Package Insert Research Articles

Budget impact analysis of subcutaneous infliximab (CT-P13 SC) for treating inflammatory bowel disease in Saudi Arabia: Analysis from payer perspective

Background The Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers. Methods and materials A prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC." The model’s time horizon spanned over 2 years (2021–2023), aligning with the biennial national pharmaceutical procurement cycle. The comparison focused on infliximab SC versus all available formulations of infliximab IV in the Saudi market for two inflammatory bowel diseases (IBD): Ulcerative Colitis (UC) and Crohn’s Disease (CD). Treatment comparators’ comparability and dose escalations were substantiated by published studies, utilizing dosing information from the summary of product characteristics. Drug acquisition costs were derived from SFDA registered prices, with IV formulation administration costs included. Scenario analysis assessed the budget impact of infliximab SC introduction at uptake rates ranging from 0% to 100%. Results Introducing infliximab SC demonstrated cost-saving potential in the treatment of IBD. At 100% uptake with UC patients for 2 years, infliximab SC resulted in savings of -SAR-31.9 million (-SAR29,145 per patient). Similarly, for CD, introducing infliximab SC at 100% uptake over 2 years yielded savings of -SAR106.2 million (-SAR36,585 per patient). Conclusion This study reveals that infliximab SC is associated with cost-saving potential when compared to infliximab IV formulations available in Saudi Arabia. Future research should address uncertainties related to real-world comparative effectiveness, the convenience of administration, patient tolerability, and physician acceptance of the SC formulation of infliximab, alongside comparisons with other TNF-alpha inhibitors.

Physicians' and pharmacists' perspective on clarity and clinical relevance of absolute contraindications in "Summaries of Product Characteristics".

Previous work has identified several limitations in "Summaries of Product Characteristics" (SmPCs), which are associated with risks for patients. The aim of this study was to evaluate pharmacists' and physicians' interpretation of contraindications in SmPCs and reasons for their nonadherence in clinical routine. For 20 commonly missed or ignored absolute contraindications, an anonymous online survey providing 24 clinical example cases (one or two per contraindication) for physicians and pharmacists was developed. Experts in medication safety were asked whether the respective case fulfilled the definition of the contraindication in the SmPC: (a) formally, irrespective of the clinical relevance of the contraindication (17 cases), and (b) whether the contraindication was deemed clinically relevant in each respective case (24 cases). Twenty-seven pharmacists and 27 physicians completed the survey. For only one case (1/17; 5.8%) did all experts agree on the same answer option regarding the formal fulfilment of a given contraindication statement. Experts gave heterogeneous answers regarding the interpretation of a contraindication. For instance, among 10 predefined answer options for the contraindication "active liver disease" in the SmPC of simvastatin, every option was selected by at least six experts. In 17/24 (70.8%) clinical example cases a majority of experts agreed on the clinical relevance of a given contraindication. Key reasons for nonadherence to contraindications were "patient monitoring possible", "lack of alternative treatment" and "acute/severe situations". Experts' disagreement on the interpretation of contraindications in SmPCs using clinical example cases indicates that further efforts are needed to improve their usability in clinical routine.

Artificial Intelligence Chatbots (ChatGPT and Google Gemini) Versus Traditional Patient Information Leaflets for Local Anesthesia in Eye Surgery: Correspondence

Artificial Intelligence Chatbots (ChatGPT and Google Gemini) Versus Traditional Patient Information Leaflets for Local Anesthesia in Eye Surgery: Correspondence

Management of inoperable malignant bowel obstruction using the 4-step BOUNCED diet.

Malignant bowel obstruction (MBO) presents with multiple symptoms. The 4-step BOUNCED diet educates patients to self-manage oral intake according to symptoms. It includes clear fluids, thin liquids, purée and soft, sloppy foods, which are low in fibre. This mixed methods single-arm feasibility study aimed to establish if the diet could reduce MBO symptoms in patients with inoperable colorectal and gynaecological malignancies. The secondary objectives were to investigate if it was easily followed, improved quality of life (QOL) and reduced hospital admissions. Patients able to tolerate an oral diet with one or more symptoms (pain, bloating, early satiety, nausea and vomiting) were eligible. Following informed consent, an oncology dietitian took a diet history and determined which step of the diet they needed to follow using a detailed patient information leaflet. Patients remained on the trial for 28 days. Symptom and QOL data were collected on Days 1 and 28 using the Memorial Symptom Assessment Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) questionnaires. Thirty patients (24 female, 6 male) aged 18-85 years consented from March 2021 to November 2022. Twenty-six participants completed the trial and 25 found the diet very easy or easy to understand. There was a significant reduction in pain from 96% on Day 1 to 63% on Day 28 (p = 0.004). The mean increase of EORTC global health status/QOL was 23.5 points, 95% CI (12.4-32.5) (p ≤ 0.001). There was a significant difference between number of admissions (p = 0.018) and bed days (p = 0.004) in the 28 days prior to consent compared to the trial period. A modified consistency low-fibre diet is easily followed, may reduce symptoms of MBO, admissions to hospital and improve QOL.

A magnetic epitope-imprinted microsphere used for selective separation and rapid detection of SHV-type β-lactamases in bacteria: a novel strategy of antimicrobial resistance detection

BackgroundThe production of β-lactamases is the most prevalent resistance mechanism for β-lactam antibiotics in Gram-negative bacteria. Presently, over 4900 β-lactamases have been discovered, and they are categorized into hundreds of families. In each enzyme family, amino acid substitutions result in subtle changes to enzyme hydrolysis profiles; in contrast, certain conserved sequences retained by all of the family members can serve as important markers for enzyme family identification.ResultsThe SHV family was chosen as the study object. First, a unique 10-mer peptide was identified as SHV family's epitope by an approach of protein fingerprint analysis. Then, an SHV-specific magnetic epitope-imprinted gel polymer (MEI-GP) was prepared by an epitope surface imprinting technique, and its sorption behavior and recognition mechanism for template epitope and SHV were both elaborated. Finally, the MEI-GP was successfully applied to selectively extract SHV from bacteria, and the extracted SHV was submitted to MALDI-TOF MS for specific determination. By following this strategy, other β-lactamase families can also be specifically detected. According to the molecular weight displayed in mass spectra, the kind of β-lactamase and its associated hydrolysis profile on β-lactams can be easily identified. Based on this, an initial drug option scheme can be quickly formulated for antimicrobial therapy. From protein extraction to medication guidance reporting, the mean time to detection (MTTD) was less than 2 h, which is much faster than conventional phenotype-based methods (at least 16–20 h) and gene-based techniques (usually about 8 h).ConclusionsThis enzyme-specific detection strategy combined the specificity of epitope imprinting with the sensitivity of mass spectrometry, enabling β-lactamase to be selectively extracted from bacteria and clearly presented in mass spectra. Compared with other drug resistance detection methods, this technique has good specificity, high sensitivity (≤ 15 mg of bacteria), a short MTTD (less than 2 h), and simple operation, and therefore has a broad application prospect in clinical medicine.Graphical

Evaluation of Crushed Posaconazole Delayed Release Tablets in Lung Transplant Recipients.

Invasive fungal infections can cause serious complications after lung transplant; therefore, prophylaxis with posaconazole is common. The posaconazole delayed-release (DR) tablet is preferred. Although the package insert states DR tablets cannot be crushed, recent data suggest it is reasonable. We hypothesized that crushed posaconazole DR tablets could reach therapeutic levels in lung transplant recipients. A retrospective study of lung transplant recipients between January 2018 and July 2023, who received crushed posaconazole DR for at least 5 days was completed. Posaconazole troughs were evaluated, and differences were compared between subjects who were therapeutic to those who were subtherapeutic. A cost analysis was also performed. Thirty subjects received crushed posaconazole DR and 50% were therapeutic. The median trough was 1mg/L for those who were therapeutic and 0.4mg/L for those who were not (p < 0.001). The median cumulative dose was 2000mg, and there were no significant differences in the incidence of diarrhea or tube feeds. More subjects in the therapeutic group were loaded (33%vs. 13%), although this was not statistically significant (p = 0.39). No subjects had breakthrough aspergillus one month after starting crushed therapy. Crushed posaconazole DR tablets are a viable and cost savings option, but loading doses and higher maintenance doses may be required to reach therapeutic levels. Those who received loading doses (intravenously or crushed) followed by a daily crushed dose of 400mg were more likely to be therapeutic. Limitations of our study include that it is single-center, small in sample size, and retrospective.

Preventing Influenza Virus Infection and Severe Influenza Among Pregnant People and Infants.

The landscape of research on the benefits of influenza vaccines and antivirals to protect pregnant persons and infants has increased in recent years, while influenza vaccination rates and antiviral usage have declined. Pregnant people and infants <6 months of age are at increased risk of hospitalization with influenza, making protection of this population essential. Maternal influenza vaccination at any time during pregnancy is the best way to reduce the risk of influenza and severe influenza in both pregnant people and their infants <6 months of age. Influenza antiviral medications for pregnant people and infants are also recommended as early as possible if influenza is confirmed or suspected. This report will update on the current research on the benefits of influenza vaccination during pregnancy and influenza antiviral medication for the pregnant person and infant, current Advisory Committee on Immunization Practices recommendations for influenza vaccination in pregnancy and vaccination coverage rates, current influenza antiviral medication guidance and usage rates in pregnancy and among infants, and future directions for influenza pregnancy research. With over half a century of maternal influenza vaccination in the United States, we have improved protection for pregnant persons and infants against influenza, but we still have room for improvement and optimization with new challenges to overcome following the COVID-19 pandemic. By continuing to fill research gaps and increase vaccination coverage and antiviral usage, there is potential for significant reductions in the domestic and global burden of influenza in pregnant persons and infants.

Utilisation en vie réelle d’une triple thérapie fixe dans la BPCO : étude Trilife. Triple association fixe béclometasone/formotérol/glycopyrronium en particules extra-fines

Introduction: The Trilife study describes the real-life use, in France, of the beclomethasone/formoterol/glycopyrronium triple fixed-dose combination in solution for inhalation, which is indicated as continuous treatment for moderate-to-severe chronic obstructive pulmonary disease.Methods: This prospective, non-interventional, multicentric study, involving hospital and office-based pulmonologists, evaluates the proportion of patients for whom the triple fixed combination was prescribed in compliance with the indication and dosage specified in the summary of product characteristics (SPC). Patients were followed for six months.Results: In a population of 346 patients, the prescription was compliant with the SPC for 75.1% of patients (95% confidence interval: [70.6; 79.7]). The only variable associated with compliance with SPC in multivariate analyses was smoking (p=0.019). The results also show improved patient adherence to treatment and improved clinical status in terms of moderate or severe exacerbations, dyspnea, quality of life and satisfaction with treatment.Conclusion: Three quarters of the fixed triple combination prescriptions by French pulmonologists comply with the indication and dosage specified in the summary of product characteristics.

Pseudo-Worsening of Kidney Function Due to Inhibition of Renal Creatinine Secretion: Quality of Information Provided in Prescribing Information/SmPC.

Determination of serum creatinine concentrations and subsequent calculation of estimated glomerular filtration rates (eGFR) is a cornerstone of clinical medicine. Crucial clinical decisions such as drug treatment discontinuations are based on eGFR calculated from serum creatinine measurements. However, creatinine is not only filtered in the kidneys, but also actively secreted into urine. Creatinine transporters such as OCT2, OCT3, MATE1, MATE2-K, and OAT2 expressed in proximal tubular cells are responsible for active renal secretion of creatinine. Multiple drugs (e.g., oral antitumor drugs) inhibit these transporters thereby causing a pseudo-worsening of kidney function with an increase in serum creatinine concentrations and a decrease in eGFR while other methods for eGFR determination (e.g., by cystatin C) reveal normal kidney function. Since US Prescribing Information (PI) and European Summaries of Product Characteristics (SmPCs) are the most relevant source of information for physicians, we investigated the quality of information in US PI/German SmPCs of drugs with clear evidence for pseudo-worsening of kidney function. 514 drugs putatively interacting with creatinine transporters were identified. For 149 of those drugs, an increase in serum creatinine concentrations has been described. Available data confirmed the existence of pseudo-worsening of kidney function for 30 of those drugs, for the remaining 119 drugs existing data are insufficient. Only 23.5% (12/51) of the 30 drugs' PI/SmPCs contained unambiguous statements on this proven pseudo-worsening of kidney function and gave clear recommendations for clinical management. Taken together, inadequate information provided in PI or SmPCs on the pseudo-worsening of kidney function poses patients at unnecessary risks.

Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory Rheumatic Diseases: Risks and their Minimization Measures.

Tumor necrosis factor alpha (TNF- α) inhibitors are widely employed for the management of chronic inflammatory rheumatism. However, their usage carries significant risks, including site and infusion reactions, serious infections, malignancy, heart failure autoimmune and demyelinating disorders. These risks are comprehensively outlined in risk management plans (RMPs) associated with these molecules. RMP provides information on the safety profile of a medicinal product as well as the measures that will be taken to minimize risks; these are known as risk minimization measures. These measures are divided into routine measures related to elements, such as the summary of product characteristics, labeling, pack size, package leaflet, or legal supply status of the product, while additional measures may include educational programs, including tools for healthcare providers and patients, controlled access or pregnancy prevention programs, among others. Additional measures can consist of one or more interventions that need to be implemented in a sustainable way in a defined target group, while respecting the timing and frequency of any intervention and procedures to reach the target population. An evaluation of the effectiveness of these measures is required to determine whether or not an intervention has been effective. This comprehensive review offers an in-depth exploration of the current treatment, uses, and associated risks of TNF-α inhibitors. Additionally, it provides a detailed account of risk minimization measures and risk management practices while shedding light on their real-world implementation and effectiveness.

How is gout currently managed, and is there interest in changing the way we deliver care? A qualitative exploratory study.

This study aimed to understand how gout is currently managed in Australian primary care and to assess the level of interest in changing the delivery of care for gout. This pragmatic qualitative study was conducted among Australian general practitioners (GPs), pharmacists and adults living with gout. Semi-structured interviews were conducted and analysed using thematic analysis. The key theme identified was that chronic gout has low priority compared to managing other conditions, and management is often responsive to patient action. Lack of confidence was expressed about medication regimens for multimorbidities. Regarding changing care delivery, there was widespread interest in enhancing pharmacists' role in providing medication reviews and guidance, but there were conflicting views between some pharmacists and GPs about clinical decisions and prescribing arrangements. Interpreting findings based on Wagner's chronic care model, it is apparent that there are multiple potential opportunities to change practice that might improve goutmanagement.

Paper waste and carbon emissions from oral contraceptive leaflets.

Oral contraceptives (OC) are the most used form of contraception among women in the U.S. and Europe. Like other medications, their packaging must include patient information leaflets. This study quantifies the environmental impact of paper waste generated by these leaflets. We conducted an observational analysis, measuring the weight of leaflets, pills, and packaging components across various OC brands. Significant variations in leaflet weights were observed. On average, leaflets accounted for 55% of the package weight, while pills and blister dispensers represented only 32%. The mean weight of OC leaflets was 12.3 ± 5.5 grams (4.7-21.9 grams), leading to an estimated annual paper waste of 6,118.4 tons, 5,763.5 tons of carbon dioxide equivalent emissions, and the use of approximately 146,841 trees for production. Standardizing leaflet weight to the lightest reported can reduce annual waste by 3780.5 tons of paper. This study highlights the substantial environmental cost of the waste generated from OC leaflets and proposes practical strategies to mitigate waste, including electronic leaflets and standardized packaging. Targeting these materials presents a significant opportunity to enhance sustainability, aligning with global efforts to reduce greenhouse gas emissions from the healthcare sector.

Norms of Translating Medical Terms in English Patient Information Leaflets into Kurdish

Patient Information Leaflets (PILs) are documents included in medicine packages and provide important information about the medication for patients. This study investigates the translation problems of English PILs into Sorani Kurdish. The aim of this study is to identify the translation procedures used for translating medical terminologies in PILs for lay people. It also aims to reveal which translational norms are operating in Kurdish translations of PILs. To do so, the study employs a corpus of 150 English PILs along with their Kurdish translations. To analyse the corpus, the researcher adopts Toury’s (1995-2012) three-phase methodology within the descriptive approach of translation. It also uses Vinay and Darbelnet’s (1995) translation procedures to determine how translators handled terminological rendering in the Kurdish PILs. According to the findings, nine types of translation procedures were used in translating the terminologies, with borrowing had the highest frequency, and modulation having the lowest frequency. They also revealed that Toury’s initial norms were predominantly operating in the translated PILs which labelled them as adequate translations. The translators’ choice to closely follow the original PILs was indicative of their attempt to meet the expectations of PILs’s target users, thus, revealing Chesterman’s expectancy norms therein. The study concludes that the translation of PILs into Kurdish is not regulated within the medical field and that is mainly related to the absence of an officially regulated body in the Kurdistan Region of Iraq. It also concludes that while the seemingly established norm of PIL translation into Kurdish highly relies on English borrowings, it is a significant step towards developing Kurdish medical language.

Patient Information Leaflet Feedback on Delusional Infestation.

Delusional parasitosis, also known as Ekbom syndrome, is a poorly understood condition often surrounded by misinformation. Patients and their families frequently encounter skepticism regarding their experiences. This research aimed to create a patient information leaflet (PIL) with a patient centred approach and to gather feedback on its usefulness for sharing information and validating their experiences. To evaluate patient feedback on a newly developed PIL designed for individuals with delusional parasitosis, assessing its perceived usefulness and impact. A survey was administered to 18 patients before their appointments, incorporating the new PIL. The survey included questions on the leaflet's clarity, usefulness, ability to validate patient experiences and other pointers, measured on a 10-point Likert scale (0 = No answer, 1 = Strongly Disagree, 10 = Strongly Agree). Data was analysed using descriptive statistics and factor analysis. Additionally, the final question allowed for written feedback, which was examined through thematic analysis. The survey results revealed that the majority of patients were satisfied with the new PIL. Specifically, 94% agreed or strongly agreed that the leaflet was logical and easy to follow, 72% found it useful for understanding their condition, and 89% felt it validated their experiences. Mean scores for these concepts were 8.83, 7.61, and 7.78, respectively. Thematic analysis of written feedback highlighted themes of improved understanding but uncertainty around acknowledgement of experiences. This new patient-centered PIL for delusional parasitosis was well-received, indicating its potential as a valuable tool for patients and their support networks. By addressing the specific needs and experiences of patients, the leaflet can improve communication and reduce the stigma associated with the condition. Future research should explore long-term impacts and the effectiveness of similar resources in other patient populations.

A quantitative investigation in a territory of Italy on citizens' attitudes towards medicines through the COVID-19 pandemic: the importance of possible indirect effects caused by the pandemic.

The COVID-19 pandemic has greatly influenced many aspects of everyday life, particularly that of the general population health. In order to better understand the potential impacts of the COVID-19 pandemic on people's attitudes toward medicines use, a quantitative investigation was conducted in a territory of Sardinia region, Italy. Stratification of the random multilevel population sample was based on gender, age range, and territory. The methodological strategy to verify the potential approach changes towards medicines due to the COVID-19 pandemic consisted of oral interviews with adult citizens and unrecognizability preservation. Investigation, also supported by a study completed before the insurgence of the pandemic about taking medicines, interrupting treatments without consulting, and reading the information leaflet, allowed to explore citizens' attitudes before and during pandemic, and changing. The most relevant findings are the tendency towards a higher occurrence of self-interruption of treatments and an increased interest in the information leaflet (package leaflet), but not an increased self-administration of medicines. These results indicate new indirect effects of the COVID-19 pandemic that could exert an additional impact on the state of citizens' health and health systems. The study, with reference to prophylactic medical treatments and based on some considerations concerning the pandemic from its insurgence to today, also provides solutions for related problems for the present or future periods of health emergencies.

Prospective screening and proposed treatment algorithm for immune checkpoint inhibitor induced myositis in neoadjuvant-treated rectal cancer patients: data from the phase II CHINOREC trial

Abstract Background Myositis is an infrequent (&amp;lt;1%) but potentially life-threatening (case fatality rate 40-50%) immune-related adverse event (irAEs) of immune checkpoint inhibitors (ICI), such as ipilimumab (IPI) and nivolumab (NIVO). The true incidence is likely to be underestimated and may not be representative for curative neoadjuvant treatment approaches in gastrointestinal (GI) cancers, especially in combination with chemoradiotherapy (CRT). Currently, the summary of product characteristics (SmPC) does not suggest any pre-emptive screening or surveillance. Methods The CHINOREC study is an ongoing prospective, randomized, open-label, multicenter, phase II investigator-initiated trial (IIT). Patients with intermediate to locally advanced rectal cancer (LARC) receive either neoadjuvant CRT alone or in combination with a single dose of IPI and 3 cycles of NIVO, following surgical resection. Patients are monitored at baseline and throughout the whole study period for myotoxicity biomarkers, including cardiac troponin T (cTnT) and cardiac troponin I (cTnI). Findings From 06/2020 to 11/2023, 80 patients have been enrolled of whom 50 patients were randomized to the CRT+IPI/NIVO arm. Six patients (12%) developed biopsy-verified myositis. Myositis treatment was promptly implemented using a pragmatic step-up approach. Patients received glucocorticoids (GC) with concomitant intravenous immunoglobulin (IVIG). If myotoxicity biomarkers did not improve, patients received infliximab (INFLIXI) and/or plasma exchange (PLEX). Although all patients had strikingly elevated cTnT (median peak 284 ng/L, 95% CI 39-3097), cTnI levels remained largely normal, correlating with a negative cardiac magnetic resonance (CMR). All patients underwent successful tumor surgery without any major surgical complication. As of today, all patients' creatine kinase (CK) and myoglobin (MB) levels have normalized and they are tumor free without any major sequela. Interpretation Longitudinal biomarker screening (cTnT/cTnI) for ICI-induced myotoxicities is pivotal in curative neoadjuvant-treated cancer patients to initiate an early counter treatment in a holistic step-up approach, without compromising oncological principles.

Exercise-induced cardiac troponins in long-distance walkers: a preliminary observation.

Abstract Background Elevated concentrations of cardiac troponin (cTnT and cTnI), the preferred biomarker to diagnose myocardial infarction, can be detected in other (cardiac) conditions and even post-exercise. Whether these exercise-induced elevations reflect a (patho)physiological process, as well as their clinical implications, is unknown. In this preliminary study, pre- and post-exercise high-sensitivity cTn (hs-cTnT and hs-cTnI) concentrations were investigated in long-distance walkers. Purpose Gain insight of elevated cTnT and cTnI concentrations post-exercise in long-distance walkers. Methods From 478 participants, walking 30-50 km on the first day of the 4Daagse 2023, blood-samples were collected pre- and &amp;lt;6h post-exercise. In addition, health and exercise questionnaires were conducted. Hs-cTnT (Roche) and hs-cTnI (Abbott) concentrations were determined and the unisex, female and male Upper Reference Limit (URL) were according to package inserts (Roche: 14 ng/L, 9 ng/L, 16 ng/L, Abbott: 26 ng/L, 16 ng/L, 34 ng/L). Results Participants (51% female) were 57±7.6 years (mean±SD). At baseline, median [IQR] hs-cTnT and hs-cTnI were 5.9 [4.5-8.0] and 1.7 [1.1-2.9] ng/L, which increased significantly post-exercise to 8.7 [6.4-12.4] ng/L (P&amp;lt;0.001) and 5.2 [3.1-9.5] ng/L (P&amp;lt;0.001). Pre-exercise, the unisex-URL for hs-cTnT was exceeded by 4.4% walkers and for sex-specific URLs, this resulted in 6.6% females and 3.8% males. For hs-cTnI, the unisex-URL was exceeded by 0.6%, as for sex-specific URLs, 0.8% females and 1.3 % males surpassed. Post-exercise, hs-cTnT URLs were exceeded by 18.2%, 35.1%, 16.5% and as for hs-cTnI post-exercise, 7.3%, 11.6%, 3.8% for unisex, female and male. Alternatively, the absolute median delta difference was 2.4 [0.9-4.6] ng/L for hs-cTnT and 3.0 [1.6-5.7] ng/L hs-cTnI. Conclusion Post-exercise long-distance walkers had significantly increased hs-cTnT and hs-cTnI concentrations, in particular in women when using sex-specific cutoffs. In order to understand clinical implications of these findings, status of cardiac vascular diseases, risk-factors and exercise characteristics will be analyzed in the future.

Harm to myself or others? A qualitative study of the preferences of people who smoke for messages to be included in cigarette pack inserts.

Tobacco package inserts [TPIs] are a novel channel to transmit smoking cessation messages. Research has shown associations between inserts, intentions to quit and increased self-efficacy. In Israel, TPIs have been legislated, but not yet implemented. This study aimed to learn what kind of messages would appeal to people who smoke, for the purpose of developing effective TPIs. Semi-structured interviews with 25 people who smoke or formerly smoked, aged 18-67. An inductive and deductive thematic analysis was conducted to enable a dynamic process coding and identifying themes and categories across interviews. Two main themes identified were: harms of smoking and motivators for quitting. Many participants were averse to information about the harms of smoking but interested in specific information about the harm of smoking to others, particularly children, on comparative risks of different tobacco/nicotine products, and about how to address the challenge of addiction. There was a preference for motivational messages encouraging quitting, including how the body recovers, personal quit stories, practical quit tips, and information on cessation services. Adult who smoke were receptive to the idea of TPI, but considered some types of information superfluous. It is important to emphasize harm to others, provide information on quit services, and deliver information that is reliable, specific, and evidence-based regarding quitting, so that it can be encouraging, useful, and practical. The merits of providing information to people who smoke on relative risks of different nicotine and tobacco products should also be considered. The findings provide a basis for developing TPI content. A large proportion of adults who smoke are interested in quitting. Pack inserts with positive motivating messages, quitline details, and novel information about risks to people who smoke and particularly to others, should be developed and tested, and subsequently distributed nationally to reach all those who open a cigarette package.

Real-World Experience of Erenumab in Patients with Migraine in Germany: The SPECTRE Study.

To provide real-world insights into migraine patient population in Germany treated with erenumab, focusing on the prescription patterns and reasons for the initial dosage choice. SPECTRE was an observational, non-interventional, multicenter, open-label, single-arm study in patients treated with erenumab according to approved local dose and guidelines. The study enrolled adult patients (n = 571; Germany: 105 sites) with migraine who had received erenumab for not more than 3months before the start of the study. The mean (standard deviation) patient age was 45.0 (12.3) years, and most patients were female (89.0%), Caucasian (97.6%), and non-smokers (85.1%). The starting dose of erenumab was 70mg in 68.5% of patients and 140mg in 31.5%. The proportion of patients with 140mg as the starting dose was the highest (43.5%) in those aged 30-40years. The most common reason for starting a higher dose of erenumab 140mg was severity of migraine (47.4%). During the observational period, the proportion of patients taking erenumab 140mg increased to 64.6% (visit 5; V5) after 12months. Due to attrition of patients towards the end of the study (V9: 90 participants), data at V9 must be interpreted with caution. At least one dose change was performed in 45.3% of patients (i.e., erenumab 70 to 140mg or 140 to 70mg), 21.2% of patients attempted at least once to discontinue treatment (i.e., period with erenumab discontinuation and no other antibody treatment for migraine prevention), and 15.3% discontinued erenumab treatment, mainly because of no or insufficient treatment response (13.5%). The mean time until the first omission attempt was 332.3 (range 37-633) days. Constipation (12.1%) was the most frequently reported adverse event, in line with the summary of product characteristics (SmPC) of erenumab. Most patients with migraine were prescribed erenumab 70mg as the starting dose. No new safety signals were observed for erenumab versus the previous trials.

A Dual-Mode Optical Sensing Strategy for Rapid Detection of D-Penicillamine in Pharmaceutical Formulations

Accurate, rapid, and quantitative detection of D-penicillamine (D-PA) in pharmaceutical formulations is imperative for drug quality and clinical medication guidance. Various colorimetric and fluorescent assays have been constructed for D-PA based on nanomaterials. However, the reliable and rapid detection of D-PA in pharmaceutical formulations remains a challenge because these methods suffer from shortcomings such as time-consuming procedures, poor uniformity, and complicated nanomaterial preparation. In this work, an effective and facile homogeneous dual-mode optical sensing strategy was established based on the strong complexation between D-PA and Cu2+ and catalyzed the oxidation of O-phenylenediamine. This platform displayed a sensitive response to D-PA from 5 to 100 µmol/L, with a detection limits of 0.54 µmol/L (fluorescence) and 0.76 µmol/L (colorimetry). As expected, the method was successfully applied to the determination of D-PA in pharmaceutical formulations with satisfactory results. Overall, this developed strategy provides a facile and rapid dual-mode optical platform for D-PA and has great potential in D-PA-related pharmaceutical quality control.