[Information Gaps in Package Inserts Cause Insufficient Patient Information on Correct Handling of Transdermal...

The multi-step administration process of transdermal patches requires sufficient knowledge and skills of patients to prevent administration errors. The package insert is an easily accessible information source that reaches the patient automatically with drug dispensing. However, information gaps potentially limit their suitability as appropriate patient information material.

Package inserts of all transdermal patches available on the German drug market were analyzed for medication administration recommendations.

In total, 81 package inserts were analyzed including buprenorphine (N = 13), fentanyl (N = 33), granisetron (N = 1), glyceroltrinitrate (N = 2), nicotin (N = 4), oxybutynin (N = 1), rivastigmin (N = 10), rotigotin (N = 2), scopolamin (N = 1), and hormone preparations with estradiol, estradiol hemihydrate, ethinyl estradiol, gestodene, levonorgestrel, norelgestromin, and norethindrone acetate (N = 14). None of the package inserts included all 28 administration recommendations that were previously identified as relevant through a systematic literature search. In particular, information was lacking on transdermal patch-specific characteristics such as mechanism of drug absorption, monitoring, storage, and disposal.

The package inserts insufficiently inform patients on correct transdermal patch administration and thus, comprehensive patient education by healthcare professionals is required. In the long-term, regulatory requirements for package inserts should include standardized and dosage form-specific recommendations for correct medication administration.