To see the other types of publications on this topic, follow the link: Pharmaceutical marketing. eng.
Journal articles on the topic 'Pharmaceutical marketing. eng'
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 50 journal articles for your research on the topic 'Pharmaceutical marketing. eng.'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.
1
Smolynets, I. B., B. V. Gutyj, І. І. Khariv, O. Y. Petryshak, and R. I. Lytvyn. "PHARMACEUTICAL MARKETING: OBJECTIVES AND TYPES." Scientific Messenger of LNU of Veterinary Medicine and Biotechnologies 18, no. 2 (August 5, 2016): 151–54. http://dx.doi.org/10.15421/nvlvet6929.
Full textAbstract:
Pharmaceutical marketing objectives and types depending on demand state are overviewed in this article. Pharmaceutical enterprise has always a certain idea of the desired level of market demand. In practice demand is not always in accordance with level that has been predicted. One can strictly outline eight situations that characterise the state of demand. Every such situation is in accordance with certain marketing managerial task and its types. Conversional marketing is related tomedicines’ negative demand and medical services availability, e.g. such kind of situation, when they cannot find their own buyer at substantial part of potential market. Stimulating marketing is related to demand absence, e.g. state, when potential market does not reveal (or almost does not reveal) interest towards concrete proposal. Marketing that develops is related to medicines demand, that is at the stage of formation (hidden demand). Potential (hidden) demand occurs when certain consumers part need real problem solving, that cannot remain satisfied with the medicines and medical services that are available at the market. Remarketing is related to medicines or medical services decreasing demand situation for a particular period of time, as a result of moral degradation, not consideration sale stimulation tools, advertising updates, and competition factors. Sync marketing (irregular marketing) is related to uneven demand, its fluctuation: seasonality (medicines against a cold,stomach–intestinal diseases and etc.); daily (pharmacies are more often attended during the weekdays, less – at the weekend); hourly (pharmacies are most often attended in a period of time from eight to eleven in the morning and from five to seven in the evening accordingly to research data). Supportive marketing is related to satisfied demand availability. Demarketing is related to surplus of demand, so medicines demand is higher than its supply (producing opportunities). Counteractive marketingis related to irrational (non rational) demand, with harmfulness in terms of health, consumer and society welfare. Market research provisions medicines demand study and projection, price analysis and rivals medicines, market capacity determination and enterprise’s share on it. Such kind of analysis assists to estimate market opportunities and determine attractive marketing activity direction, where enterprise can acquire competitive advantages
2
Mohammadzadeh, Mehdi, Nima Bakhtiari, Reza Safarey, and Tayebeh Ghari. "Pharmaceutical industry in export marketing: a closer look at competitiveness." International Journal of Pharmaceutical and Healthcare Marketing 13, no. 3 (September 2, 2019): 331–45. http://dx.doi.org/10.1108/ijphm-02-2018-0011.
Full textAbstract:
Purpose Competition is tremendously increasing in all business areas, among which the pharmaceutical sector is one of the most profitable fields. Accordingly, an important research effort is to examine whether competitiveness in pharmaceutical markets follows the same rules. The purpose of this paper is to evaluate competitive strategies in this industry and present a proper framework. Design/methodology/approach To this end, a conceptual model of competitive strategies including cost leadership, quality and differentiation was designed based on previously proposed models in the literature. More precisely, the framework was established with the consideration of the pharmaceutical’s specific requirements. For testing the practicality the model, a questionnaire was designed and 80 generic pharmaceutical companies in Iran were selected as the statistical sample and effects of each strategy on export performance was evaluated. The questionnaires were distributed to senior managers and filled through in-person interviews. The collected data were analyzed using binomial, partial least square, confirmatory factor analysis and Friedman tests. Findings Among the strategies under investigation, cost leadership strategy had the strongest effects, while quality ranked second. The proposed framework can also be used for the evaluation of pharmaceutical companies’ export readiness. The results demonstrated that export readiness of the pharmaceutical companies was not desirable. Originality/value The ideas in this paper, which have untold value for pharmaceutical industries, are unique to competitive strategies in export marketing.
3
Chhabra, Gurpreet Kaur. "Factors Influencing the Prescription Behaviour of Doctors-An Insight for the Pharmaceutical CRM Strategy Formulation." IRA-International Journal of Management & Social Sciences (ISSN 2455-2267) 15, no. 4 (August 27, 2019): 131. http://dx.doi.org/10.21013/jmss.v15.n4.p6.
Full textAbstract:
<p>Marketing has always been a major thrust area for the Pharmaceutical industry. Pharma firms usually bear a huge expenditure on marketing, especially sales efforts. Marketing in the Pharmaceutical industry is mainly done through personal selling techniques of promotion through MRs.Marketing of pharmaceutical products to doctors takes place through relationship marketing. Company representatives called medical reps meet the doctors in their specific geographic territory and promote their products to them. The doctors, in turn, prescribe the products to the patients who buy them from the chemist shop. Factors influencing doctor’s prescription behaviour can be classified into three categories: Socio-cultural factors, Personal-Psychological factors, Pharma Marketing factors. Now a day’s companies give a major thrust to the CRM aspect of their marketing strategies. Customer relationship management (CRM) is the strategic process of shaping the interaction between a company and its customers with the goal of maximizing current and lifetime value of customers for the company as well as maximizing, satisfaction for customers.CRM helps Pharma companies to generate revenue from shelf life by reaching more new prescribers (doctors) and patients (end customer) thereby keeping them loyal by increasing their well- being.</p>
4
Jablonski, Tomasz. "End of the Transitional Period for Traditional Herbal Medicinal Products Coming Soon." European Journal of Risk Regulation 1, no. 2 (June 2010): 156–59. http://dx.doi.org/10.1017/s1867299x0000026x.
Full textAbstract:
This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.
5
Sah, Sunita, and Adriane Fugh-Berman. "Physicians under the Influence: Social Psychology and Industry Marketing Strategies." Journal of Law, Medicine & Ethics 41, no. 3 (2013): 665–72. http://dx.doi.org/10.1111/jlme.12076.
Full textAbstract:
It is easier to resist at the beginning than at the end.– Leonardo da VinciPhysicians often believe that a conscious commitment to ethical behavior and professionalism will protect them from industry influence. Despite increasing concern over the extent of physician-industry relationships, physicians usually fail to recognize the nature and impact of subconscious and unintentional biases on therapeutic decision-making. Pharmaceutical and medical device companies, however, routinely demonstrate their knowledge of social psychology processes on behavior and apply these principles to their marketing. To illustrate how pharmaceutical marketing strategies use psychological techniques to promote targeted therapies, we draw on the relevant social psychology literature on conflicts of interest and on the six principles of influence articulated by the eminent social psychologist Robert Cialdini. Hospitals, professional organizations, medical educators, and other stakeholders must also draw on social psychology to respond effectively to commercial activities that compromise good medical practice.
6
Yousefi, Nazila, Gholamhossein Mehralian, Hamid Reza Rasekh, and Hossein Tayeba. "Pharmaceutical innovation and market share: evidence from a generic market." International Journal of Pharmaceutical and Healthcare Marketing 10, no. 4 (November 7, 2016): 376–89. http://dx.doi.org/10.1108/ijphm-06-2015-0028.
Full textAbstract:
Purpose Pharmaceutical market value in Iran exceeded to more than US$4bn in 2013, indicating annually over 20 per cent growth. In the past decades, Iranian pharmaceutical industry was supported by government policies, namely, generic substitution, import limitation and local production support; however, the local pharmaceutical manufacturer’s market share in value has been decreased gradually. This study aims to provide historical data on Iran pharmaceutical market to show the importance of new product development to attain greater market share and tries to motivate the pharmaceutical industry located in developing countries to develop more innovative medicines. Design/methodology/approach This is a descriptive cross-sectional study that investigates the Iranian pharmaceutical market by focusing on new products over a five-year period (2009-2014), and that was augmented by an expert panel to rank subjectively firms’ performance indicators to shed light on the importance of new product development to firms’ performance. Findings The expert panel results find out that new product development is one of the most important “result indicators” for Iranian pharmaceutical companies. Historically, in line with the experts’ opinion on the new product development, the Iranian pharmaceutical industry has shown its capability to develop new medicines by developing 3,095 new products (mostly new-to-firm) across about 100 firms. Despite this fact, the share of local manufacturers in new medicines’ market decreased from 52 per cent at the beginning of studied period to 24 per cent at the end, and the gap between the unit value of imported and domestically produced medicines has been significantly increased due to low-innovative medicines locally produced. Research limitations/implications This research was challenged with limitations such as lack of reliable published data on new medicines in the Iran pharmaceutical market. Practical implications This study highlights the fact that developing more innovative products in the generic pharmaceutical industry such as Iran can grant its market share. Originality/value This is an original study that shows the effect of innovative product development on market share through historical data.
7
Murzabaeva, Elvira, and Isabek Ismailov. "MARKETING ASSESSMENT OF DRUGS USED FOR TREATMENT OF ACID-RELATED DISEASES IN BISHKEK." Avicenna Bulletin 22, no. 1 (March 1, 2020): 67–73. http://dx.doi.org/10.25005/2074-0581-2020-22-1-67-73.
Full textAbstract:
Objective: Marketing assessment of anti-ulcer medicines in pharmacies in Bishkek. Methods: The study was used by data from the Department of Medicines and Medical Technology at the Ministry of Health of the Kyrgyz Republic on the registration of pharmaceutical products in the KR – State Registry of Medicines and Medical Products of 2019, as well as price sheets and invoices of wholesale pharmaceutical companies and retail pharmacies in Bishkek. Results: Depending on the value of the turnover rate (TR), the drugs were divided into three groups: drugs with slow TR (0.5 < К < 1.0); drugs with constant TR (0.26 < К < 0.49); drugs with high TR (0 < К < 0.25). According to the results of studies, proton pump inhibitors and colloidal bismuth-based drugs are high-end drugs of TR. Conclusions: We have determined that the pharmaceutical market in Bishkek demonstrates incomplete saturation of anti-ulcer drugs from the total number of registered medicines. At the same time, the largest part of the range are drugs from the group of proton pump inhibitors. Keywords: Anti-ulcer drugs, proton pump inhibitors, marketing assessment, turnover rate.
8
Abideen, Ahmed Zainul, and Fazeeda Binti Mohamad. "Supply chain lead time reduction in a pharmaceutical production warehouse – a case study." International Journal of Pharmaceutical and Healthcare Marketing 14, no. 1 (December 9, 2019): 61–88. http://dx.doi.org/10.1108/ijphm-02-2019-0005.
Full textAbstract:
Purpose The purpose of this study is to apply value stream mapping (VSM) in Malaysian pharmaceutical production warehouse. A current and future state value stream map from the raw material receiving end to the production unit was developed to find out waste and unwanted lead time. It was very much essential to cut down the supply chain lead time at the initial phase as the raw material unloading, sorting, temporary storage and dispatch to production were seen contributing to a huge lead time build-up. Design/methodology/approach The study was initiated with the selection of a product family, construction of the current state map, identification of various wastes and the development of future state map. Findings The expected outcomes of the study include the quantification of wastes, improvement in value-added percentage and lead time reduction. Research limitations/implications The study was carried out in a single pharmaceutical company. The results of the study are deployable and can be functional in similar production organizations. Contrary to common VSMs that capture core production processes, this study provides strong insights that shall help design lean supply chains, especially in the pharmaceutical domain. This paper has also addressed the viability of the lean in the pharmaceutical warehouse and the reduction in lead time to improve demand forecasting, marketing and sales. Practical implications The results of this study have indicated that a significant reduction in pharmaceutical warehouse supply chain lead time is possible as a result of the implementation of VSM from the supply chain’s perspective. Social implications The insights from this study help in understanding the pharmaceutical supply chain risks and their outcomes. Originality/value The paper reports a real-time study conducted in a warehouse of a pharmaceutical organization. Hence, the contributions are original.
9
Wang, Qing. "R&D/Marketing Interface in a Firm's Capability-Building Process: Evidence from Pharmaceutical Firms." International Journal of Innovation Management 01, no. 01 (March 1997): 23–52. http://dx.doi.org/10.1142/s1363919697000036.
Full textAbstract:
A considerable number of studies have been assembled over the last decade on the management of the R&D/marketing interface in product innovation. Most of these studies focus on the R&D/marketing interface as a self-contained unit of analysis, offering little explanation of the interface's contribution to a firm's competence building in ways essential to innovation success. This paper is based upon research that demonstrates that the importance of the R&D/marketing interface lies in its dynamic capability in influencing the direction of product development projects towards enhancing existing, or building new, competencies. The case study results show that the shared tasks performed by R&D and marketing departments are concentrated in three areas, i.e. corporate conceptual development (CCD), product conceptual development (PCD) and project implementation (Ip). The results reveal that the performance of the cross-functional team in general, and the R&D/marketing interface in particular, during a project's implementation, is heavily dependent on earlier activities in the areas of CCD and PCD. The former usually involves a sustained period of company-wide strategic preparation, which may or may not be directly targetted at a specific project, whilst the latter refers to previous co-operative experience at the project level. The evidence shows that, even when top management attempts to build an instant platform (e.g. by means of heavyweight project management), in the absence of such earlier activities, the effectiveness of this kind of platform has been far from satisfactory, thus pinpointing the vital importance of learning-before-doing in the innovation process.
10
Suraj Kushe Shekhar, Tony P Jose, and Rehin K R. "Consumer buying behavior and attitude towards pharmaceuticals." International Journal of Research in Pharmaceutical Sciences 10, no. 4 (November 2, 2019): 3392–97. http://dx.doi.org/10.26452/ijrps.v10i4.1649.
Full textAbstract:
Pharmaceutical industry is a fastest growing industry in India. It is valued at above US 40 billion dollars. India exports large amount of drugs to difference parts of the world. Nowadays people are conscious of what they buy. Even if doctors prescribe a medicine, consumers resort to internet to get more information on the medicine before they consume it. Consumers have different perceptions on various kinds of drugs. Understanding the consumer attitude towards drugs will help the marketers to formulate marketing strategies better. The present study examines as to what the consumers look out when they reach to purchase a drug from the pharmacy. This paper scrutinizes and gives insights on consumer behavior and their attitudes towards buying different types of pharmaceuticals (like over-the counter drugs, herbals, ayurvedic, analgesics etc). The paper highlights the importance of factors like price, trust and brand in making importance purchase decisions. Further it was also observed that most of the people prefer buying over-the-counter drugs, which might end up being misused by the consumers. However, it was also found that consumers try to be well-aware of the medicine before buying or consuming it. Along with it, price sensitivity is something which majorly dominates the buying behavior of the consumers.
11
Simonet, Daniel. "Evaluation of downstream integration in the US pharmaceutical industry." International Journal of Pharmaceutical and Healthcare Marketing 1, no. 2 (July 3, 2007): 143–58. http://dx.doi.org/10.1108/17506120710762997.
Full textAbstract:
PurposeThis paper aims to review the vertical or quasi‐vertical integration that characterized the pharmaceutical industry in the mid‐1990s. The acquisitions and vertical partnerships that linked pharmacy benefits managers and drug manufacturers modified the structure of the market at that time. What were the motivations of those agreements? Did they induce any distortion on competition in the drug market? And why did they fail to achieve their desired strategic advantages?Design/methodology/approachThe paper uses established theoretical perspectives, such as the resource‐based view and the theory of contestable markets, as the basis for a descriptive analysis, documenting strategic decisions of vertical integration using supporting literature in marketing and strategy.FindingsVertical integration did not obtain the intended results (e.g. acquisition of competitive advantages). This perspective provides a framework to examine vertical integration strategies, applicable to other industries.Originality/valueThe paper reviews the objectives of vertical integration strategies of US drug firms in the 1990s and their hidden agendas.
12
Parmata, Uma Maheswari Devi, and Surya Prakash Chetla. "Effect of service quality on doctor’s satisfaction and prescribing behavior in pharmaceutical supply chain – a study with reference to a major Indian pharmaceutical company." International Journal of Pharmaceutical and Healthcare Marketing 15, no. 2 (April 7, 2021): 173–211. http://dx.doi.org/10.1108/ijphm-04-2018-0024.
Full textAbstract:
Purpose The purpose of this paper is to develop a scale for the measurement of service quality at the manufacturer–doctor interface of the pharmaceutical supply chain and to study the impact of service quality on doctor’s satisfaction and doctor’s prescribing behavior. Doctors from two major states of South India were selected for the study. A doctor perceived service quality scale with three dimensions having eight items was developed through confirmatory factor analysis (CFA) in the pharmaceutical context. Structural equation modeling (SEM) technique was used to show the relationship between service quality, satisfaction and prescribing behavior. The critical factors of service quality were identified, and a model was developed showing the relationship between service quality, doctor’s satisfaction and doctor’s prescribing behavior which has not been explored in any research. This model will be helpful in further development of new concepts and for analyzing the reasons for the failure of doctors in providing quality service. Design/methodology/approach A total of 200 doctors from three major cities of South India were selected. A doctor perceived service quality scale with three dimensions having eight items was developed through CFA using Parasuraman Service quality scale (Parasuraman, 1985, 1986, 1988) as the basis in the pharmaceutical context after focus group discussions with company experts, retailers, doctors and academicians. SEM technique was used to examine the impact of service quality on doctor’s satisfaction and prescribing behavior. Findings There is no universal set of dimensions and items that determine service quality in manufacturing industries, especially at the manufacturer–doctor interface of the pharmaceutical supply chain though service quality plays a very important role in affecting the performance of manufacturing industries. The critical factors affecting the quality of service for a pharmaceutical company at the manufacturer–doctor interface of the supply chain were identified, and its impact on doctor’s satisfaction and their prescribing behavior were studied. Research limitations/implications This research contributes to the development of service quality scale for measuring service quality in pharmaceutical manufacturing company, especially with reference to manufacturer–doctor interface of the supply chain which was not thoroughly explored earlier. A model was developed showing the positive relationship between service quality and doctor’s satisfaction and doctor’s prescribing behavior in pharmaceutical supply chain which is a new concept not proved experimentally. Practical implications The study is very useful for the pharmaceutical manufacturing companies to identify the service quality factors affecting doctor’s satisfaction and their prescribing behavior thereby leading to development of new measures for improving the performance of the pharmaceutical supply chain. This study can lead to identification of problems involved in pharmaceutical supply chain and also leads to generation of new ideas and development of new concepts for influencing doctor’s satisfaction and doctor’s prescribing behavior which in turn can help in providing better health. Social implications This study actually has a direct impact on the society. If factors affecting doctor’s satisfaction and prescribing behavior are identified automatically, the end consumer, i.e. patient, can be satisfied in a better way, and better medical care can be provided. If doctor’s problems are identified, then better solutions can be provided to patients; this in turn has a lot of positive impact on the pharmaceutical company and society in general. Originality/value This research will act as a base for generating ideas relating to how quality service provided by a company will have an impact on doctor’s satisfaction and his prescribing behavior in pharmaceutical supply chain .To the best of the authors’ knowledge, this study is the first of its kind of the conceptual aspects of service quality, satisfaction and loyalty explained in terms of pharmaceutical supply chain as service quality, doctor’s satisfaction and doctor’s prescribing behavior and proved experimentally.
13
Ledford, Christy J. W. "Content Analysis of Internet Marketing Strategies: How Pharmaceutical Companies Communicate about Contraceptives with Consumers Online." Social Marketing Quarterly 15, no. 1_suppl (March 2009): 55–71. http://dx.doi.org/10.1080/15245000903038308.
Full textAbstract:
As the Internet has grown as a powerful source for consumer health information seekers, it has also become a commercial tool for marketing health products and services. Along with direct-to-consumer television and print advertising, websites present consumers with prescription drug options outside the context of the clinic. While consumers who encounter health product commercials in television and print are likely to recognize their promotional nature, when they seek health information on the Internet, the distinctions between marketing and health education may be blurred. Recognizing women as a primary target of this marketing, the social amplification of risk framework and elaboration likelihood model guided a content analysis of ten promotional contraceptive websites, sponsored by pharmaceutical companies. Overall, the websites promoted physiological advantages other than the effectiveness of the contraceptive itself, convenience, and the drugs' relative lower risk as compared to other forms of contraception. Websites presented risk information in text smaller than the majority of text and at the end of the webpage, requiring the user to scroll down to view the information. The websites also presented content and design strategies that social marketers can employ in the design of public health websites, such as the expert and peer sources presented, ethnic diversity of women depicted, and the plain language, nonbranded website addresses used.
14
Phua, K. L., and F. I. Achike. "Vioxx and other pharmaceutical product withdrawals: ethical issues in ensuring the integrity of drug and medical device research, development and commercialization." Clinical Ethics 2, no. 3 (September 1, 2007): 155–62. http://dx.doi.org/10.1258/147775007781870029.
Full textAbstract:
The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of products by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems.
15
Antonova, Irina, Anna Vesnina, and Vladislav Shadrin. "Dietary Supplements Market Research." Food Processing: Techniques and Technology 50, no. 3 (October 12, 2020): 503–14. http://dx.doi.org/10.21603/2074-9414-2020-3-503-514.
Full textAbstract:
Introduction. The market of dietary supplements is actively developing due to the general deterioration of public health and the fact degenerative diseases affect younger population. Functional foods and biologically active additives can prevent and treat various pathological processes. Unlike pharmaceuticals, they provoke neither addiction nor allergic reactions and do not accumulate in the human body. Therefore, consumer interest in dietary supplements is a relevant research issue. The research objective was to conduct marketing research in order to study the current state of the market of dietary supplements.
Study objects and methods. This research was based on a systematic approach and abstract-logical, statistical-economic, and graphical methods.
Results and discussion. The marketing research made it possible to classify biologically active additives on the pharmaceutical market of Kemerovo (Russia). The market included 45 organizations and 15 brands. A sociological survey of 100 respondents revealed that the younger participants were familiar with the concept of dietary supplements. All respondents monitored the state of their health; however, their attitude to functional food additives was quite neutral. They used supplements for general health promotion and to solve particular problems, e.g. acne. On average, they took one course of administration per year based on medical prescriptions and recommendations of close relatives. The survey identified the most popular brands and producers of dietary supplements in Kemerovo. Most supplements were purchased in pharmacies and specialized stores. Packaging appeared to be the least important factor that affected the consumer behavior. The paper introduces some recommendations on attractive packaging.
Conclusion. Biologically active additives replenish the necessary amount of nutrients to maintain health, which makes them a popular product on Kemerovo market. Further study is required, despite the obvious benefits of functional additives.
16
Malikova, Marina A. "Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance." Therapeutic Advances in Drug Safety 11 (January 2020): 204209862090961. http://dx.doi.org/10.1177/2042098620909614.
Full textAbstract:
Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, etc.).
17
Bleidt, Barry. "Marketing Activities: The Keystone of Capitalism — Increasing the Availability of Prescription Drugs through Pharmaceutical Promotion." Journal of Drug Issues 22, no. 2 (April 1992): 277–93. http://dx.doi.org/10.1177/002204269202200208.
Full textAbstract:
This article extolls the advantages of promotional efforts by the pharmaceutical industry, especially in providing information on technological advances, recently approved indications and new products. However, one aspect of marketing, price, is creating quite a controversy, especially since manufacturers are raising prices at rates several times that for general consumer goods. Additionally, the complex, multi-tier distribution network is causing problems by leaving some practitioners feeling that they are being unfairly disadvantaged in the marketplace, thereby, creating significant ill will. In order for the industry to elicit pharmacy's help in future promotional activities, especially those aimed at the general public (such as wellness campaigns), it is going to have to get more pharmacists involved in the planning and implementation of such projects and pay more attention to how industry policies and actions impact on the profession (e.g., multi-tier pricing).
18
Caetano, Rosângela, Marilena Cordeiro Dias Villela Correa, Pedro Villardi, Paulo Henrique Almeida Rodrigues, and Claudia Garcia Serpa Osorio-de-Castro. "Dynamics of patents, orphan drug designation, licensing, and revenues from drugs for rare diseases: The market expansion of eculizumab." PLOS ONE 16, no. 3 (March 5, 2021): e0247853. http://dx.doi.org/10.1371/journal.pone.0247853.
Full textAbstract:
Background This study examines the dynamics of the eculizumab patenting, orphan designation, and marketing authorization process in different countries and regulatory systems and analyzes drug revenues since its first marketing authorization. Methods A retrospective case study was conducted. Multiple information sources were used to: determine the status of eculizumab patents; examine the designation of orphan drug status by US, European, Japanese, and Brazilian regulatory authorities to determine registration status and approved clinical indications; estimate the prevalence of associated clinical conditions; investigate the history of the drug manufacturer, Alexion Pharmaceuticals, Inc., and its financialized business model; and examine global eculizumab sales revenues since its first marketing authorization. Results Our search yielded 32 patent families divided into 98 applications. The first patent granted was filed in 1995 by Alexion Pharmaceuticals, Inc. in the US. Eculizumab has always been as an orphan drug, except in the Brazilian regulatory agency. All clinical indications approved thus far refer to rare diseases (e.g., paroxysmal nocturnal hemoglobinuria syndrome, atypical hemolytic-uremic syndrome, refractory and generalized myasthenia gravis, and neuromyelitis optica spectrum disorder). Alexion’s revenues amounted to more than US$25 billion between 2007 and 2019, showing a growing trend. Eculizumab led sales from the beginning, being the only product in the company’s portfolio until 2015. In 2019, the drug accounted for 79.1% of all revenues. Discussion Our findings show that a strategy focused on obtaining orphan drug designation, expanding therapeutic indications and the geographic range of marketing approvals, extending monopoly periods, and prioritizing public procurement niches has enhanced revenues and helped the company achieve leadership in a highly specific and profitable market.
19
Haughton, Dominique, Guangying Hua, Danny Jin, John Lin, Qizhi Wei, and Changan Zhang. "Optimization of the promotion mix in the healthcare industry." International Journal of Pharmaceutical and Healthcare Marketing 9, no. 4 (November 2, 2015): 289–305. http://dx.doi.org/10.1108/ijphm-03-2013-0008.
Full textAbstract:
Purpose – The purpose of this paper is to propose data mining techniques to model the return on investment from various types of promotional spending to market a drug and then use the model to draw conclusions on how the pharmaceutical industry might go about allocating promotion expenditures in a more efficient manner, potentially reducing costs to the consumer. The main contributions of the paper are two-fold. First, it demonstrates how to undertake a promotion mix optimization process in the pharmaceutical context and carry it through from the beginning to the end. Second, the paper proposes using directed acyclic graphs (DAGs) to help unravel the direct and indirect effects of various promotional media on sales volume. Design/methodology/approach – A synthetic data set was constructed to prototype proposed data mining techniques and two analyses approaches were investigated. Findings – The two methods were found to yield insights into the problem of the promotion mix in the context of the healthcare industry. First, a factor analysis followed by a regression analysis and an optimization algorithm applied to the resulting equation were used. Second, DAG was used to unravel direct and indirect effects of promotional expenditures on new prescriptions. Research limitations/implications – The data are synthetic and do not incorporate any time autocorrelations. Practical implications – The promotion mix optimization process is demonstrated from the beginning to the end, and the issue of negative coefficient in promotion mix models are addressed. In addition, a method is proposed to identify direct and indirect effects on new prescriptions. Social implications – A better allocation of promotional expenditures has the potential for reducing the cost of healthcare to consumers. Originality/value – The contributions of the paper are two-fold: for the first time in the literature (to the best of the authors’ knowledge), the authors have undertaken a promotion mix optimization process and have carried it through from the beginning to the end Second, the authors propose the use of DAGs to help unravel the effects of various promotion media on sales volume, notably direct and indirect effects.
20
Foteeva, A. V., O. S. Barshadskaya, and N. B. Rostova. "Description of the System of State Registration of Medicines in the Republic of Georgia as a Development Potential of Domestic Manufacturers." Drug development & registration 10, no. 2 (May 29, 2021): 155–61. http://dx.doi.org/10.33380/2305-2066-2021-10-2-155-161.
Full textAbstract:
Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs registration procedure.Aim. The purpose of this study is to overview general aspects of registration procedure for generic drugs in Georgia for potential launching on pharmaceutical market.Materials and methods. For research purposes we have utilized data obtained from research articles, official websites, regulatory documents for drug registration procedure in both Russian Federation and Republic of Georgia, and documents of registration dossier. Also for this research we have applied benchmarking study, generalized and classified obtained information.Results and discussion. The similarities and differences of drug registration procedure have been determined, e.g. timelines, dossier format, and legal frameworks in both Russian Federation and Republic of Georgia. Also we have emphasized a list of features that could be benefiting for drug registration in Georgia.Conclusion. A review of the state regulation procedure in the field of drug circulation in the Republic of Georgia allows us to conclude that there are favorable conditions for state registration of drugs from a Russian manufacturer.
21
Kleijnen, Sarah, Iris Pasternack, Marc Van de Casteele, Bernardette Rossi, Agnese Cangini, Rossella Di Bidino, Marjetka Jelenc, et al. "STANDARDIZED REPORTING FOR RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS." International Journal of Technology Assessment in Health Care 30, no. 5 (November 2014): 488–96. http://dx.doi.org/10.1017/s0266462314000609.
Full textAbstract:
Objectives:Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals.Methods:Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model.Results:The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report.Conclusions:The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.
22
Hellander, Ida. "A Review of Data on the Health Sector of the United States January 2002." International Journal of Health Services 32, no. 3 (July 2002): 579–99. http://dx.doi.org/10.2190/64hr-u27h-c3tq-0jxl.
Full textAbstract:
This report presents data on the state of U.S. health care at the end of 2001. It provides information on access to health care, inequalities in incomes and medical care, the increasing costs of health care and health insurance, and the role of corporate money in the provision of health care and the development, marketing, and patenting of pharmaceuticals. The author also looks at the state of health maintenance organizations, the results of some recent surveys on physicians' and public opinion on managed care, and news about the nursing professions. Also provided is an update on Congressional activity on health care legislation, the role of health care industry money in politics, and some developments in health care systems elsewhere in the world.
23
Kleijnen, Sarah, Iris Pasternack, Piia Rannanheimo, Jenni M. Vuola, Marc Van de Casteele, Anna Bucsics, Isabelle Zahra Pulis, et al. "PILOTING INTERNATIONAL PRODUCTION OF RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS." International Journal of Technology Assessment in Health Care 30, no. 5 (November 2014): 521–29. http://dx.doi.org/10.1017/s0266462314000622.
Full textAbstract:
Background: This article describes the lessons learned from an international pilot assessment using the first version of the HTA Core Model® and Guidelines for rapid Relative Effectiveness Assessment (REA) of pharmaceuticals based on input from three different perspectives: the assessors, the users (health technology assessment organisations) and the marketing authorisation holder.Methods: A pilot assessment was performed of pazopanib for the treatment of advanced or metastatic renal cell carcinoma for which 54 individuals from 22 EUnetHTA member organisations from 16 European countries gave their contribution. The work was divided in eight domain teams. Subsequently, results of these domain teams were synthesised in one pilot report. Feedback on the outcomes of the pilot was gathered throughout the project and through structured surveys.Results: The first version of the assessment was produced in six months and consisted of 55 question and answer pairs, 8 domain reports and a synthesis section that combined the results from the different domains. The organisation of the pilot required intense coordination. Main points of criticism on the assessment were the lengthiness of the document and overlap of information throughout the assessment.Conclusions: A reduction in the number of authoring organisations and individuals participating is necessary to avoid information overlap and increase efficiency in undertaking the assessment. Involving several organisations (e.g. five) in an in-depth review could still ensure the benefit of broad participation from various countries. The focus of a rapid REA should be on the first four domains of the Model.
24
Gralinski, Michael R. "The Dog's Role in the Preclinical Assessment of QT Interval Prolongation." Toxicologic Pathology 31, no. 1_suppl (January 2003): 11–16. http://dx.doi.org/10.1080/01926230390174887.
Full textAbstract:
During the development of a new therapeutic, few pharmacodyamic outcomes currently receive as much scrutiny as the effect of a potential medication on the electrocardiographic QT interval. The recent withdrawal from marketing of several drugs due to potential drug-related cardiac arrhythmias have greatly increased concern about drug-related changes on the QT interval. In order to reduce the incidence of these idiosyncratic episodes, regulatory agencies have suggested that sponsors use more rigorous methodology during the safety evaluation of new pharmaceuticals. Along with enhanced electrocardiographic assessments during clinical trials, advanced preclinical examinations of effect on QT interval and ventricular repolarization have become de rigueur. In this arena, the beagle dog is the preclinical species often associated with the most reliable predictivity for human safety assessment. To this end, canine models of cardiovascular safety assessment are discussed along with the relevance of these assays to human electrocardiography.
25
Ab Rashid, Norasekin, and Jamil Bojei. "The relationship between halal traceability system adoption and environmental factors on halal food supply chain integrity in Malaysia." Journal of Islamic Marketing 11, no. 1 (June 22, 2019): 117–42. http://dx.doi.org/10.1108/jima-01-2018-0016.
Full textAbstract:
Purpose Muslim consumers have been shocked with the news of cross-contamination issues in the Halal food that they consumed. These issues make them put more effort in ensuring the products that they purchased being monitored throughout the supply chain. In this case, food companies must be prepared to implement systematic traceability system to ensure the authenticity of Halal products and comprehend the importance of Halal industry environmental factors (HIEF) in enhancing integrity of Halal food supply chain and protect from any risk of cross-contaminations. This paper aims to clarify the relationship between the Halal traceability system adoption (HTSA) and HIEFs on Halal food supply chain integrity (HFSCIn). Design/methodology/approach The study opted quantitative research approach by using the self-administrated questionnaires. The questionnaires were distributed during Malaysia International Halal Showcase (MIHAS) 2014 and Halal Fiesta Malaysia (HALFEST) 2014. 127 Malaysian Halal food and beverages companies have been involved in the study. Most of the respondents are the general manager or owner of the company, Halal executives, quality assurance managers, operation managers and sales manager. Findings The study found that there is a significant relationship between HTSA and HIEF on HFSCIn. The study also found that the highest adoptions of Halal traceability system are among the producer and end user, while the highest contributions in influencing the HIEF are the economic and socio-cultural factors. Research limitations/implications This study only focused on Halal food industry particularly the food and beverages category. Thus, future study can explore further on every category in food industry such as raw materials and ingredients; poultry, meat and dairy; fast food and premises and make comparison between pharmaceutical, cosmetics and health care in Halal industry. In addition, the sample size (N = 127) can be considered small; therefore, it is recommended that in future the subject matter be explored with a much larger sample to allow generalization of the result. Originality/value This study provided, perhaps for the first time, an analysis of the relationship between traceability adoptions and HIEF on HFSCIn.
26
Rae, Ian D. "Vitamin A and Australian Fish Liver Oils." Historical Records of Australian Science 25, no. 1 (2014): 55. http://dx.doi.org/10.1071/hr14005.
Full textAbstract:
Research by an organic chemist at the University of Melbourne and support from Australia's Council for Scientific and Industrial Research provided the basis for a wartime industry when Australia was unable to maintain access to traditional supplies of cod liver oil from Britain and Norway in the 1940s. Two major pharmaceutical companies gathered oil from the livers of sharks in southern Australia that was rich in vitamin A, and so met domestic and military needs for this nutritional supplement. Other companies joined in and by the end of the war Australia had a flourishing industry that derived synergy from the marketing of shark flesh for human consumption. South Africa was a leader among countries that expanded fish-oil production in the late 1940s, as a result of which Australian producers suffered from import competition. A Tariff Board hearing found that the Australian industry was unable to meet local needs and so did not recommend increased tariffs. The industry struggled for years until the perceived nutritional benefits of other components of the fish oils helped to revive markets.
27
Kaneko, Reina, and Shunsuke Ono. "Exploratory analysis of comparative clinical trials used for marketing approval in patients with type 2 diabetes in Japan." SAGE Open Medicine 7 (January 2019): 205031211882340. http://dx.doi.org/10.1177/2050312118823407.
Full textAbstract:
Background/objectives: The results of phase 2 and 3 clinical trials, which justify decisions regarding marketing approval for new drugs, are used for comparison of drugs in the post-marketing phase. A number of meta-analyses of approved antidiabetics have been performed, but the heterogeneity of trials has not been fully examined. The aim of this study was to explore factors that may influence baseline HbA1c in trial samples and treatment outcomes (i.e. HbA1c reductions and effect sizes), with the goal of providing unbiased and fair retrospective comparisons between different antidiabetics. Method: We conducted three meta-regression analyses using 78 randomized or non-randomized comparative phase 2 or 3 trials of 24 approved antidiabetics in Japan, conducted from 1987 to 2012. Results: Baseline HbA1c of each arm was higher in phase 2 trials, trials with a greater number of subjects, trials with a lower proportion of male subjects, trials of combination therapy, or trials with longer subject disease duration. Entry criteria were different among drug classes and caused variations in baseline HbA1c. HbA1c reductions were larger in non-randomized trials, trials with a shorter treatment period, or trials with a lower proportion of male subjects. Effect sizes were larger in phase 2 trials, or trials of combination therapy. Larger effect sizes were observed in drugs with later market entry for alpha-glucosidase inhibitors and glinides. Conclusion: Baseline HbA1c, an important characteristic of subjects enrolled in trials of antidiabetics, differed significantly across trials. Differences in features of study subjects were caused by explicit stipulations in eligibility criteria of HbA1c and also by other conditions (e.g. trial design, regulatory guidance, treatment guideline) and/or interventions of investigators and pharmaceutical companies that were specific to drugs and trials. Healthcare professionals should carefully consider these heterogeneities in trials used for marketing approval review when making a retrospective comparison to select the best treatment option for patients.
28
Moon, Jihwan, and Steven M. Shugan. "Nonprofit Versus For-Profit Health Care Competition: How Service Mix Makes Nonprofit Hospitals More Profitable." Journal of Marketing Research 57, no. 2 (March 5, 2020): 193–210. http://dx.doi.org/10.1177/0022243719901169.
Full textAbstract:
This article studies the intersection between the largest U.S. industry—health care—and the $1 trillion nonprofit sector. Using analytical and empirical analyses, the authors reveal the marketing strategies helping private nonprofit hospitals achieve higher output, prices, and profits than for-profit hospitals. Nonprofit hospitals, focusing on both profits and output, obtain these outcomes by expanding their service mix with high-priced premium specialty medical services (PSMS), whereas for-profit hospitals can be more profitable with higher prices for basic services. Competition increases the differences between nonprofit and for-profit hospitals in PSMS breadth, output, and prices. Nonprofit hospitals lose their competitive advantage when competing with other nonprofits; that is, presence of a for-profit competitor broadens available nonprofit PSMS. With broader service mixes, nonprofits focus more on national advertising than for-profits because PSMS (e.g., pediatric trauma, neurosurgery, heart transplants, oncology) require larger geographic markets than local basic services (e.g., laboratory, diagnostics, nursing, pharmaceutics). Exogenous, heterogeneous state regulations restricting for-profit hospital entry help econometric identification (i.e., markets prohibiting for-profits act as controls). Service mix may be a key difference between nonprofit and for-profit hospitals.
29
Baraldi, Enrico, Francesco Ciabuschi, Ross Leach, Chantal M. Morel, and Alexandra Waluszewski. "Exploring the Obstacles to Implementing Economic Mechanisms to Stimulate Antibiotic Research and Development." American Journal of Law & Medicine 42, no. 2-3 (May 2016): 451–86. http://dx.doi.org/10.1177/0098858816658276.
Full textAbstract:
This Article examines the potential stakeholder-related obstacles hindering the implementation of mechanisms to re-ignite the development of novel antibiotics. Proposed economic models and incentives to drive such development include: Public Funding of Research and Development (“R&D”), Tax Incentives, Milestone Prizes, End Payments, Intellectual Property (“IP”) and Exclusivity Extensions, Pricing and Reimbursement Incentives, Product Development Partnerships (“PDPs”), and the Options Market for Antibiotics model. Drawing on personal experience and understanding of the antibiotic field, as well as stakeholder consultation and numerous expert meetings within the DRIVE-AB project and Uppsala Health Summit 2015, the Authors identify obstacles attributable to the following actors: Universities and Research Institutes, Small and Medium-sized Enterprises (“SMEs”), Large Pharmaceutical Companies, Marketing Approval Regulators, Payors, Healthcare Providers, National Healthcare Authorities, Patients, and Supranational Institutions.The analysis also proposes a characterization and ranking of the difficulty associated with implementing the reviewed mechanisms. Public Funding of R&D, Pricing and Reimbursement Incentives, and PDPs are mechanisms expected to meet highly systemic barriers (i.e., obstacles across the entire antibiotic value chain), imposing greater implementation challenges in that they require convincing and involving several motivationally diverse actors in order to have much effect.
30
Broich, Karl, and Hans-Karl Heim. "Selective COX-2 inhibitors and risk of thromboembolic events – regulatory aspects." Thrombosis and Haemostasis 96, no. 10 (2006): 423–32. http://dx.doi.org/10.1160/th06-08-0462.
Full textAbstract:
SummaryIn the 1990s, the pharmaceutical industry developed selective COX-2 inhibitors (coxibs) as alternatives to conventional nonsteroidal anti-inflammatory drugs (NSAIDs), with the expectation of similar analgetic and anti-inflammatory efficacy but a reduced risk of adverse gastrointestinal (GI) effects. Marketing authorisation (MA) was granted for rofecoxib and celecoxib as first representatives of this new pharmacological class at the end of the 1990s in the EU. In the following years MAs were granted for the ´second generation` coxibs etoricoxib, parecoxib/valdecoxib and lumiracoxib. However, data from large clinical ´outcome studies` as well as epidemiological data raised concerns about the cardiovascular (CV) safety of the coxibs. In consequence, two comprehensive review processes (referrals) were initiated by the European Medicines Agency (EMEA).As a result, in the EU the use of coxibs has been contraindicated in patients with established coronary heart disease, cerebrovascular disease and peripheral arterial disease and a number of warning statements concerning CV, GI and skin toxicity have been introduced in the coxib product informations. This article provides a description of the regulatory actions taken and discusses some specific aspects of the past and future regulatory assessment of coxibs.
31
Esteva Salà, Emili. "CONSIDERATIONS REGARDING INCREMENTAL DRUG INNOVATION." Anales de la Real Academia Nacional de Farmacia, no. 87(02) (2021): 185–94. http://dx.doi.org/10.53519/analesranf.2021.87.02.07.
Full textAbstract:
The concept of incremental innovation encompasses adaptations resulting from the analysis of the use of existing medicinal products, in order to incorporate a modification or propose a new use designed to benefit patients. It can be classified into 6 different categories, depending on the nature or objective of the innovation carried out. Incremental innovation can be very interesting for health professionals because these variations provide improvements in treatment, in the continuation of treatments, in the reduction of adverse effects or in adherence. Incremental innovation is also very well received from the patient’s perspective, since it facilitates treatment and in many cases opens up a therapeutic expectation for certain subgroups that did not exist before the medicinal product was marketed. It is also interesting for the National Health System, since certain patients treated with incremental innovations obtain better health results and require less frequent use of other health services. From an economic perspective, many pharmaceutical companies established in our country and relevant from a strategic point of view, could also improve the therapeutic arsenal with this type of innovations by providing products of therapeutic interest that, unfortunately, do not currently have the ideal conditions for viability. For all these reasons, the promulgation of a Spanish regulation that protects and provides legal certainty to the marketing authorization holders of this type of innovations seems necessary. This future regulation should include a procedure to qualify incremental innovations of interest to the National Health System and have economic effects to guarantee their effective commercialization.
32
Moore, J. Bernadette. "From personalised nutrition to precision medicine: the rise of consumer genomics and digital health." Proceedings of the Nutrition Society 79, no. 3 (May 29, 2020): 300–310. http://dx.doi.org/10.1017/s0029665120006977.
Full textAbstract:
Advances in genomics generated the concept that a better understanding of individual characteristics, e.g. genotype, will lead to improved tailoring of pharmaceutical and nutritional therapies. Subsequent developments in proteomics and metabolomics, in addition to wearable technologies for tracking parameters, such as dietary intakes, physical activity, heart rate and blood glucose, have further driven this idea. Alongside these innovations, there has been a rapid rise in companies offering direct-to-consumer genetic and/or microbiome testing, in combination with the marketing of personalised nutrition services. Key scientific questions include how disparate datasets are integrated, how accurate are current predictions and how these may be developed in the future. In this regard, lessons can be learned from systems biology, which aims both to integrate data from different levels of organisation (e.g. genomic, proteomic and metabolomic) and predict the emergent behaviours of biological systems or organisms as a whole. The present paper reviews the origins and recent advancement of ‘big data’ and systems approaches in medicine and nutrition. Conclusions are that systems integration of multiple technologies has generated mechanistic insights and informed the evolution of precision medicine and personalised nutrition. Pertinent ethical issues include who is entitled to access new technologies and how commercial companies are storing, using and/or re-mining consumer data. Questions about efficacy (both long-term behavioural change and health outcomes), cost-benefit and impacts on health inequalities remain to be fully addressed.
33
Wong, Vincent Chi, Lei Su, and Howard Pong-Yuen Lam. "When Less Is More: How Mindset Influences Consumers’ Responses to Products with Reduced Negative Attributes." Journal of Marketing 84, no. 5 (May 14, 2020): 137–53. http://dx.doi.org/10.1177/0022242920920859.
Full textAbstract:
Marketing communications often describe a reduction in a product’s negative attributes (e.g., “our mineral water now uses 34% less plastic”). This claim may be interpreted as a trend of improving relative to previous state. However, such a claim may also call attention to a negative product feature that might have otherwise been overlooked. The authors suggest that whether consumers are positively or negatively influenced by such claims depends on whether the claims are interpreted through an incremental or entity mindset. When a reduction in negative attributes is viewed through an incremental mindset—the tendency to think of attributes as malleable—a trend-based interpretation results in improved product evaluations. In contrast, an entity mindset that emphasizes attributes are unlikely to change produces a negative effect for the claim. Four experiments and a field survey (N = 2,543) across food, pharmaceuticals, and plastic bottle products confirm the effects and indicate that the effects diminish when consumers believe the attribute is easy to eliminate or when the attribute has extremely threatening consequences. The opposite is observed for claims of reduced positive attributes, such that an entity mindset produces more positive evaluations. The findings offer marketers consumer insights to guide the communication of negatively framed attributes.
34
Bitter, I. "What will be the Consequences from the Changes in ICD-11/DSM-V for Decision Making in Clinical Psychopharmacotherapy?" European Psychiatry 24, S1 (January 2009): 1. http://dx.doi.org/10.1016/s0924-9338(09)70329-3.
Full textAbstract:
The preparations of DSM V/ICD-11 are in progress. The frustrations and limitations engendered by the categorical model in psychiatry led to the suggestion of alternative dimensional models of classification, e.g. to the suggestions for a dimensional view of psychosis. However there are strong arguments for keeping the categorical classification maybe with inclusion of new criteria, such as neurocognitive impairment for schizophrenia and even there are suggestions for new categories such as nonaffective remitting acute psychosis.Therapeutic indications of drugs are developed by the industry and are approved by regulatory agencies (FDA, EMEA). Indications are linked to diagnostic categories as defined by DSM-IV/ICD-11, e.g. one antipsychotic is indicated for the treatment of both schizophrenia and bipolar disorder, while another is only indicated for the treatment of schizophrenia. These indications are used by the insurance industry to manage financing of drug treatment.Changes in the criteria of a diagnostic category will result in a revision of approval which may include the obligation for new studies. Generic companies are now an important part of the major pharmaceutical markets, however many of them do not have the capacity to launch clinical studies, which may lead to the withdrawal of marketing authorization of important drugs. Clinical studies seem to be unavoidable for licensing recently available drugs for the new diagnostic categories of DSM V/ICD 11. The introduction of diagnostic categories by a dimensional approach may lead to “double book keeping”: a dimensional diagnosis used for the medical practice and a categorical one for the insurance.
35
Armando, Pedro D., Sonia A. Uema, and Elena M. Vega. "Integration of Community pharmacy and pharmacists in primary health care policies in Argentina." Pharmacy Practice 18, no. 4 (October 22, 2020): 2173. http://dx.doi.org/10.18549/pharmpract.2020.4.2173.
Full textAbstract:
Argentina is a federal republic with approximately 44 million people, divided into 23 provinces and an autonomous city, Buenos Aires. The health system is segmented into public, social security and private subsystems. The social security and private sectors cover more than 60% of the population. Total health expenditure in 2017 was 9.4% of gross domestic product. Primary health care (PHC) was considered as the principal strategy for universal coverage policy for health system reform in Latin America at the end of 20th century. The most remarkable characteristics of the Argentinian health system are its fragmentation and disorganization. An increase of public sector demands, due to a socioeconomic crisis, led to the subsequent collapse of the system, caused primarily by a sustained lack of investment. First care level decentralization to the Integral Health Service Delivery Networks (IHSDN) becomes the cornerstone of a PHC-based system. Pharmacists and community pharmacies are not formally mentioned in PHC policies or IHSDN. However, pharmacies are recognized as healthcare establishments as part of the first care level. Community pharmacists are the only health care professional whose profit comes from the margin on product sales. Contracts with social security and private insurances provide small margins which reduce the viability of community pharmacies. There is a preference by community pharmacies to diversify product sales instead of providing professional services. This is driven by marketing and economic pressures rather than patient care and health policies. Dispensing is the main professional activity followed by management of minor illness and associated product recommendations. Currently, there are no national practice guidelines or standard operating procedures for the provision of pharmaceutical services and there is no nationally agreed portfolio of services. National pharmacy organizations appear to have no official strategic statements or plans which would guide community pharmacies. There are some isolated experiences in community pharmacies and in public first care level pharmacies that demonstrate the possibilities and opportunities for implementing pharmaceutical services under the PHC approach. There is a real lack of integration of community pharmacies and pharmacists in the healthcare system.
36
Aluri Nandini and Ravi G. "Process validation of sucralfate oral suspension." International Journal of Research in Pharmaceutical Sciences 12, no. 3 (July 15, 2021): 2005–13. http://dx.doi.org/10.26452/ijrps.v12i3.4808.
Full textAbstract:
Drugs are the critical elements in the health care system. They must be manufactured in the high-quality levels. End product testing by itself does not guarantee of the quality of the product. Quality assurance techniques must be used. In pharmaceutical industry, process validation performs this task, by ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. This study is intended to demonstrate and standardize the data that should be routinely included in the marketing authorization dossier describing evolution and validation of the manufacturing process and distinguish from the validation data which more properly fall under the remit of GMP inspection. During the study of critical process variables of sucralfate oral suspension were validated to demonstrate consistency of manufacturing process to produce the produce the product of desired quality. The validation studies were conducted which were intended for the use of commercial purpose so this validation study is concurrent type. All the in-process variables and finished product characteristics were monitored; the statistical analysis of data was carried out. Further from the results, it is inferred that the manufacturing process of sucralfate oral suspension was validated.
37
Matloub, Yousif, Lia Gore, Mignon L. Loh, Chin-Hon Pui, Michael J. Hanley, Vickie Lu, E. Jane Leonard, Muriel Granier, Andrea Biondi, and Lewis B. Silverman. "A Phase 1/2 Study to Evaluate the Safety and Efficacy of Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)." Blood 136, Supplement 1 (November 5, 2020): 47. http://dx.doi.org/10.1182/blood-2020-134724.
Full textAbstract:
Introduction: Ph+ ALL accounts for 3-5% of pediatric ALL and is associated with improved outcomes when tyrosine kinase inhibitors (TKIs) are added to chemotherapy, with 5-year event-free survival (EFS) and overall survival (OS) of 58-60% and 70-86%, respectively. Ponatinib is a potent third-generation TKI pan-BCR-ABL1 inhibitor that is active against BCR-ABL1 and all identified single resistance mutations, including the gatekeeper alteration, T315I, which confers resistance to other TKIs. Ponatinib has marketing approval in more than 50 countries, which includes the United States and European Union, for adults with chronic-/accelerated-/blast-phase chronic myeloid leukemia or Ph+ ALL that are resistant/intolerant to other TKIs or are T315I+. Ponatinib may also overcome drug resistance in pediatric patients with relapsed or resistant Ph+ ALL. This study will assess the pharmacokinetics, safety, and efficacy of ponatinib in pediatric patients. Methods: This Phase 1/2, single-arm, open-label, multicenter study (NCT04501614) will enroll approximately 18 patients in Phase 1 and 68 patients in Phase 2, including those enrolled in Phase 1 at the recommended Phase 2 dose (RP2D). Patients (aged ≥1 year to ≤21 years) with Ph+ ALL, Ph+ mixed phenotype acute leukemia, or Ph-like ALL (US only) with ABL class lesions will be enrolled. Enrolled patients must have either relapsed or are resistant or intolerant to ≥1 prior therapy with a BCR-ABL1-targeted TKI or have a BCR-ABL1 T315I mutation. Patients >16 years must have a Karnofsky performance status ≥50%; patients ≤16 years must have a Lansky Play Scale ≥50%. During Phase 1, prior to availability of an age-appropriate formulation (AAF), patients must weigh ≥30 kg and be able to swallow tablets. The Phase 1 study will establish the RP2D of ponatinib in combination with the chemotherapy backbone using the adult tablet formulation in patients able to swallow tablets. Patients will receive fixed doses of ponatinib based on body weight ranges. The initially selected doses are expected to achieve systemic exposures that approximately match adult exposures after a 30-mg dose. Dose selection for the AAF will be in a separate cohort and informed by the results of a relative bioavailability study in healthy adult volunteers. A rolling 6 design will be used for both cohorts; additional cohorts may be enrolled at lower or higher doses based on the emerging data. In both Phase 1 and Phase 2, patients will receive two 35-day blocks of therapy (reinduction and consolidation). Each block includes 29 days of study treatment consisting of daily ponatinib and a modified United Kingdom ALL R3 chemotherapy backbone regimen, followed by a rest period of at least 6 days with daily ponatinib only. Disease assessment will occur at the end of each block. Patients will undergo an end-of-treatment visit 25 to 30 days after the last dose of study treatment in the consolidation block, or earlier if the patient is proceeding to alternate therapy or optional ponatinib continuation therapy. For the Phase 1 study, the primary endpoint is the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy. Secondary endpoints are complete response (CR) rate at the end of the reinduction block and characterization of BCR-ABL1 domain mutations prior to and following ponatinib treatment. For the Phase 2 study, the primary endpoint is the CR rate at the end of the reinduction block. Secondary endpoints will be summarized descriptively, and include the proportion of patients in continued CR or who achieve CR at the end of consolidation, the proportion with minimal residual disease-negative status <0.01% at the end of each block, and the proportion who relapsed or progressed, and time-to-event estimates including EFS, progression-free survival, and OS. The study will include approximately 70 study sites in approximately 16 countries. Disclosures Matloub: Takeda: Current Employment. Gore:Amgen, Novartis, Roche: Membership on an entity's Board of Directors or advisory committees. Loh:Medisix Therapeutics: Membership on an entity's Board of Directors or advisory committees; Pfizer: Other: Institutional Research Funding. Pui:Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees. Hanley:Takeda: Current Employment. Lu:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Leonard:Takeda: Current Employment. Granier:Incyte: Current Employment. Silverman:Servier: Other: advisory board; Syndax: Other: advisory board; Takeda: Other: advisory board. OffLabel Disclosure: Ponatinib has marketing approval in the United States and European Union for adult patients with chronic-/accelerated-/blast-phase chronic myeloid leukemia or Ph+ ALL that are resistant/intolerant to other TKIs or are T315I+. This trials-in-progress abstract describes a study in pediatric patients.
38
Dang, Tran-Thai, Thanh-Hang Nguyen, and Tu-Bao Ho. "Causality Assessment of Adverse Drug Reaction: Controlling Confounding Induced by Polypharmacy." Current Pharmaceutical Design 25, no. 10 (August 5, 2019): 1134–43. http://dx.doi.org/10.2174/1381612825666190416115714.
Full textAbstract:
Background: Post-marketing pharmaceutical surveillance, a.k.a. pragmatic clinical trials (i.e., PCT), plays a vital role in preventing accidents in practical treatment. The most important and difficult task in PCT is to assess which drug causes adverse reactions (i.e., ADRs) from clinical texts. The confounding (i.e., factors cause confusions in causality assessment) is generated by the polypharmacy (i.e., multiple drugs use), which makes most of existing methods poor for detecting drugs that capably cause observed ADRs. Objective: We aim to improve the performance of detecting drug-ADR causal relations from clinical texts. To this end, a mechanism for reducing the impact of confounding on the detecting process is needful. Methods: We proposed a novel model which is called the analogy-based active voting (i.e., AAV) for improving the ability of detecting causal drug-ADR pairs, in case multiple drugs are prescribed for treating the comorbidity. This model is inspired by the analogy principle which was proposed by Bradford Hill. Results: The experimental results show the improvement of recognizing causal relations between drugs and ADRs that are confirmed by the SIDER. In addition, the proposed model is promising to detect infrequently observed causal drug-ADR pairs when the drug is not commonly used. Conclusion: The proposed model demonstrates its ability for controlling the polypharmacy-induced confounding, to improve the quality of causality assessment of ADRs. Additionally, this also shows that the analogy principle is applicable for the assessment.
39
Hoppu, Kalle, and Helena Fonseca. "Why are certain age bands used for children in paediatric studies of medicines?" Archives of Disease in Childhood 106, no. 7 (January 8, 2021): 631–35. http://dx.doi.org/10.1136/archdischild-2020-319019.
Full textAbstract:
Rational prescribing of medicines requires evidence from clinical trials on efficacy, safety and the dose to be prescribed, based on clinical trials. Regulatory authorities assess these data and information is included in the approved summary of product characteristics. Regulatory guidelines on clinical investigation of medicinal products in the paediatric population generally propose that studies are done in defined age groups but advise that any classification of the paediatric population into age categories is to some extent arbitrary or that the age groups are intended only as a guide. The pharmaceutical companies tend to plan their studies using age groups the regulatory guidelines suggest, to avoid problems when applying for marketing authorisation. These age bands end up in the paediatric label, and consequently into national paediatric formularies. The age bands of the most commonly used age-subsets: neonates, infant/toddlers, children and adolescents, are more historical than based on physiology or normal development of children. Particularly problematic are the age bands for neonates and adolescents. The age of 12 years separating children from adolescents, and the upper limit of the adolescents set by the definition of paediatric age in healthcare, which varies according to the region, are particularly questionable. Modern pharmacometric methods (modelling and simulation) are being increasingly used in paediatric drug development and may allow assessment of growth and/or development as continuous covariables. Maybe time has come to reconsider the rational of the currently used age bands.
40
Mahajan, Varun. "Is productivity of Indian pharmaceutical industry affected with the introduction of product patent act?" Indian Growth and Development Review 13, no. 1 (February 13, 2020): 227–58. http://dx.doi.org/10.1108/igdr-11-2018-0116.
Full textAbstract:
Purpose The purpose of this paper is to empirically study the impact of product patent regime on the productivity of different categories such as ownership, R&D, size and product-wise of Indian pharmaceutical firms using non-parametric data envelopment analysis. Design/methodology/approach The present study has applied Ray and Desli’s Malmquist productivity index and its decomposition to measure total factor productivity (TFP) change, pure technical efficiency change, scale efficiency change and technical change under variable returns to scale (VRS) technology assumption for 141 Indian pharmaceutical firms during 2000-2001 to 2014-2015. Findings The study found the negligible impact of product patent regime on productivity. The technological change has played a positive role in the growth of productivity, whereas technical efficiency change depicts the judicious utilization of resources for improving performance. From the results, it is found that R&D intensive firms depict better stability in the TFP than the non-R&D firms. However, Granger causality between R&D and productivity found no relationship. Productivity is more directly affected by investment in fixed assets rather than in R&D, which focusses on incremental value additions in a largely branded/plain generic product market. In case of ownership, private foreign firms found to have registered progress in TFP while others have recorded marginal regress, which probably could be attributed to the superior marketing and management skills of the foreign firms, besides possessing proprietary technology. Both small and large firms have shown positive growth in the new regime as compared to the pre-patent regime. These small firms are able to compete with large firms because of their up-gradation of the technological base by improving access to better foreign technology. TFP growth for all the firms can be attributed to improvement in technology, and innovation in terms of high capital-output ratio. Further, the paper tried to identify the determinants of productivity from panel random effect regression, and it is found that export intensity, age and the new patent regime have negative and significant relationship with productivity, whereas other variables such as R&D, ownership, size and capital imports are insignificant. In the end, the results of sensitivity analysis have confirmed the validity of the selected variables. Practical implications The results suggest that Indian pharmaceutical firms need substantive improvement in TFP by improving managerial and scale efficiency. Indian pharmaceutical industry (IPI) needs to improve productivity across the network and drive cost excellence initiatives across the spend base through operational excellence and digital initiatives. The results of this paper can be applied in framing policies for future growth and improvement in the productivity of IPI. Originality/value The paper aims to make several new contributions to the existing literature. Most of the research papers only analysed TFP of the industry as a whole and detailed firm-wise analysis is needed to capture the true impact at a unit level. This study has analysed the impact of different categories such as ownership, R&D, size and product-wise, and determinants of productivity. The study has used a broader time period and larger panel data to predict the better picture.
41
Levine, Mitchell, Kathryn Gaebel, and Michael Spino. "A Study of Patient Responses to a Perceived Change in Salbutamol Metered Dose Inhalers." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 2, no. 3 (April 2005): 201–8. http://dx.doi.org/10.1057/palgrave.jgm.4940070.
Full textAbstract:
Experience in the clinic reveals that some patients have attributed negative changes in their respiratory health status to generic substitution of inhaled medications, even though — from a pharmacological perspective — therapeutic equivalence would be expected. The objective of this study was to evaluate patient-reported changes in efficacy or toxicity following a perceived switch of an inhaled drug product. Forty-eight patients with air flow limitation had their usual brand of salbutamol metered-dose inhaler (MDI) replaced for one week with a new MDI. Patients were not informed that the replacement MDI was exactly the same brand as their usual MDI, and the product identity was disguised by a label. Forced expiratory volume in one second, respiratory symptoms and MDI use were compared between the week when the patients knew they were using their usual brand of MDI and the week they were using the perceived new MDI. Patient MDI preference was assessed at the end of the study. Even though there was no change in the brand of salbutamol MDI, 46 per cent of patients thought that the new MDI was better at managing their symptoms, 27 per cent thought that the new MDI was worse and 27 per cent perceived no difference (p<0.05 for rejecting the null hypothesis that all responses would be for no difference). Seventy per cent of patients stated that they had a preference for one MDI over the other, even though there had been no change in inhaler. Factors other than product differences are likely to be responsible for patient claims of changes in respiratory health status subsequent to generics substitution with inhaled medications when equivalent products are used. If such changes are reported following the introduction of a new generic product, the changes may be incorrectly attributed to the new product, confounding the ability to assess the quality of the new product in post-marketing evaluation.
42
Hsiue, Emily Han-Chung, Thomas J. Moore, and G. Caleb Alexander. "Estimated costs of pivotal trials for U.S. Food and Drug Administration–approved cancer drugs, 2015–2017." Clinical Trials 17, no. 2 (February 29, 2020): 119–25. http://dx.doi.org/10.1177/1740774520907609.
Full textAbstract:
Background: Pivotal clinical trials provide critical evidence to regulators regarding a product’s suitability for marketing approval. The objectives of this study are (1) to characterize select features of trials for oncology products approved by the U.S. Food and Drug Administration between 2015 and 2017; and (2) to quantify the costs of these trials and how such costs varied based on trial characteristics. Methods: We identified novel oncology therapeutic drugs, and their respective pivotal trials, approved between 2015 and 2017 using annual summary reports from the Food and Drug Administration. Cost estimates for each pivotal trial were calculated using IQVIA’s CostPro, a clinical trial cost estimating tool based on executed contracts between pharmaceutical manufacturers and contract research organizations. Measures of drug and trial characteristics included trial design, end point, patient enrollment, and regulatory pathway. We also performed sensitivity analyses that varied assumptions regarding how efficiently each trial was conducted. Results: A total of 39 pivotal clinical trials provided the basis for Food and Drug Administration approval of 30 new oncology drugs from 2015 to 2017. Among these trials, primary end points were objective response rate in 20 (51.3%), progression-free survival in 13 (33.3%), and overall survival in 6 (15.4%). Twenty trials (51.3%) were single-arm studies. The median estimated cost of oncology pivotal trials was $31.7 million (interquartile range = $17.0–$60.4 million). Trials with objective response rate as primary end point had a median estimate of $17.7 million (interquartile range = $11.9–$27.1 million), compared with trials examining progression-free survival ($42.3 million, interquartile range = $34.6–$101.2 million) or overall survival ($79.4 million, interquartile range = $56.9–$97.7 million) (p < 0.001). Estimated costs for single-arm trials ($17.7 million, interquartile range = $11.9–$23.7 million) were less than for trials with a placebo-controlled ($56.7 million, interquartile range = $40.9–$103.9 million) or active control arm ($67.6 million, IQR = $35.5–$93.5 million) (p < 0.001). Conclusions: Relative to the estimated costs of drug development, the costs of these oncology pivotal trials were modest, with trials that produced more valuable scientific information costing more than their counterparts.
43
Binding, Jörg, and Ulrich Heuschkel. "Market Surveillance in the People's Republic of China." European Journal of Risk Regulation 3, no. 4 (December 2012): 489–506. http://dx.doi.org/10.1017/s1867299x00002427.
Full textAbstract:
This paper provides a holistic review of market surveillance in China from a legal perspective, supplemented by the authors’ practical knowledge. The fundamental legal bases of market surveillance, namely the Law on Product Quality, the Law on Import and Export Commodity Inspection and the Law on Standardization, along with their associated implementation regulations, are thoroughly examined. Thereby the special features of market surveillance in the Chinese context are presented. This, in particular, includes the differentiation between market surveillance on the production and circulation stages (pre-marketand post-market) and an introduction of the two major competent authorities, the GeneralAdministration of Quality Supervision, Inspection and Quarantine, the State Administrationfor Industry and Commerce, and their respective statutory functions specified by a range of laws and administrative regulations as well as the demarcation of their competencies. The authors also take efforts to explore market surveillance on two spe cial markets, foodand pharmaceuticals, which also includes the legal basis, legal instruments and competent authorities, representing different supervision approaches compared with ordinary products.In the end, market surveillance on and by conformity assessment bodies are briefl yreviewed to provide another angle for the observation of the Chinese system.
44
Lhotska, Lida, Judith Richter, and Maryse Arendt. "Protecting Breastfeeding From Conflicts of Interest." Journal of Human Lactation 36, no. 1 (December 9, 2019): 22–28. http://dx.doi.org/10.1177/0890334419885859.
Full textAbstract:
In order to maximize profits from sales of breastmilk substitutes, manufacturers use a whole gamut of strategies to interfere with the effective implementation of policies that protect, promote, and support breastfeeding (e.g., the International Code of Marketing of Breastmilk Substitutes with its subsequent World Health Assembly resolutions and the Global Strategy on Infant and Young Child Feeding). Their strategies create, among other problems, personal and institutional conflicts of interest. Effective Conflict of Interest policies are therefore needed for ensuring that governments, international organizations, non-governmental organizations, and health professionals can protect their independence, integrity, and credibility in order to work in the best interests of children. Conflicts of interest are discussed by Dr Lida Lhotska and Dr Judith Richter, who have been actively involved in these issues internationally. Lida Lhotska holds a BSc in Biology and a PhD in Anthropology. Her international work spans over 25 years. She headed the Infant Feeding and Care team for UNICEF and subsequently joined the IBFAN-Geneva Infant Feeding Association team, always focusing on advancing the protection of breastfeeding through legal and other policy measures. Judith Richter has a multidisciplinary background combining knowledge in the humanities with health sciences (PhD Social Sciences; MA Development Studies; MSc Pharmaceutical Sciences). Her work as a freelance researcher for United Nations agencies, governments, and civil society organizations and networks has centered on safeguarding their capacity to hold transnational corporations accountable. In her interview, Judith Richter explains why conflict of interest regulation matters to health professionals working in the field of lactation. (MA = Maryse Arendt; LL = Lida Lhotska; JR = Judith Richter)
45
Jensen, Mie Birk, and Stefan Jänicke. "‘Potency is important for a real man’: Affective Readings of Shame and Performance Anxiety in Spam Selling Viagra and other Sexuopharmaceuticals." Somatechnics 11, no. 1 (April 2021): 68–91. http://dx.doi.org/10.3366/soma.2021.0340.
Full textAbstract:
Viagra is a popular topic in spam, but contrary to Pfizer's official marketing of Viagra, little attention has been directed at how the content of spam plays into gendered discourse on masculinity and men's sexual performances. This is not surprising, if we consider how spam is mostly treated as a nuisance to digital infrastructures. Yet, studies have demonstrated how spammers build on, reflect and transmit gender ideologies (e.g. Mullany 2004 ; Paasonen 2009 ; Yu 2014 ). In the present paper, we contribute insights to the existing studies on Viagra and spam, as we examine how spammers promote Viagra and other sexuopharmaceuticals. Taking our point of departure in an online spam archive ( Guenter 2010 ), we combine qualitative and quantitative methods to analyse the textual content of spam emails. Using TagSpheres models, we have produced an overview of the most frequent and relevant terms in spam which we further subject to a qualitative analysis. Drawing on Sara Ahmed (2004) , we engage in an affective reading of selected spam emails, generated by randomised samples. In the analysis, we argue that spammers attempt to move possible consumers away from official and legal sale methods by emphasising shame and anxiety related to procuring Viagra and other sexuopharmaceuticals. While shame moves the consumer away from legal sale methods, anxiety is invoked to encourage the possible consumer to envision a hypermasculine future, in which virility is everlasting. We further discuss our findings in relation to masculinity, arguing that spammers capitalise on existing communication- and pharmaceutical technologies, whilst taking gendered discourse in advertising to their ‘functional extremes’ ( Brunton 2019 : xiv).
46
Peráček, T., B. Mucha, P. Brestovanská, and Ľ. Strážovská. "Legal regulation of drug advertising and its restrictions in the conditions of the Slovak Republic." European Pharmaceutical Journal 66, no. 1 (June 1, 2019): 4–10. http://dx.doi.org/10.2478/afpuc-2019-0001.
Full textAbstract:
Abstract The question of drug availability is a key requirement for each country. Their deficiency can cause fatal consequences for the health of the population. For this reason, the production and distribution of medicines represents the economic potential of the state, which is also protected and regulated in the Slovak Republic. Drug distribution is also part of every market economy as it is the primary form of business-to-customer (B2C) offering. At first glance, the promotion of drugs might seem to be just marketing. But this area is under the scrutiny of the Slovak legislations. From the point of view of the systemic nature of law, advertising of medicinal products is regulated both in public law and private law. This is particularly the area of administrative law, commercial law and civil or criminal law, which must respect the often complicated penetration of European law into national law. The issue of ad management and the associated availability of medicines, in our terms, is at the centre of public interest. The main aim of the authors in this paper is to examine not only the European but especially the national legal regulation of the advertising of medicines in the context of the decision-making activity of the Slovak authorities supervising compliance with the legal restrictions on the promotion of pharmaceutical products. Another goal is to identify the problems in application practice and to propose ways to eliminate identified shortcomings by specific procedures. The authors, through scientific and doctrinal interpretation, examine selected statutes of the Law on Advertising and related legislation pertaining to the issue of drug advertising. Through expert literature, jurisprudence and the decision-making processes of the administrative authorities, they seek answers to practical application problems. At the end of the contribution, they critically analyse the identified shortcomings and propose appropriate measures to eliminate them.
47
Pujiastuti, Dwi Yuli, Laksmi Sulmartiwi, and Ahmad Shofy Mubarak. "Increasing the value added of production citronella oil and carrageenan in Rungkut Barata Surabaya." Kontribusia (Research Dissemination for Community Development) 4, no. 2 (August 3, 2021): 399. http://dx.doi.org/10.30587/kontribusia.v4i2.2065.
Full textAbstract:
In this PKM program, our partner is residents in Rungkut Barata, Surabaya, East Java Province. This community has generated the production of citronella oil. However, the product only in the form of citronella oil in a simple package. Citronella oil from the refining process is one of the jobs for the people in Rungkut Barata where to improve welfare, a product diversification process is necessary. Seaweed is forms of algae that grow in the sea and has the biological activity for health. Carrageenan is the product result of seaweed extraction that have several function as thickener, emulsifier, suspension, and stabilizer. The pharmaceutical industry uses carrageenan for the manufacture of drugs, syrups, tablets, toothpaste, and shampoo. The cosmetics industry uses it as a gelling agent or binding agent.
Based on interviews and observations in the field, there are 2 main focuses of the problems currently faced by partners, namely: 1) lack of knowledge about non-consumption seaweed and 2) product diversification of seaweed and citronella oil which have an added value.
Some of the things planned by the PKM team are innovating citronella oil to be aromatic soap as well as providing training and mentoring for financial analysis, soap packaging and marketing. The purpose of this activity is to transfer knowledge of making soap, develop the creativity of the partner, increase the soap production and improve the welfare of the partner.
This activity was realized with an approach in the form of making a sustainable cooperation program until the end of PKM, creating a family atmosphere between the two and understanding that the problems experienced were a shared problem so that they could be solved together according to the level of responsibility to achieve the expected benefits, namely increased yields, production and productivity and competitiveness, independence and welfare of the community.
48
Dalén, J., A. Puenpatom, K. Luttropp, and C. Black. "FRI0513 TREATMENT PERSISTENCE IN PATIENTS CYCLING ON SUBCUTANEOUS TUMOR NECROSIS FACTOR-ALPHA INHIBITORS IN INFLAMMATORY ARTHRITIS – A RETROSPECTIVE STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 855.2–856. http://dx.doi.org/10.1136/annrheumdis-2020-eular.687.
Full textAbstract:
Background:Patient persistence with biologic treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) (collectively inflammatory arthritis, IA) may be considered a proxy for efficacy, safety and treatment satisfaction. Patients who discontinue their first line of subcutaneous tumor necrosis factor alpha inhibitors (SC-TNFis) and switch to at least one subsequent line of SC-TNFi can be defined as cyclers.Objectives:To assess persistence by line of therapy in Swedish IA patients cycling on SC-TNFis.Methods:Using data from the Swedish Health Data Registers, adult IA patients initiating treatment with any available SC-TNFi (adalimumab, etanercept, certolizumab, or golimumab) between May 1st2010 and October 31st2016 were eligible for inclusion. Treatment persistence was derived using information from filled prescriptions (e.g. dispensing date, pack information, and defined daily dose) with a 60-day grace period. Analyses were restricted the first two lines of treatments (i.e. 1stand 2nd) in patients defined as SC-TNFi cyclers. Persistence estimates across treatment lines were assessed graphically using Kaplan-Meier curves. Unadjusted and adjusted marginal Cox proportional hazards models were fitted to estimate the relative risk of discontinuation across treatment lines, using robust sandwich covariance matrix estimates to account for intrapatient dependence (i.e. multiple treatment lines per patient). Covariates in the adjusted analysis included age, gender, diagnosis, year of treatment initiation, comorbidities, co-medication, and the number of specialized outpatient care visits and inpatient stays.Results:Of 11,668 patients initiating SC-TNFi treatment, 3,181 patients were identified as cyclers. Among these, a majority were female (68%) with a mean age of 50 years; 46%, 28%, and 26% were diagnosed with RA, AS and PsA, respectively. Figure 1 indicated that, among cyclers, persistence with second line treatment was higher compared to first line treatment persistence. This finding was confirmed by the analyses accounting for intrapatient dependence. Both the unadjusted and the adjusted analyses showed that the relative risk of discontinuing SC-TNFi treatment were significantly lower in 2ndline compared to 1stline (Hazard Ratio [HR]; 0.60 [0.57, 0.63] and 0.59 [0.56, 0.62], respectively). This finding was also consistent across IA indications (Table 1).Table 1.Relative risk of discontinuing subcutaneous Tumor Necrosis Factor-α inhibitor treatment for IA in 2nd line treatment compared to 1st line treatment, by analysis populationAnalysis populationNUnadjusted analysis, HR [95%CI]Adjusted analysis, HR [95%CI]Cyclers overall3,1810.60 [0.57, 0.63]0.59 [0.56, 0.62]RA1,4790.62 [0.57, 0.67]0.61 [0.56, 0.66]PsA8910.60 [0.54, 0.67]0.59 [0.53, 0.65]AS8110.58 [0.52, 0.64]0.55 [0.50, 0.61]HR: Hazard Ratio, 95%CI: 95% confidence intervalFigure 1.Persistence, among cyclers, with subcutaneous Tumor Necrosis Factor-α inhibitors treatment for IA by line of treatmentConclusion:In this preliminary analysis of IA patients cycling on SC-TNFis, persistence was greater in 2ndline compared to 1stline treatment. The finding was consistent across all IA indications. Hence, IA patients who fail to respond, lose response, or for other reasons discontinue their 1stline treatment may still benefit from switching to an alternative SC-TNFi as a 2ndline therapy.Disclosure of Interests:Johan Dalén Consultant of: Merck & Co., Inc. in conjunction with the development of this abstract. JD is an employee of ICON plc. ICON plc have received funding from several pharmaceutical companies involved in the marketing products for treatment of inflammatory arthritis., Amy Puenpatom Shareholder of: shareholder at Merck & Co, Inc, Employee of: Employed at Merck & Co, Inc., Karin Luttropp Consultant of: Merck & Co., Inc. in conjunction with the development of this abstract. KL is an employee of ICON plc. ICON plc have received funding from several pharmaceutical companies involved in the marketing products for treatment of inflammatory arthritis., Christopher Black Shareholder of: I own shares of MSD, Employee of: I am an employee of MSD
49
Donyai, P., N. Patel, and H. Almomani. "Why do people end up buying fake medicines online? A thematic analysis of newspaper articles." International Journal of Pharmacy Practice 29, Supplement_1 (March 26, 2021): i1. http://dx.doi.org/10.1093/ijpp/riab016.000.
Full textAbstract:
Abstract Introduction The internet provides a platform for both legal and illegal online suppliers of medicines, which are sometimes difficult to distinguish between. Therefore, consumers accessing the internet are at risk of purchasing fake medicines from illegal suppliers. This is particularly problematic when people buy Prescription-Only Medicines (POMs) from the internet, despite an abundance of governmental campaigns 1. This under-researched issue has nonetheless been highlighted in news articles in the past few years which are a potential source of information, albeit informally, about how and why people end up buying fake medicines via the internet. This study is phase-1 of a larger study that aims to develop a questionnaire using the Theory of Planned Behaviour (TPB)2 to examine risky online purchasing of medicines to help focus future campaigns. Aim The aim is to identify the factors that lead people to inadvertently buy fake POMs online by examining newspaper articles covering this topic and categorising the findings according to the TPB’s indirect measures; namely, behavioural beliefs, normative beliefs, and control beliefs. Methods Newspaper articles were collected from the electronic database “ProQuest” using a series of search words for retrieving newspaper articles covering the purchasing of fake medicines online throughout the world. The search was limited to articles published from April-2019 to March-2020 to retrieve relevant articles in this fast-developing field. Articles that did not focus on POMs or only covered the supply side (e.g. efforts to combat illegal suppliers) were excluded. After evaluating each article using the inclusion/exclusion criteria, 52 articles remained. Thematic analysis was employed to analyse the newspaper articles against the TPB. The NVivo software program (version 12) was used to aid the generation of the themes. Results Using thematic analysis, 12 themes were generated and categorised according to the TPB’s indirect measures as follows. The behavioural beliefs (i.e. advantages and disadvantages of buying medicines online) included a perception of convenience, low price, privacy of the purchase, potential harmful effect, low quality, and lack of medical oversight. The normative beliefs (i.e. social factors influencing decisions to buy medicines online) included endorsement by influencers, deceptive marketing by suppliers, as well as organizations fighting the fake supply chain. The control beliefs (i.e. what encourages or stops purchasing medicines online) included encountering medicines shortages, outbreak of pandemic diseases, and accessibility issues. Conclusion This newspaper-analysis study created an initial map of ideas for why consumers might inadvertently buy fake POMs online highlighting the complexity of personal beliefs as well as a range of external circumstances. Further exploring these factors provides the basis for future campaigns for changing/controlling the purchasing of fake medicines online. Although the newspaper articles offer a wide range of data and provide different points of view, the validity of their content cannot be proven and are taken at face value. Therefore, the next step for this study is to complete semi-structured interviews with consumers purchasing medicines online (Phase-2) to verify the themes generated in Phase-1 before developing a larger questionnaire study (Phase-3). References 1. HM Government. Protect your health when buying medicines online. Accessed 08 October 2020 from: https://fakemeds.campaign.gov.uk/ 2. Ajzen, I. The theory of planned behaviour. Organizational behaviour and human decision processes. 1991; 50 (2),179–211.
50
Roulet, Steve, Christelle Chrea, Claudia Kanitscheider, Gerd Kallischnigg, Pierpaolo Magnani, and Rolf Weitkunat. "Potential predictors of adoption of the Tobacco Heating System by U.S. adult smokers: An actual use study." F1000Research 8 (July 14, 2021): 214. http://dx.doi.org/10.12688/f1000research.17606.2.
Full textAbstract:
Background: This was a pre-market, observational, actual use study with the Tobacco Heating System (THS), a candidate modified risk tobacco product. The main goal of the study was to describe THS adoption within current adult daily smokers by replicating the usage of THS in real-world conditions with participants being able to consume cigarettes, THS, and any other nicotine-containing products (e.g., e-cigarettes, cigars, etc.) ad libitum. Methods: This study assessed self-reported stick-by-stick consumption of THS compared with the use of commercial cigarettes over six weeks. The aim of the analysis was to identify potential predictors for adoption of THS using stepwise logistic regression analysis. Results: By the end of the observational period (in Week 6), 14.6% of participants (n=965) had adopted THS meaning that THS formed 70% or more of their total tobacco consumption. The main predictors of adoption were the liking of the smell, taste, aftertaste, and ease of use of THS. The proportion of adoption was higher in participants aged 44 years and older and in Hispanic or Latino adult smokers. Additionally, adoption of THS was more likely in participants who had never attempted to quit smoking and in participants who smoked up to 10 cigarettes per day. Finally, the adoption of THS was higher in participants who consumed both regular and menthol THS compared with those who consumed only one THS variant. Conclusions: The findings suggest that the introduction of THS in the U.S. has the potential to result in adoption by current adult smokers who would otherwise continue to smoke cigarettes, and that the adoption of THS is unlikely to result in an increase of tobacco consumption. Post-marketing studies will provide further insights on THS adoption and THS use patterns to allow assessment of the impact of the THS at the individual and the overall population level.