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Osteoporosis and Sarcopenia Sep 2021Romosozumab is a potent pharmacological tool to prevent fractures in osteoporosis patients, and its mechanism of action is distinct from any other drugs. The efficacy of... (Review)
Review
Romosozumab is a potent pharmacological tool to prevent fractures in osteoporosis patients, and its mechanism of action is distinct from any other drugs. The efficacy of romosozumab to prevent osteoporotic fractures is remarkable. However, there remains a concern of increased cardiovascular adverse events. Further relevant investigations are essential to understand whether romosozumab is actually involved in the development of cardiovascular events or not. We need more robust evidence to establish an appropriate and reasonable guide to prescribe romosozumab in our clinical practice.
PubMed: 34632110
DOI: 10.1016/j.afos.2021.09.002 -
Therapeutic Advances in Drug Safety 2022Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs).
BACKGROUND
Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs).
METHODS
Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2021 were selected for disproportionality analysis to assess the connection between antifungal triazoles, and AEs and important medical events (IMEs).
RESULTS
A total of 22,566 records associated with triazole antifungals were identified, with 9584 triazole antifungal-IME pairs. The following system organ classes (SOCs) appeared as significant signals: 'Endocrine disorders' [reported odds ratio (ROR) = 167.94], 'Metabolism and nutrition disorders' (ROR = 46.30), and 'Skin and subcutaneous tissue disorders' (ROR = 21.37). Strong signals were observed with respiratory failure, rash, hepatic function abnormal, and hypokalemia. Uncommon security signals included a change in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations.
CONCLUSION
Various triazole antifungals cause AEs of different types and intensities of association. Our results are broadly consistent with prescribing information and previous studies; however, additional pharmacoepidemiological studies are required to verify AEs with modest incidence but high signal.
PLAIN LANGUAGE SUMMARY
The triazole antifungals we studied include fluconazole, itraconazole, voriconazole, posaconazole, and isavuconazole. Triazole antifungals are widely used as broad-spectrum antifungals; however, there are many undetected and unreported adverse events (AEs). The Food and Drug Administration Adverse Event Reporting System (FAERS) database contains AEs reported to the FDA by different countries regarding post-marketing drugs. Through the FAERS database, we retrieved a total of 22,566 AE reports related to triazole antifungals. We not only counted information about patients' gender, age, weight, reporting country, outcome indicators, and indications but also analyzed the system organ classes (SOCs) of AEs, and the number of reported drug-related AEs and the degree of relevance. We found a total of 22,566 records related to triazole antifungal agents, of which 9584 reports made important medical events (IMEs) about triazole antifungal agents, which are serious AEs. The following SOCs appear as important signals: 'endocrine disorders', 'metabolic and nutritional disorders', and 'skin and subcutaneous tissue disorders'. Triazole antifungals produce AEs, such as respiratory failure, rash, hepatic function abnormal, and hypokalemia. They also produce uncommon AEs, including changes in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations. By analyzing data from the FAERS database, we identified more AEs associated with these five triazole antifungals than were indicated in the instructions and our findings provide additional insight into triazole-related AEs to inform clinicians before and during treatment.
PubMed: 36545565
DOI: 10.1177/20420986221143266 -
Vaccine Jan 2022COVID-19 has spread worldwide and is one of the most threatening infectious diseases in the world. Vaccination is known as an effective method to protect susceptible...
COVID-19 has spread worldwide and is one of the most threatening infectious diseases in the world. Vaccination is known as an effective method to protect susceptible populations against such diseases. The Coronavirus vaccine developed by Sinovac has been shown to have a high protective effect, but it also has potential adverse events. For example, our department saw two patients with reported cases of deafness that occurred after inoculation with the Sinovac Coronavirus vaccine. While deafness is only a rare adverse event from the Coronavirus vaccine, whether other vaccination centers, hospitals, and centers for disease control (CDCs) have encountered similar cases still needs to be investigated, reported, and analyzed.
Topics: COVID-19; COVID-19 Vaccines; Deafness; Humans; SARS-CoV-2; Vaccination
PubMed: 34895936
DOI: 10.1016/j.vaccine.2021.11.091 -
PloS One 2022Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are... (Review)
Review
INTRODUCTION
Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are many reports of adverse events (or undesirable outcomes) following such interventions, there is no common definition for an adverse event or clarity on any severity classification. This impedes advances of patient safety initiatives and practice. This scoping review mapped the evidence of adverse event definitions and classification systems following spinal and peripheral joint manipulation and mobilization for musculoskeletal conditions in adults.
METHODS
An electronic search of the following databases was performed from inception to February 2021: MEDLINE, EMBASE, CINAHL, Scopus, AMED, ICL, PEDro, Cochrane Library, Open Grey and Open Theses and Dissertations. Studies including adults (18 to 65 years old) with a musculoskeletal condition receiving spinal or peripheral joint manipulation or mobilization and providing an adverse event definition and/or classification were included. All study designs of peer-reviewed publications were considered. Data from included studies were charted using a standardized data extraction form and synthesised using narrative analysis.
RESULTS
From 8248 identified studies, 98 were included in the final synthesis. A direct definition for an adverse event and/or classification system was provided in 69 studies, while 29 provided an indirect definition and/or classification system. The most common descriptors to define an adverse event were causality, symptom severity, onset and duration. Twenty-three studies that provided a classification system described only the end anchors (e.g., mild/minor and/or serious) of the classification while 26 described multiple categories (e.g., moderate, severe).
CONCLUSION
A vast array of terms, definition and classification systems were identified. There is no one common definition or classification for adverse events following spinal and peripheral joint manipulation and mobilization. Findings support the urgent need for consensus on the terms, definition and classification system for adverse events related to these interventions.
Topics: Adolescent; Adult; Aged; Humans; Manipulation, Spinal; Middle Aged; Musculoskeletal Diseases; Young Adult
PubMed: 35839253
DOI: 10.1371/journal.pone.0270671 -
PloS One 2022Recognizing the values and norms significant to healthcare organizations (Safety Culture) are the prerequisites for safety and quality care. Understanding the safety...
INTRODUCTION
Recognizing the values and norms significant to healthcare organizations (Safety Culture) are the prerequisites for safety and quality care. Understanding the safety culture is essential for improving undesirable workforce attitudes and behaviours such as lack of adverse event reporting. The study assessed the frequency of adverse event reporting, the patient safety culture determinants of the adverse event reporting, and the implications for Ghanaian healthcare facilities.
METHODS
The study employed a multi-centre cross-sectional survey on 1651 health professionals in 13 healthcare facilities in Ghana using the Survey on Patient Safety (SOPS) Culture, Hospital Survey questionnaire. Analyses included descriptive, Spearman Rho correlation, one-way ANOVA, and a Binary logistic regression model.
RESULTS
The majority of health professionals had at least reported adverse events in the past 12 months across all 13 healthcare facilities. Teamwork (Mean: 4.18, SD: 0.566) and response to errors (Mean: 3.40, SD: 0.742) were the satisfactory patient safety culture. The patient safety culture dimensions were statistically significant (χ2 (9, N = 1642) = 69.28, p < .001) in distinguishing between participants who frequently reported adverse events and otherwise.
CONCLUSION
Promoting an effective patient safety culture is the ultimate way to overcome the challenges of adverse event reporting, and this can effectively be dealt with by developing policies to regulate the incidence and reporting of adverse events. The quality of healthcare and patient safety can also be enhanced when healthcare managers dedicate adequate support and resources to ensure teamwork, effective communication, and blame-free culture.
Topics: Humans; Patient Safety; Ghana; Organizational Culture; Cross-Sectional Studies; Attitude of Health Personnel; Safety Management
PubMed: 36260634
DOI: 10.1371/journal.pone.0275606 -
Preventive Medicine Reports Aug 2022Urban-rural disparity constitutes a major source of health inequity also in high-income countries. This study aimed to compare the distribution of deaths due to medical...
Urban-rural disparity constitutes a major source of health inequity also in high-income countries. This study aimed to compare the distribution of deaths due to medical adverse events across urbanization levels among US hospital inpatients. An open dataset from the National Center for Health Statistics (NCHS) comprised all certified deaths of US inpatients over the period 2010-2019. The urbanization level of each decedent was determined in accordance with the 2013 NCHS Urban-Rural Classification Scheme (large metropolitan, medium or small metropolitan, or nonmetropolitan). The outcome was death due to a medical adverse event (ICD-10 codes Y40-Y84) proportional to total inpatient deaths. The data were standardized for sex, ethnicity, and age, and analyzed with linear mixed models. Of the 8 071 907 certified inpatient deaths during the study period, 21 444 (0.27%) were primarily attributed to medical adverse events. Decedents who resided in medium or small metropolitans and nonmetropolitans had approximately 0.5 units higher rate of adverse events per 1000 deaths (corresponding to a relative differece of 20%) when compared to decedents who resided in large metropolitans. Moreover, the urban-rural gradients showed an increasing trend towards the end of the study period, as the difference was found to increase at a rate of approximately 0.1 units per year (3%). There were no statistically significant differences between decedents from medium or small metropolitans and nonmetropolitans. The present findings highlight gradients in adverse event deaths between geographic areas, providing a basis for targeted preventive efforts. Future studies are invited to elucidate the underlying phenomena.
PubMed: 35832639
DOI: 10.1016/j.pmedr.2022.101888 -
Drugs Sep 2019Trifluridine/tipiracil (Lonsurf) is a fixed-dose combination tablet comprising trifluridine, an antineoplastic nucleoside analogue, and tipiracil, a thymidine... (Review)
Review
Trifluridine/tipiracil (Lonsurf) is a fixed-dose combination tablet comprising trifluridine, an antineoplastic nucleoside analogue, and tipiracil, a thymidine phosphorylase inhibitor. Trifluridine/tipiracil has recently been granted an additional indication in the USA for the treatment of metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, in patients who have been previously treated with at least two systemic treatment regimens, and has received a positive opinion for this indication in the EU. In the large pivotal phase III TAGS trial, trifluridine/tipiracil plus best supportive care (BSC) significantly prolonged overall survival (OS; primary endpoint) compared with placebo plus BSC in this patient group. Progression-free survival (PFS) and the disease control rate were also improved with trifluridine/tipiracil relative to placebo. Health-related quality of life was not adversely affected by the addition of trifluridine/tipiracil to BSC and time to deterioration of Eastern Cooperative Oncology Group (ECOG) performance status was significantly delayed. The most common adverse events were mainly haematological (neutropenia, leucopenia and anaemia) and gastrointestinal (nausea, vomiting and diarrhoea), and were generally manageable with dosage modifications and/or supportive care. Adverse events ≥ Grade 3 were most frequently haematological in nature. Thus, trifluridine/tipiracil provides a valuable and much needed treatment option for patients with metastatic gastric or gastroesophageal junction adenocarcinoma that has progressed on at least two prior therapies.
PubMed: 31489588
DOI: 10.1007/s40265-019-01195-w -
Journal of Nuclear Medicine Technology Dec 2021Establishing a cause-and-effect relationship for an adverse event is one of the key steps in preventing them and involves multiple people, resources, and steps, thus...
Establishing a cause-and-effect relationship for an adverse event is one of the key steps in preventing them and involves multiple people, resources, and steps, thus requiring a root cause analysis. Here, we describe a root cause analysis performed in the nuclear medicine department for an event involving NaI contamination. Oral administration of NaI in a capsule minimizes the risk of contamination and spills. However, the patient must be able to swallow a capsule. NaI in capsule form is currently in widespread use for treatment of hyperthyroidism and thyroid cancer. NaI in liquid form is rarely available immediately on demand and must be ordered at least 24-48 h in advance of the planned administration. The events leading to the incident, immediate remedial steps taken, and subsequent root cause analysis are described. The corrective actions taken after the root cause analysis, as well as the subsequent effectiveness of these actions, are mentioned. There may be one or multiple causes for an adverse event. It is important to identify the root cause. Corrective actions derived from the root cause can help prevent similar adverse events in the future. Therapeutic procedures in nuclear medicine involve unsealed radioactive sources, further adding a separate layer of immediate steps and reporting to the root cause analysis itself.
Topics: Drug Contamination; Humans; Hyperthyroidism; Iodine Radioisotopes; Root Cause Analysis
PubMed: 34862264
DOI: 10.2967/jnmt.121.262492 -
Annual Review of Pharmacology and... Jan 2021In the past decade of microbiome research, we have learned about numerous adverse interactions between the microbiome and medical interventions such as drugs, radiation,... (Review)
Review
In the past decade of microbiome research, we have learned about numerous adverse interactions between the microbiome and medical interventions such as drugs, radiation, and surgery. What if we could alter our microbiomes to prevent these events? In this review, we discuss potential routes to mitigate microbiome adverse events, including applications from the emerging field of microbiome engineering. We highlight cases where the microbiome acts directly on a treatment, such as via differential drug metabolism, and cases where a treatment directly harms the microbiome, such as in radiation therapy. Understanding and preventing microbiome adverse events is a difficult challenge that will require a data-driven approach involving causal statistics, multiomics techniques, and a personalized means of mitigating adverse events. We propose research considerations to encourage productive work in preventing microbiome adverse events, and we highlight the many challenges and opportunities that await.
Topics: Gastrointestinal Microbiome; Humans; Microbiota; Pharmaceutical Preparations
PubMed: 33049161
DOI: 10.1146/annurev-pharmtox-031620-031509