Pharmacovigilance & WHO Drug Monitoring Program.pptx

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

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