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Abstract In the developing world, rheumatic fever and rheumatic heart disease (RHD) although less prevalent than they were 50 years ago, are still major health problems. The highest total deaths from RHD were reported from Egypt, Pakistan, Iran, Afghanistan, and Yemen, representing 80% of the total death rates for the Eastern Mediterranean Region (EMR). Rheumatic heart disease has been estimated to affect millions of people, of which, about 20% require heart valve surgery within 5–10 years. Vitamin K antagonists (warfarin is the most widely prescribed agent) are recommended lifelong due to the inherent thrombogenicity of the mechanical valves. Nevertheless, thromboembolic events and anticoagulant-related bleeding account for 70-75% of all complications post-surgery, with high mortality and morbidity rates. Furthermore, warfarin is fraught with several problems such as; variation in dose requirement, delayed onset with prolonged continuation after cessation, serious interactions, and difficulty in maintaining a stable target due to its narrow therapeutic index. Thus, it is still challenging to maintain a safe and efficient treatment with warfarin. Major bleeding, intracranial bleeding, and fatal bleeding are observed in almost 5%, 0.4%, and 1.0%, respectively with warfarin per year. There is growing evidence that the management of anticoagulation by experienced pharmacists can lead to better clinical outcomes which can be reflected in; significantly better international normalized ratio control, significant reductions in emergency department visits, hospitalizations, hospital length of stay, and hospital readmission rates. Pharmacists can enhance PpSummary PhD Thesis 2022 Page. 87 treatment outcomes through several important functions; patients’ education, counseling, and regular follow-up, by which they can motivate and prepare the patients to follow their treatment regimens and monitoring plans. Further, these functions are most effective when carried out in a space or room to offer the opportunity for confidential communication and ensure privacy for patients and their caregivers as well. Numerous pharmacist-managed clinics for chronic diseases, including warfarin therapy management, have been set up in different countries that provide education and counseling for patients. In consequence, cost savings have been well reported due to decreased rates of both adverse events and complications. Thus, this trial-based economic study evaluated both the clinical and the cost-effectiveness of the pharmacist-managed warfarin therapy (PMWT) services in Egypt, and the results revealed a significantly higher median time-in-therapeutic range in the intervention group compared to the control group; 96.8% (IQR 77.9-100%) versus 73.1% (52.7-95.1%), respectively, P= 0.008. A significant association between standard care and poor anticoagulation control (P= 0.021) was demonstrated by the multivariate regression analysis. For the cost-effectiveness analysis, the total cumulative quality-adjusted life years and total costs per patient were 21.53 and 10.43; 436.38 USD and 1242.25 USD in the intervention and control groups, respectively with an incremental cost-effectiveness ratio of -72.5796 for the intervention group. For the one-way sensitivity analyses, the PMWT strategy would become cost-effective rather than cost-saving by a 10% reduction in the probability of remaining within the therapeutic range for the intervention group. So, the conclusion was that the pharmacist-managed warfarin therapy strategy provides a significantly better anticoagulation control and is a cost-saving approach in Egyptian patients with PpSummary PhD Thesis 2022 Page. 88 mechanical mitral valve prostheses. Nevertheless, the dominance of this strategy is sustained by maintaining the therapeutic international normalized ratio control within the recommended range. Several recommendations were highlighted; First, the implementation of the pharmacistmanaged warfarin therapy (PMWT) strategy in different Egyptian institutions is recommended for better anticoagulation control, reducing warfarin-related complications, improving clinical outcomes, and enhancing cost-saving attempts for better allocation of scarce healthcare resources. Further large-scale, multicentre studies with a larger sample size are recommended to investigate the real-world data about the incidence of warfarin-related complications in the Egyptian population, and hence demonstrate the real savings by implementing the PMWT approach. Additional cost-effectiveness evaluation that incorporates the out-of-pocket expenditures and the cost of the international normalized ratio test is recommended to display the potential savings in other costs that are incurred by the patients. Further economic evaluation that demonstrates the budget impact analysis is recommended to reveal the actual savings that could be achieved from a governmental perspective. Finally, further studies are needed to investigate the potential benefits of establishing pharmacist-managed counseling clinics for other chronic diseases |