Impact of Pharmacist-Led Cognitive Behavioural Therapy for Chronic Insomnia.

BACKGROUND: Chronic insomnia is a common medical condition that negatively impacts quality of life and daytime function. Access to the first-line treatment for insomnia, cognitive behavioural therapy (CBT-i), is limited. Pharmacists are well positioned to provide this service, but evidence regarding pharmacist delivered CBT-i is sparse. The aim of this study was to evaluate the effectiveness of CBT-i delivered by pharmacists practicing in an outpatient clinic setting. METHODS: This study was a retrospective chart audit of adult patients with chronic insomnia who received CBT-i from a pharmacist at one of two outpatient clinics in Canada. The primary endpoints were the differences between patient self-reported sleep diary parameters and utilization of hypnotic medications before and after CBT-i was delivered. The differences in patient reported sleep parameters were compared using Wilcoxon Signed Rank test and paired samples t-test and changes in hypnotic utilization was compared using McNemar Chi-square test. RESULTS: 183 patients were referred for CBT-i and attended an initial appointment with a pharmacist. Of these, 105 did not receive the CBT-i. This resulted in 78 patients who met the inclusion criteria. Changes in sleep diary parameters were all statistically significantly improved after patients received CBT-i, except for total sleep time. Hypnotic medication use was also reduced. At baseline, 71.8% (n=56/78) of patients were taking one or more hypnotic medications compared to 52.6% (n=41/78) after CBT-i (p=0.0003). DISCUSSION: The results of this study provide preliminary evidence that pharmacists working in an outpatient clinic setting may be able to effectively deliver CBT-i for patients with chronic insomnia. The external validity of these results is limited by the observational study design and the inclusion of pharmacists practicing in outpatient clinics, which is not the setting where most pharmacists currently practice. CONCLUSION: This observational study found improvements in sleep quality and efficiency, as well as, a reduction in hypnotic medication use, in patients who received CBT-i from pharmacists practicing in an outpatient clinic setting. Future randomized, controlled trials should evaluate the impact of CBT-i in a larger sample of patients, provided by pharmacists practicing in both outpatient clinics and community pharmacies.

Jurisdictional Guidance on DOAC Use-Will It Affect Practice? A Comparison of European, American, and Canadian Product Monographs.

Objective: To identify clinically relevant areas of concordance and discordance between product monographs for 4 direct oral anticoagulants (DOACs) approved by regulatory authorities in Europe, the United States, and Canada. Data Sources: For each DOAC (apixaban, dabigatran, edoxaban, rivaroxaban), manufacturer product monographs were retrieved from the European Medicines Database, US Food and Drug Administration, and Health Canada Drug Product Database. Data Extraction: Monographs for each DOAC were independently reviewed by 2 investigators to identify areas of concordance and discordance. Discordance existed if it was deemed that a potentially clinically relevant difference existed. A heat map summarizing the data was created to identify areas of complete concordance, partial concordance (concordance between 2 of 3 monographs), and complete discordance. Data Synthesis: The areas of concordance were indications for use, use in extremes of weight, and switching to/from the DOAC. Areas of discordance included the following: differing recommendations for use/dosing with renal dysfunction; contraindication or use with caution with drug interactions, pregnancy, and hepatic/renal dysfunction; and timing of DOAC with spinal/epidural anesthesia after a procedure or traumatic puncture. Relevance to Patient Care and Clinical Practice: Concordance was most evident for uncomplicated patients with atrial fibrillation or venous thromboembolism, whereas discordance emerged for those having characteristics/factors wherein clinicians may seek clarification within product monographs (eg, impaired renal/hepatic function, drug interactions). As such, clinicians must be familiar with product information within their country of practice. Conclusion: Variability between jurisdictions was evident, and variability of DOAC use is likely to increase with expanding worldwide uptake.

Coding of heart failure diagnoses in Saskatchewan: a validation study of hospital discharge abstracts.

BACKGROUND: Validity of Heart Failure (HF) diagnoses from administrative records has not been extensively evaluated, especially with respect to small / unselected hospitals. OBJECTIVES: To determine the positive predictive value of a primary / most responsible diagnosis of HF among a general population of subjects discharged from Saskatchewan hospitals. METHODS: Using administrative health records from the Province of Saskatchewan, Canada, we identified subjects experiencing their first HF hospitalization between 1994 and 2003. From this cohort, we randomly selected 500 subjects for individual validation using Framingham and Carlson criteria. RESULTS: The 466 charts available for analysis, 74% (345/466) and 63.9% (298/466) of subjects met criteria for a clinical diagnosis of HF based on Framingham or Carlson criteria, respectively; 57.5% (268/466) met both criterion. Provincial hospitals (located in the largest urban centres) were associated with the highest proportion of confirmed HF diagnoses (87.8% by Framingham criteria) compared to progressively smaller hospitals (regional 77.9%; district 64.2%; and community 60.0%). Accuracy also differed when stratified by physician category. Cardiologists and internists were associated with the highest rates of confirmed diagnoses [(97.5% (39 / 40) and 85.0% (34 / 40)]) compared to general practitioners [(73.1% (95 / 130)]) and other physicians [(69.1% (177 / 256)]), by Framingham criteria. CONCLUSIONS: Hospital discharge abstracts indicating HF are frequently inaccurate. These findings have important implications for the epidemiologic study of HF as well as the clinical management of patients.

Increased use of acid-suppressing drugs before the occurrence of ischemic events: a potential source of confounding in recent observational studies.

STUDY OBJECTIVE: To determine if the use of acid-suppressing drugs is increased before the occurrence of ischemic events. DESIGN: Population-based, nested case-control analysis. DATA SOURCE: Administrative databases in Saskatchewan, Canada. PATIENTS: Cases were 1612 patients (aged ≥ 40 yrs) who started a first-ever antihypertensive drug between January 1, 1994, and December 31, 2003, and were hospitalized for a first ischemic heart event of either myocardial infarction (1002 patients) or unstable angina (610 patients); five control patients were matched to each case patient by age, sex, and year of first antihypertensive prescription (8060 controls). MEASUREMENTS AND MAIN RESULTS: Within the case and control groups, we calculated exposure to acid-suppressing therapy, defined as proton pump inhibitors (PPIs) or histamine(2)-receptor antagonists (H(2)RAs), within 90 days leading up to the event. Exposure to acid-suppressing therapy was higher among cases than controls (15.3% [246/1612] vs 10.4% [837/8060], adjusted odds ratio [AOR] 1.26, 95% confidence interval [CI] 1.06-1.49, p<0.009). Exposure to each acid suppressant was similarly higher among cases than controls: H(2)RA users (11.7% [188/1612] vs 8.4% [678/8060], AOR 1.21, 95% CI 1.00-1.46, p<0.048) and PPI users (4.0% [64/1612] vs 2.2% [179/8060], AOR 1.32, 95% CI 0.95-1.84, p=0.094). Use of other drugs was also significantly increased during this period. CONCLUSIONS: Use of acid-suppressing drugs increased before the occurrence of ischemic events regardless of the type (PPI or H(2)RA) or whether other drugs, such as clopidogrel, were concurrently administered. In addition, significant increases in overall drug use were observed during this time frame, suggesting that many patients exhibit warning signs before an acute hospitalization. Thus, PPI use before the occurrence of ischemic events may simply be a marker of unmeasured and uncontrolled confounding in observational studies that have implicated a PPI-clopidogrel interaction as a cause of recurrent ischemic 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 beta-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 >or=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.

Retrospective observational assessment of statin adherence among subjects patronizing different types of community pharmacies in Canada.

BACKGROUND: Community pharmacies vary widely in terms of ownership structures, location, and dispensing policies. It is unknown if an association exists between the type of community pharmacy and the degree of medication adherence exhibited by patrons-patients. OBJECTIVE: To describe adherence to statin therapy among subjects patronizing different types of community pharmacy categories (department- mass merchandise, chain-franchise, and independent-banner) in Saskatchewan, Canada, between 2000 and 2005. METHODS: Study data were obtained from the Saskatchewan Drug Plan and Extended Benefits database, which is maintained by the government of Saskatchewan, Canada. The study included all subjects who (a) filled a statin prescription within selected community pharmacies between January 1, 2000, and December 31, 2005; (b) had no record of statin prescriptions during the year prior to the first statin prescription, according to the records of the Saskatchewan Drug Plan and Extended Benefits; and (c) demonstrated active utilization in the drug plan database for at least 1 year after the first statin prescription. The proxy criterion for activity was any dispensing record for statin or nonstatin medications at least 1 year following the index claim. Statin adherence level was estimated as tablets per day, defined as the total number of tablets dispensed divided by the total number of days of observation. Each subject's observation period began on the index date and ended on the earlier of (a) 30 days after the last recorded fill for any type of prescription medication (statin or nonstatin), or (b) December 31, 2005. The primary end point was the proportion of subjects within each pharmacy category who maintained an adherence level of 80% or greater during their individual observation period. Additional adherence calculations were performed for each of 3 time periods, beginning on the index date and ending on days 365, 729, and 1094 (i.e., 1, 2, and 3 years). Patients were included in the analysis for each time period if they met a proxy criterion for availability for observation, defined as the dispensing of any drug at least 1 day after the end date of each period. Pearson chi square tests were used to assess the significance of differences in baseline characteristics and adherence proportions, comparing pharmacy categories. Logistic regression analysis estimated the odds of an adherence level of at least 80% during the individual observation period, adjusting for pharmacy category, sex, age 65 years or older, known low-income drug coverage, number of distinct drug classes filled concurrently during the first year of observation, loyalty to index pharmacy, and length of observation. Using similar methods, we also estimated "pharmacy loyalty" by calculating the proportion of subjects who refilled 75% or more of their statin prescriptions at the pharmacy that dispensed their first statin prescription. RESULTS: From an initial sample of 12,818 subjects who had at least 1 pharmacy claim for a statin in the period from January 1, 2000, through December 31, 2005, 8699 subjects met the inclusion criteria. Subjects were observed for a mean (SD, range) of 3.7 (1.7, 1.0-7.0) years after the index statin prescription. During the first year following the index claim, statin adherence rates were at least 80% for 1799 of 3761 (47.8%) patrons of department-mass merchandise, 1778 of 3235 (55.0%) patrons of chain-franchise, and 921 of 1703 (54.1%) patrons of independent-banner stores (P < 0.001). Measured from the index date through day 1094, 869 of 2292 (37.9%), 874 of 1887 (46.3%), and 457 of 975 (46.9%) subjects in the department-mass merchandise, chain-franchise, and independent banner categories, respectively, had a statin adherence level of at least 80% (P < 0.001). In logistic regression analysis, pharmacy category type was significantly associated with statin adherence; subjects in the chain franchise and independent-banner categories were more likely to be adherent to their statin medications during their observation periods than were those in the department-mass merchandise category (adjusted odds ratio [OR] = 1.36, 95% CI = 1.23-1.50, P < 0.001 and OR = 1.39, 95% CI = 1.24-1.57, P < 0.001, respectively). From the index date through day 1094, 1752 of 2292 (76.4%), 1475 of 1887 (78.2%), and 795 of 975 (81.5%) subjects remained pharmacy-loyal in the department-mass merchandise, chain franchise, and independent-banner categories, respectively (P = 0.006). Controlling for several potential confounders using logistic regression, independent-banner pharmacy patrons were more likely to remain pharmacy- loyal during their observation periods than were those patronizing department-mass merchandise (adjusted OR = 1.34, 95% CI = 1.16-1.54, P < 0.001) or chain-franchise stores (adjusted OR = 1.22, 95% CI = 1.06-1.42, P = 0.009). CONCLUSION: One year after their first statin fill, subjects demonstrated low rates of adherence, ranging from 48% to 55%, regardless of the type of pharmacy they patronized. Although the differences by type of pharmacy reached statistical significance, their clinical importance is not evident, reinforcing the fact that the problem of nonadherence appears to exist among all types of community pharmacies, regardless of their categorization.

Risk of heart failure in patients with recent-onset type 2 diabetes: population-based cohort study.

BACKGROUND: Although thiazolidinediones precipitate fluid retention in clinical trials, current guidelines advocate their use for patients with diabetes who are felt to be at low risk for heart failure (HF). METHODS AND RESULTS: An inception cohort study was conducted using Saskatchewan Health databases spanning the years 1991 to 1999 (before use of thiazolidinediones) to compare incidence rates of new HF in patients with recent-onset diabetes vs. the general population. Of 12,272 patients with new-onset type 2 diabetes (mean age 63 years), 718 (6%) developed HF over 5.2 years; median time until development of HF was 2.8 years. The adjusted rate of incident HF for the diabetes cohort was 794 cases per 100,000 person years compared with 275 per 100,000 person-years in the general population. Patients with recent-onset diabetes were more likely to develop HF than the general population (adjusted rate ratio 2.9; 95% CI 2.6 to 3.2) and the relative risk was most pronounced in those younger than 60 years (adjusted rate ratio 12.8; 95% CI 8.2 to 20.0). CONCLUSIONS: The incidence of HF is relatively high within 5 years of diabetes onset, calling into question the ease with which individuals with diabetes "at low risk of HF" can be identified.

Atenolol as initial antihypertensive therapy: an observational study comparing first-line agents.

OBJECTIVE: The role of atenolol in the management of patients with hypertension is currently under scrutiny. Our aim was to evaluate the real-world consequences of recent clinical trial findings. METHODS: We conducted a retrospective, cohort study using linked administrative data from the province of Saskatchewan, Canada. Eligible subjects were first-ever users of antihypertensive medications between 1 January 1994 and 31 December 2003 and were grouped into four cohorts: atenolol, angiotensin-converting enzyme inhibitors (ACEI), thiazide diuretics, or calcium antagonists. Patients remained eligible during monotherapy only. RESULTS: We identified 19 249 eligible individuals (mean age 60.6 years) who were followed for a mean of 2.3 years (SD 2.0). The rate of myocardial infarction, unstable angina, stroke, or death occurred in similar frequencies among all cohorts: atenolol (2.3%), ACEI (3.6%), thiazide diuretics (2.9%), and calcium antagonists (3.9%). After adjustment for potential confounders, atenolol therapy was not associated with higher event rates than the other first-line agents, with hazard ratios ranging between 1.03 [95% confidence intervals (CI) 0.72-1.46] and 1.24 (95% CI 0.91-1.68) for all cohorts compared with atenolol. Similar results were observed upon stratifying the sample into subjects above and below 60 years of age. CONCLUSION: The low event rates for all cohorts suggest that atenolol has not been associated with a significant burden of cardiovascular morbidity or mortality in its traditional role for uncomplicated hypertension. Further study is needed to identify the specific types of patients that should avoid atenolol as an antihypertensive agent.