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Executive Summary: Clinical Practice Guideline Safe Medication Use in the ICU

Kane-Gill, Sandra L. PharmD, MS, FCCM, FCCP (Chair)1,2; Dasta, Joseph F. MS, FCCP, MCCM3; Buckley, Mitchell S. PharmD, FCCM, FCCP, FASHP, BCCCP4; Devabhakthuni, Sandeep PharmD, BCPS-AQ Cardiology5; Liu, Michael PharmD, BCCCP, BCNSP, BCPS6; Cohen, Henry PharmD, MS, FCCM, BCPP, CGP7,8; George, Elizabeth L. CCRN-K, MSN, PhD, RN9; Pohlman, Anne S. CCRN-K, CNS, MSN, FCCM10; Agarwal, Swati MD11; Henneman, Elizabeth A. PhD, RN, FAAN12; Bejian, Sharon M. PharmD, BCPS13; Berenholtz, Sean M. MD, MHS, FCCM14; Pepin, Jodie L. PharmD15; Scanlon, Mathew C. MD, CPPS16; Smith, Brian S. PharmD17,18

doi: 10.1097/CCM.0000000000002519
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1Department of Pharmacy, Critical Care Medicine, Biomedical Informatics and Clinical Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.

2Critical Care Medication Safety Pharmacist, UPMC, Pittsburgh, PA

3Division of Pharmacy Practice and Science, The Ohio State University, College of Pharmacy, Columbus, OH.

4Clinical Pharmacy Specialist – Critical Care, Banner – University Medical Center Phoenix, Department of Pharmacy, Phoenix, AZ.

5Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy, Baltimore, MD.

6Department of Pharmacy, Yale-New Haven Hospital, New Haven, CT.

7Dean and Professor, Touro College of Pharmacy, New York, NY.

8Chief Pharmacotherapy Officer, Kingsbrook Jewish Medical Center, Brooklyn, NY.

9UPMC-Presbyterian, Pittsburgh, PA.

10Department of Medicine, University of Chicago, Chicago, IL.

11Pediatric Critical Care, Department of Pediatrics, Inova Children’s Hospital, Falls Church, VA.

12College of Nursing, University of Massachusetts Amherst, MA.

13Pediatric Intensive Care Clinical Specialist, Inova Fairfax Hospital, Falls Church, VA.

14Armstrong Institute for Patient Safety and Quality, Professor, Departments of Anesthesia/CCM and Surgery, and Health Policy & Management, Johns Hopkins Schools of Medicine and Bloomberg School of Public Health, Baltimore, MD.

15Director of Pharmacy, Seton Medical Center Williamson, Round Rock, TX.

16Department of Pediatrics, Critical Care Medicine, Medical College of Wisconsin, Milwaukee, WI.

17Department of Pharmacy, UMass Memorial Specialty Pharmacy, Worcester, MA.

18Department of Nursing and Surgery, University of Massachusetts Medical School, Worcester, MA.

Mr. Dasta received funding from Bayer Pharma (consultant: health economics pneumonia), the Medicines Company (consultant: pain management), and he disclosed that he owns stock in Merck, Pfizer, Abbvie, Abbott Labs, Bristol-Myers Squibb, Eli Lilly, and Express Scripts. Dr. George participates in the American Association of Critical Care Nurses (journal article reviews for continuing education); and she disclosed that she had a onetime contract with Medtronic for speaking engagement on capnography, presented at the American Association of Critical Care Nurses National Teaching Institute (May 2016). The remaining authors have disclosed that they do not have any potential conflicts of interest.

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Medication errors (MEs) and adverse drug events (ADEs) are a common and significant concern in the ICU since they represent a leading cause of iatrogenic errors in the critically ill population. MEs occur more frequently and with a greater likelihood of harm in ICU patients compared with non-ICU patients. MEs can lead to ADEs associated with deleterious outcomes and enormous economic burden on the healthcare system.

An ideal patient safety culture in an ICU setting should incorporate multiple ME prevention strategies at all phases of the medication use process. Several strategies seem promising in circumventing MEs and improving patient outcomes. The use of technology including computerized prescriber order entry (CPOE), clinical decision support systems (CDSS), bar-coded medication administration (BCMA) systems, and smart IV infusion pumps can minimize the risk of error. Also, implementing new practices such as medication reconciliation and standardized IV medication concentration practices may reduce MEs (1). An active patient safety surveillance system may identify possible drug-related events to either prevent injury in real time or prevent events in future patients (2).

MEs and ADEs in the ICU remain problematic despite increased awareness, regulatory mandates, and technological advances. Unfortunately, most hospitals face logistic, financial, and cultural challenges in implementing safe medication practices. Given the complexity of critically ill patients throughout the continuum of care and limited hospital resources, each institution must evaluate potential strategies to adopt in their respective ICUs. Patient safety is a priority for several government agencies, nonprofit organizations, and regulatory bodies considering the detrimental and financial consequences associated with MEs and ADEs. Despite the focus to improve safe medication use in the acute care setting, recommendations for safe medication practices are not specific to the ICU setting. We addressed this unmet need by developing this clinical practice guideline that recommends safe medication use practices based on supporting evidence, specifically in the critically ill. This is the first national guideline to evaluate safe medication use in the ICU.

The authors collectively developed Population, Intervention, Comparator, Outcome (PICO) questions and quality of evidence statements pertaining to MEs and ADEs based on three key components: 1) environment and the patient; 2) medication use process; and 3) patient safety surveillance system. A total of 34 PICO questions, five quality of evidence statements, and one commentary on disclosure were developed. A sample of 11 key PICO recommendations is provided in this executive summary. A summary of the remaining questions and statements is provided in Table 1.



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Grade Recommendations for the Environment and Patients

Safety Culture.

Question: In adult and PICU patients, do changes in the climate or culture of safety in the environment of the medication use process increase the frequency of reporting MEs, or ADEs?

Answer: We “suggest” implementing changes in the culture of safety to increase the incidence of ME reporting (2D).

Environment: Educational Efforts. Question: In adult and PICU patients, do educational efforts reduce the incidence of MEs/ADEs?

Answer: We “suggest” including education as part of any comprehensive program to reduce MEs in the ICU (2C).

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Grade Recommendations for the Medication Use Process Node: Prescribing

Critically ill patients are at high risk for prescribing errors since they receive twice the number of medications compared with non-ICU patients (3). Over the past 2 decades, efforts have been made to address these prescribing and transcribing issues by introducing new standards and technologies designed to correct these problems. These strategies include CPOE, and CDSS and medication reconciliation.

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Question: In adult and PICU patients, does CDSS (electronic or article format) reduce ME/ADEs when compared with traditional medication decision-making?

Answer: We “suggest” the use of CDSS (either electronic or article format) to decrease the number of MEs/ADEs (2C).

Medication Reconciliation. Question: In adult and PICU patients, does medication reconciliation reduce MEs/ADEs when compared with not having medication reconciliation?

Answer: We make “no recommendation” regarding the use of medication reconciliation to decrease MEs/ADEs, in ICU patients (OD).

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Grade Recommendations for the Medication Use Process Node: Dispensing

Dispensing medications is a complex process under the close supervision of the pharmacist. Traditionally, the dispensing process involved pharmacy staff manually selecting medications from shelves, counting the correct amount of medication, transferring this amount to a container, and labeling this product. However, because of the concern for dispensing errors, there has been a paradigm shift from this traditional process to the implementation of robotic automated dispensing systems and automated dispensing machines that use bar-code technology. This shift occurred to improve efficiency, maximize storage capacity, and minimize dispensing errors. Strategies including medication labeling practices and safer medication concentration practices have been implemented to further resolve dispensing issues (4).

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Automated Dispensing of Medications.

Question: In adult and PICU patients, does the use of robotics versus human personnel for the preparation of medications impact outcomes such as MEs/ADEs?

Answer: We “suggest” installing robot automated dispensing systems as a component of the medication dispensing process of solid dosage forms to reduce MEs (2C).

Medication Concentration Practices. Question: In adult and PICU patients, does the use of safe medication concentration practices versus not establishing safe medication concentration practices impact rates of MEs/ADEs?

Answer: We “recommend” compliance with safe medication concentration practices (i.e., use of premade IV preparations, requirement of pharmacists to prepare all IV medications) to reduce the number of MEs and potential ADEs (1B).

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Grade Recommendations for the Medication Use Process Node: Administration

Medication administration in the ICU is a multifaceted process requiring communication among nurses, pharmacists, and physicians. The complexity of the process of medication administration creates competing demands on caregivers with distractions and interruptions creating an opportunity for MEs. The administration phase is the final step in the medication process and hence is the last chance for detection of an error before reaching the patient. New processes and technological advancements targeted to improve the medication administration phase include BCMA and smart infusion pump technology (5). To address additional aspects of medication administration, changes in systems of care delivery (i.e., double-checks) have been implemented.

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Double-Checking during Medication Administration.

Question: In adult and PICU patients, does mandatory double-checking versus no mandatory double-checking during administration of high-risk medications impact outcomes such as ME/ADE rates?

Answer: We make “no recommendation” for the inclusion of mandatory double-checking during administration of high-risk medications to prevent MEs/ADEs based on the lack of supporting evidence (OD).

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Grade Recommendations for the Medication Use Process Node: Monitoring

Inadequate monitoring is a contributing factor to MEs. Medications with complex dosing strategies, narrow therapeutic indices, and unique administration techniques may require intense monitoring to ensure safe and effective use. Clinical decision support that generates alerts as a reminder for monitoring drugs has the potential to be useful.

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Reflex Laboratory Monitoring.

Question: In adult and PICU patients, does reflex (automatic) versus clinician initiated laboratory orders impact outcomes such as reducing drug-related hazardous conditions?

Answer: We “suggest” the use of reflex (automatic) ordering of laboratory values with the addition of a dosing suggestion for heparin orders since there is the potential of avoiding ADEs from this high-risk drug (2C). It is unclear if this benefit could also be achieved by providing recommendations for heparin dosing suggestions alone without the reflex laboratory monitoring.

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Grade Recommendations for Patient Safety Surveillance Systems Methods of ME and ADE Detection

Several methods of detection can be considered for an active patient safety surveillance system including family and patient involvement, targeted and nontargeted chart review, and direct observation (2).

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Family and Patient Involvement.

Question: In adult and PICU patients, how do patient/family interviews compared with other methods of reporting (voluntary reporting, medical chart review, etc) impact the quantity of ME/ADE reporting?

Answer: We “suggest” the application of a patient/family reported outcome interview at or after ICU discharge to improve ME/ADE reporting (2C).

Nontargeted Chart Review. Question: In adult and PICU patients, does nontargeted chart review (manual or electronic) versus voluntary reporting strategies improve the rate of identifying MEs and ADEs?

Answer: We “suggest” performing chart reviews for detecting ADEs as part of a surveillance system (2C).

Direct Observation. Question: In adult and PICU patients, does direct observation compared with other reporting methods (voluntary reporting, chart review) impact the quantity of ME/ADE reporting?

Answer: We “recommend” including direct observation as a component of an active medication surveillance system since it provides the advantage of detecting more events and is likely to detect more administration errors than other surveillance methods (1A).

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This is the first clinical guideline to evaluate the safe use of medications in the ICU. The ICU environment as a risk for medication-related events and environmental changes that can improve safe medication use is appraised. Prevention strategies for medication-related events are reviewed at the medication use process nodes. Considerations for an active surveillance system that includes reporting, identification, and evaluation are discussed. Also, highlighted in this document is the need for future research related to important safe medication practices such as medication reconciliation and double-checking during medication administration.

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1. Moyen E, Camiré E, Stelfox HT. Clinical review: Medication errors in critical care. Crit Care 2008; 12:208
2. Cullen DJ, Sweitzer BJ, Bates DW, et al. Preventable adverse drug events in hospitalized patients: A comparative study of intensive care and general care units. Crit Care Med 1997; 25:1289–1297
3. Stockwell DC, Kane-Gill SL. Developing a patient safety surveillance system to identify adverse events in the intensive care unit. Crit Care Med 2010; 38:S117–S125
4. Larsen GY, Parker HB, Cash J, et al. Standard drug concentrations and smart-pump technology reduce continuous-medication-infusion errors in pediatric patients. Pediatrics 2005; 116:e21–e25
5. Keiffer S, Marcum G, Harrison S, et al. Reduction of medication errors in a pediatric cardiothoracic intensive care unit. J Nurs Care Qual 2015; 30:212–219

critical care intensive care unit; drug-related side effects and adverse reactions; medication errors; patient safety; safety management

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