Preventability of Voluntarily Reported or Trigger Tool-Identified Medication Errors in a Pediatric Institution by Information Technology: A Retrospective Cohort Study
The objective of this study was to categorize reported or trigger tool-identified errors and adverse events (AEs) at a pediatric tertiary care institution. Also, we sought to identify medication errors preventable by IT, determine why IT-preventable errors occurred, and to identify risk factors for errors that were not preventable by IT. Methods This was a retrospective analysis of voluntarily reported or trigger tool-identified errors and AEs occurring from 1 July 2011 to 30 June 2012. Medication errors reaching the patients were categorized based on the origin, severity, and locati...
Source: Drug Safety - May 27, 2015 Category: Drugs & Pharmacology Source Type: research

Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit
This report is an update on the cardiovascular safety of those 16 TKIs, including the post-marketing data concerning their pro-arrhythmic effects, and reviews the cardiovascular safety of the nine new TKIs approved since (afatinib, cabozantinib, ceritinib, dabrafenib, ibrutinib, lenvatinib, nintedanib, ponatinib, and trametinib). As before, we focus on specific aspects of cardiovascular safety, namely their potential to induce QT interval prolongation, left ventricular (LV) dysfunction and hypertension but now also summarise the risks of arterial thromboembolic events (ATEs) associated with these agents. Of the newer TKIs,...
Source: Drug Safety - May 26, 2015 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study From Ethiopia
Conclusions ADRs were common within the first 3 months in patients initiated on ART. Severe ADRs were negatively associated with self-reported adherence and gain in BMI. Measures need to be implemented to routinely monitor for severe ADRs to improve ART adherence and treatment outcomes. (Source: Drug Safety)
Source: Drug Safety - May 26, 2015 Category: Drugs & Pharmacology Source Type: research

Atypical Antipsychotics and the Risk of Hyperlipidemia: A Sequence Symmetry Analysis
Conclusions Among the AAPs used in Japan, only olanzapine was found to have an elevated risk of hyperlipidemia. In contrast, risperidone, perospirone hydrochloride hydrate, blonanserin, quetiapine fumarate, and aripiprazole had relatively low risks. (Source: Drug Safety)
Source: Drug Safety - May 23, 2015 Category: Drugs & Pharmacology Source Type: research

PCSK9 Inhibitors and Neurocognitive Adverse Events: Exploring the FDA Directive and a Proposal for N -of-1 Trials
Abstract Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors are a novel class of medications that greatly lower low-density lipoprotein cholesterol (LDL-C) by upregulating LDL receptor availability. In early 2014, the US Food and Drug Administration (FDA) directed developers of PCSK9 inhibitors to monitor neurocognitive adverse effects and consider neurocognitive testing in at least a subset of participants in ongoing late-stage trials. Available trial evidence indicates that neurocognitive adverse events may occur more commonly in individuals receiving an antibody to PCSK9, but these events are unco...
Source: Drug Safety - May 20, 2015 Category: Drugs & Pharmacology Source Type: research

Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications
Conclusions Using an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications. (Source: Drug Safety)
Source: Drug Safety - May 13, 2015 Category: Drugs & Pharmacology Source Type: research

Harmonizing Post-Market Surveillance of Prescription Drug Misuse: A Systematic Review of Observational Studies Using Routinely Collected Data (2000–2013)
Conclusions Routine data collections are relatively consistent across jurisdictions. Despite the heterogeneity of the current literature, our review identifies the capacity to develop universally accepted metrics of misuse applied to a core set of variables in prescription/dispensing claims. Our timely recommendations have the potential to unify the global research field and increase the capacity for routine surveillance of prescription drug misuse. (Source: Drug Safety)
Source: Drug Safety - May 13, 2015 Category: Drugs & Pharmacology Source Type: research

Is the Yellow Card Road Going in the Right Direction?
(Source: Drug Safety)
Source: Drug Safety - May 7, 2015 Category: Drugs & Pharmacology Source Type: research

Incorporating Linked Healthcare Claims to Improve Confounding Control in a Study of In-Hospital Medication Use
Conclusions Despite more than 98 % missingness on 24 variables, PS calibration and multiple imputation incorporated confounders from healthcare claims without major increases in estimate uncertainty. Additional research is needed to determine the relative bias of these methods. (Source: Drug Safety)
Source: Drug Safety - May 3, 2015 Category: Drugs & Pharmacology Source Type: research

Oral Anticoagulants and Risk of Nephropathy
This article reviews the current evidence for anticoagulant-related nephropathy and provides data for the suggested possible mechanisms underlying this adverse effect. (Source: Drug Safety)
Source: Drug Safety - April 26, 2015 Category: Drugs & Pharmacology Source Type: research

Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases
Conclusions In designing signal detection systems, careful consideration should be given to the criteria that are used to define an SDR. The choice of disproportionality statistic does not appreciably affect the achievable range of signal detection performance and so this can primarily be based on ease of implementation, interpretation and minimisation of computing resources. The changes in sensitivity and precision obtainable by replacing one algorithm with another are predictable. However, the absolute performance of a method is specific to the database and is best assessed directly on that database. New method...
Source: Drug Safety - April 22, 2015 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Renal Damage in Preterm Neonates: State of the Art and Methods for Early Detection
Abstract Only a small fraction of drugs widely used in neonatal intensive care units (NICU) are specifically authorized for this population. Even if unlicensed or off-label use is necessary, it is associated with increased adverse drug reactions, which must be carefully weighed against expected benefits. In particular, renal damage is frequent among preterm babies, and is considered a predisposing factor for the development of chronic kidney disease in adulthood. Apart from specific conditions affecting premature neonates (e.g. respiratory distress syndrome, perinatal asphyxia), drugs play an important role in imp...
Source: Drug Safety - April 12, 2015 Category: Drugs & Pharmacology Source Type: research

Topical Corticosteroid-Induced Skin Atrophy: A Comprehensive Review
This study aims to review clinical data on skin atrophy induced by TCs. Searches of the PubMed, EMBASE, and Cochrane (Central) databases from 1965 to May 2013 were undertaken using the keywords ‘corticosteroid’, ‘skin’, and ‘atrophy’. Skin and epidermal thickness values were retrieved from trials on healthy skin, and studies including skin atrophy as a safety endpoint in trials testing the efficacy of TCs were analyzed. Overall, 60 articles were retrieved. Whole skin and epidermal thickness were relevant parameters to measure early skin atrophy on healthy skin before it becomes clinicall...
Source: Drug Safety - April 11, 2015 Category: Drugs & Pharmacology Source Type: research

Chimeric Fusion Proteins Used for Therapy: Indications, Mechanisms, and Safety
Abstract Chimeric fusion proteins, produced by genetic engineering, are currently made up of effector peptides, for example, a ligand-binding portion of a cytokine or growth factor, extracellular domains of lymphocyte antigens, or a toxin linked to a suitable fusion partner. This review covers eight fusion proteins that have received regulatory approval for human therapy: etanercept, belatacept, abatacept, alefacept, rilonacept, romiplostim, aflibercept, and denileukin-diftitox. Important requirements for an effective fusion protein are effective targeting and binding, cytotoxicity, and a stable molecule with an e...
Source: Drug Safety - April 2, 2015 Category: Drugs & Pharmacology Source Type: research

The Monitoring Medicines Project: A Multinational Pharmacovigilance and Public Health Project
The objectives were to support and strengthen consumer reporting of adverse drug reactions (ADRs); expand the role and scope of national pharmacovigilance centres concerning medication errors; promote improved use of pharmacovigilance data; and develop methods to complement spontaneous reporting. The work was organised into four themes: patient reporting; medication errors; drug dependence, counterfeit and substandard medicines and clinical risk estimation; and active and targeted spontaneous pharmacovigilance. MM differed from some other major pharmacovigilance initiatives by having participants from developing countries ...
Source: Drug Safety - March 31, 2015 Category: Drugs & Pharmacology Source Type: research

Risks and Benefits of Triple Oral Anti-Thrombotic Therapies After Acute Coronary Syndromes and Percutaneous Coronary Intervention
Abstract The key pathophysiological process underlying symptomatic coronary artery disease, including acute coronary syndromes (ACS), is usually a rupture or an erosion of an atherosclerotic plaque, followed by platelet activation and subsequent thrombus formation. Early clinical trials showed benefit with long-term aspirin treatment, and later—based on large clinical trials—dual anti-platelet therapy (DAPT), initially with clopidogrel, and more recently with prasugrel or ticagrelor, has become the established treatment in the post-ACS setting and after percutaneous coronary intervention (PCI). Treatme...
Source: Drug Safety - March 31, 2015 Category: Drugs & Pharmacology Source Type: research

Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies
Abstract Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Included studies assessed the number of patients who were admitted to hospital due to an ADR, studies that assessed the number of patients who developed an ADR during hospitalization, and studies that measured ADRs in the outpatient setting. In total, 47 articles were included in the final review. T...
Source: Drug Safety - March 31, 2015 Category: Drugs & Pharmacology Source Type: research

Organ-On-A-Chip: Development and Clinical Prospects Toward Toxicity Assessment with an Emphasis on Bone Marrow
Abstract Conventional approaches for toxicity evaluation of drugs and chemicals, such as animal tests, can be impractical due to the large experimental scale and the immunological differences between species. Organ-on-a-chip models have recently been recognized as a prominent alternative to conventional toxicity tests aiming to simulate the human in vivo physiology. This review focuses on the organ-on-a-chip applications for high-throughput screening of candidate drugs against toxicity, with a particular emphasis on bone-marrow-on-a-chip. Studies in which organ-on-a-chip models have been developed and utilized to ...
Source: Drug Safety - March 29, 2015 Category: Drugs & Pharmacology Source Type: research

Safety and Effectiveness of Highly Active Antiretroviral Therapy in Treatment-Naïve HIV Patients: Preliminary Findings of a Cohort Event Monitoring Study in Belarus
Conclusion CEM is an effective tool for safety and effectiveness monitoring and could be successfully implemented for intensive study of important safety issues and for overcoming knowledge gaps regarding safety. In order to achieve a favorable benefit–risk ratio for HAART in the specific sections of the population with pre-existing risk factors for development of ART toxicities, more vigilant consideration and careful assessment before therapy is commenced and further regular monitoring of key laboratory parameters is required. (Source: Drug Safety)
Source: Drug Safety - March 26, 2015 Category: Drugs & Pharmacology Source Type: research

Comparative Safety and Tolerability of Endothelin Receptor Antagonists in Pulmonary Arterial Hypertension
Abstract Pulmonary arterial hypertension (PAH) is a condition that leads to progressive right heart failure and death unless recognized and treated early. Endothelin, a potent endogenous vasoconstrictor, has been identified as an important mediator of PAH. Endothelin receptor antagonists (ERAs) have been associated with an improvement in exercise capacity and time to clinical worsening in patients with Group 1 PAH, and three different ERAs are currently approved for use in this population: bosentan, ambrisentan, and macitentan. While all three ERAs are generally well-tolerated, they each have important adverse eff...
Source: Drug Safety - March 19, 2015 Category: Drugs & Pharmacology Source Type: research

Relationship Between Structural Alerts in NSAIDs and Idiosyncratic Hepatotoxicity: An Analysis of Spontaneous Report Data from the WHO Database
Conclusions This study shows that although spontaneous reports have many limitations, the findings are in line with previous research on the reactive metabolite concept. Whether SAs and the number of SAs in the NSAIDs actually play a role in the observed hepatotoxicity must be investigated in future studies. (Source: Drug Safety)
Source: Drug Safety - March 19, 2015 Category: Drugs & Pharmacology Source Type: research

Addressing Limitations in Observational Studies of the Association Between Glucose-Lowering Medications and All-Cause Mortality: A Review
We described these methodological issues and their potential impact on observed associations, providing examples from the reviewed literature, and suggested possible approaches to manage these methodological challenges. We evaluated 67 publications of observational studies evaluating the association between glucose-lowering treatments and all-cause mortality. The identified methodological challenges included trade-offs associated with the outcome of all-cause mortality, incorrect temporal sequencing in administrative databases, inadequate treatment of time-varying hazards and treatment duration effects, unclear definition ...
Source: Drug Safety - March 12, 2015 Category: Drugs & Pharmacology Source Type: research

Computational Approaches for Pharmacovigilance Signal Detection: Toward Integrated and Semantically-Enriched Frameworks
Abstract Computational signal detection constitutes a key element of postmarketing drug monitoring and surveillance. Diverse data sources are considered within the ‘search space’ of pharmacovigilance scientists, and respective data analysis methods are employed, all with their qualities and shortcomings, towards more timely and accurate signal detection. Recent systematic comparative studies highlighted not only event-based and data-source-based differential performance across methods but also their complementarity. These findings reinforce the arguments for exploiting all possible information sources ...
Source: Drug Safety - March 8, 2015 Category: Drugs & Pharmacology Source Type: research

Targeted Spontaneous Reporting of Suspected Renal Toxicity in Patients Undergoing Highly Active Anti-Retroviral Therapy in Two Public Health Facilities in Uganda
Conclusion Although the occurrence of suspected tenofovir renal toxicity of HIV patients is low, there is need to monitor those at risk so as to prevent irreversible kidney injury. TSR can complement spontaneous reporting for collecting safety data on particular drugs and increase ADR reporting rates. (Source: Drug Safety)
Source: Drug Safety - March 7, 2015 Category: Drugs & Pharmacology Source Type: research

Initiatives to Identify and Mitigate Medication Errors in England
This article describes the initiative, the structure of which may act as a template for other countries. (Source: Drug Safety)
Source: Drug Safety - March 4, 2015 Category: Drugs & Pharmacology Source Type: research

User-Driven Development of a Web-Based Tool for Patient Reporting of Drug-Related Harm
Abstract Commissioned by the Monitoring Medicines project, the Uppsala Monitoring Centre (UMC) led the design and development of a web-based ADR (adverse drug reaction) reporting tool intended for use by patients. The software design was undertaken in close collaboration with representatives of national pharmacovigilance centres (NPCs) and with patient and consumer organizations. The web-based tool was developed by these participants through several telephone conferences, a workshop and site testing. The tool is directly compatible with the UMC’s Individual Case Safety Report (ICSR) data management system Vi...
Source: Drug Safety - February 25, 2015 Category: Drugs & Pharmacology Source Type: research

Evaluation of an Automated Surveillance System Using Trigger Alerts to Prevent Adverse Drug Events in the Intensive Care Unit and General Ward
Conclusions The number and type of clinically significant alerts were similar irrespective of patient population, suggesting that the alerts may be equally as beneficial in the ICU population, despite the challenges in drug-related event adjudication. An opportunity exists to improve the performance of alerts in both settings, so quality improvement programs for measuring alert performance and making refinements is needed. (Source: Drug Safety)
Source: Drug Safety - February 25, 2015 Category: Drugs & Pharmacology Source Type: research

Comparative Safety and Tolerability of Anti-VEGF Therapy in Age-Related Macular Degeneration
Abstract Neovascular age-related macular degeneration (NVAMD) is one of the leading causes of blindness. Over the last decade, the treatment of NVAMD has been revolutionized by the development of intravitreal anti-vascular endothelial growth factor (VEGF) therapies. Several anti-VEGF medications are used for the treatment of NVAMD. The safety and tolerability of these medications deserve review given the high prevalence of NVAMD and the significant utilization of these medications. Numerous large randomized clinical trials have not shown any definitive differential safety relative to ocular or systemic safety of t...
Source: Drug Safety - February 21, 2015 Category: Drugs & Pharmacology Source Type: research

Empowering Consumers as Contributors for Health Product Safety: Lessons from the Philippines
Abstract Empowering consumers to contribute to adverse drug reaction reporting seems a sensible innovation, particularly when traditional reports emanating from healthcare professionals are neither increasing nor improving. This work, inspired by an EU-FP7-funded project, describes an attempt by the Philippines to introduce a consumer reporting system through education and an online platform for reporting, and the lessons that were captured in the process. While participating consumers did not contribute to the adverse drug reporting process in the traditional sense as originally expected, the reports received by ...
Source: Drug Safety - February 19, 2015 Category: Drugs & Pharmacology Source Type: research

Neurodevelopmental Effects of Fetal Antiepileptic Drug Exposure
Abstract Many studies investigating cognitive outcomes in children of women with epilepsy report an increased risk of mental impairment. Verbal scores on neuropsychometric measures may be selectively more involved. While a variety of factors contribute to the cognitive problems of children of women with epilepsy, antiepileptic drugs (AEDs) appear to play a major role. The mechanisms by which AEDs affect neurodevelopmental outcomes remain poorly defined. Animal models suggest that AED-induced apoptosis, altered neurotransmitter environment, and impaired synaptogenesis are some of the mechanisms responsible for cogn...
Source: Drug Safety - February 19, 2015 Category: Drugs & Pharmacology Source Type: research

Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites
Conclusion While application of the algorithm to VigiBase allowed identification of some substandard medicines, some key prerequisites have been identified that need to be fulfilled at the national level for the algorithm to be useful in practice. Such key factors are fast handling and transfer of incoming reports into VigiBase, detailed information on the product and its distribution channels, the possibility of contacting primary reporters for further information, availability of samples of suspected products and laboratory capacity to analyse suspected products. (Source: Drug Safety)
Source: Drug Safety - February 17, 2015 Category: Drugs & Pharmacology Source Type: research

Drug Safety Meta-Analysis: Promises and Pitfalls
Abstract Meta-analysis has increasingly been used to identify adverse effects of drugs and vaccines, but the results have often been controversial. In one respect, meta-analysis is an especially appropriate tool in these settings. Efficacy studies are often too small to reliably assess risks that become important when a medication is in widespread use, so meta-analysis, which is a statistically efficient way to pool evidence from similar studies, seems like a natural approach. But, as the examples in this paper illustrate, different syntheses can come to qualitatively different conclusions, and the results of ...
Source: Drug Safety - February 17, 2015 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability Profile of Second-Line Anti-Tuberculosis Medications
Abstract Tuberculosis (TB) remains a major public health problem, representing the second leading cause of death from infectious diseases globally, despite being nearly 100 % curable. Multidrug-resistant (MDR)-TB, a form of TB resistant to isoniazid and rifampicin (rifampin), two of the key first-line TB drugs, is becoming increasingly common. MDR-TB is treated with a combination of drugs that are less effective but more toxic than isoniazid and rifampicin. These drugs include fluoroquinolones, aminoglycosides, ethionamide, cycloserine, aminosalicyclic acid, linezolid and clofazimine among others. Minor adver...
Source: Drug Safety - February 13, 2015 Category: Drugs & Pharmacology Source Type: research

Pediatric Drug Safety Signal Detection: A New Drug–Event Reference Set for Performance Testing of Data-Mining Methods and Systems
Conclusion We propose a drug–event reference set that can be used to compare different signal detection methods in the pediatric population. (Source: Drug Safety)
Source: Drug Safety - February 8, 2015 Category: Drugs & Pharmacology Source Type: research

Benefit–Risk Assessment of Diacerein in the Treatment of Osteoarthritis
Abstract Osteoarthritis (OA) is the leading musculoskeletal cause of disability. Despite this, there is no consensus on the precise definition of OA and what is the best treatment to improve symptoms and slow disease progression. Current pharmacological treatments include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX) inhibitors. None of those treatments are disease-modifying agents that target the core pathological processes in OA. Diacerein, a semi-synthetic anthraquinone derivative, inhibits the interleukin-1-beta (IL-1β) cytokine which, according to animal studies, pla...
Source: Drug Safety - February 5, 2015 Category: Drugs & Pharmacology Source Type: research

Safety Surveillance of Traditional Chinese Medicine: Current and Future
This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed. (Source: Drug Safety)
Source: Drug Safety - February 3, 2015 Category: Drugs & Pharmacology Source Type: research

ADR Reporting by the General Public: Lessons Learnt from the Dutch and Swedish Systems
Abstract Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the s...
Source: Drug Safety - January 28, 2015 Category: Drugs & Pharmacology Source Type: research

Cancer Chemotherapy and Cardiac Arrhythmias: A Review
Abstract Cardiovascular toxicity is a potential complication of cancer chemotherapy (CC) that increases the morbidity and mortality of cancer patients. Cardiac arrhythmias have been reported as an adverse effect of many chemotherapeutic drugs, including novel targeted therapies. The relationship between chemotherapy and arrhythmias has not been well-established and the proarrhythmogenic mechanisms remain uncertain as they can be the result of a direct electrophysiological effect or of changes in cardiac structure and function, including myocardial ischaemia and heart failure, which create an arrhythmogenic substra...
Source: Drug Safety - January 11, 2015 Category: Drugs & Pharmacology Source Type: research

Risk of Anaphylaxis with Repeated Courses of Rasburicase: A Research on Adverse Drug Events and Reports (RADAR) Project
Abstract Background Rasburicase, a recombinant urate oxidase, is used to rapidly metabolize uric acid in patients with hyperuricaemia. Rasburicase is an immunogenic therapeutic protein, which has been shown to elicit antibody response in 64 % of healthy volunteers within 1–6 weeks after the initial course, with persistent antibodies for over 1 year. Drug labelling indicates that anaphylaxis rarely occurs (in
Source: Drug Safety - January 8, 2015 Category: Drugs & Pharmacology Source Type: research

Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance
Abstract The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for ‘real-world’ post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to s...
Source: Drug Safety - January 6, 2015 Category: Drugs & Pharmacology Source Type: research

Treating Severe Malaria in Pregnancy: A Review of the Evidence
Abstract Severe malaria in pregnancy is a large contributor to maternal morbidity and mortality. Intravenous quinine has traditionally been the treatment drug of choice for severe malaria in pregnancy. However, recent randomized clinical trials (RCTs) indicate that intravenous artesunate is more efficacious for treating severe malaria, resulting in changes to the World Health Organization (WHO) treatment guidelines. Artemisinins, including artesunate, are embryo-lethal in animal studies and there is limited experience with their use in the first trimester. This review summarizes the current literature supporting 2...
Source: Drug Safety - January 4, 2015 Category: Drugs & Pharmacology Source Type: research

Consensus Recommendations for Systematic Evaluation of Drug–Drug Interaction Evidence for Clinical Decision Support
Conclusion Evidence-based decision support for DDIs requires consistent application of transparent and systematic methods to evaluate the evidence. Drug compendia and clinical decision support systems in which these recommendations are implemented should be able to provide higher-quality information about DDIs. (Source: Drug Safety)
Source: Drug Safety - January 3, 2015 Category: Drugs & Pharmacology Source Type: research

Safety Considerations with Pharmacological Treatment of Gestational Diabetes Mellitus
Abstract The number of women with gestational diabetes mellitus (GDM: diabetes first diagnosed in pregnancy) continues to grow, as do the associated risks of antenatal and postnatal complications and the chance of future diabetes and obesity in both mother and offspring. Recent randomised controlled trials have demonstrated clear benefits for intensive management of GDM using lifestyle modification, self blood glucose monitoring, close clinical supervision and, where glycaemia remains inadequately controlled, insulin therapy. More recently, metformin and glibenclamide have been shown to adequately reduce hyperglyc...
Source: Drug Safety - December 26, 2014 Category: Drugs & Pharmacology Source Type: research

Structured Assessment for Prospective Identification of Safety Signals in Electronic Medical Records: Evaluation in the Health Improvement Network
Conclusions Exploratory analysis of electronic medical records can detect important potential safety signals. However, effective signal detection requires that statistical signal detection be combined with clinical and epidemiological review to achieve an acceptable false positive rate. (Source: Drug Safety)
Source: Drug Safety - December 25, 2014 Category: Drugs & Pharmacology Source Type: research

The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges
Abstract On 19 February 2014, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced the formation of a cluster on pharmacovigilance topics. The cluster is designed to complement, and not replace, other international activities in this field. It builds upon years of interactions between the two agencies. The creation of the cluster formalizes this longstanding and productive relationship and facilitates more systematic exchange of information and expertise. (Source: Drug Safety)
Source: Drug Safety - December 25, 2014 Category: Drugs & Pharmacology Source Type: research

Effect of An Educational Intervention to Improve Adverse Drug Reaction Reporting in Physicians: A Cluster Randomized Controlled Trial
Conclusions Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas. A high baseline notification rate could account for the educational program having a moderate effect. (Source: Drug Safety)
Source: Drug Safety - December 25, 2014 Category: Drugs & Pharmacology Source Type: research

Assessment of a New Instrument for Detecting Preventable Adverse Drug Reactions
Conclusion The analysis of the agreements and disagreements between reviewers highlighted where improvements might be made. Given that no standard assessment tool exists in the WHO Programme, the transparency of the assessment process in this method provides a substantial basis for further development and for support in signalling possible preventability. (Source: Drug Safety)
Source: Drug Safety - December 24, 2014 Category: Drugs & Pharmacology Source Type: research

Causal Assessment of Pharmaceutical Treatments: Why Standards of Evidence Should not be the Same for Benefits and Harms?
This study illustrates the tension between implicit epistemologies adopted in evaluating evidence and causality; furthermore, it also shows that discounting causal evidence may be a result of unacknowledged low priors or lack of valid alternative options. We conclude with a presentation of the changing landscape in pharmacology and the trend towards an increased use of Bayesian tools for assessment of harms. (Source: Drug Safety)
Source: Drug Safety - December 18, 2014 Category: Drugs & Pharmacology Source Type: research

Authors’ Reply to Hennessy and Leonard’s Comment on “Desideratum for Evidence-Based Epidemiology”
(Source: Drug Safety)
Source: Drug Safety - December 16, 2014 Category: Drugs & Pharmacology Source Type: research

Comment on: “Desideratum for Evidence-Based Epidemiology”
(Source: Drug Safety)
Source: Drug Safety - December 16, 2014 Category: Drugs & Pharmacology Source Type: research