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ABSTRACT: Aims
The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years.Methods
Data on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA.Results
For infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0.96 YC per day. There was a male preponderance (male 49.1%, female 44.4%, unknown 6.5%), and only 34 (1.0%) of YC reports stated a gestational age. The medications most frequently reported were: transplacental and transmammary (fluoxetine, n = 21 and n = 4 respectively), neonate (swine flu vaccine, n = 8) infant (oseltamivir, n = 37) and vaccines (meningococcal vaccine, n = 693). Paternal, transmammary, neonatal and infant YC did not reflect clinical concerns raised by the UK regulator. Transplacental and vaccination reports did correlate with some of the changes in practice and clinical alerts received.Conclusions
The frequency of YC reports for those <2 years is low, neonates are poorly represented, and recording of gestational age is poor. With the exception of vaccinations, spontaneous reports alone are not currently generating the data required, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies are required to improve the quantity and quality of suspected ADR data in young children.
SUBMITTER: Hawcutt DB
PROVIDER: S-EPMC5099553 | biostudies-literature | 2016 Dec
REPOSITORIES: biostudies-literature
Hawcutt Daniel B DB Russell Nicki-Jayne NJ Maqsood Hannah H Kouranloo Koushan K Gomberg Simon S Waitt Catriona C Sharp Andrew A Riordan Andrew A Turner Mark A MA
British journal of clinical pharmacology 20160912 6
<h4>Aims</h4>The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years.<h4>Methods</h4>Data on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA.<h4>Results</h4>For infants age <2 years, 3496 suspected ADRs were reported ...[more]