Persistence to Basal Insulin: Association With Health Outcomes in a Population With Type 2 Diabetes.

This study examined the association between persistence to basal insulin and clinical and economic health outcomes. The question of whether a persistence measure for basal insulin could be leveraged in quality measurement was also explored. Using the IBM-Truven MarketScan Commercial and Medicare Supplemental Databases from 1 January 2011 to 31 December 2015, a total of 14,126 subjects were included in the analyses, wherein 9,898 (70.1%) were categorized as persistent with basal insulin therapy. Basal insulin persistence was associated with lower A1C, fewer hospitalizations and emergency department visits, and lower health care expenditures. Quality measures based on prescription drug claims for basal insulin are feasible and should be considered for guiding quality improvement efforts.

Gender equity perceptions among social and administrative science faculty: A qualitative evaluation.

BACKGROUND: Anecdotal evidence suggests that gender inequity persists in academic pharmacy. To date, there are limited published data about the perception of gender inequity in academic pharmacy. OBJECTIVE: The objective of this project was to determine themes associated with gender inequity perceptions in social and administrative science faculty from 2 national pharmacy organizations. METHODS: A gender equity task force comprising 13 members from Social and Administrative Sciences (SAS) sections of the American Pharmacists Association and the American Association of Colleges of Pharmacy was formed. The task force designed a semistructured interview guide comprising questions about demographics and core areas where inequities likely exist. When the survey invitation was sent to faculty members of the SAS sections via Qualtrics, faculty indicated whether they were willing to be interviewed. Interviews were conducted by 2 members of the task force via video conferencing application. The interviews were transcribed. Topic coding involving general categorization by theme followed by refinement to delineate subcategories was used. Coding was conducted independently by 3 coders followed by consensus when discrepancies were identified. RESULTS: A total of 21 faculty participated in the interviews. Respondents were primarily female (71%), were white (90%), had Doctor of Philosophy as their terminal degree (71%), and were in nontenure track positions (57%). Most respondents (90%) experienced gender inequity. A total of 52% reported experiencing gender inequity at all ranks from graduate student to full professor. Four major themes were identified: microaggression (57%), workload (86%), respect (76%), and opportunities (38%). Workload, respect, and opportunities included multiple subthemes. CONCLUSION: Faculty respondents perceive gender inequities in multiple areas of their work. Greater inequity perceptions were present in areas of workload and respect. The task force offers multiple recommendations to address these inequities.

The decline in graduating student pharmacist positivity for the profession of pharmacy.

BACKGROUND: The pharmacy marketplace has shifted considerably in recent years. The decline in job openings and stagnant growth in wages, along with public reports about adverse working conditions for some pharmacists, may have tarnished the optimism of young pharmacists toward the profession of pharmacy. OBJECTIVE: The objective of this study was to analyze the trend among graduating student pharmacists regarding their positivity toward a career in pharmacy. METHODS: Data for this study were extracted from the Graduating Student Survey that is maintained by the American Association of Colleges of Pharmacy. This set of analyses focused on respondents' agreement with the statement "If I was starting my college career over again, I would choose to study pharmacy." Descriptive statistics are reported for this item across 2014 to 2021, and chi-square analyses were used to compare the trend in agreement rates across years and to compare responses between public and private colleges of pharmacy. RESULTS: Survey response rates ranged from 71.1%-80.2% across years and categories (public vs. private). Across 2014-2021, there was an overall decline in the percentage of graduating student pharmacists who indicated that they would choose pharmacy again if they were starting over in college with the greatest decline occurring after 2016. Across all colleges, agreement declined from 81.8% (2014) to 72.2% (2021) (χ2 = 398.2; P < 0.001). The percentage of agreement responses for private college graduates declined from 80.7% (2014) to 74.8% (2021) whereas the percentage of agreement responses for public college graduates declined from 83.0% (2014) to 69.8% (2020). In 2021, public college graduates had lower agreement than private college graduates (χ2 = 33.8; P < 0.001). CONCLUSION: The positivity of graduating student pharmacists toward a career in pharmacy has deteriorated since 2014. Further investigation of this phenomenon is warranted.

Medicare Advantage-pharmacy partnership improves influenza and pneumococcal vaccination rates.

OBJECTIVES: To evaluate the impact of a collaborative effort of a Medicare Advantage and prescription drug (MAPD) plan and community pharmacies to improve vaccination rates for pneumonia and influenza. STUDY DESIGN: This quasiexperimental, cluster-randomized intervention study used MAPD data to assess the impact of community pharmacists on vaccination rates. Pharmacies in specific regions (districts) were randomly assigned to intervention or control groups. Intervention pharmacies received reports of patients with a gap in influenza (aged 19-89 years) and/or pneumococcal (aged 65-89 years) vaccinations based on medical and pharmacy claims history. Vaccine-naïve patients were offered vaccinations. METHODS: The vaccination rates for the previously vaccine-naïve patients utilizing intervention and control pharmacies were compared 6 months post randomization. Inverse probability weighted hierarchical generalized linear models determined the odds of receiving pneumonia and influenza vaccinations for intervention and control groups, controlling for baseline clinical and demographic characteristics. RESULTS: Intervention and control groups had similar ages in the pneumococcal older-adult cohort (mean age, 73.0 vs 73.4 years, respectively; P = .1255). The intervention group was older than the control group in the influenza cohort (mean age, 67.7 vs 66.4 years, respectively; P = .0006). Slightly more than half of each cohort were women, and the proportion of women was not significantly different between the intervention and control groups in each cohort. In multivariable analyses, intervention pharmacies were associated with higher odds of delivering pneumococcal (odds ratio [OR], 1.91; 95% CI, 1.26-2.87) and influenza (OR, 2.18; 95% CI, 1.37-3.46) vaccinations than control pharmacies. CONCLUSIONS: A health plan-enabled, pharmacist-led intervention was effective in increasing the number of older adults receiving pneumococcal vaccination and individuals receiving influenza vaccination.

Is It Time for a Quality Rating System for Colleges of Pharmacy?

The quality of educational programs, including Doctor of Pharmacy (PharmD) programs, has largely escaped the societal trend towards public reporting. Recent criticisms of pharmacy academia by practitioners should prompt us to reexamine how the quality of pharmacy education is measured and reported to the public. In supporting greater transparency related to quality, important questions that should be addressed include: Is the current public reporting of quality indicators for pharmacy schools sufficient for determining the quality of education provided by a school? Can a quality rating system be developed that will not only provide a valid assessment of quality, but also be easy to interpret by potential applicants and employers? The intent of this commentary is to initiate a discussion centered around this issue and to encourage the development of a new measure of pharmacy school quality.

Community pharmacy owners' views of star ratings and performance measurement: In-depth interviews.

OBJECTIVES: The star rating system implemented by Medicare has the potential to positively affect patient health and may have financial implications for community pharmacies. Learning from owners of community pharmacies with high performance on these quality measures may help us to identify and further understand factors contributing to their success. This study described high-performing community pharmacy owners' current awareness and knowledge of star ratings, attitudes toward star ratings and performance measurement, and initiatives being offered in pharmacies that aim to improve the quality of care. METHODS: Qualitative interviews with owners of independent community pharmacies were conducted in Spring 2015. Fifteen community pharmacies with high performance on the star rating measures were invited to participate. Recruitment did not end until the saturation point had been reached. All interviews were transcribed verbatim. Interview data were analyzed with the use of ATLAS.ti by 2 coders trained in thematic analysis. Krippendorf's alpha was calculated to assess intercoder reliability. RESULTS: Ten high-performing pharmacy owners participated. Analysis identified 8 themes, which were organized into the following categories: 1) current awareness and knowledge (i.e., superficial or advanced knowledge); 2) attitudes toward star ratings (positive perceptions, skeptical of performance rewards, and lack a feeling of control); and 3) pharmacy initiatives (personal patient relationships, collaborative employee relationships, and use of technology). Intercoder reliability was good overall. CONCLUSION: Interviews with high-performing pharmacies suggested that awareness of the star rating measures, overall positive attitudes toward the star ratings, the relationships that pharmacy owners have with their patients and their employees, and the use of technology as a tool to enhance patient care may contribute to high performance on the star rating measures. Future research is needed to determine if and how these constructs are associated with pharmacy performance in a larger population.

Recommendations for improving adherence to type 2 diabetes mellitus therapy--focus on optimizing oral and non-insulin therapies.

Adherence to therapy in patients with type 2 diabetes mellitus is contingent upon a number of variables, including variables specific to the patient, to the provider, and to the treatment. While treatment selection will involve consideration to maximize effectiveness and minimize side effects, the physician must also take into account the priorities and preferences of each individual patient. For some patients, the risk of weight gain may exert a significant influence on adherence, while for others the risk of hypoglycemia or the cost of medications may be more important factors. It is incumbent upon physicians to discuss these issues with patients and to develop a patient-centric treatment plan to achieve optimal adherence and therapeutic outcomes. The nature of the clinical setting can also influence the likelihood of patient adherence to treatment. A multidisciplinary team approach to diabetes management has been shown to improve outcomes and to have a neutral or beneficial effect on costs. The treatment plan itself plays an additional role in the likelihood of a patient adhering to treatment. Less complex treatment regimens with fewer pills are associated with higher rates of adherence, as are fixed-dose combinations for those patients requiring combination therapy. Frequency and timing of dosing are also important aspects of adherence, as once-daily dosing is associated with higher rates of adherence than twice-daily dosing for anti-hyperglycemic medications.

Intersection of quality metrics and Medicare policy.

The federal government is increasing its push for a high-value health care system by increasing transparency and accountability related to quality. The Medicare program has begun to publicly rate the quality of Medicare plans, including prescription drug plans, and is transforming its payment policies to reward plans that deliver the highest levels of quality. These policies will have a cascade effect on pharmacies and pharmacists as the Medicare plans look for assistance in improving the quality of medication use. This commentary describes the Medicare policies directed toward improvement of quality and their effect on pharmacy payment and opportunities for pharmacists to affirm their role in a high-quality medication use system.

Pharmacy Quality Alliance: Five phase I demonstration projects: descriptions and lessons learned.

OBJECTIVES: To describe the five Phase I Pharmacy Quality Alliance (PQA) demonstration projects and discuss lessons learned across the projects. DESIGN: Descriptive nonexperimental study. SETTING: United States from July 2008 to November 2009. PARTICIPANTS: Community pharmacies from five states. INTERVENTION: Pharmacies viewed their performance scores on a reporting website and provided feedback. MAIN OUTCOMES MEASURES: Pharmacy performance scores and pharmacist feedback about the scores and reporting websites. RESULTS: Considerable variation was found in the pharmacy performance scores. Some pharmacies did not have enough patients taking medications that were included in specific performance measures. Use of a website to report pharmacy performance was feasible across several different approaches. PQA has developed measures of pharmacy performance that can be used in programs intended to report pharmacy performance. CONCLUSION: It is feasible to calculate pharmacy performance scores and create Web-based pharmacy performance reports to provide feedback to community pharmacists. Further development of pharmacy performance reporting should occur.

Nonadherence to oral linezolid after hospitalization: a retrospective claims analysis of the incidence and consequence of claim reversals.

BACKGROUND: Linezolid is available in an oral as well as an intravenous formulation. It is an oxazolidinone antibiotic and is effective in treating resistant gram-positive organisms such as methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae. OBJECTIVES: The goals of this study were to identify the incidence of claim reversals for oral linezolid in members who were recently discharged from a hospital and to study the subsequent pattern of health care utilization to quantify the consequences for members who have a reversed linezolid claim. METHODS: This study was a retrospective claims analysis of Humana Medicare Advantage Prescription Drug patients who had a claim for oral linezolid after an inpatient discharge between April 1, 2006, and June 30, 2008. The incidence of reversed claims among those with a linezolid prescription was measured as a proxy for medication adherence. Propensity scores were calculated to account for differences in patients' propensity to have a reversed claim. The association of the claim reversal with subsequent expenditures was assessed through 3 multivariate regression models wherein the dependent variables were drug, medical, and total costs for the 60-day period after discharge. The key independent variable was the occurrence of a reversed linezolid claim, and control variables included the propensity score quartiles and other clinical and demographic characteristics. All costs were provided in US dollars and from the year in which they occurred. RESULTS: Of 1046 patients identified (mean [SD] age, 69 [12] years; 51% male), 252 patients (24.1%) had a claim reversal for linezolid. Among these, 125 patients (49.6%) received linezolid within 10 days of the initial reversal, 39 patients (15.5%) received other antibiotics, and 88 patients (34.9%) did not receive any antibiotics. The unadjusted, mean outpatient drug costs were $696 and $2265 for patients with and without a reversal, respectively, whereas mean medical costs were $13,567 and $9355. Multivariable analyses revealed that members who did not receive linezolid after the claim reversal had significantly higher medical expenditures (Wald χ(2), 8.370; P = 0.004) and lower drug expenditures (Wald χ(2), 122.630; P < 0.01). The total costs did not differ significantly between the 2 groups (Wald χ(2), 1.540; P = 0.215), however, as the medical savings were partially negated by the higher drug costs. CONCLUSION: These patients with a reversed outpatient claim for linezolid had lower outpatient drug costs and higher medical costs in the 60-day period after the reversal.

Measuring pharmacy quality.

OBJECTIVE: To describe methods for measuring health care quality and how these methods can be applied to the measurement of pharmacy quality and to describe ways of stimulating the use of quality improvement methods in pharmacy. SUMMARY: The health care system is moving toward value-based purchasing of professional services, which is also known as value-driven health care. Value is often described as the balance between quality and costs, and thus, we can enhance value by improving quality while controlling costs. Although community pharmacies have not experienced the demand for evidence of quality and value, this is likely to change in the near future as the federal government and private purchasers expand their search for quality-related evidence to all sectors of health care. PQA, a pharmacy quality alliance, has been created to coordinate the efforts of numerous pharmacy stakeholders in developing measures of pharmacy quality and in educating pharmacists about quality improvement methods. In addition to educational strategies for stimulating quality improvement, the pharmacy sector is likely to experience regulatory changes that mandate quality improvement, public reports on the quality of individual pharmacies, and pay-for-performance systems that reward pharmacies for achieving higher levels of quality. CONCLUSION: All stakeholders in pharmacy (i.e., pharmacists, owners, managers, technicians, benefits managers) must become more aware of the movement toward value-driven health care and the ramifications for pharmacy practice. Community pharmacists will soon see an increased demand for evidence of quality and value as this sector is integrated within the broader framework for value-driven health care.

Development and testing of performance measures for pharmacy services.

OBJECTIVE: To report on the status of the pilot work of PQA, a pharmacy quality alliance, to develop and test performance metrics of pharmacy services for use in quality improvement, benchmarking, and pay-for-performance benchmarks. DESIGN: Observational cohort study. SETTING: Three health plans (commercial, Medicare and Medicaid) located in the northeastern United States and one nationwide prescription drug plan. PATIENTS: Pharmacies of health plans with membership ranging from approximately 3,330 to nearly 1.7 million members. INTERVENTION: Pharmaceutical claims data for prescriptions dispensed at community pharmacies were analyzed. MAIN OUTCOME MEASURES: Not applicable. RESULTS: The four plans had pharmacy networks ranging from 653 to 53,153 pharmacies. When using a minimum sample of 30 members per measure, less than 10% of the pharmacies within the plans' networks were evaluable for all measures except the measure of high-risk drugs in the elderly. The measure for high-risk drugs in the elderly had 6,210 evaluable pharmacies in a network of 53,153. The measures for high-risk drugs in the elderly and medication adherence appear to have the greatest potential for use as performance measures in that they show room for improvement and variation among pharmacies. CONCLUSION: The ideal performance measure is relevant, scientifically sound, and feasible. Several of the measures that underwent testing possessed some, if not all, of the properties of an ideal performance measure. Strategies for aggregating data across health and drug plans may be useful for overcoming sample size challenges.

Effects of gender and depression on oral medication adherence in persons with type 2 diabetes mellitus.

BACKGROUND: In a range of chronic conditions including diabetes, it has been observed that depressive symptoms may be associated with nonadherence to medications. OBJECTIVE: The objective of the study was to determine the main effects, and interactive effect, of depression and gender on patients adherence to oral diabetes medications. METHODS: A cross-sectional design was employed, in which persons with type 2 diabetes mellitus completed a questionnaire regarding medication use behaviors, depressive symptoms (measured by the 8-item Patient Health Questionnaire [PHQ-8]), health beliefs, and demographics. A 2x2 factorial analysis of variance was used to determine the effects of gender and depression on medication adherence after adjusting for age, education, self efficacy, social support, and number of doses of diabetes medications. RESULTS: Of the 391 respondents who completed the questionnaire, 73 (18.7%) were categorized as having depression (ie, PHQ-8 score>0). Overall, women (n=196) had a mean (SD) score of 6.10 (6.19) on the PHQ-8, and men (n=195) had a lower score of 4.62 (5.28) (t=2.75; P<0.01). There was a significant main effect of depression, but not gender, on patients' adherence to diabetes medications in that those who were categorized as depressed had significantly worse adherence to diabetes medications (F=4.82; P=0.03). Additionally, there was a significant "gender x depression" interaction effect on adherence (F=5.93; P=0.01). Men with depression had mean adherence scores that indicated more nonadherence than did men without depression (9.44 [3.45] vs 7.47 [2.50], respectively), but adherence varied little between women with depression and women without depression (7.83 [2.69] vs 7.55 [2.58], respectively). CONCLUSIONS: The association between depression and medication adherence appears to be stronger in men than in women. Clinicians should be cognizant of the potential effect of depression on self-care for diabetes, particularly in men with depressive symptoms.

Adherence analysis using visual analog scale versus claims-based estimation.

BACKGROUND: Although visual analog scales (VAS) have been used frequently in outcomes research, there is little evidence regarding the validity of this scale for measuring medication adherence. OBJECTIVE: To determine whether a VAS self-report measure of medication adherence is concordant with claims-based measurement of adherence. METHODS: A mail survey was conducted in 2005 of persons with diabetes. Prescription claims were obtained for the 1985 survey respondents who used oral diabetes medications and lipid-modifying drugs. The self-reported measure of adherence was a VAS scored 0-100%, and the claims-based measure was the continuous measure of medication gaps (CMG), reverse-coded to yield a score of 0-100%. Dichotomous measures (highly adherent vs poorly adherent) were also created from the VAS and CMG using a cutoff value of 80%. For diabetes and lipid-modifying drugs, the scores on the VAS and CMG (continuous versions) were compared using a Pearson correlation coefficient, while the concordance of the dichotomous versions of the measures was compared using the kappa coefficient. RESULTS: The mean +/- SD for the VAS and CMG for oral diabetes drugs were 95.9 +/- 9.2 and 84.1 +/- 19.2, respectively, and for lipid-modifying drugs, 95.2 +/- 11.2 and 85.3 +/- 20.0, respectively. The VAS-diabetes and CMG-diabetes scales were moderately correlated (r = 0.22), as were the VAS-lipid and CMG-lipid (r = 0.26). The majority (69.0%) of subjects had consistent adherence classifications across the dichotomous versions of VAS-diabetes and CMG-diabetes (kappa = 0.13), while 73.1% of subjects had consistent classifications for the dichotomous VAS-lipid and CMG-lipid (kappa = 0.19). CONCLUSIONS: The VAS self-reports of adherence to medications had moderate concordance with estimates derived from drug benefit claims. Although the majority of subjects were consistently classified by the VAS and claims, the concordance may not be sufficient for direct comparisons of studies using VAS data with studies using claims-based estimates.

Impact of pharmacy care services on patients' perceptions of health care quality for diabetes.

OBJECTIVES: To (1) construct and evaluate a measure of patients' perceptions of the quality of diabetes care and (2) determine the impact of pharmacy care services (PCSs) on patients' perceptions of the quality of their diabetes care while controlling for patient-related factors. DESIGN: Two-phased study using a single-group, pretest-posttest design. SETTING: Community pharmacies that provided PCSs to diabetic patients as part of the Patient Self-Management Program for Diabetes in North Carolina, Georgia, Ohio, and Wisconsin. PARTICIPANTS: 218 patients with diabetes covered by self-insured employers' health plans. INTERVENTIONS: Pharmacist-provided care services using scheduled consultations, clinical goal setting, monitoring, and collaborative drug therapy management with physicians and referrals to diabetes educators. MAIN OUTCOMES MEASURES: Changes in patients' perceptions of quality measured by a self-administered questionnaire that included a six-item scale of information quality, a five-item scale of provider quality, and a one-item overall rating of care. RESULTS: The assessment of the baseline data (Phase I) demonstrated that the measures of perceived quality possessed acceptable psychometric properties. After PCSs were implemented (Phase II), the scores for the information scale improved significantly (paired t = 7.64, P < 0.01), as did the scores for the provider scale (paired t = 6.30, P < 0.01) and the overall rating (paired t = 5.54, P < 0.01). In multivariate analyses, the improvement in perceived quality was not explained by the change in glycosylated hemoglobin when controlling for age, gender, race/ethnicity, and baseline quality perceptions. CONCLUSION: PCSs enhanced patients' perceived quality of their diabetes care. The improvement in perceived quality was not explained by the change in glycemic control, which suggests that nonclinical factors in care are important to patients' evaluations of quality.

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.

Patient-reported perceptions of side effects of antihyperglycemic medication and adherence to medication regimens in persons with diabetes mellitus.

BACKGROUND: With recent media attention to drug safety, patients may have heightened concerns about the side effects of medications that may affect their compliance with treatment. OBJECTIVES: The purpose of this study was to determine the proportion of patients with type 2 diabetes mellitus who perceived having experienced side effects of antihyperglycemic medications, the proportion of these patients who communicated their concerns to physicians, and the potential association between the perception of experiencing side effects and adherence to medication regimens. METHODS: Patients with diabetes were identified through the claims of a Midwest US managed care organization, using Health Plan Employer Data and Information Set criteria. Questionnaires were mailed to randomly selected patients. Patients receiving oral antihyperglycemic medications were selected as prospective subjects. Patients were excluded if they were receiving insulin. RESULTS: The responses of 445 patients meeting the study criteria were collected and analyzed. The subjects were pre-dominantly white, with a mean (SD) age of 56 (11) years and a mean duration of diabetes of 7.3 (8.8) years. One hundred forty-eight (33%) subjects reported a perception of having experienced side effects of antihyperglycemic medication; 126 (85%) subjects reported that they had communicated these concerns to their physicians. Analysis of the subjects' responses indicated an association between the perception of having experienced side effects and nonadherence to antihyperglycemic medication regimens (beta=-0.15; P < 0.010). CONCLUSIONS: Nearly one third of subjects with diabetes receiving oral noninsulin antihyperglycemic medications reported a perception of having experienced medication-related side effects. Despite the large portion of subjects who reported that they had communicated these concerns to their physicians, the perception of experiencing medication-related side effects was significantly associated with nonadherence to antihyperglycemic drug regimens.

A checklist for medication compliance and persistence studies using retrospective databases.

The increasing number of retrospective database studies related to medication compliance and persistence (C&P), and the inherent variability within each, has created a need for improvement in the quality and consistency of medication C&P research. This article stems from the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) efforts to develop a checklist of items that should be either included, or at least considered, when a retrospective database analysis of medication compliance or persistence is undertaken. This consensus document outlines a systematic approach to designing or reviewing retrospective database studies of medication C&P. Included in this article are discussions on data sources, measures of C&P, results reporting, and even conflict of interests. If followed, this checklist should improve the consistency and quality of C&P analyses, which in turn will help providers and payers understand the impact of C&P on health outcomes.