Journal of Literature Pharmacy Sciences

Farmakovijilans Sistemi ve Eczacının Rolü: Sistematik Derleme
Pharmacovigilance System and the Role of Pharmacist: Systematic Review
Özge CEMİLOĞLU ÜLKERa, Büşra ESENa
aAnkara Üniversitesi Eczacılık Fakültesi, Farmasötik Toksikoloji ABD, Ankara, TÜRKİYE
J Lit Pharm Sci. 2021;10(2):211-22
doi: 10.5336/pharmsci.2020-80107
Article Language: TR
Full Text
ÖZET
 Bireyler, ilaç tedavileri boyunca var olan yaşam kalitelerinin sürmesini ve/veya artmasını istemektedir. Bununla birlikte tarihsel olarak ilaçlarla ilişkili yaşanan trajediler de önlem almayı ve bunu sistemli bir hâle getirmeyi gerekli kılmış ve farmakovijilans kavramı ortaya çıkmıştır. Bir ilacın pazarlama öncesi gözetimi ve piyasaya sürüldükten sonra takibi, etkili ve güvenli ilaç tedavilerinin sağlanması için önemlidir. Çünkü farmakovijilans sistemi aracılığıyla ilaca dair potansiyel riskin, yarardan fazla olduğu durum tespit edilmekte ve pazarlama izinlerinin feshi veya geçici iptali gibi radikal kararlar alınabilmektedir. Bu nedenle farmakovijilans faaliyetlerine katılım, ilaç güvenliğinin geliştirilmesine yardımcı olmaktadır. Farmakovijilans sistemlerinde zararlı ve amaçlanmayan bir cevap olan advers ilaç reaksiyonlarının (AİR) bildirimi, önemli bir veri kaynağı olarak kullanılmaktadır. Bir hastanın, ilacını veya ilaçlarını kullanmaya başlamadan önce görüştüğü son sağlık profesyoneli eczacılardır ve mesleki görevleri, ilaç dağıtımından farmasötik danışmanlığa kadar genişleyen eczacıların AİR bildirimleri, yaşam koşullarında ilaç izlemine imkân tanımaktadır. Eczacılar, AİR bildirimine karşı olumlu tutum sergilese de farmakovijilans sistemi konusundaki bilgilerinin yetersiz olduğu görülmüştür. Giderek artan ilaç çeşitliliği (gıda takviyeleri, bitkisel ilaçlar, hedefli ilaçlar ve ek izlemeye tabi ilaçlar gibi), eczacılar tarafından AİR bildirimlerinin önemini artırmaktadır. Eczacıların kapsamlı lisans eğitimi ve çalışma hayatındaki deneyimleri, farmakovijilans sistemine kaliteli AİR raporlama kapasitelerini göstermektedir. Bu bilgiler ışığında makalemiz, özellikle farmakovijilans sisteminde eczacının rolüne vurgu yapılarak hazırlanmış ve eczacılara farmakovijilans uygulamalarına ilişkin bilgi vermek amaçlanmıştır.

Anahtar Kelimeler: Farmakovijilans; eczacı; raporlama; ilaç güvenliliği
ABSTRACT
 Throughout their drug treatments, individuals want their quality of life to continue and/or increase. However, historically, drugrelated tragedies have also made it necessary to take precautions and to systematize this and the concept of pharmacovigilance has emerged. Pre-marketing surveillance and the follow-up of a drug after its release to the market are important for providing effective and safe drug treatments. Because, through the pharmacovigilance system, it is determined that the potential risk of the drug is more than its benefit and radical decisions can be taken, such as termination of marketing approval or temporary cancellation. Therefore, participation in pharmacovigilance activities helps improve drug safety. The reporting of adverse drug reactions (ADRs), a harmful and unintended response in pharmacovigilance systems, is used as an important data source. Pharmacists are the last healthcare professionals with whom patients have contact before starting to use their drug or drugs and the ADR notices of pharmacists, the professional duties of whom has expanded from drug distribution to pharmaceutical counseling, allow drug monitoring in living conditions. Although pharmacists exhibit a positive attitude towards the ADR reporting, it has been observed that their knowledge on the pharmacovigilance system is insufficient. A growing diversity of drugs (such as food supplements, herbal medicines, targeted medicines, and medicines subject to additional monitoring) has increased the importance of ADR notifications by pharmacists. The comprehensive undergraduate education of pharmacists and their experience in business life is indicated their capacity for qualified ADR reporting in the pharmacovigilance system. In the light of this information, our article has been prepared with an emphasis on the role of the pharmacist in the pharmacovigilance system, and it is aimed to give information to pharmacists about pharmacovigilance practices.

Keywords: Pharmacovigilance; pharmacist; reporting; drug safety
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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