William Semchuk

Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP): A Randomized Trial Design of the Effect of a Community Pharmacist Intervention Program on Serum Cholesterol Risk

OBJECTIVE: To determine the efficacy of a program of intervention by pharmacists on lipid risk management in patients at high risk for cardiovascular events. METHODS: Randomized, multicenter (44 sites in Alberta and Saskatchewan) study of community pharmacist intervention versus usual care in 1000 patients. Patients are those at high risk of vascular events (existing atherosclerotic vascular disease, or diabetes with ≥1 other risk factor). After obtaining consent, the pharmacist calls the Project Office to randomize. Patients allocated to intervention receive a brochure and education about cardiovascular risk factors. Pharmacists also complete a physician contact form, which lists the patients risk factors, medications, and any recommendations. A point-of-care cholesterol test is performed, the result is discussed with the patient, and it is entered on the contact form. If appropriate, the patient is asked to see his or her primary care physician for further assessment and/or treatment, and the form is faxed to the physician. Patients are followed up at two, four, eight, 12, and 16 weeks. During follow-up visits, pharmacists provide educational reinforcement and check for primary end point occurrence. Patients allocated to usual care receive the brochure only, with minimal follow-up. The primary end point is a composite of measurement of a complete lipid panel by the physician, or addition or modification of lipid-lowering drug therapy. Substudies will evaluate economics (third-party payer and pharmacy manager perspective), patient satisfaction, and quality of life. CONCLUSIONS: SCRIP (Study of Cardiovascular Risk Intervention by Pharmacists) is a unique ongoing trial that is evaluating a community pharmacist intervention designed to optimize cholesterol risk management in patients at high risk for cardiovascular events.

Changes in Adherence to Evidence-Based Medications in the First Year After Initial Hospitalization for Heart Failure Observational Cohort Study From 1994 to 2003

Background—The use of evidence-based medications in patients with heart failure has increased over the past 10 years. We aimed to determine whether adherence to these medications has also increased during this time. Methods and Results—A retrospective cohort was created using administrative databases from the province of Saskatchewan, Canada. Subjects discharged alive from their first hospitalization for heart failure between 1994 and 2003 were eligible. Those filling a prescription for a &bgr;-blocker (BB), angiotensin-converting enzyme inhibitor (ACEI), or angiotensin receptor blocker (ARB) within 6 months of discharge were followed for 1 year after the initial prescription. Of 8805 eligible patients, 67% of BB users (941/1414) and 74% of ACEI/ARB users (4441/5991) exhibited optimal adherence at 1 year (defined as ≥80% adherence calculated from pharmacy refill records). When grouped by year of initial heart failure hospitalization, the proportion of optimally adherent patients improved from 54% to 75% with BB and from 67% to 80% with ACEI/ARBs between 1994/1995 and 2002/2003 (P for trend <0.001 for both). Mean 1-year adherence improved from 71% to 83% for BB and 80% to 88% for ACEI/ARBs. After adjustment using multivariable logistic regression, subjects discharged in 2003 were significantly more likely to exhibit optimal adherence to a BB (odds ratio, 2.04; 95% CI, 1.21 to 3.44) or an ACEI/ARB (odds ratio, 1.65; 95% CI, 1.30 to 2.08) than those prescribed therapy in 1994/1995. Conclusions—One-year adherence to BB and ACEI/ARB is improving over time in patients discharged after first heart failure hospitalization. Patients taking multiple cardiac medications were not any less likely to exhibit optimal adherence than patients taking only 1 medication.

2006 Canadian Hypertension Education Program Guidelines for the Management of Hypertension by Pharmacists

that pharmacists take responsibility for medication management and patient outcomes. Hypertension is a prevalent and deadly condition; pharmacists, alone or in collaboration with other health professionals, should play a major role in its management. To enable best practices in the management of hypertension by pharmacists, we have adapted guidelines directly from the Canadian Hypertension Education Program (CHEP) 2006 recommendations. These represent the first nationally recognized, peer-reviewed practice guidelines developed specifically for Canadian pharmacists. It is hoped that these guidelines will be used to help pharmacists further contribute to the improved care of patients with hypertension and ultimately enhance patient outcomes. For more background on any of the CHEP guidelines outlined here, please see the full recommendations, available at www.hypertension.ca.

Ketoconazole in the Prevention of Acute Respiratory Distress Syndrome

We conducted a critical review of the literature on ketoconazole in preventing acute respiratory distress syndrome (ARDS), a serious disorder associated with high mortality. Two double‐blind, prospective, placebo‐controlled, randomized trials compared ketoconazole with placebo for prophylaxis of ARDS. In one trial, compared with placebo, ketoconazole resulted in a reduced frequency of ARDS (6% vs 31%, p<0.01), lower plasma thromboxane B2 levels (33 vs 75 pg/ml, p<0.05), and shorter intensive care unit stay (7 vs 15.5 days, p<0.05). In the second trial the drug reduced the frequency of ARDS (15% vs 64%, p=0.002), lowered thromboxane B2 levels (83 vs 143 pg/ml), and reduced mortality (15% vs 39%, p=0.05) compared with placebo. Larger multicenter studies are warranted to validate the findings of these two trials.

Southern Saskatchewan Ticagrelor Registry experience.

Background As ticagrelor enters into clinical use for acute coronary syndrome, it is important to understand patient/physician behavior in terms of appropriate use, adherence, and event rates. Methods The Southern Saskatchewan Ticagrelor Registry is a prospective, observational, multicenter cohort study that identifies consecutive patients started on ticagrelor. We aimed to evaluate both on- and off-label use, identify characteristics of patients who prematurely stop ticagrelor, and describe patient/physician behavior contributing to inappropriate stoppage of this medication. Results From April 2012 to September 2013, 227 patients were initiated on ticagrelor, with a mean age of 62.2±12.1 years. The participants were 66% men and had a mean follow up of 157.4±111.7 days. Seventy-four patients (32.4%) had off-label indications. Forty-seven patients (20.7%) prematurely stopped ticagrelor and were more likely to be older, women, nonwhite, present with shock, and complain of dyspnea. Twenty-six of the 47 patients stopped ticagrelor inappropriately because of patient nonadherence (18 patients) and physician advice (eight patients). A composite outcome event of death from vascular causes, myocardial infarction, or stroke occurred in 8.8% of the entire cohort and was more likely to occur in those older then 65 years, those presenting with cardiogenic shock, and those who prematurely stopped ticagrelor. Conclusion In this real-world registry of patients started on ticagrelor, a third have off-label indications and a fifth prematurely stop the medication. Premature discontinuation was an independent predictor of major life-threatening bleeding and increased composite event rate of death from vascular causes, myocardial infarction, or stroke.

Development of Left Atrial Thrombus After Coadministration of Dabigatran Etexilate and Phenytoin

Dabigatran etexilate is a substrate of the P-glycoprotein (adenosine triphosphate-binding cassette subfamily B member 1) transport system and is subject to interactions with medications that induce or inhibit this system. The clinical relevance of the interaction between dabigatran and phenytoin has not been well described. We report a case of left atrial thrombus in a patient receiving concomitant dabigatran etexilate and phenytoin, which is a P-glycoprotein inducer. This case illustrates the potential clinical significance of the interactions of medications that affect P-glycoprotein and dabigatran.

Prevention and Treatment of Venous Thromboembolism in Patients with Cancer

Background: Many patients who experience a venous thromboembolic event have cancer, and thrombosis is much more prevalent in patients with cancer than in those without it. Thrombosis is the second most common cause of death in cancer patients and cancer is associated with a high rate of recurrence of venous thromboembolism (VTE), bleeding, requirement for long-term anticoagulation and poorer quality of life. Methods: A literature review was conducted to identify guidelines and evidence pertaining to anticoagulation prophylaxis and treatment for patients with cancer, with the goal of identifying opportunities for pharmacists to advocate for and become more involved in the care of this population. Results: Many clinical trials and several guidelines providing guidance to clinicians in the treatment and prevention of VTE in patients with cancer were identified. Current clinical evidence and guidelines suggest that cancer patients receiving care in hospital with no contraindications should receive VTE prophylaxis with unfractionated heparin (UFH), a low-molecular-weight heparin (LMWH) or fondaparinux. Patients who require surgery for their cancer should receive prophylaxis with UFH, LMWH or fondaparinux. Cancer patients who have experienced a VTE event should receive prolonged anticoagulant therapy with LMWH (at least 3 months to 6 months). No routine prophylaxis is required for the majority of ambulatory patients with cancer who have not experienced a VTE event. Most publicly funded drug plans in Canada have developed criteria for funding of LMWH therapy for patients with cancer. Conclusions: Evidence suggests that LMWH for 3 to 6 months is the preferred strategy for most cancer patients who have experienced a thromboembolic event and for hospital inpatients, but this is often not implemented in practice. Concerns about adherence with injectable therapy should not prevent use of these agents. Pharmacists should assess cancer patients for their risk of VTE and should advocate for optimal VTE pharmacotherapy as appropriate. If LMWH is the preferred agent, on the basis of the evidence, the pharmacist should educate the patients appropriately and work with the prescriber to ensure best care. Can Pharm J

Pharmacist Intervention in Risk Reduction Study in High-Risk Cardiac Patients: The Effect of 2 Methods of Pharmacist Training

Objective: To assess the effect of intensive vs conventional training on pharmacist-suggested implementation of cardiac risk reduction efforts in community practice. Methods: Sixty-one volunteer pharmacists from 40 pharmacies were randomized to 1 of 2 educational groups: intensive or conventional training in cardiac risk reduction. With training complete, pharmacists identified and approached patients at high risk for coronary artery disease (CAD) at their practice sites to participate in the program. After a patient interview, pharmacists documented the relevant CAD risk factors and medication history, and then faxed this information, along with risk reduction recommendations, to the primary care physician. Patients were then encouraged to book a medical appointment for further assessment and treatment, if warranted. Follow-up occurred at 4, 16, and 24 weeks to determine if any pharmacist-suggested risk reduction measures had been implemented. Pharmacists were reimbursed

Checklists for the use of novel oral anticoagulants by the front-line clinician:

30 per patient accrued. Results: A total of 217 patients were enrolled in the study, and of those, 216 had follow-up data available for analysis. No significant differences were observed between the groups with respect to mean number of patients enrolled per pharmacist (4.3 vs 2.7) and the proportion of pharmacists completing at least 1 patient (17/27 vs 14/34). Feedback from pharmacists on program delivery indicated no significant difference in satisfaction with the training provided. The recommendations forwarded by pharmacists of the intensive group (35.8%) received greater acceptance by physicians than those in the conventional group (23.8%). Conclusion: Although results are preliminary, intensive training for pharmacists was more likely to result in improvements in cardiovascular risk reduction therapy than when conventional training was used.

Community Pharmacists Assisting in Total Cardiovascular Health (CPATCH): A Cluster‐Randomized, Controlled Trial Testing a Focused Adherence Strategy Involving Community Pharmacies

Author Contributions:T.J. Bungard drafted the initial manuscript and revised it along the way. J. Bolt participated in writing the initial draft and reviewing the final draft. P. Thomson participated in initiating the checklist project, writing the initial draft and reviewing the final draft. W. Semchuk participated in writing the initial draft and reviewing checklists. J. Lowerison participated in initiating the checklist project, writing the initial draft and reviewing the final draft. Declaration of Conflicting Interests:Tammy J. Bungard has received honoraria from Bayer, Boehringer Ingelheim and Bristol Myers Squibb-Pfizer within the past 2 years. Jennifer Bolt has received honoraria from Boehringer Ingelheim in the past 2 years. Peter Thomson has received speaker honoraria from Bayer, Boehringer Ingelheim, Pfizer and Sanofi within the past 2 years. He has served as a consultant or on an Advisory Board for Boehringer Ingelheim, Pfizer and Sanofi within the past 2 years. William Semchuk has received honoraria from Bayer, Pfizer, Bristol Myers Squibb and Boehringer Ingelheim within the past 2 years. He has served as a consultant or on an Advisory Board for Bayer and Pfizer/Bristol Myers Squibb in the last 2 years and has received a research grant from Pfizer in the last 2 years. Jennifer Lowerison has nothing to disclose. Funding:The authors received no financial support for the research, authorship and/or publication of this article.