A Conceptual model on the pharmacogenomics implementation complications: An applied qualitative research based on national drug policy components

Pharmacogenomics may well have substantial effects on the clinical, economic and regulatory aspects of health sector; which can lead to complications in access. Therefore, there is a need for evidence-based frameworks based on national drug policy components. The objective of the current study is to identify pharmacogenomics-based complications and develop a conceptual model.

The current, is an applied-quantitative study using soft system methodology. The first step adopted scoping review with systematic-search to identify early-adopters experiences. The second used cognitive mapping technique with strategic options development and analysis method using expert panels to assess the relativeness of the challenges and evaluated influence with interpretive structural modeling. In addition, stakeholder mapping was conducted using semi-structured questioners. The third step is used to develop the conceptual model.

Systematic search acknowledged 82 studies for qualitative analysis on the challenges. The identified challenges, which were confirmed by the experts subsequently, were clinical trial protocols, clinical utility of tests and identifying biomarkers in the efficacy/safety component, pricing, coverage and economic assessment in the affordability component, regulations, availability and stakeholders management in the access component and education, guidelines, patient compliance, information technology, bench-to-bedside strategies and ethical/legal/social hazards in the rational use of medicine component. The most influential issue was biomarker validity. The main stakeholder, as the owner and customer, was identified to be the ministry of health. All the results were included in the complicated conceptual model.

The current, was the first study identifying dynamic complications ahead of pharmacogenomics adoption, using soft system methodology. The results may be the basis of the first evidence-based policy on pharmacogenomics, in Iran and other developing countries.