Journal of Pharmacology and Pharmacotherapeutics

CORRESPONDENCE
Year
: 2019  |  Volume : 10  |  Issue : 1  |  Page : 33--34

Targeted spontaneous reporting on drug safety alerts issued by pharmacovigilance programme of India: A new origin of pharmacovigilance in India


Prasad Thota1, Shabir Sidhu2, Bikash Medhi3, Phulen Sarma3, Ajay Prakash3, Kalaiselvan Vivekanandan4, Anusha Thota4,  
1 Department of Life Sciences, IKG-Punjab Technical University, Jalandhar, Punjab; National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India
2 Department of Life Sciences, IKG-Punjab Technical University, Jalandhar, Punjab, India
3 Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
4 National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India

Correspondence Address:
Dr. Prasad Thota
Department of Life Sciences, IKG-Punjab Technical University, Kapurthala, Jalandhar - 144 603, Punjab; National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad - 201 002, Uttar Pradesh
India




How to cite this article:
Thota P, Sidhu S, Medhi B, Sarma P, Prakash A, Vivekanandan K, Thota A. Targeted spontaneous reporting on drug safety alerts issued by pharmacovigilance programme of India: A new origin of pharmacovigilance in India.J Pharmacol Pharmacother 2019;10:33-34


How to cite this URL:
Thota P, Sidhu S, Medhi B, Sarma P, Prakash A, Vivekanandan K, Thota A. Targeted spontaneous reporting on drug safety alerts issued by pharmacovigilance programme of India: A new origin of pharmacovigilance in India. J Pharmacol Pharmacother [serial online] 2019 [cited 2020 Aug 9 ];10:33-34
Available from: http://www.jpharmacol.com/text.asp?2019/10/1/33/258146


Full Text



Sir,

To find out the prevalence among safety alerts issued by National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI). The Department of Pharmacology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, took an opportunity to closely monitor PvPI alerts by implementing targeted spontaneous reporting system on already issued alerts, mentioned in [Table 1]. Although PGIMER is functioning as one of the Adverse Drug Reaction (ADR) Monitoring Centre (AMC) under NCC-PvPI, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, since 2010. Furthermore, it is also functioning as a regional training center for pharmacovigilance in the north zone to create awareness among the health-care professionals (HCPs) in reporting ADRs through continuous medical education programs.[1] However, our primary goal is to increase the safety alerts by utilizing already established AMC setup. There are some methods which are employed in the collection of ADRs, a few of which include enclosure of suspected ADR reporting form with inpatients case sheets, using social networking sites, websites, and handouts being placed. Apart from the active surveillance, passive surveillance also plays a pivotal role in present topic of interest. The objective of this study was to analyse the reporting rate of safety alerts by adopting targeted spontaneous reporting methodology, which is a complementary method to routine safety monitoring system. To implement a targeted spontaneous reporting method, initial data are required to support the study; however, in the present scenario, we considered PvPI alerts[2],[3] as basic data. We conducted this study to increase the reporting rate on safety alerts to establish the safety signals,[4] and to further communicate to the national database for regulatory inventions.[5] Hence, the information is communicated to all HCPs working at the PGIMER to pay attention during the medical care and treatment while prescribing respective medications.{Table 1}

Acknowledgment

The research facility provided by NCC for PvPI, Indian Pharmacopeia Commission; Department of Pharmacology, PGIMER, Chandigarh; and IKG-Punjab Technical University, Kapurthala, gratefully acknowledged.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1Post Graduate Institute of Medical Education and Research. Available from: http://www.pgimer.edu.in/PGIMER_PORTAL/PGIMERPORTAL/Department/Global/JSP/empview.jsp?id=325. [Last accessed on 2018 Mar 15].
2Thota P, Thota A, Medhi B, Sidhu S, Kumar P, Selvan VK, et al. Drug safety alerts of Pharmacovigilance Programme of India: A scope for targeted spontaneous reporting in India. Perspect Clin Res 2018;9:51-5.
3Drugs Safety Alerts of PvPI. Available from: http://www.ipc.nic.in/index2.asp?slid=541&sublinkid=449&lang=1&EncHid=. [Last accessed on 2017 Aug 23].
4Vivekanandan K, Tripathi A, Saurabh A, Kumar R, Kumar R, Prasad T, et al. Quantitative methods for the identification of signals for individual case safety reports in India. Ther Innov Regul Sci 2015;49:898-902.
5Indian Pharmacopoeia Commission. Available from: http://www.ipc.nic.in/index2.asp?slid=541&sublinkid=449&lang=1&EncHid=. [Last accessed on 2018 Mar 15].