Package Insert Research Articles

Spasmolytic Effect of Flopropione Does Not Involve Catechol-O- methyltransferase (COMT) Inhibition.

Flopropione (Flo) has been used for gallstone and urolithiasis as a spasmolytic agent almost exclusively in Japan. According to the package insert, its main mechanism is catechol-O-methyltransferase (COMT) inhibition and anti-serotonergic effect. This is obviously contrary to pharmacological common sense, but it is described that way in pharmacology textbooks and occurs in questions in the National Examination for Pharmacists in Japan. As this is a serious problem in education, we re-examined the action of Flo. The guinea pig ureter was hardly contracted by serotonin, but noradrenaline (NA) elicited repetitive twitch contraction, which was inhibited by Flo. The sphincter of Oddi (SO) exhibited a spontaneous repetitive twitch contraction, which was inhibited by NA and Flo. The inhibitory effect of NA was reversed by α- and β-blockers, whereas that of Flo was not. Entacapone, a representative COMT inhibitor, did not affect the movement of the ureter and the SO. Nifedipine suppressed carbachol-induced contraction of the taenia coli, spontaneous movement of the SO, and NA-induced contraction of the ureter to almost the same extent, whereas Flo did not inhibit the taenia coli, but inhibited the contraction of the SO and the ureter. The inhibitory pattern of Flo resembled that of the ryanodine receptor agonist 4-chloro-m-cresol and the inositol 1,4,5-trisphosphate (IP3) receptor antagonist 2-aminoethoxydiphenyl borate. It is concluded that COMT inhibition or serotonin inhibition is not involved in the spasmolytic action of Flo. Flo might act on ryanodine receptors and/or IP3 receptors, which are responsible for periodic Ca release from Ca stores, to disrupt coordinated Ca dynamics.

Nominalization in Arabic translations of patient information leaflets

Patient information leaflets (PILs) inserted in medicine packages constitute a genre written by experts for an audience of laymen, but studies of PILs in Arabic report low readability. According to the lay friendliness framework developed by Jensen (2013) for translated PILs, nominalization is one of the linguistic factors that contribute to PILs’ low readability. Although nominalization has been extensively studied in scientific texts including medical papers, no studies examine its use and effect on lay friendliness in PILs translated into Arabic. This study analyzes a parallel corpus of English PILs and their Arabic translations to examine the frequency and forms of nominalization introduced into the Arabic translations. Considering Givon’s (1993) definition of nominalization, all instances of finite verb phrases in the Source Texts (ST) that are fully or partially nominalized in the Target Texts (TT) were examined. Examples are discussed in terms of the level and function of nominalization in the target language.

Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts.

The addition of clinically significant adverse reactions (CSARs) to Japanese package inserts (PIs) is an important safety measure that can be used to inform medical personnel of potential health risks; however, determining the necessity of their addition can be lengthy and complex. Therefore, we aimed to construct a machine learning-based model that can predict the addition of CSARs at an early stage due to the accumulation of both Japanese and overseas adverse drug reaction (ADR) cases. The target comprised CSARs added to PIs from August 2011 to March 2022. The control group consisted of drugs without the same CSARs in their PIs by March 2022. Features were generated using ADR case accumulation data obtained from the Japanese Adverse Drug Event Report and the U.S. Food and Drug Administration Adverse Event Reporting System databases. The model was constructed using DataRobot, and its performance evaluated using the Matthews correlation coefficient. The target for the addition of CSARs included 414 cases, comprising 302 due to domestic case accumulation, 22 due to both domestic and overseas case accumulation, 12 due to overseas case accumulation, and 78 due to revisions of the company core data sheet. The best model was a generalized linear model with informative features, achieving a cross-validation of 0.8754 and a holdout of 0.8995. In conclusion, the proposed model effectively predicted CSAR additions to PIs resulting from the accumulation of ADR cases using data from both Japan and the United States.

Integrating Full Bayesian Inference and Student's t-Distribution Method for Enhanced Outlier Handling in Caffeine Population Pharmacokinetics: Assessing Drug-Drug Interactions with Enasidenib in Relapsed or Refractory AML and MDS Patients.

As the first-in-class, selective, and potent inhibitor of the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation. Known for its interactions with various cytochrome P450 (CYP)enzymes and transporters in vitro, a clinical pharmacokinetics (PK) trial was initiated to assess the impact of multiple doses of enasidenib on the single-dose PK of sensitive probe substrates of several cytochrome P450 enzymes and transporters. In this study, a population pharmacokinetic analysis approach was employed to address challenges posed by high, nonzero baseline caffeine concentrations. Moreover, we integrated full Bayesian inference into this approach innovatively for a more detailed understanding of parameter uncertainty and greater modeling flexibility, alongside Student's t-distribution for robust error modeling in handling the abnormal outlier caffeine concentration data observed in this trial. Our analyses demonstrated that multiple doses of enasidenib altered caffeine clearance to a clinically meaningful extent, as evidenced by an approximate 8-fold decrease. This finding led to a specific recommendation in the package insert to avoid the concurrent use of certain CYP1A2 substrates with enasidenib, unless directed otherwise in the prescribing information. Furthermore, this research underlines the technical benefits of integrating full Bayesian inference and incorporating Student's t-distribution for residual error modeling in the PK field.

Preliminary investigation on the analysis of the whole components of Pogejiuxin decoction and its formulation pattern based on ultrahigh-performance liquid chromatography with quadrupole time-of-flight mass spectrometry.

Pogejiuxin decoction (PGJXD) is one of the most important formulas for the treatment of heart failure. However, there is a great lack of research on the material basis of this formula, especially research on its compatibility laws, which restricts its clinical use. Studying the complete ingredients and compatibility rules of PGJXD has great significance for guiding clinical medication. The entire formula, the major single herbs, the drug pairs and the disassembled formula were analyzed by ultrahigh-performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UHPLC/QTOFMS/MS), matching the chemical composition database and global natural product social molecular networking to explain the chemical composition as well as the combination pattern of PGJXD. A total of 1048 chemical constituents were fully analyzed from the major single herbs, the drug pairs and the disassembled formula and 188 chemical constituents, including 13 potential novel compounds, were firstly identified from the whole formula. We found that the chemical compositions were reduced after the single herbs were matched to the other herbs, especially the significant reduction of highly toxic diester alkaloids after compatibility, indicating that the medicines of PGJXD were interdependent and controlled by each other. This study innovatively researches and compares the compositional differences between the entire formula of PGJXD, the single, paired and separated formulas, greatly extending our understanding of the chemical substance basis of these compounds, and preliminarily explores the compatibility laws of PGJXD, providing some theoretical guidance for clinical medication.

Do Nurses Follow The “Right Response”? Mixed Methods Research

Aim: Drug administration and management is an important procedure among clinical nursing practices and is one of the significant indicators affecting patient safety and quality of care. It was aimed to determine the nurses' monitoring of drug effects after drug treatment.
 Methods: In the study, sequential explanatory design from exploratory and mixed research methods was used. Quantitative data were collected using a data collection form and qualitative data were collected through in-depth and individual interviews using a semi-structured interview form. The interviews were recorded with a voice recorder.
 Results: It was determined that the average age, working years, weekly working hours, and daily number of patients cared for by the nurses were respectively 30.46±6.96, 7.1±6.31, 44.92±5.71, 15.42±11.89 years. It was found that 54.2% of the nurses checked the drug package insert before administering the medication, 74.5% of the nurses always considered the history of drug and food allergy to be of vital importance before drug administration, and 97.9% of the nurses reported unexpected side/toxic effects. As a result of in-depth interviews with the nurses participating in the study, three themes were identified: the approach of right drug administration principles, the approach of following the right response, and the follow-up status of nurses after drug administration.
 Conclusion: In the study, it was determined that nurses lacked knowledge about the right to correct medication, and could not implement the right to correct response due to high workload, low number of nurses and lack of time. It was observed that nurses gave the responsibility of correct response follow-up to the patient or the patient's relatives. By evaluating the reasons for not implementing the right to correct response, it is recommended that the number of nurses should be increased, the workload should be regulated, and nurses should receive training on correct drug administration and especially on the importance of correct response. It is also recommended that nurses receive training and counseling on their duties, authorities and responsibilities.

Observation on the Clinical Efficacy of Mind Map-based Medication Guidance in the Treatment of HP with Quadruple Therapy

Observation on the Clinical Efficacy of Mind Map-based Medication Guidance in the Treatment of HP with Quadruple Therapy

Patient information leaflets and package inserts of ibuprofen provided in the UK and Thailand: a comparative assessment.

Written medicine information (WMI) is important for ensuring patients understand and use their medicines optimally, but relatively little research has assessed the quality of available WMI. This study assessed the quality of WMI using a sample of leaflets for ibuprofen in the UK and Thailand. Leaflets were obtained by purchasing a product from retail outlets or community pharmacies, 18 from each country. In the UK, these were patient information leaflets (PILs); in Thailand, they were package inserts PIs not specifically designed for patients. Leaflets were assessed for content, layout, and readability using standard methods and compared to relevant guidelines. The UK PILs were uniform and conformed to EU regulatory requirements for content, whereas Thai PIs varied considerably, many failing to include important information required by Thai regulations. Several forms of Thai PIs were found, including some very short leaflets, containing minimal information. The readability of both was rated as poor, all used small font size and had less than desirable white space. Fewer Thai PIs than UK PILs met the Keystone Criteria for ibuprofen. The extent of variation in format and content of Thai WMI could potentially cause confusion and reduce willingness to read it. PILs, conforming to Thai regulatory guidelines, should be provided with medicines instead. Leaflets in both countries would benefit from improved readability and layout.

"Arming half-baked people with weapons!" Information enclaving among professionals and the need for a care-centred model for antibiotic use information in Uganda, Tanzania and Malawi.

The overuse of antimicrobial medicines is a global health concern, including as a major driver of antimicrobial resistance. In many low- and middle-income countries, a substantial proportion of antibiotics are purchased over-the-counter without a prescription. But while antibiotics are widely available, information on when and how to use them is not. We aimed to understand the acceptability among experts and professionals of sharing information on antibiotic use with end users - patients, carers and farmers - in Uganda, Tanzania and Malawi. Building on extended periods of fieldwork amongst end-users and antibiotic providers in the three countries, we conducted two workshops in each, with a total of 44 medical and veterinary professionals, policy makers and drug regulators, in December 2021. We carried out extensive documentary and literature reviews to characterise antibiotic information systems in each setting. Participants reported that the general public had been provided information on medicine use in all three countries by national drug authorities, health care providers and in package inserts. Participants expressed concern over the danger of sharing detailed information on antibiotic use, particularly that end-users are not equipped to determine appropriate use of medicines. Sharing of general instructions to encourage professionally-prescribed practices was preferred. Without good access to prescribers, the tension between enclaving and sharing of knowledge presents an equity issue. Transitioning to a client care-centred model that begins with the needs of the patient, carer or farmer will require sharing unbiased antibiotic information at the point of care.

Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis

The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinical study situation for the preparations was also analyzed. For this purpose, the clinical studies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers’ claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.

Patient information videos via QR codes: An innovative and sustainable approach in ophthalmology.

We explore an innovative approach by transforming patient information leaflet (PILs) into Quick Response (QR) code linked patient information videos (PIVs) in ophthalmology. Our objectives are to assess the subjective utility of a PIV on glaucoma and analyse the use of QR codes as a delivery method. A prospective study was conducted in Ninewells Hospital, NHS Tayside. A glaucoma PIV was created and linked to a QR code provided to 130 glaucoma patients. Pre- and post-video questionnaires evaluated the patients' perception of using a QR code and subjective improvement in their understanding of glaucoma. Out of 102 responses collected, 55% of patients had no prior experience with QR codes. However, 81% of patients were able to watch the PIV. The average view duration of the video was 3:26, with 82.5% view retention. Statistically significant improvement in glaucoma knowledge was observed across all six areas questioned (p < 0.001) using a 5-point Likert scale. Overall, 70% of patients preferred PIVs over PILs, and 77% acknowledged that PIVs could be a sustainable alternative. QR codes for delivering PIVs were well-received, with patients finding them easy to use. Our PIV on glaucoma effectively enhanced patients' understanding of the condition.

From textbooks to online sources: An Investigation of drug information resource preference and utilization among healthcare Professionals

BackgroundProviding drug information (DI) is one of the essential pharmaceutical care services. Previous research has documented varying DI preferences and utilization practices among Healthcare Professionals (HCPs). This study aimed to determine the preference and utilization of DI resources among HCPs and identify the main barriers that impede their ability to utilize them. MethodsA cross-sectional survey was conducted in selected government, private hospitals, and primary healthcare clinics. A thirteen-item survey instrument was developed to assess the utilization, accessibility, preferences, and satisfaction with various DI resources and barriers. HCPs meeting the inclusion criteria were identified and contacted. The collected data were analyzed using the Statistical Package for Social Sciences (SPSS) 27. Results311 responses were considered for the final analysis. Most HCPs who contributed to this survey were pharmacists, nurses, and physicians. Google was the most frequently used reference resource, at 64.3% (n = 200), followed by other subscription-based databases at 36% (n = 112) and package inserts at 30.5% (n = 95). UpToDate was the most commonly used database, i.e., 42.1% (n = 131) (RII = 0.749196). Treatment was the most common category of DI, and 69.8% (n = 217) searched (RII = 0.899517). Lack of time, 46% (n = 201), was the most limiting factor for seeking DI. Variables such as work experience, practice setting, education level, and continuing medical education hours were the significant (p < 0.05) predictors of some DI utilization components and preferences. ConclusionThis study shows differences in preference and utilization of drug information resources (DIR) by HCPs, depending upon their clinical practice and background. Therefore, educational strategies are needed to empower HCPs about DIR.

Noninvasive Ocular Surface Workup in Patients with Meibomian Gland Dysfunction Using Microwave-Heated Eye Bag.

To report the outcomes of a novel microwave heating device (Blepha EyeBag®) used serially for the treatment of meibomian gland dysfunction (MGD). This prospective single center study was conducted at University Magna Graecia of Catanzaro. Patients were instructed to apply the compress twice daily for 15 days and once per day every two days, as reported in the package insert. Outcome measures were i) ocular surface disease index (OSDI) score, ii) tear meniscus height (TMH), iii) non-invasive keratograph break-up time (NIKBUT) (first and average), iv) meiboscore, v) bulbar redness. Evaluations were performed at baseline (T0) after 15 days (T1) and after 45 days of therapy (T2). Overall, 19 patients with MGD (8 males, 11 females; mean age 64.58 ± 9.72 years) were included. The mean value of OSDI score showed a significant decrease from 28.16 ± 17.46 at T0 to 13.69 ± 7.62 at T2 (p=0.008). The mean value of NIKBUT first significantly increased from 6.67 ± 3.51 seconds (s) at T0 to 10.46 ± 4.64 at T2 (p=0.0121); in parallel, the mean value of NIKBUT average increased significantly from 11.09 ± 4.15 s at T0 to 14.95 ± 4.85 at T2 (p=0.0049). No significant differences were detected at each time point for bulbar redness, meiboscore and TMH. Throughout the entire study, no adverse events were recorded. The microwave-heated eye bag treatment is both safe and effective for treatment of MGD, being able to significantly ameliorate both patient-reported symptoms and tear film stability.

Evaluation of ChatGPT for Pelvic Floor Surgery Counseling.

Large language models are artificial intelligence applications that can comprehend and produce human-like text and language. ChatGPT is one such model. Recent advances have increased interest in the utility of large language models in medicine. Urogynecology counseling is complex and time-consuming. Therefore, we evaluated ChatGPT as a potential adjunct for patient counseling. Our primary objective was to compare the accuracy and completeness of ChatGPT responses to information in standard patient counseling leaflets regarding common urogynecological procedures. Seven urogynecologists compared the accuracy and completeness of ChatGPT responses to standard patient leaflets using 5-point Likert scales with a score of 3 being "equally accurate" and "equally complete," and a score of 5 being "much more accurate" and much more complete, respectively. This was repeated 3 months later to evaluate the consistency of ChatGPT. Additional analysis of the understandability and actionability was completed by 2 authors using the Patient Education Materials Assessment Tool. Analysis was primarily descriptive. First and second ChatGPT queries were compared with the Wilcoxon signed rank test. The median (interquartile range) accuracy was 3 (2-3) and completeness 3 (2-4) for the first ChatGPT query and 3 (3-3) and 4 (3-4), respectively, for the second query. Accuracy and completeness were significantly higher in the second query (P < 0.01). Understandability and actionability of ChatGPT responses were lower than the standard leaflets. ChatGPT is similarly accurate and complete when compared with standard patient information leaflets for common urogynecological procedures. Large language models may be a helpful adjunct to direct patient-provider counseling. Further research to determine the efficacy and patient satisfaction of ChatGPT for patient counseling is needed.

Physiologically Based Pharmacokinetic Modeling to Investigate the Disease-Drug-Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID-19 Patients with CYP2C19 Phenotypes.

Coronavirus disease 2019 (COVID-19)-associated pulmonary aspergillosis superinfection with cytokine storm is associated with increased mortality. This study aimed to establish a physiologically-based pharmacokinetic (PK) model to investigate the disease-drug-drug interactions between voriconazole and nirmatrelvir/ritonavir in patients with COVID-19 with elevated interleukin-6 (IL-6) levels carrying various CYP2C19 phenotypes. The model was constructed and validated using PK data on voriconazole, ritonavir, and IL-6, and was subsequently verified against clinical data from 78 patients with COVID-19. As a result, the model predicted voriconazole, ritonavir, and IL-6 PK parameters and drug-drug interaction-related fold changes in healthy subjects and patients with COVID-19 with acceptable prediction error, demonstrating its predictive capability. Simulations indicated ritonavir could increase voriconazole exposure to CYP2C19 intermediate and poor metabolizers rather than decrease it, in contrast to what is indicated in the drug package insert. However, the predicted ritonavir exposures were comparable across subjects. In patients with COVID-19, both ritonavir and IL-6 increased voriconazole trough concentrations, which may lead to CYP2C19 phenotype-dependent overexposure. In conclusion, COVID-19-induced IL-6 elevation and ritonavir increased voriconazole exposure, and the magnitude of interactions was influenced by CYP2C19 phenotype. Thus, caution is warranted when prescribing voriconazole concomitantly with Paxlovid in patients with COVID-19.

Patient leaflets on respiratory tract infections did not improve shared decision making and antibiotic prescriptions in a low-prescriber setting

Patient information leaflets can reduce antibiotic prescription rates by improving knowledge and encouraging shared decision making (SDM) in patients with respiratory tract infections (RTI). The effect of these interventions in antibiotic low-prescriber settings is unknown. We conducted a pragmatic pre-/post interventional study between October 2022 and March 2023 in Swiss outpatient care. The intervention was the provision of patient leaflets informing about RTIs and antibiotics use. Main outcomes were the extent of SDM, antibiotic prescription rates, and patients’ awareness/knowledge about antibiotic use in RTIs. 408 patients participated in the pre-intervention period, and 315 patients in the post- intervention period. There was no difference in the extent of SDM (mean score (range 0–100): 65.86 vs. 64.65, p = 0.565), nor in antibiotic prescription rates (no prescription: 89.8% vs. 87.2%, p = 0.465) between the periods. Overall awareness/knowledge among patients with RTI was high and leaflets showed only a small effect on overall awareness/knowledge. In conclusion, in an antibiotic low-prescriber setting, patient information leaflets may improve knowledge, but may not affect treatment decisions nor antibiotic prescription rates for RTIs.

Comparison of the physicochemical properties of branded and generic glucose-added maintenance hypotonic infusion fluids to assess the potential for phlebitis and incompatibility with other drugs.

In Japan, the switch from branded to generic infusion fluids has been promoted as a national policy. Recently, as generic products have been in short supply, the switch from generic to branded infusion fluids has increased. However, certain additives for injectable infusion fluids, such as nonvolatile acids like acetic acid and hydrochloric acid, are not required to be listed in the package insert. We hypothesized that the addition of nonvolatile acids may be one of the reasons for the differences in physicochemical properties between the branded and generic infusion fluids. We have previously reported that in other types of electrolyte infusion fluids, a variation in pH can cause incompatibility with other drugs, and variation in titratable acidity and osmolality can lead to phlebitis. Glucose-added maintenance hypotonic infusion fluid (listed as type-3G) is commonly used as a maintenance solution when energy support is needed. However, nonvolatile acid is added to prevent the caramelization of glucose, resulting in higher osmolality and titratable acidity and lower pH. Therefore, we hypothesized that both phlebitis and incompatibility with other drugs are likely to occur; hence, we measured and evaluated the physicochemical properties of branded and generic type-3G infusion fluids. We show that the osmolality, pH, and titratable acidity of all evaluated branded and generic products differed significantly and that these properties should be evaluated together to avoid phlebitis and incompatibility with other drugs when switching between branded and generic type-3G infusion fluids.

Comprehensive analysis of responses from ChatGPT to consumer inquiries regarding over-the-counter medications.

Background: The use of generative artificial intelligence (AI) applications such as ChatGPT is becoming increasingly popular. In Japan, consumers can purchase most over-the-counter (OTC) drugs without having to consult a pharmacist, so they may ask generative AI applications which OTC drugs they should purchase. This study aimed to systematically evaluate responses from ChatGPT to consumer inquiries about various OTC drugs. Methods: We selected 22 popular OTC drugs and 12 typical consumer characteristics, including physical and disease conditions and concomitant medications. We input a total of 264 questions (i. e., all combinations of drugs and characteristics) to ChatGPT in Japanese, asking whether it is safe for consumers with each characteristic to take these OTC drugs. We used the generic name for 10 of the 22 drugs and the brand name for the remaining 12. Responses were evaluated based on the following three criteria: 1) coherence between the question and response, 2) scientific correctness, and 3) appropriateness of the instructed actions. When we received a response that satisfied all three criteria, we input the exact same question on a different day to assess reproducibility. Results: The proportions of ChatGPT's answers that satisfied criteria 1, 2, and 3 were 79.5%, 54.5%, and 49.6%, respectively. However, the proportion of responses that satisfied all three criteria was only 20.8% (55/264); 61.8% (34/55) of these responses were reproduced when the same question was input again on a different day. Compared with questions using generic names, those using brand names resulted in lower coherence and scientific correctness. Among the 12 characteristics, the appropriateness of the instructed actions tended to be lower in responses to questions about driving and concomitant medications. Conclusions: Our study revealed that ChatGPT was less accurate in its responses and less consistent in its instructed actions compared with the package inserts. Our findings suggest that Japanese consumers should not consult ChatGPT regarding OTC medications, especially when using brand names.

Development and Validation of Patient Information Leaflet for Schizophrenia

Abstract Context: People with severe mental illnesses like schizophrenia demonstrate a high rate of therapeutic noncompliance in contrast to other forms of mental illnesses. Educating patients regarding the disease and treatment helps to overcome the barriers of their resistance toward the prescribed regimen. Numerous tools have been developed for educating patients and the most convenient and cost-effective form of educational tool is a leaflet. Aims: The study aims to develop and validate a patient information leaflet (PIL) for patients with schizophrenia. Methods: The PIL contents were generated from various sources of literature and discussion with several experts in the fields of psychiatry, dietetics, and pharmacy, followed by validation using the content validation index (CVI) method. The Flesch reading ease (FRE) and Flesch–Kincaid Grade Level (FKGL) formulas were employed to assess readability and evaluate layout and design, Baker-Able Leaflet Design (BALD) criteria were utilized. Results: The prepared draft PIL obtained CVI scores of 0.94 (relevance) and 0.84 (clarity), indicating good content validity. The readability scores 74.4 (FRE) and 4 (FKGL) denoted that the textual contents in the PIL are relatively easy to read by any person with an educational grade of four and above. The BALD scores of 29 (English) and 26 (Malayalam and Kannada) represent the PIL good layout and design. Conclusion: A draft PIL for patients with schizophrenia is prepared and validated. Further user-testing analysis is needed to evaluate the PIL’s efficiency in the target population.

Exploring the level of agreement among different drug-drug interaction checkers: a comparative study on direct oral anticoagulants

ABSTRACT Background Direct oral anticoagulants (DOACs) may be involved in drug–drug interactions (DDIs) potentially increasing the risk of adverse drug reactions. This study aimed to evaluate the level of agreement among interaction checkers (ICs) and DOACs’ summary of product characteristics (SPCs), in listing DDIs and in attributing DDIs’ severity. Research design and methods The level of agreement among five ICs (i.e. INTERCheck WEB, Micromedex, Lexicomp, Epocrates, and drugs.com) in identifying potential DDIs and in attributing severity categories was evaluated using Gwet’s AC1 on all five ICs and by comparing groups of four- and two-pair sets of ICs. Results A total of 486 potentially interacting drugs with dabigatran, 556 for apixaban, 444 for edoxaban, and 561 for rivaroxaban were reported. The level of agreement among the ICs in identifying potential DDIs was poor (range: 0.12–0.16). Similarly, it was low in 4 and 2 sets analyses. The level of agreement among the ICs in classifying the severity of potential DDIs was poor (range: 0.32–0.34), also in 4 and 2 sets analyses. Conclusions The heterogeneity among different ICs and SPCs underscores the need to standardize DDI datasets and to conduct real-world studies to generate evidence regarding the frequency and clinical relevance of potential DOAC-related DDIs.