Drug Safety (eBook)

Front Cover 1
Drug Safety: Progress and Controversies 5
Copyright Page 2
Table of Contents 9
PREFACE 13
ALLOCUTION DE BIENVENUE 17
Introduction 19
PART I: DRUG SAFETY: A MULTIFACETED PROBLEM DIVERSITE DES PROBLEMES POSES PAR L'EVALUATION DE LA SECURITE ENMATIERE DE MEDICAAIENTS 25
Chapter 1. 
27 
HOW CAN DRUG SAFETY BE REGULATED? 27
DO DRUG SAFETY REQUIREMENTS IMPEDE DRUG INNOVATION ? 28
WHAT IS THE SIGNIFICANCE OF THE BENEFIT-TO-RISR RATIO ? 29
WHERE ARE THE LIMITS OF SAFETY REGULATIONS ? 31
CAN CLINICAL TRIALS BE EXPEDITED WITHOUT NEGLECTING DRUG SAFETY ? 33
HOW CAN THE SCIENTIFIC BASIS OF DRUG SAFETY BE IMPROVED ? 33
REFERENCES 35
Chapter 2. 
37 
Abstract 37
A FOLLOW-UP STUDY OF REJECTIONS 38
A RETROSPECTIVE STUDY OF RESTRICTIVE DECISIONS 40
MAJOR IATROGENIC ACCIDENTS IN RETROSPECT 43
EFFICIENCY OF REGULATORY ACTIVITY ON SAFETY MATTERS 44
OTHER TECHNIQUES 45
AN INVALID TECHNIQUE 45
CONCLUSIONS 47
REFERENCES 48
Chapter 3. 
51 
Abstract 51
THE EARLY STAGES : LESS-STHINGENT CONTROL 53
SEQUENTIAL SUBMISSION AND REVIEW 55
REALISTIC STANDARDS OF EVIDENCE FOR EFFICACY 55
ACCEPTANCE OF FOREIGN AND IRREGULAR DATA 56
IMPROVED ADMINISTRATIVE AND MANAGEMENT TECHNIQUES 56
POSTMARKETING ISSUES 56
CONCLUSIONS 57
REFERENCES 58
Chapter 4. Les grainds médicaLinents d'hier auraient-ils franchi avec succes le bairrage de la réglementation préclinique actuelle? 59
Resume 59
LES COMMISSIONS D'AGREMENT 60
LE PRIX ET LA DURÉE DES ESSAIS PRÉCLINIQUES 61
LES LABORATOIRES DE RECHERCHE PHARMACEUTIQUE 62
QUELQUES DOSSIERS DE GRANDS MEDICAMENTS ANCIENS 63
CONCLUSIONS 67
REFERENCES 67
Chapter 5. 
69 
Abstract 69
Chapter 6. Ethicad Considerations in Drug Saifety Evaduation 73
Abstract 73
CONFLICT OF INTEREST IN RESEARCH 74
ETHICAL ISSUES IN CLINICAL DRUG TRIALS 75
THE MARKETING AND USE OF DRUGS 76
DRUGS IN T H E THIRD WORLD 77
THE CARE AND FEEDING OF PHARAiACEUTICAL PHYSICIANS 79
REFERENCES 80
Chapter 7. A Compairisoii of International Guidelines for the Clinicad Evaduation of Psychotropic Drugs The Price of Safety 81
Abstract 81
Chapter 8. 
85 
Resume 85
PART II:POST MARKETING SAFETY ASSESSMENT INTERET ET LIMITES DES METHODES D'EVALUATION CLINIQUE DES EFFETS INDESIRABLES DES MEDICAMENTS APRES MISE SUR LE MARCHE: PRESENT METHODS 89
Chapter 9. Spontaneous Notification 91
Abstract 91
DEFICIENCIES OF PRE-MARKETING TESTS 91
PRESCRIBING CONDITIONS 92
ADR REGISTERS IN PMS 92
ADVANTAGES AND DISADVANTAGES 93
SPONTANEOUS REPORTING AND IDENTIFICATION OF A NEW HAZARD 94
RELATIVE RISKS OF VARIOUS DRUGS 96
ADR'S AND IN-DEPTH STUDIES 97
WHEN AND WHAT TO REPORT 97
FEEDBACK OF INFORMATION 98
CONCLUDING REMARKS 99
REFERENCES 99
Chapter 10. Assessment of the Cause and Effect Relationship of Suspected Adverse Drug Reactions 101
Abstract 101
REFERENCES 108
Chapter 11. Experiences of Registers in Drug Safety Assessment in Sweden 111
Abstract 111
REGISTERS, CLASSIFICATIONS AND CODES 111
THE MORTALITY REGISTER 112
CANCER REGISTER 112
PATIENT REGISTER 114
MALFORMATION REGISTER AND MEDICAL BIRTH RECORD REGISTER 115
DRUG SALES AND PRESCRIPTION REGISTERS 116
WHOLESALE LEVEL 117
PRESCRIPTION LEVEL 118
CONCLUDING REMARKS 119
Acknowledgments 120
REFERENCES 120
Chapter 12. Méthodes actuelles pour évaluer rinnocuité des médicsmíients : etiquetes prospectives 123
Resume 123
CAS RELATIVEMENT SIMPLES 124
CAS DE COAiPLEXITE MOYENNE 125
CAS TRES DIFFICILES 126
REFERENCES 128
Chapter 13. Case-Control Studies in the Evaduation of Drug Safety 129
Abstract 129
Determining the size of the study 131
Selecting the cases 132
Selecting the controls 133
Identifying the exposure 135
Controlling confounding factors 136
Analysing the data 137
Interpreting the results 137
Conclusion 138
REFERENCES 138
Chapter 14. Hospitad Surveys 141
REFERENCES 143
Chapter 15. Cost and Effectiveness of Post-marketing Surveillance 145
Abstract 145
PART III: POST MARKETING SAFETY ASSESSMENT INTERET ET LIMITES DES METHODES D'EVALUATION CLINIQUE DES EFFETS INDESIRABLES DES MEDICAMENTS APRES MISE SUR LE MARCHE: NEW METHODS 147
Chapter 16. Scientific Obstacles to Overcome in Establishing Systematic Post-mairketing Surveillance 149
Abstract 149
Cohorts From Data Bainks 151
Abstract 151
DESCRIPTION OF THE RESOURCE 151
REFERENCES 153
Chapter 17. 
155 
Abstract 155
BACKGROUND 155
INCIDENCE OF ADR'S 156
PRESCRIPTION-EVENT MONITORING (PEM) 157
BARRIERS TO PROGRESS 158
SUMMARY AND CONCLUSIONS 160
Chapter 18. Post-mairketing Saifety Assessment New Zeadand Experience 161
Abstract 161
REPORTING 162
RELATING TO USAGE 162
MEDICINES 163
SALES 163
NUMBER OF REPORTS 164
RESULTS 165
BETA BLOCKING AGENTS 165
OTHER MEDICINES 165
CESSATION OF THERAPY 166
UNUSUAL ASSOCIATIONS 167
SODIUM VALPROATE FOLLOW-UP 167
ADVANTAGES OF AN INTENSIFIED VOLUNTARY TYPE OF MONITORING SCHEME 167
Chapter 19. Post-marketing Surveillaince in U. K. A Study of Cimetidine Recipients
Abstract 169
Chapter 20. 
171 
Abstract 171
Chapter 21. 
173 
Resume 173
Faire connaítre son nouveau medicament 175
Poursuivre l'étude du médicamet 176
Mettre en place un processus de recueil de I'information 176
PART IV: INFORMING THE PRESCRIBER L'INFORMATION AU NIVEAU DU PRESCRIPTEUR 179
Chapter 22. 
181 
Chapter 23. 
187 
EXEMPLES DE DROITS INTERNES 188
LES PRO JETS DE TEXTES COMMUNAUTAIRES 192
CONCLUSION 192
Chapter 24. 
195 
Abstract 195
REFERENCES 200
Chapter 25. 
201 
Abstract 201
Chapter 26. Future Systems in Providing the Prescriber with Drug Information 203
Abstract 203
REFERENCES 205
Chapter 27. Role du prescripteur dams l'information du patient sur les effets du médicaiment 207
Abstract 207
LA PRESCRIPTION PAR LE MÉDECIN 207
LA REDACTION DE LORDONNANCE 208
LA GRILLE THERAPEUTIQUE 208
PARTICIPATION DU PATIENT 209
FORMATION DU MEDECIN 210
Chapter 28. Phairmacist Contribution to Patient Information aind Drug Saifety 211
Abstract 211
Chapter 29. The Patient Packaige Insert The FDA Concept and Plans 217
Abstract 217
REFERENCES 222
Chapter 30. Evaduation de l'observaüice 225
Resume 225
DETERAUNATION DE LOBSERVANCE PAR METHODES DIRECTES 226
DETERMINATION PAR EFFETS PHARMACODYNAMIQUES 229
DETERMINATION PAR METHODE INDIRECTE 229
REFERENCES 230
Chapter 31. Cross Culturad Problems with Regaurd to Product Information and Drug Saifety 231
Abstract 231
SOURCES AND TARGETS OF DRUG INFORMATION 232
DRUG INFORAiATION FOR THE HEALTH PROFESSIONS 233
DRUG INFORMATION FOR THE PATIENT 234
REFERENCES 237
Chapter 32. Product Information : Proposal for a Coherent Action Program 239
Abstract 239
PART V: FREE COMMUNICATIONS AND POSTERS COAAMUNICATIONS LIBRES ET POSTERS 245
Chapter 33. A Diploma Course in Phairmaceuticad Medicine 247
Abstract 247
Chapter 34. Diploma in PhairmaceuticaLl Medicine (D.P.M.): A survey of Attitudes of A.M.A.P.I. members. 249
Abstract 249
Chapter 35. Test of Smadl Airways Function in Monitonng Respiratoty Effects of Medicinais 251
Abstract 251
Chapter 36. Algorithms and the Science of Systematic Drug Development 253
Abstract 253
Chapter 37. Management of Clinicad Triads in Developing Countries 255
Abstract 255
ON THE PHOTOCOL, ITS STANDARDIZATION AND PROJECT WORKSHOPS 256
ON STAFF AND SUPERVISION 258
ON LOGISTICS AND LOCATIONS 259
ON DRUGS AND COAiPLIANCE 260
ETHICS 261
DATA COLLECTION AND ANALYSIS 262
REFERENCES 263
Chapter 38. The Pathologist's Role in the Intetpretation of Caircinogemcity Studies on Laboratory Animals 265
Abstract 265
Chapter 39. Methodologicad Problems in the Detection and Evaluation of Adverse Events during the Phases I, II and III of the Drug Development 267
Abstract 267
Chapter 40. Post-marketing Surveillance in Italy :A Compairison between Firm-Sponsored and Independent Trials with Prsizosin 269
Abstract 269
RESULTS 271
DISCUSSION 272
REFERENCES 273
Chapter 41. Current Concepts for Assessing the Drug Adverse event Relationship and their Problems 275
Abstract 275
REFERENCES 279
Chapter 42. Methodologicad aind Statisticad Problems in the Evaluation of Data on Adverse Drug Reaction 281
Abstract 281
Chapter 43. Post-mairketing Surveillance Methodology as Applied in a Phsomaceuticad Medicad Depairtment 283
Abstract 283
INDUSTRY ORGANIZED PMS 290
REFERENCES 290
Chapter 44. Cimetidine as a Model for Post-marketing Saifety Assessment 293
Abstract 293
Chapter 45. Improving Drug Compliaince in a Multi-cultural Multí-linguistíc Society 295
Abstract 295
Chapter 46. 1984 and the Committee on Safety of Surgery 297
Abstract 297
Chapter 47. Adverse Drug Reaction Monitoring in Psychiatric Hospitads 299
Abstract 299
AiETHODS 299
RESULTS 300
REFERENCES 303
Chapter 48. A Post-marketing Surveillaince Study on Bacampicillin 305
Abstract 305
REFERENCES 308
Chapter 49. Post-marketing Surveillance: Computerized Evaluation of Side Effects 309
Abstract 309
REFERENCES 318
Chapter 50. CNS Safety Evaluations of New Drugs Based on Computerized Bio-electricad Potentiads 319
Abstract 319
ALLOCUTION DE CLOTURE 321
TABLE OF SPEAKERS 323