Prospective validation of eight different adherence measures for use with administrative claims data among patients with schizophrenia.

OBJECTIVE: The aim of this study was to compare the predictive validity of eight different adherence measures by studying the variability explained between each measure and hospitalization episodes among Medicaid-eligible persons diagnosed with schizophrenia on antipsychotic monotherapy. METHODS: This study was a retrospective analysis of the Arkansas Medicaid administrative claims data. Continuously eligible adult schizophrenia (ICD-9-CM = 295.**) patients on antipsychotic monotherapy were identified in the recruitment period from July 2000 through April 2004. Adherence rates to antipsychotic therapy in year 1 were calculated using eight different measures identified from the literature. Univariate and multivariable logistic regression models were used to prospectively predict all-cause and mental health-related hospitalizations in the follow-up year. RESULTS: Adherence rates were computed for 3395 schizophrenic patients with a mean age of 42.9 years, of which 52.5% (n = 1782) were females, and 52.8% (n = 1793) were white. The proportion of days covered (PDC) and continuous measure of medication gaps measures of adherence had equal C-statistics of 0.571 in predicting both all-cause and mental health-related hospitalizations. The medication possession ratio (MPR) continuous multiple interval measure of oversupply were the second best measures with equal C-statistics of 0.568 and 0.567 for any-cause and mental health-related hospitalizations. The multivariate adjusted models had higher C-statistics but provided the same rank order results. CONCLUSIONS: MPR and PDC were among the best predictors of any-cause and mental health-related hospitalization, and are recommended as the preferred adherence measures when a single measure is sought for use with administrative claims data for patients not on polypharmacy.

An empirical basis for standardizing adherence measures derived from administrative claims data among diabetic patients.

OBJECTIVE: To compare the predictive validity of 8 different adherence measures by studying the variability explained between each measure and 2 outcome measures: hospitalization episodes and total nonpharmacy cost among Medicaid eligible persons diagnosed with diabetes. RESEARCH DESIGN: This study was a retrospective analysis of the Arkansas Medicaid administrative claims data from January 2000 to December 2006. SUBJECTS: Diabetic (ICD-9-CM = 250.0 x - 250.9 x, where x = 0 or 2) patients were identified in the recruitment period July 2000 through April 2004. Patients had to be >or=18 years old and have at least 2 prescription fills in the index period for an oral antidiabetic drug. MEASURES: : Adherence rates to oral antidiabetic therapy were contrasted using the following 8 measures; including the medication possession ratio (MPR), proportion of days covered (PDC), refill compliance rate (RCR), compliance ratio (CR), medication possession ratio, modified (MPRm), continuous measure of medication gaps (CMG), and continuous multiple interval measure of oversupply (CMOS and continuous, single interval measure of medication acquisition (CSA). Multivariate and univariate linear and logistic regression models were used to prospectively predict nonpharmacy costs and hospitalizations in the follow-up year. RESULTS: A total of 4943 diabetic patients were studied. In predicting any cause hospitalization, univariate models with PDC and CMG had the highest predictive validity (C-statistic: 0.544). Multivariate models with MPR, PDC, CMG or continuous multiple interval measure of oversupply (CMOS) as adherence measures had the highest C-statistics of 0.701 in predicting diabetes specific hospitalizations. None of the adherence measures were significantly associated with nonpharmacy cost. CONCLUSIONS: MPR and PDC had the highest predictive validity for hospitalization episodes. These 2 measures should be considered first when selecting among adherence measures when using administrative prescription claims data.

Prevalence and treatment of metabolic syndrome in adolescents with type 2 diabetes.

BACKGROUND: The incidence of obesity and type 2 diabetes among adolescents has risen dramatically in recent years, and it is likely that many of these adolescents also have metabolic syndrome. OBJECTIVE: To investigate the prevalence of metabolic syndrome in the patient population enrolled in a children's hospital type 2 diabetes clinic and to describe baseline pharmacologic treatment and adherence patterns. METHODS: In this retrospective cohort study, the medical charts of 52 adolescents were reviewed. A data collection instrument was used to collect demographic data, laboratory values, medication lists, and documented adherence patterns from the patient's initial clinic visit. Data collected were used to identify patients with metabolic syndrome. Data were entered into a database and analyzed using SPSS 13.0. RESULTS: Data were collected for 52 patients; of these, 40 (76.9%) had characteristics of metabolic syndrome meeting 3 or more of the 5 criteria, although only 8 (15.4%) were diagnosed with the metabolic syndrome. Among patients with characteristics of metabolic syndrome, 92.5% were taking a glucose-lowering drug, with 85% of those receiving metformin. Sixteen (40%) patients were receiving a blood pressure-lowering medication at baseline, and 4 (10%) were taking a lipid-lowering agent. Forty-three percent of these patients reported nonadherence to their prescribed drugs. CONCLUSIONS: Given these treatment patterns, pharmacologic management of metabolic syndrome in adolescents with type 2 diabetes may be suboptimal and may impact cardiovascular outcomes. It is important for clinicians to be aware of the incidence of type 2 diabetes and metabolic syndrome in adolescents so that treatment with lifestyle modifications and pharmacologic therapy may be implemented earlier.

Assessment of medication management by community-living elderly persons with two standardized assessment tools: a cross-sectional study.

BACKGROUND: The ability of patients to adhere to a medication regimen is imperative for achieving optimal outcomes. Elderly patients, especially those with memory loss, should be evaluated for their ability to manage medications to prevent significant drug-related problems. Assessment tools to determine the ability to manage medication therapy have not been tested in elderly patients with cognitive impairment. OBJECTIVES: This study compared the Medication Management Ability Assessment (M1V1AA) and the Drug Regimen Unassisted Grading Scale (DRUGS) as standardized tools to assess medication management skills in elderly patients with a range of cognitive function and evaluated the association between the results obtained from these scales and self-reported drug-related problems. METHODS: This was a cross-sectional study of older individuals living in the community. At a scheduled study visit, the research assistant (RA) questioned participants with a structured interview to document demographic information, medical history, prescription use, over-the-counter drug and dietary supplement use, health care resource use, medication management practices, and adverse drug events. Cognitive status was assessed with the Mini-Mental State Examination (MMSE) and functional status with the instrumental activities of daily living rating scale. The MMAA, which uses a fictitious medication regimen with labeled prescription bottles, and the DRUGS, which uses the patient's own prescription bottles, were administered. Three months after the visit, the RA telephoned participants to determine recent changes in living situation and drug-related problems. RESULTS: The study group comprised 52 people with a mean (SD) MMSE score of 28.3 (2.5). The participants had a mean (SD) age of 75.8 (6.2) years; 69% (36/52) were women, and 96% (50/52) were white. Participants reported an average of 4.1 medical conditions, and 88% (46/52) reported good to excellent health. Skipping doses or cutting them in half was reported by 25% (13/52) of participants who adjusted doses themselves. Almost half (44%) reported medication problems and/or medication ineffectiveness during the past 3 months at both the study visit and the 3-month follow-up (23/52 for both). The 49 participants who took the MMAA had a mean (SD) score of 19.4 (6.1), with a range of 0 to 25. Of the 49 participants with scores, 34 took less than the correct number of tablets and 13 took more. The 46 participants who took the DRUGS had a mean (SD) score of 91.6 (24.7), with a range of 0 to 100. Forty of 46 participants attempting the test attained the maximum score. Higher scores for both tests indicate better accuracy. Analysis revealed that the MMAA and the DRUGS correlated with one another (P = 0.000). We found no significant associations between these medication management assessment tools and selfreported adherence or drug-related events. CONCLUSIONS: The MMAA and DRUGS tools correlated positively with cognitive function in this population of community-living elderly persons but need further evaluation of their ability to predict who is at greatest risk for drug related problems due to nonadherence to medication regimens.

A 30-month evaluation of the effects on the cost and utilization of proton pump inhibitors from adding omeprazole OTC to drug benefit coverage in a state employee health plan.

OBJECTIVE: On March 1, 2004, the state employee health plan began covering omeprazole OTC (over the counter) at a $5 copayment. Reimbursement to pharmacy providers for omeprazole OTC increased by $10.50 per claim, from $2.50 to a $13 dispensing fee. Initially, neither generic omeprazole prescription (Rx) nor brand omeprazole Rx was covered because omeprazole OTC was available in the same strength as the Rx products at a lower cost, but an omeprazole OTC shortage necessitated coverage of generic omeprazole Rx at a $10 copay. The objective of this study was to evaluate the long-term financial impact of a drug benefit policy change on a mid-size state employee health plan and its beneficiaries associated with the addition to coverage of omeprazole OTC. METHODS: The pharmacy claims database for the employee benefits division (EBD) was used to examine utilization and cost data for beneficiaries who received proton pump inhibitors (PPIs). Pharmacy claims for the 30-month period for dates of service from December 1, 2002, through May 31, 2005, were extracted from the database, yielding a preperiod of 15 months and a postpolicy change period of 15 months. RESULTS: In the 15-month postperiod, the number of PPI claims per member per month (PMPM) decreased by 3.9%, but the days of PPI therapy PMPM increased from 1.71 to 1.82 (6.4%). Price as measured by the allowed charge per day of drug therapy decreased from $4.25 to $2.74 (35.6%) despite an increase of $1.89 (76%) in the average dispensing paid per PPI claim to pharmacies, from $2.49 to $4.38. The average beneficiary copayment decreased by $0.50 (2.0%) per PPI claim, from $25.06 in the preperiod to $24.56 per claim in the postperiod. Therefore, the net heath plan cost for PPIs decreased by $2.20 PMPM (37.6%) during the 15-month postperiod, from $5.84 to $3.64 PMPM, producing savings of $4,207,350, or annualized savings of $3,365,880, in this employee benefit plan of 127,495 members. CONCLUSION: A change in policy to include coverage of omeprazole OTC and an increase in pharmacy reimbursement for omeprazole OTC resulted in 38% net savings to a state employee health plan. The large difference in drug acquisition cost between omeprazole OTC and the other Rx-only PPIs made it possible to implement a program intervention that provided financial benefit to pharmacists, beneficiaries, and the drug plan sponsor despite a 6% increase in PPI utilization.

Effects of a medication assistance program on health outcomes in patients with type 2 diabetes mellitus.

PURPOSE: The effects of a clinic-based medication assistance program (MAP) on the health outcomes and medication use of patients with type 2 diabetes mellitus were studied. METHODS: In this retrospective analysis, data from the University of Arkansas for Medical Sciences pharmacy-managed MAP and outpatient pharmacy databases were collected for adult patients with type 2 diabetes mellitus who were monitored in the university's internal medicine clinic one year before and after enrollment in the MAP. Data on patient demographics, medication use, and disease indicators (glycosylated hemoglobin [HbA(1c)], high-density-lipoprotein [HDL] cholesterol, low-density-lipoprotein [LDL] cholesterol, total cholesterol, triglyceride, and blood pressure levels) were collected for the year before enrollment and for one year after enrollment. Statistical analyses were conducted using descriptive analyses, paired t tests, and the Wilcoxon signed rank test. RESULTS: Of the 401 patients enrolled in the internal medicine clinic who were enrolled in the MAP, sufficient data were available for 52 patients, of whom 73% were women, 50% were African American, and 48% were white. Their mean age was 59 years. All were self-paying customers, with 67.3% receiving Medicare benefits. Patients received more prescription medications (p < 0.001) and antihyperglycemic medications (p = 0.001) after enrollment in the program. Mean HbA(1c) and LDL cholesterol levels decreased significantly after enrollment (p < 0.001 for both). Mean HDL cholesterol levels and systolic and diastolic blood pressure measurements did not change significantly. CONCLUSION: A clinic-based MAP managing the use of pharmaceutical manufacturers' drug assistance programs increased indigent patients' access to antihyperglycemic medications and improved patients' clinical outcomes.

Role of pharmacy experience and argument types in forming beliefs about pharmacist trustworthiness.

The role of pharmacy experience and argument types in forming beliefs about pharmacist trustworthiness was studied. Study participants were recruited from three primary care clinics. They were provided a pharmacy scenario that contained information that could be used to form causal and authoritative arguments. The participants rated the trustworthiness of the pharmacist in the scenario on a 10-point, Likert-type scale and provided the arguments used to form the trustworthiness belief. Information that contradicted the pharmacist's trustworthiness was then presented in the form of an addendum, and the participants reassessed the pharmacist's trustworthiness. Participants rated the pharmacist using a Likert-type scale. Responses were coded and analyzed. Initial trustworthiness and post-trustworthiness scores were calculated. Participants' pharmacy experience score was also determined. Reliability and principal components analyses were conducted to determine the quality of the trustworthiness and pharmacy experience scores. A total of 130 patients participated in the study. There was a positive correlation between pharmacy experience and the number of causal arguments that subjects used to form their beliefs about pharmacist trustworthiness (r = 0.223, p = 0.012). Results of t tests revealed that belief strength was similar among subjects using more causal than authoritative arguments to form beliefs and in those using fewer causal arguments (t = 1.35, p = 0.179), but belief tenacity differed significantly between the groups (t = -2.303, p = 0.023). The role of external sources in influencing the formation of beliefs about trustworthiness of a pharmacist may be limited as a patient gains pharmacy experience, as experience is based on causal associations. Moreover, causal arguments are correlated with belief tenacity.

Effects on the cost and utilization of proton pump inhibitors from adding over-the counter omeprazole to drug benefit coverage in a state employee health plan.

OBJECTIVE: To evaluate the financial effects in a state employee health plan of a change in the drug coverage policy to include over-the-counter (OTC) omeprazole in a tier-copayment drug benefit design that favored the OTC drug. METHODS: The policy change in the Arkansas State Employee Benefit Division (EBD) involved 2 principal parts: OTC omeprazole placed in a new OTC copayment tier (5 dollars) and an increase in pharmacy reimbursement to a 13 dollars dispensing fee for each OTC omeprazole prescription. The prescription claims database was used to examine utilization and cost data for beneficiaries who received prescriptions for a proton pump inhibitor (PPI) during the 2-month period (January and February 2004) preceding the change in policy to cover OTC omeprazole compared with the 2-month period following the policy change (March and April 2004). RESULTS: During the first week of the new policy (March 1-7, 2004), OTC omeprazole accounted for 47% of all PPI claims. From the third week through the end of the 2-month study period, OTC omeprazole represented 60% of PPI claims. This shift to OTC omeprazole from prescription PPIs produced EBD average savings of 40.86 dollars (40.5%) per PPI claim in the first 2 months after implementation of coverage of OTC omeprazole compared with the immediate previous 2-month period. The average copayment savings for EBD beneficiaries were 4.20 dollars (16.5%) per PPI claim. The average increase in pharmacy reimbursement was 118% (6.27 dollars per claim in the postperiod versus 2.88 dollars per claim in the preperiod). Despite a 17.2% increase in utilization as measured by days of PPI therapy per member per month (1.91 PMPM) in the postperiod versus 1.63 in the preperiod, EBD savings were 2.11 dollars (38.9%) PMPM. Based upon PMPM savings of 2.56 dollars in the second month of coverage of OTC omeprazole, annual savings would be about 3,978,240 dollars for average eligible membership of 129,500 in this state employee health plan. CONCLUSION: This policy change to include coverage of OTC omeprazole in the state employee drug benefit plan produced savings to the state of as much as 50% of the total cost of PPI drugs despite an apparent small increase in utilization of PPIs and an increase in pharmacy reimbursement of more than 100%. Plan beneficiaries realized significant savings on average for PPI drugs and particularly for each OTC omeprazole prescription.

Good and poor adherence: optimal cut-point for adherence measures using administrative claims data.

OBJECTIVE: To identify the adherence value cut-off point that optimally stratifies good versus poor compliers using administratively derived adherence measures, the medication possession ratio (MPR) and the proportion of days covered (PDC) using hospitalization episode as the primary outcome among Medicaid eligible persons diagnosed with schizophrenia, diabetes, hypertension, congestive heart failure (CHF), or hyperlipidemia. RESEARCH DESIGN AND METHODS: This was a retrospective analysis of Arkansas Medicaid administrative claims data. Patients > or =18 years old had to have at least one ICD-9-CM code for the study diseases during the recruitment period July 2000 through April 2004 and be continuously eligible for 6 months prior and 24 months after their first prescription for the target condition. Adherence rates to disease-specific drug therapy were assessed during 1 year using MPR and PDC. MAIN OUTCOME MEASURE AND ANALYSIS SCHEME: The primary outcome measure was any-cause and disease-related hospitalization. Univariate logistic regression models were used to predict hospitalizations. The optimum adherence value was based on the adherence value that corresponded to the upper most left point of the ROC curve corresponding to the maximum specificity and sensitivity. RESULTS: The optimal cut-off adherence value for the MPR and PDC in predicting any-cause hospitalization varied between 0.63 and 0.89 across the five cohorts. In predicting disease-specific hospitalization across the five cohorts, the optimal cut-off adherence values ranged from 0.58 to 0.85. CONCLUSIONS: This study provided an initial empirical basis for selecting 0.80 as a reasonable cut-off point that stratifies adherent and non-adherent patients based on predicting subsequent hospitalization across several highly prevalent chronic diseases. This cut-off point has been widely used in previous research and our findings suggest that it may be valid in these conditions; it is based on a single outcome measure, and additional research using these methods to identify adherence thresholds using other outcome metrics such as laboratory or physiologic measures, which may be more strongly related to adherence, is warranted.

Understanding how patients form beliefs about pharmacists' trustworthiness using a model of belief processing.

OBJECTIVE: To determine what information people use in forming beliefs about pharmacists' trustworthiness and to determine whether these pieces of information can be categorized using elements of a model of belief processing. DESIGN: Participants in two focus groups were asked about the trustworthiness of pharmacists in one dispensing scenario and two pharmaceutical care scenarios. Transcripts were analyzed, and each piece of information provided was coded as an evidence statement or a claim, according to a model of belief processing. SETTING: University campus. PARTICIPANTS: University staff and students. MAIN OUTCOME MEASURES: Information used to form beliefs about pharmacists' trustworthiness and classification of the information using constructs from the model of belief processing. RESULTS: Coders identified 92 evidence statements and 19 claims. An evaluation of the data across the scenarios using predetermined criteria showed 20 evidence statements and 11 claims to be the most salient pieces of information used to form beliefs about pharmacists' trustworthiness. In considering the pharmaceutical care scenarios, participants focused more on communication and interpersonal skills when forming a trustworthiness belief. The information could be categorized as evidence statements or claims, which are parts of arguments as described by a model of belief processing. CONCLUSION: The study participants used the pharmacists' credentials, communication skills, personableness, and appearance to form trustworthiness beliefs. Overall, they wanted pharmacists to be honest, knowledgeable, and caring. Variables used to form trustworthiness beliefs represent different levels of abstraction that can be detected and coded using a model of belief processing.