xx醫(yī)院門診口服中成藥說明書情況調(diào)查與分析.doc
約8頁DOC格式手機(jī)打開展開
xx醫(yī)院門診口服中成藥說明書情況調(diào)查與分析,摘要:目的 調(diào)查中成藥說明書中各項(xiàng)目的缺失情況及其內(nèi)容的完整性,提高臨床用藥的合理性，進(jìn)一步完善中成藥說明書。方法 收集xx醫(yī)院門診口服中成藥說明書共127張，參照《藥品說明書和標(biāo)簽管理規(guī)定》及《關(guān)于中藥、天然藥物處方藥說明書格式內(nèi)容書寫要求及撰寫指導(dǎo)原則的通知》中的有關(guān)規(guī)定，...
內(nèi)容介紹
此文檔由會(huì)員 一切如愿8 發(fā)布
xx醫(yī)院門診口服中成藥說明書情況調(diào)查與分析
摘要:目的 調(diào)查中成藥說明書中各項(xiàng)目的缺失情況及其內(nèi)容的完整性,提高臨床用藥的合理性，進(jìn)一步完善中成藥說明書。方法 收集xx醫(yī)院門診口服中成藥說明書共127張，參照《藥品說明書和標(biāo)簽管理規(guī)定》及《關(guān)于中藥、天然藥物處方藥說明書格式內(nèi)容書寫要求及撰寫指導(dǎo)原則的通知》中的有關(guān)規(guī)定，對(duì)127份中成藥說明書的所有項(xiàng)目標(biāo)注情況、安全項(xiàng)及特殊人群用藥項(xiàng)進(jìn)行統(tǒng)計(jì)分析。結(jié)果 127份中成藥說明書中項(xiàng)目標(biāo)注情況上，警示語、藥物相互作用、臨床試驗(yàn)等項(xiàng)目缺失率較高；特殊人群用藥項(xiàng)上，只有一份說明書將兒童用藥、老年用藥、孕婦及哺乳期婦女用藥作為單獨(dú)一項(xiàng)列出，孕婦及哺乳期婦女用藥在別項(xiàng)中提到比率較高；安全項(xiàng)標(biāo)注情況較完整，標(biāo)注率均接近100%，但其內(nèi)容缺乏完整性。結(jié)論 中成藥說明書中仍存在許多不足，我們要提高警惕，進(jìn)一步完善中成藥說明書。
關(guān)鍵詞: 中成藥說明書；標(biāo)注情況；特殊人群用藥；安全項(xiàng)調(diào)查
The ninth hospital outpatient proprietary Chinese medicine oral instruction situation investigation and analysis
Abstract: Objective to investigate the lack of integrity and the content of each item of proprietary Chinese medicines in the specification, improve the rationality of clinical medicine, to further improve the Chinese patent medicines. Methods the data of nine five hospital outpatient oral Chinese patent medicines, a total of 127, according to "drug instructions and labeling regulations" and "Regulations on traditional Chinese medicine, natural medicine prescription drug instruction format requirement of writing content and notice" writing guidelines in 127 Chinese patent medicines, for all items, safety and drug use in special populations a statistical analysis. Results of the 127 projects in the Chinese traditional medicine manual annotation status, lack of a higher rate of warnings, drug interaction, clinical trials and other projects; drug use in special populations item, only a description will use for children, elderly patients, pregnant and lactating women use as a separate item list, pregnant and lactating women use mentioned higher ratios in don't item; security label is complete, labeling rate is close to 100%, but its content is lack of integrity. There are still many problems conclusion Chinese medicine instructions, we must be vigilant, to further improve the Chinese patent medicines.
Keywords: Proprietary Chinese medicine specifications; the mark; Special populations medication; Safety survey
摘要:目的 調(diào)查中成藥說明書中各項(xiàng)目的缺失情況及其內(nèi)容的完整性,提高臨床用藥的合理性，進(jìn)一步完善中成藥說明書。方法 收集xx醫(yī)院門診口服中成藥說明書共127張，參照《藥品說明書和標(biāo)簽管理規(guī)定》及《關(guān)于中藥、天然藥物處方藥說明書格式內(nèi)容書寫要求及撰寫指導(dǎo)原則的通知》中的有關(guān)規(guī)定，對(duì)127份中成藥說明書的所有項(xiàng)目標(biāo)注情況、安全項(xiàng)及特殊人群用藥項(xiàng)進(jìn)行統(tǒng)計(jì)分析。結(jié)果 127份中成藥說明書中項(xiàng)目標(biāo)注情況上，警示語、藥物相互作用、臨床試驗(yàn)等項(xiàng)目缺失率較高；特殊人群用藥項(xiàng)上，只有一份說明書將兒童用藥、老年用藥、孕婦及哺乳期婦女用藥作為單獨(dú)一項(xiàng)列出，孕婦及哺乳期婦女用藥在別項(xiàng)中提到比率較高；安全項(xiàng)標(biāo)注情況較完整，標(biāo)注率均接近100%，但其內(nèi)容缺乏完整性。結(jié)論 中成藥說明書中仍存在許多不足，我們要提高警惕，進(jìn)一步完善中成藥說明書。
關(guān)鍵詞: 中成藥說明書；標(biāo)注情況；特殊人群用藥；安全項(xiàng)調(diào)查
The ninth hospital outpatient proprietary Chinese medicine oral instruction situation investigation and analysis
Abstract: Objective to investigate the lack of integrity and the content of each item of proprietary Chinese medicines in the specification, improve the rationality of clinical medicine, to further improve the Chinese patent medicines. Methods the data of nine five hospital outpatient oral Chinese patent medicines, a total of 127, according to "drug instructions and labeling regulations" and "Regulations on traditional Chinese medicine, natural medicine prescription drug instruction format requirement of writing content and notice" writing guidelines in 127 Chinese patent medicines, for all items, safety and drug use in special populations a statistical analysis. Results of the 127 projects in the Chinese traditional medicine manual annotation status, lack of a higher rate of warnings, drug interaction, clinical trials and other projects; drug use in special populations item, only a description will use for children, elderly patients, pregnant and lactating women use as a separate item list, pregnant and lactating women use mentioned higher ratios in don't item; security label is complete, labeling rate is close to 100%, but its content is lack of integrity. There are still many problems conclusion Chinese medicine instructions, we must be vigilant, to further improve the Chinese patent medicines.
Keywords: Proprietary Chinese medicine specifications; the mark; Special populations medication; Safety survey
