Elements of Pharmacovigilance: Be Vigilant. Be Safe
Contents: 1. History and Introduction to Pharmacovigilance/Shobha Rani R. Hiremath, Ramjan Shaik and Raman Sehgal. 2. Spontaneous Reporting/Shobha Rani R. Hiremath and Ramjan Shaik. 3. Introductory Pharmacoepidemiology/Robert A Freeman and Rajat Sethi. 4. Pharmacoeconomics and Outcomes Research: An Overview/Robert A Freeman and Rajat Sethi. 5. Status of Adverse Drug Reaction Monitoring and Pharmacovigilance in Various Countries/Sachdev Yadav. 6. Pharmacovigilance and Postmarket Surveillance in the United States: The Role of the U.S. Food and Drug Administration/Laura M. Plunkett and Laura E. Timmerman. 7. Pharmacovigilance in Unani Medicine – A Challenge/Syed Zia-ur Rahman, Rahat Ali Khan and Abdul Latif. 8. Pharmacovigilance of Over the Counter (OTC) Drugs/Sandeep Kaushal, Kirandeep Kaur and S.C. Chopra. 9. The Current Scenario of Herbal Pharmacovigilance/Papiya Bigoniya. 10. Vaccine Pharmacovigilance/Mandeep Singh Dhingra. 11. Pharmacovigilance: A Dental Perspective/Sohil A Khan, Sunitha Carnelio and Gabriel Rodrigues. 12. Integrated Safety Platform – Role of Information Technology/Partha Chakraborthy. 13. Postmarketing Surveillance and Periodic Safety Updates and Reports/Rakesh Kumar Rishi. 14. Risk Assessment and Management Plan in Pharmacovigilance/Sazal Patyal and Bikash Medhi. 15. Medical Dictionary for Regulatory Activities/Raman Sehgal. 16. Biostatistical Aspects in Pharmacovigilance/Vrijesh Tripathi and Shanaz A Wahid. 17. Medication Errors and Safe Use of Drugs/H.P. Tipnis. 18. Role of Community Pharmacist in Pharmacovigilance/Shobha Rani R Hiremath and Ramjan Shaik. 19. Teaching Pharmacovigilance/P.R. Shankar. 20. Teaching Pharmacovigilance – Therapeutic Drug Monitoring in the Curriculum/Barry Bleidt and David Mathew. 21. Adverse Drug Reactions and Anti-Epileptic Drugs/Nidhi Agarwal, Nitin Agarwal and Raman Sehgal. 22. Pharmacovigilance – Obligations of Pharmaceutical Companies/Sreedhar, R. Thiyagu, M.D. Janodia, Virendra S Ligade and N. Udupa. 23. Hazards of Blood Transfusion/R.N. Makroo. Annexures.
The book is written by national and international team of outstanding contributors who have an excellent standing within the Pharmacovigilance community. It includes the latest theoretical and practical aspects of Pharmacovigilance and provides an exemplary coverage of all the relevant issues on drug safety. Some of the key topics discussed are:
Spontaneous Reporting Dr. Shobha Rani R Hiremath (Bangalore, India). Introductory Pharmacoepidemiology Dr. Robert A Freeman & Dr. Rajat Sethi (Texas, USA). Pharmacoeconomics and Outcomes Research An Overview Dr. Robert A Freeman & Dr. Rajat Sethi (Texas, USA). Pharmacovigilance and Postmarket Surveillance in the United States The Role of the USFDA Dr. Laura M. Plunkett (Houston, USA) Pharmacovigilance in Unani Medicine A Challenge Dr. Syed Zia Ur Rahman (Aligarh, India). Pharmacovigilance of Over the Counter Drugs Dr. Sandeep Kaushal (Ludhiana, India). The Current Scenario of Herbal Pharmacovigilance Dr. P. Bigoniya (Bhopal, India). Vaccine Pharmacovigilance Dr. Mandeep Singh Dhingra (Hyderabad, India). Pharmacovigilance A Dental Perspective Sohil A Khan (Sydney, Australia) Postmarketing Surveillance and PSURs R. K. Rishi (Kolkata, India). Medical Dictionary for Regulatory Activities Raman Sehgal (New Delhi, India). Biostatistical Aspects in Pharmacovigilance Dr. Vrijesh Tripathi (Trinidad & Tobago, West Indies). Medication Errors and Safe Use of Drugs Dr. H. P. Tipnis (Mumbai, India). Teaching in Pharmacovigilance Dr. P. R. Shankar (Lalitpur, Nepal). Teaching Pharmacovigilance Therapeutic Drug Monitoring in the Curriculum Dr. Barry Bleidt and Dr. C. David Matthew (Texas, USA). Hazards of Blood Transfusion Dr. R. N. Makroo (New Delhi, India). Risk Assessment & Management Dr. Bikas Medhi. (Chandigarh, India). ADRs and Anti Epileptic Drugs Dr. Nidhi Agarwal (New Delhi, India). Integrated Safety Platform Role of Information Technology Partha Chakraborty (Bangalore, India)
