Redesigning pictographs for patients with low health literacy and establishing preliminary steps for delivery via smart phones.

BackgroundPictographs (or pictograms) have been widely utilized to convey medication related messages and to address nonadherence among patients with low health literacy. Yet, patients do not always interpret the intended messages on commonly used pictographs correctly and there are questions how they may be delivered on mobile devices.ObjectiveOur objectives are to refine a set of pictographs to use as medication reminders and to establish preliminary steps for delivery via smart phones.MethodsCard sorting was used to identify existing pictographs that focus group members found "not easy" to understand. Participants then explored improvements to these pictographs while iterations were sketched in real-time by a graphic artist. Feedback was also solicited on how selected pictographs might be delivered via smart phones in a sequential reminder message. The study was conducted at a community learning center that provides literacy services to underserved populations in Seattle, WA. Participants aged 18 years and older who met the criteria for low health literacy using S-TOFHLA were recruited.ResultsAmong the 45 participants screened for health literacy, 29 were eligible and consented to participate. Across four focus group sessions, participants examined 91 commonly used pictographs, 20 of these were ultimately refined to improve comprehensibility using participatory design approaches. All participants in the fifth focus group owned and used cell phones and provided feedback on preferred sequencing of pictographs to represent medication messages.ConclusionLow literacy adults found a substantial number of common medication label pictographs difficult to understand. Participative design processes helped generate new pictographs, as well as feedback on the sequencing of messages on cell phones, that may be evaluated in future research

A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems.

The objective of this review is to describe the implementation of human factors principles for the design of alerts in clinical information systems. First, we conduct a review of alarm systems to identify human factors principles that are employed in the design and implementation of alerts. Second, we review the medical informatics literature to provide examples of the implementation of human factors principles in current clinical information systems using alerts to provide medication decision support. Last, we suggest actionable recommendations for delivering effective clinical decision support using alerts. A review of studies from the medical informatics literature suggests that many basic human factors principles are not followed, possibly contributing to the lack of acceptance of alerts in clinical information systems. We evaluate the limitations of current alerting philosophies and provide recommendations for improving acceptance of alerts by incorporating human factors principles in their design

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices

A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking. This extrapolation issue arises in the medicines context when an approved drug or device that is already being marketed is being considered (1) for new conditions (such as off-label diagnostic categories), (2) for new patients (such as new subpopulations), (3) for new dosages or durations, or (4) as the basis for approving a related drug or device (such as a generic or biosimilar drug). Although the logic of preapproval testing and the precautionary principle—first, do no harm—would counsel in favor of prohibiting extrapolation approvals until after traditional safety and efficacy evidence exists, such delays would unreasonably sacrifice beneficial uses. The harm of accessing unsafe products must be balanced against the harm of restricting access to effective products. In fact, the Food and Drug Administration\u27s (FDA\u27s) current regulations in many ways reject the precautionary principle because they largely permit individual physicians to prescribe medications for off-label uses before any testing tailored to those uses has been done. The FDA\u27s approach empowers physicians, but overshoots the mark by allowing enduring use of drugs and devices with insubstantial support of safety and efficacy. This Article instead proposes a more dynamic and evolving evidence-based regime that charts a course between the Scylla and Charybdis of the overly conservative precautionary principle on one hand, and the overly liberal FDA regime on the other. Our approach calls for improvements in reporting, testing, and enforcement regulations to provide a more layered and nuanced system of regulatory incentives. First, we propose a more thoroughgoing reporting of off-label use (via the disclosure of diagnostic codes and detailing data) in manufacturers\u27 annual reports to the FDA, in the adverse event reports to the FDA, in Medicare/Medicaid reimbursement requests, and, for a subset of FDA-designated drugs, in prescriptions themselves. Second, we would substantially expand the agency\u27s utilization of postmarket testing, and we provide a novel framework for evaluating the need for postmarket testing. Finally, our approach calls for a tiered labeling system that would allow regulators and courts to draw finer reimbursement and liability distinctions among various drug uses, and would provide the agency both the regulatory teeth and the flexibility it presently lacks. Together, these reforms would improve the role of the FDA in the informational marketplace underlying physicians\u27 prescribing decisions. This evolutionary extrapolation framework could also be applied to other contexts

Identifying Medication Management Smartphone App Features Suitable for Young Adults With Developmental Disabilities: Delphi Consensus Study

Background: Smartphone apps can be a tool to facilitate independent medication management among persons with developmental disabilities. At present, multiple medication management apps exist in the market, but only 1 has been specifically designed for persons with developmental disabilities. Before initiating further app development targeting this population, input from stakeholders including persons with developmental disabilities, caregivers, and professionals regarding the most preferred features should be obtained. Objective: The aim of this study was to identify medication management app features that are suitable to promote independence in the medication management process by young adults with developmental disabilities using a Delphi consensus method. Methods: A compilation of medication management app features was performed by searching the iTunes App Store, United States, in February 2016, using the following terms: adherence, medication, medication management, medication list, and medication reminder. After identifying features within the retrieved apps, a final list of 42 features grouped into 4 modules (medication list, medication reminder, medication administration record, and additional features) was included in a questionnaire for expert consensus rating. A total of 52 experts in developmental disabilities, including persons with developmental disabilities, caregivers, and professionals, were invited to participate in a 3-round Delphi technique. The purpose was to obtain consensus on features that are preferred and suitable to promote independence in the medication management process among persons with developmental disabilities. Consensus for the first, second, and third rounds was defined as ≥90%, ≥80%, and ≥75% agreement, respectively. Results: A total of 75 responses were received over the 3 Delphi rounds—30 in the first round, 24 in the second round, and 21 in the third round. At the end of the third round, cumulative consensus was achieved for 60% (12/20) items in the medication list module, 100% (3/3) in the medication reminder module, 67% (2/3) in the medication administration record module, and 63% (10/16) in the additional features module. In addition to the medication list, medication reminder, and medication administration record features, experts selected the following top 3 most important additional features: automatic refills through pharmacies; ability to share medication information from the app with providers; and ability to share medication information from the app with family, friends, and caregivers. The top 3 least important features included a link to an official drug information source, privacy settings and password protection, and prescription refill reminders. Conclusions: Although several mobile apps for medication management exist, few are specifically designed to support persons with developmental disabilities in the complex medication management process. Of the 42 different features assessed, 64% (27/42) achieved consensus for inclusion in a future medication management app. This study provides information on the features of a medication management app that are most important to persons with developmental disabilities, caregivers, and professionals

Euglycemic Diabetic Ketoacidosis in Concurrent Very Low-carbohydrate Diet and Sodium-glucose Transporter-2 Inhibitor Use: A Case Report

Introduction: With the incredibly high incidence of Type 2 Diabetes in the current population of emergency department patients, it is critical for clinicians to understand the possible complications of the treatment of this disease. Medication like canagliflozin are more common to encounter on patient’s home medication lists and clinicians should be aware of how these medications, alone or combined with dietary modifications, can result in significant pathology and even mortality if not appropriately treated.Case Report: We report a case of a patient with type II diabetes mellitus who presented with euglycemic diabetic ketoacidosis in the setting of concurrent use of canagliflozin, a sodium-glucose transporter-2 (SGLT-2) inhibitor, and strict adherence to a low-carbohydrate ketogenic diet for weight control.Discussion: Euglycemic ketoacidosis has previously been observed in both diabetic and non-diabetic patients following strict ketogenic diets, as well as in diabetic patients being treated with SGLT-2 inhibitors.Conclusion: As more patients choose ketogenic diets for weight control and diabetes management, clinicians should be aware of this potentially life-threatening complication in patients concurrently taking SGLT-2 inhibitors

It Doesn\u27t Pass the \u3ci\u3eSell\u3c/i\u3e Test: Focusing on The Facts of the Individual Case in Involuntary Medication Inquiries

Criminal defendants who are incompetent to stand trial have a significant liberty interest in refusing the antipsychotic medication that could restore their competency. The Supreme Court cautioned that instances of intrusion upon that right “may be rare,” and, in Sell v. United States, it laid out what it believed to be stringent criteria for when a defendant could be medicated against his will. Yet, since Sell, trial courts have ordered over sixty-three percent of defendants involuntarily medicated. These individuals did not pose a danger to themselves or others, and they were rarely accused of crimes that involved damage to individuals or property. But the medication of these defendants, once predicted to be “rare,” has instead become routine. In this article, I argue that the overmedication of non-dangerous defendants is a result of the structure of the Sell test and its tilt in favor of the government. The use of a checklist of four threshold elements favors the issuance of medication orders because the court need not balance the defendant’s liberty interest in avoiding medication against the government’s interest in administering it. In addition, three of the four boxes on the checklist concern medical questions about the efficacy and side effects of antipsychotic medication that will fall in the government’s favor in the vast majority of cases. However, while the Sell test contains the seeds of the overmedication problem, it also contains the solution. The first factor of the test requires courts to consider whether the government interest at stake is “important,” and it mandates that courts assess the “facts of the individual case” to determine if the government interest crosses that bar. While few courts have delved deeply into this factor, some have looked to the nonviolent nature of the crime or the government’s minimal likelihood of success on the underlying criminal charge in concluding that the government interest in prosecuting the defendant was not important. I argue that more courts can and should follow this path. Such an approach would limit the involuntary medication of defendants to those exceptional cases where it is truly warranted

Losing the Battle: The Challenges of Military Suicide

This report, by Dr. Margaret Harrell, CNAS Senior Fellow and Director of the Joining Forces Initiative, and Nancy Berglass, CNAS Non-Resident Senior Fellow, suggests that the health of the all-volunteer force is dependent on our nation's ability to take care of its service members and veterans.According to the report, "Suicide among service members and veterans challenges the health of America's all-volunteer force." From 2005 to 2010, service members took their own lives at a rate of approximately one every 36 hours. This tragic phenomenon reached new extremes when the Army reported a record-high number of suicides in July 2011 with the deaths of 33 active and reserve component service members reported as suicides. Additionally, the Department of Veterans Affairs estimates 18 veterans die by suicide each day. Yet the true number of veterans who die by suicide, as Harrell and Berglass point out, is unknown. As more American troops return home from war, this issue will require increasingly urgent attention. Harrell and Berglass present a number of concrete policy recommendations that will help reduce the number of service member and veteran suicides, including establishing an Army unit cohesion period; removing the congressional restriction on unit leaders discussing personally owned weapons with service members; and increasing coordination between the Department of Defense (DOD), the Department of Veterans Affairs (VA) and the Department of Health and Human Services (HHS) to improve the analysis of veteran suicide data. Despite the efforts of the DOD and the VA to address military suicide, obstacles remain, and policymakers must bring a renewed urgency to their efforts if America is to both honor the sacrifices made by the all-volunteer force and protect its future health and ability to defend the nation