Pharmacovigilance / edited by Ronald D. Mann, Elizabeth B. Andrews.

Format:

Book

Contributor:

Mann, Ronald D. (Ronald David), 1928-

Andrews, Elizabeth B.

Language:

English

Subjects (All):

Drugs--Side effects--Reporting.

Drugs.

Drugs--Testing.

Epidemiology.

Drug-Related Side Effects and Adverse Reactions.

Drug-Related Side Effects and Adverse Reactions--classification.

Pharmacoepidemiology--methods.

Product Surveillance, Postmarketing.

Medical Subjects:

Drug-Related Side Effects and Adverse Reactions.

Drug-Related Side Effects and Adverse Reactions--classification.

Pharmacoepidemiology--methods.

Product Surveillance, Postmarketing.

Physical Description:

xxi, 560 pages : illustrations ; 26 cm

Place of Publication:

Chichester, West Sussex, England ; Hoboken, NJ, USA : John Wiley & Sons, [2002]

Contents:

Part I. Basis of pharmacovigilance 1

2. Legal Basis

EU / Nicholas Macfarlane, Gabrielle Turner, Caroline Moore, Christoph Hiltl, Paule Drouault-Gardrat, Paolo Ricci 11

3. Legal Basis

US / Robert P. Brady, Mark D. Learn 27

4. Ethical Oversight, Consent, and Confidentiality / Donna A. Boswell, Elizabeth B. Andrews 37

5. Pre-clinical Safety Evaluation / Norma Kellett, Stuart J. Mair, Walter S. Nimmo 51

6. Metabolic Mechanisms / Munir Pirmohamed, B. Kevin Park 57

7. Drugs and the Elderly / Una Martin, Charles George 77

8. Natural History / Paul E. Stang 97

9. Responding to Signals / Patrick C. Waller, Peter Arlett 105

10. Micturin and Torsades de Pointes / Richard N. Wild 129

11. Withdrawal of Terodiline: A Tale of Two Toxicities / Rashmi R. Shah 135

12. Nomifensine and Haemolytic Anaemia / Peter D. Stonier, J. Guy Edwards 155

Part II. Signal Generation 167

13. WHO Programme

Global Monitoring / I. Ralph Edwards, Sten Olsson 169

14. Regulatory Pharmacovigilance in the EU / Patrick C. Waller, Priya Bahri 183

15. Spontaneous Reporting

UK / Sarah Davis, June M. Raine 195

16. Spontaneous Reporting

France / Nicholas Moore, Carmen Kreft-Jais, Alban Dahnani 209

17. Spontaneous Reporting

USA / David J. Graham, Syed R. Ahmad, Toni Piazza-Hepp 219

18. Algorithms / John A. Clark 229

19. Overview

Spontaneous Signalling / John A. Clark, Stephen L. Klincewicz, Paul E. Stang 247

20. Statistical Methods of Signal Detection / Stephen Evans 273

21. Statistical Methods of Evaluating Pharmacovigilance Data / Bernard Begaud 281

22. Data Mining / I. Ralph Edwards, Marie Lindquist, Andrew Bate, Roland Orre 291

23. Epidemiology of Adverse Events Associated with Epilepsy and Use of Lamotrigine / Patricia Tennis 301

24. Pharmacovigilance in the Netherlands / A.C. van Grootheest, E.P. van Puijenbroek 309

25. CIOMS Working Groups and their Contribution to Pharmacovigilance / Sue Roden 317

26. PEM in the UK / Saad A.W. Shakir 333

27. PEM in New Zealand / David M. Coulter 345

28. MEMO in the UK / Douglas Steinke, Josie M.M. Evans, Thomas M. Macdonald 363

29. GPRD in the UK / Louise Wood 373

30. Overview of North American Databases / Brian L. Strom, Judith L. Kinman 379

31. Pharmacovigilance in the HMO Research Network / Richard Platt et al. 391

32. Other databases in Europe / Miriam C.J.M. Sturkenboom 399

33. Surveillance for Medical Devices

USA / Thomas P. Gross, Larry G. Kessler 411

Part III. Pharmacovigilance and Selected System Organ Classes 423

34. Dermatological ADRs / Laurence Valeyrie, Jean-Claude Roujeau 425

35. Gastrointestinal ADRs / John R. Wood, Graham A. Pipkin 435

36. Haematological ADRs / Sarah Davis, Ronald D. Mann 449

37. Hepatic Adverse Drug Reactions / Guruprasad P. Aithal, Christopher P. Day 459

38. Ocular ADRs / F.W. Fraunfelder, F.T. Fraunfelder 475

39. Drug Safety in Pregnancy / Christina D. Chambers, Elizabeth B. Andrews 483

40. ADRs and Drug Safety 1999-2000 / Pauline Curel, Rosie Stather 491

Part IV. Lessons and Directions 503

41. Teaching Pharmacovigilance / Ronald Meyboom, Sten Olsson, Margaret Thorogood 505

42. Medical Errors and Lessons from Drug-Related Deaths / Richard E. Ferner, R.M. Whittington 509

43. Pharmacogenetics and the Genetic Basis of ADRs / Penelope K. Manasco, Patricia Rieser, Gaile Renegar, Michael Mosteller 515

44. Keynote Clinical Lessons from Pharmacovigilance / David H. Lawson 535.

Notes:

Includes bibliographical references and index.

ISBN:

0471494410

OCLC:

47983960