Reported paediatric adverse drug reactions in the UK 2000-2009

Abstract

Aims: The 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.

Methods: Data 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.

Results: Of 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).

Conclusions: Although 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.

Figure 1

(A) Graph of the total (adult and paediatric) and paediatric (age < 17 years) adverse drug reactions (ADR) reported to the MHRA annually for the years 2000–2009 (including vaccines). (B) Graph of the percentage of paediatric ADR reports from vaccines for the years 2000–2009 (C) Graph of the number of Yellow Card reports per year grouped by profession of the reporter. Nurse reporting was initially introduced in 2000, but this was limited. Full nurse reporting was introduced in 2002, and parent and carer reporting introduced in 2005. *2000 contained a spike in reports related to Neisseria meningitidis Group C vaccine. (A) () Total number; () Total number < 17 years; (C) () Doctors; () Nurses; () Pharmacist; () Parent/Carer

Figure 2

Graphs of number of reports received per year of age in the years 2000–9 for (A) vaccines only and (B) excluding vaccines

Figure 3

Graph of the number of Yellow Card reports listing Bacillus Calmette Guerin (BCG) vaccination as a possible causative agent per year. A new BCG vaccine was introduced in December 2002