2016 CDC Guidelines for Opioid Prescribing

transcript

D a v i d A . E d w a r d s , M D P h DV a n d e r b i l t U n i v e r s i t y

• DavidAEdwardshasdocumentedthathehasnothingtodisclose.

• Thispresentationdoesnotcontainoff-labelorinvestigationaluseofdrugsorproducts.

Disclosures

Introduction

1. To be able to list the 12 CDC Guidelines for prescribing Opioids

2. To know how to prescribe controlled substances and remain compliant

Objectives

Opioid GuidelinesFederal

CDC Guidelines for Prescribing Opioids for Chronic Pain -2016

• ~20%ofpatientsvisitingaDr.’sofficewithpainareprescribedanopioid(1)

• ~14%ofadultshavechronicpain(7)

• 165,000overdosedeathsin1999-2014(16)

• 420,000EDvisitsforopioidmisusein2011(19)

• OpioidUseDisorder(DSM-IV)– 1.9million

CDC Guidelines for Prescribing Opioids for Chronic Pain -2016

• 1in550patientswithcancerdiedfromopioidO.D.atmedian2.6years(21)

• 1in32atdoses>200MME

CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016

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Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months

Incorporatestrategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines

ReviewPDMPdatawhenstartingopioidsandevery3months

Useurinedrugtestingatleastannually

Avoidprescribingopioidpainmedicationandbenzodiazepinesconcurrentlywheneverpossible

Offerorarrangetreatmentforpatientswithopioidusedisorder

Nonpharmacologic,nonopioidarepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapyBeforestartingopioids,establishtreatmentgoals,considerhowopioidtherapywillbediscontinued,andcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunctionDiscusswithpatientsknownrisksandrealisticbenefitsandpatientandclinicianresponsibilities

Prescribethelowesteffectivedosage,andcarefullyreassesswhenincreasingto ≥50MME/day,andavoidorcarefullyjustifyadecisiontotitratedosageto≥90MME/dayForacutepain,prescribethelowesteffectivedoseofimmediate-releaseopioids,nogreaterquantitythanneededforexpecteddurationofpain,threedaysorless;>sevendaysrarelyneeded

Prescribeimmediate-releaseopioidsinsteadofextended-release/long-acting(ER/LA)opioids

Nonpharmacologic therapyandnonopioidpharmacologictherapyarepreferredforchronicpain.Cliniciansshouldconsideropioidtherapyonlyifexpectedbenefitsforbothpainandfunctionareanticipatedtooutweighriskstothepatient.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy,asappropriate(recommendationcategory:A,evidencetype:3)

Nonpharmacologic,nonopioid arepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy.

Beforestartingopioidtherapyforchronicpain,cliniciansshouldestablishtreatmentgoalswithallpatients,includingrealisticgoalsforpainandfunction,andshouldconsiderhowopioidtherapywillbediscontinuedifbenefitsdonotoutweighrisks.Cliniciansshouldcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunctionthatoutweighsriskstopatientsafety(recommendationcategory:A,evidencetype:4)

Beforestartingopioids,establishtreatmentgoals,considerhowopioidtherapywillbediscontinued,andcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunction.

Beforestartingandperiodicallyduringopioidtherapy,cliniciansshoulddiscusswithpatientsknownrisksandrealisticbenefitsofopioidtherapyandpatientandclinicianresponsibilitiesformanagingtherapy(recommendationcategory:A,evidencetype:3).

Discusswithpatientsknownrisksandrealisticbenefitsandpatientandclinicianresponsibilities.

Whenstartingopioidtherapyforchronicpain,cliniciansshouldprescribeimmediate-releaseopioidsinsteadofextended-release/long-acting(ER/LA)opioids(recommendationcategory:A,evidencetype:4).

Discusswithpatientsknownrisksandrealisticbenefitsandpatientandclinicianresponsibilities.

Whenopioidsarestarted,cliniciansshouldprescribethelowesteffectivedosage.Cliniciansshouldusecautionwhenprescribingopioidsatanydosage,shouldcarefullyreassessevidenceofindividualbenefitsandriskswhenconsideringincreasingdosageto ≥50morphinemilligramequivalents(MME)/day,andshouldavoidincreasingdosageto≥90MME/day orcarefullyjustifyadecisiontotitratedosageto≥90MME/day (recommendationcategory:A,evidencetype:3).

Nonpharmacologic,nonopioid arepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy

Beforestartingopioids,establishtreatmentgoals,considerhowopioidtherapywillbediscontinued,andcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunction

Discusswithpatientsknownrisksandrealisticbenefitsandpatientandclinicianresponsibilities

Prescribethelowesteffectivedosage,andcarefullyreassesswhenincreasingto ≥50MME/day,andavoidorcarefullyjustifyadecisiontotitratedosageto≥90MME/day

Long-termopioiduseoftenbeginswithtreatmentofacutepain.Whenopioidsareusedforacutepain,cliniciansshouldprescribethelowesteffectivedoseofimmediate-releaseopioidsandshouldprescribenogreaterquantitythanneededfortheexpecteddurationofpainsevereenoughtorequireopioids.Threedaysorlesswilloftenbesufficient;morethansevendayswillrarelybeneeded (recommendationcategory:A,evidencetype:4).

7Cliniciansshouldevaluatebenefitsandharmswithpatientswithin1to4weeksofstartingopioidtherapyforchronicpainorofdoseescalation.Cliniciansshouldevaluatebenefitsandharmsofcontinuedtherapywithpatientsevery3months ormorefrequently.Ifbenefitsdonotoutweighharmsofcontinuedopioidtherapy,cliniciansshouldoptimizeothertherapiesand workwithpatientstotaperopioidstolowerdosagesortotaperanddiscontinueopioids(recommendationcategory:A,evidencetype:4).

7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months.

Beforestartingandperiodicallyduringcontinuationofopioidtherapy,cliniciansshouldevaluateriskfactorsforopioid-relatedharms.Cliniciansshouldincorporate intothemanagementplanstrategiestomitigaterisk,includingconsideringofferingnaloxonewhenfactorsthatincreaseriskforopioidoverdose,suchashistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepine use,arepresent (recommendationcategory:A,evidencetype:4).

7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months

Incorporate strategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines

Cliniciansshouldreviewthepatient’shistoryofcontrolledsubstanceprescriptionsusingstateprescriptiondrugmonitoringprogram(PDMP)datatodeterminewhetherthepatientisreceivingopioiddosagesordangerouscombinationsthatputhimorherathighriskforoverdose.CliniciansshouldreviewPDMPdatawhenstartingopioid therapyforchronicpainandperiodically duringopioidtherapyforchronicpain,rangingfromeveryprescriptiontoevery3months(recommendationcategory:A,evidencetype:4)

ReviewPDMPdatawhenstartingopioids andevery3months

Whenprescribingopioidsforchronicpain,cliniciansshoulduseurinedrugtestingbeforestartingopioidtherapyandconsiderurinedrugtestingatleastannuallytoassessforprescribedmedicationsaswellasothercontrolledprescriptiondrugsandillicitdrugs (recommendationcategory:B,evidencetype:4).

Cliniciansshouldavoidprescribingopioidpainmedicationandbenzodiazepinesconcurrentlywheneverpossible(recommendationcategory:A,evidencetype:3).

Avoidprescribingopioidpainmedicationandbenzodiazepinesconcurrentlywheneverpossible

Cliniciansshouldofferorarrangeevidence-basedtreatment(usuallymedication-assistedtreatmentwithbuprenorphineormethadoneincombinationwithbehavioraltherapies)forpatientswithopioidusedisorder(recommendationcategory:A,evidencetype:2).

Opioid LawsFederal

Federal Opioid Prescribing Laws

H.R.4978– NASHealthyBabiesAct– click hereH.R.3680– Co-PrescribingtoReduceOverdosesActof2016– click hereH.R.3691– ImprovingTreatmentforPregnantandPostpartumWomenActof2016–click hereH.R.1818– VeteranEmergencyMedicalTechnicianSupportActof2016– click hereH.R.4969– JohnThomasDeckerActof2016– click hereH.R.4586– Lali’s Law – click hereH.R.4599– ReducingUnusedMedicationsActof2016– click hereH.R.4976– OpioidReviewModernizationActof2016– click hereH.R.4982– ExaminingOpioidTreatmentInfrastructureActof2016– click hereH.R.4981– OpioidUseDisorderTreatmentExpansionandModernizationAct– click hereH.R.5046– TheComprehensiveOpioidAbuseReductionAct– click hereH.R.5052– TheOpioidProgramEvaluationAct– click hereH.R.5048– TheGoodSamaritanAssessmentActof2016– click hereH.R.4985– TheKingpinDesignationImprovementActof2016– click hereS.32– DrugTraffickingActof2015– click here

2016- HousePassesNumerousOpioid-AbuseDeterrentBills

Government to establish laws to prevent:

Trafficking

Diversion

Government to establish laws to prevent:

Trafficking

Diversion

...while balancing the need to ensure

availability for medical and scientific use

Prescribers must obey

federal and

state laws.

Prescribersshouldpracticebythemoststringentrule

What if they differ?

Prescribers must obey

federal and

state laws.

01 Manner of issuance of prescriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner" (21 CFR, Section 1306.05).

02 According to federal law, a prescription for a controlled substance must include the following information (21 CFR 1306.05[a]):

Date of issuePatient's name and addressPractitioner's name, address, and DEA registration numberDrug nameDrug strengthDosage formQuantity prescribedDirections for useNumber of refills (if any) authorizedManual signature of prescriber

ControlledSubstancesAct(CSA),21USC801-890DEAregulations,Title21,CodeofFederalRegulations(CFR),Parts1300to1316

Federal Opioid Prescribing LawsControlledSubstancesAct(CSA),21USC801-890

DEAregulations,Title21,CodeofFederalRegulations(CFR),Parts1300to1316

…. the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations" (21 CFR 1306.05).

The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction Treatment Act of 2000 amended the CSA with respect to the use of controlled substances in the medical treatment of addiction. Practitioners wishing to administer and dispense approved Schedule II controlled substances (that is, methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program.

CanIdischargeanaddictwithopioidsaftersurgery?

Federal law does not prohibit prescribing, dispensing, or treating a narcotic addicted patient with controlled substances as long as the purpose is for alleviating pain and not treatment of addiction.

The DEA does not limit a physician from treating (NOT prescribing) a patient with controlled substances in a hospital for maintenance or detoxification as an incidental adjunct to other treatments.

06 Treatment of addiction requires licensure to dispense controlled substances for this purpose (Office of National Drug Control Policy Reauthorization Act of 2006): up to 100 patients at a time.

1306.07 – Narcotic dependent patient:

Can administer (not prescribe) a narcotic drug to relieve acute withdrawal while arranging for an opioid treatment program.

- One day at a time- Up to 3 days- No renewals or extensions

Summary

1. FederalLawsfollowguidelineandpolicydecisions– understandtheCDC’s12guidelines

2. Highdoseopioidprescribinggraduallybeingconstrainedtospecialists

3. Perioperativeclinicianscantreataddictsinthecourseofmanagingpain,butcannotrecommendlongerthan7dayspost-dischargeopioidtreatmentinmanyinstances(lawisvague).

Thank-you

2016 CDC Guidelines for Opioid Prescribing

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