Large Pharmaceutical Companies Research Articles

Follower persuade Leader Green Commitment: Exploring Sustainability in Pharma Companies

This study investigates the impact of follower green knowledge (FGK) on leader green commitment through moderation (follower perceived organizational support) and mediation (leader motivation toward sustainable development goals). A total of 429 respondents from large pharmaceutical companies operating in different regions of Pakistan were selected. PLS-SEM and Johnson–Neyman plots were used for the conditional moderation mediation model. The results of the hypotheses including the conditional moderation mediation model were significant. Moreover, follower knowledge is a vital asset for persuading leader commitment when followers receive organizational support and leaders are motivated to adopt sustainable development goals. This study opens new avenues for leadership development programs. Moreover, enhancing green awareness and knowledge through training stimulates innovation and promotes experimentation with new environmentally friendly practices within the organization. Organizations must recruit new employees who possess green knowledge. This study adopts a leadership perspective based on the concept of sustainable followership. This study reveals the importance of followers in bringing leaders’ internal willingness toward sustainability development goals. This study uses leader–member exchange theory to highlight the importance of followers in creating a sustainable culture through their knowledge, awareness and support from peers.

New Drug Development Strategy in Japan: Flexibility in Guideline Adherence.

Recently, a new type of drug lag, known as "drug loss" has emerged in Japan. It is a condition where the development of a drug approved in other countries has not been initiated in Japan. For 265 new drugs approved in the United States or Europe during 2010-2020, only 31% had commenced development in Japan as of December 31, 2020. A characteristic feature of Japanese guidelines on new drug development is that, in principle, clinical trial data in Japanese participants are required in each study phase. Given key players in new drug development are shifting from large pharmaceutical companies to emerging biopharma companies, primarily based outside Japan, the necessity for Japanese data may contribute to the drug lag. This study aimed to clarify the guideline adherence to new drug applications in Japan. Of the 159 new drugs approved in Japan between April 2019 and March 2024, the clinical data packages for almost all drugs included both pharmacokinetic (PK) data and efficacy and safety data in Japanese participants, irrespective of the study phase or design. We identified three flexible development approaches: the absence of Japanese dose-response data (39.6%), absence of Japanese confirmatory data generated from phase III randomized controlled trials (35.2%), and post-hoc Japanese PK data (43.0%, 34/79). Biologics, orphan drug designation, antineoplastic agents, and same applicant and originator were identified as factors significantly associated with these flexibilities. The results will help foreign companies, including emerging biopharmas, in formulating effective new drug development strategies, potentially alleviating the drug lag in Japan.

Evaluating the impact of an automated drug retrieval cabinet and robotic dispensing system in a large hospital central pharmacy.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. To determine the impact of implementing 2 technologies in succession, the Carousel system and XR2 robot, in a hospital central pharmacy. The study examined the technologies' impact on workload shifted from fully human-involved, labor-intensive filling from shelves to Carousel and/or XR2, prevention of dispensing errors, and efficiency. Implementation occurred in 3 phases from August 2021 through October 2022. In phase I, medications were manually filled from the shelves for immediate doses and automated dispensing cabinet stock. RobotRx was used for unit-dose (UD) carts. In phase II, the Carousel system was introduced, while RobotRx was used for UD carts. In phase III, the XR2 robot was added and RobotRx was decommissioned. Epic data and time studies were utilized and analyzed with ANOVA. Over the 3 phases of implementation, workload shifted away from filling from the shelves, with 2,479, 1,044, and 864 orders filled from the shelves for phase I through phase III, respectively. The Carousel workload was 1,234 orders (phase II) and 348 orders (phase III). Nearly 71% of the workload was shifted to the XR2. The overall prevented error rate did not significantly change from phase I to phase II, remaining at 0.5%. In comparison, the error rate significantly decreased to 0.41% in phase III. Use of the Carousel system resulted in a significant reduction in dispensing errors compared to manual filling from the shelves. Use of the XR2 robot resulted in a dispensing error rate of 0%. The savings in time when using both Carousel and XR2 led to a decrease in full-time equivalents of 0.77 for pharmacists and 1.76 for pharmacy technicians. Carousel and/or XR2 significantly shift workload from manual filling to automated technologies, decrease dispensing errors, and improve efficiency, reducing pharmacist and technician workload. Time saved could allow staff to spend more time on patient-centric tasks.

Effect of impaired kidney function on outcomes and treatment effects of oral anticoagulant regimes in patients with atrial fibrillation in a real-world registry.

The impact of impaired kidney function on outcomes and treatment benefits of vitamin-K antagonists (VKA) versus direct oral anticoagulants (DOAC) in patients with atrial fibrillation (AF) has insufficiently been investigated in randomized controlled studies (RCTs). Most studies and registries are either biased due to incomplete enrolment of consecutive patients in large pharma industry sponsored registries, or due to short recruitment periods or incomplete assessment of important variables in national registries. This study uses data from the Heidelberg Registry of Atrial Fibrillation (HERA-FIB), a retrospective single-center registry of 10,222 consecutive patients with AF presenting to the emergency department of University Hospital of Heidelberg from June 2009 until March 2020. Rates of all-cause mortality, stroke, major bleeding and myocardial infarction (MI) were related to the presence and severity of impaired presenting kidney function, as well as to assigned treatment with VKA vs. DOAC. The risks for all-cause mortality (HR: 3.26, p<0.001), stroke (HR: 1.58, p<0.001), major bleeding (HR: 2.28, p<0.001) and MI (HR: 2.48, p<0.001) were significantly higher in patients with an eGFR<60 ml/min at admission and increased with decreasing eGFR. After adjustment for variables of CHA2DS2VASc-score, presence of eGFR <60 ml/min remained as an independent predictor for all-cause mortality, major bleeding and MI. The hazard ratio (HR) for all-cause mortality, major bleedings and MI was significantly lower in patients receiving DOAC compared to VKA. Findings from our large real-life registry confirm the data from RCTs and extend our knowledge on the effectiveness and safety of DOACs to subjects that were underrepresented in RCTs.

Fluorescence-Based HTS Assays for Ion Channel Modulation in Drug Discovery Pipelines.

Ion channels represent a druggable family of transmembrane pore-forming proteins with important (patho)physiological functions. While electrophysiological measurement (manual patch clamp) remains the only direct method for detection of ion currents, it is a labor-intensive technique. Although automated patch clamp instruments have become available to date, their high costs limit their use to large pharma companies or commercial screening facilities. Therefore, fluorescence-based assays are particularly important for initial screening of compound libraries. Despite their numerous disadvantages, they are highly amenable to high-throughput screening and in many cases, no sophisticated instrumentation or materials are required. These features predispose them for implementation in early phases of drug discovery pipelines (hit identification), even in an academic environment. This review summarizes the advantages and pitfalls of individual methodological approaches for identification of ion channel modulators employing fluorescent probes (i.e., membrane potential and ion flux assays) with emphasis on practical aspects of their adaptation to high-throughput format.

Proportion of Patients in the United States Who Fill Their Nirmatrelvir/Ritonavir Prescriptions.

Although real-world studies demonstrate that those prescribed nirmatrelvir/ritonavir (and particularly within 5days of symptom onset) are less likely to experience severe COVID-19 outcomes, prior studies show that only a small fraction of patients with COVID-19 who are eligible for nirmatrelvir/ritonavir receive a prescription. Studies calculating the proportion of nirmatrelvir/ritonavir prescriptions filled and identifying individual- and pharmacy-level correlates of filling nirmatrelvir/ritonavir are lacking. This retrospective cohort study included individuals aged ≥ 12years with a nirmatrelvir/ritonavir prescription ordered at a large national retail pharmacy (December 22, 2021-August 12, 2023). Those taking contraindicated medications were excluded. For those with only one nirmatrelvir/ritonavir prescription ordered, the outcome was whether the prescription was filled (yes/no). In a subanalysis of these individuals, the outcome was whether the prescription was filled within 5days of symptom onset (yes/no). For those with multiple prescriptions ordered, the outcome was whether > 1 (vs. 0 or 1) prescriptions were filled. A log-binomial regression with generalized estimating equations was used to identify individual (clinical and demographic) and pharmacy-level (percentage of trade area that is non-Hispanic white, urbanicity, US Census region, and tract-level area deprivation index) correlates. A total of 2,103,570 unique nirmatrelvir/ritonavir prescriptions were ordered for 1,985,990 individuals. Among the 95% of individuals prescribed only one nirmatrelvir/ritonavir course, 88% filled their prescription. Among those with > 1 prescription ordered, 77% (82,993/108,411) filled one and 13% (13,662/108,411) filled > 1. Patients ≥ 50years of age and those with documented high-risk conditions were slightly more likely to fill prescriptions, regardless of whether one or multiple courses were ordered. Individuals with cancer, asthma, or taking corticosteroids or immunosuppressive medications were more likely to fill multiple prescriptions. Most patients filled their nirmatrelvir/ritonavir prescriptions. Interventions to improve uptake should focus on increasing patient and provider awareness, reducing nirmatrelvir/ritonavir prescribing disparities, and ensuring treatment initiation within 5days.

The Patent Landscape of mTOR and PTEN Targets.

PTEN and mTOR signaling have many roles, including antiinflammatory, immunosuppressant and cancer. US patents were retrieved to show the current landscape of the mTOR and PTEN targets. PTEN and mTOR targets were analyzed by patent analysis. The U.S. granted patents from January 2003 to July 2022 were performed and analyzed. The results showed that the mTOR target was more attractive in drug discovery than the PTEN target. Our findings indicated that most large global pharmaceutical companies focused the drug discovery related to the mTOR target. The present study demonstrated that mTOR and PTEN targets showed more applications in biological approaches compared to BRAF and KRAS targets. The chemical structures of the inhibitors of the mTOR target demonstrated some similar features to those of the inhibitors of KRAS targets. At this stage, the PTEN target may not be an ideal target subjected to new drug discovery. The present study was the first one which demonstrated that the group of O=S=O may play a critical role in the chemical structures of mTOR inhibitors. It was the first time to show that a PTEN target may be suitably subjected to new therapeutic discovery efforts related to biological applications. Our findings provide a recent insight into therapeutic development for mTOR and PTEN targets.

Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies.

Provisions of the Inflation Reduction Act mandating drug price negotiation by the Centers for Medicare & Medicaid Services have been criticized as a threat to pharmaceutical innovation. This study models potential impacts of the Inflation Reduction Act on drug approvals based on the differential contributions of large pharmaceutical companies and smaller biotechnology firms to clinical trials and the availability of capital. This study examined research and development expense, revenue, and new investment (sale of common and preferred stock) by public biopharmaceutical companies and sponsorship of phased clinical trials in ClinicalTrials.gov. Financial data were incorporated in a model that estimates the number of drugs in each phase and approvals from reported phase-specific costs and transition rates, proportional sponsorship of trials by companies of different size, projected reductions in research and development spending based on company size, and three scenarios by which large companies may allocate reductions in research and development spending among clinical phases: (1) research and development proportionally reduced across phases; (2) research and development disproportionally reduced in phases 2-3; and (3) research and development disproportionately reduced in phases 1-2. Financial data were examined for 1378 public biopharmaceutical companies (2000-2018). Research and development expense was associated with revenue for 79 large companies with market capitalization ≥$7 billion with a 10% reduction in revenue reducing research and development expense by 8.4%. For 1299 smaller companies with market capitalization <$7 billion, research and development was associated with new investment, but not revenue. Smaller companies sponsored 55.2% of phase 1, 55.6% of phase 2, and 49.8% of phase 3 trials in ClinicalTrials.gov 2013-2018. In a model of clinical development that apportions clinical trials between large and smaller companies and determines the number of trials based on research and development resources, 400 drugs entering development produced 47.3 approvals (11.83% rate). A 10% reduction in revenue, reflecting the upper boundary of observed changes 2000-2018, with (1) proportional reduction across phases 1-3 produced 45.1 approvals (4.61% reduction); (2) disproportional reduction of phases 2-3 produced 42.8 approvals (9.55% reduction); and (3) disproportional reduction of phases 1-2 produced 46.9 approvals (0.95% reduction). This work suggests that the drug price negotiation provisions of the Inflation Reduction Act could have little or no impact on the number of drug approvals. While large pharmaceutical companies may reduce research and development spending, continued research and development by smaller companies and strategic allocation of research and development resources by large companies may mitigate any negative effects of the Inflation Reduction Act.

Investigation of the Biosafety of Commercially Available Natural Rubber Latex and Synthetic Polyurethane Condom Materials

To investigate the biological safety of commercially available natural rubber latex and synthetic polyurethane condoms. Natural rubber latex condom brands of A1 and A2 and polyurethane condom brands of B1 and B2 were purchased from large chain pharmacies in Chengdu, with three packages randomly selected for each brand. The study assessed the toxic effects of condom extracts on L-929 mouse fibroblasts according to GB/T standards. Gross observation and histopathological evaluation were conducted to assess the irritation reactions of condoms on the vagina and penis of rabbits (3 rabbits were used for each brand), as well as their sensitization effects on guinea pig skin. Additionally, the impact of continuous perfusion of condom extracts of the vaginas of SD rats for 30 days on their reproductive systems was evaluated, following GB/T standards (5 rats were used for each brand). Extracts from natural rubber latex condom brands A1 and A2, at concentrations of 100% and 50%, exhibited significant cytotoxicity, with optical density (OD) values being significantly lower than those of the blank control group and the polyurethane condom brands B1 and B2 (P<0.01). There was no significant difference in cell morphology and OD values between the extracts of B1 and B2 and the blank control group (P>0.05). Vaginal congestion was found in 3 rabbits from A1 group and 1 rabbit from the A2 group, while no obvious congestion was noted in rabbits from the B1 and the B2 groups. Histopathological examination showed scattered inflammatory cell infiltration in the vaginal tissue of 3 rabbits from the A1 group and 2 rabbits from the A2 group, and slight congestion in the blood vessels of the lamina propria. No obvious pathological changes were observed in the vaginal tissue of polyurethane brand rabbits. Two rabbits from the A1 group and 1 rabbit from the A2 group showed transient and mild erythema on the penis during the experiment. Histopathological examination showed that 1 rabbit from A1 group had small foci of pericapillary lymphocytes in the dermis of the penis, while no significant pathological changes were observed in the penile tissue of A2, B1, and B2 groups. After 30 days of continuous vaginal perfusion with condom extract, 3 rats in A1 group and 2 rats in the A2 group had uterine congestion, with the degree of congestion being lower in the A2 group. No significant congestion or pathological changes were observed in the vaginal and penile tissues of rabbits, or in the uterine tissues of rats from the polyurethane groups. None of the 4 groups of guinea pigs showed significant skin allergic reactions to the condom extracts. Significant differences in biosafety exist among condoms of various materials and brands. To ensure product safety, it is crucial to strengthen quality control and regulatory oversight after condoms become commercially available.

Prevalence of Tendon Rupture and Tendinopathies Among Patients with Atherosclerotic Cardiovascular Disease Derived From United States Administrative Claims Data.

The prevalence of tendon rupture and tendinopathies (TRT) has not been determined in a large population of patients with atherosclerotic cardiovascular disease (ASCVD). We investigated TRT prevalence among patients with ASCVD and in the general population, using data from the Symphony Health Integrated Dataverse, a large US medical and pharmacy claims database. This retrospective, observational study included patients aged ≥ 19years from the claims database during the identification period (January 2019 to December 2020) and 12months of continuous enrollment. The primary outcome was evidence of TRT in the 12months following the index date (first ASCVD diagnosis in the ASCVD cohort; first claim in the claims database in the overall population). Diagnostic codes (ICD-10 and/or CPT) were used to define ASCVD and TRT diagnosis. The ASCVD cohort and overall population included 5,589,273 and 61,715,843 patients, respectively. In the ASCVD cohort, use of medications with a potential or known association with TRT was identified in 67.9% (statins), 17.7% (corticosteroids), and 16.7% (fluoroquinolones) of patients. Bempedoic acid use was reported in 1556 (< 0.1%) patients. TRT prevalence during 12-month follow-up was 3.4% (ASCVD cohort) and 1.9% (overall population). Among patients with ASCVD, 83.5% experienced TRT in only one region of the body. Factors most associated with TRT in the ASCVD cohort were increasing age, most notably in those aged 45-‍64 years (odds ratio [OR] 2.19; 95% confidence interval [CI] 2.07-2.32), obesity (OR 1.51; 95% CI 1.50-1.53), and rheumatoid arthritis (OR 1.47; 95% CI 1.45-1.79). Use of statins or bempedoic acid was not associated with increased TRT risk. Patients with ASCVD may have greater risk of TRT than the general population, which may be driven by an increased prevalence of comorbidities and use of medications with a potential or known association with TRT.

Abandonment of prescriptions in medically underserved areas: Primary medication non-adherence in community pharmacies in the delta region of the United States

BackgroundIn the U.S. alone, medication non-adherence is estimated to cause 1 in 10 hospitalizations, approximately 125,000 deaths annually, and cost the U.S. healthcare system just under $300 billion each year. Patients in medically underserved areas (MUAs) are particularly vulnerable to all forms of non-adherence and downstream morbidity and mortality; however, the extent to which primary medication non-adherence (i.e., prescription abandonment) affects the underserved is still largely unknown. ObjectivesTo assess the difference in rates of abandonment of quality measured prescriptions in areas that are medically underserved compared to areas that are not. The secondary objective is to assess the impact that the COVID-19 pandemic had on rates of prescription abandonment in both MUAs and those that are not. MethodsIn this retrospective study, data on abandoned, quality measured prescriptions were collected and analyzed using Chi-Square analyses from one regional division of a large grocery-chain pharmacy containing ninety-one pharmacies located in Tennessee, Mississippi, Arkansas, Kentucky, and Missouri. The primary objective used 2019 data while the secondary objective used data from April – November of both 2019 and 2020. ResultsPatients from MUAs abandoned quality measured prescriptions at a higher rate of 5.44% compared to 4.77% of those not living in these areas (P < 0.01). This study also discovered that during the COVID-19 pandemic, MUAs had a decrease in abandonment from 6.14% in 2019 to 6.02% in 2020 (P < 0.01). Those from non-MUAs had non-significant change in abandonment (P = 0.87). ConclusionPatients in MUAs abandon quality measured prescriptions at a statistically significant higher rate when compared to patients who live in areas that are not considered to be medically underserved. Moreover, during the COVID-19 pandemic patients living in MUAs had a statistically significant decrease in prescription abandonment while those in non-MUAs did not statistically change.

Costs of Drug Development and Research and Development Intensity in the US, 2000-2018

ImportanceUnderstanding the cost of drug development can help inform the development of policies to reduce costs, encourage innovation, and improve patient access to drugs.ObjectiveTo estimate the cost of drug development by therapeutic class and trends in pharmaceutical research and development (R&amp;amp;amp;D) intensity over time.Design, Setting, and ParticipantsIn this economic evaluation study, an analytical model of drug development constructed using public and proprietary sources that collectively cover data from 2000 to 2018 was used to estimate the cost of bringing a drug to market, overall and for specific therapeutic classes. The analysis for the study was completed in October 2020.Main Outcomes and MeasuresThree measures of development cost from nonclinical through postmarketing stages were estimated: mean out-of-pocket cost or cash outlay, mean expected cost, and mean expected capitalized cost. Pharmaceutical R&amp;amp;amp;D intensity, defined as the ratio of R&amp;amp;amp;D spending to total sales, from 2008 to 2019, based on the time frame for available data, was also analyzed.ResultsThe estimated mean cost of developing a new drug was approximately $172.7 million (2018 dollars) (range, $72.5 million for genitourinary to $297.2 million for pain and anesthesia), inclusive of postmarketing studies. The cost increased to $515.8 million when cost of failures was included. When the costs of failures and capital were included, the mean expected capitalized cost of drug development increased to $879.3 million (range, $378.7 million for anti-infectives to $1756.2 million for pain and anesthesia); results varied widely by therapeutic class. The pharmaceutical industry as a whole experienced a decline of 15.6% in sales but increased R&amp;amp;amp;D intensity from 11.9% to 17.7% from 2008 to 2019. By contrast, R&amp;amp;amp;D intensity of large pharmaceutical companies increased from 16.6% to 19.3%, whereas sales increased by 10.0% (from $380.0 to $418.0 billion) over the same 2008 to 2019 period, even though the cost of drug development remained relatively stable or may have even decreased.Conclusions and RelevanceIn this economic evaluation of new drug development costs, even though the cost of drug development appears to have remained stable, R&amp;amp;amp;D intensity of large pharmaceutical companies remained relatively unchanged, despite substantial growth in revenues during this period. These findings can inform the design of drug-related policies and their potential impacts on innovation and competition.

Creating a capital-efficient organization: Accele BioPharma

Research methodology Case information was mainly acquired through interviews with Richard Gammans, chief operating officer. Dr Gammans was a visiting professor at Fayetteville State University for a year, and two of the case authors developed personal friendships with Richard. Interviews were conducted over a two-year period as the accelerator got started. In addition, one author conducted a team-building session with the management team and one of the bio-startup researchers. An interview was also conducted with Clayton Duncan, chief executive officer, to gain his agreement with developing the case. The Accele website included a write-up on each of the pharmaceutical startup companies. The write-up included a company summary, description of the science (disease and cure), the size of the market, results from testing, regulatory considerations and intellectual property. A literature review was conducted as the basis for the information on the pharmaceutical industry. Case overview/synopsis This case is about a biopharmaceutical accelerator founded in 2011 by two senior executives with experience in both large pharmaceutical companies and running biotech startup companies. The founders were successful in raising capital to start their first venture capital fund which they used to invest in four biotech startups. All four startups were working in very different disease areas. For example, one developed a drug to help with hearing loss that the department of defense was funding. Another of the startups discovered drug candidates that attack antibiotic-resistant bacteria. Biopharmaceutical accelerators were relatively new. They differed from business incubators because they invest in the startups and provide operational support, but the degree of support provided varies across accelerators. The Accele BioPharma accelerator operated in virtual, network type of organization, and Accele BioPharma provided primary strategic and operational management for the startups. The challenge in this case is to identify how the leaders managed the virtual network, and what additional resources were needed so that the management team could expand their ability to assist startups to get drugs approved by the food and drug administration. Complexity academic level This case is suitable recommended for undergraduate/graduate strategy, undergraduate/graduate organizational behavior, entrepreneurship and health-care management courses.

The “Ripple Effect”: The Effect of Family-Work Conflict on Mentor-protégé Relationship

ABSTRACT Drawing from conservation of resources theory, this research examines how and when mentors’ family – work conflict is related to protégés’ work outcomes (i.e. job performance and career satisfaction). We proposed mentors’ family – work conflict depleted their resources, thus had a negative influence on protégés’ work outcomes. Further, we addressed the mediating role of mentoring functions (i.e. career support, psychosocial support, and role modeling) and the moderating roles of mentors’ core self-evaluation and mentor – protégé relational quality. We tested the hypothesized moderated mediation model using time-lagged data from 162 mentor – protégé dyads in a large Chinese pharmacy chain company. The results demonstrated that (a) mentors’ family – work conflict was negatively associated with protégés’ work outcomes; (b) mentoring functions mediated this relationship; (c) mentors’ core self-evaluation and mentor – protégé relational quality moderated the main effect of mentors’ family – work conflict on mentoring functions and the indirect effect of mentors’ family – work conflict on protégés’ work outcomes via mentoring functions; and (d) the indirect effect was significant when mentors’ core self-evaluation or mentor – protégé relational quality was low. Important implications for management research are discussed.

Adherence for members taking oral oncolytic agents undergoing dose modification strategies.

e23058 Background: The use of oral oncolytic agents has transformed oncology care. Previous studies have reported that patient, treatment, and health system-related factors may influence adherence rates in patients prescribed oral oncolytic agents. The purpose of this study is to assess adherence rates in members of a large national pharmacy benefit manager taking oral oncolytic agents who experienced a modification to their dosing regimen. Methods: Adult members receiving palbociclib, abemaciclib, ribociclib, axitinib, lenvatinib, or cabozantinib between 01/01/2021 and 12/31/2022 were eligible for the study. Members who did not maintain continuous eligibility for 180 days prior to and 2 years after the first fill in the study period were excluded. Members were stratified by presence of dose modification, defined by a change in daily dose from one prescription to the next. Adherence was assessed via the proportion of days covered (PDC) which is the total days with medication coverage divided by the number of days between the index fill and exhaust of the final fill in the study period. Optimal adherence was defined as PDC ≥ 0.85. Standard statistical tests for continuous and categorical variables were utilized. Logistic regression was performed with the endpoint of optimal adherence. P values &lt; 0.05 are significant. Results: 13,641 members were included in the final analysis, with 7,093 (52%) experiencing a modification to their dosing regimen during the study period. Several significant differences in sociodemographic variables were present in this study with members experiencing a dose modification being older (mean [standard deviation (SD)]: 65.7 [11.9] vs. 64.9 [13.0] yr; p &lt; 0.001), more likely to be male (23.3% vs. 15.0%; p &lt; 0.001), more likely to reside in high socioeconomic status (SES) regions (23.7% vs. 21.5%; p = 0.005) and more likely to receive tyrosine kinase inhibitors (TKIs) (37.6% vs. 23.6%; p &lt; 0.001). Adherence was high overall with 74.6% of members achieving a PDC ≥ 0.85; however, members with dose modifications were less likely to be adherent (69.7% vs. 80.0%; p &lt; 0.001). Holding other confounders constant, having a dose modification was associated with a decreased likelihood of adherence (Odds Ratio [95% Confidence Interval]: 0.6 [0.55-0.65]; p &lt; 0.001). Conclusions: Dose modification was associated with significant decreases in adherence to oral oncolytic medications. Interventions designed to minimize dose modifications or to provide additional member support during a dose modification may optimize oral oncolytic adherence.

Policies, adaptations, and ongoing challenges to naloxone, buprenorphine and nonprescription syringe access across four-states: Findings from an environmental scan and key informant interviews

BackgroundAs the US opioid-involved morbidity and mortality increase, uptake and implementation of evidence-based interventions remain key policy responses. Respond to Prevent was a multi-component, randomized trial implemented in four states and two large pharmacy chains with the aim of improving the pharmacy’s capacity to provide naloxone, dispense buprenorphine, and sell nonprescription syringes (NPS). We sought to provide context and assess how policies and organizational practices affect communities and pharmacies across the study states. MethodsUsing a multi-method approach we: 1) conducted an environmental scan of published literature and online materials spanning January 2015 to June 2021, 2) created timelines of key events pertaining to those policies and practices and 3) conducted semi-structured interviews with stakeholders (key informants) at the state and local levels (N=36) to provide further context for the policies and practices we discovered. ResultsKey informants discussed state policies, pharmacy policies and local practices that facilitated access to naloxone, buprenorphine and NPSs. Interviewees from all states spoke about the impact of naloxone standing orders, active partnerships with community-based harm reduction organizations, and some federal and state policies like Medicaid coverage for naloxone and buprenorphine, and buprenorphine telehealth permissions as key facilitators. They also discussed patient stigma, access in rural settings, and high cost of medications as barriers. ConclusionFindings underscore the important role harm reduction-related policies play in boosting and institutionalizing interventions in communities and pharmacies while also identifying structural barriers where more focused state and local attention is needed.

Immediate and long-term effects of COVID-19 on antibiotic dispensing: increasing use of Watch antibiotics.

The coronavirus disease 2019 (COVID-19) pandemic affected antibiotic usage worldwide. However, there is limited data from Serbia. Dispensing of oral antibiotics in Serbian pharmacies was analyzed to calculate monthly and yearly changes between 2018-2021, and to explore immediate and long-term effects of COVID-19 on antibiotic dispensing during this period. The number of antibiotic packages dispensed from pharmacies during the study period was analyzed with a Chi-square test to assess the average change in annual dispensing, and an interrupted time-series analysis was used to evaluate the impact of the pandemic on antibiotic dispensing. The data from 2018-2021 were retrieved from the database of a large community pharmacy chain in Serbia. The average number of antibiotic packages dispensed per day and per pharmacy was higher in 2021 compared to 2018 by one package. However, the dispensing of macrolides increased significantly; 17.7% (2018) vs. 22.5% (2021) (p < 0.05). In general, an increase in antibiotic dispensing was detected during COVID-19 for total antibiotics (16.4%), Watch antibiotics (44.8%), third-generation cephalosporins (80.4%), macrolides (45.5%) and azithromycin (83.7%). However, the immediate effect of COVID-19 was a decrease in the dispensing of Watch antibiotics, penicillin, and third-generation cephalosporins (p < 0.05); and a notable long-term COVID-19 effect was an increase in the dispensing of azithromycin (p < 0.05). In spite of a relatively stable trend of total antibiotic dispensing before and during COVID-19 pandemic, the use of Watch antibiotics, third-generation cephalosporins, and macrolides (particularly azithromycin) showed an increasing trend in dispensing that should be optimized.

A survey of community pharmacists’ and healthcare advisors’ views and experiences on the provision of a Test and Treat Service for uncomplicated lower urinary tract infection in a retail pharmacy chain in Ireland

Abstract Introduction The use of Point of Care Testing (POCT) as an aid to guide antibiotic prescribing has been highlighted in Ireland’s second One Health National Action Plan on Antimicrobial Resistance 2021-2025 (iNAP2).[1] The role of community pharmacy is expanding with the introduction of antimicrobial stewardship (AMS) POCT strategies. Uncomplicated urinary tract infections (UTIs) are frequent and burdensome in the community. With antibiotic resistance on the rise amongst uropathogens, AMS efforts to reduce inappropriate antibiotic prescribing for urinary symptoms are paramount. Aim To evaluate community pharmacy staff views and experiences on the provision of a Cystitis Test-and-Treat Service for uncomplicated UTIs, while identifying opportunities for service improvement and expansion. Methods An electronic survey on Microsoft® Forms was distributed within a large retail pharmacy chain in Ireland during November 2021, with two reminders issued. Pharmacists and Healthcare advisors over the age of 18, working in 88 pharmacies that provided the Velieve Cystitis Test-and-Treat Service were eligible to participate. The survey was subdivided into participant demographics, local UTI information, views and experiences of participants on the Cystitis Test-and-Treat Service, the patient information leaflet and the training completed by pharmacy staff providing the service and included open-ended and closed-ended or Likert-scale questions. The survey was developed based on the literature and was revised following the contributions of pharmacy chain pharmacists and its Research Governance Committee who have a working knowledge of Service. Data were analysed using Microsoft® Excel and IBM® SPSS® statistics version 28.0. Qualitative data from the open-ended survey questions were analysed using thematic analysis. Results A total of 43 pharmacy staff (18 pharmacists and 25 healthcare advisors) participated in the study (overall participation rate of 10.2%). The majority of participants were female (83.7%) and most pharmacies were located in a town/suburb area (55.8%). The majority of participants (76.7%) estimated that service users with symptoms suggestive of UTI present to the pharmacy first, before visiting their GP. Participants believed that the Cystitis Test-and-Treat Service improved service user satisfaction in symptom management, reduced antimicrobial prescribing, alongside reduced general practitioner workload. High acceptability was attributed to the speed and convenience of the service, while time cost and time required explaining the service were identified as barriers. The associated smartphone application was identified as a service weakness. Participants recommended extended training on service user eligibility with perhaps training videos to improve overall confidence. While the low response rate and small sample size is a limitation of this study, the inclusion of participants from two differing pharmacy roles strengths the findings. Conclusion This study highlights that POCT are feasible AMS initiatives that enhance management of uncomplicated UTI and could be incorporated into community pharmacy practice. The perceived ‘poor public awareness of the service’ reported by the participants, suggests the need for increased promotion and advertising.

Exploring experiences and perspectives of inclusivity amongst community pharmacists in their practice: a survey study

Abstract Introduction Inclusive healthcare is an essential component of promoting sustainable good health and wellbeing. The General Pharmaceutical Council (GPhC) published their equality, diversity, and inclusivity (EDI) strategy 2021-2026 to tackle discrimination and reduce health inequalities;[1] however, there are still significant disparities in healthcare access and outcomes faced by minority groups. Discrimination leads to higher rates of distrust, non-adherence, and poorer physical and mental health outcomes.[2] Community pharmacists can break down barriers to healthcare, but must feel a sense of inclusion themselves. Aim To explore the experiences and perspectives of inclusivity amongst community pharmacists in their practice, including training, and to investigate inclusivity-related interventions available in pharmacies. Methods Following a pilot study with 14 pharmacists, an online survey using Google Forms was distributed via email to 335 community pharmacists (based on Raosoft calculator at 95% confidence interval) in multiple London boroughs within a two-month period. To maximise response rates, paper surveys were distributed in person to pharmacies. The survey comprised 48 mixed-style questions, and was divided into four sections: experiences of inclusivity and discrimination, inclusive services provided in the pharmacy, pharmacist training, and demographics. The data were analysed using descriptive and inferential statistics, using Microsoft Excel and SPSS. Results The response rate was 55% (n=184/335). 72% were &amp;lt;40 years old. 55% were men, 43% women and 2% identified as ‘Other’. 59% pharmacists were Asian, 7% Black (of any origin), 4% White and 32% ‘Other’ (including mixed heritage). 68% worked in independent pharmacies (&amp;lt;4 branches), 27% in small chains and 25% in large chains (&amp;gt;10 branches). 18% (n=33) self-reported they had experienced discrimination, primarily from patients (88%; n=29/33), with the majority experiencing racial discrimination (79%; n=26/33), followed by 30% (n=10/33) against age. A higher proportion (24%; n=44) experienced microaggressions and 25% (n=47) reported witnessing discrimination against a patient or colleague, with 98% (n=46/47) witnessing racial discrimination. Pharmacists who had experienced microaggression were statistically less likely to feel included in the workplace. Despite this, 86% (n=159) felt their services were inclusive. However, low levels of pharmacies offered sign language interpreters (3%; n=5), pictograms (11%; n=21), pronoun badges (13%; n=23) and hearing loop systems (19%, n=35), the latter of which large chain pharmacies were statistically more likely to provide. 43% (n=79) have completed some EDI training, but under a quarter of pharmacists undertook focused training, for example, identifying skin conditions on different skin tones (22%; n=17), or making services inclusive to the LGBTQ+ community (8%, n=6). Conclusion Although limited with a relatively small sample size, and limited but diverse geographical area, the findings suggest discrimination continues to persist in community pharmacy, especially related to race.[2] Accessible and culturally responsive resources such as discrimination reporting mechanisms are necessary. Although most pharmacists felt their services were inclusive, the findings demonstrate this was lacking in most pharmacies, with issues surrounding funding and structural barriers. Pharmacists must raise their awareness of simple, effective measures such as free pronoun badges but also require specific EDI training to fulfil their potential as inclusive practitioners.

Assessment of a community pharmacist remote monitoring service in patients using continuous glucose monitors

BackgroundDiabetes is the eighth leading cause of death and has a substantial impact on the U.S. health care system. Recent changes to major insurance formularies allow for increased access to continuous glucose monitors (CGMs). Community pharmacists routinely assist and educate patients about diabetes care, including usage of CGM. ObjectivesThe purpose of this study was to evaluate the clinical impact of a community pharmacist remote CGM monitoring service on patients’ glycemic metrics. Patient completion of comprehensive diabetes standards of care and pharmacist interventions and recommendations were assessed as secondary objectives. MethodsThis study was a prospective, feasibility study conducted at two pharmacies within 1 regional division of a large community pharmacy chain between November 2022 and June 2023. A pharmacist conducted patient enrollment visits and remotely monitored CGM glycemic metrics via cloud-based platforms per the study protocol. CGM glycemic metrics were evaluated for each patient 3 months pre- and post-study enrollment, including time above range (TAR), time in range (TIR), time below range, glucose management indicator, average glucose, CGM utilization rate, and glucose variability. Metrics were evaluated for statistical significance using the Wilcoxon signed-rank test and descriptive statistics. ResultsPharmacists enrolled 36 patients in this study with 20 patients completing the full 3-month study period per protocol. There was a statistically significant improvement in three of eight glycemic metrics (very high TAR, TIR, and average glucose). Specifically, TIR had the largest improvement from 61.8% pre-enrollment to 69.9% (P < 0.006) postenrollment. All other pertinent glycemic metrics displayed improvements but were not statistically significant. ConclusionThe results demonstrate clinically and statistically significant improvements in several glycemic metrics for patients who participated in the community pharmacist-led remote CGM monitoring service, which may result in improved diabetes control and fewer long-term diabetes-related health complications.