Employer-based patient-centered medication therapy management program: evidence and recommendations for future programs.

OBJECTIVE: To evaluate a patient-centered employer-based medication therapy management (MTM) program. DESIGN: Randomized controlled study. SETTING: Health promotion program at the University of Michigan from June 2009 to December 2011. PARTICIPANTS: Employees, retirees, and their dependents taking seven or more prescription medications. INTERVENTION: Focus on Medicines (FOM) was a two-visit, patient-centered service with a 4-month follow-up. A comprehensive medication review occurred during the first visit. Pharmacists provided recommendations and a medication action plan at the second visit. The MAP incorporated patient preferences for problem resolution. MAIN OUTCOME MEASURES: Patient uptake, medication cost, medication adherence, patient satisfaction with treatment, patient reasons for participation, patient satisfaction with the FOM program, drug-related problems, pharmacist recommendations, implementation of recommendations. RESULTS: The FOM program attracted 128 individuals wanting information about their medications and an individualized drug regimen assessment to ensure that their therapy was safe and effective and that all medications were necessary. On average, 3.3 medication therapy problems were identified per patient; most were safety related. Overall, 63% of pharmacist recommendations were implemented. When a prescriber was contacted, 83% of pharmacist recommendations were implemented. A reduction in drug cost for patients and the employer was shown. Patients reported improved convenience in taking medications and rated the program favorably. CONCLUSION: A personalized dialogue about medication use appears to meet a need among individuals taking large numbers of medications. Understanding why patients participate in MTM programs and what program features patients appreciate is useful in designing quality MTM programs.

Patient desire to be involved in medication treatment decisions.

OBJECTIVES: To identify unmet needs of patients taking medications for chronic health conditions and identify medication-related services that patients with chronic health conditions would desire. DESIGN: Descriptive, exploratory, nonexperimental study. SETTING: Large midwestern state in spring 2010. PARTICIPANTS: 465 patients 45 years or older taking one or more prescriptions for chronic health problems. INTERVENTION: Cross-sectional survey. MAIN OUTCOME MEASURES: Patient-reported usefulness of, satisfaction with, and intention to use medication-related services. RESULTS: Respondents wanted to be highly involved in treatment decisions but found medication information they received to be moderately useful and satisfactory. Medication-related services fell into three groups based on reported intention to use: therapy advice, cost advice, and medication organization. Desire to be involved in treatment decisions was a key factor in predicting reported intention to use therapy advice and cost advice services. The perceived affordability of medications was another important factor in patients' intention to use cost advice and medication organization services. Age, chronic conditions, number of prescription drugs, and the cost of therapy were not important in predicting the intention to use medication-related services in this population. CONCLUSION: Patient desire to be involved in treatment decisions was a key factor in explaining intention to use medication-related services. Identifying individuals with desire for involvement in treatment decisions may increase medication therapy management (MTM) participation. Strategies to provide personalized MTM services to these individuals should be developed and evaluated.

Decision-making about the use of hormone therapy among perimenopausal women.

OBJECTIVES: Women reaching menopause must make a controversial decision about whether to use hormone therapy (HT). The theory of planned behaviour (TPB) was the organizing framework. The objectives were to determine if (1) influence of different TPB constructs varied with stage of menopause and HT use, (2) women with diabetes were influenced in significantly different ways from women without, (3) the overall perceived behavioural control (PBC) and self-efficacy (SE) have independent effects on intention, and (4) physician influence was mediated by subjective norm (SN). DESIGN: Cross-sectional survey of women from a managed care organization. METHODS: Multiple regression analysis was used to analyse 765 responses (230 from women with diabetes) and separately four main subgroups: (1) early menopause stage and never used HT, (2) late menopause stage and never used HT, (3) late menopause stage and previously used HT, and (4) late menopause stage currently using HT. RESULTS: For the entire sample, the model explains 68% of variance in intention, where SE, physicians' influence, self-identification with menopause as a natural part of ageing, self-identification as someone who wants to delay menopause, HT status, menopause status, and diabetes were added to the TPB. For the entire sample, SE added 2% to the explained variance and the physician determinant added 7%. CONCLUSIONS: An augmented TPB is useful for understanding women's HT use decisions. The theory explains more variance in intention before a behaviour is enacted than after, and decision structure changes over time. PBC and SE have independent effects on intention.

Women's trust in and use of information sources in the treatment of menopausal symptoms.

BACKGROUND: Frequent shifts in expert opinion over whether or not women should use hormone therapy (HT) or another menopausal treatment have left women in a difficult position; they must determine where they can obtain trustworthy menopause information. In this study, conducted 10-12 months after the Women's Health Initiative study first published results, we identified sources women use for information about menopause treatments, identified how trust-related dimensions (trustworthiness, knowledge, helpfulness, bias, and vested interest) influenced use of these sources, and determined how these trust dimensions varied with women's HT use status. METHODS: A total of 765 women >45 and <61 years of age from a Midwestern managed care organization responded to a survey. Trust dimensions regarding family, friends, physicians, pharmacists, other health care providers (HCP), and various media as sources of menopause information, and use of these sources for menopause information were examined. RESULTS: Women ranked physicians significantly higher than pharmacists and other HCP for trustworthiness, helpfulness, and knowledgeability. Perceived bias, knowledgeability, and helpfulness showed the strongest influence on trust in physician as well as nonpharmacist HCP. Menopause stage, HT use status, and helpfulness influenced use of physician for information. Helpfulness and knowledgeability influenced trust in the pharmacist, whereas actual use was predicated on having used HT, trust, and helpfulness. CONCLUSIONS: Women who had never used HT trusted HCP less. HCP have important roles in providing menopause information to perimenopausal women. HCP may need to reach out and initiate these important discussions with their patients.

The association of consumer expectations, experiences and satisfaction with newly prescribed medications.

OBJECTIVE: To examine the association between medication expectations and subsequent experience on treatment satisfaction and intention to continue using the medication. METHODS: A longitudinal study with two surveys administered to each patient. Patients prescribed a new medication were recruited in pharmacies within Michigan. Medication-related expectations were evaluated at baseline. Experiences, satisfaction and intent to continue were evaluated a month later. Analyses used included factorial ANOVA models, multiple linear regressions and structural equation modeling (SEM). Impact of satisfaction on intention to continue was evaluated using correlation analysis and SEM. RESULTS: A total of 344 usable responses were obtained. SEM showed that expectation scores were not associated with both experience (path coefficient = 0.10) and satisfaction (path coefficient = 0.02, NS). On the other hand, experience was strongly associated with satisfaction (path coefficient = 0.89) and satisfaction was strongly associated with intent to continue using the new medication (path coefficient = 0.81). CONCLUSIONS: This study empirically supports the value of the patient's experience and its contribution to satisfaction, which in turn is associated with intended continued use mainly due to greater effectiveness of the newly prescribed medication. Satisfied consumers should be more adherent, thus enhancing the probability of positive therapeutic outcomes.

Member satisfaction related to self-reported cost share and difficulty in obtaining prescription drugs in a university pharmacy benefit plan.

BACKGROUND: Utilization management tools (e.g., multitier copayment designs, prior authorization, step therapy, quantity limits) are commonly used to optimize the efficiency and appropriateness of drug therapy. However, these tools may also lead to unfavorable humanistic outcomes, including confusion or annoyance for patients. There is also some concern about whether these tools, along with the cost-sharing burden for medications, may cause patients to discontinue using their medications as well as lead to dissatisfaction with pharmacy benefits. Although anecdotal evidence can be collected from customer complaints, few studies have systematically examined the extent to which prescription drug plan enrollees experience difficulties in obtaining medications and whether these difficulties are associated with their satisfaction with the drug plan. OBJECTIVES: To determine from a member satisfaction survey (1) perception of difficulties experienced by drug plan members when they tried to obtain prescription medications, (2) whether some segments of members experienced more difficulties, and (3) whether self-reported difficulties in acquiring medications were associated with member satisfaction. METHODS: The analyses were based on a cross-sectional survey using a stratified sample of drug plan members. Four thousand employees or retirees who used the University of Michigan prescription drug plan were sent a survey in 2005 to ascertain their satisfaction with the drug plan as well as their experiences with the plan. Specifically, the analyses focused on how frequently the patients experienced difficulties in obtaining medications because of costs or drug use management interventions (e.g., prior authorization, step therapy). Logistic regression analyses examined the relationship of copayment changes and drug use management interventions on patients' satisfaction with the drug plan. RESULTS: Surveys were returned by 2,061 of the potential 3,667 eligible subjects with valid addresses (56.2% response rate). An overwhelming majority (83.7%) of respondents were satisfied with the pharmacy benefit- 17.6% reported being somewhat satisfied, 46.5% were satisfied, and 19.6% were very satisfied. Approximately 25% of drug plan members reported at least 1 difficulty in obtaining medication during the preceding year, including 11.4% who reported difficulties related to prior authorization or step therapy; only 2.0% reported that they couldn't afford their medication, and only 1.3% reported difficulty in paying the combined cost of their medications. Current employees were more likely to report difficulties than were retirees (30.7% vs. 19.1%; chi-square = 34.8; P <0.01), and users of the mail-service pharmacy were somewhat more likely to experience difficulties than users of community pharmacies (29.1% vs. 22.9%; chi-square = 9.92; P <0.01). The logistic regression analyses revealed that having difficulty obtaining medications (odds ratio [OR] = 0.27; 95% confidence interval [CI], 0.20-0.35) and experiencing a copayment increase (OR = 0.62; 95% CI, 0.48-0.81) were associated with a lower odds of member satisfaction. However, a high percentage of members were satisfied despite any difficulties or copayment changes: 66.9% for self-reported difficulty in obtaining medications compared with 89.7% (chi-square = 145.4, P <0.01) and 78.6% for self-reported copayment increase compared with 87.9% (chi-square = 30.2, P <0.01). CONCLUSION: Survey respondents were highly satisfied with their pharmacy benefits despite drug use management interventions in this pharmacy benefit plan. Respondents who reported a copayment increase or difficulty in obtaining medication were less likely to be satisfied with the drug plan.

Research-related coursework and research experiences in doctor of pharmacy programs.

OBJECTIVES: To evaluate the research-related coursework and research experiences in doctor of pharmacy programs and compare the findings to those of 2 previous studies. METHODS: A questionnaire was mailed to 88 colleges and schools of pharmacy in the United States and Puerto Rico. The survey instrument sought information on formal research-related coursework; required and elective research experiences; and perceptions of student-conducted research. RESULTS: Seventy-nine colleges and schools completed the questionnaire for a response rate of 88%. Most colleges (>90%) required students to study/complete courses in biostatistics and drug information/literature evaluation; approximately half required research methods coursework. Twenty-five percent required some form of project and requirements were not influenced by class size. Students could often work in teams to complete projects. Respondents generally thought participation in research had some value for motivated students. CONCLUSIONS: This study demonstrates the variability in extent of research-related coursework and research experiences in PharmD programs across the country.

Patient-reported underuse of prescription medications: a comparison of nine surveys.

Nine national surveys documenting patient underuse of prescription medications were examined to describe the variation and trends in that underuse and identify possible reasons for the substantially different rates that were reported. Underuse includes unfilled prescriptions, delayed therapy, reduced frequency, and lowered dosage. Rates of cost-related patient underuse in the studies ranged from 1.6 to 22 percent. Insurance coverage, level of wealth, age, and health status were the sociodemographic variables most strongly related to underuse. Seven additional factors in the design and administration of the surveys were identified as providing plausible explanations for the variance across surveys. The most conspicuous variation was between three government-sponsored periodic surveys and six generally one-time assessments, with the latter yielding higher rates and greater variance in underuse. Understanding the factors contributing to the variation in reported rates of underuse of medications is an important prerequisite for the design of effective prescription-drug benefit programs.

Self-reported adherence in patients with asthma.

BACKGROUND: Not all patients with asthma adhere to their prescribed drug regimens. The Behavioral Model of Health Services Utilization, organized as predisposing, enabling, and need variables, may be useful in identifying variables related to adherent medication-taking behavior. OBJECTIVE: To examine the relationship between predisposing, enabling, and need variables and self-reported adherence with asthma controller drugs. METHODS: A secondary analysis was conducted from a cross-sectional study using survey and claims data obtained from adults with asthma enrolled in a managed care organization. Independent variables included predisposing (age, gender, race, years with asthma, number of comorbidities, health beliefs), enabling (income, number of metered-dose inhaler [MDI] instructors, inhaler technique, perceived physician access), and need (patient-perceived severity, symptom-derived severity, health-related quality of life). Adherence was measured using a 4 item questionnaire scored as the mean of the responses, with 5 denoting highest adherence. Multivariate regression analysis was used to identify variables with statistically significant relationships to self-reported adherence. Stepwise backward elimination was used, with the final model consisting of variables considered significant at p less than 0.05. RESULTS: The 573 respondents (1270 packets sent; 45% response rate) were primarily white (89.5%) and female (71.0%), with an average age of 40.5 +/- 12.4 years (mean +/- SD) and average asthma duration of 18.3 +/- 14.2 years. The mean adherence scale score was 3.7 +/- 1.1, with 84.6% indicating some level of nonadherence (score <5). The final model had an adjusted R(2) of 0.26 and included 6 independent variables. Better adherence was associated with stronger beliefs in the benefits of treatment and trigger avoidance, greater perceived asthma severity, longer asthma duration, more MDI instructors, and higher scores on the Short-Form 36 mental component summary. CONCLUSIONS: Complex beliefs, perceptions, and experiences constitute the variables associated with adherent medication-taking behavior. Future longitudinal studies should include these variables to determine the predictive strength of the model.

Use, intentions, and beliefs about hormone replacement therapy in women with and without diabetes.

OBJECTIVES: (1) Describe women's (a) hormone replacement therapy (HRT) use patterns, (b) intentions to use or continue to use HRT among women in the early and late stages of menopause, and (c) beliefs about using HRT and (2) compare these beliefs, patterns, and intentions between women with and without diabetes 10-12 months after news from the women's health initiative was widely publicized. METHODS: A survey mailed to female enrollees of a not-for-profit managed care organization (MCO) between 46 and 60 years of age and with or without diabetes. Descriptive statistics were calculated. Chi-square analysis was used to determine significant differences between four different HRT use and menopause stage groups, (1) early stage never user, (2) late stage never user, (3) late stage current user, and (4) late stage previous user. Analysis of variance (ANOVA) was used to identify significant belief differences between the four groups. Repeated-measures ANOVA was performed to examine differences between women with and without diabetes. RESULTS: Most women did not intend to initiate HRT. About 86% of current HRT users intended to continue. Never users with diabetes were significantly more uncertain about HRT intention than non-diabetic women. All beliefs were significantly different (p<0.001) between the four groups, but not between women with and without diabetes. CONCLUSION: Women in different groups hold different beliefs about HRT use. Uncertainty among women with diabetes is not resolved as quickly as among women without diabetes.

Variation in the distribution of patient-reported outcomes based on different definitions of defining asthma severity.

OBJECTIVES: The purpose of this study was to observe the variation in the distribution of health-related quality of life and work performance scale scores based on using different methods of determining asthma severity. METHODOLOGY: Five methods of determining asthma severity were used, including three patient-derived measures (patient perceived severity or PPS; overall symptom-derived severity or OSS; and nocturnal symptom-severity or NSS); and 2 methods using retrospective pharmacy claims (reliever/oral steroid use or ROSU and multi-drug use or MDU). Three levels of severity were examined: mild, moderate, and severe, requiring condensing some severity categories of several methods. Data were obtained from a cross-sectional mail survey of 603 adults with asthma in a US managed care organization linked to pharmaceutical/medical claims data. Patient-reported outcomes included the Physical Component Summary Score (PCS) and the Mental Component Summary Score (MCS) of the SF-36, the summary score (AQLQ) of the Asthma Quality of Life Questionnaire, and the Work Performance Scale score (WPS) of the perceived work performance scale of the Functional Status Questionnaire. Analysis of variance (ANOVA) was used to examine each method's ability to distinguish between severity levels. Descriptive statistics were used to observe differences in scale scores between methods. RESULTS: Within each method, significant severity effects (except MDU) were found for PCS, AQLQ, and WPS. In post-hoc analyses, mild-moderate and mild-severe comparisons were consistently significant (p < 0.05). In the cross-method analyses, method effects were found at all levels of severity for most scale scores with ranges increasing with increases in severity level. Within-method results were consistent with previous studies demonstrating a significant relationship between severity, health-related quality of life (HRQL) and work performance (WP). However, HRQL and WP scale scores varied by the method used to define severity. CONCLUSION: This variation should be considered when performing cross-study comparisons of burden of illness and treatment effects.

Methods of measuring asthma severity and influence on patient assignment.

BACKGROUND: There is a need for nonclinical measures in studies where objective clinical data used to determine asthma severity, such as spirometry and peak expiratory flow rate meter readings, are not available. OBJECTIVE: To determine whether different methods of defining asthma severity provide different distributions of patients across the categories of mild, moderate, and severe asthma. METHODS: Data were obtained from a mail survey and the database of a managed care organization located in Michigan. Seven methods of asthma severity that used either patient self-report or claims data were evaluated and divided into 3 categories: patient-perceived severity (1 method), symptom-derived severity (4 methods), and medication-derived severity (2 methods). To further evaluate the extent of the degree of agreement among the 7 severity methods, percent agreement and Cohen K scores were calculated. RESULTS: Surveys were sent to 1,139 persons, and 603 responses were usable. Substantial differences exist in the number of patients in each severity level for different methods of determining asthma severity. The proportion of persons identified as having mild, moderate, and severe asthma ranged from 48% to 82%, 16% to 38%, and 2% to 33%, respectively. The percent agreement and Cohen kappa scores were generally low among the 7 methods. CONCLUSIONS: Due to variations caused by the method of measuring asthma severity, comparability among studies using different methods of classifying asthma severity is limited. Although a uniform evaluation of asthma severity is needed, the results of this study do not identify one preferable method. Rather, investigators should know the limitations of the methods used.

Influence of sociodemographics on the health-related quality of life of pediatric patients with asthma and their caregivers.

The relationship between socioeconomic variables and the health-related quality of life (HQL) of children with asthma and their caregivers was examined. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ) were administered to 99 pediatric asthmatic patients and caregivers in two specialty clinics. Sociodemographic data was obtained from medical records and additional questions. The relationship between sociodemographic variables and HQL was determined using multiple linear regression. The mean patient age was 12.6+/-2.1 years, more were male and from a minority race. The mean age of caregivers was 41.2+/-8.5 years; most were female and were fom a minority race. Patients tended to rate their asthma severity as mild to moderate, while caregivers tended to rate patients in the moderate to severe category. Based on prescribed medications, most patients had mild to moderate asthma. Household income was consistently associated with patient-perceived HQL. Less consistent associations were seen with other variables. Household income and the caregiver's perception of asthma severity were associated with all caregiver HQL domains. It was concluded that household income was most consistently associated with the HQL of asthmatic pediatric patients and their caregivers.

A cross-sectional analysis of work-related outcomes in adults with asthma.

BACKGROUND: Asthma is a disease with physical symptoms that can impair a person's functioning to the point of interfering with school, work, and social activities. OBJECTIVE: Describe how disease (asthma) and patient characteristics affect perceived work performance and absenteeism. METHODS: Using a cross-sectional study design, 369 adults with asthma from a managed care organization responded to a mailed questionnaire which included a perceived work performance scale (WPS) and an item assessing absenteeism. Analysis consisted of psychometric testing of the scale (internal consistency and construct validity); trend observation of influence of perceived and symptom-derived severity on WPS and absenteeism distribution; and regression analysis to examine the relationship between patient/disease characteristics and the work-related outcomes. RESULTS: The mean WPS score was 88.0 +/- 16.2 (of a possible 100), with a Cronbach's alpha of 0.79. Most respondents (84.7%) did not miss any work in the previous 4 weeks. WPS scores declined and the percentage of respondent absenteeism increased as perceived and symptom-derived severity worsened. The regression model for WPS produced an adjusted R2 of 0.32 and included the number of other illnesses, health beliefs, race, income, and perceived and symptom-derived asthma severity. The regression model for absenteeism included number of other illnesses, race, health beliefs, and symptom-derived severity. Perceived work performance and absenteeism are outcomes measures that are distinctive and complementary. CONCLUSIONS: Disease severity, race, income, and health beliefs also contribute and should be considered in health services research related to asthma.