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1.
Eur J Hosp Pharm ; 2021 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-34285110

RESUMO

OBJECTIVES: As yet, there is no European data standard for naming and describing oncology regimens. To enable real-world cancer treatment data comparisons, the Oncology Data Network created a unified reference database for systemic anti-cancer regimens used in practice across Europe. Data are extracted from clinical systems and mapped to a single standard called the "Core Regimen Reference Library (CRRL)". An automated matching algorithm has been designed based on: drug combinations; administration schedule; and dosing and route of administration. Incomplete matches are flagged for expert review. The aim of this pilot study is to have an expert pharmacist panel test the algorithm's feasibility by comparing computerised and manual matching of regimens that are currently in use in different European countries. METHODS: The combined team pooled a diverse sample of 47 reference regimens used in Europe for solid and haematological cancers. These were then codified to the developed common data standard and the algorithm was used to match them to the CRRL. The expert pharmacist panel from the European Society of Oncology Pharmacy (ESOP) selected 12 regimens from the sample set, ranging from simple to complex, and performed a single-blind test of the algorithm, by systematically matching each original regimen to the CRRL. RESULTS: ESOP validated the algorithm's feasibility based on full concurrence between manual and computer matches thereby validating the algorithm rules and logic with regard to what defines the core characteristics of a regimen and how to compare similarities and differences. CONCLUSIONS: ESOP's validation of the matching algorithm and approach to curating a master library provides confidence in their utility for reliable comparison of real-world regimen usage across Europe.

2.
J Clin Pharm Ther ; 46(5): 1238-1244, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33687085

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Chemotherapy drugs are often administered in combinations with predefined interdependent doses and cycle intervals. As yet, there is no global standardization system to describe these complex regimens in a universally comprehensive manner. The aim of this review is to identify which efforts for standardization have been undertaken and which recommendations for databases and nomenclature of chemotherapy regimens are available. METHODS: A literature review was performed to identify all peer-reviewed full-text articles about oncology therapy regimen codification. In addition, the results of this search were evaluated and consensus recommendations from a European expert panel were subsequently added. RESULTS: This review gives an overview of attempts to standardize chemotherapy nomenclature described in the literature, as well as of previously published identified gaps in regimen codification. In addition, we summarized the suggestions for improvement of chemotherapy codification found in the available literature, combining them with the expertise from a European expert panel of oncology pharmacists. WHAT IS NEW AND CONCLUSIONS: We believe that one of the most important error-prevention measures is standardization. However, there is a paucity of data how it may be achieved. Currently available data suggest that standardization has a positive impact on usability for data networks, prescription software, safety and the measurement of the quality of cancer care delivery. Standardization is also a strong pre-requisite for all discussions including oncology pharmacists and oncologists when evaluating chemotherapy regimen in countries in Europe but also all over the world. The recommendations compiled in this review can help to support overdue standardization efforts in this important therapeutic area.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Codificação Clínica/normas , Neoplasias/tratamento farmacológico , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Bases de Dados Factuais/normas , Europa (Continente) , Humanos , Guias de Prática Clínica como Assunto , Qualidade da Assistência à Saúde/normas , Terminologia como Assunto , Estados Unidos
3.
Eur J Hosp Pharm ; 26(2): 79-84, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31157104

RESUMO

Objectives: To determine how the value of new medicines is defined from the perspective of different stakeholders in nine European countries. Methods: We carried out an explorative survey by conducting in-depth qualitative interviews with a range of experts with health technology assessment, clinical provision, health economics, payer, academic and industry experience. Experts were asked to distribute 100 points over a predefined list of attributes related to value. In total, 30 interviews were conducted with seven academics, five clinicians, nine economists, five payers and four providers. Each of these categories was represented in responses from France, Germany, the Netherlands and the UK. Results: Comments on the interview guide were all positive. There was substantial variation in definitions of value provided by respondents. Most respondents indicated that delivering benefits to the patient is a prerequisite for a healthcare product to be of value, but only half included costs or resource use in their definition. Quantitative responses showed that effectiveness and efficacy were considered the most important attributes of value, followed by safety and side effects. Lower scores were given to other attributes, such as dignity and individualism, and invasiveness of the treatment. Resources and costs associated with complications and readmissions were considered important by academics and economists, but not clinicians. Conclusions: The interview findings indicate that the value of a drug is subjective in being perceived differently by different stakeholders, and for different treatment types. Future research will require evaluation of the views of a larger number of stakeholders in more and different countries to confirm these findings.

4.
Pharmacoeconomics ; 35(8): 777-791, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28477220

RESUMO

BACKGROUND: In many healthcare systems, affordability concerns can lead to restrictions on the use of expensive efficacious therapies. However, there does not appear to be any consensus as to the terminology used to describe affordability, or the thresholds used to determine whether new drugs are affordable. OBJECTIVES: The aim of this systematic review was to investigate how affordability is defined and measured in healthcare. METHODS: MEDLINE, EMBASE and EconLit databases (2005-July 2016) were searched using terms covering affordability and budget impact, combined with definitions, thresholds and restrictions, to identify articles describing a definition of affordability with respect to new medicines. Additional definitions were identified through citation searching, and through manual searches of European health technology assessment body websites. RESULTS: In total, 27 definitions were included in the review. Of these, five definitions described affordability in terms of the value of a product; seven considered affordability within the context of healthcare system budgets; and 15 addressed whether products are affordable in a given country based on economic factors. However, there was little in the literature to indicate that the price of medicines is considered alongside both their value to individual patients and their budget impact at a population level. CONCLUSIONS: Current methods of assessing affordability in healthcare may be limited by their focus on budget impact. A more effective approach may involve a broader perspective than is currently described in the literature, to consider the long-term benefits of a therapy and cost savings elsewhere in the healthcare system, as well as cooperation between healthcare payers and the pharmaceutical industry to develop financing models that support sustainability as well as innovation.


Assuntos
Atenção à Saúde/economia , Preparações Farmacêuticas/economia , Avaliação da Tecnologia Biomédica/métodos , Orçamentos , Redução de Custos , Análise Custo-Benefício/métodos , Humanos , Modelos Econômicos , Preparações Farmacêuticas/administração & dosagem , Terminologia como Assunto
6.
Pharmacoeconomics ; 34(12): 1227-1239, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27444306

RESUMO

Health Technology Assessment is increasingly used to evaluate the value of healthcare products and to prioritize resources; however, defining exactly what value is and how it should be measured remains a challenge. In this article, we report the results of a literature review, focusing on nine European countries, with the aim of investigating how value is defined from the perspective of different stakeholders, how definitions of value are used, and how value is incorporated into decision making. Only three articles were identified that presented definitions of value, and there was no single shared definition of value in healthcare, which appears to be a highly subjective concept. The majority of the countries investigated combine clinical assessment with economic evaluation to make reimbursement recommendations; the quality-adjusted life-year is the most commonly used measure of value but does not capture broader aspects of value that may be important to patients and healthcare systems. We describe the use of value-based pricing and multi-criteria decision analysis, two approaches to the incorporation of broader aspects of value into decision making. Overall, we have identified considerable variation in how a product's value is defined by different stakeholders. Although a universal understanding of value in healthcare is important, it is clear that current definitions are insufficient, potentially leading to inconsistent reimbursement decisions. Ultimately, the establishment of clearer policies for defining and measuring value in healthcare is needed, and is likely to lead to improvements in the consistency of decision making.


Assuntos
Tecnologia Biomédica/economia , Atenção à Saúde/economia , Avaliação da Tecnologia Biomédica/métodos , Custos e Análise de Custo , Tomada de Decisões , Técnicas de Apoio para a Decisão , Europa (Continente) , Humanos , Preparações Farmacêuticas/economia , Anos de Vida Ajustados por Qualidade de Vida , Mecanismo de Reembolso
7.
J Oncol Pract ; 7(1): 7-12, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21532802

RESUMO

Although there has been a significant increase in the availability and use of oral chemotherapeutic agents, the guidelines around their safe handling are still evolving. Although oral chemotherapy is associated with ease of administration, it has the same exposure risks to health care practitioners, patients, and their caregivers as intravenous formulations, and because it is administered in the home, to the families of patients. However, the general misconception appears to be that exposure risk is low and therefore oral chemotherapeutic agents present little risk and are safer to handle. In a series of three roundtable meetings, a team of international pharmacists from North America and Europe reviewed existing guidelines and identified gaps in recommendations that we believe are important for safe handling. The present article is a compilation of these gaps, especially applicable to manufacturers and distributors, storage and handling, and patient education regarding safe handling. These recommendations, on the basis of our experience and of best practices, provide an international perspective and can be adapted by institutions and practices for development of standardized procedures specific to their needs for the safe handling of oral chemotherapeutic agents.

8.
Oncology ; 81(5-6): 359-64, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-22248908

RESUMO

Treatment of metastasized colorectal cancer (mCRC) patients with anti-epidermal growth factor receptor (EGFR)-directed monoclonal antibodies is driven by the results of the KRAS mutational status (wild type [WT]/mutated [MUT]). To find out as to what extent the treatment selection based on the KRAS status had impact on overall costs, a retrospective analysis was performed. Of 73 mCRC patients 31.5% were MUT carriers. Costs of EGFR inhibitor treatment for WT patients were significantly higher compared to those for patients with MUT (p = 0.005). Higher treatment costs in WT carriers reflect a significantly higher number of treatment cycles (p = 0.012) in this cohort of patients. Savings of drug costs minus the costs for the determination of KRAS status accounted for EUR 779.42 (SD ±336.28) per patient per cycle. The routine use of KRAS screening is a cost-effective strategy. Costs of unnecessary monoclonal EGFR inhibitor treatment can be saved in MUT patients.


Assuntos
Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/economia , Detecção Precoce de Câncer/economia , Receptores ErbB/antagonistas & inibidores , Genes ras , Mutação , Inibidores de Proteínas Quinases/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Estudos de Coortes , Neoplasias Colorretais/genética , Neoplasias Colorretais/patologia , Análise Custo-Benefício/métodos , Detecção Precoce de Câncer/métodos , Receptores ErbB/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Valor Preditivo dos Testes , Inibidores de Proteínas Quinases/economia , Proteínas Proto-Oncogênicas/economia , Proteínas Proto-Oncogênicas/genética , Proteínas Proto-Oncogênicas p21(ras) , Estudos Retrospectivos , Proteínas ras/economia , Proteínas ras/genética
9.
Onkologie ; 31 Suppl 2: 25-8, 2008.
Artigo em Alemão | MEDLINE | ID: mdl-18487865

RESUMO

The procurement, transport, storage, manufacturing or compounding, the application, disposal, documentation, and the quality assurance of investigational medicinal products (IMPs) have to be done according to the pharmaceutical sciences. Medicines related to clinical trials in the European Union are regulated in volume 10 of the EudraLex. The rules for commercially manufactured medicines for human use are not valid for medicines which are individually compounded for a certain patient in the pharmacy. They are also not valid for medicines dedicated for experiments in research and development. The present article describes standards concerning the participation of the pharmacy in clinical trials, the pathway of the drug including the role of the study personnel, and its qualification and training. The issue of stability and compatibility of IMPs is an important topic which may influence the outcome of clinical trials. To avoid quality shifts Standard Operating Procedures (SOPs) have to be established.


Assuntos
Ensaios Clínicos como Assunto/normas , Composição de Medicamentos/normas , Avaliação de Medicamentos/normas , Fidelidade a Diretrizes/organização & administração , Farmácia/normas , Guias de Prática Clínica como Assunto , Pesquisa/normas , União Europeia , Alemanha
10.
Wien Klin Wochenschr ; 116(9-10): 289-95, 2004 May 31.
Artigo em Alemão | MEDLINE | ID: mdl-15237653

RESUMO

A variety of antineoplastic agents is associated with toxicity to healthy tissue and therefore represents a hazard for patients in case of extravasation. The most common risk factors include patient associated and iatrogenic risk factors. Due to the possible complications after extravasation, the knowledge of these risk factors is the basis for prevention, which is of utmost importance. A classification of antineoplastic agents according to the type of tissue damage includes the categories vesicant, irritant, and non-vesicant. Dependent on the extravasated agent, a series of emergency measures should be considered, preferably adhering to a standard operation procedure. There is good evidence for the successful use of antidotes to some antineoplastic agents. These antidotes are dimethylsulfoxide or hyaluronidase, often combined with topical measures such as cooling or application of heat. The application of sodium bicarbonate, sodium thiosulfate, and heparin is not recommended, whereas the usefulness of corticosteroids is still a matter of controversial discussions. Ambiguity in the management of extravasation is often a consequence of limited clinical evidence. Due to our deficient knowledge about some of the administered cytotoxics, there is ongoing need for action even after decades of therapy with antineoplastic agents.


Assuntos
Antineoplásicos/toxicidade , Extravasamento de Materiais Terapêuticos e Diagnósticos/prevenção & controle , Antídotos/administração & dosagem , Antineoplásicos/administração & dosagem , Queimaduras Químicas/terapia , Procedimentos Cirúrgicos Dermatológicos , Dimetil Sulfóxido/administração & dosagem , Extravasamento de Materiais Terapêuticos e Diagnósticos/etiologia , Humanos , Hialuronoglucosaminidase/administração & dosagem , Fatores de Risco , Gestão da Segurança , Pele/lesões , Retalhos Cirúrgicos
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