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Introduction
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January 1981 - September 1989
July 1970 - June 1975
September 1990 - September 2007
Publications
Publications (336)
Purpose
The purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics.
Methods
Individual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database...
The thalidomide tragedy highlighted an unacceptable harm and potential risks of taking medicines [1]. This resulted in a global resolve that such a tragedy should never occur again, and all machinery to achieve this was put in place in the more developed countries in a rather systematic manner. This initial and prompt response ultimately resulted i...
Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle...
Introduction:
The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal d...
IntroductionA number of safety signals—complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS)—have emerged with human papillomavirus (HPV) vaccines, which share a similar pattern of symptomatology. Previous signal evaluations and epidemiological studies have largely relied on trad...
The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced an...
Background: Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO...
Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance...
The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error...
Objective Quantitative Structure-Activity Relationship (QSAR) models can predict adverse drug reactions (ADRs), and thus provide early warnings of potential hazards. Timely identification of potential safety concerns could protect patients and aid early diagnosis of ADRs among the exposed. Our objective was to determine whether global spontaneous r...
Background:
High-dose short-term methylprednisolone is the recommended treatment in the management of multiple sclerosis relapses, although it has been suggested that lower doses may be equally effective. Also, glucocorticoids are associated with multiple and often dose-dependent adverse effects. This quantitative benefit-risk assessment compares...
Background:
Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO...
PurposeTo explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database.Methods
Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to comb...
Introduction:
Valproic acid is an effective first line drug for the treatment of epilepsy. Hepatotoxicity is a rare and potentially fatal adverse reaction for this medicine.
Objective:
Firstly to characterise valproic acid reports on children with fatal outcome and secondly to determine reporting over time of hepatotoxicity with fatal outcome....
This paper describes the personal views of the author about diagnosis and management of an adverse drug effect. It proposes that diagnosis is complicated and is also supported by carefully observed management of changes in drug therapy. Drug-related adverse effects may be due to the drug itself, though many are due to systematic errors occurring in...
Quantifying a medicine's risks for adverse effects is crucial in assessing its value as a therapeuticagent. Rare adverse effects are often not detected until after the medicine is marketed and used inlarge and heterogeneous patient populations, and risk quantification is even more difficult. Whileindividual case reports of suspected harm from medic...
Child age-specific information on efficacy and risk of medicines can be limited for healthcare professionals and patients. It is therefore very important to make the best use of a risk planned approach to the pharmacological treatment of children. This means pharmacovigilance in the broadest sense of gaining the best data from the use of medicines...
Joint evaluation of drugs’ beneficial and adverse effects is required in many situations, in particular to inform decisions on initial or sustained marketing of drugs, or to guide the treatment of individual patients. This synthesis, known as benefit-risk assessment, is without doubt important: timely decisions supported by transparent and sound as...
The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse event...
The aims of pharmacovigilance are early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescribing and regulation. The pharma...
Background
Around 20 % of all adverse drug reactions (ADRs) are due to drug interactions. Some of these will only be detected in the postmarketing setting. Effective screening in large collections of individual case safety reports (ICSRs) requires automated triages to identify signals of adverse drug interactions. Research so far has focused on sta...
Introduction:
Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. European experience provides several lessons as the United States (US) heal...
Healthcare professional's knowledge and attitudes to adverse drug reaction (ADR) and ADR reporting play vital role to report any cases of ADR. Positive attitudes may favour ADR reporting by healthcare professionals. This study was aimed to investigate the attitudes towards and ways to improve adverse drug reaction (ADR) reporting among healthcare p...
Questionnaire for evaluating healthcare professionals’ attitudes towards ADR reporting in Nepal.
To investigate the knowledge about ADRs and ADR reporting among healthcare professionals working at four regional pharmacovigilance centers (RPCs) of Nepal.
It was a cross sectional study, done by a survey using a validated self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four...
To explore nurses’ experiences of handling medications in paediatric clinical practice, with a focus on factors that hinder and facilitate safe medication practices.
Twenty nurses (registered nurses) from four paediatric wards at two hospitals in Sweden were interviewed in focus groups. The interviews were analysed using content analysis.
Six theme...
Objective:
Rhabdomyolysis is a rare and potentially serious adverse drug reaction (ADR) to antipsychotic medicines. The aim of this study was to investigate the clinical circumstances surrounding the diagnosis of rhabdomyolysis in children and adolescents treated with antipsychotic medicines. We also critically reviewed individual case safety repo...
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. We propose a method to incorporate qualitative information into a probabilistic decision analysis framework for quantitative benefit-risk assessment.
: To investigate...
We agree that spontaneous reporting systems are important but would like to emphasise that most suspected adverse drug reactions are not reported at all, and many reports have limited information.1
New guidelines are useful, but major problems everywhere, not only in the UK, are that the complex data analysis needed on safety is not open to public...
Background: 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. We propose a method to incorporate qualitative information into a probabilistic decision analysis framework for quantitative benefit-risk assessment. Objec...
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. During a recent WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (WHO-UMC) training workshop th...
Suspected adverse drug reactions for digoxin from Australia, France, Germany, Sweden, the UK and the US, which were reported to the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring since 1968, were examined for qualitative and quantitative differences between countries. Intercontinental Medical Statistics (IMS)...
Adverse drug reactions are the fifth most frequent cause of deaths in developed countries, effectively a global epidemic. However, progress in ameliorating the problem has been slow. Pharmacovigilance currently operates without clear objectives in relation to individual decisions, with no protocol (although risk management plans are a great step fo...
There are now 7 million reports in the Uppsala Monitoring Centre (UMC) database (VigibaseTM) held in trust for the WHO Programme for International Drug Monitoring.[1] Each of these individual case harm reports (ICHRs) represents a suspicion by the reporter that a drug may have been responsible for a harmful clinical effect. The Reverend Donald Mess...
Adverse drug reactions are the fifth most frequent cause of deaths in developed countries, effectively a global epidemic. However, progress in ameliorating the problem has been slow. Pharmacovigilance currently operates without clear objectives in relation to individual decisions, with no protocol (although risk management plans are a great step fo...
Causality has been a topic of debate by philosophers, scientists, lawyers and for centuries. It is essential to define as precisely as possible all steps in the logical chain of events, since each may strengthen or confound an argument. Almost always there are issues of missing and conflicting data that need to be addressed specifically. In pharmac...
Jur Strobos and colleagues describe the deliberations of a recent multi-stakeholder meeting discussing the creation of a sustainable global pharmacovigilance system for antiretroviral drugs that would be applicable in resource limited settings.
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.
The first aim of this study was to characterize and contrast child reports against adult reports in an overall drug and ad...
NSAIDs, particularly ibuprofen, are commonly prescribed for children but there is limited published research on real-life prescribed doses for this class of drugs.
The aim of the study was to investigate if variations in NSAID doses prescribed to children can be explained by patient age, indication, dosage form, type of NSAID or year of prescriptio...
Adverse drug interaction surveillance in collections of Individual Case Safety Reports (ICSRs) remains underdeveloped. Most efforts to date have focused on disproportionality analysis, but the empirical support for its value is based on isolated examples. Additionally, too little attention has been given to the potential value of the detailed conte...
Executive summary The regulation of the input and collation of data and information in pharmacovigilance has added considerable rigour to the discipline. The next needs of pharmacovigilance are summarised below: • A major concentration on communication of useful information to health professionals, patients and health care providers • The response...
Background: 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. Objective: The first aim of this study was to characterize and contrast child reports against adult reports in...
This study assesses the ability of Pharmacovigilance Centres (PVCs) to detect medication errors (ME) and to proceed to building Patient Safety (PS) via their information networks and to underline the limits for this challenge.
This was an exploratory study conducted in PVCs members of the World Health Organization International Drug Monitoring netw...
In screening the Intercontinental Medical Statistics (IMS) Health Disease Analyzer database of GP records from the UK, an increased registration of pneumonia subsequent to the prescription of some antipsychotic medicines was identified.
To investigate the temporal pattern between antipsychotic prescriptions and pneumonia with respect to age, type o...
Large collections of electronic patient records provide a vast but still underutilised source of information on the real world
use of medicines. They are maintained primarily for the purpose of patient administration, but contain a broad range of clinical
information highly relevant for data analysis. While they are a standard resource for epidemio...
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. There are several signal endpoints possible that depend on a multiplicity of factors, defying a deconstructural approac...
