Duygun ALTINTAŞ AYKAN, Hülya NAZİK, Yusuf ERGÜN

Advers İlaç Reaksiyonları Spontan Bildirimlerinin Değerlendirilmesi: Klinik Farmakoloji Deneyimimiz

ÖZ GİRİŞ ve AMAÇ: İlaçlar ruhsatlandırılmadan önce deney hayvanlarında ve gönüllü insanlarda denenmelerine rağmen, güvenlilik profilleri tam olarak tanımlanmamış olabilir. Bu nedenle advers ilaç reaksiyonları (AİR)’nın spontan bildirilmesi, daha önce saptanamamış AİR’nin raporlanmasında ve gerekli önlemlerin alınmasında önem taşır. Bu çalışmada, Farmakovijilans İrtibat Noktası’na AİR ile ilgili yapılan spontan bildirimler değerlendirilmiştir. YÖNTEM ve GEREÇLER: 2015-2017 yılları arasındaki spontan bildirimlerde yer alan 45 hastanın verileri incelendi. Birinci kısımda hastanın demografik bilgileri, ikinci kısımda AİR’nin tanımı, ilişkili laboratuvar tetkikleri, AİR’nin sonucu, etkinin ciddiyet kriterleri ve hastanın özel durumları kaydedildi. Üçüncü kısımda ilacın jenerik ve ticari adı, veriliş yolu, günlük dozu, intervali, ilaç maruziyet tarihi ve endikasyonu yazıldı. Dördüncü kısımda raporlayan bireyin bilgileri kaydedildi. BULGULAR: Çalışmadaki AİR spontan bildirim dönemlerinin iki hastada 2015 yılı, 18 hastada 2016 yılı ve 25 hastada 2017 yılı içinde olduğu saptandı. AİR %48,9 oranında makülopapüler erüpsiyon, %22,2 ürtiker ve/veya anafilaksi, % 15,6 kırmızı boyun sendromu, %4,4 çarpıntı, %2,2 DRESS (eozinofili ve sistemik semptomlarla izleyen ilaç reaksiyonu) sendromu, %2,2 kaşıntı, %2,2 konuşma bozukluğu ve %2,2 titreme olarak saptandı. Reaksiyonlar %95,6 iyileşme, %2,2 advers etkinin devam etmesi ve %2,2 ölüm ile sonuçlandı. Tüm vakaların %75,6’sı ciddi olmayan, %24,4’ü ise ciddi AİR olarak rapor edildi. TARTIŞMA ve SONUÇ: AİR spontan bildirim formunda yer alan her bir parametre, nedensellik ilişkisini kuvvetlendirmesi açısından önemlidir. Ülkemizde spontan bildirimlerin yıllara göre artış eğiliminde olması farmakovijilans farkındalığının artmakta olduğunu göstermekle birlikte, raporlama işleminin gelişmiş ülkelere göre yaygın olmaması dikkat çekicidir.

Evaluation of Spontaneous Statements of Adverse Drug Reactions: Our Clinical Pharmacology Experience

ABSTRACT INTRODUCTION: Although drugs are tested in animals and volunteers before they are licensed, safety profiles may not be fully defined. Therefore, reporting of adverse drug reactions (ADR) is important in previously unrecognized ADR and taking necessary precautions. In this study, spontaneous ADR to Pharmacovigilance Contact Point were evaluated. METHODS: The data of 45 patients between 2015-2017 were included. First part included patients’ demographic data, second part included information about ADR, the related laboratory tests, outcome of ADR, severity of the effect and special issues of the patient. In the third part, drugs’ generic and commercial names, route of administration, daily dose, interval, drug exposure date and indications were recorded. In the fourth part, information of the reporting individual was recorded. RESULTS: We found that two patients in 2015, 18 patients in 2016 and 25 patients in 2017 were reported as ADR. Reactions were 48.9% maculopapular eruption, 22.2% urticaria and/or anaphylaxis, 15.6% red neck syndrome, 4.4% cardiac palpitations, 2.2% DRESS (drug reaction with eosinophilia and systemic symptoms), 2.2% itching, 2.2% speech impairment and 2.2% tremor. 95.6% of reactions resulted in improvement, 2.2% continued adverse effect and 2.2% resulted in death. 75.6% of all cases were reported as non-serious, while 24.4% were reported as severe. DISCUSSION and CONCLUSION: Each parameter in ADR form is important in strengthening the causality. Spontaneous reports in our country tend to increase indicates that awareness of pharmacovigilance is increasing, but it is noteworthy that reporting process is not as common as the developed countries

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