STUDY TO EVALUATE SEVERE ADRS IN A TERTIARY CARE TEACHING HOSPITAL
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Pharmacovigilance##common.commaListSeparator## Causality##common.commaListSeparator## Severity##common.commaListSeparator## Adverse drug reactions##article.abstract##
Objective: This study attempts to analyze the severe ADRs in a tertiary care centre and assess their seriousness, outcome, causality and severity. We emphasize on the need for reporting of ADRs by all healthcare professionals as it will reduce the burden of morbidity due to drugs and ensure better and more efficient healthcare. To analyse and evaluate the severe ADVERSE DRUG REACTIONs reported from various departments in a Tertiary care Teaching hospital.
Methods: It is a prospective observational study that was carried out over a period of 6 mo (from July 2016 to December 2016) to assess the percentage of severe adverse drug reactions reported to the Pharmacovigilance cell of a tertiary care teaching hospital. The data collected included patient's demographic details, presenting complaints, clinical diagnosis and details of the drug(s) prescribed. The data was analysed for causality (as per the WHO-UMC scale) and severity (as per Hartwig and Siegel scale).
Results: Out of 64 ADRs reported, 17 were serious. The majority of serious ADRs were categorized as probable (82.35%), whilst 1(5.8%) was categorized as possible and 2(11.76%) as certain in nature. The criteria for the majority of serious ADRs were hospitalization (%) followed by intervention to prevent permanent impairment or damage (%).
Conclusion: The highest percentage of severe cases was reported with Antitubercular therapy (23.5%) followed by analgesics (23%) and anti epileptic agents (17.6%).
##submission.citations##
Current status of the monitoring of medication practice david cousins. Am J Health-Syst Pharm 2009;66(Suppl 3):S49-56.
World Health Organization. Safety of medicines-a guide to detecting and reporting adverse drug reactions-why health professionals need to take actions. Geneva: World Health Organization; 2002.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356:1255–9.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279:1200–5.
The Use of the WHO–UMC System for Standardised Case Causality Assessment. Available from: http://www.WHO-UMC.org/graphics/4409.pdf. [Last accessed 12 Feb on 2011]
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229–32.
European Commission. Proposal for a regulation amending, as regards pharmacovigilance of medicinal products for human use. Regulation (EC) No 726/2004. Impact assessment; 2008. Available from: http://ec.europa.eu/health/files/pharmacos/ pharmpack_12_2008/pharmacovigilance-ia-vol1_en.pdf. [Last accessed 03 Sep 2014].
Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a South Indian hospital–their severity and cost involved. Pharmacoepidemial Drug Saf 2003;12:687-92.
Lukshmy M Hettihewa. Bashinie Sirisena Causality. Assessment and the severity of adverse drug reactions (ADR) actively detected in hospital inpatients in a tertiary care hospital, Sri Lanka. Prospective observational survey. Asian J Res Biol Pharm Sci 2014;2:1-10.
Sharminder Kaur, Vinod Kapoor, Rajiv Mahajan, Mohan Lal, Seema Gupta. Monitoring of incidence, severity, and causality of adverse drug reactions in hospitalized patients with cardiovascular disease. Indian J Pharmacol 2011;43:22–6.
Suh DC, Woodall BS, Shin SK, Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Ann Pharmacother 2000;34:1373–9.
Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm 1993;28:1199–240.
Classen DC, Pestotnik SL, Evans RS, Lloyd JF, JP Burke. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA 1997;277:301–6.