General Assessment Of Unlicensed Medicine Usage In Turkey.

Pharmaceuticals can be used in un-approved or unlicensed indications or dosages apart from their licensed use. This is called off-label use. In principle, a drug can be considered to be off label under three conditions: (i) if the approval have not been extended, although evidence of efficacy is available; (ii) if it falls into the so-called ‘grey zone’ of evidence-based medicine, within which high-level evidence is difficult to reach even for treatments which are likely to be effective and (iii) if the drug is ineffective or at least there is no reason to believe it is effective (Koçkaya et al., 2011). Off-label use is defined by the Turkish Ministry of Health (MoH) as the use of licensed pharmaceutical products in doses outside of or exceeding the scope of the registered indication and the use of unlicensed medicinal products that are imported for the purpose of individual treatment. Hence, off-label use covers both licensed and unlicensed products (Koçkaya et al., 2012). The Turkish Medicines and Medical Devices Agency (TMMDA) gives the permission of unlicensed medicine use on patient basis. Authorized wholesalers including Turkish Pharmacists’ Association (TPA) can import the drugs based on the TMMDA`s permission. These medicines are reimbursed by the Social Security Institution (SSI), the main reimbursement agency in Turkey. Until 2014, , pharmaceuticals under this status could only be imported by the Turkish Pharmacists’ Association (TPA) when wholesalers were also authorized. This study aims to understand the trends in unlicensed medicine consumption between 2011 and 2013 when the TPA was the only authorized supplier.