Development of Comprehensible Prescription Label Instructions: A Study Protocol for a Mixed-Methods Approach

Maghroudi, Ekram; Hooijdonk, C.M.J. van; Dijk, Liset van; Boland, Gudule; Haas, Channah de; Journée-Gilissen, Marleen; Velden, Janneke van der; Vervloet, Marcia; Westerhof, Henk P.; Rademakers, Jany; Borgsteede, Sander D.

doi:10.3389/fphar.2020.00981

Cited by 4 publications

(3 citation statements)

References 34 publications

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“…This turned out to be the case regardless of whether it was a medication with simple or more complex instructions for use, and regardless of the number of other medications someone is taking according to the hypothetical scenario. It is thereby important to mention that on the PDL, there is only limited space, making it difficult to provide additional information ( Maghroudi et al, 2020 ).…”

Section: Discussionmentioning

confidence: 99%

“…PDLs are often the most read source of information before a patient starts using the medication ( Webb et al, 2008 ), and they contain dosing instructions, usage recommendations and warnings ( Wolf et al, 2007 ). On the PDL, there is only limited space, making it difficult to provide additional information ( Maghroudi et al, 2020 ). Consequently, the information on the PDLs is often not comprehensible, as up to 50% of the adult population show limited understanding of PDLs, precautions, and medication warnings ( Davis et al, 2006a ; Davis et al, 2006b ; Wolf et al, 2006 ; Wolf et al, 2007 ; Bailey et al, 2009 ; Wolf et al, 2010 ; Wolf et al, 2011 ; Bailey et al, 2012 ; Bailey et al, 2014 ).…”

Section: Introductionmentioning

confidence: 99%

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Comprehensibility of a personalized medication overview compared to usual-care prescription drug labels

Schackmann

Dijk²,

Brabers³

et al. 2022

Front. Pharmacol.

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Poor understanding of prescription drug label (PDL) instructions can lead to medication errors, suboptimal treatment (side) effects, and non-adherence. A personalized medication hard-copy overview listing PDL instructions and visual information may support patients in their medication use. This study aimed to investigate the comprehensibility of PDL instructions on a personalized medication overview compared to usual-care PDL instructions presented on a medication box. A hypothetical-online-experiment was set up, comparing groups of respondents exposed vs not exposed to the medication overview and who received PDL instructions for three, five, or eight medications. Participants were divided randomly in six groups. Online questionnaires were sent to a stratified sample of 900 members from the Nivel Dutch Healthcare Consumer Panel. Outcome measures included comprehension of instructions for medication use, e.g. how often, dose timing, usage advice and warnings for a medication with simple use instructions (omeprazol) and more complex use instructions (levodopa/carbidopa (L/C)). To analyze differences between experimental conditions ANOVA testing was used. 604 respondents (net response 67%) completed the questionnaires. Respondents exposed (E) to the overview gave a higher proportion of correct answers compared to non-exposed (NE) respondents for usage advice (L/C: mean 0.83, SD 0.4 E; 0.03, SD 0.2 NE, p < 0.001; omeprazol: mean 0.85, SD 0.4 E; 0.10, SD 0.3 NE, p < 0.001). Both groups gave the same proportion of correct answers (mean 0.80, SD 0.4, p = 1.0) for dose timing of omeprazol. More NE respondents gave correct answers for how often (mean 0.85, SD 0.4 NE; mean 0.76, SD 0.4 E, p = 0.02) and dose timing (mean 0.92, SD 0.3 NE; mean 0.86, SD 0.4 E, p = 0.04) of L/C. No differences were found regarding number of medications nor were interaction effects found between the number of medications and information type. As a medication overview contains additional information, it can be a good addition in supporting patients in their medication use compared to usual-care PDLs. Future research should focus on identifying patient groups who might benefit more from a medication overview, by testing the effect of such overview on this group.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comprehensibility of a personalized medication overview compared to usual-care prescription drug labels

Schackmann

Dijk²,

Brabers³

et al. 2022

Front. Pharmacol.

Self Cite

View full text Add to dashboard Cite

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“…Two community pharmacies and their affiliated GPs, all located in the same neighborhood in which about two thirds of inhabitants have low health literacy, are part of living lab C. The teach-back method and comprehensible prescription labels were implemented to improve patients' medication adherence by GPs and community pharmacy staff members (Ha Dinh et al, 2016;Maghroudi et al, 2020).…”

Section: Living Lab Dmentioning

confidence: 99%

Implementation and scalability of primary care interventions to improve patients medication use

Hogervorst

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Treatment with medicines is the single most used method for treating patients with chronic conditions and to prevent further damage of the disease. The use of medicines is agreed upon between healthcare provider and patient and is only effective if used correctly. However, medication use is problematic for many patients and drug-related problems are common when patients do not succeed in following their treatment. Non-adherence to treatment regimens is a major drug-related problem in 44 to 77% of chronic medication users. Many evidence-based medication adherence interventions have been developed for healthcare providers to better support patients in taking their medication. These interventions are often complex, as they must be tailored to diverse patient populations, rely on close collaboration between different healthcare providers, and require continuous monitoring of non-adherent patients. This complexity means that for these interventions to be effective, they must be continuously available for patients by a multidisciplinary team of healthcare providers. As such, they need to be fully integrated into daily clinical practice systems in a (cost-)effective manner. However, so far, their implementation is often lacking. Integrating complex interventions into daily clinical practice is complex. It requires tailoring the intervention to the context in which they will be implemented, which requires using implementation strategies that fit within the context. In order to do so, detailed information about the setting and its context is required. However, current publications on interventions generally do not provide sufficient details about the implementation and the context to be reproduced in different settings. This tailoring can be supported by dissemination and implementation science methods, which offer different models and theories on implementing complex interventions into daily clinical practice. Throughout this thesis, we provide insight into how medication use of patients with a chronic disease can be optimized by improving the implementation and scale-up of medication adherence interventions in primary care. This was described in five chapters (chapters 2 to 6). We discussed our main findings and drew conclusions in chapter 7.

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Comparing comprehensibility of standard and enhanced prescription medicine labels: a randomized simulation

Mohammad

Saini

Badcock³

et al. 2022

International Journal of Pharmacy Practice

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Objectives The objective of this study is to develop and user-test the comparative effectiveness of two enhanced label designs to improve comprehension of patients with low English proficiency versus a standard label representative of the pharmacist-affixed medicine labels currently used in practice. Methods Using a randomized two-group study design, 66 participants from Sydney, Australia were allocated to view a set of standard labels followed by a set of enhanced labels named ‘linguistically enhanced labels’ or ‘linguistically and graphically enhanced labels’. Each set of labels depicted medicine directions of three levels of complexity, which participants viewed consecutively. The ‘enhanced labels’ incorporated several features documented in the literature as improving understanding of low-health-literate/linguistically compromised individuals such as translated directions in a language the person is more proficient in, numeric presentations of numbers/counts, carriage returns and graphic depiction of directions. A user-testing questionnaire relating to comprehensibility was conducted after each label was viewed. Differences in comprehensibility were assessed using a generalized linear model, Cochran-Mantel-Haenszel test for trend and a chi-square test. Key findings Results indicated significant improvements in comprehensibility with both types of enhanced labels compared with standard labels (P < 0.0001). The ‘linguistically and graphically enhanced label’ improved comprehensibility of the most complex directions to a greater extent than the ‘linguistically enhanced label’ (P < 0.0001). Conclusions This study has highlighted the scope for improvement of existing pharmacist-affixed prescription medicine labels to ensure better understanding by individuals with low English proficiency. The enhanced labels trialled presented a means with which this may be achieved through the incorporation of key design elements, such as simpler, translated and graphically supported directions.

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Development of Comprehensible Prescription Label Instructions: A Study Protocol for a Mixed-Methods Approach

Cited by 4 publications

References 34 publications

Comprehensibility of a personalized medication overview compared to usual-care prescription drug labels

Comprehensibility of a personalized medication overview compared to usual-care prescription drug labels

Implementation and scalability of primary care interventions to improve patients medication use

Comparing comprehensibility of standard and enhanced prescription medicine labels: a randomized simulation

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