Evaluating the positive predictive values of antidote signals to detect potential adverse drug reactions (ADRs) in the medical intensive care unit (ICU)

Abstract

Protamine and sodium polystyrene performed the best by detecting ADRs in at least one out of two evaluations. Detection strategies other than signals were not as sensitive at identifying the same ADRs as antidote signals.

Improving adverse drug event detection in critically ill patients through screening intensive care unit transfer summaries

“…Other types of targeted chart review are often directed at specific sections of a chart depending on the stimulus. A targeted chart review of the administration of antidote medications was conducted retrospectively and was proven to be useful depending on the antidote under review . Protamine was very useful (positive predictive value = 0.64), whereas methylprednisolone was not as indicative of an ADE (positive predictive value = 0.50).…”

“…This involves performing a comprehensive medical record review, which is typically completed using a manual approach, and more recently, natural language processing has been applied . This may be contrasted with a targeted chart review that evaluates a specific component of the chart such as discharge notes or the notes on the day an antidote drug is administered . Other ADE detection approaches, such as direct observation and clinical decision support alert surveillance, have been proposed, as well …”

Clinical decision support for drug related events: Moving towards better prevention

“…This is apparent in the use of the alerts targeted at antidote administration designed for detection and not prevention since the event is already in the midst of treatment. Table 2[17,37-39] provides examples of alerts designed for event detection. Another type of alert geared to detection are abnormal laboratory value alerts with thresholds that exceed the recommended laboratory limit or higher.…”

Computerized detection of adverse drug reactions in the medical intensive care unit

“…Also, the alerts were sent to a pharmacist which is common practice; however, the physician response to these alerts is unknown. [30, 39-42] Since this study was conducted at a single institution, it is also possible that the patient population that was evaluated may not be similar to other MICU patients. We attempted to better characterize these patients and make our findings more generalizable by including acute physiology scores for severity of illness.…”

“…[36-38] These ADR determination instruments have been widely used in previous pharmacoepidemiology studies to determine the likelihood of whether or not the signs, symptoms, or laboratory abnormalities noted are due to a suspect drug, rather than the result of other patient-specific factors such as underlying comorbid illness. [13,39-42] The three instruments contain assessment themes such as previous reports of this ADR, temporal relationship between drug introduction and occurrence of ADR, if discontinuing the drug results in resolution of the ADR, if repeated exposure to the drug causes a similar reaction, and the presence of objective evidence (i.e., serum drug concentrations). An event was considered an ADR when 2 out of 3 instruments had agreement of possible, probable or definite and this was considered our base case or reference scenario for the sensitivity analysis.…”