History and Progress of Pharmacovigilance.pptx

This topic will take you deep into the history of Pharmacovigilance.

1. Dr. Rajendra Gode Institute of Pharmacy, University - Mardi Road, Amravati - 444602 Guided by  Prof. Pranali Chandurkar Assistant Professor M. Pharm (Pharmacology) Clinical Research and Pharmacovigilance (MPL 204T) “ History and Progress of Pharmacovigilance ” 1 Presented by Miss. Shraddha Raut M. Pharm (I st year)

2. Contents : 2 12/04/24 History and Progress in Pharmacovigilance

3. 3 Pharmacovigilance   According to WHO pharmacovigilance is defined as “ the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem .” It is derived from two words pharmacon – “drug” vigilare – “to keep watch” 12/04/24 History and Progress in Pharmacovigilance

4. 4 I mprove patient care and safety in relation to the use of medicines and all medical and paramedical interventions. I mprove public health and safety in relation to the use of medicines. C ontribute to the assessment of benefit, harm, effectiveness and risk of medicines , encouraging their safe, rational and more effective (including cost-effective) use. P romote understanding, education and clinical training in pharmacovigilance and its effective communication to the public. To identify complications associated with the use of medicines and conveying it in an appropriate manner. Aim of Pharmacovigilance 12/04/24 History and Progress in Pharmacovigilance

5. 5 History and Progress of Pharmacovigilance During the 20th century there were some serious adverse events associated with medical products and drugs that resulted in development of Pharmacovigilance system. The history of Pharmacovigilance marked its first milestone 169 years ago, when a young girl Hannah Greener of North England died after receiving chloroform anesthesia before removal of an infected toenail . Sir James Simpson had discovered that chloroform was a safer and powerful anesthetic, and he had introduced it in clinical practice. 1848 - 1901 - In USA, 13 children died from contaminated Diphtheria Vaccine . 12/04/24 History and Progress in Pharmacovigilance

6. 6 Conti…. T here were 107 deaths in the USA, because of the use of S ulfanilamide elixir (Raspberry flavored elixir), containing D iethyl G lycol as solvent. Due to elixir tragedy, the Federal F ood, Drug and Cosmetics A ct (FDCA) was enacted which began to examine the risk-benefit profile of medicinal products. Douthwaite suggested that Acetylsalicylic Acid (ASA) is responsible for causing Melena . In 1955, its toxicity was proved. 1937 - 1938 - 1938 - 12/04/24 History and Progress in Pharmacovigilance

7. 7 Conti…. 1950 - 1961 - Aplastic anemia reported due to chloramphenicol toxicity. Thalidomide Tragedy made milestone in origin and development of European Pharmacovigilance. The drug was tested in 300 patients without any prior toxicity studies. Dr. McBride , an Australian doctor suggested a connection between congenital malformation of babies and thalidomide. Hence, it was discontinued in 1962after it was reported under pharmacovigilance. 1964 - Yellow Card was structured in UK which is a specific form to compile a spontaneous report of drug toxicity. 12/04/24 History and Progress in Pharmacovigilance

8. 8 Conti…. T he disaster of thalidomide stimulated the development of a European legislation . A pilot study of Boston Collaborative Drug Surveillance Program started. T he WHO Programme for International Drug Monitoring was instituted and ten members participated in this program (Australia, UK, USA, Germany, Canada, Ireland, Sweden, Denmark, New Zealand, and Netherlands). European Medicine Agency ( EMA ) was set up. EudraVigilance was funded. Pharmacovigilance Programme of India was initiated. Amendments in the European Pharmacovigilance legislations was done. In November, the new Eudravigilance format was launched. 1965 - 1966 - 1968 - 1995 - 2001 - 2010 - 2012 - 2017 - 12/04/24 History and Progress in Pharmacovigilance

9. 9 Conti…. Pharmacovigilance in India Pharmacovigilance in India was introduced in 1986 with formal introduction of ADR M onitoring S ystem under the guidance of drug controller of India. Purpose - to generate data on adverse reactions through spontaneous reporting. In 1997 , a significant revision took place in program in which India became a part of WHO Program for International Drug Monitoring controlled by Uppsala Monitoring Centre. 1s t January, 2005 , WHO sponsored and World Bank Funded National Pv PI was started in India and enforced on 23 November, 2004. The National Pharmacovigilance Advisory Committee located at the office of CDSCO, the National Regulatory Authority in India helps in coordinating the reporting of adverse drug reaction. 12/04/24 History and Progress in Pharmacovigilance

10. 10 WHO International Drug Monitoring Programme The WHO Programme for International Drug Monitoring (PIDM) was established in 1968 to make sure that all the data on adverse reactions on patients was collected from maximum sources. T here are more than 150 countries included in this Programme . They operate their work as a team – a) For identification and monitoring the harm caused by medicines b) T o reduce patient’s risks c) T o establish the pharmacovigilance systems and standards globally S ince 1978, the Uppsala Monitoring Centre (UMC) controls and operates all the technical and operational aspects of the programme. 12/04/24 History and Progress in Pharmacovigilance

11. 11 Conti…. Functions of WHO Programme for International Drug Monitoring – Provides forum for Member States of WHO for working together in monitoring drug safety. Facilitates identifying and analyzing the adverse reaction signals from documented data handed over to the WHO global individual case safety report (ICSR) database (Vigibase) by the respective member countries. Provide information to National Centers through ‘ Vigimed ’ an email information exchange system. Publication of p eriodical newspaper, guidelines and books in pharmacovigilance and risk management area. 12/04/24 History and Progress in Pharmacovigilance

12. 12 Conti…. Diag. T hree-part network of WHO programme Uppsala Monitoring Centre - a) Collection, assessing and communicating information about drug b) Collaboration for practice and developing pharmacovigilance c) Warning National Regulatory Authorities about probable drug safety problems WHO Headquarter - manages all the issue related to any type of policy National Pharmacovigilance Centers - sent all case report to WHO ICSR database 12/04/24 History and Progress in Pharmacovigilance

13. 13 References A Book of Pharmacovigilance by Dr. Agnimitra Dinda and Monica Saxena, Thakur Publication, First edition, Pg no. 15-19 A Book of Pharmacovigilance by Pramod V. Burakale, Manish Bhise and Vishal Patond, Pee Vee Publication, Pg no. 1-11 12/04/24 History and Progress in Pharmacovigilance

14. THANK YOU 14 Any question