A survey conducted by Altroconsumo in the four countries of the Euroconsumers group reveals not only how indications, side effects and interactions vary from one country to another, but also how, despite the recent Community provisions, the package inserts continue to be difficult to understand
If the euro has eliminated the hassle of changing currency for almost all European citizens and the Schengen Treaty that of showing an identity document when leaving national borders, the EMEA has not done the same with regard to the harmonization and simplification of package inserts which should be identical everywhere in the EU. At the moment, however, this "sameness" only applies to a few hundred drugs, while for all the others (value estimated at a few thousand) the rule that each state acts as it sees is still valid. This (and more) emerges in a detailed study carried out by Altroconsumo in the four countries of the Euroconsumers group (Italy, Belgium, Spain and Portugal) after a careful qualitative analysis of the packaging and leaflets of 18 medicines. The subject of the investigation are products of various types (laxatives, cough syrups, antihistamines, contraceptives, etc.), in various forms (tablets, sprays, eye drops, etc.) sold under the same name in the four countries under investigation. The drugs examined can be purchased directly by patients, or only on medical prescription, and have undergone different authorization procedures (by the health authorities of the individual countries, by the EMEA or through mutual recognition because they are already authorized in a state of the Union). In any case, they are very popular medicines and among the best-selling in the four countries examined. «It is a long-standing problem – confirms Paola Minghetti of the University of Milan – which the Regulatory Agencies have tried to resolve several times; in fact, there is a certain discretion in the conduct of the studies and the results obtained and, consequently, in what is reported on the package leaflet. In fact, what is written on the package leaflet also depends on the clinical tests that have been carried out and on how some data are interpreted. This leads to a discrepancy in the reporting of side effects so, within a certain margin, there can be some discretion. The regulatory agencies are trying to create uniformity and homogeneity, but they are not always able to impose themselves on corporate decisions in the same way». Reading the leaflets In parallel with this study, a research was also conducted on the behavior of patients in the same countries of the Euroconsumers group (around 10,000 people were involved, of which 2,200 were Italian), from which it emerges that the vast majority of interviewees - with percentages that are around 80-90% - read the entire leaflet if they buy the drug for the first time. In Italy, for example, the 89% of those who buy an over-the-counter medicine for the first time does it and the 88% on average in the four countries of the investigation. Percentages very close to those recorded for prescription drugs: 81% for Italians against 82% for other countries. Altroconsumo evaluates the data positively, emphasizing once again the need for the "liars" to report the information as clearly as possible. On the other hand, one Italian out of a hundred, equal to about 400,000 people, admits that they never read the leaflet anywhere, while the 20% declares that he threw it away while still taking the drug. More or less similar values were found with regard to the indications on the packages (again of self-medication drugs) with average percentages in the four countries
