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. METHODS: A total of 500 participants, 83 with limited literacy, completed an at-home Web-based application to assess appropriateness for treatment with rosuvastatin 5 mg. The Web application is designed to assess eligibility for a moderate-intensity statin based on current guidelines and deny access to individuals with contraindications to rosuvastatin. Subsequently, participants visited a research site where clinicians, blinded to the information the participant entered, performed an independent Web application assessment. The Web application is programmed for 1 of 3 rosuvastatin treatment outcomes: "OK to use," "not right for you," or "ask a doctor." The primary endpoint was the percent of participants whose self-selected eligibility for nonprescription rosuvastatin was concordant with clinician assessment. RESULTS: For the primary endpoint, participant selection for statin therapy was concordant with clinician selection in 481 (96.2%) of 500 participants (95% confidence interval: 94.1%-97.7%), of whom 23 (4.6%) were deemed appropriate and 458 (91.6%) were deemed inappropriate for treatment. Discordance was due to incorrect self-selection ("OK to use") in 3 cases, incorrect rejection ("not right for you") in 14 cases and an incorrect "ask a doctor" outcome in 2 cases. CONCLUSIONS: The use of a technology-assisted approach to consumer self-selection for statin therapy resulted in participant self-selection that showed substantial agreement with clinician selection.

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. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval. RESULTS: The results for performance on six primary end points met or exceeded thresholds, including the steps "Check for a suspected overdose" (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and "Give the first dose" (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of "Call 911 immediately," but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of "Check, give, and call 911 immediately" (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9). CONCLUSIONS: Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.

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. Thirteen primary objective questions (five specific to UR risk) were included in the survey, which assessed healthcare professionals' (HCPs') understanding of UR risk and symptoms of acute UR associated with RTG/EZG. The primary outcome was the proportion of HCPs correctly answering each question. For each question, a proportion of correct responses ≥80 % was considered to represent sufficient understanding of associated risks. RESULTS: Of 1028 HCPs screened, 373 participated. Six of 13 questions (3/5 specific to UR risk) met the ≥80 % threshold for correct responses in the physician cohort. No questions achieved this threshold in the total pharmacist group; however, four questions scored ≥80 % when stratified by pharmacists who had dispensed RTG/EZG. CONCLUSIONS: Results demonstrated a mixed level of understanding of aspects of UR risk associated with RTG/EZG, although some risk questions did not meet the 80 % threshold, especially among pharmacists. This is likely to have been due to the short time that RTG/EZG has been available and its limited use. This study provides the first evaluation of the REMS communication plan on the risk of UR with RTG/EZG.