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Improving difficult-to-manage medication usage: a pharmacist led education programme for hepatitis delta virus (HDV) patients

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European Statement

Clinical Pharmacy Services

Author(s)

Sabrina Trivellato, Daniele Mengato, Francesca Venturini

Why was it done?

Bulevirtide, available in Italy since June 2023, is the sole approved drug for treating long-term HDV. It represents a precious clinical opportunity but its technical features make it a complex therapeutic regimen to handle. It is commercially available as a powder for injection that needs daily reconstitution before subcutaneous use, has strict storage requirements (+2/+8°C), and requires familiarity with needles and syringes. As home therapy, this is the responsibility of the patient, who will therefore need to be enrolled in a PEP to ensure compliance.

What was done?

A Patient Education Programme (PEP) was implemented to support patients diagnosed with hepatitis delta virus (HDV) being compliant to a complex therapeutic chronic regimen.

How was it done?

In July 2023, a specific pharmacist-led PEP (named “EXPLAIN”) was defined. It consists of two phases: education & training; follow-up & assistance. After clinical examination, patients were received by pharmacists and introduced to the therapy thanks to a simulation kit. Posology, storage conditions and special warnings were described and the drug together with the administration kit was delivered. During the follow-up phase the pharmacist was focused on proofing medication adherence, discussing with the patient about any problems or ADRs and drug refilling. Quality of Life (QoL, measured through EuroQoL5) was adopted as an effectiveness outcome. Evaluation feedback on the service was requested as well.

What has been achieved?

Up to September 2023, 15 patients, with a mean QoL starting score of 72,5/100±15, are assisted by the EXPLAIN program. 12 of them already accessed the follow-up phase. A single episode of medium gravity ADR was reported, but it did not affect therapy continuation. Globally, an excellent reported medication adherence (98.5% of doses taken) was registered and the educational support of the pharmacist was considered to be “essential on positively approaching the medication”.

What next?

QoL, adherence and feedback on the received service have to be proofed after 6, 9 and 12 months as well, together with a regular viral load detection to confirm referred compliance. Although the EXPLAIN program has just started, it represents a promising PEP model to be adopted in the case of complex therapies, where continuity is crucial to ensure effectiveness and safety.

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