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.

Physician influence on medication adherence, evidence from a population-based cohort.

BACKGROUND: The overall impact of physician prescribers on population-level adherence rates are unknown. We aimed to quantify the influence of general practitioner (GP) physician prescribers on the outcome of optimal statin medication adherence. METHODS: We conducted a retrospective cohort study using health administrative databases from Saskatchewan, Canada. Participants included physician prescribers and their patients beginning a new statin medication between January 1, 2012 and December 31, 2017. We grouped prescribers based on the prevalence of optimal adherence (i.e., proportion of days covered ≥ 80%) within their patient group. Also, we constructed multivariable logistic regression analyses on optimal statin adherence using two-level non-linear mixed-effects models containing patient and prescriber-level characteristics. An intraclass correlation coefficient was used to estimate the physician effect. RESULTS: We identified 1,562 GPs prescribing to 51,874 new statin users. The median percentage of optimal statin adherence across GPs was 52.4% (inter-quartile range: 35.7% to 65.5%). GP prescribers with the highest patient adherence (versus the lowest) had patients who were older (median age 61.0 vs 55.0, p<0.0001) and sicker (prior hospitalization 39.4% vs 16.4%, p<0.001). After accounting for patient-level factors, only 6.4% of the observed variance in optimal adherence between patients could be attributed to GP prescribers (p<0.001). The majority of GP prescriber influence (5.2% out of 6.4%) was attributed to the variance unexplained by patient and prescriber variables. INTERPRETATION: The overall impact of GP prescribers on statin adherence appears to be very limited. Even "high-performing" physicians face significant levels of sub-optimal adherence among their patients.

Factors associated with early nonpersistence among patients experiencing side effects from a new medication.

BACKGROUND: Drug discontinuation (i.e., nonpersistence) is often attributed to the emergence of adverse effects. However, it is not known whether other factors increase the risk of nonpersistence when adverse effects occur. OBJECTIVES: To identify factors associated with early nonpersistence among patients experiencing adverse effects from newly prescribed medications. METHODS: A questionnaire was mailed to new users of antihypertensive, antihyperglycemic, and lipid-lowering medications in Saskatchewan, Canada, between 2019 and 2020. Only respondents experiencing adverse effects were included. Responses were compared between the nonpersistent group (i.e., people who had discontinued their medication) and the persistent group (i.e., those who were taking their medication at the time of the survey). Statistically significant factors were tested in multivariable logistic regression models. Odds ratios (ORs) and 95% CIs were reported. RESULTS: Of the 3973 returned questionnaires, 813 respondents experienced adverse -effects from their new medication and were included in the study. Of these, 143 respondents (17.5%) had stopped their medication at the time of survey completion; most discontinuations (72.1%) occurred within 1 month of the first dose. Nonpersistent patients were older, had lower income, and were less likely to be taking an antihyperglycemic medication. After covariate adjustment, 6 factors were independently associated with nonpersistence: age less than 65 years (OR 1.56 [95% CI 1.01-2.41]), female sex (1.67 [1.08-2.59]), health condition not considered dangerous (2.09 [1.25-3.51]), medication not considered important for health (6.90 [4.40-10.84]), failure to expect adverse effects before starting medication (2.67 [1.74-4.10]), and taking 2 or more medications (0.45 [0.27-0.73]). CONCLUSION: Despite the strong link between the emergence of adverse effects and early nonpersistence, our findings confirm that this association is highly influenced by several factors external to the physical experiences caused by the new medication.

A Randomized Controlled Trial of a Pretransplant Educational Intervention in Kidney Patients.

Poor patient knowledge about transplantation is a significant problem following kidney transplant. A video-based educational intervention was developed to supplement standard education provided by transplant teams. METHODS: A multicenter randomized controlled trial tested the intervention delivered to patients undergoing assessment or waitlisted for kidney transplant. Adult participants were randomized to the control (standard education) or the intervention group, consisting of electronic access to the videos (or digital video disks if no internet) plus standard education. Differences between groups in changes in transplant knowledge (measured by the Kidney Transplant Understanding Tool), education satisfaction, self-efficacy, and quality of life (secondary outcomes) were evaluated by a preintervention and postintervention survey. Video viewing habits were tracked and described for patients in the intervention group. RESULTS: One hundred sixty-two patients were enrolled, with 132 completing both questionnaires (n = 64 intervention and n = 68 control), with similar enrollment from 3 Canadian sites. Video viewing statistics in the complete cases indicated that 78% (50/64) watched the videos, with 70% (45/64) viewing them electronically, while 8% (5/64) received digital video disks and self-reported participation. Baseline knowledge scores in the intent-to-treat population were 55.4 ± 6.5 and 55.7 ± 7.1 in the intervention and control, respectively. The mean knowledge change in the intervention (2.1 ± 3.6) was significantly higher than in the control group (0.8 ± 3.4, P < 0.02). In the per-protocol analysis (patients with objective evidence of watching at least 80% of the videos), the knowledge improvements were 3.4 ± 3.8. Video group participants reported higher satisfaction with education (P < 0.02) and expressed positive comments in open-ended feedback. CONCLUSIONS: Electronic video education in the pretransplant setting improved knowledge and satisfaction.

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.

The Saskatchewan Medication Assessment Program for Patients With Renal Failure: A Qualitative Study to Understand Health Care Provider Perspectives.

BACKGROUND: The Saskatchewan Medication Assessment Program (SMAP) compensates community pharmacists for medication reviews on eligible residents with the goal of optimizing patient care. Although medication reviews are meant to reduce risks associated with complex medication regimens, some patients may already be receiving specialized care from interdisciplinary health care teams from the renal programs in Saskatchewan. OBJECTIVE: A qualitative analysis was undertaken to examine the perceptions of health care providers about the SMAP process for patients receiving renal care in Saskatchewan. The goal was to explore potential benefits, facilitators, challenges, and/or barriers of the program in this population. DESIGN: Qualitative descriptive study. SETTING: The semi-structured interviews took place in the province of Saskatchewan. PARTICIPANTS: Community pharmacists, renal pharmacist, and nephrologists. METHODS: All nephrologists, renal pharmacists, and community pharmacies in Saskatoon and Regina were sent an invitation to participate in the study. Semi-structured interviews were completed with participants and were audio-recorded and transcribed verbatim. Coding was performed using NVIVO qualitative software, and meaning units and codes were consolidated into categories and subcategories using qualitative content analysis. RESULTS: A total of 9 community pharmacists, 10 renal pharmacists, and 8 nephrologists were interviewed. Community pharmacists had mixed levels of comfort providing SMAP assessments for renal patients, but expressed the desire to provide the best care possible and described patient benefits. Some categories (eg, barriers and improvements) and subcategories (eg, "collaboration/communication", "other challenges," and "suggestions for improvement") were consistent among all participant groups, while others (eg, "renal patients have complex care needs" and "duplication of service") were common among both renal pharmacists and nephrologists. The nephrologists had little knowledge of the program and of the role of the community pharmacist, indicating the need for improved education and communication. LIMITATIONS: The lack of renal patient perceptions on the SMAP process should be acknowledged and studied in future. A further limitation is the small sample size per subsample group. CONCLUSION: Despite some negative experiences, all of the participants believed the program can be beneficial. However, several recommendations were suggested to improve the SMAP process in renal patients and other complex patient populations.

CONTEXTE: Dans le but d'optimiser les soins aux patients, le Saskatchewan Medication Assessment Program (SMAP) rémunère les pharmaciens communautaires pour procéder à l'examen des médicaments prescrits aux résidents admissibles. Bien que ces examens visent à réduire les risques associés aux schémas posologiques complexes, certains patients reçoivent déjà des soins spécialisés par les équipes interdisciplinaires des programmes de santé rénale de la Saskatchewan. OBJECTIFS: Une analyse qualitative a été menée pour examiner la perception des fournisseurs de soins en regard du processus SMAP pour les patients recevant des soins de santé rénale en Saskatchewan. L'objectif était d'explorer les potentiels bienfaits, facilitateurs, défis et/ou obstacles du programme pour cette population. TYPE D'ÉTUDE: Étude qualitative et descriptive. CADRE: Entretiens semi-structurés s'étant tenus dans la province de la Saskatchewan. PARTICIPANTS: Des pharmaciens communautaires, des pharmaciens spécialisés en néphrologie et des néphrologues. MÉTHODOLOGIE: Tous les néphrologues, pharmaciens spécialisés en néphrologie et pharmaciens communautaires de Régina et de Saskatoon ont été invités à participer à l'étude. Des entretiens semi-structurés ont été menés auprès des participants. Les entretiens ont été enregistrés puis transcrits verbatim. Le logiciel d'analyse qualitative NVIVO a servi au codage; les unités et codes de signification ont été regroupés en catégories et sous-catégories à l'aide de l'analyse qualitative de contenu. RÉSULTATS: Neuf pharmaciens communautaires, dix pharmaciens spécialisés en néphrologie et huit néphrologues ont été interviewés. Les pharmaciens communautaires étaient plus ou moins confortables à l'idée de faire les évaluations du SMAP pour les patients atteints de néphropathies, mais ont exprimé le souhait d'en décrire les avantages aux patients et de fournir les meilleurs soins que possible. Certaines catégories (obstacles et améliorations) et sous-catégories (collaboration/communication, « autres défis ¼ et « suggestions d'améliorations ¼) étaient cohérentes entre les groupes, alors que d'autres (« les patients atteints de néphropathies ont des besoins complexes ¼ ou « dédoublement des services ¼) étaient fréquentes pour les néphrologues et les pharmaciens spécialisés en néphrologie. Les néphrologues en savaient très peu sur le programme et sur le rôle des pharmaciens communautaires, ce qui souligne la nécessité d'améliorer la sensibilisation et la communication. LIMITES: La perception des patients en regard du SMAP devrait être reconnue et étudiée dans de futurs essais. Aussi, le faible échantillon de chacun des sous-groupes de participants limite les résultats. CONCLUSION: Malgré quelques expériences négatives, tous les participants ont jugé que le programme peut être bénéfique. Plusieurs recommandations ont été avancées pour améliorer le processus du SMAP pour les patients atteints de néphropathies et pour d'autres populations de cas complexes. ENREGISTREMENT DE L'ESSAI: Sans objet.

A Canadian Survey on Adverse Symptoms Experienced by Solid Organ Transplant Recipients.

INTRODUCTION: Adverse symptoms experienced by solid organ transplant recipients remain largely unexplored despite their purported frequency. OBJECTIVE: To characterize patient perspectives on adverse symptoms, identifying the most problematic symptoms and the perceived cause and treatability, and to evaluate their impact on quality of life (QoL) and medication adherence. METHODS: An electronic survey was distributed to members of the Canadian Transplant Association, to characterize perceptions on symptom experience (Modified Transplant Symptom Occurrence and Distress Scale), and QoL (Short Form-12), medication adherence (Basel Assessment of Adherence to Immunosuppressive Medications Scale), demographics, and clinical situation. RESULTS: The questionnaire was distributed to 249 solid organ transplant recipients and achieved a 51% response rate (N = 127). Respondents reported a mean of 25 (standard deviation 10) adverse symptoms each. In women, the most prevalent and distressing symptoms were tiredness, lack of energy, sleep difficulties, difficulty concentrating or memory problems, diarrhea, joint pain, and depression. In men, they were tiredness, flatulence, lack of energy, sleep difficulties, and erectile problems. With the exception of flatulence, these symptoms were more often perceived to be caused by medical conditions rather than by immunosuppressants or other medications. Quality of life was similar to the general public, with mean physical and mental component scores of 47.4 (9.9) and 52.1 (8.2), respectively (relative to a US average of 50 [10]). However, QoL scores inversely correlated to the number of symptoms reported and were higher in patients who perceived all symptoms to be treatable. CONCLUSION: Adverse symptoms may impact patient well-being. Perceived cause and treatability should be further explored.

Predictors of hospitalization in a Canadian MS population: A matched cohort study.

OBJECTIVE: Hospitalizations are the most costly component of healthcare in Canada, and hospitalization rates are higher in the multiple sclerosis (MS) population compared to the general population. This study aimed to examine predictors of hospitalizations in the MS population in Saskatchewan, Canada. METHODS: This retrospective cohort study used population-based health administrative data from Saskatchewan, Canada from 1996 to 2016. Subjects with MS were identified using a validated definition (≥3 hospital, physician, or drug claims for MS). Up to five general population controls were identified for each MS case and matched on sex, age, and geographical location. The rate of hospitalizations and reason for admission were determined for each case and control. Negative binomial (hospitalization rate) and binary logistic (reason for admission) regression models fitted with generalized estimating equations were used to test the following potential predictors: sex, age, median household income, calendar year, prior hospitalizations, and comorbidity status. RESULTS: We identified 4,878 MS cases (11,744 hospitalizations), and 23,662 matched controls (32,541 hospitalizations). Higher comorbidity burden, older age, and prior hospital admissions were associated with an increased rate of all-cause hospitalizations for both cohorts. Males were more likely to be hospitalized than females for all-cause (adjusted rate ratio: 1.20; 95% CI: 1.07 - 1.34) and MS-specific (adjusted odds ratio: 1.34; 95% CI 1.15 - 1.55) hospitalizations. The rate of MS-specific hospitalizations decreased with age, and there was no association with comorbidity or prior hospitalizations. A diagnosis of MS was associated with decreased odds of hospitalization due to neoplasms, diseases of the circulatory system, and mental health and behavioural disorders. CONCLUSION: Increased age, comorbidity, and prior hospital admissions are predictors of all-cause hospitalizations. Conversely, MS-related hospitalizations decreased as subjects aged, and there was no association with comorbidity. Our results highlight that reasons for hospitalizations can differ by age, and clinicians should consider this when managing patients, as they make efforts to reduce hospitalizations in the MS population.

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.

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.

Establishing the Incidence and Prevalence of Multiple Sclerosis in Saskatchewan.

OBJECTIVE: To validate a case definition of multiple sclerosis (MS) using health administrative data and to provide the first province-wide estimates of MS incidence and prevalence for Saskatchewan, Canada. METHODS: We used population-based health administrative data between January 1, 1996 and December 31, 2015 to identify individuals with MS using two potential case definitions: (1) ≥3 hospital, physician, or prescription claims (Marrie definition); (2) ≥1 hospitalization or ≥5 physician claims within 2 years (Canadian Chronic Disease Surveillance System [CCDSS] definition). We validated the case definitions using diagnoses from medical records (n=400) as the gold standard. RESULTS: The Marrie definition had a sensitivity of 99.5% (95% confidence interval [CI] 92.3-99.2), specificity of 98.5% (95% CI 97.3-100.0), positive predictive value (PPV) of 99.5% (95% CI 97.2-100.0), and negative predictive value (NPV) of 97.5% (95% CI 94.4-99.2). The CCDSS definition had a sensitivity of 91.0% (95% CI 81.2-94.6), specificity of 99.0% (95% CI 96.4-99.9), PPV of 98.9% (95% CI 96.1-99.9), and NPV of 91.7% (95% CI 87.2-95.0). Using the more sensitive Marrie definition, the average annual adjusted incidence per 100,000 between 2001 and 2013 was 16.5 (95% CI 15.8-17.2), and the age- and sex-standardized prevalence of MS in Saskatchewan in 2013 was 313.6 per 100,000 (95% CI 303.0-324.3). Over the study period, incidence remained stable while prevalence increased slightly. CONCLUSION: We confirm Saskatchewan has one of the highest rates of MS in the world. Similar to other regions in Canada, incidence has remained stable while prevalence has gradually increased.

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.

Readability and Suitability of COPD Consumer Information.

BACKGROUND: Information leaflets have been shown to positively or negatively impact adherence, depending on their content. The objective of this study was to perform an appraisal of the consumer information provided in COPD inhaler monographs. METHODS: COPD inhalers were identified from the Health Canada Drug Product Database. Medication information and instructions for inhaler use were analyzed for readability by seven formulas, with an acceptability threshold of grades 6-8. Three researchers rated suitability using a modified Suitability Assessment of Materials (SAM) tool and assessed leaflets for explicit warnings. RESULTS: Twenty-six inhalers with a COPD indication were evaluated. Medication information sections were rated as "difficult to read" or "hard," and 85% (22/26) had a reading level above grade 8. The instructions for inhaler use were rated as "easy" or "fairly easy" to read and 63% (16/26) met the threshold by all formulas. While all leaflets achieved superior suitability ratings, extreme warnings included risk of premature death (n = 12), risks of serious injury (n = 26), serious interactions (n = 26), and statements that convey a serious consequence to therapy (n = 26). CONCLUSION: While COPD information leaflets in Canada performed well in terms of readability and suitability, overemphasis on side effects, warnings, and precautions may contribute to patient fear and nonadherence.

Natural Health Products and Community Pharmacy-Remove the Mysticism Not the Product.

The allure of natural products has captivated humans for centuries. Although they can be compatible with evidence-based care, attitudes surrounding natural products can seem almost mystical and may even be accompanied by contempt toward Western medicine. Considering the high volumes of natural products sold in community pharmacies, pharmacists can inject balanced information to minimize the mysticism and help patients make informed decisions. The aim of this article is to argue for standardized guidelines pertaining to the management of natural products in community pharmacy practice.

Does the association between adherence to statin medications and mortality depend on measurement approach? A retrospective cohort study.

BACKGROUND: The aim of this study was to examine the relationship between mortality and statin adherence using two different approaches to adherence measurement (summary versus repeated-measures). METHODS: A retrospective cohort study was conducted using administrative data from Saskatchewan, Canada between 1994 and 2008. Eligible individuals received a prescription for a statin following hospitalization for acute coronary syndrome (ACS). Adherence was measured using proportion of days covered (PDC) expressed either as: 1) a fixed summary measure, or 2) as a repeatedly measured covariate. Multivariable Cox-proportional hazards models were used to estimate the association between adherence and mortality. RESULTS: Among 9,051 individuals, optimal adherence (≥80%) modeled with a fixed summary measure was not associated with mortality benefits (adjusted HR 0.97, 95% CI 0.86 to 1.09, p = 0.60). In contrast, repeated-measures approach resulted in a significant 25% reduction in the risk of death (adjusted HR 0.75, 95% CI 0.67 to 0.85, p < 0.01). CONCLUSIONS: Unlike the summary measure, the repeated measures approach produces a significant reduction of all-cause mortality with optimal adherence. This effect may be a result of the repeated measures approach being more sensitive, or more prone to survival bias. Our findings clearly demonstrate the need to undertake (and report) multiple approaches when assessing the benefits of medication adherence.

Evaluation of a refill synchronization program in two community pharmacies.

OBJECTIVES: To describe medication adherence by the proportion of days covered before and after enrollment in a refill synchronization program. METHODS: We conducted a retrospective analysis of medication adherence in 2 pharmacies offering a refill synchronization program. The study population consisted of individuals who received 2 or more medications from any of 15 predefined medication classes within 6 months of enrollment in the synchronization program. Medication adherence and refill consolidation were measured over 6 months before and after enrollment. Optimal adherence was defined as proportion of days covered ≥80%. RESULTS: Among 109 patients who enrolled in the program between 2009 and 2014, 68 were included in a pre-post analysis of medication adherence. In the preenrollment period, optimal adherence was observed in 85% (217/254) of the medications taken by the 68 patients, increasing to 93% (237/254) in the postenrollment period (P <0.01). In addition, the percentage maintaining optimal adherence to all of their medications increased significantly from 60% (n = 41) to 83% (n = 57; P <0.01). CONCLUSION: Among a small group of patients who voluntarily participated in refill synchronization programs, high levels of medication adherence were observed in the preenrollment period. These results combined with previous studies suggest that voluntary participants of these programs are at a low risk for nonadherence; therefore, current estimates of benefit from refill synchronization programs may be overestimated.

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.

Multiple-domain Versus Single-domain Measurements of Socioeconomic Status (SES) for Predicting Nonadherence to Statin Medications: An Observational Population-based Cohort Study.

INTRODUCTION: Low socioeconomic status (SES) should be a robust predictor of medication nonadherence because it shares key features with the theoretical origins of this phenomenon. However, population-based studies have demonstrated weak associations overall, possibly because SES is inadequately represented. We compared the performance of multiple versus single-domain measures of SES as predictors of statin adherence. METHODS: This retrospective cohort study used population-based administrative data mapped to area-level census information of individuals who received a statin medication following a hospitalization for coronary heart disease. One-year adherence was calculated by dividing the sum of all tablets dispensed by the total number of days in the observation period (365 d following the first statin dispensation). Logistic regression models were constructed and the relative impact of each SES measure was assessed by its adjusted odds ratio (OR) and improvement over the predictive accuracy of a reference model that included non-SES factors only. RESULTS: More than two thirds (ie, 68.8%; 6517/9478) of eligible individuals exhibited optimal adherence (ie, ≥80%). The estimated impact of SES on optimal adherence differed depending on the SES measure tested. The highest performing single-domain measure, household income (OR=0.75; 95% confidence interval, 0.63-0.90; model c-statistic improvement 0.5%, P=0.04) generated a similar result to the multiple-domain measure (adjusted OR=0.74; 95% confidence interval, 0.62-0.88; model c-statistic improvement 0.7%, P=0.01). CONCLUSION: Multidomain measurements of SES using administrative databases mapped to census data are not associated with better performance in predicting statin medication adherence compared with single-domain measures such as household income.