BackgroundUK patients of all ages can contribute to the Medicines and Healthcare Regulatory Agency (MHRA) Yellow Card scheme (YCS), reporting suspected adverse drug reactions (ADRs). Children’s and young people’s (CYPs) contribution to, and awareness of, the YCS is not known.MethodsSuspected ADR reports received by the MHRA from 01/01/2008 to 29/11/2018 were examined. Prospective data from CYP and parents in paediatric outpatients were collected as part of the QUestionnaire study about Adverse Drug ReAcTions In Children (QUADRATIC) study (IRAS 242352).ResultsCYP contributed 2.3% of YCS reports for patients < 19 years. Patients from age 10 years old have contributed YCS reports, and CYP reports are increasing annually. Reports from CYP contain different suspected medications and reactions compared to YCS for all patients age < 19 years. Common CYP generated reports prioritiseadolescent vaccinations (Human papilloma virus most reported, n=69), oral contraceptives, acne medication, anti-infectives, and antidepressants.Common CYP generated reports identified depression, anxiety and suicidal ideation, which were not amongst common reports about CYP. Amongst CYP (n=50) attending outpatients, the YCS was not known to any CYP. The YCS was known to 16.3% of parents (8/49) interviewed. From this population of patients with a chronic illness, with high rates of drug therapy, 68 suspected ADRs were identified overall.ConclusionCYP contribute to YCS, with distinct patterns of suspected medications and reactions. Awareness of the YCS appears poor, particularly in populations you would expect to have a greater level of knowledge and understanding about medicines.Disclosure(s)Nothing to disclose
Assessing the usability of methods of public reporting of adverse drug reactions to the UK Yellow Card Scheme