Lots of what we do in healthcare still lacks an adequate evidence based. And some practices may be evidence-based for some healthcare venues but have never been adequately assessed in other venues. The ICU is one area often omitted in studies performed on many medication safety interventions.
So a new “Clinical Practice Guideline: Safe Medication Use in the ICU” (Kane-Gill 2017) is quite welcome. It addresses many aspects of medication safety in the ICU and puts in perspective differences that may exist between ICU settings and non-ICU settings.
It begins with an overview of the epidemiology of adverse drug events (ADE’s) and medication errors (ME’s) in the ICU setting, noting the impact in both human and financial terms. It notes that in adult ICU and PICU patients, the severity or harm associated with ME’s/ADE’s is greater compared to non-ICUs. It also notes that adult ICU and PICU patients have different risk factors for ADE’s and ME’s compared to general care (non-ICU) patients.
It then asks a number of questions about medication safety, reviews the pertinent literature on each question, grades the evidence, and makes recommendations where there is sufficient evidence to do so, and grades the recommendations.
Some of the recommendations in the guideline seem rather obvious (use of CPOE, clinical decision support, drug-dosing software, protocols/bundles, barcoded beside medication safety systems, smart infusion pumps, etc.). Others are more general (eg. establishing a culture of safety, educating all staff on medication safety, etc.).
The guideline does a good job of presenting pros and cons even for those practices they recommend. For example, though they note that most studies show CPOE reduces medication errors, they note that at least one study showed a paradoxical increase in ICU patient mortality after implementation of CPOE and they note that CPOE may introduce its own set of unexpected errors. They also note that the costs associated with initial implementation of many of the technology-based practices may be substantial but that many of these costs are offset in the long run by reductions in unwanted events.
The guideline suggests using the Broselow tape (a tool that measures a patient’s length to estimate a colorcoded weight range) in pediatric emergency situations, when patient weight is not available to determine the child’s length and then the associated colorcoded, weight-based dosing for emergency drug doses to reduce MEs and ADEs. Weight, of course, is critical in determination of dosing of many medications in pediatric patients (see our September 2017 What's New in the Patient Safety World column “”).
The guideline recommends using validated assessment tools (eg. the Richmond Agitation Sedation Scale or RASS, the Ramsay Sedation Assessment Scale, etc.) to achieve therapeutic goals during administration/titration of medications in the ICU.
The guideline endorses installation of robotic automated packaging systems and other strategies for automated dispensing of medications in the ICU.
The guideline also recommends using labeling practices such as tall man lettering to reduce the risk of LASA (look-alike, sound-alike) drug pair errors. Note that they use the acronym SALAD for sound-alike look-alike drugs.
They do also recommend use of independent double checks for dispensing high-risk medications. While we have pointed out some of the pitfalls of double checks in numerous prior columns (see, for example, our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?”) we still consider double checks to be an action of intermediate strength worth using in multiple situations. This would include using them before preparation, dispensing or administration of high-risk drugs. But they need to be truly “independent” double checks.
They also 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 ME’s and potential ADE’s.
Interestingly, they could make no recommendation about medication reconciliation, because of lack of rigorously conducted studies on medication reconciliation in the ICU. They also make no recommendation regarding pharmacist involvement in medication passes, use of point-of-care (POC) testing in the ICU, or specific handoff communication techniques.
The guideline has limited discussion about medication monitoring in the ICU but it does suggest the use of reflex (automatic) ordering of laboratory values with the addition of a dosing suggestion for heparin orders.
The guideline has mixed recommendations about patient/family involvement. For example there is no recommendation about patient/family involvement regarding notification of medication regimens. But it does recommend application of a patient/family reported outcome interview at or after ICU discharge to improve ME/ADE reporting.
Regarding the issue of disclosure of medication errors to patients/families, the authors note they could not scientifically address the question because of lack of comparator data. However, they clearly state that “the ultimate goal should be to establish policies for full disclosure of medical errors to patients and/or family members as a standard of clinical practice”.
Regarding surveillance systems for monitoring for ADE’s/ME’s, they had no recommendation on the use of electronic versus analog systems. They do suggest performing chart reviews for detecting ADEs as part of a surveillance system, both non-targeted chart reviews and trigger-initiated target chart review in addition to voluntary reports to improve the rate of identifying ADE’s.
They also 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.
When evaluating suspected drug-induced events, they recommend use of a reliable and valid ADE causality assessment instrument, noting that the ADR Probability Scale is the only ADE instrument tested for reliability and validity in the ICU. They do suggest performing ICU-specific ADE surveillance and evaluation but feel that evaluation between types of ICU units seems unnecessary. They also could not find evidence to make any recommendation on the effectiveness of prospective versus retrospective strategies at detecting ME’s/ADE’s in medication safety surveillance.
And, interestingly, they lacked evidence to make recommendations on the effectiveness of benchmarking for patient safety surveillance strategies on improving outcomes such as ME/ADE rate or on the effectiveness of strict compliance with patient safety standards set forth by regulatory bodies on impacting outcomes such as ME/ADE rates.
Note that the guideline does not really go into safety issues regarding use of individual drugs or medication categories as they pertain to the ICU. We’ve done many columns on safety of drugs like opioids, sedative/hypnotics, and neuromuscular blocking agents (NMBA’s) that are widely used in ICU’s. But these were beyond the scope of the current guideline.
Perhaps the biggest contribution by the new guideline is its extensive review of the literature. There are 374 references and the pertinent literature is summarized for each of the questions they asked.
Kane-Gill SL, Dasta JF, Buckley MS, et al. Clinical Practice Guideline: Safe Medication Use in the ICU. Crit Care Med 2017; 45(9): ee877-e915