{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,25]],"date-time":"2025-10-25T12:08:16Z","timestamp":1761394096367},"reference-count":39,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2012,2,13]],"date-time":"2012-02-13T00:00:00Z","timestamp":1329091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2012,3]]},"abstract":"<jats:p><jats:bold>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT<\/jats:bold><\/jats:p><jats:p>\u2022\u2003Use of off\u2010label and unlicensed medicines in children is associated with a higher risk of adverse drug reactions (ADRs).<\/jats:p><jats:p>\u2022\u2003Spontaneous reporting systems such as the UK Yellow Card Scheme run by the Medicines and Healthcare Products Regulatory Agency (MHRA) are important in identifying signals of ADRs.<\/jats:p><jats:p>\u2022\u2003Up to 95% of all ADRs are not reported, despite current MHRA advice to report all suspected paediatric ADRs.<\/jats:p><jats:p><jats:bold>WHAT THIS STUDY ADDS<\/jats:bold><\/jats:p><jats:p>\u2022\u2003Despite under\u2010reporting, the Yellow Card Scheme receives more than 2000 reports per year on patients &lt;17 years.<\/jats:p><jats:p>\u2022\u2003Vaccines are the most commonly reported therapeutic class in children.<\/jats:p><jats:p>\u2022\u2003Nurses now report more suspected ADRs in children than any other healthcare professional.<\/jats:p><jats:p><jats:bold>AIMS<\/jats:bold> The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme) to collect \u2018suspected\u2019 adverse drug reaction (ADR) data. MHRA advice is to report all suspected ADRs in paediatric (&lt;17 years) patients.<\/jats:p><jats:p><jats:bold>METHODS<\/jats:bold> Data on all ADRs reported to the MHRA in patients &lt;17 years from the years 2000\u20139 were supplied in two datasets, inclusive and exclusive of vaccines.<\/jats:p><jats:p><jats:bold>RESULTS<\/jats:bold> Of 222\u2003755 ADR reports received by the MHRA from 2000\u20139, 31\u2003726 (14.2%) were in children &lt;17 years. The number of reports in 2000 was greater than in subsequent years (12\u2003035) due to a national vaccination programme (Meningococcal Serogroup C conjugate vaccine). The median number of ADR reports per annum (2001\u20132009) for children was 2146 (95% CI 1801, 2575). Vaccines were included in 22\u2003102 (66.5%) paediatric ADR reports, with Meningococcal Serogroup C conjugate vaccine reported most frequently (12\u2003106 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).<\/jats:p><jats:p><jats:bold>CONCLUSIONS<\/jats:bold> Although under\u2010reporting is probably common, the Yellow Card Scheme in the UK receives more than 2000 reports per year on patients &lt;17 years. Nurses now report more suspected ADRs in children than any other healthcare professional.<\/jats:p>","DOI":"10.1111\/j.1365-2125.2011.04113.x","type":"journal-article","created":{"date-parts":[[2011,10,11]],"date-time":"2011-10-11T15:48:50Z","timestamp":1318348130000},"page":"437-446","source":"Crossref","is-referenced-by-count":58,"title":["Reported paediatric adverse drug reactions in the UK 2000\u20132009"],"prefix":"10.1111","volume":"73","author":[{"given":"Daniel B.","family":"Hawcutt","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pramod","family":"Mainie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Riordan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosalind L.","family":"Smyth","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Munir","family":"Pirmohamed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,2,13]]},"reference":[{"key":"e_1_2_7_2_2","unstructured":"Office for National Statistics. 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