Document Detail


Oseltamivir compounding in the hospital pharmacy during the (H1N1) influenza pandemic.
MedLine Citation:
PMID:  21243276     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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%. 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.
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.
Authors:
Márcia Lúcia de Mário Marin; Bruno Barbosa do Carmo Oliveira; Sonia Lucena Cipriano; Carlos Alberto Suslik; Joel Faintuch
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinics (São Paulo, Brazil)     Volume:  65     ISSN:  1980-5322     ISO Abbreviation:  Clinics (Sao Paulo)     Publication Date:  2010  
Date Detail:
Created Date:  2011-01-18     Completed Date:  2011-10-14     Revised Date:  2013-07-02    
Medline Journal Info:
Nlm Unique ID:  101244734     Medline TA:  Clinics (Sao Paulo)     Country:  Brazil    
Other Details:
Languages:  eng     Pagination:  1081-6     Citation Subset:  IM    
Affiliation:
Pharmacy Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil. marciamarin@hcnet.usp.br
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MeSH Terms
Descriptor/Qualifier:
Antiviral Agents / chemical synthesis*,  supply & distribution
Brazil / epidemiology
Chromatography, High Pressure Liquid
Drug Compounding / methods
Humans
Influenza A Virus, H1N1 Subtype*
Influenza, Human / drug therapy*,  epidemiology
Oseltamivir / chemical synthesis*,  supply & distribution
Pandemics
Pharmacy Service, Hospital
Quality Control
Time Factors
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Oseltamivir
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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