MONITORING AND ANALYSIS OF ADVERSE DRUG REACTIONS IN A PRIVATE TERTIARY CARE TEACHING HOSPITAL
Abstract
ÂObjectives: To monitor and analyse the suspected adverse drug reactions (ADRs) reported at Vydehi Hospital, Bengaluru.
Methods: A prospective observational study was conducted between July 2011 and August 2012. Suspected ADR - Central Drugs Standard Control
Organization forms submitted to pharmacovigilance unit were analysed for: (1) Type of reaction, (2) severity, (3) seriousness, (4) causal relationship
with the drug using the Naranjo and World Health Organisation (WHO) - UMC causality scale, (5) predictability of ADR and (6) group of suspected
drugs associated with ADR.
Results: 45 forms out 54 were complete as per the Pharmacovigilance Programme of India, which were analysed. 44 (97.7%) of the reactions were
Type B and 1 (2.2%) Type A. 24 (53.3%) of the reactions were mild, 20 (44.4%) were moderate, and 1 (2.2%) severe. 4 (8.8%) reactions were
considered serious. As per the Naranjo causality scale, 81.8% were possibly related and 18.2% probably related. Analysis as per WHO-UMC causality
scale showed that 16.6% of the reactions were probably or likely related and 83.3% possibly related. The predictability of an ADR was assessed for
30 of the 45 reports where single drug or fixed drug combination were prescribed. 27 (90%) were considered predictable amongst them. The major
group of drugs that caused the reactions were antimicrobials. The most common ADRs in our study were cutaneous reactions. 37.7% of ADRs were
noted in patients on combination of drugs.
Conclusions: Study revealed that the reporting rate was low. Only cutaneous reactions were reported. More awareness needs to be created to address
these issues.
Keywords: Adverse drug reactions, Pharmacovigilance, WHO-UMC, Naranjo's casuality scale.
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References
World Health Organization. International drug monitoring: The role of the hospital. In: Technical Report Series No. 425. Geneva, Switzerland: World Health Organization; 1966. p. 1-24.
Lobo MG, Pinheiro SM, Castro JG, Momenté VG, Pranchevicius MC. Adverse drug reaction monitoring: Support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol 2013 8;14:5.
Shrivastava M, Uchit G, Chakravarti A, Joshi G, Mahatme M, Chaudhari H. Adverse drug reactions reported in Indira Gandhi Government Medical College and Hospital, Nagpur. J Assoc Physicians India 2011;59:296-9.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279(15):1200-5.
Available from: http://apps.who.int/medicinedocs/en/d/Jh3009e/. [Last accessed on 2014 Feb 11].
Lihite RJ, Lahkar M. A study on cutaneous adverse drug reactions in ADR monitoring centre of tertiary care hospital, Guwahati. J Appl Pharm Sci 2013;3:78-81.
Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R, Ravi TK, et al. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci 2011;16:16-25.
Palanisamy SN, Yemineni R, Nadenla R. Monitoring and reporting of adverse drug reactions in a South Indian tertiary care hospital. Int J Pharm Sci Rev Res 2014;24(1):45, 259-62.
Available from: http://www.cdsco.nic. [Last accessed on 2011 Apr 15].
Rawlins MD. Today’s treatment clinical pharmacology adverse reactions to drugs. Br Med J 1981;282:974-6.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49(9):2229-32.
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.
Available from: http://www.cioms.ch. [Last accessed on 2014 May 05].
Aagaard L, Strandell J, Melskens L, Petersen PS, Holme Hansen E. Global patterns of adverse drug reactions over a decade: Analyses of spontaneous reports to VigiBaseâ„¢. Drug Saf 2012;35:1171-82.
Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res 2011;2:129-36.
Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2008;65(2):210-6.
Wolkenstein P, Chosidow O, Fléchet ML, Robbiola O, Paul M, Dumé L, et al. Patch testing in severe cutaneous adverse drug reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Contact Dermatitis 1996;35(4):234-6.
Amit D, Rataboli PV. Adverse drug reaction (ADR) notification drop box: An easy way to report ADRs. Br J Clin Pharmacol 2008;66(5):723-4.
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