Pharmacovigilance Reports Received from Children and Young People, and Development of Information to Aid Future...

This study aimed to determine the contribution of children and young people (CYP) to the Medicines and Healthcare Products Regulatory Agency (MHRA) Yellow Card Scheme (YCS), and to develop age appropriate information with CYP through focus groups to help aid future reporting by this cohort.

Reports for suspected adverse drug reactions (ADRs) in patients < 19 years of age received by the MHRA YCS from 1 January 2008 to 29 November 2018 were collated and analysed. Consultation activities with CYP from regional, national and international groups were undertaken from November 2017 to July 2018 to develop CYP-appropriate information from current available literature about reporting ADRs to the YCS.

CYP contributed 2.3% of YCS reports for patients < 19 years (948 self-reports from a total of 41,630 YCS reports). Patients from 10 years of age contributed YCS reports, and the number of CYP reports represented in the total YCS reports rose by 3% in October 2018 compared with the previous year. Self-reported YCS from the CYP contain different suspected medications and reactions compared with YCS reported on behalf of patients aged < 19 years. The most reported medicines by self-reported YCS from CYP were adolescent vaccinations (such as the human papilloma virus [HPV] vaccine, n = 69), oral contraceptives, acne medication, anti-infectives, and antidepressants. The most commonly reported suspected ADRs submitted by CYP to the YCS were headache (n = 107), nausea and fatigue. CYP-generated reports included alternative suspected ADRs compared with adult reports about ADRs in CYP; these included depression, anxiety and suicidal ideation. The second part of the study used focus groups involving CYP from various backgrounds to develop two information leaflets regarding reporting suspected ADRs in the YCS; this was highlighted in phase I by CYP who identified divergent information needs dependent on age. Phase II-VI updated and improved the relevant information required for both age groups in a succinct and satisfactory manner. Overall, more than 300 CYP contributed to the development of the information.

CYP's contribution to the YCS is limited, but increasing, and demonstrates distinct patterns of suspected medications and reactions. Age-appropriate information for CYP to aid reporting of suspected ADRs has been developed.