Textbook of pharmacoepidemiology

517 Pages·2006·6.606 MB·English

by  Brian L Strom, Stephen E Kimmel

TEXTBOOK OF PHARMACOEPIDEMIOLOGY

TEXTBOOK OF PHARMACOEPIDEMIOLOGY
Editors
BRIAN L. STROM and STEPHEN E. KIMMEL
University of Pennsylvania, Philadelphia, USA
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LibraryofCongressCataloginginPublicationData
Textbookofpharmacoepidemiology/editedbyBrianL.StromandStephenE.Kimmel.
p. ; cm.
Includesbibliographicalreferencesandindex.
ISBN-13:978-0-470-02924-4(hardback:alk.paper)
ISBN-10:0-470-02924-2(hardback:alk.paper)
ISBN-13:978-0-470-02925-1(pbk.:alk.paper)
ISBN-10:0-470-02925-0(pbk.:alk.paper)
1. Pharmacoepidemiology—Textbooks. I. Strom,BrianL. II. Kimmel,StephenE.
[DNLM:1.Pharmacoepidemiology—methods. 2. DrugEvaluation. 3. DrugMonitoring. 4. DrugTherapy.
5. TreatmentOutcome.QZ42T35562006]
RM302.5.T492006
615(cid:2).7042—dc22 2006017302
BritishLibraryCataloguinginPublicationData
AcataloguerecordforthisbookisavailablefromtheBritishLibrary
ISBN-13978-0-470-02924-4(HB)
ISBN-100-470-02924-2(HB)
ISBN-13978-0-470-02925-1(PB)
ISBN-100-470-02925-0(PB)
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PrintedandboundinGreatBritainbyAntonyRoweLtd,Chippenham,Wiltshire
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Contents
ListofContributors ix
Preface xiii
Acknowledgments xv
AcknowledgmentsfromPharmacoepidemiology,FourthEdition xvii
SECTION I INTRODUCTIONTOPHARMACOEPIDEMIOLOGY 1
1. WhatisPharmacoepidemiology? 3
BrianL.Strom
2. StudyDesignsAvailableforPharmacoepidemiologyStudies 13
BrianL.Strom
3. SampleSizeConsiderationsforPharmacoepidemiologyStudies 25
BrianL.Strom
4. BasicPrinciplesofClinicalPharmacologyRelevanttoPharmacoepidemiologyStudies 35
SeanHennessy
5. WhenShouldOnePerformPharmacoepidemiologyStudies? 55
BrianL.Strom
6. ViewsfromAcademia,Industry,andRegulatoryAgencies 63
LeanneK.Madre,RobertM.Califf,RobertF.Reynolds,PeterArlett,andJaneMoseley
SECTION II SOURCESOFPHARMACOEPIDEMIOLOGYDATA 89
7. SpontaneousReportingintheUnitedStates 91
SyedRizwanuddinAhmad,NormanS.Marks,andRogerA.Goetsch
8. GlobalDrugSurveillance:TheWHOProgrammeforInternationalDrugMonitoring 117
I.RalphEdwards,StenOlsson,MarieLindquist,andBruceHugman
9. Case–ControlSurveillance 137
LynnRosenberg,PatriciaF.Coogan,andJulieR.Palmer
10. Prescription-EventMonitoring 151
SaadA.W.Shakir
11. OverviewofAutomatedDatabasesinPharmacoepidemiology 167
BrianL.Strom
vi CONTENTS
12. ExamplesofAutomatedDatabases 173
AndyStergachis,KathleenW.Saunders,RobertL.Davis,StephenE.Kimmel,RitaSchinnar,K.ArnoldChan,
DeborahShatin,NigelS.B.Rawson,SeanHennessy,WinanneDowney,MaryRoseStang,PatriciaBeck,
WilliamOsei,HubertG.Leufkens,ThomasM.MacDonald,andJoelM.Gelfand
13. OtherApproachestoPharmacoepidemiologyStudies 215
BrianL.Strom
14. HowShouldOnePerformPharmacoepidemiologyStudies?ChoosingAmongtheAvailableAlternatives 227
BrianL.Strom
15. ValidityofPharmacoepidemiologicDrugandDiagnosisData 239
SuzanneL.West,BrianL.Strom,andCharlesPoole
SECTION III SPECIALISSUESINPHARMACOEPIDEMIOLOGYMETHODOLOGY 259
16. BiasandConfoundinginPharmacoepidemiology 261
IlonaCsizmadiandJean-PaulCollet
17. DeterminingCausationfromCaseReports 277
JudithK.Jones
18. MolecularPharmacoepidemiology 287
StephenE.Kimmel
19. BioethicalIssuesinPharmacoepidemiologicResearch 301
KevinHaynes,JasonKarlawish,andElizabethB.Andrews
20. TheUseofRandomizedControlledTrialsforPharmacoepidemiologyStudies 311
SamuelM.LeskoandAllenA.Mitchell
21. TheUseofPharmacoepidemiologytoStudyBeneficialDrugEffects 321
BrianL.Strom
22. Pharmacoeconomics:EconomicEvaluationofPharmaceuticals 333
KevinA.Schulman,HenryA.Glick,andDanielPolsky
23. UsingQuality-of-LifeMeasurementsinPharmacoepidemiologicResearch 345
HolgerSchünemann,GordonH.Guyatt,andRomanJaeschke
24. TheUseofMeta-analysisinPharmacoepidemiology 353
CarinJ.KimandJesseA.Berlin
25. PatientAdherencetoPrescribedDrugDosingRegimensinAmbulatoryPharmacotherapy 367
JohnUrquhartandBernardVrijens
26. NovelApproachestoPharmacoepidemiologyStudyDesignand
StatisticalAnalysis 383
SamySuissa
SECTION IV SPECIALAPPLICATIONSOFPHARMACOEPIDEMIOLOGY 397
27. SpecialApplicationsofPharmacoepidemiology 399
DavidLee,SumitR.Majumdar,HeleneLevensLipton,StephenB.Soumerai,SeanHennessy,
RobertL.Davis,RobertT.Chen,RoselieA.Bright,AllenA.Mitchell,DavidJ.Graham,DavidW.Bates,
andBrianL.Strom
CONTENTS vii
28. TheFutureofPharmacoepidemiology 447
BrianL.StromandStephenE.Kimmel
AppendixA SampleSizeTables 455
AppendixB Glossary 473
Index 481

Contributors
SYEDRIZWANUDDINAHMAD,MD,MPH Medical ROSELIE A. BRIGHT, ScD Epidemiologist, Center
Epidemiologist, Division of Drug Risk Evaluation, Office for Devices and Radiological Health, United States Food
ofSurveillanceandEpidemiology,FDA,CDER,HFD-430, and Drug Administration, 1350 Piccard Drive, HFZ-541,
Room3464,10903NewHampshireAvenue,SilverSpring, Rockville,MD20850,USA.
MD20993,USA. [email protected]
[email protected]
ROBERT M. CALIFF, MD Vice Chancellor for Clin-
ELIZABETH B. ANDREWS, PhD, MPH Vice Presi- ical Research, Director, Duke Clinical Research Institute,
dent, Pharmacoepidemiology and Risk Management, RTI Professor of Medicine, Duke University Medical Center,
Health Solutions, 3040 Cornwallis Road, PO Box 12194, 2400PrattStreet,Room0311TerraceLevel,Durham,NC
ResearchTrianglePark,NC27709-2194,USA. 27705,USA.
[email protected] [email protected]
PETER ARLETT, BSc, MBBS, MRCP, MFPM Prin- K. ARNOLD CHAN, MD, ScD Associate Professor of
cipal Administrator, Pharmaceuticals Unit, European Medicine,HarvardSchoolofPublicHealth,677Huntington
Avenue,Boston,MA02115,USA.
Commission, Honorary Senior Lecturer, Department of
[email protected]
Medicine,UniversityCollegeLondon,36FairbridgeRoad,
LondonN193HZ,UK.
ROBERT T. CHEN, MD, MA Injection Safety
[email protected]
Coordinator, Global Aids Program, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Atlanta,
DAVIDW.BATES,MD,MSc Chief,GeneralMedicine
GA30333,USA.
Division, Brigham and Women’s Hospital, 1620 Tremont
[email protected]
Street, 3rd Fl, BC3-2M, Boston, MA 02120-1613, USA;
Medical Director, Clinical and Quality Analysis, Partners
JEAN-PAUL COLLET, MD, PhD, MSc Professor,
HealthCare System, Inc.; Professor of Medicine, Harvard DepartmentofPediatrics,UBCAssociateDirector,Partner-
MedicalSchool. shipDevelopment,CFRIK-103,AmbulatoryCareBuilding,
[email protected] 4480 Oak Street, Vancouver, BC, Canada V6H 3V4.
[email protected]
PATRICIA BECK, BSP, MSc Research Consultant,
Research Services, Saskatchewan Health, 3475 Albert PATRICIA F. COOGAN, ScD Associate Professor of
Street,Regina,SaskatchewanS4S6X6,Canada. Epidemiology,SloneEpidemiologyCenter,BostonUniver-
[email protected] sity, 1010 Commonwealth Avenue, 4th floor, Boston,
MA02215,USA.
JESSE A. BERLIN, ScD Senior Director, Statis-
[email protected]
tical Science, Johnson & Johnson Pharmaceutical
ResearchandDevelopment,LLC,1125Trenton-Harbourton ILONA CSIZMADI, PhD, MSc Research Scientist/
Road, PO Box 200 (mail stop 67), Titusville, NJ 08560, Epidemiologist, Division of Population Health and
USA. Information, Alberta Cancer Board, Adjunct Assistant
[email protected] Professor, Department of Community Health Sciences