Off-label and unlicensed oncology medicine use in Turkey: a retrospective analysis of computer records of the Turkish Ministry of Health

Abstract

Objectives The use of off-label medications is very common. A study published in 2006 found that off-label use was most common for cardiac medications and anticonvulsants. The study also found that 73% of off-label use had little or no scientific support. Off-label use can lead to restrictions regarding reimbursement. Regulatory agencies have created incentives to extend indications for approved drugs in order to remove them from the off-label area. In our analysis, off-label or unlicensed use of oncology medicines was evaluated so as to provide an understanding of Turkey's perspective within this area of medical provision. Methods Unlicensed or off-label medicine use in Turkey is controlled by the General Directorate of Pharmaceuticals and Pharmacy (GDPP) of the Turkish Ministry of Health. Oncology medicines are imported for these types of uses. A computer search was performed of GDPP's database. A patient base using off-label oncology medicines applications in the years 2008, 2009 and first 6 months of 2010 was searched. Key findings Our study showed that the use of unlicensed or off-label medicine has been rising in recent years and there was a huge difference between incidence and applications in haematologic and breast cancers. Conclusions It can be said that awareness of off-label medicine use is increasing in Turkey, with physicians able to reach scientific literature immediately via the Internet. It might also be said that physicians and pharmaceutical firms may try to avoid the reimbursement procedures of the Turkish Social Security Institution by using GDPP off-label use procedures. It is necessary to evaluate off-label and unlicensed use procedures a bit more strictly. Further analysis will be required in the future.