An Overview of Spontaneous Reporting, Targeted Spontaneous Reporting and Cohort Event Monitoring-Pharmacovigilance Methods: Myths and Facts

Journal of Pharmacy Practice and Community Medicine,2022,8,1,8-13.
Published:May 2022
Type:Review Article
Author(s) affiliations:

Prasad Thota1,*, Anusha Thota2, Phulen Sarma3, Bikash Medhi4

1Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, INDIA.

2Delhi Pharmaceutical Sciences and Research University, Saket, Delhi, INDIA.

3Department of Pharmacology, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh, INDIA.

4Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, INDIA.


Adverse drug reaction (ADR) reporting is an important safety concern to monitor safety among the patient. Pharmacovigilance (PV) is usually involves in detection of spontaneous adverse reaction, therefore these shall be submitted to the National Coordination Centre Pharmacovigilance programme of India (NCC-PVPI) which is located at Ghaziabad functioning under ministry of health and family welfare, Government of India. ADR is a global concern that causes serious impact on consumers both in terms of health and financial aspects. Hence monitoring of these adverse reactions is utmost important attribute to enhance patient safety. Perhaps, India is adopting spontaneous reporting (SR) system since 1998, henceforth targeted spontaneous reporting (TSR) system came into consideration in 2010, and that is a complimentary method to spontaneous reporting. This system is useful to establish evidence-based reports generation of specific drug and ADR combination, increase alertness and also helpful in recognizing harmful risks The main aim of this article is to encourage evidence-based decision making to enhance patient safety. In addition to this, establish a functional reporting system i.e. targeted spontaneous reporting system to monitor the safety of targeted medicines and to learn more about the safety profile of new medicines in the early post marketing phase in our population.