SPCCTDM, a Catalogue for Analysis of Therapeutic Drug Monitoring Related Contents in the Drug Prescription Information

Methods And Results

SPC analysis was done by a recently established algorithm as described in the SPCC_TDM-catalogue (Ulrich, 2009). Briefly, the SPC-paragraphs “dose” (item 1), “adverse drug reactions” (item 2), “drug interactions” (item 3), “overdose” (item 4), “pregnancy/breast feeding” (item 5), and “pharmacokinetics” (item 6) are assessed in a manual process for the occurrence of implicit (1 point) or explicit (2 points) references to TDM (0 points for no references to TDM). Thus, items 1 to 6 are analysed strictly according to the paragraphs of the SPC.