Scientific Poster Session II - Clinical Pharmacy Forum

Abstract

Jynarque (tolvaptan) is the only FDA approved medication for the treatment of Autosomal Polycystic Kidney Disease (ADPKD). Due to risk of liver injury, adherence to a Risk Evaluation and Mitigation Strategy (REMS) involving routine liver function test monitoring is required. Additionally, the medication is only available through a restricted distribution program. Designated Jynarque specialty pharmacies ensure that prescribers document REMS adherence prior to dispensing, however, the burden of collecting and reviewing laboratory data falls on the prescriber. Although our institution’s specialty pharmacy performs monitoring services for medications they dispense, they are not permitted to dispense Jynarque given the limited distribution polices. As such, we developed a Jynarque pharmacy consult service to allow tolvaptan prescribing nephrologists to employ pharmacy services for Jynarque monitoring. In addition to monitoring, patients receive medication counseling and the opportunity to discuss concerns with the pharmacy specialist at each monitoring follow-up.

Justification/Documentation:

Within three years of initiating the consult service, 21 patients have initiated tolvaptan. Prior to the service, routine prescribing of tolvaptan did not occur at our institution. In 2022, our institution was named a PKD Foundation Center of Excellence, noting the presence of an ADPKD clinical pharmacy expert as key criteria for awarding the designation.

Adaptability:

Clinical pharmacy services can be utilized at institutions servicing patients with ADPKD to ensure access and safe use of Jynarque. Outside of ADPKD, proactive identification of opportunities for clinical pharmacists to perform monitoring services for high-risk specialty medications with restricted distribution is important so that limited distribution of medications does not limit patient access to necessary therapies.

Significance:

Clinical pharmacists are uniquely trained to perform medication monitoring for high-risk specialty medications. Recognition of the need for clinical pharmacy services in creation of health care policy and service payment models for limited distribution specialty medications is critical.

Presenting Author

Authors