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Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe
Kelly Plueschke1, Robert Flynn2,3, Karin Hedenmalm2
1European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands. Kelly.plueschke@ema.europa.eu.
Insights
European Union (EU) restrictions on codeine for children significantly reduced its use, with healthcare providers switching to alternative analgesics and antitussives. The measures were effective for pain relief but had minimal impact on cough/cold treatments.
Area of Science:
- Pediatric Pharmacology
- Public Health Policy
- Drug Safety Surveillance
Background:
- European Union (EU) initiated reviews in 2013 and 2015 due to concerns over codeine's respiratory risks in children.
- These reviews led to restrictions on codeine use for pain relief, cough, and cold in pediatric populations.
Purpose of the Study:
- To evaluate the effectiveness of EU risk minimization measures on codeine prescribing in children.
- To analyze trends in codeine and alternative medication use following regulatory actions.
Main Methods:
- A multinational interrupted time series analysis of electronic health records from 2010-2017.
- Data included children under 12 and aged 12-18 years across France, Germany, Norway, Spain, and the UK.
Main Results:
- Codeine prescribing decreased significantly in all studied countries, nearing zero for children under 12.
- Prescribing of alternative analgesics (opioid and non-opioid) increased, particularly for pain indications.
- The impact on antitussive use for cough/cold indications was minimal, with a notable decrease only in France.
Conclusions:
- Healthcare professionals adapted prescribing practices, shifting away from codeine for pediatric pain management.
- Regulatory measures were effective in reducing codeine use, but varied in impact across different indications and countries.
- Further evaluation is needed for the effectiveness of restrictions on cough and cold treatments.
Introduction:
Concerns over serious respiratory depression in children led to two European Union (EU) referral procedures (in 2013 and 2015) to review the benefit-risk balance of codeine in this population when used for pain relief, cough or cold. Consequently, codeine should no longer be used in children aged < 12 years and restrictions were introduced for treatment in children ≥ 12 years.
Objective:
This multinational collaborative study aimed to assess the effectiveness of these risk minimisation measures by evaluating changes in prescribing of codeine and alternative treatments.
Method:
Children under 12 and 12-18 years old were followed between 2010 and 2017 to analyse quarterly trends in prescribing of codeine and alternative treatments in electronic health records from France, Germany, Norway, Spain and the United Kingdom using interrupted time series analysis.
Results:
Overall prescribing of codeine in children decreased in all five countries, reaching near zero prevalence in children under 12 years of age. This was accompanied by an increase in use of other opioid analgesics in France (from 0.15 to 0.56 prevalence per 100 person-years immediately after the first referral), Norway (from 0.0006 to 0.0013 at the end of the study), the United Kingdom (from 0.018 to 0.05 at the end of the study), and an increase in non-opioid analgesics in Norway (from 0.045 to 0.075 at the end of the study) after the referral on pain relief indication. The referral on cough/cold indication led to a decrease in use of opioid and non-opioid antitussives in children aged < 12 years in France (from 10 to 7 and 20 to 16, respectively) and had no impact in other countries. Overall prescribing trends for codeine and alternatives were similar across both age groups within each country.
Conclusion:
The decrease in use of codeine shows that healthcare professionals followed the adopted measures and switched prescribing practices for pain management in children aged < 18 years towards opioid or non-opioid analgesics depending on national clinical and reimbursement settings. Whist the magnitude of the first referral on pain differed between countries, the second referral on cough/cold had only a minimal impact on the use of codeine and antitussives.
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