Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005-2010 period.

BACKGROUND: Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. METHODS: Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country's Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. RESULTS: Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. CONCLUSIONS: Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients.

Eventos adversos derivados del cuidado brindado en la Unidad de Cuidados Intensivos Adultos del Hospital Universidad del Norte. Barranquilla (Colombia) / Adverse Events Resulting from Care Provided on Adult Intensive Care Unit

Objetivo: Determinar los eventos adversos derivados del cuidado brindado en la Unidad de Cuidados Intensivos del Hospital Universidad del Norte (en Barranquilla) en el periodo enero-diciembre de 2012. Materiales y métodos: Estudio descriptivo transversal retrospectivo. La muestra se obtuvo mediante un muestreo sistemático, a partir de un listado ordenado de todas las personas ingresadas al Hospital Universidad del Norte (HUN) en los servicios de Urgencias, Hospitalización, Cirugía, UCI Adultos, UCI Neonatal, Gineco-Obstetricia, Consulta Externa, Radiología y Laboratorio que hubieran sufrido algún evento adverso ocurrido entre enero a diciembre de 2012. La información se obtuvo mediante la base de datos del Hospital Universidad del Norte. Para el análisis se utilizó Microsoft Excel 2010. Resultados: Durante 2012 se presentaron 130 (25 %) casos de eventos adversos; siendo el segundo servicio con mayor número de eventos, después de Hospitalización. Las tres primeras causas de eventos adversos fueron: la infección nosocomial, con un 25 %; las úlceras por presión, con en un 18 %, y la neumonía asociada a ventilación mecánica, con un 16 %. Conclusiones: Los eventos adversos que más son reportados en las unidades de cuidados intensivos adultos son aquellos que ocurren cuando hay una mayor intervención en el paciente. Condiciona la aparición de eventos adversos un personal sanitario con déficit de conocimientos y falta de preparación. La ocurrencia de estos eventos adversos pone en peligro la vida de los seres humanos, debido a que empeoran su condición, produce sobrecosto y al profesional le genera sobrecarga laboral y afectiva.

Objective: To determine adverse events arising from care provided in the Intensive Care Unit of Hospital Universidad del Norte (Barranquilla), January to December 2012. Materials and methods: A retrospective cross-sectional study. The study sample was obtained using a systematic sampling from an ordered list of all persons admitted to the University Hospital North in Emergency services, Hospitalization, Surgery, UCI Adult, Neonatal UCI, Gynecology and Obstetrics, Outpatient, Radiology and Laboratory who have suffered an adverse event occurred in the period from January to December 2012. The information was obtained from the database of the Hospital Universidad del Norte. For the analysis we used Microsoft Excel 2010. Results: In the intensive care unit of the Hospital Universidad del Norte in 2012, there were 130 (25 %) cases of adverse events, the second highest number of service events after hospitalization. The three leading causes of adverse events were nosocomial infection by 25 %, following pressure ulcers by 18 % and ventilator-associated pneumonia by 16 %. Conclusions: Adverse events are reported more in adult intensive care units are those that occur when there is greater patient involvement. Conditions the occurrence of adverse events with medical staff knowledge deficit and lack of preparation. The occurrence of these adverse events endanger the lives of human beings, as they worsen your condition, generates overhead and professional creates overload and affective.

Uso de inhaladores de dosis medida en pacientes adultos: Necesidad de educación dirigida por enfermería / Handling of Metered Dose inhaler in adult patients: a need of education directed by Professional Nursing

Objetivo: Describir el uso de inhaladores de dosis medida en pacientes adultos de consulta de neumología en dos instituciones de salud de Atlántico (Colombia), 2013. Materiales y métodos: Estudio descriptivo transversal que evaluó 131 pacientes adultos que utilizaban inhaladores de dosis medida (de cartucho presurizado) con inhalocámara o sin esta, asistentes a dos instituciones de salud del departamento del Atlántico. Se diseñó y aplicó un cuestionario que incluía lista de chequeo que permitió evaluar la técnica. Resultados: De 131 pacientes participantes, la media de edad fue de 44,75 años (DE+/-: 17.77). La tasa de éxito en el uso de la técnica fue baja, menos de 1.52% (2) fue perfecto, mientras que un 24.43% (32) tuvo una técnica adecuada y el 74.05% (97) inadecuada. 105 utilizaban inhaladores sin inhalocámara y 26 con inhalocámara. Conclusiones: Existen debilidades en el uso de los inhaladores. El 74.05% de los pacientes los usó inadecuadamente. Los pasos de la técnica de utilización de inhaladores que fallaron mayormente fueron: no exhalar el volumen residual, no comenzar a respirar cuando se activa el canister, no inhalar lento y profundo, no retener el medicamento por 10 segundos no esperar 30 segundos antes del segundo disparo y no agitar nuevamente el dispositivo antes del mismo. Es necesario implementar programas de educación en los que participen profesionales en enfermería.

Objective: To describe the handling of Metered-Dose inhaler (MDI) in adults of the pneu-mology medical consultation located in Atlántico country (Colombia), 2013. Materials and Methods: We conducted a cross-sectional descriptive study which es-timated 131 adults patients that were using MDIs (pressurized inhaler) with or without a holding chamber and were attending into two health institutions located in Atlántico County, Colombia. We designed and applied a questionnaire that contained a checklist that was allowed for the evaluation of the technique. Results: Mean age was 44.75 years (SD +/-: 17.77). The success rate in the use of the technique was low, 1.52% (2) was perfect, 24.43% (32) was adequate and 74.05% (97) inadequate. Out of 131 patients, 105 used inhalers without holding chamber and 26 with holding chamber. Conclusions: There are weaknesses in the Handling of Metered-Dose inhaler (MDI). 74.05% of patients misused the MDI. The technique steps that are often wrongly executed by patients were: not exhale the residual volume, not start breathing when activating the canister, not inhale slowly and deeply, not retain the medication for 10 seconds and not hold the breath, not wait 30 seconds in between puffs and not shake again the inhaler be-fore shooting it for a second time. It needs to implement education programs that involve professional nursing staff.

Desarrollo de inmunoterapia de la leishmaniasis cutánea americana en el Instituto de Biomedicina / The development of inmunotherapy of american cutaneous leishmaniasis at the Instituto de Biomedicina

El desarrollo de la inmunoterapia de la leishmaniasis cutánea americana en el Instituto de Biomedicina, fue un proceso complejo de más de dos décadas que involucró diversas disciplinas. Un aspecto importante fue la comparación de la leishmaniasis cutánea difusa con otras formas clínicas. Este estudio comparativo constituyó la base para proponer un espectro para la leishmaniasis cutánea americana, que se presentó en el Simposium CIBA 20 en 1974. Otra etapa importante fue el estudio de la prueba de competencia, respuesta macrofágica del enfermo de leishmaniasis cutánea difusa a la inyección intradérmica de una suspensión de promastigotes de cultivo de Lishmania. Comparando esta respuesta con la respuesta de estos mismos enfermos a la inyección intradérmica de bacilos de Calmette-Guerin pudimos demostrar que al mezclar ambos antígenos (promastigotes de Leishmania con bacilos de Calmette-Guerin) en una prueba intradérmica, se obtenía un nódulo de estructura tuberculoide con desaparición de los parásitos inoculados; esto sugirió una vacuna combinada para inmunoterapia de leishmaniasis. Esta vacuan fue estudiada en 217 pacientes con leishmaniasis cutánea localizada, en una experiencia doble ciego al azar, en el que se estudió comparativamente la inmunoterapia con quimioterapia, con meglumine antimoniato y con basilos de Calmette-Guerin solos. Los resultados demostraron que no había diferencias estadísticamente significativas entre el tratamiento con inmunoterapia o quimioterapia