Pharmacovigilance - Pharmacy Department
PART I: THE BASIS OF PHARMACOVIGILANCE
Chapter 1: The Basis of Pharmacovigilance
1. The Basis of Pharmacovigilance
2. Diagnosing Adverse Drug Reactions - Pharmacovigilance
3. Current Methods of Pharmacovigilance
4. Hypothesis-Generating Methods - Pharmacovigilance
5. Hypothesis-Testing Methods - Pharmacovigilance
6. Conclusion - Pharmacovigilance
Chapter 2: Legal Basis - EU
1. Legal Basis – EU - Pharmacovigilance
2. Guidance - Legal Basis - EU | Pharmacovigilance
3. Definitions - Legal Basis - EU | Pharmacovigilance
4. European Pharmacovigilance for Medicinal Products - Legal Basis - EU | Pharmacovigilance
5. European Pharmacovigilance for Centrally - Legal Basis - EU | Pharmacovigilance
6. European Pharmacovigilance Legislation - Legal Basis - EU | Pharmacovigilance
Chapter 3: Legal Basis - United States
1. Legal Basis - United States - Pharmacovigilance
2. Background - Legal Basis - United States | Pharmacovigilance
3. Law - Legal Basis - United States | Pharmacovigilance
4. Regulations - Legal Basis - United States | Pharmacovigilance
5. Food and Drug Administration Reporting Standards For Investigational Drugs and Biological Products - Legal Basis - United States | Pharmacovigilance
6. Food and Drug Administration Reporting Standards for Marketed Drugs and Biological Products - Legal Basis - United States | Pharmacovigilance
7. Reporting Adverse Product Experiences from Marketed Products - Legal Basis - United States | Pharmacovigilance
8. Guidance Documents - Legal Basis - United States | Pharmacovigilance
9. Enforcement - Legal Basis - United States | Pharmacovigilance
10. Conclusion - Legal Basis - United States | Pharmacovigilance
Chapter 4: Ethical Oversight, Consent and Confidentiality
1. Ethical Oversight, Consent and Confidentiality - Pharmacovigilance
2. Confidentiality Issues in Epidemiology Studies - Ethical Oversight, Consent and Confidentiality | Pharmacovigilance
3. Existing Law - Ethical Oversight, Consent and Confidentiality | Pharmacovigilance
4. State Laws - Ethical Oversight, Consent and Confidentiality | Pharmacovigilance
5. Research Ethics - Ethical Oversight, Consent and Confidentiality | Pharmacovigilance
6. Implications and Next Steps - Ethical Oversight, Consent and Confidentiality | Pharmacovigilance
Chapter 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation
1. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation - Pharmacovigilance
2. The ICH Step Process - Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation | Pharmacovigilance
3. The Pharmacovigilance-Related ICH Topics - Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation | Pharmacovigilance
4. Discussion and Conclusions - Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation | Pharmacovigilance
Chapter 6: Periodic Safety Update Reports
1. Periodic Safety Update Reports - Pharmacovigilance
2. Purpose of the PSUR - Periodic Safety Update Reports | Pharmacovigilance
3. PSUR - General Principles - Periodic Safety Update Reports | Pharmacovigilance
4. Regulatory Requirements - Periodic Safety Update Reports | Pharmacovigilance
5. PSUR Content - Periodic Safety Update Reports | Pharmacovigilance
6. Summary Bridging Reports - Periodic Safety Update Reports | Pharmacovigilance
7. Addendum Reports - Periodic Safety Update Reports | Pharmacovigilance
8. The PSUR Process - Periodic Safety Update Reports | Pharmacovigilance
9. Best Methods of Compliance - Periodic Safety Update Reports | Pharmacovigilance
10. Pragmatic Solutions - Periodic Safety Update Reports | Pharmacovigilance
11. Clinical Trial Annual Reports - Periodic Safety Update Reports | Pharmacovigilance
12. PSUR and Risk Management - Periodic Safety Update Reports | Pharmacovigilance
13. Conclusion - Periodic Safety Update Reports | Pharmacovigilance
Chapter 7: Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
1. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials - Pharmacovigilance
2. Non-Clinical Testing Requirements - Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials | Pharmacovigilance
3. Use of Animals to Predict Human Toxicities - Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials | Pharmacovigilance
4. Estimation of Safe Starting Dose and Safety Assessment and Risk–Benefit Analysis - Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials | Pharmacovigilance
5. Adverse Events in Clinical Trials - Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials | Pharmacovigilance
6. Conclusions - Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials | Pharmacovigilance
Chapter 8: Mechanisms of Adverse Drug Reactions
1. Mechanisms of Adverse Drug Reactions - Pharmacovigilance
2. Importance of Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
3. Classification of Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
4. Type a Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
5. Type B or Idiosyncratic Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
6. The Role of Drug Metabolism in Type B Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
7. An Example of a Drug That Causes Toxicity Through the Formation of a Chemically Reactive Intermediate - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
8. The Role of the Immune System in Type B Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
9. The Role of Viruses in Type B Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
10. Genetic Predisposition to Type B Adverse Drug Reactions - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
11. Conclusion - Mechanisms of Adverse Drug Reactions | Pharmacovigilance
Chapter 9: Micturin and Torsades de Pointes
1. Micturin and Torsades de Pointes - Pharmacovigilance
Chapter 10: Withdrawal of Terodiline: A Tale of Two Toxicities
1. Withdrawal of Terodiline: A Tale of Two Toxicities - Pharmacovigilance
2. Drug-Induced QT Interval Prolongation and Pharmacovigilance Planning (ICH E2E) - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
3. Re-Birth of Terodiline - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
4. Terodiline-Induced Proarrhythmias - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
5. Limitations of Formal Post-Marketing Surveillance Studies - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
6. Initial Regulatory Deliberations - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
7. Similarities Between Terodiline and Prenylamine - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
8. Prenylamine-Induced Proarrhythmias - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
9. Polymorphic CYP2D6-Mediated Stereoselective Metabolism - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
10. Pharmacokinetics and Recommended Dose Schedules - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
11. Pharmacodynamic Similarity to Prenylamine - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
12. Stereoselectivity in Proarrhythmic Potential - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
13. Lessons to be Learnt - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
14. Why the Regulatory Concerns on Drug-Induced QT Interval Prolongation? - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
15. Electrophysiological Basis of Torsade De Pointes - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
16. Drug-Induced QT Interval Prolongation and Regulatory Guidance - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
17. Preclinical Investigations of the ‘QT-Liability’ of a Drug - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
18. Pre-Approval Clinical Safety Dataset - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
19. Exceptional Circumstances Requiring Extended Database - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
20. Risk–Benefit Assessment - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
21. Development of Single Enantiomers or Metabolites of Marketed Racemic Drugs - Withdrawal of Terodiline: A Tale of Two Toxicities | Pharmacovigilance
Chapter 11: Nomifensine and Haemolytic Anaemia
1. Nomifensine and Haemolytic Anaemia
2. Background - Nomifensine and Haemolytic Anaemia | Pharmacovigilance
3. Haemolytic Anaemia - Nomifensine and Haemolytic Anaemia | Pharmacovigilance
4. Post-Marketing Experience 1977–82 - Nomifensine and Haemolytic Anaemia | Pharmacovigilance
5. Post-Marketing Experience 1983–86 - Nomifensine and Haemolytic Anaemia | Pharmacovigilance
6. Discussion - Nomifensine and Haemolytic Anaemia | Pharmacovigilance
PART II: SIGNAL GENERATION
Chapter 12: WHO Programme - Global Monitoring
1. History of WHO Programme - Global Monitoring - Pharmacovigilance
2. Present Programme Structure - WHO Programme - Global Monitoring | Pharmacovigilance
3. Current Work of WHO - WHO Programme - Global Monitoring | Pharmacovigilance
4. What is Still Missing – What We Must Do in the Future - WHO Programme - Global Monitoring | Pharmacovigilance
5. Joining the WHO Programme - WHO Programme - Global Monitoring | Pharmacovigilance
6. Conclusions - WHO Programme - Global Monitoring | Pharmacovigilance
Chapter 13: Medical Dictionary for Regulatory Activities (MedDRA)
1. Medical Dictionary for Regulatory Activities (MedDRA®) - Pharmacovigilance
2. Uses of MedDRA - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
3. MedDRA Structure - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
4. MedDRA Rules and Conventions - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
5. Using MedDRA for Data Entry - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
6. Database Searches and Data Retrieval - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
7. Data Analysis and Presentation - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
8. MedDRA and Labelling - Medical Dictionary for Regulatory Activities (MedDRA) | Pharmacovigilance
Chapter 14: Regulatory Pharmacovigilance in the EU
1. Introduction and Historical Perspective - Regulatory Pharmacovigilance in the EU | Pharmacovigilance
2. Legal Basis, Principles and Organisation of the EU Pharmacovigilance System - Regulatory Pharmacovigilance in the EU | Pharmacovigilance
3. The Process of Regulatory Pharmacovigilance in the EU - Regulatory Pharmacovigilance in the EU | Pharmacovigilance
4. Future Challenges and Conclusions - Regulatory Pharmacovigilance in the EU | Pharmacovigilance
Chapter 15: Spontaneous Reporting - UK
1. Spontaneous Reporting - UK - Pharmacovigilance
2. Background - Spontaneous Reporting - UK | Pharmacovigilance
3. Purpose and Achievements of the Yellow Card Scheme - Spontaneous Reporting - UK | Pharmacovigilance
4. Weaknesses of Yellow Cards - Spontaneous Reporting - UK | Pharmacovigilance
5. Reporting Volumes - Spontaneous Reporting - UK | Pharmacovigilance
6. Recent Initiatives to Enhance the Scheme - Spontaneous Reporting - UK | Pharmacovigilance
7. Widening the Yellow Card Reporting Base - Spontaneous Reporting - UK | Pharmacovigilance
8. Specialist Therapeutic Areas - Spontaneous Reporting - UK | Pharmacovigilance
9. Suspected ADRS in Children - Spontaneous Reporting - UK | Pharmacovigilance
10. Unlicensed Herbal Remedies - Spontaneous Reporting - UK | Pharmacovigilance
11. Facilitation of Reporting - New Technology and Media - Spontaneous Reporting - UK | Pharmacovigilance
12. The Anonymised Yellow Card - Spontaneous Reporting - UK | Pharmacovigilance
13. Independent Review of Access to the Yellow Card Scheme - Spontaneous Reporting - UK | Pharmacovigilance
14. Focus on Patients - Spontaneous Reporting - UK | Pharmacovigilance
15. Future Directions for the Yellow Card Scheme - Spontaneous Reporting - UK | Pharmacovigilance
Chapter 16: Spontaneous Reporting - France
1. The French Pharmacovigilance System - Spontaneous Reporting - France | Pharmacovigilance
2. History and Organisation - Spontaneous Reporting - France | Pharmacovigilance
3. Regional Pharmacovigilance Centres - Spontaneous Reporting - France | Pharmacovigilance
4. Source and Management of Reports - Spontaneous Reporting - France | Pharmacovigilance
5. Alert Management - Spontaneous Reporting - France | Pharmacovigilance
6. Results - Spontaneous Reporting - France | Pharmacovigilance
7. The French Imputability Method - Spontaneous Reporting - France | Pharmacovigilance
8. Basic Principles - Spontaneous Reporting - France | Pharmacovigilance
9. Time Sequence Analysis - Spontaneous Reporting - France | Pharmacovigilance
10. Signs and Symptoms - Spontaneous Reporting - France | Pharmacovigilance
11. Future Perspectives - Spontaneous Reporting - France | Pharmacovigilance
Chapter 17: Spontaneous Reporting in Germany
1. Spontaneous Reporting in Germany - Pharmacovigilance
2. Demographic and Economic Data - Spontaneous Reporting in Germany | Pharmacovigilance
3. Licences for Medicinal Products in Germany - Spontaneous Reporting in Germany | Pharmacovigilance
4. Actors in Spontaneous Reporting - Spontaneous Reporting in Germany | Pharmacovigilance
5. Adverse Drug Reaction Databases - Spontaneous Reporting in Germany | Pharmacovigilance
6. Identifying Safety Issues From the Spontaneous Reporting System - Spontaneous Reporting in Germany | Pharmacovigilance
7. Risk-Assessment Procedures - Spontaneous Reporting in Germany | Pharmacovigilance
8. Risk Communication - Spontaneous Reporting in Germany | Pharmacovigilance
9. Conclusions - Spontaneous Reporting in Germany | Pharmacovigilance
Chapter 18: Spontaneous Reporting - United States
1. Spontaneous Reporting - United States - Pharmacovigilance
2. Adverse Drug Reaction Reporting in the United States - Spontaneous Reporting - United States | Pharmacovigilance
3. Adverse Drug Reaction Reports Review Practices at the Food and Drug Administration - Spontaneous Reporting - United States | Pharmacovigilance
4. Methods of Signal Detection and Refinement - Spontaneous Reporting - United States | Pharmacovigilance
5. Case Series - Spontaneous Reporting - United States | Pharmacovigilance
6. Regulatory Action Based on Spontaneous Reports - Spontaneous Reporting - United States | Pharmacovigilance
7. The Value and Future of Pharmacovigilance in the United States - Spontaneous Reporting - United States | Pharmacovigilance
Chapter 19: Statistical Methods of Signal Detection
1. Statistical Methods of Signal Detection - Pharmacovigilance
2. What Constitutes a Signal? - Statistical Methods of Signal Detection | Pharmacovigilance
3. Classification of ADR Reports - Statistical Methods of Signal Detection | Pharmacovigilance
4. Characteristics of Spontaneous Reports - Statistical Methods of Signal Detection | Pharmacovigilance
5. Proportional Reporting Ratios - Statistical Methods of Signal Detection | Pharmacovigilance
6. Rationale for Proportional Methods - Statistical Methods of Signal Detection | Pharmacovigilance
7. The Use of PRRs in Monitoring Drugs - Statistical Methods of Signal Detection | Pharmacovigilance
8. Further Developments and Key Issues - Statistical Methods of Signal Detection | Pharmacovigilance
9. Conclusions - Statistical Methods of Signal Detection | Pharmacovigilance
Chapter 20: Statistical Methods of Evaluating Pharmacovigilance Data
1. Statistical Methods of Evaluating Pharmacovigilance Data - Pharmacovigilance
2. Risk Estimaton From SR - Statistical Methods of Evaluating Pharmacovigilance Data | Pharmacovigilance
Chapter 21: Data Mining in Pharmacovigilance
1. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
2. Data Mining - Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
3. Description of Data Mining Methodology Used by the Uppsala Monitoring Centre - Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
4. ‘Validation’ of the Data Mining Approach - Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
5. Comparison of Methods - Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
6. The Limitations and Use of Data Mining - Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
Chapter 22: Pharmacovigilance in the Netherlands
1. History and Organization - Pharmacovigilance in the Netherlands
2. The Netherlands Pharmacovigilance Centre Lareb - Pharmacovigilance in the Netherlands
3. Further Initiatives in Pharmacovigilance in the Netherlands - Pharmacovigilance in the Netherlands
Chapter 23: CIOMS Working Groups and their Contribution to Pharmacovigilance
1. CIOMS Working Groups and their Contribution to Pharmacovigilance
2. CIOMS I - Expedited Reporting of Individual ADRs - CIOMS Working Groups and their Contribution to Pharmacovigilance
3. CIOMS IA - Harmonisation of Data Elements and Fields for Electronic Reporting of Individual ADRs - CIOMS Working Groups and their Contribution to Pharmacovigilance
4. CIOMS II - Periodic Safety Updates - CIOMS Working Groups and their Contribution to Pharmacovigilance
5. CIOMS III - Core Clinical Safety Information - CIOMS Working Groups and their Contribution to Pharmacovigilance
6. CIOMS IV - Benefit–Risk Evaluation - CIOMS Working Groups and their Contribution to Pharmacovigilance
7. CIOMS V Good Case Management and Reporting Practices - CIOMS Working Groups and their Contribution to Pharmacovigilance
8. CIOMS VI - Management Of Safety Information From Clinical Trials - CIOMS Working Groups and their Contribution to Pharmacovigilance
9. CIOMS VII - The Future - CIOMS Working Groups and their Contribution to Pharmacovigilance
10. Conclusion - CIOMS Working Groups and their Contribution to Pharmacovigilance
Chapter 24: PEM in the UK
1. Background - PEM in the UK | Pharmacovigilance
2. Method - PEM in the UK | Pharmacovigilance
3. Results - PEM in the UK | Pharmacovigilance
4. Discussion - PEM in the UK | Pharmacovigilance
5. Conclusion - PEM in the UK | Pharmacovigilance
Chapter 25: PEM in New Zealand
1. PEM in New Zealand - Pharmacovigilance
2. Background - PEM in New Zealand | Pharmacovigilance
3. Selection of Medicines for Monitoring - PEM in New Zealand | Pharmacovigilance
4. OverView of Intensive Medicines Monitoring Programme Methodology - PEM in New Zealand | Pharmacovigilance
5. Prescription Data - PEM in New Zealand | Pharmacovigilance
6. Identification of Events - PEM in New Zealand | Pharmacovigilance
7. Processing of Events - PEM in New Zealand | Pharmacovigilance
8. Privacy and Ethical Considerations - PEM in New Zealand | Pharmacovigilance
9. Outputs of PEM in New Zealand - PEM in New Zealand | Pharmacovigilance
10. Routine Analysis of Data - PEM in New Zealand | Pharmacovigilance
11. Specific Studies Using Intensive Medicines Monitoring Programme Data - PEM in New Zealand | Pharmacovigilance
12. Conclusions - PEM in New Zealand | Pharmacovigilance
Chapter 26: MEMO in the United Kingdom
1. MEMO in the United Kingdom - Pharmacovigilance
2. Description of the Database - MEMO in the United Kingdom | Pharmacovigilance
3. Prescription Drug Data - MEMO in the United Kingdom | Pharmacovigilance
4. Hospital Data - MEMO in the United Kingdom | Pharmacovigilance
5. Other in-Hospital and Outcome Data Sets - MEMO in the United Kingdom | Pharmacovigilance
6. Record-Linkage of Other Databases - MEMO in the United Kingdom | Pharmacovigilance
7. Current Areas of Investigation - MEMO in the United Kingdom | Pharmacovigilance
8. Confidentiality and Ethics in Memo - MEMO in the United Kingdom | Pharmacovigilance
9. Strengths - MEMO in the United Kingdom | Pharmacovigilance
10. Weaknesses - MEMO in the United Kingdom | Pharmacovigilance
11. Future Developments in Memo and Conclusion - MEMO in the United Kingdom | Pharmacovigilance
Chapter 27: The General Practice Research Database
1. The General Practice Research Database: Now and the Future
2. Historical Overview - The General Practice Research Database | Pharmacovigilance
3. Characteristics of General Practice Research Database 2005 - The General Practice Research Database | Pharmacovigilance
4. Future Developments in the UK National Health Service - The General Practice Research Database | Pharmacovigilance
5. Current and Future Developments in General Practice Research Database - The General Practice Research Database | Pharmacovigilance
6. Strengths and Weaknesses of the General Practice Research Database - The General Practice Research Database | Pharmacovigilance
7. Conclusion - The General Practice Research Database | Pharmacovigilance
Chapter 28: Overview of North American Databases
1. Overview of North American Databases - Pharmacovigilance
2. Group Health Cooperative of Puget Sound - Overview of North American Databases | Pharmacovigilance
3. Kaiser Permanente Medical Care Program - Overview of North American Databases | Pharmacovigilance
4. Kaiser Permanente Northwest - Overview of North American Databases | Pharmacovigilance
5. Unitedhealth Group - Overview of North American Databases | Pharmacovigilance
6. Medicaid Databases - Overview of North American Databases | Pharmacovigilance
7. Health Databases in Saskatchewan - Overview of North American Databases | Pharmacovigilance
8. HMO Research Network - Overview of North American Databases | Pharmacovigilance
9. Vaccine Safety Datalink: A Special Purpose Database - Overview of North American Databases | Pharmacovigilance
10. Weighing In - Overview of North American Databases | Pharmacovigilance
Chapter 29: Other Databases in Europe for the Analytic Evaluation of Drug Effects
1. Other Databases in Europe for the Analytic Evaluation of Drug Effects - Pharmacovigilance
2. The Netherlands - Other Databases in Europe for the Analytic Evaluation of Drug Effects | Pharmacovigilance
3. Computerization of the Dutch Community Pharmacy System - Other Databases in Europe for the Analytic Evaluation of Drug Effects | Pharmacovigilance
4. Denmark - Other Databases in Europe for the Analytic Evaluation of Drug Effects | Pharmacovigilance
5. Italy - Other Databases in Europe for the Analytic Evaluation of Drug Effects | Pharmacovigilance
Chapter 30: Surveillance for Medical Devices - USA
1. Surveillance for Medical Devices - USA - Pharmacovigilance
2. Premarket Overview - Surveillance for Medical Devices - USA | Pharmacovigilance
3. Postmarket Surveillance Context - Surveillance for Medical Devices - USA | Pharmacovigilance
4. The Future - Surveillance for Medical Devices - USA | Pharmacovigilance
5. Addendum - Surveillance for Medical Devices - USA | Pharmacovigilance
Chapter 31: Pharmacovigilance and Risk Management in Japan
1. Pharmacovigilance and Risk Management in Japan - Pharmacovigilance
2. Spontaneous Reporting System (SRS) in Japan - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
3. Amendment of Pharmaceutical Affairs Law (PAL) in 2002 - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
4. Enhancement of Post-Marketing Safety Measures - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
5. Good Vigilance Practice (GVP) And ADR Reports Via Companies - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
6. Good Postmarketing Study Practice (GPSP) and ICH E2E Guideline - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
7. The New Type of Investigations Using Pharmacoepidemiologic Methods in Japan - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
8. Novel Trend of Pharmacovigilance and Risk Management by the Regulatory Body - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
9. Role of Academia and Non-Governmental Bodies in the Future Pharmacovigilance in Japan - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
10. Risk Management in Japan - Pharmacovigilance and Risk Management in Japan | Pharmacovigilance
PART III: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
Chapter 32: Dermatological ADRs
1. Dermatological ADRs - Pharmacovigilance
2. Patterns of Cutaneous ADRS - Dermatological ADRs | Pharmacovigilance
3. Other Drug-Induced Cutaneous Reactions - Dermatological ADRs | Pharmacovigilance
4. Assessment and Reporting of Cutaneous ADRS - Dermatological ADRs | Pharmacovigilance
Chapter 33: Gastrointestinal ADRs
1. Gastrointestinal ADRs - Pharmacovigilance
2. Non-Steroidal Anti-Inflammatory Drugs - Gastrointestinal ADRs | Pharmacovigilance
3. Bisphosphonates - Gastrointestinal ADRs | Pharmacovigilance
4. Selective Serotonin Re-Uptake Inhibitors - Gastrointestinal ADRs | Pharmacovigilance
5. Pancreatic Enzyme Supplements - Gastrointestinal ADRs | Pharmacovigilance
6. Rotavirus Vaccine - Gastrointestinal ADRs | Pharmacovigilance
7. Measles-Mumps–Rubella Vaccine - Gastrointestinal ADRs | Pharmacovigilance
8. Haematological ADRs - Gastrointestinal ADRs | Pharmacovigilance
9. Mechanisms of ADR-Causing Cytopenias - Gastrointestinal ADRs | Pharmacovigilance
10. Mechanisms of ADR-Affecting Haemostasis - Gastrointestinal ADRs | Pharmacovigilance
11. Some Examples of Individual ADR - Pharmacovigilance in Action - Gastrointestinal ADRs | Pharmacovigilance
12. Management of Haematological ADR - Gastrointestinal ADRs | Pharmacovigilance
13. Strategies for the Detection and Prevention of Idiosyncratic Haematological ADRS - Gastrointestinal ADRs | Pharmacovigilance
14. Conclusion - Gastrointestinal ADRs | Pharmacovigilance
Chapter 35: Hepatic ADRs
1. Hepatic ADRs - Pharmacovigilance
2. Definitions - Hepatic ADRs | Pharmacovigilance
3. Epidemiology - Hepatic ADRs | Pharmacovigilance
4. Mechanisms of Drug-Induced Liver Injury - Hepatic ADRs | Pharmacovigilance
5. Management of Idiosyncratic Hepatotoxicity - Hepatic ADRs | Pharmacovigilance
Chapter 36: Ocular Side Effects of Prescription Medications
1. Ocular Side Effects of Prescription Medications - Pharmacovigilance
2. Hydroxychloroquine (Plaquenil) - Ocular Side Effects of Prescription Medications | Pharmacovigilance
3. Isotretinoin (Accutane) - Ocular Side Effects of Prescription Medications | Pharmacovigilance
4. Sildenafil (Viagra) - Ocular Side Effects of Prescription Medications | Pharmacovigilance
5. Corticosteroids – Inhaled - Ocular Side Effects of Prescription Medications | Pharmacovigilance
6. Tamoxifen (Nolvadex) - Ocular Side Effects of Prescription Medications | Pharmacovigilance
7. Amiodarone (Cordarone) - Ocular Side Effects of Prescription Medications | Pharmacovigilance
8. Topiramate (Topamax) - Ocular Side Effects of Prescription Medications | Pharmacovigilance
9. Bisphoshonates: Pamidronate Disodium, Alendronic Acid, Risedronate Sodium Etidronate Disodium and Olpadronate - Ocular Side Effects of Prescription Medications | Pharmacovigilance
Chapter 37: Drug Safety in Pregnancy
1. Drug Safety in Pregnancy - Pharmacovigilance
2. Frequency and Variety of Medication Use Among Pregnant Women - Drug Safety in Pregnancy | Pharmacovigilance
3. Pre-Marketing Sources of Data Regarding Reproductive and Developmental Safety of Prenatal Drug Exposures - Drug Safety in Pregnancy | Pharmacovigilance
4. Post-Marketing Sources of Data Regarding Reproductive and Developmental Safety of Prenatal Drug Exposures - Drug Safety in Pregnancy | Pharmacovigilance
5. Monitoring for Pregnancy Exposures and Pregnancy Prevention for Known Human Teratogens - Drug Safety in Pregnancy | Pharmacovigilance
6. Challenges for the Future - Drug Safety in Pregnancy | Pharmacovigilance
Chapter 38: Renal Adverse Drug Reactions
1. Renal Adverse Drug Reactions - Pharmacovigilance
2. Definitions and Diagnosis - Renal Adverse Drug Reactions | Pharmacovigilance
3. Epidemiology - Renal Adverse Drug Reactions | Pharmacovigilance
4. Mechanisms of Renal Adverse Drug Reactions - Renal Adverse Drug Reactions | Pharmacovigilance
5. Diagnosis of Renal Adverse Drug Reactions - Renal Adverse Drug Reactions | Pharmacovigilance
6. Prevention of Renal Adverse Drug Reactions - Renal Adverse Drug Reactions | Pharmacovigilance
7. Conclusion - Renal Adverse Drug Reactions | Pharmacovigilance
Chapter 39: Anaesthetic Adverse Drug Reactions
1. Anaesthetic Adverse Drug Reactions - Pharmacovigilance
2. Historical Perspectives - Anaesthetic Adverse Drug Reactions | Pharmacovigilance
3. Anaphylactic Reactions - Anaesthetic Adverse Drug Reactions | Pharmacovigilance
4. Individual Agents - Anaesthetic Adverse Drug Reactions | Pharmacovigilance
5. Specific Problems - Anaesthetic Adverse Drug Reactions | Pharmacovigilance
Chapter 40: Pharmacovigilance in Pediatrics
1. Background and Introduction to Pediatric Issues - Pharmacovigilance in Pediatrics
2. Why Pediatric Studies and a Special Focus on Safety Reporting are Necessary? - Pharmacovigilance in Pediatrics
3. Experiences From Specific Focused Pediatric Postmarketing Review - Pharmacovigilance in Pediatrics
4. Why the Pediatric Population May Be More Vulnerable - Pharmacovigilance in Pediatrics
5. Data Sources for Postmarketing Pediatric Adverse Drug Events - Pharmacovigilance in Pediatrics
6. Safety Signal Detection and Evaluation in the Pediatric Population - Pharmacovigilance in Pediatrics
7. Challenges for Surveillance of Drug Adverse Events - Pharmacovigilance in Pediatrics
Chapter 41: The Cardiovascular Spectrum of Adverse Drug Reactions
1. The Cardiovascular Spectrum of Adverse Drug Reactions - Pharmacovigilance
2. Dofetilide - The Cardiovascular Spectrum of Adverse Drug Reactions | Pharmacovigilance
3. Appetite Suppressants - The Cardiovascular Spectrum of Adverse Drug Reactions | Pharmacovigilance
4. Oestrogen and Venous Thromboembolism - The Cardiovascular Spectrum of Adverse Drug Reactions | Pharmacovigilance
Chapter 42: Drugs and the Elderly
1. The Ageing Population and Changing Demography - Drugs and the Elderly | Pharmacovigilance
2. Disease Prevalence and Drug Use in the Elderly - Drugs and the Elderly | Pharmacovigilance
3. Interactions in Relation to Multiple Drug Prescribing - Drugs and the Elderly | Pharmacovigilance
4. Altered Pharmacokinetics in the Elderly - Drugs and the Elderly | Pharmacovigilance
5. Altered Pharmacodynamics in the Elderly - Drugs and the Elderly | Pharmacovigilance
6. ADRS in the Elderly and Definition of an ADR - Drugs and the Elderly | Pharmacovigilance
7. Incidence of ADRS in the Elderly - Drugs and the Elderly | Pharmacovigilance
8. Implications for Drug Development and Use - Drugs and the Elderly | Pharmacovigilance
PART IV: KEY CURRENT TOPICS
Chapter 43: US Activities in Risk Management of Pharmaceutical Products
1. US Activities in Risk Management of Pharmaceutical Products - Pharmacovigilance
2. Risk Management Guidances - US Activities in Risk Management of Pharmaceutical Products | Pharmacovigilance
3. Appendix: Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment - US Activities in Risk Management of Pharmaceutical Products | Pharmacovigilance
Chapter 44: Risk Management - a European Regulatory View
1. Risk Management - a European Regulatory View - Pharmacovigilance
2. Background - Risk Management - a European Regulatory View | Pharmacovigilance
3. European Focus on ADRS - Risk Management - a European Regulatory View | Pharmacovigilance
4. Excellence in Pharmacovigilance Model - Risk Management - a European Regulatory View | Pharmacovigilance
5. European Pharmaceutical Legislation - Risk Management - a European Regulatory View | Pharmacovigilance
6. European Risk Management Plans - Risk Management - a European Regulatory View | Pharmacovigilance
7. Safety Specification - Risk Management - a European Regulatory View | Pharmacovigilance
8. Future Development of European Risk Management Strategies - Risk Management - a European Regulatory View | Pharmacovigilance
9. Conclusion - Risk Management - a European Regulatory View | Pharmacovigilance
Chapter 45: The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
1. Abstract - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
2. Introduction - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
3. Efficacy From Published Trials - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
4. Meta-Analysis of Published and Unpublished Studies - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
5. Safety From Clinical Trial Data - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
6. Safety From Observational Studies - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
7. New Studies to Address the Research Question - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
8. Improving the Safety Infrastructure - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
9. Recent FDA Actions and Consequences - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
10. Conclusions - The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents | Pharmacovigilance
Chapter 46: Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
1. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture - Pharmacovigilance
2. Controversy Over WHI Results - Pharmacoepidemiology of Hormone Therapy: An Evolving Picture | Pharmacovigilance
3. Discussion - Pharmacoepidemiology of Hormone Therapy: An Evolving Picture | Pharmacovigilance
4. The Future - Pharmacoepidemiology of Hormone Therapy: An Evolving Picture | Pharmacovigilance
Chapter 47: NSAIDs - COX-2 Inhibitors � Risks and Benefits
1. NSAIDs - COX-2 Inhibitors - Risks and Benefits - Pharmacovigilance
2. Post-Marketing Cardiovascular Safety Signal - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
3. Spontaneous Reports - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
4. Cardiovascular Safety Signal Evaluation - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
5. Large Trials of Cox-2 Inhibitors in Disease Prevention - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
6. Meta-Analysis of Cox-2 Inhibitors and Cardiovascular Outcomes - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
7. Observational Studies Published after the Withdrawal of Rofecoxib - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
8. Cardiovascular Safety of Other Cox-2 Inhibitors - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
9. Comments - NSAIDs - COX-2 Inhibitors – Risks and Benefits | Pharmacovigilance
Chapter 48: Introduction to Pharmionics
1. Introduction and Background of Pharmionics - Pharmacovigilance
2. Pharmionics in Overview - Pharmacovigilance
3. Methodological Issues in Compiling Drug Dosing Histories of Ambulatory Patients - Introduction to Pharmionics | Pharmacovigilance
4. Electronic Medication Event Monitoring - Introduction to Pharmionics | Pharmacovigilance
5. Case Studies - Introduction to Pharmionics | Pharmacovigilance
6. Lessons Learned - Introduction to Pharmionics | Pharmacovigilance
PART V: LESSONS AND DIRECTIONS
Chapter 49: Teaching and Learning Pharmacovigilance
1. Teaching and Learning Pharmacovigilance - Pharmacovigilance
2. Current Influences on Pharmacovigilance Education - Pharmacovigilance
3. The ‘Mistakes and Mishaps in Healthcare’ Movement - Pharmacovigilance
4. ‘Safety’ as a Construct in Healthcare - Pharmacovigilance
5. Public Aspirations for ‘Drug Safety’ - Pharmacovigilance
6. Learning Pharmacovigilance
7. Interactive Techniques for Learning Pharmacovigilance
8. Teaching Pharmacovigilance
9. Conclusions - Teaching and Learning Pharmacovigilance
Chapter 49B: Practical Experience in Teaching Pharmacovigilance
1. Practical Experience in Teaching Pharmacovigilance
Chapter 50: Fatal Medication Errors and Adverse Drug Reactions - Coroners� Inquests and Other Sources
1. Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources - Pharmacovigilance
2. The Consequences of Adverse Drug Events - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
3. The Literature Relating to Fatal Adverse Drug Events - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
4. Information From Coroners’ Inquests - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
5. Search Strategies - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
6. Results - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
7. Overall Summary of the Three Series - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
8. The Genesis of Medication Errors - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
9. The Lessons From Deaths Related to Medication - Fatal Medication Errors and Adverse Drug Reactions - Coroners’ Inquests and Other Sources | Pharmacovigilance
Chapter 51: Pharmacogenetics and the Genetic Basis of ADRs
1. Pharmacogenetics and the Genetic Basis of ADRs - Pharmacovigilance
2. Pharmacogenetics
3. The Genetic Basis of ADRS - Pharmacovigilance
4. The Changing Paradigm of Drug Development and Delivery - Genetic Basis of ADRs
5. The Impact of Pharmacogenetics on Clinical Drug Development - Genetic Basis of ADRs
6. Conclusion - Pharmacogenetics and the Genetic Basis of ADRs | Pharmacovigilance
Chapter 52: Keynote Clinical Lessons from Pharmacovigilance
1. Keynote Clinical Lessons from Pharmacovigilance
2. Pharmacovigilance - Keynote Clinical Lessons from Pharmacovigilance
3. Spontaneous Reporting Schemes - Keynote Clinical Lessons from Pharmacovigilance
4. Disease Registries - Keynote Clinical Lessons from Pharmacovigilance
5. Follow-Up Studies - Keynote Clinical Lessons from Pharmacovigilance
6. Multipurpose Databases - Keynote Clinical Lessons from Pharmacovigilance
7. Evidence-Based Medicine - Keynote Clinical Lessons from Pharmacovigilance
8. Hospital Drug Monitoring - Keynote Clinical Lessons from Pharmacovigilance
9. Genome Research and Pharmacovigilance - Keynote Clinical Lessons from Pharmacovigilance
10. Responses to Risks - Keynote Clinical Lessons from Pharmacovigilance
11. Conclusions - Keynote Clinical Lessons from Pharmacovigilance
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