ReviewBritish journal of clinical pharmacology2012
Reported paediatric adverse drug reactions in the UK 2000-2009.
Review in British journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.The Cochrane database of systematic reviews · 2018Pooled it
- Parental reporting of adverse drug events and other drug-related problems in children in Finland.European journal of clinical pharmacology · 2013Trial
- Current insights into the safety and adverse effects of methylphenidate in children, adolescents, and adults - narrative review.Pharmacological reports : PR · 2025Review
- A Mobile App Leveraging Citizenship Engagement to Perform Anonymized Longitudinal Studies in the Context of COVID-19 Adverse Drug Reaction Monitoring: Development and Usability Study.JMIR human factors · 2022Article
- Safety of Antibiotics in Hospitalized Children in Romania: A Prospective Observational Study.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Implementing a specialist paediatric clinical pharmacology service in a UK children's hospital.British journal of clinical pharmacology · 2022Article
- Parental reporting of adverse drug reactions in South Africa: An online survey.African journal of primary health care & family medicine · 2021Article
- Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented.Journal of clinical pharmacy and therapeutics · 2021Article
- Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.British journal of clinical pharmacology · 2021Observational
- Pharmacovigilance Reports Received from Children and Young People, and Development of Information to Aid Future Reporting from this Age Group.Paediatric drugs · 2020Article
- Parental Experience of Potential Adverse Drug Reactions Related to Their Oral Administration of Antipyretic Analgesic Medicines in Children in Saudi Arabia.Current therapeutic research, clinical and experimental · 2020Article
- Patterns and profiles of methylphenidate use both in children and adults.British journal of clinical pharmacology · 2018Observational
- Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis.British journal of clinical pharmacology · 2016Article
- Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.British journal of clinical pharmacology · 2016Article
- A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.PloS one · 2016Article
- Adverse drug reactions experience in a teaching hospital in Jordan.International journal of clinical pharmacy · 2015Observational
- Unplanned medication discontinuation as a potential pharmacovigilance signal: a nested young person cohort study.BMC pharmacology & toxicology · 2014Article
- Article
- Methylphenidate off-label use and safety.SpringerPlus · 2014Article
- Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011.BMC pharmacology & toxicology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
aimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme) to collect 'suspected' adverse drug reaction (ADR) data. MHRA advice is to report all suspected ADRs in paediatric (<17 years) patients.
methodsData on all ADRs reported to the MHRA in patients <17 years from the years 2000-9 were supplied in two datasets, inclusive and exclusive of vaccines.
resultsOf 222 755 ADR reports received by the MHRA from 2000-9, 31726 (14.2%) were in children <17 years. The number of reports in 2000 was greater than in subsequent years (12035) due to a national vaccination programme (Meningococcal Serogroup C conjugate vaccine). The median number of ADR reports per annum (2001-2009) for children was 2146 (95% CI 1801, 2575). Vaccines were included in 22102 (66.5%) paediatric ADR reports, with Meningococcal Serogroup C conjugate vaccine reported most frequently (12106 reports) and headache the commonest symptom (3163). Excluding vaccines, methylphenidate (653 reports) and atomoxetine (491) were the most commonly reported medications, and the most commonly reported symptom was vomiting (374). Reporting by nurses increased from 396 in 2001 to 1295 in 2009 (41.8% of all reports); reporting by doctors stayed constant. Reports from patients, parents or carers more than doubled but remained infrequent (1.5% in 2005, 4.0% in 2009).
conclusionsAlthough under-reporting is probably common, the Yellow Card Scheme in the UK receives more than 2000 reports per year on patients <17 years. Nurses now report more suspected ADRs in children than any other healthcare professional.
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