Division of Fentanyl Patches Not Permitted
The German Federal Institute for Drugs and Medical Devices (BfArM) and the German Association of Pharmacists (ABDA) state that dividing fentanyl patches is not permitted due to safety and regulatory reasons.
The German Federal Institute for Drugs and Medical Devices (BfArM) has determined that patients are not permitted to divide fentanyl matrix patches.
The German Association of Pharmacists (ABDA) has informed pharmacies of the authority's position. BfArM cites several safety reasons for its decision. Firstly, dividing the patches does not comply with their original marketing authorizations under pharmaceutical law. Even if a patch does not explicitly state it cannot be divided, this does not imply legal tolerance for division.
Dividing patches can compromise dosage accuracy. If a patient cuts a patch, ensuring the correct drug concentration becomes difficult. Furthermore, proper storage and use of a cut patch become problematic. Therapeutically necessary lower doses should be covered by lower-strength formulations, not by dividing patches.
ABDA also emphasizes that cutting membrane patches, in particular, can lead to uncontrolled release of the active substance. For high-potency drugs like fentanyl, this could result in intoxication. The BfArM made its determination in March and October 2007 at the request of the AMK (German Association of QMessageBox).