Utilisation of transdermal fentanyl in Germany from 2004 to 2006.

摘要

In our study investigating the utilisation of transdermal fentanyl in Germany, we distinguished between HPO-naiVe and HPO-tolerant patients. The former were denned as patients who had not received an HPO during the 3 months preceding the first prescription of transdermal fentanyl. This distinction was based on the definition by the US Food and Drug Administration (FDA) which released a second warning regarding inappropriate use of fentanyl patches in December 2007 after having received reports of life-threatening side effects and fatalities (some related to use of transdermal fentanyl in HPO-naive patients) to the US spontaneous adverse event reporting system. In this alert, the FDA defined patients as opioid tolerant if they had been using another strong opioid narcotic pain medicine around-the-clock and regularly for a week or longer. A similar definition has been used in Canada.We used the definition provided by the FDA, since these safety concerns should also hold for Germany.