Overview of U.S. COVID-19 vaccine safety surveillance systems.

The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.

Demonstration of anticoagulation patient self-testing feasibility at an Indian Health Service facility: A case series analysis.

BACKGROUND: Anticoagulation patient self-testing (PST) represents an alternative approach to warfarin monitoring by enabling patients to use coagulometers to test their international normalized ratio (INR) values. PST offers several advantages that potentially improve warfarin management. OBJECTIVE: To describe implementation and associated performance of a PST demonstration program at an Indian Health Service (IHS) facility. METHODS: A non-consecutive case series analysis of patients from a pharmacy-managed PST demonstration program was performed at an IHS facility in Oklahoma between July 2008 and February 2009. RESULTS: Mean time in therapeutic range (TTR) for the seven patients showed a small, absolute increase during the twelve weeks of PST compared to the twelve weeks prior to PST. Four of the seven patients had an increase in TTR during the twelve week course of PST compared to their baseline TTR. Three of four patients with increased TTR in the final eight week period of PST achieved a TTR of 100%. Of the three patients who experienced a decrease in TTR after initiating self-testing, two initially presented with a TTR of 100% prior to PST and one patient had a TTR of 100% for the final eight weeks of PST. The two patients not achieving a TTR of 100% during the twelve week PST period demonstrated an increase in TTR following the first four weeks of PST. CONCLUSIONS: Although anticoagulation guidelines now emphasize patient self-management (PSM) only, optimal PST remains an integral process in PSM delivery. In the patients studied, the results of this analysis suggest that PST at the IHS facility provided a convenient, alternative method for management of chronic warfarin therapy for qualified patients. More than half of the patients demonstrated improvement in TTR. Although there is a learning curve immediately following PST initiation, the mean TTR for the entire PST period increased modestly when compared to the time period prior to PST.

Participant perspectives from the Indian Health Service Anticoagulation Training Program.

BACKGROUND: The Indian Health Service Anticoagulation Training Program serves to improve patient safety through advanced anticoagulation management training. Although post-program evaluations of program content were conducted at the time of program delivery, little is known about translation of these learned skills into clinical practice. OBJECTIVE: This research sought to describe levels of self-reported participant confidence in anticoagulation management; development, implementation, and performance management of both core and supplemental activities of anticoagulation clinics or services; and current anticoagulation clinical practices subsequent to participating in the Anticoagulation Training Program. SETTING: A federal Indian Health Service healthcare facility in Oklahoma, USA. METHODS: A cross-sectional, electronic mail survey was designed, pretested, and administered to 267 eligible Anticoagulation Training Program participants from 1999 to 2009. Data were analyzed using descriptive statistics and interpreted to identify areas of strength and opportunities for improvement. MAIN OUTCOME MEASURES: Information about confidence in anticoagulation management skills; development, implementation and improvement of both core and supplemental activities of anticoagulation clinics or services; and current anticoagulation clinical practices was collected. RESULTS: After training, over 90 % of participants reported agreement/strong agreement with statements about confidence in performing patient-care related anticoagulation activities. A smaller proportion (83.3-85.4 %) reported agreement/strong agreement with confidence in measuring, analyzing and reporting anticoagulation outcomes. Improvement activities were more common than development or implementation activities (65.4, 31.9 and 35.1 %, respectively). Not having well established reimbursement procedures, lack of dedicated clinic space, and lack of dedicated personnel salaries (47.3, 38.3 and 32.6 %, respectively) were reported as the most common barriers to developing, implementing or improving an anticoagulation clinic. Participants indicated that anticoagulation outcomes tracking was the most common supplemental development, implementation and improvement activity (37.9, 37.0 and 43.8 % respectively). Benchmarking was the least commonly reported outcomes-related activity by participants (33.6 %). Although there was only a modest gain in the number of established anticoagulation clinics after attending the Anticoagulation Training Program, approximately 21 % of participants reported using skills learned to establish other disease state management clinics. CONCLUSION: In general, a majority of participants reported high levels of confidence related to direct patient care activities after attending the Anticoagulation Training Program. However there is a need to raise confidence in performance improvement and outcomes management activities to align with current accreditation standards in anticoagulation management as the Anticoagulation Training Program evolves.

Demonstration of anticoagulation patient self-testing feasibility at an Indian Health Service facility: a case series analysis / Demostración de la factibilidad del autocontrol por pacientes de la anticoagulación en un centro del servicio sanitario indio: análisis de serie de casos

Background: Anticoagulation patient self-testing (PST) represents an alternative approach to warfarin monitoring by enabling patients to use coagulometers to test their international normalized ratio (INR) values. PST offers several advantages that potentially improve warfarin management. Objective: To describe implementation and associated performance of a PST demonstration program at an Indian Health Service (IHS) facility. Methods: A non-consecutive case series analysis of patients from a pharmacy-managed PST demonstration program was performed at an IHS facility in Oklahoma between July 2008 and February 2009. Results: Mean time in therapeutic range (TTR) for the seven patients showed a small, absolute increase during the twelve weeks of PST compared to the twelve weeks prior to PST. Four of the seven patients had an increase in TTR during the twelve week course of PST compared to their baseline TTR. Three of four patients with increased TTR in the final eight week period of PST achieved a TTR of 100%. Of the three patients who experienced a decrease in TTR after initiating self-testing, two initially presented with a TTR of 100% prior to PST and one patient had a TTR of 100% for the final eight weeks of PST. The two patients not achieving a TTR of 100% during the twelve week PST period demonstrated an increase in TTR following the first four weeks of PST. Conclusion: Although anticoagulation guidelines now emphasize patient self-management (PSM) only, optimal PST remains an integral process in PSM delivery. In the patients studied, the results of this analysis suggest that PST at the IHS facility provided a convenient, alternative method for management of chronic warfarin therapy for qualified patients. More than half of the patients demonstrated improvement in TTR. Although there is a learning curve immediately following PST initiation, the mean TTR for the entire PST period increased modestly when compared to the time period prior to PST (AU)

Antecedentes: La automedición por el paciente (PST) de la anticoagulación representa un abordaje alternativo a la monitorización de warfarina al capacitar a los pacientes a utilizar coagulómetros para medir los valores de su ratio internacional normalizado (RIN). La PST ofrece varias ventajas que mejoran el manejo de warfarina. Objetivo: describir la implantación y la actuación asociada a un programa de demostración de PST en un centro del Servicio Sanitario Indio. Métodos: Se realizó un análisis de una serie de casos no consecutivos de un programa de PST realizado por una farmacia en un Servicio Sanitario Indio de Oklahoma desde julio 2008 a Febrero 2009. Resultados: El tiempo medio en rango terapéutico (TRT) para los siete pacientes mostró un pequeño incremento absoluto durante los 12 meses de PST comparado con los 12 meses previos al PST. Cuatro de los siete pacientes tuvieron un aumento de TRT durante las 12 semanas de tratamiento comparado con el TRT al inicio. Tres de los cuatro con aumento de TRT, alcanzaron un TRT del 100% al final del periodo de 8 semanas. De los tres pacientes que tuvieron un descenso de TRT después de inicial la automedición, dos presentaban un TRT antes del PST del 100% y un paciente tenía un TRT del 100% al final de las 8 semanas de PST. Los dos pacientes que no alcanzaron un TRT del 100% durante las 12 semanas de PST demostraron un aumento de TRT después de las 4 semanas iniciales. Conclusión: Aunque las guias de anticoagulación actualmente solo enfatizan el auto-manejo por el paciente, el PST optimo es parte integral de ese auto-manejo En los pacientes estudiados, los resultados de este análisis sugieren que el PST en un centro del Servicio Sanitario Indio proporciona un método conveniente y alternativo para el manejo crónico del tratamiento con warfarina en pacientes cualificados. Más de la mitad de los pacientes demostró un aumento del TRT. Aunque existe una curva de aprendizaje inmediatamente después de la iniciación del PST, la media de TRT para el periodo completo de PST aumentó modestamente comparada con el tiempo anterior al PST (AU)

Metabolic effects of a conversion from rosiglitazone to pioglitazone in Native American patients with type 2 diabetes.

In this retrospective electronic chart review, we evaluated the metabolic changes that occurred in Native American patients with type 2 diabetes who were treated with rosiglitazone and then converted to pioglitazone with no other changes in medication regimens for diabetes or dyslipidemia. Thirty-four patients were included in the analysis. After the conversion from rosiglitazone to pioglitazone, significant decreases in the levels of total cholesterol (10.1%), low-density lipoprotein cholesterol (11.7%), and triglycerides (15.3%) were seen. No significant changes occurred in weight, body mass index, fasting glucose, hemoglobin A(1c), high-densitylipoprotein cholesterol, blood pressure, or liver function tests. Significantly more patients achieved low-density lipoprotein cholesterol and triglyceride target goals when taking pioglitazone than when taking rosiglitazone. No drug discontinuations or adverse effects were reported among the evaluable population. These results are consistent with results of other studies evaluating these two drug therapies.

Beliefs and attitudes regarding smoking cessation among American Indians: a pilot study.

BACKGROUND: American Indians (AI) have some of the highest smoking rates in the United States. The Muscogee Nation of Oklahoma developed a culturally targeted program called "Second Wind" based on the American Cancer Society's FreshStart smoking cessation program, but it has not been formally tested. METHODS: We conducted six focus groups of AI adult smokers at the Haskell Health Center (Lawrence, Kansas). Focus groups assessed beliefs, attitudes, and behaviors related to smoking cessation, as well as participants' perceptions of the "Second Wind" curriculum's appropriateness and feasibility for this diverse group. Focus groups were audiotaped, transcribed, coded, and analyzed for content themes. Participants were 41 AI adults (63% female), 21-67 years of age. Participants smoked an average of 13 cigarettes per day, half had made a quit attempt in the past year, and 63% were daily smokers. For pharmacotherapy, most preferred the nicotine patch. RESULTS: Focus group responses were categorized into three major themes: traditional tobacco use, quitting and quit attempts, and the "Second Wind" program. Those who reported that traditional tobacco use is important were less inclined to use tobacco recreationally. Second Wind modifications suggested by participants included increasing use of AI imagery and addressing the meaning of tobacco to AI cultures. CONCLUSIONS: American Indian smokers are unique because of their traditional use of tobacco. Our participants felt that smoking cessation can be accomplished without discouraging traditional use of tobacco. We suggest ways to improve the "Second Wind" curriculum so that it is targeted for a heterogeneous group of AI smokers.

"Tobacco has a purpose, not just a past": Feasibility of developing a culturally appropriate smoking cessation program for a pan-tribal native population.

Tobacco has long held spiritual significance to Native people of North America but, because of recreational use, it has become a health risk relatively recently. More Native people smoke than any other ethnic group (41 percent vs. 24 percent in whites and blacks), and death rates caused by tobacco-related diseases are disproportionately high. However, no tested, culturally tailored smoking cessation programs exist for this group. We used a critical-interpretive framework to understand the meaning of tobacco and the feasibility of smoking cessation interventions in a pan-tribal population. In June 2004, the University of Kansas Medical Center (KUMC) and the Oklahoma Area Indian Health Service (IHS) collaborated on six focus groups with (IHS) patients. The patients served represent over 200 different nations. Our participants provided us with modifications to a currently untested program designed by the Muscogee Nation of Oklahoma's Tobacco Prevention Program to enhance cultural appropriateness, including (1) an emphasis on visual presentation and a "Native" look to program educational materials; (2) comprehensive information about tobacco, quitting, and coping among Native people; (3) an acknowledgment and incorporation of traditional tobacco use and its diversity; and (4) the use of talking circles and counseling with Native facilitators.