中美日藥品說(shuō)明書適老化管理的對(duì)比研究

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中圖分類號(hào)R954 文獻(xiàn)標(biāo)志碼A 文章編號(hào) 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

老年人屬于疾病多發(fā)人群，通常具有共病，對(duì)藥品的使用量大于年輕群體，存在多種藥物共用情況，且在面對(duì)專業(yè)術(shù)語(yǔ)多、內(nèi)容繁雜的藥品說(shuō)明書時(shí)存在理解困難問(wèn)題，導(dǎo)致用藥時(shí)易發(fā)生藥物不良反應(yīng)，影響其自身

用藥安全[2]

近年來(lái)，隨著人口老齡化進(jìn)程不斷加速，國(guó)家更加重視老年患者的用藥安全，紙質(zhì)版藥品說(shuō)明書看不清、看不懂等問(wèn)題也更加受到社會(huì)關(guān)注。（剩余9180字）