Pharmacist-led intervention in iron overloaded children with beta thalassemia major

Abstract

Thalassemia is one of the most common genetic disorders worldwidewith high occurrence in the “thalassemia belt” extending from the Mediterranean basin through the Middle East to Southeast Asia. Most of pediatric thalassemic patients are born in low-income countries where it was reported that 50,000 – 100,000 beta-thalassemia major (BTM) children die each year in low and middle income countries. Beta-Thalassemia is considered to be the most frequent hemoglobinopathy in Egypt with a carrier rate ranging from 5.3 to ≥ 9% and gene frequency of 0.03. Every year, the estimated number of live births born with beta-thalassemia is 1,000/1.5 million. Iron overload is one of the major complications in beta-thalassemia major (BTM) patients arising from obligatory lifelong transfusions of packed red blood cells (RBCs), ineffective erythropoiesis and increased gastrointestinal iron absorption. Iron overload places the patient at high risk to delayed sexual and physical maturation, liver and heart diseases and reduced life expectancy. Although iron chelation therapy is considered the rescue medication for these patients, it's misperceived by most of the patients. Many Iron chelation therapy (ICT)-related issues act as obstacles to its successful use like; the lifelong need to its use, unpleasant administration, poor side effect profile and lack of patient awareness regarding iron overload risks. Clinical pharmacy service aims to provide comprehensive medication management that optimizes patient outcomes. Many studies emphasized the positive impact of implementing clinical pharmacy services in various clinical settings on patient outcome and detecting drug-related problems (DRPs). DRPs, include all the issues that may interfere with the success of pharmacotherapy, are closely linked to reduced clinical benefits of treatment and poor patient outcome. It was suggestedthat inadequate pharmacy services may be one of the risk factors contributing to the occurrence of DRPs. Till today, no reported studies have assessed the occurrence of DRPs in pediatric BTM patients. The aim of this study was to address DRPs that may arise in iron overloaded pediatric BTM patients and to investigate the impact providing clinical pharmacy services to these patients. The study was a prospective, randomized controlled study carried out on pediatric BTM patients at the Pediatric Hematology Clinic, Children's Hospital, Ain Shams University. It was conducted from November 2014 to July 2015 for a 6-month period of follow-up. A total of 48 patients were assigned to either the control or the intervention group. The control group (n=24) received standard medical care byphysician while the intervention group received standard medical care plus clinical pharmacist-provided services. For the 6-month period of the study, all the patients were assessed each 3 months for SF levels, serum creatinine (SCr) and alanine transaminase (ALT). Also, patient quality of life(QoL) and healthcare satisfaction were assessed at baseline and after 6 months at the end of the study using PedsQL™ 4.0 Generic Core Scales and PedsQL™ Healthcare Satisfaction Hematology / Oncology Module respectively. After 6 months of study implementation, a highly significant difference between the 2 groups (control vs intervention) was found in; • SF levels (Mean: 3871 µg/l vs 2362 µg/l, p=0.0042). • Patient satisfaction using PedsQL™ Healthcare Satisfaction Hematology / Oncology Module (Median: 24.47 vs 90.29, p<0.0001). • Patient health-related quality of life using PedsQL™ 4.0 Generic Core Scales (Median: 49.84 vs 63.5) In the intervention group, comparing baseline to the end of study showed that; • Drug-related problems decreased from 64 to 4. • Number of non-compliant patients decreased from 24 to 3. • Serum ferritin levels significantly decreased (Mean: 3949 µg/l vs 2362 µg/l, p<0.0001). PedsQL™ healthcare satisfaction total scores showed an extremely significant correlation with serum ferritin levels (rs= -0.4204, p <0.0001).

Conclusion: After 6 months of clinical pharmacist intervention, there was an improvement in patient compliance to iron chelators, serum ferritin levels, patient healthcare satisfaction & health-related quality of life. Recommendations: Enrollment of a clinical pharmacist as an integral member of the healthcare team of BTM children can positively impact the clinical outcome of BTM children.