Objective

To compare the prevalence of falls and fall-related concerns of medication users versus nonusers in U.S. seniors.

Design

Cross-sectional study.

Setting

The National Health and Aging Trends Study.

Participants

U.S. nationally representative sample of Medicare beneficiaries in 2011.

Outcomes

Comparing subjects who used medications with subjects who did not in the past month, the outcomes were percentages of subjects who experienced 1) a fall in the past month, 2) worry about falling in the past month, 3) being limited by this worry in the past month, 4) a fall in the past year.

Results

A greater percentage of medication users experienced falls and fall-related outcomes, compared with non-medication users. Among medication users, 10.29% had a past month fall, compared with 5.42% of non-medication users; 27.69% of medication users worried in the past month about falling, compared with 9.15% of non-medication users; 40.96% of medication users were limited by this worry, compared with 21.21%; 22.82% of medication users had a fall in the past year, compared with 13.15% of non-medication users.

Conclusion

Seniors who use medications are more likely to fall and to be concerned about falling. Pharmacist involvement in fall prevention continues to be essential.

The increasing number of pharmacists in the US has generated concern regarding potential oversupply. A 2018 analysis from the National Center for Health Workforce Analysis (NCHWA) in the US projected a best case scenario of an oversupply of more than 18,000 pharmacists in the year 2030. In this commentary, the limitations of this general health labor force analysis by the NCHWA are described. The goal of this work was to provide a more nuanced examination of the pharmacist labor demand in the US. Data from the US Bureau of Labor Statistics (BLS) and the US Medical Expenditure Panel Survey (MEPS) were utilized to examine, annually over a ten year period ending in 2017, the number of pharmacists, the ratio of pharmacists to persons living in the US, the ratio of pharmacists to older adults living in the US, and the ratio of medications to pharmacists. The number of pharmacists grew from 266,410 in 2008 to 309,330 in 2017. As anticipated, despite a growing US population, the ratio of people living in the US per pharmacist dropped unabated from 1141 to 1053 from 2008 to 2017, respectively. However, the reverse trend was observed for the ratio of persons 65 years or older per pharmacist. This ratio increased from 146.1 older adults to each pharmacist in 2008 to 164.3 in 2017. The accelerating demographic shift to an older population is also reversing an overall trend in the number of medications to pharmacist that will continue for the foreseeable future. While the ratio of medications to pharmacist dropped overall from 2008 to 2016, it has begun to rise again from 2016 to 2017. Beyond the increasing number of medications attributable to a rapidly aging population, there is a growing demand for clinical care from pharmacists due to the maturing environment of complex, costly medications for chronic disease treatment. As the portion of total health expenditure is increasingly devoted to medications and the US health delivery system continues its movement to community-based care, the demand for pharmacist care will require a larger number of pharmacists trained for advanced-practice care.

Obesity rates for older people have increased around the world¹ with rates tripling over the past four decades.² While previously considered a phenomenon of developed countries, the increased prevalence of obesity is now established in developing countries as well.³ Factors stimulating this epidemic include modifications in the global food supply chain, rise in consumption and availability of energy-dense, low-nutrient foods, sedentary occupations, expanding urbanization, changes in transportation means, as well as environmental components.³ The increasing prevalence of obesity in older people in the United States over time has been well documented by federal agencies. Over the time periods 1999-2002, 2003-2006, and 2007-2010, a linear increase in the prevalence of obesity among older men in all age groups was observed. The obesity prevalence among men 65 to 74 years of age increased from about 31.6% in 1999-2002 to 41.5% in 2007-2010. In men older than 74 years of age, obesity prevalence increased from 17.7% in 1999-2002 to 26.5% in 2007-2010. Of interest is that, in women, the change over the same time period was not statistically significant for the older age groups (40.3% obesity in 65- to 74-year-old women and 28.7% in women older than 74 years of age in the 2007-2010 analysis period).⁴.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) is the single largest payer for health care in the United States and the largest payer by spending globally. Medicare Part B, with more than 50 million beneficiaries, currently has no broad mechanisms in place for promoting cost-effective care of injectable drugs. OBJECTIVE: To conduct a real-world utilization and cost analysis comparing botulinum toxins in movement disorders. METHODS: The 2017 Medicare Provider Utilization and Payment Data: Physician and Other Supplier dataset from CMS was used for this claims level analysis. Neurologists, ophthalmologists, or physiatrists who injected predominantly for movement disorders (defined as blepharospasm, cervical dystonia, sialorrhea, and/or spasticity) were included along with their patients. Botulinum toxins with FDA indications spanning these 3 specialties were included. RESULTS: A total of 891 physicians (406 ophthalmologists, 338 neurologists, and 147 physiatrists) along with their 29,954 botulinum toxin (27,441 onabotulinumtoxinA and 2,513 incobotulinumtoxinA) patients were included in the analysis. The average total drug cost per patient per year (PPPY) was significantly lower for incobotulinumtoxinA versus onabotulinumtoxinA ($2,099 vs. $3,115; P < 0.001), for an average savings of 32.6%. Annual average out-of-pocket costs were also significantly less expensive for incobotulinumtoxinA versus onabotulinumtoxinA ($486 vs. $719; P < 0.001), for an average savings of 32.4%. Across 74,346 total injection visits, there was no significant difference in dosing between the agents, with an average dosing ratio of 0.94 incobotulinumtoxinA to 1.0 onabotulinumtoxinA. Injections PPPY were 2.42 for onabotulinumtoxinA and 2.29 for incobotulinumtoxinA. Average reported wastage was 64% higher for onabotulinumtoxinA than it was for incobotulinumtoxinA. A budget impact analysis estimated that increasing incobotulinumtoxinA use in the movement disorder space to attain an overall 20% botulinum toxin market share would save Medicare $32.9 million over a 3-year period versus current use. CONCLUSIONS: IncobotulinumtoxinA was shown to be a less costly alternative than onabotulinumtoxinA with similar dosing in real-world practice in this large national Medicare population. Policies to increase use of agents that promote cost-effective evidence-based care should be further explored and implemented for this fundamental federal payer. DISCLOSURES: This research received no external funding. Kazerooni was an employee of Merz Pharmaceuticals at the time of the analysis. Watanabe received no compensation or funding for this research project. Watanabe is a member of the National Academies of Sciences, Engineering, and Medicine Forum on Drug, Discovery, Development, and Translation. This information, content, and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by the U.S. government or the National Academies of Sciences, Engineering.

The articles in the June issue serve not only to inform senior care pharmacists on the importance of evidence-based approaches to reduce unnecessary aspirin use, but they also underscore the urgent need for the large and rapid increase in older adult representation in clinical trials and clinical research in general. A striking analysis performed in the United States that examined the trial populations used for Medicare coverage determinations found that while the average age of a Medicare enrollee was 70.8 years old (74.7 years old for older Medicare participants), the average age of the clinical trial population patients used in technology assessments for Medicare coverage determinations was 60.1 years. Hence, the US Medicare system, one of the largest national health care purchasers for older patients in the world, has relied on non-representative data to inform medical coverage decisions.

Background

Statins remain a fundamental component of pharmacologic therapy for hyperlipidemia. Health benefits of statin therapy are jeopardized when adherence is reduced.

Objectives

To (a) assess the association between copayment and copayment type on statin adherence using 2 different thresholds of adherence and (b) identify the incremental change in statin adherence associated with presence of copayment and copayment type.

Methods

We executed a retrospective cohort study of new users of statins with dyslipidemia from the Veterans Health Administration (VHA) within the Veterans Integrated Service Network 22 who initiated a statin between November 30, 2006, and December 2, 2007. We used exposure categories of Any Copayment versus No Copayment, indicating a patient had a copayment or had no copayment in order to obtain medications, respectively. As a separate analysis, we varied the exposures to the standard VHA copayment categories: (a) Service-Connected (SC) Copayment (patients with service-related injury), (b) Non-Service-Connected (NSC) Copayment (patients without a service-related injury), and (c) No Copayment. Using each set of exposures, we conducted separate multiple logistic regression analyses using 2 different adherence outcomes based on medication possession ratio (MPR) threshold: (1) adherence defined as MPR ≥ 0.8 and (2) adherence defined as MPR ≥ 0.9. We then proceeded with multiple linear regression models to determine the incremental change in MPR associated with the 2 sets of exposures. Subjects were required to be enrolled in VHA services for at least 2 years prior to index date and throughout the 1-year study period.

Results

A total of 4,886 subjects were identified for analysis based on the inclusion and exclusion criteria. Patients who did not pay a copayment for their statin medications were more likely to have adherence rates of ≥ 0.8 MPR and ≥ 0.9 MPR relative to the No Copayment Group with odds ratios (OR) of 1.19 (95% CI = 1.03-1.37) and 1.28 (95% CI = 1.11-1.48), respectively. The second analysis applied the VHA exposure categories of SC Copayment, NSC Copayment, and No Copayment. Using the 0.8 MPR or greater adherence threshold, the No Copayment group was associated with an increased likelihood of adherence versus the SC Copayment category as reference group with an OR of 1.31 (95% CI = 1.10-1.58). The NSC Copayment was associated with a nonsignificant increase in odds of adherence at the 0.8 MPR level or greater with OR of 1.12 (95% CI = 0.98-1.39). Using the 0.9 MPR level or greater, adherence threshold findings were similar. The No Copayment group produced an OR of 1.42 (95% CI = 1.17-1.71) compared with the SC Copayment group. The NSC Copayment group was associated with a nonsignificant increase in odds of adherence at the 0.9 MPR level or greater with an OR of 1.12 (95% CI = 0.97-1.38).The No Copayment group was associated with an increase in MPR of 0.02 (95% CI = 0.002-0.035) versus the Any Copayment category. Using the VHA copayment categories, we observed an increase in MPR for the No Copayment group versus the SC Copayment group of 0.03 (95% CI = 0.01-0.05). The NSC Copayment group was associated with a nonsignificant increase in MPR versus the SC Copayment group of 0.02 (95% CI = -0.003-0.036).

Conclusions

Patients without out-of-pocket payments for their statins were more likely to adhere to therapy. Patients who pay a copayment for their statin medications were also compared with each other based on whether they (a) received any of their nonstatin prescriptions without a copayment or (b) paid a copayment on all of their prescriptions including statins. Our findings suggest that, among those that pay for their statins, patients are less adherent to their statins if other medications they are prescribed are copayment free. Thus, patient consumption behavior may be influenced by the relative cost of medications in patient prescription lists. Additional counseling on the necessity of adherence should be given to patients paying a copayment for their statin prescriptions.

Background

Previous estimates of the economic burden of Crohn's disease (CD) varied widely from $2.0 to $18.2 billion per year (adjusted to 2015 $US). However, these estimates do not reflect recent changes in pharmaceutical treatment options and guidelines.

Objective

The goal of this study was to update cost estimates of Crohn's disease based on a representative sample of the US population from the most recent 11 years (2003-2013) of the Medical Expenditure Panel Survey (MEPS). A secondary aim described expenditure trends in respondents with and without Crohn's disease pre-post FDA approvals of new biologics and the American College of Gastroenterology Crohn's disease treatment guidelines.

Methods

Average annual expenditures (total, prescription, inpatient, and outpatient) were evaluated using a pooled cross-sectional design. Respondent data from the most recent 11 years (2003-2013) of MEPS were analyzed. Two-part generalized linear models with power-link were used to estimate the average annual expenditures per patient adjusted to multiple covariates. Confidence intervals (CI) were estimated using bootstrap methods. Difference-in-differences estimations were performed to compare the changes in health care expenditures pre-post FDA approvals of new biologics and the American College of Gastroenterology Crohn's disease treatment guidelines.

Results

The annual aggregate economic burden of CD was $6.3 billion in the US. Respondents with CD had higher total (+$6442; 95% CI: $4864 to $8297), prescription (+$3283; 95% CI: $2289 to $4445), inpatient (+$1764; 95% CI: $748 to $3551), and outpatient (+$1191; 95% CI: $592 to $2160) expenditures compared to respondents without CD. In the difference-in-differences estimation, respondents with CD had significantly higher total (P = 0.001) and prescription (P < 0.001) expenditures compared with respondents without CD. Although inpatient and outpatient expenditures were higher in respondents with CD, they were not statistically significant.

Conclusions

Respondents with CD diagnosis had higher expenditures compared to respondents without CD diagnosis from 2003 to 2013. This study captured the most recent availability of new treatment options and changes to treatment guidelines, while providing updated estimates of the economic burden of CD in the US. However, this research was unable to study the causes of these increased health care expenditures in respondents with CD. Future investigations will need to determine the causal factors for increased expenditures in CD.

Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

BACKGROUND:Public attention and recent US Congressional activity has intensified focus on escalating medication prices. However, the actual cost of medication use extends beyond the up-front cost of purchasing medicines. It also encompasses the additional medical costs of morbidity and mortality resulting from nonoptimized medication regimens, including medication nonadherence. OBJECTIVES:Applying the most current nationally representative data sources, our goal was to estimate the cost of prescription drug-related morbidity and mortality in the United States. METHODS:Total costs of nonoptimized prescription drug use and average pathway costs for a patient who experienced a treatment failure (TF), a new medical problem (NMP), or a TF and NMP were modeled in Microsoft Excel (Microsoft Corporation, Redmond, WA) and TreeAge Pro Healthcare, v2014 (TreeAge Software, Inc, Williamstown, MA), respectively. RESULTS:The estimated annual cost of prescription drug-related morbidity and mortality resulting from nonoptimized medication therapy was $528.4 billion in 2016 US dollars, with a plausible range of $495.3 billion to $672.7 billion. The average cost of an individual experiencing TF, NMP, or TF and NMP after initial prescription use were $2481 (range: $2233, $2742), $2610 (range: $2374, $2848) and $2572 (range: $2408, $2751), respectively. CONCLUSIONS:The estimated annual cost of drug-related morbidity and mortality resulting from nonoptimized medication therapy was $528.4 billion, equivalent to 16% of total US health care expenditures in 2016. We propose expansion of comprehensive medication management programs by clinical pharmacists in collaborative practices with physicians and other prescribers as an effective and scalable approach to mitigate these avoidable costs and improve patient outcomes.