Presentation on theme: "Presented by CO*RE Collaboration for REMS Education"— Presentation transcript:
1Presented by CO*RE Collaboration for REMS Education www.corerems.org ER/LA OPIOID REMS:Achieving Safe Use While Improving Patient CarePresented by CO*RECollaboration for REMS EducationPresented by CO*RECollaboration for REMS EducationCollaborative forREMS Education
2Faculty Information Carol Havens, MD Director of Clinical Education Kaiser PermanenteNorthern California RegionOakland, CADISCLOSURE:Dr. Havens and all staff involved in this content declare that neither they nor members of their immediate families have had financial relationships with the manufacturers of goods or services discussed, or corporate supporters of this event.
3Collaborative for REMS Education On July 9, 2012, the Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications.Founded in June, 2010, the Collaborative on REMS Education (CO*RE), a multi disciplinary team of 10 partners and 3 cooperating organizations, has designed a core curriculum based on needs assessment, practice gaps, clinical competencies, and learner self-assessment to meet the requirements of the FDA REMS Blueprint.
5Products Covered by this REMS Brand Name ProductsGeneric ProductsAvinza® morphine sulfate ER capsulesButrans® buprenorphine transdermal systemDolophine® methadone hydrochloride tabletsDuragesic® fentanyl transdermal system*Embeda® morphine sulfate/naltrexone ER capsulesExalgo® hydromorphone hydrochloride ER tabletsKadian® morphine sulfate ER capsulesMethadoseTM methadone hydrochloride tabletsMS Contin® morphine sulfate CR tabletsNucynta® ER tapentadol ER tabletsOpana® ER oxymorphone hydrochloride ER tabletsOxyContin® oxycodone hydrochloride CR tablets†Palladone® hydromorphone hydrochloride ER capsulesFentanyl ER transdermal systemsMethadone hydrochloride tabletsMethadone hydrochloride oral concentrateMethadone hydrochloride oral solutionMorphine sulfate ER tabletsMorphine sulfate ER capsulesOxycodone hydrochloride ER tablets* Not currently available due to voluntary recall (still approved); † No longer marketed (still approved)FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM pdf
6Heads Up: Zohydro Not yet officially included in FDA Blue Print Release approved by FDA in Fall, 2013Release set for March, 2014 though many seek to block its releaseConcerns revolve aroundPotential misuse as Zohydro contains five times the amount of hydrocodone found in IRZohydro does not have built in abuse deterrence mechanismStay tuned.WebMD 2/27/2014"I firmly believe that the benefits of this product outweigh its risks," the FDA’s Bob Rappaport, MD, wrote in the summary review explaining why he approved Zohydro last October. Rappaport is director of the FDA's Division of Anesthesia, Analgesia, and Addiction Products. "Many patients in the U.S. suffer from untreated or poorly treated chronic pain. Further limiting access to potential treatments is not the answer when new treatments are critically needed.”Two members of the FDA’s controlled substance staff warned about the potential for abuse in materials presented to the advisory committee. “If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” wrote medical officer Lori Love, MD, PhD, and pharmacologist James Tolliver, PhD.From Buffalo News, 3/4/14A last-ditch effort to block Zohydro from entering the market was made a week ago when 42 members of the medical and addiction-treatment communities, along with advocates against the proliferation of pain pills, sent a letter to Dr. Margaret A. Hamburg, the FDA’s commissioner, detailing the dangers of the new opioid.Sen. Charles E. Schumer, D-N.Y., urged U.S. Health and Human Services Secretary Kathleen Sebelius to overturn “a disastrous decision by the federal Food and Drug Administration that allowed an ultra-powerful painkiller to enter the market” in the early part of this month.
7WHY PRESCRIBER EDUCATION IS IMPORTANT Introduction
8Opioids Should Balance: Prescribers of ER/LAOpioids Should Balance:The benefits of prescribingER/LA opioids to treat painThe risks of serious adverseoutcomes
9Opioid Misuse/Abuse is a Major Public Health Problem Improper use of any opioid can result in serious AEs including overdose & deathThis risk can be greater w/ ER/LA opioidsER opioid dosage units contain more opioid than IR formulationsMethadone is a potent opioid with a long, highly variable half-lifeIn 2011In 201034.2 million Americans age ≥12 had used an opioid for nonmedical use some time in their life425,247 ED visits involved nonmedical use of opioidsMethadone involved in 30% of prescription opioid deathsSAMHSA. (2012). Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) Rockville, MD. SAMHSA. (2012). The DAWN Report: Highlights of the 2010 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. Rockville, MD. CDC. CDC Vital Signs. Prescription Painkiller Overdoses. Use and abuse of methadone as a painkiller FDA. Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy for Extended-Release and Long-Acting Opioid Analgesics
1039,147 Americans Nearly 14,800 DIED FROM DRUG POISONINGS Deaths involved prescriptions opioids130 people who abused or are addicted825 Nonmedical usersFor every 1 death there are:10 treatment admissions for abuse32 ED visits for misuse or abuseKochanek KD, et al. National Vital Statistics Report 2011;60: CDC Vital Signs. Prescription Painkiller Overdoses. Use and abuse of methadone as a painkiller Warner M, et al. Drug poisoning deaths in the United States, NCHS data brief, no 81. Hyattsville, MD: National Center for Health Statistics National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact. Prescription Painkiller Overdoses. Nov 2011.
11First-Time Use of Specific Drugs Among Persons Age ≥ 12 (2011) 18.104.22.168Number in millions22.214.171.1240.70.70.70.126.96.36.199.05MarijuanaPain RelieversTranquilizersEcstasyInhalantsCocaineStimulantsLSDHeroinSedativesPCPSAMHSA. (2012). Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) Rockville, MD.
12Learning ObjectivesDescribe appropriate patient assessment for treatment with ER/LA opioid analgesics, evaluating risks and potential benefits of ER/LA therapy, as well as possible misuse. Apply proper methods to initiate therapy, modify dose, and discontinue use of ER/LA opioid analgesics, applying best practices including accurate dosing and conversion techniques, as well as appropriate discontinuation strategies. Demonstrate accurate knowledge about how to manage ongoing therapy with ER/LA opioid analgesics and properly use evidence-based tools while assessing for adverse effects. Employ methods to counsel patients and caregivers about the safe use of ER/LA opioid analgesics, including proper storage and disposal. Review/assess general and product-specific drug information concerning ER/LA opioid analgesics and identifying potential adverse effects of ER/LA opioids.
14ASSESSING PATIENTS FOR TREATMENT WITH ER/LA OPIOID ANALGESIC THERAPY Unit 1THIS IS WHERE WE WILL FIND AN IMAGE – humanize, add warmth, etc – FOR EACH UNIT INTRO
15Balance Risks Against Potential Benefits Conduct thorough H&P and appropriate testingComprehensive benefit- to-harm evaluationBenefits IncludeRisks IncludeAnalgesia (adequate pain control)Improved FunctionOverdoseAbuse by patient or household contactsMisuse & addictionPhysical dependence & toleranceInteractions w/ other medications & substancesInadvertent exposure by household contacts, especially childrenGet outside records as part of the H&PChou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. Modified Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM pdf
17Clinical Interview: Patient Medical History Illness relevant to (1) effects or (2) metabolism of opioidsPulmonary disease, constipation, nausea, cognitive impairmentHepatic, renal diseaseIllness possibly linked to substance abuse, e.g.:HepatitisHIVTuberculosisCellulitisSTIsTrauma, burnsCardiac diseasePulmonary diseaseChou R, et al. J Pain. 2009;10: Zacharoff KL, et al. Managing Chronic Pain with Opioids in Primary Care. 2nd ed. Newton, MA: Inflexion, Inc., Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain
18Clinical Interview: Pain & Treatment History Description of painOnset/ DurationVariations / Patterns / RhythmsLocationIntensityQualityWhat relieves the pain?What relieves the pain?What causes or increases pain?Effects of pain on physical, emotional, and psychosocial functionPatient’s pain & functional goalsHeapy A, Kerns RD. Psychological and Behavioral Assessment. In: Raj's Practical Management of Pain. 4th ed. 2008; Zacharoff KL, et al. Managing Chronic Pain with Opioids in Primary Care. 2nd ed. Newton, MA: Inflexion, Inc., 2010.
19Clinical Interview: Pain & Treatment History, cont’d Pain MedicationsPast useCurrent useQuery state PDMP where available to confirm patient reportContact past providers & obtain prior medical recordsConduct UDTDosageFor opioids currently prescribed: opioid, dose, regimen, & durationImportant to determine if patient is opioid tolerantGeneral effectivenessNonpharmacologic strategies & effectiveness
20Perform Thorough Evaluation & Assessment of Pain Seek objective confirmatory dataComponents of patient evaluation for painOrder diagnostic tests (appropriate to complaint)General: vital signs, appearance, posture, gait, & pain behaviorsMusculoskeletal ExamInspectionPalpationPercussionAuscultationProvocative maneuversCutaneous or trophic findingsNeurologic examLalani I, Argoff CE. History and Physical Examination of the Pain Patient. In: Raj's Practical Management of Pain. 4th ed. 2008; Chou R, et al. J Pain. 2009;10:
21Assess Risk of Abuse, Including Substance Use & Psychiatric Hx Obtain a complete Hx of current & past substance usePrescription drugsIllegal substancesAlcohol & tobaccoSubstance abuse Hx does not prohibit treatment w/ ER/LA opioids but may require additional monitoring & expert consultation/referralFamily Hx of substance abuse & psychiatric disordersHx of sexual abuseSocial history also relevantEmployment, cultural background, social network, marital history, legal history, & other behavioral patternsChou R, et al. J Pain. 2009;10: SAMHSA. Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series 54. HHS Publication No. (SMA) Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain
22Risk Assessment, cont’d Be knowledgeable about risk factors for opioid abuseUnderstand & use addiction or abuse screening toolsConduct a UDTPersonal or family Hx of alcohol or drug abuseYounger agePresence of psychiatric conditionsAssess potential risks associated w/ chronic opioid therapyManage patients using ER/LA opioids based on risk assessmentUnderstand limitationsChou R, et al. J Pain. 2009;10:
23Risk Assessment Tools: Examples Administered ByTool# of itemsPatients considered for long-term opioid therapy:ORT Opioid Risk Tool5patientSOAPP® Screener & Opioid Assessment for Patients w/ Pain24, 14, & 5DIRE Diagnosis, Intractability, Risk, & Efficacy Score7clinicianCharacterize misuse once opioid treatments begins:PMQ Pain Medication Questionnaire26COMM Current Opioid Misuse Measure17PDUQ Prescription Drug Use Questionnaire40Not specific to pain populations:CAGE-AID Cut Down, Annoyed, Guilty, Eye-Opener Tool, Adjusted to Include Drugs4RAFFT Relax, Alone, Friends, Family, TroubleDAST Drug Abuse Screening Test28SBIRT Screening, Brief Intervention, & Referral to TreatmentVaries
24Prior to opioid therapy Opioid Risk Tool (ORT)Mark each box that appliesFemaleMale1.Family Hx of substance abuseAlcoholIllegal drugsPrescription drugs2.Personal Hx of substance abuse3.Age between 16 & 45 yrs4.Hx of preadolescent sexual abuse5.Psychologic diseaseADD, OCD, bipolar, schizophreniaDepressionAdminister13On initial visitPrior to opioid therapy23443344Scoring (risk)550-3: low4-7: moderate≥8: high11It is commonly believed that risk is uniform across age groups, but this is not so.32211Scoring Totals:Webster LR, Webster RM. Pain Med. 2005;6:
25Screener & Opioid Assessment for Patients with Pain (SOAPP)® Identifies patients as at high, moderate, or low risk for misuse of opioids prescribed for chronic painHow is SOAPP® administered?Usually self-administered in waiting room, exam room, or prior to an office visitMay be completed as part of an interview w/ a nurse, physician, or psychologistPrescribers should have a completed & scored SOAPP® while making opioid treatment decisionsSOAPP® Monitoring Recommendations. https://painedu.org/soapp/SOAPP_Monitoring_Recommendations.pdf The SOAPP® Version 1.0 Tutorial. https://painedu.org/soapp-tutorial_01.asp
26When to Consider a Trial of an Opioid Potential benefits are likely to outweigh risksFailed to adequately respond to nonopioid & nondrug interventionsContinuous, around-the-clock opioid analgesic is needed for an extended period of timePain is chronic and severeLabeling changes from FDA in Oct 2013 state that ER/LA opioids should be used for severe pain only – not mild or moderate.ONot for use as an as-needed analgesicNot for mild pain or pain not expected to persist for an extended durationNot for use in treating acute painNo alternative therapy is likely to pose as favorable a balance of benefits to harmsChou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic PainCollaborative for REMS Education
27When to Consider a Trial of an Opioid, cont’d 60-yr-old w/ chronic disabling OA painNonopioid therapies not effective, IR opioids provided some relief but experienced end-of-dose failureNo psychiatric/medical comorbidity or personal/family drug abuse HxHigh potential benefits relative to potential risksCould prescribe opioids to this patient in most settings w/ routine monitoring30-yr-old w/ fibromyalgia & recent IV drug abuseHigh potential risks relative to benefits (opioid therapy not 1st line for fibromyalgia)Requires intensive structure, monitoring, & management by clinician w/ expertise in both addiction & painNot a good candidate for opioid therapyChou R, et al. J Pain. 2009;10:
28When to Consider a Trial of an Opioid, cont’d Selection of patients between these 2 extremes requires:Careful assessment & characterization of patient riskStructuring of care to match riskIn patients w/ Hx of substance abuse or a psychiatric comorbidity, this may require assistance from experts in managing pain, addiction, or other mental health concernsIn some cases opioids may not be appropriate or should be deferred until the comorbidity has been adequately addressedConsider referralChou R, et al. J Pain. 2009;10:
29Referring High-Risk Patients Prescribers shouldUnderstand when to appropriately refer high-risk patients to pain management or addiction specialistsAlso check your state regulations for requirementsChou R, et al. J Pain. 2009;10:Collaborative for REMS EducationCollaborative for REMS Education
30Special Considerations: Elderly Patients Does patient have medical problems that increase risk of opioid-related AEs?Respiratory depression more likely in elderly, cachectic, or debilitated patientsAltered PK due to poor fat stores, muscle wasting, or altered clearanceMonitor closely, particularly whenInitiating & titrating ER/LA opioidsGiven concomitantly w/ other drugs that depress respirationReduce starting dose to 1/3 to 1/2 the usual dosage in debilitated, non- opioid-tolerant patientsTitrate dose cautiouslyOlder adults more likely to develop constipationRoutinely initiate a bowel regimen before it developsIs patient/caregiver likely to manage opioid therapy responsibly?American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. J Am Geriatr Soc. 2009;57: Chou R, et al. J Pain. 2009;10:Collaborative for REMS Education
31Special Considerations: Children (<18 years) Safety & effectiveness of most ER/LA opioids unestablishedPediatric analgesic trials pose challenges Transdermal fentanyl approved in children aged ≥2 yrsMost opioid studies focus on inpatient safetyOpioids are common sources of drug errorOpioid indications are primarily life-limiting conditionsExtra information about adolescent and young adult ER/LA opioid use:- Younger than 25 years old, put in moderate risk category in the least. (Goulay, et al., 2005)Pediatric demographic variables related to nonmedical use of opioids:- Female 2 times more likely to abuse than males- Race: White, non white Hispanic, mixed race, Native American/Alaskan- Education: School drop outs, no plans for college- Perceived poor to fair health, hospitalized in past year, 3 or more ED visits in past year- Weekly nonmedical opioid use, history of major depressive episode, disordered alcohol use in past year are characteristics common to prescription opioid abuse and dependence. (Frese & Eiden, 2011)References: Frese, W. A., & Eiden, K. (2011). Opioids: Nonmedical use and abuse in older children. Pediatrics in Review, 32, e44Ye52. Gourlay, D. L., Heit, H. A., & Almahrezi, A. (2005). Universal precautions in pain medicine: A rational approach to the treatment of chronic pain. Pain Medicine, 6, 107Y112.Few children with chronic pain due to non-life-limiting conditions should receive opioidsWhen prescribing opioids to children:Consult pediatric palliative care team or pediatric pain specialist or refer to a specialized multidisciplinary pain clinicBerde CB, et al. Pediatrics. 2012;129: Gregoire MC, et al. Pain Res Manag 2013;18:47-50.Mc Donnell C. Pain Res Manag. 2011;16: Slater ME, et al. Pain Med. 2010;11:
32Challenge: The Friday Afternoon Patient Red Flag:It is 4 pm on Friday and you are four patients behind schedule. Mr. Kingston asks you to increase his current dosage of hydrocodone, because he says it is not relieving his pain. It would take you two minutes to say yes.Adjusting a prescription without performing appropriate evaluation or screeningAction: Check your local PDMP. Employ practice management strategies that maximize efficiency.Patient-administered screening toolsOffice staff to administer and score tools, document results, and communicate to the prescriberScreening may be circumvented due to lack of time and availability of staff. This will create a risk in your practice and jeopardize safety for your patient.ACTION: Strategies for setting up efficienciespatient-administered tools for screeningoffice staff to facilitate the delivery of tools, scoring the tools and documenting this in medical recordsstaff to communicate results to the prescriberdocumentation of screening and plan based on screeningIt takes 30 minutes or more to say “No” including evaluating patients, screening tools, gathering collateral information.Merrill, et al., 2002; Wilsey et al., 2008) (Sehgal, et al., 2012; Chou, et al., 2009a
33Challenge: The Delayed Surgery Red Flag:Ms. Van Buskirk says she needs opioids to manage her pain until she can have surgery. She reports continued delays in getting to surgery. You phone the surgeon and discover that no date has been set and that she has cancelled several appointments.Patient may be stalling to continue an opioid regimenAction: Set expectations for time limitations. Offer non-medicine and non-opioid options for pain management. Consider referral to addiction specialist.The patient may be stalling to continue an opioid regimen, or she may have other barriers that prevent her treatment and surgery from being carried out as planned. This creates a safety concern.Action: Set expectation for time limitations, offer non-medicine and non-opioid interventions for pain management additionally. Consider referral to addiction specialist.Gourlay, Heit, & Amahregi, 2005; Stanos, 2012
36Federal & State Regulations Comply w/ federal & state laws & regulations that govern the use of opioid therapy for painFederalStateCode of Federal Regulations, Title 21 Section 1306: rules governing the issuance & filling of prescriptions pursuant to section of the Act (21 USC 829)United States Code (USC) - Controlled Substances Act, Title 21, Section 829: prescriptionsDatabase of state statutes, regulations, & policies for pain managementregulations-other-policies-pain-managementThis is something that cld go in syllabus but in “Extra” or “Additional Important Info”.
37Initiating TreatmentPrescribers should regard initial treatment as a therapeutic trialMay last from several weeks to several monthsDecision to proceed w/ long-term treatment should be intentional & based on careful consideration of outcomes during the trialProgress toward meeting therapeutic goalsPresence of opioid- related AEsChanges in underlying pain conditionChanges in psychiatric or medical comorbiditiesIdentification of aberrant drug-related behavior, addiction, or diversionChou R, et al. J Pain. 2009;10:113-30
38ER/LA Opioid-Induced Respiratory Depression Chief hazard of opioid agonists, including ER/LA opioidsIf not immediately recognized & treated, may lead to respiratory arrest & deathGreatest risk: initiation of therapy or after dose increaseManifested by reduced urge to breathe & decreased respiration rateShallow breathingCO2 retention can exacerbate opioid sedating effectsInstruct patients/family members to call 911*Managed w/ close observation, supportive measures, & opioid antagonists, depending on patient’s clinical statusBreathing patterns known as “Cheyne-Stokes respiration” – snoring, gasping, groggy, drowsy, shallow breathingChou R, et al. J Pain. 2009;10: FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics InformationforPatientsandProviders/UCM pdf
39ER/LA Opioid-Induced Respiratory Depression More likely to occurReduce riskIn elderly, cachectic, or debilitated patientsContraindicated in patients w/ respiratory depression or conditions that increase riskIf given concomitantly w/ other drugs that depress respirationProper dosing & titration are essentialDo not overestimate dose when converting dosage from another opioid productCan result in fatal overdose w/ first doseInstruct patients to swallow tablets/capsules wholeDose from cut, crushed, dissolved, or chewed tablets/capsules may be fatal, particularly in opioid-naïve individualsFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
40Initiating & Titrating: Opioid-Naïve Patients Drug & dose selection is criticalMonitor patients closely for respiratory depressionIndividualize dosage by titration based on efficacy, tolerability, & presence of AEsSome ER/LA opioids or dosage forms are only recommended for opioid-tolerant patientsANY strength of transdermal fentanyl or hydromorphone ERCertain strengths/doses of other ER/LA products (check drug PI)Especially within h of initiating therapy & increasing dosageCheck ER/LA opioid product PI for minimum titration intervalsSupplement w/ IR analgesics (opioids & nonopioid) if pain is not controlled during titrationThe ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression Chou R, et al. J Pain. 2009;10: FDA. Blueprint for Prescriber Education for ER/LA Opioid Analgesics InformationforPatientsandProviders/UCM pdf
41Initiating: Opioid-Tolerant Patients If opioid tolerant – no restrictions on which products can be usedPatients considered opioid tolerant are taking at least60 mg oral morphine/day25 mcg transdermal fentanyl/hr30 mg oral oxycodone/day8 mg oral hydromorphone/day25 mg oral oxymorphone/dayAn equianalgesic dose of another opioidStill requires caution when rotating a patient on an IR opioid to a different ER/LA opioidFor 1 Wk Or LongerTHIS IS ONLY TIME LEARNERS WILL SEE THIS SLIDES. REITERATE BEFORE CLOSINGThe ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression
42Opioid Rotation Definition: Rationale: Change from an existing opioid regimen to another opioid w/ the goal of improving therapeutic outcomes or to avoid AEs attributed to the existing drug, e.g., myoclonusRationale:Differences in pharmacologic or other effects make it likely that a switch will improve outcomesEffectiveness & AEs of different mu opioids vary among patientsPatients show incomplete cross-tolerance to new opioidPatient tolerant to 1st opioid can have improved analgesia from 2nd opioid at a dose lower than calculated from an EDTReasons for rotation: Poor opioid responsiveness: Dose titration yields intolerable/unmanageable AEs, Poor analgesic efficacy despite dose titration, Patient desire or need to try a new formulation, Cost or insurance issues, Adherence issues, Concern about abuse or diversion, Change in clinical status requires an opioid w/ different PKProblematic drug-drug interactionsFine PG, et al. J Pain Symptom Manage. 2009;38: Knotkova H, et al. J Pain Symptom Manage. 2009;38: Pasternak GW. Neuropharmacol. 2004;47(suppl 1):
43Relative potency estimates Equianalgesic DosesOpioid rotation requires calculation of an approximate equianalgesic doseRatio of doses necessary to obtain roughly equivalent effectsCalculate across drugs or routes of administrationRelative analgesic potency is converted into an equianalgesic dose by applying the dose ratio to a standardRelative potency estimatesPotency refers to dose required to produce a given effectEquianalgesic dose is a construct derived from relative opioid potency estimatesFine PG, et al. J Pain Symptom Manage. 2009;38: Knotkova H, et al. J Pain Symptom Manage. 2009;38:
44Equianalgesic Dose Tables (EDT) Many different versions:PublishedOnlineOnline InteractiveSmart-phone appsVary in terms of:Equianalgesic valuesWhether ranges are usedWhich opioids are included:May or may not include transdermal opioids, rapid-onset fentanyl, ER/LA opioids, or opioid agonist-antagonistsKnotkova H, et al. J Pain Symptom Manage. 2009;38: Shaheen PE, et al. J Pain Symptom Manage. 2009;38: Webster LR, et al. Pain Med. 2012;13: Haffey F, et al. Drug Saf. 2013;36:111-7.
45Example of an EDT for Adults Equianalgesic DoseUsual Starting DosesDrugSC/IVPOParenteralMorphine10 mg30 mg2.5-5 mg SC/IV q3-4hr( – 2.5mg)5-15 mg q3-4hr(IR or oral solution)( mg)OxycodoneNA20 mg5-10 mg q3-4( mg)Hydrocodone5 mg q3-4hHydromorphone1.5 mg7.5 mgmg SC/IV q2-3hr( 0.2mg)1-2 mg q3-4hr( mg)Emphasize the relative potency of hydromorphone ER.For Fentanly: ORAL is NA, Parenteral is 15 mcg/1 hr.Transdermal fentanyl: ~80 times as potent as morphine (based on studies converting from morphine to fentanyl) Refer to PI (product Insert).UniPAC3_Table9(AAHPM)(2012)
46Limitations of EDTsSingle-dose potency studies using a specific route, conducted in patients w/ limited opioid exposureDid Not ConsiderChronic dosingHigh opioid dosesOther routesDifferent pain typesComorbidities or organ dysfunctionGender, ethnicity, advanced age, or concomitant medicationsEmphasis on limitation of UDT, non-specific morphine metabolitesDirection of switch from 1 opioid to anotherInter-patient variability in pharmacologic response to opioidsIncomplete cross- tolerance among mu opioidsFine PG, et al. J Pain Symptom Manage. 2009;38: Knotkova H, et al. J Pain Symptom Manage. 2009;38: Shaheen PE, et al. J Pain Symptom Manage. 2009;38: Webster LR, et al. Pain Med. 2012;13:
47Utilizing Equianalgesic Doses Incomplete cross-tolerance & inter-patient variability require use of conservative dosing when converting from one opioid to anotherEquianalgesic dose a starting point for opioid rotationIntended as General GuideCalculated dose of new drug based on EDT must be reduced, then titrate the new opioid as neededClosely follow patients during periods of dose adjustmentsFollow conversion instructions in individual ER/LA opioid PI, when providedFine PG, et al. J Pain Symptom Manage. 2009;38:Knotkova H, et al. J Pain Symptom Manage. 2009;38:
48Guidelines for Opioid Rotation Reduce calculated equianalgesic dose by 25%-50%*Calculate equianalgesic dose of new opioid from EDTSelect % reduction based on clinical judgmentCloser to 50% reduction if patient isCloser to 25% reduction if patientReceiving a relatively high dose of current opioid regimenElderly or medically frailDoes not have these characteristicsIs switching to a different administration route of same drug*75%-90% reduction for methadoneFine PG, et al. J Pain Symptom Manage. 2009;38:
49Guidelines for Opioid Rotation, cont’d If switching to methadone:Reduce calculated equianalgesic dose by 75%-90%For patients on very high opioid doses (e.g., ≥1,000 mg morphine equivalents/d), be cautious converting to methadone ≥100 mg/dConsider inpatient monitoring, including serial EKG monitoringIf switching to transdermal:Fentanyl, calculate dose conversion based on equianalgesic dose ratios included in the PIBuprenorphine, follow instructions in the PIFine PG, et al. J Pain Symptom Manage. 2009;38:
50Guidelines for Opioid Rotation, cont’d Have a strategy to frequently assess analgesia, AEs and withdrawal symptomsTitrate new opioid dose to optimize outcomes & safetyDose for breakthrough pain (BTP) using a short-acting, immediate release preparation is 5%-15% of total daily opioid dose, administered at an appropriate intervalIf oral transmucosal fentanyl product is used for BTP, begin dosing lowest dose irrespective of baseline opioid doseNEVER use ER/LA opioids for BTPFine PG, et al. J Pain Symptom Manage. 2009;38:
51Breakthrough Pain in Chronic Pain Patients Patients on stable ATC opioids may experience BTPTherapiesConsider addingDisease progression or a new or unrelated painDirected at cause of BTP or precipitating factorsNonspecific symptomatic therapies to lessen impact of BTPPRN IR opioid trial based on analysis of benefit versus riskRisk for aberrant drug-related behaviorsHigh-risk: only in conjunction w/ frequent monitoring & follow-upLow-risk: w/ routine follow-up & monitoringNonopioid drug therapiesNonpharmacologic treatmentsChou R, et al. J Pain. 2009;10:
52Reasons for Discontinuing ER/LA Opioids No progress toward therapeutic goalsIntolerable & Unmanageable AEsPain level decreases in stable patientsNonadherence or unsafe behaviorAberrant behaviors suggestive of addiction &/or diversion1 or 2 episodes of increasing dose without prescriber knowledgeSharing medicationsUnapproved opioid use to treat another symptom (e.g., insomnia)Use of illicit drugs or unprescribed opioidsRepeatedly obtaining opioids from multiple outside sourcesPrescription forgeryMultiple episodes of prescription lossChou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain
53Challenge: The Broken Stereotype Red Flag:Ms. Yeun seems like a “good” patient. She has never abused opioids previously. She has been in the practice a long time, has never been a problem, and in fact, is rather enjoyable. She always brings Christmas cookies for the staff around the holidays.Making assumptions about a patient’s risk factors without objective evidenceAction: Require all patients receiving opioids to follow a treatment plan and adhere to defined expectations. Evaluate risk in all patients. Use patient-provider agreements, contracts, or other tools.Explain to patient that the office policy mandates that everyone receiving opioids for the treatment of pain follow a treatment plan and expectations explained in the Provider Agreement. If the treatment plan is not followed, then the treatment plan follows a different path that may not involve opioids.(Gourlay & Heit, 2005; Stanos, 2012)Gourlay & Heit, 2005; Stanos, 2012
54Challenge: The Early Refill Red Flag:You have prescribed Mr. Arias a long-acting opioid for low back pain and a short-acting PRN opioid for breakthrough pain. Every month he requests a refill for both prescriptions 3-8 days early. Upon questioning, Mr. Arias tells you that he takes both pills whenever he feels he needs them.Patient requests an early refill every month.Don’t assume patient knows what “prn” means, nor the time-frame for effect of long acting ER/LAs, or what ER/LA means. Be specific about dose, amount per day, and set up ceiling to include in patient education, pill counts, UDT.Other things that MIGHT have happened to cause this patient to request early refills:Pain is poorly controlled, so dose of ER/LA opioid needs to be titrated upPatient has trouble sleeping, so often takes an extra dose in the evening to make sure they sleep through the night.Patient is actually abusing the opioids. It turns out that he was never given the appropriate risk screens when opioids were first prescribed.Action: Make sure that patients understand each medication’s dosage, time of day, and maximum daily dose. Ask them to repeat these instructions back to you. Avoid clinical terms such as “PRN” that the patient may not understand.Chou, et al., 2009a; Ballantyne, J.C., 2012; Stanos, 2012
57Informed Consent The potential for & how to manage: Before initiating a trial of opioid analgesic therapy, confirm patient understanding of informed consent to establish:Analgesic & functional goals of treatmentThe potential for & how to manage:Common opioid-related AEs (e.g., constipation, nausea, sedation)Other serious risks (e.g., abuse, addiction, respiratory depression, overdose)AEs after long-term or high-dose opioid therapy (e.g., hyperalgesia, endocrinologic or sexual dysfunction)ExpectationsPotential risksAlternatives to opioidsChou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain
59Consider a PPAReinforce expectations for appropriate & safe opioid useObtain opioids from a single prescriberFill opioid prescriptions at a designated pharmacySafeguard opioidsDo not store in medicine cabinetKeep locked (e.g., use a medication safe)Do not share or sell medicationInstructions for disposal when no longer neededCommitments to return for follow-up visitsComply w/ appropriate monitoringE.g., random UDT & pill countsFrequency of prescriptionsEnumerate behaviors that may lead to opioid discontinuationAn exit strategyChou R, et al. J Pain. 2009;10:
60Monitor Patients During Opioid Therapy Therapeutic risks & benefits do not remain staticIdentify patientsPeriodically assess continued need for opioid analgesicAffected by change in underlying pain condition, coexisting disease, or psychologic/ social circumstancesWho are benefiting from opioid therapyWho might benefit more w/ restructuring of treatment or receiving additional services (e.g., addiction treatment)Whose benefits from treatment are outweighed by risksRe-evaluate underlying medical condition if clinical presentation changesPeriodically evaluate: Pain control, Document pain intensity, pattern, & effects, Functional outcomes, Document level of functioning, Assess progress toward achieving therapeutic goalsHealth-related QOL, AE frequency & intensity, Adherence to prescribed therapiesPatients requiring more frequent monitoring:High riskOn high opioid dosesChou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain
61Monitor Patients During Opioid Therapy, cont’d Periodically evaluate:Patients requiring more frequent monitoring include:Pain controlDocument pain intensity, pattern, & effectsFunctional outcomesDocument level of functioningAssess progress toward achieving therapeutic goalsHealth-related QOLAE frequency & intensityAdherence to prescribed therapiesHigh-risk patientsPatients taking high opioid dosesThis can be covered in discussion of previous slide – pasted into speaker’s notesChou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain
62Anticipate & Treat Common AEs Constipationmost common AE; does not resolve with timeNausea & vomitingtend to diminish over days or weeksInitiate a bowel regimen before constipation developsIncrease fluid & fiber intake, stool softeners, & laxativesOpioid antagonists may help prevent/treat opioid-induced bowel dysfunctionOral & rectal antiemetic therapies as neededDrowsiness & sedationtend to wane over timePruritus & myoclonustend to diminish over days or weeksConstipation is the most common side effect of opioids. It is most common after opioid initiation or dose increases, does not resolve with timeCounsel patients about driving, work & home safety as well as risks of concomitant exposure to other drugs & substances w/ sedating effectsTreatment strategies for either condition largely anecdotalChou R, et al. J Pain. 2009;10:113-30
63Monitor Adherence and Aberrant Behavior Routinely monitor patient adherence to treatment planRecognize & document aberrant drug-related behaviorIn addition to patient self-report also use:State PDMPs, where availableUDTPositive for nonprescribed drugsPositive for illicit substanceNegative for prescribed opioidFamily member or caregiver interviewsMonitoring tools such as the COMM, PADT, PMQ, or PDUQMedication reconciliation (e.g., pill counts)PADT=Pain Assessment & Documentation ToolChou R, et al. J Pain. 2009;10:
64Address Aberrant Drug-Related Behavior Behavior outside the boundaries of agreed-on treatment plan:Behaviors that are less indicative of aberrancyBehaviors that are more indicative of aberrancyUnsanctioned dose escalations or other noncompliance w/ therapy on 1 or 2 occasionsMultiple dose escalations or other noncompliance w/ therapy despite warningsUnapproved use of the drug to treat another symptomPrescription forgeryOpenly acquiring similar drugs from other medical sourcesObtaining prescription drugs from nonmedical sourcesFleming MF, et al. Pain Med. 2008;9: Passik SD, et al. J Pain Symptom Manage. 2011;41: Portenoy RK. J Law Med Ethics. 1996;24: Passik SD, et al. Clin J Pain. 2006;22: Chou R, et al. J Pain. 2009;10:
65Prescription Drug Monitoring Programs (PDMPs) 49 states & 1 territory have legislation authorizing a PDMP43 states have an operational PDMPIndividual state laws determineWho has access to PDMP informationWhich drug schedules are monitoredWhich agency administers the PDMPWhether prescribers are required to register w/ the PDMPWhether prescribers are required to access PDMP information in certain circumstancesWhether unsolicited PDMP reports are sent to prescribersNational Alliance For Model State Drug Laws. Status of Prescription Drug Monitoring Programs. Alliance of States with Prescription Monitoring Programs. Alliance of States with Prescription Monitoring Programs. Prescription Monitoring Frequently Asked Questions (FAQ).
66PDMP Benefits Prescribers can check their own prescribing Hx Record of a patient’s controlled substance prescriptionsProvide warnings of potential misuse/abuseSome are available online 24/7Opportunity to discuss w/ patientExisting prescriptions not reported by patientMultiple prescribers/pharmaciesDrugs that increase overdose risk when taken togetherPatient pays for drugs of abuse w/ cashPrescribers can check their own prescribing HxPerrone J, et al. N Engl J Med. 2012;366: Gugelmann HM, et al. JAMA. 2011;306: Clark T, et al. Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices The Prescription Drug Monitoring Program Center of Excellence, HellerSchoolfor Social Policy & Management, Brandeis University.
67PDMP Unsolicited Patient Threshold Reports Reports automatically generated on patients who cross certain thresholds when filling prescriptions. Available in some states.ed to prescribers to whom prescriptions were attributedPrescribers review records to confirm it is your patient & you wrote the prescription(s) attributed to youIf inaccurate, contact PDMPIf you wrote the prescription(s), patient safety may dictate need to discuss the patient w/ other prescribers listed on reportDecide who will continue to prescribe for the patient & who might address drug abuse concerns.Using Patient Threshold ReportsIf you receive a Patient Threshold Report, please review your records to confirm that this is your patient and that you wrote the prescription(s) attributed to you. If you find that any of the records are inaccurate, contact the Prescription Monitoring Program immediately.If you did write the prescriptions, patient safety generally dictates the need to discuss the patient with the other doctors listed on the report. During this discussion, you should decide collectively who will continue to provide prescriptions for the patient and who might address any concerns about drug abuse with them. You may also want to keep the report in your patient's chart. The goal is to get people the treatment they need if they have a substance abuse problem.Clark T, et al. Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices The Prescription Drug Monitoring Program Center of Excellence, Heller School for Social Policy & Management, Brandeis University.
68Rationale for Urine Drug Testing (UDT) Help to identify drug misuse/addictionPrior to starting opioid treatmentAssist in assessing adherence during opioid therapyAs requirement of therapy w/ an opioidSupport decision to referUDT frequency is based on clinical judgmentDepending on patient’s display of aberrant behavior and whether it is sufficient to document adherence to treatment planCheck state regulations for requirementsGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care Ed SAMHSA. Clinical Drug Testing in Primary Care. Technical Assistance Publication (TAP) 32. HHS Publication No.(SMA) Rockville, MD: SAMHSA, Chou R, et al. J Pain. 2009;10: Gourlay DL, et al. Compliance monitoring in chronic pain management. In: Bonica’s Management of Pain. 4th ed. Gourlay DL, et al. Pain Med. 2009;10 Suppl 2:S
69Main Types of UDT Methods Initial testing w/ IA drug panels:Classify substance as present or absent according to cutoffMany do not identify individual drugs within a classSubject to cross-reactivityEither lab based or at POCIdentify specific drugs &/or metabolites w/ sophisticated lab-based testing; e.g., GC/MS or LC/MS*Specifically confirm the presence of a given druge.g., morphine is the opiate causing a positive IA*Identify drugs not included in IA testsWhen results are contested* GC/MS=gas chromatography/ mass spectrometry IA=immunoassay LC/MS=liquid chromatography/ mass spectrometryGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care Ed 4. Cone EJ, et al. Postgrad Med. 2009;121: SAMHSA. Clinical Drug Testing in Primary Care. Technical Assistance Publication (TAP) 32. HHS Publication No.(SMA) Rockville, MD: SAMHSA, 2012.
70Detecting Opioids by UDT Most common opiate IA drug panelsGC/MS or LC/MS will identify specific opioidsDetect “opiates” morphine & codeine, but doesn’t distinguishDo not reliably detect semisynthetic opioidsSpecific IA panels can be ordered for someDo not detect synthetic opioids (e.g., methadone, fentanyl)Only a specifically directed IA panel will detect syntheticsConfirm presence of a drug causing a positive IAIdentify opioids not included in IA drug panels, including semisynthetic & synthetic opioidsGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care Ed 4.
71Interpretation of UDT Results Demonstrates recent useMost drugs in urine have detection times of 1-3 dChronic use of lipid-soluble drugs: test positive for ≥1 wkDoes not diagnoseDrug addiction, physical dependence, or impairmentDoes not provide enough information to determineExposure time, dose, or frequency of usePositive ResultDoes not diagnose diversionMore complex than presence or absence of a drug in urineMay be due to maladaptive drug-taking behaviorBingeing, running out earlyOther factors: eg, cessation of insurance, financial difficultiesNegative ResultGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care Ed 4. SAMHSA. Clinical Drug Testing in Primary Care. TAP 32. HHS Publication No.(SMA) Gourlay DL, et al. Pain Med ;6: Gourlay D, et al. Clin J Pain. 2010;26: Nafziger AN, et al. Clin J Pain. 2009;25:73-9.
72Interpretation of UDT Results, cont’d Be awareTesting technologies & methodologies evolveDifferences exist between IA test menu panels varyCross-reactivity patternsMaintain list of all patient’s prescribed & OTC drugsAssist to identify false-positive resultCutoff levelsTime taken to eliminate drugsDocument time of last use & quantity of drug(s) takenOpioid metabolism may explain presence of apparently unprescribed drugsGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care. Ed
73Examples of Metabolism of Opioids CodeineMorphine6-MAM*HeroinHydrocodoneHydromorphoneOxycodoneOxymorphonet½=25-30 mint½=3-5 min*6-MAM=6-monoacetylmorphineGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care. Ed
74Interpretation of UDT Results Use UDT results in conjunction w/ other clinical informationInvestigate unexpected resultsDiscuss w/ the labSchedule appointment w/ patient to discuss unexpected/abnormal resultsChart results, interpretation, & actionDo not ignore the unexpected positive resultMay necessitate closer monitoring &/or referral to a specialistGourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care. Ed
75Be Ready to ReferBe familiar w/ referral sources for abuse or addiction that may arise from use of ER/LA opioidsSAMHSA substance abuse treatment facility locatorSAMHSA mental health treatment facility locator
76Challenge: The Insistent Patient Red Flag:Mr. Lee’s daily function has improved significantly over the past two years. You suggest titrating his dosage down or trying alternative pain management options. He is extremely resistant and tells you “Nothing else relieves my pain.”Patient refuses to consider non-opioid treatment optionsAction: Work with your patient to set treatment goals and expectations. Select and document a therapy plan or use a patient- provider agreement. Evaluate Mr. Lee for potential addiction; consider referral to psychiatry or addiction medicine.Merrill, et al., 2002; Wilsey et al., 2008) (Sehgal, et al., 2012; Chou, et al., 2009a
79Use Patient Counseling Document to help counsel patients Download: opioidrems.com/IwgUI/rems/pdf/patient_counseling_document.pdfThe Patient Counseling Document (PCD) on Extended-Release/Long Acting (ER/LA) Opioid Analgesics is a toolunique to this REMS designed to facilitate importantdiscussions with your patients for whom you select an ER/LA opioid analgesic. The PCD should be provided to andreviewed with the patient and/or their caregiver at the timeof prescribing. It contains important safety informationabout the drug products subject to this REMS and includesspace for you to write additional information to help yourpatients use their ER/LA opioid analgesic safely.Order hard copies:Collaborative for REMS Education
80Counsel Patients About Proper Use ExplainInstruct patients/ caregivers toProduct-specific information about the prescribed ER/LA opioidHow to take the ER/LA opioid as prescribedImportance of adherence to dosing regimen, handling missed doses, & contacting their prescriber if pain cannot be controlledRead the ER/LA opioid Medication Guide received from pharmacy every time an ER/LA opioid is dispensedAt every medical appointment explain all medications they takeFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics Available atThe ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression.Collaborative for REMS Education
81Counsel Patients About Proper Use, cont’d Counsel patients/caregivers:On the most common AEs of ER/LA opioidsAbout the risk of falls, working w/ heavy machinery, & drivingCall the prescriber for advice about managing AEsInform the prescriber about AEsPrescribers should report serious AEs to the FDA: HowToReport/DownloadForms/UCM pdf or FDA-1088FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
82Warn PatientsNever break, chew, or crush an oral ER/LA tablet/capsule, or cut or tear patches prior to useMay lead to rapid release of ER/LA opioid causing overdose & deathWhen a patient cannot swallow a capsule whole, prescribers should refer to PI to determine if appropriate to sprinkle contents on applesauce or administer via feeding tubeUse of CNS depressants or alcohol w/ ER/LA opioids can cause overdose & deathThe use of other CNS depressants such as sedative-hypnotics and anxiolytics, alcohol, or illegal drugs with ER/LA opioid analgesics can have a potentiating affect on the sedation and respiratory depression caused by ER/LAs and may cause overdose and death.Use other CNS depressants, including other opioids, under the instruction of their prescriberExposure of some products to alcoholic beverages or medications containing alcohol may result in rapid release & absorption of a potentially fatal opioid doseUse with alcohol may result in rapid release & absorption of a potentially fatal opioid doseOther depressants include sedative-hypnotics & anxiolytics, illegal drugsFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
83Warn Patients, cont’d Misuse of ER/LA opioids can lead to death Take exactly as directedCounsel patients/caregivers on risk factors, signs, & symptoms of overdose & opioid-induced respiratory depression, GI obstruction, & allergic reactionsCall 911 or poison controlTAKE 1 TABLET BY MOUTH EVERY 12 HOURSOXYCONTIN 10 MGQty: 60 TABLETSDo not abruptly stop or reduce the ER/LA opioid useDiscuss how to safely taper the dose when discontinuingFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
84Protecting the Community Caution PatientsSharing ER/LA opioids w/ others may cause them to have serious AEsIncluding deathSelling or giving away ER/LA opioids is against the lawStore medication safely and securelyProtect ER/LA opioids from theftDispose of any ER/LA opioids when no longer neededRead product-specific disposal information included w/ ER/LA opioidFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
86Educate Patients & Families Rx medicines should only be taken when prescribed to you by a providerTaking a pill prescribed for someone else is drug abuse and illegal, “even just once”Misusing Rx drugs can be as dangerous as illegal “street” drugsMixing Rx opioids w/ alcohol or w/ sedatives / hypnotics is potentially fatalPrescription medications should only be taken by a patient prescribed them by a provider, per the provider’s instructions.They should not be used for other reasons than as prescribed, such as emotional issues or sleep.They should not be used by someone other than the patient, even if it is for the same indication. Taking a pill prescribed for someone else is drug abuse, and illegal, even when just on one occasion.A common myth among teens is that prescription medications are a safer way to get high than illicit drug use. Teens do not fully perceive the harmfulness from taking a prescription drug without a doctor’s prescription.Mixing prescription drugs with alcohol increases risk of fatal overdose.An overlapping opioid or sedative/hypnotic prescription is strongly associate with risk of overdose.Apa-Hall P, et al. J Sch Nurs. 2008;24(suppl):S Paulozzi LJ, et al. Pain Med. 2012;13: Webster LR, et al. Pain Med. 2011;12 Suppl 2:S26-35.
87Educate Parents: Not in My House Step 1: MonitorNote how many pills in each prescription bottle or pill packetKeep track of refills for all household membersIf your teen has been prescribed a drug, coordinate & monitor dosages & refillsMake sure friends & relatives—especially grandparents— are aware of the risksIf your teen visits other households, talk to the families about safeguarding their medicationsThe ready availability of prescription medications in teens’ own homes highlights the need for increased educational efforts targeting parents and other family members regarding safeguarding and monitoring prescription medications in the home, so that they do not act as “unintentional enablers.”MONITOR:Parents are in an influential position to immediately help reduce teen access toprescription drugs because these drugs are found in the home.Start by taking note of how many pills are in each of your prescription bottles or pill packets.Keep track of your refills. This goes for your own medication, as well as for your teens and other members of the household. Needing to refill medication more often than expected could indicate a problem.If your teen has been prescribed a drug, be sure you control the medication, and monitor dosages and refills.Make sure your friends and relatives—especially grandparents—are also aware of the risks. Encourage them to regularly monitor their own medicine cabinets.If there are other households your teen has access to, talk to those families as well about the importance of helping safeguard their medications.The Partnership at DrugFree.org. Rx Abuse: Not in My House.
88Educate Parents: Not in My House, cont’d Step Two: SecureStep Three: DisposeDo not store prescription meds in the medicine cabinetKeep meds in a safe place (e.g., locked cabinet)Tell relatives, especially grandparents, to lock meds or keep in a safe placeEncourage parents of your teen’s friends to secure medsTake inventory of all prescription drugs in your homeDiscard expired or unused medsSECURE:Teens abuse prescription drugs because they are easily accessible and either free or inexpensive. Approach securing your prescriptions the same way you would other valuables in your home, like jewelry or cash.Take prescription medications out of the medicine cabinet and hide them in a place only you know about.If possible, keep all medicines in a safe place, such as a locked cabinet your teen cannot access.Tell relatives, especially grandparents, to lock their medications or keep them in a safe place.Talk to the parents of your teenager’s friends. Encourage them to secure their prescriptionsHowever, in the survey of Massachusetts parents by the Partnership at DrugFree.org, 34% of respondents say that grandparents use prescription pain relievers, but only 19% have spoken to grandparents about safeguarding their medications.Safely disposing of expired or unused prescription medications is a critical step to decrease the opportunity for your teens or their friends to abuse your medications.DISPOSE:After taking an inventory of all of the prescription drugs in your home, discard expired or unused prescription drugs, when your teens are not home.The Partnership at DrugFree.org. Rx Abuse: Not in My House.
89ER/LA Opioid Drug Disposal National Prescription Drug Take-Back Day: “Got Drugs?” APRIL 26, 2014Locations TBACheck back atDrug drop boxes in some local police departments, to find a box near you:oror
90Prescription drug disposal when a program or drop box is unavailable: If take-back program or drop box unavailable, throw out in household trashTake drugs out of original containersMix w/ undesirable substance, e.g., used coffee grounds or kitty litterLess appealing to children/pets, & unrecognizable to people who intentionally go through your trashPlace in sealable bag, can, or other containerPrevent leaking or breaking out of garbage bagBefore throwing out a medicine containerScratch out identifying info on labelIf no instructions are given on the drug label and no local take-back programs are available, the drugs can be disposed of in household trash. First, they should be removed from their original containers and mixed with an undesirable substance (eg, used coffee grounds or kitty litter), so that the medication is less appealing to children and pets, and unrecognizable to people who may intentionally go through trash. Then they should be placed in a sealable bag, can, or other container to prevent the medication from leaking or breaking out of a garbage bag. Before throwing out a medicine container, scratch out all identifying information on the prescription label to protect privacy of personal health information and prevent unauthorized refills. When in doubt about proper disposal, parents should talk to their pharmacist.FDA. How to Dispose of Unused Medicines ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm pdf SMARxT Disposal. A prescription for a healthy planet.
91Prescription Drug Disposal FDA lists especially harmful medicines – in some cases fatal w/ just 1 dose – if taken by someone other than the patientInstruct patients to check medication guideFlush down sink/toilet if no take-back program availableAs soon as they are no longer neededSo cannot be accidentally taken by children, pets, or othersIncludes transdermal adhesive skin patchesUsed patch worn for 3d still contains enough opioid to harm/kill a childDispose of used patches immediately after removing from skinFold patch in half so sticky sides meet, then flush down toiletDo NOT place used or unneeded patches in household trashException is Butrans: can seal in Patch-Disposal Unit provided & dispose of in the trash
92Disposal UpdatesIn Dec 2012, DEA published a Notice of Proposed Rulemaking for Disposal of Controlled SubstancesThe Secure & Responsible Drug Disposal Act of 2010 would expand options to collect controlled substances from ultimate users for disposal to include:Take-back eventsMail-back programsCollection receptacle locationsCheck back atDEA. Federal Register. 2012; 77(246): Proposed Rules. Disposal of Controlled Substances.
93Challenge: The Offended Patient Red Flag:Mrs. Jorgensen has been your patient for eight years and has never caused any problems. When you ask her to under urine drug testing, she becomes upset and accuses you of not trusting her.You decide not to request routine risk assessment for fear of creating conflictAction: Describe UDT as a routine part of medication monitoring rather than a “drug test”. Create an office policy for performing UDT on all ER/LA opioid patients. Practice by following universal precautions. Use a patient-provider agreement to clarify expectations of treatment.Chou, et al., 2009a; Ballantyne, J.C., 2012; Stanos, 2012
94Challenge: The Daughter’s Party Red Flag:Your patient’s daughter, Jody, stole her father’s opioids from his bedside drawer to take to a “fishbowl party”. Her best friend consumed a mix of opioids and alcohol and died of an overdose.Patients do not safeguard their opioid medications correctlyPrescribers often do not know how much opioids patients have at home or have access to. It is difficult to determine stock pile.If you had run the PDMP for this patient, you would have found that Jody’s father was recently d/c from hospital with 240 tablets of oxycodone/APAP with instructions from hospitalist for 1-2 tabs every 3-4 hours prn pain in addition to the ER/LA opioid that you have prescribed.Action: Always counsel patients about safe drug storage; warn patients about the serious consequences of theft, misuse, and overdose. Tell your patients that taking another person’s medication, even once, is against the law.Chou, et al., 2009a; Ballantyne, J.C., 2012; Stanos, 2012
97General ER/LA Opioid Drug Information Prescribers should be knowledgeable about general characteristics, toxicities, & drug interactions for ER/LA opioid products:ER/LA opioid analgesic products are scheduled under the Controlled Substances Act & can be misused & abusedRespiratory depression is the most serious opioid AEConstipation is the most common long-term AEBe aware:Drug-drug interaction profiles vary among the products· Knowledge of particular opioid-drug interactions, and the underlying pharmacokinetic and pharmacodynamic mechanisms, allows for the safer administration of opioid analgesics.· Central nervous system depressants (alcohol, sedatives, hypnotics, tranquilizers, tricyclic antidepressants) can have a potentiating effect on the sedation and respiratory depression caused by opioids.· Some ER opioid formulations may rapidly release opioid (dose dump) when exposed to alcohol.Can be immediately life-threateningShould be anticipatedFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
98For Safer Use: Know Drug Interactions, PK, & PD CNS depressants can potentiate sedation & respiratory depressionSome ER/LA products rapidly release opioid (dose dump) when exposed to alcoholSome drug levels may increase without dose dumpingUse w/ MAOIs may increase respiratory depressionCertain opioids w/ MAOIs can cause serotonin syndromeCan reduce efficacy of diureticsInducing release of antidiuretic hormoneCertain opioids with MAOIs may cause serotonin syndrome.Methadone & buprenorphine can prolong QTc intervalDrugs that inhibit or induce CYP enzymes can increase or lower blood levels of some opioids
99Opioid Tolerant Patients must be opioid tolerant before using Tolerance to sedating & respiratory-depressant effects is critical to safe use of certain ER/LA opioid products, dosage unit strengths, or dosesPatients must be opioid tolerant before usingAny strength of transdermal fentanyl or hydromorphone ERCertain strengths or daily doses of other ER productsOpioid-tolerant patients are those taking at least60 mg oral morphine/day25 mcg transdermal fentanyl/hr30 mg oral oxycodone/day8 mg oral hydromorphone/day25 mg oral oxymorphone/dayAn equianalgesic dose of another opioidFOR 1 WK OR LONGERFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid AnalgesicsThe ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression
100Key Instructions: ER/LA Opioids Refer to product information for titration intervalContinually re-evaluate to assess maintenance of pain control & emergence of AEsTimes required to reach steady-state plasma concentrations are product-specificIndividually titrate to a dose that provides adequate analgesia & minimizes adverse reactionsFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
102Common Drug Information for This Class Limitations of usageDosage reduction for hepatic or renal impairmentRelative potency to oral morphineNot for use as an as-needed analgesicNot for mild pain or pain not expected to persist for an extended durationNot for use in treating acute painSee individual drug PIIntended as general guideFollow conversion instructions in individual PIIncomplete cross- tolerance & inter-patient variability require conservative dosing when converting from 1 opioid to anotherHalve calculated comparable dose & titrate new opioid as neededFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
103Transdermal Dosage Forms Do not cut, damage, chew, or swallowExertion or exposure to external heat can lead to fatal overdoseRotate location of applicationPrepare skin: clip - not shave - hair & wash area w/ waterMonitor patients w/ fever for signs or symptoms of increased opioid exposureMetal foil backings are not safe for use in MRIsFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid AnalgesicsThe ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression
104Drug Interactions Common to this Class May enhance neuromuscular blocking action of skeletal muscle relaxants & increase respiratory depressionConcurrent use w/ anticholinergic medication increases risk of urinary retention & severe constipationMay lead to paralytic ileusAvoid using partial agonists & mixed agonist/antagonist analgesics† together, may reduce analgesic effect or precipitate withdrawalConcurrent use w/ other CNS depressants can increase risk of respiratory depression, hypotension, profound sedation, or comaReduce initial dose of one or both agents†Buprenorphine, pentazocine, nalbuphine, butorphanolFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
105Drug Information Common to This Class Use in opioid-tolerant patientsContraindicationsSee individual PI for products which:Have strengths or total daily doses only for use in opioid-tolerant patientsAre only for use in opioid-tolerant patients at all strengthsSignificant respiratory depressionAcute or severe asthma in an unmonitored setting or in absence of resuscitative equipmentKnown or suspected paralytic ileusHypersensitivity (e.g., anaphylaxis)See individual PI for additional contraindicationsFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
107Challenge: The Patient in the ER Red Flag:Action: Be familiar with risk factors for respiratory depression and know when opioids are contra-indicated. Anticipate possible risks and develop contingency plans. Teach patients, family, and caregivers about respiratory depression and its symptoms.You are woken by a telephone call at 2 am reporting that your patient, Mr. Diallo, is in the ER with apparent respiratory depression.Review what might have happened here:Patient drank alcohol while taking his medicationMedication was titrated upward too quicklyPatient has severe asthmaPatient has overused NSAIDs, causing acute renal failureMerrill, et al., 2002; Wilsey et al., 2008) (Sehgal, et al., 2012; Chou, et al., 2009a
109Specific Characteristics Know for opioid products you prescribe:Drug substanceFormulationStrengthDosing intervalKey instructionsUse in opioid-tolerant patientsProduct-specific safety concernsRelative potency to morphineSpecific information about product conversions, if availableSpecific drug interactionsFor detailed information, refer to online PI: DailyMed at atFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
110Morphine Sulfate ER Capsules (Avinza) Dosing intervalOnce a dayKey instructionsInitial dose in opioid non-tolerant patients is 30 mgTitrate using a minimum of 3-d intervalsSwallow capsule whole (do not chew, crush, or dissolve)May open capsule & sprinkle pellets on applesauce for patients who can reliably swallow without chewing; use immediatelyMDD:* 1600 mg (renal toxicity of excipient, fumaric acid)Drug interactionsAlcoholic beverages or medications w/ alcohol may result in rapid release & absorption of potentially fatal dosePGP* inhibitors (e.g., quinidine) may increase absorption/exposure of morphine by ~2-foldOpioid-tolerant90 mg & 120 mg capsules for use in opioid-tolerant patients onlyProduct-specific safety concernsNone* MDD=maximum daily dose; PGP= P-glycoproteinFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
111Buprenorphine Transdermal System (Butrans) Dosing intervalOne transdermal system every 7 dKey instructionsInitial dose in opioid non-tolerant patients on <30 mg morphine equivalents & in mild-moderate hepatic impairment: 5 mcg/hWhen converting from 30 mg-80 mg morphine equivalents, first taper to 30 mg morphine equivalent, then initiate w/ 10 mcg/hTitrate after a minimum of 72 h prior to dose adjustmentMaximum dose: 20 mcg/h due to risk of QTc prolongationApplicationApply only to sites indicated in PIApply to intact/non-irritated skinPrep skin by clipping hair; wash site w/ water onlyRotate application site (min 3 wks before reapply to same site)Do not cutAvoid exposure to heatDispose of patches: fold adhesive side together & flush down toiletFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
112Buprenorphine Transdermal System (Butrans) cont’d Drug interactionsCYP3A4 inhibitors may increase buprenorphine levelsCYP3A4 inducers may decrease buprenorphine levelsBenzodiazepines may increase respiratory depressionClass IA & III antiarrythmics, other potentially arrhythmogenic agents, may increase risk of QTc prolongation & torsade de pointeOpioid-tolerant10 mcg/h & 20 mcg/h for use in opioid-tolerant patients onlyDrug-specific safety concernsQTc prolongation & torsade de pointeHepatotoxicityApplication site skin reactionsRelative potency: oral morphineEquipotency to oral morphine not establishedFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
113Methadone Hydrochloride Tablets (Dolophine) Dosing intervalEvery 8 to 12 hKey instructionsInitial dose in opioid non-tolerant patients: 2.5 to 10 mgConversion of opioid-tolerant patients using equianalgesic tables can result in overdose & death. Use low doses according to table in full PIHigh inter-patient variability in absorption, metabolism, & relative analgesic potencyOpioid detoxification or maintenance treatment only provided in a federally certified opioid (addiction) treatment program (CFR, Title 42, Sec 8)Drug interactionsPharmacokinetic drug-drug interactions w/ methadone are complexCYP 450 inducers may decrease methadone levelsCYP 450 inhibitors may increase methadone levelsAnti-retroviral agents have mixed effects on methadone levelsPotentially arrhythmogenic agents may increase risk for QTc prolongation & torsade de pointeBenzodiazepines may increase respiratory depressionDelayed/prolonged respiratory depression with methadone compared to othersFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
114Methadone Hydrochloride Tablets (Dolophine) cont’d Opioid-tolerantRefer to full PIDrug-specific safety concernsQTc prolongation & torsade de pointePeak respiratory depression occurs later & persists longer than analgesic effectClearance may increase during pregnancyFalse-positive UDT possibleRelative potency: oral morphineVaries depending on patient’s prior opioid experienceDelayed/prolonged respiratory depression with methadone compared to othersFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
115Fentanyl Transdermal System (Duragesic) Dosing intervalEvery 72 h (3 d)Key instructionsUse product-specific information for dose conversion from prior opioidHepatic or renal impairment: use 50% of dose if mild/moderate, avoid use if severeApplicationApply to intact/non-irritated/non-irradiated skin on a flat surfacePrep skin by clipping hair, washing site w/ water onlyRotate site of applicationTitrate using no less than 72 h intervalsDo not cutAvoid exposure to heatAvoid accidental contact when holding or caring for childrenDispose of used/unused patches: fold adhesive side together & flush down toiletFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
116Fentanyl Transdermal System (Duragesic), cont’d Key instructionsSpecific contraindications:Patients who are not opioid-tolerantManagement ofAcute or intermittent pain, or patients who require opioid analgesia for a short period of timePost-operative pain, out-patient, or day surgeryMild painDrug interactionsCYP3A4 inhibitors may increase fentanyl exposureCYP3A4 inducers may decrease fentanyl exposureOpioid-tolerantAll doses indicated for opioid-tolerant patients onlyDrug-specific safety concernsAccidental exposure due to secondary exposure to unwashed/unclothed application siteIncreased drug exposure w/ increased core body temp or feverBradycardiaApplication site skin reactionsRelative potency: oral morphineSee individual PI for conversion recommendations from prior opioidFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
117Morphine Sulfate ER-Naltrexone Tablets (Embeda) Dosing intervalOnce a day or every 12 hKey instructionsInitial dose as first opioid: 20 mg/0.8 mgTitrate using a minimum of 3-d intervalsSwallow capsules whole (do not chew, crush, or dissolve)Crushing or chewing will release morphine, possibly resulting in fatal overdose, & naltrexone, possibly resulting in withdrawal symptomsMay open capsule & sprinkle pellets on applesauce for patients who can reliably swallow without chewing, use immediatelyDrug interactionsAlcoholic beverages or medications w/ alcohol may result in rapid release & absorption of potentially fatal dosePGP inhibitors (e.g., quinidine) may increase absorption/exposure of morphine by ~2-foldOpioid-tolerant100 mg/4 mg capsule for use in opioid-tolerant patients onlyProduct-specific safety concernsNoneEmphasize 3-day minimum interval dose titrationFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
118Hydromorphone Hydrochloride ER Tablets (Exalgo) Dosing intervalOnce a dayKey instructionsUse conversion ratios in individual PIStart patients w/ moderate hepatic impairment on 25% dose prescribed for patient w/ normal functionRenal impairment: start patients w/ moderate on 50% & patients w/ severe on 25% dose prescribed for patient w/ normal functionTitrate using a minimum of 3 to 4 d intervalsSwallow tablets whole (do not chew, crush, or dissolve)Do not use in patients w/ sulfite allergy (contains sodium metabisulfite)Drug interactionsNoneOpioid-tolerantAll doses are indicated for opioid-tolerant patients onlyProduct-specific adverse reactionsAllergic manifestations to sulfite componentRelative potency: oral morphine~5:1 oral morphine to hydromorphone oral dose ratio, use conversion recommendations in individual product informationFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
119Morphine Sulfate ER Capsules (Kadian) Dosing intervalOnce a day or every 12 hKey instructionsPI recommends not using as first opioidTitrate using minimum of 2-d intervalsSwallow capsules whole (do not chew, crush, or dissolve)May open capsule & sprinkle pellets on applesauce for patients who can reliably swallow without chewing, use immediatelyDrug interactionsAlcoholic beverages or medications w/ alcohol may result in rapid release & absorption of potentially fatal dose of morphinePGP inhibitors (e.g., quinidine) may increase absorption/exposure of morphine by ~2-foldOpioid-tolerant100 mg & 200 mg capsules for use in opioid-tolerant patients onlyProduct-specific safety concernsNoneFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
120Morphine Sulfate CR Tablets (MS Contin) Dosing intervalEvery 8 h or every 12 hKey instructionsProduct information recommends not using as first opioid.Titrate using a minimum of 2-d intervalsSwallow tablets whole (do not chew, crush, or dissolve)Drug interactionsPGP inhibitors (e.g., quinidine) may increase absorption/exposure of morphine by ~2-foldOpioid-tolerant100 mg & 200 mg tablet strengths for use in opioid-tolerant patients onlyProduct-specific safety concernsNoneFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
121Tapentadol ER Tablets (Nucynta ER) Dosing intervalEvery 12 hKey instructions50 mg every 12 h is initial dose in opioid non-tolerant patientsTitrate by 50 mg increments using minimum of 3-d intervalsMDD: 500 mgSwallow tablets whole (do not chew, crush, or dissolve)Take 1 tablet at a time w/ enough water to ensure complete swallowing immediately after placing in mouthDose once/d in moderate hepatic impairment (100 mg/d max)Avoid use in severe hepatic & renal impairmentDrug interactionsAlcoholic beverages or medications w/ alcohol may result in rapid release & absorption of a potentially fatal dose of tapentadolContraindicated in patients taking MAOIsOpioid-tolerantNo product-specific considerationsProduct-specific safety concernsRisk of serotonin syndromeAngio-edemaRelative potency: oral morphineEquipotency to oral morphine has not been establishedFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
122Oxymorphone Hydrochloride ER Tablets (Opana ER) Dosing intervalEvery 12 h dosing, some may benefit from asymmetric (different dose given in AM than in PM) dosingKey instructionsUse 5 mg every 12 h as initial dose in opioid non-tolerant patients & patients w/ mild hepatic impairment & renal impairment (creatinine clearance <50 mL/min) & patients >65 yrsSwallow tablets whole (do not chew, crush, or dissolve)Take 1 tablet at a time, w/ enough water to ensure complete swallowing immediately after placing in mouthTitrate using a minimum of 2-d intervalsContraindicated in moderate & severe hepatic impairmentDrug interactionsAlcoholic beverages or medications w/ alcohol may result in absorption of a potentially fatal dose of oxymorphoneOpioid-tolerantNo product-specific considerationsProduct-specific safety concernsNoneRelative potency: oral morphineApproximately 3:1 oral morphine to oxymorphone oral dose ratioFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
123Oxycodone Hydrochloride CR Tablets (OxyContin) Dosing intervalEvery 12 hKey instructionsOpioid-naïve patients: initiate treatment w/ 10 mg every 12 hTitrate using a minimum of 1 to 2 d intervalsHepatic impairment: start w/ ⅓-½ usual dosageRenal impairment (creatinine clearance <60 mL/min): start w/ ½ usual dosageConsider other analgesics in patients w/ difficulty swallowing or underlying GI disorders that predispose to obstruction. Swallow tablets whole (do not chew, crush, or dissolve)Take 1 tablet at a time, w/ enough water to ensure complete swallowing immediately after placing in mouthDrug interactionsCYP3A4 inhibitors may increase oxycodone exposureCYP3A4 inducers may decrease oxycodone exposureOpioid-tolerantSingle dose >40 mg or total daily dose >80 mg for use in opioid- tolerant patients onlyProduct-specific safety concernsChoking, gagging, regurgitation, tablets stuck in throat, difficulty swallowing tabletContraindicated in patients w/ GI obstructionRelative potency: oral morphineApproximately 2:1 oral morphine to oxycodone oral dose ratioFDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics
124SummaryPrescription opioid abuse & overdose is a national epidemic. Clinicians must play a role in preventionUnderstand how to assess patients for treatment w/ ER/LA opioidsBe familiar w/ how to initiate therapy, modify dose, & discontinue use of ER/LA opioidsKnow how to manage ongoing therapy w/ ER/LA opioidsKnow how to counsel patients & caregivers about the safe use of ER/LA opioids, including proper storage & disposalBe familiar w/ general & product-specific drug information concerning ER/LA opioids
125IMPORTANT!Thank you for completing the post-activity assessment for this CO*RE session. Your participation in this assessment allows CO*RE to report de-identified numbers to the FDA. A strong show of engagement will demonstrate that clinicians have voluntarily taken this important education and are committed to patient safety and improved outcomes.THANK YOU!