Severe, life-threatening adverse reactions to capecitabine sometimes occur in the treatment of solid tumors. Screening for dihydropyrimidine dehydrogenase (DPYD) deficiency is encouraged before start ...of treatment, but the genetic variants that are commonly analyzed often fail to explain toxicities seen in clinical practice. Here we describe the case of a 79-year-old Caucasian female with breast cancer who presented with life-threatening, rapidly increasing toxicity after 1 week of treatment with capecitabine and for whom routine genetic
test resulted negative.
exon sequencing found variant c.2242+1G>T at the donor splicing site of exon 19. This variant is responsible for skipping of exon 19 and subsequent generation of a non-functional DPYD enzyme. This variant has not been described previously but was found in three other members of the patient's family. With this case, we show that exon sequencing of
in patients who experience marked toxicity to fluoropyrimidines and test negative for commonly evaluated variants can prove extremely useful for identifying new genetic variants and better explain adverse reactions causality.
one of the groups that can benefit most from healthcare applications, are cancer patients. However, not all applications have a sufficient level of evidence. Our objective is to analyze the ...characteristics of mobile healthcare applications for cancer patients and know the reliability of their information.
a descriptive observational study of mobile apps targeting cancer patients. In November 2014, we searched mobile applications for cancer patients in the App Store (iOS) and Google Play (Android), using the terms “cancer” and “oncology” (English and/or Spanish languages). Applications were downloaded and evaluated. We registered their general characteristics (classification of cancer, last date of actualization, language and others) and their purpose (whether were informative, diagnostic, or preventive purposes) on an Excel® chart. The analysis was completed with an internet search to analyze their scientific evidence.
one hundred and sixty six applications were downloaded. 23.5% were destined for breast cancer. 52.4% upgraded their software in the last year. 98.2 % were in English. Most of the applications had more than one purpose. The most frequent were informative (39.8%), diagnostic (38.6%) and preventive (28.3%). 50.6% presented sufficient scientific evidence.
there are many benefits that are expected from these applications. However, we detected a lack of validity of the information, as well as lack of update of the data. To prevent these apps from becoming a safety problem rather than a useful tool for patients, regulation should be put in place.
uno de los grupos que más se pueden beneficiar de las aplicaciones en salud son los pacientes con cáncer. Sin embargo, no todas tienen un nivel de evidencia suficiente. El objetivo es analizar las características de las aplicaciones móviles destinadas a los pacientes con cáncer y conocer la fiabilidad de su información.
estudio observacional descriptivo de las aplicaciones móviles destinadas a los pacientes con cáncer. En noviembre de 2014 se realizó una búsqueda en los sistemas operativos App Store (iOS) y Google Play (Android), utilizando los términos “cancer” y “oncology” (idiomas inglés y/o español), se descargaron y evaluaron. En una tabla Excel® se registraron sus características generales (tipo de cáncer, fecha de última actualización e idioma, entre otras) y finalidad (informativa, diagnóstica y preventiva, entre otras). El análisis se completó con una búsqueda en internet para analizar su evidencia científica.
se descargaron 166 aplicaciones. El 23,5% estaban destinadas al cáncer de mama. El 52,4% actualizaron el software en el último año. El 98,2% estaban en inglés. La mayoría tenían más de una finalidad. Las más frecuentes fueron: informativa (39,8%), diagnóstica (38,6%) y preventiva (28,3%). El 50,6% presentaban una evidencia científica suficiente.
son muchos los beneficios que se esperan de estas aplicaciones. Sin embargo, se ha detectado una falta de validez de la información, así como falta de actualización de los datos. Para evitar que se conviertan en un problema de seguridad en lugar de una ayuda para el paciente, es necesaria su regulación.
Background
Self-administration of oral chemotherapy regimens in the home setting leading to new challenges in the health system.
Objective
To develop and evaluate a comprehensive pharmaceutical care ...program for cancer outpatients treated with oral antineoplastic agents.
Setting
A Spanish tertiary hospital.
Methods
During 2012, a comprehensive pharmaceutical care program was elaborated following the standards recommended by ASCO. It comprised a standard procedure focusing on: drug indication, dosing regimen, required laboratory tests, route of administration, interactions with other current medications and adverse events; a checklist and informational brochures. A pharmaceutical follow up was defined and structured into three clinical interviews over 6 months which focused on safety and efficiency outcomes. Patients starting treatment with oral antineoplastic agents during 2011 (control group) without pharmacist monitoring were compared to patients beginning treatment at some point in 2013 who were prospectively monitored by a pharmacist (intervention group). Statistical analysis was performed by the statistical program SPSS, 21.0 and
p
< 0.05 was considered significant.
Main outcome measures
Patient demographics and clinical data were recorded. The primary endpoint was safety outcomes: detection of drug related problems, drug interactions, and adverse events. Adherence, permanence and patient satisfaction were also collected.
Results
A total of 249 patients were enrolled in the study. Two hundred and seventy-five medication errors were recorded 106 in the control group and 169 in the intervention group (
p
= 0.008). The pharmacist intervened in 362 occasions being accepted 88.8 % of the time, mainly to reinforce patient education and literacy and giving information on co-administration with other drugs and herbal medicines. Adherent patients increased at the 6th month of treatment in the intervention group by 20 % (
p
< 0.001). High satisfaction was reported.
Conclusion
The program has been implemented and evaluated successfully. It ensures a high quality and standard of pharmaceutical care with high patient satisfaction rate and the key points to prioritize for improvement in terms of safety (interactions and administration errors) and efficiency (adherence and permanence) of oral antineoplastic agents.
Rationale, aims and objectives
Implementation of robotic systems in outpatient hospital pharmacies is uncommon. Other than cost, 1 of the barriers to widespread adoption is the lack of definitive ...evidence that this technology actually reduces dispensing errors and improves inventory management.
Objective
To identify the frequency of medication dispensing errors before and after the implementation of a robotic original pack dispensing system in an outpatient hospital pharmacy and to analyse the impact of this system on the quality of stock management and staff satisfaction.
Methods
A prospective before‐and‐after medication error study was performed using a disguised observation technique. Several indicators of stock management and staff satisfaction were monitored.
Drugs were dispensed manually by technicians using a barcode‐controlled system (preimplementation phase) or the dispensing robot ROWA Vmax (ARX) (postimplementation phase). As not all drugs could be handled by the robot, residual manual dispensing was also used.
Results
The dispensing error rate was reduced from 1.31% of prescriptions (43/3284) to 0.63% (19/3004) (relative risk reduction RRR, 51.7%; 95% CI, 17.3% to 71.8%). The error rate decreased up to 0.12% (3/2496) (RRR, 90.8%; 95% CI, 70.4% to 97.1%) if errors during residual manual dispensing were excluded. The stock‐out ratio was reduced from 0.85% to 0.17% (RRR, 80.5%; 95% CI, 49.5% to 92.5%). Daily staff time (median) in stock management was reduced by 59.3% (from 1 hour 36 minutes to 39 minutes). High level of staff satisfaction with this technology was achieved, although it was slightly higher in the group of pharmacists compared to technicians (8.63 ± 0.7 vs 7.78 ± 0.7, P = .046).
Conclusion
The implementation of a robotic original pack dispensing system substantially decreased the rate of dispensing errors and optimized stock management. Minimizing the number of drugs out of the dispensing robot is critical when attempting to maximize the benefits of its implementation.
Objective
To review interactions between oral antineoplastic agents (OAAs) for the treatment of solid and hematological tumors and common food and medicinal plants.
Materials and methods
All ...potential interactions between OAAs, medicinal plants and food were reviewed. OAAs were considered to be drugs for oral administration that have direct antitumor activity and were approved by the European Medicines Agency in April 2015. We performed the literature search in Pubmed
®
considering only medicinal plants and food. In addition, available data were analyzed from each OAA in secondary data sources taken from Thomson Micromedex
®
and Lexi-comp
®
, as well as in the summary of product characteristics.
Results
Fifty-eight OAAs were analyzed. We found interactions in 60.3 % of OAAs. Those with most interactions described were: imatinib and procarbazine (4 interactions) and erlotinib, vemurafenib, pomalidomide, medroxyprogesterone and methotrexate (3 interactions).
Medicinal plants
We found 39 interactions (74.4 % important). St. John’s wort was the medicinal plant with most interactions (92.6 % were considered important). The rest were: important (ginseng–imatinib, methotrexate–cola and tobacco–erlotinib and tobacco–pomalidomide) and moderate (caffeine–vemurafenib/medroxyprogesterone, medroxyprogesterone–ruxolitinib/St. John’s wort, garlic–anagrelide and ginseng–procarbazine).
Foods
Twenty-six interactions (61.5 % important). Grapefruit had most interactions (82.4 % were considered important). The rest were: important (alcohol–procarbazine) and moderate (dairy–estramustine, methotrexate–ethanol, procarbazine–tyramine, vitamin A–tretinoin/bexarotene and grapefruit–bexarotene/etoposide/sunitinib).
Conclusion
A review of interactions of medicinal plants and food should be taken into account in the management of OAAs, since more than half have interactions with MPs and food, of which 70.3 % are considered important. The most relevant are HSJ, grapefruit, ginseng and tobacco. This review is intended to serve as a support to all healthcare professionals at the time of prescribing or dispensing OAAs.
Abstract
Purpose
Initial experience with use of a smartphone application to enhance communication with and home monitoring of hematology/oncology patients under treatment with oral antineoplastic ...agents (OAAs) is described.
Summary
Broad use of OAAs is changing the landscape of hematology/oncology patient care, with this form of therapy giving patients greater autonomy but also raising concerns about correct OAA administration and management of adverse effects (AEs) or interactions. Information and communication technologies, specifically mobile health technologies, are ideal tools in this new environment. A multidisciplinary team at a large hospital in Spain developed a smartphone application for patients receiving OAA therapy that consists of 5 modules or functionalities: (1) a treatment agenda, or electronic journal of patient activity, including medication use; (2) a treatment record; (3) continuous recording of vital signs (blood pressure and temperature), health-related quality of life, and AEs, with management of AEs based on an algorithm that displays different recommendations according to AE severity; (4) 2-way messaging capability; and (5) information and links to websites of interest. From June through November 2017, 37 patients downloaded and used the application. About two-thirds (68%) of the patients sent a total of 182 messages to the pharmacist on duty; 58% of the patients registered at least 1 AE. The mean time of registration of the first AE after initiation of OAA therapy was 8 days. As a result of patient use of the application, 2 emergency room visits were avoided and 3 patients were referred to a general practitioner.
Conclusion
The application has allowed real-time monitoring of patients treated with OAAs. This new patient-pharmacist communication channel has facilitated the early detection of AEs, contributing to the safety of treatment and patient satisfaction with healthcare.
Purpose: Abatacept was approved in our hospital by the Pharmacy and Therapeutics Committee for treatment of moderate to severe rheumatoid arthritis (RA) in adult patients with inadequate response or ...intolerance to disease modifying antirheumatic drugs (DMARDs), including at least one anti-tumour necrosis factor (anti-TNF). The objectives of this study were to analyze compliance with our protocol and to evaluate effectiveness and safety of abatacept in our patients. Methods: We performed a descriptive longitudinal study of patients with RA treated with abatacept between August 2008 and May 2010 in our day care unit. We reviewed clinical records and recorded the following data: sex, age, weight, year of diagnosis, previous antirheumatic treatments and reasons for withdrawal of anti-TNFs, indication for abatacept, dose and date of administration, Disease Activity Score (DAS28) and adverse events. Effectiveness was evaluated using the European League Against Rheumatism (EULAR) criteria. Results: We recruited 16 patients. Mean follow-up time was 10.4 (SD: 6.1) months. All patients had been previously treated with DMARDs, including at least one anti-TNF, and the mean dose of abatacept was 9.4 (SD: 1.4) mg/kg. During the first 6 months of treatment, 11/16 of patients experienced a decrease in their DAS28 value, but only 5/16 achieved a satisfactory response. Dyspnea was the most frequent adverse event (7/16), followed by fatigue and asthenia (6/16) and dry skin (5/16). Conclusions: The indication for abatacept in our hospital complied with the protocol approved by the Pharmacy and Therapeutics Committee. Only 5/16 of patients achieved a satisfactory response; however, it should be noted that these patients had moderate to severe RA that was refractory to other treatments. Adverse reactions were consistent with those described in the summary of product characteristics. Further studies with larger cohorts are needed to analyze the long-term safety and effectiveness profile in clinical practice.
This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
During the process of parenteral nutrition preparation, aseptic techniques by nursing staff must be guaranteed. Chapter 797 of the United States Pharmacopeia classifies the risk levels of sterile ...compounding and defines the requirements that must be followed throughout the compounding.
To describe the development of an aseptic technique validation procedure for nurses who compound parenteral nutrition at the compounding area Pharmacy Service according to Chapter 797 United States Pharmacopeia guidelines.
Chapter 797 United States Pharmacopeia was reviewed and parenteral nutritions were classified as medium risk level compounded sterile preparations.
We adapted the United States Pharmacopeia guidelines for medium risk level compounded sterile preparations and we performed a procedure of aseptic technique validation for parenteral nutrition compounding.
The aseptic technique validation procedure allows the validation of aseptic management quality of nursing staff. The procedure has been incorporated into practice and is performed monthly by the nursing staff in the nutrition area.
To describe the impact of a Specialized Pharmaceutical Care model that includes pharmacotherapeutic monitoring of patients through an Telepharmacy platform and home medication dispensing.
A ...descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and 31 December 2021. A new pharmaceutical care model for chronic ambulatory patients was developed, including: (i) definition of criteria for selecting Telepharmacy candidate patients; (ii) stratification of patients by risk level; (iii) definition of individualized pharmacotherapeutic monitoring; (iv) adaptation of the Pharmacy Service app platform to ensure continuous pharmacotherapeutic monitoring and patient monitoring (e-Oncohealth, e-Midcare and farMcuida), (v) implementation of an appointment system; and (vi) development of a software module for the management of home medication delivery. The impact of this pharmaceutical care model was assessed by analyzing indicators of activity, safety, adherence and perceived quality. Moreover, an additional study on the impact of COVID-19 was developed in order to assess the accessibility of medical care and continuity of treatment through a survey conducted on a random sample of 100 patients.
During the study period, 2,737 patients benefited from the new remote pharmaceutical care model. A total of 7,758 Telepharmacy consultations were performed. Pharmacotherapeutic monitoring prevented 1,043 adverse drug reactions, which affected 10.4% of patients (3.6 adverse drug reactions/patient). Mean adherence to treatment was 95.2%. Overall satisfaction with the new model was 9.8/10. All patients would recommend this model to other patients.
The new Pharmaceutical care model increases patient safety and improves treatment adherence, with a high perceived quality. Patient stratification and individualized follow-up via an Telepharmacy platform were crucial to the development of this model.
Describir el impacto de un modelo de atención farmacéutica especializada que incluye el seguimiento farmacoterapéutico de los pacientes mediante una plataforma de Telefarmacia y la dispensación de la medicación en el domicilio.
Estudio descriptivo, retrospectivo, llevado a cabo en un servicio de farmacia de un hospital terciario entre el 23 marzo de 2020 y el 31 de diciembre de 2021. Se desarrolló un nuevo modelo de atención farmacéutica para la atención de los pacientes crónicos ambulatorios, que incluye: i) definición de los criterios de selección de los pacientes candidatos a Telefarmacia, ii) estratificación de los pacientes según el nivel de riesgo, iii) definición del seguimiento farmacoterapéutico individualizado, iv) adaptación de la plataforma de apps del servicio de farmacia para garantizar el seguimiento farmacoterapéutico continuo y la monitorización de los pacientes (e-Oncosalud, e-Midcare y farMcuida), v) implantación de un sistema de citación, y vi) el desarrollo de un módulo informático para la gestión de la dispensación y entrega de la medicación en el domicilio. El impacto de este modelo de atención se evaluó mediante el análisis de indicadores de actividad, seguridad, adherencia y calidad percibida. Asimismo, se incluyó un estudio adicional sobre el impacto de la COVID-19 en la accesibilidad de la atención médica y la continuidad de los tratamientos, mediante una encuesta a una muestra aleatoria de 100 pacientes.
Durante el periodo de estudio, 2.737 pacientes se han beneficiado del nuevo modelo de atención farmacéutica a distancia. El número de consultas de Telefarmacia realizadas fue 7.758. El seguimiento farmacoterapéutico evitó 1.043 eventos adversos asociados a la medicación, que afectaron al 10,4% de los pacientes atendidos (3,6 eventos adversos asociados a la medicación/paciente). La adherencia media al tratamiento de los pacientes fue del 95,2%. La satisfacción global con el nuevo modelo de atención farmacéutica fue de 9,8/10. El 100% de los pacientes lo recomendaría a otros pacientes.
Este nuevo modelo de atención farmacéutica aumenta la seguridad del paciente y mejora su adherencia al tratamiento, con unos índices de calidad percibida elevados. La estratificación de pacientes y el seguimiento personalizado mediante la plataforma Telefarmacia resultaron clave en su desarrollo.
Inflammatory bowel disease (IBD) is more complex in children and they will have to live with the disease for much longer. For this reason, it is necessary to optimize treatment. The polymorphisms ...associated with the response to anti-tumor necrosis factor (TNF) drugs in adults with IBD have not been analyzed in children. The aim of the study was to identify genetic variants associated with the long-term response to anti-TNF drugs in children with IBD.
An observational, longitudinal, ambispective cohort's study was conducted. We recruited 209 anti-TNF-treated children diagnosed with IBD and genotyped 21 polymorphisms previously studied in adults with Crohn disease (CD) using real-time PCR. The association between single-nucleotide polymorphisms (SNPs) and time-to-failure was analyzed using the log-rank test.
After multivariate analysis, 3 SNPs in IL10, IL17A and IL6 were significantly associated with response to anti-TNF treatment among patients diagnosed with CD (rs1800872-HR, 4.749 (95% confidence interval CI 1.156-19.517), P value < 0.05; rs2275913-HR, 0.320 95% CI 0.111-0.920, P value < 0.05; and rs10499563-HR, 0.210 95% CI 0.047-0.947, P value 0.05, respectively). None of these SNPs were associated with response to infliximab in adults diagnosed with CD. Among patients diagnosed with ulcerative colitis (UC), 1 SNP in LY96 was significantly associated with response to anti-TNF treatment (rs-11465996-HR, 10.220 95% CI 1.849-56.504 P value < 0.05).
Genotyping of these DNA variants before starting treatment may help to identify children who are long-term responders to anti-TNF drugs, and thus tailor treatment of pediatric IBD.
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