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1.  Changes in Use of Lipid Lowering Medications among Black and White Dual Enrollees with Diabetes Transitioning from Medicaid to Medicare Part D Drug Coverage 
Medical care  2014;52(8):695-703.
The use of lipid lowering agents is suboptimal among dual enrollees, particularly blacks.
To determine whether the removal of restrictive drug caps under Medicare Part D reduced racial differences among dual enrollees with diabetes.
Research Design
An interrupted time series with comparison series design (ITS) cohort study.
8,895 black and white diabetes ≥18 year old patients drawn from a nationally representative sample of fee-for-service dual enrollees (January 2004–December 2007) in states with and without drug caps before Part D.
We examined the monthly (1) proportion of patients with any use of lipid lowering therapies and (2) intensity of use. Stratification measures included age (<65, ≥65), race (white vs. black) and gender.
At baseline, lipid lowering drug use was higher in no drug cap states (drug cap: 54.0% vs. non-drug cap: 66.8%) and among whites versus blacks (drug cap: 58.5% vs. 44.9%, no drug cap: 68.4% vs. 61.9%). In strict drug cap states only, Part D was associated with an increase in the proportion with any use [nonelderly: +0.07 absolute percentage points (95% CI: 0.06, 0.09), p<0.001; elderly: +0.08 (0.06,0.10), p<0.001] regardless of race. However, we found no evidence of a change in the white-black gap in the proportion of users despite the removal of a significant financial barrier.
Medicare Part D was associated with increased use of lipid lowering drugs, but racial gaps persisted. Understanding non-coverage-related barriers is critical to maximizing the potential benefits of coverage expansions for disparities reduction.
PMCID: PMC4135389  PMID: 24988304
2.  Gains in medication affordability following Medicare Part D are eroding among elderly with multiple chronic conditions 
Health affairs (Project Hope)  2014;33(8):1435-1443.
Elderly Americans, especially those with multiple chronic conditions, face difficulties paying for prescriptions, resulting in worse adherence and discontinuation of therapy (“cost-related medication nonadherence” or CRN). We investigated whether the gains in medication affordability attributable to Medicare Part D implementation in January 2006 persisted during the six years that followed. Overall, we found continued incremental improvements in medication affordability in the early years of Part D (2007–2009), which then eroded during more recent years (2009–2011). Among elderly beneficiaries with four or more chronic conditions, we observed an increase in the prevalence of CRN from 14.4% in 2009 to 17.0% in 2011, reversing previous downward trends. Similarly, the prevalence of forgoing basic needs in order to purchase medicines among the sickest elderly decreased from 8.7% in 2007 to 6.8% in 2009, then rose to 10.2% in 2011. Our findings highlight the need for targeted policy efforts to alleviate the persistent burden of drug treatment costs in this vulnerable population.
PMCID: PMC4340076  PMID: 25092846
3.  What motivates antibiotic dispensing in accredited drug dispensing outlets in Tanzania? A qualitative study 
Tanzania introduced the accredited drug dispensing outlet (ADDO) program more than a decade ago. Previous evaluations have generally shown that ADDOs meet defined standards of practice better than non-accredited outlets. However, ADDOs still face challenges with overuse of antibiotics for acute respiratory infections (ARI) and simple diarrhea, which contributes to the emergence of drug resistance. This study aimed to explore the attitudes of ADDO owners and dispensers toward antibiotic dispensing and to learn how accreditation has influenced their dispensing behavior.
The study used a qualitative approach. We conducted in-depth interviews with ADDO owners and dispensers in Ruvuma and Tanga regions where the government implemented the ADDO program under centralized and decentralized approaches, respectively; a secondary aim was to compare differences between the two regions.
Findings indicate that the ADDO program has brought about positive changes in knowledge of dispensing practices. Respondents were able to correctly explain treatment guidelines for ARI and diarrhea. Almost all dispensers and owners indicated that unnecessary use of antibiotics contributed to antimicrobial resistance. Despite this knowledge, translating it to appropriate dispensing practice is still low. Dispensers’ behavior is driven by customer demand, habit (“mazoea”), following inappropriate health facility prescriptions, and the need to make a profit. Although the majority of dispensers reported that they had intervened in situations where customers asked for antibiotics unnecessarily, they tended to give in to clients’ requests. Small variations were noted between the two study regions; for example, some dispensers in Ruvuma reported sending clients with incorrect prescriptions back to the health facility, a practice that may reflect regional differences in ADDO implementation and in Integrated Management of Childhood Illness training. Dispensers in rural settings reported more challenges in managing ARI and diarrhea than their urban counterparts did.
To reduce inappropriate antibiotic use, integrated interventions must include communities, health facilities, and ADDOs. Periodic refresher training with an emphasis on communication skills is crucial in helping dispensers deal with customers who demand antibiotics. Responsible authorities should ensure that ADDOs always have the necessary tools and resources available.
PMCID: PMC4509560  PMID: 26199723
ADDO; Antibiotics; Antimicrobial resistance
4.  Nearly Half of Families In High-Deductible Health Plans Whose Members Have Chronic Conditions Face Substantial Financial Burden 
Health affairs (Project Hope)  2011;30(2):322-331.
High-deductible health plans – typically with deductibles of at least $1,000 per individual and $2,000 per family -- require greater enrollee cost sharing than traditional plans. But they also may provide more affordable premiums and may be the lowest-cost, or only, coverage option for many families with members who are chronically ill. We surveyed families with chronic conditions in high-deductible plans and families in traditional plans to compare health care-related financial burden – such as experiencing difficulty paying medical or basic bills or having to set up payment plans. Almost half (48 percent) of the families with chronic conditions in high-deductible plans reported health care-related financial burden, compared to a fifth of families (21 percent) in traditional plans. Almost twice as many lower-income families in high-deductible plans spent more than 3 percent of income on health care expenses as lower-income families in traditional plans (53 percent versus 29 percent). As health reform efforts advance, policy makers must consider how to modify high-deductible plans to reduce the financial burden for families with chronic conditions.
PMCID: PMC4423400  PMID: 21289354
5.  Utilization of oral antidiabetic medications in Taiwan following strategies to promote access to medicines for chronic diseases in community pharmacies 
Taiwan’s National Health Insurance (NHI) has encouraged physicians to use “chronic medication prescriptions” for patients with stable chronic diseases since 1995. Patients are allowed to refill such prescriptions at community pharmacies for a maximum of three months’ supply of medications without revisiting the doctor. In 2006, NHI initiated strategies targeting the public, doctors, and healthcare facilities to enhance the overall rate of chronic medication prescriptions, aiming to achieve 30% by 2010. We examined prescribing and dispensing of oral antidiabetic drugs from 2001 to 2010, before and after the start of the promotion strategies for chronic medication prescriptions in 2006.
Using outpatient care data from the NHI database and the interrupted time series design, we analyzed changes in rate of chronic medication prescriptions, share of prescriptions filled at community pharmacies, and share of reimbursed expenditures accounted by community pharmacies.
During 2001-2010, the rate of chronic medication prescriptions for diabetes increased steadily by about 3% per year (from 3.5% to 26.2%). Three years after the promotion strategies, there was a non-significant reduction of 8.7% (95% confidence interval [CI]: -17.35%, 0.05%) in the rate of chronic medication prescriptions but increases in prescription refills at community pharmacies and associated reimbursed expenditures: 12.8% (95% C.I.:1.66%, 23.98%) and 15.8% (95% C.I.: -1.35%, 33.02%) respectively.
While rate of chronic medication prescriptions was not significantly affected by the 2006 promotion strategy, shares of prescriptions refilled at community pharmacies and associated expenditures increased slightly but significantly.
PMCID: PMC4422418  PMID: 25949816
Interrupted time series; Oral antidiabetic medications; Chronic medication prescriptions; Taiwan
6.  Policies and Programs to Facilitate Access to Targeted Cancer Therapies in Thailand 
PLoS ONE  2015;10(3):e0119945.
Increasing access to clinically beneficial targeted cancer medicines is a challenge in every country due to their high cost. We describe the interplay of innovative policies and programs involving multiple stakeholders to facilitate access to these medicines in Thailand, as well as the utilization of selected targeted therapies over time.
We selected two medicines on the 2013 Thai national list of essential medicines (NLEM) [letrozole and imatinib] and three unlisted medicines for the same indications [trastuzumab, nilotinib and dasatinib]. We created timelines of access policies and programs for these products based on scientific and grey literature. Using IMS Health sales data, we described the trajectories of sales volumes of the study medicines between January 2001 and December 2012. We compared estimated average numbers of patients treated before and after the implementation of policies and programs for each product.
Different stakeholders implemented multiple interventions to increase access to the study medicines for different patient populations. During 2007–2009, the Thai Government created a special NLEM category with different coverage requirements for payers and issued compulsory licenses; payers negotiated prices with manufacturers and engaged in pooled procurement; pharmaceutical companies expanded patient assistance programs and lowered prices in different ways. Compared to before the interventions, estimated numbers of patients treated with each medicine increased significantly afterwards: for letrozole from 645 (95% CI 366–923) to 3683 (95% CI 2,748–4,618); for imatinib from 103 (95% CI 72–174) to 350 (95% CI 307–398); and for trastuzumab from 68 (95% CI 45–118) to 412 (95% CI 344–563).
Government, payers, and manufacturers implemented multi-pronged approaches to facilitate access to targeted cancer therapies for the Thai population, which differed by medicine. Routine monitoring is needed to assess clinical and economic impacts of these strategies in the health system.
PMCID: PMC4370712  PMID: 25798948
7.  Farmácia Popular Program: changes in geographic accessibility of medicines during ten years of a medicine subsidy policy in Brazil 
The Brazilian constitution guarantees the right to health, including access to medicines. In May 2004, Brazil’s government announced the “Farmácia Popular” Program (FPP) as a new mechanism to improve the Brazilian population’s access to medicines. Under FPP, a selected list of medicines is subsidized by the government and provided in public and private pharmacies.
The aim of this study is to describe the historical stages of the FPP and to identify associated changes in the geographical accessibility of medicines through the FPP over time.
It was performed documentary review and an ecological study assessing program coverage in terms of number of facilities and a FPP Pharmacy Facilities Density (PFD) index at national and regional levels from 2004 to 2013, using the FPP database. We used geographic information system mapping to depict a pharmaceutical facilities density (PFD) index at the municipality level on thematic maps.
A growth of the PFD index coincident with the phases of the FPP was noticed. In the public sector, the program started in 2004; by 2006, there was a sharp increase in the numbers of participating pharmacies, stabilizing in 2009. In the private sector, the program started in 2006; by 2009 the PFD ratio had increased substantially and it continued to grow through 2011. There was an increase in FPP coverage in most regions between 2006, when the private pharmacy component started, and 2013, but participating pharmacies remain unequally distributed across geographical regions. Specifically, the wealthy areas in the South and Southeast have higher coverage, with lower coverage mostly in the North and Northeast, relatively poorer areas with greater need for access to medicines, health care, and other basic services such as potable water and sanitization.
There has been a substantial increase in the number of pharmacies participating in the FPP over time. This has led to greater program coverage and has potentially improved access to FPP medicines in the country. Nevertheless, disparities in pharmacy coverage remain among the regions.
Electronic supplementary material
The online version of this article (doi:10.1186/s40545-015-0030-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4403833  PMID: 25926990
Government programs; Brazil; Essential medicines; Access; Co-payment
8.  Uptake of new antidiabetic medications in three emerging markets: a comparison between Brazil, China and Thailand 
New antidiabetic medications such as insulin analogues and thiazolidinediones have been introduced over the last decade. This study compares the uptake of new agents in three emerging pharmaceutical markets: Brazil, China, and Thailand.
Using longitudinal IMS Health sales data, we calculated the quarterly percentage market share for types of insulins and oral hypoglycemic agents from 2002 through 2012 in each country. New oral hypoglycemic agents included: alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, and non-sulfonylurea secretagogues.
While China had the highest use of insulin cartridges and pens (85.6% in 2010), Brazil was the earliest adopter of insulin analogues and had the greatest use of these products overall (44.6% of the insulin market) in 2010, which then decreased by almost half by 2012. Together, sulfonylureas and metformin dominated the markets in Brazil and Thailand (~89% and ~96% respectively) over the 10-year period. Between 2002 and 2012, there was a shift in use from sulfonylureas to metformin; the market share of newer agents remained 10% or less in both countries. In China, however, market share of new oral agents grew rapidly from 13.1% to 44.4%. While metformin use was relatively stable in China (one-third of the market), sulfonylureas declined substantially over the 10-year period (41.5% to 20.8%).
Given large cost differentials between newer and older insulins and among oral hypoglycemic agents, it is important to evaluate uptake of newer products over time. Uptake patterns differed in the study countries, likely due to different medicines policy approaches. Future research should evaluate how trends in use of antidiabetic products align with national clinical practice guidelines and pharmaceutical policies, as well as the impacts of different patterns of use on cost and clinical outcomes.
PMCID: PMC4343056  PMID: 25815201
Diabetes; Brazil; China; Thailand; Drug policy; Insulin; Oral hypoglycemic agents; Access to medicines
9.  Patient access schemes in Asia-pacific markets: current experience and future potential 
Patient access (or risk-sharing) schemes are alternative market access agreements between healthcare payers and medical product manufacturers for conditional coverage of promising health technologies. This study aims to identify and characterize patient access schemes to date in the Asia-Pacific region.
We reviewed the literature on patient access schemes over the last two decades using publicly available databases, Internet, and grey literature searches. We extracted key features of each scheme identified, including the drug, clinical indication, stakeholders involved, and details of the scheme. We categorized schemes according to a previously published taxonomy of scheme types and by country.
We identified 3 schemes in South Korea, 5 in New Zealand, and 98 in Australia. Most (97.2%; n = 103) schemes focused on pharmaceuticals, few on medical technologies. More than half of the schemes related to treatments for cancer and inflammatory diseases such as rheumatoid arthritis. The majority (77.4%; n =82) involved pricing arrangements. Evidence generation schemes were rarely used. About half (41.8%; n = 41) of schemes in Australia were hybrid by nature, consisting of pricing arrangements with a conditional treatment continuation component.
Australia has the most experience with patient access schemes and its experience may provide useful insights for other Asia-Pacific countries. The main targets are pharmaceuticals likely to have high budget impact (due to high per-patient costs and/or large volumes of use), and pharmaceuticals that may be adopted more widely than indicated. With the proliferation of high-cost medicines, the use of schemes may increase to address rising cost pressures, consumer demands, and uncertainties, while attempting to provide patient access to innovative care within finite budgets. Future research is warranted to evaluate the performance of patient access schemes.
PMCID: PMC4359387  PMID: 25815200
Patient access schemes; Risk sharing; Managed entry; Conditional coverage; Health technology assessment; High cost medicines; Access to medicines
10.  Treatment of Febrile illness with artemisinin combination therapy: prevalence and predictors in five African household surveys 
To evaluate the determinants of compliance with national policies recommending Artemisinin Combination Therapy (ACT) for the treatment of uncomplicated malaria in the community.
We used data from Gambia, Ghana, Kenya, Nigeria, and Uganda national household surveys that were conducted with a standardized World Health Organization (WHO) methodology to measure access to and use of medicines. We analyzed all episodes of acute fever reported in the five surveys. We used logistic regression models accounting for the clustered design of the surveys to identify determinants of seeking care in public healthcare facilities, of being treated with antimalarials, and of receiving ACT.
Overall, 92% of individuals with a febrile episode sought care outside the home, 96% received medicines, 67% were treated with antimalarials, and 16% received ACT. The choice of provider was influenced by perceptions about medicines availability and affordability. In addition, seeking care in a public healthcare facility was the single most important predictor of treatment with ACT [odds ratio (OR): 4.64, 95% confidence intervals (CI): 2.98–7.22, P < 0.001]. Children under 5 years old were more likely than adults to be treated with antimalarials [OR: 1.28, CI: 0.91–1.79, not significant (NS)] but less likely to receive ACT (OR: 0.80, CI: 0.57–1.13, NS).
Our results confirm the high prevalence of presumptive antimalarial treatment for acute fever, especially in public healthcare facilities where poor people seek care. They show that perceptions about access to medicines shape behaviors by directing patients and caregivers to sources of care where they believe medicines are accessible. The success of national policies recommending ACT for the treatment of uncomplicated malaria depends not only on restricting ACT to confirmed malaria cases, but also on ensuring that ACT is available and affordable for those who need it.
PMCID: PMC4403946  PMID: 25926989
Artemisinin combination therapy; Household surveys; Appropriate use of medicines; Africa
11.  Rapid Rise of Breast Magnetic Resonance Imaging Use: Trends from 2000-2011 
JAMA internal medicine  2014;174(1):114-121.
Breast MRI is highly sensitive for detecting breast cancer. Low specificity, high cost and little evidence regarding mortality benefits, however, limit recommendations for its use to high risk women. How breast MRI is actually used in community settings is not known.
To describe breast MRI trends and indications in a community setting.
Retrospective cohort study.
Large not-for-profit health plan and multi-specialty group medical practice, both in New England.
: 10,518 women age 20 and older enrolled in the health plan for at least one year who had ≥ 1 breast MRIs between January 1, 2000 and December 31, 2011.
Main outcomes
Breast MRI counts were obtained from claims data. Clinical indication (screening, diagnostic evaluation, staging/treatment, or surveillance) for each MRI in the claims data was determined by a prediction model developed from electronic medical records on a subset of participants. Breast cancer risk status was assessed using claims data and, for the subset, also through electronic medical record review.
: Breast MRI use increased more than 20-fold from 6.5 per 10,000 women in 2000 to its peak of 130.7 per 10,000 in 2009. Use declined and stabilized to 104.8 per 10,000 by 2011. Screening and surveillance, rare indications in 2000, together accounted for nearly 60% of MRI use by 2011; 30% had claims-based personal and 50% family history of breast cancer, while 4% of women had a genetic mutation noted. In the subset of women who had electronic medical records and received screening or surveillance MRIs, only 21% had evidence of meeting the American Cancer Society's (ACS's) criteria for breast MRI. Conversely, only half of women with documented deleterious genetic mutations received breast MRI screening.
Breast MRI use rose steeply over ten years and then stabilized, especially for screening and surveillance among women with family or personal history of breast cancer; the majority of women receiving screening and surveillance breast MRIs did not have evidence in their medical records meeting ACS criteria and many women with mutations were not screened. Efforts are needed to ensure that breast MRI use and documentation are focused on those women who will benefit most.
PMCID: PMC4145846  PMID: 24247482
12.  Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries 
To identify pharmaceutical policy changes during the economic recession in eight European countries and to determine whether policy measures resulted in lower sales of, and less expenditure on, pharmaceuticals.
Information on pharmaceutical policy changes between 2008 and 2011 in eight European countries was obtained from publications and pharmaceutical policy databases. Data on the volume and value of the quarterly sales of products between 2006 and 2011 in the 10 highest-selling therapeutic classes in each country were obtained from a pharmaceutical market research database. We compared these indicators in economically stable countries; Austria, Estonia and Finland, to those in economically less stable countries, Greece, Ireland, Portugal, Slovakia and Spain.
Economically stable countries implemented two to seven policy changes each, whereas less stable countries implemented 10 to 22 each. Of the 88 policy changes identified, 33 occurred in 2010 and 40 in 2011. They involved changing out-of-pocket payments for patients in 16 cases, price mark-up schemes in 13 and price cuts in 11. Sales volumes increased moderately in all countries except Greece and Portugal, which experienced slight declines after 2009. Sales values decreased in both groups of countries, but fell more in less stable countries.
Less economically stable countries implemented more pharmaceutical policy changes during the recession than economically stable countries. Unexpectedly, pharmaceutical sales volumes increased in almost all countries, whereas sales values declined, especially in less stable countries.
PMCID: PMC4208566  PMID: 25378754
13.  Quality use of medicines within universal health coverage: challenges and opportunities 
Medicines are a major driver of quality, safety, equity, and cost of care in low and middle-income country health systems. Universal health coverage implementers must explicitly address appropriate use of medicines to realize the health benefits of medicines, avoid wasting scarce resources, and sustain the financial viability of universal health coverage schemes.
Medicines are major contributors to the health and well-being of individuals and populations when used appropriately, and they waste resources and endanger health when used unnecessarily or incorrectly. Stakeholders need to balance inherently competing objectives in the pharmaceutical sector. Emerging and expanding UHC schemes provide potential levers to balance competing system objectives.
To use these levers, sustainable universal coverage programs will require a) information systems that can track medicines utilization, expenditures, and quality of medicines use; b) routine monitoring of indicators of medicines availability, access, affordability, and use; c) policies and programs that facilitate appropriate medicines use by prescribers, dispensers, and patients; d) transparency in setting priorities for medicines coverage under resource constraints; and e) a system perspective to engage diverse actors.
As they operationalize paths toward universal health coverage and include targeted medicines coverage policies and programs, systems can build on, and innovate, pharmaceutical policy frameworks and management tools from different countries’ settings.
Ensuring that medicines which achieve important health outcomes are available, accessible to all, used appropriately, and sustainably affordable is essential for realizing universal health coverage. Stakeholder cooperation and use of information and financing system levers provide opportunities to work toward this goal.
PMCID: PMC4158132  PMID: 25164588
Universal health coverage; Medicines; Pharmaceutical benefit; Financial incentives; Health systems; Quality of care
14.  Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses 
To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession – a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal – on utilization of, as a proxy for access to, antipsychotic medicines.
We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends.
Both countries’ policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions.
Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended – increased use of generics – and likely unintended – slightly decreased overall sales, possibly consistent with decreased access to needed medicines – impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.
PMCID: PMC4126811  PMID: 25062657
Finland; Portugal; Antipsychotic medicines; Interrupted time series; Utilization of medicines
15.  Some Families Who Purchased Health Coverage Through The Massachusetts Connector Wound Up With High Financial Burdens 
Health affairs (Project Hope)  2013;32(5):974-983.
Health insurance exchanges created under the Affordable Care Act will offer coverage to people who lack employer-sponsored insurance or have incomes too high to qualify for Medicaid. However, plans offered through an exchange may include high levels of cost sharing. We surveyed families participating in unsubsidized plans offered in the Massachusetts Commonwealth Health Insurance Connector Authority, an exchange created prior to the 2010 national health reform law, and found high levels of financial burden and higher-than-expected costs among some enrollees. The financial burden and unexpected costs were even more pronounced for families with greater numbers of children and in families with incomes below 400 percent of the federal poverty level. We conclude that those with lower incomes, increased health care needs, and more children will be at particular risk after they obtain coverage through exchanges in 2014. Policy makers should develop strategies to further mitigate the financial burden for enrollees who are most susceptible to encountering higher-than-expected out-of-pocket costs, such as cost calculators or price transparency tools.
PMCID: PMC4103655  PMID: 23595500
16.  Improving adherence to antiretroviral treatment in Uganda with a low-resource facility-based intervention 
Global Health Action  2014;7:10.3402/gha.v7.24198.
To assess the effects of facility-based interventions using existing resources to improve overall patient attendance and adherence to antiretroviral therapy (ART) at ART-providing facilities in Uganda.
This was an interventional study which tracked attendance and treatment adherence of two distinct cohorts: experienced patients who had been on treatment for at least 12 months prior to the intervention and patients newly initiated on ART before or during the intervention. The interventions included instituting appointment system, fast-tracking, and giving longer prescriptions to experienced stable patients. Mixed-effects models were used to examine intervention effects on the experienced patients, while Cox proportional hazards models were used to determine the intervention effects on time until newly treated patients experienced gaps in medication availability.
In all, 1481 patients’ files were selected for follow-up from six facilities – 720 into the experienced cohort, and 761 into the newly treated cohort. Among patients in the experienced cohort, the interventions were associated with a significant reduction from 24.4 to 20.3% of missed appointments (adjusted odds ratio (AOR): 0.67; 95% confidence interval (CI): 0.59–0.77); a significant decrease from 20.2 to 18.4% in the medication gaps of three or more days (AOR: 0.69; 95% CI: 0.60–0.79); and a significant increase from 4.3 to 9.3% in the proportion of patients receiving more than 30 days of dispensed medication (AOR: 2.35; 95% CI: 1.91–2.89). Among newly treated patients, the interventions were associated with significant reductions of 44% (adjusted hazard rate (AHR): 0.56, 95% CI: 0.42–0.74) and 38% (AHR: 0.62; 95% CI: 0.45–0.85) in the hazards of experiencing a medication gap of 7 and 14 days or more, respectively.
Patients’ adherence was improved with low-cost and easily implemented interventions using existing health facilities’ resources. We recommend that such interventions be considered for scale-up at national levels as measures to improve clinic attendance and ART adherence among patients in Uganda and other low-resource settings in sub-Saharan Africa.
PMCID: PMC4049133  PMID: 24909408
antiretroviral therapy; adherence; management; staff motivation; intervention; Uganda
17.  The Effect of Medicare Part D on Guideline-Concordant Pharmacotherapy for Bipolar I Disorder among Dually Enrolled Beneficiaries 
In January 2006 drug insurance coverage shifted from Medicaid to Medicare Part D private drug plans for the 6 million individuals enrolled in both programs. Beneficiaries faced new formularies and utilization management policies. It is uncertain if Part D, when compared to Medicaid, relaxed or tightened psychiatric medication management, which could affect receipt of recommended pharmacotherapy, and emergency department use related to treatment discontinuities. This study examined the impact of the transition from Medicaid to Part D on guideline-concordant pharmacotherapy for bipolar I disorder and emergency department use.
Using interrupted time series and Medicaid and Medicare administrative data from 2004–2007, the authors analyzed the effect of the coverage transition on receipt of guideline-concordant anti-manic medication, guideline-discordant antidepressant monotherapy, and emergency department visits for a nationally-representative continuous cohort of 1,431 adults diagnosed with bipolar I disorder.
Sixteen months after the transition, the proportion of the population with any recommended anti-manic use was an estimated 3.1 percentage points higher than expected controlling for baseline trends. The monthly proportion of beneficiaries with 7+ days of antidepressant monotherapy was 2.1 percentage points lower than expected. The number of emergency department visits per month increased by 19% immediately post-transition.
Increased receipt of guideline-concordant pharmacotherapy for bipolar I disorder may reflect relatively less restrictive management of anti-manic medications under Part D. The clinical significance of these changes is unclear given the small effect sizes. However, increased emergency department visits merit attention for the Medicaid beneficiaries who continue to transition to Part D.
PMCID: PMC4038978  PMID: 24337444
To examine how enrollment in high-deductible health plans (HDHPs) affects use of well-child visits relative to traditional plans, in plans where preventive care is exempt from the deductible.
Study Design
Pre-post comparison between groups.
We selected children aged ≤ 18 years enrolled in a large Massachusetts health plan through employers offering only one type of plan. Children were in traditional plans for a 12-month baseline period between 2001 and 2004, then were either switched by a decision of the parent’s employer to an HDHP or kept in the traditional plan (controls) for a 12-month follow-up period. Preventive and other office visits were exempt from the deductible and subject to co-payments as in traditional plans. The primary outcome was whether the child received well-child visits recommended for the 12-month period. Using generalized linear mixed models, we compared the change in receipt of recommended well-child visits between baseline and follow-up for the HDHP group relative to controls.
We identified 1,598 children who were switched to HDHPs and 10,093 controls. Between baseline and follow-up, the mean proportion of recommended well-child visits received by HDHP children decreased slightly from 0.846 to 0.841, and from 0.861 to 0.855 for controls. In adjusted models, there was no significant difference in the change in probability that recommended well-child visits were received for HDHP children relative to controls (p=0.69).
Receipt of recommended well-child visits did not change for children switching to HDHPs which exempt preventive care from the deductible compared to those remaining in traditional plans.
PMCID: PMC3984915  PMID: 21348554
consumer-directed healthcare; cost sharing/co-payments; benefit design; insurance type; pediatrics; healthcare utilization
19.  Impact of Prior Authorization on the Use and Costs of Lipid-Lowering Medications Among Michigan and Indiana Dual Enrollees in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study 
Clinical therapeutics  2011;33(1):135-144.
Some Medicaid programs have adopted prior-authorization (PA) policies that require prescribers to request approval from Medicaid before prescribing drugs not included on a preferred drug list.
This study examined the association between PA policies for lipid-lowering agents in Michigan and Indiana and the use and cost of this drug class among dual enrollees in Medicare and Medicaid.
Michigan and Indiana claims data from the Centers for Medicare and Medicaid Services were assessed. Michigan Medicaid instituted a PA requirement for several lipid-lowering medications in March 2002; Indiana implemented a PA policy for drugs in this class in September 2002. Although the PA policies affected some statins, they predominantly targeted second- line treatments, including bile acid sequestrants, fibrates, and niacins. Individuals aged ≥18 years who were continuously dually enrolled in both Medicare and Medicaid from July 2000 through September 2003 were included in this longitudinal, population-based study, which included a 20-month observation period before the implementation of PA in Michigan and a 12-month follow-up period after the Indiana PA policy was initiated. Interrupted time series analysis was used to examine changes in prescription rates and pharmacy costs for lipid-lowering drugs before and after policy implementation.
A total of 38,684 dual enrollees in Michigan and 29,463 in Indiana were included. Slightly more than half of the cohort were female (Michigan, 53.3% [20,614/38,684]; Indiana, 56.3% [16,595/29,463]); nearly half were aged 45 to 64 years (Michigan, 43.7% [16,921/38,684]; Indiana, 45.2% [13,321/29,463]). Most subjects were white (Michigan, 77.4% [29,957/ 38,684]; Indiana: 84.9% [25,022/29,463]). The PA policy was associated with an immediate 58% reduction in prescriptions for nonpreferred medications in Michigan and a corresponding increase in prescriptions for preferred agents. However, the PA policy had no apparent effect in Indiana, where there had been little use of non-preferred medications before the policy was implemented (3.3%). The policies were associated with an immediate reduction of $24,548 in prescription expenditures in Michigan and an immediate reduction of $16,070 in Indiana.
The PA policy was associated with substantially lower use of nonpreferred lipid-lowering drugs in Michigan, offset by increases in the use of preferred medications, but there was less change in Indiana. Data limitations did not permit the evaluation of the impact of policy-induced switching on clinical outcomes such as cholesterol levels. The monetary benefit of PA policies for lipid-lowering agents should be weighed against administrative costs and the burden on patients and health care providers.
PMCID: PMC3980661  PMID: 21397779
drug expenditure; drug utilization; lipid-lowering drugs; Medicaid; prior authorization; statins
20.  The Experience Of Massachusetts Shows That Consumers Will Need Help In Navigating Insurance Exchanges 
Health affairs (Project Hope)  2013;32(1):78-86.
In 2022 twenty-five million people are expected to purchase health insurance through exchanges to be established under the Affordable Care Act. Understanding how people seek information and make decisions about the insurance plans that are available to them may improve their ability to select a plan and their satisfaction with it. We conducted a survey in 2010 of enrollees in one plan offered through Massachusetts’s unsubsidized health insurance exchange to analyze how a sample of consumers selected their plans. More than 40 percent found plan information difficult to understand. Approximately one-third of respondents had help selecting plans—most commonly from friends or family members. However, one-fifth of respondents wished they had had help narrowing plan choices; these enrollees were more likely to report negative experiences related to plan understanding, satisfaction with affordability and coverage, and unexpected costs. Some may have been eligible for subsidized plans. Exchanges may need to provide more resources and decision-support tools to improve consumers’ experiences in selecting a health plan.
PMCID: PMC3950973  PMID: 23297274
21.  Impact of Two Medicaid Prior-Authorization Policies on Antihypertensive Use and Costs Among Michigan and Indiana Residents Dually Enrolled in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study 
Clinical therapeutics  2010;32(4):10.1016/j.clinthera.2010.04.007.
In response to rising pharmaceutical costs, many state Medicaid programs have implemented policies requiring prior authorization for high-cost medications, even for established users. However, little is known about the impact of these policies on the use of antihypertensive medicines in the United States.
The aim of this longitudinal, population-based study was to assess comprehensive prior-authorization programs for antihypertensives on drug use and costs in a vulnerable Medicaid population in Michigan and Indiana.
A prior-authorization policy for anti-hypertensives was implemented in Michigan in March 2002 and in Indiana in September 2002; Indiana also implemented an antihypertensive stepwise-therapy requirement in July 2003. Our study cohort included individuals aged ≥18 years in Michigan and Indiana who were continuously enrolled in both Medicaid and Medicare from July 2000 through September 2003. Claims data were obtained from the Centers for Medicare and Medicaid Services. We included all antihypertensive medications, including diuretics, angiotensin-converting enzyme inhibitors, calcium channel blockers, β-blockers, α-blockers, and angiotensin II receptor blockers. We used interrupted time-series analysis to study policy-related changes in the total number and cost of anti-hypertensive prescriptions.
Overall, 38,684 enrollees in Michigan and 29,463 in Indiana met our inclusion criteria. Slightly more than half of our cohort in both states was female (53.29% in Michigan and 56.32% in Indiana). In Michigan, 20.23% of patients were aged ≥65 years; 77.44% were white, 20.11% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. In Indiana, 20.07% were aged ≥65 years; 84.93% were white, 13.64% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. The implementation of both policies was associated with large and immediate reductions in the use of nonpreferred medications: 83.33% reduction in the use of such drugs in Michigan (−84.30 prescriptions per 1000 enrollees per month; P < 0.001) and 35.76% in Indiana (−64.45 prescriptions per 1000 enrollees per month; P < 0.001). As expected, use of preferred medications also increased substantially in both states (P < 0.001). Overall, antihypertensive therapy immediately dropped 0.16% in Michigan (P = 0.04) and 1.82% in Indiana (P = 0.02). Implementation of the policies was also associated with reductions in pharmacy reimbursement of $616,572.43 in Michigan and $868,265.97 in Indiana in the first postpolicy year.
Prior authorization was associated with lower use of nonpreferred antihypertensive drugs that was largely offset by increases in the use of preferred drugs. The possible clinical consequences of policy-induced drug switching for individual patients remain unknown because the present study did not include access to medical record data. Further research is needed to establish whether large-scale switches in medicines following the inception of prior-authorization policies have any long-term health effects.
PMCID: PMC3844690  PMID: 20435243
prior authorization; Medicaid; anti-hypertensive; drug utilization; costs
22.  Access to medicines for acute illness in middle income countries in Central America 
Revista de Saúde Pública  2013;47(6):1069-1079.
To analyze the main predictors of access to medicines for persons who experienced acute health conditions.
This was a cross-sectional analytic study, based on data from household surveys. We examined the predictors of: (1) seeking care for acute illness in the formal health care system and (2) obtaining all medicines sought for the acute condition.
The significant predictors of seeking health care for acute illnesses were urban geographic location, head of household with secondary school education or above, age under 15, severity of illness perceived by the respondent, and having health insurance. The most important predictor of obtaining full access to medicines was seeking care in the formal health care system. People who sought care in the formal system were three times more likely to receive all the medicines sought (OR 3.0, 95%CI 2.3;4.0). For those who sought care in the formal health system, the strongest predictors of full access to medicines were seeking care in the private sector, having secondary school education or above, and positive perceptions of quality of health care and medicines in public sector health facilities. For patients who did not seek care in the formal health system, full access to medicines was more likely in Honduras or Nicaragua than in Guatemala. Urban geographic location, higher economic status, and male gender were also significant predictors.
A substantial part of the population in these three countries sought and obtained medicines outside of the formal health care system, which may compromise quality of care and pose a risk to patients. Determinants of full access to medicines inside and outside the formal health care system differ, and thus may require different strategies to improve access to medicines. 
PMCID: PMC4206104  PMID: 24626545
Pharmaceutical Preparations; Health Services Accessibility; Communicable Disease Control; Health Surveys, utilization; Cross-Sectional Studies
23.  Methods for estimating confidence intervals in interrupted time series analyses of health interventions 
Journal of clinical epidemiology  2008;62(2):10.1016/j.jclinepi.2008.08.007.
Interrupted time series is a strong quasi-experimental research design that is increasingly applied to estimate the effects of health services and policy interventions. We describe and illustrate two methods for estimating confidence intervals around absolute and relative changes in outcomes calculated from segmented regression parameter estimates.
Study Design and Setting
We used multivariate delta and bootstrapping methods to construct confidence intervals around relative changes in level and trend and around absolute changes in outcome based on segmented linear regression analyses of time series data corrected for auto-correlated errors.
Using previously published time series data, we estimated confidence intervals around the effect of prescription alerts for interacting medications with warfarin on the rate of prescriptions per 10,000 warfarin users per month. Both the multivariate delta method and the bootstrapping method produced similar results.
The bootstrapping method is preferred for calculating confidence intervals of relative changes in outcomes of time series studies since it does not require large sample sizes when parameter estimates are obtained correctly from the model. Caution is needed when sample size is small.
PMCID: PMC3828652  PMID: 19010644
Interrupted time series; Segmented regression; Confidence interval; Relative change; Bootstrapping; Delta method
24.  The Relationship Between Emergency Department Use and Cost-Related Medication Nonadherence Among Medicare Beneficiaries 
Annals of emergency medicine  2013;62(5):10.1016/j.annemergmed.2013.04.013.
The objective of this study was to evaluate the relationship between self reported cost-related nonadherence to medications and emergency department utilization among a population of Medicare beneficiaries. We hypothesized that persons who reported cost-related medication nonadherence (CRN) would have higher emergency department (ED) use.
We conducted a retrospective cohort study of continuously enrolled Medicare beneficiaries from in 2006 and 2007. We used multivariate logistic regression to evaluate the relationship between ED use and CRN. Our principal dependent variable was any emergency department visit within a 364-day period after the initial interview assessing CRN. Our principal independent variables were two variables to denote CRN: mild CRN, defined as a reduction in medication dose or delay in getting medications because of cost, and severe CRN, defined as a medication not being filled at all due to cost.
Our sample consisted of 7177 Medicare Cost Beneficiary Survey (MCBS) MCBS respondents. Approximately 7.5 percent of these respondents reported mild CRN only (n=541) and another 8.2 percent reported severe CRN (n=581). Disabled Medicare beneficiaries with severe CRN were more likely to have at least one ED visit (1.53, 95% CI 1.03–2.26) as compared to both disabled Medicare beneficiaries without CRN and elderly Medicare beneficiaries in all CRN categories.
Our results show an association between severe CRN and emergency department use. Disabled beneficiaries under age 65 who report severe CRN were more likely to have at least one emergency department visit, even when adjusting for other factors that impact utilization.
PMCID: PMC3812390  PMID: 23726522
25.  Effect of Switching to a High-Deductible Health Plan on Use of Chronic Medications 
Health Services Research  2011;46(5):1382-1401.
To examine whether high-deductible health plans (HDHPs) that exempt prescription drugs from full cost sharing preserve medication use for major chronic illness, compared with traditional HMOs with similar drug cost sharing.
Data Sources/Study Setting
We examined 2001–2008 pharmacy claims data of 3,348 continuously enrolled adults in a Massachusetts health plan for 9 months before and 24 months after an employer-mandated switch from a traditional HMO plan to a HDHP, compared with 20,534 contemporaneous matched HMO members. Both study groups faced similar three-tiered drug copayments. We calculated daily medication availability for all prescription drugs and four chronic medication classes: hypoglycemics, lipid-lowering agents, antihypertensives, and chronic obstructive pulmonary disease (COPD)/asthma controllers.
Study Design
Interrupted time-series with comparison group study design examining monthly level and trend changes in prescription drug utilization.
Principal Findings
The HDHP and control groups had comparable changes in the level and trend of all drugs after the index date; we detected similar patterns in the use of lipid-lowering agents, antihypertensives, and COPD/asthma controllers. Some evidence suggested a small relative decline in hypoglycemic use among diabetic patients in HDHPs.
Switching to an HDHP that included modest drug copayments did not change medication availability or reduce use of essential medications for three common chronic illnesses.
PMCID: PMC3207183  PMID: 21413983
High-deductible health plans; pharmaceutical use; chronic disease; differential cost-sharing

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