ArticlePharmacoepidemiology and drug safety2019
A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.
Article in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
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Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Mixed Impact of Direct Healthcare Professional Communications When Considering Proximal Outcomes and the Targeted Population: A Systematic Review.Pharmacoepidemiology and drug safety · 2025Pooled it
- Impact of medicines regulatory risk communications in the UK on prescribing and clinical outcomes: Systematic review, time series analysis and meta-analysis.British journal of clinical pharmacology · 2020Pooled it
- Trends of Opioids and Nefopam Use Among French Children: A Population-Based Study From 2009 to 2023.Clinical drug investigation · 2026Article
- Review
- Addressing Limitations and Future Directions in the Use of Glucocorticoids for Pediatric Nuss Procedure Analgesia: A Critical Appraisal [Letter].Journal of pain research · 2025Article
- Commercializing Personal Health Information: A Critical Qualitative Content Analysis of Documents Describing Proprietary Primary Care Databases in Canada.International journal of health policy and management · 2023Article
- Article
- Opioid Analgesic Prescription in French Children: A National Population-Based Study.International journal of environmental research and public health · 2021Article
- The impact of guidance on the supply of codeine-containing products on their use in intentional drug overdose.European journal of public health · 2021Article
- Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?: A Validation Study Based on Prescribing Codeine in Children.Clinical pharmacology and therapeutics · 2020Observational
- Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee.Clinical pharmacology and therapeutics · 2020Article
- A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.Pharmacoepidemiology and drug safety · 2019Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn June 2013, following recommendations from the World Health Organization (WHO) and Food and Drug Administration (FDA), the European Medicines Agency agreed updates to the codeine product information regarding use for pain in children younger than 12 years and children undergoing tonsillectomy or adenoidectomy (TA) for obstructive sleep apnoea. This study was conducted to (a) assess effectiveness of these measures on codeine prescribing in the "real-world" setting and (b) test feasibility of a study using a common protocol by regulators with access to databases.
methodsThe study was performed using BIFAP (Spain), CPRD (UK), and IMS® Disease Analyzer (France and Germany) databases. Prescribers included general practitioners (GPs) (France and UK), GPs and paediatricians together (Spain), and GPs, paediatricians, and ear, nose, and throat (ENT) specialists separately (Germany). Between January 2010 and June 2015, prevalence of codeine prescribing was obtained every 6 months, and a time series analysis (joinpoint) was performed. Codeine prescribing within ±30 days of TA was also identified. Furthermore, doses, durations, and prior prescribing of other analgesics were investigated.
resultsOver the 5-year period, codeine prescribing decreased in children younger than 12 years (by 84% in France and Spain, 44% in GP practices in Germany, and 33% in the United Kingdom). The temporal pattern was compatible with the regulatory intervention in France and the United Kingdom, whereas a decrease throughout the study period was seen in Germany and Spain. Decreased prescribing associated with TA was suggested in ENT practices in Germany.
conclusionsCodeine prescribing for children decreased in line with introduced regulatory measures. Multidatabase studies assessing impact of measures by EU regulators are feasible.
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