5PSQ-155 PK-RULES: clinical rules to enhance safety and efficacy of treatments through pharmacokinetic monitoring

<h3>Background and Importance</h3> Adverse Drug Events (ADEs) are a significant concern in clinical settings, leading to patient harm and increased healthcare costs. Pharmacokinetic monitoring is crucial for optimising drug therapy, especially for medications with narrow therapeutic indices. Our pharmacy service has a clinical decision support system (CDSS), which integrates clinical information from the hospital’s different information systems that, through the application of predefined consensual clinical rules, generates real-time alerts aimed at preventing adverse drug events (ADEs) and tailored recommendations for optimising treatment. <h3>Aim and Objectives</h3> The objective of this project was to improve the safety and efficacy of treatment by integrating pharmacokinetic monitoring rules into a CDSS to enable early detection of patients whose treatment could be optimised based on plasma concentrations and to avoid medication errors, thus reducing the occurrence of ADEs. <h3>Material and Methods</h3> A multidisciplinary team of pharmacists, IT specialists, and medical experts (nephrologist, internist, gastroenterologist, infectious disease specialist) reviewed literature on medication monitoring and created clinical rules for identifying patients needing pharmacokinetic monitoring. These rules were validated and refined over 6 months to ensure their effectiveness. <h3>Results</h3> After 6 months of validation, the system was implemented in clinical practice. In the second half of 2023, we incorporated 41 clinical rules related to pharmacokinetic monitoring, generating 188 alerts (positive predictive value=0.8). Of all pharmacokinetic interventions, 58.2% resulted from alert reviews, successfully preventing 137 moderate-to-high severity ADEs classified as ≥ E according to NCC MERP. The most frequently generated alerts were: Vancomycin for more than 3 days without levels and creatinine (Cr) &gt; 1.2 mg/dl (29.3%). Vancomycin with levels (22.3%). Valproate level &lt; 50 µg/ml (8.5%). Digoxin level &gt; 1.2 ng/ml (6.4%). Vancomycin trough/single &lt; 9 µg/ml (6.4%). Amikacin for more than 3 days without levels (4.2%). Amikacin trough &gt; 2 µg/ml (3.8%). Paracetamol level &gt; 5 µg/ml (3.4%). Voriconazole and Voriconazole trough &lt; 2 µg/ml (2.9%). Most interventions occurred in orthopaedics (20.7%), critical care units (11.8%), neurosurgery (8.5%), and internal medicine (7.4%). <h3>Conclusion and Relevance</h3> The integration of pharmacokinetic monitoring rules into the CDSS significantly improved the detection of potential ADEs and optimised treatment. The successful prevention of ADEs highlights the importance of tailored pharmacokinetic interventions. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest

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Published
2025-03-01
DOI
https://doi.org/10.1136/ejhpharm-2025-eahp.447
Primary Topic
Statistical Methods in Clinical Trials
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article
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article

5PSQ-155 PK-RULES: clinical rules to enhance safety and efficacy of treatments through pharmacokinetic monitoring

M Sanjurjo-Saez, I Taladriz-Sender, Beatriz Sanz, ML Martín-Barbero et al.
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Statistical Methods in Clinical Trials
article

5PSQ-155 PK-RULES: clinical rules to enhance safety and efficacy of treatments through pharmacokinetic monitoring

M Sanjurjo-Saez, I Taladriz-Sender, Beatriz Sanz, ML Martín-Barbero, Sara Ibáñez-García, A Herranz-Alonso, Xandra García‐González, MP Montero-Anton, Y Rioja-Diez
article en

Abstract

<h3>Background and Importance</h3> Adverse Drug Events (ADEs) are a significant concern in clinical settings, leading to patient harm and increased healthcare costs. Pharmacokinetic monitoring is crucial for optimising drug therapy, especially for medications with narrow therapeutic indices. Our pharmacy service has a clinical decision support system (CDSS), which integrates clinical information from the hospital’s different information systems that, through the application of predefined consensual clinical rules, generates real-time alerts aimed at preventing adverse drug events (ADEs) and tailored recommendations for optimising treatment. <h3>Aim and Objectives</h3> The objective of this project was to improve the safety and efficacy of treatment by integrating pharmacokinetic monitoring rules into a CDSS to enable early detection of patients whose treatment could be optimised based on plasma concentrations and to avoid medication errors, thus reducing the occurrence of ADEs. <h3>Material and Methods</h3> A multidisciplinary team of pharmacists, IT specialists, and medical experts (nephrologist, internist, gastroenterologist, infectious disease specialist) reviewed literature on medication monitoring and created clinical rules for identifying patients needing pharmacokinetic monitoring. These rules were validated and refined over 6 months to ensure their effectiveness. <h3>Results</h3> After 6 months of validation, the system was implemented in clinical practice. In the second half of 2023, we incorporated 41 clinical rules related to pharmacokinetic monitoring, generating 188 alerts (positive predictive value=0.8). Of all pharmacokinetic interventions, 58.2% resulted from alert reviews, successfully preventing 137 moderate-to-high severity ADEs classified as ≥ E according to NCC MERP. The most frequently generated alerts were: Vancomycin for more than 3 days without levels and creatinine (Cr) &gt; 1.2 mg/dl (29.3%). Vancomycin with levels (22.3%). Valproate level &lt; 50 µg/ml (8.5%). Digoxin level &gt; 1.2 ng/ml (6.4%). Vancomycin trough/single &lt; 9 µg/ml (6.4%). Amikacin for more than 3 days without levels (4.2%). Amikacin trough &gt; 2 µg/ml (3.8%). Paracetamol level &gt; 5 µg/ml (3.4%). Voriconazole and Voriconazole trough &lt; 2 µg/ml (2.9%). Most interventions occurred in orthopaedics (20.7%), critical care units (11.8%), neurosurgery (8.5%), and internal medicine (7.4%). <h3>Conclusion and Relevance</h3> The integration of pharmacokinetic monitoring rules into the CDSS significantly improved the detection of potential ADEs and optimised treatment. The successful prevention of ADEs highlights the importance of tailored pharmacokinetic interventions. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest

Hospital General Universitario Gregorio Marañón (ES)
Openalex Percentile: Top 95%
Statistical Methods in Clinical Trials
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