Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database

e20656 Background: Previous studies have shown that cancer patients are at risk of drug interactions. But the proportion of potential adverse events that turn into clinical consequences is unknown. We sought to evaluate how many hospital admissions in oncology are due to drug-drug interactions (DDI) or adverse drug reactions (ADR). Methods: All cancer patients admitted to an oncology ward during an 8-month period had their charts retrospectively evaluated for reasons of hospitalization. Clinical trial patients were excluded. Each hospital admission was independently evaluated by two blinded investigators using a 4-point scale that was developed to classify sadmissions by their probability to be associated with either a DDI or an ADR (definitely, probably, possibly or unlikely associated). All medical records were thoroughly reviewed and discussed by experts. Results: From September 2007 to May 2008, there were 550 hospital admissions and 458 were eligible. Among unplanned admissions (N=298), 39 (13.0%, 95% CI 9.4 - 17.4%) were considered to be associated with an adverse drug event: 33 (11.0%, 95% CI 7.7 - 15.2%) were associated with an ADR and 6 (2.0%, 95% CI 0.7 - 4.3%) with a DDI. The most common DDI involved warfarin, captopril and anti-inflammatory agents and the most frequent ADR was neutropenic fever post chemotherapy. Most patients were discharged completely recovered but 2 patients died. Use of chemotherapy within 4 weeks of hospital admission (Odds Ratio 10.8, 95% CI 5.3 - 22.1; p < 0.0001) and presence of hematological tumors (Odds Ratio 12.1, 95% CI 5.9 - 25; p < 0.0001) were risk factors for being hospitalized to treat an ADR. Conclusions: Approximately one in 10 unplanned hospitalizations of cancer patients is associated with an adverse drug event. Prospective and population-based studies are warranted to evaluate their magnitude in oncology. [Table: see text]

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Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05061-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jeffrey P. Hau ◽

Penelope M. A. Brasher ◽

Amber Cragg ◽

Serena Small ◽

Maeve Wickham ◽

...

Keyword(s):

Health Information ◽

Adverse Drug Event ◽

Primary Outcome ◽

Adverse Drug Events ◽

Primary Objective ◽

Drug Event ◽

Controlled Trials ◽

Drug Reactions ◽

Main Trial ◽

Randomized Controlled

Abstract Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

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