Candis M. Morello

Primary care-based, pharmacist-physician collaborative medication-therapy management of hypertension: a randomized, pragmatic trial.

PURPOSE A collaborative pharmacist-primary care provider (PharmD-PCP) team approach to medication-therapy management (MTM), with pharmacists initiating and changing medications at separate office visits, holds promise for the cost-effective management of hypertension, but has not been evaluated in many systematic trials. The primary objective of this study was to examine blood pressure (BP) control in hypertensive patients managed by a newly formed PharmD-PCP MTM team versus usual care in a university-based primary care clinic. METHODS This randomized, pragmatic clinical trial was conducted in hypertensive patients randomly selected for PharmD-PCP MTM or usual care. In the PharmD-PCP MTM group, pharmacists managed drug-therapy initiation and monitoring, medication adjustments, biometric assessments, laboratory tests, and patient education. In the usual-care group, patients continued to see their PCPs. Participants were aged ≥ 18 years, were diagnosed with hypertension, had a most recent BP measurement of ≥ 140/≥ 90 mm Hg (≥ 130/≥ 80 mm Hg if codiagnosed with diabetes mellitus), were on at least 1 antihypertensive medication, and were English speaking. The primary outcome was the difference in the mean change from baseline in systolic BP at 6 months. Secondary outcomes included the percentage achieving therapeutic BP goal and the mean changes from baseline in diastolic BP and low- and high-density lipoprotein cholesterol. FINDINGS A total of 166 patients were enrolled (69 men; mean age, 67.7 years; PharmD-PCP MTM group, n = 75; usual-care group, n = 91). Mean reduction in SBP was significantly greater in the PharmD-PCP MTM group at 6 months (-7.1 [19.4] vs +1.6 [21.0] mm Hg; P = 0.008), but the difference was no longer statistically significant at 9 months (-5.2 [16.9] vs -1.7 [17.7] mm Hg; P = 0.22), based on an intent-to-treat analysis. In the intervention group, greater percentages of patients who continued to see the MTM pharmacist versus those who returned to their PCP were at goal at 6 months (81% vs 44%) and at 9 months (70% vs 52%). No significant between-group differences in changes in cholesterol were detected at 6 and 9 months; however, the mean baseline values were near recommended levels. The PharmD-PCP MTM group had significantly fewer PCP visits compared with the usual-care group (1.8 [1.5] vs 4.2 [1.0]; P < 0.001). IMPLICATIONS A PharmD-PCP collaborative MTM service was more effective in lowering BP than was usual care at 6 months in all patients and at 9 months in patients who continued to see the pharmacist. Incorporating pharmacists into the primary care team may be a successful strategy for managing medication therapy, improving patient outcomes and possibly extending the capacity of primary care. ClinicalTrials.gov identifier: NCT01973556.

Pharmacokinetics and pharmacodynamics of insulin analogs in special populations with type 2 diabetes mellitus

Introduction The goal of insulin therapy in patients with either type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) is to match as closely as possible normal physiologic insulin secretion to control fasting and postprandial plasma glucose. Modifications of the insulin molecule have resulted in two long-acting insulin analogs (glargine and detemir) and three rapid-acting insulins (aspart, lispro, and glulisine) with improved pharmacokinetic/pharmacodynamic (PK/PD) profiles. These agents can be used together in basal-bolus therapy to more closely mimic physiologic insulin secretion patterns. Methods This study reviews effects of the multiple demographic and clinical parameters in the insulin analogs glargine, detemir, lispro, aspart, and glulisine in patients with T2DM. A search was conducted on PubMed for each major topic considered (effects of injection site, age, race/ethnicity, obesity, renal or hepatic dysfunction, pregnancy, exercise, drug interactions) using the topic words and name of each type of insulin analog. Information was also obtained from the prescribing information for each insulin analog. Results The PK/PD profiles for insulin analogs may be influenced by many variables including age, weight, and hepatic and renal function. However, these variables do not have equivalent effects on all long-acting or rapid-acting insulin analogs. Conclusion Rapid-acting and long-acting insulin analogs represent major advances in treatment for patients with T2DM who require insulin therapy. However, there are potentially important PK and PD differences between the two long-acting agents and among the three rapid-acting insulin analogs, which should be considered when designing treatment regimens for special patient groups.

Waterpipe smoking among health sciences university students in Iran: perceptions, practices and patterns of use

BackgroundIn recent years waterpipe smoking has become a popular practice amongst young adults in eastern Mediterranean countries, including Iran. The aim of this study was to assess waterpipe smoking perceptions and practices among first-year health sciences university students in Iran and to identify factors associated with the initiation and maintenance of waterpipe use in this population.ResultsOut of 371 first-year health sciences students surveyed, 358 eight students completed a self-administered questionnaire in the classrooms describing their use and perceptions towards waterpipe smoking. Two hundred and ninety six responders met study inclusion criteria. Waterpipe smoking was common among first-year health sciences university students, with 51% of students indicating they were current waterpipe smokers. Women were smoking waterpipes almost as frequently as men (48% versus 52%, respectively). The majority of waterpipe smokers (75.5%) indicated that the fun and social aspect of waterpipe use was the main motivating factor for them to continue smoking. Of waterpipe smokers, 55.3% were occasional smokers, using waterpipes once a month or less, while 44.7% were frequent smokers, using waterpipes more than once a month. A large number of frequent waterpipe smokers perceived that waterpipe smoking was a healthier way to use tobacco (40.6%) while only 20.6% thought it was addictive. Compared to occasional smokers, significantly more frequent smokers reported waterpipe smoking was relaxing (62.5% vs. 26.2%, p = 0.002), energizing (48.5% vs. 11.4%, p = 0.001), a part of their culture (58.8% vs. 34.1%, p = 0.04), and the healthiest way to use tobacco (40.6% vs. 11.1%, p = 0.005).ConclusionsSocial and recreational use of waterpipes is widespread among first-year health sciences university students in Iran. Women and men were almost equally likely to be current waterpipe users. Public health initiatives to combat the increasing use of waterpipes among university students in Iran must consider the equal gender distribution and its perception by many waterpipe smokers as being a healthier and non-addictive way to use tobacco.

Strategies for insulin therapy in type 2 diabetes.

Chronic hyperglycemia in type 2 diabetes is responsible for an array of microvascular and macrovascular complications that can lead to significant morbidity and mortality. Several well-conducted large clinical studies have shown that normalizing blood glucose levels can help prevent the onset and slow the progression of complications from diabetes. As many as 25% of patients treated with oral hypoglycemic agents require the addition of insulin therapy to compensate for the progression of β-cell failure and an inability to maintain glycemic control. Various strategies incorporating the use of insulin early in the course of the disease have been developed to meet this goal, and include the use of basal-bolus insulin regimens as well as bedtime insulin injections. The pharmacokinetic properties of the new insulin analogs (eg, insulin lispro, insulin aspart, insulin glargine) offer significant advantages, such as improved control of nocturnal hypoglycemia with basal insulin glargine, and improved postprandial glucose control, with insulin lispro or insulin aspart.

An Evidence-Based and Practical Approach to Using Bydureon™ in Patients With Type 2 Diabetes

Glucagon-like peptide (GLP)-1 agonists are one of the newer classes of medications for use in type 2 diabetes. There are currently three GLP-1 agonists on the market: exenatide twice daily, liraglutide, and exenatide extended release (ER). Exenatide ER is a new weekly formulation of exenatide. Exenatide ER reduces glycosylated hemoglobin by 1.6%, with fewer gastrointestinal side effects compared with twice-daily exenatide. Like other GLP-1 agonists, exenatide ER can be used in combination with metformin, sulfonylureas, or thiazolidinediones. Patients should be assessed for risk of pancreatitis and renal impairment. Education about proper administration technique is vital with the novel delivery system. Prescribers may also consider the use of exenatide ER to improve medication adherence in patients who have successfully tolerated exenatide twice daily or use in patients who have gastrointestinal side effects with exenatide twice daily. Exenatide is a reasonable option that can be added to the regimen of a patient with type 2 diabetes.

Strategies to Improve Medication Adherence Reported by Diabetes Patients and Caregivers: Results of a Taking Control of Your Diabetes Survey

BACKGROUND: Published studies assessing specific methods that patients with diabetes and their caregivers perceive as helpful means of increasing medication adherence are lacking. OBJECTIVE: To determine methods that patients with diabetes and their caregivers have used to improve medication adherence, investigate the perceived helpfulness of these methods, and identify motivating factors and medication characteristics that may positively influence adherence. METHODS: A cross-sectional survey was distributed to patients with diabetes and caregivers of patients with diabetes at the 11th annual Taking Control of Your Diabetes conference in October 2005 at the San Diego Convention Center. Outcome measures were self-reported medication adherence, perceived helpfulness of methods employed to improve adherence, motivating factors that may improve adherence, and medication characteristics that may improve adherence. RESULTS: A total of 524 (40.5% response rate) questionnaires were included in the final analysis, 357 from patients with diabetes and 167 from caregivers. Taking medications as part of a daily routine and using pill boxes were the most frequently reported helpful methods for improving medication adherence. The 3 motivating factors most commonly identified as improving medication adherence were: knowing that diabetes medications work effectively to lower blood glucose, knowing how to manage medication adverse effects, and understanding medication benefits. Many participants thought that newer injectable diabetes medications resulting in weight loss or no additional blood glucose monitoring would be helpful in optimizing adherence. CONCLUSIONS: Participants in this study identified medication education as a key factor in improving adherence. To empower patients to overcome medication adherence barriers, pharmacists could perform more proactive and thorough counseling sessions that include education on indication, mechanism of action, and therapeutic effects of drugs. They could recommend that patients take medications concurrently with a daily routine and use a pill box, as these actions were reported to be likely to improve medication adherence. However, our results also remind us that motivating factors and tools that may improve adherence may be very patient specific and that pharmacists should incorporate an assessment of this variance in their counseling sessions.

Effects of Dietary Fiber and Low Glycemic Index Diet on Glucose Control in Subjects with Type 2 Diabetes Mellitus

Objective: To review the effects of dietary fiber and a low glycemic index diet on glycemic risk factors in people with type 2 diabetes mellitus (T2DM) or T2DM and dyslipidemia. Data Sources: Literature search was conducted using PubMed, Cochrane Library, The Natural Standard, and The Natural Medicines through July 2010 using the terms type 2 diabetes mellitus, dietary fiber, psyllium, and glycemic index. Study Selection and Data Extraction: Articles included were randomized controlled studies or meta-analyses examining the effects of dietary interventions (dietary fiber, low glycemic index diet, or psyllium) on glycemic risk factors (glycosylated hemoglobin A1c [A1C] or postprandial plasma glucose [PPG] concentrations) in subjects with T2DM or T2DM and dyslipidemia Data Synthesis: Both psyllium supplementation and low glycemic index diets have been studied as monotherapy in the treatment of T2DM. Seven studies were reviewed (3 randomized crossover studies, 1 randomized parallel study, 3 randomized blinded parallel studies). Individually, psyllium supplementation and a low glycemic index diet improved glycemic risk factors. PPG and A1C decreased with psyllium 10.2 g per day, while A1C decreased with a low glycemic index diet (average glycemic index 59). However, the results for the low glycemic index diet are controversial. One study was underpowered to detect changes in A1C, while another study had psyllium fiber as a confounding variable. Conclusions: Psyllium supplementation might be an additional therapeutic option for people with T2DM who are already receiving diabetes medication and who still experience elevated PPG concentrations. Further well-designed clinical trials and adjustment for confounding variables are needed to determine the role of a low glycemic index diet in the treatment of T2DM.

Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services.

BACKGROUND The extant literature reveals a lack of psychometrically validated tools measuring patient satisfaction with pharmacist clinical services. The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) was developed to address this need using a mixed methods approach. OBJECTIVE To assess the psychometric properties of the PSPSQ 2.0, an instrument developed to measure patient satisfaction with clinical services provided by pharmacists. METHODS Validation studies were conducted in two Veterans Affairs (VA)-based and two community-based (diabetes and psychiatric care) disease management/medication therapy management clinics. The PSPSQ 2.0 consisted of 22-items related to three domains identified as quality of care, patient-pharmacist relationship and overall satisfaction using a 4-point, Likert-type scale. It was administered to participants following their session with a pharmacist at the clinics. Collected data were analyzed for descriptive statistics, internal consistency, and validity using exploratory factor analysis. RESULTS A total of 149 patients completed the survey. Patients from VA clinics were on average 61 years old, mostly white (63%), and predominantly male (95%). Patients from non-VA clinics were on average 47 years old, mostly White (47%) and male (53%). Non-VA patients mostly had Medicaid (42%) and commercial health insurance (31%), whereas VA patients retained benefits with the US Department of Veterans Affairs. Reliability of the scale using internal consistency metrics revealed a Cronbachs alpha of 0.98, 0.98 and 0.95 for VA, diabetes, and psychiatric care clinics, respectively, whereas the Cronbachs alpha for the pooled sample was 0.96. Factor analyses resulted in a three-factor solution accounting for 91% and 69% variance for diabetes and psychiatric care clinics, respectively; however, VA clinics and pooled sample yielded only 2-factor solution with 80% and 66% variance, respectively, with more items loading on patient-pharmacist relationship domain. CONCLUSIONS The results suggest that the PSPSQ 2.0 can serve as a reliable and valid tool for measuring patient satisfaction with pharmacists providing clinical services in VA- and non-VA settings upon further validation.

Navigating complex patients using an innovative tool: the MTM Spider Web.

OBJECTIVE To introduce a teaching tool that can be used to assess the complexity of medication therapy management (MTM) patients, prioritize appropriate interventions, and design patient-centered care plans for each encounter. SUMMARY MTM patients are complex as a result of multiple comorbidities, medications, and socioeconomic and behavioral issues. Pharmacists who provide MTM services are required to synthesize a plethora of information (medical and nonmedical), evaluate and prioritize the clinical problems, and design a comprehensive patient-centered care plan. The MTM Spider Web is a visual tool to facilitate this process. A description is provided regarding how to build the MTM Spider Web using case-based scenarios. This model can be used to teach pharmacists, health professional students, and patients. CONCLUSION The MTM Spider Web is an innovative teaching tool that can be used to teach pharmacists and students how to assess complex patients and design a patient-centered care plan to deliver the most appropriate medication therapy.

Clinical Outcomes Associated With a Collaborative Pharmacist-Endocrinologist Diabetes Intense Medical Management “Tune Up” Clinic in Complex Patients

Background: No previous studies exist examining the impact of a short-term pharmacist-endocrinologist collaborative practice model on glycemic control in complex patients. Objective: Evaluate outcomes associated with a PharmD-Endocrinologist Diabetes Intense Medical Management (DIMM) “tune up” clinic for complex patients. Methods: A retrospective cohort study of 99 patients referred to DIMM clinic versus a comparator group of 56 primary care provider (PCP) patients meeting the same criteria (adult type 2 diabetes patients, glycosylated hemoglobin [A1C] ≥ 8%, follow-up visit within 6 months) in a Veterans Affairs Medical Center. DIMM clinic used a short-term model that coupled personalized clinical care with real-time, patient-specific diabetes education during two to four 60-minute visits over 6 months. PCP patients received usual care. Primary outcome was mean A1C change after 6 months. Secondary measures included fasting blood glucose, lipids, blood pressure, weight, body mass index, and percentage of patients meeting goals. Results: Patients in each group had an average of 8 and were taking 12 to 14 medications daily. Mean A1C (%) improvement in DIMM group was significantly greater at 6 months (−2.4 [SD = 2.1] vs −0.8 [SD = 1.7]; P < 0.001), than PCP group. Percentage meeting A1C goal levels (<7%, <8%, and <9%) was significantly greater at 3 and 6 months compared with baseline in the DIMM group (P < 0.001) versus (only <8%) at 3 and 6 months compared with baseline in PCP group. Conclusions: The DIMM clinic “tune up” model demonstrates a successful collaborative practice which helped complex diabetes patients achieve glycemic control in a 6-month period.