ABSTRACT
No Brasil, a bula é usada como fonte de informação sobre medicamentos. O estudo desenvolveu uma análise de sua evolução histórica, procurando observar a influência do desenvolvimento científico, da globalização da informação e das diferentes políticas de saúde. Procedeu-se uma revisão retrospectiva da legislação sanitária brasileira até 1920, ano da instituição do Departamento Nacional de Saúde Pública. A análise documental sobre a evolução da regulamentação sanitária no Brasil se iniciou pela Coleção Farmácia Brasileira - Portarias Sanitárias. Na segunda etapa as normas foram pesquisadas nos portais: VISALEGIS - Legislação em Vigilância Sanitária, Portal de Legislação do Sistema de Informações do Congresso Nacional e Sistema de Legislação da Saúde - Saúde Legis. A bula tornou-se um importante veículo informativo no Brasil, passou por profundas transformações regulamentares na segunda metade do século XX. Entre 1946 e 2006 o número de itens obrigatórios aumentou e sua descrição aprofundou. Entretanto, a padronização da informação para os medicamentos com o mesmo princípio ativo não se efetivou, não obstante sua importância e apesar das diferentes iniciativas observadas nas normas legais.
In Brazil, package inserts provide key information on pharmaceuticals. The current study analyzes the evolution of package inserts and the impact on this process by scientific research and development, globalization of information, and various health policies. The study began with a retrospective review of Brazilian health legislation until 1920, the year when the National Public Health Department was created. The analysis of documents on the evolution of health regulation in Brazil began with the Brazilian Pharmaceutical Collection - Health Rulings. The second stage of the study involved a search of standards and norms in VISALEGIS: Health Surveillance Legislation, Portal for Legislation from the National Congressional Information System and the Health Legislation System. Package inserts became an important vehicle for information in the country and underwent important regulatory changes in the latter half of the 20th century. From 1946 to 2006, the number of mandatory items increased, with more in-depth description. However, the standardization of information for medicines with the same active ingredient failed to materialize, despite its importance and the various legal initiatives in this direction.
Subject(s)
History, 20th Century , History, 21st Century , Drug Labeling/history , Drug Packaging/history , Legislation, Drug/history , Brazil , Drug Labeling/legislation & jurisprudence , Drug Packaging/legislation & jurisprudence , Retrospective StudiesABSTRACT
Several glass stamps were excavated from sites in old Cairo, Egypt, some of which were examined for this report and which confirm the following statement regarding the early history of Arabic material medica and pharmaceutical techniques: 1. The number of seals which carry the names of the officials who ordered their manufacture or usage helped to establish the approximate dates of the original vessels. The majority fall in the first half of the eighth century during the Umayyad period in Egypt and shortly thereafter. 2. The names and kinds of commodities contained in the original vessels suggest vegetable materials commonly used for diet or therapy. 3. These Islamic seals are the earliest known of the kind, inscribed and affixed on vessels containing materia medica products. In design they are similar to glass labels used in the nineteenth and early twentieth century, especially in the United States. Painted over or molded glass label bearing inscriptions attached to bottles were also produced here and in Europe. In technological advances and aesthetic appeal, however, the Muslim examples are far more durable and better suited. This coincides with what F. Petrie remarked that the ancient Egyptians pioneered the making of glass discs stamped by dies using them as counters and weights, or the designing of cups and vessels for accurate and just measures. This appears true regarding the old Cairo excavated collections mentioned, proving a continued tradition. 4. During the Arabic period, artisans in Muslim lands excelled other ancient civilizations in their reverence to and their perfection of the art of writing, employing it on objects of art and utensils of daily life. And indeed these early technical advances in glass-making paved the way for better and varied forms of glass and earthen wares that reached the highest standards during the Middle Ages and insured adequate, varied and handsome drug containers and other tools for the apothecary and culinary shops