Pharmacovigilance program of India
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Pharmacovigilance is the science of monitoring the effects of medicines after they have been licensed for use, in order to identify new risks or risks that were previously unknown. The World Health Organization established an international drug monitoring program in 1961 after the thalidomide tragedy. The Uppsala Monitoring Centre was established as the WHO collaborating center for pharmacovigilance in 1978. The Pharmacovigilance Programme of India was started in 2010 to monitor adverse drug reactions in the Indian population and ensure the benefits of medicines outweigh the risks.
Pharmacovigilance program of India
- 2. INTRODUCTION The world health organization (WHO) initiated a program for reporting all adverse reactions possessed by drugs. pharmacovigilance is derived from the Greek word pharmacon meaning ‘drug’ and the Latin word vigilare meaning ‘to keep awake or alert, to keep watch.’
- 3. DEFINITION Pharmacovigilance is defined as “the pharmacological science relating to the recognition, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines.”
- 4. HISTORY The history of Pharmacovigilance started 169 years ago, on Jan 29, 1848, when a young girl (Hannah Greener) from the north of England died after receiving chloroform anesthetic 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. The causes of Hannah’s death was investigated to understand what happened to Hannah, but it was impossible to identify what killed her. Probably she died of a lethal arrhythmia or pulmonary aspiration
- 5. CONT.. In 1961, a big change of European Pharmacovigilance happened following the tragedy of Thalidomide. Dr. McBride, an Australian doctor, wrote a letter to the editor of the Lancet Journal, in which he suggested a connection between congenital malformation of babies and thalidomide. In fact, he observed that the incidence of congenital malformations of babies (1.5%) had increased up to 20% in women who had taken thalidomide during pregnancy
- 7. UMC The Uppsala Monitoring Centre (UMC) was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO Programme for International Drug Monitoring was transferred to Sweden Start with 3 pharmacist The Centre is an independent, self-funded, non-profit organisation. The UMC holds and maintains the largest global database of Individual Case Safety Reports (ICSRs), known as Vigi BaseTM, on behalf of WHO and its Member States.
- 8. UMC The UMC provides technical support and guidance to national centres in pharmacovigilance practice. The UMC develops and supports countries with reporting and data management tools such as VigiFlow, a web-based system that integrates international standards to record and manage ICSRs at many national centres. The UMC conducts training sessions and publishes scientific articles, books, newsletters and periodicals in pharmacovigilance and risk communication.
- 10. NEED After discovery and pre-clinical phases, a drug typically undergoes trials in human volunteers. Clinical trials are highly regulated and closely monitored by the investigators and the manufacturing company. It is a mandatory regulatory requirement to report all the adverse events in a clinical trial setting in a given time frame
- 11. CONT… In the clinical trial setting, “good clinical practice” has moved Pharmacovigilance from a reactive to a proactive approach. A robust, well-defined system for monitoring adverse events is in a place for evaluating the safety of the drugs.
- 12. PHARMACOVIGILANCE SERVES VARIOUS ROLES such as identification, quantification and documentation of drug related problems which are responsible for drug-related injuries
- 13. An adverse event is any untoward medical occurrence in a patient who is administered a medicinal product and which doesn’t necessarily have a causal relationship with this treatment. Adverse drug reactions are noxious and unintended responses to a medicinal product. A reaction, in contrast to an event, is characterized by the fact that a causal relationship between the drug and the occurrence are supposed.
- 14. A serious adverse event (SAE) is any untoward medical manifestation, that at any dose: Results in death Is life-threatening (well-defined as an event in which the subject was at risk of death at the time of the event) Requires in-patient hospitalization or causes prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon suitable medical & scientific judgment, may require intervention to prevent one of the serious outcomes as listed above)
- 15. (PVPI) The Pharmacovigilance Programme of India (PvPI) was started by the Government of India on 14th July 2010 with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordination Centre for m Reactions (ADRs) in the country for safe- guarding Public onitoring Adverse Drug
- 16. PVPI The Pharmacovigilance exertion in India is organized by The Indian Pharmacopoeia Commission and conducted by the Central Drugs Standard Control Organization (CDSCO) The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in association with Indian Pharmacopeia commission, Ghaziabad is initiating a nation-wide Pharmacovigilance Programme for protecting the health of the patients by promising drug safety The main responsibility of the IPC is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed Indian Pharmacopoeia Commission (IPC) is functioning as a National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).
- 17. NCC National Coordination Centre is operating under the observation of steering committee which recommends procedures and guidelines for regulatory interventions. The main duty of National Coordination Centre is to monitor all the adverse reactions of medicines being observed in the Indian population and to develop and maintain its own pharmacovigilance database
- 20. MISSION: Safeguard the health of the Indian population by ensuring that the benefits of use of medicine outweigh the risks associated with its use.
- 21. VISION: To improve patient safety and welfare in Indian population by monitoring the drug safety and thereby reducing the risk associated with use of medicines.
- 22. OBJECTIVES To create a nation-wide system for patient safety reporting To identify and analyze the new signal (ADR) from the reported cases To analyses the benefit - risk ratio of marketed medications To generate the evidence based information on safety of medicines To support regulatory agencies in the decision making process on use of medications To communicate the safety information on use of medicines to various stakeholders to minimize the risk
- 23. CONT.. To emerge as a national center of excellence for pharmacovigilance activities To collaborate with other national centers for the exchange of information and data management To provide training and consultancy support to other national pharmacovigilance centers located across globe