Package Insert Research Articles

BT23 Artificial intelligence generation of patient information leaflets can have a useful role in the dermatology clinic

BT23 Artificial intelligence generation of patient information leaflets can have a useful role in the dermatology clinic

Toward a Medication Information Literacy Indicator System for Older Adults: A Delphi Study.

The safety of medication use among older adults is a growing concern, given the aging population. Despite widespread attention, the exploration of medication literacy in older adults, particularly from the perspective of information literacy, is in its nascent stages. This study utilized the existing literature to define medication information literacy (MIL) as a theoretical framework. A two-round Delphi survey was conducted to identify the essential components of a MIL indicator system for older adults. The analytic hierarchy process (AHP) was then used to assign weights to each indicator. The study observed relatively high response rates in both rounds of the questionnaire, which, along with expert authority coefficients (Cr) of 0.86 and 0.89, underscores the credibility and expertise of the panellists. Additionally, Kendall's coefficient of concordance (Kendall's W) ranging from 0.157 to 0.33 (p < 0.05) indicates a consensus among experts on the identified indicators. Utilizing the Delphi process, a MIL indicator system for older adults was developed, comprising five primary and 23 secondary indicators. These indicators were weighted, with medication information cognition and acquisition emerging as pivotal factors in enhancing medication literacy among older adults. This study developed a MIL indicator system tailored for older adults using the Delphi approach. The findings can inform healthcare professionals in providing customized medication guidance and assist policymakers in crafting policies to enhance medication safety among older adults. Patient and public engagement played a pivotal role in the development of our medication information literacy indicator system for older adults. Their involvement contributed to shaping research questions, facilitating study participation, and enriching evidence interpretation. Collaborations with experts in geriatric nursing, medicine, and public health, along with discussions with caregivers and individuals with lived experience, provided invaluable insights into medication management among older adults. Their input guided our research direction and ensured the relevance and comprehensiveness of our findings.

Application of Theiler's murine encephalomyelitis virus in treatment of multiple sclerosis.

Theiler's murine encephalomyelitis virus (TMEV) infected mice have been often used as an animal model for Multiple sclerosis (MS) due to their similar pathology in the central nervous system (CNS). So far, there has been no effective treatment or medicine to cure MS completely. The drugs used in the clinic can only reduce the symptoms of MS, delay its recurrence, and increase the interval between relapses. MS can be caused by many factors, and clinically MS drugs are used to treat MS regardless of what factors are caused rather than MS caused by a specific factor. This can lead to inappropriate medicine, which may be one of the reasons why MS has not been completely cured. Therefore, this review summarized the drugs investigated in the TMEV-induced disease (TMEV-IDD) model of MS, so as to provide medication guidance and theoretical basis for the treatment of virus-induced MS.

Eco-sustainability in ophthalmology.

The purpose of this review is to evaluate the current state of eco-sustainability in ophthalmology, highlighting key practices, recent advancements, and areas requiring improvement. This review aims to provide ophthalmologists with a comprehensive overview of sustainable practices that can reduce environmental impact. Recent studies have identified several areas within ophthalmology where sustainable practices can be implemented including multidose eyedrops, adjusting surgical packs, making package inserts available electronically, and reusing surgical instruments. Moreover, there is an increasing emphasis on waste reduction both in the surgical and clinical setting, by decreasing the use of unnecessary materials and implementing more efficient use of recycling programs. Telemedicine has also emerged as a sustainable option, reducing the carbon footprint associated with patient travel. Despite these advancements, significant challenges remain, particularly in balancing the cost and accessibility of sustainable options with traditional practices. Eco-sustainability in ophthalmology is gaining momentum as the medical community aims to reduce its environmental impact. While progress has been made, further efforts are required to overcome financial and logistical barriers to widespread implementation. Continued research, education, and policy development are essential to advancing eco-sustainable practices, ensuring that environmental considerations become an integral part of ophthalmic care.

Artificial Intelligence as a Consent Aid for Carpal Tunnel Release.

Background Hand surgeons have been charged with the use of diverse modalities to enhance the consenting process following the Montgomery ruling. Artificial Intelligence language models have been suggested as patient education tools that may aid consent. Methods We compared the quality and readability of the Every Informed Decision Online (EIDO) patient information leaflet for carpal tunnel release with the artificial intelligence language model Chat Generative Pretrained Transformer (GPT). Results The quality of information by ChatGPT was significantly higher using the DISCERN score, 71/80 for ChatGPT compared to 62/80 for EIDO (p=0.014). DISCERN interrater observer reliability was high (0.65) using the kappa statistic. Flesch-Kincaid readability scoring was 12.3 for ChatGPT and 7.5 for EIDO, suggesting a more complex reading age for the ChatGPT information. Conclusion The artificial intelligence language model ChatGPT produces high-quality information at the expense of readability when compared to EIDO information leaflets for carpal tunnel release consent.

Information in summaries of product characteristics about use in children is limited and needs standardisation: a systematic analysis in Switzerland

BackgroundA considerable proportion of drugs administered to children are not authorised for this purpose, and consequently off-label use is common in paediatric care. Our aims were to quantify systematically the...

Overdosage Section in US and EU Labeling

The Prescribing Information (PI) in the United States (US) and the Summary of Product Characteristics (SmPC) in the European Union (EU) are approved by the US Food & Drug Administration (FDA), and the European Medicines Agency (EMA), respectively. The inclusion of overdosage information in these documents is a regulatory requirement in both regions. This research evaluates the content of the overdosage section of US and EU labeling. The overdosage sections of labels for drugs approved in the US in three time periods were analyzed: 2000–2001, 2010–2011, and 2020–2021. EU labels for these same products were also reviewed if registered through the Centralized Procedure. Data collection and analyses were performed using a predefined questionnaire, focusing on adherence to regulatory requirements and identifying areas where additional regulatory guidance may be beneficial. The findings indicate that the content of the overdosage sections largely comply with the regulatory requirements of their respective regions. Fewer than half of the labels included information on supratherapeutic doses observed from clinical studies, risk factors for overdose or population specific data associated with overdose. Inconsistencies were noted concerning the incorporation of animal data when human data were available, in addition to the referencing of Poison Centers. The overall utility of non-specific treatment recommendations, in addition to gastric lavage is discussed. While the content of the overdosage section generally aligns with regulatory expectations, additional regulatory guidance could enhance consistency in how this section of labeling is presented and clarify expectations to improve its usefulness for health care professionals (HCPs).

Self-reported attention and responses to cigarette package labels at the end of a two-week randomized trial of cigarette package labeling configurations.

Cigarette package inserts that describe quitting benefits and tips may promote cessation; however, research is needed to understand better their effects, including potentially enhancing the effects of pictorial health warning labels (PHWLs). A randomized trial with a 2×2 factorial design was conducted with adult smokers (n=356) assigned to either small text-only health warning labels (HWLs; control); inserts with cessation messages, and the small text-only HWLs (inserts-only); large PHWLs (PHWLs-only); both inserts and PHWLs (inserts + PHWLs). Participants received a 14-day supply of their preferred cigarettes with packs labeled to reflect their group. Upon finishing the trial, participants reported their past 14-day frequency of noticing, reading, thinking about smoking harms and cessation benefits, talking about labels, and forgoing cigarettes because of the labels. Ordered logistic models regressed these outcomes on labeling groups, and mediation analyses assessed whether attention (i.e. noticing, reading) to labels mediated effects of labeling exposure on other outcomes (i.e. thinking about harms/benefits, talking, forgoing). The inserts + PHWLs group reported higher frequencies than the control group for all outcomes. Compared to the control group, both the inserts-only and PHWLs-only groups reported higher frequency of noticing (AOR=3.53 and 2.46, respectively) and reading labels (AOR=2.89 and 1.71), thinking about smoking risks because of the labels (AOR=1.93 and 1.82), and talking about labels (AOR=2.30 and 2.70). Participants in the inserts-only group also reported more frequent thinking about quitting benefits (AOR=1.98). Attention mediated all labeling effects except for the contrast between PHWLs only and control. Compared to text-only HWLS, cigarette labeling that involves inserts, PHWLs, or both appears more effective at drawing attention to warnings, which mediated the effects on cessation-related psychosocial and behavioral outcomes.

Analysis of Package Inserts Available in the Indian Market

Medicine has advanced, necessitating access to accurate drug information. Package inserts (PIs) are crucial sources, approved by authorities, providing essential and updated drug details. Package inserts significantly impact patient compliance and drug effectiveness in chronic therapy. This study examines Indian market PIs, evaluating information quality and accessibility to improve medication safety. A prospective observational cross-sectional study was carried out. A total of 300 package inserts were collected from various pharmacies situated across different sites in Ahmedabad. Package inserts were scored out of 21 based on assessment criteria, expressed as percentages, and analysed descriptively. A total of 300 package inserts were analysed, among them 130 were tablets, 81 were injections, 17 were capsules, 15 were eye drops and the rest includes syrup, ear drops, nasal drops, suppositories, powder, ointment, gel, cream, lotion and suspension. 209 PIs were single drug preparations while 91 were fixed dose combinations. More than 90% of the score was achieved by 37 PIs. 96 PIs had scored between range 81% to 90%, while 86 PIs had scored between 71% to 80%. Only 6 PIs had scored below 50%. Most commonly missing information was the average duration of treatment (83% of PIs), excipients (93% of PIs), and shelf life (81% of PIs). The finding of this study revealed that, although only 2% of PIs had scored below 50%, some crucial information was lacking from a major number of PIs. Regular review and collaboration among stakeholders ensure updated, reliable and comprehensive information, benefiting patient care and healthcare delivery. Keywords: Drug information, Package insert, Indian market

Instructions in package inserts intended for the use of medicines for dyspepsia and constipation during lactation

Instructions in package inserts intended for the use of medicines for dyspepsia and constipation during lactation

The cenobamate KORK study-A prospective monocenter observational study investigating cenobamate as an adjunctive therapy in refractory epilepsy, with comparisons to historical cohorts treated with add-on lacosamide, perampanel, and brivaracetam.

In Europe, cenobamate has been approved for use as an adjunctive therapy in adult patients with epilepsy (PWE) with focal-onset seizures (FOS) who have not responded satisfactorily to treatment with at least two antiseizure medications (ASMs). Pivotal trials and real-world observational studies have demonstrated a high efficacy of cenobamate, even in very difficult-to-treat epilepsies. Our aim was to investigate the efficacy of add-on cenobamate in adult PWE who were prospectively monitored. We compared these results with those previously obtained for add-on lacosamide, perampanel, and brivaracetam therapy. Patients were enrolled from the CENKORK study, which is a prospective, non-interventional, open-label, monocenter cohort study of adult PWE experiencing FOS. The titration of cenobamate was performed according to the guidelines outlined in the summary of product characteristics. The primary outcome measure was the retention rate at 6 months and 1 year. In addition, we assessed seizure-free rates, the proportion of patients achieving at least a 50% seizure reduction, adverse events, and the reasons for treatment discontinuation. These outcome measures were compared with historical controls treated with adjunctive lacosamide, perampanel, or brivaracetam at our center. Between June 2021 and 2022, 172 PWE with ongoing FOS were included. 22 cases were lost to follow-up, leaving 150 cases for the 1-year assessment. The retention rates at 6 months and 1 year were 88.7% and 80%, respectively. Seizure freedom was achieved in 14% of patients at both the 6-month and 1-year marks, while the ≥50% responder rates were 50% and 61%, respectively. The 6-month retention rate was significantly higher in cenobamate than in other ASMs (p < 0.001 for each comparator). Adverse events were significantly more common with perampanel (p < 0.001). Add-on cenobamate proved to be particularly efficacious compared to our experience with other recently introduced ASMs. This observational study was carried out in 172 adult patients with difficult-to-treat epilepsy who were treated with adjunctive cenobamate. After 1 year, the data of 150 patients could be analyzed. Seizure freedom, in the preceding 3 months, was achieved in 14%. The rate of PWE continuing cenobamate was 80%. In our hands, cenobamate showed promising efficacy and tolerability even when compared to other recently introduced antiseizure medications.

“É importante que não tome mais comprimidos do que lhe foi indicado”: estratégias linguísticas de desresponsabilização da indústria farmacêutica em folhetos informativos

Legally, pharmaceutical companies are responsible for any damage, injury or harm caused to the user by their products. However, the language present in product warnings (Dumas, 1990; Shuy, 1990; Tiersma, 2002) and in patient information leaflets (PIL) (van der Waarde, 2008; Hagemeyer &amp; Coulthard, 2017) seem to protect manufacturers from possible litigation, transferring responsibility to the consumer or user. Therefore, using both a pragmatic and discoursive analysis approach, we aim to investigate which linguistic strategies in European Portuguese (EP) acquit pharmaceutical companies from holding liability for the users’ actions. The qualitative analysis of a corpus of 20 PIL in EP reveals that the use of passive voice, impersonal constructions, attenuation of directive acts, declarative sentences with imperative value and vague language represent intentional strategies for pharmaceutical companies to protect themselves from possible litigation. Additionally, the comprehensibility of the text is further compromised by grammatical inconsistencies, the constant calculation of inferences and the presence of technical terms, “medicalese”.

Research Progress on Clinical Nursing of Hypertension

High-quality nursing care can greatly reduce the occurrence of nursing accidents and help patients maintain better physical and mental health. For patients with hypertension, special attention should be given to clinical nursing. Providing scientific medication guidance, along with psychological support, can improve their medication compliance and establish a good doctor-patient relationship, aiding in their faster recovery. Based on a review of relevant literature and the author’s practical experience, this paper first analyzes the content and requirements of clinical nursing for hypertension, then discusses the main factors that restrict the effectiveness of clinical nursing for hypertension, and finally suggests improvements to the clinical nursing model for hypertension to serve as a reference for colleagues.

Differential Responses to Cigarette Package Labeling Alternatives Among Adults Who Smoke: Results From a Randomized Trial

Abstract Introduction Little experimental research has evaluated whether the effects of cigarette package inserts with efficacy messages and/or pictorial health warning labels (PHWLs) differ across key subgroups of adults who smoke. Aims and Methods Adults who reported currently smoking (n = 367) were randomly assigned to one of four groups: Small text-only HWLs on pack sides (control); inserts with efficacy messages and small HWLs (inserts-only); PHWLs showing harms of smoking (PHWLs-only); both (inserts + PHWLs). Participants received a 14-day supply of cigarettes labeled to reflect their group. Every evening over 2 weeks, participants reported forgoing and stubbing out cigarettes before they finished smoking over the prior 24 hours, combined into a binary indicator of either behavior (eg, forgoing/stubbing). Separate mixed-effects logistic models were estimated to evaluate moderation of labeling group contrasts (ie, PHWLs vs not; inserts vs. not; inserts-only vs. inserts + PHWLs; PHWLs-only vs. inserts + PHWLs) by baseline covariates (self-efficacy to quit, intention to quit, education, health literacy, and time discounting), predicting day-level forgoing/stubbing. Results Education moderated PHWL effects, with PHWLs predicting more forgoing/stubbing only among those with low education (OR = 4.68, p &amp;lt; .001). Time discounting moderated insert effects, with inserts promoting forgoing/stubbing only among those with low time discounting (ie, lower impulsivity; OR = 4.35, p &amp;lt; .001). Conclusions Inserts with efficacy messages appear effective mostly among people with low time discounting, whereas PHWLs appear most effective among those with low education, suggesting their potential to address education-related disparities. Labeling strategies appeared equally effective across subgroups defined by self-efficacy to quit, quit intention, and health literacy. Combining inserts with PHWLs did not appear to mitigate moderation effects. Implications This randomized trial with adults who smoke suggests that cigarette packs with inserts describing cessation benefits and tips can promote cessation-related behaviors (ie, forgoing or stubbing out cigarettes) among those with low-time discounting (ie, low impulsivity). Alternative interventions may be needed for people with high-time discounting, as found in cessation trials. PHWLs appear most effective among those with low education, potentially addressing education-related disparities. No differential effects were found for those with different levels of self-efficacy to quit, quit intentions, or health literacy. Combining inserts and PHWLs may not be more effective than either alone.

Comparing patient education tools for chronic pain medications: Artificial intelligence chatbot versus traditional patient information leaflets.

Artificial intelligence (AI) chatbots like Conversational Generative Pre-trained Transformer (ChatGPT) have recently created much buzz, especially regarding patient education. Such informed patients understand and adhere to the management and get involved in shared decision making. The accuracy and understandability of the generated educational material are prime concerns. Thus, we compared ChatGPT with traditional patient information leaflets (PILs) about chronic pain medications. Patients' frequently asked questions were generated from PILs available on the official websites of the British Pain Society (BPS) and the Faculty of Pain Medicine. Eight blinded annexures were prepared for evaluation, consisting of traditional PILs from the BPS and AI-generated patient information materials structured similar to PILs by ChatGPT. The authors performed a comparative analysis to assess materials' readability, emotional tone, accuracy, actionability, and understandability. Readability was measured using Flesch Reading Ease (FRE), Gunning Fog Index (GFI), and Flesch-Kincaid Grade Level (FKGL). Sentiment analysis determined emotional tone. An expert panel evaluated accuracy and completeness. Actionability and understandability were assessed with the Patient Education Materials Assessment Tool. Traditional PILs generally exhibited higher readability (P values < 0.05), with [mean (standard deviation)] FRE [62.25 (1.6) versus 48 (3.7)], GFI [11.85 (0.9) versus 13.65 (0.7)], and FKGL [8.33 (0.5) versus 10.23 (0.5)] but varied emotional tones, often negative, compared to more positive sentiments in ChatGPT-generated texts. Accuracy and completeness did not significantly differ between the two. Actionability and understandability scores were comparable. While AI chatbots offer efficient information delivery, ensuring accuracy and readability, patient-centeredness remains crucial. It is imperative to balance innovation with evidence-based practice.

Enhancing readability of USFDA patient communications through large language models: a proof-of-concept study

ABSTRACT Background The US Food and Drug Administration (USFDA) communicates new drug safety concerns through drug safety communications (DSCs) and medication guides (MGs), which often challenge patients with average reading abilities due to their complexity. This study assesses whether large language models (LLMs) can enhance the readability of these materials. Methods We analyzed the latest DSCs and MGs, using ChatGPT 4.0© and Gemini© to simplify them to a sixth-grade reading level. Outputs were evaluated for readability, technical accuracy, and content inclusiveness. Results Original materials were difficult to read (DSCs grade level 13, MGs 22). LLMs significantly improved readability, reducing the grade levels to more accessible readings (Single prompt – DSCs: ChatGPT 4.0© 10.1, Gemini© 8; MGs: ChatGPT 4.0© 7.1, Gemini© 6.5. Multiple prompts – DSCs: ChatGPT 4.0© 10.3, Gemini© 7.5; MGs: ChatGPT 4.0© 8, Gemini© 6.8). LLM outputs retained technical accuracy and key messages. Conclusion LLMs can significantly simplify complex health-related information, making it more accessible to patients. Future research should extend these findings to other languages and patient groups in real-world settings.

Development, Validation, and Psychometric Analysis of a Patient Information Leaflet for Heart Failure with Reduced Ejection Fraction

Development, Validation, and Psychometric Analysis of a Patient Information Leaflet for Heart Failure with Reduced Ejection Fraction

Comparative efficacy of commercial oral poly-herbal traditional Chinese medicine formulations combined with western medicine in benign prostatic hyperplasia management: a systematic review and network meta-analysis.

Background: Benign prostatic hyperplasia (BPH) is prevalent among the aging male population and often presents with distressing lower urinary tract symptoms. There is emerging evidence that commercial oral poly-herbal traditional Chinese medicine (TCM) formulation combined with Western medicine (WM) may offer enhanced therapeutic effects compared to WM alone in BPH treatment. Nevertheless, determining the optimal formulations for BPH remains controversial. We aimed to employ a network meta-analysis to compare and assess differences among commonly used and recommended poly-herbal TCM formulations outlined in the Chinese guidelines for BPH treatment, providing clinical medication recommendations and guidance. Methods: We extensively searched for RCTs of BPH patients that had oral poly-herbal TCM formulations and WM treatment, covering both English and Chinese databases up to 31 October 2023. The quality of the included studies was evaluated using the Cochrane risk-of-bias tool Version 2 (ROB2). A Bayesian network meta-analysis was performed to assess the effectiveness of various formulations, followed by sensitivity and subgroup analyses. Results: Our meta-analysis included 107 RCTs involving 11,037 patients across 16 oral poly-herbal TCM formulations. The quality of the selected studies was assessed as "Some concerns". Most formulations combined with WM demonstrated superior therapeutic efficacy compared to WM alone. For clinical effective rate, Jingui Shenqi pill (JGSQ) + WM had the highest-ranking probability (87.38%). Concerning International Prostate Symptom Score (IPSS) and maximum flow rate of urine, Guizhi Fuling capsule (GZFL) + WM was most effective (91.10% and 98.55%). Regarding the quality of life score and postvoid residual urine, Pulean tablet (PLA) + WM ranked first (86.71% and 91.81%). In controlling prostate volume, Huange capsule (HE) + WM demonstrated the highest efficacy (95.65%). Additionally, among the interventions, Lingze (LZ) + WM capsule exhibited the lowest incidence of adverse drug reactions (2.32%). Conclusion: Combining oral poly-herbal TCM formulations with WM may provide greater therapeutic benefits in BPH treatment compared to WM alone. JGSQ, GZFL, PLA, and HE emerged as promising treatment options. However, further rigorous empirical studies are essential to substantiate these findings. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=459651, CRD 42023459651.

A systematic review and expert Delphi Consensus recommendation on the use of vaccines in patients receiving dupilumab: A position paper of the American College of Allergy, Asthma and Immunology

BackgroundDupilumab is a monoclonal antibody that targets the interleukin (IL)-4 receptor alpha subunit, thus blocking the effects of IL-4 and IL-13, and has shown efficacy in treating various conditions including asthma, atopic dermatitis, eosinophilic esophagitis, and others. Because of its immune modulatory effects, clinical trials that studied dupilumab did not allow patients to receive live vaccines during the clinical trials because of an abundance of caution, and thus package inserts recommend that patients who are being treated with dupilumab should avoid live vaccines. Because dupilumab is now approved for use in patients from 6 months of age for the treatment of atopic dermatitis, this reported contraindication is now posing a clinical dilemma for patients and clinicians. ObjectiveTo perform a systematic review of literature on the safety and efficacy of vaccinations in patients who are receiving dupilumab and to provide expert guidance on the use of vaccines in patients who are receiving dupilumab. MethodsA systematic review of the literature was performed, and an expert Delphi Panel was assembled. ResultsThe available literature on patients who received vaccinations while using dupilumab overall suggests that live vaccines are safe and that the vaccine efficacy, in general, is not affected by dupilumab. The expert Delphi panel agreed that the use of vaccines in patients receiving dupilumab was likely safe and effective. ConclusionVaccines (including live vaccines) can be administered to patients receiving dupilumab in a shared decision-making capacity.

Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS)

ABSTRACT Background Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored. It remains unknown whether suicidality is attributed to DORAs. We aim to evaluate suicidality associated with DORAs reported to the FDA Adverse Event Reporting System (FAERS). Methods The reporting odds ratio (ROR) was determined with trazodone as the control. Significant disproportionate reporting was determined when 95% confidence intervals (CIs) did not encompass 1.0. We used information components (ICs) to calculate the lower limit of the 95% CI (IC025). IC was significantly increased when the IC025 ≥0. Results Suvorexant (0.025 ROR), lemborexant (0.019 ROR) and daridorexant (0.002 ROR) were significantly associated with lower odds of reported completed suicides compared to trazodone (p < 0.05). There was no significantly increased RORs for the DORAs regarding suicidal ideation, depression suicidal, suicidal behavior and suicide attempts. Nonsignificant associations between all parameters of suicidality were observed for each DORA using IC025. Conclusion We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.