J Fuchs1, M Hippius, M Schaefer. 1. Institute of Clinical Pharmacology, Friedrich Schiller University Jena, Germany. jfuchs-jena@t-online.de
Abstract
OBJECTIVE: Package inserts have an important impact on patients compliance and thus on the effectiveness of drug use. Despite efforts of the European or national regulatory authorities and manufacturers to improve the readability and comprehensiveness of package inserts, they are still the subject of critical discussion. MATERIAL AND METHODS: 68 German package inserts were chosen for a detailed analysis of their quality and suitability based on a set of 104 quality criteria developed prior to the survey. RESULTS: In many cases package inserts available on the German drug market did not include important information or were difficult to read or understand. In 73.5% of cases, the daily maximum dose was missing and 63.2% gave no information on the measures to take for each of the interactions. 66.2% of package inserts provided no instructions about the correct storage and 58.8% gave no instructions on the appropriate storage temperature. In 13 cases, dosage instructions were provided only in milligrams of active substance instead of a number of tablets or volume of liquid. 98.5% of the 68 package inserts included non-quantifiable statements such as "high dosage" or "take 2 - 4 tablets, 1 - 3 times daily". 97.1% contained repetitious information, 83.8% included advertising elements and 8.8% contained contradictory information. CONCLUSION: Package inserts must be optimized and tested by selected groups of patients prior to approval of the drug. This will avoid misunderstandings and lack of information and ensure that use of the drug will give the best possible outcome and avoid safety risks.
OBJECTIVE: Package inserts have an important impact on patients compliance and thus on the effectiveness of drug use. Despite efforts of the European or national regulatory authorities and manufacturers to improve the readability and comprehensiveness of package inserts, they are still the subject of critical discussion. MATERIAL AND METHODS: 68 German package inserts were chosen for a detailed analysis of their quality and suitability based on a set of 104 quality criteria developed prior to the survey. RESULTS: In many cases package inserts available on the German drug market did not include important information or were difficult to read or understand. In 73.5% of cases, the daily maximum dose was missing and 63.2% gave no information on the measures to take for each of the interactions. 66.2% of package inserts provided no instructions about the correct storage and 58.8% gave no instructions on the appropriate storage temperature. In 13 cases, dosage instructions were provided only in milligrams of active substance instead of a number of tablets or volume of liquid. 98.5% of the 68 package inserts included non-quantifiable statements such as "high dosage" or "take 2 - 4 tablets, 1 - 3 times daily". 97.1% contained repetitious information, 83.8% included advertising elements and 8.8% contained contradictory information. CONCLUSION: Package inserts must be optimized and tested by selected groups of patients prior to approval of the drug. This will avoid misunderstandings and lack of information and ensure that use of the drug will give the best possible outcome and avoid safety risks.