Systematic literature review of the methodology for developing pharmacotherapeutic interchange guidelines and their implementation in hospitals and ambulatory care settings.

PURPOSE: To summarize literature specific to therapeutic interchange (TI) focusing on methodological approaches in order to develop a list of steps that healthcare facilities can consult when developing pharmacotherapeutic interchange guidelines (PTIGs) in hospitals and primary care centers. METHODS: A search was conducted in PreMEDLINE, Medline, EMBASE, PsycINFO, and the Cochrane Library up to and including December 2015. PRISMA guidelines were used. The inclusion criteria were articles published on TI: methodology, implementation, guidelines, and position statements of scientific societies. Two authors independently reviewed all articles for eligibility and extracted the data. RESULTS: A total of 102 articles were selected for full-text review; we included three guidelines on how to effect TI, nine position papers of various scientific societies with regard to TI, two articles dealt exclusively about methodology, three articles consisted of recommendations and perspectives on TI, three articles dealt with legal aspects, four articles examined general implementation procedures, two articles were a post-discharge follow-up of patients who had TI, six were surveys referring to TI, and three were articles on the use of TI in ambulatory care The remaining 67 articles focused on therapeutic groups. Study quality was generally low. CONCLUSIONS: This review identified articles on TI as published guidelines, recommendations, and studies on TI carried out in hospital settings. As a result, eight fundamental steps were established for obtaining adequate results in the development of TI programs.

Estudio observacional de la efectividad y seguridad de nifedipino en la amenaza de parto prematuro / Observational study of the safety and effectiveness of nifedipine in pre-term labor

Objetivos. Analizar la efectividad y seguridad del nifedipino en gestantes con amenaza de parto prematuro (APP). Sujetos y métodos. Estudio observacional prospectivo de abril de 2003 a diciembre de 2004 y retrospectivo de enero a diciembre de 2008. Se incluyeron 106 gestantes a las que se aplicó el protocolo de APP del hospital. Se excluyeron 33 por diferentes motivos, principalmente falsos diagnósticos de APP. Resultados. La prolongación del parto fue superior a 48 h en el 56,2% (IC 95%: 44,8-67,5) y se administraron 2 dosis de betametasona en el 69,9% (IC 95%: 59,3-80,4). La incidencia de reacciones adversas maternas fue del 29,4% (IC 95%:7,8-51,2), principalmente hipotensión leve. De los 99 recién nacidos hubo 10 fallecimientos, principalmente por complicaciones infecciosas y bajo peso, y hubo un caso de encefalopatía hipóxico-isquémica. Conclusiones. La tocólisis con nifedipino es efectiva y segura si se respetan las precauciones de uso de forma estricta, registrando una baja incidencia de efectos adversos maternos y fetales (AU)

Objectives. To determine the effectiveness and safety of nifedipine as a tocolytic agent in pregnant women with preterm labor (PL). Subjects and methods. We performed a prospective observational study (April 2003 - December 2004) and a retrospective study (January- December 2008). A total of 106 pregnant women were included and the hospital PL protocol was applied. Thirty-three patients were excluded for different reasons, mainly because of a false PL diagnosis. Results. Pregnancy was prolonged by more than 48 hours in 56.2% [95% CI: 44.8-67.5] and 2 doses of betametasone were administered in 69.9% [95% CI: 59.3-80.4]. The incidence of maternal adverse reactions was 29.4% (95% CI: 7.8-51.2), mainly mild hypotension. Of the 99 newborns, 10 died, mainly because of infectious complications and low birthweight and there was one case of hypoxic-ischemic encephalopathy. Conclusions. Tocolysis with nifedipine is safe and effective if precautions for use are strictly respected. In this study, there was a low incidence of maternal and fetal adverse effects (AU)

Número de pacientes necesario a tratar en estudios de tiempo hasta el suceso / Number needed to treat in time-to-event studies

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Drug dosage recommendations in patients with chronic liver disease.

Chronic liver diseases (CLD) alter the kinetics of drugs. Despite dosage adjustment is based on Child-Pugh scores, there are no available recommendations and/or algorithms of reference to facilitate dosage regimens. A literature review about dose adjustment of the drugs from the hospital guide -which are included in the list of the WHO recommended drugs to be avoided or used with caution in patients with liver disease- was carried out. The therapeutic novelties from the last few years were also included. In order to do so, the summary of product characteristics (SPC), the database DrugDex-Micromedex, the WHO recommendations and the review articles from the last 10 years in Medline were reviewed. Moreover, the kinetic parameters of each drug were calculated with the aim of establishing a theoretical recommendation based on the proposal of Delcò and Huet. Recommendations for 186 drugs are presented according to the SPC (49.5%), DrugDex-Micromedex (26.3%) and WHO (18.8%) indications; six recommendations were based on specific publications; the theoretical recommendation based on pharmacokinetic parameters was proposed in four drugs. The final recommendations for clinical management were: dosage modification (26.9%), hepatic/analytical monitoring of the patient (8.6%), contraindication (18.8%), use with caution (19.3%) and no adjustment required (26.3%). In this review, specific recommendations for the practical management of patients with chronic liver disease are presented. It has been elaborated through a synthesis of the published bibliography and completed by following a theoretical methodology.

Recomendaciones para la dosificación de medicamentos en pacientes con insuficiencia hepática crónica / Drug dosage recommendations in patients with chronic liver disease

La insuficiencia hepática crónica produce alteraciones que afectan a la cinética de los medicamentos y a pesar de que su ajuste se basa en el índice Child-Pugh, no se disponen de recomendaciones y/o algoritmos de referencia que faciliten su dosificación. Se realizó una revisión bibliográfica de la dosificación en insuficiencia hepática crónica de los medicamentos de la guía del hospital incluidos en el listado de fármacos que la OMS recomienda no utilizar o utilizar con precaución en pacientes con enfermedad hepática, añadiendo las novedades terapéuticas de los últimos años. Para ello se revisaron las fichas técnicas, base DrugDex- Micromedex, recomendaciones de la OMS y artículos de revisión de los últimos 10 años en Medline; además, se calcularon los parámetros cinéticos de cada fármaco con el objeto de establecer una recomendación teórica basada en la propuesta de Delcò y Huet. Se presentan recomendaciones para 186 medicamentos, según lo indicado en la ficha técnica (49,5%), DrugDex-Micromedex (26,3%) y OMS (18,8%); 6 recomendaciones se realizaron en base a publicaciones específicas y en 4 fármacos se propuso la recomendación teórica basada en los parámetros farmacocinéticos. Las recomendaciones finales para el manejo clínico fueron de: modificación de dosis (26,9%), monitorización hepática/analítica del paciente (8,6%), contraindicación (18,8%), emplear con precaución (19,3%) y no requerir ajuste (26,3%). En esta revisión se presentan recomendaciones específicas para el manejo práctico del paciente con insuficiencia hepática crónica, obtenida mediante una síntesis de la bibliografía publicada y completada con aplicación de una metodología teórica(AU)

Chronic liver diseases (CLD) alter the kinetics of drugs. Despite dosage adjustment is based on Child-Pugh scores, there are no available recommendations and/or algorithms of reference to facilitate dosage regimens. A literature review about dose adjustment of the drugs from the hospital guide -which are included in the list of the WHO recommended drugs to be avoided or used with caution in patients with liver disease- was carried out. The therapeutic novelties from the last few years were also included. In order to do so, the summary of product characteristics (SPC), the database DrugDex- Micromedex, the WHO recommendations and the review articles from the last 10 years in Medline were reviewed. Moreover, the kinetic parameters of each drug were calculated with the aim of establishing a theoretical recommendation based on the proposal of Delcò and Huet. Recommendations for 186 drugs are presented according to the SPC (49.5%), DrugDex-Micromedex (26.3%) and WHO (18.8%) indications; six recommendations were based on specific publications; the theoretical recommendation based on pharmacokinetic parameters was proposed in four drugs. The final recommendations for clinical management were: dosage modification (26.9%), hepatic/analytical monitoring of the patient (8.6%), contraindication (18.8%), use with caution (19.3%) and no adjustment required (26.3%). In this review, specific recommendations for the practical management of patients with chronic liver disease are presented. It has been elaborated through a synthesis of the published bibliography and completed by following a theoretical methodology(AU)

Literature review on the structure and operation of Pharmacy and Therapeutics Committees.

AIM OF THE REVIEW: To review the literature on the structure and operation of hospital Pharmacy and Therapeutics Committees from an international point of view and examine the factors that influence decision-making of these committees. METHOD: We performed a literature search in the Medline and Embase databases from 1997 to January 2009 with the search terms: formulary system decision making, pharmacy and therapeutics committee, formularies hospital, drug formulary, survey, drug selection and outcome assessment health care. Inclusion criteria were the following: studies analyzing Pharmacy and Therapeutics Committees published in English or Spanish from 1997 to January 2009. Exclusion criteria were: publications which were editorials or opinion pieces, studies relating to one hospital, and studies where full text could not be attained. The analysis was divided into structural/organizational data and data on factors affecting the decision-making process. RESULTS: Seventeen studies met the inclusion criteria. Pharmacy and Therapeutics Committees and formularies were present in more than 90% of the hospitals in four of the five countries examined. Therapeutic interchange programs existed only in two of these countries. The mean number of committee members ranged between six and eight. More than 89% of the committees included a pharmacist. Standard operating procedures were implemented by 89% of the committees. The most influential factors in the decision-making were clinical trial results or drug costs rather than pharmacoeconomic studies. Other local organization-dependent factors were also important. CONCLUSIONS: The structure and operating procedures of Hospital Pharmacy and Therapeutics Committees are similar in select Western countries. Information from clinical trials is the most influential factor in the decision-making process.

Equivalencia terapéutica: concepto y niveles de evidencia / Therapeutic equivalence: concept and evidence levels

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Novedades terapéuticas del año 2000: los retos del médico y del gestor / New drugs of year 2000: the challenges of the clinic and the manager

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