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OBJECTIVE: Conduct systematic proactive pharmacovigilance screening for symptoms patients experienced after starting new medications using an electronic patient portal. We aimed to design and test the feasibility of the system, measure patient response rates, provide any needed support for patients experiencing potentially drug-related problems, and describe types of symptoms and problems patients report. METHODS: We created an automated daily report of all new prescriptions, excluding likely non-new and various OTC meds, and sent invitations via patient portal inviting patients to inquire if they had started the medication, and if "yes," inquire if they had they experienced any new symptoms that could be potential adverse drug effects. Reported symptoms were classified by clinical pharmacists using SOC MeDra taxonomy, and patients were offered follow-up and support as desired and needed. RESULTS: Of 11,724 included prescriptions for 9360 unique patients, 2758 (29.4%) patients responded. Of 2616 unique medication starts, patients reported at least 1 new symptom that represented a potential adverse drug reaction (ADR) in 678/2616 (25.9%). Nearly one-third of those experiencing new symptoms (30.3%) reported 2 or more new symptoms after initiating the drug. GI disorders accounted for 30% of the total reported ADRs. CONCLUSIONS: Systematic portal-based surveillance for potential adverse drug reactions was feasible, had higher response rates than other methods (such as automated interactive phone calling), and uncovered rates of potential ADRs (roughly 1 in 4 patients) consistent with other methods/studies.
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BACKGROUND: HIV-infected children have a higher risk of presenting infections, including the hepatitis A virus (HAV). The inactivated HAV vaccine is immunogenic in immunocompetent hosts; however, there are insufficient studies on the duration of seroprotection in HIV-infected children. METHODS: An analytical cohort study was conducted. HIV-1-infected children who received the inactivated HAV vaccine (2 doses) were included. Blood samples were taken for antibody measurement, the first one 28 days after the second dose and another 7 years after the vaccination schedule. Information on viral load, immunological category, weight, height, and response to antiretroviral treatment from diagnosis to the last assessment was obtained. RESULTS: 19 patients were included, with a mean age of 12.6 years (SD ± 2.29). 58% were male. 80% of the patients presented protective immunoglobulin G antibodies against HAV 7-year post-vaccination. The antibody concentration was found to be between 13 and 80 mIU/mL (median of 80 mIU/mL). 52% showed some degree of immunosuppression. There was no statistically significant relationship between the presence of seroprotection and viral load, treatment failure, immunological category, and malnutrition. Twelve patients presented with antiretroviral treatment failure, and in 33% of them, the antibodies did not offer satisfactory seroprotection. CONCLUSION: 7-year post-vaccination, 80% of HIV-infected children maintain seroprotection titers against HAV.
INTRODUCCIÓN: Los niños infectados por el virus de la inmunodeficiencia humana (VIH) tienen mayor riesgo de presentar infecciones, incluyendo hepatitis por virus A (VHA). La vacuna inactivada contra el VHA es inmunógena en el huésped inmunocompetente. No hay estudios suficientes sobre el tiempo de seroprotección en niños infectados por el VIH. MÉTODO: Estudio de cohorte, analítico. Se incluyeron niños con infección por VIH-1 que recibieron la vacuna inactivada contra el VHA (dos dosis). Se les tomaron muestras sanguíneas para medición de anticuerpos, una 28 días después de la segunda dosis y otra 7 años después del esquema de vacunación. Se obtuvo información de carga viral, categoría inmunológica, peso y talla, y respuesta al tratamiento antirretroviral desde el diagnóstico hasta la última valoración. RESULTADOS: Se incluyeron 19 pacientes con una edad media de 12.6 años (± 2.29). El 58% fueron del sexo masculino. El 80% de los pacientes presentaron anticuerpos immunoglobulin G (IgG) contra el VHA protectores a los 7 años de la vacunación. La concentración de anticuerpos se encontró entre 13 y 80 mUI/ml (mediana: 80 mUI/ml). El 52% mostraron algún grado de inmunosupresión. No existe relación estadísticamente significativa entre la presencia de seroprotección y la carga viral, la falla al tratamiento, la categoría inmunológica ni la desnutrición. Doce pacientes presentaron falla al tratamiento antirretroviral; en el 33% de ellos los anticuerpos no ofrecían seroprotección satisfactoria. CONCLUSIONES: A 7 años posvacunación, el 80% de los niños con VIH mantienen títulos de seroprotección frente al VHA.
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Infecciones por VIH , Anticuerpos de Hepatitis A , Vacunas contra la Hepatitis A , Hepatitis A , Carga Viral , Humanos , Masculino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/inmunología , Niño , Vacunas contra la Hepatitis A/administración & dosificación , Vacunas contra la Hepatitis A/inmunología , Femenino , Anticuerpos de Hepatitis A/sangre , Adolescente , Hepatitis A/prevención & control , Hepatitis A/inmunología , Estudios de Cohortes , Factores de Tiempo , Estudios de Seguimiento , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Vacunas de Productos Inactivados/inmunología , Vacunas de Productos Inactivados/administración & dosificaciónRESUMEN
BACKGROUND: Limited data exist regarding cardiac manifestations of Chagas disease in migrants living in non-endemic regions. METHODS: A retrospective cohort analysis of 109 patients with Chagas disease seen at Boston Medical Center (BMC) between January 2016 and January 2023 was performed. Patients were identified by screening and testing migrants from endemic regions at a community health center and BMC. Demographic, laboratory, and cardiac evaluation data were collected. RESULTS: Mean age of the 109 patients was 43 years (range 19-76); 61% were female. 79% (86/109) were diagnosed with Chagas disease via screening and 21% (23/109) were tested given symptoms or electrocardiogram abnormalities. Common symptoms included palpitations (25%, 27/109) and chest pain (17%, 18/109); 52% (57/109) were asymptomatic. Right bundle branch block (19%, 19/102), T-wave changes (18%, 18/102), and left anterior fascicular block (11%, 11/102) were the most common electrocardiogram abnormalities; 51% (52/102) had normal electrocardiograms. Cardiomyopathy stage was ascertained in 94 of 109 patients: 51% (48/94) were indeterminate stage A and 49% (46/94) had cardiac structural disease (stages B1-D). Clinical findings that required clinical intervention or change in management were found in 23% (25/109), and included cardiomyopathy, apical hypokinesis/aneurysm, stroke, atrial or ventricular arrhythmias, and apical thrombus. CONCLUSIONS: These data show high rates of cardiac complications in a cohort of migrants living with Chagas disease in a non-endemic setting. We demonstrate that Chagas disease diagnosis prompts cardiac evaluation which often identifies actionable cardiac disease and provides opportunities for prevention and treatment.
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Cardiomiopatías , Cardiomiopatía Chagásica , Enfermedad de Chagas , Humanos , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Masculino , Cardiomiopatía Chagásica/diagnóstico , Cardiomiopatía Chagásica/epidemiología , Cardiomiopatía Chagásica/complicaciones , Estudios Retrospectivos , Electrocardiografía , Enfermedad de Chagas/complicaciones , Enfermedad de Chagas/diagnóstico , Enfermedad de Chagas/epidemiología , Arritmias Cardíacas/etiología , Cardiomiopatías/complicaciones , MassachusettsRESUMEN
PURPOSE: To identify current challenges in detection of medication-related symptoms, and review technology-based opportunities to increase the patient-centeredness of postmarketing pharmacosurveillance to promote more accountable, safer, patient-friendly, and equitable medication prescribing. SUMMARY: Pharmacists have an important role to play in detection and evaluation of adverse drug reactions (ADRs). The pharmacist's role in medication management should extend beyond simply dispensing drugs, and this article delineates the rationale and proactive approaches for pharmacist detection and assessment of ADRs. We describe a stepwise approach for assessment, best practices, and lessons learned from a pharmacist-led randomized trial, the CEDAR (Calling for Detection of Adverse Drug Reactions) project. CONCLUSION: Health systems need to be redesigned to more fully utilize health information technologies and pharmacists in detecting and responding to ADRs.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Informática Médica , Humanos , Farmacéuticos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Prescripciones de Medicamentos , Rol ProfesionalRESUMEN
Background: In April 2020, the Mayo Clinic helped establish the US Food and Drug Administration Expanded Access Protocol for COVID-19 (coronavirus disease 2019) convalescent plasma (CCP). The effectiveness of CCP in the published literature is contradictory because some retrospective studies showed benefit in reducing mortality and severe illness, whereas prospective randomized controlled trials demonstrated no benefit of CCP. Objectives: To discuss (1) the implementation of CCP across Kaiser Permanente Southern California between April 2020 and April 2021, (2) retrospective multivariable analysis of 2,831 patients with COVID-19 who were transfused with CCP compared with 18,475 patients with COVID-19 who did not receive CCP, (3) how to reconcile contradictory published data regarding the efficacy of CCP, and (4) guidance regarding the future use of convalescent plasma in a large community hospital setting. Methods: Multivariable analysis was controlled for demographic characteristics, level of oxygen delivery, intensive care unit stay, selected laboratory findings, and other concurrent treatment-related variables. Tubing segments from 151 CCP units transfused between October 2020 and April 2021 were retrospectively tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) anti-spike protein receptor-binding domain IgG. Multivariable analysis showed that CCP transfusion did not affect mortality rates at 30 days and 5 months (odds ratio, 1.04, 95% CI, 0.87-1.25, and hazard ratio, 1.05, 95% CI, 0.93-1.19). Conclusions: If convalescent plasma is offered as a therapeutic in a future viral pandemic, we recommend (1) transfusing only those patients who are negative for neutralizing antibodies, (2) transfusing very early during the disease course, (3) only using convalescent plasma with known levels of neutralizing antibodies, or (4) alternatively providing fractionated hyperimmune globulin.
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PURPOSE: 18F-DOPA Positron Emission Tomography/Computed Tomography (18F-DOPA PET/CT) is a sensitive functional imaging method (65-75%) for detecting disease localization in medullary thyroid cancer (MTC). We aimed: (i) to assess the clinical usefulness of 18F-DOPA PET/CT in patients with MTC and elevated calcitonin (Ctn) and CEA levels and, (ii) to evaluate changes in disease management secondary to the findings encountered with this methodology. METHODS: Thirty-six patients with MTC and Ctn levels ≥150 pg/ml were prospectively included. Neck ultrasound, chest contrast-enhanced CT, liver magnetic resonance imaging/abdominal three-phase contrast-enhanced CT and bone scintigraphy were carried out up to 6 months before the 18F DOPA PET/CT. RESULTS: Seventy eight percent of patients were female and 27% had hereditary MTC. Median Ctn level was 1450 pg/ml [150-56620], median CEA level 413 ng/ml [2.9-7436]. Median Ctn DT was 37.5 months [5.7-240]; median CEA DT was 31.8 [4.9-180]. 18F-DOPA PET/CT was positive in 33 patients (91.6%); in 18 (56%) uptake was observed in lymph nodes in the neck or mediastinum, in seven cases (22%) distant metastases were diagnosed, and in eight additional patients (24%) both locoregional and distant sites of disease were found. Ctn and CEA levels were higher in patients with ≥3 foci of distant metastases. In 14 patients (38.8%), findings on 18F-DOPA PET/CT led to changes in management; surgery for locoregional lymph nodes was the most frequent procedure in 8 patients (22%). CONCLUSION: 18F-DOPA PET/CT was useful for the detection of recurrent disease in MTC, providing incremental value over conventional imaging procedures that led to modification in treatment strategies in nearly 40% of patients.
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Carcinoma Neuroendocrino , Neoplasias de la Tiroides , Calcitonina , Antígeno Carcinoembrionario , Carcinoma Neuroendocrino/patología , Dihidroxifenilalanina/análogos & derivados , Femenino , Fluorodesoxiglucosa F18 , Humanos , Masculino , Tomografía Computarizada por Tomografía de Emisión de Positrones , Tomografía de Emisión de Positrones , Estudios Prospectivos , Neoplasias de la Tiroides/patologíaRESUMEN
Importance: More conservative prescribing has the potential to reduce adverse drug events and patient harm and cost; however, no method exists defining the extent to which individual clinicians prescribe conservatively. One potential domain is prescribing a more limited number of drugs. Personal formularies-defined as the number and mix of unique, newly initiated drugs prescribed by a physician-may enable comparisons among clinicians, practices, and institutions. Objectives: To develop a method of defining primary care physicians' personal formularies and examine how they differ among primary care physicians at 4 institutions; evaluate associations between personal formularies and patient, physician, and practice site characteristics; and empirically derive and examine the variability of the top 200 core drugs prescribed at the 4 sites. Design, Setting, and Participants: This retrospective cohort study was conducted at 4 US health care systems among 4655 internal and family medicine physicians and 4â¯930â¯707 patients who had at least 1 visit to these physicians between January 1, 2017, and December 31, 2018. Exposures: Personal formulary size was defined as the number of unique, newly initiated drugs. Main Outcomes and Measures: Personal formulary size and drugs used, physician and patient characteristics, core drugs, and analysis of selected drug classes. Results: The study population included 4655 primary care physicians (2274 women [48.9%]; mean [SD] age, 48.5 [4.4] years) and 4â¯930â¯707 patients (16.5% women; mean [SD] age, 51.9 [8.3] years). There were 41â¯378â¯903 outpatient prescriptions written, of which 9â¯496â¯766 (23.0%) were new starts. Institution median personal formulary size ranged from 150 (interquartile range, 82.0-212.0) to 296 (interquartile range, 230.0-347.0) drugs. In multivariable modeling, personal formulary size was significantly associated with panel size (total number of unique patients with face-to-face encounters during the study period; 1.2 medications per 100 patients), physician's total number of encounters (5.7 drugs per 10% increase), and physician's sex (-6.2 drugs per 100 patients for female physicians). There were 1527 unique, newly prescribed drugs across the 4 sites. Fewer than half the drugs (626 [41.0%]) were used at every site. Physicians' prescribing of drugs from a pooled core list varied from 0% to 100% of their prescriptions. Conclusions and Relevance: Personal formularies, measured at the level of individual physicians and institutions, reveal variability in size and mix of drugs. Similarly, defining a list of commonly prescribed core drugs in primary care revealed interphysician and interinstitutional differences. Personal formularies and core medication lists enable comparisons and may identify outliers and opportunities for safer and more appropriate prescribing.
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Atención a la Salud/estadística & datos numéricos , Prescripciones de Medicamentos/estadística & datos numéricos , Médicos de Atención Primaria/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adulto , Femenino , Formularios Farmacéuticos como Asunto , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Estados UnidosRESUMEN
El cáncer en la zona de transición representa el 20-25% de los casos (en piezas de prostatectomías radicales), su diagnóstico con frecuencia es de manera incidental, siendo identificados clínicamente como supuestos adenomas. OBJETIVO: determinar la incidencia de Adenocarcinoma en la Zona transicional de Próstata e identificar etapas precancerosas en pacientes con clínica de HPB. MÉTODS: estudio longitudinal de tipo retrospectivo desde el 2013-2018 en la ciudad de Cochabamba-Bolivia; población de estudio: pacientes sometidos a prostatectomía simple, retropúbica y/o transvesical. Recolección de datos: a partir de historias clínicas, en pacientes con clínica de hiperplasia benigna de próstata y PSA total < 4 ng/ml. RESULTADOS: se identificó 76 pacientes, de los cuales; 5 pacientes resultaron con Adenocarcinoma y 9 pacientes con: Neoplasia Intraepitelial Prostática de Alto Grado 2,6 %, Proliferación acinar pequeña atípica 7,9%, representando así un 10,5%. En cuanto a la invasión representaron un 5,3% con invasión perineal, 2,6% invasión linfovascular y ninguno con invasión extravascular. DISCUSIÓN: pacientes con cáncer de próstata zona transicional, presentan un Antígeno prostático específico alto susceptibles a Adenocarcinoma. Sin embargo, en esta investigación se encontró Adenocarcinoma de próstata de alto riesgo con Antígeno prostático específico total menor a 4 ng/ml. A pesar de los instrumentos clínicos e indicaciones para la decisión de terapia quirúrgica de una supuesta hiperplasia prostática benigna, existe en el estudio una incidencia del 6,5% de Adenocarcinoma en Zona Transicional, con un 10,5 % de incidencia de presentación de formas precancerosas y el 17,1% de los pacientes del estudio se encuentran en riesgo de letalidad de la enfermedad.
Cancer in the transition zone represents 20-25% of cases, its diagnosis is often incidental, being identified clinically as suspected adenomas. OBJECTIVE: to determine the incidence of adenocarcinoma in the transitional Prostate Zone and identify the degree of adenocarcinoma and precancerous stages thereof. METHODS: longitudinal retrospective study from 2013-2018 in the city of Cochabamba-Bolivia; Study population: patients undergoing simple, retropubic and / or transvesical prostatectomy. Data collection: from medical records, in patients with benign prostatic hyperplasia and who have no atypia and neoplasms. RESULTS: 76 patients were identified, of which; 5 patients resulted with adenocarcinoma and 9 patients among: High Grade Prostatic Intraepithelial Neoplasia 2.6%, small atypical acinar proliferation 7.9%, thus representing 10.5%. As for the invasion, they represented 5.3% with perineal invasion, 2.6% lymphovascular invasion and none with extravascular invasion. DISCUSSION: Patients with transitional prostate cancer have a high specific prostate antigen susceptible to adenocarcinoma. However, this investigation found high-risk prostate adenocarcinoma with total prostate antigen total less than 4 ng / ml. Despite the clinical instruments and indications for the decision of surgical therapy of an alleged benign prostatic hyperplasia, there is a 6.5% incidence of adenocarcinoma in the Transitional Area, with a 10.5% incidence of presentation of forms of Proliferation of Atypical Small Acini and 17.1% of the patients in the study are at risk of lethality of the disease.
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Humanos , Masculino , Anciano de 80 o más Años , Adenocarcinoma , Recolección de Datos , Hiperplasia Prostática , Antígeno Prostático Específico , Neoplasia Intraepitelial ProstáticaAsunto(s)
Betacoronavirus , Enfermedad Crónica/epidemiología , Enfermedad Crónica/tendencias , Infecciones por Coronavirus/epidemiología , Manejo de la Enfermedad , Epidemias , Neumonía Viral/epidemiología , COVID-19 , Enfermedad Crónica/terapia , Infecciones por Coronavirus/terapia , Pruebas Diagnósticas de Rutina/tendencias , Prescripciones de Medicamentos , Humanos , Pandemias , Neumonía Viral/terapia , SARS-CoV-2RESUMEN
PURPOSE: To examine the extent to which outpatient clinicians currently document drug indications in prescription instructions. METHODS: Free-text sigs were extracted from all outpatient prescriptions generated by the computerized prescriber order entry system of a major academic institution during a 5-year period. Natural language processing was used to identify drug indications. The data set was analyzed to determine the rates at which prescribers included indications. It was stratified by provider specialty, drug class, and specific medications, to determine how often these indications were in prescriptions for as-needed (PRN) versus non-PRN medications. RESULTS: During the study period, 4,356,086 prescriptions were ordered. Indications were included in 322,961 orders (7.41%). From these orders, 249,262 indications (77.18%) were written for PRN orders. Although internal medicine prescribers generated the highest number of medication orders, they included indications in only 6.26% of their prescriptions, whereas orthopedic surgery providers had the highest rate of documenting indications (33.41%). Pain was the most common indication, accounting for 30.35% of all documented indications. The drug class with the highest number of sigs-containing indications was narcotic analgesics. Non-PRN chronic medication prescriptions rarely included the indication. CONCLUSION: Prescribers rarely included drug indications in electronic free-text prescription instructions, and, when they did, it was mostly for PRN uses such as pain.
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Atención Ambulatoria/estadística & datos numéricos , Prescripciones de Medicamentos/estadística & datos numéricos , Sistemas de Entrada de Órdenes Médicas/estadística & datos numéricos , Atención Ambulatoria/normas , Conjuntos de Datos como Asunto , Prescripciones de Medicamentos/normas , Humanos , Sistemas de Entrada de Órdenes Médicas/normas , Errores de Medicación/prevención & control , Procesamiento de Lenguaje NaturalRESUMEN
Importance: The indication (reason for use) for a medication is rarely included on prescriptions despite repeated recommendations to do so. One barrier has been the way existing electronic prescribing systems have been designed. Objective: To evaluate, in comparison with the prescribing modules of 2 leading electronic health record prescribing systems, the efficiency, error rate, and satisfaction with a new computerized provider order entry prototype for the outpatient setting that allows clinicians to initiate prescribing using the indication. Design, Setting, and Participants: This quality improvement study used usability tests requiring internal medicine physicians, residents, and physician assistants to enter prescriptions electronically, including indication, for 8 clinical scenarios. The tool order assignments were randomized and prescribers were asked to use the prototype for 4 of the scenarios and their usual system for the other 4. Time on task, number of clicks, and order details were captured. User satisfaction was measured using posttask ratings and a validated system usability scale. The study participants practiced in 2 health systems' outpatient practices. Usability tests were conducted between April and October of 2017. Main Outcomes and Measures: Usability (efficiency, error rate, and satisfaction) of indications-based computerized provider order entry prototype vs the electronic prescribing interface of 2 electronic health record vendors. Results: Thirty-two participants (17 attending physicians, 13 residents, and 2 physician assistants) used the prototype to complete 256 usability test scenarios. The mean (SD) time on task was 1.78 (1.17) minutes. For the 20 participants who used vendor 1's system, it took a mean (SD) of 3.37 (1.90) minutes to complete a prescription, and for the 12 participants using vendor 2's system, it took a mean (SD) of 2.93 (1.52) minutes. Across all scenarios, when comparing number of clicks, for those participants using the prototype and vendor 1, there was a statistically significant difference from the mean (SD) number of clicks needed (18.39 [12.62] vs 46.50 [27.29]; difference, 28.11; 95% CI, 21.47-34.75; P < .001). For those using the prototype and vendor 2, there was also a statistically significant difference in number of clicks (20.10 [11.52] vs 38.25 [19.77]; difference, 18.14; 95% CI, 11.59-24.70; P < .001). A blinded review of the order details revealed medication errors (eg, drug-allergy interactions) in 38 of 128 prescribing sessions using a vendor system vs 7 of 128 with the prototype. Conclusions and Relevance: Reengineering prescribing to start with the drug indication allowed indications to be captured in an easy and useful way, which may be associated with saved time and effort, reduced medication errors, and increased clinician satisfaction.
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Prescripción Electrónica , Modelos Teóricos , Mejoramiento de la Calidad , Atención Ambulatoria , Personal de Salud , Humanos , Sistemas de Entrada de Órdenes Médicas , Errores de Medicación/estadística & datos numéricos , Innovación OrganizacionalRESUMEN
BACKGROUND: Medication adverse events are important and common yet are often not identified by clinicians. We evaluated an automated telephone surveillance system coupled with transfer to a live pharmacist to screen potentially drug-related symptoms after newly starting medications for four common primary care conditions: hypertension, diabetes, depression, and insomnia. METHODS: Cluster randomized trial with automated calls to eligible patients at 1 and 4 months after starting target drugs from intervention primary care clinics compared to propensity-matched patients from control clinics. Primary and secondary outcomes were physician documentation of any adverse effects associated with newly prescribed target medication, and whether the medication was discontinued and, if yes, whether the reason for stopping was an adverse effect. RESULTS: Of 4876 eligible intervention clinic patients who were contacted using automated calls, 776 (15.1%) responded and participated in the automated call. Based on positive symptom responses or request to speak to a pharmacist, 320 patients were transferred to the pharmacist and discussed 1021 potentially drug-related symptoms. Of these, 188 (18.5%) were assessed as probably and 479 (47.1%) as possibly related to the medication. Compared to a propensity-matched cohort of control clinic patients, intervention patients were significantly more likely to have adverse effects documented in the medical record by a physician (277 vs. 164 adverse effects, p < 0.0001, and 177 vs. 122 patients discontinued with documented adverse effects, p < 0.0001). DISCUSSION: Systematic automated telephone outreach monitoring coupled with real-time phone referral to a pharmacist identified a substantial number of previously unidentified potentially drug-related symptoms, many of which were validated as probably or possibly related to the drug by the pharmacist or their physicians. Multiple challenges were encountered using the interactive voice response (IVR) automated calling system, suggesting that other approaches may need to be considered and evaluated. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02087293.
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Teléfono Celular , Consejo/métodos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/terapia , Tamizaje Masivo/métodos , Farmacéuticos , Rol Profesional , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/psicología , Registros Electrónicos de Salud , Femenino , Humanos , Masculino , Tamizaje Masivo/psicología , Persona de Mediana Edad , Farmacéuticos/psicología , Rol Profesional/psicología , Adulto JovenRESUMEN
Objective: To extract drug indications from a commercial drug knowledgebase and determine to what extent drug indications can discriminate between look-alike-sound-alike (LASA) drugs. Methods: We extracted drug indications disease concepts from the MedKnowledge Indications module from First Databank Inc. (South San Francisco, CA) and associated them with drugs on the Institute for Safe Medication Practices (ISMP) list of commonly confused drug names. We used high-level concepts (rather than granular concepts) to represent the general indications for each drug. Two pharmacists reviewed each drug's association with its high-level indications concepts for accuracy and clinical relevance. We compared the high-level indications for each commonly confused drug pair and categorized each pair as having a complete overlap, partial overlap or no overlap in high-level indications. Results: Of 278 LASA drug pairs, 165 (59%) had no overlap and 58 (21%) had partial overlap in high-level indications. Fifty-five pairs (20%) had complete overlap in high-level indications; nearly half of these were comprised of drugs with the same active ingredient and route of administration (e.g., Adderall, Adderall XR). Conclusions: Drug indications data from a drug knowledgebase can discriminate between many LASA drugs.
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Bases del Conocimiento , Errores de Medicación/prevención & control , Preparaciones Farmacéuticas , Terminología como Asunto , Prescripciones de Medicamentos , HumanosRESUMEN
PURPOSE: The incorporation of medication indications into the prescribing process to improve patient safety is discussed. SUMMARY: Currently, most prescriptions lack a key piece of information needed for safe medication use: the patient-specific drug indication. Integrating indications could pave the way for safer prescribing in multiple ways, including avoiding look-alike/sound-alike errors, facilitating selection of drugs of choice, aiding in communication among the healthcare team, bolstering patient understanding and adherence, and organizing medication lists to facilitate medication reconciliation. Although strongly supported by pharmacists, multiple prior attempts to encourage prescribers to include the indication on prescriptions have not been successful. We convened 6 expert panels to consult high-level stakeholders on system design considerations and requirements necessary for building and implementing an indications-based computerized prescriber order-entry (CPOE) system. We summarize our findings from the 6 expert stakeholder panels, including rationale, literature findings, potential benefits, and challenges of incorporating indications into the prescribing process. Based on this stakeholder input, design requirements for a new CPOE interface and workflow have been identified. CONCLUSION: The emergence of universal electronic prescribing and content knowledge vendors has laid the groundwork for incorporating indications into the CPOE prescribing process. As medication prescribing moves in the direction of inclusion of the indication, it is imperative to design CPOE systems to efficiently and effectively incorporate indications into prescriber workflows and optimize ways this can best be accomplished.
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Prescripciones de Medicamentos , Comunicación , Prescripción Electrónica , Humanos , Errores Médicos/prevención & control , Cumplimiento de la Medicación , Conciliación de Medicamentos , Grupo de Atención al Paciente , Educación del Paciente como Asunto , Seguridad del Paciente , Atención Dirigida al PacienteRESUMEN
BACKGROUND: Computerised prescriber order entry (CPOE) systems users often discontinue medications because the initial order was erroneous. OBJECTIVE: To elucidate error types by querying prescribers about their reasons for discontinuing outpatient medication orders that they had self-identified as erroneous. METHODS: During a nearly 3 year retrospective data collection period, we identified 57 972 drugs discontinued with the reason 'Error (erroneous entry)." Because chart reviews revealed limited information about these errors, we prospectively studied consecutive, discontinued erroneous orders by querying prescribers in near-real-time to learn more about the erroneous orders. RESULTS: From January 2014 to April 2014, we prospectively emailed prescribers about outpatient drug orders that they had discontinued due to erroneous initial order entry. Of 2 50 806 medication orders in these 4 months, 1133 (0.45%) of these were discontinued due to error. From these 1133, we emailed 542 unique prescribers to ask about their reason(s) for discontinuing these mediation orders in error. We received 312 responses (58% response rate). We categorised these responses using a previously published taxonomy. The top reasons for these discontinued erroneous orders included: medication ordered for wrong patient (27.8%, n=60); wrong drug ordered (18.5%, n=40); and duplicate order placed (14.4%, n=31). Other common discontinued erroneous orders related to drug dosage and formulation (eg, extended release versus not). Oxycodone (3%) was the most frequent drug discontinued error. CONCLUSION: Drugs are not infrequently discontinued 'in error.' Wrong patient and wrong drug errors constitute the leading types of erroneous prescriptions recognised and discontinued by prescribers. Data regarding erroneous medication entries represent an important source of intelligence about how CPOE systems are functioning and malfunctioning, providing important insights regarding areas for designing CPOE more safely in the future.
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Sistemas de Entrada de Órdenes Médicas , Errores de Medicación , Pacientes Ambulatorios , Humanos , Auditoría Médica , Estudios Prospectivos , Estudios Retrospectivos , Estados UnidosRESUMEN
PURPOSE: The variations in how drug names are displayed in computerized prescriber-order-entry (CPOE) systems were analyzed to determine their contribution to potential medication errors. METHODS: A diverse set of 10 inpatient and outpatient CPOE system vendors and self-developed CPOE systems in 6 U.S. healthcare institutions was evaluated. A team of pharmacists, physicians, patient-safety experts, and informatics experts created a CPOE assessment tool to standardize the assessment of CPOE features across the systems studied. Hypothetical scenarios were conducted with test patients to study the medication ordering workflow and ways in which medications were displayed in each system. Brand versus generic drug name ordering was studied at 1 large outpatient system to understand why prescribers ordered both brand and generic forms of the same drug. RESULTS: Widespread variations in the display of drug names were observed both within and across the 6 study sites and 10 systems, including the inconsistent display of brand and generic names. Some displayed drugs differently even on the same screen. Combination products were often displayed inconsistently, and some systems required prescribers to know the first drug listed in the combination in order for the correct product to appear in a search. It also appeared that prescribers may have prescribed both brand and generic forms of the same medication, creating the potential for drug duplication errors. CONCLUSION: A review of 10 CPOE systems revealed that medication names were displayed inconsistently, which can result in confusion or errors in reviewing, selecting, and ordering medications.
Asunto(s)
Sistemas de Entrada de Órdenes Médicas/normas , Errores de Medicación/prevención & control , Sistemas de Medicación en Hospital/normas , Prescripciones de Medicamentos/normas , Humanos , Estándares de ReferenciaRESUMEN
Objective: To examine medication errors potentially related to computerized prescriber order entry (CPOE) and refine a previously published taxonomy to classify them. Materials and Methods: We reviewed all patient safety medication reports that occurred in the medication ordering phase from 6 sites participating in a United States Food and Drug Administration-sponsored project examining CPOE safety. Two pharmacists independently reviewed each report to confirm whether the error occurred in the ordering/prescribing phase and was related to CPOE. For those related to CPOE, we assessed whether CPOE facilitated (actively contributed to) the error or failed to prevent the error (did not directly cause it, but optimal systems could have potentially prevented it). A previously developed taxonomy was iteratively refined to classify the reports. Results: Of 2522 medication error reports, 1308 (51.9%) were related to CPOE. Of these, CPOE facilitated the error in 171 (13.1%) and potentially could have prevented the error in 1137 (86.9%). The most frequent categories of "what happened to the patient" were delays in medication reaching the patient, potentially receiving duplicate drugs, or receiving a higher dose than indicated. The most frequent categories for "what happened in CPOE" included orders not routed to or received at the intended location, wrong dose ordered, and duplicate orders. Variations were seen in the format, categorization, and quality of reports, resulting in error causation being assignable in only 403 instances (31%). Discussion and Conclusion: Errors related to CPOE commonly involved transmission errors, erroneous dosing, and duplicate orders. More standardized safety reporting using a common taxonomy could help health care systems and vendors learn and implement prevention strategies.
Asunto(s)
Sistemas de Entrada de Órdenes Médicas , Errores de Medicación/clasificación , Prescripción Electrónica , Humanos , Seguridad del PacienteRESUMEN
BACKGROUND: Impaired fasting glucose (IFG) through the nondiabetic range (100-125 mg/dL) is not considered in the cardiovascular (CV) risk profile. AIM: To compare the clustering of CV risk factors (RFs) in nondiabetic subjects with normal fasting glucose (NFG) and IFG. MATERIAL AND METHODS: Cross-sectional study in 3739 nondiabetic subjects. Demographics, medical history, and CV risk factors were collected and lipid profile, fasting glucose levels (FBG), C-reactive protein (hsCRP), blood pressure (BP), anthropometric measurements, and aerobic capacity were determined. RESULTS: 559 (15%) subjects had IFG: they had a higher mean age, BMI, waist circumference, non-HDL cholesterol, BP, and hsCRP (p < 0.0001) and lower HDL (p < 0.001) and aerobic capacity (p < 0.001). They also had a higher prevalence of hypertension (34% versus 25%; p < 0.001), dyslipidemia (79% versus 74%; p < 0.001), and obesity (29% versus 16%; p < 0.001) and a higher Framingham risk score (8% versus 6%; p < 0.001). The probability of presenting 3 or more CV RFs adjusted by age and gender was significantly higher in the top quintile of fasting glucose (≥98 mg/dL; OR = 2.02; 1.62-2.51). CONCLUSIONS: IFG in the nondiabetic range is associated with increased cardiovascular RF clustering.