Processes and perceptions of chemotherapy supply chain in Ethiopia: A mixed-method study.

BACKGROUND: The impact and downstream effects of the chemotherapy supply chain in Ethiopia are not well understood. The purpose of this study was to identify perceived gaps in supply chain and characterize their impact on patient care. METHODS: A concurrent mixed-method study was conducted at a large academic cancer center in Ethiopia. In-depth interviews (IDIs) and surveys were completed in collaboration with external stakeholders with knowledge about chemotherapy supply chain in Ethiopia. Thematic coding was used for qualitative analysis of IDI and descriptive statistics were used to summarize quantitative survey data. RESULTS: Six stakeholders participated in the IDIs and seven completed surveys. IDIs revealed that most chemotherapeutic agents are purchased by the Ethiopian Pharmaceutical Supply Agency (EPSA) and are distributed to cancer treatment centers. A free-market purchasing option also exists, but for chemotherapy obtained outside of government-subsidized channels, the potential for substandard or falsified chemotherapy was a concern. Participants expressed confidence that the correct treatment was administered to patients, but viewpoints on reliability and consistency of medication supply were variable. Quantitative data from the survey showed that participants were not confident that medications are prepared safely and correctly. Improper storage and manipulation of high-risk medications remain a significant risk to staff. CONCLUSIONS: This study provides insight from a healthcare staff perspective on how gaps in the chemotherapy supply chain process impact patient care in a low-income country. Inventory management, disruptions in supply chain, and product integrity were perceived as the largest gaps in the current chemotherapy supply chain structure.

Layered learning pharmacy practice model in Ethiopia.

PURPOSE: Ethiopia is home to a growing population of more than 100 million people. Healthcare in the region functions with a shortage of oncologists. Pharmacists as well as other healthcare providers can assist with expanding patient access to cancer care. A pilot project was proposed to provide education, determine areas to expand pharmacy services in oncology, and recommend interventions at Tikur Anbessa Specialized Hospital and Addis Ababa University. METHODS: A layered learning practice model comprising of a clinical pharmacist, a post-graduate year two oncology pharmacy resident, and two fourth-year student pharmacists was constructed for the experience. Through collaboration with the College of Pharmacy at Addis Ababa University, an international experience was developed to provide education and advance pharmacy practice at Tikur Anbessa Specialized Hospital. RESULTS: Based on findings from a needs assessment, the participants collaborated with key stakeholders to develop practices and procedures for the implementation of high-dose methotrexate and for comprehensive chemotherapy order review. In addition, 17 didactic lectures were provided to nine students enrolled in the Master of Pharmacy in Pharmacy Practice at the College of Pharmacy at Addis Ababa University. CONCLUSION: This experience provided educational and clinical impact using a layered learning practice model, consisting of a clinical pharmacist, pharmacy resident, and pharmacy students in an international setting. There is significant potential for clinical pharmacy to positively impact patient care in the oncology setting in Ethiopia. Future initiatives for advancement include the safe handling of hazardous agents, additional therapeutic drug monitoring, and outpatient oncology pharmacist practice.

Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study.

PURPOSE: The randomized, open-label, global phase III TROPION-Lung01 study compared the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with pretreated advanced/metastatic non-small cell lung cancer (NSCLC). METHODS: Patients received Dato-DXd 6 mg/kg or docetaxel 75 mg/m2 once every 3 weeks. Dual primary end points were progression-free survival (PFS) and overall survival (OS). Objective response rate, duration of response, and safety were secondary end points. RESULTS: In total, 299 and 305 patients were randomly assigned to receive Dato-DXd or docetaxel, respectively. The median PFS was 4.4 months (95% CI, 4.2 to 5.6) with Dato-DXd and 3.7 months (95% CI, 2.9 to 4.2) with docetaxel (hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]; P = .004). The median OS was 12.9 months (95% CI, 11.0 to 13.9) and 11.8 months (95% CI, 10.1 to 12.8), respectively (HR, 0.94 [95% CI, 0.78 to 1.14]; P = .530). In the prespecified nonsquamous histology subgroup, the median PFS was 5.5 versus 3.6 months (HR, 0.63 [95% CI, 0.51 to 0.79]) and the median OS was 14.6 versus 12.3 months (HR, 0.84 [95% CI, 0.68 to 1.05]). In the squamous histology subgroup, the median PFS was 2.8 versus 3.9 months (HR, 1.41 [95% CI, 0.95 to 2.08]) and the median OS was 7.6 versus 9.4 months (HR, 1.32 [95% CI, 0.91 to 1.92]). Grade ≥3 treatment-related adverse events occurred in 25.6% and 42.1% of patients, and any-grade adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8.8% and 4.1% of patients, in the Dato-DXd and docetaxel groups, respectively. CONCLUSION: Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology. OS showed a numerical benefit but did not reach statistical significance. No unexpected safety signals were observed.

How well are color components of samples of the Natural Color System estimated?

The aim of this study was to determine how accurately color-normal subjects that have received basic information about, but do not have practical experience with, the Natural Color System (NCS) can estimate the Heringian components of a representative selection of samples. Twenty-five color-normal subjects, taking part in two trials with at least a 24 h gap between assessments, selected four samples representing individual unique hues (uHs) from a set of 40 highly chromatic NCS samples on a rotatable tray. The samples selected for assessment of components were displayed to the subjects who estimated the hue components of 16 high-chroma samples, hue and white/black components of 16 tonal color samples, and three achromatic samples with different blackness values. Variability in selection of samples representing uHs as well as the relationship between the subjects' estimates of unique hue components and the defined values of the system was obtained. It was found that hues alone are easier to correctly estimate than hues together with white and black and that the components of colors of higher chroma are easier to estimate accurately than those of lower chroma. It was also found that, for R and G, the mean uH choices of subjects differed very little from the NCS's R and G, whereas selections for yellow and blue deviated, the former by 1.22 hue steps (slightly greener than G90Y), and the latter by 1.36 hue steps (represented approximately by R85B). This may impact the accuracy of color models that employ NCS unique hues.