Maeve E. Wickham

The effect of ketamine on intracranial and cerebral perfusion pressure and health outcomes: a systematic review.

STUDY OBJECTIVE We synthesize the available evidence on the effect of ketamine on intracranial and cerebral perfusion pressures, neurologic outcomes, ICU length of stay, and mortality. METHODS We developed a systematic search strategy and applied it to 6 electronic reference databases. We completed a gray literature search and searched medical journals as well as the bibliographies of relevant articles. We included randomized and nonrandomized prospective studies that compared the effect of ketamine with another intravenous sedative in intubated patients and reported at least 1 outcome of interest. Two authors independently performed title, abstract, and full-text reviews, and abstracted data from all studies, using standardized forms. Data from randomized controlled trials and prospective studies were synthesized in a qualitative manner because the study designs, patient populations, reported outcomes, and follow-up periods were heterogeneous. We used the Jadad score and Cochrane Risk of Bias tool to assess study quality. RESULTS We retrieved 4,896 titles, of which 10 studies met our inclusion criteria, reporting data on 953 patients. One study was deemed at low risk of bias in all quality assessment domains. All others were at high risk in at least 1 domain. Two of 8 studies reported small reductions in intracranial pressure within 10 minutes of ketamine administration, and 2 studies reported an increase. None of the studies reported significant differences in cerebral perfusion pressure, neurologic outcomes, ICU length of stay, or mortality. CONCLUSION According to the available literature, the use of ketamine in critically ill patients does not appear to adversely affect patient outcomes.

The effect of early in-hospital medication review on health outcomes: a systematic review

AIMS Adverse drug events are an important cause of emergency department visits, unplanned admissions and prolonged hospital stays. Our objective was to synthesize the evidence on the effect of early in-hospital pharmacist-led medication review on patient-oriented outcomes based on observed data. METHODS We systematically searched eight bibliographic reference databases, electronic grey literature, medical journals, conference proceedings, trial registries and bibliographies of relevant papers. We included studies that employed random or quasi-random methods to allocate subjects to pharmacist-led medication review or control. Medication review had to include, at a minimum, obtaining a best possible medication history and reviewing medications for appropriateness and adverse drug events. The intervention had to be initiated within 24 h of emergency department presentation or 72 h of admission. We extracted data in duplicate and pooled outcomes from clinically homogeneous studies of the same design using random effects meta-analysis. RESULTS We retrieved 4549 titles of which seven were included, reporting the outcomes of 3292 patients. We pooled data from studies of the same design, and found no significant differences in length of hospital admission (weighted mean difference [WMD] -0.04 days, 95% confidence interval [CI] -1.63, 1.55), mortality (odds ratio [OR] 1.09, 95% CI 0.69, 1.72), readmissions (OR 1.15, 95% CI 0.81, 1.63) or emergency department revisits at 3 months (OR 0.60, 95% CI 0.27, 1.32). Two large studies reporting reductions in readmissions could not be included in our pooled estimates due to differences in study design. CONCLUSIONS Wide confidence intervals suggest that additional research is likely to influence the effect size estimates and clarify the effect of medication review on patient-oriented outcomes. This systematic review failed to identify an effect of pharmacist-led medication review on health outcomes.

Adverse drug event reporting systems: a systematic review.

AIM Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. METHODS We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. RESULTS We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). CONCLUSION We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.

Impact of early in-hospital medication review by clinical pharmacists on health services utilization

Background Adverse drug events are a leading cause of emergency department visits and unplanned admissions, and prolong hospital stays. Medication review interventions aim to identify adverse drug events and optimize medication use. Previous evaluations of in-hospital medication reviews have focused on interventions at discharge, with an unclear effect on health outcomes. We assessed the effect of early in-hospital pharmacist-led medication review on the health outcomes of high-risk patients. Methods We used a quasi-randomized design to evaluate a quality improvement project in three hospitals in British Columbia, Canada. We incorporated a clinical decision rule into emergency department triage pathways, allowing nurses to identify patients at high-risk for adverse drug events. After randomly selecting the first eligible patient for participation, clinical pharmacists systematically allocated subsequent high-risk patients to medication review or usual care. Medication review included obtaining a best possible medication history and reviewing the patient’s medications for appropriateness and adverse drug events. The primary outcome was the number of days spent in-hospital over 30 days, and was ascertained using administrative data. We used median and inverse propensity score weighted logistic regression modeling to determine the effect of pharmacist-led medication review on downstream health services use. Results Of 10,807 high-risk patients, 6,416 received early pharmacist-led medication review and 4,391 usual care. Their baseline characteristics were balanced. The median number of hospital days was reduced by 0.48 days (95% confidence intervals [CI] = 0.00 to 0.96; p = 0.058) in the medication review group compared to usual care, representing an 8% reduction in the median length of stay. Among patients under 80 years of age, the median number of hospital days was reduced by 0.60 days (95% CI = 0.06 to 1.17; p = 0.03), representing 11% reduction in the median length of stay. There was no significant effect on emergency department revisits, admissions, readmissions, or mortality. Limitations We were limited by our inability to conduct a randomized controlled trial, but used quasi-random patient allocation methods and propensity score modeling to ensure balance between treatment groups, and administrative data to ensure blinded outcomes ascertainment. We were unable to account for alternate level of care days, and therefore, may have underestimated the treatment effect in frail elderly patients who are likely to remain in hospital while awaiting long-term care. Conclusions Early pharmacist-led medication review was associated with reduced hospital-bed utilization compared to usual care among high-risk patients under 80 years of age, but not among those who were older. The results of our evaluation suggest that medication review by pharmacists in the emergency department may impact the length of hospital stay in select patient populations.

Designing an adverse drug event reporting system to prevent unintentional reexposures to harmful drugs: study protocol for a multiple methods design

Background Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs. Objective We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada. Methods To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting. Results This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs. Conclusions We take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers’ failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians’ workflow, and design the system to optimize its uptake into practice.

Incidence of clinically relevant medication errors in the era of electronically prepopulated medication reconciliation forms: a retrospective chart review

BACKGROUND To reduce medication discrepancies (unintended differences between a patients outpatient and inpatient medication regimens), Canadian institutions have implemented medication reconciliation forms that are prepopulated with outpatient medication dispensing data. These may prompt prescribers to reorder discontinued medications or continue newly contraindicated medications. Our objective was to evaluate the incidence of medication discrepancies and errors of commission after the implementation of such forms. METHODS This retrospective chart review included patients previously enrolled in an observational study in which a research pharmacist prospectively collected best-possible medication histories in the emergency department. Research assistants uninvolved with the parent study compared medication orders written in the first 48 hours after admission with the research pharmacists best-possible medication history to identify medication discrepancies and errors of commission, defined as inappropriate medication continuations and reordering of previously stopped medications. An independent panel adjudicated the clinical significance of the errors. RESULTS Of 151 patients, 71 (47.0% [95% confidence interval (CI) 39.2-54.9]) were exposed to 112 medication errors on admission. Of the 112 errors, 24 (21.4% [95% CI 14.9-29.9]) were clinically significant. Errors of commission accounted for 24.1% (27/112 [95% CI 17.3-32.8]) of all errors; 10 (37.0% [95% CI 18.8-55.2]) of the errors of commission were clinically significant. INTERPRETATION Medication errors were common after the implementation of electronically prepopulated medication reconciliation forms. Prospective research is required to examine the impact of prepopulated medication reconciliation forms and ensure they do not facilitate errors of commission.

Prospective Validation of Clinical Criteria to Identify Emergency Department Patients at High Risk for Adverse Drug Events

Abstract Objectives Adverse drug events (ADEs) cause or contribute to one in nine emergency department (ED) presentations in North America and are often misdiagnosed. EDs have insufficient clinical pharmacists to complete medication reviews in all incoming patients, even though pharmacist‐led medications reviews have been associated with improved health outcomes. Our objective was to validate clinical decision rules to identify patients presenting with ADEs so they could be prioritized for pharmacist‐led medication review. Methods This multicenter, prospective study was conducted in two tertiary and one community hospital in Canada. We enrolled 1,529 adults presenting to EDs over 12 months. We applied two clinical decision rules and collected baseline variables prior to assessments by clinical pharmacists and physicians. We compared the physician and pharmacist diagnoses with the decision rule results. The primary outcome was a moderate or severe ADE, defined as an unintended and harmful event related to medication use or misuse, which required a change in medical therapy, diagnostic testing, consultation, or admission. An independent committee adjudicated uncertain and discordant cases. We calculated the diagnostic accuracy of both rules. Results Among 1,529 patients, 184 (12.0%) were diagnosed with an ADE. Rule 1 contained the variables 1) having a preexisting medical condition or having taken antibiotics within 1 week and 2) age > 80 years or having a medication change within 28 days. They had a sensitivity of 91.3% (95% confidence interval [CI] = 86.3%–95.0%) and a specificity of 37.9% (95% CI = 35.3%–40.6%) for ADEs. Conclusions Our study validated clinical decision rules that can be applied by clinical pharmacists to limit the number of patients requiring medication review, while identifying the majority of patients presenting with clinically significant ADEs.

Action ADE: Enabling Cross-setting Communication to Prevent Adverse Drug Events

Adverse drug events (ADEs) are the harmful and unintended consequences of medication use. ADEs have become a leading cause of outpatient visits, emergency department visits, and unplanned admissions to hospital. Many of these events are not strictly pharmacological, but rather are related to practical challenges in the coordination of care,prescribing, dispensing, and medication use, and may be preventable with new modes of documentation and communication for medication management. Action ADE is a CSCW intervention that aims to enable communication of patient ADE information across healthcare settings in the province of British Columbia, Canada. Implementing Action ADE requires negotiations of political agendas and policy change, evolving medical information system infrastructures, and the needs and practices of clinicians and patients. As the initial design phase for Action ADE comes to a close and we enter into our first phase of piloting and implementation, this poster provides a snapshot of five domains in which our project intervenes and highlights findings from our extensive qualitative work.