Advancing Best Practices for Prescription Drug Labeling

Abstract

Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.

The future of safety science is happening now: The modernization of the benefit‐risk paradigm

“…The expanding scope of cognitive behavioral work will initially focus on those areas most likely to benefit. Telemedicine, medical devices, mobile applications, text message reminders, remote nurse follow‐up, and medication guides, for example, are approaches in health care that would benefit from user‐centered design and development . Regulators want sponsors to identify tools that are useful in real‐world practice and supported by evidence generated from human factors and health literacy research that impact prescribing behavior and the safe use of drugs on‐market …”

“…13,14 Regulators want sponsors to identify tools that are useful in real-world practice and supported by evidence generated from human factors and health literacy research that impact prescribing behavior and the safe use of drugs on-market. 14…”

Implementation fidelity of patient‐centered prescription label to promote opioid safe use

“…Challenges with prescription drug labeling are a major contributor to adverse drug events . Complex medication label instructions and low patient health literacy contribute to patient misunderstanding . Over a decade ago, a systematic review of prescription labeling “best practices” proposed standards for labeling; these standards were later summarized in an Institute of Medicine (IOM) workshop .…”

“…1 Complex medication label instructions and low patient health literacy contribute to patient misunderstanding. [2][3][4][5][6] Over a decade ago, a systematic review of prescription labeling "best practices" proposed standards for labeling; these standards were later summarized in an Institute of Medicine (IOM) workshop. 7,8 More recently, a systematic review by Bailey and colleagues reinforced previous findings about the importance of clear labeling, while also calling for additional assessments of labeling in actual use rather than in hypothetical experiments.…”

“…7,8 More recently, a systematic review by Bailey and colleagues reinforced previous findings about the importance of clear labeling, while also calling for additional assessments of labeling in actual use rather than in hypothetical experiments. 5 Very few studies evaluating the impact of prescription labeling have examined interventions in actual use, rather than in hypothetical scenarios. In 2005, the Target chain of pharmacies changed their label format; two manuscripts describing that system-level change were published.…”