Evaluation of human immunodeficiency virus curricular content in schools of pharmacy in the United States.

INTRODUCTION: Human immunodeficiency virus (HIV) is an important educational topic for student pharmacists given extended patient life expectancy and expanding pharmacist roles in HIV treatment and prevention. Data are lacking in regard to curricular content and type of training received by faculty to provide didactic and experiential HIV training. METHODS: A cross-sectional, population-based survey of United States (US) pharmacy schools was conducted using a 15-item questionnaire. HIV content experts were surveyed at 135 four-year, accredited programs. RESULTS: Thirty-seven responses were received from schools in the Midwestern (34%), Northeastern (26%), Southern (26%), and Western (14%) regions. Time devoted to didactic HIV education ranged from 0.5 to 60 hours. The majority of respondents (78%, n = 29) reported 10 or fewer hours of HIV-related content, with 41% (n = 15) reporting five or less hours of content. Experiential practice sites for HIV training were variable, with a majority (80%) including an outpatient infectious diseases/HIV clinic. Eighty percent of respondents also reported students receiving fewer than 25 encounters with people living with HIV (PLWH) throughout their entire experiential training. Over half (54%) of respondents reported that the primary HIV instructor devoted four hours per week or less to HIV care. CONCLUSIONS: Diversity in the amount of time devoted to HIV didactic education existed among reporting US pharmacy schools. Few schools have dedicated faculty spending a substantial amount of time in direct care of PLWH. Minimum standards for HIV education in schools of pharmacy should be established.

Sustained Virologic Response and Costs Associated with Direct-Acting Antivirals for Chronic Hepatitis C Infection in Oklahoma Medicaid.

BACKGROUND: Outcomes involving newer direct-acting antiviral (DAA) hepatitis C virus (HCV) regimens have not been studied extensively among the Medicaid population. OBJECTIVE: To assess clinical (treatment failure) and economic outcomes for chronic HCV-infected Oklahoma Medicaid members following treatment with DAAs and to measure associations with patient, treatment, and clinical characteristics. METHODS: This cross-sectional study used Oklahoma Medicaid pharmacy and medical claims data for adult members who used a newer DAA agent and had reported a successful or failed sustained virological response rate 12 weeks after therapy completion (SVR12) from January 1, 2014, to June 30, 2016. Multivariable logistic and gamma regressions assessed predictors of SVR12 failure and costs controlling for member demographics (i.e., age, sex, race, rural residence); type of DAA and adherence; clinical characteristics (e.g., comorbid conditions, advanced liver disease); and the implementation of changes to a prior authorization program. RESULTS: Of 934 Medicaid members eligible for treatment with DAAs between January 1, 2014, and June 30, 2016, 906 received DAA treatment, 40.6% (368/906) had reported SVR12 outcomes, and 59.4% (n = 538) did not have a reported SVR recorded. Of those with reported SVR12 outcomes, patients were 53.1 ± 9.7 years of age, 51.1% were male, 8.4% had SVR12 failure, and each member had mean costs of $140,283 ± $52,779. Multivariable analyses indicated higher odds of SVR12 failure was independently associated with cirrhosis (OR [decompensated] = 6.69 and OR [compensated] = 3.52, P < 0.001), while males had higher odds of failure than females (OR = 3.34, P < 0.010). No significant difference in SVR12 failure was noted, according to DAA type or a medication adherence threshold of > 95%. Ledipasvir/sofosbuvir was independently associated with lower costs (exp[b] = 0.81; P < 0.001) compared with sofosbuvir, while higher costs were associated with decompensated cirrhosis (exp[b] = 1.22; P < 0.001) and treatment failure (exp[b] = 1.18, P < 0.010). In an analysis including members without reported SVR12 outcomes, decompensated and compensated cirrhosis had lower odds (P < 0.001) of no reported SVR12 from ambulatory clinic settings. CONCLUSIONS: Almost 60% of Medicaid members receiving DAA treatment did not have a final reported SVR12 outcome. Among those with viral load measurements, treatment success was high and both decompensated and compensated cirrhosis were independently associated with significantly higher odds of treatment failure. Addressing a loss to follow-up among HCV patients and curtailing the development of cirrhosis to improve treatment success may warrant interventions that improve access to care and remove barriers that impede treatment initiation and completion. DISCLOSURES: No outside funding supported this study. Pham, Keast, Holderread, Nesser, and Skrepnek disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. Pham discloses fellowship funding from Purdue Pharma unrelated to this study. Keast and Skrepnek disclose research grant funding from Gilead Sciences and Abbvie. Holderread also reports grant funding from Gilead Sciences and fees from PRIME Education. Thompson, Farmer, and Rathbun have nothing to disclose.

Evaluating antidepressant treatment prior to adding second-line therapies among patients with treatment-resistant depression.

BACKGROUND: Patients with depression can be mistakenly labeled as treatment-resistant if they fail to receive an adequate first-line antidepressant trial. Adding second-line agents to the treatment regimens can create an additional burden on both the patients and the healthcare system. OBJECTIVES: To determine if depressed patients receive an adequate antidepressant trial prior to starting second-line therapy and to investigate the association between the type of second-line treatment and severity of illness or depression among unipolar versus bipolar patients. SETTING: Oklahoma Medicaid claims data between 2006 and 2011. METHODS: Subjects were depression-diagnosed adult patients with at least two prescriptions of antidepressants followed by a second-line agent. Patients were categorized into one of three groups: an atypical antipsychotic, other augmentation agents (lithium, buspirone, and triiodothyronine), or adding antidepressants, based on the type of second-line therapy. An adequate trial was defined per the American Psychiatric Association guidelines. Factors associated with the type of treatment were tested using multinomial logistic regression models stratified by type of depression (unipolar vs. bipolar patients). MAIN OUTCOME MEASURE: Variables used to measure receiving an adequate antidepressant trial included: trial duration, adherence, dose adequacy, and number of distinct antidepressant trials. RESULTS: A total of 3910 patients were included in the analysis. Most subjects reached the recommended antidepressant dose. However, 28 % of patients had an antidepressant trial duration <4 weeks and only 60 % tried at least two antidepressant regimens prior to adding second-line therapy. Approximately 50 % of the subjects were non-adherent across all groups. Severity of illness and receipt of an adequate antidepressant trial were not predictors of the type of second-line treatment. CONCLUSION: Many patients do not receive an adequate antidepressant trial before starting a second-line agent. The type of second-line treatment was independent of severity of depression. These findings support policies that require reviewing the recommended dose and duration of the first-line antidepressant before adding second-line agents. Healthcare providers need to review the patient's history and reconsider the evidence for prescribing second-line agents.

Does the use of atypical antipsychotics as adjunctive therapy in depression result in cost savings? Comparing healthcare costs and utilization between second-line treatment options.

BACKGROUND: Several atypical antipsychotics (AAPs) are used as second-line agents for treatment resistant depression. AAPs can be expensive compared to other treatment options and can cause several side effects. OBJECTIVES: To estimate healthcare costs and utilization of AAPs compared to other second-line agents. METHODS: Observational study using Medicaid claims data (2006-2011). Subjects were depression-diagnosed adult members with at least two prescriptions of antidepressant medications followed by a second-line agent. Gamma generalized linear models (GLM) produced estimates of the difference in mean expenditures among treatment groups after adjusting for individual baseline characteristics using propensity scores. Negative binomial models produced estimates of the difference in number of hospitalizations and emergency department (ED) visits. RESULTS: A total of 3910 members received second-line treatment. Treatment groups were AAPs (n = 2211), augmentation agents other than AAPs (n = 1008), and antidepressant switching (n = 691). AAPs resulted in higher mean adjusted pharmacy costs and higher mean adjusted total mental health-related costs. Mean adjusted total healthcare costs and number of inpatient and ED visits were not different among treatments. CONCLUSION: The results show no evidence that AAPs used as second-line treatment for depression results in overall cost savings or lower inpatient and ED visits compared to other treatment strategies.

An evaluation of three statistical estimation methods for assessing health policy effects on prescription drug claims.

BACKGROUND: While the choice of analytical approach affects study results and their interpretation, there is no consensus to guide the choice of statistical approaches to evaluate public health policy change. OBJECTIVES: This study compared and contrasted three statistical estimation procedures in the assessment of a U.S. Food and Drug Administration (FDA) suicidality warning, communicated in January 2008 and implemented in May 2009, on antiepileptic drug (AED) prescription claims. METHODS: Longitudinal designs were utilized to evaluate Oklahoma (U.S. State) Medicaid claim data from January 2006 through December 2009. The study included 9289 continuously eligible individuals with prevalent diagnoses of epilepsy and/or psychiatric disorder. Segmented regression models using three estimation procedures [i.e., generalized linear models (GLM), generalized estimation equations (GEE), and generalized linear mixed models (GLMM)] were used to estimate trends of AED prescription claims across three time periods: before (January 2006-January 2008); during (February 2008-May 2009); and after (June 2009-December 2009) the FDA warning. RESULTS: All three statistical procedures estimated an increasing trend (P < 0.0001) in AED prescription claims before the FDA warning period. No procedures detected a significant change in trend during (GLM: -30.0%, 99% CI: -60.0% to 10.0%; GEE: -20.0%, 99% CI: -70.0% to 30.0%; GLMM: -23.5%, 99% CI: -58.8% to 1.2%) and after (GLM: 50.0%, 99% CI: -70.0% to 160.0%; GEE: 80.0%, 99% CI: -20.0% to 200.0%; GLMM: 47.1%, 99% CI: -41.2% to 135.3%) the FDA warning when compared to pre-warning period. CONCLUSIONS: Although the three procedures provided consistent inferences, the GEE and GLMM approaches accounted appropriately for correlation. Further, marginal models estimated using GEE produced more robust and valid population-level estimations.

Patient-centered interventions to improve medication management and adherence: a qualitative review of research findings.

OBJECTIVE: Patient-centered approaches to improving medication adherence hold promise, but evidence of their effectiveness is unclear. This review reports the current state of scientific research around interventions to improve medication management through four patient-centered domains: shared decision-making, methods to enhance effective prescribing, systems for eliciting and acting on patient feedback about medication use and treatment goals, and medication-taking behavior. METHODS: We reviewed literature on interventions that fell into these domains and were published between January 2007 and May 2013. Two reviewers abstracted information and categorized studies by intervention type. RESULTS: We identified 60 studies, of which 40% focused on patient education. Other intervention types included augmented pharmacy services, decision aids, shared decision-making, and clinical review of patient adherence. Medication adherence was an outcome in most (70%) of the studies, although 50% also examined patient-centered outcomes. CONCLUSIONS: We identified a large number of medication management interventions that incorporated patient-centered care and improved patient outcomes. We were unable to determine whether these interventions are more effective than traditional medication adherence interventions. PRACTICE IMPLICATIONS: Additional research is needed to identify effective and feasible approaches to incorporate patient-centeredness into the medication management processes of the current health care system, if appropriate.

Have antiepileptic drug prescription claims changed following the FDA suicidality warning? An evaluation in a state Medicaid program.

OBJECTIVE: In January 2008, the Food and Drug Administration (FDA) communicated concerns and, in May 2009, issued a warning about an increased risk of suicidality for all antiepileptic drugs (AEDs). This research evaluated the association between the FDA suicidality communications and the AED prescription claims among members with epilepsy and/or psychiatric disorder. METHODS: A longitudinal interrupted time-series design was utilized to evaluate Oklahoma Medicaid claims data from January 2006 through December 2009. The study included 9289 continuously eligible members with prevalent diagnoses of epilepsy and/or psychiatric disorder and at least one AED prescription claim. Trends, expressed as monthly changes in the log odds of AED prescription claims, were compared across three time periods: before (January 2006 to January 2008), during (February 2008 to May 2009), and after (June 2009 to December 2009) the FDA warning. RESULTS: Before the FDA warning period, a significant upward trend of AED prescription claims of 0.01% per month (99% CI: 0.008% to 0.013%, p<0.0001) was estimated. In comparison to the prewarning period, no significant change in trend was detected during (-20.0%, 99% CI: -70.0% to 30.0%, p=0.34) or after (80.0%, 99% CI: -20.0% to 200.0%, p=0.03) the FDA warning period. After stratification, no diagnostic group (i.e., epilepsy alone, epilepsy and comorbid psychiatric disorder, and psychiatric disorder alone) experienced a significant change in trend during the entire study period (p>0.01). CONCLUSIONS: During the time period considered, the FDA AED-related suicidality warning does not appear to have significantly affected prescription claims of AED medications for the study population.

Influence of the type of Basal insulin and other variables on clinical outcomes in children with newly diagnosed type 1 diabetes.

Background. Basal insulin detemir and glargine each have characteristics that may make them a superior choice in children and adolescents with type 1 diabetes, but there is a paucity of data on glycemic results in this population. Objective. Examination of variables associated with achievement of HbA1c goal in children and adolescents with newly diagnosed type 1 diabetes. Methods. The primary outcome, factors associated with achievement of HbA1c goal, was examined in a retrospective chart review. Variables, including type of basal insulin, were collected during the first year of diagnosis of patients in a pediatric diabetes clinic. Secondary outcomes included change in HbA1c, severe hypoglycemic events, and episodes of DKA. Results. 94 patients were included in the study. HbA1c at diagnosis was found to be a significant predictor of achievement of goal at 3 months (P = 0.002) and of change in HbA1c at 3 and 12 months (P < 0.001 for each). Severe hypoglycemia and episodes of DKA were uncommon. Conclusions. Choice of basal insulin was not found to be a predictor of achieving HbA1c goal or of change in HbA1c over the course of the first year of diagnosis with type 1 diabetes.

Evaluation of serum prolactin levels in intellectually disabled patients using antipsychotic medications.

BACKGROUND: Patients with intellectual disabilities may be treated with antipsychotic medications for a variety of diagnoses. Use of this category of medication can increase prolactin levels and place the patient at risk for sexual dysfunction and lower bone mineral density. The proposed mechanism of action is affinity for the dopamine receptor. Use of bromocriptine, a dopamine receptor antagonist, was proposed to attenuate hyperprolactinemia. OBJECTIVES: The objectives of this study were to (1) review serum prolactin (PRL) elevations associated with the use of antipsychotic (AP) medications in an intellectually disabled adult population and (2) determine if any association existed between the level of elevation and AP used. PATIENTS AND METHODS: Medical records for adult patients at two Oklahoma facilities for the intellectually disabled were reviewed to evaluate prolactin levels for individuals prescribed antipsychotics. A linear regression model was used to evaluate the relationship between prolactin levels with intellectual disability level, bromocriptine use, demographics, and antipsychotic. RESULTS: 73 (n = 53 males, n = 20 females) patients met criteria. The average age was 41.2 years. Nearly 70% of the patients had severe to profound levels of disability. 77% were prescribed second generation antipsychotics; 19% received first generation agents. Two variables, gender and bromocriptine use, were found to be significant predictors of prolactin levels. Mean prolactin level for females was 44 ng/mL (normal range: 4-30 ng/mL, males = 4-23 ng/mL). Patients who did not receive bromocriptine had mean levels of 23 ng/mL. No significant difference in prolactin levels was found for type of AP. CONCLUSIONS: Mean prolactin levels for females were significantly higher than for males. Both sexes were found to have higher-than-normal levels. Use of bromocriptine was associated with higher prolactin levels. In this population of patients, the type of AP used had no significance on prolactin levels.

Evaluation of a diabetes management program using selected HEDIS measures.

OBJECTIVE: To evaluate the efficacy of a community-based, pharmacist-directed diabetes management program among managed care organization enrollees using National Committee for Quality Assurance (NCQA)-Healthcare Effectiveness Data and Information Set (HEDIS) performance measures. DESIGN: Randomized controlled trial. SETTING: Regional community pharmacy chain in Tulsa, OK, from November 2005 to July 2007. PATIENTS: 52 participants with diabetes and hypertension who were enrolled in a managed care organization. INTERVENTION: Diabetes management versus standard care. MAIN OUTCOME MEASURES: Comprehensive diabetes care measures of glycosylated hemoglobin (A1C <7.0%), blood pressure (<130/80 mm Hg), and low-density lipoprotein (LDL) cholesterol (<100 mg/dL). A composite research outcome of success was created by determining whether a participant achieved two of the three HEDIS goals at the end of 9 months. RESULTS: 46.7% of intervention group participants achieved the A1C goal, while 9.1% of control group participants achieved the goal ( P < 0.002). More than one-half (53.3%) of intervention participants achieved the blood pressure goal compared with 22.7% of control participants ( P < 0.02). Among control group participants, 50% achieved the LDL cholesterol goal compared with 46.67% of intervention group participants. The odds of the intervention group attaining the composite goal were 5.87 times greater than the control group. CONCLUSION: A community pharmacy-based diabetes management program was effective in achieving A1C and blood pressure goals measured by NCQA-HEDIS performance standards. Program participants were statistically significantly more likely to achieve two of three HEDIS standards during a 9-month period.

Teaching medication adherence in US colleges and schools of pharmacy.

OBJECTIVE: To determine and describe the nature and extent of medication adherence education in US colleges and schools of pharmacy. METHODS: A mixed-methods research study was conducted that included a national survey of pharmacy faculty members, a national survey of pharmacy students, and phone interviews of 3 faculty members and 6 preceptors. RESULTS: The majority of faculty members and students agreed that background concepts in medication adherence are well covered in pharmacy curricula. Approximately 40% to 65% of the students sampled were not familiar with several adherence interventions. The 6 preceptors who were interviewed felt they were not well-informed on adherence interventions, unclear on what students knew about adherence, and challenged to provide adherence-related activities for students during practice experiences because of practice time constraints. CONCLUSIONS: Intermediate and advanced concepts in medication adherence, such as conducting interventions, are not adequately covered in pharmacy curriculums; therefore stakeholders in pharmacy education must develop national standards and tools to ensure consistent and adequate medication adherence education.

Communicating non-steroidal anti-inflammatory drug risks: verbal counseling, written medicine information, and patients' risk awareness.

OBJECTIVE: To assess potential associations among physician counseling, pharmacist counseling, written medicine information (WMI) and patient awareness of non-steroidal anti-inflammatory drug (NSAID) risks. METHODS: Three-hundred and eighty-two older, white and African American patients prescribed NSAIDs were surveyed regarding their NSAID risk awareness defined as an index score ranging from zero to four correctly identified risks (i.e., gastrointestinal bleeding, heart attack, hypertension, and kidney disease). Associations among NSAID risk awareness and patient-reported physician counseling, pharmacist counseling, and reading of WMI were evaluated in multivariable ordered logistic regression models and confirmed using path analysis. RESULTS: Physician counseling was positively associated with reading WMI (p<0.001) and NSAID risk awareness (p<0.001). Pharmacist counseling was not associated with reading WMI (p=0.622) and neither pharmacist counseling (p=0.366) nor reading WMI (p=0.916) was associated with NSAID risk awareness. CONCLUSIONS: Physicians play a prominent role in facilitating NSAID risk awareness whereas pharmacist counseling and WMI may have limited impact. PRACTICE IMPLICATIONS: The lack of significant associations among pharmacist counseling and reading WMI with NSAID risk awareness suggests a missed opportunity to improve patient understanding. There is a need for coordinated and effective strategies to communicate risk information among physicians and pharmacists and to better integrate WMI into this process.

Commonly prescribed medications and potential false-positive urine drug screens.

PURPOSE: The implications of potential false-positive urine drug screen (UDS) results for patients receiving commonly prescribed medications were evaluated. SUMMARY: A comprehensive literature review was conducted to identify false-positive UDSs associated with all clinic formulary medications, as well as common nonprescription medications. The references of each report describing a medication whose use was associated with false-positive UDS results were also reviewed. If a class effect was suspected, additional agents in the category were searched. A total of 25 reports of false-positive UDS results were identified. Categories of medications included antihistamines, antidepressants, antibiotics, analgesics, antipsychotics, and nonprescription agents. Reports of false-positive results were found for the following formulary and nonprescription medications: brompheniramine, bupropion, chlorpromazine, clomipramine, dextromethorphan, diphenhydramine, doxylamine, ibuprofen, naproxen, promethazine, quetiapine, quinolones (ofloxacin and gatifloxacin), ranitidine, sertraline, thioridazine, trazodone, venlafaxine, verapamil, and a nonprescription nasal inhaler. False-positive results for amphetamine and methamphetamine were the most commonly reported. False-positive results for methadone, opioids, phencyclidine, barbiturates, cannabinoids, and benzodiazepines were also reported in patients taking commonly used medications. The most commonly used tests to screen urine for drugs of abuse are immunoassays, even though false-positive results for drugs of abuse have been reported with a number of these rapid-screening products. Results from such tests should be confirmed using additional analytical methods, including gas chromatography-mass spectrometry. CONCLUSION: A number of routinely prescribed medications have been associated with triggering false-positive UDS results. Verification of the test results with a different screening test or additional analytical tests should be performed to avoid adverse consequences for the patients.

Evaluation of a hypertension medication therapy management program in patients with diabetes.

OBJECTIVE: To evaluate the effect of a 9-month community pharmacy-based medication therapy management (MTM) program on quality of care in patients with diabetes and hypertension. DESIGN: Randomized controlled trial. SETTING: Tulsa, OK, between November 2005 and July 2007. PATIENTS: 52 patients with diabetes and hypertension who were enrolled in a managed care organization. INTERVENTION: During monthly visits, intervention group participants received MTM services for hypertension and diabetes management. MAIN OUTCOME MEASURES: Systolic blood pressure (SBP), percentage at goal blood pressure (<130/80 mm Hg), and antihypertensive medication adherence. RESULTS: The mean intervention group SBP decreased 17.32 mm Hg, whereas the mean control group SBP level increased 2.73 mm Hg (P = 0.003). The percentage of patients at goal blood pressure increased from 16.0% to 48.0% in the intervention group and decreased from 20.0% to 6.67% in the control group. Intervention group participants were 12.92 times more likely than control group participants to achieve goal blood pressure (P = 0.021). Although the mean adherence rate in the intervention group increased 7.0% while remaining fairly constant in the control group (-0.7%), this group difference was not statistically significant. CONCLUSION: A community pharmacy-based hypertension MTM program was effective in improving blood pressure control among managed care enrollees with diabetes and hypertension. Community pharmacists are strategically positioned to provide MTM services and effectively communicate with providers to improve quality of care for patients.

Identifying perceptions of professionalism in pharmacy using a four-frame leadership model.

OBJECTIVES: To determine whether professionalism in pharmacy education is addressed from Bolman and Deal's four-frame leadership model. METHODS: Students (N=624), faculty (N=57), preceptors (N=56), and academic administrators (N=8) at 6 colleges and schools of pharmacy were surveyed to assess professionalism. Using grounded theory methodology and a constant comparative process, common themes were identified for each question in each group. Themes were assigned to the four-frame model and the data were compared. RESULTS: Mechanisms of addressing professionalism consistent with all 4 frames of the Bolman and Deal's model were identified. Faculty assessment of student professionalism was significantly lower (P<0.05) than the student group, preceptors, and administrators. CONCLUSIONS: Mechanisms of addressing professionalism in pharmacy education span all four frames of Bolman and Deal's leadership model. The values students bring into a pharmacy program may play an important role in the process of professional socialization. Faculty members have a tremendous opportunity to enhance student professionalism with their daily verbal and nonverbal interactions with students.