Methods, ADR reporting and Tools used in Pharmacovigilance

Methods, ADR reporting and Tools used in Pharmacovigilance

1. A Seminar On Methods, ADR reporting and Tools used in Pharmacovigilance Goel Institute of Pharmacy and Sciences Dr. A.P.J. Abdul Kalam Technical University Presented By: Under Supervision: Sonam Yadav Mr Shiv Narayan M. Pharm Associate Professor (Pharmacology) (GIPS)

2. Contents Introduction Pharmacovigilance Methods ADR Reporting Tools used in Pharmacovigilance Conclusion References

3. Introduction

4. Aims of Pharmacovigilance

5. Pharmacovigilance Methods

6. Why ADR Reporting? ADRs are among the leading causes of death in many countries (WHO2008) Account for 5% of all hospital admission in India. Constitutes a significant economic burden on the patients and government. Adverse drug reactions? According to WHO adverse drug reactions defined as “any response to a drug which is noxious and unintended and which occurs at doses normally used in human for prophylaxis, diagnosis therapy of disease or for the modification of physiological function”

7. Benefits of ADR Reporting

8. Information required for ADR Reporting

9. ADR Reporting Procedure

10. Who can report? All healthcare professionals (Clinicians, Dentist, Pharmacist, Nurses, Physicians, Physiotherapist etc). All non- healthcare professionals including consumers/patients etc can report ADRs. What to report? All types of suspected adverse reactions known or unknown, serious or non-serious, frequent or rare. Reactions from all types of pharmaceutical products i.e. Allopathy, Ayurvedic, Vaccines, Medical devices etc.

11. How to report? Report should be on a standardized ADR reporting form. Dully filled the ADRs in the reporting from when an ADR is encountered. The completed ADR form is then returned to the nearest adverse drug reaction monitoring Centre(AMC) or to National Coordinating Centre. Any follow-up information for an ADR case that has already been reported can be sent on another ADR form, or communicated by telephone, fax or e- mail. Where to Report? Preferably directly to the pharmacovigilance center of a hospital. National Pharmacovigilance center. Zonal drug information centers.

12. ADR Reporting Form

13. ADR Reporting Process

14. Reasons for not reporting the ADRs (India) Not aware of correct reporting centers. Did not have ADR reporting form . Feeling that ADR was well known. Was not sure about the drug causing ADR. When do Practitioners Report? A positive relationship between the pharmacovigilance center and the reporter. Active personal and general feed back Encouragement from the centers. Simple and readily available reporting forms.

15. Remember! “ All healthcare professionals have a responsibility to inform colleagues about clinically important adverse drug reactions that they detect, even if a well-recognized or causal link is uncertain.” “Absence of evidence for ADR is not An evidence for absence of ADR.” If you suspect an ADR Do not assume someone else will report it!

16. Tools in Pharmacovigilance

17. Conclusion In India, Pharmacovigilance system has increased awareness in people regarding ADR reporting. Various multinational companies have started the outsourcing of Pharmacovigilance activity in India which is creating the good pharmacovigilance culture. Various universities have incorporated Pharmacovigilance courses in their curriculum as compulsory or elective subject. Still government needs to focus on the awareness and enhancement of pharmacists knowledge and providing them facilities and power to conduct Pharmacovigilance activity. Every hospitals should have special Pharmacovigilance cell for ADR monitoring.

18. References 1.Ghewari P, Salunke S, Bhatiya N, Killedar S (2014) Strategies and current scenario of pharmacovigilance in India. JADD 1:122-134. 2.Indian Pharmcopoeia Commision Pharmacovigilance Program of India. 3.World Health Organization (2002) World Health Organization Collaborating centre for International Drug Monitoring. The Importance of Pharmacovigilance Safety Monitoring of Medical Products, Geneva.

19. Thank you! Please report an ADR. “The person who takes medicine must recover twice , once from the disease and once from the Medicine.” William Osler, M.D.