Pattern of adverse drug reactions reporting in two medical colleges of Tripura, India: a cross sectional study

Authors

  • Anannya Chakraborty Department of Pharmacology, TMC and Dr. BRAM Teaching Hospital, Hapania, Po. ONGC, Agartala, India
  • Debasis Ray Department of Pharmacology, Agartala Govt. Medical College, Po. Kunjavan, Agartala, India
  • Ranjib Ghosh Department of Pharmacology, TMC and Dr. BRAM Teaching Hospital, Hapania, Po. ONGC, Agartala, India
  • Nibedita Roy Department of Pharmacology, ADR Monitoring Center (AMC), Agartala Govt. Medical College, Po. Kunjavan, Agartala, India
  • Sayan Bhattacharje Department of Pharmacology, TMC and Dr. BRAM Teaching Hospital, Hapania, Po. ONGC, Agartala, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20172226

Keywords:

ADR reporting, Causality, Naranjo’s Algorithm, Pharmacovigilance

Abstract

Background: India as an important clinical trial hub in the world. In clinical trials, many of the drug issues related to the safety are inadequately studied in highly selected and limited number of patients. Due to introduction of many new drugs in the country, it has become essential to have an effective Pharmacovigilance system nationwide. Under reporting of ADRs is widespread and a daunting challenge in Pharmacovigilance programme of India (PvPI).

Methods: A cross sectional study was conducted for two months with the objective to study the pattern of ADRs reporting in two teaching hospitals of Tripura. The data were collected in “Suspected ADR reporting forms” of Indian Pharmacopoeia Commission (IPC). Suspected ADRs were assessed for causality using Naranjo ADR probability scale.

Results: 44 ADR reporting forms were received with 58 ADRS. Among them, Gastrointestinal System ADRs were the highest (25.86%). More ADRs were seen in males than females (52.27% vs 47.72%). 68.18% cases had the medication through oral route. Out of all ADRs, 67.24% were Type A reactions. Most of the reactions reported, were mild (90.9%) based on modified Hartwig severity scale. Most of the ADRs reported were of probable causality (score 5-9) measured by Naranjo’s Algorithm.

Conclusions: This study would definitely give an insight into the pattern of ADRs in tertiary health care centers and may help to increase awareness of health care provider for further Pharmacovigilance studies.

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Published

2017-05-23

How to Cite

Chakraborty, A., Ray, D., Ghosh, R., Roy, N., & Bhattacharje, S. (2017). Pattern of adverse drug reactions reporting in two medical colleges of Tripura, India: a cross sectional study. International Journal of Basic & Clinical Pharmacology, 6(6), 1372–1376. https://doi.org/10.18203/2319-2003.ijbcp20172226

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Original Research Articles