A Multi-hospital Before –After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors
AbstractIntroductionWe previously found a high rate of errors in the administration of intravenous medications using smart infusion pumps.Objectives/DesignAn infusion safety intervention bundle was developed in response to the high rate of identified errors. A before –after observational study with a prospective point-prevalence approach was conducted in nine hospitals to measure the preliminary effects of the intervention.Main Outcome MeasuresPrimary outcome measures were overall errors and medication errors, with the secondary outcome defined as potentially harmful error rates.ResultsWe assessed a total of 418 pati...
Source: Drug Safety - February 6, 2018 Category: Drugs & Pharmacology Source Type: research

Potential Risks Related to Modulating Interleukin-13 and Interleukin-4 Signalling: A Systematic Review
ConclusionsAlthough our findings are reassuring, long-term safety assessments of biologics that target the interleukin-13/interleukin-4 pathways currently in clinical development are needed. (Source: Drug Safety)
Source: Drug Safety - February 6, 2018 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Ototoxicity: Diagnosis and Monitoring
AbstractOtotoxicity diagnosis and management has historically been approached using a variety of methods. However, in recent years a consensus on useful and practical approaches has been developed through clinical guidelines of the American Speech Language Hearing Association, the American Academy of Audiology, and multiple clinical trials published in peer-reviewed literature. Some of the guidelines and approaches are used to detect and monitor ototoxicity, while others are used to grade adverse events. Some of the audiologic measures are primary, while others are adjunct measures and may be tailored to the specific needs...
Source: Drug Safety - February 6, 2018 Category: Drugs & Pharmacology Source Type: research

The Uncertainty of the Association Between Proton Pump Inhibitor Use and the Risk of Dementia: Prescription Sequence Symmetry Analysis Using a Korean Healthcare Database Between 2002 and 2013
In this study, we applied the 3-year time window. So the patients who initiated PPIs 3 years before or after their first diagnosis of dementia were included. The pairs with the time window
Source: Drug Safety - February 3, 2018 Category: Drugs & Pharmacology Source Type: research

Gastrointestinal Perforations with Biologics in Patients with Rheumatoid Arthritis: Implications for Clinicians
AbstractGastrointestinal (GI) perforations are rare events in rheumatoid arthritis (RA) patients, but cause significant morbidity and mortality. Several studies indicate that RA patients may be at higher risk of GI perforation. Traditional RA treatments such as glucocorticoids and non-steroidal anti-inflammatory drugs increase the risk of perforation. In the past two decades, a new class of therapeutic agents called biologics has been added to the RA treatment armamentarium. Biologics are effective in controlling disease activity and are generally well tolerated; however, reports of GI perforations in association with biol...
Source: Drug Safety - February 1, 2018 Category: Drugs & Pharmacology Source Type: research

Long-Acting β2-Agonists in Asthma: Enantioselective Safety Studies are Needed
AbstractLong-acting β2-agonists (LABAs) such as formoterol and salmeterol are used for prolonged bronchodilatation in asthma, usually in combination with inhaled corticosteroids (ICSs). Unexplained paradoxical asthma exacerbations and deaths have been associated with LABAs, particularly when used without ICS. LABAs cl early demonstrate effective bronchodilatation and steroid-sparing activity, but long-term treatment can lead to tolerance of their bronchodilator effects. There are also concerns with regard to the effects of LABAs on bronchial hyperresponsiveness (BHR), where long-term use is associated with increa sed ...
Source: Drug Safety - January 13, 2018 Category: Drugs & Pharmacology Source Type: research

Evidence-Based Recommendations to Improve the Safe Use of Drugs in Patients with Liver Cirrhosis
ConclusionsOver 200 recommendations were developed for the safe use of drugs in patients with liver cirrhosis. Implementing these recommendations into clinical practice can possibly enhance medication safety in this vulnerable patient group. (Source: Drug Safety)
Source: Drug Safety - January 12, 2018 Category: Drugs & Pharmacology Source Type: research

Case Series Analysis of New Zealand Reports of Rapid Intense Potentiation of Warfarin by Roxithromycin
ConclusionIn this case series, the high prevalence of acute polypharmacy, including potentially interacting medicines, and serious infection suggests that they may have contributed to warfarin potentiation and increased the clinical significance of a roxithromycin/warfarin interaction. (Source: Drug Safety)
Source: Drug Safety - January 12, 2018 Category: Drugs & Pharmacology Source Type: research

Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database
ConclusionSCCS shows promise for signal detection: it may highlight known associations for recent marketed products and has potential for early signal identification. SCCS performance varied by design choice and the nature of both exposure and event pair. Future work is needed to determine how effective the approach is in prospective testing and determining the performance characteristics of the approach. (Source: Drug Safety)
Source: Drug Safety - January 11, 2018 Category: Drugs & Pharmacology Source Type: research

The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review
ConclusionsTreatment with biologic or tofacitinib appears to be well-tolerated with respect to CV outcomes in these patients. (Source: Drug Safety)
Source: Drug Safety - January 9, 2018 Category: Drugs & Pharmacology Source Type: research

A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials
AbstractPediatric psychotropic prescription rates are rising, emphasizing the need for careful monitoring of drug safety in this population. Currently, no standardized assessments are used in clinical trials for adverse event (AE) elicitation focused on long-term drug treatment in pediatric patients. Despite a lack of standardized AE elicitation methods in psychiatric clinical trials, it is clear that psychiatric medications have developmentally dependent AEs that differ from those observed in adults. In this review, we discuss the use of general inquiry elicitation, drug-specific checklists, and systematic elicitation sca...
Source: Drug Safety - January 9, 2018 Category: Drugs & Pharmacology Source Type: research

The Safety of Generic Prescription Drugs in the United States
(Source: Drug Safety)
Source: Drug Safety - January 8, 2018 Category: Drugs & Pharmacology Source Type: research

Setting Standards for Pregnancy Registries
(Source: Drug Safety)
Source: Drug Safety - December 28, 2017 Category: Drugs & Pharmacology Source Type: research

Safety of Human Papillomavirus Vaccines: An Updated Review
AbstractHuman papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and a...
Source: Drug Safety - December 26, 2017 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP ® : A Comparison with Classical Methods of Reporting
ConclusionOur study shows that a mobile app is an additional tool used in pharmacovigilance. Types of reporters and adverse drug reactions in VigiBIP were different to those seen in classical methods of reporting. (Source: Drug Safety)
Source: Drug Safety - December 21, 2017 Category: Drugs & Pharmacology Source Type: research

Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study
ConclusionBeta-blocker use in the first trimester of pregnancy was not found to be associated with a higher risk of specific congenital anomalies in the offspring, but a new signal between alpha- and beta-blockers and multi-cystic renal dysplasia was found. Future large epidemiological studies are needed to confirm or refute our findings. (Source: Drug Safety)
Source: Drug Safety - December 11, 2017 Category: Drugs & Pharmacology Source Type: research

The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products
ConclusionsThe RIMES statement augments relevant elements from existing quality reporting guidelines with items that address aspects of intervention design, implementation and evaluation specific to pharmaceutical risk minimization programs. Our results show that the RIMES statement reliably measures key dimensions of reporting quality. This tailored checklist is an important first step in improving the reporting quality of risk minimization evaluation studies and may ultimately help to improve the quality of these interventions themselves. (Source: Drug Safety)
Source: Drug Safety - December 7, 2017 Category: Drugs & Pharmacology Source Type: research

Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate
AbstractDelayed-release dimethyl fumarate is an oral disease-modifying therapy that has demonstrated significant efficacy in adults with relapsing –remitting multiple sclerosis. Incidences of flushing and gastrointestinal adverse events are common in the first month after delayed-release dimethyl fumarate initiation. Our objective was to propose mitigation strategies for adverse events related to initiation of delayed-release dimethyl fumara te in the treatment of patients with multiple sclerosis. Studies of individually developed mitigation strategies and chart reviews were evaluated. Those results, as well as mitig...
Source: Drug Safety - December 7, 2017 Category: Drugs & Pharmacology Source Type: research

Cardiovascular Profile of Valbenazine: Analysis of Pooled Data from Three Randomized, Double-Blind, Placebo-Controlled Trials
ConclusionsResults from double-blind, placebo-controlled trials showed no apparent difference between valbenazine and placebo on cardiovascular outcomes. No additional cardiovascular risk was detected during a longer extension study with valbenazine. (Source: Drug Safety)
Source: Drug Safety - December 7, 2017 Category: Drugs & Pharmacology Source Type: research

Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs
This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data.MethodsSelected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For t...
Source: Drug Safety - December 2, 2017 Category: Drugs & Pharmacology Source Type: research

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors
ConclusionsOur safety review of postmarketing FAERS reports associated with three FDA-approved JAK inhibitors did not find elevated reporting rates for DVT and PE specifically. However, the FAERS data indicated that pulmonary thrombosis may potentially be a class-wide issue for JAK inhibitors. Portal vein thrombosis may also be a potential risk for ruxolitinib. While these FAERS data add to a growing body of evidence that JAK inhibitors may be contraindicated in patients at risk of thromboembolic events, the data need to be confirmed by future AE reporting trends, analysis of electronic health records, and/or future clinic...
Source: Drug Safety - December 2, 2017 Category: Drugs & Pharmacology Source Type: research

Using Human ‘Experiments of Nature’ to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors
ConclusionThis novel methodology provides an opportunity to put in place new mechanisms to assess the safety and long-term tolerability of PCSK9 inhibitors specifically, and other new agents in general, as they move into human testing and expanded clinical use. (Source: Drug Safety)
Source: Drug Safety - November 28, 2017 Category: Drugs & Pharmacology Source Type: research

An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study
ConclusionThe developed system seems promising for the routine use of healthcare data for safety surveillance of drugs used in chronic diseases. (Source: Drug Safety)
Source: Drug Safety - November 28, 2017 Category: Drugs & Pharmacology Source Type: research

Comment on: “Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals”
(Source: Drug Safety)
Source: Drug Safety - November 15, 2017 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Mona Kargar and Colleagues’ Comment on “Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals”
(Source: Drug Safety)
Source: Drug Safety - November 13, 2017 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - November 11, 2017 Category: Drugs & Pharmacology Source Type: research

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs
ConclusionsThree important gaps in the evaluation plans of RMMs were identified: lack of early feedback on implementation, limited evaluation of safety outcomes, and inability to provide information on the effectiveness from an integrated measurement of different elements of a set of risk minimization tools. More robust evidence is needed to advance regulatory science and support more rapid adjustment of risk minimization strategies as needed. (Source: Drug Safety)
Source: Drug Safety - November 9, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of ‘Definite’ Anaphylaxis Drug Allergy Alert Overrides in Inpatient and Outpatient Settings
ConclusionsOverrides of ‘definite’ anaphylaxis DAI alerts were common and often appropriate. Most overrides were due to desensitizations. Allergy reconciliation for patients could further improve critical decision support. (Source: Drug Safety)
Source: Drug Safety - November 9, 2017 Category: Drugs & Pharmacology Source Type: research

Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
Correction to: Drug Saf DOI 10.1007/s40264-017-0569-3. (Source: Drug Safety)
Source: Drug Safety - November 7, 2017 Category: Drugs & Pharmacology Source Type: research

Risk of Psoriasis Following Terbinafine or Itraconazole Treatment for Onychomycosis: A Population-Based Case-Control Comparative Study
ConclusionThis large population-based case-control analysis showed that exposure to terbinafine or itraconazole is associated with an increased risk of incident psoriasis. The finding of an increased psoriasis risk for antifungal drug users, particularly for itraconazole, deserves attention in clinical practice although further prospective studies are necessary to confirm our findings and clarify the biological mechanisms that underlie these associations. (Source: Drug Safety)
Source: Drug Safety - November 6, 2017 Category: Drugs & Pharmacology Source Type: research

Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System
ConclusionsThis study examined the AEs most commonly associated with varying classes of painkillers by mining the FAERS database. Our results and methods are relevant for future secondary analyses of big data and for understanding adverse outcomes related to painkillers. (Source: Drug Safety)
Source: Drug Safety - November 2, 2017 Category: Drugs & Pharmacology Source Type: research

Correction to: Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
The following disclaimer was missing from the article. (Source: Drug Safety)
Source: Drug Safety - October 28, 2017 Category: Drugs & Pharmacology Source Type: research

Neuropsychiatric Events Associated with Leukotriene-Modifying Agents: A Systematic Review
ConclusionMany pharmacovigilance studies have been conducted to determine the association between NEs and LTMAs, but there is limited evidence from observational studies. High-quality epidemiological studies should be conducted to evaluate the association and quantify the risk, not only in children, but also in adults. (Source: Drug Safety)
Source: Drug Safety - October 26, 2017 Category: Drugs & Pharmacology Source Type: research

Severe Physical Complications among Survivors of Stevens –Johnson Syndrome and Toxic Epidermal Necrolysis
ConclusionSurvivors of SJS/TEN suffer from severe physical complications impacting their health and lives that are mostly under recognized and not sufficiently treated by medical professionals. (Source: Drug Safety)
Source: Drug Safety - October 19, 2017 Category: Drugs & Pharmacology Source Type: research

Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results
ConclusionsThe addition of bevacizumab to erlotinib prolonged progression-free survival inEGFR mutation-positive NSCLC. Follow-up safety data were consistent with the known safety profiles of both erlotinib and bevacizumab in NSCLC; this combination appeared to be manageable, and treatment was well tolerated.JapicCTI-111390. (Source: Drug Safety)
Source: Drug Safety - October 17, 2017 Category: Drugs & Pharmacology Source Type: research

Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study
ConclusionsThe data from the study adds to the existing safety database of Nasovac-S.RegistryClinical Trials Registry of India (CTRI/2015/08/006074). (Source: Drug Safety)
Source: Drug Safety - October 12, 2017 Category: Drugs & Pharmacology Source Type: research

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England
ConclusionThese results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile. (Source: Drug Safety)
Source: Drug Safety - October 10, 2017 Category: Drugs & Pharmacology Source Type: research

An Update on ISoP Special Interest Groups (SIGs)
(Source: Drug Safety)
Source: Drug Safety - October 4, 2017 Category: Drugs & Pharmacology Source Type: research

Overview of Pharmacovigilance System in Vietnam: Lessons Learned in a Resource-Restricted Country
AbstractDrug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of drugs in each nation is needed to identify and manage the exact drug-related problems faced by patients in these countries. Vietnam launched its university-based National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in 2009, a significant step towards catching up with international trends. Althoug...
Source: Drug Safety - October 3, 2017 Category: Drugs & Pharmacology Source Type: research

Preferences of Patients and Pharmacists with Regard to the Management of Drug –Drug Interactions: A Choice-Based Conjoint Analysis
ConclusionThe results showed diverging preferences regarding DDI management among both patients and pharmacists. Different groups attached different value to risk and benefit versus practical considerations. Awareness of existing variability in preferences among and between pharmacists and patients is a step towards shared decision making in DDI management. (Source: Drug Safety)
Source: Drug Safety - September 30, 2017 Category: Drugs & Pharmacology Source Type: research

All-Cause and Drug-Related Medical Events Associated with Overuse of Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a Commercially Insured US Population
ConclusionDespite modest effects of gabapentin overuse alone, overuse of gabapentin with opioids may increase risk of harm and health-service utilization, supporting calls to make gabapentin a controlled substance in the USA. (Source: Drug Safety)
Source: Drug Safety - September 27, 2017 Category: Drugs & Pharmacology Source Type: research

Can SGLT2 Inhibitors Cause Acute Renal Failure? Plausible Role for Altered Glomerular Hemodynamics and Medullary Hypoxia
AbstractSodium –glucose co-transporter-2 inhibitors (SGLT2i) provide outstanding long-term cardiovascular and renal protection in high-risk patients with type 2 diabetes mellitus. Yet, despite encouraging renal safety outcomes reported in the EMPA-REG study, scattered reports suggest that there might be a risk f or acute kidney injury (AKI), which may occasionally be fatal or might require renal replacement therapy. Reduced trans-glomerular pressure with a modest decline in kidney function, an inherent characteristic of SGLT2i therapy, conceivably forms the basis for the long-term renal protection, resembli ng agents...
Source: Drug Safety - September 26, 2017 Category: Drugs & Pharmacology Source Type: research

17th ISoP Annual Meeting “Pharmacovigilance in the 21st Century” Liverpool, UK 15–18 October, 2017
(Source: Drug Safety)
Source: Drug Safety - September 20, 2017 Category: Drugs & Pharmacology Source Type: research

Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre
ConclusionsSafety concerns described in patient reports can be identified in a global database including previously unknown ADRs as well as new aspects of known ADRs. Patient reports provide unique information valuable in signal assessment and should be included in signal detection. Novel approaches to highlighting patient reports in statistical signal detection can further improve the contribution of patient reports to pharmacovigilance. (Source: Drug Safety)
Source: Drug Safety - September 20, 2017 Category: Drugs & Pharmacology Source Type: research

Is Ribavirin Teratogenic in Humans? No Evidence So Far
(Source: Drug Safety)
Source: Drug Safety - September 14, 2017 Category: Drugs & Pharmacology Source Type: research

Use of Antihypertensive Drugs and Risk of Malignant Melanoma: A Meta-analysis of Observational Studies
ConclusionsCurrent evidence from observational studies suggests that use of diuretics or β-adrenergic blocking agents may be associated with increased risk of MM. Further large well-conducted prospective studies are required to confirm our findings. (Source: Drug Safety)
Source: Drug Safety - September 13, 2017 Category: Drugs & Pharmacology Source Type: research

Dopamine Agonists and Impulse Control Disorders: A Complex Association
AbstractImpulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The search terms were medical subject headings (MeSH) terms including “dopamine agonists” AND “disruptive disorders”, “impulse control disorders”, or “conduct disorders”. Articles had to fulfill the following criteria to be included: (i) the target problem wa...
Source: Drug Safety - August 31, 2017 Category: Drugs & Pharmacology Source Type: research

Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
(Source: Drug Safety)
Source: Drug Safety - August 30, 2017 Category: Drugs & Pharmacology Source Type: research

Drug-Induced QT Prolongation and Torsades de Pointes: An All-Exclusive Relationship or Time for an Amicable Separation?
AbstractQT prolongation was perceived as a major antiarrhythmic mechanism, but soon became a surrogate for torsades de pointes (TdP) instead. Drugs that prolong the QT interval range from having potent torsadogenic activity to no proarrhythmic action and even antiarrhythmic effects. Blockade of hERG channels is the  primary cause of TdP, but blockade/activation of other channels can also be torsadogenic. TdP is primarily caused by disturbances of TRIaD, but disturbance of wavelength can also contribute to TdP (where TRIaD is triangulation, reverse use dependence, instability and dispersion, and wavelength equ als cond...
Source: Drug Safety - August 29, 2017 Category: Drugs & Pharmacology Source Type: research

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer ’s Capture of Spontaneous Reports for Exposed Pregnancies
AbstractIntroductionPregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy.ObjectivesThe aim of this study was to evaluate postmarket capture of exposed pregnancies.MethodsPregnancy registries for drugs and biologics were identified in a systematic review. Through a standardized questionnaire, manufacturers provided information on (1) pregnancy registry enrollment and retention, and (2) worldwide receipt of spontaneous reports for exposed pregnancies. A validated algorithm for live-birth pregnancies allowed calculation of exposure rates per 100,000 live b...
Source: Drug Safety - August 24, 2017 Category: Drugs & Pharmacology Source Type: research