A Multifaceted Evaluation of National Off-label Neurology Applications
Journal Title: Turkish Journal of Neurology - Year 2020, Vol 26, Issue 3
Abstract
Objective: Off-label drug use (OLDU) of neurologic diseases is approved by a regulatory authority, the Turkish Medicines and Medical Devices Agency (TMMDA) in Turkey. It was aimed to investigate the most common neurologic drugs relevant to off-label prescribing and the most prescribed diagnosis, demographic and medical characteristics of patients with OLDU applications in Turkey. Materials and Methods: Four years “TMMDA”s electronic OLDU application records, 9,758 applications in total, were evaluated retrospectively. Information regarding patients’ demographic characteristics, diagnoses, ordered drugs, and institutions were evaluated. Results: The most OLDU applications were mostly made in 2015, the majority of which were associated with neurodegenerative diseases. The mean age of the patients was 41.6 years and 65% were female. Some 62.1% of off-label drug application patients’ age range was found as 18-64 years. The most common applications were from the Marmara region with 36% and neurology clinics of university hospitals with 81%. Multiple sclerosis (MS) was the most common diagnosis and the most frequently used group of drugs was disease-modifying drugs used in the treatment of MS. Conclusion: Based on the four-year survey of OLDU applications for adult neurologic patients showed that unlicensed drug prescriptions were high. There are very few studies on the result of OLDU applications in neurology worldwide. We believe that this study will be a guide to neurologists with off-label application processes and the results in our country and will make a significant contribution to the literature.
Authors and Affiliations
Şükran Yurtoğulları, Hanife Rahmanlar, Ali Alkan, Banu Bayar, Hakkı Gürsöz, Nurten Uzun Adatepe
Keywords
Related Articles
- EP ID EP689426
- DOI 10.4274/tnd.2020.37791
- Views 186
- Downloads 0
Correlations Between Endothelial Dysfunction and Cerebral Imaging in Migraine
Objective: Despite its high prevalence, the basic pathophysiologic mechanism of migraine is still poorly understood. Our aim was to research endothelial dysfunction in patients with recently diagnosed episodic migraine,...
The COVID-19 from Neurological Overview
No summary
The Use of Clobazam as Add-on Treatment in Resistant Epilepsy: Our Retrospective Clinical Data
Objective: Patients with drug-resistant focal or generalized epilepsy are important in terms of treatment and polytherapy necessity, adverse effect profiles of drugs, and seizure control difficulties. Clobazam (CLB), whi...
Quantitative and Qualitative Assessment of Verbal Fluency in Amnestic Mild Cognitive Impairment
Objective: The objective of this research was to compare the verbal fluency skills of patients diagnosed as having amnestic mild cognitive impairment (aMCI) with the participants without neurologic or psychiatric problem...
Neuroimaging Findings in Patients with Idiopathic Intracranial Hypertension after Treatment
Objective: Few reports have investigating the reversal of neuroimaging findings of idiopathic intracranial hypertension (IIH). Our study aimed to show to what extent these findings are reversible after treatment. Materi...