CANH GIAC DUOC – Nghiên cứu khoa học

Safety signal detection from Vietnamese spontaneous adverse drug reaction reporting system for several high-cost drugs covered by Vietnam health insurance fund = Tín hiệu an toàn của các thuốc có chi phí Bảo hiểm y tế cao nhất năm 2016: phân tích từ cơ sở dữ liệu báo cáo ADR tại Việt Nam

Luận văn Thạc sĩ Dược học tại Trường Đại học Toulouse III, Pháp.

Background: Irrational drug use causes many significant problems such as waste of money, uneffective treatment, an increase in the number of patients with ADRs. In the specific sociological context of Vietnam, the study aims to describe and quantify the noticeable ADRs relating to 41 high-cost drugs in the list of drugs of Vietnam health insurance fund using the National Pharmacovigilance Database of Vietnam.

Methods: Spontaneous reporting of adverse drug reactions (ADRs) recorded in the period of 2010 – 2016 were retrospectively analysed to identify reports of 41 high-cost drugs. Characteristics of ADR reports relating to these drugs were described. Disproportionality analysis was used for signals generation.

Results: Of the 38,521 ADR reports from healthcare units in the period of 2010 – 2016, 36,792 reports had ADR causality for suspected drugs. ADR reports of 40/41 drugs in the list were recorded except for glycyrrhizin/glycine/L-cysteine combination. Reports relating to antibiotics, especially cephalosporins were predominant. In addition to high-risk agents which were widely known causing anaphylaxis such as β-lactams and anti-cancer agents (paclitaxel, oxaliplatin), there were some important signals relating to methylprednisolone (ROR= 1.98 [1.03-3.78]), piracetam (ROR= 2.26 [1.34-3.82]), chymotrypsin (ROR= 1.70 [1.25-2.31]), glutathione (ROR= 4.02 [1.82-8.85]) and L-ornithine L-aspartate (ROR= 1.80 [1.11-2.92]). Ciprofloxacin and levofloxacin had significantly high incidence rates of application site reactions, which were 23.4%, ROR= 14.77 [12.78-17.08] and 23.8%, ROR= 12.83 [10.73-15.34] respectively. SCAR signals relating to cefixime (ROR= 7.58 [4.08-14.07]) and paracetamol (ROR= 3.46 [2.31-5.17]), and arthralgia, hepatitis signals relating to levofloxacin (ROR= 3.89 [2.09-7.22] and 2.72 [1.19-6.22] respectively) were also generated.

Conclusion: In spite of some limitations of spontaneous ADR reporting system, the finding released necessary results for drug safety in specific context of Vietnam. This study also confirmed that routine analysis of database plays an essential role in timely identifying potential risks as well as providing proper management and enhancing effective communication.