BOOK
Pharmacovigilance: A Practical Approach
Thao Doan | Cheryl Renz | Fabio Lievano | Mondira Bhattacharya | Linda Scarazzini
(2018)
Additional Information
Book Details
Abstract
Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Front Cover | Cover | ||
| Pharmacovigilance: A Practical Approach | i | ||
| Pharmacovigilance: A Practical Approach | iii | ||
| Copyright | iv | ||
| List of Contributors | v | ||
| Acknowledgments | ix | ||
| Introduction | xi | ||
| Contents | xiii | ||
| I - THE REGULATORY ENVIRONMENT | 1 | ||
| 1 - Does Regulation Drive Science or Does Science Drive Regulation? | 1 | ||
| INTRODUCTION | 1 | ||
| IMPORTANT EVENTS IN PHARMACOVIGILANCE | 1 | ||
| IMPORTANT PHARMACOVIGILANCE ORGANIZATIONS | 3 | ||
| IMPORTANT REGULATORY AUTHORITIES AND REGIONS | 4 | ||
| THE WORLD OF REGULATORY SCIENCE | 4 | ||
| EMA PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE | 5 | ||
| NEW WAVE OF GLOBAL PHARMACOVIGILANCE REGULATION | 7 | ||
| THE EU QPPV | 7 | ||
| THE RISE OF THE NATIONAL QPPV | 8 | ||
| The Pharmacovigilance System Master File | 8 | ||
| Is Regulatory Guidance Just Guidance? | 9 | ||
| How can Industry Influence Regulation? | 9 | ||
| Enforcement of Pharmacovigilance Regulations | 9 | ||
| CONCLUSIONS | 10 | ||
| REFERENCES | 10 | ||
| II - SAFETY DATA AND REAL WORLD EVIDENCE | 13 | ||
| 2 - Signal Management and Methods of Signal Detection | 13 | ||
| INTRODUCTION | 13 | ||
| SIGNALS (BOX 2.2) | 13 | ||
| SIGNAL DETECTION | 19 | ||
| SIGNAL VALIDATION | 21 | ||
| SIGNAL ASSESSMENT | 22 | ||
| DETERMINING BENEFIT/RISK (BOX 2.5) | 23 | ||
| SAFETY GOVERNANCE IN PHARMACOVIGILANCE | 24 | ||
| SAFETY GOVERNANCE FRAMEWORK | 25 | ||
| SAFETY OVERSIGHT BOARD (BOX 2.8) | 25 | ||
| SAFETY MANAGEMENT TEAMS18 | 26 | ||
| FIRST-IN-HUMAN REVIEW COMMITTEE19,20 | 26 | ||
| INTERNAL SAFETY ADVISORY GROUPS | 26 | ||
| SAFETY ASSESSMENT COMMITTEES21 | 26 | ||
| SAFETY GOVERNANCE SUPPORT | 26 | ||
| SAFETY GOVERNANCE PROCESS (BOX 2.11) | 27 | ||
| CONCLUSION | 27 | ||
| LIST OF DEFINITIONS | 27 | ||
| REFERENCES | 28 | ||
| FURTHER READING | 29 | ||
| 3 - Product Safety Monitoring in Clinical Trials | 31 | ||
| INTRODUCTION | 31 | ||
| SAFETY PLANNING | 31 | ||
| Systemic Approach | 31 | ||
| Development Risk Management Plan and Development Core Safety Information (Box 3.3) | 32 | ||
| Specific Safety Issues (Box 3.4) | 33 | ||
| DATA COLLECTION AND EVALUATION | 33 | ||
| Data Collection (Box 3.5) | 33 | ||
| General principles and considerations | 33 | ||
| Specialized data collection and adjudication | 34 | ||
| Baseline risk factor documentation | 34 | ||
| Safety topics of interest | 34 | ||
| Event adjudication | 34 | ||
| Data monitoring committee (Box 3.6) | 34 | ||
| Safety assessment committees | 35 | ||
| Data Evaluation | 35 | ||
| Quantitative analysis | 35 | ||
| III - SPECIAL TOPICS AND SPECIAL POPULATIONS | 101 | ||
| 7 - Vaccine Pharmacovigilance | 101 | ||
| INTRODUCTION | 101 | ||
| MODERN VACCINE HISTORY RELATED TO PHARMACOVIGILANCE | 102 | ||
| Rotavirus Vaccine: an Example of Safety Surveillance | 102 | ||
| Measles, Mumps, and Rubella Vaccine: Autism Controversy | 102 | ||
| Polio Eradication: the Boycott in Northern Nigeria | 103 | ||
| MONITORING VACCINE SAFETY DURING PRELICENSURE | 103 | ||
| Clinical Trials | 103 | ||
| Vaccine Product Approval Process | 106 | ||
| POSTLICENSURE | 106 | ||
| BENEFIT RISK—THE PROVIDER AND CONSUMER LEVEL | 108 | ||
| THE FUTURE | 109 | ||
| Active Surveillance | 109 | ||
| Real-World Evidence | 109 | ||
| Maternal Vaccination | 109 | ||
| Systems for monitoring the safety of maternal vaccination | 110 | ||
| REFERENCES | 110 | ||
| 8 - Pharmacovigilance in Pregnancy | 113 | ||
| INTRODUCTION | 113 | ||
| MEDICATION USE IN PREGNANT WOMEN | 113 | ||
| STAGES OF EMBRYO-FETAL DEVELOPMENT | 114 | ||
| THALIDOMIDE AND HISTORY OF REGULATIONS | 114 | ||
| DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY | 115 | ||
| Genotoxicity | 118 | ||
| CONTRACEPTIVE MEASURES IN CLINICAL TRIALS | 119 | ||
| Seminal Fluid Exposure During Pregnancy | 120 | ||
| Collection of Pregnancy Information in the Clinical Trial Setting | 121 | ||
| Data collection in postmarketing surveillance | 121 | ||
| METHODS OF SURVEILLANCE | 122 | ||
| Signal Detection by the Sponsor | 122 | ||
| Pregnancy Exposure Registries | 122 | ||
| Electronic Healthcare Databases | 123 | ||
| Case-Control Studies | 124 | ||
| Labeling | 124 | ||
| Risk Minimization | 125 | ||
| CONCLUSIONS | 125 | ||
| REFERENCES | 126 | ||
| 9 - Pharmacovigilance in Pediatrics | 129 | ||
| INTRODUCTION | 129 | ||
| LEGISLATION FOR PEDIATRIC DRUG DEVELOPMENT | 129 | ||
| The United States | 130 | ||
| European Union | 130 | ||
| UNIQUE CONSIDERATIONS IN THE PEDIATRIC POPULATION | 131 | ||
| UNIQUE PHARMACOVIGILANCE CHALLENGES FOR CHILDREN | 134 | ||
| SAFETY DATA COLLECTION TO IMPROVE CHARACTERIZATION OF THE SAFETY PROFILE OF MEDICATIONS USED IN THE PEDIATRIC POPULATION | 134 | ||
| CONCLUSION | 136 | ||
| REFERENCES | 136 | ||
| 10 - Pharmacovigilance in Special Populations: Elderly | 137 | ||
| INTRODUCTION | 137 | ||
| The Growing Elderly Population | 137 | ||
| Disease Burden in the Elderly | 137 | ||
| Medication Use in the Elderly | 138 | ||
| Altered Pharmacokinetic and Pharmacodynamic Effects | 139 | ||
| Absorption | 139 | ||
| Distribution | 139 | ||
| Metabolism | 139 | ||
| Excretion | 140 | ||
| Pharmacodynamics | 140 | ||
| Pharmacovigilance in the Elderly Throughout the Product Life Cycle | 140 | ||
| Considerations during clinical development | 140 | ||
| Pharmacokinetic studies in the elderly | 141 | ||
| Data analysis and assessment of safety in the elderly | 141 | ||
| Labeling and the elderly | 141 | ||
| Risk communication to the elderly | 141 | ||
| Postapproval safety evaluation in the elderly | 141 | ||
| CONCLUSION | 142 | ||
| REFERENCES | 142 | ||
| 11 - Medical Device Vigilance and Postmarket Surveillance | 145 | ||
| INTRODUCTION | 145 | ||
| OVERVIEW OF POSTMARKET SURVEILLANCE AND DEVICE VIGILANCE | 146 | ||
| WHAT ARE POSTMARKET SURVEILLANCE AND DEVICE VIGILANCE? | 146 | ||
| THE VALUE OF POSTMARKET SURVEILLANCE AND MEDICAL DEVICE VIGILANCE | 147 | ||
| US DEVICE VIGILANCE | 147 | ||
| Combination Products | 150 | ||
| EUROPEAN UNION DEVICE VIGILANCE | 151 | ||
| Combination Products | 154 | ||
| CONCLUSION | 154 | ||
| DISCLOSURE STATEMENT | 154 | ||
| REFERENCES | 154 | ||
| FURTHER READING | 154 | ||
| 12 - Application of Human Factors and Health Literacy in Pharmacovigilance | 155 | ||
| INTRODUCTION | 155 | ||
| HUMAN FACTORS | 155 | ||
| HEALTH LITERACY | 157 | ||
| CONCLUSION | 158 | ||
| REFERENCES | 158 | ||
| IV - THE NEXT FRONTIER | 161 | ||
| 13 - Benefit-Risk Management | 161 | ||
| INTRODUCTION | 161 | ||
| HISTORICAL BACKGROUND | 161 | ||
| STRUCTURED BENEFIT-RISK ASSESSMENT | 162 | ||
| INTEGRATING THE LIFE CYCLE APPROACH TO BENEFIT-RISK WITHIN A BIOPHARMACEUTICAL COMPANY | 165 | ||
| The Benefit-Risk Assessment Team | 165 | ||
| The Life Cycle Approach | 166 | ||
| Early development approach | 166 | ||
| Late development approach | 167 | ||
| On-market approach | 169 | ||
| VISUALIZATION OF BENEFIT-RISK ASSESSMENTS | 171 | ||
| QUANTITATIVE BENEFIT-RISK ASSESSMENTS | 172 | ||
| ROLE OF THE PATIENT IN BENEFIT-RISK ASSESSMENT | 174 | ||
| CONCLUSION | 176 | ||
| APPENDIX I. REVIEW OF RISK MINIMIZATION | 176 | ||
| Routine Risk Minimization | 176 | ||
| Additional Risk Minimization Measures | 177 | ||
| REFERENCES | 179 | ||
| 14 - Information Technology in Pharmacovigilance: Current State and Future Directions | 181 | ||
| INTRODUCTION TO PHARMACOVIGILANCE INFORMATION TECHNOLOGIES | 181 | ||
| PHARMACOVIGILANCE DATA AND DATA FLOW | 182 | ||
| Safety Data Sources | 182 | ||
| Biopharma Safety Data Flows | 182 | ||
| PHARMACOVIGILANCE INFORMATION TECHNOLOGIES FOR ADVERSE EVENT REPORT CAPTURE | 184 | ||
| Special Considerations for Adverse Event Report Capture | 184 | ||
| Current State of Pharmacovigilance Information Technologies for Adverse Event Report Capture | 185 | ||
| Data sources | 185 | ||
| Applications | 186 | ||
| Emerging Technologies for Adverse Event Report Capture | 187 | ||
| Infrastructure hosting | 187 | ||
| Intake | 187 | ||
| Processing | 187 | ||
| SURVEILLANCE PROCESS TECHNOLOGY | 187 | ||
| Current State of Pharmacovigilance Information Technologies for Surveillance | 187 | ||
| Data sources | 188 | ||
| Processes and applications | 188 | ||
| Emerging Surveillance Pharmacovigilance Information Technologies | 189 | ||
| SIGNAL AND RISK ASSESSMENT TECHNOLOGY | 190 | ||
| Current State of Pharmacovigilance Information Technologies for Signal and Risk Assessment | 190 | ||
| Emerging Pharmacovigilance Information Technologies for Signal and Risk Assessment | 191 | ||
| PHARMACOVIGILANCE INFORMATION TECHNOLOGIES FOR RISK MINIMIZATION | 192 | ||
| Technology Goals for Risk Minimization | 192 | ||
| Current State of Pharmacovigilance Information Technologies for Routine Risk Minimization | 192 | ||
| Current State of Pharmacovigilance Information Technologies for Additional Risk Minimization | 192 | ||
| Emerging Technologies for Risk Minimization | 193 | ||
| ADDITIONAL INFORMATION TECHNOLOGIES FOR PATIENT SAFETY | 194 | ||
| Pharmacovigilance Information Technologies in the Patient Care Setting | 194 | ||
| Pharmacovigilance Information Technologies and Health Authorities | 194 | ||
| CONCLUSION | 194 | ||
| APPENDIX I: GENERAL PV TECHNOLOGY FRAMEWORK | 194 | ||
| REFERENCE | 195 | ||
| 15 - The Future of Safety Science | 197 | ||
| BACKGROUND | 197 | ||
| COGNITIVE AND BEHAVIORAL SYSTEMS | 198 | ||
| Patient Centricity: Cognitive and Behavioral Systems and Medical Assessment | 198 | ||
| MEDICAL ASSESSMENT | 198 | ||
| Predictive Analytics: Medical Assessment and Data Science | 198 | ||
| DATA SCIENCE | 199 | ||
| Patient Insights: Data Science and Cognitive and Behavioral Science | 200 | ||
| BENEFIT RISK: BRINGING IT ALL TOGETHER | 201 | ||
| CONCLUSION | 202 | ||
| REFERENCES | 202 | ||
| Index | 205 | ||
| A | 205 | ||
| B | 205 | ||
| C | 206 | ||
| D | 206 | ||
| E | 207 | ||
| F | 208 | ||
| G | 208 | ||
| H | 208 | ||
| I | 208 | ||
| K | 209 | ||
| L | 209 | ||
| M | 209 | ||
| N | 209 | ||
| O | 210 | ||
| P | 210 | ||
| Q | 211 | ||
| R | 211 | ||
| S | 212 | ||
| T | 213 | ||
| U | 213 | ||
| V | 213 | ||
| W | 213 | ||
| Z | 213 |