Rebecca J Mullen1, James Duhig2, Andrea Russell3, Linda Scarazzini4, Fabio Lievano5, Michael S Wolf6. 1. Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States. Electronic address: r-mullen@northwestern.edu. 2. Pharmacovigilance and Patient Safety, AbbVie, Inc., 1 N. Waukegan Rd., GM60, AP51-2, North Chicago, IL, 60064, United States. Electronic address: james.duhig@abbvie.com. 3. Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States. Electronic address: andrearussell2021.1@u.northwestern.edu. 4. Pharmacovigilance and Patient Safety, AbbVie, Inc., 1 N. Waukegan Rd., GM60, AP51-2, North Chicago, IL, 60064, United States. Electronic address: linda.scarazzini@abbvie.com. 5. Safety Sciences, AbbVie, Inc., 1 N. Waukegan Rd., GM60, AP51-2, North Chicago, IL, 60064, United States. Electronic address: leviano@abbvie.com. 6. Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States. Electronic address: mswolf@northwestern.edu.
Abstract
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.
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.
Authors: Laxsini Murugesu; Miriam E Hopman; Sabine F Van Voorst; Ageeth N Rosman; Mirjam P Fransen Journal: Int J Environ Res Public Health Date: 2019-10-31 Impact factor: 3.390