Visual acuity, literacy, and unintentional misuse of nonprescription medications.

PURPOSE: Results of a study of associations between visual acuity and the risk of misuse of nonprescription acetaminophen products in a sample of community-dwelling adults are reported. METHODS: In a study involving English-speaking adults at 4 primary care clinics, the potential for misuse of nonprescription acetaminophen products was measured via a functional assessment of product self-dosing and by testing patients' understanding of the risks of concomitant use (i.e., taking 2 products at the same time when contraindicated). Vision was assessed using the Rosenbaum vision chart and dichotomized as normal (visual acuity of 20/20-20/25) or low (acuity of 20/30-20/100). Bivariable and multivariable analyses were performed to determine the impact of visual acuity on medication misuse outcomes. RESULTS: Among the study participants (n = 500), 39% had limited literacy, and 54% were categorized as having low vision. After controlling for age, race, and prior acetaminophen use, low vision was independently associated with an increased risk of self-dosing errors (odds ratio [OR], 1.67; 95% confidence interval [CI], 1.25-2.21; p < 0.001) and misunderstanding of concomitant-use risks (OR, 1.41; 95% CI, 1.00-2.00; p = 0.05). Limited literacy was an independent risk factor for incorrect dosing (OR, 1.71; 95% CI, 1.25-2.35; p = 0.001) and unawareness of concomitant use instructions (OR, 4.14; 95% CI, 2.80-6.12; p < 0.001). CONCLUSION: Misunderstanding of nonprescription acetaminophen product information was common among study participants and independently associated with both impaired visual acuity and low literacy skills.

Best-practices for the design and development of prescription medication information: A systematic review.

OBJECTIVE: To present evidence supporting best-practices for prescription drug labeling and educational materials. METHODS: Articles were selected from three online databases (PubMed, Embase, CINAHL). Eligible manuscripts were: 1) English-language, 2) randomized, controlled trials, and 3) focused on improving prescription drug labeling practices. RESULTS: Forty-nine articles were reviewed, and included both regulated label materials and pharmacy or health systems-generated tools. Best-practices included use of plain language principles, typographic cues, quantitative descriptors, and standardized formats, when applicable. Common outcomes included preference and comprehension, while few studies examined actual medication use (e.g. adherence, harms) or clinical health outcomes. Approximately half of studies directly engaged patients' perspectives in intervention development, which may have helped increase tool effectiveness. CONCLUSIONS: Several best practices were apparent in the literature, particularly for written materials and pharmacy-generated container labeling. Design principles for supplemental instructions and multimedia tools were less cohesive, albeit less researched. The impact of patient involvement in tool design is promising, though requiring further study. PRACTICE IMPLICATIONS: Definitive studies to inform practice standards on how to best communicate medication information to consumers are needed, especially as communication modalities continue to evolve. Increased research on if and how to incorporate patient-centered decision-making into the development process should be considered.

An efficacy trial of an electronic health record-based strategy to inform patients on safe medication use: The role of written and spoken communication.

OBJECTIVE: We tested the feasibility and efficacy of an electronic health record (EHR) strategy that automated the delivery of print medication information at the time of prescribing. METHODS: Patients (N=141) receiving a new prescription at one internal medicine clinic were recruited into a 2-arm physician-randomized study. We leveraged an EHR platform to automatically deliver 1-page educational 'MedSheets' to patients after medical encounters. We also assessed if physicians counseled patients via patient self-report immediately following visits. Patients' understanding was objectively measured via phone interview. RESULTS: 122 patients completed the trial. Most intervention patients (70%) reported receiving MedSheets. Patients reported physicians frequently counseled on indication and directions for use, but less often for risks. In multivariable analysis, written information (OR 2.78, 95% CI 1.10-7.04) and physician counseling (OR 2.95, 95% CI 1.26-6.91) were independently associated with patient understanding of risk information. Receiving both was most beneficial; 87% of those receiving counseling and MedSheets correctly recalled medication risks compared to 40% receiving neither. CONCLUSION: An EHR can be a reliable means to deliver tangible, print medication education to patients, but cannot replace the salience of physician-patient communication. PRACTICE IMPLICATIONS: Offering both written and spoken modalities produced a synergistic effect for informing patients.

Variability in Acetaminophen Labeling Practices: a Missed Opportunity to Enhance Patient Safety.

Confusion regarding a drug's active ingredient may lead to simultaneous use of multiple acetaminophen-containing prescriptions and increase the risk of unintentional overdose. The objective of this study was to examine prescription labeling practices for commonly prescribed acetaminophen-containing analgesics, specifically focusing on how active ingredient information and concomitant use warnings were conveyed. Patients with new acetaminophen-containing prescriptions were recruited upon discharge from an emergency department in Chicago or at an outpatient, hospital-based pharmacy in Atlanta. Label information was transcribed from prescription bottles and patients' knowledge of active ingredient was assessed by in-person interviews. Among the 245 acetaminophen-containing prescriptions, hydrocodone was the most common second active ingredient (n = 208, 84.8 %) followed by oxycodone (n = 28, 11.4 %). Acetaminophen was identified by its full name on 6.9 % (n = 17) of labels; various abbreviations were used in 93.1 % of cases. One hundred forty-seven bottles used auxiliary warning labels with the majority of labels (n = 130, 88.4 %) warning about maximum dose and 11.5 % (n = 17) about concomitant use. Most of the study participants (n = 177, 72.2 %) were not able to identify acetaminophen as an active ingredient in their prescription. There was no significant association between the use of unabbreviated labels including warning information and patients' awareness of acetaminophen as an active ingredient (36.4 vs. 27.3 %, p = 0.50). We noted high variability in labeling practices and warning information conveyed to patients receiving acetaminophen-containing prescriptions. Missed opportunities to adequately convey risk information may contribute to the burden of acetaminophen-related liver injury.

Patient recall of health care provider counseling for opioid-acetaminophen prescriptions.

OBJECTIVE: The aim of this study was to determine the frequency and nature of physician, nurse, and pharmacist verbal counseling at the time of a new prescription for an opioid-acetaminophen containing medication as recalled by patients. DESIGN: A mixed methods approach with data from cross sectional, structured interviews was used. SETTING: The settings were one academic emergency department in Chicago, IL and one outpatient pharmacy at a public hospital in Atlanta, GA. PATIENTS: One hundred forty-nine patients receiving a new prescription for an opioid-acetaminophen medication were enrolled. METHODS: Interviews assessed patient recall of counseling they received from their physician, nurse, and pharmacist upon receiving the new prescription. Their responses were unitized and assigned to categories. RESULTS: One hundred forty-nine patients were enrolled; 61.1% African American and 58.4% female. Seven major categories of responses were noted; frequencies of patient recall for counseling in these categories were reported. Four categories related to the content of the counseling discussion were (1) details of administration (patient recall counseling from: physician/nurse only 44.3%, pharmacist only 5.4%, both providers 12.8%); (2) activities to avoid and side effects (36.2%, 4.7%, 8.7%); (3) medication indication (32.9%, 4%, 4%); and (4) addictive potential (9.3%, 1.3%, 0%). Three categories describe patients' recall of the interaction in broad terms: (5) being referred to print informational material accompanying the prescription (MD/RN only 7.4%, pharmacist only 20.1%, both providers 2.7%); (6) having questions solicited (0%, 11.4%, 0%); (7) having no interaction relating to medication counseling (3.4%, 32.2%, 1.3%). CONCLUSIONS: Patients infrequently recall counseling from providers on topics that are important to prevent harm from opioid-acetaminophen prescriptions. Future patient-centered clinical research should target identifying optimal strategies to convey these critical messages.

Take-Wait-Stop: a patient-centered strategy for writing PRN medication instructions.

Recent studies have linked patient misunderstanding of label instructions for as needed (PRN) medications to dosing errors. This study conducted a preliminary field test of patient-centered PRN label instructions. Patients participated in a hypothetical dosing experiment and were randomized to a patient-centered label (referred to as "Take-Wait-Stop") or standard label. Participants were asked to demonstrate dosing the medicine over 24 hours. Three types of independent dosing errors were measured: (a) taking more than two pills at one time, (b) exceeding the maximum daily dose, and (c) waiting fewer than 4 hours between doses. Generalized linear models were used to assess the association between label type, health literacy, and sociodemographic characteristics. Participants' mean age was 39.8 years, 62.1% were female, 43.7% were White, and 72.4% had adequate literacy. Of participants, 31.8% who were shown the standard label demonstrated taking in excess of 6 pills in 24 hours compared with only 14.0% of participants who were shown the Take-Wait-Stop label (p = .05). Overall, only 1 person demonstrated he would take more than 2 pills in a single dose. Of the standard label group, 20.5% demonstrated dosing intervals of fewer than 4 hours compared with 23.3% of the Take-Wait-Stop label group (p=.75). In a multivariate model, participants who were exposed to the standard label were 2.5 times more likely to exceed the recommended maximum daily dose (95% CI [1.05, 7.70], p=.03). The Take-Wait-Stop label was beneficial in preventing participants from exceeding the maximum dose in 24 hours, although it did not significantly reduce other dosing errors.