adverse events. Cautin shuld be used in patients als taking benzdiazepines, as the use f benzdiazepines in additin t chrnic piid therapy increases the risk f serius adverse events. Cautin shuld be used with the administratin f methadne, as the administratin f methadne fr the treatment f chrnic pain is assciated with increased risk f harm. Prviders shuld be aware f the special Final - Revised 15 May 2014 2
pharmackinetics f methadne and the need fr careful dsing and mnitring. Cautin shuld be used with the administratin f chrnic piids in wmen f childbearing age, as chrnic piid therapy during pregnancy increases risk f harm t the newbrn. Opiids shuld be administered with cautin in breastfeeding wmen, as sme piids may be transferred t the baby in breast milk. When chrnic piid therapy is used fr an elderly patient, clinicians shuld cnsider starting at a lwer dse, titrating slwly, using a lnger dsing interval, and mnitring mre frequently. Patients with c-existing psychiatric disrder(s) may be at increased risk f harm related t chrnic piid therapy. Therefre, clinicians shuld carefully weight the risk f harm against the ptential fr benefit when cnsidering chrnic piid therapy, and if chrnic piids are used, cnsider careful dse selectin, frequent mnitring and cnsultatin where feasible. It is nt apprpriate t refer patients receiving chrnic piid therapy t the emergency department t btain prescriptins fr piids. When a dse f chrnic piid therapy is increased, the clinician is advised t prvide cunseling the patient n the risk f cgnitive impairment that can adversely affect the patient s ability t drive r safely d ther activities. The risk f cgnitive impairment is increased when piids are taken with ther centrally acting sedatives, including alchl and benzdiazepines. Ttal daily piid dses abve 100 mg / day f ral mrphine r its equivalent is nt assciated with imprved pain cntrl, but is assciated with a significant increase in risk f harm. Therefre, clinicians shuld carefully cnsider if dses abve 100 mg / day f ral mrphine r its equivalent are indicated. Cnsultatin fr specialty care may be apprpriate fr patients receiving high daily dses f piids. Clinicians shuld reassess patients n chrnic piid therapy peridically and as warranted by changing circumstances. Mnitring shuld include dcumentatin f respnse t therapy (pain intensity; physical and mental functining, including activities f daily living; and assessment f prgress tward achieving therapeutic gals), presence f adverse events, and adherence t prescribed therapies. Clinicians shuld carefully mnitr patients fr aberrant drug-related behavirs. Mnitring may include peridic review f available infrmatin regarding the prescribing f piids and ther cntrlled substances t the patient thrugh available databases, urine r saliva drug screening r pill cunts. Cnsideratin shuld be given t rutine peridic urine drug screening as a mnitring tl. Clinicians shuld cnsider increasing the frequency f nging mnitring, as well as referral fr specialty care, including psychlgical, psychiatric and addictin experts fr patients identified t be at high risk fr aberrant drug-related behavir. Final - Revised 15 May 2014 3
In patients wh have engaged in aberrant drug-related behavirs, clinicians shuld carefully determine if the risks assciated with chrnic piid therapy utweigh dcumented benefit. Clinicians shuld cnsider restructuring therapy (frequency r intensity f mnitring), referral fr assistance in management, r discntinuatin f chrnic piid therapy. Apprpriate referral fr addictin evaluatin and treatment shuld be prvided. Clinicians shuld discntinue chrnic piid therapy in patients wh engage in repeated aberrant drug-related behavirs r drug abuse-diversin, experience n prgress tward meeting therapeutic gals, r experience intlerable adverse effects. Clinicians shuld be aware f and understand current federal and state laws, regulatry guidelines, and plicy statements that gvern the use f chrnic piid therapy fr chrnic nn-cancer pain. Final - Revised 15 May 2014 4
References 1. Jhannes CB, Le TK, Zhu X, Jhnstn JA, Dwrkin RH. The prevalence f chrnic pain in United States adults: results f an Internet-based survey. The Jurnal f Pain; 2010;11:1230-9. 2. Prteny RK, Ugarte C, Fuller I, Haas G. Ppulatin-based survey f pain in the United States: differences amng white, African American, and Hispanic subjects. The Jurnal f Pain; 2004;5:317-28. 3. Cmmittee n Advancing Pain Research, Care and Educatin. Relieving Pain in America: A Blueprint fr Transfrming Preventin, Care, Educatin, and Research Washingtn (DC), 2011. 4. Wisniewski AM, Purdy CH, Blndell RD. The epidemilgic assciatin between piid prescribing, nn-medical use, and emergency department visits. Jurnal f Addictive Diseases 2008;27:1-11. 5. Levi J, Segal L, Fuchs-Miller A. Prescriptin Drug Abuse 2013: Strategies t stp the epidemic. Washingtn, DC: Trust fr America's Health, 2013. 6. Chu R, Ballantyne JC, Fanciull GJ, Fine PG, Miaskwski C. Research gaps n use f piids fr chrnic nncancer pain: findings frm a review f the evidence fr an American Pain Sciety and American Academy f Pain Medicine clinical practice guideline. The Jurnal f Pain; 2009;10:147-59. 7. Chu R, Fanciull GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, Dnvan MI, Fishbain DA, Fley KM, Fudin J, Gilsn AM, Kelter A, Mauskp A, O'Cnnr PG, Passik SD, Pasternak GW, Prteny RK, Rich BA, Rberts RG, Tdd KH, Miaskwski C, American Pain Sciety-American Academy f Pain Medicine Opiids Guidelines P. Clinical guidelines fr the use f chrnic piid therapy in chrnic nncancer pain. The Jurnal f Pain; 2009;10:113-30. 8. Chu R, Fanciull GJ, Fine PG, Miaskwski C, Passik SD, Prteny RK. Opiids fr chrnic nncancer pain: predictin and identificatin f aberrant drug-related behavirs: a review f the evidence fr an American Pain Sciety and American Academy f Pain Medicine clinical practice guideline. The Jurnal f Pain; 2009;10:131-46. Final - Revised 15 May 2014 5