Impact of a community pharmacy-based medication therapy management program on clinical and humanistic outcomes in patients with uncontrolled diabetes: a randomised controlled trial

Abstract

This study was aimed to evaluate the impact of community pharmacy (CP)-based medication therapy management (MTM) program on clinical and humanistic outcomes in patients with uncontrolled diabetes. An open label, parallel-group randomised controlled trial was undertaken at a community pharmacy in Riyadh city, Kingdom of Saudi Arabia. Patients with a diagnosis of uncontrolled diabetes (HbA1c of ≥ 8%) meeting the eligibility criteria were randomised to receive either the MTM programme provided by pharmacists or standard care. The primary outcome was change in HbA1c over 6 months. Secondary outcomes included: changes in clinical parameters (blood pressure (BP), lipid profile, serum creatinine (SCr) and albumin-to- creatinine ratio (ACR)), types of drug-related problems (DRPs), health service utilization (HSU), adherence, diabetes distress and overall patient satisfaction with the service at 6-month. A sufficiently powered sample of 160 participants with a mean age was 50 years (SD ± 11.9) was recruited. The majority of the patients (68.1%) were male and had diabetes for more than eight years [IQR 3, 14]. After adjusting for baseline HbA1c, compared to the control group, the mean HbA1c level was 0.02% (p = 0.929) and 0.2% (p = 0.47) lower in the intervention arm at 3-month and 6-month respectively. However, these differences were not statistically significant. Nonetheless, within each arm, there was a significant improvement in HbA1c from baseline. Furthermore, the intervention arm demonstrated improvement in BP control (SBP lowered by 3.2 mmHg (p = 0.05) and DBP lowered by 3.8 mmHg (p = 0.008)). During the study period, none of the participants in the intervention group reported hospitalization or ER visits compared to 14 patients in the control group [OR 0.069 (95% CI 0.004, 1.3)]. Patient satisfaction as measured by Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) was significantly higher among MTM program participants compared to standard care (p = 0.00001). Patients in the MTM program were eight times more likely to be adherent compared to the patients in the standard care [OR 7.89 (95% CI 3.6, 17.4)]. MTM program metrics showed that per patient, the pharmacists spent a median of 35 [IQR 30, 44.5] minutes at the initial visit and 20 [IQR 10, 25] minutes during the 6-month visit. The number of DRPs had significantly dropped in the intervention arm at 3 and 6-month (p = 0.0001). In conclusion, CP-based MTM program can improve health outcomes and prevent hospitalisations in patients with diabetes. These findings support the implementation of CP-based MTM services for patients with diabetes in the Kingdom of Saudi Arabia.

Keywords: Community pharmacy; Medication review program; Pharmacist; Randomized controlled trial.

Figure 1

Consort flow diagram of the study design.

Figure 2

Clinical outcomes (primary) result for both trial groups across trial visits.

Figure 3

Clinical outcomes (secondary) result for both trial groups across trial visits. (a) Mean Systolic blood pressure results for both trial groups across trial visits. (b) Mean diastolic blood pressure results for both trial groups across trial visits. (c) Mean low-density lipoproteins results for both trial groups across trial visits. (d) Median triglyceride results for both trial groups across trial visits. (e) Mean total-cholesterol results for both trial groups across trial visits. (f) Median serum creatinine results for both trial groups across trial visits. (g) Median Albumin-to- creatinine ratio results for both trial groups across trial visits.

Figure 4

DRPs in the MTM program over baseline, 3-month and 6-month follow up.

Figure 5

Adherence, Diabetes Distress and Patient Satisfaction results for both trial groups across trial visits. (a)Median Reported adherence using MARS-5 Q for both trial groups across trial visits. (b) Median Reported distress using DDQ for both trial groups across trial visits. (c) Participant satisfaction with pharmacist services at six-month follow-up.