Abstract
The health authorities of Belgium, a European country with a population of 10 million and 3 national languages, decided in 1984 to launch a mandatory patient package insert (PPI) program, to be completed in 1990. The country has a long tradition of original drug dispensing (93% of the pharmacy sales volume). Physician-oriented, highly technical inserts are present in the packages of all distributed drugs since 1963. Information officers of the drug companies will translate these traditional inserts into full information and drug-specific PPIs, written in lay language, aimed at adults with a schooling grade of 16 years. To that purpose, a writing style guide and a vocabulary of 1,400 popular medical terms were published. The regulatory authorities check congruity of the PPI with the official data sheet. The readability of the PPI is controlled with a readability formula specifically created for the drug information context and available on microcomputer.
In this article, some of the problems encountered in the Belgian PPI program are enumerated. Full information patient package inserts lead to texts that are longer than optimal for effective communication, and to legibility problems due to small print on the inserts. Writing understandable PPIs was proven to be a difficult task for physicians and pharmacists in industry without the professional help of linguists. A better knowledge of the semantics of the transfer of drug information to the patient is needed.
Formal evaluation research of the effects of this large-scale drug information program is now under way.
Keywords
Get full access to this article
View all access options for this article.