The need for appropriate registration of pregnancy outcomes under newer oral glucose-lowering therapies.

Because of the increase in type 2 diabetes (T2DM) in young adults, women of childbearing age are frequently treated with newer glucose-lowering therapies, and an increase in unintentional exposure to therapies unapproved for use during pregnancy is expected. The clinician is left with the dilemma of deciding between discontinuation of a novel agent that is providing excellent glycaemic control, while switching to other agents may cause deterioration of glycaemia, and continued use of novel agents that may have uncertain effects on the unborn child. For T2DM, pregnancy data are collected only via spontaneous reporting systems. Therefore, we evaluated the available data on pregnancy outcomes under newer glucose-lowering agents in pharmaceutical safety databases. We found that data on pregnancy outcomes with new glucose-lowering agents in T2DM are scarce, with a high risk of bias towards negative outcomes, limiting their usefulness in robustly assessing safety. Because of the lack of information at present, these agents are not recommended for use during pregnancy or when planning pregnancy. To better guide clinical practice, structured systems of assessing pregnancy outcomes in women receiving these novel agents are urgently needed.

[Drug therapy for older people : Choosing wisely]. / Arzneitherapie des älteren Menschen : "Choosing wisely".

Elderly people are the most rapidly growing sector of our society. Due to their multimorbidity they are exposed to a multitude of medications, which are accompanied by chances and risks. The problem of inappropriate medication in the elderly is exacerbated by the fact that only a holistic view can help these patients and that this is predominantly the responsibility of the general practitioner. The closely measured paid contact time is often insufficient to optimize complex medications. Clinically successfully tested aids in the form of lists give reason for hope: in particular, the positive/negative assessment of limitations of the elderly with respect to drugs by the STOPP/START criteria and the FORTA classification are clinically successful aids. Purely negative lists, such as the Beers or PRISCUS lists, have been disappointing in clinical application because they do not consider the needs, prognostic and particularly symptomatic importance and weighting of the diagnosis of patients. Further implementation of these aids to decision making should help to improve the problem of care of elderly patients in the field of drug treatment, even in IT systems.

Plaidoyer pour un renforcement du système de pharmacovigilance au Burkina Faso.

Large-scale deployment of new medicines has been observed over the last two decades in many Sub-Saharan Africa countries faced with major public health issues such as malaria and HIV/AIDS. However, some of these medicines may be responsible for varying degrees of toxicity, with adverse drug reactions leading to decreased compliance or even discontinuation of treatment. Pharmacovigilance systems therefore had to be set up in these countries, such as in Burkina Faso, West Africa, which initiated the organization of pharmacovigilance activities in 2008. Despite this progress, the systems in place have not yet achieved a sufficient level of performance to deal with drug-related health issues, highlighting the need for further actions. Pharmacovigilance in Burkina Faso can be strengthened at multiple levels: pre-service and in-service training of health workers; the establishment of active surveillance based on sentinel sites; informing the public and raising awareness; and strengthening national coordination.

Reação adversa a medicamentos em pediatria: casos relatados ao programa de farmacovigilância do Hospital de Clínicas de Porto Alegre / Adverse drug reaction in children: cases reported to the pharmacovigilance program at Hospital de Clínicas de Porto Alegre

Objetivo: Apresentar os resultados das avaliações das notificações de reações adversas a medicamentos ocorridas em pacientes internados em unidades pediátricas do Hospital de Clínicas de Porto Alegre, no período de abril de 2002 a outubro de 2003. Métodos: Por meio de um estudo retrospectivo, analisou-se o arquivo de notificações de reações adversas a medicamentos da Unidade de Assistência Farmacêutica, que contém os registros de casos suspeitos provenientes da busca ativa e notificação espontânea quanto aos dados relevantes dos pacientes, medicamentos envolvidos e sintomas. Foi utilizada análise descritiva com medidas de freqüência e tendência central. Resultados: No período, ocorreram 4.709 internações em unidades pediátricas e 113 registros de reações adversas a medicamentos: 59,3 por cento em pacientes masculinos, 63,7 por cento em pacientes da Unidade de Oncologia. A maioria das notificações foi feita por profissionais de farmácia por busca ativa (56,6 por cento). A classe de medicamentos mais comumente envolvida foi a de antiinfecciosos (47,8 por cento), e o órgão mais freqüentemente afetado foi a pele e anexos (27,4 por cento). As reações foram classificadas como definidas em 9,7 por cento dos registros (Algoritmo de Naranjo). Conclusão: A maioria dos relatos foi proveniente da busca ativa. As classes de medicamentos mais envolvidas com reações adversas a medicamentos foram as mais prescritas para pacientes pediátricos. Os resultados em relação aos órgãos/sistemas mais afetados estão de acordo com os relatos da literatura