Assessing and further developing age-appropriate information for young people about reporting suspected adverse drug reactions.

AIMS: The Medicines and Healthcare products Regulatory Agency Yellow Card scheme (YCS) is the UK's system that collects spontaneous reports about suspected adverse drug reactions (ADRs). Reporting of suspected ADRs by young people (age <19 years) in the UK is extremely uncommon, driving efforts to improve awareness and reporting. METHODS: Quality improvement project, using an anonymous online survey about updated information for young people, distributed through school pupils (age 13-18 years) across the UK through the Alder Hey Research Ambassador programme. RESULTS: Research Ambassadors were recruited in 21 schools and colleges, generating 2933 responses (15 November 2022-08 April 2023); 6.3% of respondents had heard of the YCS, and 0.8% had previously reported a Yellow Card. There were 307 suspected drug-event combinations reported, 36 of which required attendance at hospital. The updated YCS reporting guide was understood by 92.8% of young people, and 90.8% reported knowing more about ADRs after reading the guide. The percentage of young people 'Not comfortable' reporting a suspected ADR decreased from 13.3% (before reading) to 4.1% after reading (P < .000001), and 84.5% of young people reported willingness to report a side effect in the future. The most common comments regarding further improvement of the information were content, or length of the text could be altered in some way (n = 543, 26.1%) and graphic design could be improved (n = 357, 17.2%). CONCLUSIONS: The age-appropriate information provided met many of their needs, increasing willingness to report. Integration into existing education curricula in the UK would facilitate knowledge transfer and improve reporting.

Public awareness in Wales of the UK Yellow Card scheme for reporting suspected adverse drug reactions.

We used the HealthWise Wales (HWW) platform to explore public knowledge about the UK Yellow Card scheme (YCS), the spontaneous reporting scheme for suspected adverse drug reactions (ADRs) and whether a short information video could improve awareness. Members of the public in Wales (n = 1606) completed a questionnaire about the YCS, watched the information video and then completed a follow-up questionnaire. Almost half (46.5%) of respondents said they had previously experienced an ADR (>90% of the ADRs involving prescribed medicines). Before the video, 18% of respondents knew how to report an ADR via the YCS and of these, 34% were from allied-health professions. Immediately after watching it, 71% participants reported knowing how to report and 82% reported being confident to report. If this awareness were maintained, such an approach could contribute to improved reporting of suspected ADRs by the public.

Information for children and young people about reporting suspected adverse drug reactions.

BACKGROUND: When 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. METHODS: An anonymous quality improvement project to assess the guide for CYP was undertaken (September 2020-February 2021). RESULTS: The 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. CONCLUSION: The 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.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.