Joli D. Fermo

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, with 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 patients 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.

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.

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.

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.

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.

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‐Hodgkins 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 patients 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 patients 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.

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

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.

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.