Objectives:

“Off-label” is defined by the Turkish Ministry of Health as the use of licensed pharmaceutical products in doses outside the scope of the registered indication and the use of unlicensed medicinal products that are imported for the purpose of individual treatment. Aim of the study is to evaluate the use of offlabel or unlicensed endocrinology medicines.

Method:

A computer search was performed of the IEGM’s (General Directorate of Pharmaceutical and Pharmacy-Ilac ve Eczacılık Genel Mudurlugu) database. Outcomes were evaluated in the light of indications for use.

Results:

The computer search showed that 357 applications were submitted for off-label endocrinology medicine use. The highest application percentage was for osteoporosis (43%, 155/357). The highest application of osteoporosis occurred in the Ankara province (28%, 44/155). University hospitals had the highest offlabel osteoporosis medicine applications within the given timeline (65%, 102/155). Specialized physicians in the fields of endocrinology and metabolism (adult and pediatric) had the highest number of offlabel osteoporosis applications (71%, 111/155). The highest application percentage for off-label osteoporosis treatment was for teriparatide (87%, 136/155). Of the 136 applications, 92 were approved.

Conclusion:

It could be said that off-label use can lead to reimbursement restrictions in endocrinology, especially for teriparatide.

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