FDA Studies New Strategies for Presentation of Patient Information.

Abstract

It is imperative that the information provided for patients along with their prescription drugs be clear and concise so that patients use their medications correctly and can make informed decisions about their health care. Previous evaluation of consumer medication information (CMI) demonstrated that only 75% of CMI studied met the minimum criteria for usefulness. To address this deficiency, FDA has held several meetings, commissioned studies, and gathered public input on the issue of effective CMI over the past decade. We are continuing these efforts to determine whether a new form of patient information can more effectively communicate essential medication information to patients. This potentially new form of patient information, also known as Patient Medication Information (PMI), would use research on reading behavior and document simplification to increase patient comprehension. Integral to our PMI assessment efforts are continued stakeholder input, additional investigations, and consumer focused research such as the evaluation performed by Aker et al. Aker and colleagues highlighted a number of different variables that we have also determined to be important for PMI development: variables such as uniform format, patientfriendly content, and concise and clinically relevant information. Furthermore, we agree that an integral part of successful PMI development is consumer testing to inform development of future PMI prototypes. Aker et al also emphasized the use of icons or pictograms in PMI to enhance patient comprehension. Although there is support for the use of these images to enhance instructions, there are several reasons why we chose not to use them in our PMI prototypes at this time; reasons include research indicating that icons and pictograms can be the basis for confusion, the lack of universally standardized icons and pictograms, and pharmacy printing limitations. Further research and testing to standardize icons and pictograms is necessary since a picture can be interpreted many ways depending on its context and on the cultural background of the intended audience. We at the FDA make every effort to ensure that PMI will communicate essential information to patients, and we strive to stay informed of new developments in the field of patient information research. Furthermore, we commend and appreciate the efforts of Ms Aker and her colleagues in the evaluation discussed here and encourage others to publish their findings so that we may collectively design the most useful patient information possible.