Drug Categories Research Articles

Concurrent Opioid and Psychotropic Drug Use During Pregnancy: Descriptive Study from Two Canadian Provinces

ObjectivesThis study aims to describe the patterns of concurrent opioid and psychotropic drug use (CU) during pregnancy and the characteristics of the mothers dispensed these drugs. MethodsPregnancies between 2000-2020 were identified using administrative data from Manitoba and British Columbia, Canada. Prenatal opioid and psychotropic drug dispensations were assessed, and exposure groups created based on the number of dispensations within each drug category. Descriptive statistics are reported. ResultsApproximately 1.4% of 1,040,021 pregnancies involved CU. Odds of CU were greater for 2+ opioid pregnancies compared to pregnancies with only 1 opioid (OR=4.05). Among CU pregnancies, it was more likely for 2+ types of psychotropics to be dispensed for those involving 2+ opioids compared to 1 (OR=2.23). Percent of CU pregnancies did not change over time, while opioid pregnancies decreased, and psychotropic pregnancies increased. Average morphine equivalent dose of opioids/pregnancy was higher in CU than opioid only pregnancies. Compared to mothers without exposure, CU exposed mothers were of similar age, more likely to live rurally, in lower income areas, and have lower care continuity. ConclusionCU pregnancies remained stable over time. It was more likely for mothers dispensed 2+ opioids to be CU than mothers dispensed only 1 opioid, and more likely for CU mothers dispensed 2+ opioids to be dispensed 2+ psychotropic types. Overall strength of opioids was higher for CU mothers compared to opioid only exposed mothers. ImplicationsStudies measuring the impact of CU on maternal and child outcomes should be conducted to inform safe prescribing practices.

A nurse practitioner-led deprescribing bundled intervention to reduce rates of polypharmacy in the post-acute care setting.

In post-acute care (PAC) settings, residents face elevated risks of adverse drug reactions and emergency department visits because of polypharmacy. With over 90% of PAC residents nationally taking five or more medications, targeted deprescribing of inappropriate or unnecessary medications emerges as a critical strategy. The project site faces high rates of polypharmacy with a root cause analysis revealing a deficiency in evidence-based practices (EBP) for deprescribing potentially inappropriate or unnecessary medications. To address this issue, a bundled deprescribing intervention was implemented as part of a quality improvement project aimed at reducing polypharmacy rates. This project, conducted at a PAC setting in the midwestern United States, used the RE-AIM Model. Data collection involved tracking prescribing rates before and after the intervention for residents admitted to the practice setting over a 5-month period. A bundled EBP intervention comprising a deprescribing framework, pharmacist collaboration, and the utilization of an EBP guideline, established a systematic process guiding deprescribing efforts for each resident on admission to the PAC setting. Fourty-nine patients received a deprescribing bundle, resulting in a 26.67% reduction in prescribed medications. On average, patients had 5.55 medications deprescribed, with reductions noted across 85 distinct therapeutic drug categories. Nurse practitioners play a pivotal role initiating successful deprescribing interventions within the PAC setting. Using a comprehensive approach, integrating pharmacist collaboration and EBP leads to reductions in prescribing rates among PAC residents. This model demonstrates potential for sustainable improvements in patient outcomes within the PAC environment.

Real-World Large Sample Assessment of Drug-related Dry Eye Risk: Based on the FDA Adverse Event Reporting System Database

Purpose and designThis study aimed to evaluate the risk of drug-related dry eye using real-world data, underscoring the significance of tracing pharmacological etiology for distinct clinical types of dry eye. MethodsAnalyzing adverse event reports in the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to September 2023, we employed disproportionality analysis and the Bayesian confidence propagation neural network algorithm. The analysis involved categorizing drugs causing dry eye, assessing risk levels, and conducting segmental assessments based on the time of onset of drug-related dry eye adverse reactions. ResultsIn the FAERS database, adverse reactions related to dry eye were linked to 1160 drugs. Disproportionality analysis identified 33 drugs with significant risk, notably in ophthalmic (brimonidine, bimatoprost), oncology (tisotumab vedotin, erdafitinib), and other medications (isotretinoin, oxymetazoline). The top three drugs with the highest risk of drug-related dry eye are isotretinoin (Bayesian confidence propagation neural network (BCPNN) = 6.88), tisotumab vedotin (BCPNN = 6.88), and brimonidine (BCPNN = 6.77). Among different categories of drugs, respiratory medications have the shortest mean onset time for drug-related dry eye, averaging 50.99 days. The prevalence skewed towards females (69.9 %), particularly in menopausal and elderly individuals (45–70 years old, mean age 54.7 ± 18.2). Reports of drug-related dry eye adverse reactions showed an annual increase. ConclusionInformed clinical decision-making is crucial for preventing drug-related dry eye. Assessing the risk of dry eyes associated with both local and systemic medications helps optimize treatment and provide necessary cautionary information.

P017 AFTER 14 YEARS OF WAR - HYPERTENSION IN SYRIA: BETWEEN CLINICAL PRACTICE AND AVAILABLE MEDICATIONS (ANALYTICAL STATISTICAL STUDY)

Background: Hypertension is one of the most common chronic diseases worldwide. It is also one of the most important risk factors related to public health that leads to multiple consequences. On the other hand, hypertension constitutes a heavy burden on health expenditures, especially in developing countries with limited income. Through this study, we aim to identify the reality of hypertension in Syria as a country that has been suffering from war for more than 14 years, through the distribution of doctors practicing and treating hypertension, the availability of various medications to treat it, and the extent to which international guidelines can be applied in clinical practice. Methods: Cardiologists and nephrologists were mainly counted and distributed in Syrian cities. Pharmaceutical companies and drug types produced by these companies were also counted, and drugs were distributed according to therapeutic drug groups. A questionnaire was conducted on the most important types of drugs used by doctors according to different indications. Results: We found that the largest number of cardiologists and nephrologists are located in the capital, Damascus, with a significant preponderance of cardiologists. We also found a significant shortage in the presence of specialists in the eastern governorates and a severe shortage in the number of kidney doctors in the central, northern and eastern governorates, with most of them being in the capital. There was diversity and distribution in most of the drug categories for treating high blood pressure in the first lines of treatment, noting the lack of sufficient intravenous categories. Conclusions: There is a clear shortage in cardiologists and nephrologists in most governorates, with an almost complete absence of intravenous hypertension medications.

A comprehensive assessment of the association between common drugs and psychiatric disorders using Mendelian randomization and real-world pharmacovigilance database

Medications prescribed for chronic diseases can lead to short-term neuropsychiatric symptoms, but their long-term effects on brain structures and psychiatric conditions remain unclear. We comprehensively analyzed the FDA Adverse Event Reporting System database and conducted drug target Mendelian Randomization (MR) studies on six categories of common drugs, 477 brain imaging-derived phenotypes (IDPs) and eight psychiatric disorders. Genetic instruments were extracted from expression quantitative trait loci (eQTLs) in blood, brain, and other target tissues, protein quantitative trait loci (pQTLs) in blood, and genome-wide association studies (GWAS) of hemoglobin and cholesterol. Summary statistics for brain IDPs, psychiatric disorders, and gut microbiome were obtained from the BIG40, Psychiatric Genomics Consortium, and MiBioGen. A two-step MR and mediation analysis were employed to screen possible mediators of drug-IDP effects from 119 gut microbiota genera and identify their mediation proportions. Among 19 drug classes, six drugs were found to be associated with higher risks of psychiatric adverse events, while 11 drugs were associated with higher risks of gastrointestinal adverse events in the FAERS analysis. We identified ten drug-psychiatric disorder associations, 202 drug-IDP associations, 16 drug-microbiota associations, and four drug-microbiota-IDP causal links. For example, PPARG activation mediated HbA1c reduction caused a higher risk of bipolar disorder (BD) II. Genetically proxied GLP-1R agonists were significantly associated with an increase in the volume of the CA3-head of the right hippocampus and the area of the left precuneus cortex, both of which have been shown to correlate with cognition in previous studies. Common drugs may affect brain structure and risk of psychiatric disorder. Oral medications in particular may exert some of these effects by influencing gut microbiota. This study calls for greater attention to be paid to the neuropsychiatric adverse effects of drugs and encourages drug repurposing. National Natural Science Foundation of China (grant No. 82330035, 82130043, 82172685, and 82001223), National Natural Science Foundation of Hunan Province (grant No. 2021SK1010), and the Science Foundation for Distinguished Young Scholars of Changsha (grant No. kq2209006).

Medication-based profiling of older orthopedic patients: a multicenter cross-sectional study

BackgroundManaging medication use in older orthopedic patients is imperative to extend their healthy life expectancy in an aging society. However, the actual situation regarding polypharmacy, the intake of potentially inappropriate medications (PIMs), and fall risk-increasing drugs (FRIDs) among older orthopedic patients is not well characterized. This study aimed to investigate the medication-based profiles of older orthopedic patients to highlight the critical points of concern.MethodsWe retrospectively reviewed the clinical data of consecutive patients aged ≥ 65 years who underwent orthopedic surgery at two acute care hospitals between April 2020 and March 2021. The cutoff number of prescribed drugs for polypharmacy was set at 6. According to the specified guidelines, 19 categories of drugs were identified as PIMs, and 10 categories were classified as FRIDs.ResultsA total of 995 older patients with orthopedic surgery were assessed, of which 57.4% were diagnosed with polypharmacy, 66.0% were receiving PIMs, and 41.7% were receiving FRIDs. The prevalence of FRID intake did not significantly differ among patients with degenerative spinal disease (n = 316), degenerative disease of extremities (n = 331), and fractures (n = 272). Compared with patients with degenerative disease of the extremities, the multivariable-adjusted prevalence ratios (PRs) of polypharmacy and PIM intake were significantly higher in patients with degenerative spinal disease (1.26 [confidence intervals (CI): 1.11–1.44] and 1.12 [CI: 1.00–1.25]), respectively. Use of antiemetic drugs (adjusted PR, 13.36; 95% CI: 3.14–56.81) and nonsteroidal anti-inflammatory drugs (adjusted PR, 1.37; 95% CI: 1.05–1.78) was significantly higher in patients with degenerative spinal disease. Among patients with degenerative spinal disease, the prevalence of antiemetic drug intake was 8.7% in lumbar spinal patients and 0% in cervical spinal patients.ConclusionsMore than half of the orthopedic patients in this study were affected by polypharmacy, and approximately two-thirds were prescribed some form of PIMs. Patients with degenerative spinal disease showed a significantly higher prevalence of polypharmacy and PIM use compared with other orthopedic diseases. Particular attention should be paid to the high frequency of antiemetic drugs and nonsteroidal anti-inflammatory drugs intake among patients with degenerative lumbar spine conditions.

Trends in Drug Overdose Deaths by Intent and Drug Categories, United States, 1999‒2022.

Objectives. To examine trends in overdose deaths by intent and drug category to better understand the recent decrease in overdose suicides amid the overdose epidemic. Methods. We examined trends in rates of overdose deaths by intent (unintentional, suicide, or undetermined) across 9 drug categories from 1999 to 2022 using US National Vital Statistics System mortality data. Results. Unintentional overdoses involving synthetic opioids, polydrug toxicity involving synthetic opioids, psychostimulants, and cocaine increased exponentially with annual percentage changes ranging from 15.0% to 104.9% during 2010 to 2022. The death rates also increased for suicides involving these drugs, especially for psychostimulants (annual percentage change = 12.9% for 2010-2022; P < .001). However, these drugs accounted for relatively small percentages of overdose suicides. The leading drug categories among suicides were antidepressants, prescription opioids, and benzodiazepines, though these deaths have decreased or leveled off in recent years. Conclusions. Different drugs commonly involved in suicides and unintentional overdoses may contribute to their divergent trends. Public Health Implications. Amid the overdose epidemic, safe storage of medications remains a crucial strategy to prevent overdose suicides. The large increases in suicides involving psychostimulants warrant monitoring. (Am J Public Health. Published online ahead of print August 8, 2024:e1-e5. https://doi.org/10.2105/AJPH.2024.307745).

A Guide to Chemical Considerations for the Pre-Clinical Development of Oligonucleotides.

Oligonucleotide therapeutics, a pioneering category of modern medicinal drugs, are at the forefront of utilizing innate mechanisms to modulate gene expression. With 18 oligonucleotide-based FDA-approved medicines currently available for treating various clinical conditions, this field showcases an innovative potential yet to be fully explored. Factors such as purity, formulation, and endotoxin levels profoundly influence the efficacy and safety of these therapeutics. Therefore, a thorough understanding of the chemical factors essential for producing high-quality oligonucleotides for preclinical studies is crucial in their development for further clinical application. This paper serves as a concise guide to these chemical considerations, aiming to inspire and equip researchers with the necessary knowledge to advance in this exciting and innovative field.

Exploration and Practice of Introducing the Pharmaceutical Care Network Europe Classification System to Psychiatric Drugs.

This research aims to summarize and discuss issues related to psychiatric drugs by using the classification system of the Pharmaceutical Care Network Europe (PCNE) and to provide a reference for the development and direction of clinical pharmacists' work in the future. Psychiatric patients who were hospitalized in our hospital from Janurary 2023 to December 2023 were enrolled. Drug-related problems (DRPs) were evaluated using the PCNE classification system (version 9.0). The types, causes, intervention plans, acceptance of intervention plans, and statuses of DRPs were analyzed. A total of 362 patients were included, covering 405 DRP cases, with an average DRP of 1.12 for each patient. All 405 DRP cases underwent interventions, with a success rate of 83.46%. The main categories of related drugs were psychotropic drugs (70.37%), anti-infective drugs (8.89%), and cardiovascular system drugs (5.19%). The main DRPs were possible adverse drug events (21.24%), poor treatment effects (69.14%), and unnecessary medication treatment (9.63%). The main causes of DRPs were inappropriate drug selection (18.52%), inappropriate combinations of drugs (16.05%), and excessive drug dosage (13.58%). The PCNE classification system helps clinical pharmacists improve their ability to identify and solve DRPs faced by psychiatric departments, improve pharmaceutical care efficiency, and ensure rational drug use.

Management of Hypertension in Patients with Type 2 Diabetes Mellitus: Indian Guideline 2024 by Association of Physicians of India and Indian College of Physicians.

In India and the Southeast Asian population, hypertension and type 2 diabetes mellitus (T2DM) are the leading lifestyle-related diseases, responsible for a majority burden of morbidity and mortality. Multiple population-spanning studies have revealed the staggering prevalence of both diseases in India, and the prevalence of both will only increase further due to factors such as an aging population, rapid urbanization, increased obesity, and sedentary lifestyles. More than 50 percent of hypertensive patients in India are also diagnosed with T2DM, and a detailed management protocol for the same is required, especially when a major portion of the disease is managed at the primary care level. The Association of Physicians of India (API) guidelines for the management of hypertension in patients with T2DM have been formulated based on consultation with leading physicians, cardiologists, diabetologists, and endocrinologists of India and Southeast Asia, keeping in mind the challenges faced by the patients in these countries and the appropriate management protocols that will be beneficial. While standard office-based blood pressure (BP) measurement forms the cornerstone of hypertension diagnosis and demands a uniform methodology to be followed, home blood pressure monitoring (HBPM) is recommended for long-term follow-up with validated devices. Ambulatory blood pressure monitoring (ABPM) offers comprehensive insights crucial for cardiovascular (CV) risk stratification. The complications of diabetic hypertension can span from increased CV risk, heart failure (HF), and renal dysfunction, and nonpharmacological and pharmacological management should be aimed toward not only control of the BP values but also protecting the end organs. While nonpharmacological measures include a focus on nutrition and diet, they also focus on approaches to weight loss, including a novel section covering the benefits of yoga. The guideline also focuses on a novel section of factors influencing CV risk, especially in the Indian population. For the pharmacological management, the guidelines address each of the categories of antihypertensive drugs, emphasizing the significance of combination therapies in the management of diabetic hypertension. In line with leading global guidelines for the management of hypertension in T2DM, for diabetic patients who often struggle with BP management and carry a high CV risk, the recommended dual combination antihypertensive therapy is particularly crucial and should be considered as first-line management therapy. While angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) play a highly beneficial role in the management of diabetic hypertension, a combination of ACEi or ARB with dihydropyridine calcium channel blockers (DHP-CCBs) is recommended to reduce the risk of complications and enhance patient adherence. To achieve the target of effective BP control and end-organ protection, it is beneficial and recommended to include newer CCBs (e.g., cilnidipine) in the management protocol in combination with ACEi/ARBs. Combination therapy including ARBs and DHP-CCBs should be preferred over β-blockers and thiazides. Among the CCBs, cilnidipine, a novel molecule, is a more effective and safer option for diabetic hypertensive patients in India. β-blockers should be used if there is a history of myocardial infarction (MI), HF, coronary artery disease (CAD), or stable angina along with the initial hypertensive regimen. The guideline also focuses on the novel reno- and cardioprotective molecules such as finerenone and sodium-glucose cotransporter 2 inhibitors (SGLT2i) and their benefits in the management of diabetic hypertension.

Bis-benzylisoquinoline alkaloids inhibit African swine fever virus internalization and replication by impairing late endosomal/lysosomal function.

African swine fever (ASF), caused by the African swine fever virus (ASFV), is a highly infectious disease afflicting domestic pigs and wild boars. It exhibits an alarming acute infection fatality rate of up to 100%. Regrettably, no commercial vaccines or specific drugs for combating this disease are currently available. This study evaluated the anti-ASFV activities in porcine alveolar macrophages, 3D4/21 cells, and PK-15 cells of four bis-benzylisoquinoline alkaloids (BBAs): cepharanthine (CEP), tetrandrine, fangchinoline, and iso-tetrandrine. Furthermore, we demonstrated that CEP, which exhibited the highest selectivity index (SI = 81.31), alkalized late endosomes/lysosomes, hindered ASFV endosomal transport, disrupted virus uncoating signals, and thereby inhibited ASFV internalization. Additionally, CEP disrupted ASFV DNA synthesis, leading to the inhibition of viral replication. Moreover, berbamine was labeled with NBD to synthesize a fluorescent probe to study the cellular location of these BBAs. By co-staining with Lyso-Tracker and lysosome-associated membrane protein 1, we demonstrated that BBAs target the endolysosomal compartments for the first time. Our data together indicated that BBAs are a class of natural products with significant inhibitory effects against ASFV infection. These findings suggest their potential efficacy as agents for the prevention and control of ASF, offering valuable references for the identification of potential drug targets.IMPORTANCEThe urgency and severity of African swine fever (ASF) underscore the critical need for effective interventions against this highly infectious disease, which poses a grave threat to domestic pigs and wild boars. Our study reveals the potent anti-African swine fever virus (ASFV) efficacy of bis-benzylisoquinoline alkaloids (BBAs), particularly evident in the absence of progeny virus production under a 5 µM concentration treatment. The structural similarity among cepharanthine, tetrandrine, fangchinoline, and iso-tetrandrine, coupled with their analogous inhibitory stages and comparable selectivity indexes, strongly suggests a shared antiviral mechanism within this drug category. Further investigation revealed that BBAs localize to lysosomes and inhibit the internalization and replication of ASFV by disrupting the endosomal/lysosomal function. These collective results have profound implications for ASF prevention and control, suggesting the potential of the investigated agents as prophylactic and therapeutic measures. Furthermore, our study offers crucial insights into identifying drug targets and laying the groundwork for innovative interventions.

DNA Methylation as Drug Sensitivity Marker in RCC: A Systematic Review.

Patient response after treatment of renal cell cancer (RCC) with systemic agents, which include various drug categories, is generally poor and unpredictable. In this context, the ideal drug administration includes tools to predict the sensitivity of the disease to therapy. The aim of this study was to systematically summarize the reports on the predictive value of the methylation status in the systemic therapy of RCC. Only original articles reporting on the association of promoter methylation with the response of patients or cell lines to systemic agents were included in this review. We applied PRISMA recommendations to the structure and methodology of this systematic review. Our literature search concluded with 31 articles conducted on RCC cell lines and patient tissues. The majority of the studies demonstrated a methylation-dependent response to systemic agents. This correlation suggests that the methylation pattern can be used as a predictive tool in the management of RCC with various classes of systemic agents. However, although methylation biomarkers show promise for predicting response, the evidence of such correlation is still weak. More studies on the gene methylation pattern in patients under systemic therapy and its correlation with different degrees of response are needed.

Can we Predict Drug Excretion into Saliva? A Systematic Review and Analysis of Physicochemical Properties.

Saliva is a patient-friendly matrix for therapeutic drug monitoring (TDM) but is infrequently used in routine care. This is due to the uncertainty of saliva-based TDM results to inform dosing. This study aimed to retrieve data on saliva-plasma concentration and subsequently determine the physicochemical properties that influence the excretion of drugs into saliva to increase the foundational knowledge underpinning saliva-based TDM. Medline, Web of Science and Embase (1974-2023) were searched for human clinical studies, which determined drug pharmacokinetics in both saliva and plasma. Studies with at least ten subjects and five paired saliva-plasma concentrations per subject were included. For each study, the ratio of the area under the concentration-time curve between saliva and plasma was determined to assess excretion into saliva. Physicochemical properties of each drug (e.g. pKa, lipophilicity, molecular weight, polar surface area, rotatable bonds and fraction of drug unbound to plasma proteins) were obtained from PubChem and Drugbank. Drugs were categorised by their ionisability, after which saliva-to-plasma ratios were predicted with adjustment for protein binding and physiological pH via the Henderson-Hasselbalch equation. Spearman correlation analyses were performed for each drug category to identify factors predicting saliva excretion (α = 5%). Study quality was assessed by the risk of bias in non-randomised studies of interventions tool. Overall, 42 studies including 40 drugs (anti-psychotics, anti-microbials, immunosuppressants, anti-thrombotic, anti-cancer and cardiac drugs) were included. The median saliva-to-plasma ratios were similar for drugs in the amphoteric (0.59), basic (0.43) and acidic (0.41) groups and lowest for drugs in the neutral group (0.21). Higher excretion of acidic drugs (n = 5) into saliva was associated with lower ionisation and protein binding (correlation between predicted versus observed saliva-to-plasma ratios: R2 = 0.85, p = 0.02). For basic drugs (n = 21), pKa predicted saliva excretion (Spearman correlation coefficient: R = 0.53, p = 0.02). For amphoteric drugs (n = 10), hydrogen bond donor (R = - 0.76, p = 0.01) and polar surface area (R = - 0.69, p = 0.02) were predictors. For neutral drugs (n = 10), protein binding (R = 0.84, p = 0.004), lipophilicity (R = - 0.65, p = 0.04) and hydrogen bond donor count (R = - 0.68, p = 0.03) were predictors. Drugs considered potentially suitable for saliva-based TDM are phenytoin, tacrolimus, voriconazole and lamotrigine. The studies had a low-to-moderate risk of bias. Many commonly used drugs are excreted into saliva, which can be partly predicted by a drug's ionisation state, protein binding, lipophilicity, hydrogen bond donor count and polar surface area. The contribution of drug transporters and physiological factors to the excretion needs to be evaluated. Continued research on drugs potentially suitable for saliva-based TDM will aid in adopting this person-centred TDM approach to improve patient outcomes.

Global burden of anticancer drug-induced acute kidney injury and tubulointerstitial nephritis from 1967 to 2023

This study aims to figure out the worldwide prevalence of anticancer therapy-associated acute kidney injury (AKI) and tubulointerstitial nephritis (TIN) and the relative risk of each cancer drug. We conducted an analysis of VigiBase, the World Health Organization pharmacovigilance database, 1967–2023 via disproportionate Bayesian reporting method. We further categorized the anticancer drugs into four groups: cytotoxic therapy, hormone therapy, immunotherapy, and targeted therapy. Reporting odds ratio (ROR) and information component (IC) compares observed and expected values to investigate the associations of each category of anticancer drugs with AKI and TIN. We identified 32,722 and 2056 reports (male, n = 17,829 and 1,293) of anticancer therapy-associated AKI and TIN, respectively, among 4,592,036 reports of all-drug caused AKI and TIN. There has been a significant increase in reports since 2010, primarily due to increased reports of targeted therapy and immunotherapy. Immunotherapy exhibited a significant association with both AKI (ROR: 8.92; IC0.25: 3.06) and TIN (21.74; 4.24), followed by cytotoxic therapy (7.14; 2.68), targeted therapy (5.83; 2.40), and hormone therapy (2.59; 1.24) for AKI, and by cytotoxic therapy (2.60; 1.21) and targeted therapy (1.54; 0.61) for TIN. AKI and TIN were more prevalent among individuals under 45 years of age, with a female preponderance for AKI and males for TIN. These events were reported in close temporal relationship after initiation of the respective drug (16.53 days for AKI and 27.97 days for TIN), and exhibited a high fatality rate, with 23.6% for AKI and 16.3% for TIN. These findings underscore that kidney-related adverse drug reactions are of prognostic significance and strategies to mitigate such side effects are required to optimize anticancer therapy.

Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis.

The study aims to identify the drugs associated with drug withdrawal syndrome in the Food and Drug Administration Adverse Event Reporting System (FAERS) and estimate their risks of causing withdrawal syndrome. All the data were collected from FAERS from the first quarter of 2004 to the third quarter of 2023. Disproportionality analyses of odds ratio (ROR) and proportional reported ratio were conducted to identify potential adverse effects signal of drug withdrawal syndrome. A total of 94,370 reports related to withdrawal syndrome from the data. The top 50 drugs with most frequency reported were analyzed, and 29 exhibited a positive signal based on the number of reports. The top three categories of drugs with positive signals included opioids, antidepressant drugs and antianxiety drugs. Other classifications included opioid antagonist, muscle relaxant, antiepileptic drugs, analgesics, hypnotic sedative drugs and antipsychotic drugs. Our analysis of FAERS data yielded a comprehensive list of drugs associated with withdrawal syndrome. This information is vital for healthcare professionals, including doctors and pharmacists, as it aids in better recognition and management of withdrawal symptoms in patients undergoing treatment with these medications.

Oral Anti-Diabetic Semaglutide: A GLP-1 RA Peptide

T2DM has emerged as a global disorder. Although there are many treatment options available for T2DM patients, still several patients complaint about inadequate blood sugar levels. Diabetes management is not limited to just lowering of blood glucose level, it needs a multifactorial approach in treatment. Glucagon- like peptide-1 receptor agonists (GLP-1RA) are a new category of T2DM drugs that acts on various targets such as body weight reduction, renal and cardiovascular benefits. Despite of being so beneficial the major drawback of semaglutide has been its subcutaneous route of administration. Majority of the patients are unable to continue semaglutide for long because of their reluctance towards daily injectable. To avoid this oral semaglutide is introduced. Oral semaglutide is a GLP- 1RA which is displays high glycaemic control. However, in order to increase its bioavailability, it needs to be co formulated with sodium N-(8-[2-hydroxybenzyol] amino) caprylate (SNAC). Oral semaglutide has gone through a very intense series of clinical trials known as, Peptide Innovation for Early Diabetes Treatment (PIONEER). These trials have established benefits of oral semaglutide regarding reduction in glycaemic levels and body weight. It is deemed to be fit for regular consumption. In this review we discuss many aspects of oral semaglutide such as, its chemical structure, route of administration, challenges associated with the oral form of semaglutide, dosage, mechanism of oral bioavailability, robust indications, its placement in the line of defence, drug- drug interaction, various clinical trials (Phase trials and PIONEER studies) including their results. It also summarizes the benefits of oral semaglutide beyond glycaemic control and some future scope of research in the field.

Design &amp; Development Of Nano Formulations Of Various Anti Arthritic Agents For Arthritis.

Zaltoprofen and Cataflam are the NSAIDs category of drugs which could be used for the Arthritis for pain management. These are COX2 inhibitors, basically interfere with the prostaglandin synthesis and thus are able to reduce the sensation of pain in joints.

Is It Safe To Use Levofloxacin For Treating Resistant Gram-Negatıve Bacterial Infections In The Pediatric Intensive Care Unit?

Objective: Hospital-associated multidrug-resistant infections are currently on the rise. Widespread resistance to antibiotics and limited therapeutic options make it a challenge to eradicate these infections. Therefore, the use of different antibiotics was increased in pediatric intensive care (PICU). Fluoroquinolones belong to a class of broad-spectrum antimicrobials, and their use in children has not been associated with any known clinical complications. In this single-centre retrospective study, we aimed to evaluate the effects, results, and safety of levofloxacin treatment. Materials and Methods: A retrospective, single-center study was conducted at a local tertiary hospital involving 22 patients who were treated with levofloxacin in the PICU from July to December 2021. Levofloxacin was initiated at a dose of 10mg/kg twice daily intravenously for 14-21 days. The study examined and evaluated various factors related to the patients, including their demographic characteristics, medical history, comorbidities, length of stay, need for mechanical ventilation support, laboratory results, type of infection/microorganism, duration of treatment, treatment response and adverse effects, morbidity and mortality. Results: Stenotrophomonas maltophilia13(59.1%) and Pseudomonas aeruginosa9(40.9%) were detected in included patients who had levofloxacin treatment 20(90.9%) of their infections were eradicated. The mortality rate was found to be 13.6%, and 19 patients (86.4%) were successfully treated. No complications related to levofloxacin were detected during the treatment period. The duration of levofloxacin treatment in patients with eradication of gram negative bacteria was 21 days (range: 14-27 days), compared to 12 days (range: 10-14 days) in patients without eradication. This difference was found to be statistically significant (p=0.007). Conclusions: Due to the challenge of eradicating infections and the rising antibiotic resistance, it may be necessary to use antibiotics that are not typically prescribed to children or to develop new drug categories. Therefore, there is a need for more multicenter, randomized controlled, and long-term observational studies to evaluate the efficacy of different and new groups of antibiotics, including levofloxacin, in treating gram-negative bacterias.

Prescribing patterns and medications costs in patients on maintenance hemodialysis and peritoneal dialysis.

Polypharmacy is a significant clinical issue for patients on dialysis but has been incompletely studied. We investigated the prevalence and costs of polypharmacy in a population-based cohort of participants treated with hemodialysis (HD) or peritoneal dialysis (PD). We studied adults aged≥20 years in Alberta, Canada receiving maintenance HD or PD as of March 31, 2019. We characterized participants as users of 0-29 drug categories of interest and those aged≥65 as users/non-users of potentially inappropriate medications (PIM). We calculated the number of drug categories, daily pill burden, total annual cost, and annual cost per participant, and compared this to an age- and sex-matched cohort from the general Alberta population. Among 2248 participants (mean age 63 years; 39% female) on HD (n=1781) or PD (n=467), the median number of prescribed drug categories was 6 [interquartile range (IQR) 4, 8]; median daily pill burden was 8.0 (IQR 4.6, 12.6) pills/day, with 5% prescribed≥21.7 pills/day, and 16.5% prescribed≥15 pills/day. Twelve % were prescribed at least one drug that is contraindicated in kidney failure. The median annual per participant cost was ${\$}$3,831, totaling approximately ${\$}$11.6 million annually for all participants. When restricting to the 1063 participants aged≥65, the median number of PIM categories was 2 (IQR 1, 2), with a median PIM pill burden of 1.2 pills/day (IQR 0.5, 2.4). Compared to PD participants, HD participants had similar daily pill burden, higher use of PIM, and higher annual per participant cost. Pill burden and associated costs for participants on dialysis were more than 3-fold and 10-fold higher, respectively, compared to the matched participants from the general population. Participants on dialysis have markedly higher use of prescription medications and associated costs than the general population. Effective methods to de-prescribe in the dialysis population are needed.

A four-year assessment of the characteristics of Rwandan FDA drug recalls

BackgroundA drug recall is an act of removing products from the market and/or returning them to the manufacturer for disposal or correction when they violate safety laws. Action can be initiated by the manufacturing company or by the order of a regulatory body. This study aimed to assess the characteristics of Rwanda FDA drug recall and determine the association between classes of recall and recall characteristics.MethodologyThis was a retrospective descriptive cross-sectional study. Data about recalled drugs were collected from the official website of the Rwanda FDA in the section assigned to “Safety alerts”. The search included data reported between February 2019 and February 2023 covering four years. Data cleaning was conducted in Microsoft Excel to address missing data and inconsistencies, followed by importation into STATA/SE software version 17.0 for further cleaning and subsequent analysis. Descriptive statistics were computed for independent variables. Categorical variables were described in terms of counts and relative frequencies. Bivariate analyses used Pearson’s chi-square test to illustrate the associations between categorical independent variables and recall classes.ResultsThe study revealed that a large proportion (33.0%) of the recalled products belonged to Class I. Antibiotics constituted 35.8% of the recalled products, with contamination emerging as a leading cause and responsible for 26.4% of the recalls. India was the leading manufacturing country for the recalled products (29.2%), followed by France (17.9%), China (17.0%), Kenya (13.2%), and Russia (6.6%). An association was found between the class of recall and several recall characteristics, including the year of recall, drug category, safety issues, reporter, and manufacturing country.ConclusionThis study provides a comprehensive overview of the characteristics of drug recalls in Rwanda. The insights gained contribute to a nuanced understanding of recall dynamics and provide evidence-based strategies to enhance drug quality, safety, efficacy, regulatory compliance, and patient welfare.