Microbiological testing of compounded sterile analgesic preparations batch-produced: Sampling protocol
- Autores: María Encina García Mayo, Carmela Dávila Pousa, Silvia Vázquez Blanco, Carlos Crespo Diz
- Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 19, Nº. 2, 2017, págs. 143-146
- Idioma: inglés
- Texto completo no disponible (Saber más ...)
-
Resumen
The administration of multimodal or balanced analgesia improves the management of postoperative and obstetric pain, using devices which make it possible to combine drugs with different mechanisms of action, in order to achieve greater analgesic potency with a better safety profile. According to the risk matrix for sterile preparations included in the «Guide to Good Practices for the Preparation of Medicinal Products in Hospital Pharmacy Departments», such preparations are classified as medium risk in terms of microbiological contamination. Their expiry date is nine days in a refrigerator (2-8°C), provided that preparation requirements are met and physicochemical stability is ensured. The objective of this study was to design a sampling protocol for the conduct of microbiological testing of these analgesic admixtures, and to validate the current expiry date which, at 28 days when stored at 2-8°C and protected from light, is higher than that recommended by the «Guide to Good Practices for the Preparation of Medicinal Products in Hospital Pharmacy Departments». The designed sampling protocol achieves the specifications set out in the regulations in force, and since all microbiological tests carried out showed the absence of microbiological growth and physicochemical stability was previously ensured, we can conclude that the expiry date originally set meets the quality requirements of the «Guide to Good Practices for the Preparation of Medicinal Products in Hospital Pharmacy Departments» for such preparations
