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Pharmacovigilance- Drug safety

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https://www.readbyqxmd.com/read/30109708/health-benefits-of-an-adverse-events-reporting-system-for-chronic-pain-patients-using-long-term-opioids
#1
Beatriz Planelles, César Margarit, Raquel Ajo, Yolanda Sastre, Javier Muriel, María-Del-Mar Inda, María D Esteban, Ana M Peiró
BACKGROUND: Safety data from long-term opioid therapy in the real world has been poorly studied in chronic non-cancer pain (CNCP). The aim was to design a pharmacovigilance data recording system and assess whether participation in this recording system improves pain management, enhancing patient's health status. METHODS: A pharmacovigilance data recording system was conducted during 24 months. Data were self-reported by patients (pain, adverse events [AEs] and healthcare resources use) and physicians (morphine equivalent daily dose [MEDD] prescribed and suspected adverse drug reaction [ADRs])...
August 14, 2018: Acta Anaesthesiologica Scandinavica
https://www.readbyqxmd.com/read/30101375/pharmacovigilance-in-a-rare-disease-example-of-the-vigiapath-program-in-pulmonary-arterial-hypertension
#2
Marie-Camille Chaumais, Caroline O'Connell, Laurent Savale, Christophe Guignabert, Frédéric Perros, Xavier Jaïs, Olivier Sitbon, Marc Humbert, David Montani
Spontaneous reporting is the primary method used in pharmacovigilance (PV) to detect drug safety signal. Specific criteria used in pharmacovigilance to prove accountability of a drug are rarely present in rare disease. The low number of alerts also makes it challenging. The aim of this commentary is to raise awareness among pharmacists on issues and opportunities for pharmacovigilance in rare diseases, taking pulmonary arterial hypertension (PAH) as example, from which a subset of cases are drug-induced. It is demonstrated how a dedicated program named VIGIAPATH created to reinforce pharmacovigilance of drug-induced pulmonary arterial hypertension at a national level, led to increase self-reporting and confirm safety signals...
August 13, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/30099967/using-focused-pharmacovigilance-for-ensuring-patient-safety-against-antileishmanial-drugs-in-bangladesh-s-national-kala-azar-elimination-programme
#3
Md Sakhawat Hossain, Amresh Kumar, A F M Akhtar Hossain, Md Mahshin, Abhijit Sharma, Md Akter Hossain, Varun Sharma, Rashidul Haque, A K M Shamsuzzaman, Shomik Maruf, Prakash Ghosh, Vivek Ahuja, Dinesh Mondal
BACKGROUND: Adverse effects of antileishmanial drugs can affect patients' quality of life and adherence to therapy for visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL). In Bangladesh, there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas (subdistricts) of 26 districts (these include VL, PKDL, treatment failure, and relapse VL and cutaneous leishmaniasis cases). This study aimed to investigate the feasibility of using focused pharmacovigilance for VL (VLPV) in Bangladesh's National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions (ADRs)...
August 13, 2018: Infectious Diseases of Poverty
https://www.readbyqxmd.com/read/30094558/eu-pharmacovigilance-regulatory-requirements-of-anticancer-biosimilar-monoclonal-antibodies
#4
Sara Francescon, Giulia Fornasier, Paolo Baldo
An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and biosimilar versions have now also been approved in Europe. Being complex to develop and difficult to manufacture, the biosimilar is a drug similar but not identical in physicochemical characteristics, efficacy, and safety to an original biological drug already approved in the European Union, for which marketing exclusivity rights have expired. Generally, the safety monitoring of biosimilars follows the same requirements that apply to all biologicals, even if specific pharmacovigilance measures exist and some of them are still being debated...
August 9, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/30093253/mining-heterogeneous-networks-with-topological-features-constructed-from-patient-contributed-content-for-pharmacovigilance
#5
Christopher C Yang, Haodong Yang
Drug safety, also called pharmacovigilance, represents a serious health problem all over the world. Adverse drug reactions (ADRs) and drug-drug interactions (DDIs) are two important issues in pharmacovigilance, and how to detect drug safety signals has drawn many researchers' attention and efforts. Currently, methods proposed for ADR and DDI detection are mainly based on traditional data sources such as spontaneous reporting data, electronic health records, pharmaceutical databases, and biomedical literature...
August 6, 2018: Artificial Intelligence in Medicine
https://www.readbyqxmd.com/read/30090710/an-analysis-of-completeness-and-quality-of-adverse-drug-reaction-reports-at-an-adverse-drug-reaction-monitoring-centre-in-western-india
#6
Manali Mangesh Mahajan, Urmila Mukund Thatte, Nithya Jaideep Gogtay, Siddharth Deshpande
Purpose/Aim: The Adverse Drug Reaction [ADR] form is the source document for the Pharmacovigilance Programme of India [PvPI] and captures information first hand from the patient. The raw data from it then gets converted into an individual case safety report [ICSR] after entry into Vigiflow. The National Coordinating Centre [NCC] uses an instrument to assess quality of these ICSRs. We carried out the present study to assess whether the same instrument with minor modifications could be used to check the quality of ADR forms at our centre...
July 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30084285/desloratadine-and-depression-a-drug-safety-signal-based-on-worldwide-spontaneous-reporting-of-side-effects
#7
Jeltje Boer, Ellen Ederveen, Birgitta Grundmark
OBJECTIVE: Desloratadine, a third-generation antihistamine, is claimed to cause fewer central nervous system (CNS) adverse drug reactions (ADRs) than antihistamines of the first- and second-generation. While literature is inconclusive regarding the possible CNS effects, symptoms like somnolence and hallucinations are acknowledged ADRs of desloratadine, indeed suggesting some passage of this drug across the blood-brain barrier. Depression is currently not described as an ADR in the approved desloratadine product labelling...
August 7, 2018: Upsala Journal of Medical Sciences
https://www.readbyqxmd.com/read/30073879/psoriasis-during-angiotensin-receptor-blocker-exposure-an-underestimated-adverse-drug-reaction
#8
Brahim Azzouz, Malak Abou Taam, Aurore Morel, Thierry Trenque
BACKGROUND: Angiotensin receptor blockers (ARBs) can induce or exacerbate psoriasis. Psoriasis is unlisted in the Summary of Product Characteristics (SmPC) of ARBs. We aimed to investigate the association between psoriasis and ARB exposure Methods: We reviewed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD). The association between psoriasis and ARB exposure was assessed using the case/non-case method. We also analyzed literature reports. RESULTS: We identified 89 reports of psoriasis during ARB exposure in the FPVD...
August 3, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30066292/cardiovascular-and-gastrointestinal-safety-of-selective-cyclooxygenase-2-inhibitors-a-case-non-case-study
#9
Luis Hermenegildo Martin Arias, Antonio Martin Gonzalez, Rosario Sanz Fadrique, Esther Salgueiro, Maria Sainz
Background Coxibs cardiovascular (CV) safety continues being a current issue after rofecoxib worldwide withdrawal in 2004. Objective To evaluate the cardiovascular and gastrointestinal (GI) risk of coxibs through case/non-case study. Setting The Spanish Pharmacovigilance System for Human Use Drugs (FEDRA) and the Uppsala Monitoring Centre (VigiBase) databases. Method We identified adverse drug reactions (ADRs) cases reported under the MedDRA system organ classes of "cardiac disorders", "vascular disorders", "nervous system disorder" and "gastrointestinal disorders"...
July 31, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/30060680/differential-profiles-of-adverse-events-associated-with-mycophenolate-mofetil-between-adult-and-pediatric-renal-transplant-patients
#10
Keiko Hosohata, Etsuko Matsuoka, Ayaka Inada, Saki Oyama, Iku Niinomi, Yasuhiro Mori, Yuki Yamaguchi, Mayako Uchida, Kazunori Iwanaga
Objective Immunosuppressive regimens after renal transplantation usually include a combination of calcineurin inhibitors, corticosteroids, and a proliferation inhibitor, either azathioprine or mycophenolate mofetil (MMF), to prevent rejection and maintain graft function. MMF has a stronger immunosuppressive effect than does azathioprine. This study aimed to examine MMF-associated adverse events in renal transplant patients. Methods Retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report database...
July 30, 2018: Journal of International Medical Research
https://www.readbyqxmd.com/read/30053910/a-pharmacovigilance-system-for-treatment-access-and-medical-donation-programs-the-max-foundation-experience
#11
Ann Kim Novakowski, Pat Garcia-Gonzalez, Michael Wrigglesworth, Andy Stergachis
BACKGROUND: Cancer is a major burden of disease in low- and middle-income countries (LMICs) yet financial barriers limit access to life-saving oncology drugs. Medical donation and other drug access programs can help improve patient access to essential medicines, such as quality assured oncology drugs in LMICs. However, there are no published examples of the conduct of pharmacovigilance with donated medical products intended for use in LMICs where pharmacovigilance is weak. We describe a partnership between a pharmaceutical company and a non-governmental organization as a case example that addresses the challenges in performing pharmacovigilance with donated medicines in LMICs...
July 27, 2018: Globalization and Health
https://www.readbyqxmd.com/read/30053327/adverse-events-associated-with-pcsk9-inhibitors-a-real-world-experience
#12
Muhammed T Gürgöze, Annemarie Hg Muller-Hansma, Michelle M Schreuder, Annette Mh Galema-Boers, Eric Boersma, Jeanine E Roeters van Lennep
In randomized clinical trials (RCTs) pro-protein convertase subtilisin/kexin 9 (PCSK9) inhibitors showed a favorable safety profile, however "real-world" data on adverse events (AEs) is scarce. Three datasets, a hospital registry (n=164) and two Pharmacovigilance databases, Lareb (n=149) and VigiLyze (n=15,554), reporting AEs attributed to PCSK9 inhibitors (alirocumab or evolocumab) prescribed in clinical practice were analyzed. In the hospital registry 41.5% of the patients reported any AE, most often injection-site reactions (33...
July 27, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/30051225/pharmacovigilance-in-china-development-and-challenges
#13
Ying Zhao, Tiansheng Wang, Guangyao Li, Shusen Sun
Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data...
July 26, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/30043457/efficacy-and-safety-of-sodium-oxybate-in-alcohol-dependent-patients-with-a-very-high-drinking-risk-level
#14
Wim van den Brink, Giovanni Addolorato, Henri-Jean Aubin, Amine Benyamina, Fabio Caputo, Maurice Dematteis, Antoni Gual, Otto-Michael Lesch, Karl Mann, Icro Maremmani, David Nutt, François Paille, Pascal Perney, Jürgen Rehm, Michel Reynaud, Nicolas Simon, Bo Söderpalm, Wolfgang H Sommer, Henriette Walter, Rainer Spanagel
Medication development for alcohol relapse prevention or reduction of consumption is highly challenging due to methodological issues of pharmacotherapy trials. Existing approved medications are only modestly effective with many patients failing to benefit from these therapies. Therefore, there is a pressing need for other effective treatments with a different mechanism of action, especially for patients with very high (VH) drinking risk levels (DRL) because this is the most severely affected population of alcohol use disorder patients...
July 2018: Addiction Biology
https://www.readbyqxmd.com/read/30043385/assessment-of-the-utility-of-social-media-for-broad-ranging-statistical-signal-detection-in-pharmacovigilance-results-from-the-web-radr-project
#15
Ola Caster, Juergen Dietrich, Marie-Laure Kürzinger, Magnus Lerch, Simon Maskell, G Niklas Norén, Stéphanie Tcherny-Lessenot, Benoit Vroman, Antoni Wisniewski, John van Stekelenborg
INTRODUCTION AND OBJECTIVE: Social media has been proposed as a possibly useful data source for pharmacovigilance signal detection. This study primarily aimed to evaluate the performance of established statistical signal detection algorithms in Twitter/Facebook for a broad range of drugs and adverse events. METHODS: Performance was assessed using a reference set by Harpaz et al., consisting of 62 US Food and Drug Administration labelling changes, and an internal WEB-RADR reference set consisting of 200 validated safety signals...
July 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30039198/towards-preventive-pharmacovigilance-through-medicine-misuse-identification-an-example-with-recombinant-human-growth-hormone-for-aesthetic-purposes
#16
Alfredo J Rodrigues-Neto, Camila Biazoni-Albaricci, Adalton Ribeiro, Silvana Lima, Albert Figueras
PURPOSE: Historically, somatropin has been used for conditions related with ageing, but since the marketing of recombinant human growth hormone (rhGH), increasing promotional pressure has prompted aesthetic uses, despite lack of evidences about its efficacy and safety for those purposes. METHODS: A routine analysis of the Pharmacovigilance Center of São Paulo (Brazil) showed reports of suspected adverse reactions in young adults and mature patients receiving rhGH...
July 23, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/30034811/a-qualitative-exploration-of-knowledge-attitudes-and-practices-of-hospital-pharmacists-towards-adverse-drug-reaction-reporting-system-in-lahore-pakistan
#17
Rabia Hussain, Mohamed Azmi Hassali, Furqan Hashmi, Maryam Farooqui
Background: Medication safety is a major public health concern and there are well established pharmacovigilance programmes in developed countries. However, there is scarcity of literature on the issue in low and middle income countries. In this context, the current study was aimed to evaluate the knowledge, attitudes and practices of hospital pharmacists towards medication safety and ADR reporting in Lahore, Pakistan. Methods: A qualitative approach was used to conduct this study...
2018: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/30032963/pharmacovigilance-from-social-media-an-improved-random-subspace-method-for-identifying-adverse-drug-events
#18
Jing Liu, Gang Wang
OBJECTIVE: Recent advances in Web 2.0 technologies have seen significant strides towards utilizing patient-generated content for pharmacovigilance. Social media-based pharmacovigilance has great potential to augment current efforts and provide regulatory authorities with valuable decision aids. Among various pharmacovigilance activities, identifying adverse drug events (ADEs) is very important for patient safety. However, in health-related discussion forums, ADEs may confound with drug indications and beneficial effects, etc...
September 2018: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/30027343/-detection-of-drug-risks-after-approval-methods-development-for-the-use-of-routine-statutory-health-insurance-data
#19
Ronja Foraita, Louis Dijkstra, Felix Falkenberg, Marco Garling, Roland Linder, René Pflock, Mariam R Rizkallah, Markus Schwaninger, Marvin N Wright, Iris Pigeot
Adverse drug reactions are among the leading causes of death. Pharmacovigilance aims to monitor drugs after they have been released to the market in order to detect potential risks. Data sources commonly used to this end are spontaneous reports sent in by doctors or pharmaceutical companies. Reports alone are rather limited when it comes to detecting potential health risks. Routine statutory health insurance data, however, are a richer source since they not only provide a detailed picture of the patients' wellbeing over time, but also contain information on concomitant medication and comorbidities...
July 19, 2018: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/30022236/-recording-and-assessment-of-medication-errors-experience-of-the-drug-commission-of-the-german-medical-association
#20
REVIEW
Ursula Köberle, Thomas Stammschulte, Ursula Gundert-Remy, Martina Pitzer, Katrin Bräutigam
Adverse drug reactions (ADRs) are a common problem in daily clinical practice and they may in part result from medication errors. According to the extended interpretation in the new European pharmacovigilance guideline, medication error-related reactions are classified as ADRs. Therefore, the pharmacovigilance system needs to be adjusted to record medication errors. As a partner in the German pharmacovigilance system, the Drug Commission of the German Medical Association (DCGMA) has set up a project for developing a subsystem for the recording and assessment of medication errors within the existing spontaneous reporting system for ADRs...
July 18, 2018: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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