Abstract

Objectives: Package inserts are the most frequent source of patient information about medicines aside from doctors and pharmacists. Materials and methods: A representative selection of 271 German package inserts available in 2005 was investigated, using 152 validated quality criteria and by measuring 242 further values. Results: 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. Conclusion: 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.

Author Details

Authors

• J. Fuchs¹,²
• S. Werner¹,³
• C. Scheunpflug¹
• E.A. Götze¹
• K. Elstermann¹,³
• K. Scheffel¹,³
• A. Domnowski¹,³
• G. Peter¹
• C. Hertzsch¹,²
• M. Hippius³

Departments

• ¹ PAINT-Consult®, Jena,
• ² Department of Drug Regulatory Affairs at the Institute of Pharmacy, University of Bonn, Bonn, and
• ³ Department of Clinical Pharmacology, Friedrich Schiller University, Jena, Germany

Address

Dr. J. Fuchs
PAINT-Consult^®
Friedrich-Engels-Str. 19
07749 Jena, Germany
Email: [email protected]

Citation