Photodegradation and Photoprotection in Clinical Practice

Department of Pharmacy, Johannes Gutenberg-University Hospital, Mainz, Germany 

The ICH document does not make any recommendations regarding how to test for the UV-VIS proper protection of medicinal products during administration. In addition, the guideline does not cover the testing of the photostability of medicinal products during and after administration, i.e., under conditions of actual use (1). The guideline only states that it may be appropriate to test certain products such as infusion liquids, dermal creams, etc., to determine their photostability in use. The extent of this testing should depend on and relate to the directions for use, and is left to the applicant s discretion (1). 

The lack of photoprotection for the drug product during administration may lead to increased/decreased efficacy or increased toxicity of photolabile drugs. These episodes may be categorized as preventable medication errors, in particular, as wrong administration-technique errors (2). On the other hand, superfluous photoprotection measurements represent an unproductive use of nurses time and a waste of materials. 

---