Microbiological quality control of non-sterile compounded medicines prepared in a Portuguese hospital centre

Abstract

ObjectivesThis work aimed to evaluate the quality of non-sterile formulations compounded at Centro Hospitalar Cova da Beira (Covilhã, Portugal) immediately after preparation and up to the defined ‘beyond-use date’.MethodsMicrobiological quality control tests were performed in accordance with monograph 5.1.4 of the European Pharmacopoeia 8.0. Samples of compounded products were collected from January to December 2014 after preparation and were analysed immediately and reanalysed after storage under the established conditions, for each preparation.ResultsIn the test period, 392 preparations were analysed, corresponding to 24 different formulations (8 intermediate preparations, 11 oral solutions/suspensions and 5 topical preparations). All preparations were in accordance with the pharmacopoeia specifications immediately after preparation. However, for the formulations ‘prednisolone oral solution (5 mg/mL)’ and ‘nitroglycerine and cinchocaine ointment (0.25%/0.5%)’, the microbial counts of some batches exceeded the defined limits after storage up to the beyond-use date.ConclusionsThese results show that the compounding practices implemented at this pharmacy department are able to ensure the microbiological quality of compounded products. This microbiological quality control methodology also allowed identification of the need to replace formulations shown not to be stable throughout the storage period. On the basis of these results, a monthly routine of microbiological control of a random sample of compounded medicines was established in order to ensure their quality and safety for use.

"Prevalence of Microbial Contaminants in Non-sterile Pharmaceutical Antacids"

“…High microbial loads have been linked to serious illnesses, especially in immunocompromised people. Moreover, microbial metabolites can alter pH levels and cause drugs to deteriorate, which can make them less potent or even fatal due to the formation of degradation products [15]. As a result, successive editions of the Pharmacopoeia enforce microbial contamination limits in non-sterile preparations to avoid drug-induced infections.…”