BACKGROUND: Patient information leaflets (PILs) are the most important information source for older patients to effectively manage their drug therapy. OBJECTIVE: The objective of this study is to evaluate the appropriateness of current available PILs for use by older adults. METHODS: The content of the PILs were assessed by checking the availability of information relevant to older patients including pharmacokinetics, safety and dose instructions. The layout of the PILs was evaluated using criteria derived from the relevant regulatory guidelines on the design of PILs. The Gunning Fog Index was used to determine the readability of the PILs to older adults. RESULTS: Total of 48 PILs were analysed involving 25 drug substances for the treatment of cardiovascular disease and type 2 diabetes. One out of the 48 PILs contained information on pharmacokinetic changes in older patients and only 15 % of the PILs specified the age of the older person. Thirty-one percent of the PILs provided nonspecific warnings to the older population, while only 15 % included specific side effects that could occur in the older generation. Text font sizes of the PILs were generally too small for older adults to read, with only 9 % of the PILs used type size 12 or over. The readability of 63 % of the PILs had a score above 12, which is considered difficult for older people to understand. CONCLUSION: Currently available medication PILs are inappropriate for use by older adults to manage their medications effectively, which could adversely affect patient safety and adherence to drug therapy.
BACKGROUND:Patient information leaflets (PILs) are the most important information source for older patients to effectively manage their drug therapy. OBJECTIVE: The objective of this study is to evaluate the appropriateness of current available PILs for use by older adults. METHODS: The content of the PILs were assessed by checking the availability of information relevant to older patients including pharmacokinetics, safety and dose instructions. The layout of the PILs was evaluated using criteria derived from the relevant regulatory guidelines on the design of PILs. The Gunning Fog Index was used to determine the readability of the PILs to older adults. RESULTS: Total of 48 PILs were analysed involving 25 drug substances for the treatment of cardiovascular disease and type 2 diabetes. One out of the 48 PILs contained information on pharmacokinetic changes in older patients and only 15 % of the PILs specified the age of the older person. Thirty-one percent of the PILs provided nonspecific warnings to the older population, while only 15 % included specific side effects that could occur in the older generation. Text font sizes of the PILs were generally too small for older adults to read, with only 9 % of the PILs used type size 12 or over. The readability of 63 % of the PILs had a score above 12, which is considered difficult for older people to understand. CONCLUSION: Currently available medication PILs are inappropriate for use by older adults to manage their medications effectively, which could adversely affect patient safety and adherence to drug therapy.
Authors: Peter Crome; Frank Lally; Antonio Cherubini; Joaquim Oristrell; Andrew D Beswick; A Mark Clarfield; Cees Hertogh; Vita Lesauskaite; Gabriel I Prada; Katarzyna Szczerbińska; Eva Topinkova; Judith Sinclair-Cohen; David Edbrooke; Gary Mills Journal: Drugs Aging Date: 2011-08-01 Impact factor: 3.923
Authors: Yiling J Cheng; Giuseppina Imperatore; Linda S Geiss; Jing Wang; Sharon H Saydah; Catherine C Cowie; Edward W Gregg Journal: Diabetes Care Date: 2013-05-01 Impact factor: 19.112
Authors: Winona Rei R Bolislis; Charlie Mortazavi; Rossana Riccioni; Paul-Etienne Schaeffer; Thomas C Kühler Journal: Ther Innov Regul Sci Date: 2019-12-09 Impact factor: 1.778
Authors: María Ángeles Piñero-López; Pilar Modamio; Cecilia F Lastra; Eduardo L Mariño Journal: J Med Internet Res Date: 2016-05-25 Impact factor: 5.428