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Adverse drug events in an intensive care unit of a university hospital

  • Pharmacoepidemiology and Prescription
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Abstract

Purpose

Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequency of ADEs among patients in the ICU of a university hospital and the drugs implicated. Also, factors associated with ADEs are investigated.

Methods

This cross-sectional study investigated 299 medical records of patients hospitalized for 5 or more days in an ICU. ADEs were identified through intensive monitoring adopted in hospital pharmacovigilance and also ADE triggers. Adverse drug reactions (ADR) causality was classified using the Naranjo algorithm. Data were analyzed through descriptive analysis, and through univariate and multiple logistic regression.

Results

The most frequent ADEs were ADRs type A, of possible causality and moderate severity. The most frequent ADR was drug-induced acute kidney injury. Patients with ADEs related to DIs corresponded to 7% of the sample. The multiple logistic regression showed that length of hospitalization (OR = 1.06) and administration of cardiovascular drugs (OR = 2.2) were associated with the occurrence of ADEs.

Conclusion

Adverse drug reactions of clinical significance were the most frequent ADEs in the ICU studied, which reduces patient safety. The number of ADEs related to drug interactions was small, suggesting that clinical manifestations of drug interactions that harm patients are not frequent in ICUs.

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References

  1. George EL, Henneman EA, Tasota FJ (2010) Nursing implications for prevention of adverse drug events in the intensive care unit. Crit Care Med 38 [6 Suppl]:S136–S144

    Article  PubMed  Google Scholar 

  2. Stockwell DC, Slonim AD (2006) Quality and safety in the intensive care unit. J Intensive Care Med 21(4):199–210

    Article  PubMed  Google Scholar 

  3. Kane-Gill S, Rea RS, Verrico MM, Weber RJ (2006) Adverse-drug-event rates for high-cost and high-use drugs in the intensive care unit. Am J Health Syst Pharm 63(19):1876–1881

    Article  PubMed  Google Scholar 

  4. Kane-Gill SL, Jacobi J, Rothschild JM (2010) Adverse drug events in intensive care units: risk factors, impact, and the role of team care. Crit Care Med 38 [6 Suppl]:S117–S125

    PubMed  Google Scholar 

  5. Joshua L, Devi P, Guido S (2009) Adverse drug reactions in medical intensive care unit of a tertiary care hospital. Pharmacoepidemiol Drug Saf 18(7):639–645

    Article  PubMed  Google Scholar 

  6. Krähenbühl-Melcher A, Schlienger R, Lampert M, Haschke M, Drewe J, Krähenbühl S (2007) Drug-related problems in hospitals: a review of the recent literature. Drug Saf 30(5):379–407

    Article  PubMed  Google Scholar 

  7. Granowitz EV, Brown RB (2008) Antibiotic adverse reactions and drug interactions. Crit Care Clin 24(2):421–442

    Article  PubMed  CAS  Google Scholar 

  8. Vargas E, Terleira A, Hernando F, Perez E, Cordón C, Moreno A, Portolés A (2003) Effect of adverse drug reactions on length of stay in surgical intensive care units. Crit Care Med 31(3):694–698

    Article  PubMed  Google Scholar 

  9. Vargas E, Simón J, Martin JC, Puerro M, Gonzalez-Callejo MA, Jaime M, Gomez-Mayoral B, Duque F, Gomez-Delgado A, Moreno A (1998) Effect of adverse drug reactions on length of stay in intensive care units. Clin Drug Investig 15(4):353–360

    Article  PubMed  CAS  Google Scholar 

  10. Kane-Gill SL, Devlin JW (2006) Adverse drug event reporting in intensive care units: a survey of current practices. Ann Pharmacother 40(7–8):1267–1273

    PubMed  Google Scholar 

  11. Cullen DJ, Sweitzer BJ, Bates DW, Burdick E, Edmondson A, Leape LL (1997) Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units. Crit Care Med 25(8):1289–1297

    Article  PubMed  CAS  Google Scholar 

  12. Griffin FA, Resar RK (2007) IHI global triggers for measuring adverse events: IHI innovations series white paper. Cambridge: Institute for healthcare improvements. Available from URL: http//:www.ihi.org

  13. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ (1981) A method for estimating the probabiliting of adverse drug reactions. Clin Pharmacol Ther 30(2):239–245

    Article  PubMed  CAS  Google Scholar 

  14. Rawlins MD, Thompson JW (1981) Pathogenesis of adverse drug reactions. In: Daviies DM (ed) Text book of adverse drug reactions, 2nd edn. Oxford University Press, Oxford, p 11

    Google Scholar 

  15. Drug-Reax System. Thomson Reuters (Healthcare) Inc. Available from URL :http://www.thomsonhc.com>. Accessed 30 August 2009

  16. Committee of experts on management of safety and quality in health care expert group on safe medication practices(sp-sqs). Glossary of terms related to patient and medication safety. World Health Organization, 2005. Available: from:URL:http://www.who.int/patientsafety/highlights/coe_patient_and_medication_safety_gl.pdf> Accessed 3 August 2007

  17. Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P (2009) Towards an international classification for patient safety: key concepts and terms. Int J Qual Health Care 21(1):18–26

    Article  PubMed  Google Scholar 

  18. Kopp BJ, Erstad BL, Allen ME, Theodorou AA, Priestley G (2006) Medication errors and adverse drug events in an intensive care unit: direct observation approach for detection. Crit Care Med 34(2):415–425

    Article  PubMed  Google Scholar 

  19. Valentin A, Capuzzo M, Guidet B, Moreno R, Metnitz B, Bauer P, Metnitz P (2009) Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ 338:b814. doi:10.1136/bmj.b814

    Article  PubMed  Google Scholar 

  20. Van den Bemt PM, Fijn R, van der Voort PH, Gossen AA, Egberts TC, Brouwers JR (2002) Frequency and determinants of drug administration errors in the intensive care unit. Crit Care Med 30(4):846–850

    Article  PubMed  Google Scholar 

  21. Mehta RL, Pascual MT, Soroko S, Savage BR, Himmelfarb J, Ikizler TA, Paganini EP, Chertow GM (2004) Spectrum of acute renal failure in the intensive care unit: the PICARD experience. Kidney Int 66(4):1613–1621

    Article  PubMed  Google Scholar 

  22. Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C (2005) Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA 294(7):813–818

    Article  PubMed  CAS  Google Scholar 

  23. Pannu N, Nadim MK (2008) An overview of drug-induced acute kidney injury. Crit Care Med 36 [4 Suppl]:S216–S223

    Article  PubMed  CAS  Google Scholar 

  24. Bentley ML, Corwin HL, Dasta J (2010) Drug-induced acute kidney injury in the critically ill adult: recognition and prevention strategies. Crit Care Med 38 [6 Suppl]:S169–S174

    Article  PubMed  CAS  Google Scholar 

  25. Dougherty L (2008) IV therapy: recognizing the differences between infiltration and extravasation. Br J Nurs 17(14):896, 898–901

    PubMed  Google Scholar 

  26. Hadaway L (2007) Infiltration and extravasation. Am J Nurs 107(8):64–72

    PubMed  Google Scholar 

  27. Uslusoy E, Mete SJ (2008) Predisposing factors to phlebitis in patients with peripheral intravenous catheters: a descriptive study. Am Acad Nurse Pract 20(4):172–180

    Article  Google Scholar 

  28. Machado AF, Pedreira Mda L, Chaud MN (2008) Adverse events related to the use of peripheral intravenous catheters in children according to dressing regimens. Rev Latino Am Enfermagen 16(3):362–367

    Google Scholar 

  29. Wills S, Brown D (1999) A proposed new means of classifying adverse reactions to medicines. Pharm J 262:163–165

    Google Scholar 

  30. Doellman D, Hadaway L, Bowe-Geddes LA, Franklin M, LeDonne J, Papke-O’Donnell L, Pettit J, Schulmeister L, Stranz MJ (2009) Infiltration and extravasation: update on prevention and management. Infus Nurs 32(4):203–211

    Article  Google Scholar 

  31. Thomas AN, Panchagnula U, Taylor RJ (2009) Review of patient safety incidents submitted from critical care units in England & Wales to the UK national patient safety agency. Anaesthesia 64(11):1178–1185

    Article  PubMed  CAS  Google Scholar 

  32. Lundgren A, Jorfeldt L, Ek AC (1993) The care and handling of peripheral intravenous cannulae on 60 surgery and internal medicine patients: an observation study. J Adv Nurs 18(6):963–971

    Article  PubMed  CAS  Google Scholar 

  33. Maki DG, Ringer M (1991) Risk factors for infusion-related phlebitis with small peripheral venous catheters. A randomized controlled trial. Ann Intern Med 114(10):845–854

    PubMed  CAS  Google Scholar 

  34. Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet 356(9237):1255–1259

    Article  PubMed  CAS  Google Scholar 

  35. Masi S, de Cléty SC, Anslot C, Detaille T (2009) Acute amiodarone toxicity due to an administration error: could excipient be responsible? Br J Clin Pharmacol 67(6):691–693

    Article  PubMed  Google Scholar 

  36. Cushing DJ, Adams MP, Cooper WD, Zhang B, Lipicky RJ, Kowey PR (2009) Evaluation of the effects of PM101, a cyclodextrin-based formulation of intravenous amiodarone, on blood pressure in healthy humans. Am J Cardiol 104(8):1152–1157

    Article  PubMed  CAS  Google Scholar 

  37. Egger SS, Drewe J, Schlienger RG (2003) Potential drug-drug interactions in the medication of medical patients at hospital discharge. Eur J Clin Pharmacol 58(11):773–778

    PubMed  Google Scholar 

  38. Bates DW, Miller EB, Cullen DJ, Burdick L, Williams L, Laird N, Petersen LA, Small SD, Sweitzer BJ, Vander Vliet M, Leape LL (1999) Patient risk factors for adverse drug events in hospitalized patients. ADE prevention study group. Arch Intern Med 159(21):2553–2560

    Article  PubMed  CAS  Google Scholar 

  39. Atuah KN, Hughes D, Pirmohamed M (2004) Clinical pharmacology: special safety considerations in drug development and pharmacovigilance. Drug Saf 27(8):535–554

    Article  PubMed  CAS  Google Scholar 

  40. Merle L, Laroche ML, Dantoine T, Charmes JP (2005) Predicting and preventing adverse drug reactions in the very old. Drugs Aging 22(5):375–392

    Article  PubMed  Google Scholar 

  41. Evans RS, Lloyd JF, Stoddard GJ, Nebeker JR, Samore MH (2005) Risk factors for adverse drug events: a 10-year analysis. Ann Pharmacother 39(7–8):1161–1168

    PubMed  Google Scholar 

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Correspondence to Adriano Max Moreira Reis.

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Reis, A.M.M., Cassiani, S.H.D.B. Adverse drug events in an intensive care unit of a university hospital. Eur J Clin Pharmacol 67, 625–632 (2011). https://doi.org/10.1007/s00228-010-0987-y

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  • DOI: https://doi.org/10.1007/s00228-010-0987-y

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