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Technology enabling drug serialisation technology was introduced by regulators to enhance security in pharmaceutical supply chain and protect drugs from infiltration by falsified and substandard medicines. The introduction of systems for serialisation required huge financial outlays manufacturers of pharmaceuticals. This study investigated the impact of serialisation on the operational efficiency and productivity in Irish pharmaceutical sites. A qualitative study was conducted with 11 manufacturing sites in Ireland. The participating companies operated a total of 114 pack-lines, representing approximately 65% of the automated packing lines in the country. The study found that serialisation had a negative effect on packaging production line OEE and line availability and on the individuals cost per unit of packaged pharmaceuticals. The research results estimated that the capital costs of serialisation were four times greater than those estimated by the regulators. There was a 4.1 cents average cost per pack for serialisation with high volume sites reporting an annual cost of serialisation of up to €4.5 m per annum and a 2.7% increase in the average cost of goods sold. A pattern whereby where many pharmaceutical manufacturers are transitioning from smaller batch production and moving toward larger batch production sizes in order to increases efficiencies was identified. The research also proposed the use of a serialisation depreciation factor as a method to determine the impact of serialisation on the cost of goods sold. This is the first study of its kind into the cost of serialisation from a manufacturer's viewpoint and studying the effects of serialisation on productivity, line availability and operational efficiency. [ABSTRACT FROM AUTHOR]

Background: Drug administration errors (DAEs) in anaesthesia are common, the aetiology multifactorial and though mostly inconsequential, some lead to substantial harm. The extend of DAEs remain poorly quantified and effective implementation of prevention strategies sparse. Method: A cross-sectional descriptive study was conducted using a peer-reviewed survey questionnaire, circulated to 2217 anaesthetists via a national communication platform. The aim was to determine the self-reported frequency, nature, contributing factors and reporting patterns of DAEs among anaesthesia providers in South Africa. Results: Our cohort had a response rate was 18.9%, with 420 individuals populating the questionnaire. 92.5% of surveyed participants have made a DAE and 89.2% a near-miss. Incorrect route of administration, potentially resulting in serious harm, accounted for 8.2% (n = 23/N = 279) of these errors. DAEs mostly reported in cases involving adult patients (80.5%, n = 243/N = 302), receiving a general anaesthetic (71.8%, n = 216/N = 301), where the drug-administrator prepared the drugs themselves (78.7%, n = 218/N = 277), during normal daytime hours (69.9%, n = 202/N = 289) with good lightning conditions (93.0%, n = 265/N = 285). 26% (n = 80/N = 305) of DAEs involved ampoule misidentification, whilst syringe identification error reported in 51.6% (n = 150/N = 291) of cases. DAEs are often not reported (40.3%, n = 114/N = 283), with knowledge of correct reporting procedures lacking. 70.5% (n = 198/N = 281) of DAEs were never discussed with the patient. Conclusions: DAEs in anaesthesia remain prevalent. Known error traps continue to drive these incidents. Implementation of system based preventative strategies are paramount to guard against human error. Efforts should be made to encourage scrupulous reporting and training of anaesthesia providers, with the aim of rendering them proficient and resilient to handle these events. [ABSTRACT FROM AUTHOR]

Background: Cytotoxic medicine contamination of preparation and administration areas of oncology healthcare facilities poses a risk to staff facing repeated low‐level exposure over time. The use of closed‐system transfer devices (CSTDs) during preparation and administration of cytotoxic products may reduce the levels of contamination. The primary aim was to determine the levels of cytotoxic medicine contamination in preparation and administration areas of hospitals that use CSTDs compared to those that do not. Aim: The primary aim was to determine the levels of cytotoxic medicine contamination in preparation and administration areas of hospitals that use CSTDs compared to those that do not. Method: A retrospective, cross‐sectional study across four Australian hospitals was conducted. Cytotoxic medicine contamination was determined via surface wipe sampling on six specified surfaces. The samples were tested for cyclophosphamide, docetaxel, etoposide, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, topotecan, and vinblastine. This project was exempt due to the local policy requirements that constitute research by the South Eastern Sydney Local Health District Human Research Ethics Committee (Reference no: ETH01899). The justification for this ethics exemption was as follows: this was a study involving sample testing only and did not include human participants or participation. Results: Environmental contamination with cytotoxic medications was observed at all hospitals, regardless of the CSTD used. Of the 24 samples tested, the agent most frequently seen was ifosfamide with 29% (n = 7), followed by cyclophosphamide 13% (n = 3), and methotrexate 8% (n = 2). There was no statistically significant difference between hospitals that used CSTDs compared to hospitals that did not (25% vs 42%, p = 0.67). Contamination was more extensive in preparation areas than administration areas, and was observed on the biological safety cabinets (BSC) worktop, packaging bench, and floor in front of the BSCs. Conclusion: All sites had contamination present for cytotoxic medicines. There was no statistically significant difference in the proportion of contaminated surfaces between sites that used CSTDs versus sites where CSTDs were not used. Only ifosfamide contamination was identified in pharmacy areas that used CSTDs. Safe work practices and staff training are encouraged to further minimise exposure risk. [ABSTRACT FROM AUTHOR]

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

The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.S. Administration of the FDA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS). The regulatory oversight of the FDA is complex and comprehensive, requiring the various roles and responsibilities to be divided across six main centers. The activities of two of these centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the primary focus of this review. [ABSTRACT FROM AUTHOR]

This study investigates the factors influencing the lack of Braille-embossed labels in Chinese pharmaceutical product packaging. To this end, this study constructs an evolutionary game model of multi-participant behaviour in drug production regulation and conducts simulation based on the perspective of stakeholders in order to study the evolutionary steady state of regulatory authorities, pharmaceutical companies, and visually impaired individuals and the influence of each parameter variable on the choice of strategic behaviour of the participants. The simulation results show that in the legal framework of China, administrative penalties, the production subsidy rate, and the Basic Medical Insurance (BMI) reimbursement rate are the main drivers of the system's evolution towards a steady state. Reduced costs of drugs with Braille-embossed packaging is a prerequisite for the visually impaired to purchase such drugs, and the key for the whole system to converge to a stable state therefore lies in the BMI reimbursement rate for drugs with Braille-embossed packaging. This paper suggests that the Chinese government should improve the law enforcement mechanism for the regulation of the production of drugs with Braille-embossed packaging; increase the type and intensity of administrative penalties as well as production subsidies, tax incentives, and compliance incentives for pharmaceutical companies; and provide higher BMI reimbursement rates for the visually impaired. The results of the study provide valuable insights to improve accessibility to drugs and build a barrier-free environment for ensuring medication safety in China and other developing countries. [ABSTRACT FROM AUTHOR]

In the field of pharmaceutical supply chains, there is a lack of comprehensive historical data, representing a significant barrier to advancing research. To address this gap, we introduce a high-resolution dataset comprising drug packages distributed to approximately 300,000 pharmacies, hospitals, and practitioners across the US. We reconstruct 375 million distribution paths from ARCOS, a DEA-maintained database comprising half a billion shipping records between 2006 and 2014. While ARCOS tracks dyadic shipments, it does not provide information on the complete journey of single packages from manufacturers to final destinations. Our algorithm is able to reconstruct complete distribution paths from these dyadic records. The reconstructed dataset, with its high temporal and spatial resolution, offers an unprecedented view of US pharmaceutical distribution and is a valuable resource for investigating supply and distribution networks. [ABSTRACT FROM AUTHOR]

Introduction: Drug regulatory agencies are particularly interested in pharmacovigilance data relating to medication errors (MEs) involving a product-related cause (problems with drug names, packaging, labels, tablet marking, modalities of drug use, or instructions for users), an educational failure, or a 'never event'. Older adults are particularly affected by MEs but little is known about the root causes of MEs, which could be a focus for regulatory agencies. Objective: The aim of this study was to describe and characterise MEs associated or not associated with adverse reactions that have occurred in older adults and fall under the scope of drug regulatory agencies. Method: A retrospective and descriptive analysis of pharmacovigilance data from the French Pharmacovigilance Network was performed. All ME reports, with or without adverse effects (AEs), which occurred from 1 September 2019 to 31 August 2020 and involved adults aged 75 years and over were analysed. We conducted a globally descriptive analysis of MEs, in particular on root causes in the scope of drug regulatory agencies (i.e. product-related cause, educational failure, 'never events'). Results: During the study period, 802 MEs were reported to the French pharmacovigilance system; 305 (38.0%) were associated with AEs (of which 171 [56.1%] were serious and 13 [4.3%] were fatal). The mean age of patients was 85.2 years and 493 (61.5%) were females. Globally, 224 (27.9%) of MEs had at least one root cause in the scope of the regulatory agencies and were more frequently observed in cases of MEs with AEs compared with those without (174 [57.1%] vs. 46 [9.2%]). The first root cause was an educational problem (159, 71%), followed by 'never events' (94, 42%) and product-related causes (20, 9%). MEs due to problems in the scope of regulatory agencies occurred more frequently at the administration and prescription stages and consisted of a wrong drug, wrong dose, and dosage/concentration. Conclusions: In the older population, the proportion of MEs for which a drug regulatory agency could act is high, confirming the importance of reporting MEs to pharmacovigilance in order to implement risk reduction measures. The ignorance of medication use was the first reason for errors, and actions taken by the health authorities should focus on producing visible and understandable instructions for healthcare professionals and patients. It is also necessary to collaborate closely with the manufacturers to improve packaging, labelling and product nomenclature to completely safeguard the use of their products. [ABSTRACT FROM AUTHOR]

Medications are common means of suicide. Rural areas have high suicide rates, greater proportions of older adults and veterans, and few providers. We assessed the implementation potential of community pharmacy interventions for lethal means management (LMM). The feasibility, acceptability, and appropriateness of 8 LMM interventions were assessed by pharmacists in seven southeastern states via an online survey. Descriptive statistics were calculated. Pharmacists (N = 61) responded from 42 zip codes. The majority indicated that five (62.5%) interventions were very/extremely feasible, appropriate and acceptable. The greatest proportion rated medication therapy management (MTM) as very or extremely feasible, appropriate and acceptable (82%) followed by limiting prescription drug days' supplies (75.4%), blister packaging (68.9%), dispensing naloxone (62.3%), and suicide prevention training (59.0%). No pharmacies were currently distributing gun locks; however, some were already managing suicide risk with limited days' supply (31.7%), MTM (26.7%), naloxone distribution with every opioid dispensed (15.0%), monitoring patients for suicidal adverse events (16.7%), limits on sales or stock of non-prescription products (16.7%) or blister packaging (1.7%). Pharmacists endorsed LMM interventions, and most were already offering the endorsed interventions but not for LMM. The rural community pharmacists in this study believed several LMM services were highly feasible, acceptable and appropriate for use in preventing suicide. Community pharmacies offer services that may support clinicians managing patients at risk of suicide or with a history of suicidal behavior, including MTM, blister packaging, limited days' supply/more frequent refills to support monitoring of patient outcomes and suicide warning signs, distribution of naloxone and gun locks and training pharmacy staff in Pharm-SAVES gatekeeping. The majority of rural community pharmacists reported that 5 of 8 lethal means management (LMM) interventions were appropriate, feasible and acceptable with common barriers being lack of both reimbursement and time. Interprofessional training and protocols for LMM interventions and indications could support implementation by pharmacists in support of patients. [ABSTRACT FROM AUTHOR]

Background: Medical abortion with mifepristone and misoprostol can be provided up to 63 days' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India. Methods: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021. Results: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment. Conclusion: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed. Plain language summary: Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions. [ABSTRACT FROM AUTHOR]

The potential for drug substances and drug products to contain low levels of N -nitrosamines is of continued interest to the pharmaceutical industry and regulatory authorities. Acid-promoted nitrosation mechanisms in solution have been investigated widely in the literature and are supported by kinetic modelling studies. Carbonyl compounds, particularly formaldehyde, which may be present as impurities in excipients and drug product packaging components or introduced during drug substance manufacturing processes are also known to catalyze nitrosation, but their impact on the risk of N -nitrosamine formation has not been systematically investigated to date. In this study, we experimentally investigated the multivariate impact of formaldehyde, nitrite and pH on N -nitrosation in aqueous solution using dibutylamine as a model amine. We augmented a published kinetic model by adding formaldehyde-catalyzed nitrosation reactions. We validated the new kinetic model vs. the experimental data and then used the model to systematically investigate the impact of formaldehyde levels on N -nitrosamine formation. Simulations of aqueous solution systems show that at low formaldehyde levels the formaldehyde-catalyzed mechanisms are insignificant in comparison to other routes. However, formaldehyde-catalyzed mechanisms can become more significant at neutral and high pH under higher formaldehyde levels. Model-based sensitivity analysis demonstrated that under high nitrite levels and low formaldehyde levels (where the rate of formaldehyde-catalyzed nitrosation is low compared to the acid-promoted pathways) the model can be used with kinetic parameters for model amines in the literature without performing additional experiments to fit amine-specific parameters. For other combinations of reaction parameters containing formaldehyde, the formaldehyde-catalyzed kinetics are non-negligible, and thus it is advised that, under such conditions, additional experiments should be conducted to reliably use the model. [Display omitted] • Automated experimental investigation of formaldehyde-catalyzed N -nitrosation of dibutylamine in the presence of nitrite in aqueous solution. • An augmented kinetic model for the solution phase N -nitrosation of dialkyl amines including formaldehyde-catalyzed reactions is presented. • Simulations show that acid-promoted nitrosation mechanisms have significantly greater impact on nitrosamine formation than formaldehyde-catalyzed mechanisms at low formaldehyde concentrations. • Formaldehyde-catalyzed mechanisms become more significant at neutral to high pH in the presence of high levels of formaldehyde, e.g., during certain synthetic or workup steps. • Global sensitivity analysis shows that experimental data should be generated for an amine without available kinetic parameters required to use the model. [ABSTRACT FROM AUTHOR]

Background: Illicit substance sales facilitated by social media platforms are a growing public health issue given recent increases in overdose deaths, including an alarming rise in cases of fentanyl poisoning. However, little is known about how online users evaluate what features of social media posts convey safety, which can influence their intent to source illicit substances. Objectives: This study adapts conjoint analysis which assessed how attributes of social media posts (i.e., features) influence safety evaluations of mock posts selling illicit substances. 440 participants were recruited online for self-reporting use or purchase of controlled substances or prescription medicines recreationally. The following attributes were tested: drug packaging, drug offerings, profile photo of seller, payment info provided, and use of emojis. Results: Packaging was ranked the most important attribute (Average Importance =43.68, Offering=14.94, Profile=13.86, Payment=14.11, Emoji=13.41), with posts that displayed drugs in pill bottles assessed as the most safe. Attribute levels for advertising multiple drugs, having a blank profile photo, including payment information, and including emojis also ranked higher in perceived safety. Rankings were consistent across tested demographic factors (i.e., gender, age, and income). Survey results show that online pharmacies were most likely to be perceived as safe for purchasing drugs and medications. Additionally, those who were younger in age, had higher income, and identified as female were more likely to purchase from a greater number of platforms. Conclusions: These findings can assist in developing more precise content moderation for platforms seeking to address this ongoing threat to public safety. [ABSTRACT FROM AUTHOR]

In most countries, antibiotics for oral administration are put on the market in fixed packages. When there is no exact unit dispensing of antimicrobials, drug pack size may influence prescribers' choice of treatment duration. The aim of this study was to investigate the accordance of approved antibiotic packages with national guidelines for the treatment of community-acquired pneumonia (CAP). For the purpose of this study, criteria were developed to determine the accordance of approved antibiotic packages for treating CAP (criteria), which are based on recommendations from national guidelines for treating CAP. Subsequently, the accordance of approved antibiotic packages with the number of antibiotic doses resulting from the specified criteria was determined. Of 39 identified therapeutic option-package size combinations, 11 were found to be matched (28.2%), meaning there were no leftover medication units after completing therapy, and 28 were mismatched combinations (71.8%), indicating that there were excess doses of antibiotics remaining at the end of therapy. The results of this research showed a significant non-accordance of the approved antibiotic packages with the national guidelines for the treatment of CAP and, consequently, the creation of a large amount of residues of unit doses of antibiotics in the community. [ABSTRACT FROM AUTHOR]

Background: Efforts to increase capacity for oncology treatment in the author's Chemotherapy Day Unit, while allowing staff to treat more patients and offer more flexibility to patients, increased strain on the Aseptic Pharmacy at the author's Trust. Therefore, the possibility of nurse-led drug preparation was explored. Aims: Nurse-led monoclonal antibody (MAb) preparation was piloted to investigate whether a reduction in reliance on Aseptic Pharmacy could co-exist with maintaining optimal treatment capacity. The effectiveness of a closed system transfer device (CSTD) to protect nurses against drug exposure was also explored. Methods: A risk assessment for MAbs considered for nurse-led preparation was created, alongside a procedure for the safe handling of systemic anti-cancer therapy (SACT) with the use of a CSTD. Findings: The pilot resulted in an 89% reduction in the time patients had to wait for MAbs to be prepared. Seven oncology drugs were included in the new procedure without increasing the risk of exposure for nurses. Conclusion: The pilot successfully reduced demand on Aseptic Pharmacy while enabling efficient capacity use on the Chemotherapy Day Unit. The use of the CSTD minimised the risk of nurse exposure to SACT. [ABSTRACT FROM AUTHOR]

Pharmaceutical waste is a serious threat to both human health and the environment. This article discusses the impact of pharmaceutical waste, and explores the possibility of reusing unwanted medicines to mitigate the problem and the current barriers to implementation. [ABSTRACT FROM AUTHOR]

Purpose: To identify the levels of knowledge of nurses and physicians about the contamination of micro-sized glass particles in medicine content when opening glass ampoules containing parenteral medicines and the use of filter needles in reducing contamination. When the medicine ampoule is broken and opened, spill into the ampoule and contaminates the medicine. Medicines contaminated with glass particles pose a potential danger when they are administered parenterally to patients. Material and Methods: This study was planned as a descriptive cross-sectional study. The study was conducted with a total of 600 healthcare professionals, 300 physicians and 300 nurses, working in a university hospital between October and November 2020. The data were collected using the "Personal Information Form" and the "Information Form about Glass Particle Contamination and Filter Needle Use". Results: The highest response to the question "medicine contaminated with glass particles can cause complications in the patient" was I do not know at 52.7%. The highest number of correct answers at the rate of 76% was given to the question "particle scattering to buffer/fingers at glass ampoule opening". When nurses were asked "presence of micro-sized glass particles in the medicine drawn from the ampoule to the syringe" and "preventing from giving glass particles with the medicine to the patient", the rate of correct answers was higher with significant differences compared to physicians. Conclusion: Healthcare professionals had moderate knowledge of glass particle contamination and the use of filter needles. Variables such as profession, number of ampoules used in the clinic, and educational status affect the level of knowledge. Findings inform to stresses the need to raise awareness for reducing glass particle contamination. [ABSTRACT FROM AUTHOR]

Introduction: Increasing use of expensive oral anticancer medicines comes with the downside of a financial and environmental burden, partially caused by unused medication. Returned oral anticancer medicine to the pharmacy could be considered for redispensing providing guaranteed quality. This study aimed to identify and implement quality aspects and criteria for redispensing oral anticancer medicine in daily pharmacy practice. Methods: A systematic analysis was conducted to determine the eligibility of oral anticancer medicine for redispensing. Over a one-year period, the number of returned oral anticancer medicine accepted for redispensing was quantified, and the reduction in financial waste and environmental burden calculated based on this assessment. Results: Four categories of quality aspects were identified for determining the eligibility of oral anticancer medicine for redispensing: Product presentation suitability (stability characteristics, storage requirements), physical condition (unopened or opened secondary or primary packaging, visual appearance), authentication (Falsified Medicines Directive, confirmation of initial dispense, recall), and additional aspects (remaining shelf life, period of storage in uncontrolled conditions). A standardized procedure for redispensing was implemented in daily pharmacy practice. During the study period, 10,415 oral anticancer medicine dose units out of 13,210 returns (79%) were accepted for redispensing. The total value of oral anticancer medicine accepted for redispensing was €483,301, accounting for 0.9% of the total value dispensed during this period. Furthermore, the potential reduction in environmental burden was estimated at 1132.1 g of potent active pharmaceutical ingredient. Conclusions: By implementing strict procedures considering all relevant quality aspects, redispensing of oral anticancer medicine can be successfully implemented into daily pharmacy practice, resulting in a significant reduction in financial waste and environmental burden. [ABSTRACT FROM AUTHOR]

Background Herb shops are important for preparing medicinal plants. Improper packaging can lead to contamination of these plants by various types of microorganisms, fungi and yeasts. Objective This study aims to investigate the prevalence of microbial and fungal contamination in four plants from the Lamiaceae family in herb shops in Rasht, Iran. Methods In this study, 15 samples from mint, rosemary, and wild mint plants, and 16 samples from lemon balm were collected. The samples were diluted and incubated for one hour, then transferred onto Tryptic soy agar culture medium for bacterial enumeration. The sabouraud dextrose agar culture medium was used to count total mold and yeast, while McConkey Broth culture medium was used for specific identification of Escherichia coli. Data analysis was conducted in SPSS software, version 16. For comparing the bacterial and fungal contamination levels in the plant samples with the Pharmacopeial quality standard values, the non-parametric Wilcoxon signed rank test was used. Results Out of 61 plant samples, 59 (73.7%) were contaminated with bacteria, and 60 samples (86.6%) were contaminated with fungi. The number of samples contaminated with Escherichia coli was 27 (44.2%). The mean counts of bacteria and fungi in the plant samples were 3.39×105 and 6.3×105, respectively. Conclusion The microbial contamination in most of the plant samples examined in this study is significantly higher than the permissible limit. It is necessary for health authorities to implement stricter policies for monitoring the quality of natural products in herb shops of Rasht, Iran. [ABSTRACT FROM AUTHOR]

Background: Look-alike/sound-alike (LASA) drugs substantially contribute to global healthcare challenges and patient harm, necessitating a comprehensive understanding of LASA medication errors. Objective: The current study explored the prevalence and characteristics of medication errors related to LASA in a 200-bed general hospital. Methods: A mixed-methods approach was employed. The quantitative component analyzed the LASA drug error data using the hospital database. For the qualitative component, in-depth interviews with pharmacists and pharmacy staff were undertaken to gain insights into stakeholder perceptions and management of LASA-related issues. Results: Quantitative analysis highlighted three types of LASA medication errors: confusion due to similar drug names, appearance, and packaging. Drug name confusion accounted for most errors (64.62%), demonstrating the considerable risk associated with similar medication names. Packaging confusion accounted for 24.61% of errors, indicating the importance of a unique packaging design. Overall, 10.77% of errors were attributed to similar appearance, indicating that the visual resemblance of medications played a considerable role in LASA errors. Forty-six LASA drug pairs were identified, the most frequent being simvastatin 10 mg and simvastatin 20 mg. The errors were divided into two categories: Category A, with two pairs related to name and packaging similarities, and Category B, with 44 pairs involving all types of similarities. The differentiation between these categories underscores the complex nature of LASA errors. Semi-structured interviews revealed that anticipatory errors often occurred during busy periods, which could result in crucial details, such as drug strengths, being overlooked. Proposed solutions for reducing LASA errors included implementing Tall Man lettering, developing movable LASA signage, and improving workforce allocation. Root-cause analysis identified several factors, including drug similarities and staffing issues, as notable contributors to LASA errors, highlighting the need for a multi- pronged approach. Conclusion: LASA medication errors, particularly those attributed to drug name similarities, pose a considerable risk and persist despite existing safeguards. Implementing tailored strategies, such as Tall Man letters, movable LASA signage, and careful management of high-risk medication pairs, could aid in addressing these issues. [ABSTRACT FROM AUTHOR]

ObjectiveTo identify whether three types of cigarette pack designs, including three versions of graphic warning label (GWL) plain packs, one GWL absent and branding absent pack (blank) and the smoker's own GWL absent and branding present pack (US), elicit different valence, type and levels of affect.DesignUS daily smokers (n=324) were asked to handle each of the five pack types and 'think aloud' their reactions. To avoid a muted familiarity response, exposure to their own US pack followed exposure to at least one GWL plain pack. Reactions were scored on a reactivity scale (-3 to +3) and the text was coded for speech polarity (-1 to +1) and emotive word frequency.ResultsReactivity scores had excellent inter-rater reliability (agreement ≥86%; intraclass correlation coefficient ≥0.89) and were correlated with speech polarity (r=0.21-0.37, p

Background: Labelling is a strategy that contributes to the correct and faster identification of drugs, minimizing misidentification. There is a gap in knowledge on optimal labelling standards for intravenous (IV) devices applied to the care of critically ill patients. Aim: The goal of this article was to map existing knowledge on the labelling of IV drug delivery devices in critically ill patients for the prevention of medication errors. Study Design: This was a scoping review conducted according to the JBI methodology in the LILACS, MEDLINE, CINAHL, IBECS, Scopus, Embase and Web of Science databases, and on the websites of specialized institutions. Searches were conducted up to December 2022 for scientific articles and grey literature that addressed the labelling of IV devices in intensive care units, emergency departments, and anaesthesia units. The data were collected using a structured form and were later classified, summarized, and aggregated to map the knowledge related to the review question. Results: Twenty‐one documents were included, which demonstrated variability in label use with IV drug delivery devices. The following features of structure and design stood out: printed format, colour coding, letter size differentiation, and the use of sturdy material. In terms of information, the name of the drug, dose, date and time of preparation, identification of the patient, and who prepared it were found. Conclusions: The identified patterns contributed to the reduction of drug misidentification and the development of timelier drug labelling and administration. Relevance to Clinical Practice: The evidence supports the development of standardized labels for the prevention of medication errors. [ABSTRACT FROM AUTHOR]

Purpose: To develop a machine learning (ML)-based model for predicting the addition of clinically significant adverse reaction (CSAR)-associated information to drug package inserts (PIs) based on information of adverse drug reaction (ADR) cases during the post-marketing stage in Japan. Methods: We collected data on CSARs added to PIs from August 2011 to March 2020. ADR cases that led to CSARs resulting in PI revisions were considered as a positive case, and ML was used to construct a binary classification model to predict the PI revisions. We selected 34 features based on the ADR aggregate data collected 6 months before PI revisions. Prediction performance was evaluated using the Matthews correlation coefficient (MCC). Results: We found CSAR information added to PIs in 617 cases, 334 of which were due to the accumulation of domestic cases, and used only domestic case data for the prediction model. Among prediction models developed using several kinds of algorithms, the support vector machine with the radial basis function kernel with feature selection showed the highest predictive performance, having an MCC of 0.938 for the cross-validation and 0.922 for the test dataset. The feature with the highest importance in the model was the "average number of patients reported per quarter." Conclusion: Our model accurately predicted PI revisions using information on ADR cases that occurred 6 months before. This is the first ML model that can predict the necessary safety measures and is an efficient method for guiding the decision to adopt additional safety measures early. [ABSTRACT FROM AUTHOR]

Background: Here, the perspective of patients with primary and secondary immunodeficiency receiving subcutaneous immunoglobulin (SCIg) via introductory smaller size pre-filled syringes (PFS) or vials were compared. Methods: An online survey was conducted in Canada by the Association des Patients Immunodéficients du Québec (APIQ) (10/2020–03/2021). Survey questions included: reasons for choosing SCIg packaging and administration methods, training experiences, infusion characteristics, and switching methods. The survey captured structured patient-reported outcomes: treatment satisfaction and its sub-domains, symptom state, general health perception, and physical and mental function. Respondents using PFS were compared with vial users, overall and stratified by their administration method (pump or manual push). Results: Of the 132 total respondents, 66 respondents used vials, with 38 using a pump and 28 using manual push. PFS (5 and 10 mL sizes) were being used by 120 respondents, with 38 using a pump and 82 using manual push. PFS users were associated with a 17% lower median (interquartile range) SCIg dose (10 [8, 12] vs. 12 [9, 16] g/week, respectively), a significantly shorter infusion preparation time (15 [10, 20] vs. 15 [10, 30] mins, respectively), and a trend for shorter length of infusion (60 [35, 90] vs. 70 [48, 90] mins, respectively) compared with those on vials. Patient-reported treatment satisfaction scores were overall similar between vial and PFS users (including on the domains of effectiveness and convenience), except for a higher score for vials over PFS on the domain of global satisfaction (p=0.02). Conclusions: Consistent with prescribing that reflects a recognition of less wastage, PFS users were associated with a significantly lower SCIg dose compared with vial users. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction with treatment among vial users compared with PFS users was consistent with users being limited to smaller PFS size options in Canada during the study period. Patient experience on PFS is expected to improve with the introduction of larger PFS sizes. Overall, treatment satisfaction for SCIg remains consistently high with the introduction of PFS packaging compared with vials. [ABSTRACT FROM AUTHOR]

This comprehensive review traces the evolution of dentifrices from ancient concoctions to modern formulations, evaluating their role in oral health and environmental impact. Despite the global burden of oral diseases, notably dental caries and periodontitis, advancements in dentifrice technology have contributed to the decline in caries prevalence, although periodontitis remains a challenge. The historical perspective outlines the transition from abrasive powders to fluoride-enriched pastes, emphasizing the significance of toothbrushing frequency and technique, alongside the use of dentifrices, for effective plaque control and caries prevention. The modern era has seen a proliferation of dentifrice variations, with a focus on cosmetic attributes often overshadowing therapeutic benefits. The review also discusses the environmental considerations of dentifrice production and disposal, highlighting the shift towards sustainable packaging and ingredient transparency. The market analysis reveals a mature industry with a projected growth, influenced by consumer preferences and oral hygiene awareness. [ABSTRACT FROM AUTHOR]

Pancreatic cancer stands out as a recognized intractable tumor due to its high malignancy and mortality rates, which are largely attributed to the insensitivity of current clinical chemotherapies or multidrug-resistance. Combinatorial chemo and gene therapy that integrates different therapeutic targets, may increase the chemosensitivity of pancreatic cancer and synergistically enhance the antitumor efficacy. However, conventional co-delivery of gene and chemo drugs is intensively dependent on complex nanoparticle delivery systems, thus would be limited by unstable drug packaging, nonspecific biodistribution, and biosafety problem. Herein, we rationally designed an epidermal growth factor-receptor (EGFR)-targeted and gemcitabine-incorporated oligonucleotide (termed as chemogene) with anti-Bcl-2 sequence, which achieves simple and precise integration of gemcitabine into a gene regulative agent, as well as the EGFR-targeted delivery for pancreatic cancer therapy. Through solid-phase synthesis, gemcitabine, as the first-line chemodrug for pancreatic cancer, is introduced to the antisense oligonucleotide to replace all cytosine nucleosides to obtain the gemcitabine-integrated chemogene (Ge-ASOBcl-2). Thereafter, Ge-ASOBcl-2 is covalently coupled with EGFR nanobody to construct the final targeted chemogene without any exogenous carriers. Notably, this nanobody-conjugated chemogene exhibits remarkable tumor targeting capability and antitumor effects both in vitro and in vivo, which initiates a first step toward the application of combinatorial chemo and gene therapy for future pancreatic cancer treatment. [ABSTRACT FROM AUTHOR]

The article focuses on the significant impact of infusion drug costs, particularly drug waste, on oncology care costs in the U.S. Topics include the role of single-use vials in contributing to drug waste, the historical lack of incentives for manufacturers and healthcare systems to address this issue, and six strategies to reduce cancer drug dosing and waste, taking advantage of the Infrastructure Investment and Jobs Act (IIJA) incentives.

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

Introduction: Antineoplastic drugs (ADs) are commonly used pharmaceuticals for anticancer treatments. It has previously been shown that the external surface of drug vials frequently is contaminated with ADs. More than a decade ago methods to prevent occupational exposure were introduced by using plastic coverage of the glass vials or packing vials in a secondary plastic container. The aim of the pilot study was to determine contamination levels of ADs on different parts of AD packaging of two different commercially available drug vials on the Swedish market and to investigate the occurrence of cross contamination of ADs. Methods: Packagings of gemcitabine (GEM) and 5-fluorouracil (5-FU) were tested by wipe sampling. Five ADs; GEM, 5-FU, cyclophosphamide (CP), ifosfamide and etoposide were quantified using liquid chromatography mass spectrometry. Results: AD contaminations were detected in 69% and 60% of the GEM and 5-FU packaging samples. Highest levels, up to approximately 5 µ g/sample, were observed on the glass vials. The protective shrink-wrap of 5-FU vials and the plastic container of GEM were contaminated with low levels of 5-FU and GEM, respectively, and furthermore the 5-FU vials with shrink-wrap were cross-contaminated with GEM. Cross-contamination of CP and GEM was detected on 5-FU vials with plastic shrink-wrap removed. Conclusions: External contamination of ADs are still present at primary drug packagings on the Swedish market. Protection of AD vials by plastic shrink-wrap or a secondary plastic container does not remove the external contamination levels completely. The presence of cross contamination of ADs on drug packagings was also observed. [ABSTRACT FROM AUTHOR]

Purpose: In Europe, most medicines are taken orally and primarily packaged as single solid oral dosage forms (SODF) in blister chambers (alveoli) arranged on blister cards. Blister cards are constructed as multilayer laminates of aluminum (Al) foils and/or various plastic polymers bonded together, forming the alveoli, which are separated by more or less large gaps. We calculated the amount of packaging material (and thus waste) generated annually for the packaging of the most commonly prescribed SODF in Germany and estimated how much waste could be saved by rearranging the alveoli. Methods: For this purpose, we analysed the SODF of the 50 most frequently prescribed medicines that were packaged in alveoli (N = 45; 13 of aluminum-aluminum blisters, 32 of mixed materials), measured and weighed their packaging material and content, calculated the annual amount of waste produced from them, and estimated how much waste could be saved if the alveoli were optimally positioned on the blister cards. In addition, we examined the variability of the blister packaging of eight groups of commonly prescribed generics of the same strength. Results: Detailed analysis of the blister cards revealed that most of the material (69%) was used for the space between blisters and that aluminum-aluminum alveoli were more than four times larger than the packaged SODF. The (conservatively) estimated annual amount of composite waste generated for the primary packaging of these SODF was 3868 t (and extrapolated to the entire German pharmaceutical market 8533 t), of which an optimized arrangement of the blister chambers, i.e., a 2-mm sealing area around each alveolus and the arrangement of the SODF in 2 rows, would save approximately 37%. Conclusion: Considering that other ecological strategies are not yet mature, the optimal arrangement of blister chambers would be a captivatingly simple and, above all, immediately implementable strategy to avoid large amounts of avoidable waste. [ABSTRACT FROM AUTHOR]

Look-alike sound-alike (LASA) drugs cause a high proportion of medication errors in hospitals. Drug lists available in hospitals are diverse and complicated. Presently, each hospital has its own LASA drug list and unique management strategies to minimize and prevent LASA errors. Objective: This study aimed to explore the prevalence of LASA drug lists, types of LASA drugs, and categories of medication errors in hospitals in Thailand. Methods: For this cross-sectional study, questionnaires were developed and distributed along with a letter to 500 government hospitals (selected from a total of 1,309 hospitals) in Thailand via mail from April to June 2021. Data were analyzed using descriptive statistics (frequencies and percentages). Results: A total of 128 hospitals participated in this study (response rate: 25.60%), including 12 tertiary hospitals (9.38%), 33 secondary hospitals (25.78%), 24 large primary hospitals (18.75%), 51 small primary hospitals (39.84%), and eight private hospitals (6.25%). A total of 2,510 pairs of LASA drugs were identified, which included 1,674 (66.69%) tablets/capsules (Simvastatin 10-Simvastatin 20 pair had the highest frequency), 427 injections (17.01%) (Ceftriaxone-Ceftazidime pair had the highest frequency), 85 liquid dosage forms (3.39%) (Milk of magnesia-alum milk pair had the highest frequency), 74 special techniques in medicine (2.95%) (Seretide evohaler®-Seretide accuhaler® pair had the highest frequency), 49 external used drugs (1.95%) (Clotrimazole cream-Clobetasol cream pair had the highest frequency), and 28 powder dosage forms (1.12%) (ORS for pediatrics-ORS for adult pair had the highest frequency). Conclusion: Despite relevant awareness among healthcare professionals, LASA medication errors occur in hospitals. The most frequent similarities among LASA drugs were detected in their names/pronunciations, and the most common errors belonged to Category B. [ABSTRACT FROM AUTHOR]

ABSTRACTThe 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.

This paper aims to highlight how to reduce medication errors through the implementation of human factors science to the design features of medication containers. Despite efforts to employ automation for increased safety and decreased workload, medication administration in hospital wards is still heavily dependent on human operators (pharmacists, nurses, physicians, etc.). Improving this multi-step process requires its being studied and designed as an interface in a complex socio-technical system. Human factors engineering, also known as ergonomics, involves designing socio-technical systems to improve overall system performance, and reduces the risk of system, and in particular, operator, failures. The incorporation of human factors principles into the design of the work environment and tools that are in use during medication administration could improve this process. During periods of high workload, the cognitive effort necessary to work through a very demanding process may overwhelm even expert operators. In such conditions, the entire system should facilitate the human operator's high level of performance. Regarding medications, clinicians should be provided with as many perceptual cues as possible to facilitate medication identification. Neglecting the shape of the container as one of the features that differentiates between classes of medications is a lost opportunity to use a helpful characteristic, and medication administration failures that happen in the absence of such intentional design arise from "designer error" rather than "user error". Guidelines that define a container's shape for each class of medication would compel pharmaceutical manufacturers to be compatible and would eliminate the confusion that arises when a hospital changes the supplier of a given medication. [ABSTRACT FROM AUTHOR]

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

Introduction: The handling of antineoplastic drugs should follow strict supervision and safety rules to minimize the occupational exposure risks to professionals involved. The external surface contamination of drug vials is recognized as a health risk. So, our goal was to determine if there is residual contamination on the vials and containers surface of the antineoplastic drugs doxorubicin (DOX) and cyclophosphamide (CP). Methods: A cross-sectional study was conducted. Samples were collected using a uniform sampling procedure on the inner surfaces of the packages/boxes and the outer surfaces of the vials. The analyzes were executed by high-performance liquid chromatography/mass spectrometry (UHPLC-MS/MS). Results: A total of 209 samples were analyzed, 66 of CP and 143 of DOX. CP levels were detected in nine samples (13.63%), three were below the lower limit of quantification (LLQ) and the other six had contamination levels ranging from 1.24 to 28.04 ng/filter. DOX levels were detected in 36 samples (25.17%), two were below the LLQ and the others had levels between 1.32 and 664.84 ng/filter. The majority of samples with residual contamination were in vials (80.0%), however, boxes also showed contamination. Conclusions: The results revealed the presence of residual contamination in the vials and packages of CP and DOX drugs. Although the residues found in each sample are small, special care should be taken in the handling and disposal of the antineoplastic drugs. The use of personal protective equipment is fundamental while handling the vials and packaging of cytotoxic drugs. [ABSTRACT FROM AUTHOR]

Background: Antiretroviral therapy (ART) assures major gains in health outcomes among people living with HIV, however, this benefit may not be realized by all due to care interruptions. Mobile populations comprise a subgroup that is likely to have sub-optimal care engagement, resulting in discontinuation of ART. We sought to evaluate the barriers to care engagement among highly mobile individuals living with HIV and explore options aimed at improving engagement in care for this group. Methods: Qualitative in-depth interviews were conducted in 2020 among a purposive sample of twelve persons living with HIV and eight health care providers in western Kenya, within a mixed methods study of mobility in communities participating in the SEARCH trial (NCT01864603). We explored the barriers to care engagement among mobile individuals living with HIV and explored different options aimed at enhancing care engagement. These included options such as a coded card containing treatment details, alternative drug packaging to conceal drug identity, longer refills to cover travel period, wrist bands with data storage capability to enable data transfer and "warm handoff" by providers to new clinics upon transfer. Data were inductively analyzed to understand the barriers and acceptability of potential interventions to address them. Results: Stigma and lack of disclosure, rigid work schedules, and unpredictability of travel were major barriers to care engagement for highly mobile individuals living with HIV. Additionally, lack of flexibility in clinic schedules and poor provider attitude were identified as health-system-associated barriers to care engagement. Options that enhance flexibility, convenience and access to care were viewed as the most effective means of addressing the barriers to care by both patients and providers. The most preferred option was a coded card with treatment details followed by alternative drug packaging to conceal drug identity due to stigma and longer refills to cover travel periods. Conclusion: Highly mobile individuals living with HIV desire responsive, flexible, convenient and patient-centered care delivery models to enhance care engagement. They embraced simple health delivery improvements such as coded cards, alternative drug packaging and longer refills to address challenges of mobility. [ABSTRACT FROM AUTHOR]

Antimicrobial resistance is one of the most significant threats to public health worldwide. As opposed to using traditional antibiotics, which are effective against diseases that are multidrug-resistant, it is vital to concentrate on the most innovative antibacterial compounds. These innate bacterial arsenals under the term «bacteriocins» refer to low-molecularweight, heat-stable, membrane-active, proteolytically degradable, and pore-forming cationic peptides. Due to their ability to attack bacteria, viruses, fungi, and biofilm, bacteriocins appear to be the most promising, currently accessible alternative for addressing the antimicrobial resistance (AMR) problem and minimizing the negative effects of antibiotics on the host's microbiome. Nano-compounds have shown promise in a variety of applications, including antibacterial agents, drug delivery systems, food and drug packaging elements, functional food formulations, and many more. However, there are certain disadvantages in the chemical production of nanoparticles (NPs), such as toxicity and other negative impacts. Due to the dual action of biological sources combined with metallic NPs, the use of conjugated or green-synthesized nanoparticles has become more widespread during the past ten years. Recently, bacteriocin nanoparticles have emerged as a viable remedy and the most effective antibacterial agent in vitro to overcome some of these limitations. [ABSTRACT FROM AUTHOR]

Background: This study sought to analyze the leakage rate, economic loss caused by leakage, leakage reasons, and usage of upright polypropylene infusion bags and non-polyvinyl chloride (PVC) infusion bags, two types of closed intravenous infusion containers used in pharmacy intravenous admixture service (PIVAS), to improve the product quality of drug infusion packaging materials, reduce drug and clinical economic losses, and reduce the safety hazards of medication. Method: A real-world study was used to collect statistics for these infusion containers. The study was conducted in 21 hospitals in China from September to December 2022. Upright polypropylene infusion bags or non-PVC infusion bags in PIVAS of these 21 hospitals were chosen as the research material. Results: In total, 2,349,899 upright polypropylene infusion bags and 3,301,722 non-PVC infusion bags were collected. Eleven cases of upright polypropylene infusion bag leakage occurred (with a the leakage rate of 0.05‱), and 394 cases of non-PVC infusion bag leakage occurred (with a leakage rate of 1.19‱). The leakage rate of non-PVC infusion bags was significantly higher than that of upright polypropylene infusion bags (p < 0.01). The main reason for leakage in upright polypropylene infusion bags was sharp objects such as glass fragments or aluminum caps piercing the bag. The main reason for leakage in non-PVC infusion bags was squeezing, stacking, and uneven arrangement that causes folding of edges. For non-PVC bags, additional reasons for leakage included leakage at the nozzle joint, excessive manual or machine throwing force, and excessive dosage. The economic loss of upright polypropylene infusion bags was 1,116.56 CNY. The economic loss of non-PVC infusion bags was 32,210.86 CNY. Conclusion: Based on real-world study data on the leakage of upright polypropylene infusion bags and non-PVC infusion bags in multicenter PIVAS, it can be concluded that the leakage rates of upright polypropylene infusion bags are significantly lower than those of non-PVC infusion bags in PIVAS, and the economic losses due to upright polypropylene infusion bags are lower than those due to non-PVC infusion bags in PIVAS. Therefore, we can infer that upright polypropylene infusion bags are superior to non-PVC infusion bags. [ABSTRACT FROM AUTHOR]

Plastic materials have revolutionized modern life, particularly in the domain of food packaging, owing to their versatility, lightweight nature, and ease of processing. However, the environmental ramifications of non-degradable plastics have raised concerns. Polylactic acid (PLA), derived from renewable sources, represents a sustainable alternative due to its biodegradability and exceptional barrier, mechanical, and safety properties. Nevertheless, the high UV transmittance of PLA limits its use for photosensitive food and pharmaceutical packaging, where UV radiation can lead to nutritional loss and spoilage. Various methods have been explored to enhance the UV-blocking capabilities of PLA, including the integration of inorganic nanoparticles and surface coatings. Despite advancements, these approaches often compromise the inherent transparency of PLA. Incorporating large conjugated groups can maintain transparency but introduces additional challenges. This paper reviews modification methods to enhance PLA's UV-barrier properties and anticipates its expanded utility in food and drug packaging, promoting UV resistance and diversifying PLA's applications. [ABSTRACT FROM AUTHOR]

Background: Intravenous digoxin loading dose recommendations differ between clinical guidelines and Food and Drug Administration packaging for acute rate control. Objective: The objective of this study was to assess the safety and efficacy of intravenous digoxin loading in patients who received ≤12 µg/kg and >12 µg/kg of digoxin using ideal body weight (IBW). Methods: This single center retrospective cohort study with exempt status from the local Institutional Review Board included patients who received intravenous digoxin and had a serum digoxin concentration (SDC) drawn. Digoxin doses >36 hours after the first dose were excluded. Patients who received a total of >12 µg/kg and ≤12 µg/kg IBW were compared. The primary endpoint was frequency of SDCs ≥1.2 ng/mL, which have been shown to be associated with increased mortality. Results: A total of 244 patients were included (144 receiving >12 µg/kg and 100 receiving ≤12 µg/kg). There were significantly more SDC ≥1.2 ng/mL in the >12 µg/kg group than the ≤12 µg/kg group (50.6% vs. 30.0%; adjusted odds ratio, 3.19; 95% confidence interval [CI]: 1.79-5.84), with no difference in rate control failure. Major limitations of the study include retrospective nature and possible selection bias. Conclusion and Relevance: Compared to patients who received digoxin doses ≤12 µg/kg IBW, patients who received >12 µg/kg IBW had higher rates of SDC ≥1.2 ng/mL. This suggests that appropriate weight-based dosing with 8 to 12 µg/kg IBW has the potential to be a safer approach to digoxin loading, rather than frequently used dosing strategies that result in doses >12 µg/kg. [ABSTRACT FROM AUTHOR]

The rapid development of virtual reality and augmented reality technology has brought significant changes to many industries in modern society. In the field of product packaging design, the use of virtual reality and augmented reality technology in product packaging design is becoming more common in the field. Researchers are exploring the use of VR and AR technology in children’s drug packaging, employing augmented reality research that leverages natural features and artificial recognition to construct a model of children’s drug packaging that incorporates VR and AR technology. We analyze the impact of VR+AR on children’s drug packaging. Consumers’ main requirements for children’s drug packaging are bright, strong, practical, fun, novelty, and ease of understanding. The paper’s model, sample Z, ranks 5th in market competitiveness and 1st in technical competitiveness, outperforming competitors A, B, C, and D. This suggests that VR+AR children’s drug packaging still needs improvement in market competitiveness despite its high technical content. In descending order, the design evaluation dimensions score the VR+AR children’s drug packaging as follows: vivid picture (3.193)> texture (3.154) > easy to hold (3.142) > Moderate capacity (3.129) > simple and generous (3.105) > conform to the production process (3.047) > harmonious color (3.044) > convenient for transportation (3.028) > low production cost (3.012). The average score for each dimension of the VR+AR children’s drug packaging experience is approximately 4.46 points.

Most N-Nitrosamine compounds are found to be genotoxic in several animal species. Some are classified as probable or possible human carcinogens and very low acceptable daily intake has been established such as 96 ng/day for N-nitrosodimethylamine (NDMA) and 26.5 ng/N-nitrosodiethylamine (NDEA). The pharmaceutical industry has considered all processing areas for potential formation or contamination of N-nitrosamine. One risk is the potential contamination of nitrosamine during drug product blister packaging using lidding foils containing nitrocellulose, and different approaches have been used by pharmaceutical companies to evaluate and mitigate this risk. Herein we share a perspective from IQ Consortium N-nitrosamine Working Group on some of the approaches and corresponding results. From these assessments, it was concluded that the risk of nitrosamine contamination during blister packaging is negligible. The approaches shared in this perspective can be incorporated into risk assessment for nitrosamine contamination during drug product packaging at other pharmaceutical companies. [ABSTRACT FROM AUTHOR]

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Green synthesis of NPs has gained extensive acceptance as they are reliable, eco-friendly, sustainable, and stable. Chemically synthesized NPs cause lung inflammation, heart problems, liver dysfunction, immune suppression, organ accumulation, and altered metabolism, leading to organ-specific toxicity. NPs synthesized from plants and microbes are biologically safe and cost-effective. These microbes and plant sources can consume and accumulate inorganic metal ions from their adjacent niches, thus synthesizing extracellular and intracellular NPs. These inherent characteristics of biological cells to process and modify inorganic metal ions into NPs have helped explore an area of biochemical analysis. Biological entities or their extracts used in NPs include algae, bacteria, fungi, actinomycetes, viruses, yeasts, and plants, with varying capabilities through the bioreduction of metallic NPs. These biosynthesized NPs have a wide range of pharmaceutical applications, such as tissue engineering, detection of pathogens or proteins, antimicrobial agents, anticancer mediators, vehicles for drug delivery, formulations for functional foods, and identification of pathogens, which can contribute to translational research in medical applications. NPs have various applications in the food and drug packaging industry, agriculture, and environmental remediation. [ABSTRACT FROM AUTHOR]

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]

Background: Human immunodeficiency virus (HIV)-positive students at a rural university in Limpopo province are followed-up according to the national guidelines for the treatment of HIV. Blood monitoring revealed that some students on antiretroviral (ARV) treatment were not virologically suppressed despite adherence and compliance being emphasised at every visit. Objectives: The study sought to identify the students’ experiences that were hindering the viral load from improving. Method: A two-phase qualitative, explorative, descriptive study design was followed. Convenience purposive sampling methods were taken on. By means of a semi-structured interview guide, face-to-face interviews were directed. Thematic content analysis was applied. Results: Non-disclosure, noisy ARV packaging, stigma, and service delivery played a role in determining levels of student adherence and compliance with ARVs in the study sample. Conclusion: Study findings suggest practical recommendations to improve compliance among students on ARVs: provision of HIV education to all students to help reduce stigma and make it easier to disclose HIV status; use of user-friendly noise-free packaging by pharmaceutical companies to enclose medication, such as blister packs; a supermarket approach in service delivery points to reduce the stigmatising effects of consulting rooms for ARV services. Contribution: There is scope to examine the relevance of these findings for other students in the country, to compare them, and to use material from larger studies to guide targeted interventions that could improve adherence among young people.

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]