A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India

Farhan Ahmad Khan, Sheikh Nizamuddin, Najmul Huda, Hitesh Mishra


Background: Polypharmacy, advancing age and longer duration of hospital stay are the factors responsible for adverse drug reactions (ADRs). This study has attempted to analyze the pattern of antimicrobial prescription in OPD & IPD of the Otolaryngology department and to detect, document, assess and report the suspected ADRs due to antibiotic use and preparation of guidelines to minimize the incidence of ADRs.

Methods: A prospective study conducted at the TMMC&RC on patients aged >40 years, who visited the Otolaryngology department over a period of 5 months. Suspected ADRs were assessed for causality and severity using Naranjo’s probability scale and modified Hartwig’s criteria, respectively.

Results: Out of 1200, 925 prescriptions were analyzed. Most patients were from 41-60 age (59.45%) followed by 61-80 age (37.29%) and least from >80 yr (3.24%). But the incidence of ADRs were found to be higher in patients of >80 yr age group n=8 (26.66%). The most commonly prescribed antibacterials were β-Lactams (64.61%). Out of 925 prescriptions studied, only 94 were found to have 154 ADRs. The most commonly identified ADRs were Gastrointestinal 47.40%, followed by Neurotoxicity 24.67%, cutaneous reactions 20.12%, Hepatic 4.54% and Kidney 3.24%. 74.67% of the ADRs were probable and 20.77% were possible type and only 4.54% were definite. 74.67% ADRs were found to be type A, and 25.32% type B.

Conclusions: Our study showed that prevalence of ADRs was highest in elder age group and diarrhea was the most common ADR found. Therefore elderly patients should be given special attention when prescribing medications to avoid clinically significant harmful consequences. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients.


Antibacterial agents, Drug utilization, Adverse Drug reactions

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WHO. International drug monitoring: the role of national centers. Tech Rep Ser WHO 1972, no 498.

Laurence D, Carpenter J. A dictionary of pharmacology and allied topics, 2nd edn. Amsterdam: Elsevier, 1998: 8-9.

Stephens MDB. Definitions and classifications of adverse reaction terms. In: Stephens MDB, Talbot JCC, Routledge PA, eds. The detection of new adverse reactions, 4th edn. London: Macmillan Reference, 1998: 32-44.

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.

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;30:239-45.

Chan M, Nicklason F, Vial JH. Adverse drug events as a cause of hospital admission in the elderly. Intern Med J 2001; 31:199-205.

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255-9.

Mandavi, Sanjay D’Cruz, Atul Sachdev & Pramil Tiwari. Adverse drug reactions & their risk factors among Indian ambulatory elderly patients. Indian J Med Res 136, September 2012, pp 404-410.

Davies EC, Green CF, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: a pilot study. J Clin Pharm Ther. 2006; 31:335-41.

Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS one. 2009; 4(2):e4439.

Schneider JK, Mion LC, Frengley JD. Adverse drug reactions in an elderly outpatient population. Am J Hosp Pharm 1992; 49 : 90-6.

Demissew BH, Wubeante YA, and Tiwari P. Prevalence and Assessment of Factors Contributing to Adverse Drug Reactions in Wards of a Tertiary Care Hospital, India. Ethiop J Health Sci. 2013 March; 23(1): 39-48.

Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a South Indian hospital - their severity and cost involved. Pharmacoepidemiol Drug Saf. 2003;12:687-92.

Jose J, Padma GM. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006; 54:226-33.

Camargo AL, Cardoso Ferreira MB, Heineck I. Adverse drug reactions: a cohort study in internal medicine units at a university hospital. Eur J Clin Pharmacol. 2006;62:143-9.

Smith CR, Lipsky JJ, Laskin OL. Double-blind comparison of the nephrotoxicity and auditory toxicity of gentamicin and tobramycin. N Engl J Med 1980;302:1106-9.

Umstead GS, Neumann KH. Erythromycin ototoxicity and acute psychotic reaction in cancer patients with hepatic dysfunction. Arch Intern Med 1986;146:897-9.

Klimek L, Aderhold C, Sperl A. [Allergies to antibiotic drugs: Their importance in otorhinolaryngology]. HNO. 2013 May;61(5):409-15. doi: 10.1007/s00106-012-2599-6.

Brown SJ, Desmond PV. Hepatotoxicity of antimicrobial agents. Semin Liver Dis 2002;22:157-67.

Alexopoulos E. Drug-induced acute interstitial nephritis. Ren Fail 1998;20:809-19.

Onder G, Pedone C, Landi F, et al. Adverse drug reactions as cause of hospital admissions: results from the Italian Group of Pharmacoepidemiology in the elderly (GIFA). J Am Geriatr Soc. 2002;50:1962-8.