Reported paediatric adverse drug reactions in the UK 2000-2009

AIMS

The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme) to collect ‘suspected’ adverse drug reaction (ADR) data. MHRA advice is to report all suspected ADRs in paediatric (<17 years) patients.

METHODS

Data on all ADRs reported to the MHRA in patients <17 years from the years 2000–9 were supplied in two datasets, inclusive and exclusive of vaccines.

RESULTS

Of 222 755 ADR reports received by the MHRA from 2000–9, 31 726 (14.2%) were in children <17 years. The number of reports in 2000 was greater than in subsequent years (12 035) due to a national vaccination programme (Meningococcal Serogroup C conjugate vaccine). The median number of ADR reports per annum (2001–2009) for children was 2146 (95% CI 1801, 2575). Vaccines were included in 22 102 (66.5%) paediatric ADR reports, with Meningococcal Serogroup C conjugate vaccine reported most frequently (12 106 reports) and headache the commonest symptom (3163). Excluding vaccines, methylphenidate (653 reports) and atomoxetine (491) were the most commonly reported medications, and the most commonly reported symptom was vomiting (374). Reporting by nurses increased from 396 in 2001 to 1295 in 2009 (41.8% of all reports); reporting by doctors stayed constant. Reports from patients, parents or carers more than doubled but remained infrequent (1.5% in 2005, 4.0% in 2009).

CONCLUSIONS

Although under-reporting is probably common, the Yellow Card Scheme in the UK receives more than 2000 reports per year on patients <17 years. Nurses now report more suspected ADRs in children than any other healthcare professional.     

Role of terlipressin in the treatment of infants and neonates with catecholamine-resistant septic shock

The present paper is aimed at reviewing new findings on the use of terlipressin in children with septic shock. The level of evidence based on the data available in the literature is very low. Three series of cases and four isolated cases report on the use of terlipressin in children with catecholamine-refractory septic shock. The aggregated population represents 39 children. The dosages of boli vary from 7 microg/kg twice a day to 2 microg/kg every 4 hours. Low-dose continuous infusion has also been described. Terlipressin injection is associated with an approximately 30% increase in blood pressure. Mortality of these children with catecholamine refractory septic shock is 54%. The paucity of most reports does not make it possible to conclude on the global and microcirculatory effects of this treatment. Future studies are required before any recommendations on the use of terlipressin in children with septic shock can be made.     

Embracing paediatric palliative care in paediatric oncology from diagnosis onwards

Paediatric palliative care aims to support children and young people with life-limiting or life-threatening conditions, and their families, from the time of diagnosis. Early integration within oncology has been recognised as having benefits for all involved, whatever the outcome may be. Through improved communication and advance care planning, it enables user-centred care, where concerns about quality of life, preferences and values are given the same relevance as cutting-edge therapy. Challenges to the integration of palliative care within paediatric oncology include raising awareness and providing education, whilst searching for the best care model and adapting to an ever-changing therapeutic scenario.     

Malnutrition in Belgian children with congenital heart disease on admission to hospital

? In paediatrics, body weight and height are two important growth parameters. Moreover, weight for height and height for age are useful tools for evaluation of acute and chronic malnutrition during childhood. The fact that children with congenital heart disease soon deviate from their birth percentiles for weight or height is common knowledge. However, the extent of this deviation in terms of malnutrition is less well documented. ? The aim of this study was to explore the presence and the extent of malnutrition among Belgian children with congenital heart disease on admission to hospital. A retrospective chart review of 300 children (aged 0–18 years) with congenital heart disease was conducted at a large Belgian university hospital. ? Results of this study show an increase in the frequency and severity of acute and chronic malnutrition after birth; more malnutrition in children with multiple heart defects than in those with single heart defects; more chronic malnutrition in children with heart failure, cyanosis or a combination of both and in children with additional non‐cardiac anomalies; and less malnutrition in children who had never had surgery. The prevalence of malnutrition was not influenced by sex, nationality, nor reason for admission.     

The world's longest surviving paediatric practices: some themes of Aboriginal medical ethnobotany in Australia

Contemporary paediatric practices of Australian Aboriginal men and women, in more than 100 Aboriginal Language Groups, comprise a living discipline whose origins predate Western medicine by tens of millennia. The history of paediatrics acknowledges this surviving continuum of the world's oldest child-care practices. Because of the inextricable nexus between Aboriginal men and women and the land in which they live, medical ethnobotany forms a major part of the medical aspects of Aboriginal child care. Traditional tribal healers, called 'Nungungi' in some language groups of Central Australia, are identified as such whilst still young children and are given special education in the healing arts, especially that of medical ethnobotany, by older healers. Distinct from this specialized role, all Aboriginal men and women (and in particular grandmothers) in traditional communities use a sophisticated botanical materia medica in the treatment of sick and injured children. In cultures in transition, medical ethnobotanical practices may persist long after the local use of flora as sources of traditional food, weaponry, totemic identity and religious rites have disappeared. Some selected botanical 'cures' were adopted by early European settlers and a number of such relict uses have become part of mainstream Western life today, particularly as this applies to self-medication. Drugs and medicaments used in the treatment of children are obtained from leaves, bark, roots and flowers, usually as fresh preparations. They are prepared as infusions, decoctions and macerations and may be enjoined with emollients such as emu or kangaroo fat for topical application. Botanical drugs and medicaments are usually prepared fresh for each administration and are rarely stored. Contemporary Australian ethnobotany exploits the medicinal properties of more than 100 genera - using such extracts as antiseptics, analgesics, astringents, antipyretics, sedatives, hypnotics, expectorants and carminatives. Their widespread use, by the world's oldest surviving cultures, reflect perhaps 50 millennia of acute observation and clinical interpretation, trial and error, serendipidity and experimentation. Australian medical ethnobotany generally, and that used specifically for children, is characterized by several features including (i) the multipurpose or 'broad-spectrum' use of many floral species; (ii) a paradigm of the use of botanical material to treat symptoms and symptom-complexes rather than disease-based treatment; (iii) the widespread and universal medical knowledge of botanical remedies by all members of local Aboriginal communities, not only traditional community or tribal healers and (iv) the use of botanical material in the context of preventive medicine. Seventy per cent of the world's population uses traditional herbal remedies in the treatment of sick or injured children. In this context, the detailed and extensive ethnobotanical pharmacopoeia of the Aboriginal Peoples of Australia holds an important place.     

Adaptation of the Manchester-Minneapolis Quality of Life instrument for use in the UK population

Introduction

The availability of health‐related quality of life (HRQL) measures that are reliable, valid, brief and comprehensible and appropriate for use with UK children is limited. We report the validation of a HRQL measure suitable for UK use in healthy children, children with chronic disease conditions and socially disadvantaged children.

Patients

A total of 1238 children took part in the study, including healthy children as controls (n = 824) and five exemplar groups: children diagnosed with asthma (n = 87), diabetes (n = 103) or inflammatory bowel disease (IBD; n = 69), children in remission from cancer (n = 68) and children in public care (n = 87).

Methods

In phase I, the Manchester‐Minneapolis Quality of Life instrument (MMQL) Child Form was translated into UK English. In phases II and III, the questionnaire was shortened and validated.

Results

MMQL was anglicised and shortened to five components comprising 29 items. Good internal reliability was found with α reaching at least 0.69 for all subscales. Construct validity was established through moderate correlations with comparable PedsQL subscales (Pearson''s r ranged from 0.38 to 0.58, p<0.01). Discriminant validity was also demonstrated in children with asthma and IBD, children in remission from cancer and children in public care, all of whom reported significantly lower HRQL than healthy children. Children with diabetes showed similar HRQL to their healthy peers. Good reproducibility and moderate responsiveness were demonstrated for the new measure.

Conclusions

The anglicised and shortened MMQL was shown to be valid and reliable and could be a valuable new tool for the assessment of HRQL in children.