BackgroundWhen children and young people (CYP) report their own suspected adverse drug reactions (ADRs), different patterns of drugs and symptoms are noted. A new guide to reporting suspected ADRs using the Medicines and Healthcare Products Regulatory Agency (MHRA) Yellow Card scheme was developed by CYP, paediatric clinical pharmacology, Yellow Card Centres and the MHRA.MethodsAn anonymous quality improvement project to assess the guide for CYP was undertaken (September 2020–February 2021).ResultsThe survey was completed by 234 CYP age 13–18 years. Within respondents, 68/226 (30.1%) were using medicines, 209/225 (92.9%) had used medicines previously, and 211/225 (93.8%) had heard of side effects. 79/225 (35.1%) believed they had experienced a side effect, with some requiring hospitalisation. Only 8/221 (3.6%) respondents were aware of the MHRA Yellow Card scheme.Overall, 182/196 (92.9%) of CYP both understood the guide and felt more knowledgeable about how to report suspected side effects. CYP comfortable to report their own suspected ADR increased from 179/222 (80.6%) before reading guide, to 189/196 (96.4%) after reading the new CYP guide. In addition, 156/196 (79.6%) believed they would report a side effect from a medicine used in future. Over 360 free-text comments were also received, providing comments about what was good about the new guide and areas for improvement that could be made.ConclusionThe new guide for CYP to inform them about how to report a suspected ADR to the MHRA was well received and increased the knowledge, and confidence to report, in those who responded.
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
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.