Oseltamivir compounding in the hospital pharmacy during the (H1N1) influenza pandemic

AIMS: Pandemics impose large demands on the health care system. The supply of appropriate chemotherapeutic agents, namely oseltamivir solution, presented a serious challenge in the recent influenza pandemic. This study reports on the rational series of pharmacotechnical steps that were followed to appropriately handle bulk oseltamivir powder to meet the increased demand. METHODS: During a six-week period in August and September of 2009, a task force was created in the Central Pharmacy of Hospital das Clínicas to convert imported oseltamivir phosphate into ready-to-use solution for utilization by physicians and public health authorities. The protocol included dissolution, physico-chemical tests and the bottling of a liquid microdose formulation for emergency room and outpatient dispensing with adequate quality control during all phases. RESULTS: The successful production routine was based on a specially designed flowchart according to which a batch of 33210 g of oseltamivir powder was converted into 32175 solution units during the aforementioned period with a net loss of only 2.6 percent. The end products were bottles containing 50 ml of 15 mg/mL oseltamivir solution. The measured concentration was stable and accurate (97.5 percent - 102.0 percent of the nominal value). The drug was prescribed as both a prophylactic and therapeutic agent. DISCUSSION: Hospital pharmacies are conventionally engaged in the manipulation of medical prescriptions and specialty drugs. They are generally responsible for only small-scale equipment used for manufacturing and quality-control procedures. The compounding of oseltamivir was a unique effort dictated by exceptional circumstances. CONCLUSION: The shortage of oseltamivir solution for clinical use was solved by emergency operationalization of a semi-industrial process in which bulk powder was converted into practical vials for prompt delivery.

Guidelines on management of human infection with the novel virus influenza A (H1N1): a report from the Hospital das Clínicas of the University of São Paulo

The pandemic novel influenza A (H1N1) infection was considered widespread in Brazil on July, 2009. Since then, 9.249 cases were confirmed in Brazil, most of them concentrated in São Paulo. The Hospital das Clínicas of the University of São Paulo is a reference center for H1N1 cases in São Paulo. The purpose of this review is to analyze the evidence concerning diagnosis, prevention, and treatment of novel influenza A (H1N1) infection. In addition, we propose guidelines for the management of this pandemic emphasizing Hospital das Clínicas "bundles" for the control of the pandemic novel influenza A (H1N1).

Epidemiology of human infection with the novel virus influenza A (H1H1) in the Hospital das Clínicas, São Paulo, Brazil - june-september 2009

The pandemic novel influenza A (H1N1) infection was considered widespread in Brazil on July 16, 2009. Since then, 46,810 cases of acute respiratory syndrome have been reported in Brazil, most of them concentrated in São Paulo. Through September 16, we have confirmed 9,249 cases of novel influenza A H1N1in Brazil, including 699 deaths. The mortality rate observed in Brazil is 0.47/100,000 inhabitants and varies according to region. In this period, São Paulo registered 3733 cases (40.3 percent of the total) of novel influenza A (H1N1) infection and 327 deaths, reflecting a mortality rate of 0.79/100,000 inhabitants. The Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC) is a reference center for H1N1 cases in São Paulo. During the winter of 2009, 472 patients in this hospital were diagnosed with H1N1 infection; of these, 210 were admitted, and 16 died. To control this pandemic and to provide adequate care for these patients, the Hospital das Clínicas implemented "bundles" including prevention strategies, an epidemiologic surveillance service, availability of fast diagnosis, antiviral treatment and training of staff. The purpose of this manuscript is to describe the epidemiologic features of novel human influenza A (H1N1) infection in the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo during the winter period of the 2009 pandemic.