[Prescription appropriateness in elderly patients with polypharmacy in primary care: Cluster-randomized controlled trial PHARM-PC].

OBJECTIVES

To assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs.

DESIGN

Prospective, open, controlled and cluster-randomized clinical trial.

SETTING

Six primary care clinics from Balearic Islands.

PARTICIPANTS

Forty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care.

INTERVENTION

PIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician.

MEASUREMENTS

Proportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed.

STATISTICAL PLAN

Following an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI).

RESULTS

After intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources.

CONCLUSIONS

PIM detection and recommendations provided by pharmacist could contribute to reduce significantly PIM and drug expenditure; but without reaching statistically significant differences in morbidity, mortality, and healthcare resources costs.