Stephens' Detection of New Adverse Drug Reactions, Fifth Edition PDF
Preview Stephens' Detection of New Adverse Drug Reactions, Fifth Edition
Stephens’ Detection of New Adverse Drug Reactions Fifth Edition Stephens’DetectionofNewAdverseDrugReactions,FifthEdition. EditedbyJohnTalbotandPatrickWaller Copyright2004JohnWiley&Sons,Ltd.ISBN:0-470-84552-X Stephens’ Detection of New Adverse Drug Reactions Fifth Edition Edited by John Talbot Director,GlobalDrugSafety,AstraZenecaR&DCharnwood,Loughborough, Leicestershire,UK Patrick Waller ConsultantinPharmacovigilanceandPharmacoepidemiology,Southampton,UK Copyright#2004 JohnWiley&SonsLtd,TheAtrium,SourthernGate,Chichester, WestSussexPO198SQ,England Telephone(+44)1243779777 Email(forordersandcustomerserviceenquiries):[email protected] VisitourHomePageonwww.wileyeurope.comorwww.wiley.com Allrightsreserved.Nopartofthispublicationmaybereproduced,storedinaretrievalsystemortransmittedinany formorbyanymeans,electronic,mechanical,photocopying,recording,scanningorotherwise,exceptunderthe termsoftheCopyrightDesignsandPatentsAct1988orunderthetermsofalicenceissuedbytheCopyright LicensingAgencyLtd,90TottenhamCourtRoad,LondonW1T4LP,UK,withoutthepermissioninwritingofthe Publisher.RequeststothePublishershouldbeaddressedtothePermissionsDepartment,JohnWiley&SonsLtd, TheAtrium,SouthernGate,Chichester,WestSussexPO198SQ,England,[email protected] faxedto(+44)1243770571. 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BritishLibraryCataloguinginPublicationData AcataloguerecordforthisbookisavailablefromtheBritishLibrary ISBN047084552Xhardback Typesetin10/12TimesbyKeytecTypesettingLtd,Bridport,Dorset,England PrintedandboundinGreatBritainbyTJInternationalLtd.,Padstow Thisbookisprintedinacid-freepaperresponsiblymanufacturedfromsustainableforestry inwhichatleasttwotreesareplantedforeachoneusedforpaperproduction. Contents Foreword xi Preface xiii ListofContributors xv 1 Introduction 1 M.D.B.Stephens Mercury 1 Introductiontopharmacovigilance 1 Thehistoryofpharmacovigilance 3 Under-reportingofadversedrugreactions 10 Incidenceofadversedrugreactions 17 Thefinancialcostofadversedrugreactions 30 Preventabilityofadversedrugreactions 35 Risk–benefitratio 35 Thechangingriskswithnewdrugs 44 Expressionofrisk 47 Theriskswearepreparedtotake 52 Definitions 57 Classificationofadversedrugreactions 58 Adversereactionprofile 60 Adverseeventsinapatient’slife 61 Symptomsinhealthypersons 62 Adversereactionstoplacebo 63 Infectiousnessofadversedrugreactions 67 Herbalmedicines 69 Somefinalfoodforthought 70 References 71 Furtherreading 88 2 AdverseDrugReactionsandInteractions:Mechanisms,RiskFactors, Detection,ManagementandPrevention 92 P.Routledge Introduction 92 Classificationofadversedrugreactions 92 RiskfactorsfortypeAadversereactions 93 RiskfactorsfortypeBadversereactions 101 Detectionofadversedrugreactions 106 Stephens’DetectionofNewAdverseDrugReactionsFifthEditioneditedbyJohnTalbotandPatrickWaller #2004JohnWiley&Sons,Ltd ISBN:047084552X vi CONTENTS Managementofadversedrugreactions 108 Preventionofadversedrugreactions 109 Druginteractions 111 Conclusions 122 References 122 3 ToxicologyandAdverseDrugReactions 128 D.J.Snodin Introduction 128 Toxicitytesting 128 Drugdevelopment 137 Datainterpretationandriskassessment 144 Adversedrugreactionsdetectedafterauthorization 150 Examplesoftoxicologicalinvestigationofadversedrugreactions 157 Conclusions 159 Acknowledgements 159 References 159 4 ClinicalTrials:CollectionofSafetyDataandEstablishingthe AdverseDrugReactionProfile 167 J.C.C.Talbot,M.D.B.Stephens Introduction 167 Adverseevents 168 Finalanalysisofdata 229 Inadequatereportingofsafetydatafromclinicaltrials 231 Conclusions 232 Futureaspirations 233 Acknowledgements 233 References 233 5 ClinicalLaboratorySafetyDatainDrugStudies 244 A.Craig Introduction 244 Factorsthatinfluenceinterpretationofclinicallaboratorydata 245 Samplecollectionprocedure 252 Analyticalvariation 255 Referenceranges 256 Intra-individualbiologicalvariation 259 Safetytestingindrugdevelopment 261 Testselection 289 Exclusioncriteriaand‘paniclevels’ 290 Harmonizationofdatafromdifferentlaboratories 292 Dataanalysisandpresentation 294 Conclusion 298 References 298 CONTENTS vii 6 Statistics:AnalysisandPresentationofSafetyData 301 S.J.W.Evans Introductionandbackground 301 Analysisandpresentationofdatafromtrials 305 Measuresthattaketimeintoaccount 308 Statisticaltestsutilizingtimesincestartoftreatment 310 Combiningdatafromseveraltrials:meta-analysis 312 Analysisandpresentationofdatafromobservationalstudies 312 Useofstatisticalmethodsforsignaldetectionwithspontaneousreports 316 Summaryandconclusions 325 Acknowledgements 326 References 326 7 CausalityandCorrelationinPharmacovigilance 329 S.A.W.Shakir Introductionandhistoricalbackground 329 Thenotionsofnecessaryandsufficientcauses 330 Factorstobeconsideredincausalityassessment 330 Methodsforcausalityassessment 333 Whentoassesscausality 336 Assessingcausalityfrommultipleinformationsources:theBradford-Hillcriteria 337 Conclusion 342 References 342 8 ManagingDrugSafetyIssueswithMarketedProducts 345 P.C.Waller,H.H.Tilson Introduction 345 Identificationofdrugsafetyissues 346 Investigation 356 Evaluation 359 Action 361 Communicatingaboutdrugsafety 364 Beyondcommunication:riskmanagement 369 Managingtheprocess 371 Conclusion:somethoughtsonthefuture 372 References 373 9 RegulatoryAspectsofPharmacovigilance 375 B.D.C.Arnold Introduction 375 CouncilforInternationalOrganizationsofMedicalSciences 375 TheInternationalConferenceonHarmonization 379 TheEuropeanUnion 399 TheUnitedKingdom 419 France 424 Germany 428 UnitedStatesofAmerica 432 viii CONTENTS Japan 443 Acknowledgements 448 References 449 Bibliography 449 10 LegalAspectsofPharmacovigilance 453 C.Bendall Introduction 453 Legalresponsibilityforpharmacovigilance 454 Interpretinglegalprovisions 458 TherelationshipbetweenEuropeanCommunitypharmacovigilancelegislationand guidelines 460 Nationalimplementation 461 UncertaintiesinEuropeanCommunityprovisions 463 Thepotentialimpactofthe2001reviewofpharmaceuticallegislation 468 Europeanpowersandproceduresintheeventofaproductsafetyissue 469 ReferraltotheCommitteeforProprietaryMedicinalProducts 471 Failurestomeetadversedrugreactionreportingrequirements 478 Consequencesoffailuretomeetrequirements 481 Safetyinresearchproducts 487 Personaldataprivacy 490 Reference 491 11 OperationalAspectsoftheDrugSafetyFunctionwithina PharmaceuticalCompany 493 J.Steiner Introduction 493 Overviewofthecase-handlingprocess 493 Specificsofthecase-handlingprocess 494 Periodicsafetyupdates 499 Staffingmodelsforthecase-handlingprocess 504 Technologyandthecase-handlingprocess 508 Qualitycontrolandthecase-handlingprocess 513 Trainingandthecase-handlingprocess 520 Externalpartnersandthecase-handlingprocess 525 Casedistributiontoexternalpartiesotherthanregulatoryauthorities 527 Conclusion:visionforthefuture 531 Acknowledgement 531 References 531 Furtherreading 532 12 DictionariesandCodinginPharmacovigilance 533 E.Brown Introduction 533 Scopeofthischapter 534 Drugdictionaries 534 Adversedrugreactiondictionaries 537 CONTENTS ix Diseaseclassifications 538 Combinationterminology 545 Definitionofadversereactionterms 555 Conclusion 556 Acknowledgements 556 References 556 13 SafetyofBiotechnologyProducts 559 B.Brown,M.Westland Introduction 559 Propertiesofproteins 560 Categoriesofproteintherapeuticagent 560 Safetymonitoringforproteintherapeuticagents 562 Off-labeluse 566 Conclusion 568 References 568 14 VaccineSafetySurveillance 571 E.Miller Whatisspecialaboutvaccinesafetycomparedwithotherdrugs? 571 Pathogenesisofvaccinereactions 572 Criteriaforestablishingcausalityforvaccineadverseevents 575 Pre-licensureevaluationofvaccinesafety 577 Objectivesofanidealpost-licensurevaccinesafetysurveillancesystem 579 Passivepost-licensuresurveillancesystems 579 Activesurveillanceofadversevaccineevents 581 Controlledepidemiologicalstudiesofvaccinesafety 582 Ecologicalstudiesofvaccinesafety 585 Conclusions 587 References 587 15 EthicalIssuesinDrugSafety 591 M.D.B.Stephens Introduction 591 Ethicsinclinicaltrials 591 Ethicsandthepharmaceuticalindustry 608 Conclusions 636 References 637 Furtherreading 647 16 AModelfortheFutureConductofPharmacovigilance 649 P.C.Waller,S.J.W.Evans Introduction 649 Proposedmodel 649 Descriptionofmodelcomponents 650 Conclusions 665 x CONTENTS Acknowledgements 666 References 666 AppendixI 667 AppendixII 705 Bibliography 709 Index 721 Foreword When does a book become a classic? The fact that Stephens’ Detection of New Adverse Drug Reactions is now in its fifth edition speaks volumes for its value to a multiplicity of readers.Thescienceofpharmacovigilancehasgrowninbreadthanddepthovertheeighteen years of the book’s existence and the present edition shows not only how the scope of the fieldhasincreased,withchaptersonthesafetyofbiotechnologyproductsandvaccinesafety surveillance, but also how the operating techniques of statistical analysis, legal aspects and ethicalissuesnowformimportantareasfordebateinthefieldofdrugsafety. The history of drug safety is a roll call of the practice of medicine and of the science of pharmacology and toxicology which underpin it. Even the nomenclature of adverse drug reactions has evolved as we understand more of the underlying scientific basis. Nowhere is this better illustrated than in the area of drug interactions. Two examples serve to illustrate this. The broad division into pharmacokinetic and pharmacodynamic interactions has been further complicated by new understanding of how cellular transporter mechanisms are utilisedtotransferdrugsacrosstissueboundariesinthegut,liver,kidneyandbrain,andhow thisnowformsthebasisofanewsetofwaysinwhichonedrugcanalterthedispositionand response to another. Secondly, as our knowledge of the human genome has evolved, the scienceofpharamacogenomicshasincreasedourabilitytoselectpatientswhowillrespond to specific drugs, and this response may be beneficial or adverse. Again, such information mustbefactoredintoourappreciationofthebasisofdruginteractions. As well as considering how we have reached our present position in considering adverse drug reactions, this book looks to the future. The chapter by Patrick Waller and Stephen Evans is particularly important in this respect, showing how the prediction of drug safety will form the future of pharmacovigilance, whereas in the past this depended more on the demonstration of harm. Medicinal chemists who design drug molecules appreciate the toxicity potential of various chemical groupings in a molecule, and are increasingly able to design out the offending entity without impairing efficacy. The clinical pharmacologist and the drug regulator, always aiming to reconcile possible risk with benefit, appreciate how criticalisappropriatedoseselectioninachievingthisbalance.Theclinicianwillalwaysplay an important role by his careful documentation and reporting of patient harm on systems such as the Yellow Card. Such spontaneous reporting systems will always serve the public health by creating signals of drug safety which can be augmented and further analysed in othermoresophisticatedways. Theconceptofbalancingriskwithbenefit,athemetowhichthebookcorrectlyrepeatedly returns,remainsthebedrockofdrugtherapy.Itisnotanideawhicheither thepublicor the Stephens’DetectionofNewAdverseDrugReactionsFifthEditioneditedbyJohnTalbotandPatrickWaller #2004JohnWiley&Sons,Ltd ISBN:047084552X
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