Oseltamivir compounding in the hospital pharmacy during the (H1N1) influenza pandemic.
OBJECTIVE
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%. The end products were bottles containing 50 ml of 15 mg/mL oseltamivir solution. The measured concentration was stable and accurate (97.5% - 102.0% of the nominal value). The drug was prescribed as both a prophylactic and therapeutic agent.


CONCLUSIONS
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.


CONCLUSIONS
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.
Pharmacy Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil. marciamarin@hcnet.usp.br
Márcia Lúcia de Mário
ML
Marin
Bruno Barbosa do Carmo
BB
Oliveira
Sonia Lucena
SL
Cipriano
Carlos Alberto
CA
Suslik
Joel
J
Faintuch
D000998:Antiviral Agents / Q000138:chemical synthesis* / Q000600:supply & distribution; D001938:Brazil / Q000453:epidemiology; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding / Q000379:methods; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007251:Influenza, Human / Q000188:drug therapy* / Q000453:epidemiology; D053139:Oseltamivir / Q000138:chemical synthesis* / Q000600:supply & distribution; D058873:Pandemics; D010607:Pharmacy Service, Hospital; D011786:Quality Control; D013997:Time Factors
D000998:Antiviral Agents; D053139:Oseltamivir
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