PDB17 Off-Label and Non-Licensed Endocrinology Medicine Use in Turkey: A Retrospective Analysis of Computer Records in the Turkish Ministry of Health

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Kockaya G., Tanyeri P., Vural &., Akbulat A., Akar H., Tokaç M., ...More

VALUE IN HEALTH, vol.14, no.7, pp.474, 2011 (SCI-Expanded)

  • Publication Type: Article / Abstract
  • Volume: 14 Issue: 7
  • Publication Date: 2011
  • Doi Number: 10.1016/j.jval.2011.08.1320
  • Journal Name: VALUE IN HEALTH
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Scopus
  • Page Numbers: pp.474
  • Istanbul Medipol University Affiliated: No


OBJECTIVES: Off-label is defined by the Turkish Ministry of Health (MoHT) as the use of licensed pharmaceutical products in doses outside of or exceeding the scope of the registered indication, and the use of non-licensed but imported medicinal products for the purpose of individual treatment. The use of off-label or nonlicensed endocrinology medicines were evaluated in order to provide an understanding of Turkey’s perspective within this area of healthcare provisions. METHODS: A computer search was performed of IEGM’s database. A patient base using off-label endocrinology medicine applications from 19 June 2009 to 19 June 2010 were searched. RESULTS: The computer search for the showed that 357 applications were submitted for off-label endocrinology medicine use. It was concluded that the highest application percentage was established by “osteoporosis” in all of the applications (43%, 155/357). The highest application was established by Ankara province (28%, 44/155). University hospitals had the highest off-label osteoporosis medicine use applications within the given timeline (65%, 102/155). Specialized physicians in the fields of endocrinology and metabolism (adult and paediatric) had the highest number of off-label osteoporosis applications (71%, 111/ 155). It was concluded that the highest application percentage was established by “teriparatide use in osteoporosis” (87%, 136/155) in all of the osteoporosis applications. 92 of 136 applications were approved. There was a significiant difference between the T score (L1-4) of rejected and approved applications for patients (3.071,85 and 3.231.63, respectively) (p0.001). Yet there was not a significiant difference between ages of patients for whom applications were rejected or approved. CONCLUSIONS: It could be said that off-label use can lead to reimbursement restrictions in endocrinology, especially for teriparatide-like oncology medicines. In Turkey, physicians who want to prescribe an off-label or non-licensed pharmaceutical or a medicine which has a different use from reimbursement indications, need to apply through the off-label medicine use process.