Preliminary study on the block-based charging model for neonatal medication in pharmacy intravenous admixture service / 中华医院管理杂志

Objective:To explore the block-based charging method for centralized dispensing of neonatal drugs in pharmacy intravenous admixture service (PIVAS), analyze its effect on drug savings and inpatient drug cost, so as to provide the reference for the appropriate charging method of neonatal drugs.Methods:According to the balance quantity and amount of neonatal intravenous drugs that were centrally allocated by the PIVAS of our hospital, refer to the doctor′s orders, the dosage per dose as well as the number of patients per dose were analyzed, then the drug types and plans for block-based charging were formulated. Before and after the implementation of the plan, the monthly average drug balance quantity and amount, the average number of drug charges for the neonates, the average daily drug cost, and the adverse events of related drugs were used as the indicators to be investigated to clarify the implementation effect of the block-based charging mothod.Results:Fourteen medicines were charged by block-based, including 4 antibiotics, 2 ordinary infusion preparations, and 8 parenteral nutrition solution preparations. The monthly average drug balance quantity was reduced from 5 047±541 to 1 856±225, and the monthly average balance amount was reduced from 65 811±10 265 yuan to 20 659±6 002 yuan. The average drug dosage for children in the trial drug was significantly reduced with a decrease range of 39.2% to 90.1%. Both the inpatient daily drug cost of neonatus and the daily average antibacterial drug cost was decreased. During the centralized dispensing of neonatal drugs, no related adverse drug events occurred.Conclusions:The block-based charging method of centralized drug distribution can improve the utilization rate of drugs, reduce drug waste, reduce the cost of inpatient medicines the financial burden on children′s families, which is worthy of further promotion and implementation.

Pharmaceutical evaluation of compounded furosemide capsules and excipient performance

Abstract Compounding pharmacies play an important role not only in compounding personalized formulations, but also preparing drugs at the same concentration and dosage as those from commercial manufacturers. The excipients used in compounding are generally standardized for many drugs, however they do not consider the intrinsic properties, such as the poor water solubility, of each substance. The excipient performance of commercially available compounded furosemide capsules in 7 compounding pharmacies from Manaus was evaluated and compared them to the performance of the reference medicinal product (Lasix® tablets) and 2 batches of capsules made in-house (T2 and T4) with a standardized excipient. All batches were subjected to tests for weight variation, assay, uniformity of dosage units, disintegration and dissolution profile. Of the 7 different compound formulas acquired in the compounding pharmacies, only 2 passed all tests. Most formulas passed the tests for weight determination, disintegration time and assay, however batches from 2 establishments failed in regards to the uniformity of the content and 5 batches failed the dissolution test. The reference medicinal product was approved in all tests, as were the T2 capsules made in-house with drug-excipient ratio 1:2. These results confirm the importance of the excipient composition, especially for poorly soluble drugs.

Comparación y concordancia de las ecuaciones más recomendadas de estimación de filtrado glomerular para el diagnóstico de enfermedad renal crónica en una población de Lima, Perú

Objetivo: Determinar la correlación y concordancia de fórmulas recomendadas para calcular la tasa de filtración glomerular (TFG) con el aclaramiento de creatinina medido (Clcr) en una población hospitalaria peruana. Material y métodos: Estudio de correlación y concordancia de personas con estados diferentes de función renal. Fueron estudiados 175 pacientes agrupados según el Clcr: Grupo 1: valores mayores de 140, Grupo 2: entre 140 a 90, Grupo 3: entre 90 a 60 y Grupo 4 cuyos valores fueron menores de 60 ml/min/1,73 m2 de SC. Se excluyeron los pacientes obesos (IMC>29). En una junta de orina de 24 horas y una muestra de sangre matutina se midió el Clcr (normalizado a 1,73 m2 de superficie corporal). Las fórmulas consideradas fueron: Cockcroft y Gault, MDRD, CDK- EPI y una fórmula peruana propuesta por Vásquez. Se analizó la correlación de Pearson entre las diversas fórmulas consideradas y el Clcr medido y su concordancia mediante el estudio de Bland Altman, de las diversas fórmulas usando la diferencia entre el resultado de cada fórmula para cada sujeto estudiado y el Clcr medido. Resultados: Todas las fórmulas propuestas tuvieron buen grado de correlación con el Clcr pero la fórmula CKD-EPI mostró importante imprecisión. Las fórmulas de Vásquez y MDRD mostraron leves diferencias favorables en pacientes con Clcr<60 ml/min. Conclusión: Recomendamos en nuestra población el uso de cualquiera de las fórmulas propuestas excepto CKD-EPI.

SUMMARY Objective: To determine the correlation and agreement between the most frequently used formulas estimate the glomerular filtration rate (GFR) and the measured Creatinine Clearance (CrCl), in a Peruvian population. Methods : Study of correlation and agreement in a population with different stages of renal function. 175 patients were included, grouped by CrCl: Group 1: higher than 140, Group 2: between 140 and 90, Group 3: Between 90 and 60, Group 4: less than 60 ml/min/1,73 m2 . Height and weight were measured to calculate body mass index (BMI). Obese patients (BMI>29) were excluded. Using a 24-hour urine collection and a serum creatinine sample, creatinine clearance was measured (normalized for 1.73 m2 of body surface). Formulas considered for analysis were: Cockroft and Gault, MDRD, CKD-EPI and a Peruvian formula proposed by Vásquez. Correlation was analyzed by Pearson coefficient between studied formulas and the measured CrCl; and its agreement was studied by Bland Altman analysis using the difference between the result obtained by each formula and the measured CrCl. Results : All studied formulas showed an acceptable degree of correlation but CKD-EPI formula had considerable imprecision. The formulas by Vásquez and MDRD showed slightly favorable differences in patients with CrCl<60 ml/min. Conclusion : We recommend the use of any of the studied formulas with exception of CKD-EPI in our population.

Atividades farmacológicas da manteiga de bacuri (Platonia insignis Mart): revisão integrativa / Pharmacological actions of bacuri butter (Platonia insignis Mart): an integrative review

RESUMO Objetivo identificar as atividades farmacológicas da manteiga de bacuri (Platonia insignis Mart.). Métodos revisão integrativa, realizada nas bases de dados Literatura Latino-americana e do Caribe em Ciências da Saúde, Cumulative Index to Nursing and Allied Health Literature, EMBASE, MEDLINE/PubMed, Web of Science, Cochrane Library e SCOPUS, sem delimitação temporal e de idioma. A seleção se constituiu de 13 ensaios pré-clínicos. A avaliação das informações ocorreu de forma descritiva, confrontando com os achados pertinentes. Resultados observou-se que 50,0% das publicações foram indexadas na MEDLINE/PubMed, maioria das publicações ocorreram na Inglaterra (61,5%), seguidas do Brasil e dos Estados Unidos, ambos com 13,3%. Destaca-se que 100,0% dos artigos foram ensaios pré-clínicos; atividades farmacológicas para antioxidante (38,4%) e antileishmanicidas (30,7%). Registrou-se que 38,4% dos ensaios apresentaram testes de toxicidade. Conclusão a manteiga de bacuri (Platonia insignis Mart.) apresentou atividades farmacológicas em ensaios pré-clínicos, como antioxidantes, antileshimaniose, anticonvulsivante e cicatrização de feridas.

ABSTRACT Objective to identify the pharmacological activities of bacuri butter (Platonia insignis Mart.). Methods an integrative review, carried out in the databases of Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature, EMBASE, MEDLINE/PubMed, Web of Science, Cochrane Library and SCOPUS, without the time and language restriction. The selection consisted of 13 pre-clinical trials. The information assessment descriptively took place, comparing with the pertinent findings. Results it was observed that 50.0% of the publications were indexed in MEDLINE/PubMed, most publications were from England (61.5%), followed by Brazil and the United States, both with 13.3%. It is noteworthy that 100.0% of the articles were pre-clinical trials; pharmacological activities for antioxidants (38.4%) and antileishmanicides (30.7%). It was found that 38.4% of the trials presented toxicity tests. Conclusion bacuri butter (Platonia insignis Mart.) Showed pharmacological activities in pre-clinical trials, such as antioxidants, antileshimaniasis, anticonvulsant and wound healing.

Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients

BACKGROUND/AIMS: Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazine increases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilities of these formulations may influence patient adherence; however, they have not been compared to date. This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey. METHODS: UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analog scale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed. RESULTS: A total of 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2 formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence rate was slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was not significant (P=0.139). CONCLUSIONS: CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.

Characteristics of poisoning in younger children according to different forms of the drugs

PURPOSE: This study aimed to investigate the characteristics of poisoning drug ingested by younger children, and to compare the clinical outcome by drug forms.METHODS: This was a retrospective analysis based on medical records from the Emergency Department based Injury In-depth Surveillance (EDIIS) registry in Korea from January to December 2015. Patients aged 7 years or younger visiting the emergency department (ED) with drug poisoning were included. We classified the forms of drugs as tablets or syrup, and analyzed the characteristics by size, color, and shape. In addition, clinical outcomes and ED length of stay were compared according to the drug forms.RESULTS: A total of 308 cases were collected, and 202 patients finally were analyzed. Tablets and capsules (TACs) were more common than syrup (67.3% vs. 32.7%). Regarding clinical outcomes, patients who took TACs had higher admission rate (17.6% vs. 7.6%, P = 0.040) without a significant difference in ED length of stay compared to those who took syrups. While commonly ingested drugs in TACs were hormones, sedative and analgesics, frequent drugs in syrup were antihistamines and cold drugs. In 136 case of TACs, median long and short axes were 0.85 cm (interquartile range [IQR], 0.7–1.1 cm) and 0.72 cm (IQR, 0.59–0.82 cm), respectively. Chromatic TACs were 80 cases (58.8%) and more common than achromatic TACs. Round shapes were preferred than angular ones (96.3% vs. 3.7%).CONCLUSION: In younger children poisonings, the TACs showed higher incidence and admission rate compared to syrups. Especially, chromatic TACs and round shapes were preferred. Therefore, drugs with these characteristics need to be stored more carefully.

Preformulation of a liquid dosage formulation of captopril for pediatric use: drug-excipient compatibility and stability studies

Currently, medications used in children are typically modified from pharmaceutical dosage forms designed for adults. Captopril is widely adapted to liquid formulations for use in hospitals. Its stability in the aqueous medium is reduced since it undergoes oxidation producing captopril disulfide (its main metabolite). The aim of this formulation study was to suggest favorable conditions for the development of a stable captopril formulation. The compatibility between the drug and excipients was evaluated by differential scanning calorimetry analysis (DSC). For studies in solution, different formulations were prepared according to a factorial design varying EDTA concentration, water purity and pH. The resultant formulations were stored at 60°C and analyzed over a twelve-day period using HPLC. The DSC curves obtained suggested, although not conclusive to elucidation, interactions of captopril with citric acid and sucralose. The stability study of these solutions revealed that the variables significantly influenced captopril content, which degraded at zero order kinetics and rates differing by a factor of up to 7 times, where pH proved the most influential factor. Interactions between variables were observed. Therefore, development of a stable captopril formulation is feasible provided EDTA and a buffering agent is used at suitable concentrations (0.08% and pH 3.85).

Infection Control in Parenteral Nutrition Preparation and Compounding

Recently, in Korea, the importance of preparation and use of injectable drugs has been emphasized due to successive fatal accidents caused by injection infections. Parenteral nutrition (PN) has also been identified as a cause of infection. Cases of infection due to PN have been reported not only in Korea, but also abroad, and contamination occurs mainly during the preparation of PN. Because sterile preparation and compounding of injections are very important for infection control and patient safety, this article reviews the major guidelines outlined thus far. The Korea Ministry of Food and Drug Safety in 2006 published guidelines and the KSHP (Korean Society of Health-System Pharmacists) recently issued guidelines for the aseptic preparation of injections. In addition, as US guidelines, the ASHP (American Society of Health-System Pharmacists) guidelines and United States Pharmacopeia (USP) are also reviewed. The recent guidelines published by the KSHP have significance in that they were adopted in accordance with the domestic reality, even though they conform to foreign guidelines, and are expected to be guidelines for hospital pharmacists performing aseptic preparation work. In addition, the Korea Ministry of Health and Welfare is considering appropriate guidelines for the safe management of medications, training staff for infection prevention and strengthening staff capacity. Furthermore, the gradual expansion of aseptic compounding facilities and human resources, as well as the provision of adequate medical costs are also considered. Based on the establishment and standardization of injectable drugs compounding guidelines for Korean hospitals, it is believed that if human resources and facilities are supported and medical charges are improved, it will be possible to expect the safer preparation and use of injections.

Evaluation of the impact that the changes in tuberculosis treatment implemented in Brazil in 2009 have had on disease control in the country / Avaliação do impacto das mudanças do tratamento da tuberculose implantadas em 2009 no controle da tuberculose pulmonar no Brasil

ABSTRACT Objective: To analyze the impact that the 2009 changes in tuberculosis treatment in Brazil had on the rates of cure, tuberculosis recurrence, mortality, treatment abandonment, and multidrug-resistant tuberculosis (MDR-TB). Methods: An ordinary least squares regression model was used in order to perform an interrupted time series analysis of secondary data collected from the Brazilian Tuberculosis Case Registry Database for the period between January of 2003 and December of 2014. Results: The 2009 changes in tuberculosis treatment in Brazil were found to have no association with reductions in the total number of cases (β = 2.17; 95% CI: −3.80 to 8.14; p = 0.47) and in the number of new cases (β = −0.97; 95% CI: −5.89 to 3.94; p = 0.70), as well as having no association with treatment abandonment rates (β = 0.40; 95% CI: −1.12 to 1.93; p = 0.60). The changes in tuberculosis treatment also showed a trend toward an association with decreased cure rates (β = −4.14; 95% CI: −8.63 to 0.34; p = 0.07), as well as an association with increased mortality from pulmonary tuberculosis (β = 0.77; 95% CI: 0.16 to 1.38; p = 0.01). Although there was a significant increase in MDR-TB before and after the changes (p < 0.0001), there was no association between the intervention (i.e., the changes in tuberculosis treatment) and the increase in MDR-TB cases. Conclusions: The changes in tuberculosis treatment were unable to contain the decrease in cure rates, the increase in treatment abandonment rates, and the increase in MDR-TB rates, being associated with increased mortality from pulmonary tuberculosis during the study period. Keywords: Tuberculosis, pulmonary/epidemiology; Tuberculosis, pulmonary/drug therapy; Tuberculosis, pulmonary/mortality; Interrupted time series analysis; Drug resistance, multiple; Drug compounding.

RESUMO Objetivo: Analisar o impacto das mudanças do tratamento da tuberculose implantadas no Brasil em 2009 no número de casos de cura, de recidiva, de óbitos, de abandono e de tuberculose multirresistente (TBMR). Métodos: Foi realizada uma análise de séries temporais interrompida utilizando o modelo de regressão pelo método dos mínimos quadrados ordinários a partir de dados secundários coletados do Sistema de Informação de Agravos de Notificação da Tuberculose entre janeiro de 2003 e dezembro de 2014. Resultados: A análise mostrou independência entre as mudanças do tratamento e a redução do número total de casos (β = 2,17; IC95%: −3,80 a 8,14; 189 p = 0,47), a redução do número de novos casos (β = −0,97; IC95%: −5,89 a 3,94; p =190 0,70) e do abandono do tratamento (β = 0,40; IC95%: 199 −1,12 a 1,93; p = 0,60). Demonstrou ainda tendência à associação com a diminuição da cura (β = −4,14; IC95%: −8,63 a 0,34; p = 0,07) e associação com aumento da mortalidade por tuberculose pulmonar (β = 0,77; IC95%: 0,16 a 1,38; p = 0,01). A TBMR aumentou significativamente tanto no período anterior quanto no período posterior às mudanças do tratamento (p < 0,0001), embora de forma independente da intervenção (β = 0,13; IC95%: −0,03 a 0,29; p = 0,12). Conclusões: As mudanças no tratamento não impediram nem a diminuição na taxa de cura e nem o aumento do abandono e da TBMR; por outro lado, se associaram ao aumento de óbitos por tuberculose pulmonar durante o período do estudo.

Alginate encapsulation preserves the quality and fertilizing ability of Mediterranean Italian water buffalo (Bubalus bubalis) and Holstein Friesian (Bos taurus) spermatozoa after cryopreservation

The use of artificial insemination (AI) in buffalo (Bubalus bubalis) is limited by poor ovarian activity during the hot season, seasonal qualitative patterns in semen, low resistance of sperm cells in the female tract, difficulties in estrus detection, and variable estrus duration. Although AI procedures are commonly used in bovine, use of AI has been limited in buffalo. In the zootechnical field, different studies have been conducted to develop techniques for improvement of fertilizing ability of buffalo spermatozoa after AI. In this study, for the first time, the use of alginate encapsulation and cryopreservation of buffalo spermatozoa is described, and the same procedure was performed with Holstein Friesian (Bos taurus) semen. Results obtained from in vitro analyses indicate that the encapsulation process does not have detrimental effects (compared to controls) on quality parameters (membrane integrity, progressive motility, path average velocity) in either species. Similarly, there were no detrimental effects after cryopreservation in either species. The fertilizing potential of encapsulated and cryopreserved semen was evaluated after AI in 25 buffalo and 113 bovine females. Pregnancy rates were not affected in either species. The results of this study show proof of concept for the use of frozen semen controlled-release devices in buffalo.

The preparation of cold -dampness medicine iron stick and treatment clinical observation of cold -dampness lumbago / 中国基层医药

Objective To investigate the preparation process of cold -dampness medicine iron stick and the curative effect of cold -dampness medicine iron stick,thus to provide reference for the clinical treatment of cold -dampness lumbago.Methods Using science and technology of preparation and the thermal effect of cold -dampness medicine iron stick was observed.1 20 cases with cold -dampness lumbago of dampness type with low back pain, according to the order of treatment were divided into the observation group and control group.63 cases of the treatment group were given cold -dampness medicine iron stick affixed to the surface of the skin,57 cases of the control group were given kanlisha affixed to the surface of the skin.The treatment effect after one course of treatment was observed. Results Cold -dampness medicine iron stick heat effect index of heat time was 1 2min,to thermal time was 1 0.8h, the highest temperature was 56.5℃,thermal equilibrium curve was gentle and lasting.The efficacy of the two groups of drugs within the observation time effect was obvious.The total effective rate of the observation group was 90.5%(57 /63),which was higher than 75.4%(43 /57)of the control group,the difference was statistically significant (χ2 =4.87,P <0.05).During the treatment,local skin blisters,rash,itching and other low temperature burns and other allergic reaction were not found.Conclusion Cold -dampness medicine iron stick process is stable and controllable in quality and heat balance curve slow long -lasting,determine the efficacy,innovative therapies,it is easily accepted by patients and worthy to be popularized in clinical practice.

Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais / Evaluación de la calidad de cápsulas de sinvastatina de farmacias magistrales / Assessment of the quality of simvastatin capsules from compounding pharmacies

OBJETIVO: Validar metodologia por cromatografia líquida de alta eficiência para determinação do teor de sinvastatina em cápsulas manipuladas. MÉTODOS: Foram avaliadas 18 amostras de cápsulas de sinvastatina 40 mg de farmácias magistrais de São Paulo, Guarulhos, São Bernardo do Campo e Campinas, SP, prescritas para pacientes fictícios. As análises basearam-se na Farmacopéia Brasileira e no método da cromatografia, otimizado e validado de acordo com as normas nacionais e internacionais, para os ensaios de identificação, e quantificação em cápsulas manipuladas. RESULTADOS: O peso médio das cápsulas variou de 70 mg a 316 mg; quatro amostras apresentaram variação de peso em desacordo com a especificação. O teor de sinvastatina nas cápsulas estava de acordo com a especificação em 11 amostras; em seis, esse teor variou entre 4 por cento e 87 por cento do valor declarado, descumprindo os requisitos de teor do princípio ativo; a determinação do teor e uniformidade de conteúdo de uma amostra não foram realizadas. No teste de uniformidade de conteúdo, 15 amostras apresentaram valores menores que 85 por cento e com os desvios-padrões relativos maiores que 6 por cento; três farmácias atendiam a especificação desse ensaio. No ensaio de dissolução, oito amostras apresentaram resultados insatisfatórios no primeiro estágio do ensaio e as demais apresentaram resultados inconclusivos. CONCLUSÕES: O método utilizado mostrou boa adequação para aplicação em controle de qualidade, revelando a falta de qualidade de cápsulas de sinvastatina produzidas por algumas farmácias de manipulação.

OBJETIVO: Validar metodología por cromatografía líquida de alta eficiencia para determinación del tenor de sinvastatina en cápsulas manipuladas. MÉTODOS: Fueron evaluadas 18 muestras de cápsulas de sinvastatina 40 mg de farmacias magistrales de Sao Paulo, Guarulhos, Sao Bernardo do Campo y Campinas, Sureste de Brasil, prescriptas para pacientes ficticios. Los análisis se basaron en la Farmacopéia Brasileña y en el método de la cromatografia, optimizado y validado de acuerdo con las normas nacionales e internacionales, para los ensayos de identificación, y cuantificación en cápsulas manipuladas. RESULTADOS: El peso promedio de las cápsulas variaron de 70 a 316 mg; cuatro muestras presentaron variación de peso en desacuerdo con la especificación. El tenor de sinvastatina en las cápsulas estaba de acuerdo con la especificación en 11 muestras; en seis, ese tenor varió entre 4% y 87% del valor declarado incumpliendo los requisitos de tenor del principio activo; la determinación del tenor y uniformidad de contenido de una muestra no fue realizada. En la prueba de uniformidad de contenido, 15 muestras presentaron valores menores que 85% y con los desvíos-patrones relativos mayores que 6%; tres farmacias atendían la especificación del ensayo. En el ensayo de disolución, ocho muestras presentaron resultados insatisfactorios en la primera fase del ensayo, y las demás presentaron resultados inconclusitos. CONCLUSIONES: El método utilizado mostró buena adecuación para aplicación en control de calidad, revelando la falta de calidad de cápsulas de sinvastatina producidas por algunas farmacias de manipulación.