Richard R. Cline

Exploring generic drug use behavior: The role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution

Objectives. The first objective of this study was to examine the prevalence of prescriptions that offer the opportunity for generic drug use (a prescription for a multisource drug product). The second objective was to examine the prevalence of generic drug use by examining the rate of generic drug prescribing for multisource drug products and the rate of generic substitution by pharmacists. The last objective was to examine the association of prescriber, pharmacist, insurance, patient, and drug variables with the prescribing of drugs allowing the opportunity for generic drug use and generic substitution. Research Design. A database containing information for 6380 prescription orders was used for analysis. Measures. Random-effects logistic regression panel data estimation was used to examine the association of independent variables with whether a prescription allowed the opportunity for generic drug use and whether a prescription allowing generic drug use and written using the brand name was generically substituted. Results. The opportunity for generic drug use existed for 63% of prescription orders. Prescriptions covered by private third party and indemnity insurance were 33% (97.5% CI, 0.56–0.80), and 21% (97.5% CI, 0.62–0.98), less likely, respectively, to allow the opportunity for generic drug use relative to uninsured prescriptions. Unobserved prescriber characteristics accounted for 23% (95% CI, 0.14–0.34) of the variance in the opportunity for generic drug use. Pharmacists generically substituted 83.8% of prescriptions that could be generically substituted. Prescriptions covered by Medicaid were 4.57 (97.5% CI, 2.83–7.39), 5.15 (97.5% CI, 3.25–8.13), and 4.85 (97.5% CI, 2.83–8.17) times more likely, respectively, to be generically substituted relative to uninsured, private third party and indemnity prescriptions. Unobserved characteristics of pharmacists accounted for 44% (95% CI, 0.33–0.55) of the variance in the occurrence of generic substitution. Conclusions. Pharmacists play a large and important role in generic drug use and efforts to increase generic drug use directed at pharmacists should be maintained. Additional efforts to increase generic drug use likely should be targeted at prescribers.

The impact of osteoporosis medication beliefs and side-effect experiences on non-adherence to oral bisphosphonates

ABSTRACT Objective: Non-adherence to oral bisphosphonate medications is a pervasive problem that blunts their potential to prevent fractures. Using multivariate modeling, we assessed the unique contribution of six classes of variables as drivers of non-adherence to bisphosphonates: (1) beliefs about osteoporosis and its prescription drug treatment, (2) ratings of the affordability of the prescription osteoporosis medications, (3) evaluations of the convenience of the bisphosphonate dosing frequency, (4) reports of troublesome side effects, (5) ratings of aspects of the bisphosphonate dosing regimen, and (6) risk factors for fracture. These categories of predictor variables were selected for investigation because they have been suggested by clinical-trial, survey, and observational studies in osteoporosis as reasons for non-adherence among patients taking prescription osteoporosis therapy. Methods: Women aged 45 or older who filled a prescription for an oral bisphosphonate in January or February of 2006 were identified through a dispensing database of 3300 US retail pharmacies. Subjects received a mailed pre-notification letter from the retail pharmacy chain informing them that someone would be calling them to invite them to participate in a telephone survey about osteoporosis medications. Trained interviewers used a standardized telephone script to recruit patients. Our definition of adherence was provisionally based on database records across a 7-month period and then cross-validated using patient self-report during the telephone recruitment. We measured beliefs regarding bisphosphonate effectiveness and safety, osteoporosis health concerns, concerns regarding drug costs, dosing frequency convenience, and experienced side effects using multi-item scales. Data were collected by telephone interview. Bivariate analyses were conducted using χ2 and t-tests, and multivariate analyses were conducted using logistic regression. Results: Of the 3274 women contacted for study participation, 1092 (33%) completed the interview and 1015 had analyzable data. Multivariate analyses showed that those most symptomatic in terms of side effects and those with the most skeptical beliefs in drug effectiveness and drug safety had odds ratios for non-adherence of 6.78 (95% CI 4.67–9.86), 5.70 (95% CI 3.65–8.92), and 2.26 (95% CI 1.49–3.42), respectively. In multivariate models, osteoporosis health concerns, dosing frequency convenience, and concerns regarding medication costs were not statistically associated with non-adherence to bisphosphonate therapy. Conclusions: The experience of troublesome side effects and patient beliefs regarding the effectiveness and safety of oral bisphosphonate medications prescribed for them are strongly associated with bisphosphonate non-adherence. Improving adherence to oral bisphosphonates may require providers to solicit and address patients’ medication beliefs and to proactively address side effects. Limitations of our study include: (1) the study sample is not likely to be a national random sample of bisphosphonate users, and (2) some evidence of non-response bias was observed.

Association Between Copayment and Adherence to Statin Treatment Initiated After Coronary Heart Disease Hospitalization : A Longitudinal, Retrospective, Cohort Study

BACKGROUND Despite substantial evidence supporting the effectiveness of statin treatment, when administered regularly for the secondary prevention of coronary heart disease (CHD), many patients are not adherent. OBJECTIVE The objective of this study was to examine the relationship between copayment and adherence to statin treatment among patients who initiated statin treatment after discharge from a CHD hospitalization. METHODS Databases containing inpatient admission, outpatient, enrollment, and pharmacy claims from 1999 to 2003 were utilized for this study. The sample consisted of adults who initiated statin treatment after hospitalization directly related to CHD. Adherence to statins was measured by medication possession ratio (MPR), a surrogate marker of adherence calculated as a percentage of days with statins on hand during a 1-year observation period. The relationship between copayment and adherence to statin treatment was examined using multivariate logistic regression models. Demographic and clinical characteristics were selected as control variables based on modified versions of the Andersen health services utilization model as well as previous study findings. RESULTS A total of 5,548 patients met the study entry criteria and were included in the analysis. Of this number, 3,404 patients (61.4%) had an MPR of >or=80% and were considered adherent to statins. Compared with those who had a copayment or=USD20 were significantly less likely to be adherent to statins (odds ratio, 0.42; 95% CI, 0.36-0.49). Other relevant factors significantly associated with low adherence were younger age (P < 0.001), female sex (P < 0.001), absence of dyslipidemia diagnosis (P < 0.001), presence of depression (P = 0.010), and concomitant use of nonstatin lipid-lowering drugs (P < 0.001). CONCLUSIONS Adherence during the 1-year period after statin initiation among CHD hospitalized patients was suboptimal, with more than one third of the patients not adherent to statin treatment. High prescription copayment appeared to be a significant barrier to statin adherence, even after adjusting for demographic and clinical variables.

Retrospective assessment of Medicaid step-therapy prior authorization policy for atypical antipsychotic medications

BACKGROUND Antipsychotic medications account for more prescription expenditures in Medicaid than any other therapeutic category. This has made them an attractive target for states hoping to curtail rising expenditures. OBJECTIVE The objective of this study was to document the effects of a step-therapy prior authorization (PA) policy for atypical antipsychotic medications on: (1) Medicaid prescription expenditures among all Medicaid beneficiaries and (2) prescription and health service expenditures among patients with schizophrenia. METHODS Prescription, inpatient, outpatient, and long-term care State Medicaid Research Files from Georgia and Mississippi from January 1, 1996, to December 31, 1997, were used to model an interrupted time-series analysis. We compared a step-therapy PA policy implemented in Georgia to a nonequivalent/no-treatment control group (Mississippi) over 10-month prepolicy, 11-month policy, and 3-month postpolicy periods. Segmented regression was used to estimate antipsychotic prescription expenditures among all eligible Medicaid beneficiaries. We used generalized estimating equations to model prescription and other health service expenditures with difference-indifference regressions among a cohort of patients with schizophrenia. RESULTS Compared with Mississippi, Georgia saved approximately USD 7 million in atypical antipsychotic expenditures over the 11-month policy period. Among patients with schizophrenia, the PA policy was associated with a USD 19.62 per member per month (PMPM) decrease in atypical antipsychotic expenditures and a USD 2.20 PMPM increase in typical antipsychotic expenditures (both, P < 0.001). Among the same patients with schizophrenia however, the reduction in atypical antipsychotic expenditures was accompanied by a USD 31.59 PMPM increase in expenditures for outpatient services (P < 0.001). CONCLUSION Although PA of atypical antipsychotics was associated with significant prescription savings to the Georgia Medicaid program, among a vulnerable cohort of patients with schizophrenia, an increase in outpatient expenditures was associated with overall savings.

Racial variations in antiresorptive medication use: results from the 2000 Medical Expenditure Panel Survey (MEPS)

Although a number of studies have examined racial variation in antiresorptive medication use, those studies are limited to generalizing beyond the use of hormone therapy (HT), geographic region, and black ethnicity. Our primary aims were (1) to describe variation in the use of antiresorptive medications among US women of different ethnicities aged 45 years and older in the year 2000 and (2) to understand the association between ethnicity and antiresorptive medication use after adjustment for other factors that might have had an impact on use. The data source used in this study was the 2000 Medical Expenditure Panel Survey. Using a modified health services utilization model we performed hierarchical multivariate logistic regression analyses to examine the relationship between race and antiresorptive medication use. The use of HT among blacks, Hispanics, and other ethnicities was significantly less than among whites. This relationship was significant, even after we had controlled for predisposing, enabling, and need characteristics. The use of newer antiresorptive medications (bisphosphonates, raloxifene, and nasal calcitonin) also was less common among racial minorities than among whites. However, controlling for predisposing characteristics of education, income, census region, and age eliminated differences in use between Hispanics and whites. Controlling for need characteristics of health status, osteoporosis, and predisposing illnesses eliminated differences in antiresorptive use between blacks and whites. Significant differences in the use of newer antiresorptives remained between other ethnicities and whites, even in the fully specified model. The results of this study suggest that ethnicity is a significant predictor of the use of both HT and newer antiresorptive medication. These results also suggest that a number of variables are important in explaining racial differences in antiresorptive use, particularly among users of newer antiresorptive medications.

Osteoporosis Health Beliefs and Self-Care Behaviors: An Exploratory Investigation

OBJECTIVES (1) To determine whether women could be segmented into meaningful subgroups with similar profiles of osteoporosis health beliefs; (2) to explore associations among osteoporosis belief profiles and calcium/vitamin D and soy supplement use. The associations between group membership and three other self-care behaviors (cigarette smoking, weight-bearing exercise, and limiting alcohol intake) that may influence bone health also were explored. DESIGN Cross-sectional study. SETTING Minnesota. PARTICIPANTS 990 community-dwelling women aged 45 and older living in Minnesota. INTERVENTIONS Mailed survey. MAIN OUTCOME MEASURES Measures of osteoporosis health beliefs and proportions of respondents using calcium/vitamin D supplements, soy-containing products, smoking cigarettes, exercising fewer than three times weekly, and drinking alcohol more than three times weekly. RESULTS Cluster analysis revealed three distinct subgroups of respondents. Members of the first believed they were susceptible to osteoporosis and perceived many benefits and few barriers to using calcium or soy supplements. Women comprising the second group believed they were susceptible to osteoporosis and that its consequences were serious, but also perceived significant barriers and few benefits associated with calcium or soy supplements. Members of the third group perceived a lack of susceptibility to osteoporosis, strong general health beliefs, and had few opinions regarding calcium or soy supplement use. Members of group 1 were most likely to use calcium/vitamin D supplements. Women comprising groups 1 and 3 were more likely than those in group 2 to use soy supplements. CONCLUSION Women can be segmented into groups based upon osteoporosis belief profiles. These profiles are associated significantly with calcium and soy supplement use, as well as other self-care behaviors that may have an effect on bone health. Pharmacists could use this information to tailor interventions in this population.

Demand for a Medicare Prescription Drug Benefit: Exploring Consumer Preferences under a Managed Competition Framework

Several proposals for adding a prescription drug benefit to the Medicare program rely on consumer choice and market forces to promote efficiency. However, little information exists regarding: 1) the extent of price sensitivity for such plans among Medicare beneficiaries, or 2) the extent to which drug-only insurance plans using various cost-control mechanisms might experience adverse selection. Using data from a survey of elderly Wisconsin residents regarding their likely choices from a menu of hypothetical drug plans, we show that respondents are likely to be price sensitive with respect to both premiums and out-of-pocket costs but that selection problems may arise in these markets. Outside intervention may be necessary to ensure the feasibility of a market-based approach to a Medicare drug benefit.

Pharmaceutical Expenditures as a Correlate of Population Health in Industrialized Nations

Background: In recent years, healthcare spending has outpaced economic growth in developed countries, with pharmaceutical expenditures being a key driver of this trend. While a significant number of studies investigating the effect of healthcare resource productivity on health status have been done, only a few have disaggregated pharmaceutical expenditures from total healthcare expenditures. Objective: To assess the independent association between pharmaceutical expenditures and health outcomes in 14 industrialized countries. Methods: We used data from the Organisation for Economic Co-operation and Development to construct a panel data set covering the years from 1985 to 2001. These data contain information on pharmaceutical expenditures, other healthcare expenditures, environmental health determinants, lifestyle health determinants, potential years of life lost, and life expectancy at ages 65 and 80 years across 14 industrialized nations. We estimated the relationship between pharmaceutical expenditures and potential years of life lost and life expectancy at ages 65 and 80 years for both males and females, using nonlinear fixed-effects regression models that corrected for serial correlation. All explanatory variables were lagged by 5 years to account for their cumulative effect on population health outcomes. Results: Pharmaceutical expenditures proved to be a robust correlate of health outcomes from 1985 to 2001 in this sample of nations, when controlling for the effects of other variables likely to impact population health outcomes. Our estimates imply that a 10% increase in pharmaceutical expenditures during these years was associated with a 0.3% (95% CI 0.1% to 0.5%; ~21 days) increase in female life expectancy at age 65 years (p < 0.05), while a similar increase was associated with a 0.4% (95% CI 0.1 to 0.7; ~24 days) increase in male life expectancy at age 65 years (p < 0.05) and a 0.5% increase (95% CI 0.03 to 1.0; ~14 days) at age 80 years (p < 0.05). Conclusions: Our results suggest that significant, but small, marginal gains in population health outcomes were associated with increased pharmaceutical expenditures in developed nations during the period studied.

Drug benefit decisions among older adults: a policy-capturing analysis.

Purpose . Under the Medicare Prescription Drug Improvement and Modernization Act, beneficiaries remaining in the traditional fee-for-service plan will face a variety of drug benefit options provided by private stand-alone prescription drug plans. Although these plans likely will differ with regard to a number of important attributes, little is known about older adults’ judgment processes in this context. The objectives of this study were to 1) better understand the manner in which drug insurance attributes are weighted in older adults’ judgments of drug benefit suitability, 2) explore variability in judgment strategies among seniors, and 3) assess seniors’ insight into their judgment policies. Methods . Three focus groups were conducted with 19 older adults to elicit important drug plan attributes. A policy-capturing study with 32 seniors, none of whom had participated in the focus groups, then was employed to quantify the impacts of these attributes on judgments of plan suitability. Results . Focus group participants reported that copayment, monthly premium, deductible, formulary use, and mail-order pharmacy use were important drug insurance attributes. The policy-capturing study showed that deductibles and premiums were weighted most heavily in judgment formation. However, significant variability in judgment policies was apparent, with 3 distinct groups emerging from cluster analysis. The first emphasized deductibles and copayments, the second premiums and deductibles, and the third use of a mail-order pharmacy and deductibles. Study volunteers exhibited insight into the role of some plan attributes in their judgments, but notm others. Conclusions. Cost-sharing provisions appear to be most important in older adults’ evaluations of drug benefit plans. However, significant heterogeneity in attribute preferences also was apparent in this study. Older adults may not be cognizant of the manner in which some plan attributes affect their evaluations, suggesting a role for decision aids in this process.

Vaccine supply, demand, and policy: A primer

Objective To provide an overview of supply and demand issues in the vaccine industry and the policy options that have been implemented to resolve these issues. Data sources Medline, Policy File, and International Pharmaceutical Abstracts were searched to locate academic journal articles. Other sources reviewed included texts on the topics of vaccine history and policy, government agency reports, and reports from independent think tanks. Keywords included vaccines, immunizations, supply, demand, and policy. Study selection Search criteria were limited to English language and human studies. Articles pertaining to vaccine demand, supply, and public policy were selected and reviewed for inclusion. Data extraction By the authors. Data synthesis Vaccines are biologic medications, therefore making their development and production more difficult and costly compared with “small-molecule” drugs. Research and development costs for vaccines can exceed