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Journal articles on the topic 'Pharmaceutical Management Agency'
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Carswell, Christopher I. "2nd Annual New Zealand Pharmaceutical Management Agency Forum." Pharmaceutical Medicine 23, no. 5-6 (October 2009): 309–10. http://dx.doi.org/10.1007/bf03256787.
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Mott, David A., Jon C. Schommer, William R. Doucette, and David H. Kreling. "Agency Theory, Drug Formularies, and Drug Product Selection: Implications for Public Policy." Journal of Public Policy & Marketing 17, no. 2 (September 1998): 287–95. http://dx.doi.org/10.1177/074391569801700211.
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The authors describe the pharmaceutical utilization system and present the conceptual framework for agency theory. They then apply agency theory to the selection of pharmaceuticals and the role of drug formularies in drug selection. The use of drug formularies can increase the goal conflict and uncertainty related to the selection of drug products. The authors address public policy and research directions to suggest ways of reducing the level of goal conflict and uncertainty associated with drug selection. Recognition of agency relationships and the environment surrounding agency relationships appear to be important for the development and analysis of future policy regarding selection decisions pertaining to pharmaceuticals.
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Pyatigorskaya, N. V., V. V. Beregovykh, Zh I. Aladysheva, Vasiliy V. Belyaev, A. P. Meshkovskii, and A. M. Pyatigorskii. "AUTOMATED DOCUMENT MANAGEMENT SYSTEM OF PHARMACEUTICAL MANUFACTURER’S QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF GMP." Annals of the Russian academy of medical sciences 72, no. 2 (April 25, 2017): 126–33. http://dx.doi.org/10.15690/vramn808.
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Drugs must be produced in compliance with good manufacturing practice rules approved by an authorized federal agency. Pharmaceutical Quality System is a global requirement for development and production processes for pharmaceutical products. The article describes a variant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with current requirements of GMP. The peculiarity of the proposed system is the focuses on pharmaceutical production taking into account the characteristics and requirements for the pharmaceutical products production. All documents which are supposed to be used within the system are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and register documents.
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Budiarso, Novi Swandari, and Winston Pontoh. "Pecking order, earnings management and capital structure." Accounting 7, no. 6 (2021): 1389–94. http://dx.doi.org/10.5267/j.ac.2021.3.026.
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Most of studies imply that firms decrease or increase their debt capacity in context of pecking order theory or agency problems. On this point, the setting of this study is based on two main problems related to capital structure: the first is determining the source of funds for financing investments, and the second is solving the conflict between shareholders and managers, or the agency problem. The objective of this study is to provide evidence about how firms establish their capital structure in relation to pecking order theory and the agency problem by controlling earnings management in the context of Indonesian firms. This study conducts logistic regression on 28 firms in the consumer goods industry listed on the Indonesia Stock Exchange from 2010 to 2017.This study finds that pecking order theory determines the capital structure of most Indonesian firms with high debt. The results imply that agency problems are unable to explain corporate capital structure and earnings management is not effective for motivating Indonesian firms to establish corporate governance.
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Deschamps, Eleonora, Olivia Vasconcelos, Lisete Lange, Claudio Luis Donnici, Merces Coelho da Silva, and Juliana Aparecida Sales. "Management of effluents and waste from pharmaceutical industry in Minas Gerais, Brazil." Brazilian Journal of Pharmaceutical Sciences 48, no. 4 (December 2012): 727–36. http://dx.doi.org/10.1590/s1984-82502012000400017.
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Today the management of solid waste and wastewater is a major concern for humanity. In the last decade, traces of pharmaceuticals have been reported in the water cycle and have raised concerns among regulators, water suppliers and the public regarding the potential risks to human health. This study evaluated solid waste management in the state of Minas Gerais and concluded that the main fate of hazardous waste has been incineration, while the non-hazardous waste has been recycled or sent to landfills. However, complaints to the Environmental Agency - FEAM have indicated that a significant number of companies just send their hazardous wastes to landfills or even to garbage dumps, thus highlighting the urgent need for adequate waste management in Minas Gerais. Most of the pharmaceutical companies in Minas Gerais use conventional wastewater treatment. Mass spectrometry with electrospray ionization (ESI-MS) showed that the treatment routes adopted by the two 2 selected pharmaceutical industries were not effective enough since residues and degradation products of antibiotics were detected. The physicochemical analysis of the effluents showed variability in their characteristics, which may influence their treatability. The degradation assay with Fenton's reagent stood out as a promising route in achieving a higher removal capacity compared to the conventional treatment. This study contributes to enhancing our knowledge of the management of wastewater as well as of solid waste from the pharmaceutical industry in Minas Gerais and points out the need for further research.
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Küster, Anette, and Nicole Adler. "Pharmaceuticals in the environment: scientific evidence of risks and its regulation." Philosophical Transactions of the Royal Society B: Biological Sciences 369, no. 1656 (November 19, 2014): 20130587. http://dx.doi.org/10.1098/rstb.2013.0587.
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During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk–benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data.
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Faunce, Thomas A., Kellie Johnston, and Hilary Bambrick. "The Trans-Tasman Therapeutic Products Authority: Potential AUSFTA Impacts on Safety and Cost-Effectiveness Regulation for Medicines and Medical Devices in New Zealand." Victoria University of Wellington Law Review 37, no. 3 (September 1, 2006): 365. http://dx.doi.org/10.26686/vuwlr.v37i3.5574.
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Australia and New Zealand have agreed in principle to the creation of a single agency for the regulation of pharmaceuticals and other therapeutic products in a trans-Tasman market. The Australia New Zealand Therapeutic Products Authority (ANZTPA) is being developed to replace both the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). This article explores the possibility that the ANZTPA, by inheriting significant obligations imposed on the TGA under the Australia-United States Free Trade Agreement (AUSFTA), may significantly impact upon the regulation of medicines and medical devices (as well as blood products) in New Zealand. It explores the related legal obligations and their likely consequences for New Zealand: particularly quality, safety, efficacy and cost-effectiveness evaluation processes in this area, such as those of the New Zealand Pharmaceutical Management Agency (Pharmac).
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Pham, Hoang N., and Minh C. Nguyen. "Minority investor protection mechanisms and agency costs: An empirical study using a World Bank–developed approach." Accounting 8, no. 2 (2022): 235–48. http://dx.doi.org/10.5267/j.ac.2021.6.014.
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This study aims to examine the impact of minority investor protection mechanisms on agency costs. All relevant indicators of minority investor protection adapted from the World Bank’s annual ‘Doing Business’ reports, along with concentrated government ownership, are employed with a panel data sample of 135 Vietnamese listed firms during the period 2014–2018. It is found that the following mechanisms are effective in mitigating agency costs and hence agency problems at the firm level: 1) review and approval requirements for related-party transactions; 2) minority shareholders’ ability to sue and hold directors liable for their duties; 3) minority shareholders’ access to internal corporate documents; 4) investors’ rights to approve major corporate investment and sale of asset decisions; and 5) disclosure in annual reports of salaries, bonuses and other forms of remuneration to directors and management. Interestingly, board independence and controlling government shareholders are not confirmed to play significant roles in addressing agency problems. To the best of the authors’ knowledge, this is the first attempt at testing for the impact of minority investor protection mechanisms developed by the World Bank on agency costs at the firm level, hence providing empirical evidence for the adoption of the minority investor protection mechanisms promoted by the World Bank. This study also provides policy implications for selecting effective mechanisms to mitigate agency conflicts between controlling shareholders and minority investors in order to enhance the financial performance of firms in an Asian emerging market.
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Varela-Lema, Leonor, Maruxa Zapata-Cachafeiro, Yolanda Triñanes Pego, and Maria José Faraldo Vallés. "PP28 Adoption Of Non-Pharmaceuticals In Galicia: Beyond Conventional Health Technology Assessment." International Journal of Technology Assessment in Health Care 35, S1 (2019): 41–42. http://dx.doi.org/10.1017/s0266462319001934.
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IntroductionThe specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.MethodsIn depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.ResultsA multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).ConclusionsRigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.
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VALENTI, ALIX, and STEPHEN HORNER. "THE HUMAN CAPITAL OF BOARDS OF DIRECTORS AND INNOVATION: AN EMPIRICAL EXAMINATION OF THE PHARMACEUTICAL INDUSTRY." International Journal of Innovation Management 24, no. 06 (October 2, 2019): 2050056. http://dx.doi.org/10.1142/s1363919620500565.
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The human capital of corporate boards of directors is a key organizational resource affecting a variety of strategic outcomes. Using human capital theory within the broader theoretical contexts of agency theory and the resource dependence perspective, we investigate the effects of certain types of board human capital on firm innovation. Our findings are generally supportive of our theory that board human capital is associated with firm innovation. Specifically, we examine the role of certain types of board human capital on firm innovation and find that scientific expertise, industry experience, financial expertise, and women directors positively affect firm innovation in the pharmaceutical industry, with innovation measured by R&D expenditures and number of patents. These results imply that the knowledge, experience, and expertise that directors bring to corporate boards are important considerations in constituting corporate boards. Further, our work adds to understanding of the impact of board characteristics on firm strategic outcomes.
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Ring, Denis. "Manufacturing challenges in the production of high quality modified-release tablets." Boolean: Snapshots of Doctoral Research at University College Cork, no. 2011 (January 1, 2011): 193–99. http://dx.doi.org/10.33178/boolean.2011.41.
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The pharmaceutical industry is obliged and regulated to ensure that manufactured medicines (i.e., tablets) meet the highest quality standards. However, no system is perfect. The European Medicines Agency (EMEA) state that somewhere between 5-10% of pharmaceutical production batches must be either reworked or discarded, because they do not fully meet the stringent final quality specifications. Poor production quality, often due to inflexible manufacturing and insufficient process understanding represents an unnecessary burden in both time and expense. According to Cedar Management Consulting, the bulk of the global top 16 pharmaceutical companies’ budgets are spent on manufacturing (~36%), whereas the research and development (R&D) expenses (often considered to be the major cost burden) can be less than half of this (~16%). Therefore, there is great interest in making manufacturing more effective and optimising processes in order to deliver consistent high quality. The goal of this research is to facilitate greater process/production understanding ...
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Guo, Di, Xinyu Hua, and Kun Jiang. "Agency and strategic contracts: Theory and evidence from R&D agreements in the pharmaceutical industry." International Journal of Industrial Organization 54 (September 2017): 37–64. http://dx.doi.org/10.1016/j.ijindorg.2017.06.007.
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Feyisa, Diriba, Awol Jemal, Temesgen Aferu, Fikadu Ejeta, and Alem Endeshaw. "Evaluation of Cold Chain Management Performance for Temperature-Sensitive Pharmaceuticals at Public Health Facilities Supplied by the Jimma Pharmaceuticals Supply Agency Hub, Southwest Ethiopia: Pharmaceuticals Logistic Management Perspective Using a Multicentered, Mixed-Method Approach." Advances in Pharmacological and Pharmaceutical Sciences 2021 (September 14, 2021): 1–13. http://dx.doi.org/10.1155/2021/5167858.
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Background. Effective and efficient cold chain management maximizes utilization of healthcare resources, reduces cold chain products wastage, and improves the quality of health services. It eventually guarantees that clients receive cold chain products they need at service delivery points. The objective of this study was to evaluate cold chain management performance for temperature-sensitive medicines at public health facilities in Southwest Ethiopia supplied by the Jimma Pharmaceuticals Fund and Supply Agency hub. Method and Materials. The study used an institution-based cross-sectional study design. Forty-seven (47) public health facilities in Southwest Ethiopia were evaluated using checklists adopted from the Logistic Indicators Assessment Tool, Vaccine Management Assessment Tool, and Logistic System Assessment Tool. Results. The study revealed that the mean availability of essential cold chain products was 72.1 ± 14.8% while the average stock-out rate was 26.2 ± 8.6%. The median stock-out duration was 23 ± 21 days for all visited public health facilities. Two hundred and sixty-three (43.06 ± 15.3%) of the public health facilities’ stock records were found accurate, and the wastage rate due to expiration was 9.2 ± 7.8% for all visited health facilities. Thirty public health facilities (63.8 ± 36.2%) had acceptable storage conditions. Conclusions and Recommendations. Supply chain performance at the study facilities was not adequate overall, and focused efforts need to be directed at managing the availability of critical cold chain medicines. Some cold chain management challenges demand the attention of the top management, while the rest can be addressed by operational management at the facilities through provision of appropriate training and supervision of the cold chain pharmaceutical handlers.
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Chang, Wen-Shing, Shiao-Shing Chen, Jung-Hua Chang, Chih-Hui Tang, and Tzi-Chin Chang. "Odor Load Investigation for a Pharmaceutical Plant by Open Path Fourier Transform Infrared (OP-FTIR)/Environmental Protection Agency Regulatory Dispersion Model (AERMOD)." Environmental Forensics 10, no. 1 (March 16, 2009): 82–91. http://dx.doi.org/10.1080/15275920802659941.
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Chong Hock, Sia, Vernon Tay, Vimal Sachdeva, and Chan Lai Wah. "Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors." Generics and Biosimilars Initiative Journal 9, no. 4 (December 15, 2020): 171–82. http://dx.doi.org/10.5639/gabij.2020.0904.028.
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Data Integrity, which is data deemed Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA-plus), has been the focus of the pharmaceutical industry in recent years. With the growing use of computerized systems and rising prevalence of outsourcing manufacturing processes, ensuring data integrity is becoming more challenging in an increasingly complex pharmaceutical manufacturing industry. To address this issue, multiple legislation and guidance documents such as ‘Data Integrity and Compliance with CGMP Guidance for Industry’ from the US Food and Drug Administration (FDA), ‘GxP’ Data Integrity Guidance and Definitions from the UK Medicines & Healthcare products Regulatory Agency (MHRA), and ‘Guidance on Good Data and Record Management Practices’ from the World Health Organization (WHO), have been published in recent years. However, with rising data integrity issues observed by FDA, WHO, MHRA and other pharmaceutical inspectors even after these guidance documents have been published, their overall effectiveness is yet to be determined. This paper compares and evaluates the legislation and guidance currently in existence; and discusses some of the potential challenges pharmaceutical manufacturers face in maintaining data integrity with such legislation and guidance in place. It appears that these legislation and guidance are insufficient in maintaining data integrity in the industry when used alone. Last, but not least, this paper also reviews other solutions, such as the need for a company culture of integrity, a good database management system, education and training, robust quality agreements between contract givers and acceptors, and performance of effective audits and inspections, to aid in maintaining data integrity in the manufacturing industry. These proposed solutions, if successfully implemented, can address the issues associated with data integrity, and raise the standard of pharmaceutical and biopharmaceutical manufacturing worldwide.
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Ragupathy, Rajan, June Tordoff, Pauline Norris, and David Reith. "KEY INFORMANTS’ PERCEPTIONS OF HOW PHARMAC OPERATES IN NEW ZEALAND." International Journal of Technology Assessment in Health Care 28, no. 4 (October 2012): 367–73. http://dx.doi.org/10.1017/s0266462312000566.
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Objectives: The aim of this study is to examine key informants’ perceptions of how the New Zealand Pharmaceutical Management Agency (PHARMAC) operates in New Zealand.Methods: We carried out qualitative analysis of semi-structured interviews with key informants. We obtained ethics approval from the University of Otago School of Pharmacy, and all participants gave informed consent. We digitally recorded the interviews, which were then transcribed, and coded in NVivo. The data were analyzed by theme using constant comparison methods. Twenty informants who had previously published research or commentary on New Zealand's access to medicines, acted as spokespersons for interest groups, or held positions that gave them key insights into New Zealand's medicines system agreed to participate. Informants were purposefully selected to ensure a wide range of views, including five people working in medicine, four in pharmacy, three Members of Parliament from different parties, and two each from PHARMAC and the pharmaceutical industry.Results: Respondents saw PHARMAC as an organization that contained medicine costs effectively, was politically neutral, and resistant to lobbying. It enjoyed broad political support and, with extremely rare exceptions, had been allowed to carry out its functions independently regardless of who was in government. As a result of this political stability, the relationship between PHARMAC and the pharmaceutical industry has been improving.Conclusion: PHARMAC's longevity and increasing influence are largely due to political choices made to prioritize containing pharmaceutical expenditure and to respecting PHARMAC's independence. This may be difficult to replicate in other countries.
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Sihombing, Yanna Rotua, Azizah Nasution, and Rosidah Rosidah. "ECONOMIC IMPACT OF COUNSELING ON THE MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS ADMITTED TO A HOSPITAL." Asian Journal of Pharmaceutical and Clinical Research 11, no. 13 (April 26, 2018): 94. http://dx.doi.org/10.22159/ajpcr.2018.v11s1.26577.
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Objective: The objective of the study was to study the impact of counseling on costs and effectiveness of type 2 diabetes mellitus (T2DM) outpatients in An-Nisa Hospital, Tangerang, Indonesia, period July 2016 to November 2016.Methods: This 4-month prospective quasi-experimental study was undertaken to analyzed the impact of counseling on cost and effectiveness in the treatment of patients with T2DM (n=30). The cost analysis was conducted from the perspective of Badan Penyelenggara Jaminan Sosial abbreviated as BPJS (Social Security Management Agency abbreviated as SSMA). Characteristics of the patients were analyzed using the Chi-Square method. Cost-effectiveness was analyzed by calculating cost-effectiveness ratio (CER) and Incremental CER (ICER) in groups with and without counseling.Results: The study indicated that most (70%) of the patients were female with ages: >45, 83.3%; ≤45, 16.7%. It was found that CER in groups: Without counseling, Rp4,111,785; with counseling, Rp582,875. ICER was Rp67,416.Conclusion: This study proved that counseling improved the outcome on the treatment of patients with T2DM.
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Urban, Philip, Roxana Mehran, Roisin Colleran, Dominick J. Angiolillo, Robert A. Byrne, Davide Capodanno, Thomas Cuisset, et al. "Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk." European Heart Journal 40, no. 31 (May 22, 2019): 2632–53. http://dx.doi.org/10.1093/eurheartj/ehz372.
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Abstract Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
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Krishnan, Ranjani, Jamshed J. Mistry, and V. G. Narayanan. "A Field Study on the Acceptance and Use of a New Accounting System." Journal of Management Accounting Research 24, no. 1 (May 1, 2012): 103–33. http://dx.doi.org/10.2308/jmar-50203.
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ABSTRACT This study examines the attitudes, use, and acceptance of a new accounting system in a pharmaceutical corporation that switched from an activity-based costing system to the Theory of Constraints System (TOC). Using structuration theory as a framework to understand the dynamics of the change process, we posit that user responses and attitudes toward TOC are influenced not only by the technical features of the system and the potential economic benefits, but also by the fit between TOC and existing structures, modes of mediation, and agency of the users' environment. When users interact with TOC on an ongoing basis, they form interpretations of the new system, and, based on such interpretations, they exhibit actions with respect to the use of TOC ranging from championship to rejection of the system. We explore cross-sectional variations in the use of the system and link such variations to the practical features of the new system, as well as the social structures of the users' environments.
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Nuti, Sabina. "Il governo dell’innovazione farmaceutica in Italia: quali strumenti di governance regionale proporre?" Global & Regional Health Technology Assessment 3, Suppl. 1 (September 27, 2016): S7—S12. http://dx.doi.org/10.33393/grhta.2016.306.
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Managing pharmaceutical innovation in Italy: which regional governance tools can be adopted? Within the Italian federalist framework, national and regional governance tools for pharmaceutical care have been developed in recent years. From a financial perspective, the pharmaceutical outpatient expenditure has already been put under control and this has markedly contributed to reducing the overall costs. The hospital pharmaceutical expenses instead have grown. On this last element bears how innovative and expensive drugs are introduced and managed; among these drugs, cancer drugs have a decisive role.
In the last years the AIFA (Agenzia Italiana del Farmaco – Italian Drugs Agency) policies regarding the adoption process of new drugs have stressed the concept of value for money: any innovative and expensive drug is linked to a webbased control register in order to monitor outcomes. The aim is to relate the drug price to the obtained results (payment by result and risk-sharing) or at least to institute simple financial agreements (cost-sharing) that can be defined as managed entry agreements (MEA). The critical point that can cause equity problems is the way these national governance tools are applied in different regional contexts. There are in fact marked differences among Italian regions. Most regions are aware that the only way to rule the system, and in particular the use of innovative drugs, is to have stronger evidence-based management tools able to connect different systems of oncological prescriptions. The aim is to follow patients in different care settings in order to measure the pathway phases in terms of consumption, costs and quality outcomes and therefore evaluate in actual practice the value for money of innovative drugs.
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Lis, Yvonne, Melissa H. Roberts, Shital Kamble, Jeff J. Guo, and Dennis W. Raisch. "Comparisons of Food and Drug Administration and European Medicines Agency Risk Management Implementation for Recent Pharmaceutical Approvals: Report of the International Society for Pharmacoeconomics and Outcomes Research Risk Benefit Management Working Group." Value in Health 15, no. 8 (December 2012): 1108–18. http://dx.doi.org/10.1016/j.jval.2012.06.019.
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Varghese, Daigy, and Shubha Ranganathan. "Juxtaposing The Great Indian Kitchen and the Kudumbashree: Women, Work and Agency in Kerala." Indian Journal of Human Development 15, no. 2 (July 28, 2021): 353–62. http://dx.doi.org/10.1177/09737030211035863.
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The recent Malayalam film ‘The great Indian kitchen’ invoked debate in Kerala on women’s unpaid work in the house. Taking off from this film, this commentary draws on ethnographic research with women participating in the Kudumbashree, a women’s empowerment programme in Kerala, to engage with questions of paid work, household labour and care arrangements within the household. While the film depicts the struggles of a newly wedded young woman in her in-laws’ house and how she leaves the marriage to follow her dreams, this article shifts the focus to the tactics and strategies used by women in their 40s and 50s who remain within the family fold. We look at the experiences of these women who negotiate work and care arrangements to meet their needs. In doing so, we seek to understand what these strategies say about the conceptualisation of women’s agency and independence, particularly in South Asian contexts.
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Chan, Stephanie J., Veronica I. Nutting, Talia A. Natterson, and Barbara N. Horowitz. "Impacts of Psychopharmaceuticals on the Neurodevelopment of Aquatic Wildlife: A Call for Increased Knowledge Exchange across Disciplines to Highlight Implications for Human Health." International Journal of Environmental Research and Public Health 18, no. 10 (May 12, 2021): 5094. http://dx.doi.org/10.3390/ijerph18105094.
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The global use of psychopharmaceuticals such as antidepressants has been steadily increasing. However, the environmental consequences of increased use are rarely considered by medical professionals. Worldwide monitoring efforts have shown that pharmaceuticals are amongst the multitude of anthropogenic pollutants found in our waterways, where excretion via urine and feces is thought to be the primary mode of pharmaceutical contamination. Despite the lack of clarity surrounding the effects of the unintentional exposure to these chemicals, most notably in babies and in developing fetuses, the US Environmental Protection Agency does not currently regulate any psychopharmaceuticals in drinking water. As the underlying reasons for the increased incidence of mental illness—particularly in young children and adolescents—are poorly understood, the potential effects of unintentional exposure warrant more attention. Thus, although links between environmental contamination and physiological and behavioral changes in wildlife species—most notably in fish—have been used by ecologists and wildlife biologists to drive conservation policy and management practices, we hypothesize that this knowledge may be underutilized by medical professionals. In order to test this hypothesis, we created a hierarchically-organized citation network built around a highly-cited “parent” article to explore connections between aquatic toxicology and medical fields related to neurodevelopment. As suspected, we observed that studies in medical fields such as developmental neuroscience, obstetrics and gynecology, pediatrics, and psychiatry cite very few to no papers in the aquatic sciences. Our results underscore the need for increased transdisciplinary communication and information exchange between the aquatic sciences and medical fields.
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Reginster, Jean-Yves, Jean Dudler, Tomasz Blicharski, and Karel Pavelka. "Pharmaceutical-grade Chondroitin sulfate is as effective as celecoxib and superior to placebo in symptomatic knee osteoarthritis: the ChONdroitin versus CElecoxib versus Placebo Trial (CONCEPT)." Annals of the Rheumatic Diseases 76, no. 9 (May 22, 2017): 1537–43. http://dx.doi.org/10.1136/annrheumdis-2016-210860.
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ObjectivesChondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline.MethodsA prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints. Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.Results604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria, recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.ConclusionA 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.
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Hoq Masum, Mofijul, Ahmed Razman Abdul Latiff, and Mohammad Noor Hisham Osman. "Determinants of corporate voluntary disclosure in a transition economy." Problems and Perspectives in Management 18, no. 4 (November 23, 2020): 130–41. http://dx.doi.org/10.21511/ppm.18(4).2020.12.
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Corporate voluntary disclosure becomes a burning issue in the literature of accounting throughout the last two decades. The study aims to explore the most crucial determinants that influence corporate voluntary disclosure in a transition economy. A cross-sectional study based on the pharmaceutical and chemical companies listed in the Dhaka Stock Exchange is conducted to reconnoiter the crucial determinants affecting the voluntary disclosure. Based on the agency theory, stakeholder theory, and previous literature, the determinants are selected. An unweighted disclosure index is used to measure the extent of voluntary disclosure; after that, a multivariate analysis is steered to reconnoiter the key determinants of voluntary disclosure. It is found that firm leverage and firm liquidity are the key determinants that significantly influence the corporate voluntary disclosure in a transition economy. In contrast, no significant positive association is found between voluntary disclosure and board size. In additon, it is also found that market category significantly influences voluntary disclosure with an inverse direction. This study has important implications for both the corporate people and the regulatory bodies of the transition economy. The study also helps various stakeholders of the transition economy – Bangladesh, in designing their strategies regarding the most significant determinants of voluntary disclosure. Acknowledgment We are very thankful to the Institute of Advanced Research (IAR), United International University, Bangladesh, to grant us the fund by mobilizing which we generate our required data for the study and complete this empirical study.
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Kohli, Manika, and Suveera Gill. "Impact of family involvement on strategy and CEO compensation." Journal of Family Business Management 10, no. 3 (December 11, 2019): 189–212. http://dx.doi.org/10.1108/jfbm-09-2019-0060.
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Purpose As widely known and well established, strategic decision-making at family firms is an interface between business interests and family considerations. The purpose of this paper is to understand the underlying basis of decision-making in setting corporate strategy and designing chief executive officer (CEO) compensation at founder- vis-à-vis descendant-led family firms in the Indian pharmaceutical sector. Design/methodology/approach A sample of 106 BSE-listed pharmaceutical companies have been studied over the period 2012–2017 resulting in a total of 636 firm-year observations. Impact of family involvement in business (FIB) on corporate strategy and CEO compensation has been analysed by constructing multivariate panel data regression models. To deal with the problem of endogeneity, Arellano-Bond (1991) dynamic panel data estimation procedure has moreover been conducted. Findings Supporting stewardship theory, founder-owned and governed firms have been found to favour “growth” strategy and distribute “conservative” executive pay, thereby exerting a positive moderating impact on the strategy-compensation linkage. On the contrary, descendants/second-generation entrepreneurs have put forth a “conservative” stance for growth and innovation, and have rather been observed to favour a “liberal” compensation policy, thereby showcasing the application of behavioural agency theory. Originality/value The research is a novel attempt to unravel the interaction between corporate strategy and CEO compensation in a family firm backdrop carried out in the context of an emerging economy. The study, moreover, adopted an all-encompassing definition of FIB (ownership, management and governance).
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Subbotina, T. N. "INVESTMENT ATTRACTIVENESS OF THE KALUGA REGION: FACTORS AND ASSESSMENT METHODS." Scientific Review: Theory and Practice 10, no. 8 (August 31, 2020): 1600–1614. http://dx.doi.org/10.35679/2226-0226-2020-10-8-1600-1614.
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Active development of the region's economy is impossible without attracting investment. Investment activity is the most important determinant of effective social and economic development of the regional economy. It is important for potential investors to correctly assess the investment attractiveness of the region and determine the level of investment risk. The article examines the main factors of investment attractiveness of the regions of the Russian Federation. The analysis of the main methods of assessing the investment attractiveness of regions used in Russian practice is carried out. The article draws attention to the tendency of refusal from simple calculation of financial indicators towards in-depth economic analysis when assessing the investment attractiveness of regions. The conclusion is drawn about the relationship between the level of investment attractiveness and the presence of a strong regional management team capable of creating a favorable investment climate. On the example of the Kaluga region, which implements the cluster approach in the development strategy, an analysis of investment attractiveness is carried out using the rating methods of the Agency for Strategic Initiatives and the Rating Agency “Expert”. The role of the automotive, pharmaceutical and transport and logistics clusters in attracting direct investment to the region in 2017-2019 has been determined. The volume of investments in the regional economy and the change in the gross regional product of the Kaluga region for the analyzed period are analyzed. The study used a comparative method, analytical, method of economic and statistical analysis (use of statistical data). The main result of the study was to identify the reasons for the dynamics of factors of investment attractiveness. Recommendations are given for the optimal methodology for assessing investment attractiveness, in particular, on the need to provide open access to the rating results, to be adaptive, to realistically assess the regional gap and to take into account the investment and innovation activity.
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Deng, Yuhao, and Xiao-Hua Zhou. "Methods to control the empirical type I error rate in average bioequivalence tests for highly variable drugs." Statistical Methods in Medical Research 29, no. 6 (September 3, 2019): 1650–67. http://dx.doi.org/10.1177/0962280219871589.
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Average bioequivalence tests are used in clinical trials to determine whether a generic drug has the same effect as an original drug in the population. For highly variable drugs whose intra-subject variances of direct drug effects are high, extra criteria are needed in bioequivalence studies. Currently used average bioequivalence tests for highly variable drugs recommended by the European Medicines Agency and the US Food and Drug Administration use sample estimators in the null hypotheses of interest. They cannot control the empirical type I error rate, so the consumer's risk is higher than the predetermined level. In this paper, we propose two new statistically sound methods that can control the empirical type I error rate without involving any sample estimators in the null hypotheses. In the proposed methods, we consider the average level of direct drug effects and the intra-subject variance of the direct drug effects. The first proposed method tests the latter parameter first to determine whether a product should be regarded as a highly variable drug, and then tests the former using corresponding bioequivalence limits. The second proposed method tests these two parameters simultaneously to capture the bioequivalence region. Extensive simulations are done to compare these methods. The simulation results show that the proposed methods have good performance on controlling the empirical type I error rate. The proposed methods are useful for pharmaceutical manufacturers and regulators.
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van Prooijen, Jan-Willem, and Mark van Vugt. "Conspiracy Theories: Evolved Functions and Psychological Mechanisms." Perspectives on Psychological Science 13, no. 6 (September 19, 2018): 770–88. http://dx.doi.org/10.1177/1745691618774270.
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Belief in conspiracy theories—such as that the 9/11 terrorist attacks were an inside job or that the pharmaceutical industry deliberately spreads diseases—is a widespread and culturally universal phenomenon. Why do so many people around the globe believe conspiracy theories, and why are they so influential? Previous research focused on the proximate mechanisms underlying conspiracy beliefs but ignored the distal, evolutionary origins and functions. We review evidence pertaining to two competing evolutionary hypotheses: (a) conspiracy beliefs are a by-product of a suite of psychological mechanisms (e.g., pattern recognition, agency detection, threat management, alliance detection) that evolved for different reasons, or (b) conspiracy beliefs are part of an evolved psychological mechanism specifically aimed at detecting dangerous coalitions. This latter perspective assumes that conspiracy theories are activated after specific coalition cues, which produce functional counterstrategies to cope with suspected conspiracies. Insights from social, cultural and evolutionary psychology provide tentative support for six propositions that follow from the adaptation hypothesis. We propose that people possess a functionally integrated mental system to detect conspiracies that in all likelihood has been shaped in an ancestral human environment in which hostile coalitions—that is, conspiracies that truly existed—were a frequent cause of misery, death, and reproductive loss.
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Orphanidou, Maria, and Irini Kadianaki. "Between medicalisation and normalisation: Antithetical representations of depression in the Greek-Cypriot press in times of financial crisis." Health: An Interdisciplinary Journal for the Social Study of Health, Illness and Medicine 24, no. 4 (October 9, 2018): 403–20. http://dx.doi.org/10.1177/1363459318804579.
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Media offer people ways of understanding mental health and illness, shaping their attitudes and behaviour towards it. Yet, the literature on media representations of depression is limited and fails to illuminate sufficiently the content of representations. In times of financial crisis, the prevalence of depression is increased and the particular meanings associated with depression are widely diffused. To unpack these meanings, we focused on the Greek-Cypriot press during the financial crisis of 2013. Two-hundred and three articles from seven widely circulating newspapers were thematically analysed. Two antithetical themes of representations of depression were identified: Biomedical Depression, which constructed depression as a biologically grounded illness treated through medical/pharmaceutical means, and Everyday Depression, which portrayed depression as something normal, encountered in anyone, attributed to psychosocial factors (e.g. the financial crisis), and treated through self-management. Biomedical Depression reflects a widespread medical and deterministic understanding of depression. Nevertheless, this understanding has not overridden, as the literature suggests, references to individual agency, which are present in the Everyday Depression and the more normalising understanding of depression it expresses. We argue, however, that both themes promote an individualistic understanding of depression, placing individuals in a tense position of being responsible for a condition perceived to be outside their control.
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Norman, Ian J., Michael Bergin, Charles D. Parry, and Marie Claire Van Hout. "Best Practices and Innovations for Managing Codeine Misuse and Dependence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 3 (October 27, 2016): 367. http://dx.doi.org/10.18433/j3t89k.
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Purpose. Promoting and ensuring safe use of codeine containing medicines remains a public health issue given the rise in reporting of misuse and dependence particularly in countries where available over–the-counter (OTC). The aim of this unique study was to identify best practices in management of opioid abuse and dependence, particularly codeine, and innovations to meet challenges surrounding safe and compliant use, patient awareness-raising, reducing health harms and enhancing successful treatment of dependence. Methods. A mixed methods approach using three data points was used that included : (1) analysis of data from existing scoping reviews to identify potential areas for innovation (2) interviews with key national stakeholders from public health, pharmaceutical, regulatory, primary care and addiction practice in three distinct regulatory regimes (Ireland, United Kingdom and South Africa); and (3) a circular email request for information on potential innovations to members of the European Medicine’s Agency European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP). Data from these three sources were analysed to identify best practices and opportunities for innovation. Results. Best practices and potential innovations were identified under the nine headings: (1) manufacture; (2) product information and public education; (3) responsible prescribing; (4) monitoring and surveillance; (5) dispensing, screening and brief interventions in community pharmacies; (6) safety in the workplace and on the road; (7) internet supply of codeine and online support; (8) treatment of codeine dependence; and (9) learning resources and training for health professionals. Conclusions. Challenges ensuring availability of codeine containing medicines for legitimate therapeutic use, while minimising misuse, dependence and related health harms warrant consideration of new innovations. Most promising innovative potential lies across the products’ retail lifecycle from manufacture to prescriber and community pharmacy practitioner.This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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Kothari, Charmy, and Kavina Shah. "REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING." International Journal of Drug Regulatory Affairs 4, no. 2 (February 13, 2018): 19–26. http://dx.doi.org/10.22270/ijdra.v4i2.182.
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The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose of getting a common goal via verbal interaction is called a formal meeting. During development stage of any drug or biological products pharmaceutical companies face trouble for both scientific and regulatory point of view, here role of formal meetings comes. Formal meetings between sponsor or applicant and FDA are usually related to development and review of drug and biological products. Center for Drug evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulates the formal meetings. These meetings are applicable to Pre – Investigational New Drug Application, Pre – Biologics License Application, New Drug Application for drugs and biological products and not applicable to Abbreviated New Drug Applications (ANDA), application of medical devices and submission of biosimilar biological products. Meetings between FDA and sponsor or applicant are for resolution of dispute, clinical holds discussion, Assessment of protocols of clinical trial, during clinical trials, in between clinical trials – at the phase 1 ending or at the phase 2 ending, to discuss development program. The FDA has classified these formal meetings in different types based on the nature of the request, the information in the meeting request and each meeting type is handled through different procedures. The principles of Good Meeting Management Practices (GMMPs) must be maintained. There are specific requirements and procedures to request, prepare, schedule, conduct and document formal meetings. As the guidance documents for meetings are revised by FDA, Change in procedure and requirements takes place. Any pharmaceutical company need to be in line with new guidance requirements to avoid rejection. Formal meetings between sponsor or applicant and FDA save time, cost and will increase the probability of product approval.
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Vikram, Aakash Deep, and Manita. "Regulation and Challenges of Biosimilars in European Union." Applied Clinical Research, Clinical Trials and Regulatory Affairs 6, no. 3 (November 13, 2019): 192–211. http://dx.doi.org/10.2174/2213476x06666190906152404.
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Background: Biological products comprise the most complex and diverse types of drugs that are made by living cells. The use of biological products has increased significantly in recent decades and has contributed significantly to improving the efficacy of treatment in many diseases. Patent protection for pharmaceutical products, including biological products, generally expires about 20 years after development. Expiration of patents of biological innovative medicines allows regulatory authorities to approve copies of biological medicines, such as medicines called similar biological products (biosimilar) and to enter in clinical use. Biosimilar products are comparable but not identical with innovator biological products and are not a generic version of the innovator biological product. While biosimilars are subjected to rigorous characterization and clinical trials to demonstrate their safety and efficacy, in the case of biosimilars certain regulatory requirements apply for registration. Biosimilars are very complex and large molecules and minor changes in the manufacturing process can have important implications in their safety and efficacy profiles. To ensure that biosimilar reaches their potential in clinical application, intensive Pharmacovigilance system and risk management plan must be established to demonstrate the true similarity between the biosimilar products and original biological products. Biosimilars are part of the growing sector of the pharmaceutical industry and normally used by human beings since manufacturers of biosimilars face some challenges in regulatory approval and manufacturing of biosimilars in the European Union. Objectives: The current manuscript will provide the information regarding the regulation of biosimilar products with guidelines and challenges faced by manufacturers during approved and manufacturing of biosimilar products in the European Union. This manuscript also provides the status of approved and rejected biosimilars by EMA (European Medicine Agency). Conclusion: Biosimilars may reduce costs when patent protection of biological products expires and compared to the original products, savings are not as large as seen with traditional generics. In the coming years, there will be an increasing number of biological and biosimilar products available on the market, highlighting the need for specific short and long term post-marketing surveillance programs for these medicines. It is essential to understand how the concept of compatibility, interchangeability will be managed and regulated in the future. An important aspect for future a high quality, clinical and non-clinical studies will be conducted to evaluate the safety and efficacy of biosimilars. Scientific guidelines on biosimilar issued by the EMA (European Medicine Agency) that established a process to demonstrate the similarity between a biosimilar product and the innovator reference product.
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Garattini, Livio, and Gianluigi Casadei. "Risk sharing agreements: What lessons from Italy?" International Journal of Technology Assessment in Health Care 27, no. 2 (March 24, 2011): 169–72. http://dx.doi.org/10.1017/s0266462311000079.
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Italy is one of the few countries that have matured substantial experience of risk-sharing agreements so far. The first performance-based arrangement was agreed in July 2006, and as of October 2010, eighteen contracts have been in force.The complex management of discount schemes is entirely based on Web registries run by AIFA, the Italian drug agency. The system validates each prescription and automatically requests the hospital pharmacy by e-mail to release the drug. If a patient meets nonresponder criteria, the hospital pharmacist should apply for pay-back to the manufacturer.There are still some important question marks to address. First of all, nonresponders have to be documented by health authorities, otherwise any undocumented nonresponder will be paid as a success. Another question concerns pre-set timing. Although the scientific rationale of the nonresponder criteria for each drug has not been made public, time frames appear too short to allow a reliable assessment. Another question is whether regions, which are financially accountable in Italy for pharmaceutical expenditure, are really able to claw back refunds from manufacturers. Unfortunately here again there are no official figures, and regions do not seem yet able to quantify the amount of pay-back matured in the 4 previous years. The delayed and incomplete availability of pay-back procedures may be one explanation.
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Morgan, L., and G. Gartlehner. "Comparative efficacy, effectiveness and harms of second-generation antidepressants in the pharmacologic treatment of adult depression." European Psychiatry 26, S2 (March 2011): 1266. http://dx.doi.org/10.1016/s0924-9338(11)72971-6.
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IntroductionSecond-generation antidepressants dominate the medical management of major depressive disorder (MDD). Two published comparative effectiveness reviews (CER) provide conflicting evidence about the comparative efficacy and safety of second-generation antidepressants for treating MDD.ObjectivesTo compare the benefits and harms of bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, and venlafaxine for the treatment of MDD in adults.MethodsWe updated a CER published in 2007 by the Agency for Healthcare Research and Quality searching MEDLINE, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts up to May 2010. Two persons independently reviewed the literature, abstracted data, and rated the risk of bias. If data were sufficient, we conducted meta-analyses of head-to-head trials of the relative benefit of response to treatment. In addition, we conducted mixed treatment comparisons to derive indirect estimates of the comparative efficacy among all second-generation antidepressants.ResultsOverall, no substantial differences in efficacy could be detected among second-generation antidepressants. Statistically significant differences in response rates between some compared drugs are small and likely not clinically relevant. Differences exist in the incidence of specific adverse events and the onset of action. Venlafaxine leads to higher rates of nausea and vomiting, sertraline to higher rates of diarrhea, and mirtazapine to higher rates of weight gain than comparator drugs. Bupropion caused lower rates of sexual dysfunction than other antidepressants.ConclusionsOur findings indicate that the existing evidence does not warrant the choice of one second-generation antidepressant over another based on greater efficacy and effectiveness.
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Lessing, Charon, Toni Ashton, and Peter Davis. "The impact on health outcome measures of switching to generic medicines consequent to reference pricing: the case of olanzapine in New Zealand." Journal of Primary Health Care 7, no. 2 (2015): 94. http://dx.doi.org/10.1071/hc15094.
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INTRODUCTION: New Zealand's Pharmaceutical Management Agency (PHARMAC) manages the list of medicines available for prescribing with government subsidy, within a fixed annual medicines budget. PHARMAC achieves this through a mix of pricing strategies including reference pricing. In 2011, PHARMAC applied generic reference pricing to olanzapine tablets. AIM: This study sought to evaluate change in outcome measures of patients switching from originator to generic olanzapine consequent to the introduction of the policy. METHODS: A retrospective study using national health data collections was conducted. Outcome measures included medicines indicators (change in dosage, concomitant therapy and treatment cessation), health care service indicators (use of emergency departments, hospitals and specialist services), surveillance reports of adverse events, and mortality. RESULTS: Subsequent to the removal of funding for originator brand olanzapine tablets, 99.7% of patients meeting the inclusion criteria switched to using generic olanzapine. Limited case reports of suspected therapeutic loss were received in the study time period. No increase in use of additional oral or injectable antipsychotic medication was observed after switching, nor any increase in other unique, non-antipsychotic prescription items. However, a high incidence of multiple switching between available brands was found. No net impact of switching brands on health service utilisation or mortality was found. DISCUSSION: The study shows that a switch can be made safely from originator olanzapine to a generic brand, and suggests that switching to generics should generally be viewed more positively. Generic reference pricing achieves considerable savings and, as a pricing policy, could be applied more widely. KEYWORDS: Antipsychotic agents; drug costs; drugs, generic; olanzapine
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Lessing, Charon, Toni Ashton, and Peter Davis. "New Zealand patients’ understanding of brand substitution and opinions on copayment options for choice of medicine brand." Australian Health Review 40, no. 3 (2016): 345. http://dx.doi.org/10.1071/ah15004.
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Objective The aim of the present study was to better understand the views and experiences of New Zealand patients on switching between brands of prescription medicines and on alternative funding options for the provision of medicines, including an increase in copayments. Methods A self-administered questionnaire was offered to selected patients through participating community pharmacies. Pharmacies were stratified according to level of deprivation of the community served before random selection and invitation for involvement in the study. Patient understanding of and rationale for brand substitution was assessed. Preference for different copayment options was elicited, together with demographic and other explanatory information. Results In all, 194 patient-completed questionnaires were returned. Some gaps in patient knowledge and understanding of brand changes were evident. Most respondents indicated a preference for the existing subsidy arrangements with little desire expressed for alternatives. Around half were willing to contribute towards paying for a choice of brand other than the subsidised brand; however, the maximum contribution nominated was disproportionately lower than real cost differences between originator brand and generics. Conclusion The findings of the present study suggest that although most patients have experienced brand changes without any problems occurring, a lack of knowledge about substitution does persist. There may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing to reinforce the benefits of the Pharmaceutical Management Agency (PHARMAC) purchasing model. What is known about the topic? Generic reference pricing is used as a mechanism to make savings to pharmaceutical budgets; however, reticence to the use of generic medicines persists. What does this paper add? Most New Zealand patients experience brand changes without any problems occurring; however, a lack of knowledge about substitution does persist. The dollar value patients indicate they would contribute for brand choice is lower than the true cost difference between brands. What are the implications for practitioners? Opportunities exist for healthcare professionals to reinforce generic policies and there may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing.
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Saxton, Peter J. W., and Susan M. McAllister. "Enumerating the population eligible for funded HIV pre-exposure prophylaxis (PrEP) in New Zealand." Sexual Health 16, no. 1 (2019): 63. http://dx.doi.org/10.1071/sh18058.
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Background Pre-exposure prophylaxis (PrEP) became publicly funded in New Zealand (NZ) on 1 March 2018. PrEP could have a substantial population-level effect on HIV transmission if scaled up rapidly. An accurate estimate of the size of the PrEP-eligible population would guide implementation. Methods: We drew on nine sources to estimate the PrEP-eligible population, namely Statistics NZ data, Pharmaceutical Management Agency (PHARMAC) data on adults receiving funded antiretroviral treatment (ART), expert advice, estimates of the HIV care cascade, surveillance of undiagnosed HIV in a community sample of gay and bisexual men (GBM), surveillance of HIV diagnoses, NZ Health Survey data on sexual orientation among males, behavioural surveillance among GBM and behavioural data among people living with HIV (PLWH) from the HIV Futures NZ study. From these sources we derived three estimates relating to GBM, non-GBM and total eligible population. Sensitivity analyses examined different assumptions (GBM denominators, proportion PLWH diagnosed, proportion of diagnosed PLWH treated). Results: We estimated that 17.9% of sexually active HIV-negative GBM would be eligible for PrEP, equating to 5816 individuals. We estimated that 31 non-GBM individuals would be eligible for PrEP. Thus, in total, 5847 individuals would be eligible for PrEP, comprising 99.5% GBM and 0.5% non-GBM. Sensitivity analyses ranged from 3062 to 6718 individuals. Conclusions: Policy makers can use enumeration to monitor the speed and scale in coverage as implementation of publicly funded PrEP proceeds. Sexual health and primary care services can use enumeration to forecast PrEP demand and plan accordingly. Better quality data, especially on transgender adults in NZ, would improve the accuracy of estimates.
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Saxton, Peter J. W., and Susan M. McAllister. "Corrigendum to: Enumerating the population eligible for funded HIV pre-exposure prophylaxis (PrEP) in New Zealand." Sexual Health 16, no. 1 (2019): 99. http://dx.doi.org/10.1071/sh18058_co.
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Background:Pre-exposure prophylaxis (PrEP) became publicly funded in New Zealand (NZ) on 1 March 2018. PrEP could have a substantial population-level effect on HIV transmission if scaled up rapidly. An accurate estimate of the size of the PrEP-eligible population would guide implementation. Methods: We drew on nine sources to estimate the PrEP-eligible population, namely Statistics NZ data, Pharmaceutical Management Agency (PHARMAC) data on adults receiving funded antiretroviral treatment (ART), expert advice, estimates of the HIV care cascade, surveillance of undiagnosed HIV in a community sample of gay and bisexual men (GBM), surveillance of HIV diagnoses, NZ Health Survey data on sexual orientation among males, behavioural surveillance among GBM and behavioural data among people living with HIV (PLWH) from the HIV Futures NZ study. From these sources we derived three estimates relating to GBM, non-GBM and total eligible population. Sensitivity analyses examined different assumptions (GBM denominators, proportion PLWH diagnosed, proportion of diagnosed PLWH treated). Results: We estimated that 17.9% of sexually active HIV-negative GBM would be eligible for PrEP, equating to 5816 individuals. We estimated that 31 non-GBM individuals would be eligible for PrEP. Thus, in total, 5847 individuals would be eligible for PrEP, comprising 99.5% GBM and 0.5% non-GBM. Sensitivity analyses ranged from 3062 to 6718 individuals. Conclusions: Policy makers can use enumeration to monitor the speed and scale in coverage as implementation of publicly funded PrEP proceeds. Sexual health and primary care services can use enumeration to forecast PrEP demand and plan accordingly. Better quality data, especially on transgender adults in NZ, would improve the accuracy of estimates.
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Christiansen, Nanna, Tayyaba Javid, Jasper Thomson, Heather Calvert, and Olapeju Bolarinwa. "P29 Impact of a medicines facilitation pharmacist on a paediatric ward." Archives of Disease in Childhood 103, no. 2 (January 19, 2018): e2.32-e2. http://dx.doi.org/10.1136/archdischild-2017-314585.38.
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AimRecruiting sufficient numbers of nurses can provide a challenge for hospitals. Pharmacists have been identified as being able to support nurses by taking on medicines management tasks alongside traditional nursing responsibilities such as medicines administration and discharge planning.1 At Barts Health NHS Trust there was increased pressure on nursing staff particularly on one of the complex medical wards during the winter pressure months. Paediatric pharmacists were identified as being able to support nurse:Safe nursing time by taking on some of nursing responsibilitiesActive discharge planning and coordinationReduce discharge prescription waiting timesImprove education and training for nurses, doctors and patients in relation to medicines management.MethodA pilot project on one paediatric medical ward was started in February 2016. The pharmacist is supernumerary to standard ward pharmacy service, reporting to the ward manager and lead pharmacist. Working hours are 9 am–5 pm Monday to Friday.Intensive training was provided over 2.5 weeks with subsequent sign off for administration of oral medication, 2nd checking for intravenous (IV) medication and IV giving.Drug listing for discharge prescription (TTA) was introduced, which involves a discussion with the doctor for medicines on discharge, transcribing these onto the TTA and using ward based dispensing where possible. Results were collected pre and post implementation.ResultsMedication administration activity:Nurse time – 60 hours/month (medication administration and 2nd checking) saved.Discharge information:Proportion of TTAs dispensed at ward level increased from 19% to 78% post implementation, avoiding delays in dispensary.Average time writing TTA to being ready for discharge reduced from 280 min to 91 min.Drug listing reduced discharge time further to 52 min.Missed and delayed doses:Random sample of 5 patients audited over 48 hour period, shown to reduce missed doses from 14% to 0%.Comments from staff:‘Because of skill mix and use of agency staff, assisting in preparing and giving IVABs has been a major help as on many days only 1 IV giver.’‘Junior staff value and support WFP and have felt has been useful to them.’‘Junior and agency staff feels better supported in understanding medicines usage’.‘Lot of complex patients with many drugs, the pharmacist has helped reducing delay in administration times’.‘TTAs for patients identified as going home have been validated sooner’.‘She helped us to reduce the number of incidents with expiry dates of medicines’.ConclusionThe role of the medicines facilitation pharmacist has been very well received by the nursing staff and the pharmacist is now an integral part of the ward team. The pharmacist was able to save a significant amount of nursing time and reduced risks of delayed and missed doses significantly and is able to provide continuous input into all aspects of medicines management. The average discharge time has reduced to substantially due to improved discharge planning, drug listing and ward based dispensing.ReferenceRobinson S. Hospital hires pharmacists for wards amid nurse shortage. Pharmaceutical Journal 23/30 May 2015;294(7863/4). [online] doi:10.1211/PJ.2015.20068544
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Harkin, Kathleen. "OP93 Collaboration Between Health Technology Assessment And Procurement: A Rapid Mixed-Methods Study." International Journal of Technology Assessment in Health Care 35, S1 (2019): 23–24. http://dx.doi.org/10.1017/s0266462319001454.
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IntroductionThe Irish Health Service (HSE) Health Technology Assessment Group (HTAG) aims to maximise the impact of its work by collaborating with HSE Procurement, formalised through an evidence-based Memorandum of Understanding (MOU). This study aims to inform the MOU.MethodsA sequential mixed-methods study design was used. A rapid review of the literature identified no substantive body of evidence on collaboration between independent national health technology assessment (HTA) and procurement bodies. Personnel involved in HTA or procurement were invited by email to complete a survey, take part in an interview, or both. The quantitative and qualitative data were analysed using descriptive statistics and thematic analysis, respectively. Findings were integrated using a conceptual framework that examined the complementarity of HTA and procurement processes relevant to an MOU.ResultsThirteen surveys were completed (response rate was 13 percent). Eleven interviews (five Ireland, two Canada, three UK, one New Zealand) were conducted between August and November, 2017. No formalised collaboration between independent national HTA and procurement bodies was identified. However in New Zealand, HTA and procurement are an integrated function of the Pharmaceutical Management Agency (PHARMAC). In other jurisdictions, successful ad hoc collaborations occurred where there was a clear need expressed by Procurement for additional evidence required for decision-making, and where HTA personnel tailored their research approaches accordingly. Key themes to successful collaboration were relationships, communication, clear roles, rigorous research and ‘system support’. Good individual relationships and ready access/communication promoted successful outcomes. Successful outcomes included improved clinical practice, and major cost savings. Collaboration may be focussed on: innovative or established devices; specific types of HTA/research products; specific categories/specialties; or specific procurement departments.ConclusionsAll participants considered collaboration to be beneficial but requiring good relationships and ‘system support’. Furthermore, successful collaboration requires clarity regarding the purpose, parties involved, their roles, responsibilities, modes of communication, information to be shared, and the expected outcomes.
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Sharma, Abhinav, Neha J. Pagidipati, Robert M. Califf, Darren K. McGuire, Jennifer B. Green, Dave Demets, Jyothis Thomas George, et al. "Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus." Circulation 141, no. 10 (March 10, 2020): 843–62. http://dx.doi.org/10.1161/circulationaha.119.041022.
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Responding to concerns about the potential for increased risk of adverse cardiovascular outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were granted regulatory approval primarily from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on cardiovascular outcomes. The 2008 guidance aimed to ensure the cardiovascular safety of new glucose-lowering therapies to treat patients with type 2 diabetes mellitus. This resulted in a plethora of new cardiovascular outcome trials, most designed primarily as placebo-controlled noninferiority trials, but with many also powered for superiority. Several of these outcome trials demonstrated cardiovascular benefits of the newer agents, resulting in the first-ever cardiovascular protection indications for glucose-lowering therapies. Determining whether the guidance continues to have value in its current form is critically important as we move forward after the first decade of implementation. In February 2018, a think tank comprising representatives from academia, industry, and regulatory agencies convened to consider the guidance in light of the findings of the completed cardiovascular outcome trials. The group made several recommendations for future regulatory guidance and for cardiovascular outcome trials of glucose-lowering therapies. These recommendations include requiring only the 1.3 noninferiority margin for regulatory approval, conducting trials for longer durations, considering studying glucose-lowering therapies as first-line management of type 2 diabetes mellitus, considering heart failure or kidney outcomes within the primary outcome, considering head-to-head active comparator trials, increasing the diversity of patients enrolled, evaluating strategies to streamline registries and the study of unselected populations, and identifying ways to improve translation of trial results to general practice.
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Adler, N. E., J. Koschorreck, and B. Rechenberg. "Environmental impact assessment and control of pharmaceuticals: the role of environmental agencies." Water Science and Technology 57, no. 1 (January 1, 2008): 91–97. http://dx.doi.org/10.2166/wst.2008.816.
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In 2005, the new legislation for pharmaceuticals came into effect. Since then environmental risk assessments are required for all new marketing authorisation applications. The German Federal Environment Agency has been assessing the environmental impact of 136 veterinary and 134 human pharmaceuticals. The authorisation of pharmaceuticals has shown that the authorisation of some groups of substances have to be combined with risk mitigation measures. Environmental risks may also arise from those pharmaceuticals which were authorised before the environmental risk assessment was added to the requirements of authorisation. Four examples of “existing” pharmaceuticals, i.e. diclofenac, ethinyl estradiol, ivermectin, and florfenicol are highlighted in this article. Risk management options for veterinary and human pharmaceuticals are discussed.
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Styhre, Alexander, and Björn Remneland-Wikhamn. "The institutional work of life science innovation leadership: the case of a bio venture hub." Qualitative Research in Organizations and Management: An International Journal 11, no. 4 (November 14, 2016): 253–75. http://dx.doi.org/10.1108/qrom-10-2015-1331.
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Purpose Life science innovation is a complex domain of professional work including scientific know-how, regulatory expertise, and commercialization and marketing skills. While the investment in basic life science research has soared over the last decades, resulting in a substantial growth in scientific know-how, the life science industry (and most notably pharmaceutical companies) unfortunately reports a meagre innovative output. In order to counteract waning innovation productivity, new organizational initiatives seek to better bridge and bond existing life science resources. The purpose of this paper is to report a case study of bio venture hub initiative located in a major multinational pharmaceutical company. Design/methodology/approach Drawing on institutional work literature, an empirical study based on case study methodology demonstrates that new life science collaborations demand both external and internal institutional work to challenge conventional wisdom, making the legal protection of intellectual properties a key factor in the field and that in turn complicates much firm collaborations. Such institutional work questions existing practices and opens up new pathways in life science innovation work. Findings The bio hub initiative, which in considerable ways breaks with the traditional in-house and new drug development activities located in enclosed R&D departments and in collaboration with clinical research organizations, demands extensive institutional work and political savoir-faire to create legitimacy and operational stability. Not only are there practical, legal, and regulatory issues to handle, but the long-term legitimacy and financial stability of the bio hub initiative demands support from both internal and external significant actors and stakeholders. The external institutional work in turn demands a set of skills in the bio venture hub’s management team, including detailed scientific and regulatory expertise, communicative skills, and the charisma and story-telling capacities to convince and win over sceptics. The internal institutional work, in turn, demands an understanding of extant legal frameworks and fiscal policies, the ability to handle a series of practical and administrative routines (i.e. how to procure the chemicals used in the laboratory work or how to make substance libraries available), and to serve as a “match-maker” between the bio venture hub companies and the experts located at the hosting company. Originality/value The case study provides first-hand empirical data from an unique initiative in the pharmaceutical industry to create novel collaborative spaces where small-sized life science companies can take advantage of the mature firm’s expertise and stock of know-how, also benefitting the hosting company as new collaborations unfold and providing a detailed understanding of ongoing life science innovation projects. In this view, all agencies embedded in institutional field (i.e. what has been addressed as “institutional work” – the active work to create, maintain, or disrupt institutions) both to some extent destabilize existing practise and create new practices better aligned with new conditions and relations between relevant and mutually dependent organizations. The empirical study supports the need for incorporating the concept of agency in institutional theory and thus contributes to the literature on institutional work by showing how one of the industries, the pharmaceutical industry, being strongly fortified by intellectual property rights (i.e. a variety of patents), inhibiting the free sharing of scientific and regulatory know-how and expertise, is in fact now being in the process of rethinking the “closed-doors” tradition of the industry. That is, the institutional work conducted in the bio venture hub is indicative of new ideas entering Big Pharma.
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Malaca, Sara, Massimo Gottardi, Federica Pigliasco, Sebastiano Barco, Alessia Cafaro, Elisabetta Amadori, Antonella Riva, et al. "UHPLC-MS/MS Analysis of Cannabidiol and Its Metabolites in Serum of Patients with Resistant Epilepsy Treated with CBD Formulations." Pharmaceuticals 14, no. 7 (June 29, 2021): 630. http://dx.doi.org/10.3390/ph14070630.
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Cannabidiol (CBD) is a promising therapeutic agent with analgesic, myorelaxant, and anti-epileptic actions. Recently, a purified form of CBD (Epidiolex®) has been approved by the European Medicines Agency (EMA) for the treatment of two highly-refractory childhood-onset epilepsies (Dravet and Lennox-Gastaut syndrome). Given the interindividual response and the relationship between the dose administered and CBD blood levels, therapeutic drug monitoring (TDM) is a valuable support in the clinical management of patients. We herein report for the first time a newly developed and validated method using ultra-high-performance liquid chromatography coupled with tandem mass spectrometry (UHPLC–MS/MS) to evaluate CBD and its metabolites (i.e., cannabidiol-7-oic acid (7-COOH-CBD), 7-hydroxycannabidiol (7-OH-CBD), 6-α-hydroxycannabidiol (6-α–OH–CBD) and 6-β-hydroxycannabidiol (6-β–OH–CBD)) in serum samples. The method reached the sensitivity needed to detect minimal amounts of analytes under investigation with limits of quantification ranging from 0.5 to 20 ng/mL. The validation results indicated in this method were accurate (average inter/intra-day error, <15%), precise (inter/intra-day imprecision, <15%), and fast (8 min run time). The method resulted to be linear in the range of 1–10,000 ng/mL for CBD-COOH, 1–500 ng/mL for 7-OH-CBD and CBD and 1–25 ng/mL for 6-α–OH–CBD and 6-β–OH–CBD. Serum levels of CBD (88.20–396.31 and 13.19–170.63 ng/mL) as well as of 7-OH-CBD (27.11–313.63 and 14.01–77.52 ng/mL) and 7-COOH-CBD (380.32–10,112.23 and 300.57–2851.82 ng/mL) were significantly higher (p < 0.05) in patients treated with GW pharma CBD compared to those of patients treated with galenic preparations. 6-α–OH–CBD and 6-β–OH–CBD were detected in the first group and were undetectable in the second group. 7-COOH-CBD was confirmed as the most abundant metabolite in serum (5–10 fold higher than CBD) followed by 7-OH-CBD. A significant correlation (p < 0.05) between the dose administrated and a higher bioavailability was confirmed in patients treated with a GW pharma CBD preparation.
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Boche, Bekele, Tidenek Mulugeta, and Tadesse Gudeta. "Assessment of Inventory Management Practices at the Ethiopian Pharmaceuticals Supply Agency, Addis Ababa, Ethiopia." Integrated Pharmacy Research and Practice Volume 9 (October 2020): 175–83. http://dx.doi.org/10.2147/iprp.s269421.
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Wong, Carlos, Olivia Wu, and Bernard Cheung. "OP30 Health Technology Assessment And The Decision-Making Process Of New Drug Listing In Hong Kong." International Journal of Technology Assessment in Health Care 33, S1 (2017): 14. http://dx.doi.org/10.1017/s0266462317001295.
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INTRODUCTION:In Hong Kong, the Drug Advisory Committee (DAC) has had the role of evaluating and advising new drugs to be included in the listing of the Hospital Authority Drug Formulary since July 2005. The drug review process was subject to challenge due to a lack of transparency to members of the public and documentation of the scientific basis for decision making. The purpose of this review was to describe the process, evaluation criteria and possible outcomes of decision making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to Health Technology Assessment (HTA) policies in overseas countries.METHODS:Details of the decision-making processes including new drug listing submissions, the DAC meeting, procedures before and after the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly available information related to new drug decision making processes for four HTA agencies (National Institute for Health and Clinical Excellence (NICE), Scottish Medicines Consortium (SMC), Australian Pharmaceutical Benefits Advisory Committee (PBAC), and Canadian Agency for Drugs and Technologies in Health (CADTH)) were reviewed and retrieved from official documents on their public domains.RESULTS:The DAC is in charge of the systematical and critical appraisal of new drugs for listing on the formulary, reviewing submitted applications, and making decisions of drug listing based on scientific evidence in which safety, efficacy and cost-effectiveness are primary considerations. When compared to other HTA agencies, transparency of decision-making processes of the DAC, relevance of clinical and health economic evidence, and lack of health economic and methodological input to submissions were major challenges of the new drug listing policy in Hong Kong.CONCLUSIONS:Despite the challenges identifed, this review provided suggestions for establishing a more transparent, credible, evidence-based decision-making process for the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority in healthcare reform.
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Stepanova, Anastasia, and Anna Tereshchenko. "The Influence of Independent Directors, Insider Ownership and Scientific Connections on Risky R&D Investments: Evidence from Emerging Markets." Journal of Corporate Finance Research / Корпоративные Финансы | ISSN: 2073-0438 10, no. 3 (October 5, 2016): 5–23. http://dx.doi.org/10.17323/j.jcfr.2073-0438.10.3.2016.5-23.
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Anastasia N. Stepanova - National Research University The Higher School of Economics,
E-mail: anstepanova@hse.ru
Anna Alexandrovna Tereshchenko - National Research Institute "Higher School of Economics
R&D projects in the pharmaceutical industry are extremely risky and bring benefits in the long-run period. Self-interested managers try to avoid risk and underinvest in R&D. In this paper we study the effect of independent directors, insider ownership and scientific connections on R&D investments. Independent directors and insider ownership can mitigate the agency problem by additional monitoring and convergence of interests. Scientific collaboration promote technological development and increase R&D. The research reveals the difference of the effects in emerging and developed markets.In emerging markets theproportion of independent directors is positively connected with R&D investments. Such results can be explained by the fact that independent directors monitor risk-averse managers that underinvest in risky but perspective projects. Scientific connections significantly positively influence R&D investments. Empirical evidence also shows that companies with a higher proportion of independent directors have more collaborations with scientific institutions in emerging markets. Insider ownership also has no significant influence on R&D investments. Such a result can be explained by the fact that not all the insiders can influence the investment process. Moreover, beneficial owners can lack industry specific knowledge that allows them to monitor the process. In developed markets the situation is different. The proportion of independent directors is associated with lower R&D investment intensity. As R&D investments are extremely high in developed markets, we suppose that the overinvestment problem can exist. Thus, better corporate governance can decrease the investments closer to an optimal level. Scientific connections and insider ownership are not a significant factor. The research has wide policy implications. The results can be used by shareholders and government regulating institutions in creating optimal management structures.
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Gobachew, Asrat Mekonnen, Daniel Kitaw, Eshetie Berhan, and Hans-Dietrich Haasis. "ABC/XYZ Analysis for Kanban System Implementation in Pharmaceutical Supply Chain." International Journal of Information Systems and Supply Chain Management 14, no. 3 (July 2021): 63–78. http://dx.doi.org/10.4018/ijisscm.2021070104.
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The purpose of this study is to show how the implementation of the Kanban system based on ABC/XYZ analysis helps in improving the inventory management system in the supply chain where there is a lack of proper inventory management. Ethiopian pharmaceutical supply agency's distribution network is taken as a case to show the significance of the Kanban system. Monthly data for one year is collected and is accompanied by primary data obtained from direct observation and discussion with the company's management staff. ABC, XYZ, and ABC/XYZ matrix analyses were performed to determine items to be considered in Kanban implementation. By analysis, it is shown that the Kanban system can improve inventory-related costs by about 75%. While the Kanban system is rarely implemented in the pharmaceutical sector so far, it is understood in this study that it can bring improvements in the sector if properly implemented. Though it is shown by analyzing data on how the Kanban system can improve inventory-related costs, it is imperative to practically implement it for validation of its effectiveness.
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Gies, A. "Government view of endocrine disruption in wildlife." Pure and Applied Chemistry 75, no. 11-12 (January 1, 2003): 2563–74. http://dx.doi.org/10.1351/pac200375112563.
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Like hardly any other issue in ecotoxicology, endocrine disruption has given rise to public concern. Reproductive, behavioral, and immunological effects in wildlife were publicly not only understood as possible threats to wildlife populations, but also as early warning signals that human health could be at risk. Above all, the public has been concerned about negative outcomes in reproductive health, and effects like feminization in fish were regarded as evidence for the biological plausibility of the hypothesis that environmental levels of hormonally active chemicals are high enough to affect human reproductive health. Public concern has been mirrored by several parliamentary and governmental decisions emphasizing the need for extensive research and rapid measures to reduce the risk associated with endocrine-disrupting substances. Endocrine disruption in wildlife is clearly a priority issue. At least in densely populated areas like Europe, symptoms of endocrine disruption in wildlife cannot only be detected in areas with abnormally high levels of pollution, but have also occurred in main river systems, estuaries, and even in the open sea. Imposex in mollusks and feminization in fish that were clearly related to disturbances in the hormonal system of these organisms by exogenous substances have been used as markers in monitoring programs. Though symptoms of endocrine disruption can be clearly identified, it is much more difficult to link these outcomes to causative chemicals or mixtures of substances. Natural and pharmaceutical hormones, phytoestrogens, pesticides, and industrial chemicals may all play a role to a different degree depending on the site under study. This means that several different risk-reduction strategies have to be applied, including bans of substances, use restrictions, and installation and optimization of sewage treatment works embedded in a strategy for the overall reduction of chemical input into the environment. It should be noted that, in addition to national and international regulatory actions taken by state authorities, a considerable reduction of the environmental input could be achieved in several countries by voluntary actions taken by industry. Regulatory bodies are still facing major problems in the field of risk assessment and risk reduction. Association between effects and causative agents or mixtures are in many cases weak. Important tools for risk assessment such as dose-response relationships or the existence of thresholds are not yet agreed on. These uncertainties are the reason that many national governments and the European Commission have identified precaution as the main element in chemicals policy for the management of endocrine disruptors. This paper is based on documents of the German Federal Environmental Agency, but solely represents the view of the author from a regulatory perspective and emphasizes the wildlife aspects of endocrine disruption.