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Evaluation of adverse drug reactions in medical intensive care units

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Abstract

Purpose

Patterns of adverse drug reactions (ADRs) in the medical intensive care unit (MICU) were analysed, and signals for detecting ADRs were developed from the analysis.

Method

A retrospective study was conducted in MICU wards at a tertiary care teaching hospital in Seoul, Korea. The areas included one general MICU and one cancer centre MICU. Two pharmacists evaluated ADRs in terms of length of stay, causality, severity, preventability, types, related organs, and incidence. Differences in ADR perception rates between physicians and pharmacists were also evaluated. ADR cases detected through the evaluation were reviewed to develop specific alerting signals for ICU ADRs.

Results

The study group included 346 patients admitted to the ICU over 4 months. The overall incidence of ADRs was 32%. ICU length of stay is closely related to ADRs (p = 0.014). Most ADR cases were mild, temporary, and harmful to the patient. Twenty percent of ADRs were preventable, and 74% were type A. Of the ADRs, 70% were noted by physicians; 80% required intervention. The most commonly implicated drug was amphotericin B, and the clinical presentation was a haematologic reaction. Data on the time required for pharmacists to identify ADRs indicated that they were not slower than physicians. Six signals for early detection of the ADRs were developed.

Conclusions

The overall ADR incidence in the MICU was about one-third, and the length of stay of the ADR group was longer than that of those without this experience. Automated signal generation was developed. It seemed to be a valuable tool for faster and more efficient patient management, and possibly prevention of ADRs. A future study should scientifically evaluate the clinical relevance of this tool.

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Author information

Authors and Affiliations

  1. Department of Pharmacy, Samsung Medical Center, Seoul, South Korea

    Sojin Park & Yongwon In

  2. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

    Gee young Suh

  3. College of Pharmacy, Kyungsung University, Busan, South Korea

    Kieho Sohn

  4. College of Pharmacy, Chungnam National University, 99 Daehak-Ro, Yuseing-Gu, Daejeon, South Korea

    Eunyoung Kim

Authors
  1. Sojin Park
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  2. Yongwon In
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  3. Gee young Suh
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  4. Kieho Sohn
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  5. Eunyoung Kim
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Corresponding author

Correspondence to Eunyoung Kim.

Appendices

Appendix 1

Table 7 presents the Naranjo scale for assessing ADRs.

Table 7 Naranjo scale
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Appendix 2

Fig. 1
figure 1

Korean algorithm (ver. II)

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Appendix 3

Fig. 2
figure 2

National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) categories

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Category A: Circumstances or events that have the capacity to cause error

Category B: An error occurred but the error did not reach the patient

Category C: An error occurred that reached the patient but did not cause patient harm

Category D: An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm

Category E: An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention

Category F: An error occurred that may have contributed to or resulted in temporary harm to the patient and resulted initial or prolonged hospitalization

Category G: An error occurred that may have contributed to or resulted in permanent patient harm

Category H: An error occurred that resulted intervention necessary to sustain life

Category I: An error occurred that may have contributed to or resulted in the patient’s death

Appendix 4

Table 8 presents the LDS scale for assessing the severity of an ADR.

Table 8 LDS scale
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Appendix 5

Table 9 presents Schumock and Thornton’s criteriafor determining if an ADR was preventable.

Table 9 Schumock and Thornton’s preventability criteria
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Appendix 6

Table 10 distinguished between type A and type B ADRs.

Table 10 Types of ADR
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Park, S., In, Y., Suh, G. et al. Evaluation of adverse drug reactions in medical intensive care units. Eur J Clin Pharmacol 69, 119–131 (2013). https://doi.org/10.1007/s00228-012-1318-2

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  • DOI: https://doi.org/10.1007/s00228-012-1318-2

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