Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project

\ua9 2023, The Author(s).Introduction and Objective: The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the possibility of developing a distributed data processing and analysis infrastructure using a common data model that could form a foundational platform for future surveillance and research. A prerequisite would be that data from various data access providers (DAPs) can be harmonised according to an agreed set of standard rules concerning the structure and content of the data. To do so, a reference framework of core data elements (CDEs) recommended for primary data studies on drug safety during pregnancy was previously developed. The aim of this study was to assess the ability of several public and private DAPs using different primary data sources focusing on multiple sclerosis, as a pilot, to map their respective data variables and definitions with the CDE recommendations framework. Methods: Four pregnancy registries (Gilenya, Novartis; Aubagio, Sanofi; the Organization of Teratology Information Specialists [OTIS]; Aubagio, Sanofi; the Dutch Pregnancy Drug Register, Lareb), two enhanced pharmacovigilance programmes (Gilenya PRIM, Novartis; MAPLE-MS, Merck Healthcare KGaA) and four Teratology Information Services (UK TIS, Jerusalem TIS, Zerifin TIS, Swiss TIS) participated in the study. The ConcePTION primary data source CDE includes 51 items covering administrative functions, the description of pregnancy, maternal medical history, maternal illnesses arising in pregnancy, delivery details, and pregnancy and infant outcomes. For each variable in the CDE, the DAPs identified whether their variables were: identical to the one mentioned in the CDE; derived; similar but with a divergent definition; or not available. Results: The majority of the DAP data variables were either directly taken (85%, n = 305/357, range 73–94% between DAPs) or derived by combining different variables (12%, n = 42/357, range 0–24% between DAPs) to conform to the CDE variables and definitions. For very few of the DAP variables, alignment with the CDE items was not possible, either because of divergent definitions (1%, n = 3/357, range 0–2% between DAPs) or because the variables were not available (2%, n = 7/357, range 0–4% between DAPs). Conclusions: Data access providers participating in this study presented a very high proportion of variables matching the CDE items, indicating that alignment of definitions and harmonisation of data analysis by different stakeholders to accelerate and strengthen pregnancy pharmacovigilance safety data analyses could be feasible

Lettre du Brésil

Stellfeld Carlos, Liberalli C. H., Votta . Lettre du Brésil. In: Revue d'histoire de la pharmacie, 42ᵉ année, n°141, 1954. pp. 269-270

Lettre du Brésil

Stellfeld Carlos, Liberalli C. H., Votta . Lettre du Brésil. In: Revue d'histoire de la pharmacie, 42ᵉ année, n°141, 1954. pp. 269-270

Vigilância de fitoterápicos em Minas Gerais. Verificação da qualidade de diferentes amostras comerciais de camomila Surveillance of phytotherapeutic drugs in the State of Minas Gerais. Quality assessment of commercial samples of chamomile

O comércio de plantas medicinais e produtos fitoterápicos encontra-se em expansão em todo o mundo. Uma portaria lançada recentemente pelo Ministério da Saúde busca regulamentar a produção dos fitoterápicos comercializados no Brasil. Com o objetivo de contribuir com a farmacovigilância deste setor, iniciamos um programa de avaliação do material fitoterápico comercializado em Minas Gerais. Foram analisadas 27 amostras de camomila, procedentes de farmácias, ervanarias e mercados, quanto à identidade, pureza e presença dos constituintes ativos. Apesar de todas as amostras serem constituídas da genuína Matricaria recutita, na maior parte os capítulos florais estavam muito destruídos, conseqüência de manuseio excessivo ou má conservação. Foram detectados contaminantes em todas as amostras, estando insetos presentes em 63% daquelas comercializadas em farmácias. Somente cerca de metade das amostras apresentaram os constituintes dos óleos essenciais, necessários à atividade antiinflamatória da planta. Os constituintes fenólicos, de ação espasmolítica, foram detectados em somente cerca de 20%. Os resultados com a camomila indicam a precariedade com que as plantas medicinais e fitoterápicos vêm sendo comercializados e confirmam a necessidade urgente de vigilância destes produtos no Brasil.<br>Marketing of medicinal plants and phytotherapeutic products is spreading all over the world. In order to assess the commercialization of medicinal plants and phytotherapeutic products in the State of Minas Gerais, we identified and tested for the presence of adulterants and active ingredients in 27 samples of chamomile. All the samples consisted of Matricaria recutita flowers, but they were badly fragmented, a result of excessive handling and poor preservation. All samples contained contaminants, and insects were observed in 63% of the samples sold in drugstores. Only 50% of the samples in each group had the essential oils needed to produce antiinflammatory activity. Flavonoids and other phenolic constituents with a spasmolytic effect were detected in only 20% of the samples from each group. Results with chamomile indicated the poor quality with which medicinal plants and phytotherapeutic products are marketed and confirm the need for surveillance of such products in Brazil

Dramatic solvent effect on the diastereoselectivity of Michael addition: study toward the synthesis of the ABC ring system of hexacyclinic acid

During our studies toward the synthesis of the ABC ring system of hexacyclinic acid, we have observed a dramatic influence of the solvent on both our key steps. The diastereoselectivity of the intermolecular Michael addition could be totally reversed by changing the polarity of the solvent, and trifluoroethanol was found to be the optimal solvent for the following Mn(III)-promoted radical cyclizatio