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Background: In Japan, engineering controls for preparing injectable anticancer drugs are inadequate and compliance with appropriate preparation procedures is vital. In this study, we evaluated the effects of adherence to appropriate anticancer drug formulation and packaging procedures on reducing anticancer drug dispersal in clinical practice, especially in Japan. Methods: We quantitatively evaluated the effectiveness of implementing procedures that were experimentally verified to help reduce the amount of anticancer drug dispersed during preparation based on procedures described in the "Anticancer Drug Preparation Manual." The target facilities were four regional hub hospitals in the Kanto area. Contamination of sheets and gloves with 5-fluorouracil (5-FU) and gemcitabine (GEM) in a safety cabinet during formulation was evaluated using wipe tests. Subsequently, the proper preparation procedure was shown on a video, training was provided, and the wipe tests were repeated. Results: Forty-one and 39 pharmacists were engaged in drug preparation before and after intervention, respectively. 5-FU had the highest dispersal per prepared vial on the sheet before intervention. The dispersal amount per prepared vial decreased significantly (P = 0.01) after intervention. The amount of GEM dispersed before and after intervention did not differ significantly. However, the percentage of sheets below the detection limit after intervention was 62%, increasing from 46% before intervention. The amount dispersed on gloves was not significantly reduced by proper preparation technique. Although not explicitly noticeable and quantifiable, pharmacists must consider that a significant amount of anticancer drug is dispersed on gloves despite following appropriate preparation procedures. Conclusions: Quantitative amounts of anticancer drugs dispersed in the preparations of 5-FU and GEM were found in our study. The difference in the amount of contamination before and after intervention was significantly reduced only for the contamination of sheets with 5-FU. There was no decrease in the amount of glove contamination. There was also no difference between medical facilities. Despite following appropriate preparation procedures, dispersed amounts cannot be maintained below the detection limit, indicating the need for a combination of education and engineering controls. [ABSTRACT FROM AUTHOR]

Background: Surgical instrument packaging quality directly affects the safety and performance of surgery. We aimed to investigate the factors causing defects in surgical instrument packaging and recommend strategies to prevent defects in surgical instrument packaging.Methods: We collected surgical instrument packaging data regarding age, gender, length of service, educational background, number of staff dealing with packaging, time period of packaging, instrument specification, where the wrap was intact, whether the wrap reached the required quality of cleaning, and whether the instruments were satisfactorily cleaned in compliance with guidelines from 5000 surgical instrument packages during June-December 2018 at Central Sterile Supply Department of the West China Second University Hospital, Sichuan University. Meanwhile, a questionnaire survey completed by the operating room staff using surgical instruments was used to measure the level of their satisfaction with the instruments in the packages. We utilized single-factor analysis to investigate possible factors that might cause defects in surgical instrument packaging, and conducted multivariate logistic regression analysis of the factors associated with defects in packaging.Results: Length of service, educational background, number of staff dealing with packaging, time period of packaging, instrument structure, whether the wrap was intact, whether the wrap reached the required quality of cleaning, and whether the surgical instruments were satisfactorily cleaned in compliance with guidelines were the factors significantly (P < 0.05) associated with defects in surgical instrument packaging.Conclusion: This study reveals that various factors are associated with defects in surgical instrument packaging. Recommendations for reducing incidences of defects include improved scheduling of packaging workload, greater provision of training in packaging skills, and standardization of packaging procedure. [ABSTRACT FROM AUTHOR]

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The article reports that initial release of the International Society of Oncology Pharmacy Practitioners (ISOPP) Standards for the Safe Handling of Cytotoxic Drugs in has evolved in oncology pharmacy. Topics include Safe handling practices have been refined and new hazardous agents developed for treatment to pose new challenges for workers caring for patients; and the ISOPP Standards task force was appointed by society to undertake a comprehensive and evidence-based review of practice.

Objectives: A review of new drug approvals (NDAs) by the US Food and Drug Administration (FDA) for 2006 to 2015 showed that approximately 20% of new drugs had labeling based on patient-reported outcomes (PROs). The purpose of this study was to review labeling text based on PRO endpoints for NDAs from 2016 to 2020, with a special focus on the comprehensibility of such statements when included.Methods: We reviewed drug approval reports on the Drugs@FDA web page of the FDA website to determine the number of NDAs from 2016 to 2020. For all identified NDAs, drug approval package and product labels were reviewed. NDAs from 2016 to 2020 were grouped by disease category as per International Classification of Diseases 10th Revision. Data were summarized for diseases that traditionally rely on PROs for evaluating treatment benefit (PRO dependent) and for diseases that traditionally do not rely on PROs (non-PRO dependent). Results were compared with NDAs from 2006 to 2010.Results: NDAs amounting to 228 were identified from 2016 to 2020, 26.3% of which had labeling statements based on PRO endpoints. From 2006 to 2015 and from 2016 to 2020, PRO labeling statements were included in 46.5% (46 of 99) and 50.0% (47 of 94), respectively, of NDAs for PRO-dependent new molecular entities and in 6.0% (12 of 199) and 9.7% (13 of 199), respectively, of NDAs for non-PRO-dependent new molecular entities. Comprehensibility of labeling statements based on PRO endpoints was judged to be complex in 56.7% of product labels.Conclusions: The increase in labeling text based on PRO endpoints in product labels is encouraging. However, there is room for improvement on the comprehensibility of labeling statements based on PRO endpoints. [ABSTRACT FROM AUTHOR]

Purpose: Patient safety errors can arise due to similarity in packaging of medications. We aimed to describe the clinical features of patients presenting with accidental application of joint pain liniments and gum lotion in the eye due to confusion arising from similarity in packaging.Methods: This was a retrospective case series with eight consecutive patients presenting from December 2020 to August 2021 with history of accidental application of joint pain liniments or gum lotion in the eye instead of eye drops. All patients underwent visual acuity assessment and slit-lamp examination with fluorescein staining of the cornea to look for corneal involvement and was reassessed till complete resolution.Results: Of the eight patients, three were males and five were females. Seven had accidentally applied joint pain liniment, while one had applied gum lotion into the eye. Five of them had corneal involvement ranging from punctate erosions to near-total epithelial defects. Two patients needed referral to a tertiary center and hospital admission. Treatment duration ranged from 2 days to 1 month. Two patients were lost to follow-up.Conclusion: This study highlights patient safety errors arising from confusion of medication due to similar labeling and packaging of different drugs. While there was no permanent morbidity, such confusions lead to needless discomfort and waste of time, money, and effort for the patient as well as the health-care system. [ABSTRACT FROM AUTHOR]

The article highlights the critical role that the investigational drug services (IDS) pharmacist plays in ensuring safe medical practices for patients receiving investigational medications. Topics include current gaps in investigational drug practices, IDS work group recommendations, and IDS participation in use of interactive response technology (IRT).

Background: The paper presents the salient features of a comprehensive treatment package for drug resistant tuberculosis (DR-TB), its adaptation and implementation in two indoor care hospital settings in Pakistan, and lessons learned from this implementation. Methods: A pilot study was undertaken on a group of 100 patients at two Programmatic Management of Drug-Resistant TB (PMDT) sites. Fifty patients each were selected from the Samli Sanatorium Murree and the Lady Reading Hospital, Peshawar by the National Tuberculosis Control authorities, and delivered a comprehensive package of services, including psychosocial and food support. Data were collected using standard TB tools and surveillance indicators. The results were compared between intervention and a historical cohort of DR-TB patients. Results: Among the total 100 patients, the treatment success rate was 88%, the failure rate was 4%, while there were 7% deaths. A patient was transferred out while none were lost to follow-up, indicating much improvement over the historical cohort. Patients ranked the economic support, free medicines and nutritional support as most helpful, while majority of providers found the intervention sustainable. Conclusion: A comprehensive package including the psychosocial support can be crucial in enhancing DR-TB outcomes. Regular interaction with patients and improved nutrition leads to improved treatment adherence, while capacity building of psychologists and home visits can further benefit the DR-TB patients leading to their cure. [ABSTRACT FROM AUTHOR]

Counterfeited medicine is a major threat to the society and economy. The easiest way of producing fake medicine is counterfeiting the packages of medicine. Medicine package printing is generally counterfeited by scanning the original printed package using camera, scanner etc. and then reprinting it. When different mobiles, camera or scanners are used to scan the original print and reproduced scanned reprinted sample, then the color values of reprinted samples are not the same as the original print sample. When the scanned objects are reprinted with different printers, the color values may be different depending on the profile of the printer. The spectral data of the solid inks used cannot be corrected as it is dependent on the inherent characteristics of the inks used. In this study, the original prints are scanned and then reprinted with the original (reference) printer, as well as in three different (test) printers, to show difference of spectrums. The inequality of spectrum of solid colors has been analyzed for printed and reprinted samples. The differences between RMSE values have been analyzed for same and different printers for different color range domains of the visible spectrum. It has been assumed that these differences could be used to detect whether a print is original or not. It may be used to protect medicine packaging from counterfeiting. [ABSTRACT FROM AUTHOR]

Background the ageing global population is living longer with complex health conditions addressed by multiple medications. Little is known about how older people manage these medications and associated packaging at home. Objectives to explore how older people manage the use of multiple medication and associated packaging in their process of self-care. Methods fifteen older, home-dwelling participants (mean age = 76.2 years) participated in this study. All participants used three or more daily medications and resided in Southern Sweden. Data were collected using photographs and written diaries completed by each participant over seven consecutive days, complemented by researcher-led interviews. Interviews and diary data were analysed using thematic analysis. Results six major themes emerged and are discussed: systematic organisation of medication, design of medication packaging, design of tablets, ease of package opening, emotional response to the need for medication, and environmental waste. Conclusion packaging plays an important role in protecting products and enabling easy storage, product longevity and transportation. Medication packaging is no exception. However, the design of medication packaging poses challenges for older people managing medications for their chronic health conditions at home. There is a need to facilitate the systematic management of multiple medications, especially for new medication regimes or changes in treatment. Design of both packaging and medication should be consistent for older users to avoid potential errors; difficulties opening packaging can potentially hinder adherence to treatment. This study highlights the need for patient-centred solutions and involvement of older people in a co-design process for medication and packaging design. [ABSTRACT FROM AUTHOR]

Introduction: The readability of prescription drug labels has been found to be faster with labels attached to flat surfaces compared to round surfaces, in persons with visual impairment. This study extends this finding by examining the readability of drug labels, as measured by speed and accuracy, as they interact with factors of age and vision acuity across different container shapes. Methods: A repeated-measure, three-factor design (container shape, age, and vision acuity) with within-subject control was used with 54 adults with vision loss. Participants read 3 unique prescription drug labels across four container shapes, for a total of 12 trials. The amount of time needed to locate and read aloud 6 pieces of label information and the number of errors made in reading were outcome measures. Results: A two-way interaction was found between container shape and acuity for the time it takes to read the label information (Wald χ 2 = 22.836, df = 3, p <.001). The legally blind group required more time to read the label and had more variation in mean times across container type, compared to the low vision group. Both age and acuity showed statistically significant (p < 0.001) main effects on reading accuracy. Discussion: Within the legally blind acuity group, cylinder-shaped containers took statistically significantly longer to read compared to the flat label by 18 seconds. Increased age and lower visual acuity negatively affected reading accuracy, across all container shapes. Implications for Practitioners: Individuals with legal blindness may need more time to read prescription drug labels and may benefit from labels adhered to flat surfaces over traditional cylindrical containers. As medication safety is a critical skill for independent living, practitioners should assess their clients' ability to access prescription drug label information, keeping in mind that these abilities may differ across different container shapes. [ABSTRACT FROM AUTHOR]

Background: Patient centricity has gained attention ranging from regulatory authorities to patient advocacy groups, calling for pharmaceutical companies to revise their traditional business approach to drug development by including the development of solutions that are meaningful in patients' lives. Medication packaging is one area where empirical evidence is lacking about the incorporation of patient centricity. This study aimed to explore patient centricity applied to pharmaceutical companies' packaging, and to identify the specific challenges faced and lessons learned when developing patient-centered packaging. Methods: The study followed a multiple-case study research approach based on five cases of patient-centered packaging development in mid- and large-sized pharmaceutical companies. Results: Patient-centered packaging is often associated with the intuitive and self-explanatory use of the medication by patients. Patient-centered packaging comes with challenges, but also offers opportunities for the creation of better solutions for patients and learning for the teams involved. To overcome these challenges, it is essential to build a business case that justifies such development, one where patient needs are present from the start and aligned with other imperative deadlines of drug development, with stakeholders onboard. Conclusion: Patient-centered packaging is the exception rather than the norm in packaging development due to a conventional approach where packaging plays an ancillary role to drug protection. The cases presented here challenge this approach and can inspire other companies to carry out patient-centered packaging development. The cases are also relevant to other actors who are interested in continuously promoting the dialogue about patient centricity in healthcare. [ABSTRACT FROM AUTHOR]

Biological medicines are synthesised within living organisms utilising biotechnology processes, and include a number of manufactured insulins. Once the patents on these medicines expire, other manufacturers are able to replicate them, producing so-called biosimilars. Although the manufacturing and approval processes for these large molecules are more complicated than for smaller, generic drugs, biosimilars can, if proven to be equivalent to the original drugs in terms of efficacy and safety, offer cost savings. This article reviews the science behind biosimilar insulins and explains the rationale for their use, as well as providing practical advice on initiating or switching to these potentially cheaper drugs. A condensed summary of these practical points can be found here. [ABSTRACT FROM AUTHOR]

High-density polyethylene tablet containers are potentially very suitable for recycling, but no data are publicly available on active pharmaceutical ingredients' (API) residues in empty containers and if they affect the recyclability of pharmaceutical packaging. Plastic tablet containers represented 15 % of pharmaceutical primary packages sold in Finland in 2020 and 2021, equalling 350 tons of plastic per year. We studied the residues of six APIs remaining or adsorbed inside plastic tablet containers. The effects of tablet coating and usage in dose-dispensing services versus households on the API residues, and rinsing water's ability to remove the residues were evaluated. Up to 940,000 µg/kg of carbamazepine was detected in a container of uncoated carbamazepine tablets. The residues from coated tablets containing the other five APIs were 2.4-6,100 µg/kg. Ten times higher paracetamol residues were obtained in containers from household use than from a dose-dispensing unit. Rinsing can remove most API residues, but it leads to environmental emissions. For example, rinsing water can double carbamazepine emissions from a Finnish wastewater treatment plant where plastic packaging waste effluents are processed. Considering the API concentrations, decreasing residues by rinsing and dilution with other plastic packaging waste, the residues of the studied APIs are not considered an obstacle to the recycling of plastic tablet containers. However, further research is needed on more toxic APIs and the fate of APIs in the plastics recycling process., 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 Ltd.. All rights reserved.)

Summary Drug repurposing is an approach used to discover new indications for existing drugs. Recently, several computational approaches have been developed for drug repurposing in cancer. Nevertheless, no approaches have reported a systematic analysis of pathway crosstalk. Pathway crosstalk, which refers to the phenomenon of interaction or cooperation between pathways, is a critical aspect of tumor pathways that allows cancer cells to survive and acquire resistance to drug therapy. Here, we innovatively developed a system biology R-based software package, DRviaSPCN, to repurpose drugs for cancer via a subpathway (SP) crosstalk network. This package provides a novel approach to prioritize cancer candidate drugs by considering drug-induced SPs and their crosstalk effects. The operation modes mainly include construction of the SP network and calculation of the centrality scores of SPs to reflect the influence of SP crosstalk, calculation of enrichment scores of drug- and disease-induced dysfunctional SPs and weighted them by the centrality scores of SPs, evaluation of the drug–disease reverse association at the weighted SP level, identification of cancer candidate drugs and visualization of the results. Its capabilities enable DRviaSPCN to find cancer candidate drugs, which will complement the recent tools which did not consider crosstalk among pathways/SPs. DRviaSPCN may help to facilitate the development of drug discovery. Availability and implementation The package is implemented in R and available under GPL-2 license from the CRAN website (https://CRAN.R-project.org/package=DRviaSPCN). Supplementary information Supplementary data are available at Bioinformatics online. [ABSTRACT FROM AUTHOR]

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low health literacy and/or limited English proficiency are at higher risk for making errors in administering medications to children in their care. Recommended strategies to reduce home medication errors relate to provider prescribing practices; health literacy-informed verbal counseling strategies (eg, teachback and showback) and written patient education materials (eg, pictographic information) for patients and/or caregivers across settings (inpatient, outpatient, emergency care, pharmacy); dosing-tool provision for liquid medication measurement; review of medication lists with patients and/ or caregivers (medication reconciliation) that includes prescription and over-the-counter medications, as well as vitamins and supplements; leveraging the medical home; engaging adolescents and their adult caregivers; training of providers; safe disposal of medications; regulations related to medication dosing tools, labeling, packaging, and informational materials; use of electronic health records and other technologies; and research to identify novel ways to support safe home medication administration. [ABSTRACT FROM AUTHOR]

Objective: To reduce drug dispensing errors through development of the barcode scanning check system in drug dispensing. Methods: Drug barcode types for various drugs were fed in the drug dictionary of the hospital information system, and commodity codes on drug packaging and/or electronic drug regulatory codes were also installed in the system, and a validation barcode switch was placed in dispensing windows to add another validation barcode process during drug dispensing. Results: After 6 months of application, the system successfully intercepted 141 drug dispensing errors due to similar packaging or similar brand names. Inventory check revealed that there was no inconsistency between accounts and drugs dispensed due to similar packaging or similar brand names. As a result, the load on pharmacists for checking was obviously relieved, work efficiency improved, and the average waiting time of the patients for taking drugs was shortened by 9.52%. Condlision: Barcode scanning check system for drug dispensing could help pharmacists to improve the accuracy and efficiency of drug checking, relieve work load at the drug dispensing window and shorten the waiting time of patients, with less input. For this reason, it is worth further promotion. [ABSTRACT FROM AUTHOR]

The efficiencies of several multivariate methods of recognition of drug classes in primary packaging using THz transmission spectra are compared. The advantage of support vector machines is demonstrated with a classification error ≤5.7% for two groups of analgesic drugs with a high level of heterogeneity of samples in the groups. [ABSTRACT FROM AUTHOR]

pH-sensitive and amphiphilic chitosan derivatives can be used as hydrophobic drug carriers, and their rheological properties play a key role in their performance. In this paper, two pH-responsive and amphiphilic chitosan derivatives, N -(2-allyl-butyl glycidyl ether)- O -carboxymethyl chitosan (HBCC) and N -(2-ethylhexyl glycidyl ether)- O -carboxymethyl chitosan (H2ECC) were synthesized, and their rheological properties were studied. The influence of parameters including concentrations of HBCC and H2ECC, the degree of substitution, solution pH, and [Ca2+] on the rheological properties were investigated. The results showed that the overlap and entanglement concentration of HBCC and H2ECC was ca. 1.7 wt% and 5 wt%, respectively. The dilute and semidilute solutions showed Newtonian behavior. Above 5 wt%, strong networks formed, and shear-thinning behavior appeared at high shear rates (>10 s−1) for entangled solutions. A high degree of substitution and pH near the isoelectric points of HBCC and H2ECC corresponded to a low viscosity and viscoelasticity. In addition, Ca2+ played a shielding effect on the –COO− groups at low concentrations (<10 mmol/L), whereas it acted as a cross-linker when [Ca2+] ≥ 20 mmol/L. The intermolecular hydrogen bonds were examined by molecular dynamics simulations. The results provide new information related to the application of HBCC and H2ECC for hydrophobic drug packaging and transportation. • Entanglement concentration of both HBCC and H2ECC was determined. • Both HBCC and H2ECC showed pH-sensitivity and amphiphility. • A high DS and pH near pI corresponded to a low viscosity and viscoelasticity. • Ca2+ played different roles at low or high concentrations of HBCC and H2ECC. [ABSTRACT FROM AUTHOR]

Many clinically important drugs come directly or indirectly from higher plants. People are increasingly aware of the role of the human immune system in maintaining good health. Diseases related to physical dysfunction, such as vertigo, have attracted increasing attention from medical researchers and clinicians. In this paper, some compounds isolated and identified from medicinal fomes showed promising antivertigo properties. Medical images were used to classify and synthesize polysaccharides in the management of drug subpackages of Cladosporium intracellular polysaccharides. The scientific explanation of how these compounds work in animal and human systems is increasing exponentially. Studies have found that all of these compounds can enhance the innate and adaptive immune responses of the host and activate various immune cells that are important for maintaining homeostasis, such as host cells and chemical messengers, triggering complement and acute phase reactions. The antivertigo compounds derived from the intracellular polysaccharides of Phellinus mucronatus had an activity interference of 35% without drug subpackage. Although the antivertigo activity of many intracellular polysaccharides from Fovea xylostella can reach 86%, only a few of them have been proved to have antivertigo activity. In addition, they can be considered as multicytokine inducers that can induce the expression of various immune-regulatory cytokines and cytokine receptor genes. Lymphocytes that control antibody production and cell-mediated cytotoxicity are also stimulated. [ABSTRACT FROM AUTHOR]

HIV has transformed from a serious acute illness with high rates of morbidity and mortality to a fairly easily managed chronic disease. However, children and adolescents living with HIV are yet to achieve similar improvement in their HIV care outcomes compared to adults. There have been a number of studies assessing the reasons for slower improvement in these age categories, mainly focusing on health systems, drug- and family- related barriers to ART adherence in children. We sought to explore school-related barriers to adherence through in-depth interviews with students living with HIV (SLHIV) aged 13–17 years who had fully disclosed their HIV status in western Kenya. Data was analysed using NVivo 8™. The study found that stigmatisation in the form of negative discussions and alienation, fear of unintended disclosure (due to the drug packaging and lack of privacy while taking their pills) were barriers to ART adherence among these SLHIV. Other barriers included challenges with drug storage while in school and the complexity of coordinating school and clinic-related activities and a lack of structured support systems in schools. In addition to hindering their adherence to ART, these barriers resulted in negative emotions (anger, sadness, frustration) and affected school performance. This study found fairly serious barriers to ART adherence among SLHIV, which calls for structured communication and coordinated support between government ministries of health and education in Kenya. [ABSTRACT FROM AUTHOR]

Rebecca J Bartlett Ellis,1 Deanna Hertz,2 Patrick Callahan,3 Todd M Ruppar4 1Department of Science of Nursing Care, Indiana University School of Nursing, Indianapolis, IN, USA; 2Ipsos Ltd., South Lake Tahoe, CA, USA; 3Becton, Dickinson and Company, San Diego, CA, USA; 4Department of Adult Health and Gerontological Nursing, College of Nursing, Rush University, Chicago, IL, USACorrespondence: Rebecca J Bartlett EllisDepartment of Science of Nursing Care, Indiana University School of Nursing, 600 Barnhill Drive, E423, Indianapolis, IN 46202, USATel +1 317 274 0047Email rjbartle@iu.eduPurpose: Medication nonadherence is a significant and multidimensional problem contributing to an increased risk of morbidity and mortality. Inconveniences in pharmacy and home contexts may increase nonadherence. This research examined inconveniences in pharmacy and home contexts associated with self-reported nonadherence, controlling for demographic and medication-taking covariates.Methods: Data from 4682 individuals who reported self-managing medications in an online marketing survey between October and December 2017 were analyzed in this secondary analysis. Nonadherence was dichotomized using a single question about likelihood to take medications as prescribed (adherence=always; nonadherence=most of the time, some of the time, never). Multivariable logistic regression with backwards elimination was used to examine the pharmacy (use of home delivery, number prescriptions picked up and visits to pharmacy) and home context (method used to organize/manage medications, satisfaction, and bother with management) variables and the demographic (age, sex, race/ethnicity, education, income, insurance) and medication (number of oral medications, medication changes and frequency of taking) covariates associated with nonadherence.Results: Overall, 25.8% of the responses indicated nonadherence. Nonadherence was more likely for individuals making fewer separate pharmacy trips (OR 0.98; 95% CI 0.97– 0.99); picking up fewer prescriptions (OR 0.96; 95% CI 0.93– 0.99); never, rarely or sometimes using mail order compared with always (OR 1.71; 95% CI 1.30– 2.26); not satisfied with managing medications (OR 2.13; 95% CI 1.42– 3.19); and using pill pouches and being bothered by them (OR 8.28; 95% CI 1.83– 37.31). Using pill pouches or a pillbox and not being bothered by them significantly decreased nonadherence likelihood. Younger and female respondents and those reporting medication changes in the last year were also more likely to report nonadherence.Conclusion: Though reasons for nonadherence are multidimensional, this study suggests that inconveniences in both the pharmacy and home context are important. Improving adherence requires addressing issues of inconvenience across the care continuum.Keywords: medication adherence, medication compliance, community pharmaceutic services, outpatient, drug packaging, behavior and behavior mechanisms, MeSH

The fast growth of counterfeiting medicines in the last two decades has created one of the biggest problems facing the pharmaceutical industry on the global level, resulting in loss of income, product withdrawal, loss of brand value, etc. But this is not only the problem of the intellectual property rights of the pharmaceutical industry, it is also the problem of the healthcare regulatory authorities, whose most significant concern is the risk to the public health. Pharmaceutical manufacturers, together with the wholesalers and retailers, have an essential role in the fight against counterfeit medicines by the implementation of different anti-counterfeit technologies for securing the supply-chain of medicines. The protection of drug packaging has a specific role in the drug development process, as well as in the fight against counterfeit medicine. The authenticity of the medicine and the forensic elements for protection on the packaging may be confirmed using different technologies. Tracking and tracing of pharmaceutical products in the supply chain, keeping electronic records for all stages of the distribution, and verification of the authenticity of a medicinal product is a key element and an effective solution for timely detection of counterfeit medicines and protection of intellectual property rights.

This work highlights the evidential value of examining plastic drinking straws to establish linkages between multiple sources for forensic intelligence, investigative or prosecution purposes. Plastic drinking straws are commonly encountered in drug cases, either as inhalational paraphernalia or as packaging material. However, to the best of our knowledge, systematic studies on the evidential value of straws have not previously been carried out. In this study, over 80 packets of clear and colourless straws—most of which were visually similar—were purchased from various commercial outlets in Singapore. Some physical characteristics (viz., polarizing patterns, thickness, circumference and mass per unit length) and the manufacturing marks of these straws were examined to assess their potentials for discriminating straws from different packets. Comparison of polarizing patterns yielded a discrimination of approximately 69%, while thickness, circumference, and mass per unit length measurements resulted in lower discriminations. Comparison microscopy of manufacturing marks was found to be the most discriminating among all techniques employed herein, with a discrimination of about 95%, even among straws with similar polarizing patterns.

Interest in minitablets (MTs) has grown exponentially over the last 20 years and especially the last decade, as evidenced by the number of publications cited in Scopus and PubMed. MTs offer significant opportunities for personalized medicine, dose titration and flexible dosing, taste masking, and customizing drug delivery systems. Advances in specialized MT tooling, manufacturing, and characterization instrumentation have overcome many of the earlier development issues. Breakthrough MT swallowability, acceptability, and palatability research have challenged the long-standing idea that only liquids are acceptable dosage forms for infants and young children. MTs have been shown to be a highly acceptable dosage form for infants, small children, and geriatric patients who have difficulty swallowing. This review discusses the current state of MT applications, acceptability in pediatric and geriatric populations, medication adherence, manufacturing processes such as tableting and coating, running powder and tablet characterization, packaging and MT dispensing, and regulatory considerations., 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 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

For the majority of cytotoxic drug preparations, such as bortezomib, the unit dose information is not available. In addition, there is a lack of information on the physicochemical stability of the pharmaceutical preparation after opening; this information is crucial for its administration to patients in successive visits, and the per-patient cost can be affected. The purpose of our proposed physicochemical stability study is to determine the shelf life of the reconstituted liquid product under refrigeration and clinical practice conditions. This evaluation was extended to both vials and ready-to-use syringes prefilled with the contents of the open vial. The stability test design includes the specified storage conditions and the critical physicochemical parameters of reconstituted injectable bortezomib. Furthermore, this approach includes the determination of impurities, the monitoring of the purity of the mean peak using a photodiode array, the control of the mass balance, the monitoring of subvisible particles using a laser diffraction analyser, and the setting of stability specifications. For the chemical stability study, the amount of bortezomib and its degradation products were determined using a stability-indicating HPLC method. The physical inspection of the samples was performed throughout the stability study, and their pH values were also monitored. Bortezomib (2.5 mg/mL) in 0.9% sodium chloride remained stable for 7 days when stored in both polypropylene syringes and vials at 5 ± 3 °C (refrigeration) and shielded from light. Additionally, it exhibits stability for 24 h under storage conditions simulating clinical use (20-30 °C and protected from light). The proposed protocol provides the stability in the vials once reconstituted and in prefilled refrigerated syringes; this protocol can be used to reduce waste and increase cost savings., (© 2024. The Author(s).)

Leachables are substances that are leached from a medical device during its clinical use and are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables as probable leachables) to assess their potential impact on patient health and safety. This profiling is accomplished by screening extracts or leachates of the medical device for released organic substances via non-targeted analysis (NTA) employing chromatographic methods coupled with mass spectrometric detection. Chromatographic mass spectral response factors (RFs) for extractables and leachables vary significantly from compound to compound, complicating the quantitation of these compounds and the application of assessment strategies such as the Analytical Evaluation Threshold (AET). The analytical uncertainty resulting from response factor variation can be expressed in terms of an uncertainty factor (UF), which estimates the magnitude of response factor variation. This manuscript discusses the concept and impact of analytical uncertainty and provides best practice recommendations for the calculation and use of the uncertainty factor, UF., 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.)

For liquid drug products, e.g., solutions or suspensions for oral or parenteral dosing, stability needs to be demonstrated in primary packaging during storage and in dosing devices during in-use periods per quality guidelines from the International Conference on Harmonisation (ICH) and the European Agency for the Evaluation of Medicinal Products (EMEA). One aspect of stability testing for liquid drug products is in-use stability, which typically includes transferring the liquid samples into another container for further sample preparation with extraction diluent and necessary agitation. Samples are then analyzed with traditional chromatography methods, which are laborious, prone to human errors, and time-consuming, especially when this process needs to be repeated multiple times during storage and in-use periods. Being able to analyze the liquid samples non-destructively would significantly improve testing efficiency. We investigated different Raman techniques, including transmission Raman (TRS) and back scatter Raman with a non-contact optic (NCO) probe, as alternative non-destructive tools to the UHPLC method for API quantitation in in-use liquid samples pulled into plastic dosing syringes. The linearity of the chemometric methods for these two techniques was demonstrated by cross-validation sample sets at three levels over an API concentration range of 60 to 80 mg/mL. The accuracy of the chemometric models was demonstrated by the accurate prediction of the API concentrations in independent samples from four different pilot plant batches manufactured at different sites. Both techniques were successful in measuring a signal through a plastic oral dosing syringe, and predicting the suspension API concentration to within 4% of the UHPLC-measured value. For future work, there are opportunities to improve the methodology by exploring additional probes or to expand the range of applications by using different sample presentations (such as prefilled syringes) or formulation matrices for solutions and suspensions., (© 2024. AbbVie Inc., under exclusive licence to American Association of Pharmaceutical Scientists.)

Residual volumes of infusion solutions vary greatly due to container and dimensional variances. Manufacturers use overfill to compensate, but the exact amounts vary significantly. This variability in overfill - when carrier solutions are used to dilute other parenteral preparations - may lead to variable concentrations and dosing, hence, potential risk for patients. We analyzed the overfill and residual volume of 22 pre-filled infusion containers and evaluated the impact on the (simulated) dosing accuracy of a therapeutic drug product for different handling scenarios. In addition, compendial properties of the diluents (i.e. sub-visible particles, pH, color and opalescence) were assessed. The overfill and residual volume between different containers for the same diluent varied. As container size increased, the relative volume of overfill decreased while the residual volume remained constant. The design and material of the containers (e.g. port systems) defined the residual volume. Different handling scenarios led to differences in dosing accuracy. As a result, no universal approach applicable for all containers can be defined. To ensure the right dose, it is recommended to pre-select the preferred diluent, evaluate fill volumes of carrier solutions, and assess in-use compatibility of the product solution with its diluent in terms of concentration and volume., 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. This research was funded by and conducted at Lonza AG (Lonza), Basel. M. W. was supported by a grant from Lonza. V. L., A. B. and A. S. S. were employed at Lonza, Basel at the time of this work. HC. M. and J. H. are not affiliated with Lonza. The authors have not received any additional benefits., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

In this study, a multi-functional packaging film was fabricated, utilizing the natural polysaccharide chitosan (CS) as the base material, integrating natural blueberry anthocyanin (AN) as pH-responsive indicator, and reinforced with cellulose nanocrystals (CNCs). The implications of addition levels of CNCs on the characteristics of the films were systematically investigated, resulting in that CS-AN-CNCs 9 % film exhibited optimal performance. Specifically, the film showed a substantial enhancement in maximum tensile strength from 15 MPa to 35 MPa; On the other hand, the swelling degree properties, the oxygen permeability and water vapor permeability decreased from 159.2 % to 92.0 %, from 51.7 g/(m 2 d) to 12.2 g/(m 2 d), from 31.6 × 10 -12  g/(m·s·Pa) to 1.6 × 10 -12  g/(m·s·Pa), respectively. Moreover, the CS-AN-CNCs 9 % film exhibited antioxidant, antibacterial, coupled with a color metrically responsive to pH variations, displaying great potential in indicating the shrimp freshness and delaying spoilage. Another notable advantage of the-prepared packaging material lies in its completely biodegradability, therefore meeting the requirement of environmental protection. Therefore, the prepared CS-AN-CNCs film as an intelligent packaging solution with potential applications in food preservation and freshness monitoring applications., 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.)

Among the common natural biomolecules, the excellent properties of proteins have attracted extensive attention from researchers for functional applications, however, in native form proteins have many limitations in the performance of their functional attribute. However, with the deepening of research, it has been found that the combination of natural active substances such as polyphenols, polysaccharides, etc. with protein molecules will make the composite system have stronger functional properties, while the utilization of pH-driven method, ultrasonic treatment, heat treatment, etc. not only provides a guarantee for the overall protein-based composite system, but also gives more possibilities to the protein-composite system. Protein composite systems are emerging in the fields of novel active packaging, functional factor delivery systems and gel systems with high medical value. The products of these protein composite systems usually have high functional properties, mainly due to the interaction of the remaining natural active substances with protein molecules, which can be broadly categorized into covalent interactions and non-covalent interactions, and which, despite the differences in these interactions, together constitute the cornerstone for the stability of protein composite systems and for in-depth research., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Hao Zhang reports article publishing charges and equipment, drugs, or supplies were provided by National Natural Science Foundation of China. Hao Zhang reports a relationship with National Natural Science Foundation of China that includes: funding grants., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Despite the prevalence of single-serve and multi-serve package formats in the pharmaceutical and functional food and beverage industries, prior research has yet to explore the effects of such package formats on consumers' perceptions of product efficacy. Building on the resource availability, product packaging, and psychological closure literature, the authors demonstrate across seven studies that when processing capacity is low, consuming a particular serving/dosage of a product from a smaller resource inventory (i.e., the entirety of a single-serve package) may subjectively feel more adequate than consuming the same amount from a larger resource inventory (i.e., a multi-serve package, namely one in which additional servings/doses remain after consumption). Results indicate that differences in felt consumption closure underlie perceptions of product adequacy. Importantly, perceived product adequacy is shown to affect consumers' actual product efficacy experiences (i.e., task performance), expectancies, and judgments. The implications of this research for marketers, consumers, and the public health community are discussed. [ABSTRACT FROM AUTHOR]