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Pharmacovigilance

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https://www.readbyqxmd.com/read/29444478/detection-of-drug-safety-signals-from-clinical-trials-data-role-of-susars
#1
Christelle Perez, Pascale Olivier, Barbara Lortal, Sophie Duranton, Jean-Louis Montastruc, Anne-Laurène Colin, Emilie Toulza, Madlyne Becker, Laura Hamy, Sabrina Crepin, Caroline Roussillon, Anne Gimbert, Nadine Petitpain, Francesco Salvo
One of the main goals of safety management in clinical trials is to detect suspected unexpected serious adverse reactions (SUSARs). The unexpectedness concerns the nature, frequency or severity of an adverse reaction. Drug safety signals could thus be retrieved, and a study was performed to investigate whether SUSARs allow signal detection in pharmacovigilance. Data from six academic safety units were collected from 2005 to 2016. Characteristics of SUSARs were analysed and signals were identified i) by evaluating the presence of other causes, ii) by assessing the summary of product characteristics (SPC), iii) by searching for specific safety information in Pubmed and health agencies, and iv) by investigating the narrative of each case...
February 11, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29437014/drug-induced-epistaxis-an-often-neglected-adverse-effect
#2
Sara Meirinho, Ricardo Relvas, Gilberto Alves
BACKGROUND: Epistaxis is an active nose bleeding with a population occurrence of approximately 60%. Although epistaxis is a common clinical complaint, the majority of the cases are benign and caused by local induced factors (e.g., trauma and local inflammation). Nevertheless, it is also recognised that epistaxis can be induced after some drugs intake. AIMS: Due to the increasing use of drugs or drug combinations that potentially may induce epistaxis, this review aims to alert healthcare professionals for this often neglected adverse drug effect and its possible complications...
February 12, 2018: Current Drug Safety
https://www.readbyqxmd.com/read/29437004/therapeutic-drug-monitoring-of-phenytoin-by-simple-rapid-accurate-highly-sensitive-and-novel-method-and-its-clinical-applications
#3
Abdul Sami Shaikh, Ruichen Guo
BACKGROUND: Phenytoin has very challenging pharmacokinetic properties. To prevent its toxicity and ensure efficacy, continuous therapeutic monitoring is required. It is hard to get a simple, accurate, rapid, easily available, economical and highly sensitive assay in one method for therapeutic monitoring of phenytoin. OBJECTIVE: The present study is directed towards establishing and validating a more simple, rapid, an accurate, highly sensitive, novel and environment friendly liquid chromatography/mass spectrometry (LC/MS) method for offering rapid and reliable TDM results of phenytoin in epileptic patients to physicians and clinicians for making immediate and rational decision...
February 9, 2018: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/29434060/impact-of-regulatory-spin-of-pioglitazone-on-prescription-of-antidiabetic-drugs-among-physicians-in-india-a-multicentre-questionnaire-based-observational-study
#4
Aman Goyal, Harmanjit Singh, Vijay Kumar Sehgal, C R Jayanthi, Renuka Munshi, K Laxminarayana Bairy, Rakesh Kumar, Sandeep Kaushal, Ashish Kumar Kakkar, Sneha Ambwani, Chhaya Goyal, Goutameswar Mazumdar, Anjan Adhikari, Nina Das, Divya John Stephy, Pugazhenthan Thangaraju, D C Dhasmana, Shakil U Rehman, Amit Chakrabarti, Basavaraj Bhandare, Dinesh Kumar Badyal, Inderpal Kaur, K Chandrashekar, Jagjit Singh, Puneet Dhamija, Sudhir Chandra Sarangi, Yogendra Kumar Gupta
Background & objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India. Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India...
October 2017: Indian Journal of Medical Research
https://www.readbyqxmd.com/read/29432844/pharmacogenomics-signature-a-novel-strategy-on-the-individual-differences-in-drug-response
#5
Chengxian Guo, Xinjian Lin, Jiye Yin, Xiaoxue Xie, Jingao Li, Xiangguang Meng, Jichu Wu, Lihua Huang, Zhijun Huang, Guoping Yang, Honghao Zhou, Xiang Chen
Patients exhibit a wide heterogeneity in their responses to a drug treatment due to variations in the molecular determinants underlying this heterogeneity. Pharmacogenomics approaches can be used to integrate information on drug responsiveness with alterations in molecular entities, often on a genome-wide scale. However, most of the studies involving pharmacogenomics of specific therapeutics are in their early stages and thus are not ready for clinical utilization. Genotyping studies tackle around a candidate gene approach using genes known to be important in the pharmacokinetics and pharmacodynamics of the administered drugs...
February 9, 2018: Cancer Letters
https://www.readbyqxmd.com/read/29430814/sglt-2-inhibitors-and-the-risk-of-lower-limb-amputation-is-this-a-class-effect
#6
Charles Khouri, Jean-Luc Cracowski, Matthieu Roustit
OBJECTIVE: Inhibitors of the sodium-glucose co-transporter-2 (SGLT-2) are a novel class of glucose lowering agents showing promising results. However, the use of canagliflozin has been associated with an increased risk of lower-limb amputation. Whether this risk concerns other SGLT-2 inhibitors is unclear. METHODS: We performed a disproportionality analysis using the WHO global database of individual case safety reports (VigiBase®) to address this issue. RESULTS: Among the 8,293,886 reports available between January 2013 and December 2017, we identified 79 reports of lower-limb amputations associated with SGLT-2 inhibitors...
February 12, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29430420/drug-safety-alerts-of-pharmacovigilance-programme-of-india-a-scope-for-targeted-spontaneous-reporting-in-india
#7
Prasad Thota, Anusha Thota, Bikash Medhi, Shabir Sidhu, Pramod Kumar, V Kalai Selvan, Gyanendra Nath Singh
Background: The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016...
January 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29417823/drug-induced-pulmonary-arterial-hypertension-a-primer-for-clinicians-and-scientists
#8
Mark E Orcholski, Ke Yuan, Charlotte Rajasingh, Halley Tsai, Elya A Shamskhou, Navneet Kaur Dhillon, Norbert F Voelkel, Roham T Zamanian, Vinicio A de Jesus Perez
Drug-induced pulmonary arterial hypertension (D-PAH) is a form of World Health Organization (WHO) Group 1 pulmonary hypertension (PH) defined by severe small vessel loss and obstructive vasculopathy, which leads to progressive right heart failure and death. To date, 16 different compounds have been associated with D-PAH, including anorexigens, recreational stimulants, and more recently, several Food and Drug Administration (FDA)-approved medications. While the clinical manifestation, pathology, and hemodynamic profile of D-PAH are indistinguishable from other forms of PAH, its clinical course can be unpredictable and to some degree dependent on removal of the offending agent...
February 8, 2018: American Journal of Physiology. Lung Cellular and Molecular Physiology
https://www.readbyqxmd.com/read/29417755/safety-signal-detection-and-evaluation-in-clinical-development-programs-a-case-study-of-tofacitinib
#9
Gorana Dasic, Thomas Jones, Vera Frajzyngier, Ricardo Rojo, Ann Madsen, Hernan Valdez
Adverse events are anticipated during a clinical development program. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We describe here the process undertaken by Pfizer to investigate a safety signal for pancreatic cancer with tofacitinib. Potential cases of pancreatic cancer across indications from Pfizer's clinical trials and safety databases were identified and underwent in-depth case review and external expert consultation. The magnitude of the signal was quantified...
February 2018: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/29412117/strategies-empowering-paediatric-drug-safety
#10
Marta Gentili, Marco Pozzi, Gabrielle Peeters, Sonia Radice, Carla Carnovale
Background Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterise fully the safety profiles of drugs. Addionally, information about rare adverse drug reactions (ADRs) in special groups or drug-drug interactions (DDIs) is often incomplete or not available for most of the drugs commonly used in the daily clinical practice...
February 6, 2018: Current Clinical Pharmacology
https://www.readbyqxmd.com/read/29409850/efficacy-and-safety-of-pueraria-candollei-var-mirifica-airy-shaw-suvat-niyomdham-for-menopausal-women-a-systematic-review-of-clinical-trials-and-the-way-forward
#11
Chuenjid Kongkaew, Norman C Scholfield, Teerapon Dhippayom, Piyameth Dilokthornsakul, Surasak Saokaew, Nathorn Chaiyakunapruk
ETHNOPHARMACOLOGICAL RELEVANCE: Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed. MATERIALS AND METHODS: International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included...
February 6, 2018: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29409745/association-of-non-immediate-drug-hypersensitivity-with-drug-exposure-a-case-control-analysis-of-spontaneous-reports-from-a-tunisian-pharmacovigilance-database
#12
Amel Chaabane, Najeh Ben Fadhel, Zohra Chadli, Haifa Ben Romdhane, Nadia Ben Fredj, Naceur A Boughattas, Karim Aouam
PURPOSE: To assess delayed-type cutaneous reactions (DTCRs) related to drugs, using a case-control approach to qualify drug risks. METHODS: The study used the Tunisian pharmacovigilance database of Monastir. The association between drugs and DTCRs was assessed using a case/non-case method. Drugs were grouped according to the ATC Classification System. Patients were defined as "cases" if they have developed DTCRs regardless of the causality assessment. All other reports were "non-cases"...
February 3, 2018: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/29402876/adverse-drug-reaction-reporting-in-primary-care-setting-in-kuwait-a-comparative-study-of-physicians-and-pharmacists
#13
Jacinthe Lemay, Fatemah M Alsaleh, Lulwa Al-Buresli, Mohammed Al-Mutairi, Eman A Abahussain, Tania Bayoud
OBJECTIVE: To investigate and compare the knowledge, attitude and practices regarding pharmacovigilance (PV) and reporting of adverse drug reactions (ADRs) among physicians and pharmacists in primary care settings. SUBJECTS AND METHODS: A cross sectional study was conducted in which a validated self-administered questionnaire was distributed to 386 physicians and 197 pharmacists in 38 primary care clinics in Kuwait. Categorical variables were described using numbers and percentages...
January 29, 2018: Medical Principles and Practice: International Journal of the Kuwait University, Health Science Centre
https://www.readbyqxmd.com/read/29397799/gaps-in-monitoring-systems-for-implanon-nxt-services-in-south-africa-an-assessment-of-12-facilities-in-two-districts
#14
D Pillay, C Morroni, M Pleaner, O Adeogba, M Chersich, N Naidoo, S Mullick, H Rees
Background. Implanon NXT, a long-acting subdermal contraceptive implant, was introduced in South Africa (SA) in early 2014 as part of an expanded contraceptive method mix. After initial high levels of uptake, reports emerged of frequent early removals and declines in use. Monitoring of progress and challenges in implant service delivery could identify aspects of the programme that require strengthening. Objectives. To assess data management and record keeping within implant services at primary care facilities...
October 1, 2017: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/29396819/severe-secondary-polycythemia-in-a-female-to-male-transgender-patient-while-using-lifelong-hormonal-therapy-a-patient-s-perspective
#15
Ellen G T Ederveen, Florence P A M van Hunsel, Marielle J Wondergem, Eugène P van Puijenbroek
After a registered drug is available on the market and used in everyday circumstances, hitherto unknown adverse drug reactions (ADRs) may occur. Furthermore, the patient can experience a previously unknown course of a known ADR. Voluntary reports by patients play an important role in gaining knowledge about ADRs in daily practice. The Netherlands Pharmacovigilance Centre Lareb received a report from a 55-year-old female-to-male transgender patient who experiences secondary polycythemia while using lifelong testosterone therapy...
February 2, 2018: Drug Safety—Case Reports
https://www.readbyqxmd.com/read/29396682/causality-assessment-of-olfactory-and-gustatory-dysfunction-associated-with-intranasal-fluticasone-propionate-application-of-the-bradford-hill-criteria
#16
REVIEW
Chandrashekhar S Muganurmath, Amy L Curry, Andrew H Schindzielorz
Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. While intranasal corticosteroids are associated with olfactory and gustatory dysfunction and are currently labeled for these adverse events, causality assessment has not been performed to date...
February 2, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29395998/treatment-of-uncomplicated-and-severe-malaria-during-pregnancy
#17
REVIEW
Umberto D'Alessandro, Jenny Hill, Joel Tarning, Christopher Pell, Jayne Webster, Julie Gutman, Esperanca Sevene
Over the past 10 years, the available evidence on the treatment of malaria during pregnancy has increased substantially. Owing to their relative ease of use, good sensitivity and specificity, histidine rich protein 2 based rapid diagnostic tests are appropriate for symptomatic pregnant women; however, such tests are less appropriate for systematic screening because they will not detect an important proportion of infections among asymptomatic women. The effect of pregnancy on the pharmacokinetics of antimalarial drugs varies greatly between studies and class of antimalarial drugs, emphasising the need for prospective studies in pregnant and non-pregnant women...
January 30, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29389968/inferring-pregnancy-episodes-and-outcomes-within-a-network-of-observational-databases
#18
Amy Matcho, Patrick Ryan, Daniel Fife, Dina Gifkins, Chris Knoll, Andrew Friedman
Administrative claims and electronic health records are valuable resources for evaluating pharmaceutical effects during pregnancy. However, direct measures of gestational age are generally not available. Establishing a reliable approach to infer the duration and outcome of a pregnancy could improve pharmacovigilance activities. We developed and applied an algorithm to define pregnancy episodes in four observational databases: three US-based claims databases: Truven MarketScan® Commercial Claims and Encounters (CCAE), Truven MarketScan® Multi-state Medicaid (MDCD), and the Optum ClinFormatics® (Optum) database and one non-US database, the United Kingdom (UK) based Clinical Practice Research Datalink (CPRD)...
2018: PloS One
https://www.readbyqxmd.com/read/29379607/pioglitazone-and-cause-specific-risk-of-mortality-in-patients-with-type-2-diabetes-extended-analysis-from-a-european-multidatabase-cohort-study
#19
Helen Strongman, Solomon Christopher, Maila Majak, Rachael Williams, Shahram Bahmanyar, Marie Linder, Edith M Heintjes, Dimitri Bennett, Pasi Korhonen, Fabian Hoti
Objectives: Describe and compare the risk of cardiovascular and non-cardiovascular mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. Research design and methods: This exploratory linked database cohort analysis used pooled health and mortality data from three European countries: Finland, Sweden and the UK. Propensity score together with exact matching was used to match 31 133 patients with type 2 diabetes first prescribed pioglitazone from 2000 to 2011, to 31 133 patients never prescribed pioglitazone...
2018: BMJ Open Diabetes Research & Care
https://www.readbyqxmd.com/read/29379335/advancing-pharmaceuticals-and-patient-safety-in-saudi-arabia-a-2030-vision-initiative
#20
Tariq M Alhawassi, Hatem A Abuelizz, Mansour Almetwazi, Mansour A Mahmoud, Ahmed Alghamdi, Yazed S Alruthia, Nasser BinDhim, Khalid A Alburikan, Yousif A Asiri, Peter J Pitts
Low-quality medicines deliver sub-optimal clinical outcomes and waste precious health resources. It is important to ensure that public funds are spent on healthcare technologies that meet national regulatory bodies such as the Saudi Food and Drug Authority (SFDA), quality standards for safety, efficacy, and quality. Medicines quality is a complicated combination of pre-market regulatory specifications, appropriate sourcing of ingredients (active pharmaceutical ingredient (API), excipients, etc.), manufacturing processes, healthcare ecosystem communications, and regular and robust pharmacovigilance practices...
January 2018: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
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