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Area of Science:

  • Pharmacology and Pharmacoepidemiology
  • General Practice and Primary Care
  • Pain Management

Background:

  • Immediate-release fentanyl (IRF) formulations, including nasal and oromucosal products, are associated with risks of dependency and overdose.
  • IRFs are approved solely for breakthrough cancer pain in patients on chronic opioid therapy.
  • Concerns exist regarding the increasing off-label prescribing of IRFs in general practice settings.

Purpose of the Study:

  • To determine the frequency of IRF prescriptions within Dutch general practices.
  • To assess the extent of off-label IRF prescribing in this population.

Main Methods:

  • Utilized electronic health records from 342 general practices in the Nivel Primary Care Database (1,297,942 patients).
  • Included adult patients with IRF prescriptions in 2019 and available dispensing data for 2018-2019.
  • Employed descriptive analyses of diagnoses (International Classification of Primary Care) and prescription patterns.

Main Results:

  • IRF prescriptions were issued to 1,368 patients (1.1 per 1,000 registered patients) in 2019.
  • A substantial 74.9% of IRF prescriptions were classified as off-label.
  • Among off-label users, 65.2% lacked maintenance opioid therapy, and 14% were opioid-naive.

Conclusions:

  • While IRF prescribing is not common in Dutch general practices, a high proportion of these prescriptions are for unapproved indications.
  • The findings highlight a significant trend of off-label IRF use, particularly in patients without established opioid maintenance therapy or opioid-naive individuals.