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Pharmacovigilance

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https://www.readbyqxmd.com/read/28104709/utility-of-social-media-and-crowd-sourced-data-for-pharmacovigilance-a-scoping-review-protocol
#1
Andrea C Tricco, Wasifa Zarin, Erin Lillie, Ba Pham, Sharon E Straus
INTRODUCTION: Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products...
January 19, 2017: BMJ Open
https://www.readbyqxmd.com/read/28101815/developing-a-crowdsourcing-approach-and-tool-for-pharmacovigilance-education-material-delivery
#2
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/28098949/identification-of-cellular-targets-involved-in-cardiac-failure-caused-by-pki-in-oncology-an-approach-combining-pharmacovigilance-and-pharmacodynamics
#3
E Patras de Campaigno, E Bondon-Guitton, G Laurent, F Montastruc, J L Montastruc, M Lapeyre-Mestre, F Despas
AIMS: To evaluate the risk of cardiac failure (CF) of 15 anticancer protein kinase inhibitors (PKIs) through a case/non-case analysis and to identify which PK(s) and pathways are involved in PKI-induced CF. METHODS: To evaluate the risk of CF, adjusted reporting odds ratios (aRORs) were calculated for the 15 anticancer PKIs in the WHO safety report database (VigiBase®). We realised a literature review to identify 21 PK possibly involved in CF caused by PKIs. Pearson's correlation coefficients (r) between aROR and affinity data of the 15 PKIs for the 21 PKs were calculated to identify the cellular target most likely involved in PKI-induced CF...
January 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28094583/signal-detection-activity-on-eudravigilance-data-analysis-of-the-procedure-and-findings-from-an-italian-regional-centre-for-pharmacovigilance
#4
Luca Monaco, Mauro Melis, Chiara Biagi, Monia Donati, Ester Sapigni, Alberto Vaccheri, Domenico Motola
BACKGROUND: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. METHOD: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe...
January 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28090715/health-care-professionals-knowledge-and-perception-of-pharmacovigilance-in-a-tertiary-care-teaching-hospital-in-amman-jordan
#5
Khawla Abu Hammour, Faris El-Dahiyat, Rana Abu Farha
RATIONALE, AIMS, AND OBJECTIVES: Underreporting of adverse drug reactions (ADRs) by health care professionals is a common inherent health problem encountered in many countries. This could be explained by the lack of awareness and knowledge about the guidelines to follow to identify and report ADRs. Thus, this study aimed to evaluate the awareness, knowledge, and perceptions among medical doctors and nurses regarding their role as ADRs reporters in Jordan. METHODS: A cross-sectional study was conducted between September 2015 to January 2016 at the Jordan University Hospital in Amman...
January 16, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28087585/standard-based-comprehensive-detection-of-adverse-drug-reaction-signals-from-nursing-statements-and-laboratory-results-in-electronic-health-records
#6
Suehyun Lee, Jiyeob Choi, Hun-Sung Kim, Grace Juyun Kim, Kye Hwa Lee, Chan Hee Park, Jongsoo Han, Dukyong Yoon, Man Young Park, Rae Woong Park, Hye-Ryun Kang, Ju Han Kim
OBJECTIVE: We propose 2 Medical Dictionary for Regulatory Activities-enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. MATRIALS AND METHODS: This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)-based pharmacovigilance method, called CLEAR...
January 13, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28079787/oral-and-vulvo-vaginal-lichenoid-reactions-due-to-mitotane-lysodren-a-case-report
#7
Arthur Schmouchkovitch, Héloïse Herry, Philippe Thuillier, Véronique Kerlan, Camille Fleuret, Guy Le Toux, Sylvie Boisramé
BACKGROUND: The purpose of pharmacovigilance (drug safety) is collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. It is meant to identify, characterize, prevent, or minimize actual or potential risks relating to medicinal products. To prevent these adverse effects and improve our practice, health professionals have a duty to report side effects to assess this risk and evaluate the benefit/risk requirements. Mitotane (Lysodren) is used for treating adrenocortical carcinoma...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28071845/influence-of-age-sex-and-seriousness-on-reporting-of-adverse-drug-reactions-in-sweden
#8
Lennart Holm, Elisabet Ekman, Kerstin Jorsäter Blomgren
PURPOSE: To investigate how reporting of adverse drug reactions (ADRs) among adults in Sweden is associated to age and sex, in addition to seriousness of the reaction and drug utilisation. METHODS: Individual case safety reports (ICSRs) reported by healthcare professionals to the national pharmacovigilance database 2008-2011 were related to defined daily dose (DDD) in the Swedish Prescribed Drug Register (SPDR) for individual's ≥20 years. Data were stratified into five age groups...
January 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28068848/the-safety-of-emerging-biosimilar-drugs-for-the-treatment-of-rheumatoid-arthritis
#9
J Braun, J Kay
Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest...
January 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28067776/sensitivity-of-quantitative-signal-detection-in-regards-to-pharmacological-neuroenhancement
#10
Maximilian Gahr, Bernhard J Connemann, Carlos Schönfeldt-Lecuona, René Zeiss
Pharmacological neuroenhancement (PNE) is a form of abuse and has not yet been addressed by methods of pharmacovigilance. In the present study, we tested if quantitative signal detection may be sensitive in regards to PNE. We evaluated the risk of drug abuse and dependence (DAAD) related to substances that are known to be used for PNE and divided this group into agents with (methylphenidate) and without a known abuse potential outside the field of PNE (atomoxetine, modafinil, acetylcholine esterase inhibitors, and memantine)...
January 5, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28066878/safety-and-effectiveness-of-sodium-stibogluconate-and-paromomycin-combination-for-the-treatment-of-visceral-leishmaniasis-in-eastern-africa-results-from-a-pharmacovigilance-programme
#11
Robert Kimutai, Ahmed M Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A G Khalil, Ermias Diro, Peninah Soipei, Brima Musa, Khalid Salman, Koert Ritmeijer, Francois Chappuis, Juma Rashid, Rezika Mohammed, Asfaw Jameneh, Eyasu Makonnen, Joseph Olobo, Lawrence Okello, Patrick Sagaki, Nathalie Strub, Sally Ellis, Jorge Alvar, Manica Balasegaram, Emilie Alirol, Monique Wasunna
INTRODUCTION: In 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa. The new treatment, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM) was an improvement over SSG monotherapy, the previous first-line VL treatment in the region. To monitor the new treatment's safety and effectiveness in routine clinical practice a pharmacovigilance (PV) programme was developed. METHODS: A prospective PV cohort was developed...
January 9, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28066097/pharmacovigilance-programme-of-india-recent-developments-and-future-perspectives
#12
Vivekanandan Kalaiselvan, Prasad Thota, Gyanendra Nath Singh
Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28065444/investigating-patient-narratives-posted-on-internet-and-their-informativeness-level-for-pharmacovigilance-purpose-the-example-of-comments-about-statins
#13
Farid Kheloufi, Anne Default, Olivier Blin, Joelle Micallef
AIM OF THE STUDY: Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. METHODS: A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines...
December 9, 2016: Thérapie
https://www.readbyqxmd.com/read/28065342/world-allergy-organization-systemic-allergic-reaction-grading-system-is-a-modification-needed
#14
Linda S Cox, Mario Sanchez-Borges, Richard F Lockey
There is no universally accepted grading system to classify the severity of systemic allergic reactions (SARs), including anaphylaxis. Although a consensus definition for anaphylaxis was established in 2005, the signs and symptoms required to define a reaction as anaphylaxis are inconsistently applied in research and clinical practice. As a result, it is difficult to compare and evaluate safety outcomes in surveys, clinical practice and trials, and pharmacovigilance data. In 2010, the World Allergy Organization (WAO) proposed a uniform grading system to classify allergen immunotherapy SARs...
January 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28063022/identification-of-a-syndrome-class-of-neuropsychiatric-adverse-reactions-to-mefloquine-from-latent-class-modeling-of-fda-adverse-event-reporting-system-data
#15
Remington L Nevin, Jeannie-Marie Leoutsakos
INTRODUCTION: Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. METHODS: Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs...
January 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28060221/valproic-acid-special-considerations-and-targeted-monitoring
#16
Angela Collins-Yoder, Jordan Lowell
Valproic acid (VPA) is a medication used to treat multiple neuroscience conditions. It is an inexpensive and useful medication, with a low incidence of adverse drug events. Nonetheless, optimal clinical outcomes require that a series of screening and laboratory steps be followed before the initiation of VPA therapy. An additional aspect of pharmacovigilance is to recognize clinical patterns signaling genetic traits that preclude VPA, background of the black box warnings, targeted assessments, and laboratory monitoring indicated while on VPA...
February 2017: Journal of Neuroscience Nursing: Journal of the American Association of Neuroscience Nurses
https://www.readbyqxmd.com/read/28057047/effect-of-an-educational-intervention-on-knowledge-and-attitude-regarding-pharmacovigilance-and-consumer-pharmacovigilance-among-community-pharmacists-in-lalitpur-district-nepal
#17
Nisha Jha, Devendra Singh Rathore, Pathiyil Ravi Shankar, Shital Bhandary, Rabi Bushan Pandit, Sudesh Gyawali, Mohamed Alshakka
BACKGROUND: Pharmacovigilance activities are in a developing stage in Nepal. ADR reporting is mainly confined to healthcare professionals working in institutions recognized as regional pharmacovigilance centers. Community pharmacists could play an important role in pharmacovigilance. This study was conducted among community pharmacists in Lalitpur district to examine their knowledge and attitude about pharmacovigilance before and after an educational intervention. METHODS: Knowledge and attitude was studied before, immediately after and 6 weeks following the intervention among 75 community pharmacists...
January 3, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28056184/feasibility-of-retrospective-pharmacovigilance-studies-in-hospice-care-a-case-study-of-antibiotics-for-the-treatment-of-urinary-tract-infections
#18
Jon P Furuno, Brie N Noble, David T Bearden, Erik K Fromme
No abstract text is available yet for this article.
January 5, 2017: Journal of Palliative Medicine
https://www.readbyqxmd.com/read/28050397/ofloxacin-induced-angioedema-a-rare-adverse-drug-reaction
#19
Gautam Rawal, Sankalp Yadav, Raj Kumar, Umar Rasool Wani
The Adverse Drug Reaction (ADR) to a commonly prescribed anti-microbial can pose a major public health problem. The authors report a rare case of 24-year-old young lady who presented with angioedema of lips after ingestion of Ofloxacin, prescribed to her for treatment of loose motions. Fluoroquinolones are widely prescribed antibiotics for various disease conditions. The history, clinical examination and normal laboratory parameters led to the diagnosis of ofloxacin induced hypersensitivity reaction and the patient was successfully treated with corticosteroids and antihistamines...
November 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28050389/haemovigilance-a-current-update-in-indian-perspective
#20
REVIEW
Somnath Mukherjee, Rituparna Maiti
Haemovigilance is an organised scheme of monitoring, identifying, reporting, investigating and analysing adverse events and reactions pertinent to transfusion and manufacturing blood products. This system is also an elemental part of quality control in a blood system, bringing about corrective and preventive measures, and for the perpetual advancement of the quality and safety of blood products and the transfusion process. Nowadays haemovigilance setups have been enforced throughout the globe in most developed countries, to monitor the adverse reactions and episodes associated with blood donations and transfusions...
November 2016: Journal of Clinical and Diagnostic Research: JCDR
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