中美日药品说明书适老化管理的对比研究

打开文本图片集

中图分类号R954 文献标志码A 文章编号 1001-0408（2025）09-1030-05

DOI 10.6039/j.issn.1001-0408.2025.09.02

ABSTRACTOBJECTIVETocompare the measures taken by China，theU.S.andJapanto adapt drug instructions to aging， and proviereferenceforthereformofelderly-friendlydrug instructionsin China.METHODsTherelevantdocumentspublished bytheoffcialwebsitesof NationalMedical ProductsAdministrationofChina，the U.S.FDA，andPharmaceuticalsandMedical DevicesAgencyofJapan，wereconsulted.Additionaly，relevantliterature fromcomprehensivedatabasessuchasCNKI，Wanfang data，and Webof Science，aswellassearchengines，wasreviewed tounderstandthe measures takenbytheabovecountries in elderly-friendlymanagementprocessofdrugistructions.Tecomparativeanalysiswasconductedforelderly-friendlyadaptatiosof druginstructionsinChina，theU.S.andJapan，andthesuggestions wereputforwardforthereformof elderly-friendlydrug instructions in China.RESULTS& CONCLUsIONs The measures taken by China，the U.S.，andJapan in the processof elderlyfriendlymanagementofdruglabelshaddiferentemphases：Chinaadoptedlargefontsandsimplifieddruginstructionstoaeviate theproblemoftheelderlybeingunabletoreadandunderstanddruginstructions；the U.S.hadsetupaspecialsectionforthe elderlyinthedruginstructionsforspecialpopulationsandissuedtheprinciplesforwritinginformationonmedicationsforthe elderlyTheU.S.andJapanhadestablishedaclasificationmanagementsystemforpatient instructionsandprofessional instructions，promotedstructuredelectronicistructions，andbuiltaunifiedelectronicinstructionsplatform.Itisrecommededthat Chinaincorporateelderly-specificmedicationinformationintothewritingrequirementsofdruginstructions，improvespecific measurestoencouragethereformofdruginstructionssuitablefortheelderly，improvetheacessbilityandreadabilityofelectronic druginstructions，andbuildadrug instruction information disclosureplatformtobeter ensurethesafetyof medicationforthe elderly.

KEYWORDS drug instructions；elderly-friendly；theelderly；medication safety；international comparison

老年人属于疾病多发人群，通常具有共病，对药品的使用量大于年轻群体，存在多种药物共用情况，且在面对专业术语多、内容繁杂的药品说明书时存在理解困难问题，导致用药时易发生药物不良反应，影响其自身

用药安全[2]

近年来，随着人口老龄化进程不断加速，国家更加重视老年患者的用药安全，纸质版药品说明书看不清、看不懂等问题也更加受到社会关注。（剩余9180字）