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Keywords:

  • pharmacoepidemiology;
  • Opioid Use;
  • Alcohol Related Disorders;
  • Alcohol Related Disorders;
  • German Pharmacoepidemiological Research Database

ABSTRACT

Purpose

In November 2010, the European Medicines Agency's Committee for Medicinal Products for Human Use completed a review of the safety and effectiveness of modified-release oral high-potency opioids (HPO). The reason for this referral procedure was the concern that some of these controlled-release systems may be unstable when co-ingested with alcohol and that the active substance would be released too quickly. The aim of this study was to estimate the prevalence of alcohol-related disorders (ARD) in German patients treated with HPO approved for pain therapy.

Methods

The source of data was the German Pharmacoepidemiological Research Database including more than 14 million members of four statutory health insurances. The age and sex standardized 3-year prevalence of ARD in patients treated with any type of HPO and in patients receiving modified-release oral HPO was compared with the prevalence of ARD in the general population excluding HPO-treated patients.

Results

The age and sex standardized prevalence of ARD was significantly higher in patients treated with any type of HPO (5.5%, 95%confidence interval [CI]: 5.2%–5.9%) or with modified-release HPO (5.4%, 95%CI: 4.8%–5.9%) than in persons belonging to the general population (2.2%, 95%CI: 2.2–2.2%).

Conclusions

Interactions with alcohol in patients receiving modified-release HPO may be of relevance in a substantial number of patients. Physicians should be aware of this potentially dangerous interaction. Copyright © 2012 John Wiley & Sons, Ltd.