ABSTRACT
En 2009, con la implementación del Modelo Nacional de Farmacia Hospitalaria en México, se establece una integración de la disposición de medicamentos en dosis unitaria, donde el reenvasado de medicamentos orales es un punto crítico y medular que debe ser normalizado y estandarizado por la legislación sanitaria mexicana, de tal forma que permita la dispensación de un medicamento de calidad. Para ello, es necesario conocer los datos de estabilidad, compatibilidad e interacciones entre medicamentos y envases utilizados, así como considerar las técnicas con las que se efectúa el reenvasado, con el objetivo de establecer la nueva fecha de caducidad. Se realizó un análisis bibliográfico de la regulación sanitaria en materia de reenvasado, el cual revela que existen imprecisiones conceptuales importantes, debido a que no existe legislación que regule esta actividad en México: todo se desempeña en un marco de recomendaciones y criterios del farmacéutico. Se concluye que la ley debe ser reformada para establecer los criterios mínimos que deben cumplir los hospitales que implementen el sistema de dosis unitaria de medicamentos orales, en materia de infraestructura, equipamiento y profesionales para el cumplimiento de las buenas prácticas en el reenvasado de medicamentos orales. Para ello, se propone implementar una norma oficial mexicana que regule el proceso de reenvasado en dosis unitaria en el que la autoridad sanitaria unifique conceptos, criterios e instrumentos de verificación, mientras la industria farmacéutica desarrolla la tecnología y recursos para el acondicionamiento en dosis unitaria de los medicamentos con formas farmacéuticas orales dirigidos al sector de la salud.
In 2009, with the implementation of the National Hospital Pharmacy Model, Mexico began regulating single-dose drugs. The repackaging of oral drugs is fundamental and critical and should be standardized by Mexican health legislation to enable quality drugs to be dispensed. Data is required on stability, compatibility, drug interactions, containers, and repackaging methods, in order to establish a new expiration date. The literature on health regulations applicable to repackaging was analyzed, revealing major conceptual imprecisions since there is no legislation in Mexico that regulates repackaging; rather, everything is carried out according to pharmacists’ recommendations and criteria. The conclusion is that the regulations need to be rewritten to establish minimum single-dose oral drug criteria for dispensing hospitals—regulations that cover infrastructure, equipment, and professionals complying with good practices in oral drug repackaging. A proposal is offered to implement an official Mexican standard that regulates single-dose repackaging and unifies concepts, criteria, and means of verification, while the pharmaceutical industry would be responsible for the technology and resources for single- dose drug packaging designed for the health sector.
Subject(s)
Legislation as Topic , Health Policy , Health Care Reform , Diagnosis of Health Situation , Mexico , Quality Control , Legislation as Topic , Health Policy , Health Care Reform , Diagnosis of Health SituationABSTRACT
Background. During the 2009 spring epidemic outbreak in Mexico, an important research and policy question faced was related to the differences in clinical profile and population characteristics of those affected by the new H1N1 virus compared with the seasonal virus. Methods and Findings. Data from clinical files from all influenza A deaths in Mexico between April 10 and July 13, 2009 were analyzed to describe differences in clinical and socioeconomic profile between H1N1 and non-H1N1 cases. A total of 324 influenza A mortality cases were studied of which 239 presented rt-PCR confirmation for H1N1 virus and 85 for seasonal influenza A. From the differences of means and multivariate logistic regression, it was found that H1N1 deaths occurred in younger and less educated people, and among those who engage in activities where there is increased contact with other unknown persons (OR 4.52, 95% CI 1.56-13.14). Clinical symptoms were similar except for dyspnea, headache, and chest pain that were less frequently found among H1N1 cases. Conclusions. Findings suggest that age, education, and occupation are factors that may be useful to identify risk for H1N1 among influenza cases, and also that patients with early dyspnea, headache, and chest pain are more likely to be non-H1N1 cases.
ABSTRACT
BACKGROUND: Mexico has experienced a disproportionate mortality burden due to the influenza A(HIN1) pandemic. A study was undertaken to investigate the sociodemographic and clinical characteristics of the first 100 patients who died from confirmed influenza A(H1N1). METHODS: A clinical evaluation was made of the first 100 consecutive deaths of confirmed cases between 10 April and 28 May 2009 reported by the Federal Ministry of Health. Statistical analysis included disease frequencies and descriptive comparisons with national health data. RESULTS: Most patients (60%) were aged 30-79 years, 53% were female and 40% were residents of Mexico City. On admission, 50% had one or more chronic medical conditions including metabolic syndrome (40%), cardiovascular disease (21%), diabetes (20%), hypertension (20%) and respiratory disease (8%). 38% of women and 26% of men were obese based on body mass index). The main clinical symptoms were fever (84%), cough (85%), dyspnoea (75%) and myalgia (30%). The frequency of all chronic diseases was higher in this sample than in the national statistics. Most (82%) developed symptoms before the Mexican government issued the influenza alert (24 April). Median hospital stay prior to death was 4 days (range 0-58). CONCLUSIONS: Patients, mostly young adults, who died from A(HIN1) influenza had a high frequency of one or more chronic diseases upon admission. Most died shortly after the health authorities initiated national influenza control measures.
Subject(s)
Influenza A Virus, H1N1 Subtype , Influenza, Human/mortality , Adult , Age Distribution , Aged , Chronic Disease/mortality , Comorbidity , Disease Outbreaks , Female , Hospitalization , Humans , Influenza, Human/diagnosis , Influenza, Human/drug therapy , Male , Mexico/epidemiology , Middle Aged , Risk Factors , Sex DistributionABSTRACT
BACKGROUND: Identifying the level of culture and awareness on patient safety is essential in order to improve the quality of care. The objective of our research was to assess patient safety culture in healthcare professionals. METHODS: Derived from the implementation of a survey on patient safety to 174 health professionals, data related to demographic characteristics were analyzed. Scores were determined on the 12 dimensions of the scale including additional items on perception and degree of overall patient safety, frequency and number of events reported, as well as Cronbach's alpha for the different dimensions. Descriptive statistics were used. RESULTS: Overall perception on safety was 51%. The lowest dimension was communication openness (38%), whereas organizational learning had the highest scores (68%). Analysis showed low Cronbach's alpha for dimensions of overall perception on safety (0.35), non-punitive response to error (0.55) and staff allocation (0.12). CONCLUSIONS: A low overall perception on patient safety indicates the need for increased institutional actions for improvement. Low Cronbach's alpha in some measurements may suggest the need for adjustments to the instrument. Results on the overall perception on patient safety, nonpunitive response to error and staff allocation (staffing) should be interpreted with caution, given the low reliability of such dimensions.
Subject(s)
Attitude of Health Personnel , Safety Management , Cross-Sectional Studies , Culture , HumansABSTRACT
OBJECTIVE: To carry out the epidemiological analysis of 122 influenza A (H1N1) deaths confirmed by laboratory and help to improve the diagnosis and timely managing of cases. MATERIAL AND METHODS: A total of 122 clinical records were analyzed of patients with confirmed influenza A (H1N1) virus infection who died. RESULTS: Fifty-one percent of patients were female and 49% were male. A total of 45.l% who died were between 20 and 39 years old. Overall fatality was 2.2% and ranged between 0.3% for the l0 to l9 year-old group to 6.3% for the 50 to 59 year-old group. Forty-three percent of deaths were concentrated in only two of the thirty-two states and 5l% received medical attention in social security institutions. Only l7% received hospital attention within 72 hours and 42% died within 72 hours of hospital attention. DISCUSSION: Novel Influenza A (H1N1) virus produces higher mortality in young people whereas seasonal influenza has a greater impact on young children and older people. Delay in medical care and the associated morbidity were relevant factors for death.
Subject(s)
Influenza A Virus, H1N1 Subtype , Influenza, Human/mortality , Adolescent , Adult , Child , Child, Preschool , Female , Humans , Infant , Influenza, Human/epidemiology , Male , Mexico/epidemiology , Middle Aged , Young AdultABSTRACT
OBJETIVO: Efectuar el análisis epidemiológico de 122 defunciones por influenza A (H1N1) confirmadas por laboratorio y contribuir a mejorar el diagnóstico y atención oportuna de casos. MATERIAL Y MÉTODOS: Se Analizaron 122 expedientes de pacientes fallecidos por influenza A (H1N1). RESULTADOS: Una proporción de 51 por ciento correspondió a mujeres y 49 por ciento a varones. Hasta 45.1 por ciento ocurrió entre los 20 y 39 años. La letalidad general fue de 2.2 por ciento y varió entre 0.3 por ciento en el grupo de 10 a 19 años y 6.3 por ciento en el de 50 a 59. Una cifra de 43 por ciento de las defunciones se concentró en dos de las 32 entidades federativas y 5l por ciento se atendió en instituciones de seguridad social. Sólo 17 por ciento recibió atención hospitalaria en las primeras 72 horas y 42 por ciento falleció en las primeras 72 horas de hospitalización. En 58.2 por ciento de los fallecidos había algún padecimiento asociado. DISCUSIÓN: El Nuevo virus A (H1N1) produce mayor mortalidad en personas jóvenes, al contrario de lo que sucede con la influenza estacional que muestra un mayor impacto en niños pequeños y personas de edad avanzada. El retraso de la atención médica y la morbilidad asociada fueron factores relevantes del fallecimiento.
OBJECTIVE: To carry out the epidemiological analysis of 122 influenza A (H1N1) deaths confirmed by laboratory and help to improve the diagnosis and timely managing of cases. MATERIAL AND METHODS: A total of 122 clinical records were analyzed of patients with confirmed influenza A (H1N1) virus infection who died. RESULTS: Fifty-one percent of patients were female and 49 percent were male. A total of 45.l percent who died were between 20 and 39 years old. Overall fatality was 2.2 percent and ranged between 0.3 percent for the l0 to l9 year-old group to 6.3 percent for the 50 to 59 year-old group. Forty-three percent of deaths were concentrated in only two of the thirty-two states and 5l percent received medical attention in social security institutions. Only l7 percent received hospital attention within 72 hours and 42 percent died within 72 hours of hospital attention. DISCUSSION: Novel Influenza A (H1N1) virus produces higher mortality in young people whereas seasonal influenza has a greater impact on young children and older people. Delay in medical care and the associated morbidity were relevant factors for death.
