Pharmaceutical Packaging Research Articles

South African Dietitians' Knowledge and Perceptions of Food-Drug Interactions and Factors Affecting It.

Dietitians ensure that patients receive tailored medical nutrition therapy to integrate with pharmacotherapy safely. Dietitians require a pharmacological understanding to prevent detrimental food-drug interactions (FDIs). The study investigated dietitians' knowledge of FDIs and their information sourcing. A cross-sectional online survey was conducted among registered South African dietitians to assess their knowledge of FDIs, the impact of food timing on drugs, and their sources of FDI information. The questionnaire included demographics, a 12-question knowledge assessment, and a qualitative section on information sourcing. Data from 70 valid responses, collected between 2 August and 19 September 2022, were analysed statistically using analysis of variance and chi-square tests to determine whether associations between knowledge scores and demographic factors were present. Out of 70 responses, most participants were female (97.1%) and 47.1% had over 10 years of experience. The participants primarily worked in the areas of dietetics related to chronic and lifestyle-related disorders (75.7%) across various work settings, including in-patient care (32.8%), out-patient care (41.4%), and multi-disciplinary team environments (31.4%). Although not generalisable due to the low response rate (70 out of the 304 required responses for a 5% margin of error), knowledge deficiencies were observed. A cumulative mean knowledge score of 38.3% was observed, with gaps identified for fundamental FDIs. Drug package inserts (55.7%) and clinical websites (68.6%) were primarily used to source information regarding FDIs; however, the former did not always provide sufficient information. Participants proposed that knowledge deficiencies could be overcome with further education, and the development and/or use of mobile applications or summarisations that elaborate on FDIs. Knowledge gaps and uncertainties were identified regarding fundamental FDIs; however, further research is needed to pinpoint the specific sources of these deficiencies and the factors influencing them. To improve dietitians' knowledge of FDIs and ensure alignment with their scope and standard of practice, undergraduate curricula should be bolstered and benchmarked to national needs to facilitate graduate development, and additional learning opportunities provided, such as webinars and continuing professional development (CPD), to allow for continuous education for practicing dietitians.

Red Room Temperature Phosphorescence from Lignin.

Materials with red room-temperature phosphorescence (RTP) derived from sustainable resources are crucial but rarely reported. Here, we produced red RTP materials from lignin. Lignin was covalently modified with Upy (1-(6-isocyanatohexyl)-3-(6-methyl-4-oxo-1,4-dihydropyrimidin-2-yl) urea) to obtain Lig-Upy. The Upy in the Lig-Upy promoted the interaction between the aromatic units of lignin and reduced energy gaps of these molecules. As a result, Lig-Upy exhibited red RTP centered at 625 nm with a lifetime of 24.2 ms. Moreover, the hydrogen bonding interactions in Lig-Upy varied when embedded into different matrices, such as polyvinyl alcohol (PVA) or sodium montmorillonite (MTM), inducing a change in RTP wavelength and lifetime. Utilizing these properties, Lig-Upy was used as building blocks for producing materials exhibiting time-dependent phosphorescent colors (TDPCs). Such TDPCs materials have exhibited great potential for visual decorations, information encryption and anti-counterfeiting logos for medicine bottles.

From paper to pixels: EMR as the solution to prescription errors in Pakistan

A prescription is a written directive that outlines instructions for medication administration, including dosage, formulation, route, frequency, and duration. It is dispensed to patients following a physician's consultation and forms the cornerstone of their treatment plan. Any deviation from this plan due to errors constitutes a prescription error, a preventable adverse event related to inappropriate deliverance of information in one or more aspects.1 While developing nations have swiftly transitioned to computer-based prescription systems, through Electronic Medical Records (EMRs), resource-constrained countries like Pakistan still lag In one Asian study, it was found that the distribution of errors differed significantly between handwritten and electronic prescriptions, with rates of 35.7% and 2.5%, respectively.2 Although the use of EMR systems has gained momentum in Pakistan, particularly in private-sector hospitals, their adoption still needs to be improved in public-sector practices. Handwritten prescriptions increase the risk of errors, particularly in busy tertiary care hospitals where healthcare staff are overwhelmed by patient volumes. Illegible handwriting, communication lapses, and confusion stemming from similar drug packaging and names compound these risks. This limitation not only compromises the readability of prescriptions but also hampers medication reconciliation processes, potentially leading to serious drug interactions and compromised patient histories. EMR systems offer numerous benefits, including a standard template with a forcing function incorporated for fields such as drug dosing, administration route, duration, and allergy information, as well as access to Prescription Drug Monitoring Programs (PDMPs) to identify potential drug-seeking behaviour. Considering Pakistan's low health literacy rate and challenges related to medication adherence and follow-up, EMRs play a crucial role in tracking past medication history and promoting patient adherence. Additionally, they reduce paper waste and the physical space required for storing patient information. In light of these significant advantages, Pakistan's healthcare must expedite the integration of EMR systems across all medical practices. By doing so, we can enhance patient safety and healthcare quality and contribute to environmental sustainability. This transition minimises paper wastage reduces the ecological footprint associated with printing and storing paper documents, and streamlines administrative processes. Furthermore, EMRs facilitate data analyses and population health management, enabling healthcare providers to make informed decisions and improve healthcare outcomes. Therefore, embracing EMR technology is a step towards modernising healthcare delivery and a responsible action towards preserving our environment for future generations.

Recent Advancements in Pharmaceutical Packaging and Regulatory Aspects

Recent Advancements in Pharmaceutical Packaging and Regulatory Aspects

Elucidating the Factors Affecting the Patient-Centric Usability of Blister Packs for Spherical Capsules.

Pharmaceutical packaging is essential for enhancing the storage stability of medicine and can improve medication adherence and usability. Despite their widespread use, blister packs can be challenging to use, especially when pushing out the medication. This study investigates how specific cavity characteristics of blister packs can enhance usability for spherical capsules, which are harder to push out than tablets. The findings of this study show that reducing the thickness of the unformed sheet, or the thickness at the top and corners of the cavities, reduces the effort required to push out the capsules. Similarly, for cavities with different shapes, reducing the thickness at the top and increasing the corner radius also eases the push-out process. These insights emphasize the importance of systematic design in pharmaceutical packaging to improve patient medication adherence.

The sale of medicines used for diabetes mellitus treatment in retail segment of Russian pharmaceutical market

Objective: to study the characteristics of the population consumption of medicines for the treatment of diabetes mellitus (DM), sold in the retail sector of the pharmaceutical market of the Russian Federation (RF).Material and methods. The study analyzed data on products assortment and sales volumes for drugs used to treat DM (according to Anatomical Therapeutic Chemical (ATС) classification) trough pharmacies in all federal districts of the RF for the period 2020–2023. In particular, the following ATС groups were studied: A10A, A10B, H04AA and A16AX (thioctic acid), as well as “sibutramine + metformin” combination prescribed to correct obesity in DM patients. The results were obtained on basis of comparative, retrospective, logical, and graphical methods as well as content analysis, data grouping in accordance with ATС groups and descriptive statistics.Results. In the retail sector of the pharmaceutical market of the RF, 54.9 million packages of antidiabetic drugs were sold for 32.4 billion rubles from 2020 to 2023. In the structure of sales in monetary terms, the share of Russian-manufactured drugs amounted to 16–17% approximately, and in physical terms, i.e. by the number of packages, it reached 37–39%. Throughout the analyzed period, the weighted average price (WAP) per 1 package of a drug for DM treatment increased from 472 to 589 rubles. Concurrently, as of year-end 2023, WAP per 1 package of an imported drug was 3 times higher than WAP of a domestic drug (784 and 259 rubles, respectively). In 2023, more than 45% of pharmacy sales in physical terms accrued to drugs of the ATC subgroup A10BA Biguanides (metformin), and about 25% to A10BB Sulfonylurea derivatives (glibenclamide, gliclazide, glimepiride, etc.). In 2023, the highest sales in monetary terms accrued to methsopamine, daphgylflozin, tytochotic acid, empagliflozin and gliclazide. In the structure of retail sales of drugs for DM treatment, fixed combinations accounted for about 15%. Despite an increase in the number of trade names of fixed combinations (from 24 in 2020 to 30 in 2023), their share in the products assortment structure remained insignificant, that did not comply with international recommendations for DM treatment.Conclusion. Using pharmacoepidemiological monitoring tools, the features of the population consumption of drugs prescribed for DM treatment in the retail sector of the pharmaceutical market of the RF were studied in a retrospective aspect (for the period from 2020 to 2023). The contribution of ATC subgroups to the retail sales structure was established. It was revealed that the share of combined drugs was not more than 15% in the total retail sales structure that did not comply with international recommendations on DM treatment.

Effects of Adjuvant Endocrine Therapy-Specific Perceptions on Response to a Behavioral Intervention for Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer.

Adjuvant endocrine therapy (AET) is a life-saving medication for patients with hormone-sensitive breast cancer, yet many struggle with adherence, warranting behavioral intervention. In our recent trial, participation in a group cognitive behavioral intervention (STRIDE) for symptom management and adherence was associated with improvements in symptom distress, coping, quality of life, and mood. We now explore whether baseline patient- and medication-specific factors-which may be modifiable by clinician-led discussions-moderated the effect of STRIDE on adherence rates. From October 2019 to June 2021, 100 patients with early-stage breast cancer reporting AET-related distress were enrolled and randomly assigned to STRIDE or a medication monitoring (MM) control group. All patients stored their AET in electronic pill bottles to track objective adherence. Patients also self-reported their adherence on the Medication Adherence Report Scale-5 and their perceptions of AET on the Cancer Therapy Satisfaction Questionnaire at baseline. We conducted hierarchical linear modeling to test moderators of intervention effects on objective adherence rates. We report the time × group × moderator effects. Among patients reporting greater perceived difficulties with AET adherence at baseline, STRIDE participants had higher adherence rates over time compared with MM (b = -13.80; SE = 4.56; P < .01). Patients with greater expectations of therapeutic benefit from AET also had improved adherence rates if they were assigned to STRIDE, versus MM (b = 0.25; SE = 0.10; P = .01). Patients who perceived taking AET as convenient and had been taking their AET for less time had higher adherence rates in STRIDE, versus MM. The current study identified patient- and medication-specific factors that may augment AET adherence interventions and may be modifiable through clinician-led discussions, such as perceptions of adherence problems, therapeutic efficacy, and convenience of AET.

Exploring the factors associated with difficulties in extracting tablets or capsules from press-through-package sheets.

Exploring factors related to difficulties in extracting tablets or capsules from press-through-packages is essential for optimizing the dosage form. To achieve this, the involvement of patient insight is important. In the present study, the preferences of patients regarding drugs that are difficult to extract from their packaging were collected using an electronic medication notebook ('harmo®') based on dispensing data. We found that approximately 30% of respondents had difficulty removing tablets or capsules from their packaging, with 125 specific drugs identified as 'hard to push out'. Independent factors related to 'hard-to-push-out' drugs were female sex and feeling of weakness in the hands or fingers. Furthermore, several 'hard-to-push-out' drugs had characteristics such as a spherical shape or small major axis or small major axis drug-to-pocket size ratio. The findings of this study may help improve the quality of drug packaging, thus enhancing the patients' medication experience.

Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy

Abstract Objective Five Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes. Methods Studies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 and NCT03110380) were double-blind, placebo-controlled and enrolled treatment-naïve or virologically suppressed adults. Adherence was calculated by pill count from returned pill bottles; virologic outcome was assessed by last on-treatment HIV-1 RNA. Results Altogether, 2622 participants (B/F/TAF: n = 1306; DTG + 2 NRTIs: n = 1316) were categorized as having high (≥95%), intermediate (≥85% to &amp;lt;95%) or low (&amp;lt;85%) adherence. Through Week 48, low adherence was observed in 46 (3.5%) participants in the B/F/TAF group (78% median adherence) and 69 (5.2%) in the DTG + 2 NRTI group (80% median adherence). Overall, 1287 (98.5%) participants in the B/F/TAF group and 1292 (98.2%) in the DTG + 2 NRTI group had virologic suppression (VS; HIV-1 RNA &amp;lt; 50 copies/mL) through Week 48. VS in participants with low adherence versus high or intermediate adherence was similar in the B/F/TAF group, but lower in the DTG + 2 NRTI group (P ≤ 0.002). Similar results were observed at Weeks 96 and 144. Two participants (&amp;lt;95% adherence) in the DTG + 2 NRTI group receiving DTG and abacavir/lamivudine developed M184V; there was no treatment-emergent resistance to B/F/TAF. Conclusions Participants with suboptimal (&amp;lt;85%) adherence to B/F/TAF maintained high levels of VS, whereas suboptimal DTG + 2 NRTI adherence was associated with lower VS.

AVALIAÇÃO DAS FERRAMENTAS DA QUALIDADE 5W2H, DIAGRAMA DE ISHIKAWA E 5S EM UMA INDÚSTRIA VIDREIRA: UM ESTUDO DE CASO EM UMA FÁBRICA DE TUBOS DE VIDRO NA CIDADE DO RIO DE JANEIRO - RJ

The pharmaceutical packaging industry has always been essential to the supply chain around the world, there is a need to fill vaccines and medicines in glass vials and ampoules that do not interact with each other and furthermore that there is no contamination of the glass, ensuring its effectiveness. In this sense, the work in question aims to treat defects related to the existence of foreign particles in the glass tube manufacturing process using the Quality tools: 5W2H, Ishikawa and 5S. The industry that uses these tools to support the treatment of defects and complaints, receives as a reward the optimization of processes, avoiding waste and rework, bringing value to direct customers, guaranteeing consumer satisfaction and security of compliance in the filling process of vials and ampoules.

Medication Errors in Psychiatric Hospitals: A Nationwide Real-World Evidence Study in Saudi Arabia.

Background: Medication errors are among the most prevalent medical errors and result in significant morbidity and mortality. They pose a major threat to patient safety in psychiatric hospitals. However, the lack of a comprehensive investigation into the root causes of these errors restricts the development of effective corrective measures. Objective: This study aimed to characterize the types of errors, determine the stages of the medication use process, and identify factors associated with errors occurring among government psychiatric hospitals in Saudi Arabia. Methods: This cross-sectional study was conducted from August 2019 to June 2020. All medication error reports submitted to the Ministry of Health General Administration of Pharmaceutical Care database from 18 government psychiatric hospitals in Saudi Arabia were assessed. The database is de-identified and contains information on all medication errors, including patient demographics, medication information, error information, causes of errors, and reporter information. Medication use was categorized as ordering/prescribing, transcribing, dispensing, administration, and monitoring. The present findings represent a descriptive analysis of the data using Statistical Analysis Software (SAS) version 9.4. Result: A total of 23,355 medication error reports were reported to the database during the study period. Among Saudi Arabian cities, Riyadh (n = 8972, 38.4%) had the highest medication error reporting rate, followed by Taif (n = 3705, 15.9%) and Jeddah (n = 2621, 11.2%). Most reported errors were frequently made by physicians (n = 20,284, 86.9%) and were primarily detected by pharmacists (n = 20,974, 89.8%). Approximately half of them (n = 13,150, 56.3%) were classified as "Category B" that occurred, but they did not reach patients. Most medication errors were reported in adults (n = 22,589, 96.7%) and male patients (n = 16,393, 70.2%). Most error reports were detected at the prescription stage (n = 16,481; 70.6%) during the medication-use process. Work overload of the staff (n = 2911, 12.8%) and drug labeling, packaging, and nomenclature (n = 2826, 12.1%) were the most common contributing factors associated with the reported errors. Olanzapine (n = 1650, 7.1%), omeprazole (n = 1350, 5.8%), and quetiapine (n = 1273, 5.5%) were the most common medications associated with medication errors. Conclusions: Preventable medication errors are typical in psychiatric hospitals and may result in severe consequences. Increased efforts are needed to control and minimize prescribing errors and improve reporting in Saudi Arabia.

Potential of Aluminum Drug Packages with Press-Through Packaging Considering Usability for a Wide Range of Users.

Press-through packages (PTPs) are frequently used for the packaging of prescription drugs in Japan. However, tablets or capsules packaged in PTPs may become unstable and difficult to store. Therefore, aluminum pouches (pillow packages) are applied as an additional packaging option. Especially for 10-sheet tablet (capsule) PTPs, there are many opportunities for health-care professionals (mainly pharmacists) to open pillow packages during the dispensing process. However, aluminum pouches (pillow packages) that are easy to open and store appropriately by not only pharmacists, but also patients, are needed. A 100-unit PTP (pillow package) with conventional specifications ① and two other products (②: open vertically by a wavy processed half-cut and ③: pinch the backlining open) were developed with the aim of improving the ease of opening. The study participants, consisting of pharmacists and patients, performed tasks such as opening and taking drugs out of the PTP for each sample, and evaluated the differences in usability. The results of a sensory test revealed that pharmacists rated products ② and ③ higher than product ①. On the other hand, patients, including those with weak grip and pinching strengths, rated ③ highly, confirming the superiority of usability in the order of ③, ②, and ①. In addition, item ③ was successfully opened by all patients. The present results indicated the superiority of the developed pillow packaging, which enables pharmacists to save time in the dispensing process. In addition, product ③ was evaluated highly by patients, especially those with disabilities, for its ease of use not only in terms of opening, but also storage. Sensory testing by actual users applying ergonomic methods enabled a multifaceted evaluation of the products and provided insights into the actual status of pharmacists' dispensing work (product issues) and patients' daily medication use.

Optimizing Compressed Air Operations for Electrical Energy Savings: A Case Study in Pharmaceutical Packaging Manufacturing

This study in pharmaceutical packaging manufacturing focuses on improving compressed air efficiency through targeted strategies at both the source and user levels by establishing a baseline to analyze energy consumption patterns. Key measures, including minimizing air leaks, adjusting pressure, and optimizing compressor performance, aim to achieve a 20-50% increase in efficiency, thereby supporting environmental sustainability. The User Point and Source Point approaches are expected to lower Specific Power Consumption (SPC), with data collected from December 2020 to May 2022 providing insights into potential energy savings. Establishing this baseline, based on machine runtime and productivity, offers a solid foundation for evaluation. Results show a 23% reduction in compressor electricity usage and a 7-8% decrease in compressed air consumption. A structured improvement process and strong collaboration between engineering and management are essential for enhancing productivity and achieving sustainable energy efficiency in the industrial sector.

Anti-pathogenic and probiotic-friendly effect of benzyloxy pyridine derivative impregnated into bacterial cellulose matrix

Bacterial cellulose (BC) has emerged as a promising biomaterial for biomedical applications due to its unique properties. In this study, firstly, the potential of BC as a carrier material for the originally synthesized benzyloxy pyridine derivative (BeOxP), and also an antimicrobial and probiotic bacteria-friendly (on Lactiplantibacillus plantarum 299v (LP299V®) (DSM 9843)) effect of BC- BeOxP was investigated. The BC- BeOxP composite material was developed using a simple and efficient method, ensuring the uniform dispersion of BeOxP within the BC matrix. Characterization of BeOxP has been carried out with High-Resolution Mass Spectroscopy (HRMS) and Nuclear Magnetic Resonance (NMR). Additionally, BC- BeOxP was characterized by Thermogravimetric analysis (TGA), Differential thermal analysis (DTA), Scanning Electron Microscopy (SEM), Texture analysis, and Fourier-transform infrared spectroscopy (FTIR), confirming the successful integration of BeOxP without compromising the structural integrity of BC. The mechanical properties of the BC- BeOxP composites were also evaluated to ensure their suitability for drug-carrying or food-packaging applications. Antimicrobial activity of the BC- BeOxP was analyzed against Staphylococcus aureus ATCC 29213 and Escherichia coli ATCC 25922 while the probiotic-friendly effect was tested on Lactiplantibacillus plantarum 299v (LP299V®) (DSM 9843). The findings open avenues for further research of BC-based drug carriers or packaging materials for advanced biomedical applications.

Cosmic-Ray Radiation Effects on Ibuprofen Tablet Formulation Inside and Outside of the International Space Station.

In extreme environments people will have different needs for medicine(s), making it crucial to understand how such environments affect drug efficacy. Ibuprofen, commonly used in tablet formulation on Earth, could fail in space despite standard pharmaceutical packaging. We introduce the concept of 'space medicines', where solid-dosage forms protect the pharmaceutical from accelerated degradation in spaceflight. We simulate dose(s) in International Space Station (ISS) through radionuclide and photon experiments, and establish the impact of alpha, beta and gamma rays. We demonstrate that tablet formulation protects from impact of alpha and beta rays; however, gamma rays decompose ibuprofen even when 'masked'. We systematically analyse 19 tablet compositions inside and outside the ISS to determine the effect of compositional changes in the tablet matrix. We confirm that the iron oxide-shielded tablets show minimal degradation (〈10%) inside the ISS, compared to moderate reductions (〉10%) for other formulations, with one exception. The tablets exhibited significantly greater ibuprofen degradation (〉 30-50%) outside ISS, due to harsh conditions. Significantly, we found that flavour have shielding potential by scavenging free radicals. We conclude that ibuprofen efficacy is adversely affected in space, and these effects are expected to worsen on missions to deeper space destinations.

A Viability Study of Thermal Pre-Treatment for Recycling of Pharmaceutical Blisters

Pharmaceutical packaging is one of the most used packaging types which contains aluminum and plastics. Due to increasing amounts of waste and rising environmental concerns, recycling approaches are being investigated. Since blisters usually contain a balanced amount of plastics and metals, most of the approaches focus on recycling only one material. Therefore, more sustainable recycling approaches which recover both plastic and aluminum fractions are needed. This study investigates the thermal behavior and degradation mechanisms of plastic-rich and aluminum-rich pharmaceutical blisters using various analytical techniques. Structural characterization revealed that plastic-rich blisters have a thicker profile with plastic and aluminum layers, while aluminum-rich blisters consist of plastic layers between aluminum sheets. Thermal degradation analysis showed two main stages for both types: plastic-rich blisters (polyvinyl chloride) exhibited significant weight loss and long-chain hydrocarbon formation between 210 and 285 °C, and aluminum-rich blisters (polyamide/nylon) degraded from 240 to 270 °C. Differential Scanning Calorimetry and Fourier Transform Infrared Spectroscopy analyses confirmed the endothermic behavior of such a transformation. The gas emissions analysis indicated an increased formation of gasses from the thermal treatment of plastic-rich blisters, with the presence of oxygen leading to the formation of carbon dioxide, water, and carbon monoxide. Thermal treatment with 5%O2 in the carrier gas benefited plastic-rich blister treatment, reducing organic waste by up to 80% and minimizing burning risk, leveraging pyrolytic carbon for protection. This method is unsuitable for aluminum-rich blisters, requiring reduced oxygen or temperature to prevent pyrolytic carbon combustion and aluminum oxidation.

Identifikasi Cacat Cetak Proses Produksi Kemasan Fleksibel Di Unit Printing PT. ACP Dengan Metode Six Sigma DMAIC

PT. ACP produces a flexible packaging that can be used in everyday life. PT. ACP is a pharmaceutical packaging manufacturer in Indonesia, in addition to being a pharmaceutical packaging manufacturer PT. ACP is also a manufacturer for packaging in various other segments, such as food, comestics, agrochemicals, etc. Research was conducted to identify print defects that occur in the process of making flexible packaging. The analysis in this study uses descriptive quantitative methods and Six Sigma DMAIC. This research uses a number of data from field observations and interviews with company employees, as well as data documentation owned by the company for the past year in 2022. The results of this study, namely after calculating six sigma, the results obtained are that PT. Avesta Continental Pack has a level of 5 sigma or the equivalent of the USA industry, then there are 3 types of defects that often occur, namely dry color, misregister, and color does not meet standards. Keywords: Defective Products, DMAIC, Flexible Packaging, Quality Control, Six Sigma

Spending on anticancer drugs among Medicare beneficiaries: Analyzing predictors of drug expenditures

ObjectiveTo evaluate the factors associated with Medicare spending on newly approved anticancer drugs in the US from 2012 through 2021. Patient and methodsUsing a cross-sectional analysis, we searched US FDA new oncology drug approvals (2012–2021). We analyzed clinical attributes and institutional factors influencing the annual cost of new anticancer drugs in the US. Annual treatment cost was calculated based on average spending per beneficiary from the Centers for Medicare and Medicaid Services, with product factors sourced from the FDA’s annual New Drug Therapy Approval reports and drug package inserts at the time of approval. ResultsOver a ten-year period, 112 new anticancer drugs were approved, of which 97 met the study's criteria. A significant majority, 93 %, received expedited development designations from the FDA. At the time of approval, 40 % of these drugs had data on progression-free survival, and 19 % had data on overall survival; 29 % were first-in-class. The study found a significant relationship between the year of approval and factors associated with the size of the treatment population. No statistically significant relationship was found between the clinical value of a drug and its price. ConclusionsSpending on anticancer drugs by Medicare are predominantly determined by reference pricing and the size of the anticipated treatment population, without an association with therapeutic value. The study advocates for reforms in reimbursement mechanisms for drugs lacking comparator arms and greater transparency for patients treated with these drugs.

Infection and infestation-related adverse events of biologics in psoriasis: insights from the Food and Drug Administration Adverse Event Reporting System (FAERS)

ABSTRACT Objective The study aims to thoroughly assess the adverse events related to infections and infestations associated with biological agents used for psoriasis using the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) database. Methods We analyzed FAERS data from the first quarter of 2004 to the fourth quarter of 2023. The study included TNF-α inhibitors (etanercept, infliximab, adalimumab), IL-12/23 inhibitors (ustekinumab), IL-23p19 inhibitors (guselkumab), and IL-17 inhibitors (secukinumab, ixekizumab). We used disproportionality analysis and Bayesian methods to quantify the related adverse event (AE) signals. Results Most AEs related to infections and infestations are already listed on the drug packaging labels. Notably, TNF-α inhibitors are associated with a significantly higher incidence of tuberculosis-related diseases compared to other biological agents. In contrast, IL-17 inhibitors show a greater variety and number of fungal infection-related AEs than their counterparts. Furthermore, our study has identified new potential AEs that require the attention of clinicians. Conclusion In clinical practice, it is advisable to monitor the risks of infections and infestations in patients receiving biological agents for psoriasis to enable early detection and intervention. Our findings highlight the need for further epidemiological investigations to establish causality and guide clinical practice in managing these risks effectively.

Leveraging Mobile Health to Improve Capecitabine Adherence Among Women With Breast Cancer: A Pilot Randomized Controlled Trial.

Oral capecitabine improves convenience compared to intravenous therapies but presents monitoring challenges. We conducted a randomized pilot trial to evaluate a mobile health intervention to remotely monitor capecitabine adherence and patient-reported outcomes (PROs) among women with breast cancer. Patients with breast cancer prescribed capecitabine, an oral chemotherapy with a complex, cyclical regimen, were randomly assigned to enhanced usual care (EUC) or PRO arm. Participants were asked to use a smart pill bottle to measure adherence (timing and dose) and complete baseline and 90-day follow-up surveys. PRO participants received text messages for missed or incorrect doses and weekly text-based symptom assessments, and their oncologists received alerts for severe symptoms or missed doses. We compared nonadherence (<80%) and changes from enrollment to follow-up on reported physical and mental health quality-of-life scores and number of severe symptoms by study arm. Overall, 32 women were randomly assigned (17 EUC and 15 PRO): 28 (87.5%) received the intervention and 24 (78.1%) completed the follow-up survey. Among participants who received the intervention, PRO participants responded to 83.3% of symptom questions; 7.7% of PRO participants were nonadherent compared with 40.0% of EUC participants (P = .049). Among those who completed the follow-up survey, 12.5% of PRO participants had reductions in their mental health composite scores compared with 69.2% of EUC participants (P = .011); 10% of PRO participants had more severe symptoms at follow-up compared with 57.1% of EUC participants (P = .019). A mobile health intervention using text message reminders and symptom assessments improved medication adherence and mental health quality-of-life scores and lowered symptom burden of patients with breast cancer prescribed capecitabine. Future work should evaluate the longer-term impacts of this intervention.