RESUMO
Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.
RESUMO
BACKGROUND: Hospitals are advised to monitor antibiotic use. Several approximation methods do exist to perform this task. Adult cohorts can easily be monitored using the defined daily dose method, or its German adaption recommended daily doses (RDD) method, that seems inapplicable in pediatric cohorts due to body weight variations. Guidelines recommend the days of therapy (DOT) method in pediatrics. Still, there is a need for more detailed analysis regarding the performance of both methods. METHODS: Based on data from 4½ years of our fully computerized patient care data managing system in a combined neonatal and pediatric intensive care unit, we compare the results for DOT and RDD per 100 patient days with exact measurement of antibiotic consumption (individual daily dose per 100 patient days) as internal reference. RESULTS: The DOT method reflected antibiotic consumption in our cohort on the level of total consumption, subgroups, and agents with almost always high accuracy (correlation with individual daily dose between 0.73 and 1.00). The RDD method showed poor correlation on the level of total consumption (r = 0.21) and fluctuating results on more detailed levels (correlation, 0.01-0.94). A detailed analysis of body weight distribution and ordered packaging sizes of single agents revealed that RDD seems to work well when only one package size of the agent was ordered in our pharmacy. CONCLUSION: The DOT method is superior to RDD for monitoring antibiotic drug consumption in pediatric cohorts. RDD seems to work satisfactory well for selected antibiotic agents that are administered with little variation in packaging size.