Registro de pacientes y tratamientos de medicamentos hospitalarios en Cataluña: 10 años de datos clínicos

Izquierdo, M.; Casanovas, Maria Alba Prat; Torner, Maria Queralt Gorgas; Pontes, Caridad

doi:10.1016/j.medcli.2019.09.009

Cited by 11 publications

(4 citation statements)

References 14 publications

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“…Although the main purpose of the RPT is administrative, to facilitate the analysis of health results and evaluate both effectiveness and safety, it also includes some clinical variables recorded at the beginning of treatment, during patient follow-up and at the end of treatment, as mentioned above. 13 However, since safety issues are only recorded in the case of treatment withdrawal due to unacceptable toxicity and no descriptions of the ADRs are required, insufficient information regarding these ADRs is registered in the RPT. It is therefore necessary to look for additional information regarding ADRs in the EHRs of patients to build on the information found in the RPT.…”

Section: Discussionmentioning

confidence: 99%

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Withdrawal of hospital outpatient treatments in severe diseases due to unacceptable toxicity: A retrospective study from the register of patients and treatments

Escasany

Aguilera

Bosch

et al. 2020

Brit J Clinical Pharma

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To retrospectively analyse hospital outpatient treatment (HOT) withdrawal due to unacceptable toxicity at our hospital. Information regarding unacceptable toxicity leading to treatment withdrawal was recorded.Methods: HOT interruptions because of unacceptable toxicity were identified from the Register of Patients and Treatments (RPT) (January 2014 to December 2017).Information regarding the demographic and clinical characteristics of patients, adverse drug reactions (ADRs) and drug treatments was retrieved from electronic health records. Causality and previous knowledge of ADRs were assessed according to the Spanish Pharmacovigilance System algorithm. Information regarding HOT risk management plans (RMPs) and their classification as inverted black triangle medicines was obtained from the European Medicines Agency (EMA).Results: HOTs were withdrawn due to unacceptable toxicity in 136 (1.5%) registries corresponding to 135 (1.7%) patients. Fifty-one different HOTs (38.6% of those registered) were involved in 240 ADR/HOT pairs: 24 (47%) were additional monitoring medicines and 37 (72.5%) were EMA RMPs. The most frequent medicines involved in ADRs were lenalidomide (30, 12.5%) (mainly neutropenia, thrombocytopenia and bicytopenia), bevacizumab (19, 7.9%) (mainly venous and pulmonary thromboembolism) and sunitinib (13, 5.4%) (mainly thromboembolic events, diarrhoea and worsening of chronic renal failure). Cytopenia (40, 17.3%), diarrhoea (15, 6.5%), asthenia (9, 3.9%) and neuropathy (6, 2.6%) were the most frequent ADRs. All ADRs were severe, 10 (6 patients) had been poorly described or were unknown and only 9 (5 patients) had been reported by spontaneous notification.Conclusions: Valuable information regarding severe and unknown ADRs was obtained from the RPT. Such registers are useful tools to complement spontaneous ADR notifications. K E Y W O R D Sadverse drug reactions, drug toxicity, hospital outpatient treatment, postmarketing drug surveillance, registriesThe authors confirm that the Principal Investigator for this paper is Antònia Agustí and that she had direct clinical responsibility for the patients.

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Section: Discussionmentioning

confidence: 99%

“…11,12 To enable a minimal clinical follow-up, the RPT includes information regarding patients, medicines, indications and select clinical variables. 13 The interruption of a drug treatment due to unacceptable toxicity is also recorded.…”

Section: Introductionmentioning

confidence: 99%

Withdrawal of hospital outpatient treatments in severe diseases due to unacceptable toxicity: A retrospective study from the register of patients and treatments

Escasany

Aguilera

Bosch

et al. 2020

Brit J Clinical Pharma

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“…The Catalan Health Service (CatSalut) centrally manages all healthcare registries in Catalonia, collecting clinical practice data on 63 hospitals and more than 1600 primary healthcare centers that provide public universal care to 7.9 million people [25,26]. For this study, we combined data from the following healthcare registries [23,27]:…”

Section: Data Sourcementioning

confidence: 99%

“…While some studies have described MM treatment patterns and costs [17][18][19][20][21][22], few of them included data after 2019 [22], and none were conducted in our setting. The detailed clinical and administrative data available in the region of Catalonia, providing universal coverage to 16% of the Spanish population, represents an opportunity to analyze valuable information [23]. Thus, this study aims to analyze the trends of MM drug use and expenditure in Catalonia over the recent years.…”

Section: Introductionmentioning

confidence: 99%

Evolution of Pharmacological Treatments and Associated Costs for Multiple Myeloma in the Public Healthcare System of Catalonia: A Retrospective Observational Study

Garrido-Alejos,

Saborit-Canals,

Guarga

et al. 2023

Cancers

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(1) Background: Our understanding of and treatment for multiple myeloma (MM) has advanced significantly, and new pharmacological treatments have promising benefits but high price tags. This study analyzes prescription patterns and pharmaceutical expenditure for MM treatments in Catalonia’s public healthcare system over eight years. (2) Methods: A retrospective observational study examined MM treatment data from 2015 to 2022 in Catalonia, using healthcare registries from the Catalan Health Service to collect information on patients, medicines used, and treatment costs. (3) Results: A total of 4556 MM patients received treatment, with a rising trend in the number of treated patients each year from 902 in 2015 to 1899 in 2022. The mean age was 68.9 years, and patients were almost evenly distributed by gender (51.5% male). Most patients were treated with bortezomib (3338 patients), lenalidomide (2952), and/or daratumumab (1093). Most drugs showed increased utilization annually, most significantly for lenalidomide and daratumumab. The total pharmacological treatment cost throughout the entire study period was EUR 321,811,249, with lenalidomide leading with the highest total cost (EUR 157,236,784), and daratumumab exhibiting the highest increase in annual expenditure. (5) Conclusions: The study reveals a progressive increase in the number of MM patients treated and rising pharmaceutical costs. Lenalidomide and daratumumab incurred the highest costs. The findings highlight MM treatment’s economic impact and the need to monitor prescription patterns and expenditures to optimize healthcare resources and decision making. Understanding these trends can guide resource allocation effectively.

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Characterization of the Pharmaceutical Risk-Sharing Arrangement Process in Catalonia

et al. 2021

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Pharmaceutical risk-sharing arrangements have emerged as a reasonable tool to promote sustainable access to innovative medicines with uncertain clinical evidence and/or economic impact from the payer perspective. These funding mechanisms pose an alternative option to the traditional fixed-price methods and are intended to align the price of medication with the value delivered in treating patients, balancing clinical need with affordability in the face of increasing therapeutic innovation and ever-tight budgets. The Catalan Health Service (CatSalut) has set up a systematic, traceable, and transparent methodology for the design and implementation of risk-sharing arrangements and 15 of such access schemes have been successfully implemented until December 2019. Our experience has acknowledged the need for a robust study design, appropriate financial, technical, and administrative resources, and strong stakeholder commitment and communication as critical to the success of risk-sharing arrangements. While the experience in Catalonia has been positive and has served to highlight the potential of such schemes in tackling public health policy concerns, this exchange can often be undermined by the lack of transparency surrounding risk-sharing arrangements and the fact that the literature related to their methodology, implementation, and impact is scarce. Further studies should be conducted and shared to address this obstacle.

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Registro de pacientes y tratamientos de medicamentos hospitalarios en Cataluña: 10 años de datos clínicos

Cited by 11 publications

References 14 publications

Withdrawal of hospital outpatient treatments in severe diseases due to unacceptable toxicity: A retrospective study from the register of patients and treatments

Withdrawal of hospital outpatient treatments in severe diseases due to unacceptable toxicity: A retrospective study from the register of patients and treatments

Evolution of Pharmacological Treatments and Associated Costs for Multiple Myeloma in the Public Healthcare System of Catalonia: A Retrospective Observational Study

Characterization of the Pharmaceutical Risk-Sharing Arrangement Process in Catalonia

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