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Biomedical subjects

I Choonara

Publications and source records attributed to I Choonara.

At least 19 recordsLinked to original sources
PubMed2003

Lack of appropriate formulations of medicines for children in the community.

AIM: Appropriate formulations are essential in pharmacotherapy. This study surveyed the use of different formulations by children in the community, and examined the reported lack of appropriate formulations (oral solutions) in relation to the licensing status of drugs. METHODS: A cross-sectional study based on 68,019 pharmacy dispensing records was performed in The Netherlands. For each prescription the formulation was assessed, and all prescriptions were categorized: unlicensed (no product licence), off-label (licensed drugs used outside the licence terms) and authorized (licensed drugs used according to the licence). The types of formulation used were assessed in relation to age and licensing status. RESULTS: In all age groups, approximately half of all prescriptions were for oral drugs. The only major age-related trend was within oral drugs: younger children were more likely to be prescribed oral solutions. For authorized drugs the proportion of tablet/capsules exceeded oral solutions at the age of 7 y, whereas for off-label drugs this occurred at 3 y of age. For those medicines prepared by the pharmacy, tablets and capsules were more likely to be prescribed from the age of 9 y. CONCLUSION: Many children in the community receive inappropriate oral formulations. Regulatory authorities and the pharmaceutical industry need to ensure that children have access to medicines with appropriate formulations.

Chemistry, Pharmaceutical↗
PubMed2002

Surveillance for fatal suspected adverse drug reactions in the UK.

AIM: To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme. METHODS: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed. RESULTS: There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. CONCLUSIONS: A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular.

Anesthetics↗
PubMed2001

Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies.

AIMS: To explore the usefulness of data derived from observational studies on adverse drug reactions (ADRs) in defining and preventing the risk of pharmacological interventions in children in different health care settings. METHODS: A systematic review of studies on ADRs in hospitalized children, in outpatient children, and on ADRs causing paediatric hospital admissions was performed. Studies were identified through a search of the MEDLINE and EMBASE databases. The inclusion criteria required that the population was not selected for particular conditions or drug exposure and prospective monitoring was used for identifying ADRs. Data were analysed by a random-effects model. RESULTS: Seventeen prospective studies were included. In hospitalized children, the overall incidence of ADRs was 9.53% (95% confidence interval [CI], 6.81, 12.26); severe reactions accounted for 12.29% (95%CI, 8.43,16.17) of the total. The overall rate of paediatric hospital admissions due to ADRs was 2.09% (95%CI, 1.02, 3.77); 39.3% (95%CI, 30.7,47.9) of the ADRs causing hospital admissions were life threatening reactions. For outpatient children the overall incidence of ADRs was 1.46% (95%CI, 0.7, 3.03). CONCLUSIONS: The results show that ADRs in children are a significant public health issue. The completeness and accuracy of prescription reporting as well as clinical information from studies was a rarity, making it difficult for health practitioners to implement evidence based preventive strategies. Further, methodologically sound drug surveillance studies are necessary for an effective promotion of a safer use of drugs in children.

Adolescent↗
PubMed2001

Parental perceptions of comfort during mechanical ventilation.

There are no reports of the parental perceptions of comfort during the mechanical ventilation of children. We have assessed the quality of sedation in 28 mechanically ventilated children and compared these results to an overall parental assessment of comfort, obtained by postal questionnaire. There was no correlation between the parental assessment of comfort and the paediatric intensive care unit (PICU) staff satisfaction with the level of sedation. Parental assessment of comfort was positively correlated with the duration of ventilation, whilst PICU staff satisfaction was positively correlated with the age of the child. Parents appear to become more satisfied with the degree of comfort of their children as the duration of mechanical ventilation increases, which is an effect that may have an important bearing on communication between parents and health professionals. Our results also suggest that the commonly used sedation regime of midazolam and morphine is less effective in younger children.

Adolescent↗
PubMed2001

Assessment of pain by parents in young children following surgery.

BACKGROUND: We asked parents to assess pain in young children following surgery. METHODS: Assessments were carried out by both parents and an independent assessor using a behavioural observational scale. RESULTS: Forms were returned from the parents of 42 children aged 1-5 years. There were 123 joint assessments and there was a strong correlation between the scores by the observer and the parents (r2=0.84). Twenty-nine children experienced pain following discharge from hospital. CONCLUSION: Our findings suggest that parents can assess pain in young children following surgery. The management of pain following discharge from hospital can be improved.

Adult↗
PubMed2001

A novel scheme for the reporting of adverse drug reactions.

BACKGROUND: The safety of medicines used in children is of considerable public interest, yet available data to monitor the safety of medicines in children is limited. AIMS: To raise awareness and stimulate reporting of adverse drug reactions (ADRs) in children in the Trent region. METHODS: A pilot Paediatric Regional Monitoring Centre (PRMC) has been established in the Trent region. The scheme operates as an extension of the UK's spontaneous reporting scheme, the Yellow Card Scheme run by the Medicines Control Agency and the Committee on Safety of Medicines. Proactive interventions including a monthly reminder letter and presentations to staff in the identified hospitals have been made. RESULTS: During the first year of the PRMC, 95 reports were received from the Trent region compared to 40 for the previous year. Twenty four of these reports were for medicines used "off label". The 95 reports involved 105 drugs and 171 suspected ADRs. Twenty six of the ADRs (15%) were considered medically significant. CONCLUSIONS: The number of ADR reports from the Trent region has increased considerably in the first year of the scheme. The results show that intensive education and promotion of ADR reporting can result in a major increase in reporting. This initiative will increase our knowledge about the safety of medicines used to treat children and so help protect public health.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

OBJECTIVE: To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries. DESIGN: Prospective study of drugs administered to children in general paediatric medical wards over four weeks. SETTING: Children's wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands). SUBJECTS: Children aged 4 days to 16 years admitted to general paediatric medical wards. MAIN OUTCOME MEASURE: Proportion of drugs that were used in an unlicensed or off label manner. RESULTS: 2262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all drug prescriptions (1036; 46%) were either unlicensed or off label. Of these 1036, 872 were off label and 164 were unlicensed. Over half of the patients (421; 67%) received an unlicensed or off label drug prescription. CONCLUSIONS: Use of off label or unlicensed drugs to treat children is widespread. This problem is likely to affect children throughout Europe and requires European action.

Adolescent↗