IV access through which IV medications, parenteral nutrition, and infusion solutions should be ad... more IV access through which IV medications, parenteral nutrition, and infusion solutions should be administered to avoid incompatibilities and whether flushing of the infusion line was required. Results In both periods, 66 patients each were included in the evaluation. Flushing volume was reduced from a median of 0.68ml/kg/day (Q25/Q75 0.35/1.33) to 0.31ml/kg/day (Q25/ Q75 0.05/0.74; p<0.001). In the control period, the median fluid overload per patient was 2.3%, while 1.5% fluid overload occurred in the intervention period (p<0.001). Also, fewer patient days with fluid overload of !10% occurred during the intervention period. Fluid overload of !20% were only observed in the control period. Conclusion The use of pharmaceutical infusion schedules with recommendations for flushing infusion lines according to compatibility has reduced the flushing volume. This can avoid the administration of unnecessary IV fluids. Reducing fluid intake helps to reduce the occurrence of fluid overload in PICU patients.
Section 5: Patient safety and quality assurance, Mar 1, 2022
(vancomycin/metronidazol), days and regimen of treatment, recurrence or death at 8 weeks. Risk fa... more (vancomycin/metronidazol), days and regimen of treatment, recurrence or death at 8 weeks. Risk factors evaluated: age >65 years, use of antibiotics in the previous 3 months, ICD in the last 6 months, severe disease (oncological patient, immunosuppressed, renal failure). Tapered dosage of fidaxomicin oral was defined as 200 mg/12 hours (5 days) and 200 mg/48 hours (D7-D25). Data were obtained from the pharmacy dispensation program and the patients' digital clinical records. Results Forty-one patients were included, 25 women (61%), mean age 69 (21-99) years, 73.2% (n=30) were older than 65 years. 95.1% (n=39) had received antibiotics in the previous 3 months, 51.2% (n=21) had suffered CDI in the last 6 months, 60.9% (n=26) had severe baseline disease and 21.9% (n=9) were immunosuppressed. As first line, 41.4% (n=17) received vancomycin and metronidazole, 44% (n=18) received vancomycin and 14.6% (n=6) received fidaxomicin. 63.4% (n=26) received fidaxomicin 200 mg/12 hours (10 days), in 14.6% (n=9) the extended regimen was used and 22% (n=6) received 200 mg/12 hours for longer. 82.9% (n=34) of fidaxomicin-treated patients had no CDI recurrence at 8 weeks. 22% (n=9) of the patients died. Nine fidaxomicin-treated patients were administered bezlotuxumab and none subsequently developed CDI. All were older than 65 years and 66.6% (n=6) were oncology patients. Conclusion and relevance The CDI treatment was mostly adjusted to the recommendedations in the therapeutic guidelines, with vancomycin/metronidazole as first-line and fidaxomicin in recurrences. The use of bexlotuxumab was adapted to the considerations of the Therapeutic Positioning Index and was used in patients with a higher risk of recurrence. Although in the pivotal studies the recurrence rate with bexlotuxumab was 16.5%, in our study there were no recurrences. In the case of fidaxomicin, the recurrence rate was 17.1%, which was higher than the published studies. Limitations: small sample size and the impact of the joint use of bexlotuxumab and fidaxomicin has not been measured.
Today, the increasing number of illicit internet pharmacies is a global phenomenon, however, the ... more Today, the increasing number of illicit internet pharmacies is a global phenomenon, however, the size of the online pharmaceutical market is still relatively unknown and the dubious quality of products is questionable and warrants investigation. Descriptive data from this black market channel are derived from studies analyzing the online availability of different medications procured over the internet and their methodology is quite heterogeneous. Our aim was to develop a comprehensive and specific risk assessment for selecting high patient safety risk medications from the online pharmaceutical market. A rapid tool was developed based upon the two quality and safety standard resolutions in pharmaceutical practice, published by the European Directorate for the Quality of Medicines, and was illustrated on eye drops. We developed five dimensions in support of the risk assessment including intrinsic, extrinsic and potential risks of counterfeiting. The five criteria were integrated in a comprehensively weighted risk-scoring format. The probability of procuring the product from the internet was also assessed based on the number of relevant links within the first twenty search engine results and the cost of the products. With the application of the tool a dorzolamide & timolol combination eye drop represented the highest overall patient safety risk score. In consideration of our literature review of the past 20 years, there is no current, standardized methodology to effectively identify pharmaceutical products associated with high patient safety risks. Notably, the fully comprehensive analysis of the internet pharmaceutical market and the test purchase of all online available medicines is unrealistic. Therefore, we developed a method to aid online surveillance researches and targeted international organizational led joint actions against the uncontrolled sale of falsified and substandard medications (e.g.: Operation Pangea).
Microbiological preservatives play a great role in the preparation of artificial tears because th... more Microbiological preservatives play a great role in the preparation of artificial tears because they protect the eyes from further microorganisms and the preparation from contamination. In this contribution we are summarizing our experimental results given by pharmaceutical and microbiological optimalization of artificial tears. The incidental adaptability of povidone-iodine (PVP-I) as a preservative in artificial tears was examined compared to usually used materials. Some artificial tears (Oculogutta carbomerae and Oculogutta viscosa) were prepared according to the Formulae Normales Edition VII., others were isotonisated and buffered containing 3.0% and 3.5% povidonum as active substance. The analysed samples as a preservative instead of generally used agents contained 0.10%, 0.05% and 0.01% PVP-I. Reference preparations were dispensed using microbiological preservatives (Cetrimidum, Thiomersalum solutum 0.1%, Benzalconium chloratum solutum 10%). Pharmaceutical (pH, viscosity, freez...
Microbiological preservatives play a great role in the preparation of artificial tears because th... more Microbiological preservatives play a great role in the preparation of artificial tears because they protect the eyes from further microorganisms and the preparation from contamination. In this contribution we are summarizing our experimental results given by pharmaceutical and microbiological optimalization of artificial tears. The incidental adaptability of povidone-iodine (PVP-I) as a preservative in artificial tears was examined compared to usually used materials. Some artificial tears (Oculogutta carbomerae and Oculogutta viscosa) were prepared according to the Formulae Normales Edition VII., others were isotonisated and buffered containing 3.0% and 3.5% povidonum as active substance. The analysed samples as a preservative instead of generally used agents contained 0.10%, 0.05% and 0.01% PVP-I. Reference preparations were dispensed using microbiological preservatives (Cetrimidum, Thiomersalum solutum 0.1%, Benzalconium chloratum solutum 10%). Pharmaceutical (pH, viscosity, freez...
Microbiological preservatives play a great role in the preparation of artificial tears because th... more Microbiological preservatives play a great role in the preparation of artificial tears because they protect the eyes from further microorganisms and the preparation from contamination. In this contribution we are summarizing our experimental results given by pharmaceutical and microbiological optimalization of artificial tears. The incidental adaptability of povidone-iodine (PVP-I) as a preservative in artificial tears was examined compared to usually used materials. Some artificial tears (Oculogutta carbomerae and Oculogutta viscosa) were prepared according to the Formulae Normales Edition VII., others were isotonisated and buffered containing 3.0% and 3.5% povidonum as active substance. The analysed samples as a preservative instead of generally used agents contained 0.10%, 0.05% and 0.01% PVP-I. Reference preparations were dispensed using microbiological preservatives (Cetrimidum, Thiomersalum solutum 0.1%, Benzalconium chloratum solutum 10%). Pharmaceutical (pH, viscosity, freez...
IV access through which IV medications, parenteral nutrition, and infusion solutions should be ad... more IV access through which IV medications, parenteral nutrition, and infusion solutions should be administered to avoid incompatibilities and whether flushing of the infusion line was required. Results In both periods, 66 patients each were included in the evaluation. Flushing volume was reduced from a median of 0.68ml/kg/day (Q25/Q75 0.35/1.33) to 0.31ml/kg/day (Q25/ Q75 0.05/0.74; p<0.001). In the control period, the median fluid overload per patient was 2.3%, while 1.5% fluid overload occurred in the intervention period (p<0.001). Also, fewer patient days with fluid overload of !10% occurred during the intervention period. Fluid overload of !20% were only observed in the control period. Conclusion The use of pharmaceutical infusion schedules with recommendations for flushing infusion lines according to compatibility has reduced the flushing volume. This can avoid the administration of unnecessary IV fluids. Reducing fluid intake helps to reduce the occurrence of fluid overload in PICU patients.
Section 5: Patient safety and quality assurance, Mar 1, 2022
(vancomycin/metronidazol), days and regimen of treatment, recurrence or death at 8 weeks. Risk fa... more (vancomycin/metronidazol), days and regimen of treatment, recurrence or death at 8 weeks. Risk factors evaluated: age >65 years, use of antibiotics in the previous 3 months, ICD in the last 6 months, severe disease (oncological patient, immunosuppressed, renal failure). Tapered dosage of fidaxomicin oral was defined as 200 mg/12 hours (5 days) and 200 mg/48 hours (D7-D25). Data were obtained from the pharmacy dispensation program and the patients' digital clinical records. Results Forty-one patients were included, 25 women (61%), mean age 69 (21-99) years, 73.2% (n=30) were older than 65 years. 95.1% (n=39) had received antibiotics in the previous 3 months, 51.2% (n=21) had suffered CDI in the last 6 months, 60.9% (n=26) had severe baseline disease and 21.9% (n=9) were immunosuppressed. As first line, 41.4% (n=17) received vancomycin and metronidazole, 44% (n=18) received vancomycin and 14.6% (n=6) received fidaxomicin. 63.4% (n=26) received fidaxomicin 200 mg/12 hours (10 days), in 14.6% (n=9) the extended regimen was used and 22% (n=6) received 200 mg/12 hours for longer. 82.9% (n=34) of fidaxomicin-treated patients had no CDI recurrence at 8 weeks. 22% (n=9) of the patients died. Nine fidaxomicin-treated patients were administered bezlotuxumab and none subsequently developed CDI. All were older than 65 years and 66.6% (n=6) were oncology patients. Conclusion and relevance The CDI treatment was mostly adjusted to the recommendedations in the therapeutic guidelines, with vancomycin/metronidazole as first-line and fidaxomicin in recurrences. The use of bexlotuxumab was adapted to the considerations of the Therapeutic Positioning Index and was used in patients with a higher risk of recurrence. Although in the pivotal studies the recurrence rate with bexlotuxumab was 16.5%, in our study there were no recurrences. In the case of fidaxomicin, the recurrence rate was 17.1%, which was higher than the published studies. Limitations: small sample size and the impact of the joint use of bexlotuxumab and fidaxomicin has not been measured.
Today, the increasing number of illicit internet pharmacies is a global phenomenon, however, the ... more Today, the increasing number of illicit internet pharmacies is a global phenomenon, however, the size of the online pharmaceutical market is still relatively unknown and the dubious quality of products is questionable and warrants investigation. Descriptive data from this black market channel are derived from studies analyzing the online availability of different medications procured over the internet and their methodology is quite heterogeneous. Our aim was to develop a comprehensive and specific risk assessment for selecting high patient safety risk medications from the online pharmaceutical market. A rapid tool was developed based upon the two quality and safety standard resolutions in pharmaceutical practice, published by the European Directorate for the Quality of Medicines, and was illustrated on eye drops. We developed five dimensions in support of the risk assessment including intrinsic, extrinsic and potential risks of counterfeiting. The five criteria were integrated in a comprehensively weighted risk-scoring format. The probability of procuring the product from the internet was also assessed based on the number of relevant links within the first twenty search engine results and the cost of the products. With the application of the tool a dorzolamide & timolol combination eye drop represented the highest overall patient safety risk score. In consideration of our literature review of the past 20 years, there is no current, standardized methodology to effectively identify pharmaceutical products associated with high patient safety risks. Notably, the fully comprehensive analysis of the internet pharmaceutical market and the test purchase of all online available medicines is unrealistic. Therefore, we developed a method to aid online surveillance researches and targeted international organizational led joint actions against the uncontrolled sale of falsified and substandard medications (e.g.: Operation Pangea).
Microbiological preservatives play a great role in the preparation of artificial tears because th... more Microbiological preservatives play a great role in the preparation of artificial tears because they protect the eyes from further microorganisms and the preparation from contamination. In this contribution we are summarizing our experimental results given by pharmaceutical and microbiological optimalization of artificial tears. The incidental adaptability of povidone-iodine (PVP-I) as a preservative in artificial tears was examined compared to usually used materials. Some artificial tears (Oculogutta carbomerae and Oculogutta viscosa) were prepared according to the Formulae Normales Edition VII., others were isotonisated and buffered containing 3.0% and 3.5% povidonum as active substance. The analysed samples as a preservative instead of generally used agents contained 0.10%, 0.05% and 0.01% PVP-I. Reference preparations were dispensed using microbiological preservatives (Cetrimidum, Thiomersalum solutum 0.1%, Benzalconium chloratum solutum 10%). Pharmaceutical (pH, viscosity, freez...
Microbiological preservatives play a great role in the preparation of artificial tears because th... more Microbiological preservatives play a great role in the preparation of artificial tears because they protect the eyes from further microorganisms and the preparation from contamination. In this contribution we are summarizing our experimental results given by pharmaceutical and microbiological optimalization of artificial tears. The incidental adaptability of povidone-iodine (PVP-I) as a preservative in artificial tears was examined compared to usually used materials. Some artificial tears (Oculogutta carbomerae and Oculogutta viscosa) were prepared according to the Formulae Normales Edition VII., others were isotonisated and buffered containing 3.0% and 3.5% povidonum as active substance. The analysed samples as a preservative instead of generally used agents contained 0.10%, 0.05% and 0.01% PVP-I. Reference preparations were dispensed using microbiological preservatives (Cetrimidum, Thiomersalum solutum 0.1%, Benzalconium chloratum solutum 10%). Pharmaceutical (pH, viscosity, freez...
Microbiological preservatives play a great role in the preparation of artificial tears because th... more Microbiological preservatives play a great role in the preparation of artificial tears because they protect the eyes from further microorganisms and the preparation from contamination. In this contribution we are summarizing our experimental results given by pharmaceutical and microbiological optimalization of artificial tears. The incidental adaptability of povidone-iodine (PVP-I) as a preservative in artificial tears was examined compared to usually used materials. Some artificial tears (Oculogutta carbomerae and Oculogutta viscosa) were prepared according to the Formulae Normales Edition VII., others were isotonisated and buffered containing 3.0% and 3.5% povidonum as active substance. The analysed samples as a preservative instead of generally used agents contained 0.10%, 0.05% and 0.01% PVP-I. Reference preparations were dispensed using microbiological preservatives (Cetrimidum, Thiomersalum solutum 0.1%, Benzalconium chloratum solutum 10%). Pharmaceutical (pH, viscosity, freez...
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