The Pulmonary Hypertension Association (PHA) continues its effort to improve safety protocols known as Risk Evaluation and Mitigation Strategies (REMS) for certain pulmonary hypertension (PH) drugs. The Food and Drug Administration requires REMs protocols for medications with known risks of serious complications, such as liver failure or birth defects.
PHA is talking with the Bosentan REMS Group after successfully working with the Ambrisentan REMS Consortium to merge two Ambrisentan REMS programs. PHA advocated for the merge and other safety improvements after engaging patients and health care professionals.
The Bosentan recommendations focus on improvements to decrease medication delivery delays. Jeffery Sager, M.D., Juliana Liu, R.N., and members of PHA’s Scientific Leadership Council, based the recommendations on their clinical experience and a stakeholder survey PHA conducted in the spring.
Conversations with the Bosentan REMS Group and Ambrisentan REMS Consortium are ongoing as part of PHA’s efforts to advance quality PH care and advocate on behalf of the PH community.