Cost-Related Non-Adherence to Prescribed Medicines: What Are Physicians' Moral Duties?

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient's interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified.

Phase IV Drug Trials With a Canadian Site: A Comparison of Industry and Non-Industry-Funded Trials.

Recent regulatory reforms have favored expedited drug marketing and increased reliance on Phase IV clinical trials for safety and efficacy assurance. This study, utilizing ClinicalTrials.gov, assesses the characteristics of Phase IV trials, with at least one site in Canada, examing those funded by industry sponsors and those lacking industry funding. Additionally, it compares the publication status of industry-funded and non-industry-funded trials through a manual review of the medical literature. Between 2000 and 2022, 864 Phase IV trials were completed, with 480 (55.6%) receiving industry funding and 384 (44.4%) funded solely by non-industry sources. Industry-funded clinical trials were larger (mean 204 enrollees versus 70), more likely to be international (57.7% versus 9.6%) and reported results more promptly (1.21 years after completion versus 1.85 years), yet both types shared similar design, outcomes, and completion time. Publication rates were 81.8% for industry-funded and 65.8% for non-industry-funded trials. The ClinicalTrials.gov registry displayed 48 inaccuracies in publication associations, raising concerns about its accuracy. Our findings underscore the existing institutional limitations in ensuring comprehensive reporting and publication of Phase IV trial results funded by both industry and non-industry sources.

Academia-pharmaceutical industry linkage: An academic perspective.

Background: The pharmaceutical sector in Pakistan has grown over a period, however, there are several barriers in the framework governing the growth of the country's pharmaceuticals. The lack of academia-industry linkage (AIL) is among the critical barriers; hence the focus of the study is to find out the reasons for the lack in the above collaboration. Understanding barriers may help their redressal. Method: This qualitative phenomenology-based study has been conducted in the most prominent pharmacy institutes, located in Lahore, Islamabad, Peshawar, Sargodha, and Quetta. Academic participants, with a minimum experience of 10 years and designation of assistant professor or above were recruited with a two-stage selection process, purposive sampling and snowball sampling. The data were collected using semi-structured interviews with academic experts. Thematic content analysis was employed to conclude the data. Results: Analysis of data yielded 8 themes with 18 codes. The main reasons for neglected AIL were explained by a partial or complete lack of industrial research and development activities. Other key factors for the scarcity of AILs were the lack of positive attitude from both industry and academia, applied research in academics, and the research and development of the new molecules in the pharmaceutical industry. Support by the government and the drug regulatory authority of Pakistan in terms of regulatory and academic policies was also perceived to be absent. New horizons in research and development could be opened by providing applied research to industry, including but not limited to new molecule development. Conclusion: Academia-industry linkage could be boosted with government-backed funded projects and policies. Academia should focus on the industrial-demanded applied research.

Antarctic marine sediment as a source of filamentous fungi-derived antimicrobial and antitumor compounds of pharmaceutical interest.

Antarctica harbors a microbial diversity still poorly explored and of inestimable biotechnological value. Cold-adapted microorganisms can produce a diverse range of metabolites stable at low temperatures, making these compounds industrially interesting for biotechnological use. The present work investigated the biotechnological potential for antimicrobial and antitumor activity of filamentous fungi and bacteria isolated from marine sediment samples collected at Deception Island, Antarctica. A total of 89 microbial isolates were recovered from marine sediments and submitted to an initial screening for L-glutaminase with antitumoral activity and for antimicrobial metabolites. The isolates Pseudogymnoascus sp. FDG01, Pseudogymnoascus sp. FDG02, and Penicillium sp. FAD33 showed potential antiproliferative action against human pancreatic carcinoma cells while showing no toxic effect on non-tumor cells. The microbial extracts from unidentified three bacteria and four filamentous fungi showed antibacterial activity against at least one tested pathogenic bacterial strain. The isolate FDG01 inhibited four bacterial species, while the isolate FDG01 was active against Micrococcus luteus in the minimal inhibitory concentration of 0.015625 µg mL -1. The results pave the way for further optimization of enzyme production and characterization of enzymes and metabolites found and reaffirm Antarctic marine environments as a wealthy source of compounds potentially applicable in the healthcare and pharmaceutical industry.

Operational Differences between Product Development Partnership, Pharmaceutical Industry, and Investigator Initiated Clinical Trials.

Medicine development is a lengthy endeavour. Increasing regulatory stringency and trial complexity might lead to reduced efficiency, dwindled output, and elevated costs. However, alternative models are possible. We compared the operational differences between pharmaceutical industry sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research. We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. The findings were triangulated with an online survey polling clinical research professionals. The operational differences were grouped under five categories: (i) trial start-up differences including governance and management structure; (ii) study complexity; (iii) site structural and organisational differences; (iv) study conduct, quality approaches, and standard operating procedures; and (v) site capacity strengthening and collaboration. Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance. Differences between the types of trials reviewed pertained to planning, operational complexities, quality approaches, and support to the sites. Integration of quality-by-design components has the potential to alleviate unnecessary process burden.

Excelzyme: A Swiss University-Industry Collaboration for Accelerated Biocatalyst Development.

Excelzyme, an enzyme engineering platform located at the Zurich University of Applied Sciences, is dedicated to accelerating the development of tailored biocatalysts for large-scale industrial applications. Leveraging automation and advanced computational techniques, including machine learning, efficient biocatalysts can be generated in short timeframes. Toward this goal, Excelzyme systematically selects suitable protein scaffolds as the foundation for constructing complex enzyme libraries, thereby enhancing sequence and structural biocatalyst diversity. Here, we describe applied workflows and technologies as well as an industrial case study that exemplifies the successful application of the workflow.

Environmental considerations along the life cycle of pharmaceuticals: Interview study on views regarding environmental challenges, concerns, strategies, and prospects within the pharmaceutical industry.

Environmental impacts of medicines arise throughout their entire life cycle. The pharmaceutical industry has a key role in reducing these impacts in early production phases, but currently has limited possibilities to reduce the environmental exposure arising from drug consumption and end-of-life. The aim of this interview study was to explore the current environmental actions within the industry, as well as the views and attitudes toward the strategies to address the environmental challenges and concerns. Semi-structured interviews were conducted among representatives (n = 15) from twelve pharmaceutical companies operating in Finland in February-May 2021. The data were analyzed using qualitative content analysis. The representatives of pharmaceutical industry were overall well aware of the multifaceted environmental challenges related to the life cycle of pharmaceuticals and of their role in improving sustainability in production. Improving waste management and reducing impacts from companies' own operations were the most commonly mentioned actions already taking place within the companies (15/15). "Environmental impacts arising from drug consumption" (6/15) and "centralized drug manufacturing in countries with lax environmental regulation" (4/15) were most frequently brought up challenges difficult to resolve. "Development of environmentally more sustainable drug production in the company" was the most frequently raised key development need (5/15). To address this, establishment of tangible economic drivers, regulatory incentives, or reputational rewards were called for. "Incorporation of environmental aspects into decision-making in different situations" was suggested by 11/15 interviewees as a means to promote sustainable development, e.g. in selection of medicines by physicians and consumers. However, the attitudes towards the types of criteria and their evaluation differed between interviewees. Attitudes towards the "incorporation of environmental fate assessment into early phases of drug design and development" were mostly positive (10/11), suggesting that there is a keen interest in the industry to foster the introduction of new tools enabling the development of pharmaceuticals intrinsically less harmful for the environment.

Key drivers of investment initiatives in Uganda's pharmaceutical industry.

This study examines the key drivers of investment initiatives in Uganda's pharmaceutical industry. We adopted a qualitative research design using an in-depth interview guide to collect data from 12 board chairpersons/assistants at the selected manufacturing, marketing and sales pharmaceutical firms. The theory of Investment Behavior (Jorgenson, 1967) was used to underpin the actors' investment objectives beyond profit maximization locus subject to utility maximization. The results indicate two complementary investment drivers in pharmaceuticals: an investment gap and government policy initiatives. We recommend that the government should formulate an integrated human resource planning policy and further establish a one-in-all-stop hub to support pharmaceutical investments in the country. Besides, the hub should take charge of the operationalization of government policy initiatives intended to close the investment gap in the pharmaceutical industry.

Research on waste gas treatment technology and comprehensive environmental performance evaluation for collaborative management of pollution and carbon in China's pharmaceutical industry based on life cycle assessment (LCA).

China is the largest industrial and pharmaceutical country in the world. The pharmaceutical industry, being a highly polluting sector, is the primary target of environmental regulation in the industry. The rapid development of pharmaceutical industry has posed a severe challenge to the environmental protection strategy of "carbon reduction and carbon neutrality" and the goal of "synergizing the reduction of pollution and carbon emissions" in China's "14th Five-Year Plan". Therefore, this paper starts from the whole industry, takes the life cycle of the whole production process of the pharmaceutical industry as the guidance, and selects a pharmaceutical company in Tianjin as the research object. Then using Life Cycle Assessment (LCA) to Characterization, Standardization, and Weighting the environmental impact of the waste gas treatment process before and after improvement based on waste gas emission characteristics from the pharmaceutical factory. LCA results show that GWP and AP are the most important environmental impact types, which account for >85 % of the total characterization value. I and II - Chemical Pharmaceutical Stage is the critical life cycle stage, accounting for over 80 % of the total characteristic values. This research proposes emission reduction countermeasures based on LCA results and simulates Emission reduction scenarios and economic evolution. If effectively implementing emission reduction countermeasures, reducing the environmental characterization value by 80 to 90 %, and generating economic benefit of 2.66 × 108 RMB/year. This research could guide improvement plans and emission reduction countermeasures of waste gas treatment in the pharmaceutical industry, which realizes collaborative management about efficient reduction of pollution and carbon and generates significant environmental, technological, economic, and social benefits.

[Implementation of an Advanced Planning and Scheduling System in a pharmaceutical context]. / Mise en place d'un système de planification et d'ordonnancement avancé dans un contexte pharmaceutique.

Optimizing its supply chain has now become more than a necessity for any company seeking to expand its national and international market, so that it is able to continue its progress and fulfil its obligations towards its employees and its customers, particularly in the pharmaceutical context. The Covid-19 pandemic has shown the importance of resilience in the pharmaceutical industry to deal with unexpected disruptions and high demand from patients and authorities. Better production planning based on data management and predictive analysis, through the use of new Industry 4.0 tools, improves operational performance in terms of productivity and flexibility in relation to the vagaries of the request. It is in this vision that we approach the implementation of an "Advanced Planning and Scheduling -APS" system, in a pharmaceutical laboratory. It is a leading company in the Tunisian pharmaceutical market that seeks to expand its national and international market. In this work, we describe its project to implement an "Advanced Planning and Scheduling" system and its integration with its already functional "Enterprise Resource Planning" software system, as complementary decision-making tools.

Research on the impact of China's reform to delegate power, streamline administration, and optimize government services on the technology innovation efficiency of the pharmaceutical manufacturing industry.

Objective: The government has recently implemented reforms aimed at delegating power, streamlining administration, and optimizing government services. This reform has eliminated barriers that impede the growth of various industries, thereby unleashing innovative potential. Additionally, there have been several medical policies, including changes to medical insurance and centralized volume-based procurement. China's pharmaceutical market has undergone significant changes, leading to increased demands for innovation technology efficiency in pharmaceutical manufacturing. Methods: The three-stage BCC theory was employed to assess the effectiveness of technology innovation in the industry under this reform. Calculate precise comprehensive technical efficiency values, pure technical efficiency values, and scale efficiency values for technological innovation in the pharmaceutical industry across 30 provinces from 2018 to 2020, after removing environmental factors. Results: In 2020, Jiangsu and Shandong and nine other provinces reached the comprehensive technical efficiency frontier surface, joining Tianjin, Zhejiang, and Guangdong provinces. However, Gansu, Qinghai, Ningxia, and Xinjiang still need to catch up due to their smaller industrial scale and lack of technology. Discussion: To ensure the effectiveness of reforms, it is crucial to fully consider provincial differences. Articulating national and provincial policies is necessary to allow efficient provinces to continue and allocate resources toward less efficient provinces to improve overall efficiency.

Use of Expired Drugs: Patients Benefits versus Industry Interest.

The question of the use of expired medication is a constant debate of many years most especially in a difficult environment. In this research, a literature review and reported practice of some countries are used. Findings show that some medications, if properly stored, remain safe to use after the expiry date and this sometimes could be extended by many years. However, the pharmaceutical manufacturers have an interest in producing products with short shelf life. To dispose of expired ones is to generate a sale and therefore put the profit into the improvement and development of new products for the benefit of medicine. This paper emphasizes the benefit of use of some drugs after expiration and the interest for the pharmaceutical industry to dispose of expired drugs and to shorten their shelf life.

Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation.

OBJECTIVES: Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor. STUDY DESIGN AND SETTING: This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors' data sharing policies. RESULTS: There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor. CONCLUSION: CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.

Stakeholder Insights into Czech Performance-Based Managed Entry Agreements: Potential for Transformative Change in Pharmaceutical Access?

Managed Entry Agreements (MEAs) play a pivotal role in addressing the challenges arising from escalating prices of innovative medical technologies, especially in areas like oncology, immunology, and rare diseases. Among MEAs, Performance-Based MEAs (PB MEAs) and Outcome-Based MEAs (OB MEAs) stand out as innovative strategies. This study examines the adoption of PB MEAs in the Czech Republic post a 2022 legislative change. Interviews with key stakeholders, including the Ministry of Health, pharmaceutical companies, insurers, and patient groups, were conducted to explore perceptions and challenges. Stakeholders expressed concerns about legislation completeness, data quality, transparency, and methodology. Interestingly, pharmaceutical companies were less concerned about transparency and methodology, likely due to their multinational experience. Despite legislative progress, challenges persist, especially in data infrastructure, risk-sharing perceptions, and stakeholder readiness. Addressing these issues requires collaboration between pharmaceutical companies and payers. Patient involvement, though mandated, remains limited, potentially due to a lack of awareness. This study emphasizes the need for a comprehensive transformation beyond legislation for a successful PB MEA implementation. Trust, technical infrastructure, and data availability are crucial, necessitating a holistic approach. It contributes to the global discourse on PB MEAs, stressing the adjustment of financial frameworks, embracing value-based healthcare principles, and ensuring high-quality health data metrics. A more holistic, value-based MEA approach could reshape pharmaceutical reimbursement in the future.

[The transparency committee of the French National Authority for Health]. / La Commission de la transparence de la Haute Autorité de santé.

The Transparency Committee (TC) in France plays a crucial role in the evaluation of post-market authorization (MA) drugs for reimbursement by the social security system. Although its organization has evolved since its creation, the principle of its existence has persisted since the establishment of the social security system. The TC, transitioning from the Medicines Agency to the Haute Autorité de santé in 2005, focuses on the medico-scientific evaluation of drugs, influencing decisions on reimbursement eligibility and price negotiations. It assesses the benefit and added medical value of drugs. Comprising experts with no conflicts of interest with pharmaceutical companies, the TC conducts a scientific evaluation of submissions by pharmaceutical laboratories. Recently, it has also been involved in evaluating requests for early access authorization prior to MA.

The Application of Membrane Separation Technology in the Pharmaceutical Industry.

With the advancement in membrane technology, membrane separation technology has been found increasingly widespread applications in the pharmaceutical industry. It is utilized in drug separation and purification, wastewater treatment, and the recycling of wastewater resources. This study summarizes the application history of membrane technology in the pharmaceutical industry, presents practical engineering examples of its applications, analyzes the various types of membrane technologies employed in the pharmaceutical sector, and finally, highlights the application cases of renowned international and Chinese membrane technology companies in the pharmaceutical field.

A Comprehensive Review on Deep Eutectic Solvents and Its Use to Extract Bioactive Compounds of Pharmaceutical Interest.

The extraction of bioactive compounds of pharmaceutical interest from natural sources has been significantly explored in recent decades. However, the extraction techniques used were not very efficient in terms of time and energy consumption; additionally, the solvents used for the extraction were harmful for the environment. To improve the environmental impact of the extractions and at the same time increase the extraction yields, several new extraction techniques were developed. Among the most used ones are ultrasound-assisted extraction and microwave-assisted extraction. These extraction techniques increased the yield and selectivity of the extraction in a smaller amount of time with a decrease in energy consumption. Nevertheless, a high volume of organic solvents was still used for the extraction, causing a subsequent environmental problem. Neoteric solvents appeared as green alternatives to organic solvents. Among the neoteric solvents, deep eutectic solvents were evidenced to be one of the best alternatives to organic solvents due to their intrinsic characteristics. These solvents are considered green solvents because they are made up of natural compounds such as sugars, amino acids, and carboxylic acids having low toxicity and high degradability. In addition, they are simple to prepare, with an atomic economy of 100%, with attractive physicochemical properties. Furthermore, the huge number of compounds that can be used to synthesize these solvents make them very useful in the extraction of bioactive compounds since they can be tailored to be selective towards a specific component or class of components. The main aim of this paper is to give a comprehensive review which describes the main properties, characteristics, and production methods of deep eutectic solvents as well as its application to extract from natural sources bioactive compounds with pharmaceutical interest. Additionally, an overview of the more recent and sustainable extraction techniques is also given.

Integrated physicochemical processes to tackle high-COD wastewater from pharmaceutical industry.

Wastewater decontamination in pharmaceuticals is crucial to prevent environmental and health risks from API residues and other contaminants. Advanced oxidation processes (AOPs) combined with cavitational treatments offer effective solutions. Challenges include designing reactors on a large scale and monitoring the effectiveness and synergies of the hybrid technology. In the present work, pilot-scale treatment of a real high COD (485 g/L) pharmaceutical wastewater (PW) was investigated using hydrodynamic cavitation (HC) operated individually at 330 L/h or in combination with oxidants and electrical discharge (ED) with cold plasma (15 kV and 48 kHz). The first approach consisted of PW cavitational treatment alone of 7 L of 1:100 diluted PW at a HC-induced pressure of 60 bar and a flow rate of 330 L/h. However, this strategy did not provide satisfactory results for COD (∼15% less), and only when HC treatment was extended to more than 30 min in a recirculation mode, encouraging results were obtained (∼45% COD reduction). Consequently, a hybrid approach combining HC with ED-cold plasma was chosen to treat this high-COD PW. Aiming to establish an efficient flow-through hybrid process, after optimising all cavitation and electrical discharge parameters (45 bar HC pressure and 10 kHz ED frequency), the best COD abatement of ∼50 % was recorded with a 1:50 diluted PW. However, a subsequent adsorption step over activated carbon was required to achieve an almost quantitative COD reduction (95%+). Our integrated physicochemical process proved to be extremely efficient in treating high-COD industrial wastewater and resulted in a remarkable reduction of the COD value. In addition, the residual surfactants content in the PW were also drastically reduced (98%+) when a small amount of oxidants was added in the hybrid HC/ED treatment.

Nanotechnology, a frontier in agricultural science, a novel approach in abiotic stress management and convergence with new age medicine-A review.

Climate change imposes various environmental stresses which substantially impact plant growth and productivity. Salinity, drought, temperature extremes, heavy metals, and nutritional imbalances are among several abiotic stresses contributing to high yield losses of crops in various parts of the world, resulting in food insecurity. Many interesting strategies are being researched in the attempt to improve plants' environmental stress tolerance. These include the application of nanoparticles, which have been found to improve plant function under stress situations. Nanotechnology will be a key driver in the upcoming agri-tech and pharmaceutical revolution, which promises a more sustainable, efficient, and resilient agricultural and medical system Nano-fertilizers can help plants utilise nutrients more efficiently by releasing nutrients slowly and sustainably. Plant physiology and nanomaterial features (such as size, shape, and charge) are important aspects influencing the impact on plant growth. Here, we discussed the most promising new opportunities and methodologies for using nanotechnology to increase the efficiency of critical inputs for crop agriculture, as well as to better manage biotic and abiotic stress. Potential development and implementation challenges are highlighted, emphasising the importance of designing suggested nanotechnologies using a systems approach. Finally, the strengths, flaws, possibilities, and risks of nanotechnology are assessed and analysed in order to present a comprehensive and clear picture of the nanotechnology potentials, as well as future paths for nano-based agri-food applications towards sustainability. Future research directions have been established in order to support research towards the long-term development of nano-enabled agriculture and evolution of pharmaceutical industry.