Outcomes of a Undiluted, One-Bag Desensitization Protocol for Chemotherapeutic Agents.

BACKGROUND: Hypersensitive reactions (HSRs) often require that the provoking medication be discontinued but chemotherapeutic drugs are often essential for the treatment of the disease. Rapid drug desensitization is a procedure that induces temporary tolerance to the drug allowing continuation of treatment in patients who have presented HSRs. Most of the desensitization protocols use 3 bags with sequential dilutions of the drug, which are infused in gradual steps. However, it has not been sufficiently investigated whether dilution is essential for successful desensitization. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of a new one-bag desensitization protocol which uses a single solution of 1 mg/mL throughout the procedure allowing to reduce time and simplifying the desensitization procedure. METHODS: Retrospective observational study was carried out in adult patients with HSRs to chemotherapy agents who received a new nondilution one-bag desensitization protocol between 2016 and 2021. RESULTS: A total of 130 desensitization procedures with an undiluted one-bag protocol were performed on 17 patients with HSRs to chemotherapy. One hundred and seven (82.3%) were for desensitization to CBDCA, 15 (11.5%) for oxaliplatin, 4 (3.1%) for paclitaxel and 4 (3.1%) for brentuximab. All of the 130 procedures were successfully accomplished, and all patients could receive their target dose. No breakthrough reactions (BTRs) occurred in 77% (100/130) of desensitizations, and only mild reactions (grade 1) with skin symptoms were observed in 23% (30/130) of desensitizations. CONCLUSION AND RELEVANCE: The undiluted one-bag desensitization protocol was safe and effective and has been adopted as the standard of care at our institution in treating patients with HSRs to chemotherapeutic drugs as it requires less time and simplifies the desensitization procedure, optimizing risk management.

[Translated article] Retrospective study of home antibiotic infusion therapy using elastomeric infusion pumps.

OBJECTIVES: To describe the experience of home antibiotic infusion therapy using elastomeric infusion pumps, administered to patients admitted to the Home Hospitalisation Unit of a tertiary hospital for 3 years and to analyse clinical evolution and mortality. METHOD: Retrospective observational study. The medical history of the patients included in the study was reviewed. Information was obtained on personal history, antimicrobial therapy received, and clinical evolution. Statistical analysis was performed using SPSS® 19 software. RESULTS: 81 patients were included, 61.7% men, with a mean age of 73.5±17.5 years. The most frequent comorbidities were diabetes mellitus (30.9%) and chronic kidney disease (28.4%). Patients received a mean of 11.9±8.5 days of antibiotic treatment in an elastomeric infusion pump. The main focus of infection was respiratory (27.2%), followed by bacteremia (16%) and skin and soft tissue infections (12.3%). Of the infections, 65.4% were monomicrobial, with Pseudomonas aeruginosa being the main microorganism involved (39.6%). The most commonly used antimicrobial was piperacillin/tazobactam (33.3%). The clinical course was good in 85.2% of the patients, but the mortality rate in the 30 days following the end of treatment was 24.7%. In the univariate analysis, a history of neoplasia in the last 5 years (p=.01) and having received fewer days of antibiotic therapy prior to the start of outpatient antimicrobial therapy in infusion pump (p=.04) were associated with worse clinical outcome. Age over 80 years was associated with better outcome (p=.03). The diagnosis of heart failure was associated with higher mortality (p=.026) and patients from surgical services, with lower mortality (p=.047). In the multivariate analysis, the presence of neoplasia was associated with unfavourable evolution (p=.012) and heart failure with higher mortality (p=.027). CONCLUSIONS: Outpatient antimicrobial therapy in elastomeric infusion pumps is an alternative in patients requiring prolonged intravenous treatment, and age is not a conditioning factor for inclusion in these programs. However, the presence of certain comorbidities can negatively affect the clinical course and mortality of patients.

Retrospective study of home antibiotic infusion therapy in elastomeric infusion pumps. / Estudio retrospectivo de la terapia de infusión de antibióticos domiciliaria en bombas de infusión elastoméricas.

OBJECTIVES: To describe the experience of home antibiotic infusion therapy using elastomeric infusion pumps, administered to patients admitted to the Home Hospitalization Unit of a tertiary hospital for three years and to analyse clinical evolution and mortality. METHOD: Retrospective observational study. The medical history of the patients included in the study was reviewed. Information was obtained on personal history, antimicrobial therapy received and clinical evolution. Statistical analysis was performed using SPSS® 19 software. RESULTS: Eighty-one patients were included, 61.7% men, with a mean age of 73.5 ± 17.5 years. The most frequent comorbidities were diabetes mellitus (30.9%) and chronic kidney disease (28.4%). Patients received a mean of 11.9 ± 8.5 days of antibiotic treatment in an elastomeric infusion pump. The main focus of infection was respiratory (27.2%), followed by bacteremia (16%) and skin and soft tissue infections (12.3%). Of the infections, 65.4% were monomicrobial, with Pseudomonas aeruginosa being the main microorganism involved (39.6%). The most commonly used antimicrobial was piperacillin/tazobactam (33.3%). The clinical course was good in 85.2% of the patients, but the mortality rate in the 30 days following the end of treatment was 24.7%. In the univariate analysis, a history of neoplasia in the last 5 years (p = 0.01) and having received fewer days of antibiotic therapy prior to the start of outpatient antimicrobial therapy in infusion pump (p = 0.04) were associated with worse clinical outcome. Age over 80 years was associated with better outcome (p = 0.03). The diagnosis of heart failure was associated with higher mortality (p = 0.026) and patients from surgical services, with lower mortality (p = 0.047). In the multivariate analysis, the presence of neoplasia was associated with unfavorable evolution (p = 0.012) and heart failure with higher mortality (p = 0.027). CONCLUSIONS: Outpatient antimicrobial therapy in elastomeric infusion pumps is an alternative in patients requiring prolonged intravenous treatment, and age is not a conditioning factor for inclusion in these programs. However, the presence of certain comorbidities can negatively affect the clinical course and mortality of patients.

Inhalation technique assessment and evaluation for the need of pharmaceutical intervention in respiratory pathologies patients.

OBJECTIVE: To evaluate rate and type of errors in inhalation technique of patients seen in hospitals at the observation area in the  emergency department, as well as patients seen in the outpatients clinic  at the primary care pharmaceutical consultation, and at the  community pharmacy. METHOD: Descriptive observational study carried out by a hospital  pharmacist, along with a primary care pharmacist and a community  pharmacist. An anonymous survey was performed in order to collect  different analyzed data. Each patient was asked to execute a complete  demonstration on how they used their inhalers, to actively check the  inhalation technique. Two checklists regarding the type of inhaler were  established in order to assess said technique. Results were tabulated  through Microsoft Excel® 2010 software and analyzed through R 3.5  statistical program. RESULTS: A total of 66 patients (42 male, 24 female; mean age 67) were  recruited. Out of all patients, 48.5% used more than one  inhaler, which 34.4% used different types of inhaler, and 65.6% used  different systems. A total of 39 patients were under dry powder inhaler  therapy, and 38 were using pressurized metered dose inhalers. The  most frequent errors -both in dry powder inhalers and pressurized  metered dose inhalers-were: not performing a 10 second apnea and not  slowly expelling air from the lungs. Around 50% of patients needed  new learning after assessing their inhalation technique, even though  88.5% had already received previous training. Older aged patients  performed a worse inhalation technique. CONCLUSIONS: There is a high rate of errors in the use of inhaled  therapy, being even higher among older aged patients. The inhalation  technique training by the medical staff seems inadequate, as it is crucial  to raise awareness about the importance of health education for  patients and their use of inhalers, to which a scheduled follow up and a  technical and feedback obtained from the patient assessment is  required.

Objetivo: Analizar la tasa y los tipos de errores en la técnica de  inhalación de pacientes atendidos a nivel hospitalario en el área de  observación del servicio de urgencias y a nivel ambulatorio en la  consulta farmacéutica de atención primaria y en la farmacia  comunitaria.Método: Estudio observacional de tipo descriptivo realizado por un farmacéutico hospitalario en colaboración con un farmacéutico de  atención primaria y un farmacéutico comunitario. Se realizó una  entrevista anónima para registrar los distintos datos analizados y se  solicitó a cada paciente que ejecutara una demostración completa de  cómo utilizaba su inhalador habitualmente para comprobar de forma  activa la técnica de inhalación. Para evaluar dicha técnica se  establecieron dos checklist en función del tipo de inhalador. Los  resultados fueron tabulados mediante el software Microsoft Excel® 2010  y analizados mediante el programa estadístico R 3.5. Resultados: Se reclutaron 66 pacientes (42 varones y 24 mujeres; edad media 67 años). El 48,5% usaban más de un inhalador,  de ellos el 34,4% utilizaban distintos tipos de inhalador y el 65,6%  diferentes sistemas. Un total de 39 pacientes estaban en tratamiento  con inhaladores de polvo seco y 38 con inhaladores de cartucho  presurizado. Los errores más frecuentes, tanto con inhaladores de polvo  seco como con inhaladores de cartucho presurizado, fueron: no  realizar la apnea de 10 segundos y no expulsar lentamente el aire de los  pulmones. En torno al 50% precisaron nuevo aprendizaje tras la  evaluación de la técnica de inhalación, a pesar de que el 88,5% ya  habían recibido formación previa. Los pacientes de edad más avanzada  realizaban peor la técnica inhalatoria.Conclusiones: Existe una elevada tasa de errores en el empleo de la terapia inhalada, siendo mayor en los pacientes de edad más  avanzada. La instrucción en la técnica inhalatoria por parte del personal  sanitario parece inadecuada, por lo que es preciso sensibilizar al mismo  sobre la importancia de la educación sanitaria a los pacientes en el  empleo de los inhaladores, realizando un seguimiento programado y una  evaluación de la técnica y del feedback obtenido por el paciente.

Desabastecimiento de medicamentos: un problema en constante crecimiento / Drugs Shortage: a constantly growing problema

OBJETIVO: Análisis de los desabastecimientos de medicamentos ocurridos en España en el año 2018. MÉTODO: Estudio observacional, descriptivo, retrospectivo. Los datos de los medicamentos con problemas de suministro se obtuvieron, trimestralmente, realizando una descarga a través de la página web de la Agencia Española de Medicamentos y Productos Sanitarios. El estudio estadístico de las comparaciones bivariantes se realizó mediante el test Chi-cuadrado (variables categóricas) y la prueba U Mann-Whitney (variables continuas). RESULTADOS: El número de desabastecimientos ocurridos fue 1143, afectando a 990 especialidades y 429 principios activos, lo que supone 3,16% y 17,44% de las especialidades y principios activos comercializados, respectivamente. 324 especialidades eran de uso hospitalario y 447 genéricas. Se vieron implicados el 100% de los códigos ATC y 178 compañías farmacéuticas. La mediana de días de desabastecimiento fue 79, sufriendo retraso en el restablecimiento del suministro el 30,2% de las especialidades. El 73,6% de las especialidades afectadas tenían alternativa con mismo principio activo, dosis y vía de administración. De las 302 para las que no existía una alternativa igual, 41 tampoco disponían de alternativa terapéutica. CONCLUSIONES: Los resultados obtenidos ratifican la fuerte evidencia de que la escasez de medicamentos es un problema extremadamente común tanto a nivel hospitalario como comunitario y un problema de gestión diario en los servicios de farmacia. Se ve dificultada la atención farmacéutica, sobrecargadas las consultas médicas y comprometida la seguridad del paciente. Es necesario que las autoridades sanitarias apliquen soluciones rápidas y efectivas para frenar el problema y que la situación no se cronifique

OBJECTIVE: Analysis of the drugs shortages that occurred in Spain in 2018. METHODS: Observational, descriptive, retrospective study. Data on medications with supply problems were obtained, quarterly, by downloading them from the website of the Spanish Agency for Medicines and Health Products. The statistical study of the bivariate comparisons was developed using the Chi-square test categorical variables) and the Mann-Whitney U test (continuous variables). RESULTS: The number of shortages occurred was 1143, affecting 990 specialties and 429 active principles, which represents respectively, 3.16% and 17.44% of the specialties and active principles marketed. 324 specialties were hospital drugs and 447 generic ones. 100% of the ATC codes and 178 pharmaceutical enterprises were involved. The average of shortages days was 79, with 30.2% of the specialties delayed in the restoration of supply. 73.6% of the affected specialties had an alternative with the same active substance, dose and route of administration. Among the 302 for which there was no equal alternative, 41 nor had a therapeutic alternative. CONCLUSIONS: The obtained results confirmed the strong evidence that nowadays drugs shortage is a common problem both, at the hospital and community level but also a problem of daily management in pharmacy services. Pharmaceutical care is hampered, medical consultations overloaded and patient safety compromised. It would be necessary that health authorities apply solutions quickly and effectively reverse the situation and try to avoid that the problem becomes chronic

Evaluación de la técnica inhalatoria y valoración de la necesidad de intervención farmacéutica en pacientes con patología respiratoria / Inhalation technique assessment and evaluation for the need of pharmaceutical intervention in respiratory pathologies patients

Objetivo: Analizar la tasa y los tipos de errores en la técnica de inhalación de pacientes atendidos a nivel hospitalario en el área de observación del servicio de urgencias y a nivel ambulatorio en la consulta farmacéutica de atención primaria y en la farmacia comunitaria. Método: Estudio observacional de tipo descriptivo realizado por un farmacéutico hospitalario en colaboración con un farmacéutico de atención primaria y un farmacéutico comunitario. Se realizó una entrevista anónima para registrar los distintos datos analizados y se solicitó a cada paciente que ejecutara una demostración completa de cómo utilizaba su inhalador habitualmente para comprobar de forma activa la técnica de inhalación. Para evaluar dicha técnica se establecieron dos checklist en función del tipo de inhalador. Los resultados fueron tabulados mediante el software Microsoft Excel(R) 2010 y analizados mediante el programa estadístico R 3.5. Resultados: Se reclutaron 66 pacientes (42 varones y 24 mujeres; edad media 67 años). El 48,5% usaban más de un inhalador, de ellos el 34,4% utilizaban distintos tipos de inhalador y el 65,6% diferentes sistemas. Un total de 39 pacientes estaban en tratamiento con inhaladores de polvo seco y 38 con inhaladores de cartucho presurizado. Los errores más frecuentes, tanto con inhaladores de polvo seco como con inhaladores de cartucho presurizado, fueron: no realizar la apnea de 10 segundos y no expulsar lentamente el aire de los pulmones. En torno al 50% precisaron nuevo aprendizaje tras la evaluación de la técnica de inhalación, a pesar de que el 88,5% ya habían recibido formación previa. Los pacientes de edad más avanzada realizaban peor la técnica inhalatoria. Conclusiones: Existe una elevada tasa de errores en el empleo de la terapia inhalada, siendo mayor en los pacientes de edad más avanzada. La instrucción en la técnica inhalatoria por parte del personal sanitario parece inadecuada, por lo que es preciso sensibilizar al mismo sobre la importancia de la educación sanitaria a los pacientes en el empleo de los inhaladores, realizando un seguimiento programado y una evaluación de la técnica y del feedback obtenido por el paciente

Objective: To evaluate rate and type of errors in inhalation technique of patients seen in hospitals at the observation area in the emergency department, as well as patients seen in the outpatients clinic at the primary care pharmaceutical consultation, and at the community pharmacy. Method: Descriptive observational study carried out by a hospital pharmacist, along with a primary care pharmacist and a community pharmacist. An anonymous survey was performed in order to collect different analyzed data. Each patient was asked to execute a complete demonstration on how they used their inhalers, to actively check the inhalation technique. Two checklists regarding the type of inhaler were established in order to assess said technique. Results were tabulated through Microsoft Excel(R) 2010 software and analyzed through R 3.5 statistical program. Results: A total of 66 patients (42 male, 24 female; mean age 67) were recruited. Out of all patients, 48.5% used more than one inhaler, which 34.4% used different types of inhaler, and 65.6% used different systems. A total of 39 patients were under dry powder inhaler therapy, and 38 were using pressurized metered dose inhalers. The most frequent errors -both in dry powder inhalers and pressurized metered dose inhalers- were: not performing a 10 second apnea and not slowly expelling air from the lungs. Around 50% of patients needed new learning after assessing their inhalation technique, even though 88.5% had already received previous training. Older aged patients performed a worse inhalation technique. Conclusions: There is a high rate of errors in the use of inhaled therapy, being even higher among older aged patients. The inhalation technique training by the medical staff seems inadequate, as it is crucial to raise awareness about the importance of health education for patients and their use of inhalers, to which a scheduled follow up and a technical and feedback obtained from the patient assessment is required