NYSMPEP Chronic Non-Cancer Pain (CNCP) Module
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1 NYSMPEP Chrnic Nn-Cancer Pain (CNCP) Mdule Key Message 2: Patients with CNCP wh cntinue t experience mderate-t-severe pain despite an adequate trial f nnpharmaclgical and nn-piid therapies shuld be evaluated t determine if a SHORT-TERM trial f a shrt-acting piid (SAO) is apprpriate. Prescriptins fr a trial f SAO shuld be written fr the shrtest time pssible; 7-day trial per New Yrk State Public Health Law Sectin 3331, 5. (b), (c) Patients started n piids shuld be reevaluated every 1-2 weeks Patients started n piid therapy fr CNCP will nt achieve ttal pain relief; studies suggest that pain imprvement averages less than 2-3 pints n a 0-10 pint scale. 1 Prir t initiating an SAO all patients MUST underg a cmprehensive evaluatin that includes assessment f baseline pain severity and current and past substance abuse disrders A baseline risk assessment fr ptential piid misuse and abuse shuld be perfrmed fr all patients. Helpful Risk Assessment Tls 2,3 : Opiid Risk Tl (ORT)- screens fr risk f piid addictin CAGE-AID (Cut dwn, Annyance, Guilty, Eye Opening)- 4 questin survey that screens fr alchl and/r drug prblems Baseline urine drug test (UDT)- 2 types f UDTs are currently available Immunassay UDT- based in a lab r ffice (pint-f-care test) Mst cmmn UDT used Detects presence r absence f a drug r drug class accrding t predetermined cutff threshld It is imprtant t btain f a list f the drug/drug classes that the immunassay drug test screens fr. It may be helpful t add additinal screening fr benzdiazepines and semi-synthetic r synthetic piids High perfrmance chrmatgraphy/mass spectrmetry UDT - available nly thrugh a labratry (cnfirmatry drug test) Typically nly used if verificatin r identificatin f a specific drug and/r metablite(s) is needed PEP@nysdh.suny.edu 1
2 Sample Patient Risk Assessment Tls CAGE-AID Screening Tl 4 Patient Answer 1: Have yu ever felt that yu ught t cut dwn n yur drinking r drug use? Yes / N 2: Have peple annyed yu by criticizing yur drinking r drug use? Yes / N 3: Have yu felt bad r guilty abut yur drinking r drug use? Yes / N 4: Have yu ever had a drink r used drugs first thing in the mrning t steady yur Yes / N nerves r t get rid f a hangver (eye-pener)? Scring: 1 r mre psitive respnses (yes respnses) t the CAGE-AID is cnsidered a psitive screen Once a cmplete baseline risk assessment as been perfrmed: Discuss and sign a Patient Prescriber Cntrlled Substance Agreement. Review Internet System fr Tracking Over-Prescribing (ISTOP) prir t prescribing piids. Fr patients with a histry f drug abuse, psychiatric issues, r serius aberrant drug-related behavirs, initiatin f an piid trial in the primary care setting shuld nly be cnsidered if frequent and stringent mnitring can be implemented PEP@nysdh.suny.edu 2
3 Safety Checklist fr Prescribing Opiids 5 : Single prescriber Single pharmacy Signed patient and prescriber piid agreement Lwest pssible effective dse shuld be used Use piids with cautin in patients that have c-mrbidities that may piid adverse effects (COPD, CHF, sleep apnea, current/past alchl r substance abuse, elderly r histry f renal r hepatic dysfunctin) DO NOT cmbine piids with sedative hypntics, benzdiazepine r barbiturates, unless there is a specific medical r psychiatric indicatin Rutinely assess functin and pain status Mnitr fr medicatin misuse Perfrm randm urine drug testing t assure adherence Maintain a multimdal apprach t therapy: piids + nn-pharmaclgical + nn-piid/adjunct pharmaclgical agents Opiid Pharmaclgical Overview 6-8 : Opiid receptrs are lcated within the central nervus system (CNS) and thrughut the peripheral tissues. The 4 classical piid receptrs are mu, kappa, delta and sigma. Opiid activity depends n the affinity fr piate receptrs and ther mechanisms. Opiid Classificatin Opiids Clinical Cnsideratins Pure Agnists Partial Agnists Cdeine, dihydrcdeine, fentanyl, hydrcdne, hydrmrphne, levrphanl, meperidine, mrphine, methadne, xycdne, xymrphne, prpxyphene (n lnger cmmercially available) Buprenrphine -High binding affinity and efficacy at the mu receptr -N dsage ceiling effect -High binding affinity but lw efficacy at the mu receptr -Ceiling effect fr analgesia -Beneficial in abuse deterrence and detxificatin Mixed Agnist- Antagnists Pure Antagnists Other Butrphanl, nalbuphine, pentazcine Nalxne, naltrexne methlynaltrexne Tramadl, tapentadl -High affinity but lw efficacy at the mu receptr als have partial kappa agnist activity -Partial agnist activity at the kappa receptr -Antagnists at mu, kappa, and delta receptrs -High binding affinity t mu receptr with NO efficacy -Beneficial in abuse deterrence and detxificatin -Weak agnist at the mu receptr; als inhibits reuptake f nrepinephrine and sertnin PEP@nysdh.suny.edu 3
4 Pure piid agnists have n ceiling effect fr analgesia. In thery as the dse is increased analgesic effects als increase; the degree f analgesia induced is LIMITED ONLY by intlerable dse-related adverse side effects. 7 Opiids 2,6,8 Special Cnsideratins SHORT-ACTING OPIOIDS Cdeine (alne r in cmb with APAP) Cdeine alne is a weak analgesic mre effective in cmb with APAP Hydrcdne (in cmb with APAP/IBU) Metablized t active metablite hydrmrphne Hydrmrphne Dse adjustment in renal and hepatic impairment Mrphine Active metablite, M6G, may accumulate in renal impairment Oxycdne (alne r in cmb with Use cnservative dse initiatin in renal and hepatic APAP) impairment Oxymrphne Take n an empty stmach at least 1hr befre r 2hrs after a meal. DO NOT take with alchl-can have highly variable effects n peak drug levels Tapentadl Cautin in pts n sertnergic agents. If used in cmb with ther CNS depressants reduce dse f 1 r bth agents Tramadl (alne r in cmb with APAP) Slwer initiatin and titratin imprves tlerability Use anther agent in patients n sertnergic agents LONG-ACTING OPIOIDS Fentanyl transdermal system* Methadne Optin in pts with persistent mderate t severe pain wh cannt take ral mrphine r methadne. May prlng QTc interval Mrphine CR/SR/ER Preferred 1st line lng acting due t similar efficacy t ther lng acting piids Oxycdne CR Initiate at ne-third t ne-half the usual recmmended dse in hepatic impairment and cncmitant use f CNS depressants Patients receiving xycdne cntrlled-release tablets and a CYP3A4 inhibitrs shuld be carefully mnitred fr an extended perid f time, and dse adjustment shuld be made if warranted. (ICSI guideline) Oxymrphne ER Take n an empty stmach at least 1hr befre r 2hrs after a meal. DO NOT take with alchl-can have highly variable effects n peak drug levels Tapentadl ER Use with cautin in pts with a histry f seizures. Nt recmmended in pts with renal/hepatic impairment. Pts shuld avid cnsumptin f alchlic beverages Tramadl ER D nt prescribe in patients wh are suicidal r addictinprne due t increased risk f suicide. *Nte OTFC (ral transmucsal fentanyl citrate) prducts are FDA apprved fr treatment f cancer pain ONLY (e.g. Abstral, Actiq, Fentra, Lazanda, etc.) PEP@nysdh.suny.edu 4
5 OPIOID SIDE EFFECTS 2,3 Cnstipatin, drwsiness, nausea, pruritus, dizziness, tiredness, dry muth, sweating, hyperalgesia, sexual dysfunctin, sedatin and cnfusin Tips fr managing side effects: Nausea and cnstipatin can be minimized by the use f antiemetic and bwel regimens Many adverse effects spntaneusly reslve with cntinued administratin and develpment f tlerance EXCEPTION is cnstipatin; prphylactic initiatin and maintenance f a bwel regimen t prevent cnstipatin is strngly recmmended SLOW titratin and use f LOW dses can help t minimize side effects Guidelines Recmmendatins n the Use f Opiids in CNCP Interagency Chice f piid shuld nt exceed mre than an average daily MED f 120mg withut either the patient demnstrating imprvement in functin and pain r first btaining a cnsultatin frm a pain management expert. VA/DD Opiid therapy shuld be initiated at a lw dse and may be increased until limited by adverse effects r clear evidence f lack f efficacy. If a high dse f medicatin (greater than 200 mg/day mrphine equivalent) prvides n further imprvement in functin, cnsider cnsultatin rather than further increasing the dse. ICSI Opiid dses shuld be titrated up until there is adequate pain relief, but generally nt exceeding dses equivalent t mrphine 100 mg/day. APS Opiid selectin, initial dsing, and titratin shuld be individualized accrding t the patient s health status, previus expsure t piids, attainment f therapeutic gals, and predicted r bserved harms. ASIPP Gal f piid therapy- use lwest pssible dse t prvide adequate analgesia with minimum side effects. Evidence fr the effectiveness f lng-term piids in reducing pain and imprving functinal status fr 6 mnths r lnger is variable. WHO Recmmendatin f a weak piid if nn-piid/adjuvant therapy fails. Strnger ptency piids are reserved fr patients that cntinue t experience mderate t severe pain. CDC 11 When deciding n an piid dse strategy, it is imprtant t administer lw dses and titrate slwly f an immediate release frmulatin. Mnitr patients fr imprvement in pain and functin. SUMMARY There is a clear cnsensus acrss all current CNCP guidelines that, althugh there is n preference fr ne piid ver anther, the piid f chice shuld be: (i) patient specific; (ii) started lw; and (iii) gradually titrated upwards until satisfactry imprvement f pain is bserved. Cautin is advised nce the average daily MED exceeds 90 mg/day t 100mg/day. MED: mrphine equivalent dse; VA/DD: Dept. f Veterans Affairs and Dept. f Defense; ICSI: Institute fr Clinical Systems Imprvement; APS: American Pain Sciety; ASIPP: American Sciety f the Interventinal Pain Physicians; WHO: Wrld Health Organizatin; CDC: Centers fr Disease Cntrl and Preventin PEP@nysdh.suny.edu 5
6 NY State Legislatin TO FURTHER REDUCE OVERPRESCRIBING OF OPIOID MEDICATIONS, EFFECTIVE JULY 22, 2016, INITIAL OPIOID PRESCRIBING FOR ACUTE PAIN IS LIMITED TO A 7 DAY SUPPLY PER NEW YORK STATE PUBLIC HEALTH LAW SECTION 3331, 5. (b), (c). A practitiner may nt initially prescribe mre than a 7-day supply f an piid medicatin fr acute pain. Acute pain is defined as pain, whether resulting frm disease, accidental r intentinal trauma, r ther cause, that the practitiner reasnably expects t last nly a shrt perid f time. An piid trial shuld be started with: Opiid naïve patients shuld NEVER receive an LAO fr initial piid therapy Lwest pssible dse 1 medicatin at a time Shrt duratin (Limit quantity (e.g., 7-day supply per NY State Public Health Law Sectin 3331, 5. (b), (c); with fllw-up required) SAOs are safer than LAOs fr initial therapy since they have a shrter half-life and may be assciated with a lwer risk f inadvertent verdse. The piid selected shuld be based n each individual patient s specific needs. Patient Reassessment 3 : Once piid therapy is initiated, patients shuld be reassessed every 1-2 weeks t determine if therapy is effective. At each f these assessments patients shuld be mnitred fr the 4 As: ANALGESIA: Has the patient s pain severity decreased? ACTIVITY: Has there been imprvement in the patient s daily functinality? ABERRANT BEHAVIOR: Has the patient requested early refills r used all medicatin befre refill is due? Is a randm urine test necessary? Has an ISTOP review been cnducted? ADVERSE EFFECTS: Is the patient experiencing cnstipatin, dizziness, tiredness, etc.? Des the patient avid taking medicatin at prescribed time due t side effects they are experiencing? 1) Chu R, et al. Clinical guidelines fr the use f chrnic piid therapy in chrnic nncancer pain. J Pain. 2009; 2) VA/DD Clinical Practice Guidelines fr Management f Opiid Therapy fr Chrnic Pain. Accessed Jan ) Tresct AM et al. Opiids in the management f chrnic nn-cancer pain: an update f American Sciety f the Interventinal Pain Physician (ASIPP) guidelines. Pain Physcians. 2008;11(2 Suppl):S5-S62. 4) Brwn RL, Runds LA. Cnjint screening questinnaires fr alchl and ther drug abuse: criterin validity in a primary care practice. Wis Med J 1995;94(3): ) Interagency Guideline n Opiid Dsing fr Chrnic Nn-cancer pain: an educatinal aid t imprve care and safety with piid therapy. Files/ Opiid Gdline.pdf. Accessed Jan ) DiPir, J. T. Pharmactherapy: A pathphysilgic apprach, 8 th editin. New Yrk: McGraw-Hill Medical ) Tresct A, et al. Opiid Pharmaclgy. Pain physician. 2008;11:S133-S153 8) Zacharff K, et al. A pcket guide t pain management- a cmpanin t 4 th editin. Newtn, MA. Infelxxin, Inc ) Hten WM, et al. Institute fr Clinical Systems Imprvement. Assessment and Management f Chrnic Pain. Updated Nvember ) Wrld Health Organizatin. WHO s Pain Ladder. Available at: Accessed Jan ) Dwell D, Haegerich TM, Chu R. CDC guideline fr prescribing piids fr chrnic pain United States, MMWR Recmm Rep. 2016;65(1): PEP@nysdh.suny.edu 6
7 If the current piid therapy is nt prviding satisfactry pain reductin and adherence has been cnfirmed the patient shuld be assessed t determine which f the fllwing is mst apprpriate 1-3,5 : DOSAGE TITRATION- dse shuld be SLOWLY increased t minimize txicity and find the lwest effective dse that achieves a satisfactry balance between benefits and harm. OPIOID SWITCH/ROTATION- switching t a different piid may help t imprve efficacy, reduce side effects and reduce dse escalatin in patients with intlerable adverse side effects r inadequate benefit despite dse increases ADDITION OR OPTIMIZATION OF NON-OPIOID/ADJUNCT AGENT(S)- the additin r dsage increase f a nnpiid/adjunctive agent can help t manage pain thrugh a multimdal apprach and allws fr ptential decrease in current piid dse DISCONTINUATION OF OPIOID: Is the patient experiencing intlerable adverse effects, is nn-adherence r aberrant behavir suspected, is there a lack f effectiveness f current piid t meet treatment gal, r is there a desire frm the patient t discntinue therapy? PEP@nysdh.suny.edu 7
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