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The article highlights the professional policies approved by the American Society of Health-System (ASHP) House of Delegates at its March 2024 virtual meeting. Topics include the role of pharmacy workforce in improving mental health, the pharmacist access to provider networks, and risk assessment of health information technology.

Dispensing errors play a crucial role in various medical errors, unfortunately emerging as the third leading cause of death in the United States. This alarming statistic has spurred the World Health Organization (WHO) into action, leading to the initiation of the Medication Without Harm Campaign. The primary objective of this campaign is to prevent dispensing errors from occurring and ensure patient safety. Due to the rapid development of deep learning technology, there has been a significant increase in the development of automatic dispensing systems based on deep learning classification to avoid dispensing errors. However, most previous studies have focused on developing deep learning classification systems for unpackaged pills or drugs with the same type of packaging. However, in the actual dispensing process, thousands of similar drugs with diverse packaging within a healthcare facility greatly increase the risk of dispensing errors. In this study, we proposed a novel two-stage induced deep learning (TSIDL)-based system to classify similar drugs with diverse packaging efficiently. The results demonstrate that the proposed TSIDL method outperforms state-of-the-art CNN models in all classification metrics. It achieved a state-of-the-art classification accuracy of 99.39%. Moreover, this study also demonstrated that the TSIDL method achieved an inference time of only 3.12 ms per image. These results highlight the potential of real-time classification for similar drugs with diverse packaging and their applications in future dispensing systems, which can prevent dispensing errors from occurring and ensure patient safety efficiently. [ABSTRACT FROM AUTHOR]

Introduction: PF-06439535 (bevacizumab-bvzr; Zirabev®) is a bevacizumab biosimilar. The stability profile and functional activity of PF-06439535 after dilution for intravenous infusion was evaluated following extended storage conditions. Methods: PF-06439535 drug product was diluted in 0.9% sodium chloride to produce final concentrations of 1.4 and 16.5 mg/mL of PF-06439535, representing clinically relevant low and high doses for intravenous infusion. Three drug product lots and three infusion bag types (polyolefin, ethylene vinyl acetate, and polyvinyl chloride) were tested. To simulate the potential preparation and administration conditions encountered in a clinical setting, prepared drug solutions were initially stored at 25 ± 5°C for 24 ± 2 h, and then at 5 ± 3°C for up to 6 weeks. Extended storage was followed by storage at 25 ± 5°C for 24 ± 2 h before testing. Physicochemical and biological stability were evaluated according to visual characteristics and pH, protein concentration, particulate content, the proportions of molecular weight variants and charge variants, and relative potency. A wide range of analytical techniques optimized for PF-06439535 assessment were employed, such as size-exclusion chromatography, non-reducing sodium dodecyl sulfate capillary electrophoresis, cation-exchange chromatography, far-UV circular dichroism spectroscopy, differential scanning calorimetry, and an in vitro cell-based bioassay. Results: For all concentrations, drug product lots, infusion bag types, and time points tested, there were no significant changes in protein concentration and no notable differences in visual characteristics (color, clarity, and visible particulates). The abundance of molecular weight variants and charge variants remained stable over the 6-week study period. There were no stability concerns with regard to sub-visible particles. There were no significant changes in primary, secondary, or tertiary structure. Finally, the in vitro relative potency of PF-06439535 was maintained throughout the study period. Conclusions: The stability and biological activity of PF-06439535 was maintained after dilution and storage for up to 6 weeks at 2–8°C, demonstrating the integrity of diluted PF-06439535 under extended in-use conditions. [ABSTRACT FROM AUTHOR]

The article focuses on a draft proposal for the inclusion of Nirmatrelvir tablets in The International Pharmacopoeia. Topics include storage recommendations for Nirmatrelvir tablets, their categorization as antiviral, and identity tests using high-performance liquid chromatography and thin-layer chromatography.

Knowledge of and expertise in insulin prescribing is crucial for health care providers who care for people with diabetes. This article reviews the available insulin preparations, how they are packaged, and nuances related to storage and use that inform the prescribing of this life-saving medication for patients. Insulin prescribing that is done correctly will save time and reduce problematic errors that could put patients at risk. [ABSTRACT FROM AUTHOR]

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The quality-assured preparation of crushed and diluted preparations for children is a challenge. In this study, a multicenter study was conducted to validate the preparation method for the quality assurance of baclofen powder, clonidine powder, and hydrocortisone powder prepared from tablets according to a previously established method. In-hospital preparations were prepared at five medical facilities under different crushing and mixing conditions. After storage in closed bottles, in-use bottles, and laminated paper for 120 days, ingredients stability, drug elution, and content uniformity after packaging were evaluated. All three ingredients were maintained at between 90% and 110% of their initial content for 120 days under packaging conditions of 25 ± 2 °C and 60 ± 5% relative humidity, with no change in dissolution in all formulations made at all five facilities. The content uniformity was also acceptable. The established method may contribute to quality-assured pediatric dosage form modification. [ABSTRACT FROM AUTHOR]

The international postal network is one of the most widely used methods for correspondence throughout the world. Most postal traffic across the globe consists of legitimate interpersonal, business-consumer, and business-business communications. However, the global postal system is also utilized for criminal activity. In particular, it is often utilized to ship and distribute contraband, including illegal psychoactive drugs such as fentanyl and heroin, to consumers. Existing technological solutions are capable of identifying synthetic opioids and other illegal drugs within packages, but are accompanied by several disadvantages that make them unsuitable for large-scale authentication of international mail traffic. This paper presents a novel method for non-invasive authentication of mail packages that overcomes these challenges. The approach uses nuclear quadrupole resonance (NQR) spectroscopy to detect and quantify the presence of known active pharmaceutical ingredients (APIs) within the package. It has been experimentally demonstrated using a bench top prototype. Test results from a variety of package types demonstrate the effectiveness of the proposed authentication approach. [ABSTRACT FROM AUTHOR]

Introduction: The stability and functional activity of the trastuzumab biosimilar PF-05280014 (trastuzumab-qyyp; TrazimeraTM), was assessed under extended in-use conditions. Methods: PF-05280014 was diluted in 0.9% sodium chloride to final concentrations of 0.2 mg/mL and 4 mg/mL in 3 different types of infusion bags (polyolefin, ethylene vinyl acetate, and polyvinyl chloride). Infusion bags containing diluted PF-05280014 were stored at 25 ± 5° C for 24 h, before storage at 5 ± 3° C for 0, 1, 2, 4, or 6 weeks. Following extended storage, samples of PF-05280014 were removed from the infusion bags and stored at 25 ± 5° C for 24 h before biophysical and functional characterization. In addition to the visual characteristics of each sample at the various time points, the stability of PF-05280014 was assessed using a variety of biophysical techniques, including size-exclusion high-performance liquid chromatography, non-reducing sodium dodecyl sulfate capillary electrophoresis, cation-exchange chromatography, peptide mapping, far-UV circular dichroism spectroscopy, and differential scanning calorimetry. The functional activity of PF-05280014 was evaluated using a cell-based growth inhibition assay. Results: For all PF-05280014 concentrations, time points and infusion bags tested, there were no significant differences in visual characteristics or in protein concentration. The were no significant changes in the relative abundance of molecular weight or charge variants throughout the 6-week study period. Similarly, there were no significant changes in primary structure or in secondary structure content during the study. The relative potency of PF-05280014 was also maintained throughout the 6-week period. Conclusions: The stability and functional activity of PF-05280014 was maintained following dilution in 0.9% sodium chloride and storage for up to 6 weeks at 2–8° C. [ABSTRACT FROM AUTHOR]

Background. Vasopressin is frequently utilized for a variety of shock states in critically ill patients. Short stability (≤24 hours) after intravenous admixture with current manufacturer labeling requires just in time preparation and may lead to delays in therapy and increased medication waste. We aimed to evaluate vasopressin stability in 0.9% sodium chloride stored in polyvinyl chloride bags and polypropylene syringes for up to 90 days. Additionally, we evaluated the impact of extended stability on the time to administration and cost savings from reduced medical waste at an academic medical center. Methods. Dilutions of vasopressin to concentrations of 0.4 and 1.0 unit/mL were performed under aseptic conditions. The bags and syringes were stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 2, 14, 30, 45, 60, and 90. Physical stability was performed by visual examination. The pH was assessed at each point and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of vasopressin was evaluated using liquid chromatography with tandem mass spectrometry. Samples were considered stable if there was <10% degradation of the initial concentration. Results. Vasopressin diluted to 0.4 and 1.0 unit/mL with 0.9% sodium chloride injection was physically stable throughout the study. No precipitation was observed. At days 2, 14, 30, 45, 60, and 90 all bags and syringes diluted to 0.4 units/mL had <10% degradation. Vasopressin diluted to 1 unit/mL and stored under refrigeration had <10% degradation at all measured days, but when stored under room temperature was found to have >10% degradation at day 30. Implementation of a batching process resulted in reduced waste ($185 300) and improved time to administration (26 vs 4 minutes). Conclusion. Vasopressin diluted to a concentration of 0.4 units/mL with 0.9% sodium chloride injection is stable for 90 days at room temperature and under refrigeration. When diluted to 1.0 unit/mL with 0.9% sodium chloride injection it is stable for 90 days under refrigeration. Use of extended stability and sterility testing to batch prepare infusions may lead to improved time to administration and cost savings from reduced medication waste. [ABSTRACT FROM AUTHOR]

Press-through packaging (PTP) is the most common type of drug packaging in Japan, and a production procedure for PTP has been established at an acceptable cost. However, unknown problems and new needs with regard to safety among users of various age-groups still need to be examined. Considering accident reports involving children and older adults, the safety and quality of PTP and new forms of PTP, such as child-resistant and senior-friendly (CRSF) packaging, should be evaluated. We conducted an ergonomic study on children and older adults to compare types of commonly used PTP and new varieties of PTP. Opening tests were attempted by children and older adults using a common type of PTP (Type A) and child-resistant (CR) PTP (Types B1 and B2) made from soft aluminum foil. The same opening test was conducted on older patients with rheumatoid arthritis (RA). The results showed that CR PTP was difficult for children to open: only 1 out of 18 children could open Type B1. On the other hand, all eight of the older adults could open Type B1, and eight patients with RA could easily open Types B1 and B2. These findings suggest that the quality of CRSF PTP can be improved with the use of new materials. [ABSTRACT FROM AUTHOR]

Literature review reveals that adherence to prescribed therapy at hospital discharge averages around 50%. The purpose of this study was to evaluate adherence to prescribed therapy assessing the relationship between re-hospitalization rate at 30 days and degree of therapeutic adherence in a sample of elderly patients discharged from an acute geriatric ward using an Electronic Medication Packaging device, MePill. The study population (n = 56) was divided in 3 groups, a counseling group (A), a counseling + MePill device group (B) and a control group (C). Group A had 98.1% adherence to therapy, Group B had 100%, and control group had 90%. Analyzing the rate of hospitalization by type of intervention for Group A and C the hospitalization rate was 21% and 27.7%, respectively, whilst for Group B no patient was hospitalized. Participants in Group A and C had the shorter hospitalization-free survival as compared with subjects in Group B. [ABSTRACT FROM AUTHOR]

The use of unfamiliar products left in patient care areas can lead to serious medication errors. Barcode scanning errors, where a pharmacy-generated label is used in place of the manufacturer's barcode for non–unit dose products, and the lack of a standardized escalation process for barcode scanning failures, can contribute to these serious medication errors. [ABSTRACT FROM AUTHOR]

Every time an older person in a care home has a medicine prescribed or administered, there is an up to one in ten chance of a mistake being made. Nurses say that short staffing, lack of time and having to juggle multiple medications for dozens of people all contribute to the problem. [ABSTRACT FROM AUTHOR]

Counterfeit drugs are without a doubt becoming a greater hazard to consumers and the pharmaceutical sector. As a result, real-time visibility of drug manufacturing and management is required. The proposed system uses Ethereum blockchain as the main technology. The primary advantage of blockchain technology is that the transactions are maintained in immutable digital ledger format and it may be read easily without jeopardizing the users' security and privacy. In our proposed system, the admin validates and adds the manufacturers. The manufacturer after registering and logging in can perform tasks like adding the drug and seller list. The seller can place order to the manufacturer which the manufacturer can accept or reject. The seller can update status of order of accepted orders to delivered. The customer can view the order details by entering the serial number on the drug package. Any transaction or exchange that occurs in the network is recorded in the chain. It functions similarly to other networks, but blockchain technology is distinguished by the fact that no data can be removed or altered by anyone in the network. No changes to the network can be made unless it has been validated by all of the network's authorized users. All the information stored can be read by anybody so to incorporate more security, AES has been used to store data in the blockchain. The use of AES encryption technique distinguishes this system from all the existing implementations. Thus, this makes it easy to trace to the exact point in the supply chain and detect any counterfeit drugs in movement. As an extension to the drug counterfeit prevention system a Drug Recommendation System is also performed using the ensemble model with a combination of Random Forest and Logistic Regression for sentiment analysis training. Furthermore, when compared to the existing Linear SVM model, which has an accuracy of 90.39%, the suggested model has the best accuracy of 93.31%. Using the obtained sentiment for each drug, the drug is predicted accurately for the specified medical condition. [ABSTRACT FROM AUTHOR]

The presence and migration of heavy metals from food and drug packaging materials into consumables pose significant health concerns. This study explored the effects of vanadium, arsenic, cadmium, and mercury contained in the digest of packaging materials on biofilms formed by standard strains of Escherichia coli ATCC 25923, Pseudomonas aeruginosa ATCC 27853, Klebsiella pneumoniae ATCC 70063, and Enterococcus faecalis ATCC 29212. Results showed that vanadium at 1.2 µg/ml promoted strong biofilm formation in all tested bacteria, while cadmium (1 µg/ml) and mercury (6.6 µg/ml) supressed biofilm formation. Arsenic at 0.6 µg/ml initially facilitated biofilm formation, but its effectiveness decreased with higher concentrations. This interference of heavy metals digests on biofilm formation in the gut microbiota is a concern, as leached heavy metals into food when consumed could disrupt the balance of human intestinal flora and homeostasis. [ABSTRACT FROM AUTHOR]

Introduction: There is a risk of transmission of viruses and microbial pathogens during routine health care procedures due to improper injection, infusion, and medication-vial practices. Unsafe practices lead to outbreaks of infection resulting in unacceptable and devastating events in patients. The present study was undertaken to assess the compliance of nurses with safe injection and infusion practices in our hospital and to identify staff education requirements in relation to the safe-injection and infusion practices policy. Methods: Baseline data were collected and high risk areas were identified on this basis, a quality improvement project was implemented by infection control team. FOCUS PDCA methodology was used to conduct the improvement process. The study was performed from March to September 2021. An audit checklist based on the CDC guidelines was used for monitoring compliance with safe injection and infusion practices. Results: Poor compliance with safe injection and infusion practices in few clinical areas at baseline. During the pre-intervention period, non-compliance was mainly seen with the following elements: aseptic technique (79%), rubber septum disinfected with alcohol (66%), labelling of all IV lines and medications with date and time (83%), compliance with multidose-vial policy (77%), use of multidose vials for single patient (84%), safe disposal of sharps (84%), using trays instead of clothing/pockets to carry medications (81%). There was significant improvement in compliance with the following elements of safe injection and infusion practices in the post-intervention period: aseptic technique (94%), rubber septum disinfected with alcohol (83%), compliance with multidose-vial policy (96%), use of multidose vials for single patient only (98%), safe disposal of sharps (96%). Conclusion: Adherence to safe injection and infusion practices is very important to prevent outbreaks of infection in health care settings. [ABSTRACT FROM AUTHOR]

Recent years have witnessed the rapid accumulation of massive electronic medical records, which highly support intelligent medical services such as drug recommendation. However, although there are multiple interaction types between drugs, e.g., synergism and antagonism, which can influence the effect of a drug package significantly, prior arts generally neglect the interaction between drugs or consider only a single type of interaction. Moreover, most existing studies generally formulate the problem of package recommendation as getting a personalized scoring function for users, despite the limits of discriminative models to achieve satisfactory performance in practical applications. To this end, in this article, we propose a novel end-toend Drug Package Generation (DPG) framework, which develops a new generative model for drug package recommendation that considers the interaction effects between drugs that are affected by patient conditions. Specifically, we propose to formulate the drug package generation as a sequence generation process. Along this line, we first initialize the drug interaction graph based on medical records and domain knowledge. Then, we design a novel message-passing neural network to capture the drug interaction, as well as a drug package generator based on a recurrent neural network. In detail, a mask layer is utilized to capture the impact of patient condition, and the deep reinforcement learning technique is leveraged to reduce the dependence on the drug order. Finally, extensive experiments on a real-world dataset from a first-rate hospital demonstrate the effectiveness of our DPG framework compared with several competitive baseline methods. [ABSTRACT FROM AUTHOR]

BACKGROUND: In 1991, the Institute of Hematology and Transfusion Medicine (IHTM) was the first center in Poland to start the production of serum-based artificial tears, which were applied successfully in the management of multiple etiology dry eye syndrome (DES). DES is a common chronic condition associated with an abnormal tear film secretion, which may cause gritty eyes, eye pain, and often blurred vision. MATERIAL AND METHODS: The study analysis relied on the data collected over 30 years (1386 autologous whole blood donations from 662 patients), which included: the annual number of donations, patients' age, gender, and underlying disease. RESULTS: The patient's age at the first visit ranged from 7 to 92 years (55 on average). The vast majority were women (77%). DES of various severity and etiology was identified among the adult patients, and the most common disease entities were graft-versus-host disease (GvHD), Sjögren's syndrome, rheumatoid arthritis, glaucoma, cataracts, and corneal damage due to trauma and/or surgery. CONCLUSIONS: Many scientific reports confirm the effect of artificial tears in the treatment of DES. In Poland, artificial tears is still an underused therapy due to the high costs generated by expensive disposable materials and equipment and the time-consuming procedure of preparing eye drops for one patient. [ABSTRACT FROM AUTHOR]

An increase in the use of postal services to deliver drugs purchased online raises concerns about widening access to drugs markets, especially in remote and rural areas that were previously protected by geographical boundaries. Yet little is known about the geographical patterning of drugs delivered through the post. Using a novel law enforcement dataset containing details of illegal drug packages intercepted by UK Border Force en route to Scotland, we examine the geographical destination of drugs purchased online and explore the area-based characteristics associated with higher rates of delivery. This article provides previously unavailable insights into the spatial patterning of digital drugs markets at sub-national level. We use descriptive statistics, Bayesian hierarchical regression models, and spatial autocorrelation to describe the relationship between area-based characteristics and expected rate of illegal drug consignments identified across Scotland. The majority of intercepted drug packages were destined for urban centres, but there was a higher than expected delivery rate to some of Scotland's remote and rural locations. Increased rates of drug delivery within Scottish neighbourhoods was independently associated with higher levels of crime and deprivation, with Internet connectivity and with access to services, but not with higher rates of drug-related hospitalization. Analysis of spatial clustering showed that drug delivery to the most remote and rural locations was still associated with good access to services because the packages were typically delivered to addresses in larger settlements within remote locations. Overall, postal drugs delivery reflects both relatively high use in more urban, more deprived areas but also seems to open up more remote regions to drug markets, albeit with usage concentrated in larger settlements within otherwise remote areas. [ABSTRACT FROM AUTHOR]

Background: Medication organizers increased compliance, but they do not contain child protective packaging. Medications organizers have been involved in some pediatric exposures; however, previous reports do not describe if "one pill can kill" (1PCK) medications were involved in the exposures. 1PCK medications may cause toxicity even with a single tablet. Objective: The purpose of this study is to describe the type and presence of 1PCK medications dispensed in medication organizers at a single center. Methods: Adult patients who received blister packed medications from September 1, 2017 to September 30, 2017 were included in this retrospective review. Medications were excluded if dispensed traditionally during this time. The primary outcome described included 1PCK medications (quantity and type). Secondary outcomes included total number of tablets dispensed, delayed- (DR) and extended-release (ER) formulations, average age of those dispensed 1PCK medications versus those without. Results: A total of 450 patients received 486 blister packs and 75.5% of which found to include 1PCK medications. Most commonly included 1PCK medications were beta-blockers and calcium channel blockers (42.4 and 49.4%, respectively). Patients receiving 1PCK medications were older (69.1 ± 12.6 vs 62.6 ± 16.7 years old, p < 0.0001) and included more medications (8.5 ± 2.9 vs 5.7 ± 2.9 medications, p < 0.0001). DR and ER formulations were in 150 packs. Conclusion: The majority of dispensed medication organizers included 1PCK medications. Upon dispensing, patients should be questioned for possible proximity exposures. Additionally, they should receive education on medication safety for children that may be in proximity of the medications during home, work, or social activities. [ABSTRACT FROM AUTHOR]

Development of and increased access to generic oral medications to treat high-burden diseases including human immunodeficiency virus (HIV), tuberculosis, viral hepatitis, and malaria have had a major impact on reducing global morbidity and mortality. However, access and adherence to these life-saving treatments remains limited for some of the most vulnerable and underserved populations, for whom stigma, control, and discretion are critical to decisions around care. Current efforts to develop long-acting formulations to treat and prevent these conditions could overcome many of these barriers. However, generic manufacturing of these innovative products will be required to ensure affordable access to the communities and patients in greatest need. Strategic investments in new infrastructure will be required even before markets and manufacturing costs are clear, to ensure that access to these new products is not delayed, particularly for patients in low- and middle-income countries. Unlike conventional oral medications, long-acting products require greater investment for formulation, packaging, and delivery. The requirement for long-term bioequivalence studies will introduce additional delays in regulatory approval of generic long-acting products, and expedited approval pathways must be developed. Lessons learned from the development of long-acting hormonal contraceptives and long-acting antiretroviral products may provide a way forward. [ABSTRACT FROM AUTHOR]

The influence of graphene oxide (GO) decoration with polyethylene glycol (PEG) on the thermal, mechanical, antibacterial, and also biocompatibility of chitosan (CS) biopolymer was investigated. GO-PEG nanohybrids were synthesized and characterized by FTIR, AFM, UV–Vis, and XRD. The results indicated significant changes in morphology, optical properties, interlayer distances, and aqueous stability of GO as a result of the linkage of PEG chains to the surface of GO nanoplates. Afterward, GO-PEG was added to CS as graphene-based hybrid nanosheets to reinforce CS-based environmental biofilms. Outcomes demonstrated that surface decoration of GO with PEG chains effectively improved compatibility and dispersion of GO plates in the CS matrix. Therefore bionanocomposites containing modified GO (CS/GO-PEG) exhibited superior thermal stability, mechanical and antibacterial properties as well as biocompatibility. CS/GO-PEG bionanocomposite with more desirable properties, than CS biopolymer and even CS/GO nanocomposite, can be preferred for biomedical applications (tissue engineering, wound dressing, drug delivery) and also food/drug packaging industry. [ABSTRACT FROM AUTHOR]

Kiyomi Sadamoto,1– 3 Mikio Murata,2,4 Masaho Hayashi,2,4 Hiroyuki Ura,1 Kiyoshi Kubota2,4 1Department of Clinical Pharmacy, Shonan University of Medical Science, Yokohama, Kanagawa, Japan; 2MECSION, General Incorporated Association, Hiratsuka, Kanagawa, Japan; 3Sadamoto Clinic, Ninomiya, Kanagawa, Japan; 4Department of Clinical Pharmacy Yokohama University of Pharmacy, Yokohama, Kanagawa, JapanCorrespondence: Kiyomi Sadamoto, Tel +81-45-921-0111Fax +81-45-821-0116Email kiyomi.sadamoto@gmail.comBackground: Blister packs with paperboard backing, which is useful for displaying instructions and information, are the most popular type of packaging for osteoporosis drugs in Japan. However, the main users of drugs are the aged, who often find blister packs difficult to open or drop their pills during opening. In this study, we compared different types of blister packs in terms of usability and handling.Methods: We conducted a subjective and objective study to compare commonly used blister packs with newly designed ones that have a jagged notch designed to hold a pill temporarily and a perforated line that enables the pack to be held easily in one hand. Regarding subjective data, packaging and sensory tests were performed. The participants in the sensory test were healthy older adults and patients with rheumatoid arthritis (RA). We also measured the pinch power of all participants.Results: A comparison of several items, including opening status, prevention of pill dropping, and understanding of the instructions, using a numerical rating scale revealed no significant differences between ordinary (type A) and newly designed (type B) packaging. However, the scores for type B were the same or better than those for type A for every evaluation item. In addition, more than 85% of the participants reported preferring to use type B. More than 80% of the participants in both groups reported dropping pills using type A, which seemed to be related to their preference for type B. In the evaluation by the examiner (objective study), all participants could successfully remove their pills without dropping using type B, including those in the RA group who had difficulty handling packages.Conclusion: These findings suggest that the new type of blister pack assessed in this study (type B) is preferable among older and shows promise for a universal design.Keywords: drug packaging, paperboard backing, older adults, new design, rheumatoid arthritis, universal design

This paper examines the scheduling of a drug packaging operation which requires assigning resources to production lines during set-up in order to satisfy product specifications. We present mixed integer programming models of the problem and develop a Lagrangian heuristic to solve the models. Real data from a drug company and randomly generated data are used to test the models. Results show the efficacy of our solution approach to find good feasible schedules. We discuss some of the practical benefits and potential issues about the production schedules obtained using the models. [ABSTRACT FROM AUTHOR]

Introduction: As cannabis increasingly becomes a consumer product in the U.S., its product packaging has become critically important to regulators. This study examined the influence of recreational cannabis packaging characteristics.Methods: Five online between-subjects experiments were conducted in April 2021, and data were analyzed in May 2021-July 2021. Experiments randomized participants to view different (1) types of cannabis, (2) visual displays of tetrahydrocannabinol content, (3) cannabis packages designed around brand personality research, (4) health warnings, and (5) health claims. Outcomes included cognitive, affective, and behavioral responses.Results: A total of 841 adults from the U.S. (49% male, 50% young adults, 44% White, 17% Hispanic) were included in the study. Edible gummies were perceived as healthier (β=0.32, 95% CI=0.03, 0.62), less grown up (β= -0.58, 95% CI= -0.86, -0.28), and more socially acceptable to consume (β=0.30, 95% CI=0.01, 0.59) than cannabis concentrate in a medical dropper. Participants also had more interest in trying edible gummies (β=1.33, 95% CI=1.04, 1.62) and trying a free sample (β=1.30, 95% CI=1.01, 1.60) than trying cannabis concentrate. Cannabis packages with a helps-you-relax health claim elicited more happy (β=0.34, 95% CI=0.04, 0.64) and good (β=0.37, 95% CI=0.07, 0.67) feelings than cannabis packages without this claim. Minimal effects were found for visual displays of tetrahydrocannabinol content and health warnings.Conclusions: Edibles are a unique type of cannabis that should be given special consideration under state laws, and lawmakers should consider limiting and governing the use of both implicit and explicit health claims on recreational cannabis packages when implementing laws. [ABSTRACT FROM AUTHOR]

DrugTax is an easy-to-use Python package for small molecule detailed characterization. It extends a previously explored chemical taxonomy making it ready-to-use in any Artificial Intelligence approach. DrugTax leverages small molecule representations as input in one of their most accessible and simple forms (SMILES) and allows the simultaneously extraction of taxonomy information and key features for big data algorithm deployment. In addition, it delivers a set of tools for bulk analysis and visualization that can also be used for chemical space representation and molecule similarity assessment. DrugTax is a valuable tool for chemoinformatic processing and can be easily integrated in drug discovery pipelines. DrugTax can be effortlessly installed via PyPI (https://pypi.org/project/DrugTax/) or GitHub (https://github.com/MoreiraLAB/DrugTax). [ABSTRACT FROM AUTHOR]

The article presents the discussion on Tenofovir disoproxil tablets. Topics include manufacturing process and the product packaging being designed and controlled for minimizing the moisture content of the tablets; and showing appearance and intensity with the corresponding spots due to tenofovir disoproxil obtained with solution.

Difficulty opening medication packaging can have serious consequences that can lead to patient harm via medication mismanagement or poor adherence. However, the quality of literature pertaining to these issues has yet to be collated and critiqued. This systematic review examined cross-sectional studies that objectively examined the ability of participants to open different medication packaging. Of the 8,692 studies identified, 12 met the inclusion criteria, all of which were direct observational studies given that prior research has identified a mismatch between self-report and actual ability. Scoring via the Appraisal Tool for Cross Sectional Studies revealed that the methodological quality of included studies was typically low. Study samples mostly consisted of older adults. All studies reported a non-negligible proportion of participants unable to open packaging, with the most difficulty associated with child-resistant containers. Several studies examined associations; however, no factor was consistently found to be significantly associated with the ability to open packaging. Despite these studies spanning >40 years, the packaging types examined remained largely the same. This suggests that, despite decades of research demonstrating that packaging is problematic, there has been a stagnation in medication packaging development. Whether this is attributed to a paucity of high-quality research, and therefore a lack of strong evidence that change is needed, is unclear. Future research should strive for better methodological quality, with generalisable cohorts assessed via observation in their home. If the problems identified in prior research persist, this may provide the impetus for change that is overdue in the medication packaging industry. [ABSTRACT FROM AUTHOR]

Pharmaceutical companies' capital, influence, and labor force well equip them to assume responsibility for public medication disposal programs. Government- and industry-funded campaigns for medication disposal do work, but responsibility often falls on local health care organizations to provide education and services. Lack of public awareness about how to dispose of medications and the ramifications of contaminating our natural resources and ecosystems with pharmaceuticals suggest a need for collaboration among pharmaceutical companies, government officials, clinicians, and patients. [ABSTRACT FROM AUTHOR]

In the article, the authors present their cross-sectional study to estimate the wasteful spending on aducanumab dispensing for treating Alzheimer's disease in the U.S. Also cited are how the widespread use of the drug could strain Medicare's budget, and the conduct of the study on Medicare beneficiaries with mild dementia or mild cognitive impairment (MCI).

Polysorbates, widely used excipients in drug formulations, present a stability challenge due to complex degradation processes. This study investigates the hydrolysis of polysorbate (PS) under temperature stress (50 °C), focusing on the impact of primary packaging materials (glass vs. plastic vials), buffers (histidine and acetic acid), counterions (chloride vs. malate), and pH (4-7). Our findings reveal that leachables from plastic vials inhibit PS degradation in both histidine and acetic acid buffers. Kinetic parameters derived from sigmoidal fitting suggest distinct degradation mechanisms for each buffer. Furthermore, the malate counterion with histidine displays inhibitory effects on PS hydrolysis. Principal component analysis was employed to identify key factors. These results highlight the critical role of excipients and packaging in PS stability, providing valuable insights for biopharmaceutical formulation development and a deeper understanding of PS degradation complexities., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Hospital pharmacy compoundings are crucial for maintaining patient care. They are time- and cost-effective in hospital pharmacy settings because they prevent waste, preparation errors, dosage errors, microbial contamination and breakage due to handling. Unfortunately, the drawbacks of hospital pharmacy compounding include the selection of inappropriate medical devices (MDs) for long-term storage, which could directly impact patients. In this study, three important hospital pharmaceutical compoundings, vancomycin in prefilled syringes (PFSs) made of polypropylene (PP) material, paediatric parenteral nutrition (PN) in ethylene vinyl acetate (EVA) bags and diluted insulin in cyclic olefin copolymer (COC) vials, were selected for leachate study and risk assessment. These compounds were studied via a semiquantitative screening approach by means of an ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS) with postcolumn infusion and an in-house built database. 17 leachable compounds for the PFS, 25 for the PN, and 10 for the vial were identified, and their concentrations were estimated for toxicological assessments. In conclusion, all MDs used in hospital pharmacy compoundings were observed suitable thanks to risk assessments. However, suitable MDs recommended for long-term storage would remain with polymers like COC, for higher safety when exposed to frail and vulnerable patients like neonates and infants., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Oral contraceptives (OC) are the most used form of contraception among women in the U.S. and Europe. Like other medications, their packaging must include patient information leaflets. This study quantifies the environmental impact of paper waste generated by these leaflets. We conducted an observational analysis, measuring the weight of leaflets, pills, and packaging components across various OC brands. Significant variations in leaflet weights were observed. On average, leaflets accounted for 55% of the package weight, while pills and blister dispensers represented only 32%. The mean weight of OC leaflets was 12.3 ± 5.5 grams (4.7-21.9 grams), leading to an estimated annual paper waste of 6,118.4 tons, 5,763.5 tons of carbon dioxide equivalent emissions, and the use of approximately 146,841 trees for production. Standardizing leaflet weight to the lightest reported can reduce annual waste by 3780.5 tons of paper. This study highlights the substantial environmental cost of the waste generated from OC leaflets and proposes practical strategies to mitigate waste, including electronic leaflets and standardized packaging. Targeting these materials presents a significant opportunity to enhance sustainability, aligning with global efforts to reduce greenhouse gas emissions from the healthcare sector., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Safrai et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: The objective of this study was to investigate whether different dispensing processes can alter the physicochemical and structural (Q3) attributes of a topical cream product, and potentially alter its performance., Methods: Acyclovir cream, 5% (Zovirax®) is sold in the UK and other countries in a tube and a pump packaging configurations. The structural attributes of the cream dispensed from each packaging configuration were analyzed by optical microscopy, confocal Raman microscopy and cryo-scanning electron microscopy. Rheological behavior of the products was also evaluated. Product performance (rate and extent of skin delivery) was assessed by in vitro permeation tests (IVPT) using heat-separated human epidermis mounted in static vertical (Franz-type) diffusion cells., Results: Differences in Q3 attributes and IVPT profiles were observed with creams dispensed from the two packaging configurations, even though the product inside each packaging appeared to be the same in Q3 attributes. Visible globules were recognized in the sample dispensed from the pump, identified as dimethicone globules by confocal Raman microscopy. Differences in rheological behaviour could be attributed to these globules as products not dispensed through the pump, demonstrated a similar rheological behaviour. Further, IVPT confirmed a reduced rate and extent to delivery across human epidermis from the product dispensed through a pump., Conclusions: Different methods of dispensing topical semisolid products can result in metamorphosis and Q3 changes that may have the potential to alter the bioavailability of an active ingredient. These findings have potential implications for product developers and regulators, related to the manufacturing and comparative testing of reference standard and prospective generic products dispensed from different packaging configurations., (© 2024. The Author(s).)

Background: Acetaminophen toxicity remains one of the most common causes of liver failure and is treated with a course of n-acetylcysteine (NAC). This exceptionally effective medication is traditionally administered using a complicated three-bag protocol that is prone to administration errors., Objective: We aimed to assess whether switching to a novel two-bag protocol (150 mg/kg over 1 h followed by 150 mg/kg over 20 h) reduced administration errors while not increasing liver injury or anaphylactoid reactions., Methods: This was a retrospective chart review of hospital encounters for patients with acetaminophen toxicity, comparing outcomes before and after the change from a three-bag protocol to a two-bag protocol at two affiliated institutions. The primary outcome was incidence of medication errors with secondary outcomes including acute liver injury (ALI) and incidence of non-anaphylactoid allergic reactions (NAAR). The study was approved by the health system's Institutional Review Board., Results: 483 encounters were included for analysis (239 in the three-bag and 244 in the two-bag groups). NAAR were identified in 11 patients with no difference seen between groups. Similarly, no differences were seen in ALI. Medication administration errors were observed significantly less often in the two-bag group (OR 0.24) after adjusting for confounders., Conclusion: Transitioning to a novel two-bag NAC regimen decreased administration errors. This adds to the literature that two-bag NAC regimens are not only safe but also may have significant benefits over the traditional NAC protocol., (© 2024. American College of Medical Toxicology.)

Topical ophthalmic drug product development is a niche research domain as the drug formulations need to be designed to perform in the unique ocular physiological conditions. The most common array of small molecule drug formulations intended for topical ophthalmic administration include solutions, suspensions, emulsions, gels, and ointments. The formulation components such as excipients and container closure are unique to serve the needs of topical ophthalmic delivery compared to other parenteral products. The selection of appropriate formulation platform, excipients, and container closure for delivery of drugs by topical ophthalmic route is influenced by a combination of factors like physicochemical properties of the drug molecule, intended dose, pharmacological indication as well as the market trends influenced by the patient population. In this review, data from literature and packaging inserts of 118 reference listed topical ophthalmic medications marketed in the US are collected and analyzed to identify trends that would serve as a guidance for topical ophthalmic formulation development for small molecule drugs. Specifically, the topics reviewed include current landscape of the available small molecule topical ophthalmic drug products in the US, physicochemical properties of the active pharmaceutical ingredients (APIs), formulation platforms, excipients, and container closure systems., Competing Interests: Declaration of Competing Interest Anand Ubhe, Heidi Oldenkamp, Ke Wu are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication., (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

This study investigates the impact of intravenous (IV) infusion protocols on the stability of Intravenous Immunoglobulin G (IVIG) and Rituximab, with a particular focus on subvisible particle generation. Infusion set based on peristaltic movement (Medifusion DI-2000 pump) was compared to a gravity-based infusion system (Accu-Drip) at different flow rates. The impacts of different diluents (0.9 % saline and 5.0 % dextrose) and plastic syringes with or without silicone oil (SO) were also investigated. The results from the aforementioned particular case demonstrated that peristaltic pumps generated high levels of subvisible particles (prominently < 25 µm), exacerbated by increasing flow rates, specifically in formulations lacking surfactants. Other factors, such as diluent type and syringe composition, also increased the number of subvisible particles. Strategies that can help overcome these complications include surfactant addition as well as the use of SO-free syringes and a gravity infusion system, which aid in reducing particle formation and preserving antibody monomer during administration. Altogether, these findings highlight the importance of the careful selection of formulations and infusion protocols to minimize particle generation during IV infusion both for patients' safety and treatment efficacy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

This study explores the molecular interactions and structural changes in κ-carrageenan crosslinked with isovanillin to create a biocomposite material suitable for hard capsule and bio-degradable packaging applications. Proton Nuclear Magnetic Resonance ( 1 H NMR) spectroscopy revealed chemical changes in the conjugate molecule, indicating improved electronegativity due to intermolecular hydrogen bonding between κ-carrageenan and isovanillin. Time-of-flight Secondary Ion Mass Spectrometry (ToF-SIMS) analysis revealed enhanced ion intensity due to intermolecular interactions, particularly between sulphate and hydrogen ions. X-ray Photoelectron Spectroscopy (XPS) study demonstrated that κ-carrageenan and isovanillin form stronger hydrogen bonds, with a shift in binding energy indicating higher electronegativity. These findings shed light on the molecular mechanisms that underpin the formation of the biocomposite material, as well as its potential for use in hard capsule and biodegradable packaging materials, addressing the need for sustainable alternatives in the pharmaceutical and packaging industries while also contributing to environmental conservation., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Fatmawati Adam reports financial support was provided by University of Malaysia Pahang Al-Sultan Abdullah. Fatmawati Adam has patent A Composition For Hard Capsule And A Method For Producing Thereof issued to Fatmawati Adam. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)