Patient information leaflets and package inserts of ibuprofen provided in the UK and Thailand: a comparative assessment.

OBJECTIVES: Written medicine information (WMI) is important for ensuring patients understand and use their medicines optimally, but relatively little research has assessed the quality of available WMI. This study assessed the quality of WMI using a sample of leaflets for ibuprofen in the UK and Thailand. METHODS: Leaflets were obtained by purchasing a product from retail outlets or community pharmacies, 18 from each country. In the UK, these were patient information leaflets (PILs); in Thailand, they were package inserts PIs not specifically designed for patients. Leaflets were assessed for content, layout, and readability using standard methods and compared to relevant guidelines. KEY FINDINGS: The UK PILs were uniform and conformed to EU regulatory requirements for content, whereas Thai PIs varied considerably, many failing to include important information required by Thai regulations. Several forms of Thai PIs were found, including some very short leaflets, containing minimal information. The readability of both was rated as poor, all used small font size and had less than desirable white space. Fewer Thai PIs than UK PILs met the Keystone Criteria for ibuprofen. CONCLUSIONS: The extent of variation in format and content of Thai WMI could potentially cause confusion and reduce willingness to read it. PILs, conforming to Thai regulatory guidelines, should be provided with medicines instead. Leaflets in both countries would benefit from improved readability and layout.

Assessment of the Quality of Saudi Patient Information Leaflets (PILs) Based on the Accuracy of Physical Description and Frequency of Solid Dosage Forms.

The physical description of dosage forms is one of the most important considerations in avoiding patient confusion and minimizing medication errors. This study aimed to determine the quality and accuracy of the physical descriptions in patient information leaflets (PILs). This cross-sectional study constituted a total of 200 drugs and PILs that were randomly selected, by pharmacy students, from Al-Dawaa community pharmacies in the Hail region of Saudi Arabia, from January 2021 to July 2021. The drugs and PILs were thoroughly evaluated in accordance with the Gulf Cooperation Council (GCC) guidelines for PILs. The accuracy screening of the total solid dosage forms (capsules + tablets) revealed that 45% showed complete accuracy and compliance, 1.5% showed poor accuracy and compliance, and 53% showed no accuracy and no compliance with the GCC guidelines and the Saudi Food and Drug Authority (SFDA) guidelines. In the frequency test, color, shape, and imprints accounted for 95.6%, 79.1%, and 73.6%, respectively. However, the size of the dosage form was the least (2.2%) used physical description feature. These findings recommend pharmaceutical companies to pay more attention to the written physical description in their PILs. Additionally, the process of PIL approval should be optimized, evaluated, and updated systematically to ensure that they contain the essential information.

Applying behavioural science to increase uptake of the NHS Health Check: a randomised controlled trial of gain- and loss-framed messaging in the national patient information leaflet.

BACKGROUND: The NHS Health Check (NHSHC) is a national programme for the prevention of non-communicable diseases. Patients aged 40-74 without an existing cardiovascular-related condition should be invited quinquennially. Uptake is lower than anticipated. We assessed the impact on uptake of two new behaviourally-enhanced leaflets (with the current national leaflet as a control), enclosed with the invitation letter: the first trial on the leaflet. METHODS: A double-blind three-armed randomized controlled trial was conducted. The new leaflets were shorter (two pages, instead of four); one was loss-framed ('don't miss out') and the other was gain-framed ('make the most of life'). The participants were patients from 39 practices in Lewisham and 17 practices in NE Lincolnshire, who were allocated to interventions using a random-number generator and received one of the leaflets with their invitation letter from April-September 2018. The outcome measure was uptake of an NHSHC by November 2018. The trial was powered to detect a 2% effect. RESULTS: Uptake was 17.6% in the control condition (n = 3677), 17.4% in the loss-framed condition (n = 3664), and 18.2% in the gain-framed condition (n = 3697). Leaflet type was not a significant predictor of NHSHC uptake in a logistic regression that controlled for demographic variables, with GP practice as a random effect. Statistically significant predictors of uptake included location (higher uptake in Lewisham), age (increased age was associated with increased attendance) and sex (higher uptake in females). The Bayes Factor comparing the null to a hypothesis of differences between conditions was 416, which is extreme evidence in favour of the null hypothesis. CONCLUSION: There was no evidence for a meaningful effect of either a loss-framed or gain-framed behaviourally-informed leaflet type on uptake, which is surprising, given that behaviourally informed letters have improved uptake of NHSHCs. It is possible that people do not pay attention to leaflets that are enclosed with letters, or that the leaflet continues to support informed decision-making but this does not affect uptake. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03524131. Registered May 14, 2018. Retrospectively registered.

Survey of outpatients' use and needs of patient medicine information leaflets in Thailand.

Background Patient information leaflets are important sources of medicine information. Regulations of patient information leaflet provision varies among country. Little is known regarding patients' behavior and expectation on use of patient information leaflets. Objectives To explore patients' use of either package inserts or patient information leaflets and to survey patients' expectations and needs on use of patient information leaflets and their associated factors. Setting Two university hospitals in Thailand. Methods Cross-sectional study using self-administered questionnaires distributed to outpatients over a 3-month period. Participants were selected through systematic random sampling. Logistic regression was used for data analysis. Main outcome measure Patient use of medicine information. Visual Analogue Scale scores for patient needs and their expectation of knowledge gains from using patient information leaflets. Results The response rate was 77.0%. Most respondents had received package inserts (91.3%) with 59.4% reporting that they sometimes read them. While most respondents had not previously known about patient information leaflets (75.9%), 97.3% reported that patient information leaflets would be useful. Respondents scored their needs and expected knowledge gains after reading patient information leaflets as 9.68 ± 0.97 and 9.64 ± 0.99, respectively. Previous experience with package inserts was associated with increased patient need scores (p = 0.002) and higher expected knowledge gains from use of patient information leaflets (p = 0.037). In addition, patients who had not previously known about patient information leaflets had higher expectations of knowledge gains (p = 0.016). Conclusion Overall, patients showed good behavior on reading package inserts. Although many patients were not previously aware of patient information leaflets, they realized the importance. Hence, patient information leaflets should be developed and provided to Thai patients.