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Transition Between Two Formulations of Epoprostenol for Injection in Clinical Practice

Lisa Lockhart

R. Baughman

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Conference: 2011 PH Professional Network Symposium

Release Date: 09.22.2011

Presentation Type: Abstracts

L. Taylor Lockhart, RN, BA1 and R. Baughman, MD2
1. The Christ Hospital Pulmonary Hypertension Clinic, Cincinnati, OH
2. University Hospital, Cincinnati, OH

PURPOSE: The aim of this study was to develop a clinical protocol for transitioning patients with pulmonary arterial hypertension (PAH) from epoprostenol sodium (brand name Flolan®) to epoprostenol for injection (brand name Veletri®) in the home setting. Epoprostenol for injection is formulated for expanded stability and will be referred to here as epoprostenol-ES.

BACKGROUND/SIGNIFICANCE: Epoprostenol is the active ingredient in both drug formulations; however, epoprostenol-ES does not require the use of ice packs during drug delivery. Defined protocols for transitioning patients from epoprostenol to epoprostenol-ES have not been developed. Here, we present detailed instructions for such transitions.

METHODS: Twenty-seven patients on epoprostenol underwent a standard protocol to educate them regarding the transition to epoprostenol-ES by the clinic staff and the specialty pharmacy that supplies epoprostenol-ES. The physician's decision to transition a patient was based upon the following: patient drug history with all patients being on epoprostenol for greater than one year, patients' desire for more convenient drug administration, and cost-effectiveness. Patients were transitioned in accordance with the following protocol: (1) patient and RN performed appropriate hand washing; (2) patient and RN collected supplies and assessed expiration dates; (3) repeated step 1; (4) RN instructed and observed during patient mixing of two new epoprostenol-ES product cassettes (one for pump placement, and the other as a backup source); (5) RN confirmed correct dose of epoprostenol-ES, positioned the pump (in STOP mode), and placed and primed the cassette and tubing up to the indwelling catheter (the catheter itself was not primed); (6) patient monitored for two hours post-transition (temperature, pulse, respiration, and blood pressure are determined every 15 minutes for the first hour and then every 30 minutes for the second hour); (7) patient educated on signs of excessive and insufficient epoprostenol-ES dosing. Vital signs were monitored throughout the transition.

FINDINGS: Twenty-seven patients on epoprostenol were identified as candidates for transition to epoprostenol-ES. Twenty-four patients were successfully transitioned; two patients chose not to transition and one patient switched back to epoprostenol following transition. The reason for the switch back was patient preference and familiarity with epoprostenol. Delays in starting epoprostenol-ES were due to the patient's current stock of epoprostenol and the absence of epoprostenol-ES on his or her insurance formulary.

IMPLICATIONS: Using detailed instructions, we were able to safely transition 24 of 27 patients with PAH from epoprostenol to epoprostenol-ES. Future studies are warranted to provide information on transitioning patients to epoprostenol-ES from other parenteral prostanoids such as intravenous or subcutaneous treprostinil and on the long-term outcomes of patients who have been transitioned to epoprostenol-ES.