Utilisation of transdermal fentanyl in Germany from 2004 to 2006

Pharmacoepidemiol Drug Saf. 2012 Feb;21(2):191-8. doi: 10.1002/pds.2164. Epub 2011 Jun 17.


Purpose: Oral morphine is the first-choice opioid for moderate to severe cancer pain. Transdermal fentanyl is an alternative in patients with stable requirements of high-potency opioids (HPO) or if drugs cannot be taken orally. Drug regulatory authorities have issued several alerts to use transdermal fentanyl only for chronic pain and in HPO-tolerant patients to minimise the risk of severe opioid side effects. The aim of this study was to characterise utilisation of transdermal fentanyl in Germany.

Methods: The analysis was based on data from four German statutory health insurances from the years 2004-2006. Descriptive analyses were performed in new users of transdermal fentanyl to assess HPO-naïvety, potential difficulties with the oral route in HPO-naïve patients and the number of transdermal fentanyl dispensations. The initial dose in new users was assessed in 2005-2006 after marketing of transdermal fentanyl 12.5 µg/hour.

Results: Of 35 262 patients with new use of transdermal fentanyl, 29 793 (84.5%) were assessed as HPO-naïve. Of those, 21 596 (72.5%) did not have diagnoses indicating difficulties with the oral route. For 71.2% of the HPO-naïve new users of transdermal fentanyl, the first dose exceeded the recommended dose of 12.5 µg/hour, and 49.3% of them received only one prescription of the drug.

Conclusions: Transdermal fentanyl was used as a first-choice opioid, which may increase the risk of serious opioid side effects, in a substantial number of HPO-naïve patients. Inappropriate prescribing included also high initial doses in HPO-naïve patients and possible prescription for acute pain in a considerable proportion of patients.

MeSH terms

  • Aged
  • Analgesics, Opioid / administration & dosage
  • Analgesics, Opioid / adverse effects
  • Analgesics, Opioid / therapeutic use*
  • Databases, Factual / statistics & numerical data
  • Dose-Response Relationship, Drug
  • Female
  • Fentanyl / administration & dosage
  • Fentanyl / adverse effects
  • Fentanyl / therapeutic use*
  • Germany
  • Humans
  • Male
  • Middle Aged
  • National Health Programs / statistics & numerical data
  • Neoplasms / complications
  • Pain / drug therapy*
  • Pain / etiology
  • Practice Patterns, Physicians' / standards
  • Practice Patterns, Physicians' / statistics & numerical data
  • Transdermal Patch


  • Analgesics, Opioid
  • Fentanyl