Journal of Literature Pharmacy Sciences

Çocuklarda Endikasyon Dışı İlaç Kullanımı
Off-Label Drug Use in Pediatrics
N. İpek KIRMIZIa, Volkan AYDINb, Narin AKICIc, Ahmet AKICIb
aİstanbul Medipol Üniversitesi Tıp Fakültesi, Farmakoloji ABD, İstanbul, TÜRKİYE
bMarmara Üniversitesi Tıp Fakültesi, Tıbbi Farmakoloji ABD, İstanbul, TÜRKİYE
cHaydarpaşa Numune Eğitim ve Araştırma Hastanesi, Çocuk Sağlığı ve Hastalıkları Kliniği, İstanbul, TÜRKİYE
J Lit Pharm Sci. 2020;9(2):149-57
doi: 10.5336/pharmsci.2019-73101
Article Language: TR
Full Text
ÖZET
 Çocukluk çağı, dinamik ve evre evre fizyolojik değişikliklerin olduğu bir dönemdir. Pediatrik popülasyonda görülen farmakokinetik ve farmakodinamik farklılıklar, ilaç kullanımı esnasında etkililik ve güvenlilik başta olmak üzere çeşitli sorunlara yol açabilmektedir. Buna göre çocuklarda kullanılacak ilaçların, yaş grubuna özgü klinik araştırmalarla incelenip, onaylarının ayrıca alınması gerekmektedir. Oysa çocuklara özgü klinik araştırma ve bu yaş grubunda onaylı endikasyona sahip ilaç sayısı, çeşitli idari ve prosedürel nedenlerle kısıtlıdır. Hekimlerin, çocuk hastaların ilaç ile tedavisini düzenlerken çocukta kullanım endikasyonu onayı olmayan müstahzarları, sıklıkla ekstrapolasyon yoluyla kullandığı bilinmektedir. İlaçların, ruhsat aldıkları alan dışındaki farklı endikasyon, doz, uygulama şekli, yaş grubu, özel popülasyon vb. kullanımları 'endikasyon dışı ilaç kullanımı (EDİK)' olarak adlandırılır. EDİK oranı çocuklarda yüksek seyretmekte, özellikle küçük yaş gruplarında hemen hemen tüm ilaçların endikasyon dışı kullanılmak zorunda kalınabildiği durumlar görülmektedir. Özellikle son 20 yılda tüm dünyada, çocuklarda klinik araştırmaların artırılması için yapılan düzenlemeler ise çocuklarda ilaç kullanımı ile ilgili kanıta dayalı bilgi hacmini, dolayısıyla çocuklarda endikasyon onayı olan ilaç sayısını artırmaya başlamıştır. Bu gelişmelerin, pediatrik popülasyonda EDİK pratiğini mümkün olduğunca sınırlamaya yardımcı olacağı aşikârdır. Ancak EDİK'in rutin olmaktan öte istisnai durumlarda uygulanması hedefine ulaşmak için uzun zaman gerektiği göz önünde bulundurulduğunda, çocuklarda farmakoterapi sürecinin daha başarılı yönetilmesi için ilave yönlendirmelere ihtiyaç duyulmaktadır. Bu çalışmada, çocuklarda EDİK'in nedenleri, dünyada ve Türkiye'deki güncel durumu ve azaltılması/rasyonel yönetilmesi için atılabilecek adımlar ele alınmıştır.

Anahtar Kelimeler: Endikasyon dışı; ilaç kullanımı; pediatri; klinik araştırmalar; rasyonel farmakoterapi
ABSTRACT
 Childhood is a period with dynamic physiological changes stage by stage. Pharmacokinetic and pharmacodynamic variations in pediatric population can cause various problems, especially efficacy and safety issues during drug use. Hence, drugs to be used in children should also be investigated and approved through clinical trials specific to the age group. However, the number of clinical trials and drugs with approved indications in children are limited for a variety of administrative and procedural reasons. Thus physicians tend to extrapolate drug information when treating their pediatric patients with unapproved indication in pediatric population. The use of drugs outside their approved purpose, including different indications, doses, administration forms, age groups, or special populations etc. İs called "off-label drug use" (OLDU). Its prevalence is high in children, especially in very young age groups where almost all drugs may have to be used off-label. In the last 20 years, the regulations to facilitate clinical research in children throughout the world have helped to increase the volume of evidence-based information about drug use, thus the number of drugs approved, in children. Obviously, these advances will decrease OLDU practice in children. Considering the long time required to achieve the goal of applying OLDU only in exceptional cases, additional guidance is needed to make the pharmacotherapy more appropriate in children. In this review, causes of pediatric OLDU practice and the current situation in Turkey and globally are evaluated with further discussion of the steps that can be taken for reduction/rational management of OLDU.

Keywords: Off-label; drug use; pediatrics; clinical trials; rational pharmacotherapy
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"Turkiye Klinikleri" in its sole discretion may change the hereby "Terms of Use" anytime announcing within the "SITE". The changed terms of the hereby "Terms of Use" will become valid when they are announced. Hereby "Terms of Use" cannot be changed by unilateral declarations of users.

7. FORCE MAJEURE

"Turkiye Klinikleri" is not responsible for executing late or never of this hereby "Terms of Use", privacy policy and "USER Contract" in any situation legally taken into account as force majeure. Being late or failure of performance or non-defaulting of this and similar cases like this will not be the case from the viewpoint of "Turkiye Klinikleri", and "Turkiye Klinikleri" will not have any damage liability for these situations. "Force majeure" term will be regarded as outside of the concerned party's reasonable control and any situation that "Turkiye Klinikleri" cannot prevent even though it shows due diligence. Also, force majeure situations include but not limited to natural disasters, rebellion, war, strike, communication problems, infrastructure and internet failure, power cut and bad weather conditions.

8. LAW AND AUTHORISATION TO FOLLOW

Turkish Law will be applied in practicing, interpreting the hereby "Terms of Use" and managing the emerging legal relationships within this "Terms of Use" in case of finding element of foreignness, except for the rules of Turkish conflict of laws. Ankara Courts and Enforcement Offices are entitled in any controversy happened or may happen due to hereby contract.

9. CLOSING AND AGREEMENT

Hereby "Terms of Use" come into force when announced in the "SITE" by "Turkiye Klinikleri". The users are regarded to agree to hereby contract terms by using the "SITE". "Turkiye Klinikleri" may change the contract terms and the changes will be come into force by specifying the version number and the date of change on time it is published in the "SITE".

 

30.03.2014

Privacy Policy

We recommend you to read the terms of use below before you visit our website. In case you agree these terms, following our rules will be to your favor. Please read our Terms of Use thoroughly.

www.turkiyeklinikleri.com website belongs to Ortadoğu Advertisement Presentation Publishing Tourism Education Architecture Industry and Trade Inc. and is designed in order to inform physicians in the field of health

www.turkiyeklinikleri.com cannot reach to user’s identity, address, service providers or other information. The users may send this information to the website through forms if they would like to. However, www.turkiyeklinikleri.com may collect your hardware and software information. The information consists of your IP address, browser type, operating system, domain name, access time, and related websites. www.turkiyeklinikleri.com cannot sell the provided user information (your name, e-mail address, home and work address, phone number) to the third parties, publish it publicly, or keep it in the website. Gathered information has a directing feature to be a source for the website’s visitor profile, reporting and promotion of the services.

www.turkiyeklinikleri.com uses the taken information:

-To enhance, improve and maintain the quality of the website

-To generate visitor’s profile and statistical data

-To determine the tendency of the visitors on using our website

-To send print publications/correspondences

-To send press releases or notifications through e-mail

-To generate a list for an event or competition

By using www.turkiyeklinikleri.com you are considered to agree that;

-Ortadoğu Advertisement Presentation Publishing Tourism Education Architecture Industry and Trade Inc. cannot be hold responsible for any user’s illegal and immoral behavior,

-Terms of use may change from time to time,

-It is not responsible for other websites’ contents it cannot control or the harms they may cause although it uses the connection they provided.

Ortadoğu Advertisement Presentation Publishing Tourism Education Architecture Industry and Trade Inc. may block the website to users in the following events:

-Information with wrong, incomplete, deceiving or immoral expressions is recorded to the website,

-Proclamation, advertisement, announcement, libelous expressions are used against natural person or legal identity,

-During various attacks to the website,

-Disruption of the website because of a virus.

Written, visual and audible materials of the website, including the code and the software are under protection by legal legislation.

Without the written consent of Ortadoğu Advertisement Presentation Publishing Tourism Education Architecture Industry and Trade Inc. the information on the website cannot be downloaded, changed, reproduced, copied, republished, posted or distributed.

All rights of the software and the design of the website belong to Ortadoğu Advertisement Presentation Publishing Tourism Education Architecture Industry and Trade Inc.

Ortadoğu Advertisement Presentation Publishing Tourism Education Architecture Industry and Trade Inc. will be pleased to hear your comments about our terms of use. Please share the subjects you think may enrich our website or if there is any problem regarding our website.

info@turkiyeklinikleri.com