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Background/Objectives: Population ageing has been a pressing global issue for decades. Older adults, especially those residing in long-term care facilities (LTCFs), often experience frailty and polypharmacy, which can lead to negative clinical outcomes. In Portugal, LTCFs provide essential care for individuals aged 65 or older, offering temporary or permanent accommodation. These facilities are not considered healthcare providers, and as a result, pharmaceutical services are not mandatory. This study aimed to evaluate medication management practices in Portuguese LTCFs, identify which professionals are responsible for managing medications, and identify potential gaps in safety and efficacy. Methods: A cross-sectional electronic questionnaire was sent by email to 2552 Portuguese LTCFs from the Portuguese "Carta Social" database. Data collection took place between 20 July and 2 August 2023, yielding a response rate of 15.4% (392 institutions). Results: Most LTCFs (94.39%) oversee their resident's medication, with 75.95% using the same pharmacy. Individualised medication packaging is used by 57.84% of facilities, and 97.84% provide medication reconciliation and review, mainly conducted by physicians and nurses. Medication is often stored in nursing offices (81.12%) but also in kitchens or dining rooms. Nurses are responsible for medication storage (87.50%) and preparation (81.89%), although non-nursing staff are also involved. In 63.27% of LTCFs, the same individual is responsible for both the preparation and verification of medication. Assistants are involved in both the checking (30.56%) and administering (45.66%) of medication. Conclusions: The results presented illustrate the current status of LTCFs in Portugal. Medication management presents a significant challenge, and it is notable that the role of the pharmacist in this process is not as prominent as it is in other countries. [ABSTRACT FROM AUTHOR]

The space environment is incredibly hostile, and humans are vulnerable in such conditions. Astronauts encounter various stress factors during a space journey, including radiation, microgravity, forceful acceleration during launch, altered magnetic fields, and confinement. These stressors significantly impact the human body homeostasis, leading to physio-pathological adaptations, loss of bone density, muscle atrophy, cardiovascular deconditioning, alterations in liver function, vestibular adaptations, and immune system dysregulation. These alterations can potentially influence drug pharmacokinetics and pharmacodynamics, affecting the efficacy and safety of medications administered to astronauts. Due to the limited number of studies on pharmaceuticals conducted in microgravity conditions, it's challenging to assess the effectiveness and stability of these medications during spaceflight. The objective of the present work is to compare the state-of-the-art knowledge on PK/PD changes and factors likely to affect them during spaceflight, with the subjective perception of the problem by a collection of separate interviews conducted with seven experts in the field. The interviewees were chosen as "experts," i.e., representatives in a specific discipline, who possess knowledge and experience in space pharmacology, physiology, or biology. Thus, our panel included astronauts, space surgeons, and scientists aiming to bridge the lack of experimental data in the literature. Each interview explores assorted aspects of space physiology and pharmacology, including drug use and storage onboard the ISS; notable consideration has arisen regarding the current research gaps and future space expeditions. All the interviews were held remotely using online conferencing software. None of the interviewees could provide a comprehensive overview regarding potential changes in drugs PK/PD in microgravity conditions. Further, any medication brought on board (whether as part of an astronaut's medical kit or stored in the ISS pharmacy) is destroyed, thereby suppressing the possibility of analyzing any degradation products resulting from long-term exposure to microgravity and radiation. According to these results, the use of drugs without understanding how they are genuinely absorbed, distributed, metabolized, and excreted in microgravity conditions is concerning, posing risks for drug effectiveness. Conducting genotyping and phenotyping on astronauts would be beneficial for developing personalized pharmacological countermeasures for each astronaut and anticipating expected drug metabolism changes during space missions. [ABSTRACT FROM AUTHOR]

This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors have filed conflict of interest statements with the American Academy of Pediatrics. Any conflicts have been resolved through a process approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication. Technical reports from the American Academy of Pediatrics benefit from expertise and resources of liaisons and internal (AAP) and external reviewers. However, technical reports from the American Academy of Pediatrics may not reflect the views of the liaisons or the organizations or government agencies that they represent. The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. All technical reports from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time. [ABSTRACT FROM AUTHOR]

Background: Effective medication management, disposal, and donation are vital for public health and environmental sustainability. Improper handling of medications can lead to drug misuse, accidental poisoning, and environmental damage. This study examines current practices and challenges in Saudi Arabia, identifying opportunities for improvement. Method: A cross-sectional survey conducted in October and November 2023 targeted the general population in Saudi Arabia. This study employed convenience sampling to explore medication usage, storage, disposal practices, and awareness of donation procedures. Data were analyzed through both descriptive and inferential statistical methods. Results: This study involved 430 respondents. Of these, 73.0% held a university degree, yet 66.3% were unaware of drug donation programs, and 84.2% lacked knowledge about proper medication disposal. Despite this, 71.4% believed that drug donation programs positively impact healthcare, and 87.9% saw them as reducing drug waste and environmental pollution. However, 48.1% expressed concerns about the potential misuse of donated medicines. Awareness and knowledge were significantly higher among participants aged 30 and above. Conclusions: The findings highlight the need for enhanced public awareness, clear medication disposal guidelines, and ethically governed donation practices in Saudi Arabia. These measures can improve healthcare outcomes, protect the environment, and support global health and sustainability goals. [ABSTRACT FROM AUTHOR]

Biomedical silk protein optics has become the subject of intensive research aimed at solving the challenges associated with traditional medical devices in terms of biocompatibility and performance balance. With its significant potential for biomedical applications in the field of drug storage and wound monitoring, it is dedicated to reducing the perturbation of neighbouring tissues. The transparency and biocompatibility of silk proteins make them ideal materials in the field of optical device fabrication, effectively overcoming the challenges posed by conventional materials. In this paper, we explore in detail the complex aspects of the design, synthesis and application related to biomedical silk protein optical devices and comprehensively analyse the potential use of silk protein-centric microstructures (e.g., micropillars, microneedles, and photonic crystals) in the development of optical devices. This review also offers insights into the challenges of applying silk protein optical devices in healthcare and their future trends, aiming to provide a comprehensive overview of the advances, potential impacts and emerging research directions in the field of biomedical silk protein optical devices. [ABSTRACT FROM AUTHOR]

Background and Objectives The collection and storage of platelets is associated with several challenges, to prevent the activation of platelets on the one hand and maintain their functional capacity during blood transfusion on the other hand. Today, one of the problems of platelet concentrate is the existence of platelet aggregations. The suspended particles in the platelet concentrate are believed to contain platelets that accumulate during the preparation and separation. The purpose of this study was to review important variables in the formation of platelet aggregations. Materials and Methods In this review article, 47 articles about aggregates in platelet products were studied from the PubMed database with platelet concentrate and platelet aggregate keywords. Results In the reviewed studies, the accumulation of platelets in the platelet concentrates prepared by the Platelet-rich plasma (PRP) method was higher than in the buffy coat and apheresis methods. Various factors such as storage temperature, time and temperature of platelet rest, pH, induced physical stimulation, type of platelet bag, presence of bacteria, and variables related to the donor were considered as factors involved in the formation of platelet aggregation. Conclusions It is necessary to know the important variables in the formation of platelet aggregations to improve the platelet product's quality and increase the platelet transfusion's effectiveness. Using the Buffy coat method, standardizing time and temperature, preventing bacterial contamination, and considering the variables related to the donor are some of the proposed solutions to reduce the possibility of platelet aggregation. [ABSTRACT FROM AUTHOR]

Preparing for the new school year is an exciting and busy time. An important task for parents and caregivers during the back-to-school season is to ensure that their child or adolescent is up to date with their vaccines. NPs play a vital role in guiding parents and caregivers through the vaccination process, thereby ensuring that school-aged children and adolescents' health requirements are met. This article provides NPs with resources to assist in making decisions about child and adolescent immunizations. It also explores effective communication strategies to convey the benefits of vaccination to parents and caregivers, equipping NPs with the necessary knowledge and tools to navigate vaccination complexities and advocate for the health and safety of school-aged children and adolescents. [ABSTRACT FROM AUTHOR]

Currently, blockchain-based solutions for drug traceability encounter challenges related to counterfeit drug prevention, user identity verification, and scalability. This paper presents BE-AC, an enhanced blockchain-based drug traceability solution. To bolster the authenticity and integrity of drug information, we innovatively upgraded the EdDSA (Edwards-curve Digital Signature Algorithm) digital signature algorithm. Our enhancement incorporates the more advanced and efficient BLAKE3 hash function, replacing the conventional SHA-512 (Secure Hash Algorithm 512-bit). By employing larger hash windows and secure, efficient hash iteration modes, we expedite the generation and verification of digital signatures for drug information, thereby enhancing the overall performance and security of the system. Additionally, we have devised a decentralized identity authentication scheme. Through on-chain stored identity information, all participants can mutually verify each other's identities, effectively preventing identity impersonation and fraudulent transactions. Furthermore, we have implemented smart contracts to record and store all transaction information on-chain during the drug distribution process, ensuring reliable and convenient drug transaction traceability. To address scalability and information security, we introduced a collaborative on-chain and off-chain drug information storage solution. Experimental results demonstrate a remarkable 78.65% improvement in signature verification efficiency compared to the original algorithm. The designed solution exhibits noteworthy enhancements in identity authentication, system throughput, and storage efficiency. [ABSTRACT FROM AUTHOR]

Purpose In high-acuity situations such as cardiac arrest, clinicians rely on prepared medications stocked in code carts to provide timely and accurate pharmacotherapy. We examined shortage trends for medications commonly used in code carts. Methods Drug shortage data from 2001 to 2022 were retrieved from the University of Utah Drug Information Service (UUDIS) to characterize shortages reported for commonly used code cart medications. Data extracted included the number of shortages, shortage duration, drug characteristics, and reason for the shortage. Results From 2001 to 2022, 71 drug shortages for code cart medications were reported. The number of new shortages peaked in 2010, and the number of total shortages peaked in 2010. At the end of the study period, 61 (84.7%) shortages had been resolved. For resolved shortages, the mean shortage duration was 18.2 months. The drug with the greatest number of reported shortages was dextrose (10 total), the drug with the longest resolved shortage was calcium chloride injection (116 months), and the drug with the longest active shortage was atropine injection (165 months at the end of the study period). Throughout the entire study period, only 2 suppliers provided commercially available prefilled syringes of dextrose for stocking on code carts. The most common reason for shortages, when reported, was manufacturing delays. Conclusion Medications commonly used in code carts were frequently impacted by drug shortages, which have the potential to impact patient care. Institutional protocols for mitigation and larger efforts to promote a more resilient drug supply chain are critical to ensure patient safety and quality care. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

The structure of enterosgel before and after freezing (samples I and II, respectively) was comparatively analyzed by gravimetric analysis and NMR methods [PMR, 13C NMR, diffusion-ordered NMR spectroscopy (DOSY)] to understand the reason for the negative effect of freezing on the adsorption capacity of enterosgel. The methylsiloxane moieties in samples I and II were shown to be magnetically equivalent by PMR and 13C NMR methods. The molecular masses of samples I and II were estimated by the DOSY method and corresponded to the cyclic dimer of methylsilicic acid (MM 152 Da) for sample I and the linear dimer of methylsilicic acid (MM 170 Da) for sample II. It was hypothesized that the conformationally rigid cyclic dimer structure was destroyed upon freezing of enterosgel due to rupture of a siloxane bond. The adsorption capacity of enterosgel deteriorated because of the structure disruption and hydrophobicity change. Thermogravimetric analysis revealed that water did not participate in hydrogen bonding with enterosgel. [ABSTRACT FROM AUTHOR]

Background: Flucytosine is an antifungal agent used in combination with other medicines for the treatment of fungal infections. It was available as intravenous (IV), oral tablet, and capsule formulations up until October 2021, when the IV product, Ancotil, was discontinued with no alternative brands available. Aim: This study aimed to formulate a suitable formulation with appropriate stability data for medium to long‐term nasogastric (NG) administration use. Method: Flucytosine 500 mg tablets (Ancotil) were crushed and suspended in (1) Ora‐Plus (OP) + Ora‐Sweet (OS) and (2) Ora‐Blend (OB) to produce 100 mg/mL suspensions (n = 3 for each suspending base) that were stored at 2–8°C in amber glass bottles until assayed. Appearance, odour and pH, and the concentrations of flucytosine in the suspensions were determined by high‐performance liquid chromatography on days 1, 8, and 15. A subjective assessment of the ease of suspension for NG administration via a size 10fr nasogastric tube (NGT) was also tested. Ethics approval was not required for this research article as it was a stability study and did not contain human participants or human data. Results: One of the three OB suspension bottles demonstrated significant suspension clumping resulting in all OB suspensions being excluded from further analysis. There was no change in appearance, odour or pH with the OP + OS based flucytosine suspensions and they extruded easily through a size 10fr NGT with minimal force. The three OP + OS bottles of flucytosine suspension were stable (>98% at all timepoints assessed) for 15 days at 2–8°C when stored in amber glass bottles. Conclusions: The OP + OS suspensions showed chemical stability for up to 15 days when stored under refrigerated conditions and protected from light, making this a suitable multidose enteral alternative to IV flucytosine. [ABSTRACT FROM AUTHOR]

In the last decade, the glucagon-like peptide-1 (GLP-1) receptor agonist (RA) drug class has revolutionized treatment for type 2 diabetes mellitus and some of its comorbidities, including obesity and cardiovascular disease. Continued advancements in the GLP-1 RA space show clinical promise for patients, though challenges--including barriers to care such as drug expense and availability--exist. This article provides an overview of available GLP-1 RAs and their mechanisms of action, indications, adverse reactions, and risks, providing practical pearls for providers along the way. [ABSTRACT FROM AUTHOR]

Purpose: Generic lorazepam oral solution is supplied in a 30 mL multi-dose bottle requiring protection from light and refrigeration, with a beyond use date of 90 days once the bottle is opened. The repackaging of 1 mL doses of lorazepam oral solution into oral syringes allows for facilitated dispensing, yet no available data supports repackaging and storing lorazepam oral solution in syringes. The validation and application of a stability-indicating high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method for the quantification of lorazepam allowed for the determination of the stability of lorazepam oral solution when stored in oral syringes. Methods: A stability-indicating HPLC-UV method was developed for the quantification of lorazepam in oral solution. The method was validated using guidance from USP < 1225 >. For the stability investigation, 2 mg/mL lorazepam oral solution was aliquoted into clear plastic oral syringes in 1 mLmilliliter doses from 2 multi-dose stock bottles and randomly allocated for storage in room temperature or refrigerated environment. Baseline lorazepam concentrations were measured on the day the study was initiated and designated as 100% initial concentration samples. Subsequent samples were analyzed in triplicate at time points of 24, 48, and 96 hours and 7, 10, 14, 21, 30, and 60 days. Results: The calibration curves on three non-consecutive days met the linearity criteria of R 2 > 0.99. Inter- day and intra-day precision and accuracy (percent relative standard deviation and percent error) were ≤2% over three days. During the stability investigation, percent initial concentration of lorazepam from room and refrigerated syringes remained above 90% for the duration of the study. Conclusion: The stability-indicating HPLC-UV method was successfully applied to the investigation of lorazepam oral solution stability when stored in syringes at room and refrigerated temperatures. The emergent need for use of lorazepam concentrate for inpatients and the restrictions of how the medication is supplied necessitated a need for the evaluation of repackaging into unit dose syringes for immediate availability from automated dispensing cabinets. Lorazepam oral solution stored in clear plastic syringes maintained greater than 90% initial concentration at both room and refrigerated temperatures for 60 days. [ABSTRACT FROM AUTHOR]

The oxidation of polyunsaturated fatty acids (PUFAs) reduces the nutritional value of fish oil supplements and poses health risks due to the formation of free radicals and oxidative compounds. Consequently, preventing or minimizing oxidation in these supplements is a critical concern in the production industry. Tuna eye (TE) oil, similar to other fish oils, is highly prone to oxidation, leading to the need for antioxidant enhancement. Carotenoprotein, rich in astaxanthin from shrimp shells, is a powerful natural antioxidant that can potentially stabilize PUFAs in TE oil, but the application to TE oil has not been previously explored. Therefore, this study aimed to evaluate the effect of shrimp shell-derived carotenoprotein on the quality and oxidative stability of TE oil during storage. The proximate composition of tuna eye and shrimp by-products was analyzed during the investigation process. Initial TE oil and TE oil with added carotenoprotein were assessed for free fatty acid content, acid value, peroxide value, p-anisidine value, total oxidation value, and heavy metal content. Carotenoprotein was evaluated for its color and antioxidant activity. The TE oil was combined with 0.4%, 0.6%, and 0.8% (v/v) concentrations of carotenoprotein and examined for stability using the Schaal oven test method at 40°C. The variations in these concentrations were systematically selected to determine potential concentration-dependent effects on TE oil oxidative stability. The results showed that on day 60 of TE oil storage at room temperature, oxidative degradation was significantly influenced by carotenoprotein concentration. Free fatty acids increased to 1.39%, while the values of acid, peroxide, anisidine, and total oxidation identified at the 0.4, 0.6, and 0.8% concentrations were 1.61, 1.50, and 1.24 mg KOH/kg, 18.87, 15.98, and 13.29 meq/kg, 10.80, 11.40, and 9.70 meq/kg, as well as 48.54, 43.36, and 36.28 meq/kg, respectively. Moreover, 0.8% carotenoprotein addition was found to effectively prevent TE oil deterioration compared to the control group. [ABSTRACT FROM AUTHOR]

Background: This alteration in the policy of COVID-19 resulted in widespread infections throughout China. Most people only need some antiviral drugs such as lopinavir/ritonavir or Chinese herbal preparations for treatment. In this context, the lack of drug knowledge and inadequate drug availability are evident. This study aims to explore the factors influencing drug use and demand during the COVID-19 epidemic. Methods: This study used quota sampling based on gender, age, and place of residence to perform a cross-sectional survey on a sample of 771 adults. The researchers used chi-square tests to understand differences in drug use and demand across characteristics, and binary logistic regression to analyse the influencing factors. Results: The study revealed that 85.9% of the participants used drugs following the COVID-19 infection. Participants with college and above, (OR=2.49, 95% CI=1.27– 4.88) annual personal income between 30,000 and 80,000CNY (OR=2.19, 95% CI=1.35– 3.55) and over 80,000CNY (OR=1.96, 95% CI=1.05– 3.66) were more knowledgeable about using drugs. Gender, (OR=0.69, 95% CI=0.50– 0.95) age, (OR=2.11, 95% CI=1.15– 3.88) residence, (OR=1.58, 95% CI=1.06– 2.37) chronic disease conditions (OR=0.46, 95% CI=0.27– 0.78) and infection symptoms (OR=0.60, 95% CI=0.38– 0.93) as factors influencing the need for drug delivery services. (P< 0.05). Conclusion: Research has revealed that a significant proportion of infected people in China chose drug treatment during COVID-19. Individuals with severe symptoms use more medication and require more drug delivery and storage. Low-education and low-income populations are lacking in drug knowledge, and older adults with underlying medical conditions are more likely to need drug delivery services. Therefore, governments should prioritize vulnerable groups when formulating drug policies and target drug literacy and guidance. In addition, it is recommended that a drug distribution system be set up within the community so that those in need can have quick and easy access to drugs. [ABSTRACT FROM AUTHOR]

The development of a successful oncology pharmacy system includes competency training, cost-efficient procurement, proper storage, preparation and administration of chemotherapy, and appropriate waste disposal. Low–middle-income countries such as Pakistan face several challenges within the realm of oncology pharmacy such as the unavailability of training programmes, resources and financial support, and inconsistencies in the safe handling of cytotoxic drugs. The Indus Hospital and Health Network (IHHN) is among the pioneers of oncology pharmacy practices in Pakistan, with a well-established Oncology Pharmacy Team and chemotherapy preparation in accordance with the United States Pharmacopeia 797 and 800 safety guidelines. The My Child Matters Grant was awarded by the Sanofi Espoir Foundation to the Department of Paediatric Hematology and Oncology at IHHN for holistic improvement in childhood cancer care through teaching, training and capacity building. Partnerships were formed with five public-sector paediatric oncology units nationwide. Initiatives were taken to improve oncology pharmacy practices including teaching and training courses, in-person assessment visits, and mentorship and liaison efforts. Despite prevailing challenges, promising improvements were noted at each centre. However, Pakistan needs to establish a national plan for childhood cancer with the creation of regional organisations for the training and monitoring of oncology pharmacists. Centralisation of pharmacy operations within hospitals is essential to maintain the availability, storage, preparation and administration standards of chemotherapy. [ABSTRACT FROM AUTHOR]

The article presents a study which determined the national prevalence of overlapping and compounding cognitive, physical, and sensory impairments that can impact medication management abilities, how these impairments vary across living sites, and whether one receives help with medication management. Topics discussed include factors that can impact a person's ability to manage medications, and common things among older adults who take prescription medications.

Long-lasting space missions as well as space tourism are technically possible today and economically in reach. It is a matter of time until the use of biopharmaceutical drug products in space will be common practice. Until drug product manufacturing in space is possible, the products need to be brought to space with rockets, which means that stable and light-weight products are preferred. Lyophilization is a promising approach to reduce weight during transportation and achieve storage stability at room temperature without cold-chain demands. This implies that recycled water in space needs to be used for reconstitution which poses a microbiological challenge and should be considered during formulation development. Furthermore, administration of the injectable drugs in space has an impact on the chosen packaging material which needs to be considered during drug product development. [ABSTRACT FROM AUTHOR]

The treatment of infectious and autoimmune diseases has experienced many changes in the past few years. Currently, cancer treatment is usually based on pathological and clinical methods. The most common cancer treatment is limited to chemotherapy, radiation therapy, and surgery, however, the treatment is still not optimal. Common problems in some diseases treatment, especially cancer, include non-specific and systematic distribution of medicinal agents, insufficient drug concentration at the operation site, intolerable toxicity, and drug resistance. The application and development of nanotechnology for cancer treatment have attracted a lot of attention in recent years. This technology provides a unique approach to cancer through early detection and cancer treatment. The design and development of new drug delivery systems not only increase the activity of the drug in the target tissue but also reduce the toxicity of the drug to a great extent and release it at the site of operation in a controlled manner. Niosomal vesicles contain non-ionic surfactants, which are non-toxic, biodegradable, stable, and cheap and can be utilized for targeted drug delivery. High purity, greater chemical stability, proper drug storage, various types of availability of non-ionic surfactants, and cheapness are the most important advantages of niosomes. [ABSTRACT FROM AUTHOR]

Objective Unsafe opioid-related practices can lead to abuse, diversion, and accidental overdoses. In this study, we aimed to describe the patterns and beliefs regarding the storage, disposal, and use of opioids among Chinese patients with cancer in their home settings, which remain unclear. Methods A multicenter cross-sectional survey was conducted in Hubei Province from October 2022 to June 2023. We collected information on the storage, disposal, and use of opioids among cancer pain inpatients in the oncology department. Logistic regression was used to estimate the factors associated with unsafe disposal and use of opioids. Results The survey included 221 patients with a median age of 62 years. Only 3.2% stored their opioids under lock and key, and 49.8% were unaware of proper disposal methods. Nearly one-fifth (19.5%) reported having received information on the safe storage (14.0%) and/or disposal (10.0%) of opioids. A total of 44.3% reported unsafe use by sharing (1.8%), losing (4.1%), or taking opioids at a higher dose than prescribed (42.5%). Patients who did not receive information on the safe disposal of opioids (OR = 4.57, P  = .0423), had a history of alcohol use (OR = 1.91, P  = .0399), and used opioids other than morphine (OR = 2.31, P  = .0461) had higher odds of unsafe disposal practices. Individuals with an associate degree/bachelor's degree or above were less likely to dispose of (OR = 0.36, P  = .0261) and use (OR = 0.31, P  = .0127) opioids unsafely. Conclusion A significant proportion of Chinese patients with cancer exhibit unsafe practices in the storage, disposal, and use of opioids. The study highlights an urgent need for implementing routine education programs and drug "take-back" initiatives to improve opioid-related practices. [ABSTRACT FROM AUTHOR]

MIL-100(Fe), one of the water-stable metal–organic frameworks, has potential applications in water purification, sensing, drug storage, and in vivo drug delivery. Molecular adsorption is an important process in these applications, thus necessitating further research to gain a more profound understanding of adsorption mechanisms. Potential explanations for this phenomenon have been proposed, including the formation of coordination bonds to the coordinatively unsaturated site (CUS) on Fe3+, electrostatic interactions with the CUS, or π–π interaction on the aryl group of a 1,3,5-benzenetricarboxylic acid (BTC), which is a constituent ligand of MIL-100(Fe). In this study, we investigated the adsorption behavior of 40 molecules on MIL-100(Fe) using MIL-100(Fe) as a stationary phase in liquid chromatography. The relationship between log k (k is a retention factor) and log Pow shows that, unlike the commonly used reversed-phase and normal-phase LC systems, there was a difference in the retention trend between "aromatics with polar groups" and "alkanols and hydrocarbons". Aromatics with polar groups were strongly retained on the MIL-100(Fe), suggesting that the interaction with CUS and the π–π interaction play a cooperative role. This study offers the first insights into the structural features of molecules affected by the cooperative effect. The findings suggest that MIL-100(Fe) may have the potential to act as a multimodal adsorbent, where the CUS could act as a polar hydrophilic site and the aryl-π electrons as a hydrophobic site simultaneously. [ABSTRACT FROM AUTHOR]

Introduction: Lebanon faces severe economic and energy crises, impacting its healthcare system, particularly vaccine storage. Traditional gas or kerosenepowered refrigerators often fail to maintain necessary temperatures for vaccine efficacy. This study explores transitioning to solar direct-drive (SDD) refrigerators to ensure reliable vaccine storage. Methods: A multi-phase methodology was employed, beginning with an inventory assessment of existing cold chain equipment. The implementation involved stepwise replacement of identified refrigerators across health facilities, including Primary Health Care Centers (PHCCs) and dispensaries. Feasibility, cost-effectiveness, and environmental impact were evaluated. Results: Findings indicate that solarization significantly reduces vaccine wastage, ensures stable temperatures, and cuts operational costs by decreasing dependence on non-renewable energy sources. Over 1,000 SDD units were installed across more than 800 health facilities. Additionally, PHCC solarization improved vaccine preservation and enhanced the resilience of health services overall. Discussion: The solarization initiative demonstrates the critical role of renewable energy in strengthening healthcare infrastructure, especially in crisis-hit regions. Solar-powered systems provide a reliable and sustainable solution for vaccine storage, reduce carbon footprints, and build public trust in the immunization system. Challenges included geographical and structural limitations, which were addressed through comprehensive planning and collaboration with local stakeholders. Solarization of Lebanon's vaccine cold chain and PHCCs marks a significant step towards sustainable and resilient healthcare infrastructure. The model offers a robust framework for other regions facing similar economic and energy challenges, highlighting the importance of renewable energy solutions in healthcare. [ABSTRACT FROM AUTHOR]

Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

Background: Antibiotic-laden calcium sulfate beads are gaining popularity in the treatment of orthopaedic infections such as fracture-related infection and osteomyelitis. Calcium sulfate beads have several advantages over polymethylmethacrylate (PMMA) beads as they are bioabsorbable, have demonstrated improved elution characteristics, and have lower peak polymerization temperatures than seen in PMMA. The ability to make and store antibiotic beads for later use has the potential to standardize dosing and decrease operating room times and healthcare costs. This study aims to determine the antibiotic efficacy of premade, antibiotic-laden calcium sulfate beads. Methods: Calcium sulfate beads containing vancomycin or tobramycin were molded to 4.8 mm in diameter and stored for shelf-life durations of three and six months at 20 °C. A subset of beads was tested immediately after creation. At the designated time points, beads were placed into a buffer solution and incubated at 37 °C with agitation. Antibiotic eluent was collected at 1-hour, 4-hour, 24-hour, and 48-hour timepoints. Eluent concentrations were inferred from a prior study implementing the same calcium sulfate bead model. Eluent was used in microbroth dilution assays to determine its minimum inhibitory concentration (MIC) against methicillin-sensitive Staphylococcus aureus. Results: MIC assays for tobramycin and vancomycin against S. aureus yielded concentrations consistent with previously reported ranges. MIC results across different bead shelf lives also remained consistent without an increase in MIC with increasing shelf life for either antibiotic. Conclusions: Shelf life up to six months does not impact the efficacy of tobramycin or vancomycin eluent from calcium sulfate beads in vitro compared to beads made and tested immediately. These results provide preliminary evidence that tobramycin and vancomycin retain their antimicrobial activity in calcium sulfate beads for at least six months stored at room temperature. Additional studies on sterilization techniques are necessary prior to considering use of prefabricated antibiotic-loaded calcium sulfate beads in clinical practice. [ABSTRACT FROM AUTHOR]

Errors in giving first rank drugs in the pharmaceutical field, especially high alert drugs that must be made a top priority. The purpose of this study was to describe the management of high alert drug storage at the Pharmacy Installation at UNS Surakarta Hospital. This research is a descriptive study with a cross sectional approach. Data collection techniques were carried out by direct observation using checklist sheets and interviews with pharmacists based on pharmaceutical service standards in hospitals. The analyzed data is described in the form of words. The results showed that the value of 100% high alert drug list was in the appropriate category, the high alert drug management policy was 85.7% (inappropriate category), stock card recording at the emergency room depot, outpatient and inpatient care was 85.7% and in warehouse 71.4% (inappropriate category). Labeling of high alert drugs in warehouses, emergency department depots, and 80% inpatient and 60% outpatient (categories not suitable). The layout of high alert drug storage is not suitable because inpatient care shows 80% (inappropriate category) and in warehouses, emergency rooms, and outpatient care 100% (appropriate category). Storage temperature and storage system show 100% (appropriate category). Based on the results of the study it can be concluded that the management of high alert drug storage at the Pharmacy Installation at UNS Surakarta Hospital does not meet the standards of pharmaceutical

Nanosized zeolitic imidazolate frameworks (nZIFs) are being researched as 5‐fluorouracil (5‐FU) carriers for the treatment of cancer. The surface functionalization of ZIFs with periodic mesoporous organosilicas (PMOs) is expected to enhance stability and prevent the flocculation of nZIFs. In this study, ZIF‐7 nanomaterials and fluorescent organosilicas (FITC−APTES) were effectively introduced into PMO nanoparticles, and the resulting product was named ZIF‐7@PMO. The surface functionalization with the PMO nanoparticles enhanced the chemical stability of ZIF‐7 nanoparticles in ethanol. The study examined the impact of temperature on the synthesis of ZIF‐7@PMO and found that low temperatures were more conducive to the encapsulation of ZIF‐7 nanoparticles and fluorescent organosilica, as well as pore size retention. Moreover, the drug storage capacity of the ZIF‐7@PMO nanoparticles was evaluated via their loading and release of 5‐FU. The results revealed that the ZIF‐7@PMO nanoparticles could adsorb 5‐FU with a loading capacity of 100–140 mg g−1 for 24 h. ZIF‐7@PMO released half of 5‐FU amount within 8 h before releasing a maximum of 75 % within 3 days. Therefore, the fluorescent ZIF‐7@PMO nanoparticles could be a potential drug carrier in the field of controlled drug delivery. [ABSTRACT FROM AUTHOR]

Background: Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) hold great therapeutic potential in regenerative medicine. Therefore, it is crucial to establish a Good Manufacturing Practice (GMP)-compliant methodology for the isolation and culture of WJ-MSCs. Through comprehensive research, encompassing laboratory-scale experiments to pilot-scale studies, we aimed to develop standardized protocols ensuring the high yield and quality of WJ-MSCs manufacturing. Methods: Firstly, optimization of parameters for the enzymatic digestion method used to isolate WJ-MSCs was conducted. These parameters included enzyme concentrations, digestion times, seeding densities, and culture media. Additionally, a comparative analysis between the explant method and the enzymatic digestion method was performed. Subsequently, the consecutive passaging of WJ-MSCs, specifically up to passage 9, was evaluated using the optimized method. Finally, manufacturing processes were developed and scaled up, starting from laboratory-scale flask-based production and progressing to pilot-scale cell factory-based production. Furthermore, a stability study was carried out to assess the storage and use of drug products (DPs). Results: The optimal parameters for the enzymatic digestion method were a concentration of 0.4 PZ U/mL Collagenase NB6 and a digestion time of 3 h, resulting in a higher yield of P0 WJ-MSCs. In addition, a positive correlation between the weight of umbilical cord tissue and the quantities of P0 WJ-MSCs has been observed. Evaluation of different concentrations of human platelet lysate revealed that 2% and 5% concentrations resulted in similar levels of cell expansion. Comparative analysis revealed that the enzymatic digestion method exhibited faster outgrowth of WJ-MSCs compared to the explant method during the initial passage. Passages 2 to 5 exhibited higher viability and proliferation ability throughout consecutive passaging. Moreover, scalable manufacturing processes from the laboratory scale to the pilot scale were successfully developed, ensuring the production of high-quality WJ-MSCs. Multiple freeze-thaw cycles of the DPs led to reduced cell viability and viable cell concentration. Subsequent thawing and dilution of the DPs resulted in a significant decrease in both metrics, especially when stored at 20–27 °C. Conclusion: This study offers valuable insights into optimizing the isolation and culture of WJ-MSCs. Our scalable manufacturing processes facilitate the large-scale production of high-quality WJ-MSCs. These findings contribute to the advancement of WJ-MSCs-based therapies in regenerative medicine. [ABSTRACT FROM AUTHOR]

Colchicine has an important role in managing various conditions, including gout, familial Mediterranean fever, amyloidosis, Behçet's syndrome, recurrent pericarditis and calcium pyrophosphate deposition disease. The adverse effect profile of colchicine is well understood. However, due to its narrow therapeutic index, colchicine has been associated with overdose and fatalities. When ingested in toxic amounts, the mainstay of management is supportive care. Strategies to minimize the risk of colchicine poisoning can focus on three broad causes: unauthorized access, intentional overdose and inappropriate dosing. Culturally safe and appropriate education about storage and appropriate use of colchicine is essential to minimize the risk of overdose. [ABSTRACT FROM AUTHOR]

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to evaluate the stability of angiotensin II in 0.9% sodium chloride for up to 5 days. Methods: We prepared angiotensin II dilutions, by aseptically diluting 2.5 mg (1 mL) in 249 mL 0.9% sodium chloride creating a solution of 10 000 ng/mL. Admixtures were stored under refrigeration (5 ± 3°C). Stability of the dilution was assessed by: preservation of clarity, consistency of pH, and retention of concentration. Solutions were sampled at times 0, 24, 48, 72, 96, 120 hours. Solutions were analyzed via High-Performance Liquid Chromatography (HPLC-UV) and Liquid Chromatography Mass Spectrometry (LC-MS/MS). Retention of concentration was set a priori at > 90% of initial concentration. Results: Clarity, color, and pH at all sample time points remained constant. Both methods of analysis confirmed similar results. When stored under refrigeration, the concentration of angiotensin II solution remained above 90% of initial concentration throughout the entire sampling period. Conclusions: Angiotensin II in 0.9% sodium chloride stored in infusion bags under refrigeration (5 ± 3°C) maintained at least 90% of their original concentrations for up to 5 days. Stability was also demonstrated based on turbidity, color, and pH assessment. [ABSTRACT FROM AUTHOR]

Arazá is an Amazonian fruit rich in carotenoids such as lutein, which has several biological properties. This paper evaluates the storage stability of lutein in microencapsulated arazá pulp by spray drying with maltodextrin as wall material. The physicochemical properties of the pulp and microencapsulation, encapsulation efficiency, percentage yield, thermal stability (DTG and TGA), morphology, particle size, storage stability and lutein degradation kinetic were evaluated. The results were low Aw (0.33), good yield (64.22%), spherical and smooth particles, the lutein degradation kinetic with a degradation constant of 1.49 x 10-4 days-1, which is thirty- five times lower than that obtained for the freeze-dried arazá pulp used as control. In conclusion, it was possible to obtain stable microencapsulates, being a promising alternative for the preservation of this perishable fruit. [ABSTRACT FROM AUTHOR]

Knowledge about insulin pen storage significantly and directly affects treatment efficacy and quality for people with type 2 diabetes mellitus. Accurate and complete understanding and practice are vital for properly managing this chronic condition. However, studies on insulin pen use and storage have not been well-researched in Vietnam. This descriptive cross-sectional study aimed to assess the knowledge of people with type 2 diabetes regarding insulin pen use and storage. Data were collected through convenience sampling from 132 people with diabetes at a provincial hospital in Vietnam from September 2022 to May 2023. We developed the Vietnamese Insulin Pen Storage Knowledge Questionnaire (VIPSKQ) based on guidelines, Addendum 1: Forum for Injection Technique and Therapy Expert Recommendations, India 2021. Data were analyzed using descriptive statistics, the Chi-square test, and binary logistic regression. Results indicated that only 35.6% of participants had good knowledge of insulin pen storage, whereas 64.4% did not. Four factors that affected the participants' understanding of insulin-pen storage were age, education level, duration of diagnosis, and years of treatment for diabetes mellitus. Nurses need to educate people with diabetes to increase their knowledge and skills of insulin pen use and proper storage using various strategies, such as using videos, phone applications, and monitoring their practice regularly. Nurses must also keep abreast of the latest information on insulin treatment modalities and pen storage guidelines. Our questionnaire shows promise for use in practice but needs further testing in different settings with larger groups of individuals with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background: The availability of various facilities that aid in providing expected services is necessary for the practice of pharmacy, which aims to make the best use of medications and other healthcare products and services. Therefore, the aim of this study was to assess the availability of dispensing and storage facilities at public and community pharmacies in Bahir Dar and Gondar towns. Methods: In Gondar and Bahir Dar towns' public and private pharmacies, a facility-based cross-sectional study was conducted from July 2023 to September 2023. All pharmacy areas that were open during data collection were included in the study. The frequency and percentage were calculated using descriptive statistics. Results: From 239 pharmacies, 208 (87.0%) of them were open during data collection, and they are included in the study. The water supply and dispensing counter were available in the dispensing area in 79.3% and 60.1% of instances, respectively. They also had adequate room for storage (92.8%), dispensing (92.8%), and receiving (95.7%) of medicines. Additionally, about 98.1% of the facilities had shaded, ventilated, and dry areas. A therapeutic order was the most often used method (59.6%) for medication organization. Merely 1.9% of participants did not employ a strategy to arrange their medications. A refrigerator (88.0%), a refrigerator thermometer (91.3%), a spoon or spatula (81.3%), a separate storage facility (74.5%), a cold room (68.8%), a lockable cabinet (90.9%), a tablet counter (69.2%), and a fire extinguisher (safety device) (88%) were among the various storage equipment the majority of the pharmacies in the survey had. Nonetheless, air conditioning was absent from the majority (53.4%) of pharmacy facilities. Conclusion: Few pharmacies need to make improvements to their facilities in order to encourage convenient drug storage and dispensing practices, even though the majority of the pharmacies surveyed had all the necessary equipment and infrastructure. In addition to initiating the pharmacies to provide good practices of dispensing and storage, facility-focused initiation and regulation should be obtained to ensure full availability of the facilities. [ABSTRACT FROM AUTHOR]

SER-109 (VOWST™; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following standard of care (SOC) antibacterial treatment for recurrent CDI. It is a purified bacterial spore suspension sourced from healthy donors. As the first oral faecal microbiota product approved for prevention of recurrent CDI, SER-109 is administered as four capsules once daily for three consecutive days. In a well-designed, placebo-controlled, phase III trial (ECOSPOR III), SER-109 significantly reduced the risk of recurrent CDI at 8 weeks post-treatment, with a durable response seen at 6 months post-treatment. Treatment with SER-109 was also associated with rapid and steady improvement in health-related quality of life compared with placebo. SER-109 was generally well tolerated, with a safety profile similar to that of placebo. The most common adverse events were of mild to moderate severity and generally gastrointestinal in nature. Thus, with the convenience of oral administration and lack of necessity for cold storage, SER-109 is a valuable option for preventing further CDI recurrence in adults following antibacterial treatment for recurrent CDI. Plain Language Summary: Clostridioides difficile is a type of bacteria that can produce toxins leading to infection of the large intestine. Symptoms of C. difficile infection (CDI) range from mild diarrhoea to severe life-threatening sepsis. Treatment is usually antibiotics to kill the toxin-producing bacteria and resolve symptoms. However, antibiotics can disrupt the gut microbiota and leave individuals at risk of CDI recurrence. SER-109 (VOWST™; fecal microbiota spores, live-brpk) is a microbiome therapy containing purified live bacterial spores extracted from donated human faecal matter intended to repair the microbiome. It is given as four oral capsules per day over three consecutive days to prevent the recurrence of CDI in adults following standard antibiotic treatment. In a phase III clinical trial, patients with recurrent CDI who received SER-109 had a significantly lower rate of CDI recurrence at 8 weeks than those who received placebo, and this response was sustained through 6 months. SER-109 was generally well tolerated, and most adverse events were mild or moderate in severity. With the convenience of oral administration and no refrigeration requirements, SER-109 is a valuable option for preventing further CDI recurrence in adults who have received antibiotics for recurrent CDI. [ABSTRACT FROM AUTHOR]

A bottom-up approach was investigated to produce long-acting injectable (LAI) suspension-based formulations to overcome specific limitations of top-down manufacturing methods by tailoring drug characteristics while making the methods more sustainable and cost-efficient. A Secoya microfluidic crystallization technology-based continuous liquid antisolvent crystallization (SCT-CLASC) process was optimized and afterward compared to an earlier developed microchannel reactor-based continuous liquid antisolvent crystallization (MCR-CLASC) setup, using itraconazole (ITZ) as the model drug. After operating parameter optimization and downstream processing (i.e., concentrating the suspensions), stable microsuspensions were generated with a final solid loading of 300 mg ITZ/g suspension. The optimized post-precipitation feed suspension consisted of 40 mg ITZ/g suspension with a drug-to-excipient ratio of 53:1. Compared to the MCR-CLASC setup, where the post-precipitation feed suspensions contained 10 mg ITZ/g suspension and had a drug-to-excipient ratio of 2:1, a higher drug concentration and lower excipient use were successfully achieved to produce LAI microsuspensions using the SCT-CLASC setup. To ensure stability during drug crystallization and storage, the suspensions' quality was monitored for particle size distribution (PSD), solid-state form, and particle morphology. The PSD of the ITZ crystals in suspension was maintained within the target range of 1–10 µm, while the crystals displayed an elongated plate-shaped morphology and the solid state was confirmed to be form I, which is the most thermodynamically stable form of ITZ. In conclusion, this work lays the foundation for the SCT-CLASC process as an energy-efficient, robust, and reproducible bottom-up approach for the manufacture of LAI microsuspensions using ITZ at an industrial scale. [ABSTRACT FROM AUTHOR]

Background: Clofazimine is recommended as a treatment for tuberculosis in infants. Extemporaneously prepared clofazimine oral suspensions are more appropriate dosage forms for infants than tablets, however no data exist to inform appropriate storage conditions. Aim: To examine the physical and chemical stability of extemporaneously prepared clofazimine oral suspensions and determine appropriate storage conditions. Method: An oral suspension of clofazimine 10 mg/mL was prepared by grinding six 100 mg clofazimine tablets to produce a fine powder. Ora‐Blend SF (sugar free) was added to make a final volume of 60 mL. Six 10 mL aliquots were placed in amber plastic bottles with plastic bottle caps. Three bottles were stored at room temperature, and three bottles were refrigerated at 4°C. Following shaking, a 1 mL sample was taken from each bottle on days 0, 7, 14, 28, and 60. Samples were assayed using the high‐performance liquid chromatography method. The samples were visually examined for colour change and separation at each time point. Stability was defined as the retention of at least 90% of the initial concentration. Ethics approval was not required for this research article as it was a stability study that did not involve human subjects. Results: The clofazimine content remained >94% of the initial concentration throughout the 60‐day period for samples that were kept at room temperature, and slightly <90% (87.4%) for samples that were kept refrigerated at 4°C. No separation or colour change was noted throughout the 60‐day period for both preparations. Conclusion: Extemporaneously prepared suspensions of clofazimine in Ora‐Blend SF were chemically stable for at least 60 days when stored at room temperature. Clofazimine degraded slightly more rapidly at 4°C compared to room temperature. [ABSTRACT FROM AUTHOR]

Purpose: To describe the development of a comprehensive framework of safeguarding strategies to address observed/anticipated errors with organizational high-alert medications. Methods: Observed/anticipated errors were identified for organizational high-alert medications and medication classes based on a review of external literature and alerts as well as internal voluntary error reporting. Anticipated or frequently reported errors were categorized into common cause error types. Error reduction strategies to address each common cause error were identified in collaboration with medication safety specialists and specialty practice pharmacists. Results: The review of externally and internally reported errors identified 101 observed/anticipated common cause errors across the 19 high-alert medication classes (median 5 error types per medication class, interquartile range 3-6). Safeguarding strategies specific to high-alert medications were identified in the following domains: separate or sequestered storage; restricted ordering; active alerts; dispensing in patient-specific dosing, unit of use, or unit-dose packaging; dispensing from pharmacy only; auxiliary labeling; level of care restriction; required monitoring; independent double checks; certification/privileging of staff; specific guidelines for use/monitoring; and other/miscellaneous. Identification of the observed/anticipated errors and the associated safeguarding strategies facilitated the development of a comprehensive tool and visual framework for addressing common cause errors associated with organizational high-alert medications. Conclusion: A comprehensive framework of safeguarding strategies to address anticipated errors with organizational high-alert medications is proposed. Although individual safeguards are institution-specific, the framework can be leveraged by all hospitals in order to take inventory of error-reduction strategies and prospectively identify gaps to address common cause errors. [ABSTRACT FROM AUTHOR]

The stability tests of an active compound or pharmaceutical product provide information about the degradation of the active compound or the deterioration of the pharmaceutical product, which may occur due to various storage conditions—such as high temperature, light and humidity—to which these products may be exposed. The study aimed to investigate the stability of azithromycin in a reconstituted oral suspension under various in-home storage conditions over 10 days. Azithromycin oral suspension was reconstituted by boiled tap water (200 mg/5 ml) and stored under various in-home storage conditions (exposure to sunlight, refrigerated (4°C), stored at room (20°C) and higher temperatures (30°C, 40°C and 50°C). Azithromycin concentrations in the samples of the suspension were analysed daily for 10 days using an HPLC method. The results revealed that the reconstituted azithromycin stored under various in-home storage conditions is stable for 10 days. The active molecule of azithromycin showed good stability after reconstitution with boiled tap water. However, it is necessary to carry out further studies in which the reconstituted oral suspension will be evaluated in terms of the physicochemical and aesthetic appeal (odour, taste, colour and texture) properties of the formulation. [ABSTRACT FROM AUTHOR]

Context: Much of the existing work on the political economy of vaccine access has focused on how intellectual property rights agreements contribute to inequitable COVID-19 vaccine access between high-income and low- and middle-income countries (LMICs). The two solutions that emerged to scale up access in LMICs involved either voluntary arrangements under COVAX or a waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) to allow immediate access to intellectual property. However, an additional constraint on access is weak and ineffective supply chains within LMICs that have eroded over several decades of health-sector reform. Methods: This article reviews the literature on the political economy of supply chain strengthening in LMICs and identifies key challenges to equitable access to emergent vaccines and other medicines emanating from market and state failures in internal supply chains. Findings: Over the past century, supply chain policies in LMICs have alternated among an emphasis on addressing market failures contributing to unaffordability of vaccines/medicines, an emphasis on state failures contributing to unavailability of vaccines/medicines, and a more recent move toward public-private hybrid arrangements to strengthen supply chains. Conclusions: In addition to reshoring production capacity through a TRIPs waiver, the international community must address chronic weakness in internal supply chains in LMICs to ensure access to novel vaccines/medicines. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to determine the stability of cetuximab: (1) under "in-use" conditions after dilution to 1 mg/mL in 0.9% sodium chloride in polyolefin bags and (2) as an undiluted solution (5 mg/mL) repackaged in polypropylene bags or kept in the vial after opening. Methods: Ready-to-use 500 mg/100 mL vials of cetuximab solution were diluted to 1 mg/mL in 100 mL bags of 0.9% sodium chloride or repackaged as a 5 mg/mL solution into empty 100 mL bags. Bags and vials were stored at 4°C for 90 days and 25°C for 3 days. A syringe sample of 7 mL was taken from each bag for the initial determinations. The sampled bags were weighed to determine their initial weight and placed under the planned storage conditions. The physicochemical stability of cetuximab was estimated using validated methods. Results: No changes in turbidity, no protein loss, and no changes in cetuximab tertiary structure were observed after 30 days of storage or when subjected to a temperature excursion of 3 days at 25°C and when stored at 4°C for up to 90 days, regardless of the concentrations and batches. The colligative parameters did not change under any of the tested conditions. No evidence of microbial growth was found in bags after 90 days of storage at 4°C. Conclusion: These results support the extended in-use shelf-life of cetuximab vials and bags, which can be cost-effective for healthcare providers. [ABSTRACT FROM AUTHOR]

Our lab demonstrated that intratumoral Cowpea mosaic virus (CPMV) is a potent antitumor immunotherapy when used as in situ vaccine. As we pave the way for human clinical translation, formulation chemistry needs to be optimized for long‐term storage of the drug candidate. In this work, CPMV was nanoengineered with Pluronic F127 to realize liquid and gel formulations which mitigate structural changes and RNA release during long‐term storage. We evaluated the CPMV‐F127 formulations for their stability and biological activity through a combination of in vitro assays and efficacy in vivo using a B16F10 murine melanoma model. Results demonstrate that both F127 liquid and gel formulations preserve CPMV structure and function following extended periods of thermal incubation at 4°C, 25°C, and 37°C. Heat‐incubated CPMV without formulation resulted in structural changes and inferior in vivo efficacy. In stark contrast, in vivo efficacy was preserved when CPMV was formulated and protected with the F127 "nanoarmor." [ABSTRACT FROM AUTHOR]

Background: The guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which was established in 1990 to streamline and standardize drug-approval review standards across Japan, the United States, and Europe. The ICH guidelines were established approximately 30 years ago, and, since then, temperatures have risen owing to global warming. Therefore, I verified whether the ICH guidelines correspond to the latest climate by using the Arrhenius equation, which is the basis for the ICH guidelines. Methods: This study used an excerpt of the test conditions described in the ICH guidelines to calculate the mean kinetic temperature (MKT) for major Japanese cities based on temperature data from 1991 to 2020 (measured by the Japan Meteorological Agency). Results: The study confirmed that the temperature conditions prescribed by the ICH guidelines for long-term storage tests were satisfied (see Fig. 1). Additionally, as drugs can be exposed to temperatures outside the specified range during distribution from the manufacturer to the final customer, data logs/loggers were utilized to calculate the MKT using the temperature history during transportation and storage. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy doses are usually prescribed on the basis of body surface area but dose banding is emerging as an efficient alternative. Dose banding presents the possibility of in-advance preparation in a Centralized Intravenous Admixture Service. Aim of the study: To evaluate the long-term stability of 5-fluorouracil at banded doses (700 mg and 800 mg) in polyolefin bags. Materials and methods: Ten polyolefin bags were prepared under aseptic conditions and stored at 23 ± 2°C for 24 days. Five of them were composed of 14 mL 5-fluorocuracil (700 g) in 100 mL 0.9% sodium chloride solution and the five other of 16 mL 5-fluorouracil (800 mg) in 100 mL 0.9% sodium chloride solution. At defined times, physical stability parameters were assessed: optical densities, pH measurements, visual and microscopical inspections. Solutions concentrations were measured using high-performance liquid chromatography coupled with a photodiode array detector. Results: No change was observed on pH and optical density measurements during the study period. Visual and microscopical inspections remained free of colour change, precipitate, microagregate or crystal. The concentrations of 5-Fluorouracil in 800 mg bags remained stable for 24 days while the concentration in 700 mg bags showed a stability of at least 17 days. Conclusion: Five-fluorouracil at banded doses of 700 and 800 mg in polyolefin bags is physicochemically stable for at least 17 days at 23 ± 2°C. These results support the possibility of in advance centralised preparation. [ABSTRACT FROM AUTHOR]

Well-designed health communication campaigns can contribute to the uptake of preventive behaviors, but there has been a lack of attention on using communication research to develop opioid misuse prevention messages. We report the results of two studies designed to inform the development of prescription opioid misuse prevention messages for adults ages 30–59. In Study 1, 16 adults across 4 counties participated in semi-structured interviews to provide input on message concepts addressing six key prescription opioid misuse prevention behaviors. In Study 2, 1,335 adults completed an online, survey-based between-subjects experiment in which participants were randomized to a no message control condition or a message condition that aligned with a prevention behavior. The survey examined Reasoned Action Approach (RAA) predictors of intention in no message control participants and examined differences in intention to perform prevention behaviors among experimental conditions. The qualitative interviews yielded insights about message preferences and perceived facilitators and barriers related to the prevention behaviors. The online survey demonstrated that attitude and descriptive norms are important determinants of preventive behaviors and potential targets for communication interventions. Message testing results demonstrated that the draft messages were effective in changing intentions to safely store, securely dispose of, and monitor the use of prescription opioids, but they were not effective in increasing intentions to talk to healthcare providers, older adults, or children about proper opioid use. A communication campaign addressing attitudes and perceived descriptive norms may be successful in increasing intentions to engage in opioid misuse prevention behaviors. [ABSTRACT FROM AUTHOR]