Liver Disease Is a Risk Factor for Recurrent Hyperkalemia: A Retrospective Cohort Study.

Liver disease is often associated with dysfunctional potassium homeostasis but is not a well-established risk factor for hyperkalemia. This retrospective cohort study examined the potential relationship between liver disease and recurrent hyperkalemia. Patients with ≥1 serum potassium measurement between January 2004 and December 2018 who experienced hyperkalemia (serum potassium >5.0 mmol/L) were identified from the United States Veterans Affairs database. A competing risk regression model was used to analyze the relationship between patient characteristics and recurrent hyperkalemia. Of 1,493,539 patients with incident hyperkalemia, 71,790 (4.8%) had liver disease (one inpatient or two outpatient records) within 1 year before the index hyperkalemia event. Recurrent hyperkalemia within 1 year after the index event occurred in 234,807 patients (15.7%) overall, 19,518 (27.2%) with liver disease, and 215,289 (15.1%) without liver disease. The risk of recurrent hyperkalemia was significantly increased in patients with liver disease versus those without (subhazard ratio, 1.34; 95% confidence interval, 1.32-1.37; p < 0.0001). Aside from vasodilator therapy, the risk of recurrent hyperkalemia was not increased with concomitant medication. In this cohort study, liver disease was an independent risk factor strongly associated with recurrent hyperkalemia within 1 year, independent of concomitant renin-angiotensin-aldosterone system inhibitor or potassium-sparing diuretic use.

Factors Affecting Initiation and Retention of Medication-Assisted Recovery (MAR) within a Pilot Pharmacist-Involved Practice Model at a Federally Qualified Healthcare Center (FQHC) during the COVID-19 Pandemic.

BACKGROUND: During the COVID-19 pandemic, opioid-related overdose deaths increased. Although Medication-Assisted Treatment or Recovery (MAT or MAR) is available, initiation and retention rates vary. The goal of this study was to evaluate clinical, demographic, and Social Determinant of Health factors affecting MAR initiation, on-time initiation of medications, and successful retention in the program. The secondary goal was to evaluate the impact of a novel interprofessional practice model incorporating pharmacists. METHODS: A retrospective analysis was conducted using electronic health record data from a pilot MAR Program initiated within a California Federally Qualified Healthcare Center. RESULTS: From September 2019 to August 2020, 48 patients enrolled into the program. On-time initiation of medications occurred in 68% of patients and average program retention was 96.4 ± 95.8 days. Patients currently using opioids (p = 0.005) and those receiving supportive medications (p = 0.049) had lower odds of on-time MAR initiation. There were no statistically significant factors associated with successful retention in the program. The number of visits with members of the interprofessional team did not significantly affect on-time initiation or successful retention. CONCLUSIONS: Current opioid use and receipt of supportive medications were associated with lower on-time medication initiation. Further studies are warranted to explore additional factors which may affect initiation and retention.

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.

National gender differences in the prescribing of opioid medications from 2006 to 2015.

OBJECTIVE: To identify gender differences in opioid prescribing from ambulatory care settings and identify factors associated with prescribing of opioids for men and women. DESIGN AND PARTICIPANTS: Retrospective analysis of data from The National Ambulatory Medical Care Survey from January 1, 2006 to December 31, 2015. Eligible patients were at least 18 years old on the date of the physician office visit. Data were collected on patient demographics and clinical factors. Data were analyzed using bivariate and multivariate logistic regression models to explore differences in opioid prescribing among men and women. Due to the large sample size, the significance level was set to p < 0.001. MAIN OUTCOME MEASURE: Opioid prescribing during an office visit. RESULTS: A total of 322 957 ambulatory care visits for adults were included in the analysis representing 7.8 billion weighted visits nationally. In 771 601 088 (9.8 percent) visits, an opioid was prescribed. Women received an opioid prescription at 9.4 percent of visits compared to 10.4 percent of visits for men. Gender differences for factors including age, region, payment method, and pain diagnosis were observed (p < 0.001). Women had a higher number of visits with an opioid (449 277 925 vs 322 323 163), but men had higher odds of being prescribed an opioid (OR: 1.214; CI: 1.214-1.214). CONCLUSION: Men are more likely to be prescribed an opioid as compared to women, but women are being prescribed more opioids overall. Gender differences should be further explored to develop gender-specific interventions to reduce opioid prescribing.

The Landscape of Cellular and Gene Therapy Products: Authorization, Discontinuations, and Cost.

Background: Cell and gene therapy products belong to a diverse class of biopharmaceuticals known as advanced therapy medicinal products. Cell and gene therapy products are used for the treatment and prevention of diseases that until recently were only managed chronically. The objective of this study was to examine the characteristics of market authorizations, discontinuations, and prices of cellular and gene therapy products worldwide. Data and Methods: We conducted an electronic search of authorized cell, tissue-engineered, and gene therapy products from the databases of the main drug regulatory agencies. The analysis excluded hematopoietic progenitor cell cord blood products authorized by the U.S. Food and Drug Administration. Price information was derived from the Red Book (Truven Health Analytics) for the United States, health technology assessment agencies for Europe, and other public sector sources and company news for other countries. We also searched the scientific literature for authorizations, discontinuations, and price information using MEDLINE/PubMed, Cochrane Library, Google Scholar, and EMBASE databases. All cost data were converted to U.S. dollars. Descriptive analysis was conducted in this study. Results: There were 52 different cell, tissue engineering and gene therapy products with 69 market authorizations in the world as of December 31, 2018. The products included 18 (34%) cell therapies, 23 (43.4%) tissue engineered products, and 12 (22.6%) gene therapies. There were 21 (30.4% of all authorizations) cell therapy, 26 (37.7%) tissue-engineered, and 22 (31.9%) gene therapy market authorizations. The EMA withdrew the authorization for two tissue engineering products, one cell therapy and one gene therapy, and New Zealand lapsed approval of one cell therapy. Most products were first authorized after 2010, including 10 (83.3%) gene therapies, 13 (72.2%) cell therapies, and 13 (56.5%) tissue-engineered products. The treatment price for four allogenic cell therapies varied from $2,150 in India to $200,000 in Canada. The treatment price for three autologous cell therapies ranged from $61,500 in the United Kingdom to a listed price of $169,206 in the United States. Tissue-engineered treatment prices varied from $400 in South Korea to $123,154 in Japan. Gene therapy treatment prices ranged from $5,501 for tonogenchoncel-L in South Korea to $1,398,321 for alipogene tiparvovec in Germany. Conclusions: A significant number of new cell, tissue, and gene therapies have been approved in the past decade. Most products were conditionally authorized and targeted rare cancers, genetic diseases, and other debilitating diseases. However, there are also products approved for cosmetic reasons. Cell, tissue, and gene therapies are among the most expensive therapies available. Healthcare systems are not prepared to assume the cost of future therapies for a myriad of rare diseases and common diseases of epidemic proportions.

Identifying socio-demographic and clinical characteristics associated with medication beliefs about aromatase inhibitors among postmenopausal women with breast cancer.

PURPOSE: Non-adherence/persistence to adjuvant endocrine therapy can negatively impact survival. Beliefs about medicines are known to affect adherence. This study aims to identify socio-demographic and clinical characteristics associated with medication beliefs among women taking aromatase inhibitors (AIs). METHODS: Women completed an online survey on beliefs about AI therapy [Beliefs about Medicines Questionnaire (BMQ)], beliefs about breast cancer [Assessment of Survivor Concerns scale (ASC)], and depression [Personal Health Questionnaire depression scale (PHQ-8)]. Socio-demographic and clinical characteristics were collected. Bivariate analyses and linear regression models were performed to investigate relationships between variables. RESULTS: A total of 224 women reported currently taking AI therapy and were included in the analysis. Significantly higher concern beliefs were found among women who had at least mild depression, experienced side effects from AIs, and previously stopped therapy with another AI. Significant correlations were found between concern and necessity beliefs and cancer and health worry. Women age 70 and older displayed less fear of cancer recurrence and health worry, and a trend towards lower necessity and concern beliefs. No differences were found for other variables. In the regression model, greater necessity beliefs were found with increases in the number of current prescription medications (B = 1.06, 95% CI 0.31-1.81, p = 0.006) and shorter duration of current AI therapy (B = -0.65, 95% CI -1.23 to -0.07, p = 0.029), whereas greater concern beliefs were associated with higher depression scores (B = 1.19, 95% CI 0.35-2.03, p = 0.006). CONCLUSIONS: Medication necessity and concern beliefs were associated with a definable subset of patients who may be at higher risk for non-persistence.