Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. 

1. Quality Control & Standardization Of Herbals
Pharmacovigilance & The WHO International Drug
Monitoring Programme
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Objective Problem Function

3. Introduction
Pharmacovigilance is the science and activities relating to the
detection, assessment, understanding and prevention of adverse
effects or any other medicine/vaccine related problem.
 Recently, its concerns have been widened to include:
♦ Herbals
♦ Traditional & Complementary Medicines
♦ Blood Products
♦ Biologicals
♦ Medical Devices
♦ Vaccines
All medicines and vaccines undergo rigorous testing for
safety and efficacy through clinical trials before they are
authorized for use.

4.  Improve patient care and safety in relation to the use of medicines
 Improve public health and safety in relation to the use of medicines
 Contribute to the assessment of benefit, harm
 Effectiveness and risk of medicines
 Encouraging their safe, rational and more effective (including cost-effective) use
 Promote understanding, education and clinical training in pharmacovigilance
 Effective communication to the public
Objective

5. ■ Substandard medicines
■ Medication errors
■ Lack of efficacy reports
■ Use of medicines for indications that are not approved
■ Case reports of acute and chronic poisoning
■ Assessment of drug-related mortality
■ Abuse and misuse of medicines
■ Adverse interactions of medicines with chemicals, other medicines and food.
Many other issues

6. WHO International Drug Monitoring Programme, National pharmacovigilance centres
designated by the competent health authorities are responsible for the collection,
processing and evaluation of case reports of suspected adverse reactions supplied
by health-care professionals –
 Mainly spontaneous reporting by physicians of reactions associated with the use
of prescribed medicines.
The Programme currently comprises a network of more than 70 national
pharmacovigilance centres that operate independently, but whose functions are
coordinated and facilitated by WHO and UMC. UMC manages the global WHO
database to which all case reports received by the national pharmacovigilance
centres are sent.
WHO International Drug Monitoring Programme

7.  Clinical relevance, Generation of hypotheses or the identification of signals
 Quality control, in particular identification of duplicate reports
 Continuous collection of reports of suspected adverse reactions for medicines on
the market
 Communication of relevant safety information to the national and regional
regulatory authorities
 Provision of feedback to reporters
 Education and training
 Information sharing at regional and global levels
 Investigation of signals, risk factors or pharmacological mechanisms
 Assessment of case reports in respect of -
 Quality of documentation
 Causality assessment
Functions of national pharmacovigilance centres

8. THANKS!
Do you have any questions?
easyconceptkaushal@gmail.com
+91 9546688666