Assessing the potential adoption and usefulness of concurrent, action-oriented, electronic adverse drug event triggers designed for the outpatient setting.

BACKGROUND: Adverse drug event (ADE) detection is an important priority for patient safety research. Trigger tools have been developed to help identify ADEs. In previous work we developed seven concurrent, action-oriented, electronic trigger algorithms designed to prompt clinicians to address ADEs in outpatient care. OBJECTIVES: We assessed the potential adoption and usefulness of the seven triggers by testing the positive predictive validity and obtaining stakeholder input. METHODS: We adapted ADE triggers, "bone marrow toxin-white blood cell count (BMT-WBC)," "bone marrow toxin - platelet (BMT-platelet)," "potassium raisers," "potassium reducers," "creatinine," "warfarin," and "sedative hypnotics," with logic to suppress flagging events with evidence of clinical intervention and applied the triggers to 50,145 patients from three large health care systems. Four pharmacists assessed trigger positive predictive value (PPV) with respect to ADE detection (conservatively excluding ADEs occurring during clinically appropriate care) and clinical usefulness (i.e., whether the trigger alert could change care to prevent harm). We measured agreement between raters using the free kappa and assessed positive PPV for the trigger's detection of harm, clinical usefulness, and both. Stakeholders from the participating health care systems rated the likelihood of trigger adoption and the perceived ease of implementation. FINDINGS: Agreement between pharmacist raters was moderately high for each ADE trigger (kappa free > 0.60). Trigger PPVs for harm ranged from 0 (Creatinine, BMT-WBC) to 17 percent (potassium raisers), while PPV for care change ranged from 0 (WBC) to 60 percent (Creatinine). Fifteen stakeholders rated the triggers. Our assessment identified five of the seven triggers as good candidates for implementation: Creatinine, BMT-Platelet, Potassium Raisers, Potassium Reducers, and Warfarin. CONCLUSIONS: At least five outpatient ADE triggers performed well and merit further evaluation in outpatient clinical care. When used in real time, these triggers may promote care changes to ameliorate patient harm.

Understanding pharmacist decision making for adverse drug event (ADE) detection.

RATIONALE, AIMS AND OBJECTIVE: Manual chart review is an effective but expensive method for adverse drug event (ADE) detection. Building an expert system capable of mimicking the human expert's decision pathway, to deduce the occurrence of an ADE, can improve efficiency and lower cost. As a first step to build such an expert system, this study explores pharmacist's decision-making processes for ADE detection. METHODS: Think-aloud procedures were used to elicit verbalizations as pharmacists read through ADE case scenarios. Two types of information were extracted, firstly pharmacists' decision-making strategies regarding ADEs and secondly information regarding pharmacists' unmet information needs for ADE detection. Verbal protocols were recorded and analysed qualitatively to extract ADE information signals. Inter-reviewer agreement for classification of ADE information signals was calculated using Cohen's kappa. RESULTS: We extracted a total of 110 information signals, of which 73% consisted of information that was interpreted by the pharmacists from the case scenario and only about half (53%, n = 32) of the information signals were considered relevant for the detection of the ADEs. Excellent reliability was demonstrated between the reviewers for classifying signals. Fifty information signals regarding unmet information needs were extracted and grouped into themes based on the type of missing information. CONCLUSIONS: Pharmacists used a forward reasoning approach to make implicit deductions and validate hypotheses about possible ADEs. Verbal protocols also indicated that pharmacists' unmet information needs occurred frequently. Developing alerting systems that meet pharmacists' needs adequately will enhance their ability to reduce preventable ADEs, thus improving patient safety.

Pharmacists versus nonpharmacists in adverse drug event detection: a meta-analysis and systematic review.

PURPOSE: A systematic review and metaanalysis were conducted to determine if studies that included pharmacists as chart reviewers detected higher rates of adverse drug events (ADEs) than studies that included other health care professionals or hospital personnel as chart reviewers. METHODS: A systematic review and metaanalysis of studies using chart review as the method of detection of ADEs were conducted. Pooled estimates of the ADE rates were calculated using the inverse variance weight method. Meta-analysis was performed using a random effects model. Using the Mann-Whitney U test, weighted rates of studies in which pharmacists versus other clinicians were the chart reviewers were compared. RESULTS: Thirteen studies satisfied the inclusion criteria. Using random effects metaanalysis, the mean of the weighted incidence rate detected by pharmacists was 0.33 ADE per admission (95% confidence interval [CI], 0.17-0.50); the mean was 0.16 ADE per admission (95% CI, 0.11-0.22) with detection by nonpharmacists. Significant heterogeneity was present between studies in both groups. A significant difference (p=0.003) existed between the ADE rate reported by pharmacists (median=0.23; interquartile range [IQR], 0.18-0.44) and that of nonpharmacists (median=0.12; IQR, 0.02-0.49). Although there is overwhelming evidence of statistical heterogeneity, the numbers pertaining to the ADE rates detected by the two groups were large enough to indicate significant differences. Despite the heterogeneity, there is strong evidence that pharmacist-led interventions based on chart review report a higher ADE rate among inpatients. CONCLUSION: A review of the literature revealed that pharmacists make a salient contribution as manual chart reviewers in inpatient ADE interventions.

Looking for a needle in the haystack? A case for detecting adverse drug events (ADE) in clinical notes.

Detection and prevention of adverse drug events (ADEs) forms a large part of the patient safety efforts in any healthcare organization. Detection of laboratory and medication based ADEs is well-studied through the use of rule-based systems, however identifying descriptive ADEs, such as somnolence, is a challenging problem. Signals for the detection of these ADEs can often only be found in free-text clinical notes. We describe the automated detection of descriptive ADEs in free-text clinician notes.

Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project.

OBJECTIVES: We undertook the review of all available cases of hypersensitivity reactions after placement of a drug-eluting stent (DES) and classified potential causes. BACKGROUND: Six months after the approval of the first DES, the Food and Drug Administration (FDA) reported 50 hypersensitivity reactions after stent placement but later concluded these were due to concomitantly prescribed medications such as clopidogrel. Nevertheless, the FDA continued to receive reports of hypersensitivity. METHODS: Reports available from April 2003 through December 2004 for hypersensitivity-like reactions associated with the sirolimus-eluting stent (CYPHER, Cordis Corp., Miami Lakes, Florida) and paclitaxel-eluting stent (TAXUS, Boston Scientific Corp., Natick, Massachusetts) were reviewed. Sources of reports included the FDA's adverse-device-event database, the published literature, and investigators from the Research on Adverse Drug/Device events And Reports (RADAR) project. Causality was assessed using standardized World Health Organization criteria. RESULTS: Of 5,783 reports identified for the DES in the FDA database, 262 unique events included hypersensitivity symptoms. Of these reports, 2 were certainly and 39 unlikely caused by clopidogrel and 1 was certainly, 9 probably, and 13 unlikely caused by the DES. From all sources, we identified 17 distinct cases that were probably or certainly caused by the stent, of which 9 had symptoms that lasted longer than four weeks. Four autopsies confirmed intrastent eosinophilic inflammation, thrombosis, and lack of intimal healing. CONCLUSIONS: The FDA reports and autopsy findings suggest that DES may be a cause of systemic and intrastent hypersensitivity reactions that, in some cases, have been associated with late thrombosis and death.

High rates of adverse drug events in a highly computerized hospital.

BACKGROUND: Numerous studies have shown that specific computerized interventions may reduce medication errors, but few have examined adverse drug events (ADEs) across all stages of the computerized medication process. We describe the frequency and type of inpatient ADEs that occurred following the adoption of multiple computerized medication ordering and administration systems, including computerized physician order entry (CPOE). METHODS: Using explicit standardized criteria, pharmacists classified inpatient ADEs from prospective daily reviews of electronic medical records from a random sample of all admissions during a 20-week period at a Veterans Administration hospital. We analyzed ADEs that necessitated a changed treatment plan. RESULTS: Among 937 hospital admissions, 483 clinically significant inpatient ADEs were identified, accounting for 52 ADEs per 100 admissions and an incidence density of 70 ADEs per 1000 patient-days. One quarter of the hospitalizations had at least 1 ADE. Of all ADEs, 9% resulted in serious harm, 22% in additional monitoring and interventions, 32% in interventions alone, and 11% in monitoring alone; 27% should have resulted in additional interventions or monitoring. Medication errors contributed to 27% of these ADEs. Errors associated with ADEs occurred in the following stages: 61% ordering, 25% monitoring, 13% administration, 1% dispensing, and 0% transcription. The medical record reflected recognition of 76% of the ADEs. CONCLUSIONS: High rates of ADEs may continue to occur after implementation of CPOE and related computerized medication systems that lack decision support for drug selection, dosing, and monitoring.