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.

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.

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.

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.

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.

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.

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.

A clinical pathway for community-acquired pneumonia: an observational cohort study.

BACKGROUND: Six hospitals instituted a voluntary, system-wide, pathway for community acquired pneumonia (CAP). We proposed this study to determine the impact of pathway antibiotics on patient survival, hospital length of stay (LOS), and total hospital cost. METHODS: Data were collected for adults from six U.S. hospitals with a principal CAP discharge diagnosis code, a chest infiltrate, and medical notes indicative of CAP from 2005-2007. Pathway and non-pathway cohorts were assigned according to antibiotics received within 48 hours of admission. Pathway antibiotics included levofloxacin 750 mg monotherapy or ceftriaxone 1000 mg plus azithromycin 500 mg daily. Multivariable regression models assessed 90-day mortality, hospital LOS, total hospital cost, and total pharmacy cost. RESULTS: Overall, 792 patients met study criteria. Of these, 505 (64%) received pathway antibiotics and 287 (36%) received non-pathway antibiotics. Adjusted means and p-values were derived from Least Squares regression models that included Pneumonia Severity Index risk class, patient age, heart failure, chronic obstructive pulmonary disease, and admitting hospital as covariates. After adjustment, patients who received pathway antibiotics experienced lower adjusted 90-day mortality (p = 0.02), shorter mean hospital LOS (3.9 vs. 5.0 days, p < 0.01), lower mean hospital costs ($2,485 vs. $3,281, p = 0.02), and similar mean pharmacy costs ($356 vs. $442, p = 0.11). CONCLUSIONS: Pathway antibiotics were associated with improved patient survival, hospital LOS, and total hospital cost for patients admitted to the hospital with CAP.

Differences in national antiretroviral prescribing patterns between black and white patients with HIV/AIDS, 1996-2006.

OBJECTIVES: The benefit of improved health outcomes for blacks receiving highly active antiretroviral therapy (HAART) lags behind that of whites. This project therefore sought to determine whether the reason for this discrepancy in health outcomes could be attributed to disparities in use of antiretroviral therapy between black and white patients with HIV. MATERIALS AND METHODS: The 1996-2006 National Hospital Ambulatory Medical Care Surveys were used to identify hospital outpatient visits that documented antiretrovirals. Patients younger than 18 years, of nonblack or nonwhite race, and lacking documentation of antiretrovirals were excluded. A multivariable logistic regression model was constructed with race as the independent variable and use of HAART as the dependent variable. RESULTS: Approximately 3 million HIV/AIDS patient visits were evaluated. Blacks were less likely than whites to use HAART and protease inhibitors (odds ratio, 95% CI 0.81 [0.81-0.82] and 0.67 [0.67-0.68], respectively). More blacks than whites used non-nucleoside reverse transcriptase inhibitors (odds ratio, 95% CI 1.18 [1.17-1.18]). In 1996, the crude rates of HAART were relatively low for both black and white cohorts (5% vs 6%). The rise in HAART for blacks appeared to lag behind that of whites for several years, until 2002, when the proportion of blacks receiving HAART slightly exceeded the proportion of whites receiving HAART. In later years, the rates of HAART were similar for blacks and whites (81% vs 82% in 2006). Blacks appeared less likely than whites to use protease inhibitors and more likely than whites to use non-nucleoside reverse transcriptase inhibitors from 2000 to 2004. CONCLUSIONS: Blacks experienced a lag in the use of antiretrovirals at the beginning of the study; this discrepancy dissipated in more recent years.

Influenza vaccination rates among pharmacists.

OBJECTIVES: To quantify influenza vaccination rates and determine perceived barriers to influenza vaccination among U.S. pharmacists from various practice settings. DESIGN: Prospective study. SETTING: United States in 2008. PARTICIPANTS: 1,028 respondents, including 895 pharmacists. INTERVENTION: A survey request was distributed manually at the 2008 National Community Pharmacists Association annual meeting, and an initial e-mail was sent with two follow-up e-mails to all pharmacists who receive e-mails via Pharmacist e-link. MAIN OUTCOME MEASURES: Vaccination rates and barriers to vaccination among pharmacists. RESULTS: Pharmacists reported an influenza vaccination rate of 78%, with coverage varying across practice settings: hospital (88%), academia (86%), clinic (83%), and community (75%). Employers infrequently required the influenza vaccine as a condition of employment (7%), and slightly more than one-half (58%) compensated pharmacists for being vaccinated; both of these were significantly associated with higher influenza vaccination rates (P < 0.001 for both). One-quarter of pharmacists (26%) expressed at least one issue regarding the influenza vaccine. Pharmacists were significantly less likely to be vaccinated if they expressed a concern (91% vs. 43%, P < 0.0001). Community pharmacists were significantly less likely to be compensated for receiving the influenza vaccination and significantly more likely to express one or more concerns than pharmacists from any other practice setting. CONCLUSION: Pharmacists reported high influenza vaccination rates overall, with slight variability among practice settings. Although employers infrequently required influenza vaccination, approximately one-half of employers compensated their pharmacists for being vaccinated. Employer incentives and pharmacist attitudes were highly correlated with influenza vaccination.

Black race as a predictor of poor health outcomes among a national cohort of HIV/AIDS patients admitted to US hospitals: a cohort study.

BACKGROUND: In general, the Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) population has begun to experience the benefits of highly active antiretroviral therapy (HAART); unfortunately, these benefits have not extended equally to Blacks in the United States, possibly due to differences in patient comorbidities and demographics. These differences include rates of hepatitis B and C infection, substance use, and socioeconomic status. To investigate the impact of these factors, we compared hospital mortality and length of stay (LOS) between Blacks and Whites with HIV/AIDS while adjusting for differences in these key characteristics. METHODS: The 1996-2006 National Hospital Discharge Surveys were used to identify HIV/AIDS patients admitted to US hospitals. Survey weights were incorporated to provide national estimates. Patients < 18 years of age, those who left against medical advice, those with an unknown discharge disposition and those with a LOS < 1 day were excluded. Patients were stratified into subgroups by race (Black or White). Two multivariable logistic regression models were constructed with race as the independent variable and outcomes (mortality and LOS > 10 days) as the dependent variables. Factors that were significantly different between Blacks and Whites at baseline via bivariable statistical tests were included as covariates. RESULTS: In the general US population, there are approximately 5 times fewer Blacks than Whites. In the present study, 1.5 million HIV/AIDS hospital discharges were identified and Blacks were 6 times more likely to be hospitalized than Whites. Notably, Blacks had higher rates of substance use (30% vs. 24%; P < 0.001), opportunistic infections (27% vs. 26%; P < 0.001) and cocaine use (13% vs. 5%; P < 0.001). Conversely, fewer Blacks were co-infected with hepatitis C virus (8% vs. 12%; P < 0.001). Hepatitis B virus was relatively infrequent (3% for both groups). Crude mortality rates were similar for both cohorts (5%); however, a greater proportion of Blacks had a LOS > 10 days (21% vs. 19%; P < 0.001). Black race, in the presence of comorbidities, was correlated with a higher odds of LOS > 10 days (OR, 95% CI = 1.20 [1.10-1.30]), but was not significantly correlated with a higher odds of mortality (OR, 95% CI = 1.07 [0.93-1.25]). CONCLUSION: Black race is a predictor of LOS > 10 days, but not mortality, among HIV/AIDS patients admitted to US hospitals. It is possible that racial disparities in hospital outcomes may be closing with time.

Disparities in antiretroviral prescribing for blacks and whites in the United States.

PURPOSE: The health benefits for blacks on highly active antiretroviral therapy (HAART) lags behind that of whites. We therefore investigated whether this discrepancy in health outcomes is attributable to disparities in the receipt of appropriate HAART between black and white human immunodeficiency virus (HIV) patients. METHODS: The 2000-2005 National Ambulatory Medical Care Surveys were used to identify patients receiving antiretrovirals. Regimens were evaluated for appropriateness according to national antiretroviral guideline recommendations. A multivariable logistic regression model was used to assess black race as a predictor for appropriate HAART. RESULTS: An estimated 4.1 million HIV-related visits with antiretroviral therapy were identified. Eighty-six percent of visits were associated with appropriate therapy; inappropriate therapy was often due to antiretroviral monotherapy. Interestingly, blacks were more likely to receive appropriate therapy in comparison to white patients (94% vs 83%, P < .001). Multivariable analysis revealed black race as an independent predictor for an appropriate regimen (chi2 likelihood ratio, 12.3, P < .001) when controlling for age, gender, insurance status, and geographic region. CONCLUSIONS: Health outcome disparities between black and white HIV patients do not appear to be attributable to differences in receipt of appropriate HAART. Further investigations are warranted to identify factors responsible for these outcome disparities.

Evaluating HIV/AIDS disparities for blacks in the United States: a review of antiretroviral and mortality studies.

The purpose of this systematic review was to identify studies that evaluated HIV/AIDS disparities by examining differences in the receipt of antiretroviral therapy and differences in mortality between blacks and whites in the United States. The authors conducted 2 Web-based literature searches of the MEDLINE database for published peer reviewed scientific articles that analyzed black race as a predictor of antiretroviral therapy and mortality. Five reports met the criteria for the antiretroviral literature search, whereas seven reports met the criteria for the mortality literature search. After evaluating individual study results, it appears the evidence to identify racial differences in the receipt of antiretroviral therapy as well as the evidence to document disparities in mortality is either limited or mixed. Further research is needed to support or refute the hypothesis that there are inequalities for blacks with HIV/AIDS.

HIV/AIDS disparities: the mounting epidemic plaguing US blacks.

The human immunodeficiency virus (HIV)/AIDS epidemic presents a formidable challenge for the black community. Blacks, although a small proportion of the US population, are overrepresented, not only in the number of people living with HIV, but also in the categories of new diagnoses and AIDS-related deaths. Fortunately, national initiatives are in place to slow and ultimately reverse these racial inequities. While these disparities may be widely recognized, their causes are not clearly understood. A variety of underlying issues exist for blacks in the United States that may also contribute to these growing disparities. These include transmission risk factors, socioeconomic factors, underrecognition, delayed presentation, and other comorbid conditions. We present a review of the literature regarding the potential causes of racial disparities and how they may contribute to health outcomes for blacks with HIV/AIDS in the United States. We also identify possible gaps in knowledge and offer future directions for research of HIV/AIDS racial disparities.

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.

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.

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.

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.

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.