Citation

Hedenmalm K, Slattery J, Skibicka-Stepien I, Kurz X, Morales D. Eur. J. Clin. Pharmacol. 2019; 75(5): 707-716.

Affiliation

Pharmacovigilance and Epidemiology Department, European Medicines Agency, London, UK.

Copyright

(Copyright © 2019, Holtzbrinck Springer Nature Publishing Group)

DOI

10.1007/s00228-018-02622-9

PMID

30675632

Abstract

PURPOSE: There is increasing concern with regard to fatal intoxications with prescription opioids and tramadol poisonings. This study aimed to characterise prescribing patterns for tramadol in primary care in France and Germany and identify long-term treatment and potential risk factors for such treatment.

METHODS: Adult patients-prescribed tramadol between January 2006 and June 2016 in GP practices in IMS® Disease Analyzer databases in France and Germany were identified. Six-monthly prevalence and mean doses and durations were calculated by gender, age group and type of tramadol product. The proportion of incident use that resulted in treatment ≥ 366 days was calculated. The odds for long-term treatment was analysed in relation to gender, age group, type of tramadol product, start dose, indication and a diagnosis of abuse or misuse.

RESULTS: Overall prescribing of tramadol decreased in Germany and increased, then plateaued in France. Prescribing was higher in females. Predominantly prescribed products were tramadol in combination with paracetamol (COMB) in France and slow release formulations of tramadol (SR-TRAM) in Germany. SR-TRAM had the highest mean doses and durations, followed by immediate release formulations of tramadol (IR-TRAM) and COMB. Around 1.5% of incident tramadol use in France and 8.2% in Germany resulted in long-term treatment. Long-term treatment was associated with increasing age, SR-TRAM and a diagnosis of abuse or misuse.

CONCLUSIONS: The risk of long-term treatment appeared to increase with increasing age. Potential risk factors for long-term treatment included initiating treatment with SR-TRAM and a diagnosis of abuse or misuse.

Language: en

Keywords

Chronic pain; Clinical pharmacology; Drug utilisation; Opioids; Pain