Predisposing, Enabling, and Need Factors Influencing Health-related Quality of Life Among People with Metabolic Syndrome.

INTRODUCTION: Metabolic syndrome (MetS) continues to impact the health-related quality of life (HRQoL) of patients despite various available therapeutic interventions. There is a dearth of information on how patient-centered factors holistically predict HRQoL to provide more insights on addressing MetS. OBJECTIVES: To predict the HRQoL of patients with MetS in the Southern states, using the predisposing, enabling, and need factors. METHOD: The study adopted a cross-sectional approach in collecting 706 complete surveys on HRQoL assessment using the EQ-5D-5L survey and demographic characteristics based on the predisposing, enabling, and need factors of Andersen's Behavioral model. The study focused on people with MetS in the southern states of the United States. Multinomial logistic regression was conducted to investigate the relationship between the number of comorbidities and each HRQoL dimension. Ordinal regression was used to explore factors predicting HRQoL. Sensitivity analysis was conducted using bootstrapping analysis to evaluate the regression's robustness. RESULTS: Over 70% were female and 30% had at least a bachelor's degree, while 47% were married. Most respondents (71.1%) had no problem with self-care. However, 20.0% had severe problems with pain, while the highest proportion (8.6%) was observed for extreme problems with anxiety or depression. A unit increase in comorbidities resulted in higher odds of having extreme problems with mobility (OR = 1.95), usual activities (OR = 1.73), and pain (OR = 1.70). Only 40.8% of the respondents had good HRQoL, compared to 26.2% with poor HRQoL. Age, race, geographical area, marital status, household income, number of prescription drugs, comorbidities, and body mass index were predictors of HRQoL. CONCLUSION: An increase in comorbidities significantly increased the odds of having challenges with the HRQoL dimensions. Demographic, socioeconomic, and health-related factors significantly predicted HRQoL. Therefore, healthcare providers must consider these factors as a component of patient-centered care to address health disparities and promote optimal health outcomes among people with MetS.

Barriers and Facilitators to DATA Waivered Providers Prescribing Buprenorphine: A Qualitative Analysis Applying the Theory of Planned Behavior.

Background: Provider beliefs about the treatment of people with addiction may influence their prescribing behavior. Objective: This study applied the Theory of Planned Behavior (TPB), to identify the salient beliefs of Drug Addiction Treatment Act of 2000 (DATA 2000) waivered providers, concerning prescribing buprenorphine to patients with Opioid Use Disorder (OUD). Methods: Texas buprenorphine providers participated in one of four online focus group discussions conducted in fall 2019. The focus group discussion were audio recorded and the total length was between 60-90 minutes. Thematic analysis was conducted to identify emerging themes and to categorize the behavioral, normative, and control beliefs related to buprenorphine prescribing. Results: Of the 14 total participants, 57% of the participants were male and annually treated between zero to sixty patients with buprenorphine. The codes generated were represented in thematic maps, specifying the positive or negative aspects of buprenorphine prescribing. Results indicate that providers' primary motivation to prescribe buprenorphine was, implementation of a whole-patient approach through collaboration with behavioral health providers, in the provision of medications for opioid use disorder (MOUD). Providers primary normative belief was the recognition of key members of the medical community and patients' families and friends as influential groups. Providers' control beliefs focused on their ability to use buprenorphine in different practice settings. Conclusion: These results indicate that buprenorphine access may be expanded by increasing support for DATA waivered providers from other parts of the healthcare system such as behavioral health providers and pharmacists. Implications for clinical practice and future research will be discussed.

Impact of geographic access to primary care providers on pediatric behavioral health screening.

Behavioral Health (BH) screening is critical for early diagnosis and treatment of pediatric mental disorders. The objective of this study was to assess the impact of geographic access to primary care providers (PCP) on pediatric BH screening in children with different race/ethnicity. A retrospective cohort study was conducted using the 2013-2016 administrative claims data from a large pediatric Medicaid Managed Care Plan that have been linked to 2010 US Census data and the 2017 National Provider Identifier (NPI) Registry. Geographic access was defined as the actual travel distance to nearest PCP and the PCP density within 10-mile travel radius from each individual's residence. Stratified multivariate logistic regression was conducted to examine the association between the geographic access to PCP and the likelihood of receiving screening for behavioral disorders within each racial/ethnic group. BH screening rate was 12.6% among 402,655 children and adolescents who met the inclusion criteria. Multivariable analysis stratified by individual race/ethnicity revealed that Hispanic and Black children were more vulnerable to the geographic access barriers than their non-Hispanic White counterparts. The increase in travel distance to the nearest PCP was negatively associated with screening uptake only among Hispanics (10-20 miles vs. 0-10 miles: OR = 0.78, 95% CI [0.71-0.86]; 20-30 miles vs. 0-10 miles: OR = 0.35, 95% CI [0.23-0.54]). In a subgroup that had access to at least one PCP within 10 miles of travel distance, the variation in PCP density had a greater impact on the screening uptake among Hispanics and Blacks than that in non-Hispanic Whites.

Switching pharmacies leads to gaps in medication possession in individuals treated with buprenorphine.

BACKGROUND: Not all pharmacies stock and dispense buprenorphine, potentially complicating continuous access to care for patients with opioid use disorder (OUD). This may become problematic if a patient's primary pharmacy can no longer provide buprenorphine, and the patient cannot locate a new pharmacy. OBJECTIVES: To identify how often patients treated with buprenorphine for OUD switch pharmacies and to estimate the association between switching pharmacies and a clinically significant gap in therapy of 7 days or longer. METHODS: A retrospective repeated measures longitudinal cohort design was used. Patients initiating treatment with a buprenorphine product indicated for OUD were identified from the 2016-2018 Texas Prescription Monitoring Program. The predictor of interest-switching pharmacies-was defined by comparing the dispensaries used between subsequent prescriptions. The outcome of interest was defined as a gap in medication possession of 7 days or longer on the basis of the National Quality Forum's definition of continuity of pharmacotherapy for OUD. A generalized estimating equation approach was used to estimate a repeated measures logistic regression measuring the association between switching pharmacies and a gap in therapy. RESULTS: Of 13,375 eligible patients, 29.6% switched pharmacies at least once during treatment, and 51.6% of these did so more than once. The median time to initial switch was 30 days (interquartile range: 13-66 days). When patients switched pharmacies, they were significantly more likely to have a gap in therapy of between 7 and 29 days (adjusted odds ratio 1.67 [95% CI 1.57-1.78]). CONCLUSION: Patients receiving buprenorphine switch pharmacies early and frequently in treatment, which leads to clinically significant gaps in therapy. Although qualitative explanatory work is needed to understand why patients switch pharmacies so often, pharmacists and prescribers must ensure that patients have reliable access to a convenient source of buprenorphine to prevent gaps in therapy.

Patient-reported barriers to statin adherence: Excerpts from a motivational interviewing intervention in older adults.

OBJECTIVE: Despite a known benefit in the reduction of cardiovascular risk, adherence to statins remains suboptimal. A qualitative analysis was conducted within an intervention that identified trajectories of statin adherence in patients and used motivational interviewing (MoI) to improve adherence. The objective of this qualitative study was to evaluate transcripts of an MoI telephonic intervention to identify potential, past, and current barriers to statin adherence and barriers specific to distinct adherence trajectories. METHODS: The MoI intervention was customized by past 1-year adherence trajectories (rapid discontinuation, gradual decline, and gaps in adherence). Two authors independently extracted and documented barriers from phone transcripts. Themes were derived from literature a priori and by cataloging recurring themes from the transcripts. RESULTS: The transcripts of calls made to 157 patients were reviewed of which 25.2% did not communicate a specific adherence barrier despite falling into a low-adherence trajectory when examining refill data. The most commonly reported barriers to statin adherence included adverse effects (40.1%), forgetfulness (30.0%), and lack of skills or knowledge pertaining to statins (25%). More patients in the rapid discontinuation group perceived medication as unnecessary, whereas more patients in the gaps in adherence group reported a communication barrier with their health care provider. Several barriers among patients who fell into low-adherence trajectories were reported. Some patients did not report any barriers, which may have indicated denial. MoI phone calls were useful in providing knowledge, clarifying medication regimens, and reinforcing the need to take statins. CONCLUSION: This study identified patient-reported barriers to statin adherence elicited during an MoI telephonic intervention conducted by student pharmacists. There were differences in barriers reported by patients from each trajectory, which emphasize the need for additional tailored interventions to improve patient adherence.

Health care practitioner counseling encourages disposal of unused opioid medications.

OBJECTIVE: The objective of this study was to estimate the association between health care practitioner counseling on medication disposal and disposal of unused opioid medications. DESIGN: A 41-item survey instrument was created and administered to a nationally representative panel of adult opioid users with chronic pain using a cross-sectional, internet survey design via Qualtrics®. PARTICIPANTS: Four hundred adult opioid users with chronic pain were randomly selected from the Qualtrics® panel-base to participate. SETTING: United States. OUTCOME MEASURES: The dependent variable, disposal of unused opioid medications, was assessed with a single item asking participants how often they had disposed of unused opioid medications in the past year. Multiple logistic regression was used to assess the association between opioid disposal and the receipt of health care practitioner counseling on medication disposal. RESULTS: A total of 400 surveys were completed. Participants were mostly white (70.8%) and under the age of 40 (54.1%). Less than one-half of all participants (44.5%) had disposed of opioid medications in the past year, while 60.75% had received health care practitioner counseling on disposal. Of those counseled, only 21.4% were counseled by a pharmacist. Flushing medication down the toilet (33%) was the most common method of opioid disposal. After adjustment for covariates, those who received health care practitioner counseling were more likely to have disposed of opioid medications in the past year (adjusted odds ratio 1.66, 95% CI 1.03-2.69). CONCLUSIONS: Participants who received counseling on opioid disposal were more likely to have disposed of unused opioid medications. Pharmacists are uniquely positioned to counsel patients on opioid disposal and thus must be active in preventing harm and diversion due to improperly stored opioid medications. This study demonstrates the need for enhanced provider education and policy to ensure that patients are adequately counseled on proper opioid disposal.

Prevalence and Factors Associated with Multiple Provider Episodes in Texas: An Epidemiological Analysis of Prescription Drug Monitoring Program Data.

OBJECTIVE: Prescription drug abuse has reached epidemic levels, leading to overdose-related morbidity and mortality. Patient and regional-level factors are believed to contribute to higher rates of prescription drug abuse. The objective of this study was to determine the prevalence and factors associated with multiple provider episodes (MPEs) in Texas. METHODS: This was a retrospective cohort analysis of data from the Texas Prescription Drug Monitoring Program (PDMP) database, linked with Texas county census data. Descriptive statistics and a multilevel model regression analysis were employed to estimate the prevalence of MPEs and examine the association between individual controlled substance prescription (CSP) utilization and county factors associated with MPEs. RESULTS: Among the 10,381,532 Texas residents utilizing CSPs in 2013, prescription opioids were the most frequently dispensed CSP (38.64%). The prevalence of MPEs was 71.30 per population of 100,000. Of those with MPEs, 76.98% received CSPs for more than 150 days and 11.48% had an average daily morphine equivalent dose (MED) 100 mg/day or higher. Residing in metropolitan areas, traveling more than 100 miles to obtain and fill prescriptions, chronic use of CSPs, younger age, and high MED were all significantly associated with increased risk of MPEs. CONCLUSIONS: This study revealed that previous estimates of prescription drug abuse may be drastically underestimated. Prescription drug abuse is a major public health problem in Texas, especially in metropolitan areas. Therefore, prevention efforts need to be addressed at the individual level and through public health and policy legislation.

The Prevalence of and Factors Associated With Receiving Concurrent Controlled Substance Prescriptions.

BACKGROUND: Controlled substance prescription (CSP) use and abuse in the United States has become a public health epidemic. One common and dangerous indicator of abuse involves obtaining CSPs concurrently. OBJECTIVE: The objective of this study was to identify the prevalence and factors associated with individuals receiving potentially inappropriate concurrent CSPs. METHODS: This was a retrospective, cohort analysis using data from the 2013-2014 Texas prescription drug monitoring program (PDMP). Descriptive statistics and a multiple logistic regression analysis were conducted to examine the individual-level and prescription utilization factors associated with individuals obtaining concurrent CSPs. RESULTS: Among Texas residents, 1,640,015 individuals (6.10% of all Texas residents and 15.99% of all CSP utilizers) were identified with at least one concurrent CSP combination. Concurrent opioid prescriptions were found to be the most prevalent concurrent use combination (n = 1,574,572). Having prescriptions for opioids, being ≥18 years of age, utilizing CSPs for >30 days, utilizing greater than one CSP, having a multiple provider episode, and traveling >25 miles to obtain CSPs were all statistically significant predictors of utilizing concurrent CSPs. CONCLUSION: The study findings indicate a high prevalence of individuals utilizing concurrent CSPs. This practice is concerning when considering that many overdose deaths result from the concurrent use of CSPs. Prescribers should utilize PDMPs to ensure that aberrant prescription drug behaviors, such as the use of concurrent opioids and benzodiazepines do not readily occur.

Pharmacists' perceptions regarding the impact of hydrocodone rescheduling on prescription volume, workflow management, and patient outcomes.

OBJECTIVES: To determine (1) pharmacists' perceptions of how rescheduling of hydrocodone combination products (HCPs) from Drug Enforcement Agency (DEA) Schedule III to DEA Schedule II has influenced prescription volume and revenue, pharmacy workflow management, and patient outcomes; and (2) whether perceptions differed between pharmacists who support versus those who oppose HCP rescheduling. DESIGN: A cross-sectional mail survey. SETTING: Texas community pharmacies from October to December 2015. PARTICIPANTS: One thousand randomly selected, registered Texas community pharmacists drawn from the Texas State Board of Pharmacy registry. MAIN OUTCOME MEASURES: Pharmacists' perceptions, measured on a 5-point Likert scale of HCP rescheduling and its impact on prescription volume and revenue, workflow management, and patient outcomes. Measures were developed specifically for this study. RESULTS: The response rate was 17% (n = 164). The majority of pharmacists (70.4%) supported HCP rescheduling. More than 80% of respondents perceived that the volume of 2 alternative pain medications-tramadol (DEA Schedule IV) and acetaminophen with codeine (DEA Schedule III) prescriptions dispensed-either "increased" or "significantly increased" (82.0% and 85.8%, respectively) following rescheduling. Overall, pharmacists who opposed rescheduling were significantly more likely to report negative perceptions regarding revenue (P = 0.0142), inventory management (P = 0.0024), and drug shortages (P = 0.0005) than those who supported rescheduling. However, pharmacists who supported rescheduling had more positive perceptions about electronic prescribing (P <0.0115), patient safety (P <0.001), drug abuse (P <0.0001), and legitimate use (P <0.0001). CONCLUSION: Results showed that legislative efforts, such as rescheduling HCPs, influenced pharmacists' perceptions of practice and patient outcomes. Currently, little is known regarding the impact of HCP rescheduling on pharmacy practice. As new laws are passed to address the opioid epidemic in America, more research will be needed to determine whether legislation is an effective means for managing appropriate access to HCPs and other narcotic analgesics.

Comparative Cognitive Profile of Second-Generation Antidepressants in Elderly Nursing Home Residents With Depression.

BACKGROUND: Past literature suggests that the use of second-generation antidepressants improves cognition in depressed elderly patients. OBJECTIVE: This study assessed the comparative cognitive profile of commonly used second-generation antidepressant classes in elderly residents with depression. METHODS: A multiple propensity score adjusted retrospective cohort study was conducted using 2007-2010 Medicare Part D claims and Minimum Data Set (MDS). Elderly nursing home residents (65 years or older) with depression using a new prescription of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tetracyclics constituted the study cohort. The outcome of interest was cognition, measured using the MDS Cognition Scale. Cognition was measured at each quarterly assessment after antidepressant initiation for a maximum of 1 year. The propensity score-adjusted repeated-measures mixed model was used to evaluate the comparative profile of SSRIs, SNRIs, and tetracyclics with respect to cognition. RESULTS: The study cohort comprised 1518 elderly nursing home residents. Of these, 1081 received SSRIs (71.21%), 320 received tetracyclics (21.08%), and 117 received SNRIs (7.71%). The propensity score-adjusted repeated-measures mixed model did not show any statistically significant difference in cognition with the use of SSRIs (ß = -0.14; 95% CI = -0.53, 0.25) or tetracyclics (ß = -0.36; 95% CI = -0.80, 0.08) when compared with SNRIs, after controlling for other factors. CONCLUSIONS: The cognitive effect of SSRIs, SNRIs, and tetracyclics was similar in elderly nursing home residents with depression. Further studies are needed to evaluate the long-term cognitive effects of second-generation antidepressants in this vulnerable population.

Pharmacists' training, perceived roles, and actions associated with dispensing controlled substance prescriptions.

OBJECTIVES: To examine situations that prompt pharmacists to access a prescription drug monitoring program (PDMP) database and management of opioid abuse/addiction; assess pharmacists' actions when abuse is suspected; describe pharmacists' tasks when dispensing controlled substance prescriptions (CSPs); and their continuing pharmacy education (CPE). DESIGN Cross-sectional mail survey of 1,000 randomly selected pharmacists. SETTING: Texas from February 2012 to April 2012. PARTICIPANTS: 1,000 Texas community pharmacists. INTERVENTION: Mail survey instrument. MAIN OUTCOME MEASURES: Prompts to use a PDMP and pharmacists' views actions, and related CPE programs. RESULTS The usable response rate was 26.2%. Pharmacists were more supportive of mandated PDMP use by physicians than by pharmacists (mean ± SD 4.1 ± 1.2 versus 3.2 ± 1.5; P <0.001), based on a 5-point Likert scale (1, strongly disagree, to 5, strongly agree). Most pharmacists would be prompted to use a PDMP if the prescription contains mistakes (68.1%) or the patient requests an early refill (66.3%). Bivariate statistics showed that men pharmacists, those with BSPharm degrees, and pharmacists ≥50 years of age reported a greater number of CPE hours related to prescription opioid abuse and pain management. An analysis of variance showed that pharmacy owners reported significantly more (P <0.05) CPE compared with manager and staff pharmacists. CONCLUSION: Older pharmacists with a BSPharm degree may be more willing to provide counseling to patients with opioid addiction based on their work experience and additional CPE related to controlled substances. As PDMP use becomes more prevalent, pharmacists should be prepared to interact and counsel patients identified with aberrant controlled prescription drug use and properly deliver pain management care. Additionally, schools of pharmacy curricula must prepare new pharmacists to prevent abuse and diversion, as well as intervene when aberrant use is identified.

Association between buprenorphine capacity rates and percentages of ethnic/racial minorities at the county level in the United States.

OBJECTIVE: This study investigated the association between patient treatment capacity rates and the percentage of racial/ethnic minorities at the county level. DESIGN: Ecological study at the county level. EXPOSURE: The percentages of racial/ethnic minorities and the people living in poverty in 3,140 counties serve as the main exposure and confounder variables. MAIN OUTCOME MEASURE: "No or low patient capacity" was defined as a patient capacity rate less than or equal to the 40th percentile of the distribution. Patient capacity rates were calculated by adding the maximum number of patients X-waivered providers could potentially treat in each county. RESULT: Counties in higher racial/ethnic minority quintiles had significantly lower odds of "no or low patient capacity" than those in the lowest quintile in multiple logistic regression (adjusted odds ratio, 0.29; 95 percent CI, 0.14-0.61). CONCLUSION: Since racial/ethnic minorities continue to have limited access to buprenorphine, as shown in individual-level studies, merely increasing treatment capacity is largely insufficient.

Is there a disparity in medications for opioid use disorder based on race/ethnicity and gender? A systematic review and meta-analysis.

BACKGROUND: Access to medications for opioid use disorder (MOUD) among racial/ethnic minorities is a growing concern. OBJECTIVES: Inequalities in receiving MOUD among gender and racial/ethnic groups were examined in this systematic review. METHODS: Studies were retrieved by searching various databases and reference lists of reviews and selected full texts. Adjusted Odds Ratios (AORs) comparing MOUDs among racial/ethnic minorities to Whites were extracted or estimated from their findings. Meta-analysis was performed using STATA 17. RESULTS: After screening 2438 records, 19 studies were included in this review in two categories. The first category consists of 11 studies comparing receiving MOUD between different races/ethnicities and genders at the individual level. The meta-analysis regarding AORs comparing Blacks, Hispanics, Asians, Native Americans/Alaska-Natives, Hawaiians, and mixed-race patients with Whites were 0.56 (95 % CI: 0.45-0.68), 0.72 (95 % CI: 0.55-0.94), 0.85 (95 % CI: 0.72-0.99), 0.88 (95%CI: 0.73-1.04), 0.27 (95 % CI: 0.03-2.18), and 0.97 (95 % CI: 0.81-1.16), respectively. The AOR of receiving MOUD for all minorities compared to Whites was 0.70 (95 % CI: 0.61-0.80). Overall AOR comparing MOUD for females to males was 0.95 (95 % CI: 0.87-1.04). The second category of articles compared buprenorphine and methadone treatment among ethnic/racial minorities and Whites. CONCLUSIONS: Compared to Whites, Blacks, Hispanics, and Asians have limited access to MOUD. The findings suggest that methadone is the predominant medication for racial/ethnic minorities, while Whites and high-income communities receive buprenorphine more. It is crucial to re-design policies to bridge the gap in access to MOUD.

Real-World Dispensing of Buprenorphine in California during Prepandemic and Pandemic Periods.

INTRODUCTION: The opioid overdose crisis in the United States has become a significant national emergency. Buprenorphine, a primary medication for individuals coping with opioid use disorder (OUD), presents promising pharmacokinetic properties for use in primary care settings, and is often delivered as a take-home therapy. The COVID-19 pandemic exacerbated the scarcity of access to buprenorphine, leading to dire consequences for those with OUD. Most existing studies, primarily focused on the immediate aftermath of the COVID-19 outbreak, highlight the challenges in accessing medications for opioid use disorder (MOUDs), particularly buprenorphine. However, these studies only cover a relatively short timeframe. METHODS: To bridge this research gap, in our study, we utilized 33 months of California's prescription drug monitoring program (PDMP) data to provide insights into real-world buprenorphine dispensing trends since the onset of the pandemic from 2018 to 2021, focusing on outcomes such as patient counts, prescription volumes, prescriber involvement, days' supply, and dosage. Statistical analysis employed interrupted time series analysis to measure changes in trends before and during the pandemic. RESULTS: We found no significant impact on patient counts or prescription volumes during the pandemic, although it impeded the upward trajectory of prescriber numbers that was evident prior to the onset of the pandemic. An immediate increase in days' supply per prescription was observed post-pandemic. CONCLUSION: Our findings differ in comparison to previous data regarding the raw monthly count of patients and prescriptions. The analysis encompassed uninsured patients, offering a comprehensive perspective on buprenorphine prescribing in California. Our study's insights contribute to understanding the impact of COVID-19 on buprenorphine access, emphasizing the need for policy adjustments.

Perceptions of metabolic syndrome management utilization in relation to patient experience and health-related quality of life.

Background: One factor for the poor health outcomes among adult people with metabolic syndrome (MetS) is poor utilization of disease management resources, which may be attributable to prior experience with pharmacists (PEwP) and perceptions of disease management resource utilization (PMU). Therefore, understanding patients' experience could be critical to improving their perceptions and promoting health outcomes. Objectives: The study explored the influence of PEwP and PMU on the health-related quality of life (HRQoL) of people with MetS. Methods: Data on perceptions of healthcare, medication, and pharmacy services utilization, PEwP, and HRQoL were collected using validated tools via an electronic survey. Chi-square and ordinal regression tests were used to predict the association between PMU, PEwP, and HRQoL. Also, mediation analysis through Haye's model 4 explored the direct and indirect relationship of PMU and PEwP on HRQoL. Results: A total of 706 completed surveys were collected and used for analyses. On average, respondents reported three comorbidities. Of the respondents, 72.0% had good PEwP, while 32.6% had good PMU. Comparatively, 38.4% of those with good PEwP had good PMU, compared to 17.3% of those with poor PEwP. Also, 47.0% of those with good PMU had good HRQoL compared to 35.3% with poor PMU. The odds of having fair or good PMU were nearly triple (OR = 2.97, p < 0.001) among those with good PEwP compared to those with poor PEwP. Also, respondents with good PMU had 58% (OR = 1.58, p = 0.008) higher odds of having fair or good HRQoL. Analysis through bootstrap indicated a significant relationship (BootCI = -0.072, -0.022) between PEwP and HRQoL via respondents' PMU. Conclusions: MetS individuals with good experience and PMU were more likely to have good HRQoL. Prior experience with pharmacists influenced PMU and indirectly impacted HRQoL. Therefore, pharmacists must consider patients' experience and management utilization perceptions to promote health outcome among people with MetS, while implementing interventions.

Disentangling the Cost of Orphan Drugs Marketed in the United States.

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median and interquartile range (IQR) drug cost was USD 218,872 (IQR = USD 23,105) for orphan drugs and USD 12,798 (IQR = USD 57,940) for non-orphan drugs (p < 0.001). Higher market entry prices were associated with biologics (108%; p < 0.001), orphan status (177%; p < 0.001), US sponsor companies (48%; p = 0.035), chronic use (1083%; p < 0.001), treatment intent (163%; p = 0.004), and indications for oncology (624%; p < 0.001) or genetic disorders (624%; p < 0.001). Higher market entry treatment cost for newly approved drugs were associated with biologics, orphan status, US sponsor companies, chronic use, therapeutic intent, and indications for oncology or genetic disorders.

Positive Changes in Safety Perception Among Blacks with HIV and Comorbidities: Assessment of Social Determinants of Health During COVID-19.

PURPOSE: This study aimed to examine the impact of the COVID-19 lockdown on social determinants of health (SDOH) among Blacks with HIV and a comorbid diagnosis of hypertension or type 2 diabetes mellitus (T2DM). METHODS: This was a longitudinal survey study. The inclusion criteria were adults ≥ 18 years and the presence of hypertension and/or diabetes, along with a positive HIV diagnosis. This study enrolled patients in the HIV clinics and chain specialty pharmacies in the Dallas-Fort Worth (DFW) area. A survey of ten questions examining SDOH was conducted before, during, and after the lockdown. A proportional odds mixed effects logistic regression model was applied to assess differences between time points. RESULTS: A total of 27 participants were included. Respondents felt significantly safer in their living place post-lockdown than in the pre-lockdown period (odds ratio = 6.39, 95% CI [1.08-37.73]). No other statistically significant differences in the responses were found over the study timeframe. However, borderline p values indicated better SDOH status post-lockdown as compared to pre-lockdown. CONCLUSION: Study participants feel safer one year after lockdown compared to pre-lockdown. The CARES Act and the moratorium on rent and mortgage are among the factors that may explain this increase. Future research should include designing and evaluating interventions for social equity enhancement.

A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes.

BACKGROUND: Hypertension and diabetes mellitus are independent risk factors for cardiovascular diseases. Due to the cardioprotective nature of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), they are recommended for patients with comorbid hypertension and diabetes. However, poor adherence to ACEIs/ARBs among older adults is a major public health concern. This study aimed to assess the effectiveness of a telephonic motivational interviewing (MI) intervention conducted by pharmacy students among a nonadherent older population (≥ 65 years old) with diabetes and hypertension. METHODS: Patients continuously enrolled in a Medicare Advantage Plan who received an ACEI/ARB prescription between July 2017 and December 2017 were identified. Group-based trajectory modeling (GBTM) was used to identify distinct patterns of ACEI/ARB adherence during the 1-year baseline period: adherent, gaps in adherence, gradual decline, and rapid decline in adherence. Patients from the three nonadherent trajectories were randomized into MI intervention or control group. The intervention consisted of an initial call and five follow-up calls administered by MI-trained pharmacy students and tailored to the baseline ACEI/ARB adherence trajectories. The primary outcome was adherence to ACEI/ARB during the 6- and 12-month periods post-MI implementation. The secondary outcome was discontinuation, defined as no refills for ACEI/ARB during the 6- and 12-month periods post-MI implementation. Multivariable regression analyses examined the impact of MI intervention on ACEI/ARB adherence and discontinuation while adjusting for baseline covariates. RESULTS: A total of 240 patients in the intervention group and 480 patients as randomly selected controls were included in this study. At 6 months, patients receiving the MI intervention had significantly better adherence (ß = 0.06; p = 0.03) compared with the controls. Linear and logistic regression models also showed patients in the intervention group were more likely to be adherent than controls within 12 months of intervention implementation (ß = 0.06; p = 0.02 and OR: 1.46; 95% CI 1.05-2.04, respectively). MI intervention did not have any significant impact on the ACEI/ARB discontinuation. CONCLUSION: Patients who received the MI intervention were more likely to be adherent at 6 and 12 months following the intervention initiation, despite gaps in the follow-up calls due to COVID-19. Pharmacist-led MI intervention is an effective behavioral strategy to improve medication adherence among older adults and tailoring the intervention to past adherence patterns may enhance the intervention effectiveness. This study was registered with the United States National Institutes of Health (ClinicalTrials.gov identifier NCT03985098).

Exploratory study of community pharmacists' perceptions about new or transferred prescription incentives.

OBJECTIVES: To assess community pharmacists' perceptions of new or transferred prescription incentives on quality of care, pharmacy practice (e.g., workload), and patient base. DESIGN: Cross-sectional study. SETTING: Texas from March through August 2010. PARTICIPANTS: Texas community pharmacists. INTERVENTION: In-person and online surveys. MAIN OUTCOME MEASURE: Pharmacists' perceptions of the impact of new or transferred prescription incentives on pharmacy practice and patient care. RESULTS: 74 usable surveys were analyzed. Most pharmacists (74%) worked for employers who participated in prescription incentive promotions (e.g., $10 gift cards). Regarding quality of care, pharmacists perceived patients as being less likely to receive thorough drug interaction screenings (4.0 ± 1.4 [mean ± SD]) and reported medication-related problems "sometimes to very often" (3.0 ± 0.9) as a result of transferring prescriptions. Pharmacists also reported that patients commonly fill prescriptions regardless of medical necessity in order to receive incentives (4.1 ± 1.0). With respect to pharmacy practice, the majority believed that prescription incentives devalue the profession (4.3 ± 1.1) and should be eliminated (4.4 ± 1.0). Pharmacists were not inclined to believe that incentives were effective in attracting new patients and retaining their business (2.0 ± 1.0). CONCLUSION: Pharmacists believed that prescription incentives are ineffective tools for increasing patient base and may lead to lower quality of care for patients. Pharmacists view prescription incentives as devaluing the profession of pharmacy and exposing patients to medication-related problems.

Exploratory Analysis of Outpatient Visits for US Adults Diagnosed with Lupus Erythematosus: Findings from the National Ambulatory Medical Care Survey 2006-2016.

The study aims to assess office-based visit trends for lupus patients and evaluate their medication burden, chronic conditions, and comorbidities. This cross-sectional study used data from the National Ambulatory Medical Care Survey (NAMCS), a survey sample weighted to represent national estimates of outpatient visits. Adult patients diagnosed with lupus were included. Medications and comorbidities that were frequently recorded were identified and categorized. Descriptive statistics and bivariate analyses were used to characterize visits by sex, age, race/ethnicity, insurance type, region, and reason for visit. Comorbidities were identified using diagnosis codes documented at each encounter. There were 27,029,228 visits for lupus patients from 2006 to 2016, and 87% them were on or were prescribed medications. Most visits were for female (88%), white (79%), non-Hispanic (88%) patients with private insurance (53%). The majority of patients were seen for a chronic routine problem (75%), and 29% had lupus as the primary diagnosis. Frequent medications prescribed were hydroxychloroquine (30%), prednisone (23%), multivitamins (14%), and furosemide (9%). Common comorbidities observed included arthritis (88%), hypertension (25%), and depression (13%). Prescription patterns are reflective of comorbidities associated with lupus. By assessing medications most frequently prescribed and comorbid conditions among lupus patients, we showcase the complexity of disease management and the need for strategies to improve care.