In 2006, the United States Centers for Medicare and Medicaid Services implemented Medicare Part D to provide outpatient prescription drug insurance to disabled and older adults. In creating Part D, a key provision to address quality included medication therapy management (MTM) programs designed to increase proper and safe use of medications among targeted Part D beneficiaries. A preponderance of evidence shows that Part D has increased medication affordability and accessibility; however, what remains less clear is whether it has improved the quality of medication use and optimized health outcomes. Now in its sixth year, Part D is undergoing its first major revision with the gradual elimination of the coverage gap by 2020. Therefore, now is a good time to review the accumulated evidence on the impact of Part D and MTM programs on quality of medication use to help inform future policy decisions and research directions. In this review, we find that Part D’s net effect on quality of medication use mainly has been positive. Cost-related medication nonadherence improves moderately and treatment interruptions happen less than expected. However, vulnerable subgroups, such as sicker and dual-eligible beneficiaries, experienced lags in improvement. Beneficiaries who entered the coverage gap consistently experienced interruptions and displayed worsening medication adherence after entering the gap, with generic-only gap drug coverage offering only suggested limited benefit. Such findings can serve as baseline information as the coverage gap phases out. Limited availability of data is the biggest barrier to research in Part D. Part D’s overall effect on health outcomes and adverse medical events, such as hospitalizations, is inconclusive because of inadequate evidence to date. Similarly, no evaluation of quality of medication use is available on utilization management strategies and MTM programs delivered under Part D. Future research will need to further examine the added value of Part D and address whether it optimizes health outcomes in the Medicare population. As the current economic recession increases the pressure to cut costs, the effect of future spending restrictions, such as restrictions on coverage subsidies, will also be of special concern.
The full effect of Medicare Part D, after the initial policy transition period and across the U.S. Medicare population, remains unclear.
To estimate nationally-representative changes in prescription drug use and out-of-pocket drug costs two years after implementation of Part D.
Design, Setting, and Participants
We examined study outcomes over 8 years (2000–2008) and estimated changes after Part D, accounting for prior trends. Our analyses used the community-dwelling sample of the Medicare Current Beneficiary Survey (unweighted unique n=38,798). Actual post-Part D outcomes were compared to projected values using 2000–2005 data. Subgroup analyses and standardization weights were used to address population-level shifts over time in health status and demographic characteristics.
Main Outcome Measures
Annual prescription drug fills and out-of-pocket drug costs.
We observed significant average per person increases of 1.8 prescription fills (95% confidence interval [CI]: 1.1, 2.5) in 2006 and 3.4 prescription fills (95% CI: 2.7, 4.1) in 2007 above pre-Part D increases of 0.9 prescription fills per year. Average out-of-pocket drug costs decreased significantly by $143 (95% CI:−182.5,−103.1) in 2006 and $148 (95% CI: −181.2, −114.1) in 2007 above average pre-Part D increases of $12 per year. Prescription fills did not change for beneficiaries with fair to poor health until 2007 when large increases occurred (increases of 3.7 to 11.0 fills above pre-Part D trends). Poor beneficiaries without Medicaid had no reductions in out-of-pocket drug costs in 2006 or 2007.
After the transition year of 2006, the impact of Part D appeared larger and more consistent across the Medicare population. Of note, sick and poor beneficiaries experienced significant improvements in prescription drug use in 2007.
Instrumental variable (IV) analysis may offer a useful approach to the problem of unmeasured confounding in prescription drug research if the IV is: 1) strongly and unbiasedly associated to treatment assignment; and 2) uncorrelated with factors predicting the outcome (key assumptions).
Study Design and Methods
We conducted a systematic review of the use of IV methods in prescription drug research to identify the major types of IVs and the evidence for meeting IV assumptions. We searched MEDLINE, OVID, PsychoInfo, Econlit and economic databases from 1961 to 2009.
We identified 26 studies. Most (n=16) were published after 2007. We identified five types of IVs: regional variation (n=8), facility prescribing patterns (n=5), physician preference (n=8), patient history/financial status (n=3) and calendar time (n=4). Evidence supporting the validity of IV was inconsistent. All studies addressed the first IV assumption; however, there was no standard for demonstrating that the IV sufficiently predicted treatment assignment. For the second assumption, 23 studies provided explicit argument that IV was uncorrelated with the outcome, and 16 supported argument with empirical evidence.
Use of IV methods is increasing in prescription drug research. However, we did not find evidence of a dominant IV. Future research should develop standards for reporting the validity and strength of IV according to key assumptions.
The benefit of screening for decreasing the risk of death from colorectal cancer (CRC) has been shown, yet many patients in primary care are still not undergoing screening according to guidelines. There are known variations in delivery of preventive health care services among primary care physicians. This study compared self-reported CRC screening rates and patient awareness of the need for CRC screening of patients receiving care from family medicine (FPs) vs. internal medicine (internists) physicians.
Nationally representative sample of non-institutionalized beneficiaries who received medical care from FPs or internists in 2006 (using Medicare Current Beneficiary Survey). The main outcome was the percentage of patients screened in 2007. We also examined the percentage of patients offered screening.
Patients of FPs, compared to those of internists, were less likely to have received an FOBT kit or undergone home FOBT, even after accounting for patients' characteristics. Compared to internists, FPs' patients were more likely to have heard of colonoscopy, but were less likely to receive a screening colonoscopy recommendation (18% vs. 27%), or undergo a colonoscopy (43% vs. 46%, adjusted odds ratios [AOR], 95% confidence interval [CI]-- 0.65, 0.51-0.81) or any CRC screening (52% vs. 60%, AOR, CI--0.80, 0.68-0.94). Among subgroups examined, higher income beneficiaries receiving care from internists had the highest screening rate (68%), while disabled beneficiaries receiving care from FPs had the lowest screening rate (34%).
Patients cared for by FPs had a lower rate of screening compared to those cared for by internists, despite equal or higher levels of awareness; a difference that remained statistically significant after accounting for socioeconomic status and access to healthcare. Both groups of patients remained below the national goal of 70 percent.
Colorectal cancer screening; Primary care physicians; Colonoscopy; Fecal occult blood test
Reducing dosing demands of medications generally increases adherence, although this relationship has not been demonstrated with the once-monthly oral bisphosphonates (BP). The study aim is to test whether switching from once-weekly BPs to once-monthly BPs improves adherence and fracture risk.
This is an interrupted times-series analysis of new users of once-weekly BPs in a nationwide administrative health database from 2003–2007. Participants include 1835 individuals who switched to once-monthly BPs and two propensity-matched comparator groups: 1835 individuals who switched to a different once-weekly BP, and 1835 who did not switch. We measured changes in adequate adherence pre- and post-switch as monthly medication possession ratio >0.80, and calculated incidence rate ratios [IRR] of osteoporotic fractures.
All study groups experienced major adherence failure in the first year of therapy: the proportion of adequate adherers was 42% among once-monthly switchers, 47% among once-weekly switchers, and 37% among nonswitchers. However, the once-monthly switch was associated with less adherence failure (4% fewer adherers per month pre-switch vs. 1% fewer adherers per month post-switch, p<.000). There was no statistically significant change in adherence rates for the other groups. We did not detect significantly reduced fracture risk with once-monthly switch: 1 year post-switch, the fracture incidence risk ratios for once-monthly switchers relative to once-weekly switchers were IRR 0.83, 95% CI: 0.50–1.36, and IRR 0.90, 95% CI: 0.54–1.49, relative to nonswitchers).
Reducing the dosing demands of oral bisphosphonates from once-weekly to once-monthly decreased adherence failure but had an uncertain impact on fracture risk.
patient compliance; bisphosphonates; osteoporosis; osteoporotic fractures; medication adherence
Little is known about how much Medicare families can afford to pay for health care and whether the Medicare prescription drug program (Part D) will provide financial protection. In this paper we assess total out-of-pocket health care spending of Medicare families in the context of their available resources in the year prior to Part D. We find that high health spending burdens are common. Medicare families with incomes up to 250% of the Federal Poverty Level are at high risk for incurring burdensome health care costs, and this includes many who would not be eligible for Part D Low-income subsidy assistance.
Medicare Part D excludes benzodiazepines from coverage and some state Medicaid programs also limit coverage. We assessed whether such policies decrease the risk of fractures in the elderly living in nursing homes.
This is a quasi-experimental study with interrupted time-series estimation and extended Cox proportional hazards models comparing changes in outcomes pre- and post-Part D in a nationwide sample of nursing home residents in 48 states. The study included 1,068,104 residents and a subsample of 50,874 residents with fracture data from one pharmacy provider. We assessed monthly prescribing rates of benzodiazepines and potential substitutes over the period 2005- June 2007, and hazard ratios for incident hip fracture and falls, adjusted for age, sex, and race. Estimates were stratified by concurrent Medicaid limits on benzodiazepines: no coverage (n=1 state) or partial coverage (n=6 states), versus complete coverage (n=41 states).
The no coverage policy resulted in an immediate and significant reduction of 10 absolute points in benzodiazepine use (27% to 17%) after Part D (95% confidence interval [CI]: −.11- −.09, p<.0001). Benzodiazepine use remained stable in the partial and complete coverage states. Hazard ratios for incident hip fracture were 1.60 (95% CI: 1.05-2.45, p=.030) in the no coverage state after Part D, and 1.17 (95% CI: 0.93-1.46, p=.179) in the partial coverage states, relative to complete coverage states.
This study found that drug coverage exclusion policies affect the medication use of nursing home residents and may not decrease their fracture risk.
The extent of the adoption of once-monthly bisphosphonates into general clinical practice is not known, nor is it known if the novel formulation improves adherence.
We analyzed administrative claims 2003-2006 from a large employer-based health insurance database for incident use of oral bisphosphonates and stratified users by daily, weekly and monthly dosing regimen. We measured adherence as the medication possession ratio (MPR) during the first year of therapy. We compared patient characteristics by dosing regimen and evaluated how the dosing regimen influenced the MPR.
We identified 61,125 incident users of bisphosphonates (n=1034 daily, n=56,925 weekly, n=3166 monthly). Monthly bisphosphonate users were, on average, slightly older than the other groups (mean age 66 years monthly vs. 65 weekly or 66 daily, p<.05.) and more often lived in the U.S. North Central or South (76% vs. 72% weekly or 69% daily users, p<.05). There were no detectable differences among the dosing groups in the history of serious GI risk, comorbidity burden, or prior osteoporotic fractures. During the first year of bisphosphonate therapy, 49% of monthly users had MPR ≥80% compared to 49% weekly users (N.S.) or 23% daily users (p<.0001).
We found little evidence of preferential prescribing of monthly bisphosphonates to certain types of patients. Furthermore, we found no evidence of improved bisphosphonate adherence with monthly dosing relative to weekly dosing, although adherence with either weekly or monthly dosing was significantly better than with daily dosing.
patient compliance; bisphosphonates; novel formulation
Adherence with tobramycin inhalation solution (TIS) during routine cystic fibrosis (CF) care may differ from recommended guidelines and affect health care utilization.
We analyzed 2001-2006 healthcare claims data from 45 large employers. Study subjects had diagnoses of CF and at least 1 prescription for TIS. We measured adherence as the number of TIS therapy cycles completed during the year and categorized overall adherence as: low ≤ 2 cycles, medium >2 to <4 cycles, and high ≥ 4 cycles per year. Interquartile ranges (IQR) were created for health care utilization and logistic regression analysis of hospitalization risk was conducted by TIS adherence categories.
Among 804 individuals identified with CF and a prescription for TIS, only 7% (n = 54) received ≥ 4 cycles of TIS per year. High adherence with TIS was associated with a decreased risk of hospitalization when compared to individuals receiving ≤ 2 cycles (adjusted odds ratio 0.40; 95% confidence interval 0.19-0.84). High adherence with TIS was also associated with lower outpatient service costs (IQR: $2,159-$8444 vs. $2,410-$14,423) and higher outpatient prescription drug costs (IQR: $35,125-$60,969 vs. $10,353-$46,768).
Use of TIS did not reflect recommended guidelines and may impact other health care utilization.
Serious safety concerns related to use of antipsychotics have not decreased the prescribing of these agents to nursing home (NH) residents. We assessed the extent to which resident clinical characteristics and institutional prescribing practice were associated with antipsychotic prescribing.
Antipsychotic prescribing was assessed for a nationwide, cross-sectional population of 16,586 newly-admitted NH residents in 2006. We computed facility-level antipsychotic rates based on the previous year’s (2005) prescribing patterns. Poisson regressions with generalized estimating equations were used to identify the likelihood of resident-level antipsychotic utilization in 2006 given 2005 facility-level prescribing pattern and NH resident indication for antipsychotic therapy (psychosis, dementia, and behavioral disturbance).
Over 30% of study residents received at least one antipsychotic medication in 2006, of whom 32% (n=1605) had no identified clinical indication for this therapy. Residents entering NHs with the highest facility-level antipsychotic rates were 1.34 times more likely to receive antipsychotics relative to those entering the lowest prescribing rate NHs, after adjusting for potential clinical indications (relative risk [RR]=1.34; 95% confidence interval [CI], 1.22–1.47). The elevated risk associated with facility-level prescribing rates was apparent for only NH residents with dementia but no psychosis (RR=1.37; 95%CI, 1.21 to 1.54), and residents without dementia or psychosis (RR=1.51; 95% CI: 1.23–1.86).
NH antipsychotic prescribing practice was independently associated with use of antipsychotics in NH residents. Future research is needed to determine why such a prescribing culture exists and whether it could result in adverse health consequences.
To identify gaps in therapy with urate-lowering drugs for the treatment of gout as well as factors associated with resuming therapy.
We identified persons from two integrated delivery systems 18 years or older with a diagnosis of gout who initiated use of a urate-lowering drug from January 1, 2000 through June 30, 2006 and who had a gap in therapy. A gap was defined as a period of over 60 days after the completion of one prescription in which no refill for a urate-lowering drug was obtained. Survival curves were used to assess return to therapy of urate-lowering drugs. Cox proportional hazards analysis estimated the association between covariates and return to therapy.
There were 4,166 new users of urate-lowering drugs (97% received allopurinol) of whom 2,929 (70%) had a gap in therapy. Among those with a gap, in 75% it occurred in the first year of therapy. Fifty percent of patients with a gap returned to therapy within 8 months, and by 4 years it was 75%. Age 45 to 74 (<45 referent) and greater duration of urate-lowering drug use prior to the gap was associated with resuming treatment within one year. In contrast, receipt of NSAIDs or glucocorticoids in the year prior to the gap was associated with a reduced likelihood of resuming therapy.
The majority of gout patients with gaps in urate-lowering drug use returned to treatment. More investigation is needed to better understand why patients may go for months without refilling prescriptions given the clinical consequences of nonadherence.
persistence; adherence; compliance; gout; urate lowering drugs
Despite evidence of effective combination drug therapy for secondary prevention of coronary heart disease (CHD), older adults remain undertreated.
To describe time trends (1992–2003) in the adoption of combination cardiac drug therapies (beta blockers, angiotensin-converting enzyme inhibitors [ACE] or angiotensin II receptor blockers [ARB], and lipid-lowering agents) among older adults with CHD and to identify factors associated with not using combination therapy.
Nationally representative sample of adults aged ≥ 65 years with CHD (unweighted n=6,331; weighted n=20.1 million) included in the 1992–2003 Medicare Current Beneficiary Survey
Main Outcome Measurements
The outcome measure is low-intensity cardiac pharmacotherapy (no drug or single drug therapy with beta-blockers, ACE/ARBs, or lipid-lowering agents) compared to combination therapy (≥ 2 cardiac drugs) for secondary CHD prevention.
Use of combination drug therapy in older adults with CHD increased 9-fold during the study period (6% in 1992 to 54% in 2003). Adjusted analyses demonstrate that suboptimal drug therapy was independently associated with advanced age (relative risk [RR] 1.18 [95% confidence interval: 1.14–1.23]) for persons ≥85 years vs 65–74 years; being black (RR 1.05 [95% CI: 1.01–1.10]) or Hispanic (RR 1.12 [95% CI: 1.06–1.21]) vs being non-Hispanic white.
Combination drug therapy use for secondary CHD prevention increased in older adults over the last decade, but improvements were not uniform. The oldest-old, non-Hispanic blacks and Hispanics experienced slower adoption of optimal medical therapy to improve their long-term prognosis for CHD.
to assess the impact of Medicare Part D in the nursing home (NH) setting.
a population-based study using 2005–2006 prescription dispensing records, Poisson regressions with generalized estimating equations, and interrupted times series estimation with segmented regression methods.
a nationwide sample of long-stay Medicare enrollees in NHs (n=861,082)
probability of Part D enrollment, changes in source of drug payments, changes in average number of monthly prescriptions dispensed per resident.
In 2006, 81% of NH residents enrolled in Part D, 16% had other drug coverage, and 3% (n=11,000) remained without drug coverage, which was the same rate of no drug coverage as in 2005. NH residents who did not enroll in Part D were the oldest old (RR 0.82, p<.000), had no drug coverage in 2005 (RR 0.84, p<.001), and had high comorbidity burden (RR 0.94, p<.000). The proportion of prescription drugs paid out-of-pocket decreased from 11% in 2005 to 8% in 2006 (p<.001). Average monthly prescription use per resident in 2006 decreased by half a prescription relative to 2005 levels (9.6 scripts vs. 10.1 scripts, p<.003).
Part D decreased some out-of-pocket drug costs, but did not expand drug coverage in the NH population or reach some vulnerable segments. Part D was also associated with some disruption in NH drug use, especially right after implementation.
Medicare; prescription drugs; nursing home
to assess if the lower copayments often charged for generic drugs explains the improved drug adherence associated with use of generic drugs.
We analyzed 2001–2004 healthcare claims data from 45 large employers. Study subjects were aged 18 years +, had 1 or more of 5 study conditions (hypercholesterolemia, hypertension, hypothyroidism, seizure disorders, and type 2 diabetes), and new use of generic-only or brand-only drug therapy for that condition. We measured adherence as the medication possession ratio (MPR), and adequate adherence as MPR >= 80%. Logistic regressions were conducted to assess adequate adherence adjusting for copayments.
We identified 327,629 new users of drug therapy for the study conditions. Proportion of individuals starting generic therapies ranged from 9% in hypothyroidism to 45% in hypertension. After 1 year of therapy, 66.2% of individuals with hypothyroidism achieved MPR >= 80% compared to 53.4% with hypertension, 53.2% with hypercholesterolemia, 52.0% with diabetes, and 42.2% with seizure disorders. Logistic regressions of adequate adherence showed generics were associated with higher adherence relative to brands in 2 conditions (hypercholesterolemia AOR 1.52, 95% CI: 1.44–1.60; diabetes AOR 1.06, 95% CI: 1.01–1.12, p<.05), with lower adherence in 2 conditions (hypertension AOR 0.75, 95% CI:.73-.77; hypothyroidism AOR 0.86, 95% CI:.78-.94, p<.05), and no difference in seizure disorders. In comparison, the likelihood of achieving MPR >= 80% with $0 copayments relative to $1-$9 ranged from AOR 1.32 for seizure disorders (95% CI: 1.41–1.43) to AOR 1.45 for hypothyroidism (95% CI: 1.43–1.48).
Generic prescribing was associated with improved medication adherence in 2 of 5 study conditions, and the effect was modest. Copayments of $0 were associated with improved adherence across all study conditions.
adherence; type 2 diabetes; hypertension; hypercholesterolemia; hypothyroidism; and seizure disorders
This study developed a new measure of medication affordability that examines out-of-pocket drug expenses relative to available household resources. The authors assessed the spending patterns of ~2.1 million poor households (≤100% federal poverty level) of adults aged 51 and older by Medicaid status. The data were drawn from the 2000–2001 Health and Retirement Study. Household spending was categorized into three broad types: basic living, health care, and discretionary. Older (aged 51 or older) poor households without Medicaid allocated about 72% of their total resources ($17,421, SE $783) to basic living needs. In comparison, those with Medicaid had scarcer total resources ($12,498, SE $423) and allocated 85% to basic living needs. Medication costs consumed the largest proportion of health care expenses for both types of poor households (Medicaid: $463, SE $67; non-Medicaid: $970, SE $102). After paying for basic living needs and health care costs, these families had, on average, only $16 left each week. Poor families have very few resources available for anything beyond basic living needs, even when they have Medicaid coverage. There is no great reservoir of discretionary funds to pay for increases in cost-sharing under Medicaid and Medicare Part D.
Affordability; low-income; prescription drugs
Failure to reconcile medications across transitions in care is an important source of harm to patients. Little is known about medication discrepancies upon admission to skilled nursing facilities (SNFs).
To describe the prevalence of, type of medications involved in, and sources of medication discrepancies upon admission to the SNF setting.
Patients admitted to SNF for subacute care.
Number of medication discrepancies, defined as unexplained differences among documented medication regimens, including the hospital discharge summary, patient care referral form and SNF admission orders.
Of 2,319 medications reviewed on admission, 495 (21.3%) had a medication discrepancy. At least one medication discrepancy was identified in 142 of 199 (71.4%) SNF admissions. The discharge summary and the patient care referral form did not match in 104 of 199 (52.3%) SNF admissions. Disagreement between the discharge summary and the patient care referral form accounted for 62.0% (n = 307) of all medication discrepancies. Cardiovascular agents, opioid analgesics, neuropsychiatric agents, hypoglycemics, antibiotics, and anticoagulants accounted for over 50% of all discrepant medications.
Medication discrepancies occurred in almost three out of four SNF admissions and accounted for one in five medications prescribed on admission. The discharge summary and the patient care referral forms from the discharging institution are often in disagreement. Our study findings underscore the importance of current efforts to improve the quality of inter-institutional communication.
medication discrepancies; skilled nursing facilities; medication reconciliation; discharge summary; transitions of care
Information on the impact of pay-for-performance programs is lacking in the nursing home setting. This literature review (1980 – 2007) identified 13 prior examples of pay-for-performance programs in the nursing home setting: 7 programs were active as of 2007, while 6 had been terminated. The programs were mostly short-lived, varied considerably in the choice of performance measures and pay incentives, and evaluations of the impact were rare.
To determine whether prescription drug benefits are associated with the use of guideline recommended medications by older persons with type 2 diabetes mellitus.
A national sample of Medicare beneficiaries with diabetes aged ≥ 65 years and an indication for angiotensin-converting enzyme (ACE) inhibitor or angiotensin II-receptor blocker (ARB) use or increased risk of coronary heart disease (hypertension or current smoking) who participated in the 2003 Medicare Current Beneficiary Survey.
Prescription drug coverage was measured by self-report and verified by insurance claims. Outcome variables were only ACE/ARB or statin use, or combined ACE/ARB and statin use. Survey weighted multinomial logistic regression was used to identify the independent effect of drug coverage on one of two categories of recommended medication use (only ACE/ARB or statin, or combined ACE/ARB and statin) compared to the reference category of none after controlling for sociodemographics and health status.
The final study sample was 1,181 (weighted N = 4.0 million). Overall, 23% had no drug coverage, 16% Medicaid coverage, 43% employer coverage, 9% Medigap coverage, and 9% Veterans' Affairs (VA) or state-sponsored low-income coverage. Overall, 33% received both statins and ACE/ARBs, 44% only an ACE/ARB or statin, and 23% neither. After adjustment, VA and state-sponsored drug benefits were most strongly associated with combined ACE/ARB and statin use [RRR 4.83 (95% CI 2.24-10.4)], followed by employer-sponsored coverage [RRR 2.60 (95% CI 1.67-4.03)].
Prescription drug benefits from VA and state-sponsored drug programs are strongly associated with use of recommended medications by older adults with DM.
Diabetes mellitus; drug utilization; insurance; Medicare; health care quality
Cost-related medication non-adherence may be influenced by patients' perceived importance of their medications. This exploratory study addresses three related but distinct questions: Do patients perceive different levels of importance among their medications? What factors influence perceptions of medication importance? Is perceived importance associated with medications' worth, and does expense impact that association?
Study participants included individuals aged 60 and older who were taking three or more prescription drugs. Semi-structured, in-person interviews were conducted to measure how patients rated their medications in terms of importance, expense, and worth. Factors that influence medication importance were identified using qualitative analysis. Ordinal logistic regression analyses were employed to examine the association between perceived importance and worth of medications, and the impact of expense on that association.
Among 143 prescription drugs reported among 20 participants, the weighted mean rating of medication importance was 8.2 (SD=1.04) on a scale from 0 (not important at all) to 10 (most important). Of all medications, 38% were considered expensive. The weighted mean rating of worth was 8.4 (SD=1.46) on a scale from 0 (not worth it at all) to 10 (definitely worth it). Three major factors influenced medication importance: drug-related (characteristics, indications, effects, and alternatives); patient-related (knowledge, attitudes, and health); and external (the media, healthcare and family caregivers, and peers). Regression analyses showed an association between perceived importance and worth for inexpensive medications (OR=2.23; p=0.002) and an even greater association between perceived importance and worth for expensive medications (OR=4.29; p<0.001).
This study provides preliminary evidence that elderly patients perceive different levels of importance among their medications based on factors beyond clinical efficacy and their perception of importance influences how they perceive their medications' worth, especially for medications of high costs. Understanding how patients perceive medication importance may help develop interventions to reduce cost-related non-adherence.
medication prioritization; essential drugs; nonadherence; medication adherence
To compare drug adherence rates among patients with gout, hypercholesterolemia, hypertension, hypothyroidism, osteoporosis, seizure disorders, and type 2 diabetes mellitus by using a standardized approach.
Health care claims data from 2001–2004.
A total of 706,032 adults aged 18 years or older with at least one of the seven medical conditions and with incident use of drug therapy for that condition.
Measurements and Main Results
Drug adherence was measured as the sum of the days’ supply of drug therapy over the first year observed. Covariates were age, sex, geographic residence, type of health plan, and a comorbidity score calculated by using the Hierarchical Condition Categories risk adjuster. Bivariate statistics and stratification analyses were used to assess unadjusted means and frequency distributions. Sample sizes ranged from 4984 subjects for seizure disorders to 457,395 for hypertension. During the first year of drug therapy, 72.3% of individuals with hypertension achieved adherence rates of 80% or better compared with 68.4%, 65.4%, 60.8%, 54.6%, 51.2%, or 36.8% for those with hypothyroidism, type 2 diabetes, seizure disorders, hypercholesterolemia, osteoporosis, or gout, respectively. Age younger than 60 years was associated with lower adherence across all diseases except seizure disorders. Comorbidity burden and adherence varied by disease. As comorbidity increased, adherence among subjects with osteoporosis decreased, whereas adherence among those with hypertension, hypercholesterolemia, or gout increased. Add-on drug therapies and previous experience with taking drugs for the condition increased adherence among subjects with hypertension, type 2 diabetes, hypothyroidism, or seizure disorders but not the other conditions.
This uniform comparison of drug adherence revealed modest variation across six of seven diseases, with the outlier condition being gout.
drug adherence; comparative study; type 2 diabetes mellitus; hypertension; osteoporosis; hypercholesterolemia; gout; hypothyroidism; seizure disorders
New policies regulating physician/pharmaceutical company relationships propose to eliminate access to free prescription drug samples. Little is known about the prevalence of patient activity in requesting or receiving free prescription drug samples, or the characteristics of patients who access drug samples.
To determine the prevalence of free sample access and to examine demographic, clinical, and insurance characteristics of Medicare beneficiaries who access free samples.
A national sample of 13,847 Medicare beneficiaries participating in the fall 2004 Medicare Current Beneficiary Survey.
Measurements and Main Results
Prevalence of free prescription drug sample access (self-reported request for or receipt of free drug samples) and the demographic, clinical, and insurance characteristics of Medicare beneficiaries who accessed drug samples. Overall, 48.3% (95% confidence of interval [CI]: 46.6%, 49.9%) of Medicare beneficiaries reported accessing free drug samples. Access was higher among beneficiaries reporting cost-related medication nonadherence compared to those without (77.7% (95% CI: 74.5%, 80.6%) vs 43.0% (95% CI: 41.4%, 44.7%)). Multivariable analysis revealed cost-related medication nonadherence (CRN) to have the strongest relationship with accessing drug samples (adjusted odds ratio [AOR] 4.43 [95% CI: 3.64, 5.39]). Compared to beneficiaries with generous drug benefits from Medicaid, beneficiaries who lacked prescription drug benefits were more likely to access drug samples (AOR 2.42 [95% CI: 2.06, 2.85]). Beneficiaries with drug coverage from employer-sponsored plans or partial coverage (Medicare HMO, self-purchased Medicare supplement, or state-sponsored low-income plans) were also more likely to access drug samples (AOR 2.02, 1.74, respectively). Having 2–3 or ≥4 comorbidities (vs 0–1 comorbidities) also increased the likelihood of accessing drug samples (AOR 1.60 (95% CI: 1.44, 1.79) and 2.00 (95% CI: 1.74, 2.29).
Accessing free prescription drug samples is prevalent among many categories of beneficiaries, especially among individuals with cost-related medication nonadherence and poor health status. Policies restricting or prohibiting drug sample distribution may adversely impact access to medications among patients in high-risk groups.
free samples; pharmaceutical companies; Medicare
To identify the effect of insurance coverage on prescription utilization by Medicare beneficiaries.
Data Sources/Study Setting
Secondary data from the 1999 Medicare Current Beneficiary Survey (MCBS) Cost and Use files, a nationally representative survey of Medicare enrollees.
The paper uses a cross-sectional design with (1) a standard regression framework to estimate the impact of prescription coverage on utilization controlling for potential selection bias with covariate control based on the Diagnostic Cost Group/Hierarchical Condition Category (DCG/HCC) risk adjuster, and (2) a multistage residual inclusion method using instrumental variables to control for selection bias and identify the insurance coverage effect.
Data Collection/Extraction Methods
Data were extracted from the 1999 MCBS. Study inclusion criteria are community-dwelling MCBS respondents with full-year Medicare enrollment and supplemental medical insurance with or without full-year drug benefits. The final sample totaled 5,270 Medicare beneficiaries.
Both the model using the DCG/HCC risk adjuster and the model using the residual inclusion method produced similar results. The estimated price elasticity of demand for prescription drugs for the Medicare beneficiaries in our sample was −0.54.
Our results confirm that selection into prescription coverage is predictable based on observable health. Our results further confirm prior estimates of price sensitivity of prescription drug demand for Medicare beneficiaries, though our estimate is slightly above prior results.
Medicare; prescription drugs; price elasticity; moral hazard; selection bias
Adherence to urate-lowering drugs (ULDs) has not been well evaluated among those with gout. Our aim was to assess the level and determinants of non-adherence with ULDs prescribed for gout.
We identified persons using two integrated delivery systems aged 18 years or older with a diagnosis of gout who initiated use of allopurinol, probenecid or sulfinpyrazone from 1 January 2000 to 30 June 2006. Non-adherence was measured using the medication possession ratio (MPR) over the first year of therapy and defined as an MPR < 0.8. Descriptive statistics were calculated and logistic regression was used to estimate the strength of the association between patient characteristics and non-adherence.
A total of 4,166 gout patients initiated ULDs; 97% received allopurinol. Median MPR for any ULD use was 0.68 (interquartile range (IQR) 0.64). Over half of the patients (56%) were non-adherent (MPR < 0.8). In adjusted analyses, predictors of poor adherence included younger age (odds ratio (OR) 2.43, 95% confidence interval (CI) 1.86 to 3.18 for ages <45 and OR 1.44, 95% CI 1.08 to 1.93 for ages 45 to 49), fewer comorbid conditions (OR 1.46, 95% CI 1.20 to 1.77), no provider visits for gout prior to urate-lowering drug initiation (OR 1.28, 95% CI 1.05 to 1.55), and use of non-steroidal anti-inflammatory drugs in the year prior to urate-lowering drug initiation (OR 1.15, 95% CI 1.00 to 1.31).
Non-adherence amongst gout patients initiating ULDs is exceedingly common, particularly in younger patients with less comorbidity and no provider visits for gout prior to ULD initiation. Providers should be aware of the magnitude of non-adherence with ULDs.