ObjecEves' PharmaceuEcal'Care' 9/25/16' Excellence'in'Hospice'Pharmaceu3cal'Care:' Right'Drug,'Right'Dose,'Right'Now'!'
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1 ExcellenceinHospicePharmaceu3calCare: RightDrug,RightDose,RightNow! MaryMihalyo,PharmD,CGP,BCPS,CDE DeltaCareRx OregonHospice&PalliaEveCareAssociaEon September26,2016 ObjecEves DefinepharmaceuEcalcare. ExplaintheimportanceofpharmaceuEcalcarein hospicepercops2008andupdates. UnderstandtheCMSperspecEveonhospice formularymanagement. ExplainwhyhospicesshoulduElizemedicaEon usecriteria Definepharmacogenomics ExplainthepotenEalroleofpharmacogenomics inhospicecare PharmaceuEcalCare Thedirect,responsibleprovisionofmedicaEonU relatedcareforthepurposeofachievingdefinite outcomesthatimproveapaeentsqualityoflife. TheprincipalelementsofpharmaceuEcalcare arethatcareisdirectlyprovidedtothepaeent,it isprovidedtoproducedefiniteoutcomes,these outcomesareintendedtoimprovethepaeents qualityoflifeandtheprovider(pharmacist) acceptspersonalresponsibilityfortheoutcomes. AmJHospPharm.1993;50:
2 RealityofMedicaEonUse! IfmedicaEonusewerethoughtofasadisease,itwouldbe thefourthleadingcauseofdeathintheu.s.! Adversedrugevents(ADEs)areaseriouspublichealth problem.itisesematedthat:! 700,000emergencydepartmentvisitsand 120,000hospitalizaEonsareduetoADEsannually! $3.5billionisspentonextramedicalcostsof ADEsannually! Atleast40%ofcostsofambulatory(nonUhospital sedngs)adesareesematedtobepreventable 1. SloneEpidemiologyCenteratBostonUniversity.PaeernsofmedicaEonuseintheUnitedStates, BudnitzDS,PollockDA,WeidenbachKN,MendelsohnAB,SchroederTJ,AnnestJL.NaEonalsurveillanceofemergency departmentvisitsforoutpaeentadversedrugevents.jama2006;296:1858u InsEtuteofMedicine.CommieeeonIdenEfyingandPrevenEngMedicaEonErrors.PrevenEngMedicaEonErrors, Washington,DC:TheNaEonalAcademiesPress2006. PharmaceuEcalCareforHospice PharmacoUTherapeuEcSupportSystem HospiceClinicalPharmacist + FormularyManagement + HospiceP&TCommieee HospiceCoPsandPharmaceuEcalCare Drugs appears54emes Everyhospiceneedsapharmacist directlyor indirectlyto: ReviewRx,OTC,HerbalsandalternaEve treatmentsthatcouldaffectdrugtherapy including: EffecEvenessoftherapy Sideeffects DrugInteracEons Duplicatetherapy Drugtherapyrequiringmonitoring 2
3 FormularyManagement July2014CMS:Hospicehastherighttohavea formulary ManagedbytheP&TCommieee BySymptom,byDrug. MedicaEonUseCriteria SpecificobjecEvecriteriadevelopedbythe hospicep&tcommieeetopromotemaximum medicaeonefficacyandpreventthe unnecessaryuseofmedicaeonsinenduofulife care. ApplicaEonofthesecriteriamustbeonacase bycasebasis. MedicaEonUseCriteria Medicaon* Criteria* Criteria* Elavil (amitriptyline) Age<65y.o. CrCl>30ml/min Valium (Diazepam) Age<65.yo CrCl>30ml/min Effient (Prasugrel) Clopidogrelallergy ClopidogrelCYP2C19poor InhalersUall PPS>40% Inabilitytousenebulizer Lantus /Levemir Insulin Age>65 Intermediateinsulinfailure Glucophage (Mewormin) SrCr<1.5 CrCl>50ml/min OxyconEn (OxycodoneSR) +RenalFailure Fentanyl&MethadoneCI Xarelto (Rivaroxaban) PEorDVTTxonly TherapeuEcaltforLMWH Xifaxin (Rifaximin) Lactulosefailure NeomycinCI 3
4 PharmacogenomicsforHospice What*if*there*were*a*way*to*know*if*a*depressed* pa4ent*would*respond*to*an*an4depressant?*or*to* predict*a*bleeding*event*from*an*an4platelet* agent? * PersonalizedHospiceMTM PaEentswillbepresenEngtohospiceclinicianswith knowngeneecvariaeonsintheirmedicalrecord whichwillrequireanunderstandingofthe implicaeonsofthedrugugenepair What is Pharmacogenomics? The study of genetic variations that influence individual response to drugs. Combines traditional pharmacology with an understanding of common DNA variations in the human genome. Benefits Pharmacogenomics Provides Knowing whether a patient carries any of these genetic variations can help prescribers: Individualize drug therapy Decrease the chance for adverse drug events Increase the effectiveness of Drugs Clinical Decision Support Economic Implication Can lead to an overall decrease in health care costs by decreasing the following: Adverse drug reactions Number of medications patients must take to find effective therapy The effects of a disease on the body The FDA lists approved drugs with pharmacogenomic information in their? labeling. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. PGLLabs.com PGLLabs.com Pittsburgh, PA ClinicalPharmacogeneEcs ImplementaEonConsorEum(CPIC) heps:// source=cpic CPICguidelinesaredesignedtohelpclinicians understandhowavailablegeneectestresultsshouldbe usedtoopemizetherapy,ratherthanwhethertests shouldbeorderedsinceclinicianswillbefacedwith havingpaeents genotypesavailableeveniftheyhave notexplicitlyorderedatestwithaspecificdruginmind. WhataretheimplicaEonsforhospicecare? 4
5 PersonalizedHospiceMedicine AbiologicalapproachtopaEenttreatment Example: OxycodoneandCYP2D6 UseanalternaEvedrugratherthan oxycodone(notcodeineortramadol)forcyp2d6 poorandintermediatemetabolizerpaeents,orbe alerttoinsufficientpainrelief. ForCYP2D6ultrametabolizerpaEents,usean alternaevedrugratherthanoxycodone,orbe alerttoadversedrugevents Phone: Pain and PsychiatryPanel Created for: Patty Pain Accession #: 1017 DOB: 03/23/1966 Collection Date: Gender: Received Female 10/28/2015 Date: Report 10/29/2015 Ordered By: Generated: 10/29/2015 Clomipramine, Codeine, Clopidogrel, Bupropion, Atorvastatin Calcium, Detrol = med list Medications Afected by Patient Genetic Results Clomipramine (Anafranil) Consider alternative drug or prescribe clomipramine at increased dose and monitor the plasma concentration of clomipramine and desmethylclomipramine. Codeine (Codeine; Fioricet) Greatly increased morphine levels are expected and the patient is at high risk of toxicity when taking codeine. Avoid prescribing codeine and consider an alternative opioid or consider a non-opioid analgesic such as a NSAID or a COX-2 inhibitor. Unless contraindicated, available alternative opioids not sensitive to CYP2D6 function include: Fentanyl, Morphine, Hydromorphone, Oxymorphone and Tapentadol. Clopidogrel (Plavix) Consider alternative therapy. Example of alternative drugs: Prasugrel (contraindicated in TIA/Stroke patients); Ticagrelor; Aspirin; Aspirin plus Dipyridamole. Atorvastatin Calcium (Atorvastatin) The reduced SLCO1B1 function may result in elevated atorvastatin plasma levels. Because the risk of myopathy increases in patients with high statin plasma levels, the use of high atorvastatin doses in this patient should be avoided. If atorvastatin is used in this patient, a closer monitoring of serum creatine kinase and liver function is recommended. Other myopathy predisposing factors include advanced age ( 65), uncontrolled hypothyroidism, renal impairment, comedications and female gender. Genomic Findings: Increased Myopathy Risk (SLCO1B1 521T>C TC Intermediate Transporter Function). Evidence Level: 2 Bupropion (Wellbutrin, Zyban, Aplenzin) Smoking Cessation: The patients genotype is associated with a positive response with bupropion treatment. Genomic Findings: Good Response to Bupropion (ANKK1 DRD2:Taq1A GG Unaltered DRD2 function). Evidence Level: 2 Detrol (Tolterodine) Tolterodine can be prescribed at standard label recommended-dosage and administration. Genomic Findings: Normal Sensitivity to Tolterodine (CYP2D6 *1/*2 XN Rapid Metabolizer). Evidence Level: 2 Page 1 of 10 HaloperidolandCYP2D6 Reducehaloperidoldoseby50%orselectan alternaevedrugforcyp2d6poormetabolizer genotypepaeents ApplicabletoDIwithmethadone?? AlternaEvestohaloperidolvoidofCYP2D6 recommendaeonsincludeolanzapineand queeapine. 5
6 Clopidogrel(Plavix ) CYP2C19 poormetabolizers maybepoor responderstoclopidogrel(plavix ). KnowingthisallowsthecliniciantoidenEfy alternaevetherapyandvalidatewhyitisnecessary Prasugrel(Effient )maybeabeeeropeonsinceper thefdaapprovedproductlabelwhichstates thereis norelevanteffectofgeneecvariaeonincyp2b6, CYP2C9,CYP2C19orCYP3A5onthe pharmacogeneecsofprasugrel sacevemetaboliteor itsinhibieonofplateletaggregaeon. FDATableofPharmacogenomics BiomarkersinDrugLabeling hep:// ResearchAreas/PharmacogeneEcs/ucm htm TableofFDAUapproveddrugswithpharmacogenomic informaeonintheirlabeling. PertheFDA:Pharmacogenomicsmayplayanimportantrolein idenefyingrespondersandnonuresponderstomedicaeons, avoidingadverseevents,andopemizingdrugdose FDAapprovedlabelingmaycontaininformaEononspecific aceontobetakenbasedonthebiomarkerinformaeon. Remember: Itisneitherimmoralnor unethicaltothinkaboutthecost oftherapy! UMethadoneMary,
7 QuesEons? 19 References AbbasiJ,Gedngpharmacogenomicsintotheclinic,JAMA2016PublishedOnline September21,2016 ShuldinerAR,OConnellJR,BlidenKP,etal.AssociaEonofcytochromeP4502C19 genotypewiththeaneplateleteffectandclinicalefficacyofclopidogreltherapy. JAMA.2009;302:849U857. hep:// ucm htm.accessed1/30/16 7
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