Drugs - Real World Outcomes

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

List of Papers (Total 118)

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 via ...

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 ...

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 Objective Herpes 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. Methods A total of 412 patients aged ≥ 60 years ...

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 patients ...

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

Introduction Between 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. Objective To 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 ...

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

Background Regulatory 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. Objectives Using 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 drugs ...

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 ...

Characterisation of Drug-Related Problems and Associated Factors at a Clinical Pharmacist Service-Naïve Hospital in Northern Sweden

Background Polypharmacy and increased sensitivity to side effects cause adverse drug events, drug–drug interactions and medication errors in the elderly. Objective The objective of this study was to investigate the prevalence and type of drug-related problems and associated factors among patients admitted to a clinical pharmacist service-naïve medical ward in an inland hospital in ...

Risk of Hip Fracture in Older People Using Selective Serotonin Reuptake Inhibitors and Other Psychoactive Medicines Concurrently: A Matched Case–Control Study in Australia

Background Few studies have assessed the risk of hip fracture following concurrent use of psychoactive medicines, and none has investigated combinations with selective serotonin reuptake inhibitors. Objectives To assess the risk of hip fracture in older people as a result of concurrent use of selective serotonin reuptake inhibitors and other psychoactive medicines. Methods A ...

In the Real-World, Kids Use Medications and Devices

In the real world, we lack evidence guiding the use of medications and devices in children. This lack of evidence arose out of the challenges of conducting clinical trials in children and other vulnerable populations and the historical decision (reversed in recent decades) to exclude children from clinical trials. The recent focus on the potential of real-world evidence (RWE) to ...

Characterization of Stevens–Johnson Syndrome and Toxic Epidermal Necrolysis Among Patients Admitted to Kenyatta National Hospital: A Retrospective Cross-Sectional Study

Background Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous reactions. There is scant literature on the characteristics and causes of these conditions in Kenyatta National Hospital. Objective The aim of this study was to determine the prevalence, risk factors, and etiologies of SJS/TEN among patients admitted to Kenyatta National Hospital. ...

Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007–15: Report from the Medical Products Agency

Background In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. Objectives To evaluate the characteristics and frequency of adverse events recorded by the ...

Tolerability of an Immunologically Enhanced Subcutaneous Immunotherapy Preparation in Patients Treated with Concomitant Allergy Immunotherapy: A Non-Interventional Observational Study

Background For causal treatment by allergy immunotherapy (AIT) a single or few allergen products for the clinically most relevant allergens are applied to treat multiple allergies, but few data on the tolerability of multiple AIT applications are available. Objective The aim of our study was to investigate safety and tolerability in patients treated by subcutaneous immunotherapy ...

HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes

Background Pertuzumab (Perjeta®), a HER2/neu receptor antagonist, was approved by the US Food and Drug Administration in June 2012 for use in the first-line setting for patients with HER2-positive metastatic breast cancer (mBC). Objective This retrospective study investigated the clinical and demographic characteristics, treatment patterns, safety, and clinical outcomes for ...

Pharmacist’s Comprehensive Geriatric Assessment: Introduction and Evaluation at Elderly Patient Admission

Background The role of the clinical pharmacist within the healthcare system remains unclear. Objective Our objective was to describe a pharmacist’s comprehensive geriatric assessment (pCGA) at admission of elderly patients and to assess its relevance in terms of medication compliance and pharmacist interventions (PIs). Methods We conducted a prospective interventional study over 29 ...

Association Between Statin Medications and COPD-Specific Outcomes: A Real-World Observational Study

Background Disease-modifying drugs are not yet available for the management of chronic obstructive pulmonary disease (COPD). HMG-CoA reductase inhibitors (statins) have anti-inflammatory properties and are therefore being considered for use in the management of COPD. Objective Our objective was to examine the association between statin use and COPD-specific outcomes in a real-world ...

Impact of Pediatric Acute Otitis Media on Child and Parental Quality of Life and Associated Productivity Loss in Malaysia: A Prospective Observational Study

Background Acute otitis media (AOM) affects both child and parental quality of life (QoL). Data on QoL associated with AOM in Malaysia is sparse, and the burden of indirect costs have not been previously reported. Objective To determine the effect of pediatric AOM on child and parental QoL in Malaysia and its economic impact (indirect costs). Methods We utilized a set of QoL ...

Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients

Background Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. Objective The aim of this study was to validate an alternative post-market surveillance model ...

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis

Background A lack of gold standard treatment for autism spectrum disorders (ASD), no clear ASD management guidelines, and lack of evidence-based pharmacological interventions other than aripiprazole and risperidone elevate the risk of off-label prescribing and adverse effects among individuals with ASD, more so among adults. Objective The aim of this study was to identify and ...

Readmission Risk in Chronic Obstructive Pulmonary Disease Patients: Comparative Study of Nebulized β2-Agonists

Background Bronchodilators are used for managing the symptoms of chronic obstructive pulmonary disease (COPD) and minimizing the risk of hospitalization and readmission. Hospital readmission is predictive of morbidity and mortality. Objective The study objective was to compare all-cause readmission risk in COPD patients receiving nebulized long-acting β2-agonists (neb-LABAs) versus ...