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Outline Whatisadrug?Drugtherapy:BenefitandRiskMonitoringadversedrugreactionsStudyingnewdrugsRegulatoryDefinitionsPharmacovigilanceDefinitionofaDrugChemicalsubstanceornaturalproductCanprevent,diagnoseortreatdiseaseCanalterpharmacologicfunctionAvailableinastabledosageformWorksbyinteractingwithtissues,organs,cells,receptors,enzymes,transportchannelsHistoryofDrugsAncientcivilizationsusedamixtureofmagic,religionanddrugstotreatdiseaseMostdrugsinantiquitycamefromplantandanimalpartsorfluidsUnderstandingofdrugmechanismsincreasedinparallelwithknowledgeofanatomy,physiology,biochemistryandchemistryImpactmorethanthetherapeuticsite
MetabolitesmayhaveactivityDrugscaninduceorinhibitthemetabolismofotherdrugsAgeandraceimpactdrugmetabolismChildrenmetabolizemorerapidlythanadultsElderlyoftenhaveimpairedmetabolismRacialdifferences5-10%Asiansvs.50%CaucasiansareslowacetylatorsCytochromeP-450isoformpatternsdifferamongAsiansandCaucasians
DetectingAdverseEventsConsiderwhetheranyeffectassociatedwiththeuseofadrugiscausedbythedrugDramaticAEsareeasiertodetectanaphylacticreactionwithinminutesofinjectionofpenicillinAEsthatmimicdiseaseoroccurafterprolongedtreatmentaremoredifficultphocomeliaafterthalidomidetreatmentTypesofAdverseEffects(1)Knowntooccurfrompharmacologyofthedrugandaredose-relatedhemorrhageduetoanticoagulantsUnpredictable,notdose-relatedbonemarrowsuppressionbychloramphenicolEffectsthatoccurduringchronictreatmentcolonicdysfunctionduetolaxativesiatrogenicCushing’ssyndromewithprednisoloneTypesofAdverseEffects(2)DelayedeffectsoccurinoffspringofpatientcraniofacialmalformationsininfantswhosemothershavetakenisotretinoinClear-cellcarcinomaofthevaginaindaughtersofmotherswhotookDESduringpregnancyoccurinpatientyearsaftertreatmentsecondcancersinpatientstreatedwithalkylatingagentsforHodgkin’sdiseaseTypesofAdverseEffects(3)Endoftreatmenteffectsoccurswhenadrugisstoppedsometimescalled‘withdrawal’adrenocorticalinsufficiencyafterprednisoloneseizuresafterphenytoinisstoppedunstableanginaafterB-adrenoceptorantagonistsarestoppedsuddenlyWhenisadruglikelyresponsibleforanadverseeffect?IfitisalreadyknowthatthisadverseeffectoccurswiththisdrugIftheadverseeffectisknownforasimilarclassofdrugscoughisanadverseeffectknowntobeassociatedwithangiotensin-convertingenzymeinhibitorsMuchhardertoknowforanewdrugStatistical‘RuleofThree’Newdrugtestedin1500patientsIfaneventhasnotbeenobservedinnpatients,then95%certaintythatthetruefrequencyinthepopulationis0to3/nIfnofatalreactionamong1500patients,thereisstilla5%chancethedrugwillcauseupto1deathamong500patientsexposedtotreatment.DrugsWithdrawnDuetoToxicity7NSAIDsanaphylaxisnephrotoxicityhepatotoxicity2Antibiotics(temafloxicin,centoxin)multi-organtoxicityandincreasedmortality1Hypnotictriazolam-psychiatricreactionsRegulatoryDefinitions(1)AdverseEventuntowardmedicaloccurrenceinapatientadministeredadrug;maynothaveacausalrelationshiptothistreatmentAdverseDrugReactionpre-approval:allnoxiousunintendedresponsestoamedicinalproductrelatedtoanydose;causalrelationshipispossiblemarketedproduct:responsetoadrugthatisnoxiousandunintended;occursatdosesnormallyusedfortreatmentRegulatoryDefinitions(2)SeriousAdverseEvent(SAE)Anyuntowardmedicaloccurrencethatatanydoseresultsin:deathislife-threateningrequiresinpatienthospitalizationorprolongationofexistinghospitalizationresultsinpersistentorsignificantdisabilityORisacongenitalanomaly/birthdefect.RegulatoryDefinitions(3)UnexpectedAdverseDrugReactionadversereactionwherethenatureorseverityisnotconsistentwiththeapplicableproductinformationi.e.,IBorPackageInsert/SPCModerndrugdevelopmentishighlyregulatedMonitoringforAdverseEffectsCriticalateachphaseofdevelopmentAidedbyknowledgeofpharmacokinetics,pharmacodynamicsClinicaltrialsoftenuserelativelysmallnumbersofhighlyselectedpatientsPharmacovigilanceEpidemiologicstudyofdrugrelatedeventsoradversedrugeffectsEventsmaybeduetothedisease,toanintercurrentdisease,tothedrugusedfortreatment,toaconcurrentmedicationortheresultofdruginteractionDemandedbyregulatoryagenciesforallnewandmarketeddrugs.DrugTherapyhasassociatedRiskRiskunpleasantsideeffects,e.g.nauseaseriousadverseeffectsRequiresconstantvigilanceonthepartofthephysicianRegulatorysystemsinmostcountriesforreportingandanalyzingdrugriskMonitorandreportforpatientsafety.DrugsWithSeriousSideEffectsChloramphenicoliseffectiveintreatingbacterialpharyngitisBonemarrowaplasiahasbeenobservedUseonlyincaseswherenoalternativeexistsDrugswithSeriousSideEffectsIsotretinoinisaneffectivedrugforacneFetalmalformationsinuterowereobservedSho
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