Establishing a baseline of interprofessional education perceptions in first year health science students.

Interprofessional education (IPE) is increasingly utilized to prepare students for their future careers in the health sciences as collaborative practitioners. Although it is considered an accreditation requirement in most health science disciplines, little is known about first year student's perceptions of IPE in Canada. In September of 2018, students from dentistry, kinesiology, medicine, nursing, nutrition, pharmacy, and physiotherapy in their first year of their professional program at the University of Saskatchewan were surveyed to obtain a baseline of perspectives and attitudes toward IPE. The survey consisted of an adaptation of the Readiness for Interprofessional Learning Scale (RIPLS) and additional questions to assess students' skills and interest in IPE. Descriptive and univariate statistics were used to determine associations with demographic variables. The response rate was 88% (n= 509). Health science students in all disciplines had positive perceptions of IPE, with overall mean RIPLS scores for domain 1 (teamwork and collaboration), 2 (professional identity), and 3 (roles and responsibilities) of 40.5/45, 33.3/40 and 6.3/10, respectively. Students in kinesiology had significantly lower RIPLS scores than other health science disciplines (p< .05). Female gender, and having a past degree, or previous experience with interprofessional collaboration through school or work were traits that were associated with statistically significantly higher RIPLS scores (p< .05).

An Advanced Pharmacy Practice Experience for Community Pharmacies Based on a Clinical Intervention Targeting Patients With Inflammatory Bowel Disease.

Experiential education is a critical component of any pharmacy undergraduate curriculum. Establishing new, high-quality practice sites can be challenging. We designed a new advanced pharmacy practice experiential rotation suitable for implementation in most community pharmacy settings. The aim of this article is to describe the design of this rotation entitled the Targeted Pharmacy Intervention in Inflammatory Bowel Disease (TPI-IBD) and to determine its impact on student knowledge and confidence using a before-after survey design. The TPI-IBD utilizes a student-delivered intervention as a platform for experiential learning in community pharmacy practice. The TPI was focused on patients with IBD, and implementation was guided by a co-preceptor from the university in collaboration with onsite-preceptors at each pharmacy. The TPI-IBD rotation was delivered from 6 community pharmacies during 5 weeks in 2018. Students conducted standardized monitoring on patients with IBD and met weekly with the university preceptor for case presentations and therapeutic discussions. Electronic charts were maintained by students who were responsible for ensuring detailed documentation on each patient. Knowledge, confidence, and overall satisfaction were assessed by a survey given to students before and after the rotation. Students were highly satisfied with the learning experience and improvements in knowledge and confidence were clearly demonstrated. The TPI strategy was an effective way to expand rotation options in community pharmacy sites with minimal burden on local preceptors.

Self-Monitoring of Blood Glucose and Hypoglycemia-Related Hospitalization in a Population-Based Cohort of Canadian Patients With Type 1 or Type 2 Diabetes.

OBJECTIVES: The aim of this work was to determine whether: 1) blood glucose test strip use in the population is associated with hypoglycemia hospitalization rates, and 2) blood glucose test strip use among individuals is associated with a reduced risk of hypoglycemia hospitalization. METHODS: Administrative databases from Saskatchewan, Canada, were used to ascertain population-level hypoglycemia hospitalizations and test strip utilization over the period from 1996 to 2014. For objective 1, a generalized linear model with generalized estimating equations was fit to provincial data stratified by age group, sex and year. For objective 2, a nested case-control study was conducted for a cohort of insulin users with diagnosed diabetes. Multivariable conditional logistic regression was used to test the association of test strip use with hospitalization, after adjusting for clinical and demographic factors and health services use. Odds ratios (ORs) and 95% confidence intervals (95% CIs) are reported. RESULTS: A total of 5,166 hospitalizations for hypoglycemia were identified in the observation period. Annual glucose test strip use increased by over 350%; however, no association was found with provincial hypoglycemia hospitalization rate during the same period, even after controlling for all-cause hospitalizations and population demographics. In the case-control analysis, test strip use was not associated with hospitalization for hypoglycemia among insulin users (n=10,617; adjusted OR, 1.08; 95% CI, 0.88 to 1.31). A sensitivity analysis in an independent cohort of noninsulin users produced a similar finding (n=47,501; adjusted OR, 1.04; 95% CI, 0.55 to 1.94). CONCLUSION: Our findings add to the body of evidence against a protective effect of blood glucose test strip use for serious hypoglycemia.

Impact of the SIMPL-SYNC Refill Synchronization Program on medication adherence: A pragmatic randomized controlled trial.

OBJECTIVE: To determine the impact of the SIMPL-SYNC refill synchronization (SSRS) service compared with that of usual care (UC) on medication adherence when applied as an opt-out strategy among patients receiving chronic medications. DESIGN: This was a pragmatic randomized controlled trial. SETTING AND PARTICIPANTS: The study was conducted in 2 community pharmacies located in Saskatchewan, Canada. Eligible patients were chronic medication users visiting the study pharmacies. OUTCOME MEASURES: The primary outcome was the percentage of individuals achieving optimal adherence to all eligible study medications. Eligible study medications included 22 commonly used medication classes used to treat diverse conditions. Adherence was assessed for each medication class after 300 days using the proportion of days covered (PDC). Optimal adherence was defined as PDC ≥ 80%. RESULTS: A total of 488 patients were screened for eligibility, and 190 patients were included in the intention-to-treat analysis (95 in SSRS, 95 in UC). The mean age of participants was 59 years, and 34% (65/190) were older than 65 years. A total of 574 individual adherence observations representing the 22 eligible study medication classes were generated from the 190 study participants. The percentage of individuals achieving optimal adherence to all their eligible study medications was 50.5% (48/95) in the SSRS group versus 44.2% (42/95) in the UC group (P = 0.383). Similarly, no statistically significant difference was observed in a per-protocol analysis assessing people who participated fully in the service; the percentage of individuals achieving optimal adherence to all their eligible study medications was 55.1% (38/69) in SSRS versus 40.7% (33/81) in UC (P = 0.080). Patient refusal of the refill synchronization services was common among randomized patients. CONCLUSION: SSRS service failed to detect a robust improvement in medication adherence when delivered using an opt-out strategy. However, small improvements in adherence or benefits to specific subgroups of patients could not be ruled out.

Student perceptions of an experiential education clinic within a pharmacy school.

BACKGROUND AND PURPOSE: Pharmacy schools would benefit from new models of experiential education. The University of Saskatchewan (Canada) recently opened a patient care clinic called the Medication Assessment Centre (MAC) as new experiential education model. The purpose of this paper is to describe the structure and function of the MAC and to report program evaluation data. EDUCATIONAL ACTIVITY AND SETTING: The MAC is a unique application of an existing experiential education model in that it is an pharmacist-run ambulatory clinic (which is common) that is physically located on campus amongst the classrooms and supervised by pharmacy faculty (which is unique). Students are all required to participate in the clinic on a regular basis, in between lectures, throughout the four years of the pharmacy program. FINDINGS: Students were invited to participate in one of five focus groups to assess the value of the experience. Transcripts were analyzed using thematic analysis, and the results identified strong satisfaction amongst students. The overall themes fell into three categories: (1) aspects that students liked, (2) aspects that students found challenging, and (3) positive impact on student learning. Previously published studies have found strong support for the MAC amongst patients and physicians. SUMMARY: Students felt that a faculty supervised experiential education clinic that is physically located within their pharmacy school was a valuable learning experience. This paper provides a description of how the MAC has been integrated into an existing pharmacy curriculum, which may be valuable to schools contemplating a similar addition to existing experiential learning.

Reduced Out-of-Pocket Costs and Medication Adherence - A Population-Based Study.

BACKGROUND: In 2007, a drug benefit plan for Seniors (SDP) was launched in Saskatchewan, Canada. SDP capped out-of-pocket costs at $15 per prescription for individuals aged 65 and older. OBJECTIVES: To quantify the impact of the SDP on chronic medication adherence.  Methods: A retrospective cohort study was conducted for participants aged 65 or older who were eligible to the SPD, controlled by a younger group aged 40 to 64 who were ineligible. Adherence was measured over 365 days using medication possession ratio (MPR). MPRs were compared between age groups, and between pre and post SDP-launch periods. The odds ratio of optimal adherence (i.e., MPR≥80%) was estimated using logistic regression models with generalized estimating equations (GEE). RESULTS: Between 2005 and 2009, 353,568 adherence observations were observed from 188,109 unique patients. Comparing the post-SDP period vs before, the increase in the odds of optimal medication adherence was significant (OR=1.08, 95% CI: 1.04 to 1.11) and was stronger after excluding patients already receiving medication benefits from other government programs (OR= 1.21, 95% CI: 1.16 to 1.26). The SDP was associated with improved adherence among the subgroup of prevalent medication users (OR=1.08, 95% CI: 1.04 to 1.12), but not incident users (OR=1.05, 95% CI: 0.98 to 1.13). CONCLUSION: Reducing out-of-pocket medication costs for seniors was associated with small improvements in medication adherence across the population.

Trends in Blood Glucose Test Strip Utilization: A Population-Wide Analysis in Saskatchewan, Canada.

OBJECTIVES: To describe trends in blood glucose test strip (TS) utilization and cost in Saskatchewan. METHODS: A retrospective analysis of TS use between January 1, 1996, and December 31, 2013, was conducted using population-based health administrative databases in Saskatchewan. The prescription drug database was used to describe the annual number of TS dispensations, the number of strips dispensed, the number of unique beneficiaries and the total costs. A patient-level analysis was also carried out to describe the patterns of TS use (i.e. light, moderate or heavy) by the entire cohort and by diabetes treatments. Potential cost savings due to a newly implemented restriction policy were estimated based on the most recent data (2013). RESULTS: TS utilization increased dramatically between 1996 and 2013 in terms of the number of users and the average number of TSs received. The percentage of TS users receiving fewer than 4 TSs per week (i.e. light users) decreased by 20%, while the percentage of heavy users (i.e. those receiving more than 8 TSs per week) increased by 19%. During the same period, the use of high-risk oral hypoglycemic medications declined by 30% among all TS users. Heavy TS use was observed in at least one-third of all users, irrespective of treatment type. CONCLUSIONS: If Saskatchewan's newly imposed coverage limits had been applied in 2013, the costs of strips exceeding those limits would have totalled $2.5 million. Although TS use aligns with chronic disease care paradigms, the substantial costs and lack of evidence of patient outcomes demand better strategies to help reduce unnecessary use.

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

STUDY OBJECTIVE: To test a brief intervention for preventing statin nonadherence among community pharmacy patrons. DESIGN: Prospective, cluster-randomized, controlled trial (the Community Pharmacists Assisting in Total Cardiovascular Health [CPATCH] trial). SETTING: Thirty community pharmacies in Saskatchewan, Canada. PATIENTS: Participating pharmacies were randomized to 15 intervention pharmacies where a brief statin adherence intervention was delivered by pharmacists (intervention group [907 patients]) or 15 usual care pharmacies where no statin adherence intervention was delivered (usual care group [999 patients]) to new users of statins (defined as less than 1 yr of statin therapy). INTERVENTION: Staff (pharmacy managers, staff pharmacists, and technicians) from intervention pharmacies attended a 2.5-hour workshop on the CPATCH program that prepared pharmacists to deal with the adherence barriers most likely associated with statin use (e.g., safety, cost, patient-provider relationship, and tolerability). Intervention pharmacists screened for new statin users and assessed these adherence barriers. Pharmacists were then instructed to tailor their follow-up plan based on the individual patient's situation. Investigators contacted the intervention pharmacies monthly to assess their compliance with the protocol and to offer additional support to motivate ongoing participation. MEASUREMENTS AND MAIN RESULTS: The primary outcome was mean difference in statin adherence between the intervention and usual care groups. Adherence was measured by the proportion of days covered (PDC) between 6 and 12 months following the original prescription fill date. General estimating equations were used to evaluate the difference in mean adherence between groups. Secondary outcomes included the percentage of new statin users exhibiting optimal adherence (defined as PDC of 80% or higher) and the percentage exhibiting nonpersistence (defined as the cessation of all statin dispensations within 3 mo of the first dispensation). Among 1906 eligible patients, no significant differences in mean adherence were observed between those receiving the intervention and those receiving usual care (71.6% vs 70.9%, p=0.64), the percentage of patients achieving optimal adherence (57.3% vs 55.9%, p=0.51), or the percentage exhibiting nonpersistence (9.4% vs 8.3%, p=0.41). However, compliance to the study protocol was extremely low in several intervention pharmacies. In a post hoc analysis, a higher level of protocol compliance among intervention pharmacies was significantly associated with higher adherence (p<0.01 for trend). Pharmacies falling in the highest tertile of compliance to the study protocol exhibited higher mean adherence among their patients compared with those in the usual care group (ß = 0.056, 95% confidence interval [CI] 0.010-0.101, p=0.01), and a significantly higher percentage of patients achieving optimal adherence (odds ratio 1.32, 95% CI 1.08-1.61; p<0.01); however, nonpersistence did not significantly differ between the two groups (5.5% vs 8.3%, p=0.27). CONCLUSION: The CPATCH intervention was ineffective for improving patient adherence to statin therapy in community pharmacies. However, poor effectiveness may have resulted from a failure to deliver the protocol consistently in several intervention pharmacies.

Agreement between administrative data and the Resident Assessment Instrument Minimum Dataset (RAI-MDS) for medication use in long-term care facilities: a population-based study.

BACKGROUND: Prescription medication use, which is common among long-term care facility (LTCF) residents, is routinely used to describe quality of care and predict health outcomes. Data sources that capture medication information, which include surveys, medical charts, administrative health databases, and clinical assessment records, may not collect concordant information, which can result in comparable prevalence and effect size estimates. The purpose of this research was to estimate agreement between two population-based electronic data sources for measuring use of several medication classes among LTCF residents: outpatient prescription drug administrative data and the Resident Assessment Instrument Minimum Data Set (RAI-MDS) Version 2.0. METHODS: Prescription drug and RAI-MDS data from the province of Saskatchewan, Canada (population 1.1 million) were linked for 2010/11 in this cross-sectional study. Agreement for anti-psychotic, anti-depressant, and anti-anxiety/hypnotic medication classes was examined using prevalence estimates, Cohen's κ, and positive and negative agreement. Mixed-effects logistic regression models tested resident and facility characteristics associated with disagreement. RESULTS: The cohort was comprised of 8,866 LTCF residents. In the RAI-MDS data, prevalence of anti-psychotics was 35.7%, while for anti-depressants it was 37.9% and for hypnotics it was 27.1%. Prevalence was similar in prescription drug data for anti-psychotics and anti-depressants, but lower for hypnotics (18.0%). Cohen's κ ranged from 0.39 to 0.85 and was highest for the first two medication classes. Diagnosis of a mood disorder and facility affiliation was associated with disagreement for hypnotics. CONCLUSIONS: Agreement between prescription drug administrative data and RAI-MDS assessment data was influenced by the type of medication class, as well as selected patient and facility characteristics. Researchers should carefully consider the purpose of their study, whether it is to capture medication that are dispensed or medications that are currently used by residents, when selecting a data source for research on LTCF populations.

Trends in prevalence, incidence and pharmacologic management of diabetes mellitus among seniors newly admitted to long-term care facilities in Saskatchewan between 2003 and 2011.

OBJECTIVE: We aimed to describe trends in the prevalence and incidence of diabetes mellitus and also report the overall use of diabetes medications among patients newly admitted to a long-term care facility (LTCF). METHODS: A retrospective cohort study was done using health administrative databases in Saskatchewan. Eligible patients were newly admitted to LTCF in Saskatchewan between 2003 and 2011 and maintained LTCF residency for at least 6 months. Prevalence of diabetes was defined with physician or hospital claims in the 2 years preceding admission. Antihyperglycemic medication use was estimated from prescription claims data during the first 6 months after LTCF admission. All data were descriptively analyzed. RESULTS: The validated case definition for diabetes (≥2 diagnostic claims) in the 2 years before or 6 months after admission was met by 16.9% of patients (2471 of 14,624). An additional 965 patients (6.6%) had a single diabetes diagnostic claim or antihyperglycemic prescriptions only. Among patients receiving antihyperglycemic therapies, 64.9% (1518 of 2338) were exclusively managed with oral medications, and metformin was the most commonly used medication. Glyburide was commonly withdrawn after LTCF admission. Insulin use was observed in 23.9% of diabetes patients, with a mean daily average consumption of 54.7 units per day. CONCLUSIONS: Use of diabetes medications appear to generally align with Canadian practice recommendations as evidenced by declining use of glyburide and frequent use of metformin. Future studies should examine clinical benefits and safety of hypoglycemic agent use in LTCFs.

Use and misuse of ezetimibe: analysis of use and cost in Saskatchewan, a Canadian jurisdiction with broad access.

BACKGROUND: Saskatchewan is the only Canadian province that lists ezetimibe for open formulary access even though it is a second-line agent for lowering cholesterol. METHODS: A retrospective analysis of ezetimibe use in Saskatchewan between 2002 and 2011 was carried out using provincial health administrative databases. Overall use and costs of ezetimibe were described over time. Among new users of ezetimibe, the percentage who received the drug as first-line monotherapy was estimated. First-line monotherapy was defined as no statin dispensations in the 365 days before and the 60 days after the first ezetimibe dispensation. Potential predictors of first-line monotherapy were assessed using generalized linear mixed-effect models. RESULTS: In 2004, ezetimibe represented 2.5% of cholesterol-lowering dispensations. In 2011, its use increased to 8.8% of cholesterol-lowering dispensations and 13.2% of the total cost of cholesterol-lowering agents. Overall, ezetimibe was used as first-line monotherapy in 23% of all new users (4024 of 17,475 patients). Approximately half of all cases of first-line monotherapy were prescribed by 10.4% (112 of 1074) of prescribers in the cohort. Patients who had experienced previous acute coronary syndrome or who had undergone coronary revascularization procedures were significantly less likely to receive first-line monotherapy. CONCLUSIONS: A high proportion of ezetimibe's use is not in accordance with evidence-based recommendations. Suboptimal prescribing could partially explain current patterns of use; however, other factors such as medication nonadherence may have played an important role. Restricting ezetimibe use in the provincial formulary in addition to improving prescribers' awareness through academic detailing should be considered.

The association between market availability and adherence to antihypertensive medications: an observational study.

BACKGROUND: High adherence to angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) reported in observational studies has frequently been attributed to improved tolerability. However, these agents are also relatively new to the market compared to other antihypertensive medications. We aimed to determine if an association exists between adherence and market availability of a specific antihypertensive agent. METHODS: This retrospective cohort study used administrative data from Saskatchewan, Canada. Subjects were ≥40 years of age and received a new antihypertensive medication between 1994 and 2002. The primary outcome was the proportion of subjects achieving optimal adherence (≥80%) at 1 year, stratified by antihypertensive medication class and the year of availability. Adherence was measured using the cumulative mean gap ratio. RESULTS: A total of 36,214 subjects met the inclusion criteria. Optimal adherence was observed in 4987 of 8623 (57.8%) subjects receiving ACEIs and 1013 of 1600 (63.3%) subjects receiving ARBs, but adherence appeared inconsistent when examined within each antihypertensive class. A pattern of increasing mean adherence was observed according to availability in the ACEI subgroup (Spearman r = 0.82; P = 0.007) but not the ARB subgroup (Spearman r = 0.41; P = 0.49). However, the association between availability and optimal adherence converged when ARB and ACEI users were combined (Spearman r = 0.85, P < 0.001). CONCLUSIONS: Optimal adherence with ACEIs and ARBs compared to other antihypertensive agents may be associated with their relative availability. To what extent optimal adherence is also associated with improved tolerability, as currently believed, remains to be determined.

First-fill medication discontinuations and nonadherence to antihypertensive therapy: an observational study.

BACKGROUND: Medication nonadherence is a barrier to successfully managing hypertension, but little is known about the contribution that immediate discontinuations have on antihypertensive (AHT) nonadherence. The purpose of this study was to determine the proportion of new AHT users who discontinue after a single dispensation, and to examine potential predictors of these discontinuations. METHODS: This retrospective cohort study utilizing linked administrative data from Saskatchewan, Canada. Subjects were ≥40 years of age and received a new AHT between 1994-2002. The primary end point was the proportion of subjects who discontinued their AHT after the first dispensation (first-fill discontinuation). The proportion of nonadherence attributed to first-fill discontinuations was then calculated. Multivariate regression identified factors associated with first-fill discontinuations. RESULTS: 52,039 subjects were included in the analyses. Mean age was 59.4 (s.d. 12.5) years, and 42% were male. Overall, 25,812/52,039 (50%) subjects were nonadherent at 1 year; first-fill discontinuations accounted for 39.1% (10,081/25,812) of this nonadherence. Approximately 20% (10,081/52,039) of all subjects discontinued all AHT therapy after the first fill. A higher chronic disease score (adjusted odds ratio (OR) 1.09, 95% confidence interval (CI) 1.08-1.11) and antidepressant medication usage during the observation year (adjusted OR 1.17, 95% CI 1.09-1.26) was associated with increased risk for first-fill discontinuations. Older age, starting AHT therapy after 1994, frequent physician visits, or use of a statin, acetylsalicylic acid, warfarin or antihyperglycemic during the observation year was associated with a lower risk for first-fill discontinuations. CONCLUSION: A substantial proportion of nonadherence to AHT medications is due to discontinuations after only a single dispensation.

Diabetes and cardiovascular disease interventions by community pharmacists: a systematic review.

OBJECTIVE: To systematically review and assess the quality of studies evaluating community pharmacist interventions for preventing or managing diabetes or cardiovascular disease (CVD) and/or their major risk factors. DATA SOURCES: A comprehensive literature search was performed using MEDLINE (1950-February 2011), EMBASE (1980-February 2011), International Pharmaceutical Abstracts (1970-February 2011), Cumulative Index to Nursing and Allied Health Literature (1982-June 2007), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included: community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases. STUDY SELECTION AND DATA EXTRACTION: Articles published in English or French with all study designs were considered for the review. Studies were included if they contained interventions designed to reduce the incidence, risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, or hemoglobin A(1c)); and/or improve adherence to treatment strategies. Only studies involving interventions carried out primarily by pharmacists in community pharmacy settings were included. Study quality was assessed using a checklist validated for both randomized and nonrandomized studies. DATA SYNTHESIS: A total of 4142 studies were initially identified, with 40 meeting our inclusion criteria. Eleven studies were randomized controlled trials, 4 were cluster randomized trials, and 2 studies had randomized before-after designs. The remaining studies were controlled before-after (n = 2), cohort (n = 4), and uncontrolled before-after (n = 17) designs. Interventions focused on diabetes (n = 12), hypertension (n = 9), medication adherence (n = 9), lipids (n = 5), evidence-based medication initiation or optimization (n = 3), risk factor prediction scores (n = 1), and body mass index (n = 1). All studies contained interventions focused at the patient level and the majority of studies (34/40) involved interventions directed at both the physician and patient. No specific intervention emerged as superior, and study quality was generally poor, making it difficult to determine the true effect of the interventions. CONCLUSIONS: Poor study quality, time-intensive interventions, and unproven clinical significance warrant the need for further high-quality studies of community pharmacist interventions for preventing or managing diabetes or CVD and/or their major risk factors.

A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study.

BACKGROUND: Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when evaluating real-world applicability of an intervention. Although adherence interventions by community pharmacists have been tested, problems with internal and external validity have limited the usefulness of these studies, and further well-designed and well-conducted research is needed. We aimed to determine the real-world effectiveness of a community pharmacy adherence intervention using a robust study design. This novel design integrates cluster randomization and an outcome evaluation of medication adherence using a population-based administrative data source in the province of Saskatchewan, Canada. METHODS/DESIGN: Community pharmacies from across the province of Saskatchewan, Canada were randomized to deliver an adherence intervention to their patients or usual care. Intervention pharmacies were trained to employ a practical adherence strategy targeted at new users of statin medications. While randomization and implementation of the intervention occurred at the community pharmacy level, the outcome analysis will occur at the level of the individual subjects. The primary outcome is the mean statin adherence among all eligible new users of statin medications. Secondary outcomes include the proportion of new statin users who exhibit adherence>or=80%, and persistence with statin use. DISCUSSION: This novel study design was developed to combine the rigor of a randomized trial with a pragmatic approach to implementing and capturing the results in a real-world fashion. We believe this approach can serve as an example for future study designs evaluating practice-based adherence interventions. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT00971412.

Comparison of anti-infective drug use in elderly persons in Manitoba, Nova Scotia, and Saskatchewan, Canada: relationship to drug insurance reimbursement policies.

BACKGROUND: Antimicrobial drug resistance continues to be a concern. Inappropriate use of antimicrobial agents is a well-documented contributory factor in the development of resistance. Canadian publicly funded drug insurance (pharmacare) programs have various approaches to reimbursement for antimicrobial drugs and promoting the appropriate prescribing of these agents. OBJECTIVE: The objective of this study was to examine changes in antimicrobial use over a 3-year period in relation to the reimbursement policies of the public drug insurance programs for elderly persons in Manitoba, Nova Scotia, and Saskatchewan. METHODS: The pharmacare databases of the 3 provincial drug insurance programs were accessed for fiscal years 1995/96, 1996/97, and 1997/98. Antimicrobial drug use was reported as mean age- and sex-standardized defined daily doses (DDDs) dispensed per 1000 beneficiaries per year. Provincial antimicrobial drug use was compared and related to provincial reimbursement policies. RESULTS: The rates and types of antimicrobial drugs dispensed to elderly beneficiaries of the Manitoba, Nova Scotia, and Saskatchewan pharmacare programs varied. Between fiscal years 1995/96 and 1997/98, DDDs of antimicrobials per 1000 beneficiaries per year decreased by 11.5% in Saskatchewan and increased by 1.2% in Manitoba and 6.2% in Nova Scotia. Rates of use of broadspectrum agents such as amoxicillin/clavulanate, azithromycin, clarithromycin, and fluoroquinolones were lower in the provinces that had reimbursement guidelines. Even when reimbursement policies were similar, as for fluoroquinolones in Manitoba and Saskatchewan, rates of use varied markedly, possibly as a result of the method of implementing the reimbursement guidelines. Use of fluoroquinolones, macrolides, penicillins, beta-lactamase-resistant penicillins, and tetracyclines was lower and use of sulfonamides and trimethoprim was greater in Saskatchewan than in Nova Scotia and Manitoba. CONCLUSIONS: The reimbursement guidelines of provincial drug insurance programs are among the factors affecting the use of antimicrobial agents. Both the type of reimbursement policy and the policy implementation mechanism affected the rate of utilization. Further research is needed to link drug-use information with data such as antimicrobial resistance patterns, diagnoses, physician visits, and hospitalizations.