Adverse Reactions & Pharmacovigilance

Spontaneous Reporting

TRSpontan Bildirim
Also known as:Spontaneous reporting system · Passive surveillance

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.

In depth

Spontaneous reporting is the backbone of post-marketing surveillance: it covers all marketed drugs and the whole treated population throughout a product's life at low cost, and is particularly effective for detecting rare, unexpected (type B) reactions. National reports are pooled internationally in the WHO database VigiBase; in Turkey they are collected by TÜFAM.

Its main limitations are substantial under-reporting, variable report quality and reporting biases, such as increased reporting after publicity or soon after launch. Because the number of exposed patients (the denominator) is unknown, spontaneous reports cannot provide incidence rates; they generate signals that must be tested in analytical studies.

Clinical pearl

A report should be submitted even when causality is uncertain; the most useful reports state the suspected drug, concomitant medicines, time to onset, dechallenge or rechallenge and outcome.

TRIn Turkish

Spontan Bildirim

Şüphelenilen advers ilaç reaksiyonlarının, bir çalışma kapsamında talep edilmeksizin, başta sağlık meslek mensupları ve hastalar olmak üzere bildirenler tarafından ulusal farmakovijilans merkezine veya ruhsat sahibine iletilmesidir.

Spontan bildirim pazarlama sonrası sürveyansın temelidir: tüm ruhsatlı ilaçları ve tedavi edilen popülasyonun tamamını ürünün piyasadaki ömrü boyunca düşük maliyetle kapsar ve özellikle seyrek, beklenmeyen (tip B) reaksiyonların saptanmasında etkilidir. Ulusal bildirimler uluslararası düzeyde DSÖ'nün VigiBase veri tabanında birleştirilir; Türkiye'de bildirimler TÜFAM tarafından toplanır.

Başlıca sınırlılıkları belirgin eksik bildirim, bildirim kalitesinin değişkenliği ve medyada yer alma sonrasında ya da ürünün piyasaya çıkışını izleyen dönemde artan bildirim gibi yanlılıklardır. Maruz kalan hasta sayısı (payda) bilinmediğinden spontan bildirimlerden insidans hesaplanamaz; bu bildirimler analitik çalışmalarla sınanması gereken sinyaller üretir.

Nedensellik belirsiz olsa bile bildirim yapılmalıdır; en yararlı bildirimler şüpheli ilacı, eş zamanlı kullanılan ilaçları, başlangıca kadar geçen süreyi, ilacın kesilmesine veya yeniden verilmesine yanıtı ve sonucu içerir.

Diğer adları:Kendiliğinden bildirim · Spontan raporlama
Updated 24.09.2026 0 views Educational reference — verify against current sources before clinical use.

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PharmacovigilanceFarmakovijilans

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

 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.

 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.

 Serious Adverse EventCiddi Advers Olay

An adverse event that results in death, is life-threatening, requires or prolongs hospitalisation, causes persistent or significant disability, is a congenital anomaly, or is otherwise medically important.

 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.

 Naranjo AlgorithmNaranjo Algoritması

A 10-item questionnaire that estimates the probability that an adverse event was caused by a drug, classifying the relationship as definite, probable, possible or doubtful.