Title: Monitoring and Analysis of Adverse Drug Reactions in A Private Tertiary Care Hospital
Authors: Dr Pradnya Deolekar, Dr Pramila Shriram Yadav, Dr Anshul Attrey, Dr Sandesh Deolekar
DOI: http://dx.doi.org/10.18535/jmscr/v4i4.55
The detection of ADRs has become increasingly significant because of introduction of a large number of potent drugs in the last two or three decades, especially antimicrobials. ADRs could be monitored through active monitoring or through voluntary reporting system in a hospital set up. This observational prospective study spread over 12 month’s duration, was conducted on admitted patients after obtaining approval of ethics committee of the hospital. 3150 subjects receiving antimicrobial therapy were included in the study. The overall incidence of ADRs to antimicrobials in our study was 6.12%. ADRs related to gastrointestinal tract 117(60.62%) were most frequent. The lowest were blood dyscrasias 02(01.03). The highest incidence local site ADR’s was seen with piperacillin + tazobactum (1.5%) and (1.2%) respectively. Practically all antimicrobial agents cause local irritation at the site of administration. Highest incidence of GI effects was observed with ceftriaxone (10.9%). Diarrhoea occurred maximum with amoxycillin+clavulanic acid (4.1%). Amongst CNS manifestations the highest incidence of headache was with ciprofloxacin (0.9%). Cephalosporins (5.1%) had the highest incidence of development of dermatomucosal effects. Blood dyscrasias were seen in patients treated with metronidazole and cefoperazone+sulbactum. In the analysis of antimicrobial-related ADRs, it was found that most episodes were type A (87.05%). In this study majority of the ADRs episodes 106(54.9%) were judged as probable, 44(22.8%) as possible, and 43(22.3%) as definite. The implementation of adverse event monitoring and notification programs in hospital settings is an important action for the prevention of these events. These programs promote event surveillance and encourage their documentation and notification. 1. Leape LL, Brenaan TA,Laird N, Lawthers AG, Localio Ar, Barnes BA et al. The nature of adverse events in hospitalized patients-Result of Harvard medical practice study II. N Engl J Med 1991; 324: 377-84 2. Angels TA, Deogracias E, Estrellita AJ. Untoward Reactions to Antimicrobials. Phil J Microbiol Infect Dis 1986; 15(2): 57-62. 3. 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. 4. Darchy, B., Le Miere, E., Figueredo, B., Bavoux, E. and Domart, Y., Iatrogenic diseases as a reason for admission to the intensive care unit: incidence, causes, and consequences. Arch Intern Med, 159:71-78, 5. Classen DC, Pestonik SL, Evans Rs, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients-excess length stay, extra costs and attributable mortality. J Am Med Assoc 1997; 277: 301-6 6. Henry F. Chambers. General Principles of Antimicrobial Therapy. In: Brunton LL, Parker KL, editors Goodman & Gilman's the Pharmacological Basis of Therapeutics - 11th Ed. (2006): New York : McGrawHill; 2006. 7. Avorn, J., Harvey, K., Soumerai, S.B., Herxheimer, A., Plumridge, R. and Bardelay, G., Information and education as determinants of antibiotic use: report of Task Force 5. Rev Infect Dis, 3 S:286-96, 1987. 8. Mandell G, Douglas RG, Bennet J. Principles and Practice of Infectious Diseases. J. John Wily & Sons: N.Y. 1979. 171. 9. Schwartz, J., Jauregui, L., Lettieri, J., and Bachmann, K. Impact of ciprofloxacin on theophylline clearance and steady-state concentrations in serum. Antimicrob. Agents Chemother. 1988, 32:75-77. 10. Van der Linden PD, van der Lei J, Vlug AE, Stricker BH. Skin reactions to antibacterial agents in general practice. J Clin Epidemiol. 1998;51: 703-8 11. Hoffman-Terry ML, Fraimow HS, Fox TR, Swift BG, Wolf JE. Adverse effects of outpatient parenteral antibiotic therapy. Am J Med. 1999; 106:44-9 10. 12. Hsin-Yun Sun, Yee-Chun Chen, Yi-Wen Wang, Churn-Shiouh Gau, Shan-Chwen Chang – A prospective study of antimicrobial-related adverse drug reactions in hospitalized patients; Journal of Microbiology, Immunology and Infection, 2008; 41:151-159. 13. Mazzeo F, Capuano A, Avolio A, Filipelli A, Rossi F.Hospital-based intensive monitoring of antibiotic induced adverse events in a university hospital. Pharmacol Res. 2004; 51(3):269-74.Abstract
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