Evaluation of the compounding formula of compounding medicines by community pharmacies with Special Authorization for dosage individualization

The main purpose of compounding medicines is to meet individual needs, such as therapeutic dose, appropriate dosage forms, and absence of pharmaceutical ingredients for patients with a history of intolerance, among other technical reasons. This work analyzes, through documentary research, the compou...

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Detalles Bibliográficos
Autores: Pontes, Francisco Eduardo de, Zamith, Helena Pereira da Silva
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2016
País:Brasil
Institución:Fundação Oswaldo Cruz (FIOCRUZ)
Repositorio:Vigilância Sanitária em Debate
Idioma:portugués
OAI Identifier:oai:ojs.visaemdebate.incqs.fiocruz.br:article/572
Acceso en línea:https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/572
Access Level:acceso abierto
Palabra clave:Community Pharmacy
Special Authorization
Pharmaceutical Compounding
Nova Friburgo
Farmácia Comunitária
Autorização Especial
Medicamento Manipulado
Descripción
Sumario:The main purpose of compounding medicines is to meet individual needs, such as therapeutic dose, appropriate dosage forms, and absence of pharmaceutical ingredients for patients with a history of intolerance, among other technical reasons. This work analyzes, through documentary research, the compounding formula for dosage individualization of oral capsules/mono drug containing an Active Pharmaceutical Ingredient (API), according to Order No. 344/98, and prepared by community pharmacies located in Nova Friburgo, Rio de Janeiro. Data were recorded in November 2006, from prescription books of pharmacies with Special Authorization issued by ANVISA (Brazilian National Health Surveillance Agency). From the 12253 analyzed formulae, 22% met the inclusion criteria of this study. The results lead us to the conclusion that the prevalence of compounded medication for dosage individualization was low. On average, only 34% of the formulae presented a different dosage from the standard one in the available specialties on the Brazilian pharmaceutical market, which results in a diminution of personalized, compounded medications. This study therefore highlights the need of a more substantial risk assessment to justify the compounding of real compounded prescriptions.