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Routine generation of real-world evidence: an integrated system for the systematic recording of clinical data on innovative outpatient hospital medicines

European Statement

Patient Safety and Quality Assurance

Author(s)

Manuel Mazarío-García, Amparo Molina Lázaro, Gemma Garrido Alejos, Ferran Sala-Piñol, Núria Juvanet Ribot, Lluís de Haro i Martin

Why was it done?

In 2011, the Catalan Health Service (CatSalut) introduced the Registry of Patients and Treatments of Outpatient Hospital Medicines (RPT-OHM) within their Standard Health Record Platform (SHRP) for the comprehensive evaluation, effectiveness and safety of OHM. CatSalut requires fulfilling RPT-OHM before medicines billing. However, SHRP lacked integration with ICS’ clinical and billing information systems.

What was done?

The Catalan Health Institute (ICS) is the largest healthcare provider in Catalonia and is made up of eight hospitals. The ICS developed and implemented a structured data collection tool named the Hospital-Information-System-integrated Registry of Patients and Treatments (RPT-HIS). This tool systematically collects a range of critical information, spanning from prescription inception to treatment cessation, such as:
• Administrative patient, prescriber, and treatment particulars.
• Active ingredients or combinations, initiation and termination dates, therapeutic indications, and ICD-10 diagnoses.
• Baseline clinical variables recorded upon treatment commencement.
• Dynamic clinical data captured or typed from medical records throughout follow-up according to predefined intervals.
• Cessation variables detailing reasons for treatment discontinuation.

How was it done?

At ICS’ headquarters, a dedicated team of internal business analysts and functional support officers, along with contracted developers, collaborated to design, implement, and maintain RPT-HIS. Monthly coordination meetings ensure efficient integration of new OHM and monitor the registry’s progress. Simultaneously, a network of local reference pharmacists emerged in all eight ICS hospitals, fostering continuous knowledge exchange and driving innovative enhancements.

What has been achieved?

In the first half of 2023, 52,907 initiation, follow-up, or discontinuation forms were completed. Among these, 93.7% met all preset treatment-specific validation rules, underscoring the initiative’s effectiveness. Subsequently, utilization and budgetary impact reports across ICS hospitals have been elaborated, covering general and special patient populations, indicating a positive impact on operational efficiency and patient care.

What next?

In the near future, the real-world data amassed and stored in RPT-HIS could help to underpin refined drug therapy, optimize health outcomes, and strategically position medicines for specific conditions, also aiding in selection and purchase. This initiative serves as a model of good practice, demonstrating the potential of integrated data collection systems, aligned with the routine process of OHM utilization, to improve patient care. The successful implementation of RPT-HIS suggests its viability for adoption in other healthcare settings.

EXPERIENCE OF PATISIRAN OPTIMIZATION BUILDING HEALTHCARE TEAM

European Statement

Clinical Pharmacy Services

Author(s)

CRISTINA GONZALEZ PEREZ, LUCIA GALÁN DAVILA, MARTA ORTIZ PICA, ELENA GARCIA SUAREZ, MARIA MOLINERO MUÑOZ, LIDIA YBAÑEZ GARCIA, NATALIA SANCHE-OCAÑA MARTIN, MARIA DE LA TORRE ORTIZ, JAVIER CORAZON VILLANUEVA, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

Our hospital is a reference in our community for this rare disease. Since patisiran was approved, we have treated 19 patients. Due to the high cost of patisiran and the few patients treated, it is necessary to optimize patient treatments in the most efficient way.

What was done?

Transthyretin (TTR) amyloidosis is a rare disease caused by mutations in the TTR gene. These mutations alter the normal function of TTR protein, creating slowly progressive condition characterized by the buildup of abnormal deposits of amyloid in body’s organs and tissues.
Patisiran is a TTR specific small interfering RNA (siRNA) formulation in lipid nanoparticles, which has been shown to substantially reduce the production of abnormal TTR in patients with hereditary amyloidosis TTR.
With this project we look for achieve the greatest possible savings from patisiran drug without affecting the patient’s efficacy.

How was it done?

We created a working group with neurology department, to define patient’s groups according to:
– Prescribed doses (doses per patient weight; 0.3 mg/kg).
– Preparation’s losses because of the filters
– Losses of the extraction process.
– Other individual conditions as posology or personal preferences.
Patients belonging to the same group have to administrate patisiran the same days.
As the patient’s weight can change along the time, we agree with doctors and nurses to weight the patients every six months to perform doses adjustments. Therefore, every six months we should regroup the patients to optimize the most.

What has been achieved?

These clusters have made possible to reduce wasting vials and therefore to permit significant savings. We estimate around 208.115 € savings/year.

What next?

With this practice we look for a more efficient and sustainable rational health system. The savings achieved can be used to treat other patients or promote new investigations. Also, it makes possible a better healthcare team performance, working together for a better attention, health quality, security, and treatments efficiency. Monitoring weights to adjust doses and closer follow-up of patients by the different members of the multidisciplinary team are examples of the achievements.

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