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.