Saudi Vigilance Program: Challenges and lessons learned.

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program's performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.

Adverse drug reactions; as a cause for admissions to a Children's Hospital

The aim of this study was to investigate the adverse drug reactions [ADR] in pediatrics and determine the predominant symptoms of adverse drug reactions in children. This case series study was carried out at the Bahrami Pediatric Hospital, Tehran where the files of 25 admitted patients with the diagnosis of adverse drug reaction 1998 to 2005 were studied. The average age was 4.6 [ +/- 3.7] years and symptoms of adverse drug reactions were observed 12.6 [ +/- 14.3] days after initiation of the drug intake. Skin rash was seen in all patients more in form of maculopapular rash followed by urticaria. Arthralgia was the next common symptom observed in 44% of patients. The common abnormal laboratory data was high erythrocyte sedimentation rate which was seen in 40% of patients. The most common ingested drugs were phenothiazine and sulfasalazine [each of them seen in 28% of patients] followed by penicillin [16%], furazolidone [16%], cephalosporins [4%] and valproic acid [4%]. In 28% of patients poly-pharmacy was responsible for ADR. Awareness of the problem, observation of poly-pharmacy and potential drug-drug interactions, and continuous re-evaluation of the ongoing individual pharmacotherapy is important, especially in children, to reduce ADRs