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Pharmacovigilance- Drug safety

Kristina Star, Lovisa Sandberg, Tomas Bergvall, Imti Choonara, Pia Caduff-Janosa, I Ralph Edwards
PURPOSE: The purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics. METHODS: Individual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years...
February 15, 2019: Pharmacoepidemiology and Drug Safety
Minh Pham, Feng Cheng, Kandethody Ramachandran
INTRODUCTION: It is important to monitor the safety profile of drugs, and mining for strong associations between drugs and adverse events is an effective and inexpensive method of post-marketing safety surveillance. OBJECTIVE: The objective of our work was to compare the accuracy of both common and innovative methods of data mining for pharmacovigilance purposes. METHODS: We used the reference standard provided by the Observational Medical Outcomes Partnership, which contains 398 drug-adverse event pairs (165 positive controls, 233 negative controls)...
February 14, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Joyce Pijpers, Margriet L den Boer, Dirk R Essink, Koert Ritmeijer
BACKGROUND: Miltefosine (MF) is the only oral drug available for treatment of visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL). Although the drug is effective and well tolerated in treatment of VL, the efficacy and safety of MF for longer treatment durations (>28 days) in PKDL remains unclear. This study provides an overview of the current knowledge about safety and efficacy of long treatment courses with MF in PKDL, as a strategy in the VL elimination in South Asia...
February 11, 2019: PLoS Neglected Tropical Diseases
Yue Yu, Kathryn J Ruddy, Na Hong, Shintaro Tsuji, Andrew Wen, Nilay D Shah, Guoqian Jiang
OBJECTIVE: Supplementing the Spontaneous Reporting System (SRS) with Electronic Health Record (EHR) data for adverse drug reaction detection could augment sample size, increase population heterogeneity and cross-validate results for pharmacovigilance research. The difference in the underlying data structures and terminologies between SRS and EHR data presents challenges when attempting to integrate the two into a single data base. The Observational Health Data Sciences and Informatics (OHDSI) collaboration provides a Common Data Model (CDM) for organizing and standardizing EHR data to support large-scale observational studies...
February 7, 2019: Journal of Biomedical Informatics
Doaa Alkhalidi, Shazia Qasim Jamshed, Ramadan Mohamed Elkalmi, Mirza Rafi Baig, Adeel Aslam, Mohamed Azmi Hassali
Ensuring drug safety among the patients is the main domain of pharmacovigilance activities worldwide. A pharmacovigilance system was established in the United Arab Emirates (UAE) in 2008. Research evidence reflects that the current system is lacking in active participation from patients, and also, the inadequate role of healthcare professionals is anticipated. In this context, it is pertinent to know the general public's understandings and their patterns of safe use of medication, which are unexplored areas in Dubai, UAE...
February 7, 2019: Pharmacy (Basel, Switzerland)
Rumeng Li, Baotian Hu, Feifan Liu, Weisong Liu, Francesca Cunningham, David D McManus, Hong Yu
BACKGROUND: Bleeding events are common and critical and may cause significant morbidity and mortality. High incidences of bleeding events are associated with cardiovascular disease in patients on anticoagulant therapy. Prompt and accurate detection of bleeding events is essential to prevent serious consequences. As bleeding events are often described in clinical notes, automatic detection of bleeding events from electronic health record (EHR) notes may improve drug-safety surveillance and pharmacovigilance...
February 8, 2019: JMIR Medical Informatics
Dieter De Meestere, Jan Saevels
BACKGROUND: Pharmacovigilance legislation was introduced back in 2012 with new concepts such as the inverted black triangles and risk minimisation activities. Healthcare professionals need to familiarize themselves with these new notions in order to comply with their obligations such as risk mitigation and reporting of adverse drug reactions. OBJECTIVE: To measure the magnitude and relevance of these new concepts and the impact on everyday dispensing in Belgian community pharmacies...
January 10, 2019: Research in Social & Administrative Pharmacy: RSAP
Thomas Felix, John B Jordan, Catherine Akers, Bina Patel, Daniela Drago
Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs...
February 4, 2019: Expert Opinion on Drug Safety
Zahra Karimian, Mehrnaz Kheirandish, Naghmeh Javidnikou, Gholamreza Asghari, Fariba Ahmadizar, Rassoul Dinarvand
Medication errors are the second most common cause of adverse patient safety incidents and the single most common preventable cause of adverse events in medical practice. Given the high human fatalities and financial burden of medication errors for healthcare systems worldwide, reducing their occurrence is a global priority. Therefore, appropriate policies to reduce medication errors, using national data and valid statistics are required. The primary objective of this study was to provide a national 'characteristic profile' of medication error-associated adverse drug reactions (ADRs), which are also known as preventable ADRs (pADRs)...
September 18, 2018: International Journal of Health Policy and Management
Malak Abou Taam, Claire Ferard, Pauline Rocle, Patrick Maison
During the past few decades, it has been stated that a paradigm shift has occurred in the assessment and management of patient related drug safety. Some of these changes have resulted in a significant increase in the importance of pharmacoepidemiology and its use in pharmacovigilance. For European member states, the Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols and results of imposed and non-imposed post-authorization safety studies (PASS). Between 2013 and 2017, the total number of PASS during this 5-years period of the different products, including protocols and results, was 1062...
January 9, 2019: Thérapie
Marco Casciaro, Michele Navarra, Giuseppina Inferrera, Marta Liotta, Sebastiano Gangemi, Paola Lucia Minciullo
Proton pump inhibitors (PPIs) are drugs capable of blocking the gastric pump H,K-ATPase in order to inhibit gastric acid secretion. Omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole belong to PPIs category. Although PPIs have a good safety profile, allergic reactions to these molecules can occur. The real rate of hypersensitive reactions to PPIs is unknown. The aim of this retrospective study is to evaluate the rate of hypersensitive reactions to PPIs in patients admitted to our Unit between 2008 and 2013 with a history of drug hypersensitivity...
2019: Clinical and Molecular Allergy: CMA
Huan-Huan Ji, Xue-Wen Tang, Zhi Dong, Lin Song, Yun-Tao Jia
BACKGROUND AND OBJECTIVE: Immune checkpoint inhibitors (ICIs)-cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1) monoclonal antibodies (mAbs)-either as single agents or in combination have become the standard of care for an increasing number of indications. Understanding both the ICI-associated adverse events (AEs) and the possible rank-order of these drugs in terms of susceptibility is essential if we are to improve the curative effect and reduce toxicity...
January 23, 2019: Clinical Drug Investigation
Min Gyu Kang, Kyung Hee Sohn, Dong Yoon Kang, Han Ki Park, Min Suk Yang, Ju Yeun Lee, Hye Ryun Kang
PURPOSE: Despite morbidities and fatalities, nationwide epidemiologic data for severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), are not widely available. We aimed to investigate SCAR epidemiology over the last two decades in Korea. MATERIALS AND METHODS: We analyzed individual case safety reports (ICSRs) of SCARs in the Korea Adverse Event Reporting System from 1988 to 2013...
February 2019: Yonsei Medical Journal
Kyung Hee Park, Sang Chul Lee, Ji Eun Yuk, Sung Ryeol Kim, Jae Hyun Lee, Jung Won Park
PURPOSE: Eperisone is an oral muscle relaxant used in musculoskeletal disorders causing muscle spasm and pain. For more effective pain control, eperisone is usually prescribed together with nonsteroidal anti-inflammatory drugs (NSAIDs). As such, eperisone may have been overlooked as the cause of anaphylaxis compared with NSAIDs. This study aimed to analyze the adverse drug reaction (ADR) reported in Korea and suggest an appropriate diagnostic approach for eperisone-induced anaphylaxis...
March 2019: Allergy, Asthma & Immunology Research
Lucília Canesin Basile, Adriano Dos Santos, Lucilena Bardella Stelzer, Renata Camargo Alves, Cassiana Mendes Bertoncello Fontes, Maria Helena Borgato, Silvia Justina Papini, Silvana Andrea Molina Lima
OBJECTIVE: To analyze the reports of incidents related to potentially hazardous medications distributed at a teaching hospital in the interior of São Paulo. METHODS: A descriptive, retrospective study with a quantitative approach of data from the analysis of pharmacovigilance notifications that occurred between January 2009 and December 2014, from tables and graphs, showing the absolute/relative frequencies. RESULTS: From 786 reports of pharmacovigilance, 188 were related to potentially hazardous medicines, 36...
January 10, 2019: Revista Gaúcha de Enfermagem
Suehyun Lee, Jongsoo Han, Rae Woong Park, Grace Juyun Kim, John Hoon Rim, Jooyoung Cho, Kye Hwa Lee, Jisan Lee, Sujeong Kim, Ju Han Kim
INTRODUCTION: Integration of controlled vocabulary-based electronic health record (EHR) observational data is essential for real-time large-scale pharmacovigilance studies. OBJECTIVE: To provide a semantically enriched adverse drug reaction (ADR) dictionary for post-market drug safety research and enable multicenter EHR-based extensive ADR signal detection and evaluation, we developed a comprehensive controlled vocabulary-based ADR signal dictionary (CVAD) for pharmacovigilance...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Abhyuday Jagannatha, Feifan Liu, Weisong Liu, Hong Yu
INTRODUCTION: This work describes the Medication and Adverse Drug Events from Electronic Health Records (MADE 1.0) corpus and provides an overview of the MADE 1.0 2018 challenge for extracting medication, indication, and adverse drug events (ADEs) from electronic health record (EHR) notes. OBJECTIVE: The goal of MADE is to provide a set of common evaluation tasks to assess the state of the art for natural language processing (NLP) systems applied to EHRs supporting drug safety surveillance and pharmacovigilance...
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Feifan Liu, Abhyuday Jagannatha, Hong Yu
No abstract text is available yet for this article.
January 16, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Nidhi S Chauhan, Samidh P Shah, Mira K Desai, Asha Shah
Background: Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART). Materials and Methods: All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used. ADRs were also analyzed for system organ classification, seriousness, time relationship of ADRs with drug therapy, causality (as per the World Health Organization-Uppsala Monitoring Centre scale and Naranjo algorithm), and severity (Hartwig and Siegel scale)...
July 2018: Indian journal of sexually transmitted diseases and AIDS
Xi Yang, Jiang Bian, Yan Gong, William R Hogan, Yonghui Wu
INTRODUCTION: Early detection of adverse drug events (ADEs) from electronic health records is an important, challenging task to support pharmacovigilance and drug safety surveillance. A well-known challenge to use clinical text for detection of ADEs is that much of the detailed information is documented in a narrative manner. Clinical natural language processing (NLP) is the key technology to extract information from unstructured clinical text. OBJECTIVE: We present a machine learning-based clinical NLP system-MADEx-for detecting medications, ADEs, and their relations from clinical notes...
January 2, 2019: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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