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Patterns, predictors and preventability of adverse drug reactions in the coronary care unit of a tertiary care hospital

  • Pharmacoepidemiology and Prescription
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Abstract

Aim

To determine the frequency of occurrence, risk factors, clinical spectrum and drugs associated with adverse drug reactions (ADRs) occurring in the coronary care unit (CCU) of a tertiary care hospital.

Methods

This was a retrospective cohort study based on evaluation of the medical records of consecutive patients admitted to the CCU between January 2008 and December 2008. Each prescription was monitored for ADRs, and each ADR was assessed for causality, severity, predictability and preventability by two physicians using relevant scales. The chi-square test and independent t test were used to compare the ADR and non-ADR groups. Multiple binary logistic regression was used to identify risk factors for developing ADRs in the CCU.

Results

Of 595 patients, 152 (25.5%) developed ADRs, of which 45% were potentially preventable. Severe ADRs constituted 28.6% of the total ADRs. Patients who developed an ADR had a longer duration of stay in the hospital (2.8 extra days) (p < 0.05). Hypokalemia/hyperkalemia (22%), bleeding (11%) and cardiac arrhythmias (11%) were the commonest ADRs. The highest rates of ADRs were seen with streptokinase (59.4%). The predictors for developing an ADR in the CCU included renal dysfunction [odds ratio (OR) 1.66, 95% confidence interval (CI) 1.007–2.72], arrhythmias (OR 1.74, 95% CI 1.052–2.87) and polypharmacy with more than ten drugs (OR 11.3, 95% CI 1.45–87.44).

Conclusion

A high frequency of ADR occurrence was identified, with many of the ADRs being potentially preventable. Patients with renal dysfunction or cardiac arrhythmias and those receiving polypharmacy were at an increased risk for developing an ADR in the CCU.

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Abbreviations

ADE:

Adverse drug event

ADR:

Adverse drug reactions

CCU:

Coronary care unit

IERB:

Institutional Ethical Review Board

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Acknowledgments

The authors sincerely and gratefully acknowledge the time, cooperation and effort of the personnel at the medical records department of St. John’s Hospital, Bangalore and the indispensable contribution of Mrs. Sumitra, statistician at St. John’s Research Institute, Bangalore. We also thank Ms. Sandra Sarah, final year medical student, for her contribution to aspects of data entry and the construction of tables and graphs.

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Authors and Affiliations

  1. Department of Pharmacology, St. John’s Medical College, Koramangala, Bangalore, Karnataka, 560034, India

    Padmini Devi, Deepak Y. Kamath, Naveen Anthony & Sushma Santosh

  2. Department of Surgery, St. John’s Medical College, Bangalore, India

    Brendan Dias

Authors
  1. Padmini Devi
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  2. Deepak Y. Kamath
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  3. Naveen Anthony
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  4. Sushma Santosh
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Correspondence to Deepak Y. Kamath.

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Devi, P., Kamath, D.Y., Anthony, N. et al. Patterns, predictors and preventability of adverse drug reactions in the coronary care unit of a tertiary care hospital. Eur J Clin Pharmacol 68, 427–433 (2012). https://doi.org/10.1007/s00228-011-1138-9

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  • DOI: https://doi.org/10.1007/s00228-011-1138-9

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