Title of article :
pharmacogenomics implementation and hurdles to overcome; in the context of a developing country
Author/Authors :
ayati, nayyereh tehran university of medical sciences (tums) - faculty of pharmacy - department of pharmacoeconomics and pharmaceutical administration, tehran, iran , afzali, monireh tehran university of medical sciences (tums) - faculty of pharmacy - department of pharmacoeconomics and pharmaceutical administration, tehran, iran , hasanzad, mandana islamic azad university, tehran medical sciences branch - medical genomics research center, tehran, iran , hasanzad, mandana tehran university of medical sciences - personalized medicine research center, endocrinology and metabolism clinical sciences institute, tehran, iran , kebriaeezadeh, abbas tehran university of medical sciences (tums) - faculty of pharmacy - department of pharmacoeconomics and pharmaceutical administration, department of toxicology and pharmacology, tehran, iran , rajabzadeh, ali tarbiat modares university - faculty of management and economics - department of industrial management, tehran, iran , nikfar, shekoufeh tehran university of medical sciences (tums) - faculty of pharmacy, personalized medicine research center, endocrinology and metabolism clinical sciences institute - department of pharmacoeconomics and pharmaceutical administration, tehran, iran
Abstract :
having multiple dimensions, uncertainties and several stakeholders, the costly pharmacogenomics (pgx) is associated with dynamic implementation complexities. identification of these challenges is critical to harness its full potential, especially in developing countries with fragile healthcare systems and scarce resources. this is the first study aimed to identify most salient challenges related to pgx implementation, with respect to the experiences of earlyadopters and local experts’ prospects, in the context of a developing country in the middle east. to perform a comprehensive reconnaissance on pgx adoption challenges a scoping literature review was conducted based on national drug policy components: efficacy/safety, access, affordability and rational use of medicine (rum). strategic option development and analysis workshop method with cognitive mapping as the technique was used to evaluate challenges in the context of iran. the cognitive maps were face-validated and analyzed via decision explorer xml. the findings indicated a complex network of issues relative to pgx adoption, categorized in national drug policy indicators. in the rational use of medicine category, ethics, education, bench -tobedside strategies, guidelines, compliance, and health system issues were found. clinical trial issues, test s utility, and biomarker validation were identified in the efficacy group. affordability included pricing, reimbursement, and value assessment issues. finally, access category included regulation, availability, and stakeholder management challenges. the current study identified the most significant challenges ahead of clinical implementation of pgx in a developing country. this could be the basis of a policy-note development in future work, which may consolidate vital communication among stakeholders and accelerate the efficient implementation in developing new-comer countries.
Keywords :
pharmacogenomics , precision medicine , dynamic challenges , policy note , regulatory framework , developing countries , iran
Journal title :
Iranian Journal of Pharmaceutical Research(IJPR)
Journal title :
Iranian Journal of Pharmaceutical Research(IJPR)