Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi
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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.
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.
참고문헌 (23)
- Bone RC, "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, Chest, pp.1992, 101[DOI]
- Pierce G, "Current controversies in the detection of septicemia", Eur J Clin Microbiol, 5, pp.487~491 (1986)
- Bone RC, "Sepsis syndrome: a valid clinical entity. Methylprednisolone Severe Sepsis Study Group", Crit Care Med, 17, pp.389~393 (1989)
- Meremikwu MM, "Bacterial isolates from blood cultures of children with suspected septicaemia in Calabar, Nigeria", BMC Infect Dis, 5, pp.110~ (2005)
- Essential Newborn Care:Report of a Technical Working Group, "World Health Organization", World Health Organization, ~ (2005)
- Fraser A, "Benefit of appropriate empirical antibiotic treatment: thirty-day mortality and duration of hospital stay", Am J Med, 119, pp.970~976 (2006)
- "International drug monitoring: the role of national centres. Report of a WHO meeting", World Health Organ Tech Rep Ser, 498, pp.1~25 (1972)
- "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, 83(6 Pt 3), pp.665~700 (1999)
- Alam MS, "Antimicrobial therapy and outcome of septicemia patients admitted to a university hospital in Delhi", Arzneimittelforschung, 62, pp.117~122 (2012)
- Munford RS, "Harrison’s Principles of Internal Medicine Vol. 2", pp.1606~1612 (2005), McGraw Hill
- Naranjo CA, "A method for estimating the probability of adverse drug reactions", Clin Pharmacol Ther, 30, pp.239~245 (1981)
- Hartwig SC, "Preventability and severity assessment in reporting adverse drug reactions", Am J Hosp Pharm, 49, pp.2229~2232 (1992)
- Weiss J, "Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection", Pediatrics, 110(2 Pt 1), pp.254~257 (2002)
- Jha AK, "Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report", J Am Med Inform Assoc, 5, pp.305~314 (1998)
- Barranco P, "General and epidemiological aspects of allergic drug reactions", Clin Exp Allergy, 28(Suppl 4), pp.61~62 (1998)
- Riedl MA, "Adverse drug reactions: types and treatment options", Am Fam Physician, 68, pp.1781~1790 (2003)
- Abdi SA, "Study of drug utilization pattern of antihyperglycemic agents in a South Indian tertiary care teaching hospital", Indian J Pharmacol, 44, pp.210~214 (2012)
- Salvo F, "Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy", J Antimicrob Chemother, 60, pp.121~126 (2007)
- "Product information: Augmentin XR (amoxicillin/clavulanate potassium) extended release tablets" (2006)[URL]
- Liang RH, "Ofloxacin versus co-trimoxazole for prevention of infection in neutropenic patients following cytotoxic chemotherapy", Antimicrob Agents Chemother, 34, pp.215~218 (1990)
- File TM Jr, "A profile of gemifloxacin, a new respiratory fluoroquinolone", Todays Ther Trends, 21, pp.415~345 (2003)
- File TM Jr, "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, 60, pp.112~120 (2007)
- Kurata M, "Flush induced by fluoroquinolones in canine skin", Inflamm Res, 44, pp.461~465 (1995)