A Retrospective Analysis of Adherence to Risk Evaluation and Mitigation Strategies Requirements for Pulmonary Arterial Hypertension Drugs

Purpose: The purpose of this quality-improvement project was to assess risk evaluation and mitigation strategies (REMS) program compliance for pulmonary arterial hypertension (PAH) drugs following the initiation of more rigid protocols and informatics changes. The primary objective of the study was to determine the effects of these changes on overall compliance of the REMS program requirements. Method: This was a single-center, retrospective evaluation of protocols and informatics updates that were developed to increase compliance with REMS programs for four drugs used to treat PAH. Two separate time periods were examined for comparison: the preinformatics period, January 2015 to February 2016, and the postinformatics period, October 2016 to April 2017. To be included in the study, patients must have been at least 18 years of age and have been ordered one of the following agents: riociguat, macitentan, bosentan, or ambrisentan. Results: Overall, 94 patients were evaluated with 50 in the preinformatics group and 44 in the postinformatics group. The overall mean age of included patients was 55 years, 57.9% of patients were white, 69.1% were female, and 43.6% were prescribed ambrisentan during the study period. The primary composite endpoint of adherence to REMS protocol (pregnancy tests performed within 30 days of medication initiation for female patients of childbearing potential, liver function tests [LFTs] ordered within 30 days of bosentan initiation, and initiation of therapy order documented by an attending provider enrolled in the REMS program) showed an overall improvement in the postinformatics period, 95% vs 71% ( P = .07).There was a statistically significant increase in pregnancy tests performed within 30 days of medication order in the postinformatics period (36.4% vs 100%; P = .01). Furthermore, during the postinformatics period, the number of documented interventions (iVents) performed by a pharmacist was 90.9%. Conclusion: Initiation of more rigid ordering protocols for the endothelin receptor antagonists (macitentan, bosentan, or ambrisentan) and riociguat improved pharmacist and physician compliance with REMS requirements.