|Home | About | Journals | Submit | Contact Us | Français|
Adverse drug events (ADEs) are defined by the Institute of Medicine (IOM) as, “injuries resulting from a medical intervention related to a drug.”1 Institutionalized elderly experience ADEs at a rate as high as 10.8 events per 100-patient months, often as a result of polypharmacy, multiple comorbid illness, and difficulty with monitoring prescribed medications.2–4 This translates into approximately 135 ADEs each year in an average size nursing home (NH; bed size of 105) or approximately 2 million events a year among all U.S. NH patients. ADEs represent the most clinically significant and costly medication-related problems in NHs and are associated with 93,000 deaths a year and in as much as $4 billion of excess healthcare expenditures.5–6 Despite the consequences and costs associated with ADEs, the vast majority of these events go undetected using traditional methods including comprehensive chart reviews, direct observation, and voluntary reporting. Therefore, alternative surveillance strategies are needed in NHs to supplement existing detection strategies and minimize the potential consequences of ADEs.
The trigger tool methodology, developed in part by the Institute of Healthcare Improvement (IHI), greatly simplifies the chart review process by allowing rapid and systematic examination of charts to extract relevant data for the detection of potential ADEs. The technique, which requires minimal training, appears to increase the rate of ADE detection 50-fold from traditional reporting methods.7 The triggers themselves represent specific events including the ordering of certain medications (e.g., antidotes, such as Vitamin K), the results of certain laboratory studies (e.g., supratherapeutic serum medication concentrations, such as digoxin level), and change in clinical status or new sign or symptom (e.g., drug-induced fall or drug-related rash). Since the triggers are likely to differ based on specific clinical setting, multiple IHI trigger tools have been developed including those for: mental health settings, adult inpatient, adult outpatient, adult intensive care units, adult peri-operative care units, pediatric inpatient, and neonatal intensive care units.8 Many of the clinical setting-specific trigger tools have been successfully used to demonstrate the benefits of low-cost error detection strategies that produce consistent, reliable, and relevant data.9–13
Recently, a study was completed to develop a consensus list of agreed upon laboratory, pharmacy, and Minimum Data Set triggers to expand the use of the trigger tool methodology to the NH setting.14 The authors conducted a comprehensive literature search for potential ADE triggers, followed by an Internet-based, two-round, modified Delphi survey of physician, pharmacist, and advanced practitioner experts in geriatrics. Panelists reached consensus agreement on 40 triggers: 15 laboratory/medication combinations, 12 medication concentrations, 10 antidotes, and 3 Resident Assessment Protocols (RAPs). Highest consensus scores (4.6; 95% CI, 4.4–4.9 or 4.4–4.8) were for naloxone when taking opioid analgesics; phytonadione when taking warfarin; dextrose, glucagon, or liquid glucose when taking hypoglycemic agents; medication-induced hypoglycemia; supratherapeutic international normalized ratio when taking warfarin; and triggering the Falls RAP when taking certain medications.
The IHI formally adopted this set of 40 triggers as the “Nursing Home Adverse Drug Event Trigger Tool.”15 We suggest that this tool be incorporated into the consultant pharmacist medication regimen review (MRR) process. The State Operations Manual provides a definition for MRR (i.e., F428), as a thorough evaluation of the medication regimen of a resident, with goal of promoting positive outcomes and minimizing adverse consequences. The review includes preventing, identifying, reporting, and resolving medication errors, or other irregularities, and collaborating with other members of the interdisciplinary team.16 According to these new guidelines, F428 emphasizes that consultant pharmacists are expected to perform MRRs at least every 30 days, and expedited reviews for short-stay residents, as well as those residents who experience an acute change in condition.17
The IHI recommends either one of the two following strategies to detect triggers and investigate them to determine if an ADE has occurred: 1) review a sample of resident charts (letters A through I), or 2) review all resident charts (letters B through G):
The IHI recommends using the results of this tool to measure the number of ADEs in an organization over time, and determine whether or not the changes a facility is making results in improvement. Similar to other NH quality improvement initiatives, the results can be summarized and reported to the quality assessment and assurance (QAA) committee that is required to meet at least quarterly as described in F520.18 During these meetings, the committee can develop and implement plans of action to correct the future occurrence of ADEs, including monitoring the effect of implemented changes and making needed revisions to the action plans.
The future of ADE detection in the NH setting will likely rely on utilizing health information technology. This is consistent with the IOM and other patient safety organizations recommendation that all healthcare settings assess the safety of medication use through active monitoring systems within a culture of safety.1, 16–22 Although most NHs have yet to adopt a significant amount of health information technology23, the majority generate laboratory, pharmacy, and Minimum Data Set data in electronic format that can be used by active medication monitoring systems to automate the detection of ADEs. Recently, investigators have developed and tested an active medication monitoring system using the consensus set of NH triggers accepted by IHI.24 They found that they could detect ADEs with a high degree of accuracy and at a rate of nearly 2.5 times greater than that of usual care (i.e., pharmacist-conducted manual chart review).