Brian M. Gryzlak

Personal health records: a randomized trial of effects on elder medication safety

PURPOSE To examine the impact of a personal health record (PHR) on medication-use safety among older adults. BACKGROUND Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have. METHODS A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems. RESULTS Older adults were interested in keeping track of their health and medication information. A majority (55.2%) logged into the PHR and used it, but only 16.1% used it frequently. At follow-up, those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs-the most common warning generated by the system (viewed by 23% of participants). Compared with low/non-users, high users reported significantly more changes in medication use and improved medication reconciliation behaviors, and recognized significantly more side effects, but there was no difference in use of inappropriate medications or adherence measures. CONCLUSIONS PHRs can engage older adults for better medication self-management; however, features that motivate continued use will be needed. Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes.

Dietary Supplement Polypharmacy: An Unrecognized Public Health Problem?

Excessive and inappropriate use of medications, or ‘polypharmacy’, has been recognized as a public health problem. In addition, there is growing use of dietary supplements in the United States; however, little is known about the patterns of supplement use. Recent reports in the literature of cases of excessive or inappropriate use of herbal dietary supplements leading to the term ‘polyherbacy’. The clinical vignettes described in this article highlight the need for further research on the nature and extent of multiple and inappropriate dietary supplement use or ‘dietary supplement polypharmacy’. Clinical interviewing and population surveys both address this issue in complementary ways, and provide a further understanding of dietary supplement use patterns.

Efficacy and Safety of Nighttime Dosing of Antihypertensives: Review of the Literature and Design of a Pragmatic Clinical Trial

Blood pressure exhibits circadian variability, and nighttime blood pressure is one of the best predictors of cardiovascular (CV) events. Adults with hypertension who lack a nighttime dipping pattern are at particularly high risk. Several studies have found that bedtime dosing of antihypertensive agents reduces sleep blood pressure and improves the dipping pattern in nondippers. One small study and 2 substudies of diabetes and chronic kidney disease suggest that bedtime dosing of ≥1 antihypertensives significantly reduced CV events. A Cochrane review of 5 studies found no difference in adverse events between morning and evening dosing. However, several evaluations in ophthalmology have found that nocturnal arterial hypotension precipitated ocular vascular disorders such as ischemic optic neuropathy. Some authors have suggested that additional studies of nighttime dosing of antihypertensive agents that evaluate CV events need to be conducted. The authors describe a randomized controlled pragmatic trial that is being planned at the University of Iowa and Duke University. Patients with hypertension and other comorbid conditions will be randomized to either continue morning dosing of all antihypertensive agents or to switch their nondiuretic medications to bedtime dosing. Patients will be followed for 36 to 42 months. This study will determine whether nighttime dosing reduces CV risk when compared with traditional morning dosing of antihypertensive agents.

Patterns of natural herb use by Asian and Pacific Islanders

Objective. Previous studies have noted the role of race/ethnicity in use of complementary and alternative medicine (CAM). Asian and Pacific Islanders (APIs) in particular have been found to use herbs more frequently, although the patterns of use among this population have not been described. The goal of this study was to characterize the rates and patterns of herb use among the API population of the United States. Design. Data from the 2002 US National Health Interview Survey, including the supplement on CAM, were analyzed using SAS. Cross-tabulation and logistical regression were used to determine the association between herb use and race/ethnicity, while adjusting for demographic factors. Results. After adjusting for age, gender and educational attainment, we found that APIs were more likely to use herbs than non-Hispanic Whites (OR=1.3; 95% CI: 1.1, 1.5; p=0.013), with the difference being most prominent in those 60 years old or older (OR=2.9; 95% CI: 1.8, 4.5; p<0.0001). Herb use among APIs was more common among women, those with higher education and income, and those in older age groups. Patterns of use also varied among API subgroups, with Chinese Americans reporting the highest rates of herb use in their lifetimes (44%) and in the previous 12 months (33%). Conclusion. Considerable diversity exists within API subgroups with regard to the prevalence and demographic and health correlates of natural herb use. Herb use is more common among APIs than non-Hispanic Whites, particularly among the elderly. The disaggregation of APIs by racial/ethnic subgroups may be important for patient–health care professional interactions, and when designing studies of racial/ethnic minority populations.

Application of FDA Adverse Event Report Data to the Surveillance of Dietary Botanical Supplements

Background: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administrations Center for Food Safety and Applied Nutritions Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects. Objective: To characterize data on DBSs associated with adverse event reports submitted to CAERS. Methods: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. Johns wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. Results: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. Johns wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. Conclusions: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.

Design lessons for older adult personal health records software from older adults

Online Personal Health Records (PHR) software has the potential to provide older adults with tools to better manage several aspects of their health, including their use of medications. In spite of this potential, we still know little about how to make PHRs accessible for older adults. We also know little about how to design PHRs in a way that will enable older adults to get a valuable return on their time investment in using such systems. In this paper, we present our experience partnering with a group of older adults to obtain design guidelines for the design of a PHR with a focus on medication management. We discuss the outcomes of our design partnership and provide an overview of the design of a web-based PHR we designed based on these outcomes.

A centralized cardiovascular risk service to improve guideline adherence in private primary care offices

BACKGROUND Many large health systems now employ clinical pharmacists in team-based care to assist patients and physicians with management of cardiovascular (CV) diseases. However, small private offices often lack the resources to hire a clinical pharmacist for their office. The purpose of this study is to evaluate whether a centralized, web-based CV risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in primary care medical offices in rural and small communities. METHODS This study is a cluster randomized prospective trial in 12 primary care offices. Medical offices were randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. Primary outcomes will include adherence to treatment guidelines and control of key CV risk factors. Data will also be abstracted from the medical record at 30 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS This study will enroll subjects through 2015 and results will be available in 2018. This study will provide information on whether a distant, centralized CV risk service can improve guideline adherence in medical offices that lack the resources to employ clinical pharmacists.

A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence

Numerous studies have demonstrated the value of including pharmacists in team‐based care to improve adherence to cardiovascular (CV) guidelines, medication adherence, and risk factor control. However, there is limited information on whether these models can be successfully implemented more widely in diverse settings and populations. The purpose of this study is to evaluate whether a centralized, web‐based cardiovascular risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics.

Older Adults’ Views About “Managing Your Medications” Booklet

The objectives were to evaluate Managing Your Medications (MYM) booklet to improve medication management. Mailed packets, including MYM booklet and 4-page survey assessing comprehensibility, communicative effectiveness, and usefulness, were sent to a random sample of 250 older adults. The survey included perceptions of booklet, how to disseminate, and respondent’s health history. Descriptive statistics were used, and individuals were stratified by number of prescription medications and whether they reported side effects. A 59.6% response rate was obtained. The readability was Grade 8. Older adults reported it was comprehensible and 17% reported behavioral intentions to change their current actions regarding medications. Overall, 12.7% of respondents agreed that MYM changed their opinion of the topic. The most popular means to disseminate were doctors’ offices and senior citizens’ centers. Most older adults indicated the MYM booklet was readable, comprehensible, and would generate some behavior change regarding medication management.

Medication Therapy Management and Complex Patients With Disability A Randomized Controlled Trial

Background: Drug therapy problems, adverse drug events (ADEs), and symptom burden are high among adults with disabilities. Objective: To compare the effects of a modified medication therapy management (MTM) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations. Methods: Three-group randomized controlled trial among adults (age 40 and older) with self-reported activity limitations in community practice. Interventions: 8 weekly Living Well With a Disability (LWD) 2-hour workshop sessions with and without a collaborative medication management (CMM) module. Primary outcome: mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms. Process measures: changes in medication regimens and self-reported ADEs. Analysis: general linear mixed models (continuous outcomes) and generalized estimating equations (categorical outcomes). Results: Participants had high symptom burden, low physical health, and took many medications. There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups (Study group × Time P = .014), and there were significantly more changes in medication regimens in the LWD + CMM group (P = .013 LWD only vs LWD + CMM). The oldest third of participants had significantly fewer mean symptoms but received more intense CMM. There was no difference between the LWD-only, LWD + CMM, and usual care groups in symptom burden over time. Conclusion: Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations.