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Pharmacovigilance is the science and activity relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance basically targets safety of medicine. Pharmacists have crucial role in health systems to maintain the rational and safe use of medicine for they are drug experts who are specifically trained in this field. Effective use of pharmacists' workforce will improve the outcome of the pharmacotherapy as well as decrease global health costs...
2016: Online Journal of Public Health Informatics
Kingston Rajiah, Mari Kannan Maharajan, Shashina Nair
Pharmacy students' knowledge about adverse drug reaction reporting can impact their attitude towards patient care and issues on patient safety. The aim of this study was to investigate the knowledge and perception of pharmacy students about adverse drug reaction reporting and pharmacovigilance and to study their willingness to report. A cross-sectional study using a validated questionnaire was conducted among the university students. The demographic details of the respondents were studied. The number of female respondents was comparatively higher than the male respondents...
September 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Racha Fadlallah, Fadi El-Jardali, Farah Annan, Hayat Azzam, Elie A Akl
BACKGROUND: A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. OBJECTIVE: The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting...
2016: Pharmaceutical Medicine
Isabelle Récoché, Vanessa Rousseau, Robert Bourrel, Maryse Lapeyre-Mestre, Leila Chebane, Fabien Despas, Jean-Louis Montastruc, Emmanuelle Bondon-Guitton
Many patients treated with imatinib, used in cancer treatment, are using several other drugs that could interact with imatinib. Our aim was to study all the drug-drug interactions (DDIs) observed in patients treated with imatinib.We performed 2 observational studies, between the 1st January 2012 and the 31st August 2015 in the Midi-Pyrénées area (South Western France), using the French health insurance reimbursement database and then the French Pharmacovigilance Database (FPVD).A total of 544 patients received at least 1 reimbursement for imatinib...
October 2016: Medicine (Baltimore)
Osvaldo Marrero, Eric Y Hung, Manfred Hauben
BACKGROUND: Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frames, seasonality of ADEs may have implications for signal detection. OBJECTIVE: The aim of this study was to investigate whether a set of illnesses that might be expected to display seasonality in general, did so when spontaneously reported as ADEs...
September 2016: Drugs—Real World Outcomes
Gulnihal Ozcan, Emel Aykac, Yelda Kasap, Nergiz T Nemutlu, Ebru Sen, N Demet Aydinkarahaliloglu
INTRODUCTION: In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE: In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. METHODS: We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter...
March 2016: Drugs—Real World Outcomes
Magdalena M Watras, Jignesh P Patel, Roopen Arya
Hair loss is associated with the anticoagulants heparin and warfarin. With the recent availability of direct oral anticoagulants (DOACs) it is of clinical interest to know if they are implicated with hair loss and/or whether they could be successfully prescribed for patients who suffer from coumarin- or heparin-related alopecia. Initially reports of heparin- and coumarin-associated alopecia available through PubMed and Medline were explored in order to establish the cause of this side effect. Currently there is a lack of unanimity on why anticoagulants cause alopecia...
March 2016: Drugs—Real World Outcomes
Joachim Alexandre, Xavier Humbert, Marion Sassier, Paul Milliez, Antoine Coquerel, Sophie Fedrizzi
Cluster headache (CH) is a primary headache disorder with relatively effective treatments. Although few sufficiently controlled trials are available, verapamil is recommended as the first-line prophylactic drug for CH by the French Headache Society (with a low level of evidence, level B) and by the EFNS (European Federation of Neurological Societies, level A). Daily doses of more than 480 mg (and up to 1200 mg daily) are frequently used off-label, while 360 mg daily is the only dosage to have demonstrated its effectiveness in a double-blind trial against placebo, and the usual label posology used by cardiologists is 240 mg daily in hypertension...
December 2015: Drug Saf Case Rep
J-N Chatelet, M Auffret, S Combret, E Bondon-Guitton, M Lambert, S Gautier
INTRODUCTION: Several cases of hearing loss induced by hydroxychloroquine have been reported in the literature but the role of hydroxychloroquine still remains debated. CASE REPORT: We report the first case, to our knowledge, of hearing loss induced by hydroxychloroquine with a positive re challenge in a woman treated for systemic lupus. An analysis of the French pharmacovigilance database allowed to identify 23 additional cases of hearing loss in patients treated with hydroxychloroquine and, among them, 8 had systemic lupus...
October 13, 2016: La Revue de Médecine Interne
Choki Dorji, Pramote Tragulpiankit, Arthorn Riewpaiboon, Tashi Tobgay
INTRODUCTION: The Bhutan National Pharmacovigilance Centre (NPC) became an official member of the WHO Programme for International Drug Monitoring in December 2014; however, the number of adverse drug reactions (ADRs) reported is very low (50 reports per 773,722 inhabitants over 10 years). Surveys of healthcare professionals (HCPs) in similar countries have indicated that adequate knowledge of both ADRs and ADR reporting is likely to increase the number of ADR reports submitted. OBJECTIVE: The aim of this study was to investigate the level of knowledge of both ADRs and ADR reporting among HCPs, including traditional medicine practitioners...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Jisha Myalil Lucca, Madhan Ramesh, Gurumurthy Parthasarathi, Dushad Ram
AIMS/OBJECTIVES: Psychotropic drugs are associated with significant short-term and long-term safety issues which may affect patients' mental health, physical health and cost of care. EXPERIMENTAL DESIGNS: This was a prospective study conducted in psychiatry department of a tertiary care hospital. Study included patients of any age and either sex who presented with psychiatric illness as diagnosed by ICD-10 and were receiving at least one psychotropic agent. The study involved both intensive and spontaneous reporting methods to identify ADRs...
March 1, 2016: Psychopharmacology Bulletin
Olivier Colin, Sylvie Favrelière, Alexandre Quillet, Jean-Philippe Neau, Jean-Luc Houeto, Claire Lafay-Chebassier, Marie-Christine Pérault-Pochat
Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period...
October 13, 2016: Fundamental & Clinical Pharmacology
Amy Tanti, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems...
October 12, 2016: Expert Opinion on Drug Safety
Steven Jarrett, Theodor Dingermann
BACKGROUND: Pharmacists are the recognized experts in pharmacotherapy. With the recent introduction of biosimilar agents into the US market, pharmacists are poised to play a pivotal role in evaluating their risks versus benefits within the framework of cost containment. PURPOSE: This article provides hospital pharmacists with the necessary information on the principles surrounding the development, approval process, and use of biosimilars. METHODS: Information contained in this article enables hospital pharmacists to identify concerns relating to biosimilars, implement educational components, and successfully evaluate biosimilars for the addition to the formulary...
November 2015: Hospital Pharmacy
Charles Khouri, Marion Lepelley, Céline Villier, Thierry Bougerol, Michel Mallaret
PURPOSE: Cyamemazine (Tercian(®)) is currently the most widely prescribed neuroleptic in France. This widespread use is due to its anxiolytics properties and to a claimed good safety profile. Although, prescription of cyamemazine is not devoid of the risks associated with the use of neuroleptics: extrapyramidal syndromes. This study aims at describing extrapyramidal syndromes induced by cyamemazine registered in the French pharmacovigilance database. METHODS: All spontaneous reports of extrapyramidal syndromes in the French pharmacovigilance database between 1st January 1985 and 31th December 2015 were described and analyzed...
September 15, 2016: Thérapie
Hasitha Diana Manohar, Shalini Adiga, Joseph Thomas, Ajitha Sharma
OBJECTIVES: The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. MATERIALS AND METHODS: Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form...
September 2016: Indian Journal of Pharmacology
Frederike Reichmann, Annette Pfitzner, Guenter Rademacher, Elke Schwedinger, Klaus Cussler, Carola M Sauter-Louis
BACKGROUND: Several research groups from different European countries have worked on the aetiopathogenesis of bovine neonatal pancytopenia (BNP) and an association between the use of the vaccine PregSure BVD (Pfizer, Germany) and the development of this haemorrhagic disease was confirmed. Because BNP is not a notifiable disease, it is difficult to obtain information on its incidence. Based on pharmacovigilance (PhV) data, which are the only officially available data at the national level, the incidence of BNP is considered low...
October 7, 2016: BMC Veterinary Research
Sze Ling Chan, Mun Yee Tham, Siew Har Tan, Celine Loke, Belinda Foo, Yanping Fan, Pei San Ang, Liam R Brunham, Cynthia Sung
The aim of this study was to develop and validate sensitive algorithms to detect hospitalized statin-induced myopathy (SIM) cases from electronic medical records (EMRs). We developed 4 algorithms on a training set of 31,211 patient records from a large tertiary hospital. We determined the performance of these algorithms against manually curated records. The best algorithm used a combination of elevated creatine kinase (>4x upper limit of normal), discharge summary, diagnosis, and absence of statin in discharge medications...
October 5, 2016: Clinical Pharmacology and Therapeutics
Hadyl Asfari, Julien Souvignet, Agnès Lillo-Le Louët, Béatrice Trombert, Marie-Christine Jaulent, Cédric Bousquet
AIM: To propose an alternative approach for building custom groupings of terms that complements the usual approach based on both hierarchical method (selection of reference groupings in medical dictionary for regulatory activities [MedDRA]) and/or textual method (string search), for case reports extraction from a pharmacovigilance database in response to a safety problem. Here we take cardiac valve fibrosis as an example. METHODS: The list of terms obtained by an automated approach, based on querying ontology of adverse drug reactions (OntoADR), a knowledge base defining MedDRA terms through relationships with systematized nomenclature of medicine-clinical terms (SNOMED CT) concepts, was compared with the reference list consisting of 53 preferred terms obtained by hierarchical and textual method...
July 21, 2016: Thérapie
Dhivya Shanmughanandhan, Subramanyam Ragupathy, Steven G Newmaster, Saravanan Mohanasundaram, Ramalingam Sathishkumar
INTRODUCTION: India is considered the 'medicinal garden' of the world, with 8000 medicinal plants of which 960 are commercial species that are traded nationally and globally. Although scientific studies estimate herbal product adulteration as 42-66 % in North America, India does not have any published marketplace studies and subsequent estimates of adulteration in an industry facing considerable supply demands. OBJECTIVES: The goal of this project is to provide an initial assessment of herbal product authentication and adulteration in the marketplace in India by (1) developing a biological reference material (BRM) herbal DNA library for Indian herbal species using DNA barcode regions (ITS2 and rbcL) in order to facilitate accurate species resolution when testing the herbal products; and (2) assessing herbal product identification using our BRM library; and (3) comparing the use of our BRM library to identify herbal products with that of GenBank...
September 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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