To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions, and identify best practices for future evaluations.
We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity, and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations.
We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions.
Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies.
FDA; Regulatory Actions; Evaluation Methodology
Nursing home; prescription drugs; antipsychotics; intervention study; prescribing culture
Economic access to costly medications including biologic agents can be challenging. Our objective was to examine whether patients with rheumatoid arthritis (RA) are at particular risk for cost-related medication nonadherence (CRN) and spending less on basic needs.
We identified a nationally-representative sample of older adults with RA (n=1100) in the (2004–2008) Medicare Current Beneficiary Survey and compared them to older adults with other morbidities categorized by chronic disease count: 0 (n=5,898), 1–2 (n=30,538), and ≥ 3 (n=34,837). We compared annual rates of self-reported CRN (skipping or reducing medication doses or not obtaining prescriptions due to cost) as well as spending less on basic needs to afford medications and tested for differences using survey-weighted logistic regression analyses adjusted for demographic characteristics, health status, and prescription drug coverage.
In the RA sample, the unadjusted weighted prevalence of CRN ranged from 20.7% in 2004 to 18.4% in 2008 as compared to 18.5% and 11.9% respectively in patients with 3 or more nonRA conditions. In adjusted analyses having RA was associated with a 3.5-fold increase in the risk of CRN (OR: 3.52; 95% CI: 2.63–4.71) and almost 2.5-fold risk of spending less on basic needs (OR: 2.41; 95% CI 1.78–3.25) as compared to those without a chronic condition.
Patients with RA experience a high prevalence of CRN and forgoing basic needs that is greater than that of older adults with multiple chronic conditions and did not improve during a period of policy change aimed at alleviating high drug costs.
rheumatoid arthritis; biologics; disease modifying anti-rheumatic drugs; costs; adherence
Cost-related medication nonadherence (CRN) has been a persistent problem for elderly and disabled Americans. The impact of Medicare prescription drug coverage (Part D) on CRN is unknown.
To estimate changes in CRN and forgoing basic needs to pay for drugs following Part D implementation.
Design, Setting, and Participants
In a population-level design, we compared changes in study outcomes from 2005 to 2006, before and after Part D, to historical changes from 2004 to 2005. We used the community-dwelling sample of the nationally representative Medicare Current Beneficiary Survey (unweighted unique n=24,234, response rate =72.3%) Logistic regression analyses controlled for demographic characteristics, health status, and historical trends.
Main Outcome Measures
Self-reports of cost-related nonadherence (skipping or reducing doses, not obtaining prescriptions) and spending less on basic needs in order to afford medicines.
The unadjusted, weighted prevalence of CRN was 15.2% in 2004, 14.1% in 2005, and 11.5% after Part D in 2006; the prevalence of spending less on basic needs was 10.6% in 2004, 11.1% in 2005, and 7.6% in 2006. Adjusted analyses comparing 2006 to 2005, controlling for historical changes (2005 versus 2004), demonstrated significant decreases in the odds of CRN (OR ratio, 0.85; 95% CI, 0.74–0.98; P = .03) and spending less on basic needs (OR ratio, 0.59; 95% CI, 0.48–0.72; P < .000). No significant changes in CRN were observed among beneficiaries with fair-to-poor health (OR ratio, 1.00; 95% CI, 0.82–1.21; P = .97), despite high baseline CRN prevalence for this group (22.2% in 2005) and significant decreases among those with good-to-excellent health (OR ratio, 0.77; 95% CI, 0.63–0.95; P = .02). However, we did detect significant reductions in spending less on basic needs in both groups (OR ratio, 0.60; 95% CI, 0.47–0.75; P < .000, for fair-to-poor health; OR ratio, 0.57; 95% CI, 0.44–0.75; P < .000 for good-to-excellent health).
In this survey population, there was evidence for a small but significant overall decrease in cost-related nonadherence and forgoing basic needs following Part D implementation. However, we detected no net decrease in CRN after Part D among the sickest beneficiaries, who continued to experience higher rates of CRN.
We sought to examine how expansions in insurance coverage of nonbiologic and biologic disease modifying anti-rheumatic drugs (DMARDs) impacted the access, costs and health status of older patients with rheumatoid arthritis.
We identified a nationally-representative sample of older adults with rheumatoid arthritis in the 2000–2006 Medicare Current Beneficiary Survey (unweighted n=1051). We examined changes in DMARD use, self-reported health status, functional status (activities of daily living [ADL]), and total costs and out-of-pocket costs for medical care and prescription drugs. Tests for time trends were conducted using weighted regressions.
Between 2000 and 2006, the proportion of older adults with rheumatoid arthritis who received biologics tripled (4.6% vs. 13.2%, p=0.01), while the proportion of people that used a nonbiologic did not change. During the same period, the proportion of older rheumatoid arthritis patients rating their health as excellent/good significantly increased (43.0% in 2000 to 55.6% in 2006; p=0.015). Significant improvements occurred in activities of daily living measures of functional status. Total prescription drug costs (in 2006 US dollars) increased from $2645 in 2000 to $4685 in 2006, p=0.0001, while out-of-pocket prescription costs remained constant ($842 in 2000 vs. $832 in 2006; p=0.68). Total medical costs did not significantly increase ($16563 in 2000 vs. $19510 in 2006; p=0.07).
Receipt of biologics in older adults with rheumatoid arthritis increased over a period of time where insurance coverage was expanded without increasing patients’ out-of-pocket costs. During this time period concurrent improvements in self-reported health status and functional status suggest improved arthritis care.
Rheumatoid Arthritis; Disease Modifying Anti-Rheumatic Drugs (DMARD); Biologic Response Modifiers; Medication; Costs
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
The analysis presented in this paper examines the multi-year capacity of the Medicare Current Beneficiary Survey (MCBS).
We systematically reviewed the literature for methodological approaches in research using multiple years of the MCBS and categorized the studies by study design, use of survey sampling weights, and variance adjustments. We then replicated the approaches in an empirical demonstration using functional status (activities of daily living (ADL) and 2005-2007 MCBS data.
In the systematic review, we identified 22 pooled, 17 repeated cross-sectional, and 17 longitudinal studies. Less than half of these studies explicitly described the weighting approach or variance estimation. In the empirical demonstration, we showed that different study designs and weighting approaches will yield statistically different estimates.
There is a variety of methodological approaches when using multiple years of the MCBS, and some of them provide biased results. Research needs to improve in describing the methods and preferred approaches for using these complex data.
Medicare current beneficiary survey; Health Care Surveys; Survey design; Survey sampling weight; Systematic review; SAS; SUDAAN
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