A study protocol for exploring and implementing a surgical pharmaceutical service model in drug treatment management for patients with osteoporosis fracture in China.

BACKGROUND

Osteoporotic fractures are serious consequences of osteoporosis, which is a condition that can be prevented through effective therapeutic strategies, including the use of anti-osteoporotic medications. However, a significant treatment gap exists in elderly patients with osteoporotic fractures. A multicenter study conducted in China reported that only 20% of elderly patients with hip fractures received appropriate pharmacotherapy post-fracture. This lack of treatment resulted in an increased risk of refracture associated with osteoporosis. Pharmacist-led interventions have proven essential in medication management for osteoporosis and related fractures, potentially bridging the treatment gap. Accordingly, a protocol was developed to assess the impact of pharmacist-led interventions on increasing the continuation rates of anti-osteoporotic drugs and reducing the risk of refracture in patients with osteoporotic fracture, compared to no interventions (grant number: YCTJ-2023-15).

METHODS AND ANALYSIS

This study is a single-center, prospective, and randomized controlled trial. The targeted participants in this protocol were patients aged above 50 years who had been diagnosed with osteoporotic fractures in China. Eligible participants were randomized into intervention and control groups in a 1:1 ratio using a dynamic stratified block randomization method. The control group received standard care, and the intervention group received standard care combined with pharmacist-led care. The intervention group received comprehensive pharmacist-led interventions, including pharmaceutical ward rounds and medication reconciliation, refracture risk evaluation, recommendations to physicians, patient education, and counseling. A 2-year follow-up was conducted to evaluate the outcomes between groups through telephone interviews, pharmaceutical clinics, and e-hospital pharmacy practice. The primary outcome is the ongoing treatment rates of anti-osteoporotic drugs. The treatment rates are defined as the ratio of patients who remain on anti-osteoporotic medications at each follow-up visit to the total number of enrolled participants. Secondary outcomes include treatment initiation rates, medication adherence, re-fractures, and use of drugs that increase fall risk, the frequency of bone mineral density (BMD) assessments, the incidence of inappropriate medication use, adverse drug reactions (ADRs), and patient satisfaction with osteoporotic fracture treatment. Refracture rates were evaluated through a 2-year follow-up, while BMD were measured at baseline, 1 year, and 2 years using dual-energy X-ray absorptiometry (DXA). ADRs and the inappropriate use of medication were monitored through self-reports and medication reconciliation. Patient satisfaction were assessed using the Treatment Satisfaction Questionnaire for Medication version II (TSQM-II). Ethical approval was obtained from the Committee of Ethics of the First Affiliated Hospital of Shantou University Medical College (approval number: B-2023-194). The statistical analysis was performed using Statistics Package for the Social Science (SPSS), version 23.0.

DISCUSSION

We hypothesize that analyzing pharmacists-led interventions provide valuable insights into how pharmacists improve treatment outcomes for patients with osteoporotic fractures. This study aims to address the existing knowledge gap regarding the effectiveness of pharmacist-led interventions in improving the management of osteoporotic fractures in China.