Start Of Preparation Research Articles

ASA's Advocacy on USP <797>: The Campaign to End the 1-Hour Rule

Quality & Regulatory| May 2022 ASA's Advocacy on USP <797>: The Campaign to End the 1-Hour Rule Matthew Goldan; Matthew Goldan Search for other works by this author on: This Site PubMed Google Scholar Elizabeth Rebello, R.Ph, MD, FASA, CPPS Elizabeth Rebello, R.Ph, MD, FASA, CPPS Search for other works by this author on: This Site PubMed Google Scholar ASA Monitor May 2022, Vol. 86, 38. https://doi.org/10.1097/01.ASM.0000830864.68453.1c Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Cite Icon Cite Get Permissions Search Site Citation Matthew Goldan, Elizabeth Rebello; ASA's Advocacy on USP <797>: The Campaign to End the 1-Hour Rule. ASA Monitor 2022; 86:38 doi: https://doi.org/10.1097/01.ASM.0000830864.68453.1c Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentAll PublicationsASA Monitor Search Advanced Search Topics: advocacy, united states pharmacopeia For over a decade, anesthesiologists and other qualified anesthesia professionals have made their voices heard against the “one-hour rule,” a restrictive standard imposed by U.S. Pharmacopeia (USP) stating that all immediate-use sterile products must be administered within one hour after the start of preparation. Over the course of this period, anesthesiologists faced confusion and disruption to their workflows, and ASA was at the forefront of this issue in support of its members, building coalitions and submitting a number of comment letters advocating for the repeal of the one-hour rule. With positive breakthroughs in the latest draft of USP's guidance, ASA is working to finally bring this issue to a clear resolution and ensure the rules around compounded sterile preparations enable qualified anesthesia professionals to provide the highest quality of care for their patients. The one-hour rule was included in the 2008 revisions of USP Chapter <797>, a standard for sterile... You do not currently have access to this content.

Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer

PurposeThe subcutaneous (SC) administration of trastuzumab is highly preferred by patients. At home, administration of trastuzumab SC might further improve patient benefit. The aims of the BELIS study are to evaluate the safety and tolerability of trastuzumab SC when administered at home by a healthcare professional (HCP) and to evaluate patient-reported outcomes for treatment experience of at home cancer therapy.MethodsThis open-label phase IIIb study enrolled HER2-positive early breast cancer patients in Belgium and Israel who completed the first six cycles of trastuzumab IV (neo)adjuvant therapy. The study consisted of three consecutive treatment periods: three cycles of trastuzumab IV and SC each at the hospital and six cycles of trastuzumab SC at home.ResultsBetween November 2013 and December 2014, 23 centres enrolled 102 patients in the intent-to-treat population of which 101 patients entered the safety population. No new safety signals were detected with as expected, more mild administration site events with trastuzumab SC when compared to IV treatment. All patients agreed that they had benefit from at home administration to a large (18/81; 22%) or very large (63/81; 78%) extent. All HCPs (21/21) agreed that SC is the quickest method from start of preparation to finish of administration and that less resource use is needed.ConclusionThe results of the BELIS study support that trastuzumab SC can be safely administered at home by a HCP and all patients considered this setting as beneficial. HCPs consider the SC formulation as the quickest method to administer trastuzumab.Trial registrationEudraCT Identifier: 2013-000123-13. ClinicalTrials.gov Identifier: NCT01926886.

THE EFFICIENCY OF NEW PREPARATION START-T ON THE BASIS OF BACILLUS THURINGIENSIS STRAINS AGAINST MINERS

The strain of entomopathogenic bacteria Bacillus thuringiensis 0376 р.о. was selected and used for creation of new preparation STAR-t.Thepreparation`seffectivenessagainstpotatomothwasobserved during the main stages of development of its pest. The treatment of chickpea plants of cultivars Antey, Budjak, Pamyat, Rosanna and Triumf with given preparation resulted in decrease of their lesion with the miner phytophage Liriomyza cicerina and increase of plants productivity on 66,7%, 75,0%, 45,0%, 100,0%, 138,5%, correspondingly in comparison to control.

Silibinin pretreatment protects against Ochratoxin A-mediated apoptosis in primary rat hepatocytes

The inhibitory effect of silibinin on ochratoxin A (OTA)-mediated apoptosis on primary rat hepatocytes was investigated. Rat hepatocytes were prepared by two different methods: the classical enzymatic digestion method by collagenase perfusion and a new EDTA-perfusion method. The EDTA-perfusion method yielded hepatocytes, which were stably cultivated without DNA fragmentation for up to 96h, whereas the collagenase-prepared hepatocytes showed apoptosis events as early as from the start of preparation even in the absence of OTA. Treatment with 12.5μmol/l OTA of cultured hepatocytes prepared under ETDA perfusion developed DNA-laddering after 24-36h. Lipopolysaccharide (LPS) of 0.1 up to 12.5μg/ml showed no apoptotic DNA-effects under these conditions. A low concentration of 26μmol/l silibinin given prior to OTA slightly prevented OTA-mediated DNA-laddering, whereas a five times higher concentration of silibinin (130μmol/l) completely inhibited OTA-mediated apoptosis. Under the same conditions, caspase-3 activity in hepatocytes increased in a time-dependent manner under OTA exposure within 12-24h but was blocked by 130μmol/l silibinin. In contrast, LPS incubation for 12 and 24h did not alter caspase-3 activity. To measure viability of OTA-/LPS-treated hepatocytes, the MTT-test and Live/Dead kit were applied. The results demonstrated that the used OTA concentration of 12.5μmol/l only moderately decreased viability for up to 24h but showed cytotoxic effects depending on longer incubation times (≥36h). In contrast, LPS up to 12.5μg/ml exhibited no cytotoxic effects up to 48h. In summary, our results showed contrasting effects on apoptosis in primary rat hepatocytes by OTA (produces apoptosis) versus LPS (produces no apoptosis), also depending on the method of hepatocyte preparation. Silibinin at 130μmol/l showed significant hepatoprotective and antiapoptotic effects against OTA-mediated cell damage on cultured rat hepatocytes.

Frühergebnisse nach Varizenoperation – eine multizentrische Patientenbefragung als Benchmarking-Projekt der ANG

Beside varicose vein surgery, endovenous procedures (endovenous laser therapy, VNUS and foam sclerotherapy) are now therapeutic options with the following advantages: low invasiveness, only out-patient operations, quick resumption of general activities. Whether or not classical vein surgery today still fulfills patient demands was analysed by a study group of German vascular surgeons (ANG) as a multicentre patient questioning. The questionnaire was subdivided into eight main complexes with 24 questions about the early results of stripping operations (from start of preparation until suture removal) and the patients answers were analysed. Answers with points (1-6) and free answers were possible. Between 1.1.2005 and 31.3.2005 18 centres for vascular surgery collected 1708 questionnaires from patients after stripping operations. The complex "preparation and information about the operation" was scored with 1.33 to 1.39. The "general organisation" of the vascular centre was scored between 1.22 and 1.30. "Pain after operation" was rated at 1.98 (immediately), 2.26 (first day) and 2.12 (third day after operation). Reasons for other problems after surgery were haematoma (3.09), problems with the compression dressing (1.67), circulatory collapse (1.51), headache (1.33), nausea (1.25). The total score for all centres was 1.47. The early results after varicose vein surgery are good up to very good. The patients' reconvalescence time is short and there is a quick resumption of general activities. The invasiveness of vein surgery seems to be overestimated. Comparative studies to evaluate the new methods are necessary. Benchmarking projects like this study are essential parts of current quality control systems.

Increased concentrations of endothelin-1 messenger RNA in tissues and endothelin-1 peptide in plasma in septic pigs: modulation by betamethasone.

To study the expression of preproendothelin-1 messenger RNA (mRNA) in tissue after Escherichia coli lipopolysaccharide challenge and to evaluate the possible effects of betamethasone both regarding endothelin-1 production as well as hemodynamic and vascular effects during E. coli lipopolysaccharide infusion in pigs in vivo. Prospective trial. Laboratory at a university medical center. Ten domestic pigs, weighing 18 to 25 kg. Anesthetized pigs were given continuous infusions of E. coli lipopolysaccharide (15 micrograms/kg/hr for 3 hrs), with or without prior treatment with betamethasone (0.5 mg/kg im 12 hrs before the start of the surgical preparation and 0.5/kg iv at the start of the preparation). The E. coli lipopolysaccharide infusion evoked the characteristic cardiovascular changes observed in septic shock: decreased mean arterial pressure and cardiac output; increased heart rate and increased pulmonary vascular resistance. Large increases in both arterial plasma concentrations of endothelin-1-like immunoreactivity, as well as preproendothelin-1 mRNA concentrations in tissues, were also observed during the E. coli lipopolysaccharide infusion. Treatment with betamethasone significantly attenuated the E. coli lipopolysaccharide-induced increase in endothelin-1 plasma concentrations, whereas the increased mRNA concentrations were only slightly affected. Furthermore, betamethasone treatment also affected cardiovascular parameters, with significant attenuation of the E. coli lipopolysaccharide-induced increase in heart rate and a higher cardiac output after 60 mins of the E. coli lipopolysaccharide infusion. The urine production, which was markedly decreased during the E. coli lipopolysaccharide infusion, was significantly higher in the betamethasone-treated group compared with the control group. The present results indicate that the increased concentrations of endothelin-1-like immunoreactivity that are observed in septic shock may have negative effects on both cardiovascular parameters as well as renal function, which is in agreement with a possible role for endothelin-1 in the pathogenesis of septic shock.