Evidence-Based Pharmacovigilance

1. Front Matter

   Pages i-xv

   PDF

2. Congenital Malformations

   • Eugène van Puijenbroek

   Pages 1-16

3. Pharmacovigilance and the Eye

   • Anthony P. Grillo, Frederick W. Fraunfelder

   Pages 17-35

4. Pharmacovigilance of Herbal and Traditional Medicines

   • Li Zhang

   Pages 37-65

5. Pediatric Pharmacovigilance: Current Practice and Future Perspectives

   • Lise Aagaard

   Pages 67-85

6. Detecting Safety Issues in Clinical Trials

   • Emma Heeley

   Pages 87-103

7. Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance

   • Deborah Layton

   Pages 105-134

8. Electronic Health Record, Transactional Insurance Claims, and Distributed Databases in Pharmacovigilance

   • Kevin Haynes

   Pages 135-148

9. Patient Registries for Safetyness

   • Marcus Schmitt-Egenolf

   Pages 149-164

10. Patient Reported Outcomes in Pharmacovigilance

    • Linda Härmark

    Pages 165-183

11. Evidence-Based Pharmacovigilance for Medicines Used in Public Health Programs in Africa

    • Haggar Hilda Ampadu, Yvonne Esseku, Alexander N. O. Dodoo

    Pages 185-199

12. Pharmacoepidemiological Approaches for Population-Based Hypothesis Testing

    • Olaf H. Klungel

    Pages 201-216

13. Risk Management and Minimization

    • Yola Moride

    Pages 217-232

14. Benefit-Risk Assessment in Pharmacovigilance

    • Ola Caster

    Pages 233-257

15. Back Matter

    Pages 259-275

    PDF

This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment.

Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.

• Medicinal products
• Risk assessment
• PV research
• Safety in medication
• Pharmaceutical sciences

• Epidemiology Group Lead, Analytics, Worldwide Safety and Regulatory, Tadworth, UK

  Andrew Bate

Policies and ethics