Retrospective, multicenter analysis of the safety and effectiveness of direct oral anticoagulants for the treatment of venous thromboembolism in obesity.

BACKGROUND: Direct oral anticoagulants (DOACs) are the preferred treatment for venous thromboembolism (VTE). However, DOAC use in patients with a BMI greater than 40 kg/m2 has not been well studied despite the growing prevalence of obesity, and current literature is often underpowered. METHODS: This multicenter, retrospective, observational study evaluated patients 18 years and older who received DOACs for acute VTE treatment. Patients receiving DOACs for recurrent VTE or for failure of another agent were excluded. The primary efficacy outcome was recurrent VTE and the primary safety outcome was major bleeding within 12 months (or one month after stopping anticoagulation therapy). A propensity score analysis was performed to balance patient characteristics and evaluate the primary endpoints by BMI group. Time-to-event outcomes were analyzed using weighted Kaplan-Meier curves. RESULTS: There were 165 patients with a BMI of at least 40 kg/m2 and 320 patients with a BMI less than 40 kg/m2. The majority received apixaban (373, 77%). Recurrent VTE occurred in 5 (3.0%) and 13 (4.1%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 0.66; 95% CI: 0.16-2.69). Major bleeding occurred in 5 (3.0%) and 15 (4.7%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 1.19; 95% CI: 0.36-3.92). CONCLUSION: There was no significant difference in VTE recurrence or major bleeding related to BMI among patients treated with DOACs. This study showed that DOACs may be a safe and effective VTE treatment option in patients with obesity.

Successful Anticoagulation With Warfarin After Switching From Rifampin to Rifabutin.

PURPOSE: A case of a patient receiving warfarin for pulmonary embolism (PE) concomitantly with rifampin for treatment of active pulmonary tuberculosis (PTB) is presented. A successful clinical intervention whereby the patient achieved therapeutic anticoagulation after switching to an alternative rifamycin antibacterial, rifabutin, is described. SUMMARY: The drug-drug interaction between warfarin and rifampin is well known and documented. However, to our knowledge, no case reports of the interaction between warfarin and rifabutin have been published, and literature describing this interaction is lacking. We describe the case of a 27-year-old African American female referred to a pharmacist-managed anticoagulation clinic for treatment of PE with warfarin. The patient was also being treated for active tuberculosis with rifampin, isoniazid, pyrazinamide, and ethambutol. Warfarin was initiated and over the course of 1 month was continuously increased to a total weekly dose (TWD) of 140 mg without ever achieving the target international normalized ratio (INR) of 2 to 3. In an attempt to reach the target INR, rifampin was switched to rifabutin to minimize the drug-drug interaction with warfarin. Six days after this switch, the target INR was achieved with a lower warfarin TWD of 115 mg. Rifabutin interacts with warfarin to a lesser degree than rifampin and may be considered as an alternative in patients taking warfarin who require treatment with a rifamycin. CONCLUSION: For patients in whom therapeutic anticoagulation with warfarin has been difficult, the use of rifabutin may be considered in place of rifampin when the concomitant use of a rifamycin is required.

Temporomandibular Disorders: Rapid Evidence Review.

Temporomandibular disorders affect between 5% and 12% of the population and present with symptoms such as headache, bruxism, pain at the temporomandibular joint, jaw popping or clicking, neck pain, tinnitus, dizziness, decreased hearing, and hyperacuity to sound. Common signs on physical examination include tenderness of the pterygoid muscles, temporomandibular joints, and temporalis muscles, and malocclusion of the jaw and crepitus. The diagnosis is based on history and physical examination; however, use of computed tomography or magnetic resonance imaging is recommended if the diagnosis is in doubt. Nonpharmacologic therapy includes patient education (e.g., good sleep hygiene, soft food diet), cognitive behavior therapy, and physical therapy. Pharmacologic therapy includes nonsteroidal anti-inflammatory drugs, cyclobenzaprine, tricyclic antidepressants, and gabapentin. Injections of the temporomandibular joints with sodium hyaluronate, platelet-rich plasma, and dextrose prolotherapy may be considered, but the evidence of benefit is weak. A referral to oral and maxillofacial surgery is indicated for refractory cases.

Elevated international normalized ratio with the consumption of grapefruit and use of warfarin.

A 65-year-old male with documented atrial flutter who was taking warfarin chronically returned to the anticoagulation clinic for follow-up, after having been on 10 mg daily for approximately 2 weeks. He had a previous sub-therapeutic international normalized ratio of 1.7 on a dose of 65 mg/week. The international normalized ratio at this visit was now 4.77 via venipuncture, after just an 8% increase in weekly dosing. He self-reported adherence to the new warfarin dosing but had begun eating grapefruit since last visit. The patient had no active bleeding and was told to decrease his dose to 8 mg daily. He also stopped eating the grapefruit. One week later, he returned to the clinic and the international normalized ratio was 2.1. He is currently back on warfarin 65 mg/week, and his international normalized ratio has been within therapeutic range for the past 4 months. Clinicians should have a heightened awareness of the potential for elevated international normalized ratio when grapefruit juice is consumed in a patient who is taking warfarin.

Evaluation of patient perceptions and outcomes related to anticoagulation point-of-care testing in ambulatory care clinics / Evaluación de las percepciones y los resultados de los pacientes relacionados con la monitorización rápida en clínicas ambulatorias

Until recently, Prothrombin Time/International Normalized Ratio (PT/INR) measurements have typically been used to monitor patients on warfarin through institutional laboratories via venous puncture. The Point-of-Care Testing (POCT) device has revolutionized the patient care process by allowing for laboratory testing outside of the central laboratory. Objective: To analyze humanistic and clinical outcomes in patients currently treated with warfarin and monitored through a pharmacist-managed anticoagulation clinic using point-of-care testing (POCT) device versus venipuncture within ambulatory care clinics at our institution. Methods: All patients currently treated with warfarin therapy who were managed by clinical pharmacists for anticoagulation monitoring at the Medical University of South Carolina (MUSC) Family Medicine Center and University Diagnostic Center, were enrolled. Patients were asked to complete a satisfaction survey regarding their anticoagulation monitoring. In addition, data related to emergency department (ED) visits, hospitalizations and percent of time in the INR therapeutic range for 6 months pre- and post-implementation of POCT device was collected. This information was obtained through an electronic patient information database, Oacis. Results: A total of 145 patients were included in the data collection from the two clinics. The majority (41%) of these patients were taking warfarin for atrial fibrillation. Satisfaction surveys were completed by 86 (59 %) of patients. The surveys revealed that POCT device was preferred over venipuncture in 95% of patients. Reasons for the preference included more face-to-face interaction, less wait time, less pain, less blood needed, and quicker results. Of the 145 patients who were included in the objective data analysis, no significant differences were found in the number of hospitalizations, ED visits, or percent of time in the INR therapeutic range pre- and post- implementation of POCT device. Conclusion: The results of this study demonstrate improvement in patient satisfaction with POCT compared to venipuncture, with limited value in clinical outcomes (AU)

Hasta hace poco, las mediciones del tiempo de protombina/Ratio normalizado internacional (TP/RIN) se utilizaban típicamente para monitorizar pacientes con warfarina mediante laboratorios institucionales vía extracción venosa. Los aparatos de test en punto de atención (POCT) han revolucionados los procesos de cuidados de los pacientes permitiendo los análisis fuera del laboratorio central. Objetivo: Analizar los resultados humanísticos y clínicos en pacientes actualmente tratados con warfarina y monitorizados en una clínica de anticoagulación que usa aparatos de test en punto de atención (POCT) contra la venopunción en clínicas ambulatorias en nuestra institución. Métodos: Se incluyó a todos los pacientes tratados con warfarina que eran seguidos por farmacéuticos para monitorización de la anticoagulación en Centro de Medicina Familiar y en el Centro de Diagnóstico Universitario de la Universidad Médica de Carolina del Sur (MUSC). Se pidió a los pacientes que rellenasen un cuestionario de satisfacción relativo a su monitorización de anticoagulación. Además, se recogieron los datos relativos a las visitas a urgencias, hospitalizaciones y porcentaje de tiempo con RIN en margen terapéutico durante los 6 meses pre- y post-implantación del aparato POCT. Esta información se obtuvo a través de la base de datos electrónica de información de pacientes, Oacis. Resultados: Se recogió información de un total de 145 pacientes entre las dos clínicas. La mayoría (45%) de estos pacientes utilizaban la warfarina para fibrilación auricular. Los cuestionarios de satisfacción fueron completados por 86 (59%) pacientes. Los cuestionarios revelaron que el aparato de POCT era preferido sobre la venopunción por el 95% de os pacientes. Los motivos de preferencia incluyeron una interacción más personalizada, menor tiempo de espera, menos dolor, menos sangre requerida, y resultados más rápidos. De los 145 pacientes incluidos en el análisis de datos objetivos, no hubo diferencias significativas en el número de hospitalizaciones, visitas a urgencias, ni porcentaje de tiempo en el margen terapéutico de RIN pre- y post-implantación del aparato de POCT. Conclusión: Los resultados de este estudio demuestran un incremento en la satisfacción del paciente con el POCT comparado con la venopunción, con una escasa influencia en los resultados clínicos (AU)

Evaluation of patient perceptions and outcomes related to anticoagulation point-of-care testing in ambulatory care clinics.

UNLABELLED: Until recently, Prothrombin Time/International Normalized Ratio (PT/INR) measurements have typically been used to monitor patients on warfarin through institutional laboratories via venous puncture. The Point-of-Care Testing (POCT) device has revolutionized the patient care process by allowing for laboratory testing outside of the central laboratory. OBJECTIVE: To analyze humanistic and clinical outcomes in patients currently treated with warfarin and monitored through a pharmacist-managed anticoagulation clinic using point-of-care testing (POCT) device versus venipuncture within ambulatory care clinics at our institution. METHODS: All patients currently treated with warfarin therapy who were managed by clinical pharmacists for anticoagulation monitoring at the Medical University of South Carolina (MUSC) Family Medicine Center and University Diagnostic Center, were enrolled. Patients were asked to complete a satisfaction survey regarding their anticoagulation monitoring. In addition, data related to emergency department (ED) visits, hospitalizations and percent of time in the INR therapeutic range for 6 months pre- and post-implementation of POCT device was collected. This information was obtained through an electronic patient information database, Oacis. RESULTS: A total of 145 patients were included in the data collection from the two clinics. The majority (41%) of these patients were taking warfarin for atrial fibrillation. Satisfaction surveys were completed by 86 (59 %) of patients. The surveys revealed that POCT device was preferred over venipuncture in 95% of patients. Reasons for the preference included more face-to-face interaction, less wait time, less pain, less blood needed, and quicker results. Of the 145 patients who were included in the objective data analysis, no significant differences were found in the number of hospitalizations, ED visits, or percent of time in the INR therapeutic range pre- and post-implementation of POCT device. CONCLUSION: The results of this study demonstrate improvement in patient satisfaction with POCT compared to venipuncture, with limited value in clinical outcomes.

Management of chronic nonmalignant pain with nonsteroidal antiinflammatory drugs. Joint opinion statement of the Ambulatory Care, Cardiology, and Pain and Palliative Care Practice and Research Networks of the American College of Clinical Pharmacy.

Chronic nonmalignant pain is a major burden on the health care system in the United States. Frequently, nonsteroidal antiinflammatory drugs (NSAIDs) are used to assist in the management of various chronic pain syndromes. Although evidence is accumulating on the potential toxicities associated with NSAIDs, clear recommendations are lacking to guide the appropriate use of these drugs. Equivocal data, especially with respect to cardiovascular risk, further confuse a clear treatment pathway when assessing pharmacotherapy. Originally, cyclooxygenase selectivity appeared to be a determining factor in choosing an agent because of the presumed lack of effect on the cardiovascular and gastrointestinal renal systems. This theory, however, was recently dispelled. To provide guidance on the selection of an NSAID for various chronic pain syndromes, members of the Ambulatory Care, Cardiology, and Pain and Palliative Care Practice and Research Networks of the American College of Clinical Pharmacy evaluated evidence-based use of NSAIDs for frequently encountered pain syndromes, with special focus on the adverse effects of this class of agents.

Effect of patient-specific factors on weekly warfarin dose.

OBJECTIVE: To determine the influence of various patient-specific factors, use of concomitant medications, and weekly vitamin K intake on total weekly warfarin maintenance dose (TWD). METHODS: Information collected, via retrospective chart review, included TWD, general demographics, vitamin K consumption, target INR range, use of alcohol, tobacco, and cytochrome P450 (CYP)-inducing medications, and concomitant medications and diseases. RESULTS: The majority of patients (n = 131) were Caucasian (71%), with more females (55%) than males. Use of CYP-inducing medications resulted in the largest correlation coefficient (r = 0.30). The sample was divided into high warfarin dose (TWD >/= 50 mg) and low warfarin dose (TWD

5-year evaluation of electronic medical record flag alerts for patients warranting secondary prevention of coronary heart disease.

STUDY OBJECTIVES: To assess the effect of flag alerts that were placed in electronic medical records on patients' adherence with National Cholesterol Education Program (NCEP) guidelines for secondary prevention of coronary heart disease. A secondary objective was to identify the proportion of patients who were prescribed lipid-lowering agents and assess the barriers of patients who did not reach low-density lipoprotein cholesterol (LDL) goals 5.6 years after the intervention. DESIGN: Retrospective analysis of a prospective medical record intervention. SETTING: University-based primary care clinic. PATIENTS: Eighty-nine adult patients with atherosclerotic vascular disease. INTERVENTION: For each patient identified as needing secondary prevention for coronary heart disease according to NCEP guidelines, flags were inserted into the patient's electronic medical record. MEASUREMENTS AND MAIN RESULTS: Baseline patient data were collected. After 5.6 years, we performed a retrospective analysis. At that time, 72 patients were evaluated; 17 were lost to follow-up. Fifty-four percent of patients (39 of 72 patients) had reached their LDL goal compared with 25% (16 of 64 patients for whom complete lipid panels had been obtained) at baseline (p=0.001). The proportion of patients prescribed lipid-lowering agents rose from 16% at baseline to 75% at follow-up (p=0.0001). However, 33 patients (46%) were above their LDL goal levels at follow-up. Reasons for failure to reach LDL goal were as follows: drug dosage not titrated (10 patients [30%]), adverse drug reaction (four patients [12%]), planned to adjust therapy in the future (three patients [9%]), high drug cost (two patients [6%]), drug contraindicated (two patients [6%]), and non-compliance (one patient [3%]). In 11 patients (33%), the reason for failure was not addressed in the progress notes. Thus, inadequate drug dosage titration (dosage not titrated, planned to adjust therapy, and reason not addressed [assume no action]) occurred in more than 70% of these patients. CONCLUSIONS: These findings emphasize the need for regular evaluation of patients' lipid panels followed by appropriate therapy titration to reach LDL goals. Further study of factors influencing cholesterol management and methods to improve adherence is needed.

Assessment of patient knowledge of diabetic goals, self-reported medication adherence, and goal attainment

Background: Medication adherence is an integral aspect of disease state management for patients with chronic illnesses, including diabetes mellitus. It has been hypothesized that patients with diabetes who have poor medication adherence may have less knowledge of overall therapeutic goals and may be less likely to attain these goals. Objective: The purpose of this study was to assess self-reported medication adherence, knowledge of therapeutic goals (hemoglobin A1C [A1C], low density lipoprotein cholesterol [LDL-C] and blood pressure [BP]), and goal attainment in adult patients with diabetes. Methods: A survey was created to assess medication adherence, knowledge of therapeutic goals, and goal attainment for adult patients with diabetes followed at an internal medicine or a family medicine clinic. Surveys were self-administered prior to office visits. Additional data were collected from the electronic medical record. Statistical analysis was performed. Results: A total of 149 patients were enrolled. Knowledge of therapeutic goals was reported by 14%, 34%, and 18% of survived patients for LDL-C, BP, and A1C, respectively. Forty-six percent, 37%, and 40% of patients achieved LDL-C, BP, and A1C goals, respectively. Low prescribing of cholesterol-lowering medications was an interesting secondary finding; 36% of patients not at LDL-C goal had not been prescribed a medication targeted to lower cholesterol. Forty-eight percent of patients were medication non-adherent; most frequently reported reasons for non-adherence were forgot (34%) and too expensive (14%). Patients at A1C goal were more adherent than patients not at goal (p=0.025). Conclusion: The majority did not reach goals and were unknowledgeable of goals; however, most were provided prescriptions to treat these parameters. Goal parameters should be revisited often amongst multidisciplinary team members with frequent and open communications. Additionally, it is imperative that practitioners discuss the importance of medication adherence with every patient at every visit (AU)

Antecedentes: La adherencia al tratamiento es un aspecto integral de la gestión de la enfermedad para pacientes con enfermedades crónicas, como la diabetes mellitus. Se ha sugerido que los pacientes con diabetes que tienen baja adherencia a la medicación pueden tener peor conocimiento de los objetivos terapéuticos generales y puede ser menos probable que los alcancen. Objetivo: El propósito de este estudio fue evaluar la adherencia auto-comunicada a la medicación, el conocimiento de los objetivos terapéuticos (hemoglobina A1C [A1C], lipoproteinas de baja densidad [LDL-C] y presión arterial), y la consecución de objetivos en adultos con diabetes. Métodos: Se creó un cuestionario para evaluar la adherencia a la medicación, el conocimiento de objetivos terapéuticos, y la consecución de objetivos para adultos con diabetes seguidos en un departamento de medicina interna o de medicina de familia. Los cuestionarios se entregaron antes de la visita a la clínica. Se recogieron datos adicionales de las historias clínicas electrónicas. Se realizó un análisis estadístico. Resultados: Se incluyó un total de 140 pacientes. El conocimiento de los objetivos terapéuticos fue comunicado por el 14%, 34% y 18% de los pacientes encuestados para LDL-C, PA y A1C, respectivamente. El 46%, el 37% y el 40% de los pacientes alcanzó los objetivos de LDL-C, PA, y A1C, respectivamente. La baja prescripción de hipolipemiantes fue un hallazgo secundario interesante; el 36% de los pacientes no tenían prescrito un medicamento para bajar el colesterol. El 48% de los pacientes eran incumplidores; los motivos más frecuentemente comunicados para incumplir fueron el olvido (34%) y demasiado caro (14%). Los pacientes en el objetivo de A1C eran más cumplidores que los que no estaban en el objetivo (p=0,025). Conclusión: La mayoría no alcanza los objetivos y eran desconocedores de los objetivos; sin embargo, a la mayoría e les habían proporcionado medicamentos para tratar esos parámetros. Los parámetros objetivos deberían revisarse más a menudo entre los miembros del equipo multidisciplinario con comunicaciones abiertas y frecuentes. Además, es necesario que los facultativos discutan la importancia del cumplimiento de la medicación con capa paciente en cada visita (AU)

Warfarin and royal jelly interaction.

An 87-year-old African-American man came to the internal medicine clinic for a routine anticoagulation management visit. He had no complaints. His medical history was significant for stage IV-A follicular non-Hodgkin's lymphoma, atrial fibrillation, and hypertension. His long-term drug therapy consisted of warfarin, felodopine, lisinopril-hydrochlorothiazide, controlled-release diltiazem, potassium chloride, and oxycodone. He reported adherence with his prescribed drugs and denied taking any over-the-counter or herbal products. Overall, the patient's drug therapy had been consistent during the preceding 3 months, no significant changes had occurred in his clinical status, and no significant changes had been noted in his diet; his international normalized ratio (INR) had ranged from 1.9-2.4 (therapeutic range 2-3). He denied tobacco use, alcohol consumption, and recent travel. Four weeks later, the patient came to the emergency department with hematuria. He denied dysuria, taking more than the prescribed amount of warfarin, any changes in his diet, taking any over-the-counter or herbal products, and any other bleeding. On admission to the hospital, his INR was 6.88, which increased to 7.29 during his hospital stay. On further investigation, the patient admitted that he had started taking an herbal supplement, royal jelly, 1 week earlier. When asked specifically about the ingredients in the supplement, he stated that royal jelly was the only component. Relative to the patient's denial of any other changes in his condition or drug regimen, the most probable explanation for his elevated INR and subsequent bleeding is a possible interaction between royal jelly and warfarin. To our knowledge, no case reports concerning royal jelly and warfarin taken concomitantly have been reported. Clinicians should be proactive and repeatedly provide education regarding the potential dangers of dietary supplements taken with conventional drugs.

Assessment of patient knowledge of diabetic goals, self-reported medication adherence, and goal attainment.

BACKGROUND: Medication adherence is an integral aspect of disease state management for patients with chronic illnesses, including diabetes mellitus. It has been hypothesized that patients with diabetes who have poor medication adherence may have less knowledge of overall therapeutic goals and may be less likely to attain these goals. OBJECTIVE: The purpose of this study was to assess self-reported medication adherence, knowledge of therapeutic goals (hemoglobin A1C [A1C], low density lipoprotein cholesterol [LDL-C] and blood pressure [BP]), and goal attainment in adult patients with diabetes. METHODS: A survey was created to assess medication adherence, knowledge of therapeutic goals, and goal attainment for adult patients with diabetes followed at an internal medicine or a family medicine clinic. Surveys were self-administered prior to office visits. Additional data were collected from the electronic medical record. Statistical analysis was performed. RESULTS: A total of 149 patients were enrolled. Knowledge of therapeutic goals was reported by 14%, 34%, and 18% of survived patients for LDL-C, BP, and A1C, respectively. Forty-six percent, 37%, and 40% of patients achieved LDL-C, BP, and A1C goals, respectively. Low prescribing of cholesterol-lowering medications was an interesting secondary finding; 36% of patients not at LDL-C goal had not been prescribed a medication targeted to lower cholesterol. Forty-eight percent of patients were medication non-adherent; most frequently reported reasons for non-adherence were forgot (34%) and too expensive (14%). Patients at A1C goal were more adherent than patients not at goal (p=0.025). CONCLUSION: The majority did not reach goals and were unknowledgeable of goals; however, most were provided prescriptions to treat these parameters. Goal parameters should be revisited often amongst multidisciplinary team members with frequent and open communications. Additionally, it is imperative that practitioners discuss the importance of medication adherence with every patient at every visit.

ANTECEDENTES: La adherencia al tratamiento es un aspecto integral de la gestión de la enfermedad para pacientes con enfermedades crónicas, como la diabetes mellitus. Se ha sugerido que los pacientes con diabetes que tienen baja adherencia a la medicación pueden tener peor conocimiento de los objetivos terapéuticos generales y puede ser menos probable que los alcancen. OBJETIVO: El propósito de este estudio fue evaluar la adherencia auto-comunicada a la medicación, el conocimiento de los objetivos terapéuticos (hemoglobina A1C [A1C], lipoproteinas de baja densidad [LDL-C] y presión arterial), y la consecución de objetivos en adultos con diabetes. MÉTODOS: Se creó un cuestionario para evaluar la adherencia a la medicación, el conocimiento de objetivos terapéuticos, y la consecución de objetivos para adultos con diabetes seguidos en un departamento de medicina interna o de medicina de familia. Los cuestionarios se entregaron antes de la visita a la clínica. Se recogieron datos adicionales de las historias clínicas electrónicas. Se realizó un análisis estadístico. RESULTADOS: Se incluyó un total de 140 pacientes. El conocimiento de los objetivos terapéuticos fue comunicado por el 14%, 34% y 18% de los pacientes encuestados para LDL-C, PA y A1C, respectivamente. El 46%, el 37% y el 40% de los pacientes alcanzó los objetivos de LDL-C, PA, y A1C, respectivamente. La baja prescripción de hipolipemiantes fue un hallazgo secundario interesante; el 36% de los pacientes no tenían prescrito un medicamento para bajar el colesterol. El 48% de los pacientes eran incumplidores; los motivos más frecuentemente comunicados para incumplir fueron el olvido (34%) y demasiado caro (14%). Los pacientes en el objetivo de A1C eran más cumplidores que los que no estaban en el objetivo (p=0,025). CONCLUSIÓN: La mayoría no alcanza los objetivos y eran desconocedores de los objetivos; sin embargo, a la mayoría e les habían proporcionado medicamentos para tratar esos parámetros. Los parámetros objetivos deberían revisarse más a menudo entre los miembros del equipo multidisciplinario con comunicaciones abiertas y frecuentes. Además, es necesario que los facultativos discutan la importancia del cumplimiento de la medicación con capa paciente en cada visita.

Effectiveness of pharmacist-administered diabetes mellitus education and management services.

STUDY OBJECTIVES: To evaluate the effectiveness of pharmacist-administered diabetes mellitus education and management services on selected diabetes performance measures. Additional goals were to compare outcomes with goals specified for patients with diabetes by the National Committee for Quality Assurance (NCQA) and identify areas for improvement. DESIGN: One-year observational study. SETTING: Three university-based primary care clinics. PATIENTS: One hundred ninety-one patients with diabetes. Intervention. Pharmacist-provided diabetes education and management services. MEASUREMENTS AND MAIN RESULTS: Each patient was assessed for hemoglobin A1c (A1C) values, blood pressure, low-density lipoprotein cholesterol (LDL) levels, and aspirin use at baseline and at 1 year after enrollment. Cost avoidance comparators were calculated for those patients with reductions in A1C of at least 1%. Average A1C at 1 year was 7.8% (range 4.5-13.9%) versus 9.5% (range 5.4-19%) at baseline (change -1.7%, p<0.05). Seventy-two patients (38%) experienced a 1% or greater reduction in A1C. Average blood pressure decreased over the study period from 141/79 to 135/75 mm Hg (p=0.007), but average LDL levels did not change to a statistically significant extent (114 to 112 mg/dl, p>0.05). Aspirin use increased from 34% at baseline to 73% at 1 year (p<0.0001). The program achieved the A1C and LDL values required to qualify for NCQA diabetes recognition. Based on an estimated savings of $820 for each 1% decrease in A1C, cost avoidance was calculated as $59,040. CONCLUSION: Diabetes management services from clinical pharmacists achieved significant improvements in A1C values, blood pressure, and aspirin use. Continued efforts in diabetes education and management are needed to further improve clinical, economic, and humanistic outcomes.

Atomoxetine, a novel treatment for attention-deficit-hyperactivity disorder.

Atomoxetine is the first nonstimulant drug approved by the United States Food and Drug Administration (FDA) for the treatment of attention-deficit-hyperactivity disorder (ADHD), and the only agent approved by the FDA for the treatment of ADHD in adults. Atomoxetine is a norepinephrine transport inhibitor that acts almost exclusively on the noradrenergic pathway. Its mechanism of action in the control and maintenance of ADHD symptoms is thought to be through the highly specific presynaptic inhibition of norepinephrine. Clinical trials to evaluate the short-term effects of atomoxetine in children and adults have shown that atomoxetine is effective in maintaining control of ADHD. Likewise, long-term trials have determined that atomoxetine is effective in preventing relapse of ADHD symptoms without an increase in adverse effects. A comparative trial of atomoxetine with methylphenidate in school-aged children indicated similar safety and efficacy without the abuse liability associated with some psychostimulants. The most commonly reported adverse effects in children and adolescents are dyspepsia, nausea, vomiting, decreased appetite, and weight loss. The rates of adverse events in the trials were similar for both the once- and twice-daily dosing regimens. The discontinuation rate was 3.5% in patients treated with atomoxetine versus 1.4% for placebo and appeared to be dose dependent, wit a higher percentage of discontinuation at dosages greater than 1.5 mg/kg/day. In clinical trials involving adults, the emergence of clinically significant or intolerable adverse events was low. The most common adverse events in adults were dry mouth, insomnia, nausea, decreased appetite, constipation, urinary retention or difficulties with micturition, erectile disturbance, dysmenorrhea, dizziness, and decreased libido. Sexual dysfunction occurred in approximately 2% of patients treated with atomoxetine. Atomoxetine should be used with caution in patients who have hypertension or any significant cardiovascular disorder. Overall, atomoxetine therapy in patient with ADHD appears to be effective in controlling symptoms and maintaining remission, with the advantages being comparable efficacy with that of methylphenidate, a favorable safety profile, and non-controlled substance status. Additional long-term studies are needed to determine its continued efficacy for those who require lifelong treatment, and comparative trials against other stimulant and nonstimulant agents.

Azithromycin and warfarin interaction.

A 57-year-old Caucasian woman came to the clinic with symptoms of an upper respiratory tract infection. She was treated with a 5-day course of oral azithromycin 500 mg on day 1, then 250 mg/day for 4 days. During this period, the patient decreased her cigarette smoking from 1 pack/day to 1 pack every 3 days. No additional confounding variables were present. Two days after the completion of therapy, her international normalized ratio (INR) was 8.32. Six case reports documented in the literature have suggested an azithromycin-warfarin interaction with a resultant increase in INR. Many confounding variables existed in each of these cases, such as hepatic dysfunction, poor appetite, and concomitant drugs that resulted in an increased anticoagulant response. We report a case that involved only one potential confounding variable. Continued documentation of azithromycin-warfarin interactions is valuable considering no mention of this drug interaction exists in most tertiary references and in the package insert for azithromycin, the demonstration that no drug interaction occurred in a retrospective review of 52 cases, and the widespread use of azithromycin in the community. Clinicians should be mindful when prescribing azithromycin in combination with warfarin, and INR values should be monitored.

National survey of pharmacist certified diabetes educators.

We sought to determine the demographics of pharmacists who were certified diabetes educators (CDEs) and information about their training, professional affiliations, and types of diabetes education services that they provide. We also queried these pharmacists about clinical activities, reimbursement, impact of certification, and intent to pursue CDE recertification. A list of pharmacists who were CDEs as of August 31, 2000, was obtained from the National Certification Board for Diabetes Educators. We then sent a six-page anonymous survey to 415 pharmacist CDEs; 233 surveys (56.1%) were returned. Of these respondents, 140 are women and 93 are men, with a mean age of 41.5 years. Most reside in Southern or Western states. Average time since pharmacist licensure was 17 years, and average time as a CDE was 5 years. Most had completed postgraduate training, including residencies and/or fellowships; 52.8% had faculty appointments; 46.7% stated they were billing for their services; and 45.9% were obtaining reimbursement. Most pharmacists (84.4%) stated that they intended to pursue CDE recertification. Providing details about pharmacist CDEs and their clinical activities may motivate other pharmacists to pursue this credential. Pharmacists are often the most accessible of all health care providers, and earning the CDE credential may be an important contribution to diabetes care and education.