Fuchs J, Werner S, Scheunpflug C, Götze E A, Elstermann K, Scheffel K, Domnowski A, Peter G, Hertzsch C, Hippius M
PAINT-Consult®, Jena, Germany.
Int J Clin Pharmacol Ther. 2010 Dec;48(12):781-90. doi: 10.5414/cpp48781.
Package inserts are the most frequent source of patient information about medicines aside from doctors and pharmacists.
A representative selection of 271 German package inserts available in 2005 was investigated, using 152 validated quality criteria and by measuring 242 further values.
A significant increase in package insert texts over recent years was found; standing at an average of 2,005 words. This is associated with the significant increase in complicated medical information being communicated; with on an average of 114.1 difficult words and 46.3 non quantifiable phrases per package insert. Only 60.1% of the package inserts offered all dosages as number of tablets or other amounts of the ready to use medicine, while just 29.5% listed the maximum daily dose for all users. 54.6% provided actions for all possible side effects and 24.2% the frequencies of side effects in numerical form.
The significantly increased volume of medical information provided in package inserts does not meet the requirements of patients. Major efforts are required by pharmaceutical companies, authorities and legislative bodies in order to reduce information to that which is essential for patients and to ensure that this is provided in short, precise and easily comprehensible texts.
除医生和药剂师外，药品说明书是患者获取药品信息最常见的来源。
对2005年可得的271份德国药品说明书进行了代表性抽样调查，采用152条经过验证的质量标准并测量另外242个数值。
发现近年来药品说明书的文字显著增加；平均有2005个单词。这与所传达的复杂医学信息显著增加相关；每份药品说明书平均有114.1个难词和46.3个不可量化的短语。只有60.1%的药品说明书提供了所有剂型的片数或其他即用药品的用量，而仅有29.5%列出了所有使用者的最大日剂量。54.6%说明了所有可能副作用的应对措施，24.2%以数字形式列出了副作用的发生率。
药品说明书中提供的医学信息量显著增加，但未达到患者的需求。制药公司、当局和立法机构需要做出重大努力，以便将信息精简至对患者至关重要的内容，并确保以简短、精确且易于理解的文字提供这些信息。
