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

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

Background The past 10 years witnessed a significant increase in the approval of cellular and gene therapy products worldwide. The US Food and Drug Administration (FDA) approved 3 gene therapy products within the last 4 months of 2017. The objective of this study was to examine the approval characteristics, discontinuations and cost of all cellular and gene therapy products approved worldwide. Data and Methods We conducted an electronic search of approved cell and gene therapy products from the databases of the main drug regulatory agencies including the US Food and Drug Administration, the European Medicines Agency (EMA), the Korea Ministry of Food and Drug Safety (MFDS), and Japan’s Pharmaceuticals and Medical Devices Agency, China Food and Drug Administration, Ministry of Health and Social Development-Russia, Health Canada, and the Food and Drug Administration of the Philippines. We also searched the literature using MEDLINE/PubMed, Cochrane Library, Google Scholar and EMBASE databases. Cost information from the US was derived from the Reb Book (Truven Health Analytics). Costs from Europe were derived from Health Technology Assessments and from public sector, financial news and company’s web pages. Where available, we also obtained cost for products approved in other countries from public sector, financial news and company’s web pages. All cost data were converted to USD. Results There were 52 cell and gene therapy products marketed in the world as of September 2018. Of these, 39 (75.0%) were cell therapy medicinal products and 13 (25.0%) were gene therapy medicinal products. Of the approved products, 29 (74.3%) cell and 8 (61.5%) gene therapy products were first approved in the past 10 years (2008-present). Korea had the greatest number of approved cellular therapy-19 followed by US-12, Japan -4, Europe -3 and Canada -1. While Europe had the highest number of approved gene therapies - 5 followed by US - 3, China -2 and Korea, Russia and Philippines one each. Overall, 8 (66.7%) of the approved gene therapy products were granted orphan designation. Three products approved by the EMA were withdrawn or discontinued from the market. Of them, 2 remain currently marketed in the US. Cost of treatment from Gene therapy in US ranged from $447600 to$1,020,000 while in Europe the range was $370000 to$962890. Gene therapies outside US and Europe were relatively cheaper. Cell therapies in North America had a price range from $30,370-$200,000, European cell therapies ranged from $17,658-$105,000. Conclusion In the study period, more autologous cell therapy products were approved than allogenic agents. The cost of gene and cell therapy drugs is much higher in the EU and North America in comparison to Asia. Majority of the gene therapies received orphan designation by the regulatory authorities and had conditional approvals while less than a quarter of cellular therapies received the orphan designation. Most of the gene therapies are approved for rare diseases with smaller patient population, companies find it difficult to make profits which results in market withdrawal of the therapies

Contraceptive Desert? Black-White Differences in Characteristics of Nearby Pharmacies

Objectives: Race differences in contraceptive use and in geographic access to pharmacies are well established. We explore race differences in characteristics of nearby pharmacies that are likely to facilitate (or not) contraceptive purchase. Study design: We conducted analyses with two geocode-linked datasets: (1) the Relationship Dynamics and Social Life (RDSL) project, a study of a random sample of 1003 women ages 18-19 living in a county in Michigan in 2008-09; and (2) the Community Pharmacy Survey, which collected data on 82 pharmacies in the county in which the RDSL study was conducted. Results: Although young African-American women tend to live closer to pharmacies than their white counterparts (1.2 miles to the nearest pharmacy for African Americans vs. 2.1 miles for whites), those pharmacies tend to be independent pharmacies (59 vs. 16%) that are open fewer hours per week (64.6 vs. 77.8) and have fewer female pharmacists (17 vs. 50%), fewer patient brochures on contraception (2 vs. 5%), more difficult access to condoms (49% vs. 85% on the shelf instead of behind glass, behind the counter, or not available), and fewer self-check-out options (3 vs. 9%). More African-American than white women live near African-American pharmacists (8 vs. 3%). These race differences are regardless of poverty, measured by the receipt of public assistance. Conclusions: Relative to white women, African-American women may face a contraception desert, wherein they live nearer to pharmacies, but those pharmacies have characteristics that may impede the purchase of contraception

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