Adverse Reactions & Pharmacovigilance

Pharmacovigilance PV

TRFarmakovijilans
Also known as:Drug safety surveillance · Drug safety monitoring

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (WHO definition).

In depth

Pre-marketing trials are too small and too short, and enrol too selected populations, to detect rare, delayed or subgroup-specific reactions, so safety knowledge keeps accumulating after authorisation. Pharmacovigilance systems combine spontaneous reporting, periodic safety update reports, risk management plans, post-authorisation safety studies and signal detection in large databases such as the WHO global database VigiBase.

In Turkey, pharmacovigilance is overseen by TİTCK through the Turkish Pharmacovigilance Centre (TÜFAM), which collects reports from healthcare professionals, patients and marketing authorisation holders. Holders must operate a pharmacovigilance system with a responsible qualified person, and regulatory outcomes include KÜB/KT changes, restrictions of use, additional risk-minimisation measures or suspension or withdrawal of the marketing authorisation (ruhsat).

Clinical pearl

Pharmacovigilance findings reach practice through revised KÜB/KT texts and safety communications, so prescribing and counselling should rely on the current KÜB rather than an old printed copy.

TRIn Turkish

Farmakovijilans

Advers etkilerin veya ilaçla ilgili diğer sorunların saptanması, değerlendirilmesi, anlaşılması ve önlenmesine yönelik bilim ve faaliyetlerin bütünüdür (DSÖ tanımı).

Ruhsat öncesi araştırmalar, seyrek, gecikmiş veya alt gruplara özgü reaksiyonları saptamak için fazla küçük ve kısa sürelidir ve seçilmiş popülasyonlarla sınırlıdır; bu nedenle güvenlilik bilgisi ruhsattan sonra da birikir. Farmakovijilans; spontan bildirimi, periyodik güvenlilik güncelleme raporlarını, risk yönetim planlarını, ruhsat sonrası güvenlilik çalışmalarını ve DSÖ'nün VigiBase'i gibi büyük veri tabanlarında sinyal saptamayı birleştirir.

Türkiye'de farmakovijilans TİTCK bünyesindeki Türkiye Farmakovijilans Merkezi (TÜFAM) tarafından yürütülür; TÜFAM sağlık meslek mensupları, hastalar ve ruhsat sahiplerinden bildirim alır. Ruhsat sahipleri, farmakovijilans yetkilisi bulunan bir farmakovijilans sistemi işletmekle yükümlüdür; düzenleyici sonuçlar arasında KÜB/KT değişiklikleri, kullanım kısıtlamaları, ek risk minimizasyon önlemleri ve ruhsatın askıya alınması veya iptali yer alır.

Farmakovijilans bulguları uygulamaya güncellenmiş KÜB/KT metinleri ve güvenlilik duyuruları aracılığıyla yansır; bu nedenle reçeteleme ve hasta danışmanlığında eski basılı kopyalar yerine güncel KÜB esas alınmalıdır.

Diğer adları:İlaç güvenliliği izlemi
Updated 24.09.2026 1 views Educational reference — verify against current sources before clinical use.

Read next

Adverse Drug ReactionAdvers İlaç Reaksiyonu

A noxious and unintended response to a medicinal product in which a causal relationship with the drug is at least a reasonable possibility.

 Spontaneous ReportingSpontan Bildirim

The unsolicited submission of reports of suspected adverse drug reactions, mainly by healthcare professionals and patients, to a national pharmacovigilance centre or to the marketing authorisation holder.

 Safety SignalGüvenlilik Sinyali

Information from one or more sources suggesting a new potentially causal association, or a new aspect of a known association, between a medicine and an event, judged sufficient to justify verification.

 Phase IV StudyFaz IV Çalışma

A study conducted after a medicine has received marketing authorization to gather further information on its safety, effectiveness and optimal use, or on its use in populations and settings not studied before approval.

 Marketing AuthorizationRuhsat

The license granted by a competent regulatory authority that allows a medicinal product to be placed on the market, based on assessment of its quality, safety and efficacy for defined indications and conditions of use.

 Summary of Product CharacteristicsKısa Ürün Bilgisi

The regulator-approved document that sets out the properties and authorized conditions of use of a medicinal product for healthcare professionals, forming the legal basis of its prescribing information.