Paediatric Pharmacovigilance Research Articles

Identifying, Understanding and Managing Treatment-related Risks of Medicines Prescribed to Children

The relatively new field of paediatric pharmacovigilance aims to improve the clinical care of children by understanding and appropriately managing the risks of medicines administered to this group of patients. Dr Beate Aurich is an established expert in this field, and with colleagues, has published an article on the practical aspects of paediatric pharmacovigilance. She notes that the assessment of the benefit-risk balance of available treatment options should be based on multidisciplinary efforts and include both children and their families.

C4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper.

Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population-specific factors (e.g., more frequent use of off-label/unlicensed drugs). In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which are described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development, safety data collection and analysis. Furthermore, they describe the specific details of post-marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record-linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit-risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life-cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.

Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study.

Despite their frequent use in children and adolescents, the evidence for efficacy and safety of antidepressants (ATDs) in this population is scarce and off-label prescribing common. The aim of this study was to describe reported adverse drug reactions (ADRs) associated to ATDs over a 30-year period using the French Pharmacovigilance Database (FPVD). We performed an analysis of ADRs registered in the FPVD from 1985 to 2016, occurred in children and adolescents receiving an ATD. Descriptive statistics were used to obtain an overview of ADRs types and characteristics, and data were stratified by age. Among the 45,070 pediatric cases reports registered into the FPVD, we identified 1366 reports (3.0%) in which ATDs were "suspected" as the cause of 2922 ADRs. ADRs were more frequently reported in female (n = 743; 55.5%) and adolescents (n = 627; 49.3%). Neuropsychiatric ADRs were the most reported, mainly sleepiness, agitation, and suicidal thinking and behavior, followed by gastrointestinal and hepatobiliary disorders, mainly vomiting, abdominal pain, hepatitis, nausea, and three unexpected ADRs of pancreatitis. There was an increase of annual reporting between 1986 and 2003, followed by a plateau state then a decrease from 2003 to 2012, and a rapid escalation until 2016, while an increase in the number of reporting of suicidal thinking and behavior was observed after 2003, highlighting a possible impact of black box warnings on reporting practices and ATD use. This pediatric pharmacovigilance study underscored the high prevalence of neuropsychiatric and gastrointestinal ADRs, including three unexpected cases of pancreatitis.

Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre.

PurposeThe 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.MethodsIndividual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years. vigiRank, a data‐driven predictive model for emerging safety signals, was used to prioritise the list of drug events by age groups. The list was manually assessed, and potential signals were identified to undergo in‐depth assessment to determine whether a signal should be communicated.ResultsA total of 472 drug‐event pairs by paediatric age groups were the subject of an initial manual assessment. Twenty‐seven drug events from the two older age groups were classified as potential signals. An in‐depth assessment resulted in eight signals, of which one concerned harm in connection with off‐label use of dextromethorphan and another with accidental overdose of olanzapine by young children, and the remaining signals referred to potentially new causal associations for atomoxetine (two signals), temozolamide, deferasirox, levetiracetam, and desloratadine that could be relevant also for adults.ConclusionsClinically relevant signals were uncovered in VigiBase by using vigiRank applied to paediatric age groups. Further refinement of the methodology is needed to identify signals in reports with ages under 2 years and to capture signals specific to the paediatric population as a risk group.

Adverse Drug Reaction Onsets in Uganda's VigiBase®: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses.

IntroductionDeveloping countries can improve their pharmacovigilance systems by analysing their own medication safety data.ObjectiveThe aims of this study were to characterize Uganda’s reported adverse drug reaction (ADR) onsets in 2012–2015 that were registered on VigiBase® by 31 December 2017, to document delays in international visibility and the influence of covariates on this delay from ADR onsets in 2013 + 2014, to examine data quality, and to illustrate analytical approaches for safety data, particularly for patients receiving antiretroviral therapy (ART).MethodsInternational delay was defined as elapsed time from complete ADR onset date to entry date on VigiBase®, with covariates examined using Cox proportional hazards regression. Simple random sampling was used to locate the paper-based ADR forms for data quality assurance. Disproportionality for signal detection focused on serious singleton ADR onsets in patients receiving ART.ResultsUganda’s VigiBase® had 1018 patient entries with complete ADR onset dates: 260 in 2012, 293 in 2013, 305 in 2014 and 160 in 2015. Only 16% (154/953) of ADR onsets in 2012–2015 were in patients aged < 20 years for whom randomly sampled ADR forms were less fully completed; 87% (889/1018) comprised a singleton sign/symptom; half were serious. Median delay from ADR onset to international visibility was 11 months for ADR onsets in 2013 + 2014, and longest for healthcare professionals other than pharmacists and physicians. Disproportionality for serious ADR onsets in patients receiving ART included anaemia with zidovudine, renal impairment with tenofovir, Stevens–Johnson syndrome with nevirapine and skin rash with efavirenz.ConclusionsBarely one ADR onset per day was registered on VigiBase® from those submitted to Uganda’s National Pharmacovigilance Centre during 2012–2014; only one in six was from patients aged < 20 years. Paediatric pharmacovigilance requires more emphasis in Uganda. Delays from reported ADR onset to international visibility on VigiBase® need to reduce dramatically. Quality assurance revealed rectifiable data entry deficits. Signal detection performed well for patients receiving ART.Electronic supplementary materialThe online version of this article (10.1007/s40290-018-0253-7) contains supplementary material, which is available to authorized users.

Pharmacovigilance in pediatrics

The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific features of children. At the time of marketing a medicinal product intended for children, the product's safety profile is sometimes less well known than for adults due to fewer or small sample clinical trials. Furthermore, the frequent off-labeled drug use, the use of unsuitable dosage forms and the need for continuous dose adjustments increase the risk of medication errors and thus lead to avoidable adverse drug reactions (ADRs). The occurrence of child-specific ADRs (such as growth disorders) or ADRs more commonly occurring in children than in adults make it necessary to monitor the safety of child-specific drugs. Pediatric pharmacovigilance includes also the consequences of in utero exposure, whether manifestations are present from birth or occur in early childhood (such as neurodevelopmental disorders). The incidence of ADRs varies with age, setting of medical care (in- or out-patients, pediatric specialties) and by country in which the study was carried out. The drugs most frequently reported with ADRs are those most commonly used in the pediatric age group, i.e. antibiotics and vaccines. The ADRs most often reported are skin, neurological and general disorders. As in adults, spontaneous notification is essential to generate alerts and child-specific pharmacoepidemiological studies are necessary and should be developed.

Pediatric pharmacovigilance in an institute of national importance: Journey has just begun.

OBJECTIVE:The objective of this study is to determine the nature and severity of adverse drug reactions (ADRs) in pediatric patients.MATERIALS AND METHODS:In this retrospective cohort study, we extracted the data from all the available pediatric ADR forms submitted to ADR monitoring center (AMC) from May 2014 to December 2016. The data including nature, frequency, causality (World Health Organization [WHO] causality scale), and the severity (Hartwig and Siegel scale for severity) of ADR were extracted. We also assessed the preventability of the event on modified Schumock and Thornton scale of ADR preventability.RESULTS:There were a total of 20 pediatric ADRs reported during this period. Nearly two-thirds of the ADRs occurred in patients who were receiving multiple drugs (polytherapy). Antimicrobial agents were the most commonly implicated drugs. The most common ADRs were skin rash (maculopapular, erythematous, and urticaria, itching, etc.). The severity and preventability scales indicated that most reactions (18/20) were moderate in nature and all were preventable. Four reactions were “certainly” and ten ADRs were “probably” related to the suspected drug as determined by the WHO causality assessment.CONCLUSION:Frequency of ADR increased with number of medications patient was receiving. Health-care providers (HCPs) involved in the care of children must be aware of this fact and should use additional drugs when absolutely necessary. They should be involved in pharmacovigilance program by exchanging and updating each other through sharing constructive information, communication, and education concerning the appropriate use of drugs in children. Pediatric pharmacovigilance is the need of the hour and should be given utmost importance for monitoring the safety of drugs in children. Motivating HCPs for voluntary reporting of ADRs for preventing the morbidity and mortality in this vulnerable population could be of immense importance.

Core requirements for successful data linkage: an example of a triangulation method

ObjectivesThe aim was to explore the views of professional stakeholders and healthcare professionals (HCPs) on the linkage of UK National Health Service (NHS) data for paediatric pharmacovigilance purposes and to...

Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports.

Databases of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance. With increasing numbers of reports, additional statistical approaches are needed to better use the data. The present study was aimed at elucidating the European Medicines Agency's (EMA) use of a novel 'paediatric' query to analyse the data in its ADR database 'EudraVigilance'. The proportional reporting ratio (PRR) is a measure of disproportionality for which the underlying principle is that a drug-event pair of interest is reported more often than expected relative to an independence model. The EMA's paediatric query, based on PRRs, was applied to the data in EudraVigilance to investigate the extent to which the known association between enalapril and renal toxicity was reflected in reported ADRs comparing children with adults and with adjustment for the effect of multiplicity. The comparison of PRRs for children (14.91, 95% confidence interval [CI] 13.05-17.04) versus adults (2.66, 95% CI 2.52-2.82) confirmed a higher risk of renal ADRs with enalapril when used in children compared with all other medicines and compared with adults. The EMA's paediatric query can be used to highlight an imbalance for a drug-event pair among ADRs for a medicine when used in children and as compared with adults. Applying the query in practice can help the EMA to decide on whether stand-alone paediatric medicine development is warranted, and which, if any, further studies are necessary. Ongoing evaluation of the query is contributing to the development of new methods and guidance.

Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.

BackgroundAdverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs.ObjectivesThe objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland.MethodsA Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation.Results121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree – strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach.ConclusionsIt would be acceptable to stakeholders to introduce a data linkage system for pharmacovigilance as long as identified concerns are addressed. Concerns included adherence to current professional, legal and ethical standards, as well resolving practical issues.

Pharmacovigilance in Pediatric Age: The Role of Family Pediatricians- Medicines for Children Research Network (FP-MCRN)

The conduct of pharmacovigilance for paediatric use medicines requires special attention. Childhood diseases and disorders may be qualitatively and quantitatively different from their adult equivalents. Lack of clinical studies in the paediatric population leads as a consequence to drug prescriptions on an unlicensed or ‘off-label’ basis, because they have not been adequately tested and/or formulated and authorised for use in appropriate paediatric age groups. Spontaneously reported suspected adverse drug reactions remain the most important source in order to promote reasonable warning signals. Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Post Authorization Safety Studies (PASS), give much more reliable estimates of the risk of ADRs than those resulting from spontaneous reports. An improvement Family Paediatricians (FP) Pharmacovigilance training and continuous family information on the correct use of paediatric drugs may generate a better compliance of ADRs understanding. In this context, Family Paediatricians -Medicines for Children Research Network (FP-MCRN), ENPREMA and ENCEPP member, established with the aim of developing competence, infrastructure and education for paediatric clinical trials, plays a crucial role in paediatric Pharmacovigilance (PV), through an improvement of PV paediatricians training, a correct research methodology and very strong relationship with the families.

Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven African countries.

BackgroundPharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) for treatment of uncomplicated malaria in African children.MethodsWe used paediatric safety data from a multi-site, multi-country clinical study conducted in seven African countries (Burkina Faso, Gabon, Nigeria, Rwanda, Uganda, Zambia, and Mozambique). Each site compared three out of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) or chlorproguanil/dapsone and artesunate (CD+A). We examine two pharmacovigilance signal detection methods, namely proportional reporting ratio and Bayesian Confidence Propagation Neural Network on the clinical safety dataset.ResultsAmong the 4,116 children (6–59 months old) enrolled and followed up for 28 days post treatment, a total of 6,238 adverse events were reported resulting into 346 drug-event combinations. Nine signals were generated both by proportional reporting ratio and Bayesian Confidence Propagation Neural Network. A review of the manufacturer package leaflets, an online Multi-Drug Symptom/Interaction Checker (DoubleCheckMD) and further by therapeutic area experts reduced the number of signals to five. The ranking of some drug-adverse reaction pairs on the basis of their signal index differed between the two methods.ConclusionsOur two data mining methods were equally able to generate suspected signals using the pooled safety data from a phase IIIb/IV clinical trial. This analysis demonstrated the possibility of utilising clinical studies safety data for key pharmacovigilance activities like signal detection and evaluation. This approach can be applied to complement the spontaneous reporting systems which are limited by under reporting.

Pharmacovigilance for Children’s Sake

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 in clinical practice. We consider issues that complicate safe medication use in paediatric care, as well as current progress and provide suggestions for building knowledge within paediatric pharmacovigilance to be used to minimise patient harm. The continuous development in children constitutes a challenge to prescribing and administering age-suitable doses for individual children. Children are not only different from adults but differ vastly within their own age group. Physical growth during childhood is apparent to the eye, but less obvious is the ongoing maturation of organ function important for drug disposition and action. Systematic issues such as medication errors, off-label use and the lack of age-suitable formulations are considerable obstacles for safe medication use in paediatrics. The recognition of emerging adverse drug reactions could be more challenging in developing children. Initiatives to improve the situation have been made by the WHO and regulators in the USA and EU. Age-specific changes in physiology, pharmacology and psychology, as well as systematic issues specific for children need to be considered in the work of assessing spontaneous reports in children. Pharmacovigilance needs to broaden its aims considerably beyond merely capturing new associations between drugs and events, and encompass careful collection on patient characteristics and circumstances around the reported adverse drug reaction to provide essential information that will give clues on how to prevent harm to children.

Pediatric Pharmacovigilance: Enhancing Adverse Drug Reaction Reporting in a Tertiary Care Children's Hospital.

Adverse drug reactions (ADRs) are notoriously underreported within health care facilities. In 2009-2010, ADRs were detected in only 0.5% of patients at the authors' institution, a pediatric hospital in the Midwestern United States. Additionally, historical ADRs were often inaccurately or incompletely documented in the medical record. An integrative Drug Safety Service (DSS) was implemented to improve the detection and accurate documentation of ADRs. The DSS incorporated standardized ADR terminology, computerized triggers to identify ADRs, and a simplified voluntary reporting system within the facility. The DSS staff provided extensive hospital staff education on ADR reporting and the role of the DSS. The primary aim of this report was to assess the impact of the DSS on the number of ADRs reported at the authors' institution. The secondary aims were to evaluate the mechanisms by which patients with ADRs were identified and to assess the accuracy of ADR documentation after implementation of the DSS. A significant increase was observed (slope, 6.01; P < .001) in ADR detection after implementation of the DSS, with a greater than 4-fold increase from 10 cases per 10,000 admissions before initiation to 41 cases per 10,000 admissions after DSS implementation. Computerized triggers, International Classification of Diseases, 9th Edition (ICD-9) codes associated with ADRs, and the DSS identified 33%, 33%, and 24% of ADRs, respectively, while voluntary reporting only detected 9% of ADRs. Implementation of a multifaceted, interdisciplinary DSS was more effective in detecting ADRs than voluntary reporting alone. A proactive approach to ADR detection resulted in a significant increase in the identification and evaluation of ADRs.

Piperacillin-Tazobactam Toxicity Questions the Need for Pediatric Adverse Event Profiling

A 14-year-old, 86 kg, female treated with piperacillin-tazobactam [cumulative dose of 114.75 g (1.3 g/kg)] for a bone-related infection developed neutropenia and bone marrow suppression/cell line destruction after 10 days of treatment. Reported cases of piperacillin-induced myelosuppression in adults typically occur after 15 days of therapy, and this adolescent received a much shorter duration of therapy. As we are beginning to understand how the frequent use of antibiotics in the pediatric population affects their unique microbiome, which may have long-term implications on their health, we also need to consider if adverse event profiles are distinct or different in children. While this case will not answer these important questions, it underscores the need for further investigation. One could postulate that pediatric pharmacovigilance is better served by restricting data mining analysis to a smaller pediatric subset, as adverse/possible events in children cannot be solely compared to or tabulated with adult data. Further studies are needed to determine pediatric-specific drug safety profiles for piperacillin-tazobactam and other drugs used in the pediatric population.

Novel Therapies, High-Risk Pediatric Research, and the Prospect of Benefit: Learning from the Ethical Disagreements

Despite recent efforts by the US Food and Drug Administration (FDA) to improve the quality and quantity of clinical research data,1 two-thirds of drugs prescribed currently to children have not been studied for safety and efficacy in pediatric populations, and information on the efficacy and safety of drugs in children is not methodically collected and analyzed.2 According to some studies, the majority of pediatric drugs prescribed for children involve unlicensed drugs or off-label prescribing across all medication categories.3 There is evidence of a greater risk of a severe adverse drug reaction occurring in association with the off-label or unlicensed use of drugs in children.4

Pharmacovigilance in Pediatrics

Over the last decade, the striking shortfalls in the provision of safe and effective medicines for children and adolescents have been increasingly recognized. In both theUS and the EU, new legislations were introduced to improve pediatric drug therapy. Frameworks for clinical trials in children were established and significantly improved and, in the EU, pharmaceutical companies are required to prepare a Pediatric Investigation Plan (PIP) for all new drugs and licensing extensions, which has to be precisely followed. Clinical trials in children are now mandatory, as is a systematic approach to pharmacovigilance. According to the WHO, pharmacovigilance is the science of, and activities related to, the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. In adults, pharmacovigilance predominantly refers to postmarketing surveillance. However, in the pediatric population, drugs licensed for this age group are limited; therefore, it has been suggested to extend the definition of pharmacovigilance for this population to ‘‘the process of evaluating and improving the safety of medicines used in pediatric patients of all ages’’. This includes the establishment of the epidemiology of adverse drug reactions (ADRs) and the safety of medicines in a clinical trial, and the detection of new ADRs, including increasing the awareness of ADRs and reducing them by developing appropriate treatment strategies and guidelines. The aim of this editorial is to review these aspects of pediatric pharmacovigilance 4 years after the new pediatric regulation came into force in Europe, and to identify areas where more efforts are needed.

Adverse drug reactions causing admission to a paediatric hospital: a pilot study

It is known that adverse drug reactions (ADRs) cause admission to hospital in adults and children. A recent adult study showed that ADRs are an important and frequent cause of hospital admission. The objective of this study is to develop methodology to ascertain the current burden of ADRs through a prospective analysis of all unplanned admissions to a paediatric hospital. Prospective observational study over a 2-week period. There were 19 admissions to the main hospital wards related to an ADR, giving an estimated incidence of 4%, with the ADR directly leading to the admission in 71% of cases. There were no deaths attributable to ADR. 33% of the reactions were possibly avoidable. The drugs most commonly implicated in causing admissions were anti-neoplastic agents. The most common reactions were neutropenia, vomiting and diarrhoea. The health burden of ADRs in the paediatric population is likely to be significant. This pilot study will be used to inform a much larger prospective study providing more detailed evidence of the burden of ill-health from ADRs in children. This larger study will add to a body of research aiming to identify drug-related problems within children to aid paediatric pharmacovigilance. This study provides knowledge regarding the methodology to be used for a larger study investigating ADRs in children. The study will allow authors who wish to replicate the study in their own populations (internationally) to avoid some of the pitfalls in planning a large epidemiological study of paediatric ADRs. The study also provides an estimate of the incidence and problem of admissions caused by ADRs in a UK paediatric population.

Views of parents and pharmacists following participation in a paediatric pharmacovigilance study

To explore the experiences and views of community pharmacists and parents participating in a prospective paediatric pharmacovigilance study. Twenty-five pharmacists and 32 parents were approached for telephone interview. Interviews were audio-recorded, transcribed and analysed thematically to identify recurring issues and themes. Seventeen pharmacists and 22 parents were interviewed. Parents and pharmacists agreed that more information about the side effects of medicines in children was required. Both groups reported willingness to participate in future prospective pharmacovigilance studies, although pharmacists expressed concerns about the lack of financial incentives. Pharmacists reported that parents had concerns regarding the confidentiality of their child's ADR data and the study data collection process. This study highlighted positive and negative opinions of parents and pharmacists regarding their experiences in this research project. Maintaining confidentiality in relation to indication and medicines prescribed were important issues for parents whereas time constraints and lack of financial incentives were key issues influencing participation by community pharmacists.