Signal and noise: Applying a laboratory trigger tool to identify adverse drug events among primary care patients

Division of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, San Francisco, CA 94110, USA.
BMJ quality & safety (Impact Factor: 3.99). 05/2012; 21(8):670-5. DOI: 10.1136/bmjqs-2011-000643
Source: PubMed


The extent of outpatient adverse drug events (ADEs) remains unclear. Trigger tools are used as a screening method to identify care episodes that may be ADEs, but their value in a population with high chronic-illness burden remains unclear.
The authors used six abnormal laboratory triggers for detecting ADEs among adults in outpatient care. Eligible patients were included if they were >18 years, sought primary or urgent care between November 2008 and November 2009 and were prescribed at least one medication. The authors then used the clinical / administrative database to identity patients with these triggers. Two physicians conducted in-depth chart review of any medical records with identified triggers.
The authors reviewed 1342 triggers representing 622 unique episodes among 516 patients. The trigger tool identified 91 (15%) ADEs. Of the 91 ADEs included in the analysis, 49 (54%) occurred during medication monitoring, 41 (45%) during patient self-administration, and one could not be determined. 96% of abnormal international normalised ratio triggers were ADEs, followed by 12% of abnormal blood urea nitrogen triggers, 9% of abnormal alanine aminotransferase triggers, 8% of abnormal serum creatinine triggers and 3% of aspartate aminotransferase triggers.
The findings imply that other tools such as text triggers or more complex automated screening rules, which combine data hierarchically are needed to effectively screen for ADEs in chronically ill adults seen in primary care.

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    ABSTRACT: Using triggers to identify adverse events is proposed as an efficient means of consistently measuring, and tracking events that result in harm to patients. We aimed to test whether using triggers in our large provincial general practice could provide meaningful directions for improving safety. A literature review identified potential triggers and established the number of patients whose records we should review. Two teams independently reviewed 170 randomly selected patients' records for trigger presence and for evidence of harm relating to that trigger. All triggers were tested for sensitivity and specificity: triggers with low specificity were removed. Logistic regression was used on both initial and refined trigger sets to measure the odds ratio (OR) of harm occurring if a trigger was present. Initially 36 triggers were identified. Applying these to 109.6 patient-years of records for 170 patients, we identified harm in the records of 46 (27.1%) patients. There were 7 occurrences of harm per 100 consultations (harm rate per consultation=0.07 (95% confidence interval [CI] 0.05-0.09) and 41 per 100 consulting patient years (95%CI 29-55). All harms related to medication use. The initial triggers were sensitive (0.98) but non-specific (0.08): removing triggers with low specificity left only 8. The OR for harm occurring using the initial triggers was 4.0 (95% 0.5-30) and using the refined trigger set OR=6.3 (95%CI 2.7-14.8). 8 selected triggers are a useful way of measuring progress towards safer care for patients in primary care practice.
    The New Zealand medical journal 01/2013; 127(1390):45-52.
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    ABSTRACT: Adverse drug reactions (ADRs) are global problems of major concern which leads to morbidity and mortality. It causes 30% of hospitalized patients and lead 2-6% of all medical admissions. Spontaneous reporting of ADRs is the cornerstone of pharmacovigilance and is essential for maintaining patient safety. The necessity of a spontaneous ADR surveillance system is addressed by many authorities like World Health Organization, Food and Drug Administration, Joint Commission International and Uppsala monitoring center. However, existing postmarketing surveillance systems massively rely on spontaneous reports of ADRs which suffer from serious underreporting, latency, and inconsistent reporting. Studies estimated that only 6–10% of all ADRs are reported in hospitals. It is a very low percentage to go in deep and analyze the reason for the same and to resolve that underlying factors. Researchers proved that knowledge, attitude and false perceptions about the ADRs are the major challenges in the spontaneous reporting of ADRs. Which includes personal, professional, system related and organization related conflicts. Majority of them can improve by doing the system and personal targeted implications. Identifying, analyzing and working on these issues can improve the ADR surveillance system in hospitals to attain the patient safety. Understanding the pharmacovigilance, identifying and sorting out the obstacles of spontaneous reporting through an efficient pharmacovigilance department, continuous educational interventions, patient centered surveillance programs, health care team work efforts towards the detection of ADRs and implementation of the computer or personal assisted ADR trigger tool programs can furnish out a successful pharmacovigilance system in the hospitals and thereby we can constitute a good quality health care system. Keywords: Spontaneous reporting system, adverse drug reaction, pharmacovigilance, Patient safety
    Asian Journal of Pharmaceutical and Clinical Research 10/2013; 6(4):10-15.
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    ABSTRACT: Medication-related harm can be detected using the adverse drug event (ADE) trigger tool and the medication module of the Global Trigger Tool (GTT) developed by the Institute for Healthcare Improvement (IHI). In recent years, there has been some controversy on the performance of this method. In addition, there are limited data on the performance of the medication module of the GTT as compared with the ADE trigger tool. To evaluate the performance of the ADE trigger tool and of the medication module of the GTT for identifying ADEs. The methodology of the IHI was used. A random sample of 20 adult admissions per month was selected over a 12-month period in a teaching hospital in Belgium. The ADE trigger tool was adapted to the Belgian setting and included 20 triggers. The positive predictive value (PPV) of each trigger was calculated, as well as the proportion of ADEs that would have been identified with the medication module of the GTT as compared with the ADE trigger tool. A total of 200 triggers and 62 ADEs were found, representing 26 ADEs/100 admissions. Nineteen ADEs (31%) were found spontaneously without the presence of a trigger. Three triggers never occurred. The PPVs of other triggers varied from 0 to 0.67, with half of them having PPVs less than 0.20. If we had used the medication triggers included in the GTT (n = 11), we would have identified 77% of total ADEs and 67% of preventable ADEs. Applying the trigger tool method proposed by the IHI to a Belgian hospital led to the identification of one ADE out of 4 admissions. To increase performance, refining the list of triggers in the ADE trigger tool and in the medication module of the GTT would be needed. Recording nontriggered events should be encouraged.
    Annals of Pharmacotherapy 11/2013; 47(11):1414-1419. DOI:10.1177/1060028013500939 · 2.06 Impact Factor
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