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European Journal of Obstetrics,... May 2024To develop and assess the GAIA! app, designed to assist pregnant women and healthcare professionals in managing infectious diseases during pregnancy, and to bridge the...
OBJECTIVE
To develop and assess the GAIA! app, designed to assist pregnant women and healthcare professionals in managing infectious diseases during pregnancy, and to bridge the information gap between health professionals and expectant mothers.
STUDY DESIGN
This collaborative initiative in Italy involved partnerships with the University of Florence, Careggi University Hospital, and other institutions. The app, built on the Ionic framework, is available on both Apple and Google App Stores. It offers two distinct modes: "healthcare providers" and "patients." Content for the app was derived from extensive literature reviews and clinical guidelines.
RESULTS
Since its August 2022 launch, the GAIA! app has garnered over 2,500 downloads, indicating its effectiveness and acceptance within the community. The app differentiates itself from others, such as the Sanford Guide, by focusing specifically on the needs of pregnant women. It ensures cross-platform compatibility, a user-friendly interface, and offline functionality.
CONCLUSIONS
The GAIA! app has successfully addressed a niche in infectious disease management for pregnant women, gaining significant traction within the community. While it has seen substantial success, challenges like continuous updates and potential language expansion remain. Future endeavors will address these challenges and further evaluate the app's impact on maternal and child health.
PubMed: 38850898
DOI: 10.1016/j.ejogrb.2024.05.035 -
Journal of Pharmaceutical Policy and... 2024The increased utilization of opioids in low- and middle-income countries (LMICs) presents a growing threat of opioid-related abuse, misuse and diversion. Pharmacists, as...
The increased utilization of opioids in low- and middle-income countries (LMICs) presents a growing threat of opioid-related abuse, misuse and diversion. Pharmacists, as integral members of healthcare teams, are responsible for dispensing and monitoring opioid use and hold a pivotal role in opioid stewardship within LMICs. This commentary describes the potential and multifaceted roles of pharmacists in opioid stewardship in resource-constrained settings and highlights appropriate strategies for promoting responsible opioid utilization. Opioid stewardship involves prioritising evidence-based prescribing, management and practices for pain management. It includes measures such as incorporating prescription drug monitoring programmes for appropriate opioid prescription, implementing safe disposal through drug take-back programmes, promoting non-opioid pain management, addressing the opioid addiction stigma, tapering opioid dose, educating patients and caregivers, establishing drug information centers, providing rehabilitative services and integrating collaboration with communities and experts. The combined difficulties of restricted access to healthcare resources and services coupled with low levels of literacy worsen the susceptibility to opioid abuse, misuse, and diversion in LMICs. Early detection, assessment and implementation of interventions to optimise opioid use are imperative for ensuring safe and effective opioid utilization, thereby mitigating the risks of overdose and addiction. The involvement of pharmacists in promoting safe and effective opioid utilization through education, monitoring, collaboration, and policy advocacy serves as a critical component in bridging existing gaps in opioid stewardship within LMICs.
PubMed: 38845626
DOI: 10.1080/20523211.2024.2345219 -
World Journal of Radiology May 2024In cases of coronavirus disease 2019 (COVID-19), favipiravir is commonly included to the therapy regimen. Drug interactions between favipiravir and other COVID-19...
BACKGROUND
In cases of coronavirus disease 2019 (COVID-19), favipiravir is commonly included to the therapy regimen. Drug interactions between favipiravir and other COVID-19 therapy drugs are frequently researched. However, no research on possible drug interactions between Favipiravir and radiocontrast agents, which have become almost crucial in diagnostic processes while not being part of the treatment, has been found.
AIM
To determine potential medication interactions between Favipiravir and radiocontrast agents.
METHODS
The study comprised patients who were taking Favipiravir for COVID-19 therapy and underwent a contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) test while taking the medicine. The computerized patient files of the cases included in the study, as well as the pharmacovigilance forms in the designated hospital, were evaluated for this purpose.
RESULTS
The study included the evaluation of data from 1046 patients. The study sample's mean age was 47.23 ± 9.48 years. The mean age of cases with drug interactions was statistically significant greater than that of cases with no drug interactions ( = 0.003). When evaluated with logistic regression analysis, a 1-year raises in age increases the risk of developing drug interactions by 1.63 times ( = 0.023). There was no statistically significant difference in the occurrence of medication interactions between the sexes ( = 0.090). Possible medication interactions were discovered in 42 cases (4%).
CONCLUSION
The findings of this study revealed that the most notable findings as a result of the combined use of contrast agents and favipiravir were increased creatinine and transaminase values, as well as an increase in the frequency of nausea and vomiting. The majority of drug interactions discovered were modest enough that they were not reflected in the clinic. Drug interactions become more common as people get older.
PubMed: 38845605
DOI: 10.4329/wjr.v16.i5.128 -
Scientific Reports Jun 2024The misuse of benzodiazepines and opioid medications is frequent in students. To improve our understanding of this behavior, we aimed to identify factors associated with...
The misuse of benzodiazepines and opioid medications is frequent in students. To improve our understanding of this behavior, we aimed to identify factors associated with separate and concomitant use of these substances. Anonymous self-reported questionnaires were e-mailed to students enrolled at a French university between March and July 2021, covering: sociodemographic characteristics, academics, psychoactive substance use, ADHD symptomatology (adulthood and childhood), and psychiatric/psychological or addiction follow-up. Factors associated with the use of benzodiazepines and opioid medications included female sex (OR = 1.41 [1.08; 1.86]) and OR = 1.38 [1.06; 1.79], respectively), older age (OR = 1.65 [1.04; 2.6] and OR = 2.17 [1.4; 3.36], respectively), current psychiatric/psychological follow-up (OR = 6.53 [5.18; 8.24] and OR= 1.5 [1.12; 2.0], respectively), ADHD symptomatology (OR= 2.33 [1.71;3.16] and OR= 1.61 [1.15; 2.24], respectively), polyconsumption (tobacco use for benzodiazepine users, OR = 1.38 [1.04; 1.82]; alcohol use OR = 1.67 [1.17; 2.39] and tobacco use OR = 1.62 [1.23; 2.14] for opioid users). These factors were even more strongly associated with the concomitant use of benzodiazepines and opioid medications: older age (OR = 3.64 [2.22; 5.99]), female sex (OR = 1.54 [1.1; 2.14]), grade repetition (OR = 1.7 [1.14; 2.54]), psychiatric/psychological follow-up (OR = 4.51 [3.35;6.06]), ADHD symptomatology (OR = 5.3 [3.69; 7.63]), polyconsumption (tobacco use OR = 2.05 [1.39; 3] and cannabis use, OR = 2.07 [1.97; 4.16]. The factors associated with the use of benzodiazepines and prescription opioids identified in this study could lead to the development of targeted prevention methods.
Topics: Humans; Benzodiazepines; Female; Male; Cross-Sectional Studies; Analgesics, Opioid; Young Adult; Students; Adult; Adolescent; Substance-Related Disorders; Surveys and Questionnaires; France; Prescription Drug Misuse; Prescription Drugs; Attention Deficit Disorder with Hyperactivity
PubMed: 38844771
DOI: 10.1038/s41598-024-63037-4 -
International Journal of Clinical... Jul 2024Nivolumab has been approved for treating ≥ 10 cancer types. However, there is limited information on the incidence of rare, but potentially serious,...
BACKGROUND
Nivolumab has been approved for treating ≥ 10 cancer types. However, there is limited information on the incidence of rare, but potentially serious, treatment-related adverse events (TRAEs), as well as notable TRAEs in patients with certain medical disorders or older patients in Japan.
METHODS
We performed pooled analyses of data from published post-marketing surveillance in Japan of nivolumab monotherapy for patients with malignant melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck cancer, and gastric cancer to determine the frequencies of 20 categories of TRAEs of special interest overall and in patient groups with higher perceived safety risks (history of autoimmune disease, interstitial lung disease, tuberculosis, or hepatitis B/C; patients vaccinated during nivolumab treatment; and older patients [≥ 75 years]).
RESULTS
The overall population comprised 7421 patients treated with nivolumab. TRAEs were reported in 49.1% of patients, with grade ≥ 3 TRAEs in 16.7%. Endocrine disorders (14.4%), hepatobiliary disorders (10.9%), and interstitial lung disease (7.0%) were the three most common categories (any grade). The incidences of rare TRAEs with high risk of becoming serious, which occurred in < 1% of patients, were consistent with those in previous reports. The frequencies of TRAEs were not markedly increased in the specified patient groups relative to the overall population.
CONCLUSION
To our knowledge, this is the largest study examining the safety of nivolumab-treated patients in real-world clinical practice including rare but potentially serious TRAEs. We found no new signals in the safety of nivolumab among the patient groups relative to the overall population, and no additional safety measures are required in these groups. Trial registration UMIN000048892 (overall analysis), JapicCTI-163272 (melanoma), Japic-163271 (non-small cell lung cancer), JapicCTI-184071 (head and neck cancer), JapicCTI-184070 (gastric cancer), and JapicCTI-184069 (renal cell cancer).
Topics: Humans; Nivolumab; Japan; Aged; Male; Product Surveillance, Postmarketing; Female; Stomach Neoplasms; Neoplasms; Middle Aged; Melanoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Head and Neck Neoplasms; Adult; Kidney Neoplasms; Antineoplastic Agents, Immunological; Aged, 80 and over; Incidence
PubMed: 38844668
DOI: 10.1007/s10147-024-02515-1 -
Journal of Medical Internet Research Jun 2024Adverse drug reactions are a common cause of morbidity in health care. The US Food and Drug Administration (FDA) evaluates individual case safety reports of adverse...
Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration.
Adverse drug reactions are a common cause of morbidity in health care. The US Food and Drug Administration (FDA) evaluates individual case safety reports of adverse events (AEs) after submission to the FDA Adverse Event Reporting System as part of its surveillance activities. Over the past decade, the FDA has explored the application of artificial intelligence (AI) to evaluate these reports to improve the efficiency and scientific rigor of the process. However, a gap remains between AI algorithm development and deployment. This viewpoint aims to describe the lessons learned from our experience and research needed to address both general issues in case-based reasoning using AI and specific needs for individual case safety report assessment. Beginning with the recognition that the trustworthiness of the AI algorithm is the main determinant of its acceptance by human experts, we apply the Diffusion of Innovations theory to help explain why certain algorithms for evaluating AEs at the FDA were accepted by safety reviewers and others were not. This analysis reveals that the process by which clinicians decide from case reports whether a drug is likely to cause an AE is not well defined beyond general principles. This makes the development of high performing, transparent, and explainable AI algorithms challenging, leading to a lack of trust by the safety reviewers. Even accounting for the introduction of large language models, the pharmacovigilance community needs an improved understanding of causal inference and of the cognitive framework for determining the causal relationship between a drug and an AE. We describe specific future research directions that underpin facilitating implementation and trust in AI for drug safety applications, including improved methods for measuring and controlling of algorithmic uncertainty, computational reproducibility, and clear articulation of a cognitive framework for causal inference in case-based reasoning.
Topics: United States; United States Food and Drug Administration; Artificial Intelligence; Humans; Drug-Related Side Effects and Adverse Reactions; Clinical Decision-Making; Product Surveillance, Postmarketing; Adverse Drug Reaction Reporting Systems; Algorithms; Trust
PubMed: 38842929
DOI: 10.2196/50274 -
Heliyon Jun 2024The traditional Chinese patent medicine (TCPM), Simo decoction (Simo decoction oral solution), with its primary ingredient (Binglang, L.), known for its potential...
OBJECTIVE
The traditional Chinese patent medicine (TCPM), Simo decoction (Simo decoction oral solution), with its primary ingredient (Binglang, L.), known for its potential carcinogenic effects, is the subject of this study. The research aims to analyze the effectiveness and potential risks of Simo decoction, particularly as a carcinogen, and to suggest a framework for evaluating the risks and benefits of other herbal medicines.
METHODS
The study is based on post-marketing research of Simo decoction and . It utilized a wide range of sources, including ancient and modern literature, focusing on the efficacy and safety of Simo decoction. The research includes retrospective data on the sources, varieties, and toxicological studies of from databases such as Pubmed, Clinical Trials, Chinese Clinical Trial Registry, China National Knowledge Infrastructure, WHO-UMC Vigibase, and China National Center for ADR Monitoring.
RESULTS
Common adverse drug reactions (ADRs) associated with Simo decoction include skin rash, nausea, vomiting, abdominal pain, and diarrhea. However, no studies exist reporting the severe ADRs, such as carcinogenic effects. is distributed across approximately 60 varieties in tropical Asia and Australia. According to the WHO-UMC Vigibase and the National Adverse Drug Reaction Monitoring System databases, there are currently no reports of toxicity related to in the International System for Classification of ADRs (ISCR) or clinical studies.
CONCLUSION
Risk-benefit analysis in TCPM presents more challenges compared to conventional drugs. The development of a practical pharmacovigilance system and risk-benefit analysis framework is crucial for marketing authorization holders, researchers, and regulatory bodies. This approach is vital for scientific supervision and ensuring the safety and efficacy of drug applications, thus protecting public health.
PubMed: 38841513
DOI: 10.1016/j.heliyon.2024.e31373 -
Australian Journal of General Practice Jun 2024Interest in using primary care data for research is growing with increasing recognition of its potential for improving healthcare. Many issues exist, some inherent in...
BACKGROUND
Interest in using primary care data for research is growing with increasing recognition of its potential for improving healthcare. Many issues exist, some inherent in the data and others external.
OBJECTIVE
This paper explores the main issues associated with the use of primary care data for research and proposed solutions to address them.
DISCUSSION
Issues related to the use of primary care data for research are complex. Government reimbursement system administrative data have limitations as they lack clinical detail. General practice electronic medical record data are more suitable; however, challenges include variable data quality and interoperability. There are concerns from general practices and the public about data access and use. Strategies to address these issues include incorporating best-practice principles, implementing standards and data quality frameworks, creating partnerships between data custodians and ensuring robust governance systems exist. Leadership and the will of key stakeholders to reform, with governmental support in implementing required actions, must be prioritised.
Topics: Primary Health Care; Humans; Electronic Health Records
PubMed: 38840382
DOI: 10.31128/AJGP-07-23-6887 -
International Immunopharmacology Jul 2024Although immune checkpoint inhibitors (ICIs) combined with angiogenesis inhibitors (AGIs) has become increasingly used for cancers, the impact of combination therapy on...
Immune-related adverse events of immune checkpoint inhibitors combined with angiogenesis inhibitors: A real-world pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database (2014-2022).
INTRODUCTION
Although immune checkpoint inhibitors (ICIs) combined with angiogenesis inhibitors (AGIs) has become increasingly used for cancers, the impact of combination therapy on immune-related adverse events (irAEs) in real-world settings has not been well elucidated to date.
METHODS
The FDA Adverse Event Reporting System (FAERS) database from 2014 to 2022 was retrospectively queried to extract reports of irAEs referred as standardized MedDRA queries (SMQs), preferred terms (PTs) and system organ classes (SOCs). To perform disproportionality analysis, information component (IC) and reporting odds ratio (ROR) were calculated and lower limit of 95 % confidence interval (CI) for IC (IC) > 0 or ROR (ROR) > 1 with at least 3 reports was considered statistically significant.
RESULTS
Compared to ICIs alone, ICIs + AGIs demonstrated a lower IC/ROR for irAEs-SMQ (2.343/5.082 vs. 1.826/3.563). Regarding irAEs-PTs, there were fewer irAEs-PTs of significant value in ICIs + AGIs than ICIs alone (57 vs. 150 PTs) and lower signal value for most PTs (88 %) in ICIs + AGIs. Moreover, lower IC for most of irAEs-SOCs in ICIs + AGIs (11/13) compared with ICIs alone was observed. As for outcomes of irAEs, ICIs + AGIs showed a lower frequency of "fatal" for irAEs-SMQ than ICIs alone (4.88 % vs. 7.83 %), so as in cardiac disorder (SOC) (15.45 % vs. 26.37 %), and respiratory, thoracic and mediastinal disorders (SOC) (13.74 % vs. 20.06 %). Similarly, there were lower occurrence and fewer fatality of irAEs in ICIs + AGIs + chemotherapy (CT) than ICIs + CT.
CONCLUSION
ICIs combined with AGIs may reduce incidence and mortality for most of irAEs compared to ICIs alone whether or not with CT.
Topics: Humans; Immune Checkpoint Inhibitors; Pharmacovigilance; United States; Adverse Drug Reaction Reporting Systems; Male; United States Food and Drug Administration; Female; Angiogenesis Inhibitors; Retrospective Studies; Middle Aged; Databases, Factual; Aged; Neoplasms; Adult; Young Adult; Adolescent; Aged, 80 and over
PubMed: 38838553
DOI: 10.1016/j.intimp.2024.112301 -
PLoS Neglected Tropical Diseases Jun 2024Effective radical cure of Plasmodium vivax malaria is essential for malaria elimination in Brazil. P. vivax radical cure requires administration of a schizonticide, such...
Effective radical cure of Plasmodium vivax malaria is essential for malaria elimination in Brazil. P. vivax radical cure requires administration of a schizonticide, such as chloroquine, plus an 8-aminoquinoline. However, 8-aminoquinolines cause hemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, requiring prior screening to exclude those at risk. Brazil is pioneering the implementation of tafenoquine, a single-dose 8-aminoquinoline indicated for P. vivax patients with >70% of normal G6PD activity. Tafenoquine implementation in Manaus and Porto Velho, two municipalities located in the western Brazilian Amazon, included comprehensive training of healthcare professionals (HCPs) on point-of-care quantitative G6PD testing and a new treatment algorithm for P. vivax radical cure incorporating tafenoquine. Training was initially provided to higher-level facilities (phase one) and later adapted for primary care units (phase two). This study analyzed HCP experiences during training and implementation and identified barriers and facilitators. In-depth interviews and focus discussion groups were conducted 30 days after each training for a purposive random sample of 115 HCPs. Thematic analysis was employed using MAXQDA software, analyzing data through inductive and deductive coding. Analysis showed that following the initial training for higher-level facilities, some HCPs did not feel confident performing quantitative G6PD testing and prescribing the tafenoquine regimen. Modifications to the training in phase two resulted in an improvement in understanding the implementation process of the G6PD test and tafenoquine, as well as in the knowledge acquired by HCPs. Additionally, knowledge gaps were addressed through in situ training, peer communication via a messaging app, and educational materials. Training supported effective deployment of the new tools in Manaus and Porto Velho and increased awareness of the need for pharmacovigilance. A training approach for nationwide implementation of these tools was devised. Implementing quantitative G6PD testing and tafenoquine represents a significant shift in P. vivax malaria case management. Consistent engagement with HCPs is needed to overcome challenges in fully integrating these tools within the Brazilian health system.
Topics: Humans; Brazil; Malaria, Vivax; Antimalarials; Aminoquinolines; Glucosephosphate Dehydrogenase Deficiency; Health Personnel; Female; Glucosephosphate Dehydrogenase; Male; Plasmodium vivax; Adult
PubMed: 38837977
DOI: 10.1371/journal.pntd.0012197