Vial Size Research Articles

The Environmental Impact of Iodinated Contrast Media: Strategies for Optimized Use and Recycling.

Iodinated contrast media (ICM) is an integral and ubiquitous component of modern diagnostic imaging. Although most radiology practices are familiar with ICM administration and physiological excretion, they may be less aware of how much ICM is wasted on a per exam basis. Furthermore, radiologists may not recognize the environmental fate of discarded ICM waste. In an evolving world where medical practices are increasingly cognizant of their environmental footprint and radiology practices are considered high consumers of resources, it behooves the radiology community to understand the ICM lifecycle and ways to mitigate unnecessary waste. This review article explains the origin and environmental fate of discarded ICM, with special focus on wastewater contamination. Secondly, the article focuses on feasible options to both optimize use and decrease consumable waste. Specifically, the article addresses ICM vial size inventory diversification, multi-use ICM vials, syringeless contrast injectors, and the potential for using multi-energy imaging (dual-energy or photon counting CT) to accomplish these goals. Finally, the authors share their institutional experience participating in an ICM recycling program and its current departmental impact.

Study of the Excess Cost Associated with Drug Wastage Due to Limited Vial Size Options of the Intravenous Drugs for Anti-cancer Treatment, Among Patients Receiving Such Treatment at Tata Memorial Hospital

Aims and Objectives: To evaluate the drug wastage and additional costs (in INR) resulting from leftover or unused drugs due to limited vial strength options, and to propose vial size recommendations to pharmaceutical companies tailored to Indian requirements. Material and Methods: A total of 500 adult patients attending daycare oncology were prospectively evaluated. Mean, median, mode and left over or unused drug dose for each chemotherapy drugs were calculated. The economic loss estimation was done considering the unit cost for the drug. Result: The overall drug wastage for 500 prescriptions was 57,836 mg, accounting for 8.67% of the total prescribed dose. This resulted in an economic loss of 1,02,562 INR, which is 6.26% of the total cost. The highest proportions of drug wastage were observed for vincristine (28.72%), etoposide (23.20%), bleomycin (18.5%), pemetrexed (17.10%), nab-paclitaxel (16.37%), vinblastine (14.70%), Adriamycin (11.76%), and carboplatin (11.36%). The maximum economic loss was attributed to carboplatin (19.66%), nab-paclitaxel (17%), etoposide (14.5%), oxaliplatin (9.45%), and pemetrexed (7%). In combination chemotherapy regimens, gemcitabine-cisplatin-nab-paclitaxel (18.52%), pemetrexed-carboplatin (11.82%), and carboplatin-etoposide (8.97%) were responsible for the highest monetary losses due to drug wastage. Conclusion: Drug wastage due to oversized chemotherapy vials imposes significant financial and environmental burdens. We recommend offering additional vial size options for carboplatin, etoposide, gemcitabine, nab-paclitaxel, irinotecan, vincristine, and 5-FU. We hope this will reduce drug wastage to below 1-2%.

Reducing Wasteful Spending on Discarded Lecanemab in the US Medicare Program

This cross-sectional study examines the wastage observed with the use of weight-based dosing of lecanemab in treatment of Alzheimer disease and proposes alternative vial sizes to reduce wastage.

Minimizing Vaccine Wastage in Nigeria: A National Assessment of Vaccine Wastage Rates and Potential Determinants.

High vaccine wastage can serve as a critical barrier to achieving the gains of vaccination, especially in a country like Nigeria, where data on vaccine wastage are sparsely available. We determined the country-wide vaccine wastage rates and their determinants through a mixed-methods study conducted across 576 health facilities (primary and secondary) in 24 states in Nigeria. We collected facility-based immunization records from June 2018 to May 2019, in addition to healthcare workers' interviews and observations of fixed and outreach sessions. The results show that open-vial wastage ranged from 21.2% (95% CI: 20.2%, 22.2%) for the pentavalent vaccine to 72.6% (95% CI: 71.5%, 73.6%) for BCG. Open-vial wastage rates for BCG, measles, and yellow fever vaccines were higher during outreach sessions, with rates of 76.2%, 64.3%, and 65.2%, respectively. For the outreach and fixed sessions, PCV and Penta had the least wastages of 22.0% for fixed sessions and 20.4% for outreach sessions. This study identified vaccine presentation (liquid vs. lyophilized vaccines), vial size (4 dose vs. 5 dose vs. 10 dose vs. 20 dose), RI service delivery strategies (fixed vs. outreach sessions), number of children vaccinated, and human resources (healthcare workers position/cadre) as key determinants of vaccine wastages in Nigeria.

Reducing Cancer Drug Cost: 3-Year Analysis of Automated Dose Rounding in Electronic Health Records.

Globally, cancer drug expenditure exceeds $185 in US dollars (USD) billion, with the United States contributing $75 (USD) billion. Many cancer drug doses are calculated on the basis of body weight or body surface area, which often results in leftover drug in partially used single-dose vials (SDVs). The cost of wasted drug is a huge financial burden on the US health care system. We evaluated the cost savings resulting from the reduction of SDV wastage, achieved through the implementation of automated dose rounding rules in electronic health records (EHRs). Mayo Clinic implemented automated dose rounding rules within the EHR. These rules were designed to round calculated doses to the nearest SDV if the vial size closely matched the original calculated dose, within a 10% threshold. We assessed doses administered between January 2019 and December 2021, and computed cost-savings, waste reduction, and cost of waste for chemotherapy drugs. In 3 years, 36.1% of doses were rounded down, 35.8% were rounded up, and 28.1% were exact doses. By rounding doses down to a vial size, we achieved cost-savings of $39.75 (USD) million and prevented 62,065 SDV of cancer drugs from going to waste. By rounding doses up, we avoided wasting $9.95 (USD) million worth of drugs. However, there were still instances where the rounding fell outside of the 10%, resulting in wasted drugs worth $25 (USD) million. The substantial burden imposed on patients and the US health care system because of cancer drug wastage is of significant concern. Although the automated dose rounding system represents a partial solution for this issue, a comprehensive approach involves the imperative development of policy and legislative solutions to effectively mitigate the challenges associated with cancer drug waste.

Model-Informed Development of a Cost-Saving Dosing Regimen for Sacituzumab Govitecan.

The antibody-drug conjugate sacituzumab govitecan is approved for metastatic triple-negative breast cancer and has shown promising results in various other types of cancer. Its costs may limit patient access to this novel effective treatment modality. The purpose of this study was to develop an evidence-based rational dosing regimen that results in targeted drug exposure within the therapeutic range while minimizing financial toxicity, to improve treatment access. Exposure equivalent dosing strategies were developed based on pharmacokinetic modeling and simulation by using the published pharmacokinetic model developed by the license holder. The alternative dose was based on the principle of using complete vials to prevent spillage and on the established non-linear relationship between body weight and systemic exposure. Equivalent exposure compared to the approved dosing regimen of 10 mg/kg was aimed for. Equivalent exposure was conservatively defined as calculated geometric mean ratios within the 0.9-1.11 boundaries for area under the concentration-time curve (AUC), trough concentration (Ctrough) and maximum concentration (Cmax) of the alternative dosing regimen compared to the approved dosing regimen. Since different vial sizes are available for the European Union (EU) and United States (US) market, because body weight distributions differ between these populations, we performed our analysis for both scenarios. Dosing regimens of sacituzumab govitecan for the EU (<50 kg: 400 mg, 50-80 kg: 600 mg, and >80 kg: 800 mg) and US population (<40 kg: 360 mg, 40-65 kg: 540 mg, 65-90 kg: 720 mg, and >90 kg: 900 mg) were developed, based on weight bands. The geometric mean ratios for all pharmacokinetic outcomes were within the predefined equivalence boundaries, while the quantity of drug used was 21.5% and 19.0% lower for the EU and US scenarios, respectively. With the alternative dosing proposal, an approximately 20% reduction in drug expenses for sacituzumab govitecan can be realized while maintaining an equivalent and more evenly distributed exposure throughout the body weight range, without notable increases in pharmacokinetic variability.

Optimization of pediatric vaccines distribution network configuration under uncertainty

Millions of young people are not immunized in low income (LI) and lower middle income (LMI) countries because of low vaccine availability resulting from inefficiencies in cold supply chains. We create supply chain network design and distribution models to address the unique characteristics and challenges facing vaccine supply chains in LI and LMI countries. The models capture the uncertainties of demand for vaccinations and the resulting impacts on immunization, the unique challenges of vaccine administration (such as open vial wastage), the interactions between technological improvements of vaccines and immunizations, and the trade-offs between immunization coverage rates and available resources. The objective is to maximize both the percentage of fully immunized children and the vaccine availability in clinics. Our research examines how these two metrics are affected by three factors: number of tiers in the supply chain, vaccine vial size, and new vaccine technologies. We tested the model using Niger’s Expanded Program on Immunization, which is sponsored by the World Health Organization. We make many observations and recommendations to help LMI countries increase their immunization coverage.

Headspace Solid-Phase Micro-Extraction Method Optimization and Evaluation for the Volatile Compound Extraction of Bronchoalveolar Lung Lavage Fluid Samples

Headspace solid-phase micro-extraction (HS-SPME) is a prevalent technique in metabolomics and volatolomics research. However, the performance of HS-SPME can vary considerably depending on the sample matrix. As a result, fine-tuning the parameters for each specific sample matrix is crucial to maximize extraction efficacy. In this context, we conducted comprehensive HS-SPME optimization for bronchoalveolar lavage fluid (BALF) samples using two-dimensional gas chromatography with time-of-flight mass spectrometry (GC×GC-ToFMS). Our exploration spanned several HS-SPME parameters, including vial size, dilution factor, extraction time, extraction temperature, and ionic strength. The 10 mL vial size, no sample dilution, extraction time of 50 min, extraction temperature of 45 °C, and 40% salt were identified as the optimized parameters. The optimized method was then evaluated by a pair-wise comparison of ten sets of samples. The results revealed that the optimized method yielded an increase of 340% in total peak area and an increase of 80% in total peak number. Moreover, enhancements were observed across nine major chemical classes in both peak area and number. Notably, the optimized method also doubled the number of volatile compounds consistently detected across BALF samples, from 52 to 108.

Increasing optimal coagulation factor dosing in the paediatric emergency department: Update to a quality improvement study.

Prompt, appropriate coagulation factor replacement according to injury and bleeding severity in persons with haemophilia is required to prevent acute and long-term complications. Increase proportion of persons with haemophilia A (HA) and B (HB) treated appropriately for an acute injury and bleeding episode at a tertiary children's emergency department (ED) from 65% to 85% and sustain for one year. Secondary aim: increase time interval between patient ED encounters with out-of-range factor dosing. Utilizing quality improvement methodology and plan-do-study-analyze cycles, ED encounters for individuals with HA/HB receiving coagulation factor replacement for injuries were audited for in-range coagulation factor dosing. Goal factor dose defined as 50% correction for minor bleeds and 100% correction for major bleeds. Optimal dosing range defined as 90%-120% of the calculated goal dose to account for vial size variability. Interventions targeted communication via the EMR problem list and optimization of physician education. Our previous publication demonstrated 33.3% of ED encounters with out-of-range factor replacement. Following several interventions, the cumulative rate of encounters with out-of-range dosing decreased to 18%. Overall, there was an increase in the mean percent of encounters receiving optimal factor dosing for both HA/HB compared to baseline (82.2% vs. 71.1%), though this was not a statistically significant difference. Despite implementation of multiple interventions, out-of-range factor dosing continues to occur. Our team plans to reinstate simulation center education for ED staff and continue education efforts of pharmacists and hematology trainees with the goal of further reducing out-of-range dosing in our ED.

Patient Outcomes after Initial High Dose Versus Low Dose Romiplostim for Inpatient Management of Immune Thrombocytopenia

Introduction: Romiplostim is a thrombopoietin receptor agonist approved by the US FDA for chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The recommended dose is 1 mcg/kg/week subcutaneously, escalated weekly by increments of 1 mcg/kg to achieve and maintain a platelet count of 50 x 10 9 /L g ( Kuter et al 2021). It has been postulated that starting at the maximum recommended dose of 10 mcg/kg/week in patients with severe bleeding may swiftly increase platelets and minimize bleeding ( Roumier et al 2021). However, this approach may also increase the risk of major thrombotic events (TE). It is unclear if the more aggressive dosing strategy results in more rapid, robust responses and a tolerable safety profile compared to the FDA approved approach. Methods: This retrospective chart review included adult patients who initiated romiplostim while admitted for ITP at a Mayo Clinic Enterprise site from May 2018 to May 2022. Outcomes included rate of TE at 30 days and 90 days and time to first TE in patients receiving initial romiplostim doses of &amp;lt; 5 mcg/kg (low dose, LD) and &amp;gt; 5 mcg/kg (high dose, HD), median time to platelet response (defined as platelets &amp;gt; 30 x10 9/L and &amp;gt; 50 x10 9/L on 2 separate checks) in LD vs HD, and cost to the institution comparing LD to HD. Outcomes were summarized using descriptive statistics. Statistical analysis was done using BlueSky. Fischer's exact test and chi-squared were performed for categorical data, and Wilcoxon rank sum test were done for continuous variables. Results: Forty-five patients met eligibility criteria: 33 (73%) received initial romiplostim doses &amp;lt; 5 mcg/kg and 12 (27%) received doses &amp;gt; 5 mcg/kg. The majority of patients (43/45 (96%)) presented with platelets &amp;lt; 50 x 10 9/L. The median age was 65 years (68 in LD vs 57 HD). There were 24 (73%) males in the LD group vs five (42%) in the HD group. At baseline, 64% (n = 21) of LD patients and 75% (n = 9) of HD patients presented with bleeding. Major bleeding (defined by 2019 ASH ITP guidelines) was present in 21% (n= 7) vs 17% (n = 2) of patients, LD versus HD, respectively ( Neunert et al 2019). The overall incidence of TE in this study was 24% (n = 11): LD 5 (15%) and HD 6 (50%) (p = 0.044) at 90 days. Median days to TE was 21 days, 12 days in LD group (range 5-21) vs 24.5 days (range 14-58) in HD group (p = 0.067). TE included deep vein thrombosis (DVT, n = 6), DVT with pulmonary embolism (n = 1), portal vein thrombus (n = 1), multiple brain infarcts (n = 1), splenic vein thrombus (n = 1), and left atrial appendage thrombus (n = 1). The median platelet count at the time of TE was 304 x 10 9/L, 415 x 10 9/L (range 58-900) in the LD group vs 323 x 10 8/L (range 33-1427) in the HD group (p = 0.79). Thirty-two (71%) out of 45 patients had a response to romiplostim: 22 in the LD group (71%) vs 10 (83.3%) in the HD group (p = 0.698). Of the patients that responded, the median time to response was 6 days in the LD group vs 11.5 days in the HD group (p = 0.09) The median dose at time of initial response was 2 mcg/kg in the LD group and 6 mcg/kg in the HD group. Wholesale Acquisition Cost (WAC) was used to determine the cost per dose, rounded to the nearest vial size. The average WAC for the initial dose in LD patients was $1806.80 compared to $6061.79 in HD patients. Conclusion:There was a significantly increased incidence of thrombosis in patients admitted with ITP that received initial romiplostim doses &amp;gt; 5 mcg/kg, with no differences in the time to platelet response. Careful consideration of risks versus benefits should be given prior to initiating romiplostim at doses higher than recommended doses.

Quantifying Drug Wastage and Economic Loss of Chemotherapy Drugs at an Adult Oncology Care of a Tertiary Care Public Hospital in India.

Background and objective New drugs have revolutionized cancer care, but their high cost requires cost-effectiveness studies. However, these studies only consider optimal use, neglecting real-world wastage. We aim to assess chemotherapy drug wastage and financial loss in our adult oncology care. Methods A total of 100 adult patients attending daycare oncology were prospectively evaluated. The total dose of parenteral anticancer drug, the amount administered, and the amount of drug wasted were recorded for each patient. The economic loss estimation was done considering the unit cost for the drug. Results Our study evaluated 157 parenteral drug administrations of 10 different anticancer drugs in 100 enrolled patients. The most common diagnosis was breast cancer (39/100; 39%), and the most commonly prescribed drugs were paclitaxel (36/157; 23%) and cyclophosphamide (21/157; 13%). However, the wastage percentage varied from 6% to 35.06%, and the overall wastage estimated was 16,298 mg (20.06%) of the total drug procured. Notably, the highest proportion of drug wastage was observed for carboplatin (2,525/7200 mg; 35.06%), whereas oxaliplatin, gemcitabine, 5-FU, and cisplatin wastage were more than 20% of the ordered drug. The total cost of the chemotherapy drug procured was 7,26,005 INR (8,738.78 USD), and drug wastage amounted to 17.14% of the total drug cost, resulting in an economic loss of 1,24,485 INR (1,498.40 USD). Gemcitabine (542.86 USD), oxaliplatin (452.66 USD), and paclitaxel (286.15 USD) were responsible for the maximum cost of wastage. Conclusion Drug wastage and financial loss are significant for carboplatin, oxaliplatin, and gemcitabine, with small proportions of paclitaxel also contributing to economic loss. Possible solutions include planning pharmacy inventory for multiple vial sizes and drug-wise batching strategies to facilitate vial sharing. However, these approaches may present challenges. The pharmaceutical industry can consider initiatives such as providing varying packaging sizes to minimize drug wastage.

Dose Rounding and Cost Reduction of Anticancer Agents at King Fahad Medical City, Saudi Arabia: A 1-Year Feasibility Study

Introduction: The exponential increase in the price of anticancer drugs has warranted looking for a cost-saving measure to counter their price rise. We aim to study the impact of dose rounding of biological and anticancer agents within a range of 10% of the ordered dose. Method: The study involved patients treated with anticancer agents between January 2018 and December 2018 at King Fahad Medical City’s (KFMC) comprehensive cancer center. An anticancer medication database was created for data collection and processing. All the eligible orders were processed by hematology and oncology physicians. A performance improvement methodology was used. The dose rounding was based on the patient’s preprinted order and the nearest available vial size. The potential impact on cost was measured in Saudi Riyals (SAR). Descriptive statistics were applied for data analysis and interpretation of the results. Results: A total of 26 anticancer medications were used for treating cancer patients, and 208 prescriptions were found to be eligible for dose rounding. Brentuximab was among the drugs, showing the highest cost saving at an estimated 20,600 SAR. In addition to reducing wastage and cost of medications, 7 min were saved per preparation episode in the post-intervention period. Conclusion: Data reflected that dose rounding of chemotherapy and biological agents up to a limit of 10% is a feasible approach and could potentially save extra cost and wastage of medications in the comprehensive cancer center of KFMC.

PB0668 Emicizumab Treatment Regimen Based on Vial Size Along with Quantification of Emicizumab Plasma Concentration. Real-World Experience from a Single Pediatric Center in Argentina

PB0668 Emicizumab Treatment Regimen Based on Vial Size Along with Quantification of Emicizumab Plasma Concentration. Real-World Experience from a Single Pediatric Center in Argentina

Optimization of Iodinated Contrast Media Inventory Management: Effect of Inventory Diversification on Waste Reduction

PurposeIodinated contrast medium (ICM) is available in single- and multiuse vials of varying sizes, but CT departments often preferentially stock only a single or a limited number of vial sizes. The aims of this study were to assess actual ICM waste at a large safety-net hospital and to compare with estimated waste if single-use vials in a variety of vial sizes or multiuse vials were used. MethodsICM administrations were retrospectively reviewed for all CT examinations performed in 2021 in a department that stocked only 100-mL ICM vials. Administered ICM dose, opened ICM volume and number of vials, and wasted ICM were compared with hypothetical models using optimally sized single-use vials and multiuse vials. Contrast use was also compared by patient class. ResultsIn total, 40,393 ICM administrations over 49,670 CT examinations among 26,028 patients were reviewed, totaling 4,168,335 mL of contrast media. The mean dose was 103 mL, with mode of 100 mL. Exclusive use of 100-mL vials resulted in 1,006,165 mL waste (mean waste, 26 mL/administration). Optimally sized single-use vials resulted in 436,515 mL waste (mean waste, 11 mL/administration). Multiuse vials resulted in 537,074 mL waste (mean waste, 13 mL/administration). The distribution of optimal single-use vial size differed significantly by patient class (P < .001), with inpatient examinations more amenable to the use of smaller single-use vials. ConclusionsOptimizing ICM inventory can reduce contrast waste by 50% to 59%. Regular monitoring of contrast use may help optimize inventory selection across care settings. This retrospective review supports scrutiny of ICM inventory management to reduce waste, save costs, and mitigate the impacts of supply-chain disruptions.

Evaluation of potential cost savings through chemotherapy and biotherapy dose-rounding at a pediatric institution.

Rapidly increasing costs of medication acquisition can pose a challenge for health-system pharmacy budgets. The impact of dose-rounding in a pediatric oncology population has not previously been well documented and a retrospective review was undertaken to quantify the potential cost benefits. A retrospective chart review of patients with an oncologic diagnosis was performed for cytotoxic agents, asparaginase products, and biotherapy administered between January 1, 2014, and December 31, 2017. In the analysis, orders that could be rounded down to the nearest vial size by 5 or 10% were included. Medication pricing information was based on wholesale acquisition cost (WAC) and was provided by the Department of Pharmacy. Cost savings per medication were determined by multiplying the WAC of the medication by the number of vials saved. Over a 4-year span, 347 patients were evaluated and 552 out of a possible 3110 orders (17.7%) met criteria for a theoretical cost savings of approximately $1,126,000 (∼$3200 per patient). Rounding down doses by up to 5% resulted in a potential savings of about $529,000. When rounding was extended to 5-10% of the originally ordered dose, an additional $597,000 of approximate cost savings could have been realized. The medications with the largest impact on cost savings were rituximab, pegaspargase, and erwinia asparaginase. For pediatric oncology patients, there exists a unique potential cost savings opportunity if doses are rounded down within 5 or 10% of the originally ordered weight-based or body surface area-calculated dose.

Closed System Transfer Devices (CSTDs): Understanding Potential Over- and Under- Dosing of Liquid Vial Drug Products and How to Generally Mitigate

Closed system transfer devices (CSTDs) are a major challenge for drug manufacturers to assess and assure drug compatibility and acceptable dosing accuracy for a range of clinical administration strategies. In this article, we systematically investigate parameters affecting the loss of product during transfer by CSTDs from vials to infusion bags. We show that liquid volume loss increases with vial size, vial neck diameter, and solution viscosity - while dependent on stopper design. We further compared CSTDs’ performance with a traditional syringe transfer and learned that loss is larger for CSTDs than for syringe transfer. Based on experimental data, a statistical model was developed to predict drug loss upon transfer by CSTDs. The model predicted that, for single dose vials with USP<1151> conforming overfill, a complete extraction and transfer of the full dose can be assured for a broad range of CSTDs, product viscosities, and vial types (2R, 6R, 10R, 20R) if a flush (of syringe, syringe adaptor, bag spike) is performed. The model also predicted that complete transfer cannot be achieved for fill volumes ≤ 2.0 mL. For multi-dose vials and pooling of several vials, respectively, the effective dose transfer (i.e., ≥ 95%) for all CSTDs tested was predicted to be achieved if a minimum of 5.0 mL is transferred.

Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children: Research Letter.

Sugammadex Vial Wastage: Implications for the Cost of Anesthesia Care in Children: Research Letter.

Assessment of gestational age at antenatal care visits among Kenyan women to inform delivery of a maternal respiratory syncytial virus (RSV) vaccine in low- and middle-income countries.

Background: Maternal respiratory syncytial virus (RSV) vaccines that are likely to be implementable in low- and middle-income countries (LMICs) are in final stages of clinical trials. Data on the number of women presenting for antenatal care (ANC) per day and proportion attending within the proposed gestational window for vaccine delivery, is a prerequisite to guide development of vaccine vial size and inform vaccine uptake in this setting. Methods: We undertook administrative review and abstraction of ANC attendance records from 2019 registers of 24 selected health facilities, stratified by the level of care, from Kilifi, Siaya and Nairobi counties in Kenya. Additional data were obtained from Mother and Child Health (MCH) booklets of women in each of the Health and Demographic Surveillance System (HDSS) areas of Kilifi, Nairobi and Siaya. Data analysis involved descriptive summaries of the number (mean, median) and proportion of women attending ANC within the gestational window period of 28-32 weeks and 24-36 weeks. Results: A total of 62,153 ANC records were abstracted, 33,872 from Kilifi, 19,438 from Siaya and 8,943 from Nairobi Counties. The median (Interquartile range, IQR) number of women attending ANC per day at a gestational age window of 28-32 and 24-36 weeks, respectively, were: 4 (2-6) and 7 (4-12) in dispensaries, 5 (2-9) and 10 (4-19) in health centres and 6 (4-11) and 16 (10-26) in county referral hospitals. In the HDSS areas of Kilifi, Siaya and Nairobi, pregnant women attending at least one ANC visit, within a window of 28-32 weeks, were: 77% (360/470), 75% (590/791) and 67% (547/821), respectively. Conclusions: About 70% of pregnant women across three distinct geographical regions in Kenya, attend ANC within 28-32 weeks of gestation. A multidose vial size with about five doses per vial, approximates daily ANC attendance and would not incur possible wastage in similar settings.

The dosing conundrum of emicizumab: To waste product or not?

The dosing conundrum of emicizumab: To waste product or not?

The efficacy of the entire-vial dosing of emicizumab: Real-world evidence on plasma concentrations, bleeds, and drug waste

BackgroundProphylaxis with emicizumab provides effective bleeding protection in persons with hemophilia A (PwHA) but pressures healthcare budgets. The body weight–adjusted dosing at 7-, 14-, or 28-day intervals, according to the label, often mismatches the vial content. Entire-vial dosing resulted in therapeutic concentrations according to pharmacokinetic simulations and was introduced to avoid waste. ObjectivesThe objective of this study was to evaluate the efficacy of entire-vial dosing of emicizumab by investigating real-world evidence of plasma concentrations, bleeds, and drug waste. MethodsThis is a single-center, observational study with PwHA receiving emicizumab in mg/kg doses according to label but dosing interval extrapolated to the nearest vial size. Patient characteristics and bleeds were compared 1 year before starting emicizumab and during emicizumab until January 2022. Concentrations were assessed at weeks 4, 12, and annually. The mean (95% CI) annualized bleed rates were compared by using negative binomial regression. Drug waste between label-based dosing and entire-vial dosing was compared. ResultsA total of 112 individuals (94% severe phenotype and 9% positive FVIII inhibitors) were followed for a median of 56 weeks (interquartile range [IQR] 52-68) before and 51 weeks (IQR 29-75) after starting emicizumab. The median emicizumab dose was 5.9 (IQR 5.5-6.2) mg/kg/4 wk with median concentrations of 63 (IQR 51-80) μg/mL. The annualized bleed rate of treated bleeds before emicizumab was 3.6 (95% CI 2.9-4.4) and was 0.8 (95% CI 0.6-1.1) during emicizumab (P < .001). Drug waste was reduced by 9%. ConclusionThe entire-vial dosing of emicizumab is an attractive treatment option for PwHA leading to therapeutic plasma concentrations, good bleeding control, and drug waste avoidance.