Kerry Mansell

Proposing a Redefinition of Pharmaceutical Care

In many clinical practice settings, individual pharmaceutical care practitioners have thousands of patients who may receive their service. However, the pharmaceutical care approach provides virtually no guidance regarding how patients should be identified or prioritized by practicing pharmacists. We believe that pharmacists need to be “officially” accountable to specific patient groups at high risk for drug- or disease-induced morbidity within their practice. Consequently, the current definition of pharmaceutical care and its associated care processes need to be modified to ensure the activities of pharmacists are being focused on high-priority patients on a consistent basis.

Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study

AIM To determine the short-term biochemical effects and clinical tolerability of intermittent fasting (IF) in adults with type 2 diabetes mellitus (T2DM). METHODS We describe a three-phase observational study (baseline 2 wk, intervention 2 wk, follow-up 2 wk) designed to determine the clinical, biochemical, and tolerability of IF in community-dwelling volunteer adults with T2DM. Biochemical, anthropometric, and physical activity measurements (using the Yale Physical Activity Survey) were taken at the end of each phase. Participants reported morning, afternoon and evening self-monitored blood glucose (SMBG) and fasting duration on a daily basis throughout all study stages, in addition to completing a remote food photography diary three times within each study phase. Fasting blood samples were collected on the final days of each study phase. RESULTS At baseline, the ten participants had a confirmed diagnosis of T2DM and were all taking metformin, and on average were obese [mean body mass index (BMI) 36.90 kg/m2]. We report here that a short-term period of IF in a small group of individuals with T2DM led to significant group decreases in weight (-1.395 kg, P = 0.009), BMI (-0.517, P = 0.013), and at-target morning glucose (SMBG). Although not a study requirement, all participants preferentially chose eating hours starting in the midafternoon. There was a significant increase (P < 0.001) in daily hours fasted in the IF phase (+5.22 h), although few attained the 18-20 h fasting goal (mean 16.82 ± 1.18). The increased fasting duration improved at-goal (< 7.0 mmol/L) morning SMBG to 34.1%, from a baseline of 13.8%. Ordinal Logistic Regression models revealed a positive relationship between the increase in hours fasted and fasting glucose reaching target values (χ2 likelihood ratio = 8.36, P = 0.004) but not for afternoon or evening SMBG (all P > 0.1). Postprandial SMBGs were also improved during the IF phase, with 60.5% readings below 9.05 mmol/L, compared to 52.6% at baseline, and with less glucose variation. Neither insulin resistance (HOMA-IR), nor inflammatory markers (C-reactive protein) normalized during the IF phase. IF led to an overall spontaneous decrease in caloric intake as measured by food photography (Remote Food Photography Method). The data demonstrated discernable trends during IF for lower energy, carbohydrate, and fat intake when compared to baseline. Physical activity, collected by a standardized measurement tool (Yale Physical Activity Survey), increased during the intervention phase and subsequently decreased in the follow-up phase. IF was well tolerated in the majority of individuals with 6/10 participants stating they would continue with the IF regimen after the completion of the study, in a full or modified capacity (i.e., every other day or reduced fasting hours). CONCLUSION The results from this pilot study indicate that short-term daily IF may be a safe, tolerable, dietary intervention in T2DM patients that may improve key outcomes including body weight, fasting glucose and postprandial variability. These findings should be viewed as exploratory, and a larger, longer study is necessary to corroborate these findings.

Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults.

Background Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation. Objective This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood. Methods A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date. Results Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks. Conclusions Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years. Trial Registration Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA)

Collaborative Cardiovascular Risk Reduction in Primary Care II (CCARP II): Implementation of a systematic case-finding process for patients with uncontrolled risk factors.

Background: Previous pharmacist interventions to reduce cardiovascular (CV) risk have been limited by low patient enrolment. The primary aim of this study was to implement a collaborative pharmacist intervention that used a systematic case-finding procedure to identify and manage patients with uncontrolled CV risk factors. Methods: This was an uncontrolled, program implementation study. We implemented a collaborative pharmacist intervention in a primary care clinic. All adults presenting for an appointment with a participating physician were systematically screened and assessed for CV risk factor control by the pharmacist. Recommendations for risk factor management were communicated on a standardized form, and the level of pharmacist follow-up was determined on a case-by-case basis. We recorded the proportion of adults exhibiting a moderate to high Framingham risk score and at least 1 uncontrolled risk factor. In addition, we assessed before-after changes in CV risk factors. Results: Of the 566 patients who were screened prior to visiting a participating physician, 186 (32.9%) exhibited moderate or high CV risk along with at least 1 uncontrolled risk factor. Physicians requested pharmacist follow-up for 60.8% (113/186) of these patients. Of the patients receiving the pharmacist intervention, 65.5% (74/113) were at least 50% closer to 1 or more of their risk factor targets by the end of the study period. Significant risk factor improvements from baseline were also observed. Discussion: Through implementation of a systematic case-finding approach that was carried out by the pharmacist on behalf of the clinic team, a large number of patients with uncontrolled risk factors were identified, assessed and managed with a collaborative intervention. Conclusion: Systematic case finding appears to be an important part of a successful intervention to identify and manage individuals exhibiting uncontrolled CV risk factors in a primary care setting.

Prevalence of Metabolic Syndrome Among College Football Linemen

OBJECTIVE To determine the prevalence of metabolic syndrome among Canadian amateur football players. METHODS University football players from Saskatchewan were invited to participate in this study. Each subject underwent screening for blood pressure using a BpTRU monitor, and serum cholesterol and fasting blood glucose using a Cholestech LDX analyzer. Waist circumference was recorded and body composition was measured by dual-energy x-ray absorptiometry. RESULTS were compared between linemen and non-linemen using independent sample t-tests for continuous data and chi-square for dichotomous variables. RESULTS Out of 39 players who consented to participate, 14% of linemen (3/21) and no non-linemen satisfied metabolic syndrome criteria. Compared to non-linemen, linemen had a higher waist circumference (108.0 vs. 82.9 cm; p<0.001), higher total body fat composition (26.4% vs. 11.2%; p<0.001), lower mean high-density lipoprotein cholesterol (0.93, vs. 1.12 mmol/L; p=0.021) and higher fasting blood glucose (5.22 vs. 4.77 mmol/L; p<0.001). CONCLUSION Despite their young age and participation in an elite-level athletic program, many collegiate-level football linemen had features of metabolic syndrome. Although our study focused on a single team, we suspect these trends may be consistent across the country.

Prevalence of Diabetes-Related Complications and Their Association with Determinants Identified in Canada's Survey on Living with Chronic Diseases—Diabetes Component (SLCDC-DM-2011)

Abstract Objective This study aims to estimate the prevalence of diabetes-related complications, and the factors associated with them in the Canadian patients with diabetes. Methods Data from the 2011 Survey on Living with Chronic Diseases in Canada – Diabetes Component (SLCDC-DM-2011) were used to calculate the weighted prevalence of 16 diabetes-related complications. A multivariable sex-stratified logistic regression model was used to examine the association between each diabetes-related complication and select determinants. Results Among Canadian patients who self-reported having diabetes, 80.26 percent reported having at least one type of diabetes-related complications. The most frequently reported complications were high blood pressure (54.65%), cataracts (29.52%) and poor circulation (21.68%).Male patients were more associated to have at least one complication if they had an inappropriate BMI (OR=2.94 CI: 1.39-6.23),and had a high level of HbA1c (OR=2.32 CI: 1.05-5.13,) were older (OR=6.92 CI: 1.82-24.74), had diabetes for a longer period of time (OR=3.42 CI: 1.71-6.85) Among female patients more duration of having diabetes is significant variable associated with complication ( OR=2.00 CI: 1.05-3.81) Conclusion This study suggests that socio-economic factors including marital status, income and education had significant associations with most types of complications. Our findings also confirmed that low levels of physical activity and high levels of HbA1c were important determinant for many diabetes–related complications.

Influence of Flaxseed Lignan Supplementation to Older Adults on Biochemical and Functional Outcome Measures of Inflammation

ABSTRACT Evidence from the literature suggests that dietary flaxseed lignans have the ability to modulate inflammation, which is recognized as the underlying basis of multiple chronic human diseases in older adults. Our objective was to determine the effects of oral lignan supplementation on biochemical and functional indicators of inflammation as well as safety and tolerability in older healthy adults. We designed a randomized, double-blind, placebo-controlled clinical trial in older healthy adults (60–80 years) to assess flaxseed lignan–enriched complex (∼38% secoisolariciresinol diglucoside [SDG]; 600 mg SDG dose) oral supplementation effects on biochemical and functional indicators of inflammation and safety and tolerability in older healthy adults after 6 months of once-daily oral administration. The clinical trial confirmed that plasma concentration of total flaxseed lignans (free and conjugated forms) secoisolariciresinol (SECO), enterodiol (ED), and enterolactone (ENL) were significantly associated with daily oral supplementation of flaxseed lignan–enriched complex (p < 0.05). A significant decrease in systolic blood pressure (SBP; from a mean of 155 ± 13 mm Hg at baseline to 140 ± 11 mm Hg at 24 weeks) was observed in lignan-supplemented participants stratified into an SBP ≥140 mm Hg subcategory (p = 0.04). No differences were found between treatment or placebo groups in terms of cognition, pain, activity, physical measurements (calf, waist, and upper arm circumstances), and grip strength. With respect to blood inflammatory markers, lipid profiles, and biochemical parameters, no significant differences were found between treatment and placebo groups at the end of the 6-month supplementation. No adverse effects were reported during supplementation. These data further support the safety and tolerability of long-term flaxseed lignan–enriched complex supplementation in older adults and identify an ability to favorably modulate SBP, an important risk factor in cardiovascular disease.

Pharmacist Interventions: Improving Adherence to Evidence-Based Therapy

“Butterfl y Effect” explains that if a butterfl y spreads its wings in Tokyo, the weather in New York may change. This theory provides an excellent example of how a seemingly insignifi cant change can have a surprising impact on a larger scale. As pharmacy students, we often observe a gap between the clinical skills we are taught in school and what is actually being done in practice. It is obvious that the skills currently taught in pharmacy schools will not be easily integrated into practice until the changes outlined in the Blueprint for Pharmacy are realized. However, our schooling has also taught us that there are small changes that can be immediately made to pharmacy practice that could lead to signifi cant improvements in health outcomes. This article attempts to give pharmacists (and pharmacy students) a few ideas on how to incorporate a simple intervention into any pharmacy practice, which may, as the Butterfl y Effect describes, lead to a disproportionally large improvement in patient care.

Do Postprandial Glucose Levels add Important Clinical Information When Fasting Glucose Levels are Near Normal in Non-Insulin-Dependent Patients with Type 2 Diabetes?

Background: Practice guidelines recommend that both fasting and postprandial blood glucose measurements be performed to achieve glycemic targets, yet few type 2 diabetes patients engage in postprandial glucose (PPG) testing. The purpose of this study was to determine if PPG testing provides important additional clinical information beyond fasting plasma glucose (FPG) tests in well-controlled, non-insulin-dependent type 2 diabetes patients. Methods: Subjects were recruited from 8 pharmacies and instructed to perform daily FPG tests during days 1 to 7 (run-in phase) and daily FPG and PPG tests during days 8 to 21 (test phase). Results: The mean FPG from 362 tests (n = 52 subjects) in the run-in phase was 7 mmol/L (SD 1.4). In the test phase, the mean FPG was 7 mmol/L (SD 1.6) and the mean PPG was 8.4 mmol/L (SD 2.2) from 700 tests. For FPG tests in the recommended target range of 4 to 7 mmol/L, 87% (322/370) of corresponding (same-day) PPG tests were within the target range of 5 to 10 mmol/L. In subjects whose mean FPG was 4 to 7 mmol/L, 87% of PPG tests were also within target limits. Conclusion: Community pharmacists are often asked by patients how frequently they should be monitoring their blood glucose, but the evidence supporting self-monitoring of blood glucose (SMBG) in non-insulin-dependent type 2 diabetes patients is conflicting and unclear. Given the results from this small study, testing PPG may be unnecessary for non-insulin-dependent type 2 diabetes patients achieving FPG targets, but further study is required.