Drugs - Real World Outcomes

http://link.springer.com/journal/40801

List of Papers (Total 131)

Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database

BackgroundVoluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports.ObjectiveThe aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers and healthcare professionals...

Diagnoses of Cardiovascular Disease or Substance Addiction/Abuse in US Adults Treated for ADHD with Stimulants or Atomoxetine: Is Use Consistent with Product Labeling?

BackgroundAmong US adults, utilization of pharmacotherapy for attention-deficit hyperactivity disorder (ADHD) has increased more than ninefold since 1995–1996. Potential contraindications to ADHD pharmacotherapy include serious cardiovascular disease (CVD) and, for stimulants, addictions and bipolar disorder (BPD).ObjectiveTo assess the prevalence of potential contraindications...

Quantitative Testing of Prescriber Knowledge Regarding the Risks and Safe Use of Albiglutide

Background The risk of pancreatitis and potential risk of medullary thyroid carcinoma associated with glucagon-like peptide-1 receptor agonists prompted the US Food and Drug Administration to require a Risk Evaluation and Mitigation Strategy for albiglutide, including education for prescribers and subsequent assessment of their knowledge of the risks and safe use of albiglutide...

Contact Dermatitis after Prescription of an Ophthalmic Ointment Containing Fradiomycin Sulfate: A Retrospective Database Study Using Japanese Health Insurance Claims Data

Background Topical ointments containing fradiomycin sulfate, such as fradiomycin sulfate/methylprednisolone (F/M) and fradiomycin sulfate/betamethasone sodium phosphate (F/B), are known to cause allergic contact dermatitis (CD) in some patients, especially when used for the periocular region. F/M is commonly prescribed to patients for various conditions; however, there are no...

Estimating Prevalence and Healthcare Utilization for Treatment-Resistant Depression in Japan: A Retrospective Claims Database Study

Background Major depressive disorders (MDDs) including treatment-resistant depression (TRD) are common disabling conditions, but data on their epidemiology in Japan are limited. This study investigated the incidence, epidemiology, and direct medical costs of TRD and pharmaceutically-treated depression (PTD) in Japan to increase our health economic understanding of this phenotype...

Adverse Drug Events and Medication Errors in African Hospitals: A Systematic Review

Background Medication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear. Objective The objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African...

Replication of Mini-Sentinel Study Assessing Mirabegron and Cardiovascular Risk in Non-Mini-Sentinel Databases

BackgroundIn 2014, the US Food and Drug Administration (FDA) initiated a prospective routine surveillance using the Mini-Sentinel (M-S) program to assess potential signals of acute myocardial infarction (AMI) and stroke with use of mirabegron, indicated for the treatment of overactive bladder (OAB), compared with oxybutynin.PurposeTo replicate the FDA M-S analysis of mirabegron...

Potentially Harmful Medication Use and Decline in Health-Related Quality of Life among Community-Dwelling Older Adults

Background Several scales to quantify the impact of potentially harmful medications (PHMs) have been shown to predict mortality and functional decline; however, the effect of PHMs on quality of life (QoL) has not been well-studied. Objective The aims of this study were to investigate an association between PHM use and change in health-related QoL among community-dwelling older...

Prevalence and Variability in Medications Contributing to Polypharmacy in Long-Term Care Facilities

BackgroundResearch into which medications contribute to polypharmacy and the variability in these medications across long-term care facilities (LTCFs) has been minimal.ObjectiveOur objective was to investigate which medications were more prevalent among residents with polypharmacy and to determine the variability in prescribing of these medications across LTCFs.MethodsThis was a...

Economic Burden of Herpes Zoster and Post-Herpetic Neuralgia in Adults 60 Years of Age or Older: Results from a Prospective, Physician Practice-Based Cohort Study in Kushiro, Japan

Background and ObjectiveHerpes zoster has a high incidence rate among people aged ≥ 60 years and can lead to serious complications such as post-herpetic neuralgia. There are currently no data on the economic burden of herpes zoster and post-herpetic neuralgia in Japan, and the objective of this study was to address this gap.MethodsA total of 412 patients aged ≥ 60 years diagnosed...

Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network

Background There is a need for data on the clinical safety of anthroposophic medicinal products (AMPs). Objectives The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions. Methods EvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the...

The Impact of US FDA and Health Canada Warnings Related to the Safety of High-dose Simvastatin

IntroductionBetween 2010 and 2012, the US Food and Drug Administration and Health Canada issued warnings to healthcare professionals emphasizing the increased risk of muscle problems with high-dose simvastatin.ObjectiveTo measure the impact of the Health Canada safety warning regarding dose-dependent adverse effects of simvastatin on prescribing of low, medium, and high doses of...

The Risk of Hip Fracture Due to Mirtazapine Exposure When Switching Antidepressants or Using Other Antidepressants as Add-On Therapy

Background Antidepressants are associated with adverse effects such as sedation and hypotension, which can result in falls and fractures. Few studies have assessed the risk of hip fracture due to mirtazapine, and no known studies have assessed whether the risk of hip fracture is higher in patients taking other antidepressant medicines in combination with mirtazapine. Objectives...

Prescription of Sedative Drugs During Hospital Stay: A Swiss Prospective Study

Background In recent years, the number of prescriptions for sedative drugs has increased significantly, as has their long-term use. Moreover, sedative use is frequently initiated during hospital stays. Objectives This study aimed to describe new prescriptions of sedative drugs during hospital stays and evaluate their maintenance as discharge medication. Methods This observational...

Differences in Adverse Drug Events Among Pediatric Patients With and Without Cancer: Sub-Analysis of a Retrospective Cohort Study

Objectives This study investigated the differences in the incidence and severity of adverse drug events (ADEs) in pediatric patients with and without cancer. Methods We used data from the Japan Adverse Drug Events Study for pediatrics, a cohort study enrolling pediatric inpatients at two tertiary care teaching hospitals in Japan. ADEs were identified by on-site review of all...

Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis

BackgroundRegulatory agencies often request prospective, product-specific post-authorization pregnancy exposure registries to monitor safety during pregnancy, even though studies using existing health databases could also be employed.ObjectivesUsing multiple sclerosis (MS) as a case study, we evaluated various study designs and data sources previously used to study medication...

Non-Steroidal Anti-Inflammatory Drug Use and the Risk of Acute Myocardial Infarction in the General German Population: A Nested Case–Control Study

Introduction Use of non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with an increased relative risk of acute myocardial infarction (AMI), but the label warnings refer particularly to patients with cardiovascular risk factors. The magnitude of relative AMI risk for patients with and without cardiovascular risk factors varies between studies depending on the...

Rare Cyclophosphamide-Induced Hemorrhagic Cystitis in a Chinese Population with Rheumatic Diseases

Objective The aim of this study was to investigate the prevalence, severity, risk factors, and treatment outcomes of cyclophosphamide (CYC)-induced hemorrhagic cystitis (HC) in patients with rheumatic diseases. Methods We collected the clinical data from 1284 consecutive patients admitted to The First Affiliated Hospital of Sun Yat-Sen University who were treated with CYC between...

Use of Antipsychotic Drugs by Elderly Primary Care Patients and the Effects of Medication Reviews: A Cross-Sectional Study in Sweden

Background Antipsychotics form a class of drugs that should be used with caution among elderly people because of a high risk of adverse events. Despite the risks and modest effects, their use is estimated to be high, especially in nursing homes. Objective The aim was to explore the effects of medication reviews on antipsychotic drug use for elderly primary care patients and...

Central and Peripheral Nervous System Disorders Following Ivermectin Mass Administration: A Descriptive Study Based on the Democratic Republic of Congo Pharmacovigilance System

Introduction The mainstay of onchocerciasis control currently is mass administration of ivermectin; however, this may be associated with serious adverse events, including deaths, when administered in areas where onchocerciasis and loiasis are co-endemic. Objectives The objective of the current study was to describe the central and peripheral nervous system disorders that occurred...

Treatment Satisfaction During Sublingual Immunotherapy with a Five-Grass Pollen Tablet for Allergic Rhinoconjunctivitis: A Prospective, Non-Interventional Study

Background Sublingual immunotherapy (SLIT) is a safe/well-tolerated alternative to allergen injection immunotherapy for allergic rhinoconjunctivitis (ARC). Patient adherence is essential and patient-related outcome measures including treatment satisfaction are informative/indicative of adherence. Objective The aim was to assess treatment satisfaction with five-grass pollen tablet...