Adverse Drug Events during AKI and Its Recovery

Abstract

SummaryBackground and objectives The impact of AKI on adverse drug events and therapeutic failures and the medication errors leading to these events have not been well described.Design, setting, participants, & measurements A single-center observational study of 396 hospitalized patients with a minimum 0.5 mg/dl change in serum creatinine who were prescribed a nephrotoxic or renally eliminated medication was conducted. The population was stratified into two groups by the direction of their initial serum creatinine change: AKI and AKI recovery. Adverse drug events, potential adverse drug events, therapeutic failures, and potential therapeutic failures for 148 drugs and 46 outcomes were retrospectively measured. Events were classified for preventability and severity by expert adjudication. Multivariable analysis identified medication classes predisposing AKI patients to adverse drug events.Results Forty-three percent of patients experienced a potential adverse drug event, adverse drug event, therapeutic failure, or potential therapeutic failure; 66% of study events were preventable. Failure to adjust for kidney function (63%) and use of nephrotoxic medications during AKI (28%) were the most common potential adverse drug events. Worsening AKI and hypotension were the most common preventable adverse drug events. Most adverse drug events were considered serious (63%) or life-threatening (31%), with one fatal adverse drug event. Among AKI patients, administration of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, antibiotics, and antithrombotics was most strongly associated with the development of an adverse drug event or potential adverse drug event.Conclusions Adverse drug events and potential therapeutic failures are common and frequently severe in patients with AKI exposed to nephrotoxic or renally eliminated medications.

Patient-Reported and Actionable Safety Events in CKD

“…16 Prior studies of safety in CKD used large administrative data sets 4,17 or clinical trial data to examine the frequency of selected laboratory disturbances, 18-21 but these analyses could not examine patient-reported events or be used for more extensive clinical assessments. Additional studies have also looked at the prevalence of medication errors in CKD, [22][23][24][25][26][27][28][29] but most have not examined the link between medication use and adverse safety events. This study provides a more patient-centered evaluation of safety in CKD and the conditionality of two key dimensions of adverse safety events on medication use and how events in these distinct dimensions potentially inter-relate.…”

Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup

“…Improving patient awareness of AKD and conditions or symptoms that might require evaluation of kidney function (such as oedema and volume-depleting illness), documenting that AKI and/or AKD has occurred particularly if moderate to severe or persistent, and processes of care including medication reconciliation to facilitate appropriate dosing and nephrotoxin avoidance, might help to alert future care providers to the risk of AKD, reduce the risk of adverse events including recurrent AKI, and potentially improve the probability of recovery 88,[105][106][107] …”

“…effective drugs in patients with AKD (particularly in the recovery phase), such therapeutic failure is rarely recorded 134 .…”

Utility of Electronic Medical Record Alerts to Prevent Drug Nephrotoxicity

“…This is especially applicable to patients with AKI, because nephrotoxic agents, such as angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and a variety of antibiotics, are frequently prescribed in elderly and critically ill patients. Although rare, significant risk exists for underdosing or complete avoidance of necessary medications, which may lead to potentially fatal therapeutic failure as shown by a case in which one patient with AKI received fatally subtherapeutic dosing of antibiotic for a pneumonia infection (9). Alerts may exacerbate this issue if providers place too much credence on the alert system rather than their own medical judgement.…”

“…Depending on the definition of "nephrotoxin," the prevalence of nephrotoxin exposure in hospitalized patients may exceed 75% (5,6), a significant statistic given that each exposure to a nephrotoxic agent increases a patient's odds of developing AKI by 53% (7). Among patients who develop AKI, approximately 20% of cases are thought to be due to nephrotoxin exposure (8)(9)(10). Furthermore, despite international guidelines for the appropriate management of AKI, which focus on cessation and avoidance of nephrotoxins, physicians frequently fail to stop nephrotoxic medications or dose adjust kidney-cleared medications as kidney function worsens (11)(12)(13).…”