Medication review with follow-up service by community pharmacists forpatients under treatment with coumarin anticoagulants in collaboration with Primary Care

Abstract Introduction: Anticoagulation treatment with VKA presents an optimal risk-benefit balance in patients with a Time in Therapeutic Range (TTR) >70%. Pharmacist integration in the primary health care team, using innovative tools such as the SAME-TT2R2 and pharmacogenetics information, could enhance the management of anticoagulated patients. This study aims to assess the effectiveness of a medication review with follow up service by community pharmacists, in collaboration with Primary Care for patients treated with VKA. Methods and analysis: A randomized controlled study with blinded outcome assessment will be conducted. Patients treated with VKA with TTR<70% from 2 health care centres will be included. Primary outcome is TTR during last 6 months. Secondary outcomes will be: adherence, vitamin K intake, patient’s knowledge, pharmacogenetics and SAME-TT2R2’s clinical utility, costs, quality of life and satisfaction. Potential clinical, economic, and humanistic impact of the interventions will be retrospectively analysed using CLEO tool. Intervention group will receive a medication review with follow up, physicians will receive an evidence-based report patient´s medicine-related problems, genetic and clinical limitations for the use of VKA. Patients will be followed for 6 months. Sample size: 130 patients will be recruited for 90% power based on the most conservative scenarios. Multivariate, cost-effectiveness analyses will be used. Ethics and dissemination: The study design was approved by the ethical committee of Aragon. The trial is registered at Clinical Trials.gov dated 25/05/2017: NCT03154489. Trial results will be published in peer-reviewed journals and at conferences.