Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use

Shrank, William H.; Parker, Ruth M.; Davis, Terry C.; Pandit, Anjali U.; Knox, Jo Ann Pearson; Moraras, Pear; Rademaker, Alfred; Wolf, Michael S.

doi:10.1016/j.cct.2010.07.004

Cited by 23 publications

(14 citation statements)

References 41 publications

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“…24 Further study of the possible benefits, as well as risks of the UMS strategy is warranted, and evidence will soon be available from ongoing National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) studies that are currently testing the UMS in actual use. 25–27 …”

Section: Discussionmentioning

confidence: 99%

Helping Patients Simplify and Safely Use Complex Prescription Regimens

Wolf¹,

Curtis²,

Waite³

et al. 2011

Arch Intern Med

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111

107

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Background There is considerable variability in the manner in which prescriptions are written by physicians and transcribed by pharmacists, resulting in patient misunderstanding of label instructions. A ‘universal medication schedule’ (UMS) was recently proposed for standardizing prescribing practices to four daily time intervals thereby helping patients simplify and safely use their medicine. We investigated whether patients consolidate their medications, or if there is evidence of unnecessary regimen complexity that would support standardization. Methods Structured interviews were conducted with 464 adults ages 55–74 who were receiving care at either an academic general medicine practice or one of three federally qualified health centers in Chicago, Illinois. Subjects were given a hypothetical, seven-drug medication regimen and asked to demonstrate how and when they would take all of the medicine in a 24-hour period. The regimen could be consolidated into four dosing episodes per day. The primary outcome was the number of times per day individuals would take medicine. Root causes for patients complicating the regimen (> four times a day) were examined. Results Participants on average identified six times in 24 hours to take the seven drugs (SD=1.8; range 3 to 14). One third (29.3%) found seven or more times per day to take their medicine, while only 14.9% organized the regimen into four or fewer times a day. In multivariable analysis, low literacy was an independent predictor of more times per day for dosing out the regimen (β=0.67; 95% Confidence Interval 0.12 to 1.22, p=0.018). Instructions for two of the drugs were identical, yet 31% of patients did not dose these medicines at the same time. Another set of drugs had similar instructions with the primary exception of one having the added instruction to take “with food and water”. Half (49.5%) of participants dosed these medicines at different times. When medicines had variable expressions of the same dose frequency (“every 12 hours” vs. “twice daily”), 79.0% did not consolidate the medicines. Conclusion Many patients, especially those with limited literacy, do not consolidate prescription regimens in the most efficient manner, which could impede adherence. Standardized instructions proposed with the UMS and other task-centered strategies could potentially help patients routinely organize and take medication regimens.

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Section: Discussionmentioning

confidence: 99%

Helping Patients Simplify and Safely Use Complex Prescription Regimens

Wolf¹,

Curtis²,

Waite³

et al. 2011

Arch Intern Med

Self Cite

111

107

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“…A detailed account of the evidence supporting labeling changes is described in the 2008 IOM report and also by Shrank and colleagues. 10,25 The acceptability of the labeling was also supported by patient focus groups. 21 Label changes included dose instructions that were written in UMS form, stating when to take a medication using one of four daily standard time intervals (morning, noon, evening, bedtime).…”

Section: Interventionmentioning

confidence: 91%

“…A description of the trial is provided in greater detail in a previous publication. 25 The primary goal of the study was to determine whether the PCL strategy could improve 1) demonstrated proper use of prescribed drug regimens and 2) subsequent adherence compared to the current pharmacy standard. We hypothesized that this evidencebased label would improve proper use, and that it might also have a disproportionate benefit among those with limited literacy and English proficiency, but also among patients with greater regimen complexity.…”

Section: Methodsmentioning

confidence: 99%

A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence

et al. 2016

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BACKGROUND: Patient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk. OBJECTIVE: To test the effectiveness of a patientcentered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard. DESIGN: Two-arm, multi-site patient-randomized pragmatic trial. PARTICIPANTS: English-and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications. INTERVENTION: A patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime). MAIN MEASURES: Demonstrated proper use of a multidrug regimen; medication adherence measured by selfreport and pill count at 3 and 9 months. KEY RESULTS: A total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13-4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63-2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08,) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17-6.53). CONCLUSIONS:A simple modification to pharmacygenerated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens. Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849

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“…The Table provides examples of common instructions provided in a way that implements the recommendations for patient-centred labels. [12][13][14]19 While there is work to be done to ensure patient-centred labels are implemented in Australia in a safe and effective manner, some aspects can be implemented immediately. Prescribers should, when possible, avoid 'as directed' and provide the indication.…”

Section: Guidelinesmentioning

confidence: 99%

Safer dispensing labels for prescription medicines

Caze¹

2018

Aust Prescr

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SUMMARYThe standard way in which directions are represented on dispensing labels can be misinterpreted.Errors in interpreting instructions are more common in people with low health literacy and when the timing of administration is not specified.Improving written communication on prescriptions and dispensing labels can reduce medication errors.There is an emerging international consensus on best-practice communication on dispensing labels. Medication errorsIn a US trial, 395 participants were given five common prescription medicines with a dispensing label and asked how they would take the medicine. 4 The medicines and their instructions included:

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Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use

Cited by 23 publications

References 41 publications

Helping Patients Simplify and Safely Use Complex Prescription Regimens

Helping Patients Simplify and Safely Use Complex Prescription Regimens

A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence

Safer dispensing labels for prescription medicines

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