Pattern of adverse drug reactions into psychiatric patients
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20191601Keywords:
Antidepressants, Antipsychotics, ADRs, Psychiatric, PharmacovigilanceAbstract
Background: To analyse adverse drug reactions (ADRs) reported in patients prescribed psychiatric medications at tertiary care hospital.
Methods: ADRs reported in psychiatric patients between January 2011 to June 2017 were analyzed for demographic details, causal drugs, system organ classification, causality assessment (WHO-UMC criteria and Naranjo’s scale), preventability (Modified Schumock and Thorton’s criteria) and severity (Hartwing scale).
Results: A total 4368 ADRs were reported during study period, out of which 658 (15.06%) were in psychiatric patients. The mean age of patients was 38±13.34 years and men (57.3%) were most commonly affected than women (42.7%). The most common causal drug groups were antidepressants (29.48%) followed by antipsychotics (23.12%) which include drug fluoxetine (33.9%) and olanzapine (34.3%) respectively. The most common system involved were central nervous system (32.8%) followed by gastrointestinal system (22.8%). Most of ADRs (42.7%) were observed after one month of therapy and showed possible (77%) causal relation with drug therapy. Majority of ADRs (77.4%) were not preventable and mild in nature (83.3%).
Conclusions: ADRs are commonly seen in psychiatric patients. Hence, their monitoring and assessment in these patients who require multidrug and long-term therapy may help improve patient management.
Metrics
References
WHO Meeting on International Drug Monitoring: the Role of National Centres (1971: Geneva, Switzerland) and World Health Organization. (1972). International drug monitoring : the role of national centres , report of a WHO meeting [held in Geneva from 20 to 25 September 1971]. World Health Organization. Available at: http://www.who.int/iris/handle/10665/40968.
Haddad PM, Sharma SG. Adverse effects of atypical antipsychotics. CNS Drugs. 2007;21(11):911-36.
Sengupta G, Bhowmick S, Hazra A, Datta A, Rahaman M. Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital. Ind J Pharmacol. 2011;43(1):36.
Prajapati HK, Joshi ND, Trivedi HR, Parmar MC, Jadav SP, Parmar DM, et al. Adverse drug reaction monitoring in psychiatric outpatient department of a tertiary care hospital. Depression. 2013;63:15-48.
MiShra S, Swain TR, Mohanty M. Adverse drug reaction monitoring of antidepressants in the psychiatry outpatients department of a tertiary care teaching hospital. J Clin Diagn Res JCDR. 2013;7(6):1131.
Solanke B, Mahatme MS, Dakhale G, Hiware S, Shrivastava M, Waradkar P. Adverse drug reaction pro le at psychiatry out‐patient department of a tertiary referral centre in Central India. Int J Basic Clin Pharmacol. 2013;2:341-3.
Pahari NI, Tripathi SK, Maity TA, Gupta BK, Bagchi CH, Mondal DK. Evaluation and analysis of adverse drug reactions of second generation antipsychotics in a psychiatry out-patient department. Int J Pharm Pharm Sci. 2012;4:158-62.
Thomas M, Boggs AA, DiPaula B, Siddiqi S. Adverse drug reactions in hospitalized psychiatric patients. Ann Pharmacotherapy. 2010;44(5):819-25.
Faich GA. US adverse drug reaction surveillance 1989-1994. Pharmacoepidemiol Drug Safety. 1996;5(6):393-8.
Lihite RJ, Lahkar M. A study on cutaneous adverse drug reactions in ADR monitoring centre of tertiary care hospital, Guwahati. J Applied Pharmaceut Sci. 2013;3(3):78.
Adverse drug reaction reporting form: Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare Available at: http://www.cdsco.nic.in/writereaddata/ADR%20form%20PvPI.pdf.
The use of the WHO-UMC system for standardised case causality assessment. Available at: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Therapeutics. 1981;30(2):239-45.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Heal Sys Pharmacy. 1992;49(9):2229-32.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hospital Pharmacy. 1992;27(6):538.
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. Ind J Pharmacol. 2014;46(5):543.
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 Pharmacy. 2016;7(3):80.
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 Psychiatry. 2015;17:42-9.
Murthy RS. National mental health survey of India 2015–2016. Ind J Psychiatry. 2017;59(1):21.
World Health Organization. Depression and other common mental disorders: global health estimates. World Health Organization, 2017. Available at: http://www.who.int/iris/handle/10665/254610. Accessed 25 March 2017.
Piparva KG, Buch JG, Chandrani KV. Analysis of adverse drug reactions of atypical antipsychotic drugs in psychiatry OPD. Ind J Psychol Med. 2011;33(2):153.
Downloads
Published
How to Cite
Issue
Section
