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Pharmacovigilance- Drug safety

Ronald Kiguba, Helen B Ndagije, Victoria Nambasa, Sheila M Bird
Introduction: Developing countries can improve their pharmacovigilance systems by analysing their own medication safety data. Objective: The aims of this study were to characterize Uganda's reported adverse drug reaction (ADR) onsets in 2012-2015 that were registered on VigiBase® by 31 December 2017, to document delays in international visibility and the influence of covariates on this delay from ADR onsets in 2013 + 2014, to examine data quality, and to illustrate analytical approaches for safety data, particularly for patients receiving antiretroviral therapy (ART)...
2018: Pharmaceutical Medicine
Danielle Abatemarco, Sujan Perera, Sheng Hua Bao, Sameen Desai, Bruno Assuncao, Niki Tetarenko, Karolina Danysz, Ruta Mockute, Mark Widdowson, Nicole Fornarotto, Sheryl Beauchamp, Salvatore Cicirello, Edward Mingle
Introduction: Regulations are increasing the scope of activities that fall under the remit of drug safety. Currently, individual case safety report (ICSR) collection and collation is done manually, requiring pharmacovigilance professionals to perform many transactional activities before data are available for assessment and aggregated analyses. For a biopharmaceutical company to meet its responsibilities to patients and regulatory bodies regarding the safe use and distribution of its products, improved business processes must be implemented to drive the industry forward in the best interest of patients globally...
2018: Pharmaceutical Medicine
Manfred Hauben, Robert Reynolds, Patrick Caubel
Data science is making increasing contributions to pharmacovigilance. Although the technical innovation of these works are indisputable, efficient progress in real-world pharmacovigilance signal detection may be hampered by corresponding technology life cycle effects, with a resulting tendency to conclude that, with large enough datasets and intricate algorithms, "the numbers speak for themselves," discounting the importance of clinical and scientific judgment. A practical consequence is overzealous declarations regarding the safety or lack of safety of drugs...
December 2018: Clinical Therapeutics
Vipin Kumar, Vivekanandan Kalaiselvan, A Pramod Kumar, Archana Saurabh, Prasad Thota, Shabir Sidhu, Bikash Medhi
BACKGROUND: Cefixime is a widely used third-generation cephalosporin schedule H1 drug, which is prescribed for the treatment of otitis media, respiratory tract infections, and uncomplicated urinary tract infections and is effective against infections caused by Enterobacteriaceae and Haemophilus influenzae species in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), has received rare individual case safety reports (ICSRs) for acute generalized exanthematous pustulosis (AGEP) associated with the use of cefixime...
July 2018: Indian Journal of Pharmacology
Connie Cheng, Afrouz Nayernama, S Christopher Jones, Denise Casey, Peter E Waldron
The U.S. Food and Drug Administration (FDA) has approved several vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors, including lenvatinib, for thyroid and renal malignancies. Inhibition of the VEGFR signaling pathway impairs angiogenesis and can disrupt wound healing. The objective of this work was to evaluate wound healing complications as a potential safety risk for patients treated with lenvatinib. We searched the FDA Adverse Event Reporting System (FAERS) database for postmarketing reports of wound healing complications with lenvatinib between 13 February 2015 (FDA approval date) and 15 February 2017...
November 30, 2018: Journal of Oncology Pharmacy Practice
Xavier Humbert, Sophie Fedrizzi, Basile Chrétien, Marion Sassier, Haleh Bagheri, Sandrine Combret, Milou-Daniel Drici, François Le Bas, Paolo E Puddu, Joachim Alexandre
Drug-induced hypertension was described with several pharmacological classes, especially with serotonin reuptake inhibitors (SRIs). However, this link has remained controversial: the French summary of product characteristics specify a risk of hypertension only with paroxetine and sertraline. To identify a possible class effect common to all SRIs, our study investigated the reports of hypertension associated with SRIs in two pharmacovigilance databases. Two different types of investigations were performed: (1) a comparative study in VigiBase® , which is the World Health Organization (WHO) pharmacovigilance database (PVDB), from where notifications of hypertension with six SRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) were extracted...
November 29, 2018: Fundamental & Clinical Pharmacology
Marco Sardella, Glyn Belcher
The assessment of the safety of medicines for rare diseases during the development phase is often limited by the few data available from small numbers of patients. This also applies to a lesser extent during the postmarketing phase of the lifecycle of a medicine. By using all available sources of data for rare diseases drugs, and by carefully assessing these data, the most informed safety profile can be obtained. This should also allow a clear view of data that are not available at any given time point and facilitates planning of strategies to obtain data through appropriate postmarketing risk management...
November 2018: Therapeutic Advances in Drug Safety
Fei Li, Weisong Liu, Hong Yu
BACKGROUND: Pharmacovigilance and drug-safety surveillance are crucial for monitoring adverse drug events (ADEs), but the main ADE-reporting systems such as Food and Drug Administration Adverse Event Reporting System face challenges such as underreporting. Therefore, as complementary surveillance, data on ADEs are extracted from electronic health record (EHR) notes via natural language processing (NLP). As NLP develops, many up-to-date machine-learning techniques are introduced in this field, such as deep learning and multi-task learning (MTL)...
November 26, 2018: JMIR Medical Informatics
Devesh Tewari, Pooja Rawat, Pawan Kumar Singh
Cancer, a life threatening disease adversely affects huge population worldwide. Naturally derived drug discovery has emerged as a potential pathway in search of anticancers. Natural products-based drugs are generally considered safe, compared to their synthetic counterparts. A systematic review on adverse drugs reactions (ADRs) of the anticancer natural products has not been performed till date. We reviewed anticancer drugs, derived from plants, microbes and marine sources with their mechanistic action and reported ADRs...
November 21, 2018: Food and Chemical Toxicology
Bruce A Donzanti
In recent decades, the field of drug safety/pharmacovigilance (PV) has advanced dramatically in some ways and yet has remained stagnant or progressed slowly in others. One way to assess the PV landscape is to view it through both a regulatory lens and a science and technology lens. This commentary highlights some of the current PV issues that can be resolved by sustained collaboration among all relevant stakeholders.
October 26, 2018: Clinical Therapeutics
Wei He, Difei Yao, Yangmin Hu, Haibin Dai
Background: Spontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in China have been a major source of ADE case reports, but the proportion of reports from tertiary hospitals is low due to the serious underreporting of case reports. The same problem existed in the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU). Objective: In order to increase the number of ADE reports and promote hospital pharmacovigilance, SAHZU's clinical pharmacists established a pharmacist-led ADE management model...
2018: Therapeutics and Clinical Risk Management
Niels S Vermeer, Thijs J Giezen, Sofia Zastavnik, Elena Wolff-Holz, Ana Hidalgo-Simon
Biologicals are established treatment options that require pharmacovigilance adapted to their specific nature, including the need for products to be identifiable up to the specific manufacturer in reports of adverse drug reactions (ADRs). This study explored the identifiability of ten classes of similar and related biologicals up to the level of the manufacturer in ADR reports received from European clinical practice between 2011 and June 2016. Adequate identifiers were reported for 96.7% of the suspected biologicals, ranging from 89...
November 21, 2018: Clinical Pharmacology and Therapeutics
Marie-Laure Kürzinger, Stéphane Schück, Nathalie Texier, Redhouane Abdellaoui, Carole Faviez, Julie Pouget, Ling Zhang, Stéphanie Tcherny-Lessenot, Stephen Lin, Juhaeri Juhaeri
BACKGROUND: While traditional signal detection methods in pharmacovigilance are based on spontaneous reports, the use of social media is emerging. The potential strength of Web-based data relies on their volume and real-time availability, allowing early detection of signals of disproportionate reporting (SDRs). OBJECTIVE: This study aimed (1) to assess the consistency of SDRs detected from patients' medical forums in France compared with those detected from the traditional reporting systems and (2) to assess the ability of SDRs in identifying earlier than the traditional reporting systems...
November 20, 2018: Journal of Medical Internet Research
Kanecia O Zimmerman, P Brian Smith, Ann W McMahon, Jean Temeck, Debbie Avant, Dianne Murphy, Susan McCune
Importance: The increasing prevalence of pediatric chronic disease has resulted in increased exposure to long-term drug therapy in children. The duration of recently completed drug trials that support approval for drug therapy in children with chronic diseases has not been systematically evaluated. Such information is a vital first step in forming safety pharmacovigilance strategies for drugs used for long-term therapy in children. Objective: To characterize the duration of clinical trials submitted to the US Food and Drug Administration (FDA) for pediatric drug approvals, with a focus on drugs used for long-term therapy...
November 19, 2018: JAMA Pediatrics
Joe-Elie Salem, Ali Manouchehri, Melissa Moey, Bénédicte Lebrun-Vignes, Lisa Bastarache, Antoine Pariente, Aurélien Gobert, Jean-Philippe Spano, Justin M Balko, Marc P Bonaca, Dan M Roden, Douglas B Johnson, Javid J Moslehi
BACKGROUND: Immune checkpoint inhibitors (ICIs) have substantially improved clinical outcomes in multiple cancer types and are increasingly being used in early disease settings and in combinations of different immunotherapies. However, ICIs can also cause severe or fatal immune-related adverse-events (irAEs). We aimed to identify and characterise cardiovascular irAEs that are significantly associated with ICIs. METHODS: In this observational, retrospective, pharmacovigilance study, we used VigiBase, WHO's global database of individual case safety reports, to compare cardiovascular adverse event reporting in patients who received ICIs (ICI subgroup) with this reporting in the full database...
November 9, 2018: Lancet Oncology
Thamir M AlShammari, Mohammed J Almoslem
Introduction: Adverse drug reactions ( ADRs) are a major global clinical problem, causing substantial mortality and morbidity especially in hospitals. Healthcare professionals (HCPs) knowledges', attitude and practices are crucial points to evaluate the hospital safety environment. Objective of the study was to investigate the knowledge, attitudes, and practices of HCPs regarding the ADRs reporting system. Methods: A cross-sectional survey was conducted between January and February of 2013 in nine tertiary care hospitals (governmental and private) that provide highly specialized medical services in Riyadh, Qassim, and the Eastern region of the Kingdom of Saudi Arabia...
November 2018: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Ornella Moreno-Mattar, Rosana Ramírez, Andrés Alvarado, Francisco Sierra
The Colombian National Food and Drug Surveillance Institute (INVIMA) is responsible for monitoring the safety and efficacy of medicines circulating in the Colombian market. This article summarizes the strategies implemented by INVIMA to strengthen the National Pharmacovigilance Program, including the expansion of the National Pharmacovigilance Network and the implementation of the electronic submission of adverse events. Results: the number of adverse events reported in Colombia increased from 5,447 in 2013 to 95,658 in 2017, reaching a population-based reporting ratio within international standards...
November 9, 2018: Current Drug Safety
Ilsa L Haeusler, Xin Hui S Chan, Philippe J Guérin, Nicholas J White
BACKGROUND: Several quinoline and structurally related antimalarial drugs are associated with cardiovascular side effects, particularly hypotension and electrocardiographic QT interval prolongation. A prolonged QT interval is a sensitive but not specific risk marker for the development of Torsade de Pointes-a potentially lethal polymorphic ventricular tachyarrhythmia. The increasing use of quinoline and structurally related antimalarials in mass treatments to eliminate malaria rapidly highlights the need to review their cardiovascular safety profiles...
November 7, 2018: BMC Medicine
Cristiano Matos, Gerda Weits, Florence van Hunsel
INTRODUCTION: Patient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance. AIM: The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance. METHODS: A descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018...
October 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Violeta I Getova, Stanislav R Georgiev, Assena H Stoimenova, Elina S Petkova-Georgieva
BACKGROUND: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system...
September 1, 2018: Folia Medica
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