Tackling potentially inappropriate prescriptions in older adults: development of deprescribing criteria by consensus from experts in Colombia, Argentina, and Spain.

BACKGROUND: Potentially inappropriate medication use is prevalent among older adults in primary care, leading to increased morbidity, adverse drug reactions, hospitalizations, and mortality. This study aimed to develop and validate a tool for identifying PIMs in older adults within the primary care setting. The tool is composed of a list of criteria and was created based on consensus among experts from three Spanish-speaking countries, including two from Latin America. METHODS: A literature review was conducted to identify existing tools, and prescription patterns were evaluated in a cohort of 36,111 older adults. An electronic Delphi method, consisting of two rounds, was used to reach a formal expert consensus. The panel included 18 experts from Spain, Colombia, and Argentina. The content validity index, validity of each content item, and Kappa Fleiss statistical measure were used to establish reliability. RESULTS: Round one did not yield a consensus, but a definitive consensus was reached in round two. The resulting tool consisted of a list of 5 general recommendations per disease, along with 33 criteria related to potential problems, recommendations, and alternative therapeutic options. The overall content validity of the tool was 0.87, with a Kappa value of 0.69 (95% CI 0.64-0.73; Substantial). CONCLUSIONS: The developed criteria provide a novel list that allows for a comprehensive approach to pharmacotherapy in older adults, intending to reduce inappropriate medication use, ineffective treatments, prophylactic therapies, and treatments with an unfavorable risk-benefit ratio for the given condition. Further studies are necessary to evaluate the impact of these criteria on health outcomes.

Algorithm for the evaluation of therapeutic failure reports--proposal and pilot analysis.

PURPOSE: To propose and validate an algorithm to analyze the reports of suspected therapeutic failure (TF) received in pharmacovigilance programs. METHODS: A Delphi consensus method with a group of 12 international experts was used to identify the different causes that prompt TF and to propose an algorithm to analyze reports of suspected lack of efficacy of medicines. A pilot analysis of 50 reports was the basis to evaluate the interrater and intrarater validity of the algorithm. RESULTS: A 10-question algorithm was proposed. The evaluation of 50 reports of suspected TF showed that only 8% could be actually attributed to a manufacturing quality problem, whereas the real reason underlying the alleged TF was the inappropriate use of the prescribed drug in 28%. Minimum information to attribute the cause to a TF was lacking in 31% of these reports. The interrater reliability was "moderate" (kappa coefficient = 0.55), and the intrarater reliability ranged from 0.732 to 0.908 ("substantial" to "almost perfect"). CONCLUSIONS: The proposed TF algorithm is a valid, reliable, and reproducible analysis tool that can help to disentangle the frequent and complex reports of suspected TF.

From private incentives to public health need: rethinking research and development for pandemic preparedness.

Pandemic preparedness and response have relied primarily on market dynamics to drive development and availability of new health products. Building on calls for transformation, we propose a new value proposition that instead prioritises equity from the research and development (R&D) stage and that strengthens capacity to control outbreaks when and where they occur. Key elements include regional R&D hubs free to adapt well established technology platforms, and independent clinical trials networks working with researchers, regulators, and health authorities to better study questions of comparative benefit and real-world efficacy. Realising these changes requires a shift in emphasis: from pandemic response to outbreak control, from one-size-fits-all economies of scale to R&D and manufacture for local need, from de novo product development to last-mile innovation through adaptation of existing technologies, and from proprietary, competitive R&D to open science and financing for the common good that supports collective management and sharing of technology and know-how.

Development of a stepwise tool to aide primary health care professionals in the process of deprescribing in older persons.

OBJECTIVE: The aim of this study was to develop and validate a stepwise tool to aid primary health care professionals in the process of deprescribing potentially inappropriate medication in older persons. METHODS: We carried out a systematic review to identify previously published tools. A composite proposal of algorithm was made by following the steps from clinical experience to deprescribe medications. A 2-round electronic Delphi method was conducted to establish consensus. Eighteen experts from different countries (Colombia, Spain and Argentina) accepted to be part of the panel representing geriatricians, internists, endocrinologist, general practitioners, pharmacologists, clinical pharmacists, family physicians and nurses. Panel members were asked to mark a Likert Scale from 1 to 9 points (1= strongly disagree, 9= strongly agree). The content validity ratio, item-level content validity, and Fleiss' Kappa statistics was measured to establish reliability. The same voting method was used for round 2. RESULTS: A 7-question algorithm was proposed. Each question was part of a domain and conduct into a decision. In round 1, a consensus was not reached but statements were grouped and organized. In round 2, the tool met consensus. The inter-rater reliability was between substantial and almost perfect for questions with Kappa=0.77 (95% CI 0.60-0.93), for domains with Kappa= 0.73 (95%CI 0.60-0.86) and for decisions with Kappa= 0.97 (95%CI 0.90-1.00). CONCLUSIONS: This is a novel tool that captures and supports healthcare professionals in clinical decision-making for deprescribing potentially inappropriate medication. This includes patient's and caregiver's preferences about medication. This tool will help to standardize care and provide guidance on the prescribing/deprescribing process of older persons' medications. Also, it provides a holistic way to reduce polypharmacy and inappropriate medications in clinical practice.

Herramientas y criterios para la de prescripción de medicación inapropiada en adultos mayores: una revisión de la literatura con implicaciones para la atención al paciente y la práctica clínica / Assessment tools and criteria for deprescribing inappropriate medication in older adults: A literature review with implications for patient care and clinical practice

Objetivo: Identificar las herramientas y los criterios para deprescribir medicación potencialmente inapropiada en adultos mayores. Métodos: Se realizó una búsqueda de literatura en MEDLINE (vía PubMed), EMBASE, LILACS, SCIELO, para recopilar las herramientas y criterios de evaluación para deprescribir medicamentos inapropiados en adultos mayores. Se incluyeron herramientas, algoritmos y enfoques, hasta marzo de 2020. Los términos se ajustaron para cada una de las bases de datos. Resultados: La estrategia de búsqueda produjo 3326 publicaciones potencialmente relevantes. Se evaluaron un total de 258 artículos y se incluyeron 69 en el análisis descriptivo. Estos se organizaron en dos categorías: criterios específicos (n =55) y algoritmos o enfoques para evaluar la medicación inapropiada (n =14). La mayoría de las herramientas y criterios fueron desarrollados basados en la evidencia. Conclusiones: Esta revisión proporciona una compilación de herramientas disponibles para identificar medicación potencialmente inapropiada en adultos mayores. Las herramientas y los criterios de evaluación sirven de apoyo a los profesionales de la salud para la toma decisiones en torno a los medicamentos usados en esta población. Además, estos resultados ilustran la complejidad de la farmacoterapia actual en los adultos mayores debido al número y tipo de medicamentos incluidos en las herramientas, como una alerta frente a su posible uso inapropiado. Los AINE y las benzodiazepinas son los fármacos más comunes en los criterios explícitos.(AU)

Objective: To identify tools and criteria for evaluating potentially inappropriate medication in older adults with implications in patient care and clinical practice. Methods: A literature search was conducted in MEDLINE (via PubMed), EMBASE, LILACS, SCIELO, to gather relevant data regarding assessment tools and criteria for deprescribing inappropriate medication in older adults. Assessment tools, algorithms, and approaches to identify potentially inappropriate medication were included from inception to March 2020. The terms were adjusted for each of the databases. Results: The search strategy produced 3326 potentially relevant publications. A total of 258 were evaluated. A total of 69 articles were included in the descriptive analysis. These were organized into two categories: specific criteria (n =55) and algorithm or frameworks for assessing medication (n =14). Most tools and criteria were developed using an evidence-based approach. Conclusions: This review provides a compile of available tools to identify potentially inappropriate medication in older people. Tools support health care professionals to make decisions around older adults and frail elderly medication. These results show the complexity of current pharmacotherapy in older people due to the number and type of drugs classes included in all of tools which is an alert of inappropriate use. NSAIDs and benzodiazepines are the most common drugs in the explicit criteria.(AU)

Development of a stepwise tool to aide primary health care professionals in the process of deprescribing in older persons

OBJECTIVE: The aim of this study was to develop and validate a stepwise tool to aid primary health care professionals in the process of deprescribing potentially inappropriate medication in older persons. METHODS: We carried out a systematic review to identify previously published tools. A composite proposal of algorithm was made by following the steps from clinical experience to deprescribe medications. A 2-round electronic Delphi method was conducted to establish consensus. Eighteen experts from different countries (Colombia, Spain and Argentina) accepted to be part of the panel representing geriatricians, internists, endocrinologist, general practitioners, pharmacologists, clinical pharmacists, family physicians and nurses. Panel members were asked to mark a Likert Scale from 1 to 9 points (1= strongly disagree, 9= strongly agree). The content validity‏ ratio, item-level content validity, and Fleiss' Kappa statistics was measured to establish reliability. The same voting method was used for round 2. RESULTS: A 7-question algorithm was proposed. Each question was part of a domain and conduct into a decision. In round 1, a consensus was not reached but statements were grouped and organized. In round 2, the tool met consensus. The inter-rater reliability was between substantial and almost perfect for questions with Kappa=0.77 (95% CI 0.60-0.93), for domains with Kappa= 0.73 (95%CI 0.60-0.86) and for decisions with Kappa= 0.97 (95%CI 0.90-1.00). CONCLUSIONS: This is a novel tool that captures and supports healthcare professionals in clinical decision-making for deprescribing potentially inappropriate medication. This includes patient's and caregiver's preferences about medication. This tool will help to standardize care and provide guidance on the prescribing/deprescribing process of older persons' medications. Also, it provides a holistic way to reduce polypharmacy and inappropriate medications in clinical practice

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El debate de la regulación de medicamentos biotecnológicos: Colombia en el contexto internacional / The debate on regulating biotechnology drugs: Colombia in the international context

En septiembre de 2014, Colombia emitió su norma para la evaluación de los medicamentos biológicos en el marco del proceso de autorización de comercialización. La aproximación colombiana incluye de manera explícita una ruta abreviada para la evaluación de los biológicos competidores que generó una gran polémica a nivel nacional e internacional. En el presente artículo se explica el contexto que justifica la necesidad de adoptar la aproximación abreviada, se analiza de manera crítica la comparabilidad como paradigma para la evaluación de los biogenéricos y se evidencia que la posición de Colombia no es aislada y está basada en tendencias regulatorias globales.

In September 2014, Colombia issued standards for the evaluation of biological drugs within the framework of the marketing authorization process. The Colombian approach explicitly includes a fast track for evaluating competing biologicals, which caused great national and international controversy. This article explains the context that justifies the need for this fast-track approach, critically analyzes comparability as a paradigm for the evaluation of biogenerics, and shows that Colombia’s position is not isolated and is based on global regulatory trends.

Propuesta de un modelo de gestión de medicamentos en indicaciones no registradas en Colombia / Proposed model for managing drugs used for unregistered indications in Colombia

El uso de medicamentos en indicaciones no registradas (INR), conocido como uso “off-label”, es una práctica que genera problemas de uso racional y de acceso cuando no existen alternativas disponibles. Los sistemas de salud deben gestionar esta realidad, sobre todo cuando se trata de decisiones de cobertura, buscando minimizar los riesgos para la salud y estableciendo de forma clara los papeles y las responsabilidades de los agentes involucrados. El Ministerio de Salud y Protección Social de Colombia (MinSalud), junto con con la Universidad Nacional de Colombia y expertos nacionales, diseñaron una propuesta de modelo de gestión del uso de medicamentos en indicaciones no registradas (off-label) y su potencial reembolso con recursos públicos, teniendo en cuenta prácticas internacionales y la realidad nacional. El modelo de gestión es no punitivo y está orientado a la promoción del uso racional de estos medicamentos, de forma que se reduzcan las barreras al acceso cuando su uso está respaldado por pruebas cientificas de calidad. El modelo incorpora elementos de garantías bioéticas del paciente, los papeles y las responsabilidades del prescriptor y de las entidades de gobierno.

The use of drugs for unregistered indications, known as “off-label” use, is a practice that creates problems of rational use and access when other options are not available. Health systems should address this situation, particularly in connection with decisions concerning coverage, while trying to minimize health risks and clearly define the roles and responsibilities of the parties involved. Colombia's Ministry of Health and Social Protection (MinSalud), together with the National University of Colombia and national experts, developed a proposal for a model for managing drugs being used for unregistered indications (off-label) and their potential reimbursement with public resources, taking into account international practices and country characteristics. The management model is non-punitive and is geared toward promoting the rational use of these drugs so that barriers to access are reduced whenever their use is supported by solid scientific evidence. The model addresses patient safeguards in the bioethical domain and the roles and responsibilities of the prescriber and government entities.