By Injection Research Articles

Environmental Outcomes of Reducing Medication Waste by Redispensing Unused Oral Anticancer Drugs

Medications are associated with substantial environmental outcomes, yet frequently end up being unused by patients. Waste-minimizing interventions, such as redispensing of quality-approved oral anticancer drugs remaining unused by patients at home, could reduce the environmental footprint of cancer treatment. To assess the environmental outcomes of redispensing quality-assured oral anticancer drugs and to explore how redispensing could be environmentally optimized. In this quality improvement study, a cradle-to-grave life cycle assessment was performed in the outpatient pharmacy of 4 Dutch hospitals, based on a prospective multicenter trial comprising 1071 patients with a clinical diagnosis of cancer and an active prescription for an oral anticancer drug stored at room temperature from February 1, 2021, to February 1, 2023, with a follow-up of 12 months per patient. Participants received prescribed oral anticancer drugs with additional quality-assurance materials (ie, seal bags and time-temperature indicators), so the pharmacy could redispense quality-assured drugs based on authenticity, appearance, remaining shelf life, and/or adequate storage. The estimated environmental outcomes avoided due to waste reduction (ie, production and transport and incineration of redispensed oral anticancer drugs) corrected for outcomes of process burdens (ie, quality assurance materials), quantified in 3 outcome measures: human health damage (disability-adjusted life-years), ecosystems damage (species × year), and climate change (kg of carbon dioxide equivalent [CO2-eq]) per patient per year. A volunteer sample of 1071 patients (median age, 70 years [IQR, 62-75 years]; 622 men [58.1%]) participated in the intervention. Redispensing oral anticancer drugs was initially associated with an environmental burden, mainly because of the high impact of time-temperature indicators. However, when quality-assurance materials were selectively used for temperature-sensitive oral anticancer drugs (ie, maximum storage temperature of 25 °C), redispensing was environmentally beneficial to human health and ecosystems, providing estimated climate benefits of 1.9 kg (95% CI, 1.4-2.6 kg) of CO2-eq per patient per year. In this quality improvement study, redispensing unused oral anticancer drugs was found to be a suitable strategy to reduce waste and improve environmental sustainability of cancer treatment after process optimization. Redispensing unused oral anticancer drugs could contribute to sustainability of cancer treatment through reduced costs and environmental outcomes.

Utilization of Lean Six Sigma and the DMAIC process on oral treatment regimen entry and consent to improve patient care and mitigate practice risk.

281 Background: Oral medication (chemo/hormone) volumes in oncology treatment selection will continue to increase year over year. In 22’, oral meds accounted for the largest market share in dollars at 51% vs IV treatment at 49%. Oral medication volume is projected to increase by proliferation and utilization, though revenues may decrease due to decreasing drug margins. Medication regimen consent is a critical part of specialty pharmacy accreditation through one of the national accrediting organizations. This accreditation is vital to meeting the requirements and maintaining contracts with pharmacy benefit managers (PBMs) and specialty-focused pharmacy services administrative organizations (PSAO). Without improved and continued consent compliance, OHC was at a significant risk of losing the ability to provide care for this impacted patient population, thus resulting in increased risk of financial toxicity. PBMs and accreditations require quality components be completed to maintain the ability to run a specialty oncology pharmacy. When a new oral prescription is written, the oral must be 1.) entered as a regimen and not a single script-only in the EHR and 2.) must have a completed teaching visit and legal consent. Methods: Following the DMAIC (define, measure, analyze, implement and control) process, OHC’s Lean Team deployed Lean Six Sigma strategies and tools in PY23’ to bridge the gap to goal for both oral medication risk areas. OHC followed the lean methodology A3 process using DMAIC, deployed implementation strategies and curated data analytic reports to ensure oral medications were entered as regimens vs script-only, that teaching/consents were completed, and that the control phase maintained a steady state. Results: In 23’, OHC providers accurately prescribed in the EHR a new oral chemo/hormone at 98% (1037/1055) accuracy vs 22’ at 69% (586/845). Additionally, OHC achieved a 93% (986/1055) teach/consent compliance rate vs 22’ at 59% (499/845). With mitigation of compliance risk (est. at 12,114,000), OHC ensured no loss of pharmacy accreditation and contracts. Increased oral medication teaching visits capture rate increased (n=399) resulting in $114,000 additional return on investment in calendar year 23’. Conclusions: Utilizing Lean Six Sigma tools and the DMAIC process, OHC was able to implement strategies to meet both measure goals in one performance year, resulting in improved patient care, organizational risk mitigation, and sustainable profitability. The results have been maintained in the control phase of PY24’. Lean Six Sigma and the DMAIC process are vital to organization success. Tactics deployed have proven to be reproducible and scalable to other projects. Measure PY2022 PY2023 Goal Oral Medication Regimen NCCN Entry vs Script-only 69% (586/845) 98% (1037/1055) 90% Oral Medication Regimen Teach/Consent 59% (499/845) 93% (986/1055) 93%

Review on the role of nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome pathway in diabetes: mechanistic insights and therapeutic implications.

This review explores the pivotal role of the nucleotide-binding oligomerization domain (NOD)-like receptor protein 3 (NLRP3) inflammasome in the pathogenesis of diabetes and its complications, highlighting the therapeutic potential of various oral hypoglycemic drugs targeting this pathway. NLRP3 inflammasome activation, triggered by metabolic stressors like hyperglycemia, hyperlipidemia, and free fatty acids (FFAs), leads to the release of pro-inflammatory cytokines interleukin-1β and interleukin-18, driving insulin resistance, pancreatic β-cell dysfunction, and systemic inflammation. These processes contribute to diabetic complications such as nephropathy, neuropathy, retinopathy, and cardiovascular diseases (CVD). Here we discuss the various transcriptional, epigenetic, and gut microbiome mediated regulation of NLRP3 activation in diabetes. Different classes of oral hypoglycemic drugs modulate NLRP3 inflammasome activity through various mechanisms: sulfonylureas inhibit NLRP3 activation and reduce inflammatory cytokine levels; sodium-glucose co-transporter 2 inhibitors (SGLT2i) suppress inflammasome activity by reducing oxidative stress and modulating intracellular signaling pathways; dipeptidyl peptidase-4 inhibitors mitigate inflammasome activation, protecting against renal and vascular complications; glucagon-like peptide-1 receptor agonists attenuate NLRP3 activity, reducing inflammation and improving metabolic outcomes; alpha-glucosidase inhibitors and thiazolidinediones exhibit anti-inflammatory properties by directly inhibiting NLRP3 activation. Agents that specifically target NLRP3 and inhibit their activation have been identified recently such as MCC950, Anakinra, CY-09, and many more. Targeting the NLRP3 inflammasome, thus, presents a promising strategy for managing diabetes and its complications, with oral hypoglycemic drugs offering dual benefits of glycemic control and inflammation reduction. Further research into the specific mechanisms and long-term effects of these drugs on NLRP3 inflammasome activity is warranted.

Exploring the determinants of oral health care uptake among women with gestational diabetes mellitus: A qualitative study to develop a logic model and framework for an oral health intervention.

Gestational diabetes mellitus (GDM) is a condition of glucose intolerance in pregnancy. Oral health has been shown to mediate blood glucose management and pregnancy outcomes. There is also a greater prevalence of poor oral health in GDM pregnancies when compared to normoglycemic pregnancies. While current guidelines recommend an oral health review as part of diabetes and pregnancy management, it is under-considered in GDM care. Hence, it is important to understand how to improve oral health care in this context. To explore the determinants of oral health care uptake among women with GDM to develop a logic model for an intervention to improve awareness and activation of oral health behaviours in this population. Semi-structured interviews were used to collect the data and the Theoretical Domains Framework inspired the interview guide. The study population consisted of UK-based women with GDM over 18 years of age. The data were analysed with Framework Analysis and the COM-B Model was used to orientate the data. Seventeen women participated in the study. Five themes including knowledge about oral health; the health of the baby; the impact of the GDM diagnosis; social support and barriers and facilitators were found to influence the uptake of oral health care. This study developed an evidence-based logic model of the determinants of oral health care uptake among women with GDM. This will serve as a framework for developing an oral health intervention. This study may be the starting point for initiating conversations about implementing oral health care in GDM management.

Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling.

Omaveloxolone is a nuclear factor (erythroid-derived 2)-like 2 activator approved in the United States and the European Union for the treatment of patients with Friedreich ataxia aged ≥16 years, with a recommended dosage of 150 mg orally once daily on an empty stomach. The effect of the US Food and Drug Administration (FDA) high-fat breakfast on the pharmacokinetic profile of omaveloxolone observed in study 408-C-1703 (NCT03664453) deviated from the usual linear correlation between fed/fasted maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) ratios reported for various oral drugs across 323 food effect studies. Here, physiologically based biopharmaceutics modeling (PBBM) was implemented to predict and explain the effect of the FDA high-fat breakfast on a 150-mg dose of omaveloxolone. The model was developed and validated based on dissolution and pharmacokinetic data available across dose-ranging, food effect, and drug-drug interaction clinical studies. PBBM predictions support clinical observations of the unique effect of a high-fat meal on omaveloxolone pharmacokinetic profile, in which the Cmax increased by 350% with only a 15% increase in the AUC. Key parameters influencing omaveloxolone pharmacokinetics in the fasted state based on a parameter sensitivity analysis included bile salt solubilization, CYP3A4 activity, drug substance particle size distribution, and permeability. Mechanistically, invivo omaveloxolone absorption was solubility and dissolution rate limited. However, in the fed state, higher bile salt solubilization led to more rapid dissolution with predominant absorption in the upper gastrointestinal tract, resulting in increased susceptibility to first-pass gut extraction; this accounts for the lack of correlation between Cmax and AUC for omaveloxolone.

The impact of oral oncology drugs in the era of value-based care.

15 Background: Oncology drug expenditures are a significant contributor to increasing total cost of care (TCOC). Oral oncolytics (OO), such as small molecule inhibitors (CDK 4/6 inhibitors, tyrosine kinase inhibitors, etc.), and immunomodulators, have revolutionized the treatment landscape for many cancers. We evaluated the patterns of OO use and spend for Medicare patients over time at a large community oncology practice participating in the Center for Medicare and Medicaid Innovation (CMMI)’s Value-based care (VBC) Program, the Oncology Care Model (OCM), with a focus on the seven cancers that are part of a successor model, the Enhancing Oncology Model. Methods: Using CMMI claims for attributed 6-month OCM episodes, we evaluated drug use and expenditures by performance period (PP) from July 2016 – June 2022 (11 PPs), with an emphasis on OO drugs. We used Part D expenditures as a proxy for OO. Results: From 2016-22, average TCOC per PP increased by 15.5% in the 7 EOM diagnoses (breast, lung, colon, prostate cancer, myeloma, lymphoma, and chronic leukemia). Average drug expenditures per PP grew 33% percent and represented 71% of total cost by PP11, up from 61% in PP1. Average expenditures per episode increased by 11.7% for Part B and 82.6% for Part D drugs (p<0.01). Increase in Part D drug expenditures was partly due to an increase in the number of unique oral drugs which grew by 32% over the evaluation period. The greatest increases in Part D drug expenditures occurred in breast cancer (87%) and lymphoma (153.7%). Table reports average OO expenditures per PP, percent change from PP1 to PP11, and the change in the % Part D drugs contributed to TCOC. Conclusions: Increases in drug expenditures represent the greatest impact on TCOC for cancer patients. OO medicines have an increasing role in the treatment landscape and represent a growing focus in VBC models. Utilization and cost of OO medication have a significant bearing on VBC performance. Diagnosis Avg. OO Expenditures PP1 Avg. OO Expenditures PP11 Avg. OO Expenditures Change Contribution of OO to TCOC Change from PP1 - 11 Breast $4,208 $7,869 87.0% 9.9% Leukemia $25,334 $41,128 62.3% 19.9% CRC $1,206 $2,158 78.9% 3.1% Lung $3,650 $3,625 -0.7% -2.5% Lymphoma $4,193 $10,637 153.7% 13.0% Myeloma $25,109 $39,298 56.5% 6.7% Prostate $18,815 $20,114 6.9% 3.2% Total $8,291 $15,140 82.6% 10.8%

Herbal Medicinal Nanoformulations for Psoriasis Treatment: Current State of Knowledge and Future Directions

Background: Psoriasis is a persistent immune system disorder that influences the skin, leading to red, flaky patches that can be painful and irritated. Objective: Traditional treatments for psoriasis, such as topical creams and oral medications, may be effective but also have potential side effects. Herbal remedies have been used for centuries to treat skin conditions, and advancements in nanotechnology have led to the development of herbal nanoformulations that offer several advantages over traditional herbal remedies, such as efficacy, safety, and targeted delivery. Methods: The studies and reviews published under the title were looked up in several databases (including PubMed, Elsevier, and Google Scholar). Results: Several herbal nanoformulations, including those containing curcumin, aloe vera, and neem, have been shown to exhibit anti-inflammatory and immunomodulatory impacts, which will be useful within the treatment of psoriasis. However, more study is required to decide the efficacy and safety of these details, as well as the optimal dosing, duration of treatment, and potential side effects. Conclusion: Overall, herbal nanoformulations represent a promising area of research for the treatment of psoriasis, and may offer a safe and effective alternative or adjunct therapy to conventional treatments. This review article summarizes the present state of information for the herbal nanoformulations role in the treatment of psoriasis and their future perspectives.

Elevating the patient voice: Understanding treatment preferences in patients with advanced prostate cancer.

262 Background: With multiple oral non-chemotherapy medications for prostate cancer patients, there is a need to explore the impact of pill burden on overall quality of life, patient experience, and adherence. This study aimed to understand medication preferences from patients with advanced prostate cancer. Methods: We conducted a cross-sectional, online survey of patients with advanced prostate cancer living in the United States. Inclusion criteria included: men with a self-reported diagnosis of prostate cancer that has spread beyond the prostate and are receiving any treatment for prostate cancer. This survey was conducted in January 2024. Patients were recruited through physician referral. Results: The survey enrolled 100 participants with a median age of 65 years (range 39-75). 53 (53%) patients identified as white, 31 (31%) identified as black, 15 (15%) were Hispanic. 81 (81%) stated that they had undergone previous chemotherapy and 80 (80%) patients reported taking oral medications for prostate cancer. Regarding overall pill burden, 48 (48%) took >5 pills/day and 50 (50%) took >3 pills/day including treatment for prostate cancer. Regarding treatment frequency, 63 (63%) patients reported difficulty remembering to take the pills multiple times per day and 92 (92%) patients said they would choose a 1 pill once daily option over a multi-pill regimen. 20 (20%) patients admitted to either having difficulty swallowing pills or being unsure about swallowing pills. Of these 20, 18 (95%) consider it important if a pill can be dispersed in water, or vehicles such as applesauce. 89 (89%) patients said they would prefer a non-chemotherapy treatment option compared to a chemotherapy-containing regimen. Conclusions: Most patients prefer the option of an oral treatment regimen compared with chemotherapy. Due to the challenges of polypharmacy as well as worsening memory, most patients also prefer a one pill once a day regimen. In an older population, therapies with formulations that allow for patient choice in administration schedule may avoid treatment interruptions. When discussing treatment options with patients, providers should take these factors into consideration.

Complications of pediatric macrocystic lymphatic malformations of the head and neck: a survival analysis of treated and untreated patients.

To compare events of recurrent swelling between treated and untreated patients with macrocystic lymphatic malformations of the head and neck not involving the airway. The frequency and timing of emergency department (ED) visits related to the event were analysed to provide data on efficacy and ideal timing of treatment. A 5-year retrospective review of a hospital database was conducted reviewing 35 patients (15 female, 20 male; mean age 3.9 years) with macrocystic lymphatic malformations of the head and neck not involving the airway. Patients treated with oral medications were excluded. A survival analysis was performed comparing the incidence of recurrent swelling of the malformation. A Cox regression analysis was conducted using age, gender, diameter of lymphatic malformation at presentation, and echogenicity on US as covariates. Fisher's test and mean comparisons were performed to correlate the populations baselines and the number and frequency of ED visits between the 2 groups. Thirteen patients underwent sclerotherapy soon after initial presentation and 22 elected for observation. The two baseline populations differed at presentation with the treatment group being younger (1.4 ± 2.4 vs. 5.4 ± 6.3 years, p = 0.03) and with larger lesions (5.7 ± 2.7 vs. 4.0 ± 1.7cm p = 0.03). Mean follow-up time was 2.7 years. Survival analysis showed 1 or multiple recurrences affected 16 patients in the untreated group and 3 patients in the treated group. (p = 0.04). Age, gender, diameter of the lesion at presentation and increased echogenicity on US were not predictive factors of recurrence. Although the probability of visiting the ED at least once did not differ between the two groups (p = 0.42), patients from the non-treatment group were more likely to visit the ED more than once (p = 0.03). Sclerotherapy treatment may reduce the chance of recurrent swelling or an event after initial presentation to the ED.

Immune-mediated meibomian gland dysfunction and dry eye disease related to trastuzumab emtansine chemotherapy in HER2 breast cancer: A case report

One of the most commonly administered drugs for human epidermal growth factor receptor 2 (HER2) breast cancer is trastuzumab emtansine (TDM-1). Unfortunately, this drug causes ocular surface disease as an adverse effect. This case report describes the diagnosis and management of meibomian gland dysfunction (MGD) and dry eye related to TDM-1 in HER2 a breast cancer patient. Our patient was a 43-year-old female diagnosed with HER2 breast cancer with metastasis to the peritoneum and liver. After a cycle of TDM-1 chemotherapy, she complained of recurrent hordeolum, ocular discomfort, and blurry vision. We initially prescribed topical and oral medications and gradually combined them with hordeolum incision and drainage, in-office meibomian gland expression, and intense pulse light therapy to improve symptoms. Ocular adverse effects due to anticancer agents are not preventable. Ophthalmologists must be aware of them and instigate needed therapy to ensure patients’ compliance with cancer treatment and improve quality of life.

Bridging the gap: Innovative human-based in vitro approaches for nanomaterials hazard assessment and their role in safe and sustainable by design, risk assessment, and life cycle assessment

The application of nanomaterials in industry and consumer products is growing exponentially, which has pressed the development and use of predictive human in vitro models in pre-clinical analysis to closely extrapolate potential toxic effects in vivo. The conventional cytotoxicity investigation of nanomaterials using cell lines from cancer origin and culturing them two-dimensionally in a monolayer without mimicking the proper pathophysiological microenvironment may affect a precise prediction of in vitro effects at in vivo level. In recent years, complex in vitro models (also belonging to the new approach methodologies, NAMs) have been established in unicellular to multicellular cultures either by using cell lines, primary cells or induced pluripotent stem cells (iPSCs), and reconstituted into relevant biological dimensions mimicking in vivo conditions. These advanced in vitro models retain physiologically reliant exposure scenarios particularly appropriate for oral, dermal, respiratory, and intravenous administration of nanomaterials, which have the potential to improve the in vivo predictability and lead to reliable outcomes. In this perspective, we discuss recent developments and breakthroughs in using advanced human in vitro models for hazard assessment of nanomaterials. We identified fit-for-purpose requirements and remaining challenges for the successful implementation of in vitro data into nanomaterials Safe and Sustainable by Design (SSbD), Risk Assessment (RA), and Life Cycle Assessment (LCA). By addressing the gap between in vitro data generation and the utility of in vitro data for nanomaterial safety assessments, a prerequisite for SSbD approaches, we outlined potential key areas for future development.

Clinical Analysis of Reversible Posterior Encephalopathy Syndrome after Allogeneic Hematopoietic Stem Cell Transplantation in Children

To summarize the clinical features of reversible posterior encephalopathy syndrome (PRES) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in children. The clinical data of six children who developed PRES after undergoing allo-HSCT in the Department of Hematology of Wuhan Children's Hospital from June 2016 to December 2022 were retrospectively analyzed, and their clinical characteristics, imaging examination, laboratory examination, and treatment regression were summarized. Among 281 children underwent allo-HSCT, 6 cases (2.14%) developed PRES, with a median age of 5.1(1.5-9.7) years old. 4 cases underwent related haploidentical donor transplantation, and 2 cases underwent sibling allografting and unrelated donor allografting donor transplantation, respectively. All six children had an acute onset of illness, with clinical manifestations of nausea and vomiting, seizures, psychiatric disorders, visual disturbances. The five cases elevated blood pressure. All children with PRES were treated with oral immunosuppressive drugs during seizures, and 3 cases were combined with different degrees of graft-versus-host disease. Most of the children showed effective improvement in clinical symptoms and imaging after adjusting/discontinuing suspected medications (cyclosporine, etc.) and symptomatic supportive treatments (oral antihypertensive, diazepam for antispasmodic, mannitol to lower cranial blood pressure), and one of them relapsed more than 8 months after the first seizure. PRES is rare after hematopoietic stem cell transplantation in children, and its onset may be related to hypertension, cytotoxic drugs, graft-versus-host disease, etc. Most of them can be recovered after active treatment, but not completely reversible, and the prognosis of those who combined with TMA is poor.

Review about the Application of Biocompatible Materials in Oral Cavity Drug Delivery Systems

Review about the Application of Biocompatible Materials in Oral Cavity Drug Delivery Systems

Formulation and Evaluation of Gastroretentive Floating Beads of an Oral Hypoglycemic Drug Glimepiride

Formulation and Evaluation of Gastroretentive Floating Beads of an Oral Hypoglycemic Drug Glimepiride

A Long-Term Retrospective Real-World Evidence to Understand the Pattern of Insulin Prescription in Patients with Type 2 Diabetes Mellitus: Evaluating the Role of Insulin Initiation

Abstract Aims and Objective: To evaluate the prescription pattern of insulin and oral antidiabetic drugs (OADs) and the trend of glycemic control in people with diabetes (PwD) with type 2 diabetes mellitus attending a tertiary care center in India. Materials and Methods: This retrospective, cross-sectional observational study included clinic records of 647 PwD collected at three different time points (2011, 2015, and 2019). Population characteristics, patterns of glycemic parameters, and trends of antidiabetic medication were analyzed. Results: PwD population was similar in terms of anthropometric and clinical variables. Dysglycemia was observably higher in the 2015 population (mean HbA1C = 8.37 ± 1.8%) compared with the 2011 population (6.4 ± 0.4%) and stabilized in the 2019 population (8.35 ± 1.9%) compared with the 2015 population. This correlated with the trend of increase in basal and bolus insulin prescriptions as more subjects were initiated on insulin to address the higher dysglycemia in 2015 than in 2011 and were later titrated in 2019. The proportion of subjects with uncontrolled diabetes increased marginally in 2015 (50.9%) compared with 2011 (45.6%) and decreased significantly in 2019 (34.1%) compared with 2015. This correlated with the additive increases of premix insulin, sodium-glucose transport protein 2 inhibitors (SGLT2i), and dipeptidyl peptidase 4 inhibitors (DPP4i) prescriptions. Conclusion: We observed a judicious usage of insulin prescriptions correlating with the higher need for PwD to be initiated with basal insulin to counter the increasing trend of dysglycemia, followed by more premix insulin prescriptions to address stabilized dysglycemia. Optimal diabetes control can be partly attributed to dysglycemia stabilization by insulin initiation and usage of newer OADs, such as SGLT2i and DPP4i.

Exploring disparities: A comparative analysis of insulin-naïve, regular users, and inertia patients among type 2 diabetes mellitus outpatients in India

ABSTRACT Introduction: Insulin utilization pattern varies greatly in type 2 diabetes mellitus (T2DM) patients. Clinical inertia in treatment intensification hinders glycemic control in T2DM management. This study investigated insulin prescription trends and various predictors among insulin naive, user, and insulin inertia (II) patients in T2DM. Methodology: A retrospective analysis of T2DM patient records from the diabetes clinic at a tertiary care center was conducted. Data on socio-demographics, anthropometry, disease characteristics, comorbidities, adherence, and medication prescribing patterns were collected. Analysis was done using tests of significance, odds ratio (OR), and multivariate logistic regression. Results: A total of 950 records were analyzed, with 17.3% of patients identified as insulin users (IU), 70.9% being insulin-naïve (IN), and 11.8% having II. IUs had significantly higher glycemic levels including HbA1c, fasting, postprandial, and random blood sugars compared to the other groups. Higher HbA1c levels were associated with significantly increased odds of insulin usage (OR: 3.46, confidence interval (CI): 1.94–6.16), while individuals taking sulfonylureas had lower odds of insulin usage (OR: 0.27, CI: 0.08–0.91). A significant association was also seen with the total number of oral antidiabetic drugs prescribed (four drugs; OR: 15.6, and five drugs; OR: 9.1). Other factors did not show a significant association. The regression model showed HbA1c level as low as 7.9% could indicate a future insulin requirement in 22% of patients. Conclusion: The study outlines differences in characteristics and parameters among T2DM patients who require or do not require insulin and highlights the challenges in insulin initiation in Indian T2DM patients. Findings on II underscore the need for timely treatment intensification.

Niosome as a drug delivery carrier for Sorafenib: Preparation, investigation of physicochemical properties, and in vitro effects on HepG2 cell line

Purpose: Sorafenib is known as one of the oral anti-cancer drugs used in liver cancer. However, its lipophilic nature can lead to side effects, variable pharmacokinetics, and poor absorption. The use of novel drug delivery systems, such as niosomes, may help address these issues and improve the effectiveness of sorafenib. Methods: Different niosomal formulations of sorafenib were prepared. The morphology, size analysis, and physical stability were investigated. The encapsulation efficiency percent of the selected formulations was measured using the dialysis method, and the release of sorafenib was checked for four hours using the Franz diffusion cell. The cytotoxicity and in vitro effect on the HepG2 cell line was investigated using the MTT assay and flow cytometry. Results: The mean volume diameter of Span 60/ Tween 60/ cholesterol (45/45/10 mole%) niosomal formulation was 6 µm with minimal size changes and good stability over six months of storage. The encapsulation efficiency percent of this formulation was 66.40±1.11, and 61.43±1.42 percent of the drug was released within four h. In vitro release followed Higuchi kinetics. Cytotoxicity tests showed an IC50 of 7.5 µg/mL for the niosomal formulation, compared to 15.96 µg/mL for the sorafenib solution. Conclusion: Niosomes containing Span 60/ Tween 60/ cholesterol (45/45/10 mole%) are promising for loading and sustained release of sorafenib. The use of niosome as a carrier can enhance the effectiveness of sorafenib on the HepG2 cell line. This niosomal formulation of sorafenib shows potential for future studies.

Bladder Pain Syndrome (BPS): A Comprehensive Review of Treatment Strategies and Management Approaches.

Bladder pain Syndrome presents a multifaceted challenge in contemporary urological practice, marked by LUTS, negative behavioural, sexual, or emotional experiences, and the potential for sexual dysfunction. We meticulously explored the existing literature of conservative, non-invasive and invasive interventions, aiming to provide clinicians with a nuanced understanding of available options for comprehensive BPS management. We delve into the effectiveness and safety profiles from behavioural approaches through lifestyle changes and physical therapy, to oral or intravesical medications, until the definitive surgical treatment. The best option evaluated is the involvement of a multidisciplinary team, including urologists, urotherapists, gynaecologists, pain specialists, primary care physicians and psychologists, educating those patients regarding the condition and its chronic course and tailoring the perfect treatment for each person. Despite this, BPS remains a challenge for urologists. Indeed, our objective is to contribute to the evolving landscape of BPS management, fostering informed decision-making and personalized care for individuals grappling with this challenging condition.

Dedicated OAM Oncology Navigation program to improve access to medication education, ePRO enrollment, and physician treatment plan completion adherence.

234 Background: Effective coordination of oncology care is essential for optimizing patient outcomes and ensuring adherence to treatment plans. When an Oncology Navigation program is implemented specifically related to patients on Oral Anticancer Medications (OAMs), it directly improves patient access to medication education and treatment adherence through enrollment in ePRO (electronic patient reported outcomes) tracking systems. Currently, there is limited evidence published related to the quantitative impact of dedicated OAM Navigation programs on patient treatment review and coordination visits, and provider completion adherence to treatment plans. Methods: This quality improvement initiative aimed to evaluate the impact of implementing an OAM Navigation program. Data were collected over a 90-day pilot period from a single geographic region within a community oncology practice. The patients’ medical records were reviewed to assess completion of treatment review and coordination visits by an APP or Physician, ePRO enrollment, and provider adherence to completion of treatment plans. Results: Analysis of the data revealed a significant increase in completed treatment review and coordination visits following the implementation of the OAM Navigation program, with a 28% increase observed compared to pre-implementation levels. Enrollment to ePRO system increased from 46 patients’ pre-pilot to 272 patients within the pilot period, a 491% increase in enrollment. Additionally, provider adherence to completion of treatment plans showed a marked improvement, increasing by 50% post-implementation. These findings suggest that the OAM Navigation program effectively facilitated enhanced quality and safety of care provided. Conclusions: Dedicated OAM Navigation programs play a crucial role in improving patient outcomes and optimizing oncology care delivery. Our findings demonstrate the significant positive impact of an OAM Navigation program on increasing patient education, ePRO enrollment, and improving provider adherence to completion of treatment plans. Incorporating OAM Navigation programs into ambulatory oncology practices can lead to more efficient and effective care coordination, ultimately enhancing the quality and safety of care. As we continue to expand and refine this program, we look forward to sharing our research findings and insights with the broader oncology healthcare community.

Comparison of ََQuality of Life and Treatment Satisfaction among Sample of Iraqi Patients Using Anticoagulant Therapy (Warfarin or Non-Vitamin K Antagonist Oral Anticoagulants)

Background: Oral anticoagulation medication, warfarin and non-vitamin k antagonist oral anticoagulants (NOAC) may require long term use which may affect patients’ satisfaction with their treatment and their quality of life (QOL). Objective: To compare the quality of life and treatment satisfaction among groups of patients using different anticoagulant therapies (warfarin and NOAC). Patients and methods: A cross-sectional study was performed at Ibn Al-Bitar Hospital for cardiac surgery in Baghdad in the period between December 2022 to May 2023. The study population included a convenient sample of patients receiving either warfarin or non-vitamin k antagonist oral anticoagulants treatment. The Arabic version of the short form 12 (SF-12) questionnaire and the Anti-Coagulant Treatment Satisfaction Scale (ACTS) questionnaire were used to assess the quality of life and satisfaction with treatment respectively. Results: The study included 181 patients in total. The mean physical and mental quality of life scores for study participants were 42.3±9.92 and 52.6±10.36 respectively. There was no significant difference in the QOL between patients taking warfarin and those on non-vitamin k antagonist oral anticoagulants treatment. The mean total satisfaction score was 65.4±6.73. Patients receiving non-vitamin k antagonist oral anticoagulants had significantly higher satisfaction compared to those receiving warfarin (P=0.000). The physical score correlated significantly with gender, educational level, employment status, number of chronic medications and number of chronic diseases. The total satisfaction score correlated significantly with gender, number of chronic medications, number of side effects and duration of anticoagulation. There was a significant correlation between the QOL and treatment satisfaction (P=0.000). Conclusion: Treatment with non-vitamin k antagonist oral anticoagulants showed comparable QOL and higher treatment satisfaction than that of warfarin. Better treatment satisfaction can improve patients’ QOL which may ultimately enhance their adherence to treatment.