The US Food and Drug Administration (FDA) is developing a new framework to provide patients with quality, up-to-date prescription product information that will promote the safe use of prescribed medication. The goal of this new Patient Medication Information is to provide patient-oriented information for each prescription product. Described in this article are the efforts of the FDA to help ensure that patients receive essential prescription medication information.
WintersteinAGLindenSLeeAEFernandezEMKimberlinCL. Evaluation of consumer medication information dispensed in retail pharmacies. Arch Intern Med. 2010;170(15):1317–1324.
2.
ShiffmanSGerlachKKSembowerMARohayJM. Consumer understanding of prescription drug information: an illustration using an antidepressant medication. Ann Pharmacother. 2011;45(4):452–458.
3.
RaynorDKSvarstadBKnappP. Consumer medication information in the United States, Europe, and Australia: a comparative evaluation. J Am Pharm Assoc. 2007;47(6):717–724.
Food and Drug Administration. Development and distribution of patient medication information for prescription drugs; public hearing. http://www.fda.gov/drugs/newsevents/ucm219716.htm. Published 2010. Updated April 17, 2013.
6.
National Consumers League, et al. Withdrawal of citizen petition requesting FDA action on a “one document solution” for all pharmacy-based communications [Docket No. FDA-2008-P-0380]. http://www.regulations.gov/#!documentDetail;D=FDA-2008-P-0380-0008. Published November 23, 2010.
7.
MayerGVillaireM. Enhancing written communications to address health literacy. OJIN: The Online Journal of Issues in Nursing. 2009;14(3). doi:10.3912/OJIN.Vol14No03Man03
8.
LukAAslaniP. Tools used to evaluate written medicine and health information: document and user perspectives. Health Educ Behav. 2011;38(4):389–403.
9.
SeedorffMPetersonKJNelsenLA. Incorporating expert terminology and disease risk factors into consumer health vocabularies. Pac Symp Biocomput. 2013:421–432.
10.
JiangLYangCLiJ. Discovering consumer health expressions from consumer-contributed content. In: GreenbergAKennedyWBosN, eds. Social Computing, Behavioral-Cultural Modeling and Prediction. Berlin: Springer; 2013:164–174.
11.
Pander MaatHLentzL. Improving the usability of patient information leaflets. Patient Educ Couns. 2010;80(1):113–119.
