Pharmacist-led intervention on potentially inappropriate prescription in patients with polypharmacy: PHARM-PC clinical trial protocol.

Jesús Martínez-Sotelo, Manel Pinteño-Blanco, Rosario García-Ramos, Joan Llobera-Cànaves, María Isabel Cadavid-Torres

Polypharmacy and potentially inappropriate medications (that  is, those associated with an unfavorable risk-benefit ratio) are common concerns in the context of elderly patients treated in primary care as they may increase the risk of morbidity and mortality, as well as  healthcare costs. Several studies have assessed the impact of pharmacist- led systematic reviews with respect to prescription appropriateness, health outcomes and/or costs. However, no cluster-randomized controlled  trial has been identified that provides an overall assessment of these  variables. The objective is to determine the effectiveness of a pharmacist- led systematic medication review in reducing the mean number and proportion of patients on potentially inappropriate medications (primary  goal); as well as in decreasing morbidity and mortality and the cost of  medications and the use of healthcare resources (secondary goals). An open-label, cluster-randomized controlled trial will be conducted; where primary care physicians will be randomized either to receive (intervention group) or not to receive pharmacist  recommendations to withdraw potentially inappropriate medications  detected through the combined use of explicit and implicit criteria (control  group). Primary end-points will be the proportion of patients on potentially inappropriate medications and the mean number of such medications per  patient. Secondary endpoints will be healthcare resources used, the  proportion of patients who die and the mean number of days survived, as  well as the cost of medications and cost of healthcare resources used. In line with similar reports and based on our study´s design, we hope to obtain statistically significant reductions in the use  of potentially inappropriate medications and in medication costs overall.  We do not however expect to obtain significant reductions in  morbimortality or the cost of health resources employed.