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

Bhoombla, NIkita; Preston, Jennifer; Ainsworth, Jenny; Bird, Helena; Jadeja, Mitul; King, Charlotte; Hawcutt, Daniel B

doi:10.1007/s40272-020-00391-6

Cited by 5 publications

(13 citation statements)

References 15 publications

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“…Using the form of words about how to inform and empower CYP to report suspected ADRs previously developed by 300 CYP working across five iterative phases,4 an ad hoc working group at the MHRA was convened. This group included regulatory experts, pharmacovigilance experts, paediatric clinical pharmacologists, as well as contribution from regional Yellow Card Centres.…”

Section: Methodsmentioning

confidence: 99%

“…The Medicines and Healthcare Regulatory Agency’s (MHRA) Yellow Card scheme (YCS) collects spontaneous reports about suspected adverse drug reactions (ADRs) from a range of stakeholders in the UK, including healthcare professionals, patients, parents and carers. Spontaneous reports from patients are of similar quality to,1 2 and identify additional information beyond, those from healthcare professionals 3 4. The inclusion of patient and carer reports in spontaneous reporting schemes has increased worldwide 5.…”

Section: Introductionmentioning

confidence: 99%

“…While there is considerable literature about reports of suspected ADRs submitted by others about CYP,9–14 and clinical services are now being developed that promote paediatric pharmacovigilance activities,15 there are limited data on reports that CYP have submitted themselves. Within the UK, these data from suspected ADR reports to the MHRA YCS have been analysed; direct reports from CYP only comprise 2.3% of all reports about patients <19 years old; different medicines were reported; a range of important but previously uncommonly reported suspected ADRs were included 4…”

Section: Introductionmentioning

confidence: 99%

“…There is therefore a need for specific guidance aimed at CYP to inform, educate and empower them to self-report or at least be aware they can report their suspected ADRs. CYP have developed outline text for such a document previously,4 and since then this has been developed further by the MHRA pharmacovigilance team and paediatric clinical pharmacologists. This work details the quality improvement project undertaken to assess what CYP in the UK think of this updated information.…”

Section: Introductionmentioning

confidence: 99%

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

Hawcutt

Jadeja²,

Bhoombla

et al. 2022

Arch Dis Child

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Hawcutt

Jadeja²,

Bhoombla

et al. 2022

Arch Dis Child

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“…The types of suspected ADRs reported were not formally scored for severity, but included clinically significant events such as anaphylaxis, acute kidney injury, intracranial haemorrhage, and demyelinating illness. The suspected ADRs identified were from a wide range of drugs, and the pattern of medications differs markedly from both the overall Yellow Card Reports for children and neonates in the UK, 16 but also those from CYP themselves, 27 demonstrating the necessity of having multiple routes of reporting to capture the full range of possible ADRs.…”

Section: Trust Level Contributionmentioning

confidence: 97%

Implementing a specialist paediatric clinical pharmacology service in a UK children's hospital

Hawcutt

Warner

Kenyon

et al. 2021

Brit J Clinical Pharma

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Aims: Royal College of Paediatrics and Child Health subspecialist training in Paediatric Clinical Pharmacology and Therapeutics has been delivered in the UK for 20 years, but no specialist clinical services have been set up previously. Methods: Prospective audit and service evaluation of paediatric clinical pharmacology service pilot phase and dedicated service at a UK children's hospital. Results: Pilot scheme (May-October 2019), then weekly service (established June 2020). Service covers the High Dependency Unit, and inpatients with polypharmacy.The pilot demonstrated high levels of acceptance, with 89% of suggested medication changes agreed by lead clinical team, and success, with 97.5% of suggested changes continued until discharge/pilot completion. Economic analysis estimated direct annualised cost savings on medications of up to £10 000. After 20 ward rounds of the established service, 270 potential medication changes were identified, 213 were carried out (78.9%). The most common were deprescribing (n = 143), prescribing (n = 47) and dose adjustment (n = 8). Seventy-five different medications were deprescribed, most commonly chloral hydrate (n = 12), Lactulose, ibuprofen, Bio-Kult and sodium alginate (all n = 4). The percentage of inpatients prescribed ≥10 medications decreased from 38.5 to 32.1%, while the subset prescribed ≥20 medications decreased from 11.0 to 5.67%. The mean number of medicines prescribed decreased from 9.0 to 8.0, while the median was unchanged at 7. Annual Yellow Card reports of suspected adverse drug reactions more than doubled (n = 66). Conclusion:A UK model for subspecialist paediatric clinical pharmacology service delivery has demonstrated a positive clinical impact and could be replicated at other UK secondary/tertiary children's hospitals.

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Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa

Kiguba

Olsson²,

Waitt

2022

Brit J Clinical Pharma

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Low‐ and middle‐income countries (LMIC) face unique challenges with regard to the establishment of robust pharmacovigilance systems capable of generating data to inform healthcare policy and practice. These include the limited integration and reliability of pharmacovigilance systems across LMIC despite recent efforts to harmonize pharmacovigilance rules and regulations in several regional economic communities. There are particular challenges relating to the need to translate reporting tools into numerous local languages and the low numbers of healthcare providers relative to number of patients, with very short consultation times. Additional factors frequent in LMIC include high uptake of herbal and traditional medication, mostly by self‐medication; disruptive political conflicts jeopardizing fragile systems; and little or no access to drug utilization data, which makes it difficult to reliably estimate the true risks of medicines use. Pharmacovigilance activities are hindered by the scarcity of well‐trained personnel with little or no budgetary support from national governments; high turnover of pharmacovigilance staff whose training involves a substantial amount of resources; and little awareness of pharmacovigilance among healthcare workers, decision makers and consumers. Furthermore, little collaboration between public health programmes and national medicines regulatory authorities coupled with limited investment in pharmacovigilance activities, especially during mass drug administration for neglected tropical diseases and mass vaccinations, produces major challenges in establishing a culture where pharmacovigilance is systematically embedded. Very low spontaneous reporting rates with poor quality reports hinders robust signal detection analyses. This review summarises the specific challenges and areas of progress in pharmacovigilance in LMIC with special focus on the situation in Africa.

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

Cited by 5 publications

References 15 publications

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

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

Implementing a specialist paediatric clinical pharmacology service in a UK children's hospital

Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa

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