Risk management in pharmacovigilance

2. PRACTICE SCHOOL (BP706PS)
Course structure and content for
B pharm final year ( Sem 7 )
Domain – 18
Risk management in pharmacovigilance

3. A Review Article By
Diksha Jitendra Medhane
Final Year B Pharmacy
Prn - 1952811823001
Guide By – Dr Sushil Patil

4. RISK MANAGEMENT IN
PHARMACOVIGILANCE

5. INDEX
1. Introduction
2. Objective
3. Risk management
4. Important steps in risk management
5. Banned drugs
6. Steps involved in risk management
7. Conclusion

6. INTRODUCTION
1. What is pharmacovigilance
2. Pharmacovigilance has been described as “the
science and activities relating to the
detection, assessment, understanding and
prevention of the adverse effects of drugs or
any other possible drug-related problems.

7. • Pharmacovigilance supports safe and
appropriate use of drugs. Spontaneous
reporting of adverse drug reactions (ADRs) is
an essential component of pharmacovigilance.

8. OBJECTIVE
1. Safe use of drugs .
2. To identify risk at early stage .
3. To take necessary steps to minimize the harmful effect of drugs.
4. Reduce the duplication of drugs.

9. RISK MANAGEMENT
• Risk management in pharmacovigilance is vital for
the safe use of medicines and safeguarding the
health of patients.

10. Drugs have changed the way in which diseases
are treated. Adverse reactions are recognized
hazard of drug therapy. Adverse drug reactions
(ADRs) are a common, frequently preventable
cause of illness, disability and death.

11. • ICH guideline structured, Some process for
identifying and assessing risks by introducing
two foundational concepts: the Safety
Specification that describes the product’s risk
profile, and the Pharmacovigilance Plan that
describes how these risks are monitored and
characterised.

12. WHAT IS IMPORTANT IN RISK MANAGEMENT
1. Risk Detection
2. Risk Assesment
3. Risk Minimisation
4. Risk Communication

13. Some drugs are banned in India because of the benefit-risk ratio.
That are metamizole. It is nonsteroidal antinflammatory agent .
Metamizole is banned in India in 2013
Side effect – Bone marrow depression.
Which reduce production of blood cells.

14. STEPS INVOLVED IN RISK MANAGEMENT
• Safety specification
• Pharmacovigilance plan
• Evaluation of the need for risk minimization
activities
• Risk minimisation plan

15. 1. SAFETY SPECIFICATION
• Summarizes important identified risk ,and important
missing information and addresses populations
potentially at risk and outstanding safety question
• Hepls identify needs for specification data collection
and facilitates construction of a pharmacovigilance
plan .

16. 2. PHARMACOVIGILANCE PLAN
• Describes pharmacovigilance activities (routine
and additional) and action plan for each safety
concern
• Process actions to address identified safety
concerns Complementing the procedures in
place to detect safety signals .

17. 3. EVALUATION OF THE NEED FOR RISK
MINIMIZATION ACTIVITIES
• Discuss safety concerns including potential for
medication errors and the need for routine or
additional risk minimization strategies.
• Assesses for each safety concern whether risk
minimization strategies are needed beyond the
pharmacovigilance action plans.

18. 4. RISK MINIMIZATION PLAN
• List safety concern for which risk minimization activities
are proposed.
• Discuss associated routine and additional risk
minimization activities and the assessment of their
effectiveness.

19. • Educating to health care professionals.
• Restricted use of medicine.
• Take training programs associated with the
proper use of medicine.

20. CONCLUSION
• Improve patient safety.
• Increase focus on security.
• Optimised benifit-risk profile of drugs.

21. REFERENCE
Risk Management Plan and Pharmacovigilance System. Biopharmaceuticals:
Biosimilars
Begoña Calvo and Leyre Zuñiga
Submitted: October 6th, 2010 Published: July 28th, 2011
• Risk Management for the 21st Century: Current Status and Future Needs
• Rania Mouchantaf, Doris Auth, [...], and Meredith Y. Smith

22. Thank you