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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/28205099/evaluation-of-potentially-drug-related-patient-reported-common-symptoms-assessed-during-clinical-medication-reviews-a-cross-sectional-observational-study
#1
Tim W A Schoenmakers, Martina Teichert, Michel Wensing, Peter A G M de Smet
INTRODUCTION: Healthcare professionals tend to consider common non-alarming drug-related symptoms to be of little clinical relevance. However, such symptoms can have a substantial impact on the individual patient. Insight into patient-reported symptoms could aid pharmacists to identify improvements in medication treatment, for instance in the patient interview at the start of a clinical medication review (CMR). OBJECTIVE: The objectives of this study were to describe the numbers and types of patient-reported symptoms assessed during a CMR and to elucidate their potential association with the drugs in use...
February 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28194654/the-risk-of-ischemic-cardio-and-cerebrovascular-events-associated-with-oxycodone-naloxone-and-other-extended-release-high-potency-opioids-a-nested-case-control-study
#2
Kathrin Jobski, Bianca Kollhorst, Edeltraut Garbe, Tania Schink
INTRODUCTION: In Germany, an extended-release (ER) combination of the high-potency opioid (HPO) oxycodone and the antagonist naloxone was approved in 2006. In recent years, the cardio- and cerebrovascular safety of opioid antagonists and of opioids themselves has been discussed. OBJECTIVES: The objective of this study was to estimate the risk of major ischemic cardio- and cerebrovascular events in patients receiving ER oxycodone-naloxone compared with those receiving other ER HPOs...
February 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28188601/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
#3
R A Charlton, A McGrogan, J Snowball, L M Yates, A Wood, J Clayton-Smith, W H Smithson, J L Richardson, N McHugh, S H L Thomas, G A Baker, R Bromley
INTRODUCTION: Electronic healthcare data have several advantages over prospective observational studies, but the sensitivity of data on neurodevelopmental outcomes and its comparability with data generated through other methodologies is unknown. OBJECTIVES: 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...
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28188600/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
#4
LETTER
Marine Auffret, Julien Labreuche, Alain Duhamel, Sylvie Deheul, Olivier Cottencin, Régis Bordet, Sophie Gautier, Benjamin Rolland
No abstract text is available yet for this article.
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28185070/antenatal-exposure-and-diseases-in-the-offspring-the-role-of-big-data
#5
LETTER
Christoph R Meier, Susan S Jick
No abstract text is available yet for this article.
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28185069/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
#6
LETTER
Alain Braillon
No abstract text is available yet for this article.
February 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28181126/anti-angiogenic-tyrosine-kinase-inhibitors-and-reversible-posterior-leukoencephalopathy-syndrome-could-hypomagnesaemia-be-the-trigger
#7
REVIEW
Rashmi R Shah
Reversible 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...
February 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28155198/validation-of-new-signal-detection-methods-for-web-query-log-data-compared-to-signal-detection-algorithms-used-with-faers
#8
Susan Colilla, Elad Yom Tov, Ling Zhang, Marie-Laure Kurzinger, Stephanie Tcherny-Lessenot, Catherine Penfornis, Shang Jen, Danny S Gonzalez, Patrick Caubel, Susan Welsh, Juhaeri Juhaeri
INTRODUCTION: Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions. METHODS: Recently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data...
February 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28130774/pre-exposure-prophylaxis-for-hiv-prevention-safety-concerns
#9
REVIEW
Raymond A Tetteh, Barbara A Yankey, Edmund T Nartey, Margaret Lartey, Hubert G M Leufkens, Alexander N O Dodoo
Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28130773/identification-of-substandard-medicines-via-disproportionality-analysis-of-individual-case-safety-reports
#10
Zahra Anita Trippe, Bruno Brendani, Christoph Meier, David Lewis
INTRODUCTION: The distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28130772/digitalis-use-and-the-risk-of-breast-cancer-a-systematic-review-and-meta-analysis
#11
REVIEW
Chen Zhang, Shao-Hua Xie, Bingfei Xu, Shi Lu, Pian Liu
INTRODUCTION: Previous epidemiological studies have indicated an increased risk of breast cancer associated with digitalis medication, though results are inconsistent. We performed this systematic review of available epidemiological studies to clarify the association between digitalis use and the risk of breast cancer. METHODS: A search of studies published through May 2016 in MEDLINE and EMBASE databases was performed, supplemented by manual searches of reference lists...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28120270/feasibility-and-educational-value-of-a-student-run-pharmacovigilance-programme-a-prospective-cohort-study
#12
Tim Schutte, Jelle Tichelaar, Michael O Reumerman, Rike van Eekeren, Leàn Rolfes, Eugène P van Puijenbroek, Milan C Richir, Michiel A van Agtmael
INTRODUCTION: Pharmacovigilance, 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. METHODS: In this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre...
January 25, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28101815/developing-a-crowdsourcing-approach-and-tool-for-pharmacovigilance-education-material-delivery
#13
Andrew Bate, Jürgen Beckmann, Alexander Dodoo, Linda Härmark, Kenneth Hartigan-Go, Anna Hegerius, Marie Lindquist, Eugène van Puijenbroek, Marco Tuccori, Ulrich Hagemann
The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product...
January 18, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28083785/erratum-to-association-between-statin-use-and-bell-s-palsy-a-population-based-study
#14
Shih-Han Hung, Li-Hsuan Wang, Herng-Ching Lin, Shiu-Dong Chung
No abstract text is available yet for this article.
January 12, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28074424/signal-detection-based-on-time-to-onset-algorithm-in-spontaneous-reporting-system-of-china
#15
Tianyi Zhang, Xiaofei Ye, Xiaojing Guo, Guizhi Wu, Yongfang Hou, Jinfang Xu, Wentao Shi, Tiantian Zhu, Yuan Zhang, Xinji Zhang, Jiaqi Song, Jia He
INTRODUCTION: The method of time-to-onset (TTO) has been proposed to overcome the drawbacks of traditional disproportionality analyses (DPAs), and it has been used for detecting safety signals of vaccines and some non-vaccine products in spontaneous reporting systems (SRSs). However, there is no consensus on its superiority over DPAs. Further, it is still not clear whether this novel approach can be generalized to the entire national SRS database. OBJECTIVE: The purpose of this study was to generalize the TTO method to the Chinese SRS and to identify suitable parameters for its optimal performance...
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28074423/effectiveness-of-risk-evaluation-and-mitigation-strategies-rems-for-lenalidomide-and-thalidomide-patient-comprehension-and-knowledge-retention
#16
Nancy A Brandenburg, Robert Bwire, John Freeman, Florence Houn, Paul Sheehan, Jerome B Zeldis
INTRODUCTION: The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages. METHODS: Results from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category...
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28070742/authors-reply-to-jouanjus-and-colleagues-comment-on-social-media-mining-for-toxicovigilance-automatic%C3%A2-monitoring-of-prescription-medication-abuse-from-twitter
#17
LETTER
Abeed Sarker, Dan Malone, Graciela Gonzalez
No abstract text is available yet for this article.
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28070741/comment-on-social-media-mining-for-toxicovigilance-automatic-monitoring-of-prescription-medication-abuse-from-twitter
#18
LETTER
Emilie Jouanjus, Michel Mallaret, Joëlle Micallef, Camille Ponté, Anne Roussin, Maryse Lapeyre-Mestre
No abstract text is available yet for this article.
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28070740/generating-evidence-of-clinical-outcomes-of-drug-drug-interactions
#19
LETTER
Katsiaryna Bykov, Joshua J Gagne
No abstract text is available yet for this article.
January 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28044249/evaluation-of-facebook-and-twitter-monitoring-to-detect-safety-signals-for-medical-products-an-analysis-of-recent-fda-safety-alerts
#20
Carrie E Pierce, Khaled Bouri, Carol Pamer, Scott Proestel, Harold W Rodriguez, Hoa Van Le, Clark C Freifeld, John S Brownstein, Mark Walderhaug, I Ralph Edwards, Nabarun Dasgupta
INTRODUCTION: The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal detection from spontaneous report data. OBJECTIVE: Our objective was to examine whether specific product-adverse event pairs were reported via social media before being reported to the US FDA Adverse Event Reporting System (FAERS)...
January 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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