Stability of meropenem in portable elastomeric infusion devices: which protocol should be implemented in clinical practice?

Meropenem has an excellent activity against gram-positive and gram-negative bacteria, including multi-resistant microorganisms. Even though meropenem is a great candidate for outpatient parenteral antimicrobial therapy (OPAT), its physicochemical stability is a major challenge. This work aimed to demonstrate the suitability of including meropenem in OPAT by elucidating its physicochemical stability in a range of commonly prescribed concentrations within portable elastomeric infusion devices. Physical and chemical stability were evaluated at two concentrations commonly used in clinical practice (2 and 25 mg/mL), and three temperatures (2°C-8°C, 25°C, and 32°C) using Accufuser portable elastomeric infusion devices. Drug adsorption onto portable elastomeric infusion devices was also determined at the end of the experiment. Meropenem stability significantly decreased at higher temperatures and when higher drug solution concentrations were used. Meropenem solutions at 2 mg/mL kept the drug content above 95% over 24 h at 2°C-8°C but just for 8 h at 25°C. Nevertheless, solutions containing 25 mg/mL of meropenem showed a dramatic decrease in chemical stability after 8 h 2°C-8°C and just after 4 h at 25°C or 32°C. However, physical stability was kept favorable during this period. The drug adsorption on the material of the elastomeric infusion device was below 1%, indicating the suitability of the chosen device. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the results obtained in our study. The results obtained in this study open up the possibility of administering meropenem in an OPAT setting despite its short stability.IMPORTANCEAlthough outpatient parenteral antibiotic therapy can be a good approach to treating infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe and effective use. Actually, meropenem is used for prolonged periods above 24 h, and it is not physicochemically stable, which can compromise efficacy and toxicity. This work is of high importance to show the clinicians the real shelf life of meropenem when administered in portable elastomeric infusion devices. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the stability drug results obtained in our study.

Stability of meropenem in portable elastomeric infusion devices: which protocol should be implemented in clinical practice?

IMPORTANCE: Although outpatient parenteral antibiotic therapy can be a good approach to treating infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe and effective use. Actually, meropenem is used for prolonged periods above 24 h, and it is not physicochemically stable, which can compromise efficacy and toxicity. This work is of high importance to show the clinicians the real shelf life of meropenem when administered in portable elastomeric infusion devices. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the stability drug results obtained in our study.

Antibiotic stability in portable elastomeric infusion devices: A systematic review.

PURPOSE: Although outpatient parenteral antibiotic therapy (OPAT) can be a good approach to treatment of infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe, appropriate, and effective use. The objective of this work was to complete a systematic peer-reviewed analysis of published articles about antibiotic stability in elastomeric infusion devices that provide evidence supporting their use in OPAT. SUMMARY: A systematic review following PRISMA guidelines was conducted in January 2021 to identify published articles about antibiotic stability in portable elastomeric infusion devices. The databases used were PubMed, Embase, Web of Science, and a Cochrane database. A total of 1,615 original studies and conference communications were found. After title, abstract, and full-text review, 33 articles met the inclusion criteria. The data obtained included information about the stability of 30 different antibiotics. To our knowledge, this is the first review to summarize the available published data on the stability of antibiotics in portable elastomeric infusion devices. The results highlight the poor stability of some antibiotics in solution and the variability of the laboratory conditions in the included studies. CONCLUSION: This systematic review can serve as a useful resource for healthcare professionals involved in providing OPAT using portable elastomeric infusion devices. However, further stability studies should be performed, especially high-quality studies simulating real-life time and temperature conditions.

Systematic review of computerized prescriber order entry and clinical decision support.

PURPOSE: Results of a systematic review of published data on the effect of computerized prescriber order entry (CPOE) with clinical decision support on medication error (ME) and adverse drug event (ADE) rates are presented. METHODS: Literature searches of MEDLINE, Embase, and other databases were conducted to identify English- and Spanish-language articles on selected CPOE outcomes published from 1995 through 2016; in addition, 5 specific journals were searched for pertinent articles published during the period 2010-16. Publications on controlled prospective studies and before-and-after studies that assessed MEs and/or ADEs as main outcomes were selected for inclusion in the review. RESULTS: Nineteen studies met the inclusion criteria. Data on MEs and ADEs could not be pooled, mainly due to heterogeneity in outcome definitions and study methodologies. The reviewed evidence indicated that CPOE implementation led to an overall reduction in errors at the prescription stage of the medication-use process (relative risk reduction, 0.29 [95% confidence interval, 0.10-0.85]; I 2 = 99%) and reductions in most types of prescription errors, but CPOE also resulted in the emergence of other types of errors. CONCLUSION: CPOE reduces the overall ME rate in the prescription process, as well as specific types of errors, such as wrong dose or strength, wrong drug, frequency, administration route, and drug-drug interaction errors. The implementation of CPOE can lead to new errors, such as wrong drug selection from drop-down menus.

Grading the potential safety risk of medications used in hospital care / Clasificación de los grupos de medicamentos según su nivel de riesgo en el ámbito hospitalario

Objective: The aim of this study was to stratify medications used in hospital care according to their potential risk. Method: The RAND/UCLA Appropriateness Method was used. Anatomical Therapeutic Chemical subgroups were classified according to their potential risk. A literature search, bulletins, and alerts issued by patient safety organizations were used to identify the potential safety risk of these subgroups. Nine experts in patient/medication safety were selected to score the subgroups for their appropriateness in the classification. Two evaluation rounds were conducted: the first by email and the second by a panel meeting. Results: A total of 298 Anatomical Therapeutic Chemical subgroups were evaluated. They were classified into three scenarios (low, medium, and high risk). In the first round, 266 subgroups were classified as appropriate to the assigned scenario, 32 were classified as uncertain, and none were classified as inappropriate. In the second round, all subgroups were classified as appropriate. The most frequent subgroups in the low-risk scenario belonged to group A "Alimentary tract and metabolism" (44%); the most frequent in the medium-risk scenario belonged to group J "Antiinfectives for systemic use" (32%); and the most frequent in the high-risk scenario belonged to group L "Antineoplastic and immunomodulating agents" (29%) and group N "Nervous system" (26%). Conclusions: Based on the RAND/UCLA appropriateness method, Anatomical Therapeutic Chemical subgroups used in hospital care were classified according to their potential risk (low, medium, or high). These lists can be incorporated into a risk-scoring tool for future patient/medication safety studies (AU)

Objetivo: Estratificar los medicamentos utilizados en el ámbito hospitalario según el riesgo de provocar daño al paciente. Método: Se utilizó la metodología RAND/UCLA para clasificar los subgrupos terapéuticos del código Anatómica, Terapéutica, Química según el riesgo de provocar daño al paciente. Para ello se realizó una revisión de la evidencia disponible en publicaciones, boletines y alertas de organismos de seguridad del paciente. A continuación se seleccionaron nueve expertos en seguridad del paciente/medicamento para evaluar la clasificación de los subgrupos terapéuticos: una primera ronda de evaluación por vía telemática y una segunda ronda en una reunión presencial en la que se presentaron y discutieron los resultados de la primera. Resultados: Se evaluaron 298 subgrupos terapéuticos. Se clasificaron en tres escenarios (riesgo bajo, medio y alto). En la primera ronda se clasificaron 266 subgrupos como adecuados al escenario asignado, 32 subgrupos fueron clasificados como inciertos y ninguno fue clasificado como inapropiado. En la segunda ronda, todos los subgrupos fueron clasificados como adecuados. Los subgrupos más frecuentes en el escenario de riesgo bajo pertenecieron al Grupo A: "Tracto alimentario y metabolismo" (44%), en el de riesgo medio al Grupo J: "Antiinfecciosos para uso sistémico" (32%), y en el de riesgo alto al Grupo L: "Agentes antineoplásicos e inmunomoduladores" (29%) y al Grupo N: "Sistema nervioso" (26%). Conclusiones: La metodología RAND/UCLA ha permitido estratificar los subgrupos utilizados en el ámbito hospitalario según el riesgo potencial de provocar daño al paciente. Esta estratificación puede servir como herramienta para futuros estudios de seguridad en la utilización de medicamentos (AU)

Grading the potential safety risk of medications used in hospital care.

OBJECTIVE: The aim of this study was to stratify medications used in hospital  care according to their potential risk. METHOD: The RAND/UCLA Appropriateness Method was used. Anatomical Therapeutic Chemical subgroups were classified according to their potential risk. A literature search, bulletins, and alerts issued by patient safety organizations were used to identify the potential safety risk of  these subgroups. Nine experts in patient/medication safety were selected to score the subgroups for their appropriateness in the classification. Two evaluation rounds were conducted: the first by email and the second by a  panel meeting. RESULTS: A total of 298 Anatomical Therapeutic Chemical subgroups were  evaluated. They were classified into three scenarios (low, medium, and high  risk). In the first round, 266 subgroups were classified as appropriate to the  assigned scenario, 32 were classified as uncertain, and none were classified as  inappropriate. In the second round, all subgroups were classified as appropriate.  The most frequent subgroups in the low-risk scenario belonged to  group A "Alimentary tract and metabolism" (44%); the most frequent in the  medium-risk scenario belonged to group J "Antiinfectives for systemic use"  (32%); and the most frequent in the high-risk scenario belonged to group L  "Antineoplastic and immunomodulating agents" (29%) and group N "Nervous  system" (26%). CONCLUSIONS: Based on the RAND/UCLA appropriateness method, Anatomical  Therapeutic Chemical subgroups used in hospital care were classified according  to their potential risk (low, medium, or high). These lists can be incorporated  into a risk-scoring tool for future patient/medication safety studies.

Objetivo: Estratificar los medicamentos utilizados en el ámbito hospitalario según el riesgo de provocar daño al paciente.Método: Se utilizó la metodología RAND/UCLA para clasificar los subgrupos terapéuticos del código Anatómica, Terapéutica, Química según el  riesgo de provocar daño al paciente. Para ello se realizó una revisión de la  evidencia disponible en publicaciones, boletines y alertas de organismos de  seguridad del paciente. A continuación se seleccionaron nueve expertos en  seguridad del paciente/medicamento para evaluar la clasificación de los  subgrupos terapéuticos: una primera ronda de evaluación por vía telemática y  una segunda ronda en una reunión presencial en la que se presentaron y  discutieron los resultados de la primera.Resultados: Se evaluaron 298 subgrupos terapéuticos. Se clasificaron en tres  escenarios (riesgo bajo, medio y alto). En la primera ronda se clasificaron 266  subgrupos como adecuados al escenario asignado, 32 subgrupos fueron  clasificados como inciertos y ninguno fue clasificado como inapropiado. En la  segunda ronda, todos los subgrupos fueron clasificados como adecuados. Los  subgrupos más frecuentes en el escenario de riesgo bajo pertenecieron al Grupo  A: "Tracto alimentario y metabolismo" (44%), en el de riesgo medio al Grupo J:  "Antiinfecciosos para uso sistémico" (32%), y en el de riesgo alto al Grupo L:  "Agentes antineoplásicos e inmunomoduladores" (29%) y al Grupo N: "Sistema  nervioso" (26%).Conclusiones: La metodología RAND/UCLA ha permitido estratificar los  subgrupos utilizados en el ámbito hospitalario según el riesgo potencial de  provocar daño al paciente. Esta estratificación puede servir como herramienta  para futuros estudios de seguridad en la utilización de medicamentos.

A continuous usability evaluation of an electronic medication administration record application.

RATIONALE, AIMS, AND OBJECTIVES: The complexity of an electronic medication administration record (eMAR) has been underestimated by most designers in the past. Usability issues, such as poorly designed user application flow in eMAR, are therefore of vital importance, since they can have a negative impact on nursing activities and result in poor outcomes. The purpose of this study was to evaluate the usability of an eMAR application during its development. METHODS: A usability evaluation was conducted during the development of the eMAR application. Two usability methods were used: a heuristic evaluation complemented by usability testing. Each eMAR application version provided by the vendor was evaluated by 2 hospital pharmacists, who applied the heuristic method. They reviewed the eMAR tasks, detected usability problems and their heuristic violations, and rated the severity of the usability problems. Usability testing was used to assess the final application version by observing how 3 nurses interacted with the application. RESULTS: Thirty-four versions were assessed before the eMAR application was considered usable. During the heuristic evaluation, the usability problems decreased from 46 unique usability problems in version 1 (V1) to 9 in version 34 (V34). In V1, usability problems were categorized into 154 heuristic violations, which decreased to 27 in V34. The average severity rating also decreased from major usability problem (2.96) to no problem (0.23). During usability testing, the 3 nurses did not encounter new usability problems. CONCLUSION: A thorough heuristic evaluation is a good method for obtaining a usable eMAR application. This evaluation points key areas for improvement and decreases usability problems and their severity.

Effect of an electronic medication administration record application on patient safety.

RATIONALE, AIMS, AND OBJECTIVES: To evaluate the effect of an electronic medication administration record (eMAR) application on the rate of medication errors in medication administration recording (ME-MAR). METHODS: A before-and-after, quasiexperimental study was conducted in a university hospital that implemented the eMAR application in March 2014. Data collection was conducted in April 2012 (pre-) and June 2014 (post-) by two pharmacists. The ME-MARs were analysed by the staff involved to identify their cause. The two pharmacists independently classified the ME-MARs. In the case of disagreement, a research team examined the ME-MARs and categorized them by consensus. Three classifications were used: A classic medication error taxonomy and 2 technology-induced error taxonomies. RESULTS: The pharmacists analysed 2835 (pre-) and 2621 (post-) medication administration records (MAR), respectively. Overall, the ME-MAR rate decreased from 48.0% (pre-) to 36.9% (post-) (P < .05). The same types of ME-MAR were observed in both phases except for "MAR with incomplete information," which was not observed in the postimplementation phase. In both phases, the most frequent ME-MAR was "MAR at the wrong time" (MAR before or after medication administration) (31.6% vs 30.2%). The main cause of ME-MARs in both phases was the failure to follow work procedures. The potential future risk of ME-MARs significantly decreased after the eMAR implementation (P < .05). All ME-MARs were "use errors" because of human factors. New ME-MARs (1.24%; n = 12) were observed in the postimplementation phase. CONCLUSION: Use of the eMAR application significantly reduces the rate of ME-MAR and their potential risk. The main cause of ME-MAR was the failure to follow work procedures.

Potential future risk of errors in medication administration recording.

RATIONALE, AIMS AND OBJECTIVES: The aim of this study is to adapt and assess the interrater reliability of a potential future risk matrix for medication errors in medication administration recording (ME-MAR). METHODS: The study was carried out in a teaching hospital. It was conducted in two phases. In the first phase, a consensus method was used in order to adapt the potential future risk matrix published by the National Patient Safety and Otero et al. to the ME-MAR. The consensus method consisted in a nominal group formed by four pharmacists. In the second phase, a multidisciplinary group of experts in patient safety assessed the reliability of the adapted matrix. Five raters evaluated 100 ME-MAR. Its reliability was evaluated using the kappa statistic. RESULTS: In the first phase, two meetings were necessary until consensus was reached to adapt the potential future risk matrix to the ME-MAR. For this purpose, the two following categories were defined: likelihood of ME-MAR's recurrence and most likely consequences of ME-MAR. The definition of each grade of likelihood of recurrence was based on the incidence of ME-MAR from an unpublished study carried out in our hospital. In order to determine the most likely consequences of ME-MAR, a two-dimensional matrix was designed, with severity per type of ME-MAR on one axis and the class of medication on the other. In the second phase, the reliability of the matrix was tested. The overall interrater agreement for the five raters was substantial at 0.68 (Confidence interval 95% 0.60-0.76). CONCLUSION: The adapted matrix of potential future risk to ME-MAR is reliable and can serve as a guide for future studies.

Intervención farmacéutica en la prescripción de metformina en pacientes con diabetes mellitus tipo 2 e insuficiencia renal / Pharmaceutical intervention in metformin prescribing in patients with type 2 diabetes mellitus and renal insufficiency

OBJETIVO: Implantar un programa de seguimiento farmacoterapéutico a pacientes ingresados con insuficiencia renal moderada-severa en tratamiento con metformina y analizar el impacto de la intervención farmacéutica en su prescripción. MATERIAL Y MÉTODO: Estudio prospectivo de intervención desarrollado en un hospital general de 1.080 camas de 2,5 meses de duración. Se diseñó un algoritmo con el fin de hacer un uso seguro de la metformina en función del aclaramiento de creatinina. En pacientes con insuficiencia renal grave se recomendó la suspensión del fármaco, mientras que en los de moderada se valoraron otros factores. Se analizó asimismo el grado de aceptación de la intervención farmacéutica, así como si hubo algún episodio de acidosis láctica inducida por metformina. RESULTADOS: Un 11,5% de los pacientes a los que se prescribió metformina presentó insuficiencia renal (16,1-59,8 ml/min de aclaramiento de creatinina). Un 65,3% de ellos además presentaba otra comorbilidad que a priori contraindicaba su uso. La aceptación de las intervenciones farmacéuticas fue del 65,7%, alcanzando un 80% cuando el paciente presentaba insuficiencia renal grave y se recomendaba suspenderla. CONCLUSIONES: La implantación de un programa de seguimiento farmacoterapéutico a pacientes diabéticos con insuficiencia renal moderada-severa en tratamiento con metformina ha resultado en un uso seguro del fármaco. El grado de aceptación de las intervenciones farmacéuticas ha sido bueno, y no se registró ningún episodio de acidosis láctica inducida por metformina

OBJECTIVE: To implement a pharmaceutical care program for hospitalized patients with moderate to severe renal insufficiency treated with metformin and to analyze the impact of pharmaceutical intervention in its prescribing. MATERIAL AND METHOD: Prospective intervention study developed in a general hospital of 1,080 beds over a 2.5 month period. An algorithm was designed in order to use metformin depending on creatinine clearance. In patients suffering from severe renal insufficiency the pharmaceutical intervention was to recommend the discontinuation of the drug, while for moderate insufficiency other factors were considered. The degree of acceptance of the pharmaceutical intervention was calculated, and whether there was any episode of metformin-induced lactic acidosis. RESULTS: Renal insufficiency (16.1-59.8 ml/min creatinine clearance) was observed in 11.5% of the patients taking metformin. Almost two-thirds (65.3%) of them had other comorbidities that also contraindicated the use of metformin. Acceptance of pharmaceutical interventions was 65.7%, reaching 80% if the patient suffered from severe renal impairment. CONCLUSIONS: The implementation of a pharmaceutical care program for diabetic patients with moderate to severe renal insufficiency using metformin resulted in the safe use of the drug. The degree of acceptance of the pharmaceutical interventions was good and there were no episodes of metformin-induced lactic acidosis

Resultados de la integración de la atención farmacéutica en una Unidad de Agudos de Geriatría / Results of integrating pharmaceutical care in an Acute Geriatric Unit

Objetivo. Evaluar un programa de atención farmacéutica en la detección de prescripciones potencialmente inapropiadas (PPI) y resultados negativos de la medicación (RNM), y en la información al alta en pacientes mayores hospitalizados. Método. Estudio descriptivo, prospectivo, de 9 meses de duración, en pacientes mayores hospitalizados en una Unidad de Agudos de Geriatría de un hospital universitario. En el ingreso, el farmacéutico elaboró la historia farmacoterapéutica de dichos pacientes y procedió a la detección de RNM, según las directrices del Tercer Consenso de Granada, y de PPI según los criterios STOPP-START. Al alta, el farmacéutico informó verbalmente y por escrito al paciente y/o sus cuidadores, del tratamiento, entregándole documentación informativa generada por un programa informático. Resultados. Se incluyeron 189 (84,7%) pacientes en el programa de atención farmacéutica. El 71,9% fueron mujeres y la edad media fue 87,2±5,5 años. Se analizaron 1.523 prescripciones (media de fármacos/paciente 8,1±3,3), detectándose 356 (23,4%) PPI y 580 (38,1%) RNM, (media por paciente de 1,9 PPI y 3,2 RNM). El 74,2% de los pacientes tuvieron al menos una PPI: STOPP (48,9%) y START (26,9%). El RNM más frecuente fue la existencia de un problema de salud no tratado. El farmacéutico proporcionó información oral y escrita al 74,7% de los pacientes dados de alta. Conclusión. La atención farmacéutica mediante la integración del farmacéutico en el equipo multidisciplinar de un servicio de Geriatría permitió detectar un elevado número de PPI y RNM al ingreso hospitalario, y proporcionar información al alta a dichos pacientes(AU)

Objective. To evaluate whether the integration of pharmaceutical care in an acute geriatric unit can promote the detection of potentially inappropriate drug prescriptions (PIP) and adverse drug events (ADE), and if this can improve patient and caregiver information at hospital discharge. Method. Descriptive prospective study in older patients admitted for acute care in the Geriatric Department of a university hospital. On admission, a pharmacist recorded a comprehensive drug history from the patient, caregiver and other available sources, and reviewed preadmission treatments in order to detect adverse drug events (using the 3rd Granada consensus criteria) and potentially inappropriate prescriptions (using STOPP-START criteria). At hospital discharge, the pharmacist informed patients and caregivers about the treatment and gave them computer generated written information for all drugs prescribed. Results. In a 9 month period 189 patients (84.7% of all admissions) were included in the pharmaceutical care program (71.9% women, mean age 87.2±5.5 years). After analysing 1523 prescriptions (mean drugs/patient 8.1±3.3), 356 (23.4%) potentially inappropriate prescriptions and 580 (38.1%) adverse drug events were detected (1.9 PIP and 3.2 ADE per patient). Almost three-quarters (74.2%) of the patients had at least one PIP: STOPP (48.9%) and START (26.9%). The most frequent adverse drug event was an untreated health problem. The pharmacist offered verbal and written information to 74.7% of the discharged patients. Conclusion. Adding pharmaceutical care to the multidisciplinary activity of an acute geriatric care unit enables a great number of potentially inappropriate prescriptions and adverse drug events to be detected, and increases patient and caregiver information at hospital discharge(AU)

[Results of integrating pharmaceutical care in an Acute Geriatric Unit]. / Resultados de la integración de la atención farmacéutica en una Unidad de Agudos de Geriatría.

OBJECTIVE: To evaluate whether the integration of pharmaceutical care in an acute geriatric unit can promote the detection of potentially inappropriate drug prescriptions (PIP) and adverse drug events (ADE), and if this can improve patient and caregiver information at hospital discharge. METHOD: Descriptive prospective study in older patients admitted for acute care in the Geriatric Department of a university hospital. On admission, a pharmacist recorded a comprehensive drug history from the patient, caregiver and other available sources, and reviewed preadmission treatments in order to detect adverse drug events (using the 3(rd) Granada consensus criteria) and potentially inappropriate prescriptions (using STOPP-START criteria). At hospital discharge, the pharmacist informed patients and caregivers about the treatment and gave them computer generated written information for all drugs prescribed. RESULTS: In a 9 month period 189 patients (84.7% of all admissions) were included in the pharmaceutical care program (71.9% women, mean age 87.2±5.5 years). After analysing 1523 prescriptions (mean drugs/patient 8.1±3.3), 356 (23.4%) potentially inappropriate prescriptions and 580 (38.1%) adverse drug events were detected (1.9 PIP and 3.2 ADE per patient). Almost three-quarters (74.2%) of the patients had at least one PIP: STOPP (48.9%) and START (26.9%). The most frequent adverse drug event was an untreated health problem. The pharmacist offered verbal and written information to 74.7% of the discharged patients. CONCLUSION: Adding pharmaceutical care to the multidisciplinary activity of an acute geriatric care unit enables a great number of potentially inappropriate prescriptions and adverse drug events to be detected, and increases patient and caregiver information at hospital discharge.