Pharmacovigilance study in psychiatry out-patient department of a tertiary care teaching hospital

Nalini R.

doi:10.18203/2319-2003.ijbcp20174362

Authors

Nalini R. Department of Pharmacology, Tirunelveli Medical College, Tirunelveli, Tamilnadu, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20174362

Keywords:

Adverse drug reactions, Adverse drug monitoring, Pharmacovigilance, Psychotropic drugs, Psychiatry outpatient department

Abstract

Background: Adverse drug reactions are important in psychiatry practice like any other branch of medicine. Adverse drug reactions associated with psychotropic drugs causes either noncompliance or at times discontinuation of therapy. The objective of the study was to evaluate the incidence and nature of adverse drug reactions in psychiatry outpatient department and to assess the causality and severity of the documented adverse drug reactions.

Methods: Prospective observational study was done in the psychiatry outpatient department. All the patients were interviewed for basic details, history of medications and relevant history for adverse drug reactions. The causality, severity and modes of management assessment of the documented adverse drug reactions were done.

Results: 2,727 patients attended psychiatry outpatient department, of which 582 patients developed at least one adverse drug reaction. The incidence of adverse drug reaction observed to psychotropic drugs was 21.34%. Majority of adverse drug reactions were seen with antidepressants 298 (10.93%) followed by antipsychotics 187 (6.86%), sedative hypnotics, anticonvulsants and antimanics. The most common adverse drug reactions were sedation 3.44%, weight gain 3.04%, and extrapyramidal symptoms 2.79%. Reported adverse drug reactions were assessed for causality and maximum belonged to probable (15.6 9%). The severity assessment of the reported adverse drug reactions revealed that most of the adverse drug reactions were mild (16.83%) in nature and majority of patients were made to continue the same treatment.

Conclusions: Active monitoring of adverse drug reactions in psychiatry outpatient department can help in early detection and management of adverse drug reactions.

Metrics

Metrics Loading ...

References

Shah VM, Mehta DS. A longitudinal study of monitoring adverse drug reaction at psychiatry out-patient department in our tertiary care teaching hospital, Surendranagar. JDDT. 2014;4(1):49-52.

Sridhar SB, Al‑Thamer SSF, 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(3):80-6.

Sengupta G, Bhowmick S, Hazra A, Datta A, Musifikur R. Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital. Indian J. Pharmacol. 2011;43(1):36-9.

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 Science. 2014;16(4):156-60.

Solanke B, Mahatme MS, Dakhale G, Hiware S, Shrivastava M, Waradkar P. Adverse drug reaction profile at psychiatry out‑patient department of a tertiary referral centre in Central India. Int J Basic Clin Pharmacol. 2013;2:341‑3.

Gummadi T, Harave VS, Aiyar LN, Raja Lekshmi SG, Kunnavil R. Adverse drug reaction monitoring in a tertiary care psychiatry setting: a comparative study between inpatients and outpatients. Indian J Psychol Med. 2017;39(3):306-11.

Pahari N, Tripathi SK, Maity T, Gupta BK, Bagchi C, Mondal DK. Evaluation and analysis of adverse drug reactions of second generation antipsychotics in a psychiatry out-patient department. Int J Pharm Sci. 2012;4(5):158-62.

Rani FA, Byrne PJ, Murray ML, Carter P, Wong IC. Paediatric atypical antipsychotic monitoring safety (PAMS) study: Pilot study in children and adolescents in secondary and tertiary care settings. Drug Saf. 2009;32:325-33.

Tripathi KD. Adverse drug effects. Essentials of medical pharmacology. 7th Edition New Delhi: Jaypee Brothers; 2013:82-83.

Prajapati HK, Joshi ND, Trivedi HR, Parmar MC, Jadav SP, Parmar DM. Adverse drug reaction monitoring in psychiatric outpatient department of a tertiary care hospital. Natl J Integr Res Med. 2013;4:102‑6.

Lucca JM, Madhan R, Gurumurthy P, Dushad R. A prospective observational study to evaluate safety reporting of antidepressants at a tertiary care hospital in India. Indian J. Pharmacol. 2014;46(5):543-6.

Piparva KG, Buch JG, Chandrani KV. Analysis of adverse drug reactions of atypical antipsychotic drugs in psychiatry OPD. Indian J Psychol Med. 2011;33(2):153-7.