Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union
ConclusionsMedication error safety concerns were listed for almost a quarter of centrally authorised products approved during the study period. Further research is needed to evaluate the effectiveness and continued need for additional risk minimisation measures for medication errors. (Source: Drug Safety)
Source: Drug Safety - October 16, 2019 Category: Drugs & Pharmacology Source Type: research

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports
ConclusionsThe majority of signals regarding asthma therapy in children were already known, but we also identified new signals. We showed that signals can be masked if age stratification is not conducted. Further exploration is needed to investigate the risk and causality of the newly found signals. (Source: Drug Safety)
Source: Drug Safety - October 15, 2019 Category: Drugs & Pharmacology Source Type: research

Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination
ConclusionsThe results of this study indicate that a neural network approach can provide an accurate and scalable solution for potentially augmenting pharmacovigilance practitioner determination of adverse event seriousness in spontaneous, solicited, and medical literature reports. (Source: Drug Safety)
Source: Drug Safety - October 11, 2019 Category: Drugs & Pharmacology Source Type: research

Psoriasis After Exposure to Angiotensin-Converting Enzyme Inhibitors: French Pharmacovigilance Data and Review of the Literature
AbstractIntroductionAngiotensin-converting enzyme inhibitors (ACEIs) can induce or aggravate psoriasis. This risk is not specified in the Summary of Product Characteristics (SmPC) of some drugs of this class, such as captopril or enalapril. We aimed to investigate the association between psoriasis and ACEI exposure.MethodsWe analyzed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD) from 1985 to 31 December 2018. The association between psoriasis and ACEI exposure was assessed using the case/non-case method. We also reviewed literature reports.ResultsOne hundred reports of psoriasis afte...
Source: Drug Safety - October 9, 2019 Category: Drugs & Pharmacology Source Type: research

Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis
This study evaluated the impact of cumulative corticosteroid exposure on the risk of developing specific adverse events in men with CRPC.MethodsData were obtained from administrative claims databases. Adult chemotherapy-na ïve men who initiated CRPC treatment following surgical or medical castration were selected. Patients were grouped into four cohorts based on cumulative corticosteroid dose: no exposure, low exposure (  2.0 g). Time to each adverse event was assessed using Kaplan–Meier analyses and time-dependent Cox proportional hazard models, adjusting for baseline characteristics.ResultsOverall,...
Source: Drug Safety - October 5, 2019 Category: Drugs & Pharmacology Source Type: research

Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures
ConclusionsFuture research is needed to investigate whether the wide variability in reporting rates for severe HSRs associated with these intravenous iron products are due to potential differences in the safety profiles of these substances. (Source: Drug Safety)
Source: Drug Safety - October 3, 2019 Category: Drugs & Pharmacology Source Type: research

Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports
ConclusionAnalysis of Japanese adverse event reporting patterns in a global context has revealed key features that may reflect possible  pharmaco-ethnic vulnerabilities in the Japanese, as well as differences in adverse event reporting and clinical practice. This knowledge is essential in the global collaboration of signal detection afforded by the WHO Programme for International Drug Monitoring. (Source: Drug Safety)
Source: Drug Safety - September 26, 2019 Category: Drugs & Pharmacology Source Type: research

Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
ConclusionAntipsychotic safety warnings were followed by a reduction in stroke incidence among older antipsychotic users in the UK, but not Italy. (Source: Drug Safety)
Source: Drug Safety - September 25, 2019 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Ravi Jandhyala’s Comment on “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
(Source: Drug Safety)
Source: Drug Safety - September 24, 2019 Category: Drugs & Pharmacology Source Type: research

Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
(Source: Drug Safety)
Source: Drug Safety - September 24, 2019 Category: Drugs & Pharmacology Source Type: research

Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews
AbstractDirect oral anticoagulants are now recommended by major guidelines as first-choice agents for both stroke prevention in non-valvular atrial fibrillation and treatment/prevention of venous thromboembolism in non-cancer patients. Although there are no published head-to-head trials comparing different direct oral anticoagulants, a growing body of evidence from indirect comparisons and observational studies is suggesting that each direct oral anticoagulant may have a specific risk profile. This review aims to (1) synthesize and critically assess the latest evidence in comparative effectiveness and safety research in th...
Source: Drug Safety - September 24, 2019 Category: Drugs & Pharmacology Source Type: research

19th ISoP Annual Meeting “New Opportunities for New Generations” Bogotá, Colombia, 26–29 October, 2019
(Source: Drug Safety)
Source: Drug Safety - September 11, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Patient Registries: An Underused Resource for Medicines Evaluation
The fourth sentence under the heading “1.1 Use of Patient Registries for Supporting Regulatory Assessments” in “1 Introduction” section should read as below. (Source: Drug Safety)
Source: Drug Safety - September 5, 2019 Category: Drugs & Pharmacology Source Type: research

Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate ‘Real World’ Evidence of Comparative Effectiveness and Safety
AbstractResearch that makes secondary use of administrative and clinical healthcare databases is increasingly influential for regulatory, reimbursement, and other healthcare decision-making. Consequently, there are numerous guidance documents on reporting for studies that use ‘real-world’ data captured in administrative claims and electronic health record (EHR) databases. These guidance documents are intended to improve transparency, reproducibility, and the ability to evaluate validity and relevance of design and analysis decisions. However, existing guidance does n ot differentiate between structured and unst...
Source: Drug Safety - August 26, 2019 Category: Drugs & Pharmacology Source Type: research

Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR
AbstractOver a period of 3  years, the European Union’s Innovative Medicines Initiative WEB-RADR project has explored the value of social media (i.e., information exchanged through the internet, typically via online social networks) for identifying adverse events as well as for safety signal detection. Many patients and cl inicians have taken to social media to discuss their positive and negative experiences of medications, creating a source of publicly available information that has the potential to provide insights into medicinal product safety concerns. The WEB-RADR project has developed a collaborative Engli...
Source: Drug Safety - August 24, 2019 Category: Drugs & Pharmacology Source Type: research

Prevalence and Nature of Medication Errors and Preventable Adverse Drug Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review
ConclusionsMedication errors occur frequently in critically ill children admitted to paediatric and neonatal intensive care units and may lead to patient harm. Important targets such as dosing errors and anti-infective medications were identified to guide the development of remedial interventions. (Source: Drug Safety)
Source: Drug Safety - August 13, 2019 Category: Drugs & Pharmacology Source Type: research

The  Association between Metformin Therapy and Lactic Acidosis
ConclusionsAlmost all cases of metformin-associated lactic acidosis reviewed presented with independent risk factors for lactic acidosis, supporting the suggestion that metformin plays a contributory role. The prescribed metformin dose, on average, exceeded the dosing recommendations by 1000  mg/day in patients with varying degrees of renal impairment but the predicted pre-admission plasma concentrations did not exceed the therapeutic range. (Source: Drug Safety)
Source: Drug Safety - August 1, 2019 Category: Drugs & Pharmacology Source Type: research

A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool
ConclusionsThis pilot demonstrated a novel application of a visual, rapid analysis technique to assess RM effectiveness, and supported a hypothesis that prescribers altered some behaviors after the MHRA label change, such as channeling patients at risk of fracture or osteoporosis away from PPI use and potentially reducing fracture outcomes. Limitations include lack of confounding control and outcomes defined only by diagnosis code. Results demonstrate the potential to use large healthcare databases with chronographs to rapidly assess RM effectiveness, similar to signal detection in pharmacovigilance, and may help design mo...
Source: Drug Safety - July 31, 2019 Category: Drugs & Pharmacology Source Type: research

Non-Vitamin K Antagonist Oral Anticoagulants and Angioedema: A Cohort and Case-Crossover Study
ConclusionsOur estimates were inconsistent with substantial short-term relative increases in the rate of angioedema associated with oral anticoagulant therapy. (Source: Drug Safety)
Source: Drug Safety - July 18, 2019 Category: Drugs & Pharmacology Source Type: research

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem
AbstractBecause clinical trials conducted for US Food and Drug Administration (FDA) approval occur in carefully monitored settings and often have strict inclusion criteria for participation, new information about drug safety is commonly discovered once a medication is FDA approved and used by larger numbers of patients. The FDA issues Drug Safety Communications when new information arises about the safety of marketed drugs that may change decision making by healthcare providers and patients. Since their inception, over 250 Drug Safety Communications have been issued alerting consumers and prescribers in the USA about safet...
Source: Drug Safety - July 13, 2019 Category: Drugs & Pharmacology Source Type: research

Patient Registries: An Underused Resource for Medicines Evaluation
ConclusionsThese are the first explicit proposals, from a regulatory perspective, on operational methods for increasing the use of patient registries in medicines regulation. They apply to registry holders, patients, regulators, marketing authorisation holders/applicants and healthcare stakeholders broadly, and their implementation would greatly facilitate the use of these valuable data sources in regulatory decision-making. (Source: Drug Safety)
Source: Drug Safety - July 13, 2019 Category: Drugs & Pharmacology Source Type: research

Prevalence of Medication Errors Among Paediatric Inpatients: Systematic Review and Meta-Analysis
ConclusionsMedication errors are a frequent occurrence in paediatric inpatient settings, particularly in intensive care wards and emergency departments. Hospitals using electronic charts tended to have a lower rate of medication errors compared to those using paper charts. Future research employing controlled designs is needed to determine the true impact of electronic charts and other interventions on medication errors and associated harm among hospitalized children. (Source: Drug Safety)
Source: Drug Safety - July 9, 2019 Category: Drugs & Pharmacology Source Type: research

Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin –Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study
ConclusionAfter exposure to piperacillin –tazobactam and vancomycin in combination, there was a greater release of AKI biomarkers in patients who develop AKI than with piperacillin–tazobactam or vancomycin monotherapy and the combination is associated with possible increased long-term adverse outcomes. (Source: Drug Safety)
Source: Drug Safety - June 25, 2019 Category: Drugs & Pharmacology Source Type: research

Androgen Deprivation Therapy for Prostate Cancer and the Risk of Rheumatoid Arthritis: A Population-Based Cohort Study
ConclusionIn this population-based study, the use of ADT was not associated with an increased risk of RA in men with prostate cancer. (Source: Drug Safety)
Source: Drug Safety - June 25, 2019 Category: Drugs & Pharmacology Source Type: research

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study
ConclusionsIn this large-scale Italian observational multi-database study, switching versus non-switching as well as switching from biosimilar/originator ESA  α to any other epoetin in CKD patients is not associated with any effectiveness and safety outcomes. (Source: Drug Safety)
Source: Drug Safety - June 21, 2019 Category: Drugs & Pharmacology Source Type: research

Intravenous Infusion Administration: A Comparative Study of Practices and Errors Between the United States and England and Their Implications for Patient Safety
ConclusionInfusion administration is a complex adaptive system with multiple interacting agents (professionals, patients, software systems, etc.) that respond in rich ways to their environments; safety depends on complex, interrelated factors. (Source: Drug Safety)
Source: Drug Safety - June 13, 2019 Category: Drugs & Pharmacology Source Type: research

Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance
ConclusionsThis analysis of simulated data suggests that pooling AE data from solicited sources with spontaneous case data may impact the results of disproportionality analyses, masking true safety signals and identifying false positives. Therefore, increased volumes of safety data do not necessarily correlate with improved safety signal detection. (Source: Drug Safety)
Source: Drug Safety - June 12, 2019 Category: Drugs & Pharmacology Source Type: research

Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers
ConclusionThere was no evidence of any pharmacodynamic effect of 300-mg single-dose tafenoquine on the retina or any short-term clinically relevant effects on ophthalmic safety. This clinical trial is registered with ClinicalTrials.gov (identifier: NCT02658435). (Source: Drug Safety)
Source: Drug Safety - June 11, 2019 Category: Drugs & Pharmacology Source Type: research

Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis of Observational Studies
ConclusionsAs head-to-head trials comparing different DOACs do not exist, available evidence derives exclusively from observational studies. These data suggest that while dabigatran, rivaroxaban, and apixaban have a similar effect on the risk of ischemic stroke, apixaban may be associated with a decreased risk of major bleeding compared with either dabigatran or rivaroxaban. (Source: Drug Safety)
Source: Drug Safety - June 7, 2019 Category: Drugs & Pharmacology Source Type: research

Prevalence, Safety and Long-Term Retention Rates of Biologics in Hong Kong from 2001 to 2015
ConclusionThis population-based study revealed an increasing prevalence of biologic prescribing. Results from the study described the long-term retention rates and incidence rates of serious infections of biologic treatments for all indications, and confirmed the safety of biologic treatments. Since this study provides an overview of all biologic utilization, further studies on cost effectiveness, safety and compliance of treatment in different patient groups are still warranted. (Source: Drug Safety)
Source: Drug Safety - June 5, 2019 Category: Drugs & Pharmacology Source Type: research

Antidepressants and the Risk of Hemorrhagic Stroke in the Elderly: a Nested Case –Control Study
ConclusionOur study shows that the use of medications inhibiting serotonin and/or noradrenaline reuptake increases the risk of HS in patients aged 65  years and older and that the risk varies across individual ADs. (Source: Drug Safety)
Source: Drug Safety - June 4, 2019 Category: Drugs & Pharmacology Source Type: research

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature
AbstractCommunications about the safety and effectiveness of human drugs can influence patients ’ and prescribers’ perceptions and behaviors, which in turn can affect the public’s health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about safety issues with prescription and over-the-counter drugs. We searched PubMed for peer-reviewed studies published from 1990 to 2017 where study authors reported probable unintended effects of communicating drug safety. The types of communications included in these studies were news r...
Source: Drug Safety - May 31, 2019 Category: Drugs & Pharmacology Source Type: research

Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350
ConclusionsMatching, trimming, and PS stratification yielded comparable cohorts in four of five data sources. Use of these methods could not achieve balance for key covariates within the German cohort, likely due to reimbursement differences in Germany. (Source: Drug Safety)
Source: Drug Safety - May 27, 2019 Category: Drugs & Pharmacology Source Type: research

Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study
ConclusionsThe pooled incidence rate ratio estimate was consistent with no indication of an increased risk above the pre-specified safety threshold of 3.00 for major adverse cardiovascular events in patients with chronic constipation using prucalopride as compared with PEG. (Source: Drug Safety)
Source: Drug Safety - May 27, 2019 Category: Drugs & Pharmacology Source Type: research

Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning
ConclusionThe model has been deployed to evaluate safety reporting performance in a set of ongoing studies in the form of a QA/dashboard cockpit available to Roche Quality Program Leads. Applicability and production performance will be assessed over the next 12 –24 months in which we will develop a validation strategy to fully integrate our model into Roche QA processes. (Source: Drug Safety)
Source: Drug Safety - May 23, 2019 Category: Drugs & Pharmacology Source Type: research

Auto-Generated Physiological Chain Data for an Ontological Framework for Pharmacology and Mechanism of Action to Determine Suspected Drugs in Cases of Dysuria
ConclusionOur method is novel in that it generates PC data from anatomical structural properties and could serve as a knowledge base for determining suspected drugs by potential mechanisms of action. (Source: Drug Safety)
Source: Drug Safety - May 22, 2019 Category: Drugs & Pharmacology Source Type: research

Evaluation of Use of Technologies to Facilitate Medical Chart Review
ConclusionNew technologies including OCR and NLP are currently in use by various organizations involved in medical chart review. While technology-enhanced approaches could scale up capacity to validate key variables and make information about important clinical variables from medical records more generally available for research purposes, they often require considerable customization when employed in a distributed data environment with multiple, diverse healthcare settings. (Source: Drug Safety)
Source: Drug Safety - May 20, 2019 Category: Drugs & Pharmacology Source Type: research

Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: Results of the COMPEL Study
The objective of this subanalysis was to examine the safety and tolerability of onabotulinumtoxinA after each of nine treatment cycles.MethodsOnabotulinumtoxinA 155 U was administered every 12  weeks. Safety and tolerability, overall and by treatment cycle, were assessed. Treatment-emergent adverse events reported between successive treatments were attributed to the preceding treatment. The safety population received one or more doses of onabotulinumtoxinA. The primary efficacy outcome w as the reduction in headache days at week 108 compared with baseline.ResultsOf 716 patients enrolled, 373 patients (52.1%) completed...
Source: Drug Safety - May 17, 2019 Category: Drugs & Pharmacology Source Type: research

Evaluation of Potential Drug –Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis
ConclusionsImproving the understanding of clinically significant pDDIs and alerts that clinicians encounter may guide better development of surveillance through clinical decision support and decrease alert fatigue. (Source: Drug Safety)
Source: Drug Safety - May 16, 2019 Category: Drugs & Pharmacology Source Type: research

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA ’s Adverse Event Reporting System
(Source: Drug Safety)
Source: Drug Safety - May 16, 2019 Category: Drugs & Pharmacology Source Type: research

Fluoroquinolone Use and the Risk of Collagen-Associated Adverse Events: A Systematic Review and Meta-Analysis
ConclusionsFluoroquinolone use incurs a risk of developing three collagen-associated diseases (aortic aneurysm or aortic dissection, retinal detachment, and tendon disorders). Patients at an increased risk of collagen-associated diseases should not use fluoroquinolones unless no other options are available. (Source: Drug Safety)
Source: Drug Safety - May 10, 2019 Category: Drugs & Pharmacology Source Type: research

Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study
ConclusionsIn this study measuring blood bismuth concentrations in real-life practice, in    50 μg/L. No serious neurological adverse events were observed.Study registrationEU-PAS register EUPAS3142 atwww.encepp.eu; ENCePP study seal. (Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

Inflammation, Monoclonal Antibodies and Depression: Joining the Dots
(Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

A Profile of Adverse Drug Reactions of Atazanavir- and Lopinavir-Based Antiretroviral Regimens in Namibia
(Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

Advances in Diagnosis and Management of Cutaneous Adverse Drug Reactions: Current and Future Trends
(Source: Drug Safety)
Source: Drug Safety - May 8, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity
AbstractPharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epistemology of pharmacovigilance. After reviewing some of the persistent challenges, recent measures, and suggestions in the current pharmacovigilance literature, we support the argument that the detection of potential adverse drug reactions ought to be seen as a serendipitou...
Source: Drug Safety - May 6, 2019 Category: Drugs & Pharmacology Source Type: research

Identifying the DEAD: Development and Validation of a Patient-Level Model to Predict Death Status in Population-Level Claims Data
ConclusionsUS claims data often lack complete death records. The DEAD model can be used to impute death at various sensitivity, specificity, or positive predictive values depending on the use of the model. The DEAD model can be readily applied to any observational healthcare database mapped to the Observational Medical Outcome Partnership common data model and is available fromhttps://github.com/OHDSI/StudyProtocolSandbox/tree/master/DeadModel. (Source: Drug Safety)
Source: Drug Safety - May 3, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
In the original publication of this article, the following correction should be noted in Table  1. (Source: Drug Safety)
Source: Drug Safety - April 30, 2019 Category: Drugs & Pharmacology Source Type: research

The 10th International Congress on Cutaneous Adverse Drug Reactions, Shimane, Japan, 2018: Focus on New Discoveries
(Source: Drug Safety)
Source: Drug Safety - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Mechanisms of Severe Cutaneous Adverse Reactions: Recent Advances
AbstractCutaneous adverse drug reactions are unpredictable and include various different skin conditions of varying degrees of severity. The most concerning are usually referred to as severe cutaneous adverse reactions (SCARs) and include acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), also known as drug-induced hypersensitivity syndrome (DiHS) or hypersensitivity syndrome (HSS), Stevens –Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). All are delayed type IV hypersensitivity reactions in which a T-cell-mediated drug-specific immune respon...
Source: Drug Safety - April 24, 2019 Category: Drugs & Pharmacology Source Type: research