ABSTRACT
Objective: Health information, including the labelling, must be presented in a manner that is easily understandable to consumers. In recent years, the European Union and the United States have introduced standards for providing health information in a way that is easy for consumers to understand. The Clear Communication Index (CCI) published by the Centers for Disease Control and Prevention (CDC) is a useful tool for this purpose. Unfortunately, there is no such tool in Japan. Therefore, focusing on the package labelling of foods with functional claims (FFCs) sold in Japan, we constructed a Functional Clear Communication Index (F-CCI) and evaluated the FFCs.Methods: The F-CCI was developed by six people, including university staff with pharmacist qualifications and public health experts, by referring to the CDC CCI. The evaluation of FFCs using the F-CCI was performed using the Delphi method, which is one of the formal consensus-building methods in the field of health and medical information. The evaluation was conducted by three qualified pharmacists on five FFC products, and the degree of internal agreement among the evaluators was calculated using Fleiss’ κ.Results: The F-CCI consisted of 18 items that assessed the FFC characteristics. After assessing the labelling of FFCs using the F-CCI, the scores of all the materials ranged between 70 and 80% on the F-CCI, and none achieved 90%, which was considered the acceptable standard (overall κ value_ 0.865). Moreover, it was clear that the ‘readability’ and ‘understandability’ of the labelling were inadequate.Conclusion: The F-CCI developed in this study for the objective evaluation of the labelling of FFC products will act as a tool that will subsequently lead to the proper understanding and use of FFCs by consumers. Further efforts are needed to build and disseminate such tools and user-friendly ways of providing relevant information.
ABSTRACT
<b>Objective: </b>A perception survey of healthcare providers and pharmaceutical industries about the current package insert (PI) was conducted to evaluate whether its layout and issues such as the contents concerning drug-drug interactions are found appropriate.<br><b>Methods: </b>A questionnaire was sent via the Internet to physicians of various subspecialties, or via the postal service to pharmacy-employed pharmacists and pharmaceutical industries. It consisted of questions regarding the PI layout, the information contents on drug-drug interactions and other matters about PI revision.<br><b>Results: </b>The survey showed that the PI is a major source of drug information for physicians (82.4%) and pharmacists (98.7%). The layout (order of appearance of headings and information about drug interactions in a tabular format) of the current PI is widely accepted by physicians, pharmacists, and pharmaceutical industries. There was, however, some degree of disagreement within these three groups in the perceptions about the presentation/contents of the several drug interactions, as well as about the timing for its updating. Around 24% of physicians and 35% of pharmacists view that the content of drug interactions is insufficient, and that information about adverse drug reactions and drug interactions is not enough updated in the PIs. On the other hand, near 86% of pharmaceutical industries were prone to wait for accumulation of enough data until revising the information in PIs.<br><b>Conclusions: </b>Differences of perception were found between healthcare providers (<i>i.e</i>., PI users) and industries. Our survey revealed that the basic layout of the current PI should be preserved, but there are issues such as the contents and updating of information regarding drug interactions and adverse drug interactions that may require modifications according to the healthcare providers’ point of view.