DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20163235

Adverse drug reactions: a retrospective review of hospitalized psychiatric patients at tertiary care hospital

Priyanka Pravinbhai Hotha, Shilpa P. Jadav, Hiren R. Trivedi

Abstract


Background: Hospital data based monitoring of ADRs can shed light on their extensiveness and pattern of occurrence. Study is expected to enable us in obtaining information on the incidence and pattern of ADRs in the local population. The objective of this study was to do surveillance, detect incidence of ADR and to analyse the ADRs according to their demographic distribution, reporting, presentations and causality assessment scale.

Methods: A retrospective study conducted from January 2011 to December 2014 and psychiatric hospitalized patients were analysed and ADR reports were assessed for probability, severity, psychotropic drugs involved, and preventability.

Results: A total number of 101 ADRs were reported in 72 patients. Most common ADR were mainly tremor 14 (13.86%), salivation 11 (10.89%) followed by muscle rigidity 6 (5.94%) and slurring of speech 6 (5.94%). In majority of the instances, it was antipsychotic agents 41 (56.94%) followed by antidepressants 11(15.27%) and mood stabilizers 11 (15.27%). As per causality assessment, 95 (94.05%) cases were ‘possible’ in WHO-UMC criteria and 72 71.28%) cases were ‘possible’ in Naranjo scale respectively. As per Schumock and Thornton preventability assessment, 91(90.09%) of total ADRs were in the not-preventable category. As per Hartwig and seigle’s severity assessment, majority of ADRs 74 (73.26%) were mild in severity.

Conclusions: ADRs were most commonly associated with antipsychotic drugs. Developing an on-going ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspecting ADR will help to continue reporting and improving the patient’s safety.


Keywords


ADRs, Drug interactions, Psychotropic drugs

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References


Tripathi KD, Essentials of Medical Pharmacology. 7th ed. Jaypee Brothers medical publishers, New Delhi, India; 2009:82-92.

Vora MB, Trivedi HR, Shah BK, Tripathi CB. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital: a prospective cohort study. Journal of pharmacology and pharmacotherapeutics. 2011;2(1):21-5.

Pimpakhute SA, Jaiswal KM, Sontakke SD, Bajait CS, Gaikwad A. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring in resident doctors of a tertiary care teaching hospital. Indian J Med Sci. 2012;66(34):55-61.

Cruz SD, Sachdev A, Tiwari P. Adverse drug reactions and their risk factors among Indian ambulatory elderly patients. Indian J Med Res. 2012;136:404-10.

Pimpalkhute SA, Jaiswal KM, Sontakke SD, Bajait CS, Gaikwad A. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring in resident doctors of a tertiary care teaching hospital. Indian Juornal of Medical Science. 2012;66(3):55-61.

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. National Journal of Integrated Research in Medicine. 2013;4(2):102-6.

Kuruvilla A, Kuruvilla K. Incidence of severe reaction to commonly prescribed psychopharmacological agents during early phase of therapy. Indian J PsychiaL. 1995;37(3):113-8.

Iuppa AC, 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.

Hartwing S, Seigel J. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

The use of the WHO-UMC system for standardized case causality assessment, 2012. Available at http://www.who umc.org/graphics/4409.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 Ther. 1981;30(2):239-45.

Hartwing S, Seigel J. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.

Lucca JM, Madhan R, Parthasarathi G, Ram D. Identification and management of adverse effects of antipsychotics in a tertiary care teaching hospital. Journal of Research in Pharmacy Practice. 2014;3(2):247-54.

Shah LP, Ayyar KP, Agrawal BR, Pradha PV. Drug surveillance programme in psychiatry adverse drug reaction. Indian J Psychiaty. 1983;25(3):229-34.

Kurmi P, Paul PK, Dutta SK, Das S, To Study the Pattern of Adverse Drug Reaction of Antipsychotic Drugs in a Tertiary Care Hospital of Assam, International Journal of PharmTech Research. 2015,8;1:101-5.

Rothschild JM, Mann K, Keohane CA, Williams DH, Foskett C, Rosen SL, et al. Medication safety in a psychiatric hospital. General Hospital Psychiatry. 2007;29:156-62.

Thomas M, Boggs AA, Paula BD, Siddiqi S. Adverse drug reactions in hospitalized psychiatric patients. The Annals of Pharmacotherapy. 2010;44:819-25.