Impacto de la adición de pictogramas farmacéuticos como ayuda visual sobre la comprensión de prospectos en estudiantes de educación secundaria / Impact of the addition of pharmaceutical pictograms as visual aids on the comprehension of package inserts in students completing secondary education

Introducción: La Atención Farmacéutica requiere que los pacientes comprendan la información brindada. La inclusión de ayudas visuales podría mejorar la comprensión de textos complejos como son los prospectos de los medicamentos. Nuestro objetivo fue evaluar los efectos de la inclusión de pictogramas farmacéuticos sobre la comprensión de instrucciones elementales para el uso de medicamentos por estudiantes que finalizan la enseñanza básica. Método: De un total de 309 alumnos participantes, se aleatorizaron 160 para leer tres prospectos de medicamentos de uso frecuente (ibuprofeno, amoxicilina/ácido clavulánico y omeprazol), mientras que 149 recibieron pictogramas junto a los prospectos. La aleatorización fue alterna según la posición de los alumnos en el aula. La comprensión fue estimada mediante cuestiones básicas del uso de medicamentos. Resultados: En el grupo control solo el 38.75% de los alumnos contestaron correctamente cuándo tomar el ibuprofeno en relación a las comidas el 32.25% acertaron cual es la dosis habitual del antibiótico y el 61.88% identificó la indicación del omeprazol. En los tres casos, se encontraron diferencias significativas en favor de la comprensión en el grupo experimental (OR = 1.93; 95% IC, 1.23 – 3.05; p = 0.0041, OR = 3.87; 95% IC, 2.43 – 6.25; p = 10-7 y OR = 3.55; 95% IC, 2.07 – 6.29; p = 3.67x10-5 respectivamente). Conclusiones: La inclusión de pictogramas farmacéuticos en los prospectos es una estrategia sencilla que podría potencialmente favorecer el uso racional del medicamento. (AU)

Introduction: Pharmaceutical Care requires that patients understand the information provided. The inclusion of visual aids could improve the comprehension of complex texts such as drug package inserts. Our objective was to evaluate the effects of the inclusion of pharmaceutical pictograms on the comprehension of elementary instructions for the use of drugs by students completing basic education. Methods: Among a total of 309 participating students, 160 were randomized to read three frequently used drug package inserts (ibuprofen, amoxicillin/clavulanic acid and omeprazole), while 149 received pictographs together with the package inserts. Randomization was alternated according to the position of the students in the classroom. Comprehension was estimated by means of basic questions on the use of drugs. Results: In the control group only 38.75% of the students answered correctly when to take ibuprofen in relation to meals, 32.25% were right about the usual dose of the antibiotic and 61.88% identified the indication for omeprazole. In all three cases, significant differences in favor of understanding were found in the experimental group (OR = 1.93; 95% CI, 1.23 - 3.05; p = 0.0041, OR = 3.87; 95% CI, 2.43 - 6.25; p = 10-7 and OR = 3.55; 95% CI, 2.07 - 6.29; p = 3.67x10-5 respectively). Conclusions: The inclusion of pharmaceutical pictograms in package inserts is a simple strategy that could favor potentially the rational use of drugs. (AU)

Impacto en la producción de material contaminante y eficiencia del reetiquetado respecto al reenvasado de medicamentos / The environmental impact of relabeling process compared with the unitary dose repackaging

Objetivo: Analizar el impacto en la producción de material contaminante y la eficiencia del reetiquetado con el programa Dale color a tu dosis unitaria respecto al reenvasado. Método: Se analizó la cantidad de material empleado en la elaboración de 100.000 dosis unitarias mediante reetiquetado y reenvasado para calcular el ahorro de material obtenido con el proceso de reeetiquetado. Además, se midió el espacio ocupado por el material contaminante generado en ambos procesos y se realizó una estimación de la producción en función de la capacidad del hospital. Se calculó el coste asociado al material empleado en ambos procesos para el acondicionamiento de 100.000 dosis unitarias, así como el de la maquinaria necesaria para reetiquetar y reenvasar durante 20 años. Resultados: Se generaron 2,11-4,54 kg de plástico en el reetiquetado de 100.000 dosis unitarias (según el formato de etiqueta), y 67,82 kg de material contaminante para la misma cantidad de reenvasados, siendo el reetiquetado 15-32 veces menos contaminante en peso. Además, el reetiquetado supuso un ahorro de 620,64-702,43 m2 de material contaminante (6-13 veces menos contaminante en espacio). Un hospital de tercer nivel que elabore 1-2 millones de reenvasados al año, produciría anualmente hasta 1.356,40 kg de material contaminante. En cuanto a los costes, el reetiquetado supuso un ahorro de material del 89% (1.580 €), y del 98,2% (17.830 €) en cuanto a la amortización de la maquinaria durante 20 años. Conclusiones: El reetiquetado parece ser una alternativa más eficiente y respetuosa con el medio ambiente en materia de generación de residuos contaminantes respecto al reenvasado. (AU)

Objective: To analyze the environmental impact of relabeling process with “Color your unitary dose” program and the efficiency compared to the traditional repackaging. Method: The contaminating material used in the relabeling and repackaging of 100,000 unitary dose was calculated. In addition, the area occupied by the contaminating material produced in both processes was measured to determinate the saving of material with the relabeling process, and an approximate estimation of material production was made according to the hospital capacity. The cost associated to the material required in both processes and the machinery needed to relabeling and repackaging during 20 years was evaluated. Results: The contaminating material used in the relabeling of 100,000 unitary dose was 2.11 kg and 4.54 kg of plastic (depending on the label model used), and 67.82 kg (plastic, aluminum and tracing) in the traditional repackaging process. The area occupied by the contaminating material produced in both processes was 56.81 m2 and 138.60 m2 (relabeling), and 759.24 m2 (repackaging), which means a saving of 620.64 m2 and 702.43 m2 of contaminating material (15-32 times less polluting in weight and 6-13 times, in space). A third level hospital that repackages 2 million unitary dose would annually produce around 1,356.40 kg. A saving of 89% (1,580 €) of material used was obtained with the relabeling, and 98.2% (17,830 €) in terms of the cost of amortization of the machinery necessary for 20 years. Conclusions: The relabeling was an efficient and less polluting process than the traditional repackaging system, so we should only use it for medications that can not be relabelled. (AU)

La seguridad de las cosas sencillas / The security of simple things

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Guessability of U. S. pharmaceutical pictograms in Iranian prospective users

OBJECTIVE: This study examined the gueassability of US pharmaceutical pictograms as well as associated demographic factors and cognitive design features among Iranian adults. METHODS: A total of 400 participants requested to guess the meaning of 53 US pharmaceutical pictograms using the open-ended method. Moreover, the participants were asked to rate the cognitive design features of each pictorial in terms of familiarity, concreteness, simplicity, meaningfulness and semantic closeness on a scale of 0-100. RESULTS: The average guessability score (standard deviation) was 66.30 (SD=24.59). Fifty-five percent of pharmaceutical pictograms understudy met the correctness criteria of 67% specified by ISO3864, while only 30% reached the criterion level of 85% set by ANSIz535.3. Low literate participants with only primary school education had substantial difficulty in the interpretation of pharmaceutical pictograms compared to those completed higher education levels. Younger adults of <30 years significantly performed better in the interpretation of pharmaceutical pictograms as compared to >31 years old participants. 'Home patient care' and 'daily medication use' had no effect on guessability performance. Concerning cognitive design features, meaningfulness better predict geussability score compared to the others. CONCLUSIONS: Several USP pictograms fail to be correctly interpreted by Iranian users and need to be redesigned respecting cognitive design features. Interface designers are recommended to incorporate more familiar and concrete elements into their graphics in order to create more meaningful pictorial symbols and to avoid any misinterpretation by the user. Much effective medication use is expected to be achieved by means of this approach, through the improvement of the communication property of pharmaceutical pictograms

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Efectos del cambio de apariencia de medicamentos en seguridad y adherencia en pacientes crónicos mayores de 65 años en atención primaria. Estudio CAMBIMED / Effects of changing the appearance of medications in safety and adherence in chronic patients over 65 years of age in primary care. CAMBIMED Study

OBJETIVO: Estudiar si en pacientes mayores de 65años con tratamientos antihipertensivos e hipolipemiantes los cambios de fármacos bioequivalentes con diferente apariencia se asocian a un aumento de errores de uso y pérdida de adherencia al tratamiento. DISEÑO: Estudio observacional, longitudinal, prospectivo, de cohorte de 1año de seguimiento entre el 1 de enero de 2013 y el 31 de diciembre de 2014. Emplazamiento: Centros de Salud de la Comunidad de Madrid. PARTICIPANTES: Pacientes ≥ 65 años con diagnóstico de HTA (CIAP K86) y/o dislipidemia (CIAP T93) en tratamiento con enalapril y/o amlodipino y/o simvastatina. Mediciones principales: Se recogieron mediante entrevista en consulta variables sociodemográficas (edad, sexo, nivel de estudios), clínicas, adherencia (test de Morisky-Green y recuento directo), errores de medicación (número y tipo), cambios de fármacos y número, parámetros bioquímicos (colesterol total, colesterol HDL, colesterol LDL, triglicéridos) y variable combinada (error y/o adherencia). Se realizaron 5 visitas: una basal y 4 trimestrales. RESULTADOS: Se incluyeron 274 pacientes, edad media 72 (6,6) años, 47,8% mujeres. Presentaron algún cambio de medicamento 134 pacientes (48,9%), con una mediana de cambios de 3 (RIQ 1-5) y máximo de 11. El riesgo de presentar algún error o disminuir la adherencia estaba aumentado en expuestos a cambios en todas las visitas con RR 1,14 (1,16-1,69) al año de seguimiento. El error más frecuente fue la pérdida de dosis. Por cada cambio la probabilidad de un evento combinado aumenta en un 41%. CONCLUSIONES: Los cambios realizados entre fármacos bioequivalentes con diferente apariencia podrían aumentar el número de errores de medicación y disminuir la adherencia. Habría que realizar más estudios para valorar en qué medida afecta al control de la enfermedad. No se contempla el apartado intervención por tratarse de un estudio observacional

OBJECTIVE: To study whether the changes in bioequivalent drugs with different appearances are associated with an increase in lack of adherence and medication use errors, in patients > 65 years old treated with antihypertensive and lipid-lowering medications. DESIGN: Observational longitudinal prospective cohort study with a one-year follow-up period between 1 January 2013 and 31 December 2014. LOCATION: Primary Healthcare Centres in the Community of Madrid. PARTICIPANTS: Patients ≥ 65 years-old with a diagnosis of hypertension and/or dyslipidaemia receiving treatment with Enalapril and/or Amlodipine and/or Simvastatin. MAIN MEASUREMENTS: Variables collected during a Primary Care consultation by means of a personal interview were: sociodemographic (age, gender, level of education), clinical variables, adherence (Morisky-Green test and direct counting), medication errors (number and type), medication changes and number, analytical (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) and combined variable (error and/or adherence). There were 1 baseline and 4 quarterly visits. RESULTS: The study included 274 patients with a mean age 72 (6.6) years, of whom 47.8% were female. Some medication changes were observed in 134 patients (48.9%), with a median of 3 (IQR 1-5) and a maximum of 11 changes. The risk of presenting with a medication use error or decreased adherence was increased in patients exposed to changes in all visits with RR 1.14 (1.16-1.69) at one year of follow-up. The most frequent error was the loss of dose. For each change in medication, the probability of a combined event increases by 41%. CONCLUSIONS: The changes made in bioequivalent drugs with different appearance could increase the number of medication use errors and decrease the adherence. More studies should be carried out to assess how much this affects the control of the disease. The intervention section is not considered because it is an observational study

Uso de medicamentos en condiciones no aprobadas en cuidados intensivos neonatales / Use of off-label drugs in neonatal intensive care

Objetivo: Evaluar la prevalencia de prescripciones en condiciones no autorizadas (off-label y unlicensed) en una Unidad de Cuidados Intensivos Neonatales (UCIN) y definir qué características de los neonatos se asocian a un mayor uso de fármacos en estas condiciones. Material y métodos: Estudio observacional prospectivo en una UCIN nivel III-C durante un periodo de 6 meses. Se evaluó la condición de uso de cada fármaco, tomando como referencia su ficha técnica. Se utilizó un algoritmo secuencial para la clasificación de las prescripciones en: aprobadas, unlicensed u off-label (por edad, por indicación, por vía de administración, y por dosis). Resultados: Se incluyeron 84 pacientes y 564 prescripciones. Un total de 127 prescripciones fueron consideradas off-label y 45 unlicensed; lo cual supuso el 22,5% y el 8% del total, respectivamente. El 59,5% de los pacientes recibieron al menos un fármaco en una de estas condiciones, ascendiendo este porcentaje al 100% en los grandes prematuros y en los pacientes quirúrgicos (p < 0,001). Se encontró una correlación lineal positiva entre la estancia en UCIN y el número de prescripciones off-label (coeficiente de correlación 0,6 p < 0,001). Conclusiones: La prescripción de fármacos en condiciones no autorizadas es habitual en UCIN, siendo especialmente frecuente en los pacientes con mayor vulnerabilidad. Estos resultados ponen de manifiesto la necesidad de avanzar en la investigación y homogeneizar la información existente sobre los fármacos en neonatología, con el objetivo de realizar una prescripción eficaz y segura

Objective: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. Materials and methods: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). Results: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P < .001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P < .001). Conclusions: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription

Investigating the efficacy of an interactive warning for use in labeling strategies used by us pharmacies

Background: United States pharmacies repackage medications into multi-dose vials, enabling customized dosing for prescription drugs. Investment in infrastructure has made this the predominant approach to packaging for US prescriptions. Although recent changes to labeling now discourage the use of auxiliary labels (small stickers highlighting information germane to the safe and effective use), they are still allowed by USP<17>, provided their use comes from an evidence-based perspective. Objectives: Evaluate how 'interactive,' placements of auxiliary labels (placement requiring physical manipulation of the warning to accomplish a task (e.g. opening)) garner attention as compared to those placed vertically or horizontally. Methods: Ninety-six participants were eye tracked while opening three prescription vials (each with an auxiliary warning label with a different placement: vertical, horizontal and interactive). Recall and recognition were tested subsequently. Linear mixed models were used to analyze the continuous variables while the binary response variables were analyzed using generalized linear mixed models. The effect of auxiliary labels was fitted as a fixed effect and the subject-to-subject variation was considered as a random effect in the model. Participants' age, health literacy and sex were added to the models if their effect was statistically significant at alpha=0.05. Results: The placement of the warnings significantly impacted the time spent viewing the information they contained at alpha=0.05; people spent significantly longer on interactive placements (0.96; SD 0.13 seconds) than either, horizontal placements (0.27; SD 0.037 seconds) or those placed vertically (0.18 seconds; SD 0.035). Participants were equally as likely to see information presented in an interactive placement (90%; SD 3.8) or horizontal placement (78%; SD 05.5) but less likely to view warnings placed vertically (60%; SD 6.9). Free recall responses also supported the use of interactive placement (62%; SD 6.8 recall) as compared to horizontal placements which were 29%; SD 3.0 and 20%; SD 6.0 for vertical placements. Conclusions: Data provides evidence which suggests that interactive and horizontal placements out-perform auxiliary labels placed vertically on prescription vials with regard to garnering patient attention

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Neurotoxicidad de la anestesia general, niños menores de 3 años y la FDA: ¿cuál es el alcance de la alarma? / Neurotoxicity of general anaesthesia in children younger than 3 years and FDA: how far is the warning?

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Fármacos biosimilares: un nuevo escenario en las terapias biológicas / Biosimilars: a new scenario in biologic therapies

No cabe duda de que los productos biológicos aportan un valor añadido a los sistemas de salud, aunque también plantean grandes interrogantes debido a su especial naturaleza, lo que obliga a ser muy rigurosos y exigentes en su control de calidad y seguimiento. Este hecho se ha visto reforzado por la entrada en escena de los fármacos biosimilares, cuyo menor coste está permitiéndoles alcanzar un mayor protagonismo en el mercado mundial. El propósito de este artículo es revisar en profundidad los principales interrogantes que se plantean en su producción, distribución y control, así como los aspectos más importantes relacionados con su seguridad en la práctica clínica. En este trabajo revisamos lo que representa la farmacovigilancia de estos productos, prestando especial atención a su trazabilidad, como herramienta fundamental para la detección precoz de acontecimientos adversos (AU)

There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events (AU)

Trazabilidad de medicamentos oncohematológicos a través de códigos de captura de datos / Traceability of oncohematological drugs through data capture codes

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Medicamentos: cuando las apariencias engañan. Propuesta de norma para que los pacientes puedan identificar claramente los medicamentos, especialmente los que tienen la misma composición pero distintos nombres y aspectos que llevan a confusión / Drugs: When appearances mislead. Proposed standard for patients to clearly identify medications, especially those with the same composition but with different names and aspects that lead to confusion

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Improving pediatric liquid medication labeling of the hospital information system in Malaysia: qualitative analysis of pharmacists' perceptions

Background: Inadequacies of drug labeling have been frequently reported among Malaysian healthcare institutes, in which the Hospital Information System (HIS) is used. Objective: To identify potential areas to improve the existing labels used for pediatric liquid medications. Methods: This study was qualitative in nature, whereby focus group discussions (FGDs), face-to-face interviews (FTFIs), and onsite observation were used for data collection. Pharmacists stationed at three units (outpatient, inpatient and clinical pharmacy) of a tertiary hospital were targeted. Both FGDs and FTFIs were facilitated using a semi-structured interview guide, video-recorded and transcribed verbatim. All transcripts were thematically analyzed using content analysis approach. Results: Thirteen pharmacists participated in FGDs, while five were approached for FTFIs. Data analysis resulted in four major themes: format of labels, presentation of medication instructions, insufficiency of information, and the need for external aids and education. Participants unanimously agreed on the need for enlarging font sizes of key information. Suggestions were made to use more specific instructions for administration times and pictograms to illustrate important directions. The absence of information about storage, stability and handling of liquid medications was also highlighted. While discussion mainly focused on improving drug labeling, participants consistently stressed the need for an instruction sheet and pharmacist-based, one-to-one education regarding medication instructions. Conclusion: This study provides important insights into critical shortcomings in current labeling practice, underlying the need for developing a new label that incorporates a new format, additional information and pictograms for pediatric liquid medications (AU)

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Patients' views on electronic patient information leaflets

Background: Information in society and in health care is currently undergoing a transition from paper to digital formats, and the main source of information will probably be electronic in the future. Objective: To explore patients’ use and perceptions of the patient information leaflet included in the medication package, and their attitude towards a transition to an electronic version. Methods: The data was collected during October to November 2014 among individuals in South-Eastern Sweden, using a questionnaire (n=406, response rate 78%) and interviews (n=15). Results: The questionnaire showed that the majority of the respondents (52%) occasionally read the patient information leaflet, 37% always read it, and 11% never read it. Almost half of the patients (41%) were positive towards reading the patient information leaflet electronically while 32% were hesitant and 26% neutral. A majority of the patients would request to get the patient information leaflet printed at the pharmacy if it was not included in the package. There were differences in attitude related to age and gender. The interviews showed that patients had mixed views on a transition to an electronic patient information leaflet. The patients perceived several positive aspects with an electronic patient information leaflet but were concerned about elderly patients. Conclusion: Although many were positive towards reading the patient information leaflet electronically, the majority prefer the patient information leaflet in paper form. Providing appropriate and useful eHealth services for patients to access the patient information leaflet electronically, along with education, could prepare patients for a transition to electronic patient information leaflet (AU)

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Assessment of the quality of sample labelling for clinical research / Evaluación de la calidad del etiquetado de muestras para investigación clínica

Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors (AU)

Objetivo: Evaluar la calidad de las etiquetas de muestras para ensayos clínicos mediante la normativa vigente y analizar su posible correlación con las características específicas de cada muestra. Método: Estudio transversal multicéntrico en el que se analizaron las muestras de ensayos clínicos de dos hospitales de tercer nivel. Se estudió la presencia de los once ítems de la Directiva 2003/94/CE, el nombre del ensayo y la dosis en la portada de la etiqueta como variables de calidad del etiquetado. Se analizó la influencia de las características propias de la muestra con la calidad del etiquetado. Resultado: Se analizaron un total de 503 muestras de 220 ensayos. La calidad media del etiquetado, entendido como el porcentaje de ítems del Anexo 13, fue del 91,9%. El 6,6% no contenía el nombre de la muestra en la cara externa de la etiqueta, mientras que a un 9,7% les faltaba la dosis. Las muestras con presentación de tipo ensayo clínico presentaron mayor calidad (p < 0,049), el enmascaramiento disminuía la calidad (p = 0,017) y la identificación por número de kit o por paciente la aumentaban (p < 0,01). La variable promotor fue la que más variabilidad introdujo en el análisis. Conclusiones: La calidad media del etiquetado es adecuada en la mayoría de las muestras del ensayo clínico. Resulta preocupante la ausencia de información esencial, como el código del ensayo clínico y el período de validez, en algunas muestras que pueden ser fuente potencial de errores de dispensación o de administración (AU)

Inclusion of salt form on prescription medication labeling as a source of patient confusion: a pilot study

Background: It has been estimated that 10,000 patient injuries occur in the US annually due to confusion involving drug names. An unexplored source of patient misunderstandings may be medication salt forms. Objective: The objective of this study was to assess patient knowledge and comprehension regarding the salt forms of medications as a potential source of medication errors. Methods: A 12 item questionnaire which assessed patient knowledge of medication names on prescription labels was administered to a convenience sample of patients presenting to a family practice clinic. Descriptive statistics were calculated and multivariate analyses were performed. Results: There were 308 responses. Overall, 41% of patients agreed they find their medication names confusing. Participants correctly answered to salt form questions between 12.1% and 56.9% of the time. Taking more prescription medications and higher education level were positively associated with providing more correct answers to 3 medication salt form knowledge questions, while age was negatively associated. Conclusions: Patient misconceptions about medication salt forms are common. These findings support recommendations to standardize the inclusion or exclusion of salt forms. Increasing patient education is another possible approach to reducing confusion (AU)

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Quality of drug information for healthcare professionals: the ARCA acronym / Calidad de la información sobre medicamentos para profesionales de la salud: el acrónimo ARCA

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Análisis causal e impacto de un error sistemático detectado en el consumo de trastuzumab / Causal analysis and impact of a systematic error detected about consumption associated with trastuzumab

Objetivo: determinar la causa de la diferencia constante entre las unidades teóricas de trastuzumab consumidas y las reales en una unidad de mezclas intravenosas. Métodos: se realizó un estudio del procedimiento completo manual y electrónico de la preparación de mezclas con trastuzumab mediante observación visual y revisión de los datos de control cuantitativo proporcionados por el sistema electrónico de preparación asistida y segura de la aplicación Farmis-Oncofarm. Resultados: se encontró diferencia entre el volumen óptimo del vial de trastuzumab que informa la ficha técnica del producto y el contenido en la ficha del medicamento de la aplicación. Además se encontró un defecto del volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución del vial. Conclusiones: el defecto de volumen óptimo de las jeringas de 10 ml utilizadas en el proceso de reconstitución es la causa del mayor número de viales reales consumidos en la preparación de mezclas con trastuzumab. Esto produce un impacto económico muy importante, estimando un sobrecoste anual de aproximadamente 46.508 Euros, sin provocar consecuencias negativas en el paciente (AU)

Objective: determine the cause of the constant difference between the theoretical and real number of trastuzumab units consumed in an Intravenous Mixtures Unit. Methods: was studied the manual and electronic full procedure about preparing mixtures with trastuzumab. Was performed by visual observation and review of quantitative monitoring data from the electronic preparation support and safe system of the application Farmis-Oncofarm. Results: difference between the optimum volume of trastuzumab contained in the summary of product characteristics and the same included in Farmis_Oncofarm was found. Also found a defect of the optimum volume of 10ml syringes used in the reconstitution vials process. Conclusions: the default in the optimal volume of 10ml syringes used in the reconstitution process increases the real consumed units of trastuzumab. This produces a significant economic impact calculated in an annual additional cost in approximately 46.508 Euros without negative consequences for the patient (AU)

An overview of upcoming changes in pregnancy and lactation labeling information / Revisión de los próximos cambios en la información sobre medicamentos en embarazo y lactación

Background: Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined with the generalizations of the current risk category system (A, B, C, D, X) makes risk versus benefit assessment difficult. Discussion: In response to these concerns, the U.S. Food and Drug Administration (FDA) has decided to implement a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers; this rule is set to take effect in June of 2015. This change is designed to provide clear and detailed information for both patients and healthcare providers pertaining to three main categories: pregnancy, lactation, and females and males of reproductive potential. The new labeling rule also removes the previous letter risk categorization system. Conclusion: The upcoming changes regarding pregnancy and lactation safety labeling are going to have a vast impact on drug safety interpretation and prescribing practices. While this rule will provide practitioners with more detailed information pertaining to pregnancy, lactation, and reproduction, it will also place more responsibility on the practitioners to ensure the safety of their patients. This review will summarize these changes and discuss their potential effect on clinical practice (AU)

Antecedentes: Muchos medicamentos pueden ser utilizados con seguridad y efectividad para mejorar la salud en la gestión de enfermedades durante el embarazo con mínimo riesgo para la madre o el feto. Hoy, 9 de cada 10 mujeres toman al menos un medicamento durante el embarazo, y el número de ellas que toma 4 o más medicamentos se ha más que doblado en los últimos 30 años. Sin embargo, la falta de datos de seguridad, combinada con las generalizaciones de la actual categoría de riesgos (A, B, C, D, X) hace difícil la evaluación riesgo contra beneficio. Discusión: En respuesta a estas preocupaciones, la U.S. Food and Drug Administration (FDA) ha decidido implantar una nueva regla de información en embarazo y lactación diseñada para mejorar la evaluación riesgo contra beneficio de los medicamentos usados em madres embarazadas o lactando; esta regla entrará en vigor en junio de 2015. Este cambio está diseñado para proporcionar una información clara y detallada tanto para pacientes como para profesionales de la salud comprendiendo 3 apartados principales: embarazo, lactación, y potencial reproductivo masculino y femenino. La nueva información elimina el anterior sistema de categorización por letras. Conclusión: Los próximos cambios en la información de seguridad de embarazo y lactación van a producir un gran impacto en la interpretación de la seguridad en las prácticas de prescripción. Mientras esta regla proporcionará a los facultativos una información más detallada sobre embarazo, lactación y reproducción, también les dará más responsabilidad para asegurar la seguridad de sus pacientes. Esta revisión resume estos cambios y discute sus efectos potenciales sobre la práctica clínica (AU)

Resultados comunicados por el paciente en las fichas técnicas de medicamentos aprobados en España durante el período 2000-2012 / Review of patient reported outcomes in the summary of the product characteristics of medicines approved in Spain

Fundamentos: El término Patient Reported Outcomes (PRO) es definido como el resultado de la evaluación de un medicamento por el paciente y basada en su percepción de la enfermedad y su(s) tratamientos(s). El objetivo del estudio es determinar la utilización de PRO y compararla con otros tipos de variables de la eficacia contenidas en las fichas técnicas (FT) de medicamentos. Métodos: Revisión y análisis descriptivo de las variables de eficacia utilizadas en los ensayos clínicos de principios activos aprobados en España durante el período 2000-2012, descritas en las fichas técnicas clasificándolas en las siguientes categorías: PRO, resultados informados por el clínico (CRO) y resultados finales basados en pruebas de laboratorio (ML). Para las comparaciones se realizaron la prueba chi2 o la prueba exacta de Fisher, y se calcularon odd ratios para valorar la intensidad de la asociación Resultados: De las 330 FT estudiadas se incluyeron PROs en 65 (19,7%), los CRO en 188 (57%) y los ML en 128 (38,7%). Los PRO se utilizaron como único resultado final de eficacia en 6 medicamentos. Se observó una tendencia creciente de la significación estadística en la utilización de PRO a lo largo del tiempo estudiado (R2=0,525; p=0,079). Conclusiones: La frecuencia de utilización de PRO en FT es claramente inferior a la de las otras medidas de la eficacia, siendo la diferencia significativamente mayor en el caso de su inclusión como variable única final. La utilización de PROs fue más frecuente en medicamentos del sistema nervioso, agentes inmunomoduladores, sistema respiratorio y sistema musculoesquelético (AU)

Background: The term "Patient Reported Outcomes" (PRO) is defined as any result assessed directly by the patient and based on his perception of the illness and its treatment. The scope of the study is to determine and compare the use of PRO measures with other types of effectiveness endpoints in the summary of the products characteristics (SPC) of medicines with active substances approved by first time from 2000 to 2012 in Spain. Methods: A review and descriptive analysis of the effectiveness endpoints used in the clinical trials described in the SPCs studied, classifying them into the following categories: PRO, clinician-reported outcomes (CROs), and laboratory test/device measurement endpoints (ML). Chisquare and Fisher exact texts were used for comparative purposes, and odds ratio to determine the strongest of association. Results: PROs were included in 65 (19.7%) of the SPCs studied. CRO were the most frequently reported 188 (57%) cases, followed by ML: 128 (38,7%). PROs were included as only effectiveness endpoint in 6 medicines. A growing trend toward statistical significance (R2=0.525; p=0.079) has been observed in reporting PROs during the period of time studied. Conclusion: The use frequency of PRO in SPCs is clearlyminor compared to other efficacy endpoints considered, being the difference significantly higher in case of its use as only efficacy endpoint. The therapeutic areas where PROs were most reported were nervous system medicines, immunologic system modulator medicines, respiratory system, muscle and skeleton system (AU)

Utilidad y satisfacción de los pacientes de un instrumento educacional en dolor irruptivo oncológico: resultados preliminares / Usefulness and patient satisfaction with an educational tool on breakthrough cancer pain: preliminary results

JUSTIFICACIÓN: El dolor oncológico irruptivo se define como una exacerbación transitoria de dolor que aparece con un dolor basal adecuadamente controlado. Una nueva generación de fármacos (fentanilo) de absorción transmucosa mimetizan las características del dolor irruptivo, proporcionando un perfil analgésico ideal. Una correcta educación del paciente sobre las características del dolor y el modo de titulación de estos fármacos es esencial para un abordaje satisfactorio. OBJETIVO: Evaluar el grado de comprensión y utilidad que los pacientes otorgan a una hoja de información y soporte a la titulación (HIT) creada para facilitar la comprensión del empleo y titulación del fentanilo nasal en pectina. MATERIAL Y MÉTODO: Inclusión consecutiva de pacientes que ya habían completado el proceso de titulación y a los que se les había entregado la hoja informativa (HIT) para evaluar mediante encuesta su grado de comprensión y satisfacción. RESULTADOS: De los 20 pacientes incluidos, 2 no la habían utilizado como material de consulta. De los restantes, todos la consultaron al menos en una ocasión, el 85% la consideró muy útil y el 80% muy comprensible. El 33% sugirió modificaciones menores

JUSTIFICATION: Breakthrough cancer pain is defined as a transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain. Anew generation of drugs (fentanyl) with transmucosal absorption mimic the characteristics of breakthrough pain by providing an ideal analgesic profile. Good patient education on pain characteristics and the mode of titration of these drugs is essential for a successful approach. OBJECTIVE: To evaluate the degree of understanding and usefulness that patients given to a titration sheet created to facilitate the use and titration of nasal fentanyl pectin. METHODS: Twenty consecutive patients who had completed the titration and had received the titration sheet were included. A survey was used to assess their satisfaction. RESULTS: Of the 20 patients enrolled, 2 had not consulted the titration sheet because they were happy enough with the verbal instructions given. Of the rest, all had consulted it at least once, 85% considered it very useful and 80% very understandable and 33% suggested minormodifications