Post on 02-Feb-2022
2016 CDC Guidelines for Opioid Prescribing
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
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
21
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1234567
Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months
Incorporatestrategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines
ReviewPDMPdatawhenstartingopioidsandevery3months
Useurinedrugtestingatleastannually
Avoidprescribingopioidpainmedicationandbenzodiazepinesconcurrentlywheneverpossible
Offerorarrangetreatmentforpatientswithopioidusedisorder
8910
11
12
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)
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
21
Nonpharmacologic,nonopioid arepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy.
Beforestartingopioidtherapyforchronicpain,cliniciansshouldestablishtreatmentgoalswithallpatients,includingrealisticgoalsforpainandfunction,andshouldconsiderhowopioidtherapywillbediscontinuedifbenefitsdonotoutweighrisks.Cliniciansshouldcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunctionthatoutweighsriskstopatientsafety(recommendationcategory:A,evidencetype:4)
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
21
Nonpharmacologic,nonopioid arepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy.
Beforestartingopioids,establishtreatmentgoals,considerhowopioidtherapywillbediscontinued,andcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunction.
Beforestartingandperiodicallyduringopioidtherapy,cliniciansshoulddiscusswithpatientsknownrisksandrealisticbenefitsofopioidtherapyandpatientandclinicianresponsibilitiesformanagingtherapy(recommendationcategory:A,evidencetype:3).
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
21
Nonpharmacologic,nonopioid arepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy.
Beforestartingopioids,establishtreatmentgoals,considerhowopioidtherapywillbediscontinued,andcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunction.
Discusswithpatientsknownrisksandrealisticbenefitsandpatientandclinicianresponsibilities.
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
Whenstartingopioidtherapyforchronicpain,cliniciansshouldprescribeimmediate-releaseopioidsinsteadofextended-release/long-acting(ER/LA)opioids(recommendationcategory:A,evidencetype:4).
1
2
3
4
21
Nonpharmacologic,nonopioid arepreferred.Ifopioidsareused,theyshouldbecombinedwithnonpharmacologictherapyandnonopioidpharmacologictherapy.
Beforestartingopioids,establishtreatmentgoals,considerhowopioidtherapywillbediscontinued,andcontinueopioidtherapyonlyifthereisclinicallymeaningfulimprovementinpainandfunction.
Discusswithpatientsknownrisksandrealisticbenefitsandpatientandclinicianresponsibilities.
Whenopioidsarestarted,cliniciansshouldprescribethelowesteffectivedosage.Cliniciansshouldusecautionwhenprescribingopioidsatanydosage,shouldcarefullyreassessevidenceofindividualbenefitsandriskswhenconsideringincreasingdosageto ≥50morphinemilligramequivalents(MME)/day,andshouldavoidincreasingdosageto≥90MME/day orcarefullyjustifyadecisiontotitratedosageto≥90MME/day (recommendationcategory:A,evidencetype:3).
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
Prescribeimmediate-releaseopioidsinsteadofextended-release/long-acting(ER/LA)opioids
1
2
3
4
5
21
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).
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
Prescribeimmediate-releaseopioidsinsteadofextended-release/long-acting(ER/LA)opioids
1
2
3
4
5
6
21
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
4
5
6
7Cliniciansshouldevaluatebenefitsandharmswithpatientswithin1to4weeksofstartingopioidtherapyforchronicpainorofdoseescalation.Cliniciansshouldevaluatebenefitsandharmsofcontinuedtherapywithpatientsevery3months ormorefrequently.Ifbenefitsdonotoutweighharmsofcontinuedopioidtherapy,cliniciansshouldoptimizeothertherapiesand workwithpatientstotaperopioidstolowerdosagesortotaperanddiscontinueopioids(recommendationcategory:A,evidencetype:4).
21
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
4
5
6
7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months.
Beforestartingandperiodicallyduringcontinuationofopioidtherapy,cliniciansshouldevaluateriskfactorsforopioid-relatedharms.Cliniciansshouldincorporate intothemanagementplanstrategiestomitigaterisk,includingconsideringofferingnaloxonewhenfactorsthatincreaseriskforopioidoverdose,suchashistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepine use,arepresent (recommendationcategory:A,evidencetype:4).
8
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
4
5
6
7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months
Incorporate strategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines
Cliniciansshouldreviewthepatient’shistoryofcontrolledsubstanceprescriptionsusingstateprescriptiondrugmonitoringprogram(PDMP)datatodeterminewhetherthepatientisreceivingopioiddosagesordangerouscombinationsthatputhimorherathighriskforoverdose.CliniciansshouldreviewPDMPdatawhenstartingopioid therapyforchronicpainandperiodically duringopioidtherapyforchronicpain,rangingfromeveryprescriptiontoevery3months(recommendationcategory:A,evidencetype:4)
8
9
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
4
5
6
7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months
Incorporate strategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines
ReviewPDMPdatawhenstartingopioids andevery3months
Whenprescribingopioidsforchronicpain,cliniciansshoulduseurinedrugtestingbeforestartingopioidtherapyandconsiderurinedrugtestingatleastannuallytoassessforprescribedmedicationsaswellasothercontrolledprescriptiondrugsandillicitdrugs (recommendationcategory:B,evidencetype:4).
8
9
10
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
4
5
6
7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months
Incorporate strategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines
ReviewPDMPdatawhenstartingopioids andevery3months
Useurinedrugtestingatleastannually
Cliniciansshouldavoidprescribingopioidpainmedicationandbenzodiazepinesconcurrentlywheneverpossible(recommendationcategory:A,evidencetype:3).
8
9
10
11
21
CDC Guidelines for Prescribing Opioids for Chronic Pain - 2016
1
2
3
4
5
6
7 Evaluatebenefitsandharmswithin1to4weeksofstartingopioids,andevery3months
Incorporate strategiestomitigaterisk,offernaloxonewhenhistoryofoverdose,historyofsubstanceusedisorder,higheropioiddosages(≥50MME/day),orconcurrentbenzodiazepines
ReviewPDMPdatawhenstartingopioids andevery3months
Useurinedrugtestingatleastannually
Avoidprescribingopioidpainmedicationandbenzodiazepinesconcurrentlywheneverpossible
Cliniciansshouldofferorarrangeevidence-basedtreatment(usuallymedication-assistedtreatmentwithbuprenorphineormethadoneincombinationwithbehavioraltherapies)forpatientswithopioidusedisorder(recommendationcategory:A,evidencetype:2).
8
9
10
11
12
Opioid LawsFederal
26
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
26
Federal Opioid Prescribing Laws
Government to establish laws to prevent:
Trafficking
Diversion
Abuse
26
Federal Opioid Prescribing Laws
Government to establish laws to prevent:
Trafficking
Diversion
Abuse
...while balancing the need to ensure
availability for medical and scientific use
26
Federal Opioid Prescribing Laws
Prescribers must obey
federal and
state laws.
26
Federal Opioid Prescribing Laws
Prescribersshouldpracticebythemoststringentrule
What if they differ?
Prescribers must obey
federal and
state laws.
19
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).
Federal Opioid Prescribing Laws
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
19
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).
03
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.
04
Federal Opioid Prescribing Laws
CanIdischargeanaddictwithopioidsaftersurgery?
Federal Opioid Prescribing LawsControlledSubstancesAct(CSA),21USC801-890
DEAregulations,Title21,CodeofFederalRegulations(CFR),Parts1300to1316
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.
05
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.
Federal Opioid Prescribing LawsControlledSubstancesAct(CSA),21USC801-890
DEAregulations,Title21,CodeofFederalRegulations(CFR),Parts1300to1316
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
07
Summary
1. FederalLawsfollowguidelineandpolicydecisions– understandtheCDC’s12guidelines
2. Highdoseopioidprescribinggraduallybeingconstrainedtospecialists
3. Perioperativeclinicianscantreataddictsinthecourseofmanagingpain,butcannotrecommendlongerthan7dayspost-dischargeopioidtreatmentinmanyinstances(lawisvague).
Thank-you