Browse > Article
http://dx.doi.org/10.3904/kjim.2016.001

Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi  

Alam, Muhammad Shamshir (Department of Pharmacy Practice and Clinical Pharmacy, Unaizah College of Pharmacy, Qassim University)
Pillai, Krishna Kolappa (Department of Pharmacy Practice and Clinical Pharmacy, Unaizah College of Pharmacy, Qassim University)
Abdi, Syed Aliul Hasan (Department of Pharmacy Practice and Clinical Pharmacy, Unaizah College of Pharmacy, Qassim University)
Kapur, Prem (Department of Medicine, Hamdard Institute of Medical Sciences & Research and Hakeem Abdul Hameed Centenary Hospital, Hamdard University)
Pillai, Paru Kutty (Department of Microbiology, Majeedia Hospital, Hamdard University)
Nagarajan, Kandasamy (Department of Pharmaceutical Chemistry, KIET School of Pharmacy)
Publication Information
The Korean journal of internal medicine / v.33, no.6, 2018 , pp. 1203-1209 More about this Journal
Abstract
Background/Aims: Adverse drug reaction (ADR) is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product. The present study was conducted in order to monitor the frequency and severity of ADR during antimicrobial therapy of septicemia. Methods: A prospective, observational, and noncomparative study was conducted over a period of 6 months on patients of septicemia admitted at a university hospital. Naranjo algorithm scale was used for causality assessment. Severity assessment was done by Hartwig severity scale. Results: ADRs in selected hospitalized patients of septicemia was found to be in 26.5% of the study population. During the study period, 12 ADRs were confirmed occurring in 9, out of 34 admitted patients. Pediatric patients experienced maximum ADRs, 44.4%. Females experienced a significantly higher incidence of ADRs, 66.7%. According to Naranjo's probability scale, 8.3% of ADRs were found to be definite, 58.3% as probable, and 33.3% as possible. A higher proportion of these ADRs, 66.7% were preventable in nature. Severity assessment showed that more than half of ADRs were moderate. Teicoplanin was found to be the commonest antimicrobial agent associated with ADRs, followed by gemifloxacin and ofloxacin. Conclusions: The incidence and severity of ADRs observed in the present study was substantially high indicating the need of extra vigilant during the antimicrobial therapy of septicemia.
Keywords
Sepsis; Antimicrobial therapy; Anti-bacterial agents;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Fraser A, Paul M, Almanasreh N, et al. Benefit of appropriate empirical antibiotic treatment: thirty-day mortality and duration of hospital stay. Am J Med 2006;119:970-976.   DOI
2 International drug monitoring: the role of national centres. Report of a WHO meeting. World Health Organ Tech Rep Ser 1972;498:1-25.
3 Executive summary of disease management of drug hypersensitivity: a practice parameter. Joint Task Force on Practice Parameters, the American Academy of Allergy, Asthma and Immunology, the American Academy of Allergy, Asthma and Immunology, and the Joint Council of Allergy, Asthma and Immunology. Ann Allergy Asthma Immunol 1999;83(6 Pt 3):665-700.   DOI
4 Alam MS, Pillai PK, Kapur P, Pillai KK. Antimicrobial therapy and outcome of septicemia patients admitted to a university hospital in Delhi. Arzneimittelforschung 2012;62:117-122.   DOI
5 Munford RS. Severe sepsis and septic shock. In: Kasper DL, Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson JL, eds. Harrison's Principles of Internal Medicine. 16th ed. Vol. 2. New York: McGraw Hill, 2005:1606-1612.
6 Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-245.   DOI
7 Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-2232.
8 Barranco P, Lopez-Serrano MC. General and epidemiological aspects of allergic drug reactions. Clin Exp Allergy 1998;28 Suppl 4:61-62.
9 Weiss J, Krebs S, Hoffmann C, et al. Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection. Pediatrics 2002;110(2 Pt 1):254-257.   DOI
10 Jha AK, Kuperman GJ, Teich JM, et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc 1998;5:305-314.   DOI
11 Riedl MA, Casillas AM. Adverse drug reactions: types and treatment options. Am Fam Physician 2003;68:1781-1790.
12 Abdi SA, Churi S, Kumar YS. Study of drug utilization pattern of antihyperglycemic agents in a South Indian tertiary care teaching hospital. Indian J Pharmacol 2012;44:210-214.   DOI
13 Salvo F, Polimeni G, Moretti U, et al. Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. J Antimicrob Chemother 2007;60:121-126.   DOI
14 File TM Jr, Mandell LA, Tillotson G, Kostov K, Georgiev O. Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study. J Antimicrob Chemother 2007;60:112-120.   DOI
15 GlaxoSmithKline. Product information: Augmentin XR (amoxicillin/clavulanate potassium) extended release tablets [Internet]. Durham (NC): GlaxoSmithKline, c2006 [cited 2017 Aug 18]. Available from: https://www.accessdata. fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf.
16 Liang RH, Yung RW, Chan TK, et al. Ofloxacin versus co-trimoxazole for prevention of infection in neutropenic patients following cytotoxic chemotherapy. Antimicrob Agents Chemother 1990;34:215-218.   DOI
17 File TM Jr, Iannini PB. A profile of gemifloxacin, a new respiratory fluoroquinolone. Todays Ther Trends 2003;21:415-345.
18 Kurata M, Kasuga Y, Nanba E, Nakamura H, Asano T, Haruta K. Flush induced by fluoroquinolones in canine skin. Inflamm Res 1995;44:461-465.   DOI
19 Pierce G, Murray PR. Current controversies in the detection of septicemia. Eur J Clin Microbiol 1986;5:487-491.   DOI
20 Bone RC, Balk RA, Cerra FB, et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest 1992;101:1644-1655.   DOI
21 Bone RC, Fisher CJ Jr, Clemmer TP, Slotman GJ, Metz CA, Balk RA. Sepsis syndrome: a valid clinical entity. Methylprednisolone Severe Sepsis Study Group. Crit Care Med 1989;17:389-393.   DOI
22 Meremikwu MM, Nwachukwu CE, Asuquo AE, Okebe JU, Utsalo SJ. Bacterial isolates from blood cultures of children with suspected septicaemia in Calabar, Nigeria. BMC Infect Dis 2005;5:110.   DOI
23 World Health Organization. Essential Newborn Care: Report of a Technical Working Group. Geneva: World Health Organization, 2005.