ABSTRACT: BACKGROUND: Members of the public can submit reports about adverse drug reactions (ADRs) directly to the UK Yellow Card Scheme. As they submit Yellow Cards on behalf of their children, parents may have distinct perspectives that can help to enhance participation in reporting ADRs. However, previous research has not specifically investigated their views. AIMS: To investigate parents' views and experiences of direct reporting of a suspected ADR in their child. METHODS: We audio recorded semi-structured qualitative interviews with parents of children with suspected ADRs. Our sample included parents with (n=17) and without (n=27) previous experience of submitting a Yellow Card. RESULTS: Parents in both groups described poor awareness of the Yellow Card Scheme.Parents who had participated in the Yellow Card Scheme were generally happy to report their child's ADR via the Scheme and valued the opportunity to report concerns independently of health practitioners. They expressed motivations for reporting that have not previously been described linked to the parental role, including how registering a concern about a medicine helped to resolve uncomfortable feelings about their child's ADR. Parents who had not previously submitted a Yellow Card expressed uncertainty about the legitimacy of their involvement in reporting and doubts about the value of the information that they could provide. CONCLUSION: Promoting wider participation in pharmacovigilance schemes will depend on raising public awareness. Additionally, our findings point to the need to empower lay people to submitting reports and to reassure them about the value of their reports.
British Journal of Clinical Pharmacology 08/2012; · 2.96 Impact Factor
ABSTRACT: To obtain reliable information about the incidence of adverse drug reactions, and identify potential areas where intervention may reduce the burden of ill-health.
Prospective observational study.
A large tertiary children's hospital providing general and specialty care in the UK.
All acute paediatric admissions over a one year period.
Any medication taken in the two weeks prior to admission.
Occurrence of adverse drug reaction.
240/8345 admissions in 178/6821 patients admitted acutely to a paediatric hospital were thought to be related to an adverse drug reaction, giving an estimated incidence of 2.9% (95% CI 2.5, 3.3), with the reaction directly causing, or contributing to the cause, of admission in 97.1% of cases. No deaths were attributable to an adverse drug reaction. 22.1% (95% CI 17%, 28%) of the reactions were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44/249 (17.7%) of adverse drug reactions, the remainder originating from hospital. 120/249 (48.2%) reactions resulted from treatment for malignancies. The drugs most commonly implicated in causing admissions were cytotoxic agents, corticosteroids, non-steroidal anti-inflammatory drugs, vaccines and immunosuppressants. The most common reactions were neutropenia, immunosuppression and thrombocytopenia.
Adverse drug reactions in children are an important public health problem. Most of those serious enough to require hospital admission are due to hospital-based prescribing, of which just over a fifth may be avoidable. Strategies to reduce the burden of ill-health from adverse drug reactions causing admission are needed.
PLoS ONE 01/2012; 7(12):e50127. · 4.09 Impact Factor
ABSTRACT: There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines.
To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction.
Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method.
Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction.
Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for linking children's symptoms to medicines could be a starting point for improved communication.
PLoS ONE 01/2012; 7(10):e46022. · 4.09 Impact Factor
ABSTRACT: To develop and test a new adverse drug reaction (ADR) causality assessment tool (CAT).
A comparison between seven assessors of a new CAT, formulated by an expert focus group, compared with the Naranjo CAT in 80 cases from a prospective observational study and 37 published ADR case reports (819 causality assessments in total).
Utilisation of causality categories, measure of disagreements, inter-rater reliability (IRR).
The Liverpool ADR CAT, using 40 cases from an observational study, showed causality categories of 1 unlikely, 62 possible, 92 probable and 125 definite (1, 62, 92, 125) and 'moderate' IRR (kappa 0.48), compared to Naranjo (0, 100, 172, 8) with 'moderate' IRR (kappa 0.45). In a further 40 cases, the Liverpool tool (0, 66, 81, 133) showed 'good' IRR (kappa 0.6) while Naranjo (1, 90, 185, 4) remained 'moderate'.
The Liverpool tool assigns the full range of causality categories and shows good IRR. Further assessment by different investigators in different settings is needed to fully assess the utility of this tool.
PLoS ONE 01/2011; 6(12):e28096. · 4.09 Impact Factor
ABSTRACT: To establish the safety and efficacy of single daily intravenous netilmicin 6 mg/kg with piperacillin 100 mg/kg every 8 h for empirical, first-line management of children with neutropenic pyrexia following cytotoxic chemotherapy.
Observational study of children admitted to a regional oncology unit from October 1999-April 2002. Primary outcome measure was temperature 72 h after commencing antibiotic therapy; secondary measures were mortality, nephrotoxicity, symptomatic ototoxicity and serum netilmicin levels.
280 episodes for 128 patients (median age 7.1 y) were documented, and 248 episodes were evaluated and compared with a previous cohort of 100 episodes for which the only difference was administration of netilmicin three times daily. Twenty-seven per cent of single-dose netilmicin episodes remained febrile at 72 h compared to 32% in the comparator group (difference -4.7%; 95 % CI: -6.8% to 16.2%; p = 0.41). No patients died and we were unable to find evidence of nephrotoxicity or ototoxicity. Eighty-nine per cent of "peak" serum netilmicin levels measured 30 min after infusion were 10 mg/l or greater, and 94% and 86% measured 12-16 h after the first and third dose, respectively, were 1 mg/l or less. Peak serum netilmicin level measurements and 12-16-h measurements after the first dose were abandoned after the first 180 episodes.
Netilmicin can safely be given as a single daily dose to children with febrile neutropenia who do not have biochemical evidence of nephrotoxicity. Monitoring peak serum levels of netilmicin is unnecessary. Levels taken 12-16 h after the third dose are adequate to monitor therapy if used in conjunction with a therapeutic guideline detailing the response to abnormal serum creatinine and netilmicin levels.
Acta Paediatrica 04/2005; 94(3):268-74. · 2.07 Impact Factor