title: Utilisation of transdermal fentanyl in Germany from 2004 to 2006.
abstract: OBJECTIVE
  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.
authors.affiliation: Bremen Institute for Prevention Research and Social Medicine (BIPS), Bremen, Germany. garbe@bips.uni-bremen.de.
authors.forename: Edeltraut
authors.initials: E
authors.lastname: Garbe
authors.forename: Kathrin
authors.initials: K
authors.lastname: Jobski
authors.forename: Ulrike
authors.initials: U
authors.lastname: Schmid
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016208:Databases, Factual / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009313:National Health Programs / Q000706:statistics & numerical data; D009369:Neoplasms / Q000150:complications; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010818:Practice Patterns, Physicians' / Q000592:standards / Q000706:statistics & numerical data; D057968:Transdermal Patch
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl