Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy.

Background: Although statins reduce cardiovascular morbidity and mortality, only about one-half of eligible patients receive treatment. Safe and appropriate consumer access to statins could have a significant positive public health impact.

Objectives: This study compares the concordance between a participant and clinician assessment of eligibility for statin therapy using a technology-assisted approach.

FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone.

Background: The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use.

Methods: In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends.

Physician and Pharmacist Understanding of the Risk of Urinary Retention with Retigabine (Ezogabine): A REMS Assessment Survey.

Background: The Risk Evaluation and Mitigation Strategy (REMS) for retigabine/ezogabine (RTG/EZG) required an evaluation of the effectiveness of the communication plan to communicate about the risks with use of RTG/EZG.

Objective: GlaxoSmithKline conducted a survey to assess understanding of the risk of urinary retention (UR) with RTG/EZG and to evaluate the effectiveness of the communication plan.

Methods: This was a US-based, cross-sectional, non-interventional, observational survey, conducted from February to April 2013, of physicians who had prescribed RTG/EZG in the past year, and pharmacists who had dispensed an antiepileptic drug within the past 3 months.