Pharmacoeconomy & Pharmacovigilance Of thalassemic patients in Tabriz

Abstract

Beta thalassemia is an autosomal recessive disease, which is inherited with Mendelian rules. It is characterized by absent or braid in both constructive beta chain genes. Besides severe anemia; which is the most important symptom of this disease different signs like facial changes, growth and developmental disturbance are also seen in the patients. Iran is placed on the universal thalassemia belt and has 15,000 beta thalassemia major patients. The main thalassemia treatment is blood transfusion, but in time causes accumulation of excess iron in plasma, which results in sedimentation of iron in many organs and their damage. Deferoxamine mesylate, an iron-chelating agent is used for removing of extra iron from plasma. Because of this disease and its treatments, different side effects such as organs hemosiderosis occur. Because of the untoward side effects and also the treatment itself, thalassemia is considered a costly disease. This study emphasizes on pharmacovigilance and pharmacoeconomy of the treatments in these patients. Patients registered with the thalassemia clinics of Shahid Ghazi and Pediatric hospitals in Tabriz were invited to the study. Those who volunteered were enrolled to the study with no age or sex limitation and were asked to complete a simple questionnaire. The questionnaire was consisted of four sections; the demographic information, the treatments and the cost of treatment and their side effects. The questionnaire were completed by reviewing patients records, direct questions from the patients and also by gathering information from various sources such as pharmacies, laboratories, physicians, blood bank, etc. The data were analyzed by using SPSS (ver. 13) software. Data collection was conducted between August 2008 and July 2009. Hundred Beta-thalassemia major patients attending two hematology centers in Tabriz were enrolled in the study. The median age of subjects was 14.0 ± SD 11.32 (4 months to 65 years), and 43% were female. Number of medications, received by the patients at the time of the study was 3.9 ± SD1.9 (0 – 9 medications). Hemosiderosis of heart (11%) and endocrine system (8%) were reported as main blood transfusion side effects. The costs of blood transfusion (33.58%) and nursing staff (19.29%) were the most costly parts of thalassemia treatment, respectively. The total annual direct cost of a standard therapy for 100 patients added up to €146,621.49 and the indirect cost was € 26430.22. The total annual cost of thalassemia treatment for 100 patients was € 173,051.71. Our study reveals the prevalence of side effects of common therapies in thalassemia patients. This study shows a need for an adverse reactions team in these clinics in order to achieve better therapeutic outcomes. There is a need in reviewing and improving treatment protocols by designing new medicines or using new chelating agents with lower side effects. Currently employed preventative methods in Iran are great but further work is needed for reducing the financial burden of this disease.