Ali Alkan

Assessment Of The Prescriptions Written In Different Provinces Of Turkey In Terms Of Drug Utilization Principles

Objective: To learn how physicians’ prescribing habits contribute to the rational use of medicine (RUM). We investigated the content of prescriptions written out in different provinces. Material and Method: A total of 3201 prescriptions written in Bartin, Bayburt, Cankiri, Denizli, Eskisehir, Gumushane, Karabuk, Kirsehir, Nevsehir and Nigde were collected from pharmacies. Prescriptions were analyzed using some indicators such as average number of medicines per-prescription (NMPP), average cost per-prescription (CPP) etc. Prescriptions indicating anxiety, hypertension, osteoarthritis, acute (A) otitis media, A.sinusitis, A.tonsillopharyngitis, A.cystitis, diabetes mellitus, dyspepsia and A.diarrhea were evaluated by provinces. Results: Except in three provinces, respiratory drugs were the most commonly written agents. NMPP was highest in Denizli (3.21±0.95), lowest in Cankiri (2.65±1.09). CPP was highest in Denizli (133.35±650.92TRL), lowest in Bartin (42.54±49.91TRL). As for gold standard-compatibility, the prescribed medicines in 4/10 indications seemed better in Cankiri and Gumushane. Injections, antibiotics, analgesics and gastroprotectives were most commonly prescribed in Denizli (14.1%), Kirsehir (43.3%), Gumushane (48.1%) and Bayburt (19.8%) respectively. Conclusion: In the provinces, there were substantial differences in the content of prescriptions. Generally, rational drug prescribing performance was found quite low. These findings should be considered in the activities to the extension of RUM. (Marmara Medical Journal 2011;24:162-73)

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australias Therapeutic Goods Administration (TGA), Health Canada, Singapores Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agencys overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval.

A nationwide evaluation of off-label drug utilization in Turkey

Background/aim: Off-label drug use (OLDU) is under the control of the Turkish Medicines and Medical Devices Agency (TMMDA) in Turkey. It was aimed to investigate demographic and medical features of patients with OLDU applications in Turkey. Materials and methods: A total of 4426 electronic OLDU application records of the TMMDA were evaluated retrospectively. Information regarding patients? demographic characteristics, diagnoses, requested drugs, institutions, and specialties of the physicians were evaluated. Results: OLDU applications were mostly made by rheumatologists (21.5%) and 95.2% of them were approved by the TMMDA. The mean age of the patients was 35 years and 54.4% of them were female. Off-label drugs were mostly prescribed for patients aged 18?64 years (62.1%) and were most frequently prescribed by physicians from university medical centers (81.0%). Systemic lupus erythematosus (10.1%) was the most common diagnosis. Mycophenolate (16.1%) and rituximab (10.1%) were the most frequently prescribed off-label drugs. There were differences regarding some characteristics of patients and their physicians among most frequently prescribed off-label drugs (P < 0.05). Conclusion: It is noteworthy that OLDU applications showed demographical and institutional differences. It is expected that this study will provide important contributions to physicians working in the relevant area with respect to treatment alternatives of diseases with treatment challenges.

Investigation of Physicians’ Perspectives of Drug Promotional Activities

Programlanmis hucre olumu olan apoptoz bircok fizyolojik surecte aktif rol oynamaktadir. Apoptozun, buyume faktorlerinin eksikligi, DNA hasari ve birden fazla faktoru iceren cesitli hucresel stresle aktive olan ‘hucre ici’ ve olum reseptorlerine ligandin baglanmasiyla kaspazlarin aktive oldugu ‘hucre disi’ olmak uzere iki yolagi vardir. Apoptotik hucre sayisi ile organizmanin saglikli olup olmadigi belirlenir. Apoptoz oraninin azalmasi hucre sayisini arttirirken, apoptoz oraninin artmasi hucre sayisini azaltarak dokularda tahribata neden olmaktadir. Apoptotik sinyallemede duzensizlik cesitli hastaliklarda/bozukluklarda primer ya da sekonder rol oynamaktadir. Son yillarda apoptozun norodejeneratif hastaliklarla ilgili calismalari on plana cikmaya baslamistir. Apoptotik sinyal yolaklarinin daha iyi tanimlanmasi, pro- ve anti-apoptotik genlerin belirlenmesiyle, calismalar hiz kazanmistir. Travma Sonrasi Stres Bozuklugu gibi norodejeneratif bozukluklarda beyindeki yapisal ve fonksiyonel degisiklikler mitokondriyal stres ile iliskilidir. Fizyolojik kosullarda hayati oneme sahip olan apoptoz, patolojik kosullarda mekanizmanin tetiklenmesine ve kontrolsuz hucre cogalmasina yol acmaktadir. Hucre olumunu engelleyen terapotik ilaclarin gelistirilmesiyle apoptoz aracili norodejenaratif bozukluklarin tedavisine yeni umutlar olusacaktir.