Appl Clin Inform 2012; 03(02): 221-238
DOI: 10.4338/ACI-2012-03-RA-0009
Research Article
Schattauer GmbH

Real-time pharmacy surveillance and clinical decision support to reduce adverse drug events in acute kidney injury

A randomized, controlled trial
A.B. McCoy
1   Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN
,
Z.L. Cox
2   Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN
3   College of Pharmacy, Lipscomb University, Nashville, TN
,
E.B. Neal
2   Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN
,
L.R. Waitman
4   Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS
,
N.B. Peterson
5   Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
,
G. Bhave
6   Division of Nephrology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
,
E.D. Siew
6   Division of Nephrology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
,
I. Danciu
1   Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN
,
J.B. Lewis
6   Division of Nephrology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
,
J.F. Peterson
1   Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN
5   Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
7   Geriatric Research Education Clinical Center (GRECC), VA Tennessee Valley Healthcare System, Nashville, TN
› Author Affiliations
Further Information

Correspondence to:

Allison B. McCoy, PhD
School of Biomedical Informatics, The University of
Texas Health Science Center at Houston (UTHealth)
UT Houston-Memorial Hermann Center for Healthcare
Quality and Safety
6410 Fannin St, UPB 1100
Houston, TX 77030
Phone: (713) 500–6931   

Publication History

received: 23 March 2012

accepted: 29 May 2012

Publication Date:
16 December 2017 (online)

 

Summary

Objectives: Clinical decision support (CDS), such as computerized alerts, improves prescribing in the setting of acute kidney injury (AKI), but considerable opportunity remains to improve patient safety. The authors sought to determine whether pharmacy surveillance of AKI patients could detect and prevent medication errors that are not corrected by automated interventions.

Methods: The authors conducted a randomized clinical trial among 396 patients admitted to an academic, tertiary care hospital between June 1, 2010 and August 31, 2010 with an acute 0.5 mg/dl change in serum creatinine over 48 hours and a nephrotoxic or renally cleared medication order. Patients randomly assigned to the intervention group received surveillance from a clinical pharmacist using a web-based surveillance tool to monitor drug prescribing and kidney function trends. CDS alerting and standard pharmacy services were active in both study arms. Outcome measures included blinded adjudication of potential adverse drug events (pADEs), adverse drug events (ADEs) and time to provider modification or discontinuation of targeted nephrotoxic or renally cleared medications.

Results: Potential ADEs or ADEs occurred for 104 (8.0%) of control and 99 (7.1%) of intervention patient-medication pairs (p=0.4). Additionally, the time to provider modification or discontinuation of targeted nephrotoxic or renally cleared medications did not differ between control and intervention patients (33.4 hrs vs. 30.3hrs, p=0.3).

Conclusions: Pharmacy surveillance had no incremental benefit over previously implemented CDS alerts


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Conflicts of interest

The authors declare that they have no conflicts of interest in the research.

  • References

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  • 2 Galanter WL, Polikaitis A, DiDomenico RJ. A trial of automated safety alerts for inpatient digoxin use with computerized physician order entry. J Am Med Inform Assoc 2004; 11 (04) 270-277.
  • 3 Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma’Luf N. et al. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc 1999; 6 (04) 313-321.
  • 4 Bates DW, O’Neil AC, Boyle D, Teich J, Chertow GM, Komaroff AL. et al. Potential identifiability and preventability of adverse events using information systems. J Am Med Inform Assoc 1994; 1 (05) 404-411.
  • 5 van der Sijs H, Aarts J, Vulto A, Berg M. Overriding of drug safety alerts in computerized physician order entry. J Am Med Inform Assoc 2006; 13 (02) 138-147.
  • 6 Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE. et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005; 293 (010) 1197-1203.
  • 7 Ash JS, Sittig DF, Dykstra R, Campbell E, Guappone K. The unintended consequences of computerized provider order entry: findings from a mixed methods exploration. Int J Med Inform 2009; 78 (Suppl. 01) S69-S76.
  • 8 Sittig DF, Singh H. Defining health information technology-related errors: new developments since to err is human. Arch Intern Med 2011; 171 (014) 1281-1284.
  • 9 McCoy AB, Waitman LR, Lewis JB, Wright JA, Choma DP, Miller RA. et al. A framework for evaluating the appropriateness of clinical decision support alerts and responses. J Am Med Inform Assoc 2012; 19 (03) 346-352.
  • 10 Kucukarslan SN, Peters M, Mlynarek M, Nafziger DA. Pharmacists on rounding teams reduce preventable adverse drug events in hospital general medicine units. Arch Intern Med 2003; 163 (017) 2014-2018.
  • 11 Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI. et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999; 282 (03) 267-270.
  • 12 Kaushal R, Bates DW, Abramson EL, Soukup JR, Goldmann DA. Unit-based clinical pharmacists’ prevention of serious medication errors in pediatric inpatients. Am J Health Syst Pharm 2008; Jul 1 65 (013) 1254-60.
  • 13 Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E. et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med 2006; 166 (05) 565-571.
  • 14 Fertleman M, Barnett N, Patel T. Improving medication management for patients: the effect of a pharmacist on post-admission ward rounds. Qual Saf Health Care 2005; 14 (03) 207-211.
  • 15 Falconnier AD, Haefeli WE, Schoenenberger RA, Surber C, Martin-Facklam M. Drug dosage in patients with renal failure optimized by immediate concurrent feedback. J Gen Intern Med 2001; 16 (06) 369-375.
  • 16 Brown G. Assessing the clinical impact of pharmacists’ interventions. Am J Hosp Pharm 1991; 48 (012) 2644-2647.
  • 17 Bladh L, Ottosson E, Karlsson J, Klintberg L, Wallerstedt SM. Effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs: a randomised controlled trial. BMJ Qual Saf 2011; 20 (09) 738-746.
  • 18 Kilbridge PM, Alexander L, Ahmad A. Implementation of a system for computerized adverse drug event surveillance and intervention at an academic medical center. J Clin Outcomes Manage 2006; 13 (02) 94-100.
  • 19 Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991; 266 (020) 2847-2851.
  • 20 Jha AK, Laguette J, Seger A, Bates DW. Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application. J Am Med Inform Assoc 2008; 15 (05) 647-653.
  • 21 Evans RS, Pestotnik SL, Classen DC, Burke JP. Evaluation of a computer-assisted antibiotic-dose monitor. Ann Pharmacother 1999; 33 (010) 1026-1031.
  • 22 McCoy AB, Waitman LR, Gadd CS, Danciu I, Smith JP, Lewis JB. et al. A computerized provider order entry intervention for medication safety during acute kidney injury: a quality improvement report. Am J Kidney Dis 2010; 56 (05) 832-841.
  • 23 Chertow GM, Lee J, Kuperman GJ, Burdick E, Horsky J, Seger DL. et al. Guided medication dosing for in-patients with renal insufficiency. JAMA 2001; 286 (022) 2839-2844.
  • 24 Sellier E, Colombet I, Sabatier B, Breton G, Nies J, Zapletal E. et al. Effect of alerts for drug dosage adjustment in inpatients with renal insufficiency. J Am Med Inform Assoc 2009; 16 (02) 203-210.
  • 25 Rind DM, Safran C, Phillips RS, Wang Q, Calkins DR, Delbanco TL. et al. Effect of computer-based alerts on the treatment and outcomes of hospitalized patients. Arch Intern Med 1994; 154 (013) 1511-1517.
  • 26 Field TS, Rochon P, Lee M, Gavendo L, Baril JL, Gurwitz JH. Computerized clinical decision support during medication ordering for long-term care residents with renal insufficiency. J Am Med Inform Assoc 2009; 16 (04) 480-485.
  • 27 Cox ZL, Nelsen CL, Waitman LR, McCoy JA, Peterson JF. Effects of clinical decision support on initial dosing and monitoring of tobramycin and amikacin. Am J Health Syst Pharm 2011; 68 (07) 624-632.
  • 28 Geissbühler A, Miller RA. A new approach to the implementation of direct care-provider order entry. Proc AMIA Annu Fall Symp 1996; 689-693.
  • 29 Giuse DA. Supporting communication in an integrated patient record system. AMIA Annu Symp Proc 2003; 1065.
  • 30 Phillips I, Nelsen C, Peterson J, Sullivan T, Waitman L. Improving aminoglycoside dosing through computerized clinical decision support and pharmacy therapeutic monitoring systems. AMIA Annu Symp Proc 2008; 1093.
  • 31 Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC. et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003; 289 (09) 1107-1116.
  • 32 McCoy AB, Peterson JF. The Greasemonkey Firefox Add-On for Altering Display of Data in a Web-Based Electronic Medical Record. AMIA Annu Symp Proc 2011; 1884.
  • 33 Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993; 8 (06) 289-294.
  • 34 Pippins JR, Gandhi TK, Hamann C, Ndumele CD, Labonville SA, Diedrichsen EK. et al. Classifying and predicting errors of inpatient medication reconciliation. J Gen Intern Med 2008; 23 (09) 1414-1422.
  • 35 Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T. et al. Systems Analysis of Adverse Drug Events. JAMA 1995; 274 (01) 35-43.
  • 36 Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM. et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998; 280 (015) 1311-1316.
  • 37 Jha AK, Kuperman GJ, Teich JM, Leape L, Shea B, Rittenberg E. et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc 1998; 5 (03) 305-314.
  • 38 Kane-Gill SL, Visweswaran S, Saul MI, Wong A-KI, Penrod LE, Handler SM. Computerized detection of adverse drug reactions in the medical intensive care unit. Int J Med Inform 2011; 80 (08) 570-578.
  • 39 Kilbridge PM, Noirot LA, Reichley RM, Berchelmann KM, Schneider C, Heard KM. et al. Computerized surveillance for adverse drug events in a pediatric hospital. J Am Med Inform Assoc 2009; 16 (05) 607-612.
  • 40 Tinoco A, Evans RS, Staes CJ, Lloyd JF, Rothschild JM, Haug PJ. Comparison of computerized surveillance and manual chart review for adverse events. J Am Med Inform Assoc 2011; 18 (04) 491-497.
  • 41 Forster AJ, Worthington JR, Hawken S, Bourke M, Rubens F, Shojania K. et al. Using prospective clinical surveillance to identify adverse events in hospital. BMJ Qual Saf 2011; 20 (09) 756-763.
  • 42 Reynolds G, Boyer D, Mackey K, Povondra L, Cummings A. Alerting strategies in computerized physician order entry: A novel use of a dashboard-style analytics tool in a childrens hospital. AMIA Annu Symp Proc 2008; 1108.
  • 43 Zimmerman CR, Jackson A, Chaffee B, O’Reilly M. A dashboard model for monitoring alert effectiveness and bandwidth. AMIA Annu Symp Proc 2007; 1176.
  • 44 Waitman LR, Phillips IE, McCoy AB, Danciu I, Halpenny RM, Nelsen CL. et al. Adopting real-time surveil-lance dashboards as a component of an enterprisewide medication safety strategy. Jt Comm J Qual Patient Saf 2011; 37 (07) 326-332.
  • 45 Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon C. et al. Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention. J Gen Intern Med 2010; 25 (01) 31-38.

Correspondence to:

Allison B. McCoy, PhD
School of Biomedical Informatics, The University of
Texas Health Science Center at Houston (UTHealth)
UT Houston-Memorial Hermann Center for Healthcare
Quality and Safety
6410 Fannin St, UPB 1100
Houston, TX 77030
Phone: (713) 500–6931   

  • References

  • 1 Miller RA, Waitman LR, Chen S, Rosenbloom ST. The anatomy of decision support during inpatient care provider order entry (CPOE): empirical observations from a decade of CPOE experience at Vanderbilt. J Biomed Inform 2005; 38 (06) 469-485.
  • 2 Galanter WL, Polikaitis A, DiDomenico RJ. A trial of automated safety alerts for inpatient digoxin use with computerized physician order entry. J Am Med Inform Assoc 2004; 11 (04) 270-277.
  • 3 Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma’Luf N. et al. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc 1999; 6 (04) 313-321.
  • 4 Bates DW, O’Neil AC, Boyle D, Teich J, Chertow GM, Komaroff AL. et al. Potential identifiability and preventability of adverse events using information systems. J Am Med Inform Assoc 1994; 1 (05) 404-411.
  • 5 van der Sijs H, Aarts J, Vulto A, Berg M. Overriding of drug safety alerts in computerized physician order entry. J Am Med Inform Assoc 2006; 13 (02) 138-147.
  • 6 Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE. et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005; 293 (010) 1197-1203.
  • 7 Ash JS, Sittig DF, Dykstra R, Campbell E, Guappone K. The unintended consequences of computerized provider order entry: findings from a mixed methods exploration. Int J Med Inform 2009; 78 (Suppl. 01) S69-S76.
  • 8 Sittig DF, Singh H. Defining health information technology-related errors: new developments since to err is human. Arch Intern Med 2011; 171 (014) 1281-1284.
  • 9 McCoy AB, Waitman LR, Lewis JB, Wright JA, Choma DP, Miller RA. et al. A framework for evaluating the appropriateness of clinical decision support alerts and responses. J Am Med Inform Assoc 2012; 19 (03) 346-352.
  • 10 Kucukarslan SN, Peters M, Mlynarek M, Nafziger DA. Pharmacists on rounding teams reduce preventable adverse drug events in hospital general medicine units. Arch Intern Med 2003; 163 (017) 2014-2018.
  • 11 Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI. et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999; 282 (03) 267-270.
  • 12 Kaushal R, Bates DW, Abramson EL, Soukup JR, Goldmann DA. Unit-based clinical pharmacists’ prevention of serious medication errors in pediatric inpatients. Am J Health Syst Pharm 2008; Jul 1 65 (013) 1254-60.
  • 13 Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E. et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med 2006; 166 (05) 565-571.
  • 14 Fertleman M, Barnett N, Patel T. Improving medication management for patients: the effect of a pharmacist on post-admission ward rounds. Qual Saf Health Care 2005; 14 (03) 207-211.
  • 15 Falconnier AD, Haefeli WE, Schoenenberger RA, Surber C, Martin-Facklam M. Drug dosage in patients with renal failure optimized by immediate concurrent feedback. J Gen Intern Med 2001; 16 (06) 369-375.
  • 16 Brown G. Assessing the clinical impact of pharmacists’ interventions. Am J Hosp Pharm 1991; 48 (012) 2644-2647.
  • 17 Bladh L, Ottosson E, Karlsson J, Klintberg L, Wallerstedt SM. Effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs: a randomised controlled trial. BMJ Qual Saf 2011; 20 (09) 738-746.
  • 18 Kilbridge PM, Alexander L, Ahmad A. Implementation of a system for computerized adverse drug event surveillance and intervention at an academic medical center. J Clin Outcomes Manage 2006; 13 (02) 94-100.
  • 19 Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991; 266 (020) 2847-2851.
  • 20 Jha AK, Laguette J, Seger A, Bates DW. Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application. J Am Med Inform Assoc 2008; 15 (05) 647-653.
  • 21 Evans RS, Pestotnik SL, Classen DC, Burke JP. Evaluation of a computer-assisted antibiotic-dose monitor. Ann Pharmacother 1999; 33 (010) 1026-1031.
  • 22 McCoy AB, Waitman LR, Gadd CS, Danciu I, Smith JP, Lewis JB. et al. A computerized provider order entry intervention for medication safety during acute kidney injury: a quality improvement report. Am J Kidney Dis 2010; 56 (05) 832-841.
  • 23 Chertow GM, Lee J, Kuperman GJ, Burdick E, Horsky J, Seger DL. et al. Guided medication dosing for in-patients with renal insufficiency. JAMA 2001; 286 (022) 2839-2844.
  • 24 Sellier E, Colombet I, Sabatier B, Breton G, Nies J, Zapletal E. et al. Effect of alerts for drug dosage adjustment in inpatients with renal insufficiency. J Am Med Inform Assoc 2009; 16 (02) 203-210.
  • 25 Rind DM, Safran C, Phillips RS, Wang Q, Calkins DR, Delbanco TL. et al. Effect of computer-based alerts on the treatment and outcomes of hospitalized patients. Arch Intern Med 1994; 154 (013) 1511-1517.
  • 26 Field TS, Rochon P, Lee M, Gavendo L, Baril JL, Gurwitz JH. Computerized clinical decision support during medication ordering for long-term care residents with renal insufficiency. J Am Med Inform Assoc 2009; 16 (04) 480-485.
  • 27 Cox ZL, Nelsen CL, Waitman LR, McCoy JA, Peterson JF. Effects of clinical decision support on initial dosing and monitoring of tobramycin and amikacin. Am J Health Syst Pharm 2011; 68 (07) 624-632.
  • 28 Geissbühler A, Miller RA. A new approach to the implementation of direct care-provider order entry. Proc AMIA Annu Fall Symp 1996; 689-693.
  • 29 Giuse DA. Supporting communication in an integrated patient record system. AMIA Annu Symp Proc 2003; 1065.
  • 30 Phillips I, Nelsen C, Peterson J, Sullivan T, Waitman L. Improving aminoglycoside dosing through computerized clinical decision support and pharmacy therapeutic monitoring systems. AMIA Annu Symp Proc 2008; 1093.
  • 31 Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC. et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003; 289 (09) 1107-1116.
  • 32 McCoy AB, Peterson JF. The Greasemonkey Firefox Add-On for Altering Display of Data in a Web-Based Electronic Medical Record. AMIA Annu Symp Proc 2011; 1884.
  • 33 Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993; 8 (06) 289-294.
  • 34 Pippins JR, Gandhi TK, Hamann C, Ndumele CD, Labonville SA, Diedrichsen EK. et al. Classifying and predicting errors of inpatient medication reconciliation. J Gen Intern Med 2008; 23 (09) 1414-1422.
  • 35 Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T. et al. Systems Analysis of Adverse Drug Events. JAMA 1995; 274 (01) 35-43.
  • 36 Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM. et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998; 280 (015) 1311-1316.
  • 37 Jha AK, Kuperman GJ, Teich JM, Leape L, Shea B, Rittenberg E. et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc 1998; 5 (03) 305-314.
  • 38 Kane-Gill SL, Visweswaran S, Saul MI, Wong A-KI, Penrod LE, Handler SM. Computerized detection of adverse drug reactions in the medical intensive care unit. Int J Med Inform 2011; 80 (08) 570-578.
  • 39 Kilbridge PM, Noirot LA, Reichley RM, Berchelmann KM, Schneider C, Heard KM. et al. Computerized surveillance for adverse drug events in a pediatric hospital. J Am Med Inform Assoc 2009; 16 (05) 607-612.
  • 40 Tinoco A, Evans RS, Staes CJ, Lloyd JF, Rothschild JM, Haug PJ. Comparison of computerized surveillance and manual chart review for adverse events. J Am Med Inform Assoc 2011; 18 (04) 491-497.
  • 41 Forster AJ, Worthington JR, Hawken S, Bourke M, Rubens F, Shojania K. et al. Using prospective clinical surveillance to identify adverse events in hospital. BMJ Qual Saf 2011; 20 (09) 756-763.
  • 42 Reynolds G, Boyer D, Mackey K, Povondra L, Cummings A. Alerting strategies in computerized physician order entry: A novel use of a dashboard-style analytics tool in a childrens hospital. AMIA Annu Symp Proc 2008; 1108.
  • 43 Zimmerman CR, Jackson A, Chaffee B, O’Reilly M. A dashboard model for monitoring alert effectiveness and bandwidth. AMIA Annu Symp Proc 2007; 1176.
  • 44 Waitman LR, Phillips IE, McCoy AB, Danciu I, Halpenny RM, Nelsen CL. et al. Adopting real-time surveil-lance dashboards as a component of an enterprisewide medication safety strategy. Jt Comm J Qual Patient Saf 2011; 37 (07) 326-332.
  • 45 Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon C. et al. Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention. J Gen Intern Med 2010; 25 (01) 31-38.