Measuring the Influence of Side Effect Expectations, Beliefs, and Incident Side Effects on the Risk for Drug Discontinuation Among Individuals Starting New Medications, a Cross-sectional Study.

Purpose: To measure the impact of beliefs, expectations, side effects, and their combined effects on the risk for medication nonpersistence. Patients and methods: Using a cross-sectional design, individuals from Saskatchewan, Canada who started a new antihypertensive, cholesterol-lowering, or antihyperglycemic medication were surveyed about risk factors for nonpersistence including: (a) beliefs measured by a composite score of three questions asking about the threat of the condition, importance of the drug, and harm of the drug; (b) incident side effects attributed to treatment; and (c) expectations for side effects before starting treatment. Descriptive statistics and logistic regression models were used to quantify the influence of these risk factors on the outcome of nonpersistence. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Results: Among 3,029 respondents, 5.8% (n=177) reported nonpersistence within four months after starting the new drug. After adjustment for numerous covariates representing sociodemographics, health-care providers, medication experiences and beliefs, both negative beliefs (OR: 7.26, 95%CI: 4.98-10.59) and incident side effects (OR: 8.00, 95%CI: 5.49-11.68) were associated with the highest odds of nonpersistence with no evidence of interaction. In contrast, expectations for side effects before starting treatment exhibited an important interaction with incident side effects following treatment initiation. Among respondents with incident side effects (n=741, 24.5%), the risk for early nonpersistence was 11.5% if they indicated an expectation for side effects before starting the medication compared to 23.6% if they did not (adjusted OR: 0.38, 95%CI: 0.25-0.60). Conclusion: Expectations for side effects may be a previously unrecognized but important marker of the probability to persist with treatment. A high percentage of new medication users appeared unprepared for the possibility of side effects from their new medication making them less resilient if side effects occur.

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.

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.

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.

The Collaborative Cardiovascular Risk Reduction in Primary Care (CCARP) study.

STUDY OBJECTIVE: To evaluate whether a simple pharmacist protocol, consisting of patient screening and cardiovascular risk stratification, identification and reminders about uncontrolled risk factors, and drug adherence support, can significantly reduce cardiovascular risk. DESIGN: Prospective, randomized, controlled pilot study. SETTING: Large primary care medical clinic in Saskatoon, Saskatchewan, Canada. PATIENTS: One hundred seventy-six adult patients (mean age 60 yrs) who exhibited a 10-year Framingham risk score of 15% or greater, or a coronary artery disease risk equivalent (coronary artery disease, peripheral artery disease, cerebrovascular disease, or diabetes mellitus). INTERVENTION: Eligible patients initially met with the pharmacist to receive general counselling about cardiovascular disease and were then randomly assigned to receive ongoing follow-up by the pharmacist (follow-up group [88 patients]) or to return to usual care (single-contact group [88 patients]) for a minimum of 6 months. MEASUREMENTS AND MAIN RESULTS: The primary end point was mean reduction in the 10-year Framingham risk score. Secondary end points included individual modifiable risk factors (systolic and diastolic blood pressures; total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL], and triglyceride levels; total cholesterol:HDL ratio; and hemoglobin A(1c) value), as well as statin utilization, initiation, and adherence rates. Baseline characteristics were similar across both groups. Neither the mean reduction in 10-year risk (-2.68 for the follow-up group and -1.25 for the single-contact group, one-tailed p=0.098) nor individual risk factors were significantly different between groups. The proportion of patients exhibiting statin adherence of 80% or greater did not significantly differ between groups at study end (73.1% [57/78] and 80.0% [52/65], respectively, p=0.333). However, 85.2% (75/88) in the follow-up group continued with statin therapy at the end of the study compared with 67.0% (59/88) in the single-contact group (p=0.005). Statin initiations were more frequent in the follow-up group than in the single-contact group (75.0% [30/40) vs 48.9% [22/45], p=0.013). CONCLUSION: This simple cardiovascular care protocol for nonspecialist pharmacists did not result in a clear improvement to cardiovascular risk reduction success among patients in a primary care medical clinic. The intervention did, however, appear to improve statin utilization.

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.

Barriers to healthful eating and supplement use in lower-income adults.

PURPOSE: We investigated barriers to healthful eating and vitamin/mineral supplement use among groups at risk for low nutrient intakes, particularly those with low income. METHODS: Twelve focus groups (73 participants) and 11 key informant interviews were conducted in Saskatoon, Saskatchewan. Focus group participants represented a diverse population. Key informants included health professionals and personnel from community-based organizations who worked in a low-income area. Focus group meetings and key informant interviews were audiotaped and transcribed; thematic coding was used to identify key concepts. RESULTS: The focus groups and interviews revealed five themes on barriers to healthful eating and to the use of vitamin/mineral supplements: knowledge, income, accessibility, health, and preferences. Key informants were aware of the barriers, and were able to see not only individual and family reasons but also societal influences. CONCLUSIONS: The study results provide valuable information for focusing efforts on reducing barriers to healthful eating and to appropriate vitamin/mineral supplement use.

Taking the lead: community pharmacists' perception of their role potential within the primary care team.

BACKGROUND: Patient-focused care provided by an interprofessional team has long been presented as the preferred method of primary care delivery. Community pharmacists should and can provide leadership for many clinical and managerial activities within the primary care team. OBJECTIVE: To determine the extent to which community pharmacists are prepared to be members of the health care team, and to assess their support for general expansion of clinical responsibilities. METHODS: A mail questionnaire (in either English or French) was sent to 1500 community pharmacists between February and April 2004. Respondents were asked to indicate the necessity of pharmacy leadership for a range of clinical and managerial services associated with a primary care team. Respondents were also asked to indicate the extent to which they should be more involved in drug therapy selection and monitoring, as well as assuming greater responsibility for treating both minor and chronic illnesses. RESULTS: The response rate was 35.2% (470/1337) with the highest response rate in the Prairie provinces (40.6%) and the lowest in Quebec (24.4%). Most pharmacists in the study did not advocate a strong leadership role for non-discipline-specific clinical and managerial activities. Most of them indicated that community pharmacists should be more involved in selecting (69.9%) and monitoring (81.0%) drug therapy, and be more responsible for treating minor illnesses (72.0%). Support for more responsibility declined to 50% for chronic illnesses. CONCLUSIONS: The findings of the study suggest substantial variability among pharmacists in their perception of the need for pharmacy leadership across 16 clinical and managerial activities.

Interprofessional health care teams: attitudes and environmental factors associated with participation by community pharmacists.

The purpose of this study was to determine whether community pharmacists are prepared to assume a more active role as members of the primary health care team. A secondary objective was to develop multi-items scales for future studies involving pharmacists, as well as other health professions. This paper reports on rates of participation by community pharmacists as members of interprofessional health care teams, the extent to which this participation was related to pharmacists' attitudes about their preparedness for this role, their relationship with physicians, and their assessment of potential barriers to interprofessional teamwork within their practice setting. A mail questionnaire was sent to community pharmacists across Canada between February and April, 2004. The overall response rate was 35.2% (470/1337) with the highest response rate in the Prairie Provinces (40.6%) and the lowest in Quebec (24.4%). Pharmacists on teams were more likely to agree their training and skills were sufficient to participate, and to report good relations with physicians. Pharmacists on teams were more likely to agree there was more opportunity to meet and get to know other health disciplines, and to see teamwork as part of their role. They were also more likely to agree physicians wanted their input, and less likely to see other disciplines as being too protective of their professional "turf". Pharmacists on teams did not differ from those not on teams in rating lack of time, bad past experiences with teamwork, financial reimbursement or proximity to other health care workers as barriers to being a member of a community-based primary care team.

A randomized trial of the effect of community pharmacist intervention on cholesterol risk management: the Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP).

BACKGROUND: Despite clear evidence for the efficacy of lowering cholesterol levels, there is a deficiency in its real-world application. There is a need to explore alternative strategies to address this important public health problem. This study aimed to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events. METHODS: A randomized controlled trial conducted in 54 community pharmacies (1998-2000) included patients at high risk for cardiovascular events (with atherosclerotic disease or diabetes mellitus with another risk factor). Patients randomized to pharmacist intervention received education and a brochure on risk factors, point-of-care cholesterol measurement, referral to their physician, and regular follow-up for 16 weeks. Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions. Usual care patients received the same brochure and general advice only, with minimal follow-up. The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication. RESULTS: The external monitoring committee recommended early study termination owing to benefit. Of the 675 patients enrolled, approximately 40% were women, and the average age was 64 years. The primary end point was reached in 57% of intervention patients vs 31% in usual care (odds ratio, 3.0; 95% confidence interval, 2.2-4.1; P<.001). CONCLUSIONS: A community-based intervention program improved the process of cholesterol management in high-risk patients. This program demonstrates the value of community pharmacists working in collaboration with patients and physicians.