WITHDRAWN: Developing an Evidence-Based Policy Note on the Implementation of Pharmacogenomics: A Qualitative-Applied Study

OBJECTIVES: Due to multidimensional nature, numerous stakeholders and uncertainties, pharmacogenomics is associated with implementation-related dynamic challenges. This study, aimed to address these issues and provide solutions through development of a national evidence-based policy-note.

METHODS: This was a qualitative-applied study using soft system methodology. Firstly, a scoping review was conducted on PubMed, ISI, Scopus, Cochrane, and Google Scholar, as well as the gray literature, to identify challenges facing pharmacogenomics adoption from the global perspective. These were categorized into four national drug policy components of efficacy, affordability, access and rational use. In order to review the validity of results in the context of Iran, a focus group using strategic opinion decision analysis method was held and a cognitive map was generated. Challenges were prioritized using multi-criteria decision-making method with structural-interpretive modeling and a conceptual model was developed. Secondary comparative study was used to suggest solutions, using the global experiences and national experts’ feedbacks through a three-rounded Delphi. Results were used to develop a policy-note.

RESULTS: Results indicated the existence of a complex network of dynamic challenges following the implementation of pharmacogenomics in Iran. These challenges, identified via 82 scientific and 103 gray literature articles, included validity and clinical utility of test results as efficacy, price, coverage and health technology assessments as affordability, availability and stakeholders’ management as access and education, development of guidelines, adherence, information technology, establishment and ethical/legal/social issues (ELSI) as rational consumption issues. Among these, the highest penetration index was related to clinical utility of biomarkers and ELSI. The main beneficiary, in form of owner, was identified to be Ministry of Health. Conceptual model was developed and solution strategies were stated in the policy report.

CONCLUSIONS: The present study was the first to investigate the pharmacogenomics adoption complexities and provided solutions to the decision-makers in order to harness its full potential.