An Electronic Health Record-Based Strategy to Systematically Assess Medication Use Among Primary Care Patients With Multidrug Regimens: Feasibility Study.

BACKGROUND: Medication nonadherence and misuse are public health and patient safety concerns. With the increased adoption of electronic health records (EHRs), greater opportunities exist to communicate directly with, and collect data from, patients through secure portals linked to EHRs. OBJECTIVE: The study objectives were to develop and pilot test a method of monitoring patient medication use in outpatient settings and determine the feasibility and acceptability of this approach. METHODS: Adult primary care patients on multidrug regimens were recruited from an academic internal medicine clinic by a trained research assistant. After completing a baseline, in-person interview, patients were sent a link to a questionnaire about medication use via the patient portal. One week later, the RA contacted patients to complete a follow-up telephone interview assessing patient satisfaction and experience with the questionnaire. Patient EHRs were also reviewed to determine the questionnaire completion rate. RESULTS: Of 100 patients enrolled, 89 completed the follow-up interview and 82 completed the portal questionnaire. The mean age of the sample was 61.8 (range 31-88) years. Approximately half (54/100, 54%) of the sample was male, two-thirds were white (67/100, 67%) and 26% (26/100) African-American. A total of 44% reported an annual household income of <$50,000 per year, and 17% (17/100) reported a high school or less level of education. No significant differences were found in questionnaire completion rates by sociodemographic characteristics or prior portal use. Most (68/73, 93%) found the questionnaire easy to access, easy to complete (72/73, 99%), and valuable (73/89, 82%). Time constraints and log-in difficulties were the main reasons for noncompletion. CONCLUSIONS: The portal questionnaire was well received by a socioeconomically diverse group of patients with high completion rates achieved. Routine use of a portal-based questionnaire could provide a valuable signal to providers and care teams about patient medication use and identify patients needing additional support.

The electronic medication complete communication (EMC2) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

BACKGROUND: Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. OBJECTIVE: To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC2) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care. METHODS: The automated EMC2 Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated. CONCLUSIONS: The EMC2 Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care.

Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy.

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse.

Non-initiation of hepatitis C virus antiviral therapy in patients with human immunodeficiency virus/hepatitis C virus co-infection.

AIM: To assess whether reasons for hepatitis C virus (HCV) therapy non-initiation differentially affect racial and ethnic minorities with human immunodeficiency virus (HIV)/HCV co-infection. METHODS: Analysis included co-infected HCV treatment-naïve patients in the University of North Carolina CFAR HIV Clinical Cohort (January 1, 2004 and December 31, 2011). Medical records were abstracted to document non-modifiable medical (e.g., hepatic decompensation, advanced immunosuppression), potentially modifiable medical (e.g., substance abuse, severe depression, psychiatric illness), and non-medical (e.g., personal, social, and economic factors) reasons for non-initiation. Statistical differences in the prevalence of reasons for non-treatment between racial/ethnic groups were assessed using the two-tailed Fisher's exact test. Three separate regression models were fit for each reason category. Odds ratios and their 95%CIs (Wald's) were computed. RESULTS: One hundred and seventy-one patients with HIV/HCV co-infection within the cohort met study inclusion. The study sample was racially and ethnically diverse; most patients were African-American (74%), followed by Caucasian (19%), and Hispanic/other (7%). The median age was 46 years (interquartile range = 39-50) and most patients were male (74%). Among the 171 patients, reasons for non-treatment were common among all patients, regardless of race/ethnicity (50% with ≥ 1 non-modifiable medical reason, 66% with ≥ 1 potentially modifiable medical reason, and 66% with ≥ 1 non-medical reason). There were no significant differences by race/ethnicity. Compared to Caucasians, African-Americans did not have increased odds of non-modifiable [adjusted odds ratio (aOR) = 1.47, 95%CI: 0.57-3.80], potentially modifiable (aOR = 0.72, 95%CI: 0.25-2.09) or non-medical (aOR = 0.90, 95%CI: 0.32-2.52) reasons for non-initiation. CONCLUSION: Race/ethnicity alone is not predictive of reasons for HCV therapy non-initiation. Targeted interventions are needed to improve access to therapy for all co-infected patients, including minorities.

Factors associated with polypharmacy and the prescription of multiple medications among persons living with HIV (PLWH) compared to non-PLWH.

Persons living with HIV (PLWH) may be at increased risk for polypharmacy (≥5 concomitant medications) over non-PLWH, presumably due to antiretroviral therapy (ARV). Potential concerns associated with polypharmacy include clinically significant drug-drug interactions, adverse drug reactions, increased pill burden, and rising treatment-related costs. Our objective was to evaluate prescription of multiple non-ARV medications to PLWH, compared to non-PLWH, in US outpatient clinics and to identify factors associated with polypharmacy. Cross-sectional data from the 2006-2010 National Hospital Ambulatory Medical Care Survey were used for this study. Visits for PLWH were identified using HIV ICD9-CM codes 042, V08, and 079.53. Patients < 18 years of age were excluded. Relevant demographics included sex, age, race/ethnicity, and insurance status, while comorbid conditions included hypertension, diabetes, and hyperlipidemia. Multivariate logistic regression analyses evaluated factors independently associated with prescription of ≥ 5 medications. In total, 7,360,000 weighted visits for PLWH (13% aged 18-29 y; 55% aged 30-49 y; 32% aged ≥ 50 y) and 374,626,000 weighted visits for non-PLWH (18% aged 18-29 y; 32% aged 30-49 y; 50% aged ≥ 50 y) met study criteria. The greatest prevalence of hypertension, diabetes, and hyperlipidemia was in those ≥ 50 years of age (p < .001 for all comorbidities in PLWH and non-PLWH). In 2006, 16% of PLWH were prescribed ≥ 5 medications, doubling to 35% in 2010. In 2006, 24% of non-PLWH were prescribed ≥ 5 medications, only increasing to 32% in 2010. Older age (30-49 y and ≥ 50 y) was associated with ≥ 5 prescription medications in PLWH (adjusted odds ratio [aOR] = 2.538, 95% CI; 1.31-4.918 and aOR = 2.703, 95% CI; 1.678-4.354) and in non-PLWH (aOR = 2.546, 95% CI; 2.235-2.9 and aOR = 5.208, 95% CI; 4.486-6.047), respectively. Prescription of multiple medications is on the rise in PLWH, more so than in non-PLWH. Additional research is needed to explore how prescription of multiple medications differentially affects younger PLWH vs. older PLWH.

Using Pharmacies in a Structural Intervention to Distribute Low Dead Space Syringes to Reduce HIV and HCV Transmission in People Who Inject Drugs.

Ongoing injection drug use contributes to the HIV and HCV epidemics in people who inject drugs. In many places, pharmacies are the primary source of sterile syringes for people who inject drugs; thus, pharmacies provide a viable public health service that reduces blood-borne disease transmission. Replacing the supply of high dead space syringes with low dead space syringes could have far-reaching benefits that include further prevention of disease transmission in people who inject drugs and reductions in dosing inaccuracies, medication errors, and medication waste in patients who use syringes. We explored using pharmacies in a structural intervention to increase the uptake of low dead space syringes as part of a comprehensive strategy to reverse these epidemics.

Comparative value of four measures of retention in expert care in predicting clinical outcomes and health care utilization in HIV patients.

This study compared the ability of four measures of patient retention in HIV expert care to predict clinical outcomes. This retrospective study examined Veterans Health Administration (VHA) beneficiaries with HIV (ICD-9-CM codes 042 or V08) receiving expert care (defined as HIV-1 RNA viral load and CD4 cell count tests occurring within one week of each other) at VHA facilities from October 1, 2006, to September 30, 2008. Patients were ≥18 years old and continuous VHA users for at least 24 months after entry into expert care. Retention measures included: Annual Appointments (≥2 appointments annually at least 60 days apart), Missed Appointments (missed ≥25% of appointments), Infrequent Appointments (>6 months without an appointment), and Missed or Infrequent Appointments (missed ≥25% of appointments or >6 months without an appointment). Multivariable nominal logistic regression models were used to determine associations between retention measures and outcomes. Overall, 8,845 patients met study criteria. At baseline, 64% of patients were virologically suppressed and 37% had a CD4 cell count >500 cells/mm3. At 24 months, 82% were virologically suppressed and 46% had a CD4 cell count >500 cells/mm3. During follow-up, 13% progressed to AIDS, 48% visited the emergency department (ED), 28% were hospitalized, and 0.3% died. All four retention measures were associated with virologic suppression and antiretroviral therapy initiation at 24 months follow-up. Annual Appointments correlated positively with CD4 cell count >500 cells/mm3. Missed Appointments was predictive of all primary and secondary outcomes, including CD4 cell count ≤500 cells/mm3, progression to AIDS, ED visit, and hospitalization. Missed Appointments was the only measure to predict all primary and secondary outcomes. This finding could be useful to health care providers and public health organizations as they seek ways to optimize the health of HIV patients.

The pharmacist's role in preventing medication errors in older adults.

Approximately 1.5 million medication errors occur each year in the United States. Older adults may be at increased risk for these errors as a result of a variety of contributing factors such as inappropriate medication use, polymorbidity, and complexities in managing dosage adjustments for geriatric patients. Pharmacists, as trained medication experts, are uniquely poised to lead efforts to prevent, detect, and resolve medications errors. As the American population continues to age, future pharmacists are likely to play an even greater role in promoting safe and effective medication use in older adults. In this paper, we highlight common settings for medication errors in older individuals, explore tools and solutions for error prevention, and outline the unique role that pharmacists have in preventing medication errors in older adults.

National trends in hospitalization and mortality rates for patients with HIV, HCV, or HIV/HCV coinfection from 1996-2010 in the United States: a cross-sectional study.

BACKGROUND: The comparative impact of chronic viral monoinfection versus coinfection on inpatient outcomes and health care utilization is relatively unknown. This study examined trends, inpatient utilization, and hospital outcomes for patients with HIV, HCV, or HIV/HCV coinfection. METHODS: Data were from the 1996-2010 National Hospital Discharge Surveys. Hospitalizations with primary ICD-9-CM codes for HIV or HCV were included for HIV and HCV monoinfection, respectfully. Coinfection included both HIV and HCV codes. Demographic characteristics, select comorbidities, procedural interventions, average hospital length of stay (LOS), and discharge status were compared by infection status (HIV, HCV, HIV/HCV). Annual disease estimates and survey weights were used to generate hospitalization rates. RESULTS: ~6.6 million hospitalizations occurred in patients with HIV (39%), HCV (56%), or HIV/HCV (5%). The hospitalization rate (hospitalizations per 100 persons with infection) decreased in the HIV group (29.8 in 1996; 5.3 in 2010), decreased in the HIV/HCV group (2.0 in 1996; 1.5 in 2010), yet increased in the HCV group (0.2 in 1996; 0.9 in 2010). Median LOS from 1996 to 2010 (days, interquartile range) decreased in all groups: HIV, 6 (3-10) to 4 (3-8); HCV, 5 (3-9) to 4 (2-6); HIV/HCV, 6 (4-11) to 4 (2-7). Age-adjusted mortality rates decreased for all three groups. The rate of decline was least pronounced for those with HCV monoinfection. CONCLUSION: Hospitalizations have declined more rapidly for patients with HIV infection (including HIV/HCV coinfection) than for patients with HCV infection. This growing disparity between HIV and HCV underscores the need to allocate more resources to HCV care in hopes that similar large-scale improvements can also be accomplished for patients with HCV.

The association of health literacy with time in therapeutic range for patients on warfarin therapy.

Patients on warfarin therapy need to achieve and maintain anticoagulation control in order to experience the benefits of treatment while minimizing bleeding risk. Low health literacy skills may hinder patients' ability to use and adhere to warfarin in a safe and effective manner. The authors conducted this study to evaluate the relationship between health literacy and anticoagulation control among patients on chronic warfarin therapy. Participants were recruited from 2 diverse anticoagulation clinics in North Carolina. Time in therapeutic range (TTR) for warfarin therapy was used as a measure of anticoagulation control. Health literacy was assessed using the short form of the Test of Functional Health Literacy in Adults (S-TOFHLA). Of the 198 study participants, 51% had limited health literacy (S-TOFHLA score of 0-90) and 33% had poor anticoagulation control (TTR<50%). Participants with limited health literacy were less likely to correctly answer warfarin-related knowledge questions. Limited health literacy was significantly associated with TTR<50% (adjusted odds ratio=2.34, 95% CI [1.01, 5.46]). Findings indicate that limited health literacy is associated with poor anticoagulation control for patients on warfarin therapy. Lack of medication understanding may hinder the safe and effective use of this narrow therapeutic index drug.

Differences in outpatient care and treatment utilization for patients with HIV/HCV coinfection, HIV, and HCV monoinfection, a cross-sectional study.

BACKGROUND: Few studies have explored how utilization of outpatient services differ for HIV/HCV coinfected patients compared to HIV or HCV monoinfected patients. The objectives of this study were to (1) compare annual outpatient clinic visit rates between coinfected and monoinfected patients, (2) to compare utilization of HIV and HCV therapies between coinfected and monoinfected patients, and (3) to identify factors associated with therapy utilization. METHODS: Data were from the 2005-2010 U.S. National Hospital Ambulatory Medical Care Surveys. Clinic visits with a primary or secondary ICD-9-CM codes for HIV or HCV were included. Coinfection included visits with codes for both HIV and HCV. Monoinfection only included codes for HIV or HCV, exclusively. Patients <15 years of age at time of visit were excluded. Predictors of HIV and HCV therapy were determined by logistic regressions. Visits were computed using survey weights. RESULTS: 3,021 visits (11,352,000 weighted visits) met study criteria for patients with HIV/HCV (8%), HIV (70%), or HCV (22%). The HCV subgroup was older in age and had the highest proportion of females and whites as compared to the HIV/HCV and HIV subgroups. Comorbidities varied significantly across the three subgroups (HIV/HCV, HIV, HCV): current tobacco use (40%, 27%, 30%), depression (32%, 23%, 24%), diabetes (9%, 10%, 17%), and chronic renal failure (<1%, 3%, 5%), (p < 0.001 for all variables). Annual visit rates were highest in those with HIV, followed by HIV/HCV, but consistently lower in those with HCV. HIV therapy utilization increased for both HIV/HCV and HIV subgroups. HCV therapy utilization remained low for both HIV/HCV and HCV subgroups for all years. Coinfection was an independent predictor of HIV therapy, but not of HCV therapy. CONCLUSION: There is a critical need for system-level interventions that reduce barriers to outpatient care and improve uptake of HCV therapy for patients with HIV/HCV coinfection.

Barriers to hepatitis C antiviral therapy in HIV/HCV co-infected patients in the United States: a review.

This review synthesized the literature for barriers to HCV antiviral treatment in persons with HIV/HCV co-infection. Searches of PubMed, Embase, CINAHL, and Web of Science were conducted to identify relevant articles. Articles were excluded based on the following criteria: study conducted outside of the United States, not original research, pediatric study population, experimental study design, non-HIV or non-HCV study population, and article published in a language other than English. Sixteen studies met criteria and varied widely in terms of study setting and design. Hepatic decompensation was the most commonly documented absolute/nonmodifiable medical barrier. Substance use was widely reported as a relative/modifiable medical barrier. Patient-level barriers included nonadherence to medical care, refusal of therapy, and social circumstances. Provider-level barriers included provider inexperience with antiviral treatment and/or reluctance of providers to refer patients for treatment. There are many ongoing challenges that are unique to managing this patient population effectively. Documenting and evaluating these obstacles are critical steps to managing and caring for these individuals in the future. In order to improve uptake of HCV therapy in persons with HIV/HCV co-infection, it is essential that barriers, both new and ongoing, are addressed, otherwise, treatment is of little benefit.

The effect of statin therapy on the incidence of infections: a retrospective cohort analysis.

BACKGROUND: Statins have been postulated to prevent infection through immunomodulatory effects. OBJECTIVES: To compare the incidence of infections in statin users to that in nonusers within the same health care system. METHODS: This was a retrospective cohort study of patients enrolled as Tricare Prime or Plus in the San Antonio military multimarket. Statin users were patients who received a statin for at least 3 months between October 1, 2004 and September 30, 2005. Nonusers were patients who did not receive a statin within the study period (October 1, 2003-September 30, 2009). Inpatient and outpatient International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes were used to determine the incidence of infections during the follow-up period (October 1, 2005-September 30, 2009) via multivariable regression analysis and time to infection via Cox regression analysis. RESULTS: Of 45,247 patients who met the study criteria, 12,981 (29%) were statin users and 32,266 were nonusers. After adjustments for age, gender, Charlson Comorbidity Score, tobacco use, alcohol abuse/dependence, health care utilization and use of specific medication classes, statin use was associated with an increased incidence of common infections (odds ratio [OR]: 1.13; 95% confidence interval [CI]: 1.06-1.19) but not influenza or fungal infections (OR: 1.06, 95% CI: 0.80-1.39; OR: 0.97; 95% CI: 0.91-1.04, respectively). Time-to-first infection was similar in statin users and nonusers in all infection categories examined. CONCLUSIONS: Statin use was associated with an increased incidence of common infections but not influenza or fungal infections. This study does not support a protective role of statins in infection prevention; however, the influence of potential confounders cannot be excluded.

Rethinking adherence: a health literacy-informed model of medication self-management.

Medication adherence has received a great deal of attention over the past several decades; however, its definition and measurement remain elusive. The authors propose a new definition of medication self-management that is guided by evidence from the field of health literacy. Specifically, a new conceptual model is introduced that deconstructs the tasks associated with taking prescription drugs; including the knowledge, skills and behaviors necessary for patients to correctly take medications and sustain use over time in ambulatory care. This model is then used to review and criticize current adherence measures as well as to offer guidance to future interventions promoting medication self-management, especially among patients with low literacy skills.

Hospitalizations for cardiovascular disease in African Americans and whites with HIV/AIDS.

Therapeutic advances have resulted in an epidemiological shift in the predominant causes of hospitalization for patients with HIV/AIDS. An emerging cause for hospitalization in this patient population is cardiovascular disease (CVD); however, data are limited regarding how this shift affects different racial groups. The objective of this observational, retrospective study was to evaluate the association between race and hospitalization for CVD in African Americans and whites with HIV/AIDS and to compare the types of CVD-related hospitalizations between African Americans and whites with HIV/AIDS. Approximately 1.5 million hospital discharges from the US National Hospital Discharge Surveys for the years of 1996 to 2008 were identified. After controlling for potential confounders, the odds of CVD-related hospitalization in patients with HIV/AIDS were 45% higher for African Americans than whites (odds ratio [OR]=1.45, 95% CI, 1.39-1.51). Other covariates that were associated with increased odds of hospitalization for CVD included chronic kidney disease (OR=1.43, 95% CI, 1.36-1.51), age≥50 years (OR=3.22, 95% CI, 2.94-3.54), region in the Southern United States (OR=1.17, 95% CI, 1.11-1.23), and Medicare insurance coverage (OR=1.71, 95% CI, 1.60-1.83). Male sex was not significantly associated with the study outcome (OR=0.99, 95% CI, 0.96-1.02). Compared to whites with HIV/AIDS, African Americans with HIV/AIDS had more hospitalizations for heart failure and hypertension, but fewer hospitalizations for stroke and coronary heart disease. In conclusion, African Americans with HIV/AIDS have increased odds of CVD-related hospitalization as compared to whites with HIV/AIDS. Furthermore, the most common types of CVD-related hospitalizations differ significantly in African Americans and whites.

The state of disparities in opportunistic infection prophylaxis for blacks with HIV/AIDS.

OBJECTIVES: The purpose of this review is to identify and analyze published studies that have evaluated disparities for opportunistic infection (OI) prophylaxis between blacks and whites with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) in the United States. METHODS: The authors conducted a web-based search of MEDLINE (1950-2009) to identify original research articles evaluating the use of OI prophylaxis between blacks and whites with HIV/AIDS. The search was conducted utilizing the following MeSH headings and search terms alone and in combination: HIV, AIDS, Black, race, ethnicity, disparities, differences, access, opportunistic infection, and prophylaxis. The search was then expanded to include any relevant articles from the referenced citations of the articles that were retrieved from the initial search strategy. Of the 29 articles retrieved from the literature search, 19 articles were excluded. RESULTS: Ten publications met inclusion criteria, collectively published between 1991 and 2005. The collective time periods of these studies spanned from 1987 to 2001. Four studies identified a race-based disparity in that blacks were less likely than whites to use OI prophylaxis, whereas 5 studies failed to identify such a relationship between race and OI prophylaxis. One study identified disparities for Mycobacterium avium complex prophylaxis, but not for Pneumocystis jiroveci pneumonia prophylaxis. CONCLUSIONS: The evidence regarding race-based disparities in OI prophylaxis is inconclusive. Additional research is warranted to explore potential race-based disparities in OI prophylaxis.