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Pharmacovigilance- Drug safety

Olufunsho Awodele, Rebecca Aliu, Ibrahim Ali, Yetunde Oni, Christianah Mojisola Adeyeye
Adverse drug reactions (ADRs) are expected to be associated with an economic drain on the healthcare systems. The study was carried out to determine the occurrence of ADRs reported to NAFDAC Pharmacovigilance from January to June 2015, to illustrate the pattern of organ system affected by ADRs, to assess the completeness of ADR report, to determine the relationship between the occurrence of ADRs with suspect drugs and the use of concomitant drugs as well as to generate possible signals from the reported ADRs...
October 2018: Pharmacology Research & Perspectives
Carlos A López-Morales, Alejandra Tenorio-Calvo, Rodolfo Cruz-Rodríguez, Julio Sánchez Y Tepoz, Lahouari Belgharbi, Sonia Mayra Pérez-Tapia, Emilio Medina-Rivero
Biotherapeutic products which are derived from living organisms using recombinant DNA technology significantly contribute to the progress in the treatment of life-threatening and chronic diseases. The worldwide sale of biological drugs in 2016 was near US $263,700 million. In Latin America, where monoclonal antibodies market was worth US $7000 million, being Mexico the second largest market. Approval is one of the key aspects which influences the market of medicinal products, thus it is responsibility of the regulatory authority to establish a regulatory framework that ensure safety and efficacy of the products, and it is responsibility of the applicants to provide a high quality dossier in accordance with the registration requirements of the country...
2018: Frontiers in Medicine
Agnese Gugliandolo, Federica Longo, Maria Giovanna Marrosu, Giovanni Luigi Mancardi, Ilaria Gandoglia, Maurizio Melis, Fabrizio Lo Giudice, Placido Bramanti, Emanuela Mazzon
Purpose: We performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions. Patients and methods: We collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months. Results: We received a total of 411 adverse reactions, of which 84...
2018: Therapeutics and Clinical Risk Management
Karel Allegaert, Paola Mian, Alexandre Lapillonne, John N van den Anker
Recent case reports describe an association between maternal paracetamol intake and fetal ductus arteriosus constriction or closure. To put these cases into perspective and explore causality, a structured literature search was conducted. The World Health Organization Uppsala Monitoring Center (WHO-UMC) causality tool was applied to the cases retrieved. The search resulted in 12 papers with 25 case descriptions, of whom 1 case was classified as unlikely, 9 as possible, 11 as probable and 4 as certain. Consequently, we conclude that a causal relationship between maternal paracetamol intake and fetal ductus arteriosus constriction or closure is likely...
October 9, 2018: British Journal of Clinical Pharmacology
Irma Convertino, Sara Ferraro, Corrando Blandizzi, Marco Tuccori
Social media mining could be a possible strategy to retrieve drug safety information. The mining of social media is a complex process under progressive evolution, falling into three broad categories: listening (safety data reporting), engaging (follow-up) and broadcasting (risk communication). This systematic review is aimed at evaluating the usefulness and quality of proto-signals by social media listening. Areas covered: In this systematic search, performed according to MOOSE and PRISMA statements, we selected studies, published in MEDLINE, EMBASE and Google Scholar until December 31st , 2017, that listened at least one social media to identify proto-adverse drug events and proto-signals...
October 4, 2018: Expert Opinion on Drug Safety
Agnes Kant, Loes de Vries, Leàn Rolfes
INTRODUCTION: Surveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear. AIM: The aim of this study was to provide insight into current activities, future intentions and need for support of national PV centres in the field of drug safety during pregnancy. METHOD: A web-based questionnaire was used to ask PV centres about their current activities concerning the surveillance of drug safety during pregnancy, their intentions to implement or improve activities and need for support...
October 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Begoña Calvo, Javier Martinez-Gorostiaga, Enrique Echevarria
The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies. The European Medicines Agency (EMA) has been the first to issue scientific guidelines related to regulatory requirements for the approval of biosimilars. These guidelines have been being updated in line with advances in analytical techniques and growing experience in the clinical use of these drugs. Given the complex nature of biological medicines, they pose a greater potential risk of immunogenicity than nonbiological medicines, and hence warrant special consideration...
October 2018: Therapeutic Advances in Drug Safety
Frank Moriarty, Shegufta Razzaque, Ronald McDowell, Tom Fahey
INTRODUCTION: Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among general practitioner (GP) practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB)...
October 3, 2018: Journal of Clinical Medicine
Massimo Uguccioni, Antonio Terranova, Luca Di Lullo
The introduction into clinical practice of direct oral anticoagulants (DOAC) has widened the scenario in the prevention and treatment of thromboembolism. However, the evaluation of the balance between the thrombotic and hemorrhagic risks is a critical issue in the choice of an oral anticoagulant agent. The availability of safety and efficacy data for each drug represents the basis to operate treatment choices. As there are no head-to-head studies comparing the different DOACs in terms of safety and efficacy, and considering the differences in registrative trial designs and characteristics of enrolled populations, several meta-analyses and real-life studies have tried to trace the safety and efficacy profiles on DOACs, but at present no definitive conclusions can be drawn due to numerous existing biases...
October 2018: Giornale Italiano di Cardiologia
Andrea Farcaş, Andreea Măhălean, Noémi Beátrix Bulik, Daniel Leucuta, Cristina Mogoșan
BACKGROUND: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC). METHODS: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014-November 2017 were analyzed and classified. RESULTS: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC...
October 2018: Expert Review of Clinical Pharmacology
V Kalaiselvan, Sushma Srivastava, Abhishank Singh, S K Gupta
Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken...
September 29, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Yusuf Ergün, Tansel Bekiroglu Ergün, Eylem Toker, Esengül Ünal, Mine Akben
Background: Pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) have pivotal roles in drug safety. This study aimed to evaluate the knowledge, attitude and practice of health professionals towards pharmacovigilance in a university hospital in Turkey. Methods: An observational, cross-sectional study via a 25-item self-administered questionnaire was conducted among physicians (n=161) and nurses (n=321). Results: Although 66% (320/482) of the subjects were aware of the 'pharmacovigilance' term, the awareness of the Turkish Pharmacovigilance Center was as low as 30% (161/482)...
September 28, 2018: International Health
Sofia B Santos, José M Sousa Lobo, Ana C Silva
This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area and more approved biosimilars are expected over the next few years, providing cost-effective drugs to more patients...
September 19, 2018: Drug Discovery Today
Ippazio Cosimo Antonazzo, Elisabetta Poluzzi, Emanuele Forcesi, Trond Riise, Kjetil Bjornevik, Elisa Baldin, Luigi Muratori, Fabrizio De Ponti, Emanuel Raschi
BACKGROUND: Drug-induced liver injury (DILI) has been observed in patients with multiple sclerosis (MS), raising concerns on the liver safety of MS drugs. OBJECTIVE: To describe DILI events with MS drugs by analyzing the FDA Adverse Event Reporting System. METHODS: DILI reports were extracted and classified in overall liver injury (OLI), including asymptomatic elevation of liver enzymes, and severe liver injury (SLI). We performed disproportionality analysis by calculating adjusted reporting odds ratios (RORs) with 95% confidence interval (CI) and case-by-case evaluation for concomitant drugs with hepatotoxic potential...
September 19, 2018: Multiple Sclerosis: Clinical and Laboratory Research
Katrin Druschky, Stefan Bleich, Renate Grohmann, Katharina Burda, Helge Frieling, Thomas Hillemacher, Alexandra Neyazi, Susanne Stübner, Sermin Toto
BACKGROUND: The study aimed to investigate severe hair loss related to psychotropic drugs (PDs) by using data from the drug safety programme Arzneimittelsicherheit in der Psychiatrie (AMSP). METHODS: Data on PD utilization and reports of severe PD-related hair loss were collected in 83 psychiatric hospitals in Austria, Germany and Switzerland during the period 1993-2013. RESULTS: Out of 432,215 patients under surveillance, 404,009 patients were treated with PDs for the main indications of depression, schizophrenic disorder, neurosis, mania, and organic psychosis...
October 2018: European Psychiatry: the Journal of the Association of European Psychiatrists
Alexandra Pacurariu, Kelly Plueschke, Patricia McGettigan, Daniel R Morales, Jim Slattery, Dagmar Vogl, Thomas Goedecke, Xavier Kurz, Alison Cave
OBJECTIVE: Electronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. In this paper, we provide insight into available EHDs to support regulatory decisions on medicines. METHODS: EHDs were identified from publicly available information from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance resources database, textbooks and web-based searches...
September 5, 2018: BMJ Open
Rubina Mulchandani, Ashish Kumar Kakkar
Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug's life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians' perceptions towards reporting, problems with establishing reporting systems in hospitals and insufficient training to recognize ADRs...
August 31, 2018: International Journal of Risk & Safety in Medicine
F M Alsaleh, J Lemay, R R Al Dhafeeri, S AlAjmi, E A Abahussain, T Bayoud
Introduction: To improve patient safety and care, the identification and reporting of adverse drug reactions (ADRs) should be systematic and mandatory for all healthcare professionals (HCPs). Physicians remain the main HCPs with direct patient care whose role in ADRs reporting should not be ignored. Objective: To document the awareness and attitude of physicians working in private and government hospitals in Kuwait with regard to pharmacovigilance (PV) and ADR reporting and to identify their practices of reporting ADRs...
December 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
N V Khachanova, K Z Bakhtiyarova, A N Boyko, Ya V Vlasov, M V Davydovskaia, E P Evdoshenko, M N Zakharova, N A Malkova, S A Sivertseva, N N Spirin, I D Stolyarov, T E Schmidt, F A Khabirov
Modern multiple sclerosis therapy with disease-modifying drugs is characterized by the risks of dangerous infectious complications. In the last 5 years, there have been several reports of severe, sometimes lethal, listeriosis infection in patients treated with alemtuzumab. This article presents a clinical case of lethal listeriosis meningoencephalitis, which developed within 7 days after the completion of the first cycle of alemtuzumab therapy. In January 2018, a meeting of the expert Council was held, at which the clinical recommendations published in 2017 were revised and updated...
2018: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Marlene P Freeman, Tiffany Farchione, Lynn Yao, Leyla Sahin, Lockwood Taylor, Krista F Huybrechts, Ruta Nonacs, Alexandra Z Sosinsky, Adele C Viguera, Lee S Cohen
Pregnancy labeling of prescription medications in the US is in the midst of a major transformation. The FDA's previous system, which used letter ratings to convey drug safety, was simple but led to misunderstandings-both faulty assurances and undue concerns. The new system, established under the Pregnancy and Lactation Labeling Rule, aims for more descriptive and up-to-date explanations of risk as well as context needed for informed decision-making based on available data. In April 2017, a conference titled "Pharmacovigilance, Reproductive Safety, and the Pregnancy and Lactation Labeling Rule" brought together clinicians and researchers, FDA officials, and representatives of the public and industry to discuss a host of questions relating to the new system...
July 17, 2018: Journal of Clinical Psychiatry
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