Pharmacovigilance

Includes summary of all things related to the Pharmacovigilance

1. Pharmacovigilance Submitted By- Anurag Chourasia M.Pharma 2 nd Year Pharmacology

2. CONTENTS Introduction Aims of Pharmacovigilance What’s the need ? A Lesson from history Facts about Safety of Medicines Improving AE reporting Pharmacovigilance Program of India ADRs monitoring center ADR reporting Status Action taken from the Pharmacovigilance

3. Pharmacovigilance - Study of Adverse Drug reaction PREVENTION REPORTING UNDERSTANDING ASSESMENT DETECTION

4. ( Pharmacon ) is a Greek word meaning Drug ( Vigilare ) in French means to keep watch Emergence of newer discipline that widens the area of drug safety known as Pharmacovigilance Adverse Drug Reaction- A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or the therapy of a disease. May also include drug overdoses, medication errors, and substance abuse

5. Aims of pharmacovigilance Identify previously unrecognized adverse effects or changes in the patterns of adverse effects Assess the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use Provide information to healthcare professionals and patients to optimize safe and effective use of medicines - Thus, the ultimate purpose of ADR reporting and monitoring is to reduce risks associated with drug prescribing and administration - Improve patient care and patient safety - Communication with international institutions working in pharmacovigilance

6. What’s the need? Reason 1 : Insufficient evidence of safety Animal experiments Clinical trials prior to marketing Reason 2 : Dying from a disease may be inevitable, dying from a medicine is unacceptable (WHO,2005) Reason 3 : ADR are expensive

7. Before drugs become available to the patients, they are subjected to rigorous clinical studies. However, some adverse drug reactions (ADRs) are often detected ONLY after marketing.

8. A lesson from history 1959 – 1961 thalidomide 4,000 - 10, 000 cases of phocomelia (congenital limb defects) This lead to withdrawal of the drug from the market

9. Facts about safety of Medicines Approximately 5.3% of hospital admissions associated with ADRs Higher rates found in elderly patients who are likely to be receiving multiple medications for long-term illnesses Nearly 10–20% of acute geriatric hospital admissions are related to ADRs Nearly 7% of medication errors potentially harmful but preventable ADRs

10. “ The c er t a i n ty of r eas onab l e un c er t a i n t y ”

11. “ The T i p o f t he i c ebe r g ” R e p o r t e d AE s Under reporting of AEs Illu s io n v er su s R e a lit y !

12. Predictable Unpredictable ADR AE

13. I m p r o v i ng A E R ep o r t i ng Good R ep o rt i n g P r a ct i c e

14. AMC’S Pharmaceutical Industries Safety Alerts Communication Mobile App Case Processing/ Quality Review ADR Monitoring Center (s) [ AMC’s ] Invalid/ Incomplete Report Valid/ Complete Report Causality assessment & data mining of reports Case Reverted Case Reverted ADVERSE DRUG REACTION (ADR) REPORTING IN INDIA HOW INDIAN POPULATION GETTING BENIFITED... Global safety data collection Regulatory action Reporting Tools NCC - PvPI

15. Module 1 Module 2 Module 3 Module 4 Module 5 Module 6 Pharmacovigilance System Master File & capacity building Processing of ICSRs Preparation & Submission of PSURs Site Performing Pharmacovigilance Quality Management System Audits And Inspections of Pharmacovigilance Sites Submission of Risk Management Plan Modules in the Guideline

16. Pharmacovigilance Program of India India joined WHO program of International Drug Monitoring in 1997. It started as the National Pharmacovigilance Program (NPP) officially in 2004. The Pharmacovigilance Program of India ( PvPI ) was initiated with AIIMS, New Delhi as National Coordination Centre (NCC) for monitoring ADR in the country in July 2010 by CDSCO (Central Drug Standard Control Organization) under the aegis of Ministry of Health & Family Welfare. The NCC shifted from AIIMS, New Delhi to Indian Pharmacopoeia Commission (IPC) Ghaziabad on 15th April 2011.

17. ADRs Monitoring Centers (AMCs): 250 86 102 17 20 11 1 8 5 Govt. Hospitals Non govt. hospitals TB treament centres ART centres Corporate hospitals Army hospitals District Hospitals Municipal Hospital 250 AMC ADR MONITORING CENTRES 17 RNTCP REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME 20 ART ANTIRETROVIRAL THERAPY

18. ADRs Reporting Status in India 14847 23138 28411 41926 50533 67115 71586 10000 20000 30000 40000 50000 60000 70000 80000 2011 2012 2013 2014 2015 2016 2017

19. ICSRs Completeness Score: India Vs Other Countries

20. Actions taken from the PV findings include Restriction in use Changes in the specified dose of the medicine Introduction of specific warnings in the product information Changing the legal status of a medicine, e.g., from over-the-counter to prescription only Product recall: In rare cases, removal of the medicine from the market , if the risks of a medicine are found to outweigh the benefits