Identificação dos riscos sanitários na manipulação de medicamentos alopáticos não estéreis em farmácia comunitária e o papel das boas práticas de manipulação no controle desses riscos / Identification of sanitary risks related to the pharmaceutical compounding of non-sterile drug products in community pharmacy and the role of Good Compounding Practices in controlling these risks

AUTOR(ES)
DATA DE PUBLICAÇÃO

2009

RESUMO

Pharmaceutical compounding is the essence of pharmaceutical profession. Compounded drug products are addressed to an individual patient and for this reason they are considered an important tool in therapeutics. However, the literature states that the absence of scientific confirmation of clinical safety and efficacy, as required to the manufactured drug products, make the health professionals to assume a sanitary risk each time a compounded drug product is dispensed. In order to regulate this market, ANVISA approved the brazilian Good Compounding Practices RDC 67/2007, which are being criticized due to their hard requirements for community pharmacies. The objectives of this work were to identify the sanitary risks, the impact and effect of them in quality-safety-efficacy triad and the control measures that can be applied to reduce the identified risks, in order to see if these control measures are requirements of Good Compounding Practices. This work, considered theoretical-conceptual, was written based on the documental research and hermeneutics of RDC 67/2007, the development and application of the tool Hazard-Effect Analysis and Control Measures and the bibliographic research, which aided in the identification of sanitary risks and control measures. The results showed that the pharmaceutical compounding process encompass sanitary risks that can be reduced through some control measures that are most related to the regulatory requirements of RDC 67/2007. However, there are some control measures, such as software and cleaning validation, the qualification of all equipments used in compounding/quality control, that are not covered by the brazilian Good Compounding Practices and some requirements of them need to be reviewed in order to avoid misunderstanding errors and facilitate the implementation of the Quality Management System. We conclude that to assure the quality-safety-efficacy triad of compounded drug products is necessary more than the galenic know-how of the pharmacists. Is necessary to know the sanitary risks in pharmaceutical compounding, their impact, effects and control measures, in order to create an organizational culture of risk management though a Quality Management System implemented and monitored designed to keep the sanitary risks under control.

ASSUNTO(S)

quality management system sanitary risks risco sanitário drug product boas práticas de manipulação em farmácia sistema de gestão da qualidade good compounding practices

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