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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis
British Journal of Clinical Pharmacology, Volume 82, No. 6, Year 2016
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Description
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. © 2016 The British Pharmacological Society
Authors & Co-Authors
Hawcutt, Daniel B.
United Kingdom, Liverpool
University of Liverpool
United Kingdom, Liverpool
Alder Hey Children's Hospital
Waitt, Catriona John
United Kingdom, Liverpool
University of Liverpool
Riordan, Andrew F.
United Kingdom, Liverpool
Alder Hey Children's Hospital
Turner, Mark A.
United Kingdom, Liverpool
University of Liverpool
United Kingdom, Liverpool
Liverpool Women's Nhs Foundation Trust
Statistics
Citations: 17
Authors: 4
Affiliations: 3
Identifiers
Doi:
10.1111/bcp.13067
ISSN:
03065251
Research Areas
Health System And Policy
Maternal And Child Health
Participants Gender
Male
Female