Factors Related to the Evaluation of Essential Medicines Use in Health Facilities in Indonesia

Background: Indonesia has recently implemented a national policy to ensure equitable access to medicines, promote their rational use, and maintain a reliable and quality supply, specifically for essential medicines. Several organizations have conducted evaluations on essential medicines use but have yielded varying results and cannot reflect the actual situation. Objectives: This study aims to discover the current situation regarding essential medicines and identify the most important factors to be considered during future indicator-based evaluations in health facilities in Indonesia. Methods: This qualitative study was carried out using FGDs and interview from January to February 2022. The sample population consisted of ten experts selected based on predetermined criteria. The discussions were recorded and transcribed verbatim in the original language, thematically coded with Nvivo, and analyzed for common themes. Results: This study found 32 factors related to the use of essential medicines in Indonesia, divided into three categories of components, namely access, medicine handling quality, and rational use. Furthermore, a total of 10, 8, and 14 main factors were related to access, handling quality, and rational use, respectively. The discussion provided various perspectives on measuring drug use, specifically essential medicines. Based on expert opinions, evaluating the utilization of essential medicines by relying on existing guidelines was insufficient due to superficiality and irrelevance within the Indonesian health system. Conclusion: Based on the results, one of the crucial factors to consider during evaluation was the accessibility of medicines, which encompassed their availability in health facilities and affordability to patients... (AU)

Optimal assessment share structured of Pharmacoeconomics for medical drugs according to minimax criterion

Objective: To develop a comprehensive methodology for the optimal assessment of the share of the use of medicines, based on the procedure for ranking drugs according to the pharmacoeconomic point scale and the minimax criterion was applied. Methods: The author’s approach is based on the minimax principle and allows solving the problem of optimizing the pharma drug portfolio based on available data, without the need to obtain the parameters of the Markowitz model associated with correlation analysis of data. Results: The authors obtained the optimal distribution of medicines in group A, B: 37% to 63%, which the authors consider a promising recommendation for a pharmaceutical company. The use of a similar approach, which does not contradict the Markowitz methodology, but allows us to reasonably accept the parameters of the model and give the optimal solution for the share distribution of drugs in medical practice. Conclusion: These mathematical tools, justified and equipped with an alternative confirmation, the minimax task can and should take a significant place in the complex pharma-analytical methodology of the management of large companies supplying concomitant drugs to the Russian and foreign market. (AU)

Evaluation of The Rational Drug Use (RDU) Literacy Among Undergraduate Students

Background: Irrational drug usage is a global concern. WHO recommended a strategy for integrating education and awareness on the rational use of medicine into general education programs. Objective: To evaluate the rational drug use (RDU) literacy among the undergraduate students of Ubon Ratchathani University. Methods: This mixed-methods research consists of a quantitative cross-sectional study with a self-administered RDU literacy questionnaire and a qualitative in-depth interview study. Descriptive statistics and inferential statistics were used in the quantitative study. Thematic analysis was used in the qualitative study. Results: Students who participated in this study included 640 undergraduate students. Approximately half of the participants never studied a RDU-related course (50.94%). Although the findings revealed that most of the participants (73.13%) had good RDU literacy, many participants had less frequency of the right options on some questions (e.g., advertisement of health products). Health sciences students were 2.8 times more likely than non-health sciences students to have good RDU literacy (AOR=2.835, 95% CI: 1.752-4.587). Four main themes were derived from the qualitative study: 1. Definition of RDU; 2. Facilitators; 3. Concerns; 4. RDU country. Conclusion: While the majority of participants demonstrated good RDU literacy, some actually engaged in irrational drug use. Activities promoting RDU literacy among undergraduate students, particularly in faculties other than health sciences, are still required (AU)

Farmacia hospitalaria ecológica: un enfoque sostenible del proceso de utilización de medicamentos en un hospital de tercer nivel / Green hospital pharmacy: A sustainable approach to the medication use process in a tertiary hospital

Background Sustainable management of healthcare waste has a positive impact on the global environment. In order to reduce it, the sustainable practice of the pharmacotherapeutic process in all its stages is essential. Objective To analyze the sustainability strategies proposed by the pharmacy service to reduce drug waste derived from the pharmacotherapeutic process. Secondary objectives: to analyze the stage of the pharmacotherapeutic process and the number and type of drugs involved. Methods The study was carried out in a tertiary level hospital. To coordinate the proposals, a referent pharmacist from every pharmacy department area was selected. Four stages of the process were evaluated (procurement, validation, dispensing and compounding), patients concerned were classified as outpatients or inpatients, and drugs potentially involved were analyzed by the administration route: into oral or parenteral. Results 28 ideas were proposed, which could affect more than 1200 drugs. 39.3% would affect the validation process, 17.9% the procurement management, 17.9% dispensing and 7.1% the compounding. Implementation feasibility and acceptability of these proposals were evaluated. Those with the greatest potential were: limiting the duration of treatments when possible, favoring the implementation of computer prescription order entry, favoring the use of the oral route over the parenteral route, and implementing computers in the preparation areas to avoid the use of paper guides. Discussion In our study, many ideas have been proposed by hospital pharmacists to improve the sustainability of the medication use process. When assessing these proposals by impact and feasibility, according to our results, shorten as much as possible the duration of treatments, computerization of the medication use process and oral administration over intravenous should be prioritized in order to reduce environmental impact. (AU)

Antecedentes La gestión sostenible de los residuos sanitarios tiene un impacto positivo en el medio ambiente mundial. Para reducirlo, es esencial la práctica sostenible del proceso farmacoterapéutico en todas sus etapas. Objetivo Analizar las estrategias de sostenibilidad propuestas por el servicio de farmacia para reducir los residuos de medicamentos derivados del proceso farmacoterapéutico. Objetivos secundarios: Analizar la etapa del proceso farmacoterapéutico y el número y tipo de medicamentos implicados. Métodos El estudio se realizó en un hospital de tercer nivel. Para coordinar las propuestas se seleccionó un farmacéutico referente de cada área del servicio de farmacia. Se evaluaron cuatro etapas del proceso (Adquisición, validación, dispensación y formulación), se clasificaron los pacientes afectados como ambulatorios u hospitalizados y se analizaron los fármacos potencialmente implicados según la vía de administración: oral o parenteral. Resultados Se propusieron 28 ideas, que podrían afectar a más de 1.200 medicamentos. El 39,3% afectarían al proceso de validación, el 17,9% a la gestión, el 17,9% a la dispensación y el 7,1% a la formulación. Se evaluó la viabilidad de la aplicación y la aceptabilidad de estas propuestas. Las de mayor potencial fueron: limitar la duración de los tratamientos cuando sea posible, favorecer la implantación de la entrada de órdenes de prescripción por ordenador, favorecer el uso de la vía oral frente a la parenteral e implantar ordenadores en las áreas de preparación para evitar el uso de guías en papel. Conclusiones En nuestro estudio, son muchas las ideas propuestas por los farmacéuticos de hospital para mejorar la sostenibilidad del proceso de utilización de medicamentos... (AU)

Facilitators and barriers of the rational drug use hospital program in Thailand

The Thailand Ministry of Public Health has started a rational drug use (RDU) policy, which includes multifaceted strategies as well as the RDU hospital program to tackle irrational drug use. Objective: To investigate facilitators and barriers related to the CIPP model of the RDU hospital program in Thailand. Methods: This is a qualitative study. Data were collected through semi-structured interviews with regional policymakers who were members of the executive board for RDU management in the 10th health region. The interviews were conducted via telephone using a topic guide informed by the CIPP framework and reviewed for content validity by the research team. Data were transcribed, and thematically analyzed. Results: Fifteen pharmaceutical policymakers were interviewed. The main facilitators related to context, input, and process were the national policy on RDU, RDU awareness/practices among health professionals, particularly prescribers, and multidisciplinary teamwork under the organization’s leadership to use data feedback to improve the program. The main barriers related to context, input, and process were a lack of policy advocacy at the regional and provincial levels, doctor-related reasons such as medicolegal concerns, and a lack of multidisciplinary teamwork. For the product theme, participants were very satisfied and perceived positive impacts at both the individual and organizational levels, such as increased RDU awareness in patients and multidisciplinary teams, as well as RDU prescription. However, negative impacts, such as tensions surrounding professional responsibility and accountability, have been observed. (AU)

Empowerment interventions for pharmacies to comply with the Good Pharmacy Practice (GPP) in Thailand

Good Pharmacy Practices (GPP) is to provide people with quality pharmacy services as well as to promote drug use safety. Objectives: To find out the effect of the process of empowering modern pharmacies to meet the GPP standards and to investigate the problems and obstacles that affect the pharmacy licensees in complying with the GPP. Methods: An action research using the Deming Cycle (PDCA) to design a process, in collaboration with relevant parties, to promote GPP compliance. The process consisted of a group intervention and an individual intervention designed to be consistent with the SOAP assessment. The action plan was implemented over a 9-month period. The GPP outcomes were assessed. Samples were 32 pharmacy licensees in Nakhon Ratchasima Province, which have not yet passed the GPP assessment. They were randomly selected by the stratified sampling method. Results: After participating in the empowerment process, there were 62.50% or 20 pharmacies passed the GPP assessment in all categories. The average GPP compliance score had statistically significantly higher than before the process (p<0.001). For the satisfaction of the participants, the overall score was at the highest level. Conclusion: The process of empowering modern pharmacies to meet GPP standards showed a positive effect. The rate of pharmacies that passed the GPP criteria also increased. In addition, the participants in the process were highly satisfied. Therefore, the PDCA cycle should be used in pharmacy development. Meanwhile, GPP self-assessment is a tool to help pharmacy licensees in systematic problem resolution. (AU)

Automedicación en profesionales de un laboratorio farmacéutico paraguayo / Self-medication among professionals in a Paraguayan pharmaceutical company

Objetivo: determinar la prevalencia de la automedicación entre las personas trabajadoras de un laboratorio farmacéutico del área metropolitana de Asunción (Paraguay) y describir sus características.Método: estudio descriptivo transversal (nov 2016). Se incluyó a todas las personas adultas trabajadoras del laboratorio (N= 400). Se solicitó su participación por correo electrónico en dos ocasiones. Se midieron variables sociodemográficas, laborales y la automedicación mediante cuestionario heteroadministrado diseñado ad hoc y pilotado (síntomas que motivaron, frecuencia, grupo de fármaco, motivos, fuente de la recomendación, eficacia y peligro percibido, finalización, acción en caso de persistencia del síntoma, publicidad, lugar de compra, fuentes de información). Se realizó estadística descriptiva y bivariante.Resultados: participaron 166 personas (edad media 33,2 años; 60,2% hombres). El 34,3% se había automedicado en los tres meses anteriores. El 90,4% consideraba que la automedicación era peligrosa. La práctica de automedicación fue mayor en el nivel universitario que en el secundario (44,8% vs. 22,8%; p= 0,004). No se encontraron diferencias en función de la edad, el sexo, ni el tiempo trabajado en la empresa. La causa más frecuente fue el tratamiento del dolor de cabeza (64,9%) y los fármacos más consumidos, los analgésicos/antiinflamatorios (82,4%). El 66,6% no consideró necesario ir al médico para la prescripción y en el 35,1% de los casos fue el familiar o amigo quien lo recomendó.Conclusiones: la automedicación fue una práctica habitual en la población estudiada, aunque inferior a otros estudios. Es necesario el abordaje de este problema.(AU)

Objective: to determine the prevalence of self-medication among the persons working at a pharmaceutical company from the metropolitan area of Asunción (Paraguay), and to describe its characteristics.Method: a descriptive cross-sectional study (November 2016). All adult persons working at the company were included (N= 400). Their participation was requested by email in two occasions. Sociodemographic and occupational variables were measured, as well as self-medication, through a self-administered questionnaire, designed ad hoc and piloted (symptoms causing it, frequency, drug class, reasons, source of recommendation, efficacy and perceived danger, conclusion, action in case of symptom persistence, publicity, place of purchase, sources of information). Descriptive and bivariate statistics was conducted.Results: the study included 166 persons (mean age 33.2 years; 60.2% were male). Of these, 34.3% had self-medicated within the past three months; 90.4% considered that self-medication was dangerous. Self-medication was higher with university than with high school level (44.8% vs. 22.8%; p= 0.004). No differences were found based on age, gender or time worked at the company. The most frequent cause was treatment for headache (64.9%) and the drugs more widely used were analgesics / anti-inflammatories (82.4%); 66.6% of the participants did not consider it was necessary to see their doctor for prescription, and they followed recommendations by relatives or friends in 35.1% of cases.Conclusions: self-medication was a frequent practice among the population studied, although lower than in other studies. It is necessary to address this problem.(AU)

Efectos de la COVID-19 en el consumo de antidepresivos en la provincia de Santa Cruz de Tenerife, Islas Canarias / Effects of COVID-19 on the consumption of antidepressants in the Province of Santa Cruz de Tenerife, Canary Islands

Fundamento: en este trabajo se analiza el impacto de la COVID-19 en el consumo de antidepresivos durante el primer año de la pandemia (2020) tomando como línea de base las tendencias de prescripción durante los 4 años anteriores (2016-2019) en la provincia de Santa Cruz de Tenerife y las cuatro islas que la conforman. Métodos: los datos de ventas en las farmacias comunitarias se tomaron como base de datos agregados. La dosis por 1000 habitantes y día se utilizó como indicador de consumo.Resultados: en las islas de El Hierro y La Gomera, el aumento de población no justifica por sí solo los incrementos relevantes observados en el consumo de antidepresivos y, posiblemente, la COVID-19 y sus consecuencias sobre la salud de la población podrían ser responsables de dichos aumentos. En la isla de Tenerife el incremento de población podría justificar, en gran medida, el ligero aumento de consumo observado. La isla de La Palma presenta un aumento de tan solo un 1,40 %, pero menor al valor esperado tomando como línea de base el periodo 2016-2019. Todas las islas presentan las mismas tendencias en el consumo de los diferentes subgrupos de antidepresivos y principios activos, aunque con ligeras variaciones, con la excepción de la isla de la Palma que presenta un comportamiento y tendencias estadísticamente diferentes.Conclusiones: las diferencias de prescripción observadas podrían estar relacionadas con las características sociosanitarias y demográficas de cada una de las islas. (AU)

Effectiveness of a continuing education program of drugs with fiscalized substance to improve pharmacy staff competencies: a multicenter, cluster-randomized controlled trial

Background: Drugs with fiscalized substances without a correct prescription may lead to undesirable side effects. Pharmacy staff needs to improve their competencies (knowledge, skills, and attitudes) to contribute to providing ambulatory pharmacy services and minimizing medication errors. Continuing education programs (CEP) could favor access to relevant and quality information on health promotion, disease prevention, and the rational use of drugs. Objective: To evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies to enhance the use of drugs with fiscalized substances. Methods: A multicenter, prospective, parallel-group, cluster-randomized, controlled clinical trial was conducted in drugstores and pharmacies in Colombia (ambulatory retail establishments). The intervention group (IG) received a CEP: a web-based social networking site, a virtual course, a dispensing information system, and face-to-face training. The control group (CG) received general written material on the correct use of drugs. We measured pharmacy staff’s skills, attitudes, and knowledge self-reported scores, and the simulated patient technique was used to assess the participant skills and attitudes in real practice. We used a questionnaire designed for this study, which was evaluated by a group of experts and piloted and showed a Cronbach’s alpha of 0.96. (AU)

Proyecto Revisa. Medicamentos “alerta” a la hora de ofrecer el servicio RUM / Project Review. Medicines "alert" when it comes to offering the RUM service

JUSTIFICACIÓN: una clave para poder ayudar a los pacientes con el servicio de Revisión del Uso de los Medicamentos (RUM) es identificar a los pacientes que más se pueden beneficiar de él. Conocer los medicamentos que más incidencias generan en el RUM puede ayudar a los farmacéuticos a lograr ese objetivo. OBJETIVO: identificar los grupos terapéuticos que más incidencias generan en el RUM, con el fin de detectar pacientes “diana” del servicio y facilitar los medicamentos “clave” en los que prestar mayor atención durante este. MATERIAL Y MÉTODOS: estudio descriptivo, transversal, observacional retrospectivo sobre los grupos terapéuticos según la clasificación ATC, de los medicamentos implicados en diferentes incidencias detectadas en 564 RUM realizados por farmacéuticos capacitados por el proyecto Revisa® hasta el 15-02-2022 y registrados en la plataforma SEFAC e_XPERT. Para cada tipo de incidencia detectada se comparó la proporción de incidencia de cada grupo terapéutico con respecto al resto de grupos. Para el análisis estadístico se empleó el test Chi-cuadrado con la corrección de Yates, considerándose la diferencia significativa si p<0,05. El tratamiento informático de los datos se realizó con el programa Microsoft Excel. (AU)

Proyecto revisa. 6 años de RUM: repercusiones en la farmacia y el farmacéutico comunitario / Project revises. 6 years of RUM: impact on pharmacy and the community pharmacist

JUSTIFICACIÓN: el proyecto revisa®, que busca la implantación del servicio de Revisión del Uso del Medicamento (RUM) en la farmacia comunitaria española, cumple 6 años. Tras este periodo se han capacitado 275 farmacéuticos para la prestación del servicio. Desconocemos el nivel de implantación del servicio en la actualidad, así como los aspectos en los que se podría prestar un mayor apoyo desde SEFAC. OBJETIVO: conocer el grado de implantación del servicio RUM entre los farmacéuticos capacitados e identificar en que aspectos necesitan apoyo y cuál es su percepción sobre el servicio. MATERIAL Y MÉTODOS: se envió una encuesta a los farmacéuticos capacitados por SEFAC para el servicio RUM. Con 15 ítems, relativos a la puesta en práctica del servicio en sus farmacias, que tuvieron abierta para contestar desde el 25 de Febrero y el 7 de Marzo de 2022. La encuesta permanece abierta, por lo que los datos finales pueden diferir ligeramente de los expuestos aquí. RESULTADOS: el 15.2 % de los capacitados contestaron a la encuesta. El 29.3 % no hacen ningún RUM al año, el 51.2 % hacen menos de 5 RUMs al año, mientras que el 14.6 % hacen entre 5 y 10, y el 4.9 % hacen más de 10. Las principales dificultades que encuentran son el tiempo 52.8 % y la dificultad para promocionar el servicio 44.4 %, seguidos por el precio 36.1 % y dificultad para implementar el servicio 33.3 %. El 50 % cobra menos de 15€ por el RUM y un 47,2 % no cobra nada. El 83.9 % emplea menos de 40 minutos por RUM. En los pacientes que se ha hecho más de un RUM, el 88.9 % de los encuestados refiere haber apreciado cambios significativos en el uso de los medicamentos y el estado de salud. (AU)

Estudio de utilización de linezolid en el Hospital Central de la Defensa «Gómez Ulla» / Study of the Linezolid usage at Hospital Central de la Defensa Gómez Ulla

El linezolid es un antimicrobiano del grupo de las oxazolidinonas, desarrollado en la década de 1990, siendo elprimero comercializado en su grupo a principios de los años 2000. Está indicado, según ficha técnica, en el tratamiento de la neumonía nosocomial y de la neumonía adquirida en la comunidad, cuando se conoce o se sospecha que está causada por bacteriasgram-positivas, y en el tratamiento de infecciones complicadas de piel y partes blandas (IPPBC) con certeza de microorganismosgram-positivos. Debido a su buena farmacocinética, rentabilidad e indicaciones anteriormente mencionadas ha cobrado especial importancia tanto en ámbito hospitalario como ambulatorio. Sujetos y métodos: Se llevó a cabo un estudio de utilizaciónde medicamentos (EUM) prescripción-indicación retrospectivo, en el Hospital Central de la Defensa (HCD) «Gómez Ulla»,durante el mes de septiembre de 2019, con el objetivo de conocer el patrón de uso de linezolid (indicaciones, adecuación o no aficha técnica, pauta posológica, vía de adminsitración utilizada, sospecha de reacciones adversas medicamentosas, características socio-demográficas y clínicas de los pacientes). El tipo de muestreo fue consecutivo no probabilístico. Se realizó un análisisestadístico descriptivo a través del programa informático SPSS 25.0. Resultados: Un total de 28 pacientes recibieron durante elmes de septiembre de 2019 al menos una dosis de linezolid. (AU)

Linezolid is an antimicrobial from the group of oxazolidinones, developed in the 1990s, being the first marketed inits group in the early 2000s. It is indicated, according to the data sheet, in the treatment of nosocomial pneumonia. and community-acquired pneumonia, when known or suspected to be caused by gram positive bacteria, and in the treatment of complicatedskin and soft tissue infections with certain gram positive organisms. Due to its good pharmacokinetics, profitability and aforementioned indications, it has gained special importance both in hospital and outpatient settings. Subjects and methods: A retrospectiveprescription-indication drug use study was carried out at the Central Defense Hospital (HCD) «Gómez Ulla», during the monthof September 2019, with the objective of knowing the pattern of use of linezolid (indications, adequacy or not to the data sheet,dosage regimen, route of administration used, suspected adverse drug reactions, sociodemographic and clinical characteristics ofthe patients). The type of test was non-probabilistic consecutive. A descriptive statistical analysis was performed using the SPSS 25.0computer program. Results: A total of 28 patients received at least one dose of linezolid during the month of September 2019. IPPBwas the most prevalent indication (53.5%) (15/28) followed by pneumonia (28.5%) (8/28). It was not adapted in 5 cases (17.8%) (5/28)to the indications of the data sheet: Complicated Urinary Tract Infection (3/5), Complicated Intra-abdominal Infection (1/5) andfebrile syndrome without source (1/5). (AU)

Listado de medicamentos a evitar en atención primaria y su aplicación en pacientes polimedicados / List of medicines to avoid in Primary Care Health and their application in polymedicated patients

Introduction: The high prevalence of inappropriate medication use andits important health consequences for health require specific and agiletools to detect and avoid it.The objective of this work was to elaborate a list of medications toavoid in Primary Care and to apply it on the polymedicated patients ofa Primary Care assistance service.Methods: In the Database of the Spanish General Council of OfficialAssociations of Pharmacists (BOT-Plus) the status and availability ofeach of the 93 MAE of the Prescrire 2019 List was checked. The list ofmedications to be avoided in Primary Care was drawn up with thosethat were marketed in Spain and excluded those that were not financedand those for exclusive hospital use.With the list of medicines to avoid in Primary Care, a retrospectiveanalysis was made of all the prescription reports of polimedicated >10medications for 2017 in a Primary Care services (N=262) in 5 healthcenters. Frequency analysis, central tendency measures and dispersionwere carried out; they were estimated [CI: 95%] and X or Fisher’s exactwas used to determine the association between variables and logisticregression analysis.Results: A prevalence of polymedicated drugs of 1.2% was observed,with a mean age of 71.7 years (DT± 12.4) and a mean prescription of12 drugs (DT±1.7).The list of medications to be avoided in PC included 45 active ingredients. The 50.4% of the polymedicated had at least one drug to avoidand an average age of 68.5 years (DT±11.8). Sex was a risk factor forinappropriate prescription, the fact of being a woman increases withan OR=1.8 (IC95%=1, 3-3.0) the probability of having some medicinesto avoid. The most commonly used drugs to avoid were: duloxetine,sitagliptin and olmesartan. ...

Introduction: La alta prevalencia del uso de medicación inadecuada ysus importantes consecuencias para la salud requieren herramientasespecíficas y ágiles que ayuden a detectarla y evitarla.Objetivo de este trabajo fue elaborar un listado de medicamentos aevitar en AP y aplicarlo en pacientes polimedicados de un servicio asistencial de Atención Primaria (AP).Métodos: En la Base de datos del Consejo General de Colegios Oficialesde Farmacéuticos español (BOT-Plus) se comprobó el estado y disponibilidad de cada uno de los 93 medicamentos del Listado Prescrire2019. Se elaboró el Listado de medicamentos a evitar en AP con aquellos que estaban comercializados en España y se excluyeron los que noestaban financiados y los de uso exclusivo hospitalario.Con el listado de medicamentos a evitar en AP se hizo un análisis retrospectivo de todos (N=262) los informes de prescripción de polimedicados >10 medicamentos del año 2017 en un servicio asistencial deAP (5 centros de salud). Se realizó análisis de frecuencias, medidasde tendencia central y dispersión; se estimaron (IC 95%) y se utilizóX o exacta de Fisher para determinar la asociación entre variables yanálisis de regresión logística.Resultados: Se observó una prevalencia de polimedicados de 1,2%, conuna media de edad de 71,7 ± 12,4 años y una media de prescripcionesde 12 ±1,7 medicamentos.El listado de medicamentos a evitar en AP incluyó 45 principios activos.Los fármacos a evitar más usados han sido: duloxetina, sitagliptina yolmesartán. El 50,4% de los polimedicados tenían al menos un medicamento a evitar y una edad media de 68,5±11,8 años. El sexo fue unfactor de riesgo de prescripción inadecuada, el hecho de ser mujerincrementa con un OR=1,8 (IC 95%=1,3-3,0) la probabilidad de medicamentos a evitar. ...

Eficacia de las medidas de minimización de riesgos del ácido valproico: estudio de utilización del fármaco en Europa, análisis de datos de España / Effectiveness of risk minimisation measures for valproate: a drug utilisation study in Europe, analysis of data from Spain

Introducción: En 2015 se aplicaron en España distintas medidas para la minimización de los riesgos (MMR) del ácido valproico. Objetivo: El objetivo de este estudio es evaluar la eficacia de las MMR del ácido valproico en España, con el fin de reducir el uso de ácido valproico como terapia de primera línea y evaluar los patrones de prescripción de ácido valproico en las mujeres, incluidas las mujeres en edad fértil (MEF), en los períodos previos y posteriores a la implementación de las MMR. Materiales y métodos: Los patrones de prescripción del ácido valproico en mujeres y MEF antes y después de la implementación de las MMR se examinaron utilizando la base de datos longitudinales de pacientes (longitudinal patient data, LPD por sus siglas en inglés), que incluye información de pacientes de dos paneles: médicos de atención primaria (MAP) y neurólogos/psiquiatras. El criterio principal de valoración fue la proporción de prescripciones iniciales de ácido valproico con al menos un medicamento relacionado con indicaciones de ácido valproico antes de la fecha de inicio del ácido valproico. Resultados: La proporción de prescripciones de ácido valproico secundarias con uso previo de medicamentos relacionados con indicaciones de ácido valproico fue del 78% –intervalo de confianza (IC) al 95%: 73,9-81,5%– y del 78,2% (IC al 95%: 74,5-81,4%) en los períodos principales previo y posterior a la implementación en el panel de MAP. Las cifras correspondientes a MEF fueron del 79,6% (IC al 95%: 73,6-84,5%) y del 75,5% (IC al 95%: 69,7-80,6%), respectivamente. La tasa de incidencia de embarazos expuestos al ácido valproico (por 1.000 personas-años) en MEF disminuyó de 17,4 en el período completo previo a la implementación a 8,5 en el período completo posterior a la implementación...(AU)

Introduction: Risk minimisation measures for valproate were implemented in Spain in 2015.Objective: The objective of this study is to assess the effectiveness of valproate risk minimisation measures in Spain intended to decrease the use of valproate as a first-line therapy, and to evaluate the prescribing patterns of valproate in women, including women of childbearing potential, in the pre- and post-implementation risk minimisation measures periods. Materials and methods: The prescribing patterns of valproate in females and women of childbearing potential before and after risk minimisation measures implementation were examined using the longitudinal patient data database, which includes patient information from two panels: primary care physicians and neurologists/psychiatrists. Primary endpoint was the proportion of initial valproate prescriptions with at least one medication related to the valproate indications before the valproate initiation date. Results: The proportion of incident valproate prescriptions with previous use of medication related to valproate indications was 78.0% (95% CI, 73.9%; 81.5%), and 78.2% (74.5%; 81.4%) in the main pre-and post-implementation periods in the primary care physician panel. The corresponding figures for women of childbearing potential were 79.6% (73.6%; 84.5%) and 75.5% (69.7%; 80.6%), respectively. The incidence rate of pregnancies exposed to valproate (per 1,000 person-years) in women of childbearing potential decreased from 17.4 the entire pre-implementation to 8.5 in the entire post-implementation periods. Conclusion: After the implementation of risk minimisation measures for valproate in Spain, no meaningful change in prescribing was observed regarding the proportion of valproate initiations preceded by prior medication related to valproate indications. The preventative measures recommended for use of valproate in women of childbearing potential should be considered.(AU)