Results
There are 381 drugs listed in PharmGKB drug label annotations and 278 of these have biomarkers. The numbers of drug labels containing PGx approved by the FDA, EMA, Swissmedic, HCSC, and PMDA are 306 (80.32%), 127 (33.33%), 125 (32.81%), 104 (27.30%), and 52 (13.65%), respectively. A total of 242 (63.52%) drugs are approved and available in Turkey. Of these, 207 (54.33%) contain the same information as in or similar to that in the labels approved by the other agencies. Some labels contain two levels of information if different genes are involved and/or if the drug is a combination of two or more active ingredients. The details of the information levels are shown in Table 1.
One hundred ninety-one (50.13%) of the drugs had labels approved by more than one agency, and the levels of PGx were inconsistent for 63 (32.98%) of these drugs. For example, in one country label, the information level is testing required while that in the others is testing recommended or actionable or informative information. Among the 132 drugs that are not currently on the Turkish market, the labels of 55 (41.67%) have no PGx at all. Twenty-three (17.42%) of these drugs are on the import drug list. This list contains the drugs that are not currently licensed and/or not marketed in Turkey but their import in line with a set of regulations is permitted by the Turkish Ministry of Health. Of the 23 drugs that are on the import list, three have SmPCs in Turkish and two in English. Eighteen (13.63%) are licensed but are currently unavailable due to not being produced, not being imported, or not being marketed. Of these, 11 (61.11%) have PGx in their approved SmPCs. RX Media Pharma database monographs for active ingredients contain the PGx for 46 (34.85%) of the drugs.