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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]

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: 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]

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: 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]

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]

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]

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]

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: 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]

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: 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]

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]

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]

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]

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.

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

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

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

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

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

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

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

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

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

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]

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

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

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

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

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

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

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

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

Background: Automated dispensing cabinets have the potential to create technology-induced errors that can arise during controlled substance medication dispensing. Despite enhancements made to the medication use process, the impact of ADC functionality on technology-induced controlled substance discrepancies have yet to be described. Objective: To evaluate the impact of ADC functionality expansion on technology-induced errors such as controlled substance discrepancies created during "blind inventory counts" and cassette dispensing errors. Methods: This quasi-experimental study was conducted over 18 months that evaluated the expanded use of dispensing cassettes within 8 ADCs at the University of Chicago Medicine. Unit-dose controlled substances with high usage were directed for inventory reassignment to cassettes. Controlled substance dispenses, blind inventory counts discrepancies and cassette dispensing errors were evaluated before and after cassette expansion. ADC discrepancy and Cassette Dispensing Error rates were calculated using 1-week segments across the study period. Results: Of the 64 040 dispenses during the study period, the proportion of cassette dispenses increased from 16% to 72% after cassette expansion. Controlled substance discrepancies decreased from 11 to 7 discrepancies for every 1000 dispenses (P <.0001). After cassette expansion, cassette dispensing errors increased to roughly 28 errors for every 1000 dispenses (P <.0001). Conclusion: Expansion of ADC functionality created opportunities for reduced technology-induced controlled substance discrepancy rates at the expense of increased cassette dispensing errors. [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]

Naltrexone extended‐release injectable (generic) – Vivitrol (brand) [ABSTRACT FROM AUTHOR]

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 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.

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).