Adverse drug reaction profile at psychiatry outpatient department of a tertiary care centre
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20174371Keywords:
Drug-related side effects and adverse reactions, Psychotropic agents, Psychiatry outpatients, PharmacovigilanceAbstract
Background: Monitoring adverse drug reactions (ADRs) helps in alerting physicians and developing strategies to prevent and minimize the risk of developing ADRs. Data regarding pattern of ADRs due to psychotropic medications is scanty. Hence, the study was planned to assess ADRs among psychiatry outpatients of a tertiary care hospital in Maharashtra.
Methods: A prospective, observational study was conducted in psychiatry outpatient department of a tertiary care centre for 3 months. Cases were enrolled by active and passive surveillance after obtaining informed consent. Demographic details, adverse event details, history of medications were recorded. Pattern of ADRs was studied according to demographic parameters, drug class, organ system affected, causality (WHO - Uppsala Monitoring Centre Scale) and severity (modified Hartwig and Siegel Scale).
Results: Out of total 1200 patients screened, 77 qualified the inclusion and exclusion criteria and 92 ADRs were reported; overall incidence rate of 6.41%. Maximum ADRs were reported in the age group of 31- 40 years. 63.63% subjects received more than 2 psychotropic drugs. Among 24 types of ADRs observed, tremor (13.04%) was the commonest, closely followed by somnolence. Antipsychotics (45.65%) were most frequently incriminated and central nervous system (46.73%) the most often affected. Trifluoperazine (11.96%) was the commonest drug, followed by olanzapine and haloperidol (10.53% each). Causality analysis yielded 66 ADRs as “probable” and on severity analysis 80.43% were mild.
Conclusions: The study provides an insight into pattern of ADRs in psychiatry outpatients. It is prudent to communicate this to treating physicians as well as counsel patients (and caregivers). Initiatives and concerted efforts involving all stakeholders in healthcare can go a long way in decreasing drug-related morbidity and health costs.
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References
Vos T, Barber RM, Bell B, Bertozzi-Villa A, Biryukov S, Bolliger I, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. The Lancet. 2015 Aug 22;386(9995):743-800.
National Institute of Mental Health and Neurosciences [Internet]. India. National Mental Health Survey 2015-16. 2016 [cited 2017 March 9]. Available at: http://www.nimhans.ac.in/sites/default/files/u197/National%20Mental%20Health%20Survey%20-2015-16%20Summary_0.pdf
Black Dog Institute [Internet]. Australia. Psychotropic Medications: increased prescription and wider application. 2014 Jul [cited 2016 Aug 19]. Available at: http://www.blackdoginstitute.org.au/public/research/PsychotropicMedicationsincreasedprescriptionandwiderapplication.cfm
Jorm AF, Christensen H, Griffiths KM. Changes in depression awareness and attitudes in Australia: the impact of beyondblue: the national depression initiative. Austral N Z J Psych. 2006;40:42-6.
Cooper C, Bebbington P, King M, Brugha T, Meltzer H, Bhugra D, et al. Why people don’t take their psychotropic drugs as prescribed: Results of the 2000 National Psychiatric Morbidity Survey. Acta Psychiatr Scand. 2007;116:47-53.
Faich GA. US adverse drug reaction surveillance 1984-1994. Pharmacoepidemiol Drug Saf. 1996;5:393-8.
Amit D, Rataboli P. Adverse drug reaction notification drop box: an easy way to report ADRs. Br J Clin Pharmacol. 2008;66:723-4.
Shridhar 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 Pharma. 2016;7:80-6.
The use of the suspected adverse drug reaction reporting form [Internet]. [Cited 2016 Aug 20]. Available at: http://www.cdsco.co.in.
The use of the WHO-UMC system for standardized case causality assessment [monograph on the Internet]. [cited 2016 Aug 20] Available at: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.
Common Terminology Criteria for Adverse Events - Adverse Event by System Organ Class - Classes. [Internet] NCBO Bio Portal. Bioportal.bioontology.org. 2017. [cited 2017 February 20] Available at: http://bioportal.bioontology.org/ontologies/CTCAE?p=classes&conceptid=Adverse_Event_by_System_Organ_Class.
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.
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. Natl J Integr Res Med. 2013;4:102‑6.
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.
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 Journal of Medical Education and Research. 2014 Oct-Dec;16(4):156-60.
Iuppa CA, Nelson LA, Elliott E, Sommi RW. Adverse Drug Reactions: A Retrospective Review of Hospitalized Patients at a State Psychiatric Hospital. Hosp Pharm. 2013;48(11):931-5.
West Wales Adverse Reaction - Swansea University. [Internet] Sustaining the West Wales ADR Profile for Mental Health Medicines in Practice. [cited 2017 February 23] Available at: http://www.swansea.ac.uk/wwadr.
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