Role of Medicines of Unknown Identity in Adverse Drug Reaction-Related Hospitalizations in Developing Countries: Evidence from a Cross-Sectional Study in a Teaching Hospital in the Lao People ’s Democratic Republic
ConclusionAccording to the results of this study, there is a need to ensure appropriate labelling of medicines at dispensing and to provide well-suited tools to identify MUIs in clinical settings to improve drug safety and patients ’ care in developing countries with limited capacities for drug analysis. (Source: Drug Safety)
Source: Drug Safety - May 20, 2017 Category: Drugs & Pharmacology Source Type: research

Preliminary Results of a Novel Algorithmic Method Aiming to Support Initial Causality Assessment of Routine Pharmacovigilance Case Reports for Medication-Induced Liver Injury: The PV-RUCAM
ConclusionWithin the PV setting of a pharmaceutical company, the PV-RUCAM has the potential to facilitate and improve the assessment done by non-expert PV professionals compared with other methods when incomplete reports must be evaluated for suspected DILI. Prospective validation of the algorithmic tool  is necessary prior to implementation for routine use. (Source: Drug Safety)
Source: Drug Safety - May 15, 2017 Category: Drugs & Pharmacology Source Type: research

People ’s Understanding of Verbal Risk Descriptors in Patient Information Leaflets: A Cross-Sectional National Survey of 18- to 65-Year-Olds in England
DiscussionThe current verbal risk descriptors used in PILs are ineffective at best and misleading at worst. Discontinuing the use of verbal risk descriptors would limit the likelihood of people overestimating the risk of side effects. (Source: Drug Safety)
Source: Drug Safety - May 11, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of the Case –Crossover (CCO) Study Design for Adverse Drug Event Detection
ConclusionsThe CCO performed best for acute-onset outcomes, but may be useful for exploring adverse outcomes with accumulative effects. Careful consideration must be given to the hypothesized drug exposure and outcome distribution because specification of risk and control window duration affects CCO performance. (Source: Drug Safety)
Source: Drug Safety - May 4, 2017 Category: Drugs & Pharmacology Source Type: research

Detecting Signals of Disproportionate Reporting from Singapore ’s Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test
ConclusionsUsing a combination of hRRs for SPRT could be a useful screening tool for regulatory agencies, and more detailed investigation of the medical utility of the system is merited. (Source: Drug Safety)
Source: Drug Safety - April 28, 2017 Category: Drugs & Pharmacology Source Type: research

Antipsychotic Prescribing to Patients Diagnosed with Dementia Without a Diagnosis of Psychosis in the Context of National Guidance and Drug Safety Warnings: Longitudinal Study in UK General Practice
ConclusionsIncreased surveillance and evaluation of drug safety warnings and guidance are needed to improve the impact of future interventions. (Source: Drug Safety)
Source: Drug Safety - April 24, 2017 Category: Drugs & Pharmacology Source Type: research

Comment on: “Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts”
(Source: Drug Safety)
Source: Drug Safety - April 19, 2017 Category: Drugs & Pharmacology Source Type: research

Macrolides, Digoxin Toxicity and the Risk of Sudden Death: A Population-Based Study
ConclusionThis finding reinforces the cardiovascular safety of macrolide antibiotics in a high-risk population. (Source: Drug Safety)
Source: Drug Safety - April 18, 2017 Category: Drugs & Pharmacology Source Type: research

Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt
ConclusionLessons learned highlight the importance of investigating plausible biological mechanisms between vaccines and potentially associated adverse outcomes, and the importance of selecting appropriate study settings and designs for safety signal investigations. (Source: Drug Safety)
Source: Drug Safety - April 17, 2017 Category: Drugs & Pharmacology Source Type: research

Patient Reporting in the EU: Analysis of EudraVigilance Data
ConclusionPatient reporting complemented reporting by HCPs. Patients were motivated to report ADRs, especially those that affected their quality of life. Sharing these results with NCAs and patient associations can inform training and awareness on patient reporting. (Source: Drug Safety)
Source: Drug Safety - April 17, 2017 Category: Drugs & Pharmacology Source Type: research

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis
ConclusionsIn a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report. (Source: Drug Safety)
Source: Drug Safety - April 12, 2017 Category: Drugs & Pharmacology Source Type: research

Managing Cardiovascular Risk of Macrolides: Systematic Review and Meta-Analysis
ConclusionsMore studies are required to investigate the short-term cardiovascular outcomes associated with different types of macrolides. Future studies are warranted to evaluate the effect of statins for preventing excess acute cardiovascular events associated with clarithromycin or other macrolides. (Source: Drug Safety)
Source: Drug Safety - April 10, 2017 Category: Drugs & Pharmacology Source Type: research

Species Adulteration in the Herbal Trade: Causes, Consequences and Mitigation
AbstractThe global economy of the international trade of herbal products has been increasing by 15% annually, with the raw material for most herbal products being sourced from South and Southeast Asian countries. In India, of the 8000 species of medicinal plants harvested from the wild, approximately 960 are in the active trade. With increasing international trade in herbal medicinal products, there is also increasing concern about the widespread adulteration and species admixtures in the raw herbal trade. The adverse consequences of such species adulteration on the health and safety of consumers have only recently begun...
Source: Drug Safety - April 8, 2017 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Arrhythmia: Bridging the Gap Between Pathophysiological Knowledge and Clinical Practice
(Source: Drug Safety)
Source: Drug Safety - April 8, 2017 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals
ConclusionHospitalization due to an ADR is a common occurrence in this older population. There is need for future studies to implement and evaluate interventions to reduce the risk of ADR-related admissions in elderly populations. (Source: Drug Safety)
Source: Drug Safety - April 6, 2017 Category: Drugs & Pharmacology Source Type: research

Drospirenone-Containing Oral Contraceptive Pills and the Risk of Venous Thromboembolism: An Assessment of Risk in First-Time Users and Restarters
ConclusionsWe found an elevated risk of VTE associated with drospirenone-containing COCs in comparison with levonorgestrel-containing COCs in both cohorts. While left truncation of healthcare databases is a concern for the identification of first-time users, the use of a more explicit cohort of restarters suggests a doubling of VTE risk with drospirenone-containing COCs. (Source: Drug Safety)
Source: Drug Safety - April 5, 2017 Category: Drugs & Pharmacology Source Type: research

Impact of Safety-Related Regulations on Codeine Use in Children: A Quasi-Experimental Study Using Taiwan ’s National Health Insurance Research Database
ConclusionsOur study provides a successful example of how to effectively reduce the codeine prescriptions in children in the ‘real-world’ settings, and highlights areas where future effort could be made to improve the safety use of codeine. Future research is warranted to explore whether there was a simultaneous decrease in the incidence rates of codeine-related adverse events following the safety-related regulations. (Source: Drug Safety)
Source: Drug Safety - March 30, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals
ConclusionAlthough drugs approved with a boxed warning or priority review are more likely to experience serious post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with post-marketing safety events. It appears that these post-marketing events are not discernible during a pre-marketing review and therefore might not be avoidable using current review data. (Source: Drug Safety)
Source: Drug Safety - March 24, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of ‘SAEFVIC’, A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia
ConclusionSAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia. (Source: Drug Safety)
Source: Drug Safety - March 24, 2017 Category: Drugs & Pharmacology Source Type: research

Targeting Interleukin-5 or Interleukin-5R α: Safety Considerations
AbstractAsthma is a highly prevalent chronic disease of the airways; approximately 10% of patients with asthma will experience a severe form of the disease. New understanding of the pathogenesis of asthma has enabled the development of novel drugs and provided hope for patients with asthma. Interleukin (IL)-5 and IL-5 receptor subunit α (IL-5-Rα) plays a crucial role in the development, maturation, and operation of eosinophils so were the first important therapeutic target of these new drugs. While the results of early clinical trials of these drugs were not promising, results improved once researchers discover...
Source: Drug Safety - March 20, 2017 Category: Drugs & Pharmacology Source Type: research

Medicines Save, Medicines Kill
(Source: Drug Safety)
Source: Drug Safety - March 17, 2017 Category: Drugs & Pharmacology Source Type: research

Summarising the Evidence for Drug Safety: A Methodological Discussion of Different Meta-Analysis Approaches
AbstractEvidence on drug safety obtained from randomised clinical trials is very limited due to, among other reasons, their relatively small sample size. Hence, combining the results of available studies can prove particularly useful. This paper reviews the different data sources for summarising drug safety outcomes, according to study design, publication of data, and origin of the information. It then discusses the various types of overviews that can be used in the study of treatment harms, focusing on meta-analyses of aggregate data and meta-analyses of individual patient data, with their advantages and drawbacks, such a...
Source: Drug Safety - March 15, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan
AbstractTwo Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called ‘Conditional Approval,’ specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of ‘Medical Devices’ prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects...
Source: Drug Safety - March 15, 2017 Category: Drugs & Pharmacology Source Type: research

Using Probabilistic Record Linkage of Structured and Unstructured Data to Identify Duplicate Cases in Spontaneous Adverse Event Reporting Systems
ConclusionsThe algorithm was shown to be effective at identifying pre-linked duplicate VAERS reports. The narrative text was not shown to be a key component in the automated detection evaluation; however, it is essential for supporting the semi-automated approach that is likely to be deployed at the Food and Drug Administration, where medical reviewers will perform some manual review of the most highly ranked reports identified by the algorithm. (Source: Drug Safety)
Source: Drug Safety - March 14, 2017 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Event Causality Analysis (ADECA): A Process for Evaluating Evidence and Assigning Drugs to Risk Categories for Sudden Death
AbstractGrowing evidence indicates that many drugs have the ability to cause a potentially lethal cardiac arrhythmia, torsades de pointes (TdP). This necessitates the development of a compilation of drugs that have this potential toxicity. Such a list is helpful in identifying the etiology of TdP in patients taking multiple drugs and assists decision making by those caring for patients at high risk of TdP. The Arizona Center for Education and Research on Therapeutics (AZCERT) has developed a process to standardize the identification of drugs and place them in risk categories for their clinical ability to cause TdP and QT p...
Source: Drug Safety - March 8, 2017 Category: Drugs & Pharmacology Source Type: research

Causality Assessment in Pharmacovigilance: Still a Challenge
AbstractCausality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle the many issues involved in, for example, medication error and the many other factors that lead to bad outcomes from therapy, including failure to recognise known risk factors. The aim of pharmacovigilance is not only a bureaucratic exercise in public health norms, but is...
Source: Drug Safety - February 28, 2017 Category: Drugs & Pharmacology Source Type: research

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study
ConclusionsSome risks of medications are effectively communicated to patients and physicians; however, there is still a noticeable gap between information issued by the Food and Drug Administration and patient and physician awareness of this knowledge, as well as patients ’ decisions to act on this information. Disseminators of emerging drug safety information should explore ways of providing user-friendly resources to patients and healthcare professionals that can update them on new risks in a timely manner. (Source: Drug Safety)
Source: Drug Safety - February 28, 2017 Category: Drugs & Pharmacology Source Type: research

A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms
ConclusionSpontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals. (Source: Drug Safety)
Source: Drug Safety - February 28, 2017 Category: Drugs & Pharmacology Source Type: research

Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification
ConclusionRegulatory authorities have been justified in making withdrawal decisions when deaths have been attributed to medicinal products, using the precautionary principle when alternative decisions could have been made. Medicinal products are likely to be quickly withdrawn from the market when there is a short interval to the first reported deaths. The use of an algorithm such as we have used in this study could help to expedite the process of decision making. (Source: Drug Safety)
Source: Drug Safety - February 25, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed During Clinical Medication Reviews: A Cross-Sectional Observational Study
ConclusionMany patient-reported symptoms and symptoms potentially related to drugs in use were identified by administering the PROMISE instrument to users of at least five drugs being taking long-term. This information can be used in CMRs to improve patients ’ drug therapy. (Source: Drug Safety)
Source: Drug Safety - February 15, 2017 Category: Drugs & Pharmacology Source Type: research

The Risk of Ischemic Cardio- and Cerebrovascular Events Associated with Oxycodone –Naloxone and Other Extended-Release High-Potency Opioids: A Nested Case–Control Study
ConclusionsOur study does not indicate an association between oxycodone –naloxone and ischemic cardio- or cerebrovascular events. However, our findings do suggest that every change in ER HPO therapy should be conducted with caution. (Source: Drug Safety)
Source: Drug Safety - February 13, 2017 Category: Drugs & Pharmacology Source Type: research

Sensitivity of the UK Clinical Practice Research Datalink to Detect Neurodevelopmental Effects of Medicine Exposure in Utero: Comparative Analysis of an Antiepileptic Drug-Exposed Cohort
The objectives of this study were to determine whether data from the UK Clinical Practice Research Datalink (CPRD) produces similar risk estimates to a prospective cohort study in relation to the risk of neurodevelopmental disorders (NDDs) following prenatal antiepileptic drug (AED) exposure.MethodsA cohort of mother –child pairs of women with epilepsy (WWE) was identified in the CPRD and matched to a cohort without epilepsy. The study period ran from 1 January 2000 to 31 March 2007 and children were required to be in the CPRD at age 6 years. AED exposure during pregnancy was determined from prescription da...
Source: Drug Safety - February 10, 2017 Category: Drugs & Pharmacology Source Type: research

Antenatal Exposure and Diseases in the Offspring: The Role of Big Data
(Source: Drug Safety)
Source: Drug Safety - February 10, 2017 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Alain Braillon’s Comment on “Proactive regional pharmacovigilance system versus national spontaneous reporting for collecting safety data on concerning off-label prescribing practices: An example with baclofen and alcohol dependence in France’’
(Source: Drug Safety)
Source: Drug Safety - February 10, 2017 Category: Drugs & Pharmacology Source Type: research

Comment on: “Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France”
(Source: Drug Safety)
Source: Drug Safety - February 10, 2017 Category: Drugs & Pharmacology Source Type: research

Anti-Angiogenic Tyrosine Kinase Inhibitors and Reversible Posterior Leukoencephalopathy Syndrome: Could Hypomagnesaemia Be the Trigger?
AbstractReversible posterior leukoencephalopathy syndrome (RPLS), also known frequently as posterior reversible encephalopathy syndrome (PRES), is a characteristic acute neuro-radiology syndrome with clinical presentation that typically includes acute hypertension, seizures and other neurological symptoms and signs. Many patients with RPLS have (a history of) pre-existing hypertension and in receipt of diuretics. It is being diagnosed more frequently and in association with an increasing number of morbidities and medications. Drugs most frequently implicated are immunosuppressant drugs and anticancer agents, including a nu...
Source: Drug Safety - February 9, 2017 Category: Drugs & Pharmacology Source Type: research

Validation of New Signal Detection Methods for Web Query Log Data Compared to Signal Detection Algorithms Used With FAERS
ConclusionFuture research is needed to find better refinements of query data and/or the metrics to improve the specificity of these web query log algorithms. (Source: Drug Safety)
Source: Drug Safety - February 2, 2017 Category: Drugs & Pharmacology Source Type: research

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns
We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was te nofovir disoproxil fumarate/emtricitabine in a combined form as Truvada® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically ...
Source: Drug Safety - January 28, 2017 Category: Drugs & Pharmacology Source Type: research

Digitalis Use and the Risk of Breast Cancer: A Systematic Review and Meta-Analysis
ConclusionsExisting epidemiological evidence regarding the association between digitalis use and the risk of breast cancer remains inconclusive and more well-designed studies are still needed. (Source: Drug Safety)
Source: Drug Safety - January 28, 2017 Category: Drugs & Pharmacology Source Type: research

Identification of Substandard Medicines via Disproportionality Analysis of Individual Case Safety Reports
ConclusionThis study illustrates the value of data mining of spontaneous adverse event reports and the applicability of disproportionality analysis to identify potential SSMs. (Source: Drug Safety)
Source: Drug Safety - January 28, 2017 Category: Drugs & Pharmacology Source Type: research

Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study
AbstractIntroductionPharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme.MethodsIn this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized fe...
Source: Drug Safety - January 25, 2017 Category: Drugs & Pharmacology Source Type: research

Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery
We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations condu cted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine ‘democratic’ approach to sharing educational material to a wider community and an openness for access. (Source: Drug Safety)
Source: Drug Safety - January 18, 2017 Category: Drugs & Pharmacology Source Type: research

Erratum to: Association Between Statin Use and Bell ’s Palsy: A Population-Based Study
(Source: Drug Safety)
Source: Drug Safety - January 12, 2017 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Jouanjus and Colleagues’ Comment on “Social Media Mining for Toxicovigilance: Automatic Monitoring of Prescription Medication Abuse from Twitter”
(Source: Drug Safety)
Source: Drug Safety - January 10, 2017 Category: Drugs & Pharmacology Source Type: research

Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention
ConclusionThe lenalidomide and thalidomide REMS programs enhance patient understanding of safe-use messages, resulting in high levels of compliance with the birth control precautions essential to prevent fetal exposure to these known and potential human teratogens. Overall compliance was maintained after 3  months of follow-up and throughout therapy. (Source: Drug Safety)
Source: Drug Safety - January 10, 2017 Category: Drugs & Pharmacology Source Type: research

Signal Detection Based on Time to Onset Algorithm in Spontaneous Reporting System of China
ConclusionsTTO can detect signals missed by traditional DPAs and could be an important complementary tool to the currently used DPAs in the SRS of China. We recommend a significance level of 0.2 and no restrictions on time windows for TTO. (Source: Drug Safety)
Source: Drug Safety - January 10, 2017 Category: Drugs & Pharmacology Source Type: research

Comment on: & quot;Social Media Mining for Toxicovigilance: Automatic Monitoring of Prescription Medication Abuse from Twitter & quot;
(Source: Drug Safety)
Source: Drug Safety - January 10, 2017 Category: Drugs & Pharmacology Source Type: research

Generating Evidence of Clinical Outcomes of Drug –Drug Interactions
(Source: Drug Safety)
Source: Drug Safety - January 9, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts
ConclusionsAn efficient semi-automated approach to social media monitoring may provide earlier insights into certain adverse events. More work is needed to elaborate additional uses for social media data in pharmacovigilance and to determine how they can be applied by regulatory agencies. (Source: Drug Safety)
Source: Drug Safety - January 2, 2017 Category: Drugs & Pharmacology Source Type: research

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study
ConclusionsFurther research is needed to assess associations between user characteristics and the direction (positive or negative) of the factors potentially influencing app use. (Source: Drug Safety)
Source: Drug Safety - December 29, 2016 Category: Drugs & Pharmacology Source Type: research