Interventional effect of off-label use of alprostadil lipid microsphere injection in neurosurgical patients: a before-after study

Abstract

Background As adjuvant drug, alprostadil lipid microsphere injection (Lipo-PGE1) is one of the highest-selling classes of drugs in China in recent years and the off-label use of Lipo-PGE1 is very common. To investigate the situation of the use of alprostadil lipid microsphere injection (Lipo-PGE1) and evaluate the clinical and economic impacts of administrative intervention in reducing inappropriate use of Lipo-PGE1 in neurosurgical patients in a Chinese tertiary hospital. Methods: A self-control study before and after an intervention of patients receiving Lipo-PGE1 was performed in the Department of Neurosurgery of the Affiliated Hospital of Southwest Medical University. Administrative interventions were implemented from January to December 2018, including reducing the volume of procurement of Lipo-PGE1, judging the rationality of medical records, establishing reward and punishment mechanism. The effects of administrative interventions on utilization and expenditure of Lipo-PGE1 were analyzed. Then patients admitted from January to December 2017 and from January to December 2018 were randomized extracted and then served as the pre-intervention and the post-intervention group for appropriateness analysis. Results: Administrative interventions significantly decreased prescribing rate (49.98% vs 22.49%), utilization (22311DDDs vs 8334 DDDs), drug use density (43.52 DDDs/TID vs 15.84 DDDs/TID), total cost (3.58 million CNY vs 1.30 million CNY) and average cost (2025.04 CNY vs 1466.49 CNY) of Lipo-PGE1 for all patients in neurosurgery. After administrative interventions, the rate in the use of no indications for Lipo-PGE1 and in the cases of inappropriate drug dose, frequency, menstruum type, combination and contraindications significantly decreased in cases collected (P < 0.05 or P < 0.001), yet the percentage of cases adhering to all the criteria was zero. Moreover, significant reductions were found in the average usage quantity (P=0.008), mean cost (P<0.001) and mean duration (P < 0.001) of Lipo-PGE1. Conclusion: As adjuvant drug, the off-label use of Lipo-PGE1 is very common in neurosurgery. The results from simple administrative intervention are unsatisfied. Combination of administrative intervention and clinical pharmacist real-time intervention should be introduced.