醫(yī)學論文：違法涉藥產(chǎn)品狀況分析及對策探討

違法涉藥產(chǎn)品狀況分析及對策探討
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武沙 * 雷蕾1 胡明1# 于濤2
1四川大學華西藥學院，成都市 610041
2四川省食品藥品監(jiān)督管理局，成都市 610017

摘要: 目的 統(tǒng)計分析目前違法涉藥產(chǎn)品的品種特點和違法狀況，促進涉藥產(chǎn)品的規(guī)范化管理。方法：對四川省藥品監(jiān)督管理局于2009年11～12月在集中整治非藥品冒充藥品專項行動第一階段工作所發(fā)現(xiàn)的違法涉藥產(chǎn)品數(shù)據(jù)，采用SPSS17.0軟件統(tǒng)計違法涉藥產(chǎn)品的類型、劑型、批準文號、生產(chǎn)企業(yè)類型、經(jīng)營企業(yè)類型、購貨渠道以及主要違法行為等。結果 426個品規(guī)違法涉藥產(chǎn)品主要包括食品、保健食品、保健用品、消毒產(chǎn)品、化妝品和無文號產(chǎn)品六類，其中保健用品占57.7%，食品占18.8%；保健食品占16.7%。多以透皮貼劑和軟膏劑形式冒充藥品。違法涉藥產(chǎn)品批準文號或標示文號種類繁多，其中食品和保健食品的批準文號分別有14種、9種，保健用品有18種；違法涉藥產(chǎn)品的經(jīng)營主體有零售藥店、成人用品店、保健品店、商場超市和基層醫(yī)療機構，其中在藥店中銷售者最多，有337個品規(guī)；違法涉藥產(chǎn)品生產(chǎn)企業(yè)包括制藥企業(yè)、醫(yī)藥
……（新文秘網(wǎng)http://120pk.cn省略947字，正式會員可完整閱讀）……　
d illegal activities of illegal pharmaceutical-related products. Results 426 illegal pharmaceutical-related products include food, health food, health products, disinfection products and cosmetics, which are separately accounted for 18.8%,16.7%,57.7%,2.8% and 3.3%. Most of them pretended to be drugs with the dosage form of transdermal patch or ointment. The approval numbers of the illegal pharmaceutical-related products were various, including 14 food,9 health food and 18 health products. There were 337 illegal pharmaceutical-related products sold in retail pharmacy, the others were sold in adult shop, health food stores, markets and primary medical organizations. The manufacturers of the illegal pharmaceutical-related products contained drug industry, meditech-company, biotech-company and other companies, 321 of them were characterized by drug in their names. The illegal pharmaceutical-related products claimed therapeutic effect, no approval numbers and their name were similar with drug name,etc.222 of them had misleading information about function or action. Conclusion and Suggestion The definition of pharmaceutical-related products is equivocal, the types of approval numbers are multiplicity, the names of manufacturers are misleading, illegal activities and manners of purchase are too many; It is suggested to improve the relevant laws and regulations of pharmaceutical-related products; delimit the scope and category of pharmaceutical-related products; set up a unified information platform; strengthen the management of manufacturing enterprises and drugstore；strengthen education of the consumers to make sure the safety of medications.
Keywords: Illegal pharmaceutical-related products; pretend to be drugs; countermeasures
藥品是一種特殊商品，它關系到公眾身體健康和生命安全�？墒�，近年來在零售市場涌現(xiàn)出大量冒充藥品的涉藥產(chǎn)品，使得藥品質(zhì)量公信力受到質(zhì)疑。違法涉藥產(chǎn)品[1]不僅危害著消費者的用藥安全和身體健康，還擾亂了正常的藥品市場秩序，給我國藥品市場特別是零售市場的長期發(fā)展帶來不利影響。隨著涉藥產(chǎn)品冒充藥品違法行為逐年增多，國家藥品監(jiān)管部門多次要求整頓藥品零售市場，并分階段開展涉藥產(chǎn)品冒充藥品專項整治行動[2-4]。本文通過四川省藥監(jiān)局對涉藥產(chǎn)品冒充藥品專項整治行動第一階段結果的數(shù)據(jù)分析，總結概括目前違法涉藥產(chǎn)品的品種特點和違法狀況，結合相關文獻，探討應如何加強我國相應產(chǎn)品的監(jiān)督管理，保證消費者用藥安全和身體健康。 ……（未完，全文共11174字，當前僅顯示2658字，請閱讀下面提示信息。收藏《醫(yī)學論文：違法涉藥產(chǎn)品狀況分析及對策探討》）