The problems of unifying information in the patient leaflets in Ukraine during the COVID-19 pandemic and wartime

Ю. В. Качерай, З. О. Заболотня, О. М. Заліська, І. Г. Мудрак, О. М. Кушта
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Abstract

The information in the patient leaflets on the medicines must be unified, have a good structure and be clearly presented to the patient for prevent information asymmetry. We substantiated and worked a methodic of comparative analysis of antibiotic using for example of 74 instructions on the drug of one INN, which are registered on the markets of Ukraine, EU countries and Japan. Ways to unify information in to improve patient awareness of the correct use of drugs, especially antibiotics, are substantiated and presented. Aim – to conduct a comparative analysis of the patient leaflets for antibacterial medicines and determine the presence or absence of information asymmetry using the example of antibiotics of one INN that are registrated on the Ukrainian market or they received as a humanitarian aid from Europe in wartime, in order to establish inconsistencies in the information structure and data in the information leaflets. The objects were information leaflets for antibiotics: azithromycin, amoxiclav, amoxicillin, zinnate, cefazolin, cefatoxin. Methods were informational, comparative and content analysis. Methodology of information asymmetry analysis using the example of information leaflets for the medicine azithromycin from various manufacturers available on the market of Ukraine. As a result, significant differences were established in 3 sections: «Indications», «Peculiarities of use», suspension preparation, etc. Significant differences were found in the information leaflets for prescribing azithromycin for skin infections, which requires immediate unification in the information leaflets of data for correct prescribing by a doctor using an electronic prescription and good use for a treatment course. It was established that in the  for azithromycin from one manufacturer, which is on the market of Ukraine and EU countries, significant differences in information were found in 10 sections of the information leaflets, which requires the unification of information accordingly. We have reasoned that the information leaflets should contain information that is important for the correct use of the medicine, in order to prevent potentially dangerous consequences that may arise from incorrect preparation or dosage. We grounded the information leaflets should include a section on the disposal of expired or unused medicines to harmonize with the information leaflets іn the EU countries.
新冠肺炎大流行和战争期间乌克兰患者传单中统一信息的问题
药品说明书中的信息必须统一,结构良好,并清晰地呈现给患者,以防止信息不对称。例如,我们使用在乌克兰、欧盟国家和日本市场注册的一家INN的74份药品说明书,证实并制定了抗生素的比较分析方法。统一信息以提高患者正确使用药物(尤其是抗生素)的意识的方法得到了证实和介绍。目的——对抗菌药物的患者传单进行比较分析,并以在乌克兰市场上注册的一家INN的抗生素或战时从欧洲获得的人道主义援助为例,确定是否存在信息不对称,以便确定信息结构和信息传单中的数据的不一致性。对象是抗生素的信息传单:阿奇霉素、阿莫西林、锌酸盐、头孢唑林、头孢托新。方法采用信息分析法、比较分析法和内容分析法。信息不对称分析方法,以乌克兰市场上各种制造商的阿奇霉素药品信息传单为例。因此,在“适应症”、“使用特殊性”、混悬剂制剂等3个部分中发现了显著差异。在为皮肤感染开阿奇霉素处方的信息传单中发现了明显差异,这需要在信息传单中立即统一数据,以便由医生使用电子处方进行正确的处方并良好地用于治疗过程。据证实,在乌克兰和欧盟国家市场上的一家制造商的阿奇霉素中,在信息传单的10个部分中发现了显著的信息差异,这需要相应地统一信息。我们认为,信息传单应包含对正确使用药物至关重要的信息,以防止因不正确的制剂或剂量而产生潜在的危险后果。我们在信息传单的基础上应包括一节关于过期或未使用药品的处理,以与欧盟国家的信息传单相协调。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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