Journal of Research in Pharmacy Practice

Adverse Drug Reactions in Psychiatry Outpatient Department of a Tertiary Care Hospital in Western Uttar Pradesh: An Observational Study

Document Type : Original Article

Authors

. Jaspreet Kaur Sidhu 1
. Kiran Jakhar 2
. Deepti Chopra 3
. Aditi Dhote 1
. Vishakha Babber 4
. Mohammad Shadman 4
. C. D. Tripathi 1

1 Department of Pharmacology, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India

2 Department of Psychiatry, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India

3 Department of Pharmacology, All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India

4 Third Year MBBS Student, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India

Abstract
Objective: Psychiatric disorders are chronic in nature which require medications 
for a long duration. These medications have been associated with many adverse 
events. Failure to recognize an adverse drug reaction (ADR) exposes the patient 
to continuing risk of ADR, leading to a significant impact on patient’s quality of 
life. Thus, the present study carried out to identify the pattern of ADRs reported 
due to psychotropic medication. Methods: This was a cross-sectional study 
conducted to analyze ADRs reported from the psychiatry department of a tertiary 
care teaching hospital from October 2021 to March 2022. Findings: A total of 
137 ADRs were identified from 102 patients. Majority of the ADRs were reported 
from antidepressants, with paroxetine being the leading offending drug. The 
central nervous system was most commonly affected, and dizziness (13.13%) 
was the most common ADR noted. On causality assessment, 97 ADRs (70.8%) 
were of “possible” type. Almost half of the patients with ADRs (47.5%) recovered 
spontaneously. No ADR encountered turned out to be fatal. Conclusion: The 
present study revealed that the majority of ADRs reported from psychiatry OPD 
were mild in nature. We reinforce the identification of ADR is crucial in the 
hospital setting process as it gives an insight into the risk‑benefit ratio for rational 
use of the drug.

Keywords

Adverse drug reactions
adverse event
antidepressants
Paroxetine
1. India State-Level Disease Burden Initiative Mental Disorders 
Collaborators. The burden of mental disorders across the states 
of India: The global burden of disease study 1990-2017. Lancet 
Psychiatry 2020;7:148-61.
2. Math SB, Srinivasaraju R. Indian psychiatric epidemiological 
studies: Learning from the past. Indian J Psychiatry 
2010;52 Suppl 1:S95-103.
3. Sridhar SB, Al-Thamer SS, Jabbar R. Monitoring of adverse 
drug reactions in psychiatry outpatient department of a secondary 
care hospital of Ras Al Khaimah, UAE. J Basic Clin Pharm 
2016;7:80-6.
4. Sengupta G, Bhowmick S, Hazra A, Datta A, Rahaman M. Adverse 
drug reaction monitoring in psychiatry out-patient department of an 
Indian teaching hospital. Indian J Pharmacol 2011;43:36-9.
5. Patel TK, Bhabhor PH, Desai N, Shah S, Patel PB, Vatsala E, 
et al. Adverse drug reactions in a psychiatric department of 
tertiary care teaching hospital in India: Analysis of spontaneously 
reported cases. Asian J Psychiatr 2015;17:42-9.
6. Busto U, Naranjo CA, Sellers EM. Comparison of two recently 
published algorithms for assessing the probability of adverse 
drug reactions. Br J Clin Pharmacol 1982;13:223-7.
7. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity 
assessment in reporting adverse drug reactions. Am J Hosp 
Pharm 1992;49:2229-32.
8. World Health Organization. Quality Assurance and Safety 
of Medicines Team. In: Safety of Medicines: A Guide to 
Detecting and Reporting Adverse Drug Reactions: Why Health 
Professionals Need to Take Action. World Health Organization. 
2002. Safety of Medicines. Available from: whqlibdoc.who.int/
hq/2002/WHO_EDM_QSM_2002.2.pdf. [Last assessed on 2022 
Nov 19].
9. Schumock GT, Thornton JP. Focusing on the preventability of 
adverse drug reactions. Hosp Pharm 1992;27:538.
10. Gawali UP, Kesari HV, Gawand KS. Adverse drug reaction 
profile at psychiatry outpatient department of a tertiary care 
centre. Int J Basic Clin Pharm 2017;6:2428-33.
11. Mahakalkar S, Tiple P, Mohod B, Dhargawe N. Monitoring of 
adverse drug reactions in psychiatry outpatient department of a 
tertiary care hospital in Central India. Int J Basic Clin Pharmacol 
2020;9:802-5.
12. Prajapati HK, Joshai ND, Trivedi HR, Parmar MC, Jadav SP, 
Parmar DM, et al. Adverse drug reaction monitoring in 
psychiatric outpatient department of a tertiary care hospital. Natl 
J Integr Res Med 2013;4:102-6.
13. Sharma T, Vishwakarma K, Dhasmana DC, Gupta R, Kalra J, 
Sharma U. Adverse drug reaction monitoring in psychiatry 
outpatient department of a tertiary care teaching hospital. JK Sci 
2014;16:156-60.
14. Ambwani S, Dutta S, Mishra G, Lal H, Singh S, Charan J. 
Adverse drug reactions associated with drugs prescribed in 
psychiatry: A retrospective descriptive analysis in a tertiary care 
hospital. Cureus 2021;13:e19493.
Journal of Research in Pharmacy Practice
Volume 11, Issue 3
Summer 2022
Pages 99-102

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