schedule ii medicaons: laws and regulaons · 2017-04-25 · • dispense or deliver a controlled...

CharissaKam,PharmDClinicalPharmacySpecialist–LungTransplant/PHM

ScheduleIIMedica-ons:LawsandRegula-ons

TaraHaworth,PharmDClinicalPharmacySpecialist–Oncology

April29,2017

DISCLOSUREDECLARATION

•  ThefollowingdeclaretheyhavenorelevantfinancialinterestinrelaJontothisacJvity:

•  CharissaKam,presenter•  TaraHaworth,presenter

•  Off-labelusesofmedicaJonswillbedisclosedduringthepresentaJon

•  Brandnames,kepttoaminimum,areusedwhennecessarytodifferenJateproducts

LEARNINGOBJECTIVES

1.  DiscussfederalandstatelawspertainingtoscheduledII(C-II)medicaJons

2.  DefinerequirementsforC-IImedicaJonprescripJons

3.  ReviewadvancednursepracJJoners(APRNs)andphysiciansassistants(PAs)authoritytoprescribeC-IImedicaJons

4.  RecognizerecentchangesinlawsandregulaJonsofcontrolledmedicaJonsthataffectpracJJoners

•  TheUnitedStateshas5%oftheworld’spopulaJon&consumes75%oftheworld’sprescripJondrugs

•  DeathsfromprescripJonopioids—likeoxycodone,hydrocodone,andmethadone—havemorethanQUADRUPLEDsince1999

•  NearlyhalfofallopioidoverdosedeathsinvolveaprescripJonopioid

FASTFACTS

Yachter,David(2009).BornaChampion:TheMasterStrategyforMaximumHealthandLas<ngSuccess.OutskirtsPress.CDC.Wide-rangingonlinedataforepidemiologicresearch(WONDER).Atlanta,GA:CDC,NaJonalCenterforHealthStaJsJcs;2016.

RISKFACTORSFORABUSE

CDC.OpioidOverdose.Atlanta,GAAccessedMarch30,2017.

WHATABOUTPEDIATRICPATIENTS?

FreseW.PediatricsinReviewApr2011,32(4)e44-e52

PEDIATRICS


•  In2013,2millionAmericans≥12yearsofageabusedorweredependentonopioids

•  2.6per100,000personsintheU.S.ages15-24diedofaprescripJonopioidoverdose

PEDIATRICSFASTFACTS

SchechterNL.JAMAPediatr.2016;170(5):425-426.

CONTROLLEDSUBSTANCES(CS)

•  GovernmentRegulaJon•  Establishcontrolstoprevent

•  Abuse

•  Trafficking

•  Diversion

•  EnsureavailabilityformedicalandscienJficuse

•  AccessibletopaJentswhoneedthem

ControlledSubstanceSchedules.DrugEnforcementAdministraJonwebsite.

FEDERALENFORCEMENTAUTHORITY

•  DrugEnforcementAdministraJon(DEA)•  Established1973

•  Toenforcefederaldruglaws

•  TaskedwithcombaJngdrugsmugglingandusewithintheUS

•  LeadagencyfordomesJcenforcementoftheControlledSubstancesAct

DrugEnforcementAdministraJonwebsite.

CONTROLLEDSUBSTANCES

•  TightlyregulatedduetoabusepotenJalorrisk•  PlacedinSchedulesaccordingtoabusepotenJalbytheDEA•  ScheduleI:HighestabusepotenJal•  ScheduleIV:LowestabusepotenJal

ControlledDrugs.TexasStateBoardofPharmacyWebsite.

SCHEDULESOFCS

•  ScheduleI•  HighabusepotenJal

•  Nosafe,acceptedmedicaluse

•  ScheduleII•  HighabusepotenJal

•  Safeandacceptedmedicaluse

•  ScheduleIII,IV,V•  LessriskofabusepotenJalthantheclassabove

•  Safeandacceptedmedicaluse

KingS.etal.Pain.2011;152(12):2729–2738.

ControlledSubstanceSchedules.DrugEnforcementAdministraJonwebsite

SCHEDULEIIMEDICATIONS

•  HighabuseriskbutalsosafeandacceptedmedicalusesintheUnitedStates

•  1981:TexasLawrequiresdoctorstowriteallprescripJonsforScheduleIIdrugsonspecialthree-part(triplicate)form

•  1999:TriplicateprescripJonwasreplacedbyofficialprescripJonformwhichareissuedbytheTexasDepartmentofPublicSafety(DPS)toprescribers


•  2016:OfficialprescripJonformsarenowissuedbytheTexasStateBoardofPharmacy(TSBP)

•  2018:PharmacistswillberequiredtosearchtheprescripJonmonitoringdatabase,AWARXE,priortodispensingCS•  MustenterdispensinginformaJonintoAWARXEwithin1businessdayofdispensingCS

UPDATES


FEDERALVS.STATEREGULATION

•  MustcomplywithbothfederalandstatelawsandregulaJons

•  WhenlawsorregulaJonsdiffer,themorestringentruleapplies


FACTORFICTION?


MostpediatricnonmedicalopioidusersobtainopioidmedicaJonsforfreefromacquaintances

andstrangers.

FICTION

FEDERALTENETSOFLAWFULPRESCRIBING

•  IssuedbyaregisteredpracJJoner•  ForalegiJmatemedicalpurpose

•  IntheusualcourseofprofessionalpracJce

FederalLawCFR1306.04(a)


PRESCRIBINGANDDISPENSINGCS

•  CorrespondingresponsibilityofproperprescribinganddispensingbetweentheprescribingpracJJonerandthepharmacistwhofillsanddispensestheprescripJon

FederalLawCFR1306.04(a)


TEXASCONTROLLEDSUBSTANCESACT•  ApracJJonermaynot:

•  Prescribe,dispense,deliveroradministeracontrolledsubstanceorcauseacontrolledsubstancetobeadministeredunderthepracJJonersdirecJonandsupervisionexceptforvalidmedicalpurposeandintheusualcourseofmedicalpracJce

Sec481.071(a)

TexasControlledSubstancesAct.TexasStateBoardofPharmacyWebsite.

TEXASCONTROLLEDSUBSTANCESACT•  Apharmacistmaynot:

•  DispenseordeliveracontrolledsubstanceexceptunderavalidprescripJonandinthecourseofprofessionalpracJce

•  Dispenseacontrolledsubstanceiftheyknow/shouldhaveknownthattheprescripJonwasissuedwithoutapaJent-pracJJonerrelaJonship

Sec481.071(a)

TexasControlledSubstancesAct.TexasStateBoardofPharmacyWebsite.

TEXASDANGEROUSDRUGACT

•  PharmacistrequestedtodispenseadangerousdrugunderaprescripJonissuedbyapracJJonershalldetermine,intheexerciseoftheirprofessionaljudgment,thattheprescripJonisvalid

•  Pharmacistmaynotdispenseadangerousdrugiftheyknows/shouldhaveknownthattheprescripJonwasissuedwithoutavalidpaJent-pracJJonerrelaJonship

Sec.483.021(a)

TexasControlledSubstancesAct.TexasStateBoardofPharmacyWebsite.HydrocodonecombinaJonproductsscheduleII.TexasMedicalAssociaJonwebsite.

Only11%ofpediatricnonmedicalopioidusersendorseusingopioidssolelyto“gethigh.”

FACTORFICTION?


FACT


•  Aprescribermay,directlyorbystandingorder,prescribeanopioidantagonistto:•  Apersonatriskofexperiencinganopioid-relateddrugoverdose

•  Afamilymember,friend,orotherpersoninaposiJontoassistapersonatriskofexperiencinganopioid-relateddrugoverdose

Sec.483.102(a)



•  Apharmacistwho,acJngingoodfaithandwithreasonablecare,dispensesordoesnotdispenseanopioidantagonistunderavalidprescripJonisnotsubjecttoanycriminalorcivilliabilityoranyprofessionaldisciplinaryacJonfor:•  Dispensingorfailingtodispensetheopioidantagonist

•  Ifthepharmacistchoosestodispenseanopioidantagonist,anyoutcomeresulJngfromeventualadministraJonoftheopioidantagonist

Sec.483.103(c)


TEXASPHARMACYACT

•  Pharmacistshalldetermine,intheexerciseofsoundprofessionaljudgment,thattheprescripJonisavalidprescripJon

•  PharmacistmaynotdispenseaprescripJondrugifthepharmacistknows/shouldknowthattheprescripJonwasissuedonthebasesofandInternet-basedortelephonicconsultaJonwithoutavalidpracJJoner-paJentrelaJonship

Sec.562.056(a)

TexasControlledSubstancesAct.TexasStateBoardofPharmacyWebsite.ControlledDrugs.TexasStateBoardofPharmacyWebsite.hqps://www.pharmacy.texas.gov/consumer/broch2.asp

HydrocodonecombinaJonproductsscheduleII.TexasMedicalAssociaJonwebsite.

FEDERALANDSTATELAW

•  CommonThread•  PrescripJonmustbeforlegiJmatemedicaluse

•  Validphysician-paJentrelaJonshipmustexist

•  PhysicianandpharmacisthavecorrespondingresponsibilitytodetermineprescripJonisvalid


EnoughprescripJonpainkillerswereprescribedin2010tomedicateeveryAmericanadultevery4hours

foronemonth.

Kane,Jason.“PrescripJonDrugAbuse:Top10thingsCDCSaysYouShouldKnow.”PBSNewshour,2013.

CRIMINALOFFENSES

•  Felonycharge(effecJve9/1/2011)•  PersonobtainingaprescripJonforacontrolledsubstancethatisnot

medicallynecessary

•  DoctorShopping•  PersonregisteredundertheCSAorworkingforaregistrantto

knowinglytakecontrolledsubstances

•  Forpersonaluse•  Todivertforunlawfulusebyanotherperson

Sec.481.1289&481.1285


PRESCRIPTIONDRUGMONITORING

•  AWARXE•  OnlinemonitoringprogramlaunchedSeptember1,2016

hqp://www.dps.texas.gov/director_staff/public_informaJon/pr080212.htm.

AWARXE

Morethan50%ofsurveyed12thgradersreportfewerthanfiveoccasionsoflifeJmenonmedical

opioiduse.

FACTORFICTION?


FACT

ELECTRONICPRESCRIPTIONFORCS

•  FederalLaw21CFR75(61).16236•  EffecJveJune1,2010theCFRwasrevisedto:

•  ProvidepracJJonerswiththeopJonofwriJngprescripJonsforCSselectronicallyfollowingexisJngrules

•  Permitpharmaciestoreceive,dispense,andarchivetheseelectronicprescripJons

•  Providepharmacies,hospitals,andpracJJonerswiththeabilitytousemoderntechnologyforCSprescripJonswhilemaintainingtheclosedsystemofcontrolsonCSs



•  FederalLaw21CFR1306.08•  ApracJJonermaysignandtransmite-prescripJonsifallofthe

followingrequirementsaremet:

•  MustcomplywithallotherrequirementsforissuingCSprescripJons

•  MustuseanapplicaJonthatmeetsspecificrequirements(inPart1311)

•  MustcomplywithrequirementsforelectronicordersandprescripJons(inPart1311)



•  FederalLaw21CFR1311.102•  PracJJonerresponsibiliJesrapidreporJngofidenJfiedbreaches

•  SameresponsibiliJeswhenissuinge-prescripJonsforCSsaswhenissuingapaperororalprescripJonincludingissuingprescripJonsonlyforalegiJmatemedicalpurposeandintheusualcourseofprofessionalpracJce

•  TheprescripJonmustconforminallessenJalrespectstothelawandregulaJon


E-PRESCRIBINGC-IIPRESCRIPTIONS

•  DEAissuedrulesin2010allowingelectronictransmissionofCSprescripJons(EPCS)•  RequirementforthecerJficaJonofboththeprescribersotware

systemandpharmacysotwaresystembyanindependentthirdpartyauditor

•  TexasDPSadoptedthesamerequirementsandupdatedtheirrulesOctober2013,toallowC-IICStobetransmiqedelectronically

ControlledDrugs.TexasStateBoardofPharmacyWebsite.DrugEnforcementAdministraJonWebsite.

E-PRESCRIBINGC-IIPRESCRIPTIONS

•  March1,2014,TexasDPSconcludedbetatesJngofelectronictransmissionofC-IIdrugswithasmallnumberofprescribingphysiciansandpharmacies

•  PurposeofthepilotwastoensurethatC-IIprescripJonswerereportedaccuratelytotheTexasPrescripJonMonitoringProgram(PMP)

•  ListofpharmaciesandproviderswithEPCScapabiliJes•  hqp://surescripts.com/network-connecJons/mns/prescriber-

sotware?epcs=true

ControlledDrugs.TexasStateBoardofPharmacyWebsite.DrugEnforcementAdministraJonWebsite.

Almosthalfofchildrenages10to18yearsreportusinganopioidduringtheirlifeJmesformedical

andnonmedicalpurposes.

FACTORFICTION?


FACT

PRESCRIBINGCSINTEXAS

1.  EvaluaJonofpaJentwithmedicalhistoryandphysicalexam

2.  Wriqentreatmentplan

3.  InformingpaJentofrisksandbenefitsofplanandtreatmentopJons

4.  ObtainingpaJentagreementforcompliancewithtreatmentplan

ControlledSubstances.TexasMedicalBoardWebsite.

PRESCRIBINGCSINTEXAS(CONT.)

5.  PeriodicreviewsofthepaJentandmodificaJonoftreatmentplan

6.  ReferringforfurtherevaluaJonortreatmentwhennecessary

7.  DocumenJngraJonalfortreatmentplanandcontrolledsubstanceprescripJonsinmedicalrecords


C-IIPRACTITIONERRESPONSIBILITIES

•  FederalandStaterequirements:•  PracJJoner’sname,address,DEA#

•  PaJent'sname,addressandageordateofbirth

•  Controlledsubstanceprescribed

•  QuanJtyofcontrolledsubstanceprescribed,wriqennumericallyandasaword

•  Intendeduseordiagnosis

•  IfnotdeemeddetrimentaltothepaJent'swell-being


C-IIPRACTITIONERRESPONSIBILITIES

•  FederalandStaterequirements:•  Datewriqen(cannotbepost-dated)•  Preferenceforbrand,ifnecessary•  Prescribersignature

•  APRN/PAs•  MustusetheofficialprescripJonformsissuedwiththeirname,

address,phonenumber,DPSandDEAnumbers,andthedelegaJngphysician'snameandDPSnumber

•  OfficialprescripJonorderformmustbesignedbytherequesJngARPN/PA,andbythedelegaJngphysician


PrescripJonForms.TexasDepartmentofPublicSafetywebsite.

OFFICIALPRESCRIPTIONFORMS

ControlledSubstances.TexasMedicalBoardWebsite.PrescripJonForms.TexasDepartmentofPublicSafetywebsite.

•  TSBPnowdistributesofficialprescripJonpads

OFFICIALPRESCRIPTIONFORMORDERING

SECURITYFEATURES

•  Controlnumber•  UniquenumberforeachprescripJonformthatmustbereportedinthe

recordwhenaC-IIprescripJonisfilled

•  Pantograph•  ScanningandcopyingproduceaVOIDonthefaceoftheprescripJon

•  ThermochromaJcink•  Applyingheatorvigorouslyrubbingthethumbprint,onthebackofthe

prescripJon,willcausethecheckmarksymboltodisappear

•  StateofTexasorTexasDepartmentofPublicSafetyseal

•  AppearsasawatermarkonthefaceoftheprescripJon

PrescripJonForms.TexasDepartmentofPublicSafetywebsite.

AccordingtoFederalandStateLaw,canthefollowingbechangedonC-IIprescripJons?a.  NameofthepaJent?b.  AddressofpaJent?c.  Nameofthedrug?d.  Strengthofthedrug?e.  Nameoftheprescribingphysician?f.  DateoftheprescripJon?

QUIZ

MODIFICATIONSTOC-IIPRESCRIPTIONS

•  FederalandStateLaw•  MayNOTbechanged

1.  NameofthepaJent

2.  Nameofthedrug

3.  Nameoftheprescribingphysician

4.  DateoftheprescripJon

•  Anyotheritemmaybechangedifthepharmacist

1.  Contactsprescribingphysicianforverbalpermission

2.  Documentschange,nameofauthorizer,iniJalofpharmacist


C-IIPRESCRIPTION:QUANTITY

•  AmountorduraJonthatcanbeprescribedatoneJme•  FederalRegulaJons

•  Nolimit

•  Statespecific

•  Texas:90daysupply


C-IIPRESCRIPTION:EXPIRATION

•  LengthofJmeaC-IIprescripJonisvalid•  FederalRegulaJons

•  Nolimit

•  Statespecific

•  Texas:21days


MedicalusersofopioidsreportsimilarratesofabuseofprescripJondrugs,specificallyopioids

FACTORFICTION?


FICTION

EMERGENCYDISPENSING

•  Appropriatewhen:•  ImmediateadministraJonoftheC-IIisnecessaryforpropertreatment

•  NoappropriatealternaJvesareavailable,includingdrugsinlowerschedulesornon-controlleddrugs

•  NotreasonablypossibleforpracJJonertoprovideawriqenprescripJonbeforedispensing

21CFR290.10


EMERGENCYDISPENSING(CONT.)

•  Appropriatewhen:•  ApharmacistmaydispenseaC-IImedicaJonaterreceivinganoral

authorizaJonif:

•  QuanJtyislimitedtotheemergencyperiodonly

•  PrescripJonshallbereducedtowriJngwithalltherequiredinformaJonexceptthesignatureofthepracJJoner

•  PharmacistmakesareasonableaqempttomakesuretheoralauthorizaJoncamefromaregisteredpracJJoner

21CFR290.10


EMERGENCYDISPENSING(CONT.)

•  Appropriatewhen:•  ApharmacistMUSTreceivethewriqenprescripJonwithin7days

fromanoralauthorizaJon

•  TheprescripJonshouldinclude:•  ANotaJon:“AuthorizaJonforEmergencyDispensing”

•  DateoforalauthorizaJon

•  IftheinformaJonisnotreceivedwithin7days,thepharmacistisrequiredtoreportthismissinginformaJontotheDEA.

21CFR290.10


PRESCRIPTIVEAUTHORITY

•  Mustbedelegatedbyaphysicianthroughawriqendocumentprescribedbylaw•  PrescripJveAuthorityAgreement(PAA)

•  LimitaJonsapplytoprescribingCS

PrescripJveAuthorityAgreement.TexasMedicalBoardWebsite.

PRESCRIPTIVEAUTHORITYOFC-IIS

•  OrderingandprescribingmaybedelegatedtoAPRN/PAswhoare:•  Topa-entsondischargefromthehospital,IFtheprescrip-onis

filledatthehospital’spharmacy

•  AspartoftheplanofcareforthetreatmentofapaJentwho:

•  TreaJngterminallyillpaJentswhoarecaredforthroughhospice

•  Facility-basedinahospitalandtreaJngpaJentsinthathospital’semergencydepartment

•  Facility-basedinahospitalandtreaJngpaJentsadmiqedforanintendedlengthof≥24hours


DELEGATINGPHYSICIANCONSULTATION

•  DuraJonofprescripJon,includingrefillscannotexceed90days

•  APRNs/PAsmustconsultwiththedelegaJngphysicianforrefillsofaprescripJonforcontrolledsubstancesatertheiniJal90daysupply

•  Alsorequiredwhenprescribingcontrolledsubstancesforchildrenundertheageoftwoyears

•  Inbothcases,theconsultaJonmustbedocumentedinthepaJent’smedicalrecord


SITEANDDISTANCERESTRICTIONS

•  EliminatedwithimplementaJonofSenateBill406•  November1,2013

•  PhysiciansmaydelegateprescripJveauthoritytoAPRN/PAsinanylocaJoninTexas


MODIFYINGREGISTRATION

•  ToindicateyouhaveauthoritytoprescribeC-IImedicaJons•  FaxormailmodificaJonformtoDPS

Fax:(512)424-5799

ControlledSubstancesRegistraJonsMSC-0438POBox4087AusJn,TX78773-0438


WhichprescripJonopioidisabusedmostandusedfornonmedicalpurposesinTexas?

Hydrocodone

PRESCRIPTIONABUSE•  HydrocodoneconJnuestobethemostprevalentprescripJon

opioidusedfornonmedicalpurposesinTexas

•  Ingredientinthe“HoustonCocktail”or“HolyTrinity,”alongwithalprazolamandcarisoprodol.

HYDROCODONECOMBINATIONPRODUCTS

•  MovedtoscheduleIIOctober6,2014

•  ProhibitsARPN/PAsauthoritytoprescribethesedrugsoutsideofahospitalorhospicesezng•  MayneedtoupdatedelegatedprescripJveauthorityagreements

•  Cannolongerbecalledintopharmacies•  Exceptinemergencies

•  OfficialprescripJonpadsmustbeused•  ObtainedfromtheTexasStateBoardofPharmacy(TSBP)

•  TriplicateprescripJonpadsissuedbyDPSpriortoSeptember1,2016,aresJllvalid

Hydrocodone:scheduleIIcontrolledsubstance.TexasDepartmentofPublicSafetywebsite.HydrocodonecombinaJonproductsscheduleII.TexasMedicalAssociaJonwebsite.

C-III,IV,VREGULATIONS

•  December2013,meeJng,theTexasMedicalBoard(TMB)reviewedSecJon157.0511(b)(2)oftheMedicalPracJcesActthatreads:•  TheprescripJon,includingarefilloftheprescripJon,isforaperiod

nottoexceed90days

•  TMBdeterminedthatthissecJonmeansthat“anAPRN/PAmayissueprescripJonsforatotalof90-days’supplyofaCSincludingrefills


C-III,IV,VREGULATIONS(CONT.)

•  TMBstatedthattheintentofthesecJonistoallow90-days’supplyandnottolimitthepaJenttoonerefill

•  APRN/PAcanissueaprescripJonwithmorethanonerefillprovidedthetotalquanJtydoesnotexceedmorethana90-daysupply

•  FurtherdiscussionswithstaffoftheMedicalBoardhavealsoresultedintheinterpretaJonthatessenJallyaCSprescripJonissuedbyanAPRN/PA,expires90-daysaterissuance


•  RecentlycontractedwithvariousinsurancecompaniesforthirdpartyprocessingofprescripJons

•  ManypaJentsexperiencesignificantbarrierstoaccessofopioidanalgesicsupondischargefromTCH

•  TCHOutpaJentPharmacy–3rdFloorClinicalCareCenter•  AnypaJentseenortreatedinaTexasChildren’sAmbulatoryClinic,

Office,orSurgeryAreawhoaregivenaprescripJonforanopioidanalgesic

•  AnypaJentdischargedfromtheinpaJentsezngatTCH,thePavilionforWomen,ortheTCHEmergencyCenterwhoaregivenaprescripJonforanopioidanalgesic

TEXASCHILDREN’SHOSPITAL

THANKYOU!

QUESTIONS?