Large Pharmaceutical Companies Research Articles

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.

Pharmacists as clinical care partners: How a pharmacist-led intervention is associated with improved medication adherence in older adults with common chronic conditions.

Hypertension, hyperlipidemia, and type 2 diabetes (T2D) are 3 of the most common chronic conditions, but related medication adherence rates are far below 80%. Consequences of poor adherence include high health care utilization/costs and increased mortality. There is accumulating evidence in support of the benefits of affording pharmacists the opportunity to practice at the full scope of their licensure by engaging in patients' clinical care. To examine the impact of a large national pharmacy chain's pharmacist-led interventions to improve medication adherence among older adults with hypertension, hyperlipidemia, or T2D. A secondary objective was to estimate the potential cost savings associated with improved adherence. Participants were Medicare patients aged 18 years or older who had 2 or more prescription fills in at least 1 of the 3 therapeutic classes. The primary outcome, optimal adherence, was defined as proportion of days covered (PDC) of 80% or higher. A difference-in-differences (DID) design with a generalized linear model analytical approach was applied to examine differences between intervention participants and controls. The study period spanned from 2020 to 2022. Intervention participants (n = 317,613, age 70.1 years, female sex 57.0%) had lower baseline optimal adherence than controls (n = 943,389, age 73.3, female sex 56.1%) for diabetes (76.9% vs 79.8%), hypertension (79.0% vs 83.0%), and cholesterol (78.6% vs 82.1%). The DID results showed that between 2020 and 2022, optimal adherence had significant absolute increases for intervention participants (diabetes: +4.0%, hypertension: +6.3%, cholesterol: +6.1%) vs controls who declined in adherence (diabetes: -1.6%, hypertension: -0.4%, cholesterol: -1.4%). All DID models were significant at P < 0.0001. Total cost of care was projected based on improvements in adherence. Based on PDC improvements for the test population, we estimate that the pharmacist consultations were associated with annual total health care cost savings of $10,329,284 ($109 per capita), $31,640,660 ($122 per capita), and $21,589,875 ($75 per capita) for test population patients with diabetes, hypertension, and hyperlipidemia, respectively. The study found that the pharmacist-led interventions were significantly associated with increased optimal adherence over 2 years. These findings demonstrate the potential of pharmacist-led interventions to improve medication adherence among older adults with chronic conditions. Strategies to expand pharmacist-provided care must be further examined.

A Sectoral Analysis of BSE-Listed Indian Pharma Companies

Purpose: Investors, including domestic and international firms, venture capitalists, and financial institutions, rely on research to evaluate investment opportunities in the Indian pharmaceutical sector. Research helps assess factors such as market potential, company performance, R&amp;D capabilities, regulatory environment, and risk-return profiles. Research plays a crucial role in guiding research and development (R&amp;D) investments and priorities within the Indian pharmaceutical industry. By identifying unmet medical needs, emerging therapeutic areas, and technological advancements, research helps companies allocate resources effectively and focus on areas with the highest potential for impact and return on investment. The current research includes analysing financial statements, such as income statements and cash flow statements, to assess the profitability and earnings stability of pharmaceutical firms, and also investigate factors influencing EPS growth, such as revenue trends, cost structures, research and development (R&amp;D) investments, regulatory environments, and market dynamics. Additionally, the study of DPS involves evaluating dividend payout ratios, dividend yield, dividend stability, and factors driving dividend decisions, including company profitability, cash flow generation, capital requirements, and shareholder preferences. Understanding the relationship between EPS and DPS in the Indian pharmaceutical sector provides valuable insights for investors, analysts, and policymakers in assessing the financial health, investment attractiveness, and shareholder value creation of pharmaceutical companies. Pharmaceutical companies listed on the Bombay Stock Exchange were selected for the study. Speculations were tested using ANOVA and T-TEST. The audit revealed that investors can invest in Dr. Reddys Laboratories, Abbott India, and Themis Medicare for their EPS to be maximum and Dr. Reddys Laboratories, Abbott India, and Novartis India for their DPS to be maximum. Methodology: Fifteen BSE-listed pharmaceutical companies are considered for the present research work and analysed by using EPS and DPS. Result: Selected Large, medium, and small Indian pharmaceutical companies listed on the BSE were the subjects of this study's analysis of their EPS and DPS. The websites of Money Control and the BSE provided the majority of the time series data used in the study on two different variables, EPS and DPS. Five years, from 2019 to 2020 to 2022–2023 are included in the analysis of the EPS and DPS. The BSE-listed Indian pharmaceutical businesses' EPS and DPS were examined in this study. Descriptive statistics (mean, standard error, standard deviation, skewness, and kurtosis) were computed for the determined EPS and DPS. An ANOVA test is run on the EPS and DPS data to find the differences between the chosen pharmaceutical businesses listed on the BSE. It is recommended that investors put their money into Abbott India, Themis Medicare, and Dr. Reddys Laboratories in order to maximise their EPS, and Novartis India, Abbott India, and Dr. Reddys Laboratories in order to maximise their DPS. Originality/Value: The BSE-listed Indian pharmaceutical businesses' EPS and DPS were examined in this study. Descriptive statistics (mean, standard error, standard deviation, skewness, and kurtosis) were computed for the determined EPS and DPS. Based on the study, the right companies for the investors are recommended. Paper Type: Exploratory research.

Changes in pharmacist’s recommendations of over-the-counter treatments for the common cold during the COVID-19 pandemic

BackgroundThe common cold is one of the most frequently occurring illnesses worldwide. The aim of this study was to determine which OTC anti-common cold medications were most often recommended by pharmacists and if the COVID-19 pandemic affected such recommendations. MethodsNon-interventional, observational research trial using a self-developed questionnaire to collect data on pharmacists’ recommendations for anti-common cold OTC treatment. The data were collected during the COVID-19 pandemic (December 2021-February 2022) in four large community network pharmacies in Lodz (Poland) and then compared with an analogue period of time before the pandemic (December 2019-February 2020). ResultsDuring COVID-19 pandemic there was a significant (p < 0.05) reduction in paracetamol, acetylsalicylic acid, metamizole magnesium, inosines, alpha-mimetics, mucolytics, homeopathics, and sore throat products and an increase in other tablets/capsules and add-on product recommendations. There was a significant relationship (p < 0.05, OR > 1) between the recommended frequency of paracetamol, inosines, sore throat products (each symptom), metamizole magnesium (headache, fever), acetylsalicylic acid (headache, fever, fatigue), NSAIDs, alpha-mimetics (headache, rhinorrhea), pseudoephedrine (rhinorrhea), homeopathics (headache), herbal products (fatigue), antihistamines (rhinorrhea, cough), and mucolytics (headache, fever, cough). ConclusionsFavorable prices (before COVID-19 pandemic) and reports on common NSAIDs side effects (beginning of the pandemic) led to high sale of paracetamol. Increased awareness of clinical effectiveness of some medications or their reduced availability influenced their limited recommendations.

Abstract A034: A new international program to accelerate novel therapeutics for brain tumors: presenting the brain tumor research novel therapeutics accelerator

Abstract Each year, we see many journal manuscripts highlighting successful pre-clinical experiments for potential new brain tumor therapies. Only a few of these therapies move forward into successful clinical trials. Indeed, developing a comprehensive translational program covers many aspects, including but not limited to, medicinal chemistry, blood brain barrier penetration, tumor heterogeneity, delivery, commercialization, and navigating the regulatory environment. Because of this, bringing a successful translational project from bench to bedside requires access to a diverse set of cutting-edge expertise to give promising therapies the best chance of succeeding. Recognizing that this journey is not easy to navigate, the Tessa Jowell Brain Cancer Mission has launched an international Brain Tumor Research Novel Therapeutics Accelerator (BTR-NTA). This program is led by an international group of drug development and brain tumor experts who provide independent guidance to researchers to position their therapeutic along a realistic pathway to clinical trials. The BTR-NTA is open to any international academic and industry researchers developing a medicinal product, delivery technology or device for brain tumors. The BTR-NTA welcomes groups at any stage of pre-clinical or clinical work. Academics and smaller biotech’s could benefit from feedback on their pre-clinical studies and plans for commercialization, while larger pharmaceutical companies could benefit from access to brain tumor specific expertise and patient input into clinical trial design. Researchers can apply to BTR-NTA twice a year, and if accepted will go through the following process: 1. Complete an application form covering work to date and future plans under strict confidentiality agreements; 2. Attend an in-person meeting with a tailored group of experts to further discuss their work; and 3. Receive a comprehensive written report from the BTR-NTA committee with feedback on strengths and weaknesses and guidance on next steps. The expert committee dedicates half a day to reviewing the applicants’ work in-person, and extensive time pre- and post-meeting. Throughout the process, applicants receive up to 150 hours of expert input. The multidisciplinary nature of the review committee spans the entirety of the drug development pathway to support longitudinal collaboration and avoid a siloed approach to research. The BTR-NTA was designed after a similar program in another rare disease field yielded impressive results. Thanks to charitable funding, the BTR-NTA is free to academics and at low cost for industry. The BTR-NTA aims to help address barriers for researchers by highlighting potential pitfalls or risks, providing multi-disciplinary feedback on work to date, giving constructive guidance on next steps and strengthening international collaboration in the brain tumor field. The ultimate goal of the BTR-NTA is to enable researchers with therapy for brain tumors to navigate the drug development journey and make it to the clinic in a low-cost and timely way. Citation Format: Nicky Huskens, Charlotte Aitken, Katie Bushby. A new international program to accelerate novel therapeutics for brain tumors: presenting the brain tumor research novel therapeutics accelerator [abstract]. In: Proceedings of the AACR Special Conference on Brain Cancer; 2023 Oct 19-22; Minneapolis, Minnesota. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_1):Abstract nr A034.

Implementation and evaluation of an EHR-integrated perpetual inventory system in a large tertiary hospital oncology 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. This study aimed to compare the impact of an electronic health record (EHR)-integrated perpetual inventory management system (EIMS) versus a traditional inventory management system (TIMS) on inventory accuracy, visibility, and turnover in a large academic tertiary hospital. The quasi-experimental study was conducted over 12 months (a 6-month preimplementation period and a 6-month postimplementation period, with an 11-month washout period) at Houston Methodist Hospital. The EIMS was implemented following the use of TIMS. A total of 114 matched inventory items from both systems were identified and compared. The primary outcome was inventory accuracy, calculated as cycle count accuracy. The secondary outcomes were inventory visibility and monthly inventory turnover rate. Analysis demonstrated a 6.02% absolute increase in inventory accuracy (P < 0.001) with use of the EIMS versus the TIMS. After adjusting for inflation, there was an increase in the captured cost of goods sold from $4.16 million to $5.16 million. The monthly inventory value, adjusted for inflation in the prices of studied inventory items, increased from $2.05 million to $2.33 million. The monthly inventory turnover rate increased from 2.03 to 2.23 turns per month (P = 0.305) when compared to the pre- and post-implementation periods. Inventory visibility increased from 133 inventory items to 264 inventory items after EIMS implementation, indicating a 98% visibility increase compared to preimplementation levels. This study found that implementing an EIMS significantly increased pharmacy inventory accuracy and inventory visibility, which are essential for optimizing patient care and pharmacy financial management.

Minimization of preventable drug waste through use of a vial combination calculator tool.

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. This project aimed to determine whether a supportive calculator that automates the vial selection process might offer a practical and efficient method of reducing pharmaceutical expenditures through minimizing preventable drug waste in outpatient pharmacy settings from fiscal year (FY) 2021 to FY 2023. Drug waste is a substantial target of cost-saving efforts in the areas of oncology and autoimmune therapy, which involve use of a vast number of high-cost medications packaged in single-dose vials of varying strength. To facilitate selection of the optimal combination of medication vials and thereby minimize preventable drug waste, a Microsoft Excel-based calculator was developed for use by staff of a large oncology pharmacy network. Twenty-three high-cost chemotherapy and monoclonal antibody medications were identified as initial targets for the drug waste prevention initiative. After dissemination and implementation of the calculator and provision of monthly pharmacy staff education, the dollar value of preventable drug waste and the number of suboptimal vial combination selections were reduced by 51% ($412,300) and 54% (315 selections), respectively, in fiscal year 2022 and further reduced by 46% ($183,400) and 27% (71 selections), respectively, in fiscal year 2023. After implementation of an automated vial selection tool, preventable drug waste and the quantity of suboptimal vial combination selections were markedly reduced across 11 outpatient compounding pharmacies.

Aggregate IND Safety Reporting for Smaller Companies and Programs.

The United States (US) Food and Drug Administration (FDA) Investigational New Drug (IND) Final Rule (US FDA, Final rule: Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans, 2010) applies to all human drugs and biological products being studied under an IND. The Final Rule specifies that a sponsor must file an IND safety report for any Suspected Unexpected Serious Adverse Reaction (SUSAR) of a medicinal product being investigated. To make a proper SUSAR classification, sponsors need to go beyond conventional Data Monitoring Committees (DMCs) with an interdisciplinary effort, using all relevant data (including data outside clinical trials), to make judgments on the possibility of serious adverse events being caused by the study drug-rather than the underlying condition of the patient or a concomitant therapy. Ball et al. (Ball et al. in Ther Innov Regul Sci 55:705-716, 2021) have reported on how the Final Rule has been implemented by large pharmaceutical companies. This paper explores the experiences of small sponsor companies regarding the Final Rule, to understand the current challenges that they have been facing to meet aggregate IND safety reporting requirements.

The rise of spin-offs: Fueling pharmaceutical innovation through collaboration

Collaboration among various organizations is important for the sustainable creation of new innovative drugs. Previously, drug discovery was dominated by large pharmaceutical companies; however, various new players are now actively involved in this endeavor. Nevertheless, the factors affecting the financing needed to sustain and expand the research and development (R&D) of spin-off firms has received little research attention in the U.S. and Europe, which have produced many successful spin-offs in recent years. Therefore, considering the recent changes in inter-organizational deal networks in the pharmaceutical industry, this study conducted network and statistical analyses of the factors affecting the amount of financing raised by a total of 53 spin-off firms from the U.S. and the U.K., to sustain their businesses. The results show that the amount of funding raised by spin-off firms is positively affected by their betweenness centrality and the number of international inter-organizational deals. This study’s findings have strategic implications for increasing collaboration between pharmaceutical and spin-off firms by identifying the factors necessary for spin-off firms to sustainably expand their R&D activities.

Increased contribution of small companies to late-entry drugs: a changing trend in FDA-approved drugs during the 2020s

Small- and medium-sized enterprises (SMEs) have significantly boosted innovative drug discovery, whereas large pharmaceutical companies have focused on incremental drug innovation. I explored the evolving role of SMEs in late-entry drug discovery. A comparative analysis of new drugs approved by the US Food and Drug Administration (FDA) during the 2020s with those approved previously revealed that SMEs have expanded their role to late-entry drug discovery while maintaining their contribution to first-in-target drug discovery. I analyzed the characteristics of SMEs responsible for the discovery of late-entry drugs approved during the 2020s, and the modality, market entry timing, and differentiation points of the drugs. I also discuss encompassing opportunities for SMEs, pharmaceutical industry future alliance strategies, and the importance of startup promotion measures.

PHARMACIST INTERVENTION IS ASSOCIATED WITH MEDICATION ADHERENCE IN OLDER ADULTS WITH CHRONIC CONDITIONS

Abstract Hypertension, hyperlipidemia, and type 2 diabetes (T2D) are prevalent chronic diseases among older Americans, but related medication adherence rates are less than optimal. Consequences of poor adherence include increased mortality, healthcare utilization, and costs. Compounding evidence supports the integration of pharmacists in patients’ care across the care continuum. This study’s purpose was to examine the impact of a large national pharmacy chain’s pharmacist-led interventions to improve medication adherence among older adults with hypertension, hyperlipidemia, or T2D. Participants were Medicare D patients who had ≥2 prescription fills in ≥1 of the three therapeutic classes. The primary outcome, optimal adherence (OA), was defined as proportion of days covered (PDC) ≥80%. A difference-in-differences (DID) design with a generalized linear model approach was applied to examine differences between participants exposed to the intervention and controls across the study period (2020-2022). At baseline, intervention participants (n=317,613, age 70.1, female 57.0%) had lower OA for diabetes (76.9% vs. 79.8%), hypertension (79.0% vs. 83.0%), and cholesterol (78.6% vs. 82.1%) compared to controls (n=943.389, age 73.3, female 56.1%). The DID results showed that between 2020 - 2022, OA had significant absolute increases for intervention participants (diabetes: +4.0%, hypertension: +6.3%, cholesterol: +6.1%) versus controls (diabetes: -1.6%, hypertension: -0.4%, cholesterol: -1.4%). All DID models were significant at p&amp;lt; 0.0001. The pharmacist-led intervention was significantly associated with increased OA over 2 years. These findings reinforce the potential for pharmacists as care providers among older adults with chronic conditions. Future research should examine the expansion of pharmacist-provided care.

Key problems of the foreign medicines contract production organization in developing countries

Contract manufacturing is gaining momentum in the pharmaceutical industry. Many pharmaceutical companies that do not have enough time and financial resources to build a fullfledged drug development chain transfer some or all phases of development and production to outsourcing. Today, many even large pharmaceutical companies transfer production to developing countries on a contract basis in order to reduce costs. However, despite a number of advantages of outsourcing, it is worth considering the rather significant barriers to the organization of contract manufacturing of medicines in developing countries. The article discusses the main difficulties in organizing contract manufacturing, primarily on examples from other science-intensive and capital-intensive industries. The study shows the similarity of the difficulties that arise when transferring this practice to the pharmaceutical industry. It is also emphasized that in the world of pharmaceuticals there is a growing trend towards the use of generic drugs. One of the undeniable advantages of their production is their economic availability compared to the originals, however, it imposes increased requirements on the contract manufacturer due to the importance of not deviating too far from the original recipe. The research revealed that countries such as China, India and Japan occupy significant shares of the pharmaceutical contract manufacturing market, including generics - primarily due to various combinations of low labor costs, capital and overhead costs (compared to the United States and Europe), tax incentives and, as a result, underestimated production costs. This circumstance is extremely important for the current situation in the pharmaceutical industry in Russia, which must simultaneously make up for the dropped import volumes of finished drugs, and at the same time speed up the stalled import substitution of a number of the most critical products. As a result and purpose of the study, it is possible to identify the identified barriers to speeding up the organization of pharmaceutical contract manufacturing of drugs necessary for the domestic market, to take them into account in the process of developing appropriate government measures.

Using thematic analysis to evaluate views of community pharmacy staff about the Enablers and Barriers of Antibiotic Amnesty campaigns

Abstract Introduction Antibiotic-resistant infections are the biggest threat to modern medicine. In 2019 there were 1.27 million deaths globally as a result of antibiotic resistance. Without a solution, estimates predict that by 2050 that number will be closer to 10 million people every year who are dying from previously treatable bacterial infections1. The end of the antibiotic era is a rising concern, as antimicrobial resistance continues to be recognised as a global health threat2. Promoting appropriate use and disposal of antibiotics is a key aspect of antibiotic amnesty campaigns, which work towards the bigger picture of reducing antimicrobial resistance (AMR)3. Studies that fill in the gaps in knowledge regarding the challenges and solutions to antibiotic amnesties are lacking. Aim To investigate the main enablers and barriers of antibiotic amnesty campaigns in community pharmacies in Huddersfield, Bradford, Leeds and Sheffield and to identify the most commonly returned antibiotics. Methods This study required and received ethics approval from the University of Huddersfield. A semi-structured interview guide was developed and used to interview consenting community pharmacy staff located in Huddersfield, Bradford, Leeds and Sheffield. Data was collected over a designated 5-week period in January and February 2023 by audio recorded interviews either over Microsoft Teams or face-to-face. Data was groups into themes. All recordings were deleted once transcribed. Results There were 20 interviews conducted, averaging 20 minutes in duration. Participants included 10 pharmacists, 5 pharmacy technicians and 5 medicine counter staff which were evenly divided between age groups 18-39 (n=10) and 40-59 (n=10). The main themes extracted at analysis included; factors enabling campaigns, antibiotic challenges relating to unnecessary use, education enabling amnesty campaigns, and raising awareness to maximise return of unwanted antibiotics. The sub-themes from all three staff groups which suggested enablers for antibiotic amnesty campaigns were, counselling patients, promotional resources and personal approach. The barriers were lack of educating staff, antibiotic misuse by patients, fear of re-infection (saving spare), minor ailments service, inappropriate prescribing and lack of patient education. The most frequently returned antibiotics were penicillins, especially amoxicillin. Discussion/Conclusion The main enablers of antibiotic amnesties are effective counselling and successful use of promotional resources. The main barriers were lack of patient education and lack of staff education. These barriers can be tackled with provision of sufficient education, training and knowledge for patients. Staff could increase the chances of success with antibiotic amnesty campaigns in the future by addressing these issues. Amoxicillin was the most returned antibiotic. It is used to treat many types of bacterial infections, especially respiratory. Shorter courses, back-up prescriptions or alternative treatment options should be considered to reduce leftovers. Study limitations include accounting for ethnicity. Future studies should include more medium and large chain pharmacies over a wider geographical area.

Retail Price of Imatinib Negotiated By Medicare Part D Plans with National or Regional Coverage at Large Chain and Mail Order Pharmacies

Title Retail price of imatinib negotiated by Medicare Part D plans with national or regional coverage at large chain and mail order pharmacies Background Direct-to-consumer pharmacies or websites such as Cost Plus or GoodRx has made imatinib more affordable even without prescription drug coverage. Wholesale acquisition cost (WAC) or list price is often used to compare drug prices. However, the pharmacy retail price negotiated by prescription drug plans and pharmacies is more relevant to patient as it directly impacts out-of-pocket costs and affects decisions on how to acquire oral cancer medications. The price of imatinib for Medicare beneficiaries through different Part D prescription drug plans is variable and not well known. Methods Part D Plan Finder was used to identify Medicare drug' plans offered in Portland, OR at zip code 97239. The monthly retail price of imatinib 400 mg was compared for all available Part D plans for a representative list of nationwide and regional large chain pharmacies (Walgreens, CVS, Rite Aid, Safeway) and for mail order pharmacy. The premium and deductible for each drug plan was extracted. The highest and lowest retail price available for each drug plan and the drug cost for first, second and third fill for each retail price was extracted. This drug cost of imatinib was compared to the out-of-pocket cost of imatinib available from Cost Plus pharmacy and GoodRx in zip code 97239. Results Nine insurance companies offered 24 drug plans in July, 2023. The premium ranged from $1.6 to $113 and the deductible was $0 to $505. All insurance companies offered 2-3 plans with low premium/high deductible or high premium/low deductible. Plans were categorized to low deductible plans (less than $100), medium deductible plans ($100 to $300) and high deductible plans (more than $300). There were 19 high deductible plans. The median retail price was $4340 (IQR 945-5467). The median drug cost for the patient at first fill was $1464 (IQR 583-1745). There were 4 low deductible plans with median retail price of $823 (IQR 187-6419) and median drug cost at first fill of $275 (IQR 61-1971). There was one medium deductible plan and the retail price was $4374 and patient drug cost at first fill was $1425. The lowest retail price was $77 for Asuris Medicare Script Enhanced (PDP) if prescription was filled at Safeway. The highest retail price was $8881 for Elixir RxPlus (PDP) if prescription was filled at Safeway, CVS or Rite Aid. The monthly imatinib from Cost Plus is $33 (+$5 shipping). GoodRx offered coupons for Walgreens at $150, Rite Aid at $64, CVS at $789 and Safeway $90. Conclusions The retail price of imatinib for patients with Medicare Part D drug plan is highly variable depending on the drug plan and filling pharmacy and the out-of-pocket drug cost is often higher than the cost of buying imatinib at Cost Plus by mail order or at the same pharmacy using a GoodRx coupon.

Science and technology as fundamental rights: an analysis in times of the Covid-19 pandemic

Covid-19 pandemic has put humanity in check, forcing the entire world to implement social distancing and isolation measures, affecting the planet's economy and public health. Big pharma financed, on many occasions, with public money, got involved in a runaway race to get a vaccine that could return the planet to the long-awaited normality, leaving their coffers full in the process. This paper analyzes the consequences of preventing the release of the patent for this vaccine in relation to the human right to use advances in science and technology. Using a qualitative methodology, with a descriptive scope, based on the bibliographical review, the contrast that occurs between the rights of peoples to receive the vaccine against Covid-19, as part of the right to to the use of advances in science and technology as a third generation human right, and the interests of large pharmaceutical companies and private business conglomerates, in the light of Law, ethics and public health, discerning on a controversial issue that has humanity in suspense. Concluded that what is at stake goes beyond economic interests, since those who own and maintain ownership of patents will have an advantage in terms of geopolitics and, incidentally, greater control over biopolitics.

Development of pharmacy information databases

In the work, the task of creating a pharmacy database was set, and a study of this subject area was conducted. The development of the information database was implemented by means of the Master’s program in order to improve the efficiency of its work. This development can be used in small pharmacies and large pharmacy chains, as well as in pharmaceutical companies involved in the production and pharmacy automation.

Effectiveness of BNT162b2 BA.4/5 Bivalent mRNA Vaccine Against Symptomatic COVID-19 Among Immunocompetent Individuals Testing at a Large US Retail Pharmacy.

Data on the effectiveness of BA.4/5 bivalent vaccine stratified by age and prior infection are lacking. This test-negative study used data from individuals ≥5 years of age testing for SARS-CoV-2 with symptoms (15 September 2022 to 31 January 2023) at a large national retail pharmacy chain. The exposure was receipt of 2-4 wild-type doses and a BNT162b2 BA.4/5 bivalent vaccine (>2 months since last wild-type dose). The outcome was a positive SARS-CoV-2 test. Absolute (vs unvaccinated) and relative (vs 2-4 wild-type doses) vaccine effectiveness (VE) were calculated as (1 - adjusted odds ratio from logistic regression) × 100. VE was stratified by age and self-reported prior infection. Overall, 307 885 SARS-CoV-2 tests were included (7916 aged 5-11, 16 329 aged 12-17, and 283 640 aged ≥18 years). SARS-CoV-2 positivity was 39%; 21% were unvaccinated, 70% received 2-4 wild-type doses with no bivalent vaccine, and 9% received a BNT162b2 BA.4/5 bivalent dose. At a median of 1-2 months after BNT162b2 BA.4/5 bivalent vaccination, depending on age group, absolute VE was 22%-60% and was significantly higher among those reporting prior infection (range, 55%-79%) than not (range, no protection to 50%). Relative VE was 31%-64%. BNT162b2 BA.4/5 bivalent showed early additional protection against Omicron-related symptomatic COVID-19, with hybrid immunity offering greater protection.