[Recommendations for the preservation and good-for-use period of multi-dose containers after being opened]. / Recomendaciones de conservación y período de validez de los envases multidosis tras su apertura.

OBJECTIVE: The aim of this work is to establish the standard procedure for use and preservation of drugs, dietary products and cosmetic products in multi-dose containers. METHOD: a summary table containing all the drugs, dietary and cosmetic products included in the hospital vademecum available in multi-dose containers was elaborated and information on preservation and good-for-use periods was gathered from the products technical sheets, consultation to the pharmaceuticals companies, and lite rature search. RESULTS: 205 pharmaceutical specialties and magisterial formulations elaborated at the hospital were reviewed. A standardized working procedure was created with general instructions and a table of recommendations in case of missing information. CONCLUSIONS: with the present study, the information on the good-for-use period and preservation of multi-dose containers after being opened is improved. This information should always be kept available and updated.

Objetivo: El objetivo de este trabajo es establecer un procedimiento normalizado de utilización y conservación de fármacos, dietoterápicos y productos cosméticos en envases multidosis. Método: Se procede a elaborar una tabla resumen de los fármacos, dietoterápicos y productos cosméticos incluidos en la guía farmacoterapéutica del hospital disponibles en envases multidosis y se recopilan informaciones de conservación y perío - do de validez de los ítems seleccionados mediante consulta a las fichas técnicas de los productos, consulta a laboratorios o revisión bibliográfica. Resultados: Se ha revisado un total de 205 envases multidosis incluídos en la Guía Farmacoterapéutica (GFT) del Hospital. Se ha elaborado un procedimiento normalizado de trabajo con instrucciones generales y tabla de recomendaciones para los casos de no disponer de información. Conclusiones: En conclusión, con el presente estudio se facilita información sobre el período de validez y conservación de los envases multidosis tras su apertura. Esta información deberá mantenerse siempre disponible y actualizada.

Evaluación de la efectividad del colirio de suero autólogo en el tratamiento de patologías oculares / Effectiveness of 100% autologous serum drops in ocular surface disorders

Objetivo: Evaluar la efectividad del tratamiento con colirio de suero autólogo al 100% en pacientes con diversas patologías oculares. Métodos Estudio descriptivo, observacional, prospectivo de mayo de 2005 a febrero de 2009. La población del estudio fueron los pacientes que iniciaron tratamiento con colirio de suero autólogo al 100% elaborado en dosis unitarias. Para la evaluación de la efectividad del estudio se valoraron la desaparición o la mejoría de la sintomatología ocular en los pacientes mediante un cuestionario sobre los signos y los síntomas apreciados por el paciente al inicio y al final del tratamiento. Resultados Se evaluó a un total de 15 pacientes (24 ojos). Los síntomas, como el ojo rojo, el ardor o la quemazón, los pinchazos y la pesadez de los ojos, mejoraron en el 100% de los pacientes que los sufrían, mientras que la sensación del ojo seco y la arenilla mejoraron en el 92% de los casos. Para el 66,7% de los pacientes evaluados la mejoría en los síntomas justificó la incomodidad por la extracción de sangre. Con respecto a la tolerancia del colirio al 100%, solo un paciente presentó alguna molestia relacionada con la instilación del colirio. Conclusión La utilización de colirio de suero autólogo al 100% se asoció a una mejoría de la sintomatología ocular en la mayoría de los pacientes evaluados(AU)

Objective: To evaluate the effectiveness of 100% autologous serum eye drops for the treatment of various ocular surface disorders. Methods: A descriptive prospective observational study carried out from May 2005 to February2009 which included patients with ocular surface disorders treated with single-dose autologous serum eye drops. Treatment effectiveness was evaluated by using a clinical questionnaire inorder to assess symptoms experienced by patients at the beginning and end of treatment. Results: A total of 15 patients (24 eyes) were evaluated. Clinical symptoms such as redness, burning, sharp pain and tired eyes improved in 100% of the patients, whereas dryness and sandy/gritty sensation improved in 92% of the patients. The overall improvement of clinical symptoms was worth the inconvenience of venipuncture according to 66.7% of the patients. Regarding tolerance for autologous serum eye drops, only one patient experienced some discomfort when using the single-dose eye drops. Conclusion: The treatment with 100% autologous serum eye drops improved ocular symptoms for most patients (AU)

Análisis de la estabilidad de dos suspensiones orales de carbamazepina / Analysing the stability of two oral carbamazepine suspensions

Objetivo Analizar la estabilidad fisicoquímica y microbiológica de dos suspensiones orales de carbamazepina al 2,5 y al 5%.MétodoLas suspensiones orales se elaboraron a partir de carbamazepina en polvo y los vehículos comerciales Ora-sweet SF® y Ora-plus®. Se realizaron controles de calidad físicos (pH, estado de la suspensión y características organolépticas), químicos (cromatografía líquida de alta resolución [HPLC]) y microbiológicos a los 2, 4 y 6 meses de la preparación. Resultados La concentración a los 6 meses de las suspensiones de carbamazepina al 2,5% y al 5% resultó de 22,9mg/ml y de 45,9mg/ml, respectivamente, con valores de riqueza obtenidos mediante la cromatografía líquida de alta resolución se encontraron entre el 90 y el 110%, tal y como exige la Farmacopea Americana 23 NF18. Durante el período del estudio no se observó modificación de los parámetros físicos ni crecimiento en los cultivos microbiológicos realizados. Conclusiones Ambas suspensiones orales son estables física, química y microbiológicamente durante al menos 6 meses a temperatura ambiente y en frasco de vidrio topacio (AU)

Objective To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%.MethodsBoth oral suspensions were compounded from powdered carbamazepine and Ora-Sweet SF® and Ora-Plus® commercial compounding excipients. At the 2, 4 and a 6-month marks, different quality assays were performed, comprising physical (pH, state of the suspension, organoleptic properties), chemical (HPLC) and microbiological assays. Results The final concentration at 6 months for both the 2.5% and 5% carbamazapine suspensions was 22.9 and 45.9mg/ml respectively, with calculated richness values between 90 and 110% fulfilling USP23 NF18 requirements. No changes in physical properties and no culture growth were observed during the study period. Conclusion Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks(AU)

Analysing the stability of two oral carbamazepine suspensions.

OBJECTIVE: To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%. METHODS: Both oral suspensions were compounded from powdered carbamazepine and Ora-Sweet SF(®) and Ora-Plus(®) commercial compounding excipients. At the 2, 4 and a 6-month marks, different quality assays were performed, comprising physical (pH, state of the suspension, organoleptic properties), chemical (HPLC) and microbiological assays. RESULTS: The final concentration at 6 months for both the 2.5% and 5% carbamazapine suspensions was 22.9 and 45.9 mg/ml respectively, with calculated richness values between 90 and 110% fulfilling USP23 NF18 requirements. No changes in physical properties and no culture growth were observed during the study period. CONCLUSION: Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks.

Effectiveness of 100% autologous serum drops in ocular surface disorders.

OBJECTIVE: To evaluate the effectiveness of 100% autologous serum eye drops for the treatment of various ocular surface disorders. METHODS: A descriptive prospective observational study carried out from May 2005 to February 2009 which included patients with ocular surface disorders treated with single-dose autologous serum eye drops. Treatment effectiveness was evaluated by using a clinical questionnaire in order to assess symptoms experienced by patients at the beginning and end of treatment. RESULTS: A total of 15 patients (24 eyes) were evaluated. Clinical symptoms such as redness, burning, sharp pain and tired eyes improved in 100% of the patients, whereas dryness and sandy/gritty sensation improved in 92% of the patients. The overall improvement of clinical symptoms was worth the inconvenience of venipuncture according to 66.7% of the patients. Regarding tolerance for autologous serum eye drops, only one patient experienced some discomfort when using the single-dose eye drops. CONCLUSION: The treatment with 100% autologous serum eye drops improved ocular symptoms for most patients.

[Therapeutic exchange of angiotensin II receptor antagonists in patients hospitalised in a traumatology unit]. / Intercambio terapéutico de antagonistas del receptor de angiotensina II en pacientes hospitalizados en una unidad de traumatología.

OBJECTIVE: To analyse the proportion of patients whose blood pressure values have remained within the established therapeutic aim, so as to reduce cardiovascular risk following therapeutic exchange of angiotensin II receptor antagonists (AIIRA.) METHODS: Analytical, observational, prospective, longitudinal study with pre-post analysis. Patients undergoing AIIRA treatment who were not included in the hospital's pharmaco-therapeutic guide were included in the study over those who had undergone a normalised therapeutic exchange of AIIRA. Variable response: proportion of patients whose blood pressure levels (BP levels) remained within the established therapeutic aim for the prevention of cardiovascular accidents. Other variables: systolic and diastolic blood pressure values (SBP and DBP) in the month prior to hospitalisation and after therapeutic exchange, antihypertensive medication, comorbidities. RESULTS: 37 patients were included in the study. Following therapeutic exchange, 81.08 % maintained BP values within the range established by the European Society of Hypertension-European Society of Cardiology Committee. SBP difference: 4.82 (confidence interval [CI] 95 %: 1.09 to 10.74; p = 0.107); DBP difference: 0.15 (CI 95 %: 3.27 to 2.97; p = 0.924), and therefore not clinically significant. CONCLUSIONS: The normalised procedure for therapeutic exchange of AIIRA is effective and safe for patients in terms of maintaining BP, which allows for adequate control of BP during the hospital stay.

Intercambio terapéutico de antagonistas del receptor de angiotensina II en pacientes hospitalizados en una unidad de traumatología / Therapeutic exchange of angiotensin II receptor antagonists in patients hospitalised

Objetivo: Analizar la proporción de pacientes que mantiene los valores de presión arterial (PA) dentro del objetivo terapéutico establecido para reducir el riesgo cardiovascular tras el intercambio terapéutico de antagonistas del receptor de angiotensina II (ARA-II). Métodos: Estudio observacional, analítico, prospectivo y longitudinal, con análisis pre-post. Se incluyeron pacientes en tratamiento con ARA-II no incluidos en la guía farmacoterapéutica del hospital en los que se realizó un intercambio terapéutico normalizado de ARA-II. Variable respuesta: proporción de pacientes que mantienen los valores de PA dentro del objetivo terapéutico establecido para la prevención de accidentes cardiovasculares. Otras variables: valores de PA sistólica (PAS) y diastólica (PAD) el mes previo al ingreso y tras el intercambio terapéutico, medicamentos antihipertensivos, comorbilidades. Resultados: Se incluyó a 37 pacientes. Tras el intercambio terapéutico el 81,08 % de los pacientes mantiene los valores de PA dentro del objetivo establecido por la European Society of Hypertension-European Society of Cardiology Committee. Diferencia PAS: 4,82 (intervalo de confianza [IC] del 95 %, ¿1,09 a 10,74; p = 0,107); diferencia PAD: ¿0,15 (IC del 95 %, ¿3,27 a 2,97; p = 0,924) y, por tanto, sin significación clínica. Conclusiones: El procedimiento normalizado para intercambio terapéutico de ARA-II es efectivo y seguro para los pacientes en términos de mantenimiento de la PA, permitiendo un adecuado control de la PA durante la estancia hospitalaria (AU)

Objective: To analyse the proportion of patients whose blood pressure values have remained within the established therapeutic aim, so as to reduce cardiovascular risk following therapeutic exchange of angiotens in II receptor antagonists (AIIRA.)Methods: Analytical, observational, prospective, longitudinal study with pre-post analysis. Patients undergoing AIIRA treatment who were not included in the hospital’s pharmaco-therapeutic guide were included in the study over those who had undergone a normalised therapeutic exchange of AIIRA. Variable response: proportion of patients whose blood pressure levels (BP levels) remained within the established therapeutic aim for the prevention of cardiovascular accidents. Other variables: systolic and diastolic blood pressure values (SBP and DBP) in the month prior to hospitalisation and after therapeutic exchange, antihypertensive medication, comorbidities. Results: 37 patients were included in the study. Following therapeutic exchange, 81.08 % maintained BP values within the range established by the European Society of Hypertension-European Society of Cardiology Committee. SBP difference: 4.82 (confidence interval [CI] 95 %: —1.09 to 10.74; p = 0.107); DBP difference: —0.15 (CI 95 %: —3.27 to 2.97; p = 0.924), and therefore not clinically significant. Conclusions: The normalised procedure for therapeutic exchange of AIIRA is effective and safe for patients in terms of maintaining BP, which allows for adequate control of BP during the hospital stay (AU)

[Evaluation of patient satisfaction in outpatient pharmacy]. / Evaluación de la satisfacción y de la insatisfacción de pacientes atendidos en la unidad de atención farmacéutica a pacientes externos.

OBJECTIVE: To establish the level of satisfaction and dissatisfaction with the service received by patients attending the Outpatient Pharmacy regarding the care received. METHOD: Two-month long cross-sectional study. The study included all patients who had attended the Outpatient Pharmacy (OP) and had given their consent. Satisfaction was measured using a previously validated survey (Likert-type scale), with 5 possible closed answers (1: Disagree and 5: Strongly agree) and the Satisfaction Index established by the Regional Ministry of Health for the Autonomous Community of Valencia. Dissatisfaction was assessed via the complaints received by the Patient Service Department over the last 10 years. RESULTS: Patient satisfaction survey (nfinal=138). Overall Satisfaction Index (SI): 76% (95% CI: 72-80%). Greatest satisfaction: Pharmacists Skills (SI: 88%; 95% CI: 87-88%). Lowest satisfaction: dispensing area (SI: 63%; 95% CI: 60-66%) and dispensing process (SI: 68%; 95% CI: 67-70%). Complaints (n=22). Reasons for dissatisfaction: dispensing process (72%) and dispensing area (10%). CONCLUSIONS: Although the Satisfaction Index is a useful indicator for identifying improvements, the reasons for dissatisfaction are also required as a complement to this information. Those aspects in need of improvement are the dispensing area and process and increased structural and human resources are required.

[Mycophenolate mofetil and cyclosporine in the treatment of steroid-dependent nephrotic syndrome with frequent relapses]. / Micofenolato de mofetilo y ciclosporina en el tratamiento del síndrome nefrótico dependiente de corticoides con recaídas frecuentes.

We describe the case of an 8-year-old patient, with steroid-dependent minimal lesion nephrotic syndrome, with frequent relapses despite treatment with cyclosporine. After the switch to mycophenolate mofetil the patient had new relapses, and there was difficulty in controlling the disease. The reintroduction of cyclosporine combined with mycophenolate mofetil obtained an optimal response, with a longer relapse-free time. Due to their kinetic variability, the blood levels of both drugs were closely monitored during follow-up.

Micofenolato de mofetilo y ciclosporina en el tratamiento del síndrome nefrótico dependiente de corticoides con recaídas frecuentes / Mycophenolate mofetil and cyclosporine in the treatment of steroid-dependent nephrotic syndrome with frequent relapses

Describimos el caso de un paciente de 8 años de edad, con síndrome nefrótico por lesiones mínimas dependiente de corticoides, con recaídas frecuentes a pesar del tratamiento con ciclosporina. Tras la conversión a micofenolato de mofetilo, el paciente sufre nuevas recaídas, con una situación de difícil control de la enfermedad. La reincorporación de la ciclosporina asociada al tratamiento con micofenolato de mofetilo consiguió una remisión de la enfermedad, con un tiempo libre de recaída superior a los obtenidos hasta ese momento, siendo necesario un adecuado seguimiento de las concentraciones sanguíneas de ambos fármacos debido a su variabilidad en el comportamiento cinético

We describe the case of an 8-year-old patient, with steroid-dependent minimal lesion nephrotic syndrome, with frequent relapses despite treatment with cyclosporine. After the switch to mycophenolate mofetil the patient had new relapses, and there was difficulty in controlling the disease. The reintroduction of cyclosporine combined with mycophenolate mofetil obtained an optimal response, with a longer relapse-free time. Due to their kinetic variability, the blood levels of both drugs were closely monitored during follow-up

Evaluación de la satisfacción y de la insatisfacción de pacientes atendidos en la unidad de atención farmacéutica a pacientes externos / Evaluation of patient satisfaction in outpatient pharmacy

Objetivo: Conocer tanto el grado de satisfacción como los motivosde insatisfacción de los pacientes que acuden a la Unidad deAtención Farmacéutica a Pacientes Externos (UFPE) respecto a laatención recibida.Método: Estudio transversal de dos meses de duración. Se incluyerontodos los pacientes atendidos por la UFPE que dieron su consentimiento.La satisfacción se midió con una encuesta previamente validada,de tipo Likert, con 5 posibles respuestas cerradas (1: endesacuerdo, y 5: muy de acuerdo), utilizándose el indicador índice desatisfacción establecido por la Conselleria de Sanitat de la ComunidadValenciana. La insatisfacción se evaluó a través de las quejas formuladasen el Servicio de Atención e Información al Paciente en losúltimos 10 años.Resultados: encuesta de satisfacción (nfinal = 138). Índice de satisfacción(IS) global: 76% (IC 95%: 72-80%). Mayor satisfacción: habilidadesdel farmacéutico (IS: 88%; IC 95%: 87-88%). Menor satisfacción:zona de dispensación (IS: 63%; IC 95%: 60-66%) y proceso dedispensación (IS: 68%; IC 95%: 67-70%). Reclamaciones (n = 22).Motivos de insatisfacción: proceso de dispensación (72%) y zona dedispensación (10%).Conclusiones: Aunque el índice de satisfacción es un indicador útilpara poder establecer mejoras, es necesario conocer también losmotivos de insatisfacción como complemento a esta información.Los aspectos a mejorar son la zona y el proceso de dispensación,siendo necesario un aumento de los recursos estructurales y humanos

Objective: To establish the level of satisfaction and dissatisfactionwith the service received by patients attending the Outpatient Pharmacyregarding the care received.Method: Two-month long cross-sectional study. The study includedall patients who had attended the Outpatient Pharmacy (OP) andhad given their consent. Satisfaction was measured using a previouslyvalidated survey (Likert-type scale), with 5 possible closedanswers (1: Disagree and 5: Strongly agree) and the Satisfaction Indexestablished by the Regional Ministry of Health for the AutonomousCommunity of Valencia. Dissatisfaction was assessed via thecomplaints received by the Patient Service Department over the last10 years.Results: Patient satisfaction survey (nfinal=138). Overall SatisfactionIndex (SI): 76% (95% CI: 72-80%). Greatest satisfaction: Pharmacist’sSkills (SI: 88%; 95% CI: 87-88%). Lowest satisfaction: dispensingarea (SI: 63%; 95% CI: 60-66%) and dispensing process (SI: 68%;95% CI: 67-70%). Complaints (n=22). Reasons for dissatisfaction:dispensing process (72%) and dispensing area (10%).Conclusions: Although the Satisfaction Index is a useful indicator foridentifying improvements, the reasons for dissatisfaction are also requiredas a complement to this information. Those aspects in need ofimprovement are the dispensing area and process and increasedstructural and human resources are required

[Identifying improvement opportunities in the management of hepatitis C]. / Identificación de oportunidades de mejora del tratamiento de la hepatitis C.

OBJECTIVE: Hepatitis C represents a public health concern with more than 170 million carriers. The goal of this study was to identify improvement opportunities in the management of hepatitis C, and the pharmaceutical actions performed for the prevention and solution of medication-related problems in patients seen at the Pharmaceutical Care Outpatient Unit. METHOD: A longitudinal study (January to October 2005) with patients monoinfected by hepatitis C virus receiving ribavirin and peginterferon alfa (2a or 2b). Data collection took place during the interview at the time of antiviral dispensation. Adverse reactions were classified according to CTCEA v3.0 criteria. Iaser methodology was used to identify patients with improvement opportunities regarding treatment. RESULTS: In all 109 patients and 201 improvement opportunities were identified. Pharmacotherapeutic morbidity was identified from adverse events (blood toxicity, pseudoflu syndrome, etc.) in 425 occasions; 388 pharmaceutical actions were performed, 41.23% to prevent adverse effects and 39.95% to provide patients or carers with information. CONCLUSIONS: In all, 99.01% of patients had safety problems. Pharmacotherapeutic morbidity from adverse effects was less common than reported in clinical trials of these drugs. Most pharmaceutical actions were preventive in nature. Iaser methodology allows to identify patients with improvement opportunities regarding hepatitis C treatment and the prevention of pharmacotherapeutic morbidity.

Identificación de oportunidades de mejora del tratamiento de la hepatitis C / No disponible

Objetivo: El objetivo de este estudio es identificar las oportunidadesde mejora del tratamiento de la hepatitis C y las actuacionesfarmacéuticas realizadas para la prevención y resolución deproblemas relacionados con la medicación en los pacientes atendidosen la unidad de atención farmacéutica a pacientes externos.Método: Estudio longitudinal (enero a octubre de 2005) conpacientes monoinfectados por el virus de la hepatitis C en tratamientocon ribavirina y peginterferón alfa (2a o 2b). La recogidade datos se realizó durante la entrevista con el paciente en elmomento de la dispensación de los antivirales. Las reaccionesadversas se clasificaron según los criterios CTCEA v3.0. Para laidentificación de pacientes con oportunidades de mejora en sutratamiento se empleó la metodología Iaser®.Resultados: Se incluyeron 109 pacientes con 201 oportunidadesde mejora. Se identificó morbilidad farmacoterapéutica porefectos adversos (toxicidad hematológica, síndrome pseudogripal,etc.) en 425 ocasiones. Se realizaron 388 actuaciones farmacéuticas,el 41,23% para prevenir efectos adversos y el 39,95% paraproveer de información al paciente o cuidador.Conclusiones: El 99,01% de pacientes presentaba problemasde seguridad. La morbilidad farmacoterapéutica por efectosadversos es de menor frecuencia que la publicada en ensayos clínicoscon estos medicamentos. Las principales actuaciones farmacéuticasrealizadas fueron de tipo preventivo. La metodologíaIaser® permite la identificación de pacientes con oportunidades demejora del tratamiento de la hepatitis C y la prevención de morbilidadfarmacoterapéutica

Objective: Hepatitis C represents a public health concernwith more than 170 million carriers. The goal of this study was toidentify improvement opportunities in the management of hepatitisC, and the pharmaceutical actions performed for the preventionand solution of medication-related problems in patients seenat the Pharmaceutical Care Outpatient Unit.Method: A longitudinal study (January to October 2005) withpatients monoinfected by hepatitis C virus receiving ribavirin andpeginterferon alfa (2a or 2b). Data collection took place duringthe interview at the time of antiviral dispensation. Adverse reactionswere classified according to CTCEA v3.0 criteria. Iaser®methodology was used to identify patients with improvementopportunities regarding treatment.Results: In all 109 patients and 201 improvement opportunitieswere identified. Pharmacotherapeutic morbidity was identifiedfrom adverse events (blood toxicity, pseudoflu syndrome, etc.) in425 occasions; 388 pharmaceutical actions were performed,41.23% to prevent adverse effects and 39.95% to providepatients or carers with information.Conclusions: In all, 99.01% of patients had safety problems.Pharmacotherapeutic morbidity from adverse effects was lesscommon than reported in clinical trials of these drugs. Most pharmaceuticalactions were preventive in nature. Iaser® methodologyallows to identify patients with improvement opportunities regardinghepatitis C treatment and the prevention of pharmacotherapeuticmorbidity