Discover scientific publications on pharmacovigilance
Original research and thinking in the science of pharmacovigilance
This is a non-exhaustive list of scientific papers with key authors from the UMC. Most of the references link to full articles.
211 documents found.
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Scientific publicationsThe impact of duration of treatment on reported time-to-onset in spontaneous reporting systems for pharmacovigilance
Within pharmacovigilance, knowledge of time-to-onset (time from start of drug administration to onset of reaction) is important in causality assessment of drugs and suspected adverse drug reactions (ADRs) and may indicate pharmacological mechanisms involved. PLoS ONE 8(7): e68938. doi:10.1371/journal.pone.0068938
Author: Karimi G, Star K, Norén GN, Hägg S.
Date: 2013-07-15 -
Scientific publications
Outlier removal to uncover patterns in adverse drug reaction surveillance – a simple unmasking strategy
Pharmacoepidemiol Drug Saf (2013), 22: 1119–1129. doi:10.1002/pds.3474.
Author: Kristina Juhlin, Xiaofei Ye, Kristina Star, G. Niklas Norén
Date: 2013-07-07 -
Scientific publications
Logistic Regression in Signal Detection: Another Piece Added to the Puzzle
Clin Pharmacol Ther. 2013 Sep;94(3):312. doi: 10.1038/clpt.2013.107.
Author: O Caster, G N Norén, D Madigan, A Bate
Date: 2013-05-21 -
Scientific publicationsThe Development and Evaluation of Triage Algorithms for Early Discovery of Adverse Drug Interactions
Around 20 % of all adverse drug reactions (ADRs) are due to drug interactions.Drug Saf (2013) 36:371–388.
Author: Johanna Strandell, Ola Caster, Johan Hopstadius, I. Ralph Edwards, G. Niklas Norén
Date: 2013-05-03 -
Scientific publications
Time-to-onset in spontaneous reports: the possibility to detect the unexpected
Letter to the Editor. Pharmacoepidemiol Drug Saf. 2013 May;22(5):556-7. doi: 10.1002/pds.3397.
Author: Ghazaleh Karimi, Kristina Star, Staffan Hägg, G. Niklas Norén
Date: 2013-05-03 -
Scientific publications
Effective vaccine safety systems in all countries: A challenge for more equitable access to immunization
Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Vaccine. 2013 Apr 18;31 Suppl 2:B108-14. doi: 10.1016/j.vaccine.2012.10.119.
Author: Amarasinghe A, Black S, Bonhoeffer J, Carvalho SM, Dodoo A, Eskola J, Larson H, Shin S, Olsson S, Balakrishnan MR, Bellah A, Lambach P, Maure C, Wood D, Zuber P, Akanmori B, Bravo P, Pombo M, Langar H, Pfeifer D, Guichard S, Diorditsa S, Hossain MS, Sato Y
Date: 2013-04-18 -
Scientific publications
Challenges of safe medication practice in paediatric care – a nursing perspective
Acta Paediatr, 102: 532–538. doi:10.1111/apa.12212.
Author: Kristina Star, Karin Nordin, Ulrika Pöder, I Ralph Edwards
Date: 2013-04-09 -
Scientific publications
Rhabdomyolysis Reported for Children and Adolescents Treated with Antipsychotic Medicines: A Case Series Analysis
Rhabdomyolysis is a rare and potentially serious adverse drug reaction (ADR) to antipsychotic medicines.J Child Adolesc Psychopharmacol. 2012 Dec;22(6):440-51. doi: 10.1089/cap.2011.0134.
Author: Star K, Iessa N, Almandil NB, Wilton L, Curran S, Edwards IR, Wong IC
Date: 2013-03-23 -
Scientific publicationsWHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems
Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Drug Saf (2013) 36:75–81
Author: Shanthi N. Pal, Chris Buncombe, Dennis Falzon, Sten Olsson
Date: 2013-01-18 -
Scientific publications
Knowledge about adverse drug reactions reporting among healthcare professionals in Nepal
The International Journal of Risk & Safety in Medicine 25(1):1-16 · February 2013.
Author: Santosh KC, Traqulpiankit P, Edwards IR, Gorsanan S
Date: 2013-01-01 -
Scientific publicationsGlobal Patterns of Adverse Drug Reactions Over a Decade
Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income.Drug Saf 2012; 35 (12): 1171-1182.
Author: Lise Aagaard, Johanna Strandell, Lars Melskens, Paw S.G. Petersen, Ebba Holme Hansen
Date: 2012-12-01 -
Scientific publicationsCommunicating the New Pharmacovigilance Landscape
Ralph Edwards explores some of the particular features of the new pharmacovigilance landscape, prompted by the 12th ISoP Annual Meeting held in Cancun, Mexico, 2012. Drug Saf 2012; 35 (12): 1085-1089
Author: I. Ralph Edwards
Date: 2012-12-01 -
Scientific publicationsKey Elements in Adverse Drug Interaction Safety Signals - An Assessment of Individual Case Safety Reports
A large proportion of potential drug interactions are known from pre-authorization studies, but adverse drug reactions (ADRs) due to interactions (adverse drug interactions) are often first detected through astute observation in clinical practice.Drug Saf (2013) 36:63–70.
Author: Johanna Strandell, G. Niklas Norén, Staffan Hägg
Date: 2012-11-23 -
Scientific publicationsProtecting the People? Risk Communication and the Chequered History and Performance of Bureaucracy
The history and characteristics of bureaucracy are examined with a view to understanding the impact of the bureaucratic mindset on medicines’ regulation, the pharmaceutical industry and healthcare delivery with a focus on risk communication, pharmacovigilance and patient safety. Drug Saf 2012; 35 (11): 1005-1025.
Author: Bruce Hugman
Date: 2012-11-01 -
Scientific publicationsRisk Perception and Communication in Sub-Saharan Africa
In this narrative review, a brief summary of theoretical approaches to risk perception is followed by an analysis of some of the special factors influencing risk perception and risk communication in sub-Saharan Africa. Drug Saf 2012; 35 (11): 1041-1052.
Author: Alexander Dodoo, Bruce Hugman
Date: 2012-11-01 -
Scientific publications
Quantitative Benefit-Risk Assessment Using Only Qualitative Information on Utilities
Utilities of pertinent clinical outcomes are crucial variables for assessing the benefits and risks of drugs, but numerical data on utilities may be unreliable or altogether missing.Med Decis Making 2012;32:E1–E15.
Author: Ola Caster, G. Niklas Norén, Love Ekenberg, I. Ralph Edwards
Date: 2012-08-30 -
Scientific publications
Detecting Unexpected Adverse Drug Reactions in Children
Paediatr Drugs. 2011;13(2):71-3.
Author: Kristina Star
Date: 2012-08-21 -
Scientific publicationsDecision Dilemmas - Worse in Emerging Economies
One frequently asked question about pharmacovigilance is ‘how does one assess causality?’ Another is ‘how does one do signal detection?’ These are weighty questions indeed, to which there is no easy single answer.Drug Saf 2012; 35 (8): 611-614.
Author: Ralph Edwards
Date: 2012-08-01 -
Scientific publications
Safety surveillance of longitudinal databases: results on real-world data
Pharmacoepidemiology and Drug Safety, Volume 21, Issue 6, pages 673–675, June 2012.
Author: G. Niklas Norén, Johan Hopstadius, Andrew Bate, I. Ralph Edwards
Date: 2012-06-07 -
Scientific publicationsGood Pharmacovigilance Practice and the Curate’s Egg
In February 2012, the European Medicines Agency (EMA) placed on the Internet the first seven Good Pharmacovigilance Practice (GVP) modules, out of a full set of 16, for public consultation; the remainder will be available over the next few months.Drug Saf 2012; 35 (6): 429-435.
Author: I. Ralph Edwards
Date: 2012-06-01 -
Scientific publications
Severe muscle symptoms with lipid-lowering agents may be confused with neurogenic claudication associated with spinal canal stenosis
Screening of the WHO global individual case safety report database (VigiBase) has recently identified case reports with HMG CoA reductase inhibitors and muscle symptoms co-reported with spinal stenosis.The International Journal of Risk & Safety in Medicine 24(4):215-9, November 2012.
Author: Ruth Savage, Kristina Star, Richard Hill
Date: 2012-04-24 -
Scientific publicationsClinical Diagnosis - A Topic Worth Revisiting for Pharmacovigilance
There are now 7 million reports in the Uppsala Monitoring Centre (UMC) database (Vigibase) held in trust for the WHO Programme for International Drug Monitoring.Drug Saf 2012; 35 (4): 261-264.
Author: I. Ralph Edwards
Date: 2012-04-01 -
Scientific publicationsSpecific features of medicines safety and pharmacovigilance in Africa
The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products.Therapeutic Advances in Drug Safety, (2012) 3(1) 25–34.
Author: Ambrose O. Isah, Shanthi N. Pal, Sten Olsson, Alexander Dodoo and Rachida Soulayami Bencheikh
Date: 2012-02-03 -
Scientific publicationsPrevention and Pharmacovigilance: What Should We Do, What Can We Do?
The last annual International Society of Pharmacovigilance (ISoP) meeting, held in Istanbul from 26–28 October 2011, was a well organized and run occasion with a potpourri of topics that must have provided something for everybody.Drug Saf 2012; 35 (2): 87-90.
Author: Ralph Edwards
Date: 2012-02-01 -
Scientific publications
Robust discovery of local patterns: subsets and stratification in adverse drug reaction surveillance
The identification of unanticipated statistical associations is a core activity in exploratory analysis of high-dimensional biomedical data. Proceedings of the 2nd ACM SIGHIT International Health Informatics Symposium; pages 265-274.
Author: Johan Hopstadius, G. Niklas Norén
Date: 2012-01-28 -
Scientific publications
Forensic pharmacovigilance and substandard or counterfeit drugs
Identification of harm in the form of adverse drug reactions that are caused by counterfeit or other substandard medicinal products by application of standard pharmacovigilance methods of registration, analysis and investigation could be forensic pharmacovigilance.International Journal of Risk & Safety in Medicine 24 (2012) 37–39.
Author: Labadie J.
Date: 2012-01-01 -
Scientific publicationsExperiences with Adverse Drug Reaction Reporting by Patients
Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe.Drug Saf 2012; 35 (1): 45-60.
Author: Florence van Hunsel, Linda Härmark, Shanthi Pal, Sten Olsson, Kees van Grootheest
Date: 2012-01-01 -
Scientific publications
Considerations on causality in pharmacovigilance
Causality has been a topic of debate by philosophers, scientists, lawyers and for centuries.The International Journal of Risk & Safety in Medicine; 24(1):41-54 · January 2012.
Author: Edwards, I. Ralph
Date: 2012-01-01 -
Scientific publications
Combining Second-Order Belief Distributions with Qualitative Statements in Decision Analysis
There is often a need to allow for imprecise statements in real-world decision analysis.In: Managing Safety of Heterogeneous Systems (Lecture Notes in Economics and Mathematical Systems 658), Publisher: Springer-Verlag, 2012; Editors: Yuri Ermoliev, Marek Makowski, Kurt Marti, pp.67-87.
Author: Ola Caster, Love Ekenberg
Date: 2011-10-17 -
Scientific publicationsCommunication in Drug Safety - A Report from an Interactive Debate Held at the 10th Annual Meeting of the International Society of Pharmacovigilance (ISoP), 2010
Public communication on safety concerns over medicines and advice on how to prevent medicine induced patient harm is a decisive challenge for the overall success of those responsible for pharmacovigilance.Drug Saf 2011; 34 (10): 881-882.
Author: Priya Bahri, Peter G. M. Mol, Hélène Théophile, I. Ralph Edwards, Bruce P. J. Hugman
Date: 2011-10-01 -
Scientific publicationsConflicts of Interest in Medicines Safety and Regulation How Much Conflict and How Much Interest Should We Allow?
Conflict of interest is a well-known and growing controversy in many areas of healthcare, not least in medicines safety and regulation.Drug Saf 2011; 34 (8): 617-621.
Author: I. Ralph Edwards
Date: 2011-08-01 -
Scientific publicationsThe Fatal Love of Forms
Ask any group of people how many of them love completing forms, and the number is likely to be ‘nil’. Drug Saf 2011; 34 (8): 705-707
Author: Bruce Hugman
Date: 2011-08-01 -
Scientific publicationsGlobal Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities
As of 2010, over 5 million people worldwide have access to antiretroviral drugs (ARVs). With increased access comes a greater need to monitor and promote the safety and effectiveness of these essential medicines.PLoS Med 8(7): e1001054. doi:10.1371/journal.pmed.1001054.
Author: Nyasha Bakare, Ivor Ralph Edwards, Andy Stergachis, Shanthi Pal, Charles B. Holmes, Marie Lindquist, Chris Duncombe, Alex Dodoo, Joel Novendstern, Jude Nwokike, Ricardo Kuchenbecker, Judith A. Aberg, Veronica Miller, Jur Strobos
Date: 2011-07-05 -
Scientific publicationsShrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery
Large observational data sets are a great asset to better understand the effects of medicines in clinical practice and, ultimately, improve patient care.Statistical Methods in Medical Research; Volume: 22 issue: 1, page(s): 57-69. First published online: June 24, 2011.
Author: G Niklas Norén, Johan Hopstadius, Andrew Bate
Date: 2011-06-24 -
Scientific publicationsFraudulent and Substandard Medicines: Getting Away with Murder?
Several women have bled to death after childbirth because the oxytocin used was totally inactive and there was no emergency blood and other necessary facilities to hand.Drug Saf 2011; 34 (6): 445-448.
Author: I. Ralph Edwards
Date: 2011-06-01 -
Scientific publicationsSuspected Adverse Drug Reactions Reported For Children Worldwide - An Exploratory Study Using VigiBase
As a first step towards implementing routine screening of safety issues specifically related to children at the Uppsala Monitoring Centre, this study was performed to explore reporting patterns of adverse reactions in children. Drug Saf. 2011;34(5):415-28.
Author: Kristina Star, G. Niklas Norén, Karin Nordin, I. Ralph Edwards
Date: 2011-05-01 -
Scientific publicationsSocial Media and Networks in Pharmacovigilance Boon or Bane?
Whether one likes them or not, social media such as Twitter and blogs in general, and networks such as Facebook and LinkedIn have become a very widely used form of social discourse. Drug Saf. 2011;34(4):267-71.
Author: I. Ralph Edwards, Marie Lindquist
Date: 2011-04-01 -
Scientific publicationsDose Variations Associated with Formulations of NSAID Prescriptions for Children - A Descriptive Analysis of Electronic Health Records in the UK
NSAIDs, particularly ibuprofen, are commonly prescribed for children but there is limited published research on real-life prescribed doses for this class of drugs. Drug Saf. 2011;34(4):307-17.
Author: Kristina Star, Ola Caster, Andrew Bate, I. Ralph Edwards
Date: 2011-04-01 -
Scientific publicationsAssessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring.
In spite of enhanced control efforts, malaria continues to be a major public health problem in 108 countries mostly in Africa and parts of Asia.Malaria Journal 2011, 10:57. http://www.malariajournal.com/content/10/1/57.
Author: Andrea Kuemmerle, Alex NO Dodoo, Sten Olsson, Jan Van Erps, Christian Burri, Paul S Lalvani
Date: 2011-03-09 -
Scientific publicationsReporting Patterns Indicative of Adverse Drug Interactions: A Systematic Evaluation in VigiBase
Adverse drug interaction surveillance in collections of Individual Case Safety Reports (ICSRs) remains underdeveloped.Drug Saf. 2011;34(3):253-66.
Author: Johanna Strandell, Ola Caster, Andrew Bate, Niklas Norén, I. Ralph Edwards
Date: 2011-03-01 -
Scientific publications
Vaccine safety
Int J Risk Saf Med. 2011;23(2):113-5.
Author: Labadie Jerry
Date: 2011-02-23 -
Scientific publications
New vaccine reports from FDA to the Uppsala Monitoring Centre
International Journal of Risk & Safety in Medicine 23(2):117-8 · January 2011.
Author: Hill Richard
Date: 2011-02-23 -
Scientific publicationsPharmacovigilance and the Null Hypothesis - Do We do Much for Public Health?
Over the past few years, the media has been replete with criticism of the failure of pharmacovigilance systems to prevent harm to people.Drug Saf. 2011;34(2):93-6.
Author: I. Ralph Edwards, Ambrose Isah
Date: 2011-02-01 -
Scientific publicationsUse of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase
Diabetes Care. 2011;34(2):369-74.
Author: Willemen MJ, Mantel-Teeuwisse AK, Straus SM, Meyboom RH, Egberts TC, Leufkens HG
Date: 2011-01-20 -
Scientific publicationsAfrican heat
It is common for Northern Europeans and North Americans to seek warmer climates in the autumn, but for anyone interested in pharmacovigilance the ‘hottest’ location was certainly Accra, Ghana.Drug Saf 2010; 33 (12): 1059-1063.
Author: I. Ralph Edwards
Date: 2010-12-01 -
Scientific publications
Earlier discovery of pregabalin’s dependence potential might have been possible
Letter to the Editor. Eur J Clin Pharmacol. 2011;67(3):319-20.
Author: Ola Caster, Ralph Edwards, G. Niklas Norén, Marie Lindquist
Date: 2010-10-23 -
Scientific publications
Pneumonia following antipsychotic prescriptions in electronic health records: a patient safety concern?
An investigation into the temporal pattern between antipsychotic prescriptions and pneumonia with respect to age, type of pneumonia and other chest infections, and antipsychotic class.Br J Gen Pract 2010; 60 (579): e385-e394.
Author: Kristina Star, Andrew Bate, Ronald HB Meyboom and I Ralph Edwards
Date: 2010-10-01 -
Scientific publicationsOff-Label Pharmacovigilance
The outcomes (effectiveness and safety) of all off-label uses should be systematically evaluated and reported.Drug Saf 2011; 34 (10): 795-797.
Author: I. Ralph Edwards
Date: 2010-10-01 -
Scientific publicationsReflections on Attribution and Decisions in Pharmacovigilance
In general, a causal relationship depends upon the nature and amount of evidence supporting an attribution hypothesis, such that ‘A causes B’.Drug Saf 2010; 33 (10): 805-809.
Author: Ola Caster, I. Ralph Edwards
Date: 2010-10-01 -
Scientific publicationsAlopecia in Association with Lamotrigine Use - An Analysis of Individual Case Safety Reports in a Global Database
A study examining the association between lamotrigine and alopecia by outlining the characteristics of the accumulated reports in VigiBase. Drug Saf. 2010;33(8):653-8.
Author: Maria Tengstrand, Kristina Star, Eugène P. van Puijenbroek, Richard Hill
Date: 2010-08-01 -
Scientific publicationsPharmacovigilance Activities in 55 Low- and Middle-Income Countries - A Questionnaire-Based Analysis
The WHO Programme for International Drug Monitoring aims to develop a comprehensive global pharmacovigilance strategy that responds to the healthcare needs of low- and middle-income countries. Drug Saf. 2010;33(8):689-703.
Author: Sten Olsson, Shanthi N. Pal, Andy Stergachis, Mary Couper
Date: 2010-08-01 -
Scientific publicationsWhat do Stakeholders Think about Pharmacovigilance?
A commentary on ‘‘Discourse on Safe Drug Use: Symbolic Logics and Ethical Aspects’’ by medical anthropologist Sylvie Fainzang. Drug Saf. 2010;33(8):619-21.
Author: I. Ralph Edwards, Teresa Graedon
Date: 2010-08-01 -
Scientific publicationsA Decade of Data Mining and Still Counting
The introduction of database-wide disproportionality screening for signal detection in spontaneous reporting systems (SRS) sparked a renaissance in pharmacovigilance research notable for numerous peer reviewed research articles, three expert working groups/white papers, countless meetings, symposia, workshops, graduate school theses and aggressive promotion of proprietary software. Drug Saf 2010; 33 (7): 527-534
Author: Manfred Hauben and G. Niklas Norén
Date: 2010-07-01 -
Scientific publications
Large-scale regression-based pattern discovery: The example of screening the WHO global drug safety database.
A presentation of the first implementation of shrinkage logistic regression for large-scale pattern discovery, with an evaluation of its usefulness in real-world binary transaction data.Statistical Analy Data Mining, 3: 197–208. doi:10.1002/sam.10078
Author: Caster, O., Norén, G. N., Madigan, D. and Bate, A.
Date: 2010-06-30 -
Scientific publicationsPlacebo Harm
A single placebo/nocebo (P/N) mechanism of action probably does not exist, but there is general agreement that conditioning and expectation are important factors in determining a particular response. This editorial does not to review the literature on (P/N) response in any depth, but considers the consequences of variability in the (P/N) response and its impact on drug safety and therapeutics. Drug Saf. 2010;33(6):439-41.
Author: I. Ralph Edwards, Joe Graedon, Terry Graedon
Date: 2010-06-01 -
Scientific publicationsFirst, Catch Your Signal!
Over the years there have been many attempts to define what we mean by a signal. We have come to the view that attempts to provide a single, concise definition cannot succeed because a signal in pharmacovigilance is not an entity. Drug Saf. 2010;33(4):257-60.
Author: I. Ralph Edwards, Marie Lindquist
Date: 2010-04-01 -
Scientific publicationsWonder vigilance
A commentary on the article by the British Medical Journal’s ‘ethics man’, Daniel K. Sokol, ‘Wonder in Medicine’. Drug Saf. 2010;33(2):83-6.
Author: I. Ralph Edwards
Date: 2010-02-01 -
Scientific publicationsTomorrow's world
What is lurking in the shadows for pharmacovigilance of the future? Participants at two recent meetings have felt strongly enough about their discussions to issue statements that have the future clearly in mind. Drug Saf. 2009;32(12):1105-8.
Author: I. Ralph Edwards
Date: 2009-12-01 -
Scientific publicationsTemporal pattern discovery in longitudinal electronic patient records
This paper presents a framework for open-ended pattern discovery in large patient records repositories. At the core is a graphical statistical approach to summarising and visualising the temporal association between the prescription of a drug and the occurrence of a medical event.Data Mining and Knowledge Discovery. May 2010, Volume 20, Issue 3, pp 361–387.
Author: G. Niklas Norén, Johan Hopstadius, Andrew Bate, Kristina Star, I. Ralph Edwards.
Date: 2009-11-30 -
Scientific publicationsA Risk Worth Taking?
Vaccine vigilance has a number of significant and well known challenges associated with it.Drug Saf. 2009;32(10):801-4.
Author: I. Ralph Edwards
Date: 2009-10-01 -
Scientific publicationsOutliers and Patients with Adverse Drug Reactions
Professor David Finney is arguably the initiator of global pharmacovigilance, and, in his 90th year, he can still provoke us to thought! Drug Saf. 2009;32(8):623-4.
Author: I. Ralph Edwards
Date: 2009-08-01 -
Scientific publicationsUnderstanding and Communicating Key Concepts in Risk Management What do we Mean by Benefit and Risk?
Words can be used to express ideas and knowledge in ways that are not intended nor understood in the same way by the recipient. Drug Saf. 2009;32(6):449-52.
Author: I. Ralph Edwards, Marie Lindquist
Date: 2009-06-01 -
Scientific publicationsThe Good Old Drugs!
The Centres for Medicare and Medicaid Services (CMS) blames increasing drug safety concerns for slower growth in health spending. Drug Saf. 2009;32(4):271-3.
Author: I. Ralph Edwards
Date: 2009-04-01 -
Scientific publicationsThe ISoP Bengt-Erik Wiholm Memorial Lecture
The International Society of Pharmacovigilance (ISoP) decided to create an annual Bengt-Erik Wiholm Memorial Lecture with the broad theme of pluralistic approaches to pharmacovigilance. Drug Saf. 2009;32(3):181-5.
Author: I. Ralph Edwards
Date: 2009-03-01 -
Scientific publicationsRisk Management of Medicines and Compensation for Harm
Total drug safety is impossible to attain, and there are many cases of drug injury that go to court where negligence may not be the issue, although the injuries are dire. Drug Saf. 2009;32(2):87-90.
Author: I. Ralph Edwards
Date: 2009-02-01 -
Scientific publicationsStratification for Spontaneous Report Databases
Correspondence : Letter in response to Evans comments on paper concerning the use of routine adjustment by stratification in adverse drug reaction surveillance. Drug Safety 2008; 31 (12): 1145-1147
Author: Johan Hopstadius, G. Niklas Norén, Andrew Bate, I. Ralph Edwards
Date: 2008-12-01 -
Scientific publicationsImpact of Stratification on Adverse Drug Reaction Surveillance
Automated screening for excessive adverse drug reaction (ADR) reporting rates has proven useful as a tool to direct clinical review in large-scale drug safety signal detection. Drug Safety 2008; 31 (11): 1035-1048.
Author: Johan Hopstadius, G. Niklas Norén, Andrew Bate, I. Ralph Edwards
Date: 2008-11-01 -
Scientific publicationsControlled Trials and Risk of Harm
I regularly read and hear declarations claiming that spontaneous reports are the poorest form of epidemiological evidence and, conversely, that controlled clinical trials provide the only evidence to base decisions on Drug Saf. 2008;31(11):961-3.
Author: I. Ralph Edwards
Date: 2008-11-01 -
Scientific publications
VigiBase, the WHO global ICSR database system: basic facts
Apart from data management and quality assurance tools, the VigiBase system includes a web-based reporting tool, an automated signal detection process using advanced data mining, and search facilities, available to the member countries and, on request, to other stakeholders.The Drug Information Journal, 42(5):409-419.
Author: Marie Lindquist
Date: 2008-09-01 -
Scientific publicationsAssociations between venous thromboembolism and antipsychotics. A study of the WHO database of adverse drug reactions.
Concern has been raised about the occurrence of venous thromboembolism (VTE) during treatment with antipsychotics.Drug Safety 2008; 31 (8): 685-694.
Author: Staffan Hägg, Andrew Bate, Malin Stahl, Olav Spigset
Date: 2008-08-01 -
Scientific publicationsTNF-α Inhibitors and Leukaemia: International Pharmacovigilance Reports
Since the first report in 2003 of the development of leukaemia in a patient using etanercept, three more observations regarding leukaemia in suspected connection with a tumour necrosis factor-[alpha] inhibitor (TNFI) have appeared in the literature: one of etanercept and two concerning infliximab (together with reactivation of tuberculosis in one). Drug Saf. 2008;31(5):445-7.
Author: Ronald H.B. Meyboom, Kristina Star, Jenny Bate, Ruth Savage, I. Ralph Edwards
Date: 2008-05-01 -
Scientific publications
The future of pharmacovigilance: a personal view
Can we say that progress has been made towards the goal of safer use of medicines for patients? Professor Edwards argues that the answer is doubtful. He looks at current challenges and highlights some possible ways forward as well as additional changes needed and obstacles to progress.Eur J Clin Pharmacol (2008) 64: 173. doi:10.1007/s00228-007-0435-9
Author: I. Ralph Edwards
Date: 2008-01-03 -
Scientific publicationsAn Analysis of Vigimed, a Global E-Mail System for the Exchange of Pharmacovigilance Information
The Internet provides novel ways for communication and data exchange between national regulators.Drug Saf. 2007;30(10):883-9.
Author: Kristina Johansson, Sten Olsson, Björn Hellman, Ronald H. B. Meyboom
Date: 2007-10-01 -
Scientific publicationsThe Need for Definitions in Pharmacovigilance
All human communication depends on our ability to convey and correctly interpret messages; the language is the means by which a message is transmitted.Drug Saf. 2007;30(10):825-30.
Author: Marie Lindquist
Date: 2007-10-01 -
Scientific publicationsAllergic Reactions to Medicines Derived from Pelargonium Species
Pelargonium (Pelargonium sidoides DC and P. reniforme Curtis) is reported to have immune modulating properties and antibacterial activity, and Pelargonium extracts have been used for the treatment of respiratory tract and gastrointestinal infections.Drug Saf. 2007;30(8):677-80.
Author: Hugo J. de Boer, Ulrich Hagemann, Jenny Bate, Ronald H. B. Meyboom
Date: 2007-08-01 -
Scientific publicationsUse of Triage Strategies in the WHO Signal-Detection Process
An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. Drug Saf. 2007;30(7):635-7.
Author: Marie Lindquist
Date: 2007-07-01 -
Scientific publicationsBayesian Confidence Propagation Neural Network
A Bayesian confidence propagation neural network (BCPNN)-based technique has been in routine use for data mining the 3 million suspected adverse drug reactions (ADRs) in the WHO database of suspected ADRs, as part of the signal detection process, since 1998. Drug Saf. 2007;30(7):623-5.
Author: Andrew Bate
Date: 2007-07-01 -
Scientific publicationsStatins, Neuromuscular Degenerative Disease and an Amyotrophic Lateral Sclerosis-Like Syndrome
The WHO Foundation Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre [UMC]) has received many individual case safety reports (ICSRs) associating HMG-CoA reductase inhibitor drug (statin) use with the occurrence of muscle damage, including rhabdomyolysis, and also peripheral neuropathy. Drug Saf. 2007;30(6):515-25.
Author: I. Ralph Edwards, Kristina Star, Anne Kiuru
Date: 2007-06-01 -
Scientific publicationsGuidelines for Submitting Adverse Event Reports for Publication
Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance.Drug Saf. 2007;30(5):367-73.
Author: William N. Kelly, Felix M. Arellano, Joanne Barnes, Ulf Bergman, Ralph I. Edwards, Alina M. Fernandez, Stephen B. Freedman, David I. Goldsmith, Kui A. Huang, Judith K. Jones, Rachel McLeay, Nicholas Moore, Rosie H. Stather, Thierry Trenque, William G. Troutman, Eugene van Puijenbroek, Frank Williams, Robert P. Wise
Date: 2007-05-01 -
Scientific publicationsThe Erice Manifesto for Global Reform of the Safety of Medicines in Patient Care
The science of pharmacovigilance – monitoring and evaluating drug safety issues and communicating them effectively – is a vital activity of worldwide significance in the safeguarding of patient welfare and public health. Drug Saf. 2007;30(3):187-90.
Author: Velo G, Hugman B.
Date: 2007-03-01 -
Scientific publications
Duplicate detection in adverse drug reaction surveillance
In this paper, the authors propose a duplicate detection method based on the hit-miss model for statistical record linkage described by Copas and Hilton, which handles the limited amount of training data well and is well suited for the available data (categorical and numerical rather than free text).Data Mining and Knowledge Discovery. June 2007, Volume 14, Issue 3, pp305–328.
Author: G. Niklas Norén, Roland Orre, Andrew Bate, I. Ralph Edwards.
Date: 2007-02-07 -
Scientific publicationsBotanical Nomenclature in Pharmacovigilance and a Recommendation for Standardisation
Nomenclature of plants in pharmacology can be presented by pharmaceutical names or scientific names in the form of Linnaean binomials. Drug Saf. 2006;29(11):1023-9.
Author: Mohamed H. Farah, Sten Olsson, Jenny Bate, Marie Lindquist, I. Ralph Edwards, Monique S.J. Simmonds, Christine Leon, Hugo J. de Boer, Mats Thulin
Date: 2006-11-01 -
Scientific publicationsWhat is Drug Safety? Celebrating 20 Years of the Drug Safety Journal
The year is 1986 and drug safety stands at a crossroads. The term ‘pharmacovigilance’ is not yet used outside of France and the WHO Programme for International Drug Monitoring, which was set up in 1968, consists of a membership of 27 mainly ‘developed’ countries.Drug Saf. 2006;29(6):461-5.
Author: I. Ralph Edwards
Date: 2006-06-01 -
Scientific publications UMC materialThe Erice declaration : the critical role of communication in drug safety
The Erice Declaration on Communicating Drug Safety Information, first published in September 1997, provides a vision of vigorous, open, ethical, patient-centred communications in drug safety that the world has yet to achieve. Drug Saf. 2006;29(1):91-3.
Author: Bruce Hugman
Date: 2006-01-01 -
Scientific publicationsWhat are the Real Lessons from Vioxx®?
In major medical journals, as well as in the public media, it has been said that regulators have not managed the risk issues of rofecoxib (Vioxx®) well.Drug Saf. 2005;28(8):651-8.
Author: I. Ralph Edwards
Date: 2005-08-01 -
Scientific publicationsFrom the Uppsala Monitoring Centre - A Review of Viewpoint Part 1 and Part 2
The core task of the Uppsala Monitoring Centre (UMC) is the collection and processing of adverse drug reaction reports from member countries of the WHO Programme for International Drug Monitoring to detect early signals of potential drug hazards.Drug Saf. 2005;28(7):645-6.
Author: Bruce Hugman
Date: 2005-07-01 -
Scientific publicationsThe WHO World Alliance for Patient Safety - A New Challenge or an Old One Neglected?
The WHO World Alliance on Patient Safety is a new, all-encompassing project to improve medical care.Drug Saf. 2005;28(5):379-86.
Author: I. Ralph Edwards
Date: 2005-05-01 -
Scientific publications
Case Based Imprecision Estimates for Bayes Classifiers with the Bayesian Bootstrap
This article outlines a Bayesian bootstrap method for case based imprecision estimates in Bayes classification.Machine Learning, January 2005, Volume 58, Issue 1, pp 79–94.
Author: G. Niklas Norén, Roland Orre
Date: 2005-01-01 -
Scientific publicationsData Quality Management in Pharmacovigilance
Pharmacovigilance relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data.Drug Saf. 2004;27(12):857-70.
Author: Marie Lindquist
Date: 2004-10-01 -
Scientific publications
Intuition, evidence, and safety
The Lancet, Volume 364, No. 9431, p387, 24 July 2004
Author: I Ralph Edwards
Date: 2004-07-24 -
Scientific publicationsAssessing the Impact of Drug Safety Signals from the WHO Database Presented in ‘SIGNAL’ Results from a Questionnaire of National Pharmacovigilance Centres
Introduction: A major task for the Uppsala Monitoring Centre (UMC) is to detect early signals of suspected adverse drug reactions (ADRs) in the WHO Database.Drug Saf. 2003;26(10):721-7.
Author: Malin Ståhl, I. Ralph Edwards, Geoffrey Bowring, Anne Kiuru, Marie Lindquist
Date: 2003-08-01 -
Scientific publicationsGlucose Intolerance with Atypical Antipsychotics
Previous studies have suggested that the atypical antipsychotics clozapine and olanzapine may be associated with an increased risk of glucose intolerance and diabetes mellitus.Drug Saf. 2002;25(15):1107-16.
Author: Karin Hedenmalm, Staffan Hägg, Malin Ståhl, Örjan Mortimer, Olav Spigset
Date: 2002-12-01 -
Scientific publicationsLabelling and ‘Dear Doctor’ Letters - Are They Noncommittal?
Over the past few years, a number of drugs have been withdrawn for safety reasons, either by drug approval authorities, or by the manufacturer.Drug Saf. 2002;25(15):1051-5.
Author: A.C. Kees van Grootheest, I. Ralph Edwards
Date: 2002-12-01 -
Scientific publicationsThe Value of Reporting Therapeutic Ineffectiveness as an Adverse Drug Reaction
Therapeutic ineffectiveness is a frequent drug-related problem that can occur in a variety of different situations and be caused by different mechanisms. Drug Saf. 2000;23(2):95-9.
Author: Ronald H.B. Meyboom, Marie Lindquist, Anna-Karin Flygare, Cecilia Biriell, I. Ralph Edwards
Date: 2002-08-01 -
Scientific publicationsA Data Mining Approach for Signal Detection and Analysis
The WHO database contains over 2.5 million case reports, analysis of this data set is performed with the intention of signal detection. Drug Saf. 2002;25(6):393-7.
Author: Andrew Bate, Marie Lindquist, I. Ralph. Edwards, Roland Orre
Date: 2002-05-01 -
Scientific publicationsSignal Selection and Follow-Up in Pharmacovigilance
The detection of unknown and unexpected connections between drug exposure and adverse events is one of the major challenges of pharmacovigilance. Drug Saf. 2002;25(6):459-65.
Author: Ronald H.B. Meyboom, Marie Lindquist, Antoine C.G. Egberts, I. Ralph Edwards
Date: 2002-05-01 -
Scientific publicationsA Retrospective Evaluation of a Data Mining Approach to Aid Finding New Adverse Drug Reaction Signals in the WHO International Database
The detection of new drug safety signals is of growing importance with ever more new drugs becoming available and exposure to medicines increasing. Drug Safety 2000 Dec; 23 (6): 533-542
Author: Marie Lindquist, Malin Ståhl, Andrew Bate, I. Ralph Edwards, Ronald H.B. Meyboom
Date: 2000-12-01 -
Scientific publicationsAn ABC of Drug-Related Problems
Practically all medicine-related problems can be classified in one basic system, taking into account their characteristics and distinctions. This system distinguishes between appropriate and inappropriate drug use, dose-related and dose unrelated problems, and types A (‘drug actions’), B (‘patient reactions’) and C (‘statistical’) adverse effects.Drug Saf. 2000;22(6):415-23.
Author: Ronald H.B. Meyboom, Marie Lindquist, Antoine C.G. Egberts
Date: 2000-08-01 -
Scientific publicationsPharmacovigilance in Perspective
Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. Drug Saf. 1999;21(6):429-47.
Author: Ronald H. B. Meyboom, Antoine C. G. Egberts, Frank W. J. Gribnau, Yechiel A. Hekster
Date: 1999-12-01 -
Scientific publications
A Bayesian neural network method for adverse drug reaction signal generation
European Journal of Clinical PharmacologyJuly 1998, Volume 54, Issue 4, pp 315–321
Author: A. Bate, M. Lindquist, I. R. Edwards, S. Olsson, R. Orre, A. Lansner, R. M. De Freitas
Date: 1998-07-01