Community pharmacist intervention to enhance adherence in patients initiating cardiovascular medication: the PHARM-ADHERE randomized controlled trial

Background Poor adherence to cardiovascular (CV) medication is common and significantly contributes to CV morbidity and mortality. The initiation phase is particularly critical, as many patients discontinue key medications within the first year after initiation. Purpose We aimed to investigate whether additional community pharmacist guidance for patients starting CV medication will improve adherence. Methods A pragmatic 12-week randomized controlled trial was conducted in 204 community pharmacies in Belgium, enrolling adults filling a first prescription for first-line treatments of hypertension, hyperlipidaemia or type 2 diabetes. Patients were randomized 1:1 to usual pharmacist care or a predefined pharmacist intervention, including protocolled first prescription counselling (patient education and guidance on integrating medication into daily routine) and a follow-up consultation to proactively tackle adherence issues. Primary outcome was self-reported adherence (using PROMIS Medication Adherence Scale, PMAS). Secondary outcomes were: adherence rate based on dispensing data (using Proportion of Days Covered, PDC), discontinuation rate, patient’s knowledge and beliefs about their medication, clinical response and healthcare utilization. Results In total, 883 patients were enrolled with a mean age of 62.6 years (SD: 13.0) and 55.2% were female. Over half of patients (54.0%) were initiated on an antihypertensive, 36.4% on a lipid-lowering drug and 9.6% on an antidiabetic. About a quarter (25.7%) had a history of a CV event and 18.9% had diabetes. At 12 weeks, self-reported adherence was high among patients still taking the initial medicine in both study groups (median PMAS score of 44), with no significant between-group difference. In the intervention group 80.0% of participants were adherent according to PDC (PDC≥80%) compared to 73.3% in the control group (p<0.05). At 12 weeks, 17.4% of intervention group patients had discontinued treatment compared to 23.6% in the control group (p<0.05). Half of the discontinuers (50.7%) stopped their treatment because of side effects. The remaining secondary outcomes will be presented at the congress. Conclusions Although self-reported adherence showed no significant difference between the control and intervention groups, the community pharmacist intervention improved early adherence to CV medication, as indicated by higher PDC and lower discontinuation rates.