Drug Safety Information Research Articles

Transformer-based Named Entity Recognition for Clinical Cancer Drug Toxicity by Positive-unlabeled Learning and KL Regularizers

Background: With increasing rates of polypharmacy, the vigilant surveillance of clinical drug toxicity has emerged as an important With increasing rates of polypharmacy, the vigilant surveillance of clinical drug toxicity has emerged as an important concern. Named Entity Recognition (NER) stands as an indispensable undertaking, essential for the extraction of valuable insights regarding drug safety from the biomedical literature. In recent years, significant advancements have been achieved in the deep learning models on NER tasks. Nonetheless, the effectiveness of these NER techniques relies on the availability of substantial volumes of annotated data, which is labor-intensive and inefficient. Methods: This study introduces a novel approach that diverges from the conventional reliance on manually annotated data. It employs a transformer-based technique known as Positive-Unlabeled Learning (PULearning), which incorporates adaptive learning and is applied to the clinical cancer drug toxicity corpus. To improve the precision of prediction, we employ relative position embeddings within the transformer encoder. Additionally, we formulate a composite loss function that integrates two Kullback-Leibler (KL) regularizers to align with PULearning assumptions. The outcomes demonstrate that our approach attains the targeted performance for NER tasks, solely relying on unlabeled data and named entity dictionaries. Conclusion: Our model achieves an overall NER performance with an F1 of 0.819. Specifically, it attains F1 of 0.841, 0.801 and 0.815 for DRUG, CANCER, and TOXI entities, respectively. A comprehensive analysis of the results validates the effectiveness of our approach in comparison to existing PULearning methods on biomedical NER tasks. Additionally, a visualization of the associations among three identified entities is provided, offering a valuable reference for querying their interrelationships.

Postmarketing Surveillance: Review of Open Sources of Drug Safety Data

INTRODUCTION. Postmarketing surveillance is the main mechanism to monitor and evaluate the safety of drugs approved for widespread clinical use. This mechanism provides up-to-date information on adverse drug reactions and facilitates the implementation of necessary measures to prevent or minimize the risks associated with pharmacotherapy. Marketing authorization holders should regularly conduct searches for and analyses of drug safety data from all available sources. The lack of practical recommendations for selecting relevant information sources complicates the development of an optimal strategy for collecting drug safety data necessary for timely detection of changes in the safety profile of a drug that may affect the benefit–risk ratio.AIM. This study aimed to select the most appropriate methods for collecting drug safety information from the open sources used to monitor the safety profiles of approved drugs and assess their benefit–risk ratios.DISCUSSION. The main sources of new information on the safety of drugs include pharmacovigilance databases, websites of regulatory authorities, publications in medical scientific journals, and real-world clinical practice. According to the analysis results, the most widely used databases are the World Health Organization (WHO) VigiBase database, the European Union (EU) EudraVigilance database, and the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). This article also discusses the capabilities and interfaces of various applications for working with safety data, as well as the conditions for accessing databases. Additionally, the article provides detailed instructions on how to search for safety information on the websites of the European Medicines Agency (EMA) and FDA, which are considered to be the most reliable sources of information. Further, the article provides an overview of reputable medical journals most likely to publish articles on adverse drug reactions. In addition, the article covers bibliographic databases and search engines, which can simplify the search for scientific publications. Systematic monitoring of these sources can help marketing authorization holders to effectively assess the safety profiles and benefit–risk ratios of approved drugs.CONCLUSIONS. The use of recommended data sources can optimize the process of safety monitoring, significantly increase the identification rate for potential risks of pharmacotherapy, and facilitate the timely development of measures to prevent these risks. This, in turn, can contribute to improving the safety of patients and the quality of medical care.

Automatic text classification of drug-induced liver injury using document-term matrix and XGBoost.

Regulatory agencies generate a vast amount of textual data in the review process. For example, drug labeling serves as a valuable resource for regulatory agencies, such as U.S. Food and Drug Administration (FDA) and Europe Medical Agency (EMA), to communicate drug safety and effectiveness information to healthcare professionals and patients. Drug labeling also serves as a resource for pharmacovigilance and drug safety research. Automated text classification would significantly improve the analysis of drug labeling documents and conserve reviewer resources. We utilized artificial intelligence in this study to classify drug-induced liver injury (DILI)-related content from drug labeling documents based on FDA's DILIrank dataset. We employed text mining and XGBoost models and utilized the Preferred Terms of Medical queries for adverse event standards to simplify the elimination of common words and phrases while retaining medical standard terms for FDA and EMA drug label datasets. Then, we constructed a document term matrix using weights computed by Term Frequency-Inverse Document Frequency (TF-IDF) for each included word/term/token. The automatic text classification model exhibited robust performance in predicting DILI, achieving cross-validation AUC scores exceeding 0.90 for both drug labels from FDA and EMA and literature abstracts from the Critical Assessment of Massive Data Analysis (CAMDA). Moreover, the text mining and XGBoost functions demonstrated in this study can be applied to other text processing and classification tasks.

Text summarization with ChatGPT for drug labeling documents

Text summarization is crucial in scientific research, drug discovery and development, regulatory review, and more. This task demands domain expertise, language proficiency, semantic prowess, and conceptual skill. The recent advent of large language models (LLMs), such as ChatGPT, offers unprecedented opportunities to automate this process. We compared ChatGPT-generated summaries with those produced by human experts using FDA drug labeling documents. The labeling contains summaries of key labeling sections, making them an ideal human benchmark to evaluate ChatGPT's summarization capabilities. Analyzing >14000 summaries, we observed that ChatGPT-generated summaries closely resembled those generated by human experts. Importantly, ChatGPT exhibited even greater similarity when summarizing drug safety information. These findings highlight ChatGPT's potential to accelerate work in critical areas, including drug safety.

Postmarket safety communications on drugs approved in Japan: A 25-year analysis.

Drug safety communications (DSCs) are essential tools for communicating important postmarket serious drug safety information to healthcare professionals and patients. Previous studies characterized DSCs issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA); however, knowledge about the activities of the Pharmaceuticals and Medical Devices Agency (PMDA)/the Ministry of Health, Labor and Welfare (MHLW) is limited. This study characterized DSCs by the PMDA/MHLW in comparison with previously reported DSCs by the FDA and the EMA. We retrospectively analyzed 37 DSCs of 41 adverse drug reactions (ADRs) for 33 drugs in Japan from 1997 to 2022. Most DSCs were related to non-oncology drugs (30/37, 81.1%), and the median (interquartile range) time from approval to DSC issuance was 19 (10-51) months. Notably, the regulatory review reports and the latest labels before DSC issuance did not describe 16/28 (57.1%) and 12/37 (32.4%) of the ADRs related to DSCs, respectively. Most DSCs resulted in label revisions (36/37, 97.3%) and seven drugs were eventually withdrawn. Some DSC characteristics are similar among the PMDA/MHLW, the FDA, and the EMA; however, the number, contents, and range of new safety issues addressed by DSCs differ among the three jurisdictions. Our study emphasized the importance of continuous efforts to gather postmarket drug safety information because substantial ADRs that led to DSCs were recognized after approval and were associated with critical label revisions and withdrawals. Future studies are required to address global challenges for regulatory harmonization of safety-related regulatory actions.

How Do Risk Evaluation and Mitigation Strategies Impact Clinical Practice? A National Survey of Physicians.

The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS-covered drugs: (1) ambrisentan; (2) bosentan; (3) clozapine; (4) isotretinoin; (5-7) the multiple myeloma (MM) drugs lenalidomide, pomalidomide, thalidomide; and (8) sodium oxybate. Between May 2022 and January 2023, we surveyed 5,331 physician prescribers of these drugs, and 1,295 (24%) returned surveys (range: 149 for bosentan to 226 for MM drugs). Although 765 (68%) respondents thought the certification process provided useful drug information, 757 (67%) wanted materials to include benefit data and 944 (84%) non-REMS-related risk data. A majority (704, 63%) thought the safe use requirements facilitated discussion with patients, but a similar number (637, 57%) attributed delayed medication access to these requirements. In multivariable modeling, MM drug and isotretinoinrespondents were less likely than sodium oxybate respondents to agree that the certification process provided useful drug information (MM drug: odds ratio (OR) = 0.37, 95% confidence interval (CI) = 0.25-0.55; isotretinoin: OR = 0.39, 95% CI = 0.25-0.61), and isotretinoin, clozapine, and bosetan respondents were more likely than sodium oxybate respondents to agree that the safe use requirements often delayed medication access (isotretinoin: OR = 5.83, 95% CI = 3.70-9.19; clozapine: OR = 1.65, 95% CI = 1.08-2.54; bosentan: OR = 1.78, 95% CI = 1.12-2.85). Most physicians believe REMS programs convey useful drug safety information and facilitate discussion with patients but also seek information on benefits and non-REMS-related risks and better integration of REMS processes into clinical workflows.

Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study.

The Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, but whether adverse event (AE) information collected from these systems adequately captures experiences of the overall United States (US) population is unknown. To examine determinants of consumer AE reporting in the USA. Five-year AE reporting rate per 100,000 residents per US county were calculated, mapped, and quartiled for AE reports received directly from consumers between 2011 and 2015. Associations between county-level sociodemographic factors obtained from County Health Rankings and AE reporting rates were evaluated using negative binomial regression. Reporting rates were variable across US counties with >17.6 reports versus ≤5.5 reports/100,000 residents in the highest and lowest reporting quartile, respectively. Controlling for drug utilization, counties with higher reporting rates had higher proportions of individuals age ≥65 years (e.g., 2.4% reporting increase per 1% increase in individuals age >65, incidence rate ratio (IRR): 1.024, 95% confidence interval (CI): 1.017-1.030), higher proportions of females (IRR: 1.027, 95% CI 1.012-1.043), uninsured (IRR: 1.009, 95% CI 1.005-1.013), higher median log household incomes (IRR: 1.897, 95% CI 1.644-2.189) and more mental health providers per 100,000 residents (IRR: 1.003, 95% CI 1.001-1.004). Lower reporting was observed in counties with higher proportions of individuals age ≤18 years (IRR: 0.966, 95% CI 0.959-0.974), American Indian or Alaska Native individuals (IRR: 0.991, 95% CI 0.986-0.996), individuals not proficient in English (IRR: 0.978, 95% CI 0.965-0.991), and individuals residing in rural areas within a county (IRR: 0.998, 95% CI 0.997-0.998). Observed variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing emerging drug safety concerns among more vulnerable populations.

Neratinib safety evaluation: real-world adverse event analysis from the FAERS database.

Neratinib has emerged as significant theraputic option for breast cancer treatment. However, despite its approval, numerous adverse drug events (ADEs) associated to it remain unrecognized and unreported. This study aims to mine and analyze the signals of ADEs related to neratinib from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing insights for safe and rational clinical use of drug. All the neratinib-related ADEs data were collected from FAERS database from the third quarter (Q3) of 2017 to the fourth quarter (Q4) of 2023. After standardizing the data, 4 disproportionality methods were used to assess the correlation between neratinib and ADEs. Of the 1,544 ADEs implicating neratinib as the primary suspected drug, a combined total of 48 preferred terms (PTs) and 10 system organ classes (SOCs) showed significant disproportionality accross all four algorithms simultaneously. These SOCs included gastrointestinal disorders (n = 2,564, ROR 7.14), general disorders and administration site conditions (n = 958, ROR 0.77) and injury poisoning and procedural complications (n = 474, ROR 0.58) among others. Upon comparison with the neratinib manual, 34 ADEs not documented in the manual were found at the PT level. Our study provide new real-world evidence for drug safety information of neratinib. While the majority of our findings were aligned with the information provided in the manual. We identified additional ADEs not previously documented. Consequently, further studies are needed to validate unreported ADEs to ensure the efficacy and safety of neratinib for patients.

Sotagliflozin: Efficacy, Safety, and Potential Therapeutic Applications in Heart Failure.

To describe the pharmacology, clinical efficacy, and safety evidence of sotagliflozin, the first approved dual inhibitor of sodium-glucose cotransporter (SGLT) 1 and SGLT2, in heart failure (HF) management. A literature search of studies published between January 2012 and September 2023 were identified using PubMed, MEDLINE, and clinicaltrials.gov with search terms of "sotagliflozin," "Inpefa," or "LX4211." All available studies in English were considered. Studies were included if they investigated drug pharmacology, efficacy, or safety information. Two phase 3 trials of sotagliflozin, SOLOIST-WHF and SCORED, evaluated sotagliflozin compared with placebo in patients with type 2 diabetes mellitus (T2DM). SOLOIST-WHF reported a statistically decreased rate of cardiovascular and HF events with sotagliflozin (hazard ratio [HR] = 0.67, 95% CI = 0.52-0.85), while SCORED found a statistically significant decrease in incidence of cardiovascular events in patients with T2DM, chronic kidney disease (CKD), and risk factors for cardiovascular disease in patients in the sotagliflozin group (HR = 0.74, 95% CI = 0.63-0.88). While approval of sotagliflozin expands treatment options for patients with HF, the SGLT2 inhibitors, dapagliflozin and empagliflozin, have more data supporting their use in HF, additional risk reduction benefits in patients with CKD, and approval for use in T2DM. Landmark trials of sotagliflozin required a previous diagnosis of T2DM, despite the broader approved indication. Where sotagliflozin will be adopted into the treatment of HF is unclear due to the evidence and benefits of already established SGLT2 inhibitors and the need for comparison with SGLT2 inhibitors. Given the limitations of currently available evidence, including difficulty in fully interpreting the trial results due to changes in primary endpoints, not adjudicating the events, and not reaching the original power calculations, more investigation is warranted to determine the benefit of sotagliflozin compared with SGLT2 inhibitors.

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques.

Concerns have been raised over the quality of drug safety information, particularly data completeness, collected through spontaneous reporting systems (SRS), although regulatory agencies routinely use SRS data to guide their pharmacovigilance programs. We expected that collecting additional drug safety information from adverse event (ADE) narratives and incorporating it into the SRS database would improve data completeness. The aims of this study were to define the extraction of comprehensive drug safety information from ADE narratives reported through the Korea Adverse Event Reporting System (KAERS) as natural language processing (NLP) tasks and to provide baseline models for the defined tasks. This study used ADE narratives and structured drug safety information from individual case safety reports (ICSRs) reported through KAERS between 1 January 2015 and 31 December 2019. We developed the annotation guideline for the extraction of comprehensive drug safety information from ADE narratives based on the International Conference on Harmonisation (ICH) E2B(R3) guideline and manually annotated 3723 ADE narratives. Then, we developed a domain-specific Korean Bidirectional Encoder Representations from Transformers (KAERS-BERT) model using 1.2 million ADE narratives in KAERS and provided baseline models for the task we defined. In addition, we performed an ablation experiment to investigate whether named entity recognition (NER) models were improved when a training dataset contained more diverse ADE narratives. We defined 21 types of word entities, six types of entity labels, and 49 types of relations to formulate the extraction of comprehensive drug safety information as NLP tasks. We obtained a total of 86,750 entities, 81,828 entity labels, and 45,107 relations from manually annotated ADE narratives. The KAERS-BERT model achieved F1-scores of 83.81 and 76.62% on the NER and sentence extraction tasks, respectively, while outperforming other baseline models on all the NLP tasks we definedexcept the sentence extraction task. Finally, utilizing the NER model for extracting drug safety information from ADE narratives resulted in an average increase of 3.24% in data completeness for KAERS structured data fields. We formulated the extraction of comprehensive drug safety information from ADE narratives as NLP tasks and developed the annotated corpus and strong baseline models for the tasks. The annotated corpus and models for extracting comprehensive drug safety information can improve the data quality of an SRS database.

Ethnicity, Race and Skin Color: Challenges and Opportunities for Atopic Dermatitis Clinical Trials.

The number of clinical trials conducted in patients with atopic dermatitis is increasing steadily. These trials are conducted in several countries across all continents and include patients of different ethnicity, race and skin color. This diversity is desired, but it also brings challenges, including the diagnosis and evaluation of disease severity in patients with different skin colors; the influence of ethnicity on the perception of quality of life and patient reported outcomes; the inclusion of ethnicities that are only present in one country or that live far from clinical research sites; and the reporting of drug safety information. There is a need to better train physicians on the evaluation of atopic dermatitis in patients with different skin colors and a need to improve the systematic reporting of ethnicity, race and skin color in clinical trial publications.

Association between the Use of Suvorexant and Hip Fracture in Older Adults in Japan Using a Nationwide Administrative Claims Database: A Matched Case-Control Study.

The use of benzodiazepines and nonbenzodiazepines increases the risk for hip fracture, but the effect of suvorexant, an orexin receptor antagonist, is not clear. The objective of this study was to investigate the association between suvorexant use and hip fractures in older adults. A case-control study was conducted using real-world data (RWD) from Medical Data Vision Co., Ltd. with patients hospitalized between January 2019 and December 2020. Patients were aged 65-84years and had been prescribed suvorexant at least once. Patients with hip fracture (cases) and those without (controls) were identified by matching up to 1:4 for sex, age (± 2years), and hospital size category. Suvorexant exposure was identified the day before hospitalization. Hip fracture risk associated with suvorexant was presented as adjusted odds ratios (aOR) with 95% confidence intervals (CI) using conditional logistic regression analysis. Matching identified 389 cases and 1509 controls. The risk of hip fracture was not increased in patients treated with suvorexant [aOR: 0.86, 95% confidence interval (CI) 0.61-1.20]. Additionally, concomitant use of suvorexant with other hypnotics did not increase the risk. Benzodiazepines (1.01, 0.46-2.22), nonbenzodiazepines (1.16, 0.57-2.34), and melatonin (1.80, 0.82-3.94) were combined with suvorexant. The risk was increased for the use of benzodiazepine without suvorexant (1.88, 1.10-3.21). Using RWD in Japanese older adults, we showed that sleep therapy with suvorexant was not associated with an increased risk of hip fracture. The results provide evidence-based drug safety information for the selection of hypnotics for sleep disorders, which increase with age.

Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database.

Background: Sound drug safety information is important to optimize patient management, but the widely recognized comprehensive landscape of culprit-drugs that cause severe cutaneous adverse reactions (SCARs) is currently lacking. Objective: The main aim of the study is to provide a comprehensive landscape of culprit-drugs for SCARs to guide clinical practice. Methods: We analyzed reports associated with SCARs in the FDA Adverse Event Reporting System database between 1 January 2004 and 31 December 2021 and compiled a list of drugs with potentially serious skin toxicity. According to this list, we summarized the reporting proportions of different drugs and drug classes and conducted disproportionality analysis for all the drugs. In addition, the risk characteristic of SCARs due to different drugs and drug classes was summarized by the positive-negative distribution based on the results of the disproportionality analysis. Results: A total of 77,789 reports in the FDA Adverse Event Reporting System database were considered SCAR-related, of which lamotrigine (6.2%) was the most reported single drug followed by acetaminophen (5.8%) and allopurinol (5.8%) and antibacterials (20.6%) was the most reported drug class followed by antiepileptics (16.7%) and antineoplastics (11.3%). A total of 1,219 drugs were reported as culprit-drugs causing SCARs in those reports, and the largest number of drugs belonged to antineoplastics. In disproportionality analysis, 776 drugs showed at least one positive pharmacovigilance signal. Drugs with the most positive signals were lamotrigine, acetaminophen, furosemide, and sulfamethoxazole/trimethoprim. Conclusion: Our study provided a real-world overview of SCARs to drugs, and the investigation of SCAR positive-negative distribution across different drugs revealed its risk characteristics, which may help optimize patient management.

The drug safety information in domestic medical literature

Abstract Medical literature is an important source of drug safety information relevant for signal detection, safety profile analysis and risk-benefit assessment. The main goal of our study was to assess the utility of domestic medical literature as a source of drug safety information. All safety information identified for active substances published between 1.01.2018-31.12.2019 in domestic medical journals published in Poland were analyzed. Four thousand seven hundred eighty-nine drug safety information was reported for 500 active substances. Two thousand and forty-four submissions dealing with drug safety (48.28%) were identified in the 10 journals from the list of analyzed journals (3 of these were identified in the 2019 JCR and 5 of these were indexed in the main scientific databases and 9 of these had an affiliation to scientific society). There was a correlation between journal impact factor and scientific database indexation with the number of published individual literature reports and type of safety information. Journals publishing in Polish constituted source for about 40% of all safety information published in the examined period. Journals indexed in Medline were the source of about 37% of all safety information while 42% was published in Embase. Local medical literature is a source of valuable safety information but the list of journals for monitoring should be carefully selected with particular attention to journals with impact factor.

Maternal-Fetal Drug Development: An Industry Perspective.

Medicines and vaccines prescribed to pregnant women often have not had pregnant women or lactating women included in clinical trials and products are often not approved by regulatory agencies for use in pregnant women. As a result, practitioners may need to prescribe medicines and give vaccines to this special population with limited drug efficacy and safety information available. Multiple regulatory guidance documents regarding the development of medications for pregnant and lactating women have been developed to encourage drug development and the investigation of medicines and vaccines used in this population. However, clinical, regulatory, ethical, and drug development challenges are encountered when designing clinical trials that include pregnant women and their fetuses, in which innovative methods and trial designs are essential. This article provides an overview of an industry perspective on maternal–fetal drug development that includes a review of the regulatory landscape for developing medicines for pregnant women and their fetuses, trial designs that include pregnant women, identification of gaps and challenges, and strategies for potential maternal–fetal drug development considerations for the future development of medicines and vaccines for pregnant women. Early involvement and discussion of drug and vaccine products with multiple stakeholders, including therapeutic experts, patients, physicians, and regulators, is encouraged to optimize the development of safe and effective medicines and vaccines for pregnant women and their fetuses.

Critical Appraisal of Drug Promotional Literature in Accordance With WHO Guidelines.

BackgroundDrug promotional literature (DPL) is used as a marketing tactic to publicize the introduction of new medications. As drug companies are promoting the literature for their brand products, bias is possible. Various studies have demonstrated that printed DPLs disseminated by pharmaceutical companies are typically skewed.Material and methodA prospective, observational study was carried out in the outpatient departments of a tertiary care hospital to analyze the DPL of different pharmaceutical companies using WHO criteria for "Ethical criteria for medicinal drug promotion, 1988".ResultsOut of 192 DPLs analyzed, information regarding the generic name, brand name, amount of active ingredient, and manufacturer name was found in all the DPLs (100%). Though therapeutic uses were mentioned in 91% of DPLs, dosage schedule (regimen) was mentioned only in 60%. Drug safety information such as the side effects and significant adverse drug reactions, precautions and warnings, contraindications, and major drug interactions were present in 24%, 36%, and 20%, respectively. Address of the manufacturer and reference to scientific literature were present only in 63% and 53% of DPLs, respectively. References mainly were from journals, present in 71% of DPLs. Most of the claims made in DPLs were regarding efficacy (73%), followed by safety (34%). ConclusionIn our study, not a single DPL fulfilled all the nine WHO criteria. A doctor should rigorously evaluate study findings before prescribing because misleading and incorrect information is now frequently found in this literature.

Actual Class Contents Related to the Drug and Medical Device Safety Information Reporting System in Medical Schools across Japan

Actual Class Contents Related to the Drug and Medical Device Safety Information Reporting System in Medical Schools across Japan

Inconsistent procedures for handling new drug safety information in the Netherlands

Inconsistent procedures for handling new drug safety information in the Netherlands

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach.

IntroductionThe implementation of new drug safety information and Direct Healthcare Professional Communications (DHPCs) in hospitals is important for patient safety.ObjectivesThe aim of this study was to gain insight into which procedures and practices are in place to handle new drug safety information and particularly DHPCs in the Dutch hospital setting.MethodsWe first conducted focus groups including medical specialists and hospital pharmacists, focusing on handling of drug safety information at the individual and organisational level. A survey was then developed and distributed among hospital pharmacists in all Dutch hospitals to quantify the existence of specific procedures and committees to handle drug safety information and DHPCs.ResultsEleven specialists and 14 pharmacists from six hospitals participated in focus groups. Drug safety information was usually considered before drugs were included in formularies or treatment protocols. Furthermore, drug safety information was consulted in response to patients experiencing adverse events. DHPCs were mostly dealt with by individual professionals. DHPCs could lead to actions but this was very uncommon. Completed surveys were received from 40 (53%) of the hospitals. In 32 (80%), the hospital pharmacy had procedures to deal with new drug safety information, whereas in 11 (28%) a hospital-wide procedure was in place. Drug safety was considered in committees concerning drug formulary decisions (69%) and antibiotic policies (63%). DHPCs were assessed by a hospital pharmacist in 50% of the hospitals.ConclusionsDrug safety information was used for evaluation of new treatments and in response to adverse events. Assessment of whether a DHPC requires action was primarily an individual task.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40264-022-01149-4.

Finerenone: A Novel Mineralocorticoid Receptor Antagonist for Cardiorenal Protection in CKD and T2DM.

To describe the pharmacology, clinical and safety evidence, and relevance to clinical practice of finerenone. A literature search was conducted utilizing PubMed, MEDLINE, and clinicaltrials.gov with search terms of "finerenone" and "BAY94-8862." All available studies with human participants in English were considered. Studies were included if they investigated drug pharmacology, efficacy, and safety information. In addition to standard of care with a renin-angiotensin system inhibitor (RASi), finerenone lowered the risk of kidney disease progression (17.8% vs 21.1%) in patients with type 2 diabetes mellitus and chronic kidney disease compared to placebo. Similarly, finerenone reduced cardiovascular risk in patients with type 2 diabetes mellitus and chronic kidney disease compared to placebo (12.4% vs 14.2%). It is anticipated that finerenone will be added to therapy after a RASi and a sodium-glucose cotransporter-2 inhibitor, as tolerated, based on adverse events and potassium levels. Finerenone offers a unique approach to further delay the progression of chronic kidney disease in patients with type 2 diabetes mellitus. It also provides another option for patients who cannot tolerate RASi or sodium-glucose cotransporter-2 inhibitors.