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Dose Variations Associated with Formulations of NSAID Prescriptions for Children A Descriptive Analysis of Electronic Health Records in the UK
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
2011 (English)In: Drug Safety, ISSN 0114-5916, Vol. 34, no 4, 307-317 p.Article in journal (Refereed) Published
Abstract [en]

Background: NSAIDs, particularly ibuprofen, are commonly prescribed for children but there is limited published research on real-life prescribed doses for this class of drugs. Objective: The aim of the study was to investigate if variations in NSAID doses prescribed to children can be explained by patient age, indication, dosage form, type of NSAID or year of prescription. Study Design: Recorded daily doses for drugs within the 'Anti-rheumatics, non-steroidal plain' anatomical classification were studied. First prescriptions of a distinct NSAID substance within 13-month time periods in a patient's history were included. To enable grouping and comparison of NSAIDs, doses were analysed as prescribed daily doses (PDDs) relative to the adult defined daily dose, stated as the relative PDD (rPDD) in this study. Multiple regression analysis was performed with the rPDD as the response variable, and age, indication, dosage form, NSAID substance and year of prescription as the explanatory variables. Setting: Prescriptions from the Intercontinental Medical Statistics (IMS) Health Disease Analyzer database containing electronic health records of general practitioners in the UK issued from 1988 to December 2005. Patients: Data for children aged 2-11 years with NSAID prescriptions including daily dose information. Results: A total of 21 473 first prescriptions for 19 695 patients were studied. The vast majority of prescriptions were for ibuprofen (n = 20855), which were therefore analysed separately. The other NSAID prescriptions were grouped (n = 618), containing diclofenac, indometacin, mefenamic acid, naproxen and piroxicam ('NSAID group'). The rPDD varied considerably with dosage form in both the ibuprofen and NSAID groups. In particular, tablets/capsules were prescribed at higher doses than liquid dosage forms. In the NSAID group, naproxen was prescribed at noticeably higher doses. The rPDD varied only slightly with age in both groups. Prescriptions indicated for rheumatic disease were associated with lower doses than other indications in the NSAID group. The rPDD was not influenced by year of prescription. Conclusions: This study shows a correlation between higher prescribed NSAID doses and tablet/capsule formulation, and highlights the need for careful choice of dose formulation when prescribing medicines for children.

Place, publisher, year, edition, pages
2011. Vol. 34, no 4, 307-317 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-152910ISI: 000289539700005PubMedID: 21417503OAI: oai:DiVA.org:uu-152910DiVA: diva2:414451
Available from: 2011-05-03 Created: 2011-05-03 Last updated: 2013-08-30Bibliographically approved
In thesis
1. Safety of Medication in Paediatrics
Open this publication in new window or tab >>Safety of Medication in Paediatrics
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: In paediatrics, the limited documentation to guide medication, the lack of suitable dosage forms, and the continuous development in childhood present a scenario where safety of medication is a particular challenge.

Aim: To explore reported adverse drug reactions (ADRs) and the challenges in prescribing and administering medicines in paediatrics, in order to identify and suggest areas needing international surveillance within medication safety and improvement in the clinical setting.

Methods: Four exploratory studies were conducted. Worldwide reporting of suspected ADRs (individual case safety reports, ICSR) with ages 0-17 years were examined overall. Twenty published case reports and ICSRs for adolescents, who developed a rare and incompletely documented ADR (rhabdomyolysis) during antipsychotic medicine use, were analysed in-depth. Prescribed doses of anti-inflammatory medicines were studied in a UK electronic health record database. Transcribed focus group interviews with 20 registered nurses from four paediatric wards in Sweden were analysed for factors that may promote or hinder safe medication practices. Descriptive statistics, multiple regression, and content analyses were used.

Results: Although, skin reactions and anti-infective medicines were most frequently reported, and more reported in paediatric patients than in adults, medication errors and adverse reactions related to psychostimulant medicines were reported with increased frequency during 2005 to February 2010. The in-depth case analysis emphasised the need for increased vigilance following changes in patients’ medicine regimens, and indicated that ICSRs could contribute with clinically valuable information. Prescribed dose variations were associated with type of dosage form. Tablets and capsules were prescribed with a higher dose than liquid dosage forms. Six themes emerged from the interviews: preparation and administration was complex; medication errors caused considerable psychological burden; support from nurse colleagues was highly valued; unfamiliar medication was challenging; clear dose instructions were important; nurses handling medications needed to be accorded higher priority.

Conclusions: Age-specific screening of ICSRs and the use of ICSRs to enhance knowledge of ADRs and medication errors need to be developed. Access to age-appropriate dosage forms is important when prescribing medicines to children. To improve medication safety practices in paediatric care, interdisciplinary collaborations across hospitals on national or even global levels are needed.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2013. 81 p.
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 883
paediatrics, adverse drug reaction, drug-related problem, medication error, patient safety, individual case safety reports, pharmacovigilance, medication, nurses, health care personnel, dosage form, NSAID, dosing, prescription, antipsychotic medicines, postmarketing surveillance
National Category
Medical and Health Sciences
Research subject
Medical Science
urn:nbn:se:uu:diva-197323 (URN)978-91-554-8632-7 (ISBN)
Public defence
2013-05-16, Gustavianum Auditorium Minus, Akademigatan 3, Uppsala, 09:15 (English)
Available from: 2013-04-24 Created: 2013-03-22 Last updated: 2013-08-30Bibliographically approved

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