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

Abstract

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.

Implementation and Use of Risk Evaluation and Mitigation Strategies Programs in Practice: A Scoping Review of the Literature

“…Two full-length manuscripts and one abstract described improvement in compliance with REMS elements for specific medications after customizing existing CDS and computerized physician order entry functionalities in the commercially available EHR (Epic, Verona, Wisconsin, United States). 21,22 One abstract reported a similar result from a previously published intervention 23 that streamlined the ordering process using medication logic modules within the EHR (Allscripts, Chicago, Illinois, United States). The functionalities used included system restriction of ordering based on physician specialty, CDS popup alerts or passive banners within the patient chart (known as Best Practice Advisories or BPAs), order sets/panels, required hard-stop questions embedded within the medication order, and links to medication information and medication use guidelines from the electronic Medication Administration Record (MAR).…”

“…1 depicts the flow of citation identification and study selection. Of the seven studies, 16 17 18 19 20 21 22 three were full-text articles, 18 21 22 and four were conference abstracts. 16 17 19 20 Tables 1 and 2 depict study design and purpose and implemented workflow process changes and outcomes, respectively.…”

“…15,17 The majority of studies were reports of quality improvement projects conducted within medical centers. 21,22 Other strategies include the development of a pharmacy portal to verify REMS enrollment, 18 requiring prescribers to contact dispensing pharmacies to verify order, 20 educating providers and pharmacists, 18,20 and prescriber restriction based on specialty. 21 One study focused on the process of pharmacy claims adjudication 16 to determine the feasibility of integrating health care IT platforms to reduce claims processing time.…”

Optimization of REMS Program Compliance in a Large Academic Health System

“…In addition, it can be hard to clearly see the connection to effectiveness and impact of these programs [4][5][6][7][8] , which hampers buy-in and therefore compliance. 9,10 The Food and Drug Administration (FDA) Amendments Act in 2007 gave the FDA authority to require drug manufacturers to provide additional information, or REMS, to ensure the benefits of using a medication would outweigh the risks, as the FDA deemed appropriate. 2,[11][12][13] These programs vary by medication, but can include any of up to four components: medication guide, elements to assure safe use (ETASU), implementation plan, and communication plan.…”

“…In addition, it can be hard to clearly see the connection to effectiveness and impact of these programs 4 – 8 , which hampers buy-in and therefore compliance. 9 , 10 …”