Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands
ConclusionPatient organizations can help enable effective communication of adverse drug reactions to a relevant audience. The social media post generated more engagement than other communications from the patient organization, indicating a strong interest in this information. The additional patient experiences that were shared in the comments on social media further strengthened the original signal and its relevance to patients, creating an interesting feedback loop. The favourable experiences in this study support further consideration and exploration of this approach to communicate adverse drug reactions to patients. (Source: Drug Safety)
Source: Drug Safety - May 16, 2020 Category: Drugs & Pharmacology Source Type: research

Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project
ConclusionWe warn the community about a potentially large discrepancy between the expected performance of automated AE recognition systems based on published results and the actual observed performance on independent data. This study highlights the difficulty of implementing an all-purpose system for automatic adverse event recognition in Twitter, which could explain the lack of such systems in practical pharmacovigilance settings. Our recommendation is to use benchmark independent datasets, such as the WEB-RADR reference, to investigate the transferability of the adverse event recognition systems and ultimately enforce ri...
Source: Drug Safety - May 14, 2020 Category: Drugs & Pharmacology Source Type: research

Pathophysiology of Drug-Induced Hypomagnesaemia
AbstractMagnesium (Mg2+) is the second most abundant intracellular and fourth extracellular cation found in the body and is involved in a wide range of functions in the human cell and human physiology. Its role in most of the enzyme processes (ATP-ases) —stabilisation of nucleic acids (DNA, RNA), regulation of calcium and potassium ion channels, proliferation, glucose metabolism and apoptosis—make it one of the most important cations in the cell. Three pathogenetic mechanisms are mainly implicated in the development of hypomagnesaemia: reduced food intake, decreased intestinal absorption and increased renal exc...
Source: Drug Safety - May 12, 2020 Category: Drugs & Pharmacology Source Type: research

Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions
ConclusionThe accuracy of signal detection using social media can be improved by combining signals with those from SRSs. However, the combined system cannot achieve better AUC performance than data from FAERS alone, which may indicate that Twitter data are not ready to be integrated into a purely data-driven combination system. (Source: Drug Safety)
Source: Drug Safety - May 8, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic
(Source: Drug Safety)
Source: Drug Safety - May 7, 2020 Category: Drugs & Pharmacology Source Type: research

Critical Assessment of Pharmacokinetic Drug –Drug Interaction Potential of Tofacitinib, Baricitinib and Upadacitinib, the Three Approved Janus Kinase Inhibitors for Rheumatoid Arthritis Treatment
AbstractThe introduction of novel, small-molecule Janus kinase inhibitors namely tofacitinib, baricitinib and upadacitinib has provided an alternative treatment option for patients with rheumatoid arthritis outside of traditional drugs and expensive biologics. This review aimed to critically assess the drug –drug interaction potential of tofacitinib, baricitinib and upadacitinib and provide a balanced perspective for choosing the most appropriate Janus kinase inhibitor based on the needs of patients with rheumatoid arthritis including co-medications and renal/hepatic impairment status. Based on the c ritical assessme...
Source: Drug Safety - May 4, 2020 Category: Drugs & Pharmacology Source Type: research

Effect of Bempedoic Acid on Serum Uric Acid and Related Outcomes: A Systematic Review and Meta-analysis of the available Phase 2 and Phase 3 Clinical Studies
AbstractIntroductionBempedoic acid (ETC-1002) is a first-in-class lipid-lowering agent recently approved by the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for commercialization.ObjectiveThe aim was to assess, through a systematic review of the literature and a meta-analysis of the available phase 2 and phase 3 clinical studies, the effect of treatment with bempedoic acid on serum uric acid (SUA) concentration. Secondary outcomes were treatment-related variations in creatinine serum level and incidence of gout.MethodsA systematic literature search in SCOPUS, PubMed Medline,...
Source: Drug Safety - May 1, 2020 Category: Drugs & Pharmacology Source Type: research

Oxycodone, Hydromorphone, and the Risk of Suicide: A Retrospective Population-Based Case –Control Study
ConclusionsWhile preliminary, these findings support the possibility that some high-potency opioids might independently influence the risk of suicide in susceptible individuals. (Source: Drug Safety)
Source: Drug Safety - April 23, 2020 Category: Drugs & Pharmacology Source Type: research

The International Society of Pharmacovigilance (ISoP) Special Interest Group on Herbal and Traditional Medicines: Towards Progress in Pharmacovigilance for Herbal and Traditional Medicines and Other “Natural Health” Products
(Source: Drug Safety)
Source: Drug Safety - April 23, 2020 Category: Drugs & Pharmacology Source Type: research

DPP-4 Inhibitors in Combination with Lipid-Lowering Agents and Risk of Serious Muscular Injury: A Nested Case-Control Study in a Nationwide Cohort of Patients with Type 2 Diabetes Mellitus
ConclusionIn this study, DPP-4 inhibitor use was not associated with an increased risk of serious muscular injury among patients with type 2 diabetes mellitus using statins or fibrates. (Source: Drug Safety)
Source: Drug Safety - April 18, 2020 Category: Drugs & Pharmacology Source Type: research

Should Patients Receiving ACE Inhibitors or Angiotensin Receptor Blockers be Switched to Other Antihypertensive Drugs to Prevent or Improve Prognosis of Novel Coronavirus Disease 2019 (COVID-19)?
(Source: Drug Safety)
Source: Drug Safety - April 17, 2020 Category: Drugs & Pharmacology Source Type: research

Erice Call for Change: Utilising Patient Experiences to Enhance the Quality and Safety of Healthcare
AbstractThis ‘Erice Call for Change’ is a report from a group of experts, patients and patient representatives who met in Erice in September 2019 following previous similar meetings after the original Erice Declaration (1996). The aim of the meeting was to discuss the challenge of causal complexity and indiv idual variation in modern healthcare. The group’s concern was the impact that new clinical decision-making tools, based on statistical correlations in large databases, could have on individual patient care if they replace other types of clinical investigation and knowledge. The group calls for a c han...
Source: Drug Safety - April 15, 2020 Category: Drugs & Pharmacology Source Type: research

Evidence of Clinically Meaningful Drug –Drug Interaction With Concomitant Use of Colchicine and Clarithromycin
ConclusionClinical manifestations of colchicine –clarithromycin interaction may resemble other systemic diseases and may be life threatening. Understanding this clinically meaningful interaction can help clinicians avoid unsafe medication combinations. (Source: Drug Safety)
Source: Drug Safety - April 9, 2020 Category: Drugs & Pharmacology Source Type: research

Chloroquine for COVID-19 Infection
(Source: Drug Safety)
Source: Drug Safety - April 7, 2020 Category: Drugs & Pharmacology Source Type: research

Comment on ‘Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures’
(Source: Drug Safety)
Source: Drug Safety - April 6, 2020 Category: Drugs & Pharmacology Source Type: research

A Disproportionality Analysis of the Adverse Drug Events Associated with Lurasidone in Paediatric Patients Using the US FDA Adverse Event Reporting System (FAERS)
(Source: Drug Safety)
Source: Drug Safety - April 4, 2020 Category: Drugs & Pharmacology Source Type: research

Systemic Adverse Events Associated with Compounded Topical Pain Products
(Source: Drug Safety)
Source: Drug Safety - April 4, 2020 Category: Drugs & Pharmacology Source Type: research

Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab
AbstractEosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including the anti-IL-5 antibodies mepolizumab and reslizumab and the IL-5 receptor α (IL-5Rα)–directed cytolytic antibody benralizumab. Eosinophil-depleting therapies represent a relatively new class of asthma treatment, and it is important to understand their long-term efficacy and safety. E...
Source: Drug Safety - April 2, 2020 Category: Drugs & Pharmacology Source Type: research

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi
ConclusionRegular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi, but the transmission of reports to the national PV centre requires further improvement.Plain Language SummaryWhen a medicine or vaccine is made available for use, healthcare organisations maintain regular surveillance to confirm that the medicinal product is safe and effective. The efficiency of this surveillance depends mainly on the healthcare system and medical practices in place in each country. An important element is an effective procedure for identifying and reporting any unwanted medical occurrence...
Source: Drug Safety - April 1, 2020 Category: Drugs & Pharmacology Source Type: research

Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands
ConclusionsNewspapers covered a small proportion of DHPC safety issues only. Most drugs mentioned in DHPCs were covered in social media. Coverage in both media were higher for drugs without a specialist indication. (Source: Drug Safety)
Source: Drug Safety - March 24, 2020 Category: Drugs & Pharmacology Source Type: research

Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014 –2018
ConclusionsRates of dispensing naloxone to high risk patients were extremely low, and prescription costs varied greatly. Since improving naloxone ’s affordability may increase access, whether naloxone’s high cost is associated with low dispensing rates should be evaluated. (Source: Drug Safety)
Source: Drug Safety - March 16, 2020 Category: Drugs & Pharmacology Source Type: research

Patterns of Inpatient Antibiotic Use Among Public Hospitals in Hong Kong from 2000 to 2015
ConclusionsWe found that the overall volume of antibiotic use increased between 2000 and 2015. The rise in the dispensing of carbapenems in our study is concerning. The significant change in tetracycline use after being recommended as one of the preferred regimens demonstrated that the change in the clinical practice guideline had an immediate effect on the antibiotic prescribing practice in Hong Kong public hospitals. (Source: Drug Safety)
Source: Drug Safety - March 12, 2020 Category: Drugs & Pharmacology Source Type: research

ISoP Fellowships: Recognising Contributions to the Goals of ISoP
(Source: Drug Safety)
Source: Drug Safety - March 12, 2020 Category: Drugs & Pharmacology Source Type: research

Fluoroquinolone-Induced Photosensitivity: A Chemical Fragment-Based Approach by a Case/Non-case Study in VigiBase ®
ConclusionThis study confirms the high reporting rate of photosensitivity adverse effects for sparfloxacin from real-world data. Moreover, our data suggest more photosensitivity adverse effects reporting for fluoroquinolones with a halogen at their 8th position. (Source: Drug Safety)
Source: Drug Safety - March 7, 2020 Category: Drugs & Pharmacology Source Type: research

Prevalence and Nature of Medication Errors and Medication-Related Harm Following Discharge from Hospital to Community Settings: A Systematic Review
ConclusionsThis is the first systematic review to explore the prevalence and nature of medication errors and adverse drug events following hospital discharge. Targets for future work have been identified. (Source: Drug Safety)
Source: Drug Safety - March 3, 2020 Category: Drugs & Pharmacology Source Type: research

Identifying Drugs Inducing Prematurity by Mining Claims Data with High-Dimensional Confounder Score Strategies
ConclusionsMining complex healthcare databases with statistical methods from the high-dimensional inference field may improve signal detection in pregnant women. (Source: Drug Safety)
Source: Drug Safety - March 2, 2020 Category: Drugs & Pharmacology Source Type: research

Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use
ConclusionsBy connecting and integrating in vivo and in silico data, SA-PheWAS offers an opportunity to supplement current methods for predicting or confirming safety signals associated with therapeutic agents. (Source: Drug Safety)
Source: Drug Safety - February 28, 2020 Category: Drugs & Pharmacology Source Type: research

Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study
This study has a longitudinal design using data about patients initiating metformin collected by the Dutch National Pharmacovigilance Center Lareb through their Intensive Monitoring program. Patients were asked to complete a web-based questionnaire six times after initiation (i.e., at 2  weeks, 6 weeks and at 3, 6, 9, and 12 months). The outcome variables were the proportion of patients reporting any ADR (primary) and the dose of metformin (secondary). Sex differences in the proportions of ADRs and in the dose were tested at each assessment using Pearson Chi-Squared tests and Wi lcoxon rank-sum tests, respec...
Source: Drug Safety - February 11, 2020 Category: Drugs & Pharmacology Source Type: research

Benzodiazepine Use and Risk of Acute Angle-Closure Glaucoma: A Population-Based Case-Crossover Study
ConclusionWe found that BZD use was associated with AACG risk in the Korean population. Clinicians should carefully monitor the occurrence of visual disturbance in BZD-treated patients. (Source: Drug Safety)
Source: Drug Safety - February 7, 2020 Category: Drugs & Pharmacology Source Type: research

Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase ®
This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA).MethodsSDRs for 100 selected products were identified with two sets of thresholds (standard EudraVigilance SDR criteria for all vs Bayesian approach for FAERS and VigiBase®). Per product and database, the presence or absence of SDRs was determined and compared. Adverse events were considered at three levels: MedDRA® Preferred Term (PT), High Level Term (HLT), and HLT combined with Standardized MedDRA® Query (SMQ). Redundancy was measured in terms of recall (SDRs in EVDAS divided...
Source: Drug Safety - February 4, 2020 Category: Drugs & Pharmacology Source Type: research

Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review
ConclusionsGaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine. (Source: Drug Safety)
Source: Drug Safety - February 4, 2020 Category: Drugs & Pharmacology Source Type: research

Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations
This study aims to investigate the relationship between database size and robustness of disproportionality analysis, with regards to limiting spurious associations.MethodsThree types of subsets were created from the global database VigiBase: random subsets (500 replicates each of 11 fixed subset sizes between 250 and 100,000 reports), country-specific subsets (all 131 countries available in the original VigiBase extract) and subsets based on the Anatomical Therapeutic Chemical classification. For each subset, a spuriousness rate was computed as the ratio between the number of drug –event combinations highlighted by d...
Source: Drug Safety - February 1, 2020 Category: Drugs & Pharmacology Source Type: research

An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data
ConclusionIn patients with PsA, tofacitinib had a safety profile similar to that of other systemic therapies in real-world settings, except for the risk of HZ, a known risk of tofacitinib.Trial RegistrationClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364. (Source: Drug Safety)
Source: Drug Safety - January 31, 2020 Category: Drugs & Pharmacology Source Type: research

Adverse Events in Twitter-Development of a Benchmark Reference Dataset: Results from IMI WEB-RADR
ConclusionsA manually curated benchmark reference dataset based on Twitter data has been created and is made available to the research community to evaluate the performance of automated methods and systems for adverse event recognition in unstructured free-text information. (Source: Drug Safety)
Source: Drug Safety - January 29, 2020 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Uysal and Colleagues’ Comment on: “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis”
(Source: Drug Safety)
Source: Drug Safety - January 29, 2020 Category: Drugs & Pharmacology Source Type: research

Comment on “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-analysis”
(Source: Drug Safety)
Source: Drug Safety - January 29, 2020 Category: Drugs & Pharmacology Source Type: research

An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System
ConclusionUnderstanding the origins and characteristics of ICSRs with an outcome of death supports meaningful evaluations and interpretations of FAERS data. A wide variability in ICSR quality exists, even in those reports with the most serious outcome. (Source: Drug Safety)
Source: Drug Safety - January 24, 2020 Category: Drugs & Pharmacology Source Type: research

Hyperkeratotic Skin Adverse Events Induced by Anticancer Treatments: A Comprehensive Review
AbstractHyperkeratotic skin adverse events are a group of toxic effects, characterized by the disruption of epidermal homeostasis and interaction with keratinocyte proliferation/differentiation or keratinocyte survival, and frequently reported with systemic anticancer treatments. These types of reactions include hand –foot skin reaction or palmoplantar keratoderma, induced psoriasis, keratosis pilaris-like or pityriasis rubra pilaris-like rashes, Grover’s disease, and contact hyperkeratosis. Cutaneous squamoproliferative lesions are also described because of the presence of abnormal keratinocyte proliferatio n....
Source: Drug Safety - January 24, 2020 Category: Drugs & Pharmacology Source Type: research

Contribution of Causality Assessment for an Automated Detection of Safety Signals: An Example Using the French Pharmacovigilance Database
ConclusionThe approach therefore appears useful as an additional tool for safety signal detection, especially for antineoplastic and immunomodulating agents. (Source: Drug Safety)
Source: Drug Safety - January 23, 2020 Category: Drugs & Pharmacology Source Type: research

Developing Predictive Models to Determine Patients in End-of-Life Care in Administrative Datasets
ConclusionThese results show that developing diagnostic predictive models for determining subjects in end-of-life care at the time of a drug treatment is possible and may improve the validity of the risk profile for those treatments. (Source: Drug Safety)
Source: Drug Safety - January 14, 2020 Category: Drugs & Pharmacology Source Type: research

A New President ’s Vision for International Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - January 14, 2020 Category: Drugs & Pharmacology Source Type: research

Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study
AbstractIntroductionAlthough the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation.ObjectiveIn this prespecified analysis, we compared the cardiac safety of the trastuzumab biosimilar ABP 980 (KANJINTI ™) and the trastuzumab reference product (RP; Herceptin®) in the phase III LILAC study (ClinicalTrials.gov identifier NCT01901146).MethodsIn the neoadjuvant phase of LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to ABP  980 (n = 364) or trastuzumab RP (n = 36...
Source: Drug Safety - January 11, 2020 Category: Drugs & Pharmacology Source Type: research

Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania
ConclusionsThe national pharmacovigilance systems in the four East African countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the four national pharmacovigilance systems are at different levels of capacity and performance with respect to conducting pharmacovigilance activities. Targeted interventions are needed to strengthen the pharmacovigilance systems to enable evidence-based decision making for patient safety. (Source: Drug Safety)
Source: Drug Safety - January 9, 2020 Category: Drugs & Pharmacology Source Type: research

Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire
ConclusionAfter validation and testing, the developed questionnaire to study patient-reported adverse events of radiopharmaceuticals is a suitable and valid instrument which can be used in future research. (Source: Drug Safety)
Source: Drug Safety - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

Utility of a Computerized ICD-10 Algorithm to Identify Idiosyncratic Drug-Induced Liver Injury Cases in the Electronic Medical Record
AbstractIntroductionIdiosyncratic drug-induced liver injury (DILI) is an important cause of liver injury that is difficult to diagnose and identify in the electronic medical record (EMR).ObjectiveOur objective was to develop a computerized algorithm that can reliably identify DILI cases from the EMR.MethodsThe EMR was searched for all encounters with anInternational Classification of Diseases, Tenth Revision (ICD-10) T code for drug toxicity and a K-71 code for toxic liver injury between 1 October 2015 and 30 September 2018. Clinically significant liver injury was defined using predetermined laboratory values. An expert op...
Source: Drug Safety - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

Coronary Risks Associated with Diclofenac and Other NSAIDs: An Update
AbstractThe risk of coronary events with non-steroidal anti-inflammatory drugs has been the subject of much debate since the original trial of rofecoxib raised the issue. Since then, over almost 20  years, such risks have been shown in clinical trials of long-term high-dose users, and in observational studies comparing users with non-users. The roles of cyclooxygenase (COX)-2/COX-1 selectivity and COX-2 inhibitory potency have been proposed to explain this increased risk of myocardial infarct ion (MI). Among NSAIDs, diclofenac appeared to be associated with a relatively higher risk of MI, similar to that of rofecoxib,...
Source: Drug Safety - January 8, 2020 Category: Drugs & Pharmacology Source Type: research

Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility
ConclusionsOur model demonstrated the feasibility of developing a tool predictive of ICSR utility. The model ’s modest discriminative ability highlights opportunities for further enhancement and suggests algorithms tailored to safety issues may be beneficial. (Source: Drug Safety)
Source: Drug Safety - January 7, 2020 Category: Drugs & Pharmacology Source Type: research

Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring
We examined the laboratory values of patients with compensated cirrhosis randomized to placebo in two clinical trials for NASH. Patients in one study were followed every 13 weeks up to week 57; patients in the other study were followed every 4 weeks up to week 120.ResultsIn total, 53 and 85 patients were randomized to placebo in the trials. Baseline alanine aminotransferase (ALT) was greater than the laboratory upper limit of normal (ULN) in 53% and 49% of participants, aspartate aminotransferase (AST) was> ULN in 49% and 59%, alkaline phosphatase was> ULN in 36% and 27%, and bilirubin was>ULN in 13% and 19%. Duri...
Source: Drug Safety - January 6, 2020 Category: Drugs & Pharmacology Source Type: research

Brand-Specific Enhanced Safety Surveillance of GSK ’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season
ConclusionIn compliance with EMA guidance, this study design allowed for near real-time assessment of AEs. No safety signals were detected at any point during the study period. The study supports and confirms the acceptable safety profile of GSK ’s IIV4.ClinicalTrials.gov identifierNCT03688620. (Source: Drug Safety)
Source: Drug Safety - December 28, 2019 Category: Drugs & Pharmacology Source Type: research

The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK
ConclusionBrand name and batch number traceability for biologics in UK ADR reports are generally low. Shortcomings in the systematic recording of product details in UK clinical practice may contribute to the limited traceability. (Source: Drug Safety)
Source: Drug Safety - December 23, 2019 Category: Drugs & Pharmacology Source Type: research