ABSTRACT
BACKGROUND: Colorectal cancer (CRC) is the second-leading cause of cancer death in the US, yet screening greatly reduces CRC mortality. Rates of CRC screening at the Northeast Ohio VA (NEOVAHS) dropped below national VA average in March 2020. COVID-19 pandemic restrictions simultaneously increased reliance on fecal immunohistochemical testing (FIT) for CRC screening. At baseline, 58% of FIT samples were rejected, leading to missed preventive care, wasted test kits, and repeated testing. A Lean project team formed with the aim to reduce rejected samples to less than 10% by January 2022. METHODS: NEOVAHS provides primary care for over 100,000 veterans at 13 clinic sites. A multidisciplinary team used Lean methodology to identify root causes and implement a new process from April to December 2021. Samples were rejected if no date was written on the specimen label, sample was received over 14 days from collection, specimen vial was expired, or there was no test order. Key future state aspects included readily available tests, clear instructions and labeling to improve veteran home test success rate, and eliminating delays from receipt to laboratory processing. Interventions included enhanced patient education material, standardized specimen labeling, consolidated logistics supply chain for all clinics, and increased post office delivery to laboratory. RESULTS: Target FIT rejection rates were achieved, decreasing from 68.3% inMarch to 9.5%in December. Rejection rates for no collection date decreased from 33.7% to 4.9% and received over 14 days from 26.3% to 1.0%. No samples were rejected for lack of order from September to December and rates of expired vials decreased to 0.2%. Overall, successful FIT screen rates increased by 227% in the fourth quarter of 2021 (1,259) compared to the first quarter (554). CONCLUSIONS: Lean methodology was used to streamline a flawed process for CRC screening with FIT across multiple clinic sites in a large VA medical center. The project has led to sustained reductions in waste and rework from rejected tests, plus sustained increases in successful FIT screening. Reductions in recommended screening age as well as ongoing COVID reductions in face-to-face visits and endoscopic procedures will continue to increase demand for at-home tests.
ABSTRACT
Background: Nasal route of drug administration has gained popularity nowadays specially for drugs acting on nasopulmonary area. Atazanavir is an antiviral drug which has proved efficacy in different viral infection including COVID-19. Therefore the hypothesis is, if given through intra nasal route this formulation will be able to prevent the viral infection like COVID-19 by directly acting on the virus at its entry point. Objectives: This study aims to prepare a stable mucoadhesive microcrystal formulation of this antiviral drug with good permeation for intra nasal delivery. Materials and Methods: The formulation was prepared by high-speed homogenization process. Prepared microcrystals were estimated for in vitro drug release and permeation, drug excipient interaction study by DSC, FTIR and in vitro mucoadhesiveness study on agar gel plate. A short-term stability study was conducted on all formulations for 6 months. Results: The melting point and absorbance maxima of atazanavir were found as 200.9°C and 248 nm. The DSC and FTIR study results confirmed no drug excipient interaction was there in the formulation. The particle size of the formulations was found as 5-11 µm in range. Drug release was better and faster from the microcrystals as compare to pure powder drug. The flux for microcrystal formulation was found to be 100 whereas flux for the pure drug powder was 24. Formulations had sufficient mucoadhesive strength due to incorporation of HPMC 400 polymer and they were found stable after six months stability study. Conclusion: Lastly, it can be concluded that this formulation would be a promising system for the delivery through intra nasal route as it showed good drug release and permeation during a short time span in in vitro nasal condition with a particle size range suitable for intranasal delivery. However, further in vivo studies are required to confirm the hypothesis.