Usage Pattern and Serum Level Measurement of Amikacin in the Internal Medicine Ward of the Largest Referral Hospital in the South of Iran: A Pharmacoepidemiological Study

Namazi, Soha; Sagheb, Mohammad Mahdi; Hashempour, Mohammad Mahdi; Sadatsharifi, Arman

Usage Pattern and Serum Level Measurement of Amikacin in the Internal Medicine Ward of the Largest Referral Hospital in the South of Iran: A Pharmacoepidemiological Study

Document Type : Original Article(s)

Authors

Soha Namazi ¹

Mohammad Mahdi Sagheb ²

Mohammad Mahdi Hashempour ¹

Arman Sadatsharifi ¹

¹ Department of Pharmacotherapy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

² Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Abstract

Background: The inappropriate use of aminoglycosides has harmful effects such as the development of resistant pathogens and the incidence of nephrotoxicity and ototoxicity. Therefore, drug utilization evaluation of these drugs may improve their usage remarkably. The aim of this study was to assess the usage pattern of amikacin in an internal medicine ward.Methods: This cross-sectional study was conducted in the Internal Medicine Ward of Nemazee Teaching Hospital, Shiraz, Iran, in 2011. The guideline for amikacin use was approved by the institutional Pharmacy and Therapeutics Committee, and the study criteria were developed to assess several parameters involved in amikacin therapy such as appropriateness of drug use, dosage, duration of therapy, toxicity monitoring, and serum concentration assay. Serum concentration was assayed using a Cobas Mira AutoAnalyzer. Clinical and paraclinical parameters such as glomerular filtration rate, culture, microbial sensitivity, white blood cell count, and fever were collected.Results: Sixty-three patients were evaluated. Fifty-seven percent of the patients needed dose readjustment; however, it was not performed for 89% of them. Culture between48 and 72 hours after amikacin administration was not controlled for 79% of the patients. In 19% of the patients, optimum therapeutic effect was not achieved. The mean±SD of the trough and peak concentrations was 7.63±5.4 μg/mL and 15.67±7.79 μg/mL, respectively. Forty-five percent of the trough and 38% of the peak levels were within the therapeutic range. The overall adherence of amikacin usage to the guideline was only 48%.Conclusion: To achieve appropriate treatment and prevent toxic effects, we recommend that pharmacokinetic dosing methods, amikacin guideline, and serum monitoring be considered.

Keywords

Guideline

Amikacin

Drug utilization review

WHO Expert Committee. The selection of essential drugs. Geneva: World Health Organization; 1977. 36 p.
Sathvik B. Drug Utilisation Review/Evaluation. In: Parthasarathi G, Nyfort-Hansen K, Nahata MC, editors. A Text Book of Clinical Pharmacy Practice: Essential Concepts and Skills. India: Orient Longman; 2004. p. 362-75.
Niederman MS. Appropriate use of antimicrobial agents: challenges and strategies for improvement. Crit Care Med. 2003;31:608-16. doi: 10.1097/01.CCM.0000050464.70382.D6. PubMed PMID: 12576973.
Edson RS, Terrell CL. The aminoglycosides. Mayo Clin Proc. 1999;74:519-28. doi: 10.4065/74.5.519. PubMed PMID: 10319086.
Ramesh M, John S, Narayanappa D. Audit of aminoglycosides usage. Indian J Pediatr. 2002;69:385-8. doi: 10.1007/BF02722623.PubMed PMID: 12061669.
Shrimpton SB, Milmoe M, Wilson AP, Felmingham D, Drayan S, Barrass C, et al. Audit of prescription and assay of aminoglycosides in a UK teaching hospital. J Antimicrob Chemother. 1993;31:599-606. doi: 10.1093/jac/31.4.599.PubMed PMID: 8514654.
Davey PG, Parker SE, Orange G, Malek M, Dodd T. Prospective audit of costs and outcome of aminoglycoside treatment and of therapy for gram-negative bacteraemia. J Antimicrob Chemother. 1995;36:561-75. doi: 10.1093/jac/36.3.561.PubMed PMID: 8830023.
Wade WE, McCall CY. Drug usage evaluation of aminoglycoside-induced nephrotoxicity in a community hospital. Hosp Formul. 1990;25:1092-4, 6. PubMed PMID: 10107391.
Li SC, Ioannides-Demos LL, Spicer WJ, Berbatis C, Spelman DW, Tong N, et al. Prospective audit of aminoglycoside usage in a general hospital with assessments of clinical processes and adverse clinical outcomes. Med J Aust. 1989;151:224-32. PubMed PMID: 2761465.
MacDougall C, Polk RE. Antimicrobial stewardship programs in health care systems. Clin Microbiol Rev. 2005;18:638-56. doi: 10.1128/CMR.18.4.638-656.2005. PubMed PMID: 16223951; PubMed Central PMCID: PMC1265911.
McEvoy GK, editor. AHFS Drug Information. 1st ed. Bethesda: American Society of Health-System Pharmacists; 2006. 2265 p.
Amikacin-Drug Information [Internet]. India: Medindia, network for health. c2011. Available from: http://www.medindia.net/doctors/drug_information/amikacin.htm
Deresinski S. Principles of antibiotic therapy in severe infections: optimizing the therapeutic approach by use of laboratory and clinical data. Clin Infect Dis. 2007;45:S177-83. doi: 10.1086/519472. PubMed PMID: 17712744.
Schentag JJ, Meagher AK, Jelliffe RW. Aminoglycoides. In: Burton ME, Shaw LM, Schentag JJ, Evans WE, editors. Applied pharmacokinetics and pharmacodynamics: principles of therapeutic drug monitoring. Philadelphia: Lippincott Williams & Wilkins; 2006. p. 285-327.
Bauer LA. The Aminoglycosides Antibiotics. In: Zollo S, Edmonson KG, editors. Applied clinical pharmacokinetics. New York: McGraw-Hill Medical; 2001. p. 93-179.
Brummett RE, Morrison RB. The incidence of aminoglycoside antibiotic-induced hearing loss. Arch Otolaryngol Head Neck Surg. 1990;116:406-10. doi: 10.1001/archotol.1990.01870040028008.PubMed PMID: 2317321.
American Speech-Language-Hearing Association. Guidelines for the audiologic management of individuals receiving cochleotoxic drug therapy. ASHA. 1994;36:11-9.
Gillbert DN, Moellering RS, Eliopoulos GE, Sande MA.The Sanford guide to antimicrobial therapy. 41st ed. Hyde Park: Antimicrobial Therapy Inc.;2011.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41. doi: 10.1159/000180580.PubMed PMID: 1244564.
Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988;16:128-40. doi: 10.1016/0196-6553(88)90053-3. PubMed PMID: 2841893.
Ibrahim EH, Sherman G, Ward S, Fraser VJ, Kollef MH. The influence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting. Chest. 2000;118:146-55. doi: 10.1378/chest.118.1.146.PubMed PMID: 10893372.
Leibovici L, Shraga I, Drucker M, Konigsberger H, Samra Z, Pitlik SD. The benefit of appropriate empirical antibiotic treatment in patients with bloodstream infection. J Intern Med. 1998;244:379-86. doi: 10.1046/j.1365-2796.1998.00379.x.PubMed PMID: 9845853.
Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999;115:462-74. doi:10.1378/chest.115.2.462.PubMed PMID: 10027448.
Fraser A, Paul M, Almanasreh N, Tacconelli E, Frank U, Cauda R, et al. Benefit of appropriate empirical antibiotic treatment: thirty-day mortality and duration of hospital stay. Am J Med. 2006;119:970-6. doi: 10.1016/j.amjmed.2006.03.034. PubMed PMID: 17071166.
Gould IM, Jappy B. Trends in hospital antibiotic prescribing after introduction of an antibiotic policy. J Antimicrob Chemother. 1996;38:895-904. doi: 10.1093/jac/38.5.895.PubMed PMID: 8961062.
Dunagan WC, Woodward RS, Medoff G, Gray JL, Casabar E, Lawrenz C, et al. Antibiotic misuse in two clinical situations: positive blood culture and administration of aminoglycosides. Rev Infect Dis. 1991;13:405-12. doi: 10.1093/clinids/13.3.405.PubMed PMID: 1866543.
Franson TR, Quebbeman EJ, Whipple J, Thomson R, Bubrick J, Rosenberger SL, et al. Prospective comparison of traditional and pharmacokinetic aminoglycoside dosing methods. Crit Care Med. 1988;16:840-3. doi: 10.1097/00003246-198809000-00004.PubMed PMID: 3402229.
Bartal C, Danon A, Schlaeffer F, Reisenberg K, Alkan M, Smoliakov R, et al. Pharmacokinetic dosing of aminoglycosides: a controlled trial. Am J Med. 2003;114:194-8. doi: 10.1016/S0002-9343(02)01476-6.PubMed PMID: 12637133.
Leehey DJ, Braun BI, Tholl DA, Chung LS, Gross CA, Roback JA, et al. Can pharmacokinetic dosing decrease nephrotoxicity associated with aminoglycoside therapy. J Am Soc Nephrol. 1993;4:81-90. PubMed PMID: 8400072.
Touw DJ, Neef C, Thomson AH, Vinks AA, Cost-Effectiveness of Therapeutic Drug Monitoring Committee of the International Association for Therapeutic Drug M, Clinical T. Cost-effectiveness of therapeutic drug monitoring: a systematic review. Ther Drug Monit. 2005;27:10-7. doi: 10.1097/00007691-200502000-00004.PubMed PMID: 15665740.
Begg EJ, Barclay ML, Kirkpatrick CJ. The therapeutic monitoring of antimicrobial agents. Br J Clin Pharmacol. 1999;47:23-30. doi: 10.1046/j.1365-2125.1999.00850.x.PubMed PMID: 10073735; PubMed Central PMCID: PMC2014209.
Begg EJ, Barclay ML. Aminoglycosides--50 years on. Br J Clin Pharmacol. 1995;39:597-603. PubMed PMID: 7654476; PubMed Central PMCID: PMC1365070.
Kashuba AD, Nafziger AN, Drusano GL, Bertino JS, Jr. Optimizing aminoglycoside therapy for nosocomial pneumonia caused by gram-negative bacteria. Antimicrob Agents Chemother. 1999;43:623-9. PubMed PMID: 10049277; PubMed Central PMCID: PMC89170.
Mann HJ, Wittbrodt ET, Baghaie AA, Cerra FB. Effect of pharmacokinetic sampling methods on aminoglycoside dosing in critically ill surgery patients. Pharmacotherapy. 1998;18:371-8. PubMed PMID: 9545157.
Burton ME, Ash CL, Hill DP, Jr., Handy T, Shepherd MD, Vasko MR. A controlled trial of the cost benefit of computerized bayesian aminoglycoside administration. Clin Pharmacol Ther. 1991;49:685-94. doi: 10.1038/clpt.1991.86.PubMed PMID: 1905602.
Schonheyder HC, Hojbjerg T. The impact of the first notification of positive blood cultures on antibiotic therapy. A one-year survey. APMIS. 1995;103:37-44. PubMed PMID: 7695890.
Cunney RJ, McNamara EB, Alansari N, Loo B, Smyth EG. The impact of blood culture reporting and clinical liaison on the empiric treatment of bacteraemia. J Clin Pathol. 1997;50:1010-2. doi: 10.1136/jcp.50.12.1010.PubMed PMID: 9516883; PubMed Central PMCID: PMC500382..
Zahar JR, Rioux C, Girou E, Hulin A, Sauve C, Bernier-Combes A, et al. Inappropriate prescribing of aminoglycosides: risk factors and impact of an antibiotic control team. J Antimicrob Chemother. 2006;58:651-6. doi: 10.1093/jac/dkl288. PubMed PMID: 16867998.
DeMaria A, Jr., Treadwell TL, Saunders CA, Porat R, McCabe WR. Randomized clinical trial of aztreonam and aminoglycoside antibiotics in the treatment of serious infections caused by gram-negative bacilli. Antimicrob Agents Chemother. 1989;33:1137-43. doi: 10.1128/AAC.33.8.1137.PubMed PMID: 2679368; PubMed Central PMCID: PMC172614.
Giamarellou H, Yiallouros K, Petrikkos G, Moschovakis E, Vavouraki E, Voutsinas D, et al. Comparative kinetics and efficacy of amikacin administered once or twice daily in the treatment of systemic gram-negative infections. J Antimicrob Chemother. 1991;27:73-9. doi: 10.1093/jac/27.suppl_C.73.PubMed PMID: 1906864.
El Desoky ES, Sheikh AA, Al Hammadi AY. Aminoglycoside and vancomycin serum concentration monitoring and mortality due to neonatal sepsis in Saudi Arabia. J Clin Pharm Ther. 2003;28:479-83. doi: 10.1046/j.0269-4727.2003.00522.x.PubMed PMID: 14651671.