Ignacio José Godinho Delgado
Full Text Available Abstract: This article discusses the relations between healthcare systems and the pharmaceutical industry, focusing on state support for pharmaceutical innovation. The study highlights the experiences of the United States, United Kingdom, and Germany, developed countries and paradigms of modern health systems (liberal, universal, and corporatist, in addition to Japan, a case of successful catching up. The study also emphasizes the experiences of China, India, and Brazil, large developing countries that have tried different catching up strategies, with diverse histories and profiles in their healthcare systems and pharmaceutical industries. Finally, with a focus on state forms of support for health research, the article addresses the mechanisms for linkage between health systems and the pharmaceutical industry, evaluating the possibilities of Brazil strengthening a virtuous interaction, favoring the expansion and consolidation of the Brazilian health system - universal but segmented ‒ and the affirmation of the innovative national pharmaceutical industry.
Latten, Tom; Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk
Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. The effects of bilateral interactions reported in the literature are similar to those reported in studies concerning unilateral
Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk
Introduction Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. Material and methods We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1st, 2000 and October 31st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Results Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. Discussion and conclusion The effects of bilateral interactions reported in the literature are
Zoeckler, Jeanette M
Home healthcare work is physically and emotionally exhausting. In addition, home healthcare workers frequently work under precarious work arrangements for low wages and in poor work conditions. Little is known about how sources of job strain for home healthcare workers might be reduced. This research examines the occupational stressors among paid home care workers by analyzing home healthcare agency characteristics and individual home healthcare workers' experiences in upstate New York agencies (n = 9). The study augments existing theoretical models and describes new sources of stress arising from the nature of agency-based caregiving. Results feature the analysis of both agency executives' (n = 20) and home healthcare workers' narratives (n = 25) to make the agency's inner workings more transparent. Agency structures and culture are implicated in the lack of progress to address home care workers' health problems. Policy change should focus on compensation, healthier work conditions, and training requirements.
Latten, Tom; Westra, Daan; Angeli, Federica; Paulus, Aggie; Struss, Marleen; Ruwaard, Dirk
Introduction: Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to
Poff, Renee McCoy; Browning, Sarah Via
Creating a meaningful infection control program in the home care setting proved to be challenging for agency leaders of one hospital-based home healthcare agency. Challenges arose when agency leaders provided infection control (IC) data to the hospital's IC Committee. The IC Section Chief asked for national benchmark comparisons to align home healthcare reporting to that of the hospital level. At that point, it was evident that the home healthcare IC program lacked definition and structure. The purpose of this article is to share how one agency built a meaningful IC program.
Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand
This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.
Iñesta, Antonio; Oteo, Luis Angel
The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.
Silva Oliveira, Tatiana de Alencar; Maria, Tatiane de Oliveira Silva; Alves do Nascimento, Angela Maria; do Nascimento, Angela Alves
The scope of this study was to discuss the organization of the pharmaceutical assistance service in the family healthcare program. Qualitative research from a critical/analytical perspective was conducted in family healthcare units in a municipality of the state of Bahia, Brazil. Data was collected on the basis of systematic observation, semi-structured interviews and documents analysis from a dialectic standpoint. The organization of Pharmaceutical Assistance consisted of selection, planning, acquisition, storage and dispensing activities. The process was studied in the implementation phase, which was occurring in a centralized and uncoordinated fashion, without the proposed team work. An excess of activity was observed among the healthcare workers and there was an absence of a continued education policy for the workers. For the transformation of this situation and to ensure the organization of pharmaceutical assistance with quality and in an integrated manner, a reworking of the manner of thinking and action of the players concerned (managers, health workers and users), who participate directly in the organization, is necessary. Furthermore, mechanical, bureaucratic and impersonal work practices need to be abandoned.
... will provide the grantees with technical assistance regarding research design, data collection, data... instruments are designed to capture a combination of quantitative and qualitative data. No claim is made that... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency...
Kondo, Emiko; Torii, Mayumi; Oba, Izumi; Okamoto, Mai
The issue of drug lag in Japan has been rapidly reduced in recent years, and newly approved drugs now become available on Japanese and international markets at the same time. In this context, the risk management plan (RMP) system was introduced in 2012. RMPs describe important safety concerns recognized by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and marketing authorization holders (MAHs), as well as safety measures that MAHs request healthcare professionals (HCPs) to follow. The publication of RMPs is expected to support the sharing of drug risk management among HCPs during the postmarketing phase. In addition, to encourage risk communication between HCPs and patients, the PMDA website provides drug guides for patients and other information to promote proper understanding of drugs by patients and their families and enable them to identify serious adverse drug reactions at an early stage. However, the results of surveys conducted by the PMDA in FY2014 and FY2015 revealed low levels of awareness of RMPs and drug guides for patients in hospitals and other healthcare institutions. The surveys also showed that information regarding the proper use of drugs from MAHs and the PMDA was not incorporated into practice at healthcare institutions, resulting in the repeated release of identical safety alerts. To facilitate the increased utilization of risk communication tools, the PMDA has been providing and disseminating these tools through its website. This study addresses those efforts and the associated challenges.
Mossialos, Elias; Mrazek, M. F; Walley, T; Mossialos, E
... Breckenridge, Chairman of the Medicines and Healthcare Products Regulatory Agency, United Kingdom The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of ...
Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.
Grauer, D W
Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.
Geurts, Marlies M E; Ivens, Martijn; van Gelder, Egbert; de Gier, Johan J
BACKGROUND: In medication therapy management there is a need for a tool to document medication reviews and pharmaceutical care plans (PCPs) as well as facilitate collaboration and sharing of patient data between different healthcare providers. Currently, pharmacists and general practitioners (GPs)
... (DTC) drug advertising and prescription drug promotion has affected healthcare professionals in a... Survey of Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. [[Page... notice solicits comments on the Healthcare Professional Survey of Prescription Drug Promotion. This...
Jeffs, Lianne; Grinspun, Doris; Closson, Tom; Mainville, Marie-Claude
Working overtime, absenteeism and agency use can negatively impact working environments, the health of staff and patient outcomes, and increase healthcare costs. The purpose of this study was to explore how healthcare leaders in Ontario hospitals implement and sustain best practices that advance workforce stability within their organization. Qualitative study design using semi-structured interviews and thematic analysis. Participants included 23 healthcare leaders from 16 hospital sites. Two main themes emerged: (1) enacting proactive human resource practices and (2) having strong, caring and strategic leaders that create learning and supportive work environments. A number of sub-themes identified were reported through narratives stratified according to size (small/large) and performance (low/high) of each site. Insights gained from this study may offer healthcare leaders strategies to maximize the nursing workforce and minimize overtime, absenteeism and agency use to ensure safe, efficient and quality healthcare. Copyright © 2015 Longwoods Publishing.
Lee, Iyn-Hyang; Rhie, Sandy Jeong; Je, Nam Kyung; Rhew, Ki Yon; Ji, Eunhee; Oh, Jung Mi; Lee, Euni; Yoon, Jeong-Hyun
Purpose To explore the need for pharmaceutical care services, key features of desirable pharmacy services, and perceived barriers for advancing the services in hospital environments with doctors and nurses who are key co-workers of the interdisciplinary team care services.Methods Semi-structured, in-depth interviews with eighteen doctors and fifteen nurses employing purposive and snowballing sampling strategies were conducted in ten hospitals in South Korea. Results The level of pharmaceutical care was varied across regions or institutions in South Korea. The concept of pharmaceutical care was insufficiently defined, and tended to be limited to some parts of medication counseling. Through pharmaceutical care services, doctors desired to acquire comprehensive drug information from and to share clinical responsibilities with pharmacists. Nurses wished to lower their burdens of medication counseling services from their daily practices. Doctors and nurses asked for pharmacists providing essential and carefully selected medication information to their patients in a patient-centered manner. The listed barriers to pharmaceutical care included the lack of appropriate systems for reward, insufficient accessibility to patient records by pharmacists, ambiguous role descriptions of pharmacist, and absence of effective communication among professionals. Conclusion A successful pharmaceutical care service model should allow efficient exchange of information among healthcare professionals to build inter-professional trust and to provide a continuity of care both in terms of time and setting. As prerequisites of such system, it was warranted to develop clinical evidence and an appropriate reward system for pharmaceutical care services.
Tabash, M I; Hussein, R A; Mahmoud, A H; El-Borgy, M D; Abu-Hamad, B A
To assess knowledge, attitude and practice (KAP) of healthcare staff regarding pharmaceutical waste management; and to determine the impact of an educational programme on the KAP survey items. Pre-post-test intervention study. The pre-intervention phase was performed using a sample of 530 out of 1500 healthcare workers. A predesigned interview questionnaire was used to assess KAP. Next, an educational programme was designed and offered to a subsample of 69 healthcare workers. KAP were re-assessed for the programme attendees using the same interview questionnaire, both immediately (post-test) and six months after the end of the programme (follow-up test). The parametric paired sample t-test was used to assess the difference between pre-test and follow-up test results. Poor knowledge and poor practice levels (scores 50%) detected in the pre-intervention phase were found to improve to satisfactory levels (scores ≥75%) in the follow-up phase. Attitude was found to be positive (score ≥75%) in all phases of the study. The educational programme led to a significant improvement in KAP of healthcare staff regarding pharmaceutical waste management (P<0.001). Copyright © 2016. Published by Elsevier Ltd.
Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...
Journal Homepage Image. We seek to encourage pharmaceutical and allied research of tropical and international relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. We publish articles in pharmaceutical sciences and related ...
Bruckel, Katy; Capozzoli, Ernest A
Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.
Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey
This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.
Paumgartten, Francisco José Roma
In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.
Kasper Munk Johannesen
Full Text Available To manage the challenge of limited healthcare resources and unlimited demand for healthcare, decision makers utilise a variety of demand side policies, such as health technology appraisals and international reference pricing to regulate price and utilisation. By controlling price and utilisation demand side policies determine the earnings potential, and hence the incentives to invest in research and development (R&D of new technologies. However, the impact of demand side policies on R&D incentives is seldom formally assessed.Based on the key assumption that intellectual property rights, i.e. patents, and expected rent are key drivers of pharmaceutical R&D, this work outlines a framework illustrating the link between demand side policies and pharmaceutical R&D incentives. By analysing how policies impact expected rent and consumer surplus, the framework is used to understand how commonly used demand side policies (including timing and length of reimbursement process, international reference pricing, parallel trade, and sequential adoption into clinical practice may influence R&D incentives.The analysis demonstrates that delayed reimbursement decisions as well as sequential adoption into clinical practise may in fact reduce both expected rent and consumer surplus. It is also demonstrated how international reference pricing is likely to increase consumer surplus at the expense of lower rent and thus lower R&D incentives.Although this work illustrates the importance of considering how demand side policies may impact long-term R&D incentives, it is important to note that the purpose has not been to prescribe which demand side policies should be utilised or how. Rather, the main contribution is to illustrate the need for a structured approach to the analysis of the complex, and at times highly politicised question of how demand side policies ultimately influence population health, both in the short and in the long term.
Lapalme, Marie-Ève; Doucet, Olivier
Patient care quality is a key concern for long-term care facilities and is directly related to effective collaboration between healthcare professionals. The use of agency staff in long-term care facilities creates important challenges in terms of coordination and communication within work units. The purpose of this study is to assess the mediating effect of common in-group identity in the relationship between permanent employees' perceptions regarding the use of agency workers -namely distributive justice, perceptions of threat, perceived similarities with agency workers, and leader inclusiveness toward agency staff- and the permanent employees' adoption of collaborative behaviours. Cross-sectional study. Three long-term care facilities. 290 regular healthcare employees (nurses and care attendants). Data were obtained through questionnaires filled out by employees. Hypotheses were tested using structural equation analyses. The results showed the indirect effects of perceived distributive justice, perceived similarity and leader inclusiveness toward agency workers on permanent employees' cooperation behaviours through common group identification. Perceptions of threat were not related to common group identification or collaborative behaviours. The results also showed that common in-group identification is related to cooperation behaviours only for employees without previous experience as agency workers. This study suggests that permanent healthcare employees who feel they are fairly compensated relative to agency workers, who consider these workers as similar to them, and who believe their supervisor appreciates agency workers' contributions tend to develop a common in-group identity, which fosters collaborative behaviours. Managers of long-term care facilities who wish to foster collaboration among their blended workforce should thus create an environment conducive of a more inclusive identity, particularly if their employees have no previous experience as agency
The concept of evidence-based medicine (EBM) has promulgated among healthcare professionals in recent years, on the other hand, the problem of underuse of useful clinical evidence is coming to be important. This is called as evidence-practice gap. The major concern about evidence-practice gap is insufficient implementation of evidence-based effective treatment, however, the perspective can be extended to measures to improve drug safety and prevention of drug related adverse events. First, this article reviews the characteristics of the database of receipt (healthcare claims) and the usefulness for research purpose of pharmacoepidemiology. Second, as the real example of the study on evidence-practice gap by using the receipt database, the case of ergot-derived anti-Parkinson drugs, of which risk of valvulopathy has been identified, is introduced. The receipt analysis showed that more than 70% of Parkinson's disease patients prescribed with cabergoline or pergolide did not undergo echocardiography despite the revision of the product label recommendation. Afterwards, the issues of pharmaceutical risk management and risk communication will be discussed.
R?muzat, C?cile; Urbinati, Duccio; Kornfeld, ?sa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aball?a, Samuel; Mzoughi, Olfa; Toumi, Mondher
Background and objective: With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm).Methods: A model was built to assess policy sc...
Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
Background and Objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ ph...
Harvey, Gill; Llewellyn, Sue; Maniatopoulos, Greg; Boyd, Alan; Procter, Rob
Accelerating the implementation of new technology in healthcare is typically complex and multi-faceted. One strategy is to charge a national agency with the responsibility for facilitating implementation. This study examines the role of such an agency in the English National Health Service. In particular, it compares two different facilitation strategies employed by the agency to support the implementation of insulin pump therapy. The research involved an empirical case study of four healthcare organisations receiving different levels of facilitation from the national agency: two received active hands-on facilitation; one was the intended recipient of a more passive, web-based facilitation strategy; the other implemented the technology without any external facilitation. The primary method of data collection was semi-structured qualitative interviews with key individuals involved in implementation. The integrated-PARIHS framework was applied as a conceptual lens to analyse the data. The two sites that received active facilitation from an Implementation Manager in the national agency made positive progress in implementing the technology. In both sites there was a high level of initial receptiveness to implementation. This was similar to a site that had successfully introduced insulin pump therapy without facilitation support from the national agency. By contrast, a site that did not have direct contact with the national agency made little progress with implementation, despite the availability of a web-based implementation resource. Clinicians expressed differences of opinion around the value and effectiveness of the technology and contextual barriers related to funding for implementation persisted. The national agency's intended roll out strategy using passive web-based facilitation appeared to have little impact. When favourable conditions exist, in terms of agreement around the value of the technology, clinician receptiveness and motivation to change, active
Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012-2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (-€9,367 million), France (-€5,589 million), and, far behind them
Reyes-Alcázar, Víctor; Casas-Delgado, Marta; Herrera-Usagre, Manuel; Torres-Olivera, Antonio
The aim of this study was to identify the different groups that can affect or be affected by an agency charged with the promoting and guaranteeing of health care quality in Andalusian region (Spain) and to provide a framework with the stakeholders included in different categories. The study adopted a cross-sectional research design. A case study with structured interviews among Andalusian Agency for Healthcare Quality Steering Committee members was carried out in 2010 to define stakeholders' categories and map the interest groups using 5 attributes: influence, importance, legitimacy, power, and urgency. After identification and categorization, stakeholders were weighted qualitatively according to the attributes of importance and influence using 4 possible levels. A matrix was made with the collected data relating both attributes. Furthermore, 8 different types of stakeholders were identified according to attributes power, legitimacy, and urgency. The study concludes that identifying and classifying stakeholders are fundamental to ensuring the success of an organization that must respond to needs and expectations, especially those of its clients. Moreover, knowing stakeholder linkages can contribute to increase organizational worth. This is essential for organizations basically directed to the provision of services in the scope of health care.
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... continuous manufacturing for pharmaceutical products. Speakers from the Agency, academia, and industry will...
Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar
Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...
Keyes, Margaret A; Ortiz, Eduardo; Queenan, Deborah; Hughes, Ronda; Chesley, Francis; Hogan, Eileen M
.... While the Agency for Healthcare Research and Quality (AHRQ) has historically funded some research on patient safety, much of that support was driven by a small number of highquality investigator-initiated research projects...
Payne, Julianne; Leiter, Jeffrey
Since the 1970s, the healthcare industry has undergone significant changes. Using neo-institutional and resource dependency theories, the purpose of this paper is to explore how managers perceive constraint and enact agency amidst these historic challenges--perhaps most significantly, declining funding and increasing regulation. The data come from ten interviews with healthcare managers, spanning for-profit, non-profit, and government legal forms and hospital and nursing home sub-industries in both Queensland, Australia and North Carolina, USA. The authors look for patterns across the interviews. The paper shows that governments and umbrella "parent" organizations force managers to adhere to institutional expectations in exchange for resource investment. Managers navigate these environmental obstacles using a shared business-minded approach and competitive differentiation. Yet various interest groups--including front-line workers, physicians, and patients--challenge this paradigm, as they demand a focus on quality of care. Managers' efforts are likewise curbed by the very resource and institutional pressures they resist. The authors understand changes in the healthcare industry as resulting from an increasingly powerful managerial logic, at odds with traditional professional and societal values. Interest groups are best positioned to challenge this logic.
Full Text Available Abstract Background Strategies adopted by health administrations and directed towards drug cost control in primary care (PC can, according to earlier studies, generate tension between health administrators and healthcare professionals. This study collects and analyzes the opinions of general practitioners (GPs regarding current cost control measures as well as their proposals for improving the effectiveness of these measures. Methods A qualitative exploratory study was carried out using 11 focus groups composed of GPs from the Spanish regions of Aragon, Catalonia and the Balearic Islands. A semi-structured guide was applied in obtaining the GPs' opinions. The transcripts of the dialogues were analyzed by two investigators who independently considered categorical and thematic content. The results were supervised by other members of the team, with overall responsibility assigned to the team leader. Results GPs are conscious of their public responsibility with respect to pharmaceutical cost, but highlight the need to spread responsibility for cost control among the different actors of the health system. They insist on implementing measures to improve the quality of prescriptions, avoiding mere quantitative evaluations of prescription costs. They also suggest moving towards the self-management of the pharmaceutical budget by each health centre itself, as a means to design personalized incentives to improve their outcomes. These proposals need to be considered by the health administration in order to pre-empt the feelings of injustice, impotence, frustration and lack of motivation that currently exist among GPs as a result of the implemented measures. Conclusion Future investigations should be oriented toward strategies that involve GPs in the planning and management of drug cost control mechanisms. The proposals in this study may be considered by the health administration as a means to move toward the rational use of drugs while avoiding concerns
Aksu, Buket; De Beer, Thomas; Folestad, Staffan
however have the potential to provide considerable challenges to the establishment of cost effective and robust supply chains. To guarantee product quality and surety of supply for essential medicines it is necessary that manufacturing science keeps pace with advances in pharmaceutical R......Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals......&D. In this position paper, the EUFEPS QbD and PAT Sciences network make recommendations that European industry, academia and health agencies focus attention on delivering step changes in science and technology in a number of key themes. These subject areas, all underpinned by the sciences allied to QbD and PAT...
Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin
Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended.
California Natural Resource Agency — The Licensed Healthcare Facilities point layer represents the locations of all healthcare facilities licensed by the State of California, Department of Health...
The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064
Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul
The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.
Lexchin, Joel; Kohler, Jillian Clare; Gagnon, Marc André; Crombie, James; Thacker, Paul; Shnier, Adrienne
Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.
Wang, Dan; Liu, Chenxi; Zhang, Zinan; Ye, Liping; Zhang, Xinping
With the impressive advantages of patient-pharmacist communication being advocated and poor pharmacist-patient communication in different settings, it is of great significance and urgency to explore the mechanism of the pharmacist-patient communicative relationship. The King's theory of goal attainment is proposed as one of the most promising models to be applied, because it takes into consideration both improving the patient-pharmacist relationship and attaining patients' health outcomes. This study aimed to validate the King's transaction process and build the linkage between the transaction process and patient satisfaction in a pharmaceutical context. A cross-sectional study was conducted in four tertiary hospitals in two provincial cities (Wuhan and Shanghai) in central and east China in July 2017. Patients over 18 were investigated in the pharmacies of the hospitals. The instrument for the transaction process was revised and tested. Path analysis was conducted for the King's transaction process and its relationship with patient satisfaction. Five hundred eighty-nine participants were investigated for main study. Prior to the addition of covariates, the hypothesised model of the King's transaction process was validated, in which all paths of the transaction process were statistically significant (p process had direct effects on patient satisfaction (p process was established as one valid theoretical framework of healthcare provider-patient communication in a pharmaceutical context. Copyright © 2018 Elsevier Inc. All rights reserved.
... Clinicians & Providers Data & Measures Education & Training Health Information Technology ... Sources Available from AHRQ Healthcare Cost and Utilization Project (HCUP) Medical Expenditure Panel ...
Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.
During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...
Code of ethics represents the principles that form the fundamental basis of the roles and responsibilities of pharmacists in pharmaceutical practice. According to pharmacy practice, pharmacists are confirmed as healthcare professionals with unique knowledge, skills and responsibilities for safe and efficient medication therapy management in order to optimize therapeutic outcomes. The scope of pharmacy practice includes technical aspects of pharmaceutical services, the preparation of p...
Full Text Available Since the formation of the Social Security Agency (Badan Penyelenggara Jaminan Sosial/BPJS for Healthcare has found the public spotlight rising with its management; including the regulatory body BPJS for Healthcare activities. BPJS for Healthcare external supervisors such as DJSN, OJK, BPK are entities established according to the Law of the Republic of Indonesia 24 Year 2011. However, there are views on neutrality, independence, and supervisor capability. By using Soft System Methodology, this research invites us to understand the problem situation and what efforts should be taken in managing the complexity. This paper will analyze the co-operation with collaborative governance perspective as a cooperative approach in overseeing BPJS for Healthcare. The focus of this paper is in the stage of identifying a series of factors that are crucial within the collaborative process itself, which includes shared understanding as stated by Ansel & Gash (2008 and Emerson & Nabatchi (2015.
Rashidian, Arash; Omidvari, Amir-Houshang; Vali, Yasaman; Sturm, Heidrun; Oxman, Andrew D
The proportion of total healthcare expenditures spent on drugs has continued to grow in countries of all income categories. Policy-makers are under pressure to control pharmaceutical expenditures without adversely affecting quality of care. Financial incentives seeking to influence prescribers' behaviour include budgetary arrangements at primary care and hospital settings (pharmaceutical budget caps or targets), financial rewards for target behaviours or outcomes (pay for performance interventions) and reduced benefit margin for prescribers based on medicine sales and prescriptions (pharmaceutical reimbursement rate reduction policies). This is the first update of the original version of this review. To determine the effects of pharmaceutical policies using financial incentives to influence prescribers' practices on drug use, healthcare utilisation, health outcomes and costs (expenditures). We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (searched 29/01/2015); MEDLINE, Ovid SP (searched 29/01/2015); EMBASE, Ovid SP (searched 29/01/2015); International Network for Rational Use of Drugs (INRUD) Bibliography (searched 29/01/2015); National Health Service (NHS) Economic Evaluation Database (searched 29/01/2015); EconLit - ProQuest (searched 02/02/2015); and Science Citation Index and Social Sciences Citation Index, Institute for Scientific Information (ISI) Web of Knowledge (citation search for included studies searched 10/02/2015). We screened the reference lists of relevant reports and contacted study authors and organisations to identify additional studies. We included policies that intend to affect prescribing by means of financial incentives for prescribers. Included in this category are pharmaceutical budget caps or targets, pay for performance and drug reimbursement rate reductions and other financial policies, if they were specifically targeted at prescribing or drug utilisation. Policies in this review were defined as laws, rules
Full Text Available This study aims to determine the reliability of assessment criteria used for a portfolio at the Andalusian Agency for Healthcare Quality (ACSA. Data: all competences certification processes, regardless of their discipline. Period: 2010-2011. Three types of tests are used: 368 certificates, 17,895 reports and 22,642 clinical practice reports (N = 3,010 candidates. The tests were evaluated in pairs by the ACSA team of raters using two categories: valid and invalid. Results: The percentage agreement in assessments of certificates was 89,9%, while for the reports of clinical practice was 85,1 % and for clinical practice reports was 81,7%. The inter-rater agreement coefficients (kappa ranged from 0,468 to 0,711. Discussion: The results of this study show that the inter-rater reliability of assessments varies from fair to good. Compared with other similar studies, the results put the reliability of the model in a comfortable position. Among the improvements incorporated, progressive automation of evaluations must be highlighted.
We summarize the 2016 update of the 2004 Agency of Healthcare Research and Quality's evidence review of omega-3 fatty acids and cardiovascular disease (CVD). The overall findings for the effects of marine oil supplements on intermediate CVD outcomes remain largely unchanged. There is high strength o...
Kleywegt, Sonya; Pileggi, Vince; Lam, Yuet Ming; Elises, Alan; Puddicomb, Aaron; Purba, Gurminder; Di Caro, Joanne; Fletcher, Tim
Concentrations and percent loadings of pharmaceutically active compounds (PhACs) and other emerging contaminants released from healthcare facilities (2 hospitals and a long-term care facility) to a sewage treatment plant (STP) in a large urban sewershed were evaluated. An additional hospital outside the sewershed was also monitored. Fourteen of the 24 steroids/hormones and 88 of the 117 PhACs and emerging contaminants were detected at least once. Commonly used substances, including cotinine, caffeine and its metabolite 1,7-dimethylxanthine, ibuprofen and naproxen (analgesics), venlafaxine (antidepressant), and N,N-diethyl-meta-toluamide (insect repellant), were detected in all samples at all sites. Concentrations detected in the large specialty hospital outside the sewershed were similar to those within the sewershed. Cytotoxic drugs (tamoxifen and cyclophosphamide) and x-ray contrast media (iopamidol and diatrizoic acid) were infrequently detected in hospital effluents. Analysis for antibiotics indicated that azithromycin, clarithromycin, ciprofloxacin, erythromycin, ofloxacin, and sulfamethoxazole were consistently detected in hospital wastewaters, as was triclosan (antibacterial agent). Fifteen compounds individually contributed greater than 1% to the total PhAC and emerging contaminant load to the STP from the 2 hospitals in the sewershed, and 9 compounds in the STP effluent exceeded ecotoxicological criteria. The present survey demonstrates that point source discharges from healthcare facilities in this sewershed make a small contribution to the overall PhAC and emerging contaminant loading compared with the total concentrations entering the receiving STP. © 2015 SETAC.
Brisseau, Lionel; Bussières, Jean-François; Bois, Denis; Vallée, Marc; Racine, Marie-Claude; Bonnici, André
To establish a consensual and coherent ranking of healthcare programmes that involve the presence of ward-based and clinic-based clinical pharmacists, based on health outcome, health costs and safe delivery of care. This descriptive study was derived from a structured dialogue (Delphi technique) among directors of pharmacy department. We established a quantitative profile of healthcare programmes at five sites that involved the provision of ward-based and clinic-based pharmaceutical care. A summary table of evidence established a unique quality rating per inpatient (clinic-based) or outpatient (ward-based) healthcare programme. Each director rated the perceived impact of pharmaceutical care per inpatient or outpatient healthcare programme on three fields: health outcome, health costs and safe delivery of care. They agreed by consensus on the final ranking of healthcare programmes. A ranking was assigned for each of the 18 healthcare programmes for outpatient care and the 17 healthcare programmes for inpatient care involving the presence of pharmacists, based on health outcome, health costs and safe delivery of care. There was a good correlation between ranking based on data from a 2007-2008 Canadian report on hospital pharmacy practice and the ranking proposed by directors of pharmacy department. Given the often limited human and financial resources, managers should consider the best evidence available on a profession's impact to plan healthcare services within an organization. Data are few on ranking healthcare programmes in order to prioritize which healthcare programme would mostly benefit from the delivery of pharmaceutical care by ward-based and clinic-based pharmacists. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.
M. M. Bahlol
Full Text Available Purpose. Pharmaceutical industry is transnational and globally important. Many pharmaceutical companies operate their business in multinational and international forms in different countries. Diverse researches from different countries indicated and confirmed marketing promotion importance in pharmaceutical field. Therefore, marketing promotion and its effects are a very important issue that should be globally investigated in real life and evidence context. We oriented our research according to these scientific and practical values.Methodology. We reviewed pharmaceutical marketing promotion researches from more than 25 different countries, e.g., USA, Canada, Italy, France, Russia, India, Egypt and Syria where we employed our knowledge of three widely spread languages, i.e., English, Russian and Arabic. Such language variation supports us with large and variable amount of scientific knowledge, deep understanding and ability of analysis. Some studies investigated average response to pharmaceutical marketing promotion and few studies took into consideration heterogeneity in their effects with respect to advertising medium or drug characteristics.Originality. We investigated empirical evidences of pharmaceutical marketing promotion that can be directed to either consumer or healthcare professionals.Findings. We extracted, gathered and associated information of pharmaceutical promotion globally which oriented us to several evidence and practical facts with regard to employing promotion tools in different definite situations pertinent to main directions; their welfare and health enhancing effects and adverse effects. Practical Implications- Consequently, we developed practically-oriented guidelines for companies concerning pharmaceutical promotion globally ate the end of this paper.
Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...
Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B
Pharmaceutical care practice has been championed as the primary mission of the pharmacy profession, but its implementation has been suboptimal in many developing countries including Kuwait. Pharmacists must have sufficient knowledge, skills, and positive attitudes to practise pharmaceutical care, and barriers in the pharmacy practice model must be overcome before pharmaceutical care can be broadly implemented in a given healthcare system. To investigate hospital pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care, and the barriers to its implementation in Kuwait. Six general hospitals, eight specialized hospitals and seven specialized health centers in Kuwait. A descriptive, cross-sectional survey was distributed to all pharmacists working in the governmental hospitals in Kuwait (385 pharmacists). Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (standard deviations) were calculated and compared using statistical package for social sciences, version 20. Statistical significance was accepted at a p value of Kuwait. Completed surveys were received from 250 (64.9%) of the 385 pharmacists. Pharmacists expressed overall positive attitudes towards pharmaceutical care. They felt well prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Pharmacists with more practice experience expressed significantly more positive attitudes towards pharmaceutical care (p = 0.001) and they felt better prepared to provide pharmaceutical care competencies (p Kuwait advocate implementation of pharmaceutical care while also appreciating the organizational, technical and professional barriers to its widespread adoption. Collaborative efforts between health authorities and educational institutions, and the integration of innovative approaches in
Guérin, A; Thibault, M; Nguyen, C; Lebel, D; Bussières, J-F
While the concept of clinical pharmacy was developed in the 1960s, clinical programs are characterized by their great variety and disparity when it comes to the presence of pharmacists in healthcare sectors. This article aims to describe a method in which pharmaceutical care sectors in healthcare facilities can be upgraded. This is a descriptive study supporting the upgrade of pharmaceutical care practiced in the surgery sector of a 500-bed mother-child university hospital center, the CHU Sainte-Justine. The pharmacy department employs more than 70 healthcare professionals. The study involved these proposed upgrading steps: firstly, a review of the literature; secondly, a description of the profile of the sector; thirdly, a description of the upgrading of pharmacist practice in surgery. A total of 137 articles were compiled, seven of which were selected to evaluate the impact and eight a description of the pharmacist's role in surgery. The authors did not identify any particular pharmaceutical activity based on very good quality data (A). However, there were five based on good quality data (B) and seven that lacked adequate proof (C, D) in relation to the practice of surgery. Nevertheless, a number of other authors described the development of the pharmacist's clinical role in surgery. There are few data on the impact of pharmacists in surgery. This descriptive study proposes a number of steps aimed at upgrading pharmaceutical care within a Quebec university hospital center. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
Healthcare provision is one of the import elements of modern societies. Life sciences and technology has made substantial progress over the past century and is continuing to evolve exponentially in many different areas. The use of genotypic and phenotypic information in drug discovery and drug therapy, the increasing wealth around the world, growing patient involvement through information and communication technology and finally innovations in pharmaceutical manufacturing technology are transforming the provision of healthcare. The adoption of this new science and technology is going to happen due to the synergistic effects and visible benefits for the society and healthcare systems. The different aspects driving advanced pharmaceutical manufacturing are reviewed to identify future research direction to assure overall acceptance and adoption into healthcare practice. Copyright © 2015 Elsevier B.V. All rights reserved.
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General..., 2011, the committee will discuss current strategies for FDA's Office of Pharmaceutical Science...
...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General.... In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and...
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... session, the Office of Pharmaceutical Science and the Office of Compliance will discuss with the committee...
... Report of Covered Pharmaceutical Manufacturers and Importers (Form-8947) AGENCY: Internal Revenue Service...)). Currently, the IRS is soliciting comments concerning Form-8947, Report of Covered Pharmaceutical...: Title: Report of Covered Pharmaceutical Manufacturers and Importers. OMB Number: 1545-XXXX. Form Number...
Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J
This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main
Bowen, W Richard
Engineering makes profound contributions to our health. Many of these contributions benefit whole populations, such as clean water and sewage treatment, buildings, dependable sources of energy, efficient harvesting and storage of food, and pharmaceutical manufacture. Thus, ethical assessment of these and other engineering activities has often emphasized benefits to communities. This is in contrast to medical ethics, which has tended to emphasize the individual patient affected by a doctor's actions. However technological innovation is leading to an entanglement of the activities, and hence ethical responsibilities, of healthcare professionals and engineering professionals. The article outlines three categories of innovation: assistive technologies, telehealthcare and quasi-autonomous systems. Approaches to engineering ethics are described and applied to these innovations. Such innovations raise a number of ethical opportunities and challenges, especially as the complexity of the technology increases. In particular the design and operation of the technologies require engineers to seek closer involvement with the persons benefiting from their work. Future innovation will require engineers to have a good knowledge of human biology and psychology. More particularly, healthcare engineers will need to prioritize each person's wellbeing, agency, human relationships and ecological self rather than technology, in the same way that doctors prioritize the treatment of persons rather than their diseases.
Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
Background and objective With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods A model was built to assess policy scenarios’ impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Results Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Conclusions Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate
Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I
The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.
Lapão, Luís Velez; da Silva, Miguel Mira; Gregório, João
The rising prevalence of chronic diseases is pressing health systems to introduce reforms. Primary healthcare and multidisciplinary models have been suggested as approaches to deal with this challenge, with new roles for nurses and pharmacists being advocated. More recently, implementing healthcare based on information systems and technologies (e.g. eHealth) has been proposed as a way to improve health services. However, implementing online pharmaceutical services, including their adoption by pharmacists and patients, is still an open research question. In this paper we present ePharmacare, a new online pharmaceutical service implemented using Design Science Research. The Design Science Research Methodology (DSRM) was chosen to implement this online service for chronic diseases management. In the paper, DSRM's different activities are explained, from the definition of the problem to the evaluation of the artifact. During the design and development activities, surveys, observations, focus groups, and eye-tracking glasses were used to validate pharmacists' and patients' requirements. During the demonstration and evaluation activities the new service was used with real-world pharmacists and patients. The results show the contribution of DSRM in the implementation of online services for pharmacies. We found that pharmacists spend only 50% of their time interacting with patients, uncovering a clear opportunity to implement online pharmaceutical care services. On the other hand, patients that regularly visit the same pharmacy recognize the value in patient follow-up demanding to use channels such as the Internet for their pharmacy interactions. Limitations were identified regarding the high workload of pharmacists, but particularly their lack of know-how and experience in dealing with information systems (IST) for the provision of pharmaceutical services. This paper summarizes a research project in which an online pharmaceutical service was proposed, designed, developed
Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L
Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.
... engagement and on the current organizational culture and climate surrounding patient and family engagement... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research...
... system change and informs the implementation process and impact evaluation. Using a mixed-methods design... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research...
... system change and informs the implementation process and impact evaluation. Using a mixed-methods design... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research...
The Healthcare Cost and Utilization Project is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership and sponsored by the Agency for Healthcare Research and Quality.
Swift, Elaine K
The Agency for Healthcare Research Quality commissioned the Institute of Medicine establish a committee to provide guidance on the National Healthcare Disparities Report is of access to health care...
... Transforming Healthcare Quality through Information Technology (THQIT).'' In accordance with the Paperwork... Cooperative Agreements for Transforming Healthcare Quality Through Information Technology (THQIT) AHRQ's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency...
Dipak Dilip Gadade
Full Text Available Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.
Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar
Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.
Tanvejsilp, Pimwara; Loeb, Mark; Dushoff, Jonathan; Xie, Feng
In Thailand, pharmaceutical care has been recently introduced to a tertiary hospital as an approach to improve adherence to tuberculosis (TB) treatment in addition to home visit and modified directly observed therapy (DOT). However, the economic impact of pharmaceutical care is not known. The aim of this study was to estimate healthcare resource uses and costs associated with pharmaceutical care compared with home visit and modified DOT in pulmonary TB patients in Thailand from a healthcare sector perspective inclusive of out-of-pocket expenditures. We conducted a retrospective study using data abstracted from the hospital billing database associated with pulmonary TB patients who began treatment between 2010 and 2013 in three hospitals in Thailand. We used generalized linear models to compare the costs by accounting for baseline characteristics. All costs were converted to international dollars (Intl$) RESULTS: The mean direct healthcare costs to the public payer were $519.96 (95%confidence interval [CI] 437.31-625.58) associated with pharmaceutical care, $1020.39 (95% CI 911.13-1154.11) for home visit, and $887.79 (95% CI 824.28-955.91) for modified DOT. The mean costs to patients were $175.45 (95% CI 130.26-230.48) for those receiving pharmaceutical care, $53.77 (95% CI 33.25-79.44) for home visit, and $49.33 (95% CI 34.03-69.30) for modified DOT. After adjustment for baseline characteristics, pharmaceutical care was associated with lower total direct costs compared with home visit (-$354.95; 95% CI -285.67 to -424.23) and modified DOT (-$264.61; 95% CI -198.76 to -330.46). After adjustment for baseline characteristics, pharmaceutical care was associated with lower direct costs compared with home visit and modified DOT.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
Purpose: To explore healthcare providers' (HCPs) and medical students' attitudes to, and perceptions of the pharmaceutical services that clinical pharmacists can provide in United Arab Emirates. Methods: A total of 535 participants (265 HCPs and 270 medical students) were asked to complete a questionnaire over a ...
Navigating through the maze of pricing and affordability of branded pharmaceuticals in the midst of the financial crisis: a comparative study among five European recession countries, from a Cyprus perspective.
Petrou, Panagiotis; Talias, Michael A
healthcare, health agencies must reassess affordability of medicines and minimise catastrophic expenditure impact. Health agencies should primarily try to enhance efficiency of the system and reduce waste, instead of resorting to blunt budget reduction, which can demonstrate unpredictable consequences in public health.
For nearly 4 years, the Pittsburgh Regional Healthcare Initiative (PRHI) has been working to improve the way healthcare is delivered in southwestern Pennsylvania by combining the voices and resources of hospitals, providers, the business community, insurers, health plans, and federal agencies. As one example of borrowing from business, the PRHI has created a new learning and management system, called Perfecting Patient Care, which is based on the Toyota Production System model and is now being used successfully in hospitals.
ten Ham, Martijn
Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.
Yonemori, Kan; Hirakawa, Akihiro; Ando, Masashi; Hirata, Taizo; Yunokawa, Mayu; Shimizu, Chikako; Tamura, Kenji; Fujiwara, Yasuhiro
The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology) between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.
Vatovec, Christine; Senier, Laura; Bell, Michael
Healthcare organizations are increasingly examining the impacts of their facilities and operations on the natural environment, their workers, and the broader community, but the ecological impacts of specific healthcare services provided within these institutions have not been assessed. This paper provides a qualitative assessment of healthcare practices that takes into account the life-cycle impacts of a variety of materials used in typical medical care. We conducted an ethnographic study of three medical inpatient units: a conventional cancer ward, palliative care unit, and a hospice center. Participant observations (73 participants) of healthcare and support staff including physicians, nurses, housekeepers, and administrators were made to inventory materials and document practices used in patient care. Semi-structured interviews provided insight into common practices. We identified three major domains that highlight the cumulative environmental, occupational health, and public health impacts of medical supplies and pharmaceuticals used at our research sites: (1) medical supply procurement; (2) generation, handling, and disposal of medical waste; and (3) pharmaceutical handling and disposal. Impacts discovered through ethnographic inquiry included occupational exposures to chemotherapy and infectious waste, and public health exposures to pharmaceutical waste. This study provides new insight into the environmental, occupational, and public health impacts resulting from medical practices. In many cases, the lack of clear guidance and regulations regarding environmental impacts contributed to elevated harms to the natural environment, workers, and the broader community.
The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.
This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.
Apr 1, 2010 ... Book cover Primary Healthcare Spending: Striving for Equity under Fiscal Federalism ... Primary Healthcare Spending is an important reference for ... field of health policy and health economics, agencies involved in providing ...
Coustasse, Alberto; Kimble, Craig A; Stanton, Robert B; Naylor, Mariah
Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation.
A teoria da agência no setor da saúde: o caso do relacionamento da Agência Nacional de Saúde Suplementar com as operadoras de planos de assistência supletiva no Brasil Agency theory in the healthcare sector: the relationship between the National Supplementary Healthcare Agency and the supplementary health-care operators in Brazil
Fábio Ricardo Loureiro Sato
Full Text Available O relacionamento entre os atores do sistema supletivo de assistência à saúde no Brasil é caracterizado por uma complexa trama de conflitos de interesse e de poder, que podem ser analisados à luz da teoria da agência. Ela emprega elementos da ciência econômica, principalmente das teorias do consumidor e do funcionamento de mercado, conjuntamente com idéias derivadas dos estudos organizacionais e comportamentais, faz uma divisão entre os agentes econômicos em principais e agentes. Analisando o mercado de assistência supletiva, pode-se constatar que ele possui inúmeros atores, que exercem ao mesmo tempo papéis de agentes e principais. É justamente dessa dualidade de papéis que surgem grande parte dos conflitos, e, através de diversos mecanismos de regulação, tenta-se reduzir os custos de agência derivados dos conflitos de interesse que são a causa principal dos problemas de agência dentro desse setor.The relationship between the actors of the supplementary healthcare system in Brazil is characterized by complex conflicts of interests and power struggles, which can be analyzed by the agency theory. This theory - combining elements of economic sciences, mainly consumer and market theories, with ideas derived from organizational and behavioral studies - divides the economic agents in principals and agents. The analysis of the supplementary healthcare market reveals its many actors play simultaneously the roles of agent and principal. This duality of roles is the root of most conflicts, originating several regulation mechanisms which try to reduce agency costs derived from conflicts of interests that are the main cause of this sector's agency issues.
Full Text Available Pharmaceutical care is patient oriented pharmacy practice that required other healthcare to optimize drug therapy. In the management of diabetes mellitus indicators was established as a target in pharmaceutical care. The purpose of this paper is to evaluate pharmaceutical care program, in order to optimize clinical result and quality of life of the patient diabetes mellitus, and to identify indicators in pharmaceutical care program for patient diabetes mellitus as well. Research of the impact of pharmaceutical care program for diabetes mellitus patient have been done in other countries. The results showed that diabetes mellitus indicators in patients managed with pharmaceutical care program were better than those without that program applied. All patients with intervention of pharmaceutical care program can control clinical result such as blood glucose, blood presure, level of HbA1C, HDL, LDL and total cholesterol. The patient’s quality of life with intervention had improved compare to those without intervention. Indicators to evaluate pharmaceutical care program have changed from clinical indicators only to clinical plus quality of life indicators. Pharmaceutical care program was useful to improve clinical result and quality of life of diabetic patient. Quality of life indicators could be added to evaluate pharmaceutical care program. Pharmaceutical care program brings about positif impact for patient, provider, pharmacist and economic aspect as well.
Full Text Available Introduction. In recent years as the global problem of healthcare in many countries acts diabetes, number of patients with this disease is growing and is already 4-6% of the population in developed countries. These indicators enable WHO experts include diabetes to one of the four priority non-infectious diseases and non-infectious epidemic of the 21st century. Because of chronic disease of diabetes decreases the quality of life of citizens, develops related diseases such as stroke, heart attack, blindness, kidney failure, amputation of the lower extremities causing deaths. Therefore, programs to combat diabetes and its prevention is a priority for national healthcare systems without exception countries. Materials and methods. Circulation of the registered antidiabetic medicines in Ukraine during pricing and delivery (example; forensic and pharmaceutical practice of the complaints and appeals on the availability for them of the antidiabetic medicines; pricing characteristics of the antidiabetic medicines over the period of 2012–2015. Methods: normative and legal, documentary, bibliographic, statistical, comparative, forensic and pharmaceutical, graphical analysis. Results and discussion. The study of organization of circulation of the antidiabetic medicines requires a systematic approach from the organizational, legal and forensic and pharmaceutical research. Today in Ukraine the arsenal of drugs for the treatment of diabetes presented with more than 85 registered antidiabetic drugs for trade names, of which 60% – insulin, and the remaining 40% – oral hypoglycemic drugs offered in a 210 release forms. Given forensic and pharmaceutical example shows that the barrier, which reduces the availability of antidiabetic medicines for diabetics at discounted prescription is mandatory registration of wholesale prices, because that price mechanism of registration by the Ministry of Healthcare of Ukraine interferes with the right of privileged
Smolka, Kirstin; Gronwald, Klaus
Crime on the internet has grown accordingly to the increased use of the internet in everyday life. This includes illegal trading of pharmaceuticals via the internet. Trading in pharmaceuticals as "special commodities" underlies certain legal regulations in Germany, as in most other countries worldwide.Mail order trade (colloquially also known as internet trade) in pharmaceuticals requires approval of the competent regulatory authority. However, numerous illegal internet vendors of medicines present their websites to customers, purporting to be legal pharmacies and trading good and genuine medicines.It is not always easy for customers or patients to distinguish between legal websites, i. e. pharmacies operating with the approval of the authorities, and illegal, criminal websites. Patients accept dangerous risks when they order medicines on such illegal websites. Consumption of falsified or unlicensed pharmaceuticals of unknown origin often exposes patients' health to serious risks and dangers.Operation PANGEA is now in its tenth year of fighting illegal internet trade in pharmaceuticals at an internationally coordinated level. The results of Operation PANGEA are published in national and international media. Thus the public should be alert to the risks of buying medicines from one of the numerous illegal vendors on the internet.The competence for combatting illegal sales of medicines lies with customs and police agencies amongst others. These enforcement agencies regularly participate in the annual PANGEA Operations. The following article describes the origin and background of this operation, and outlines both the work of customs and police in this context, as well as the results of the latest PANGEA Operation.
Full Text Available BACKGROUND: The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. METHODS/PRINCIPAL FINDINGS: Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. CONCLUSION/SIGNIFICANCE: Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.
Full Text Available Pharmaceuticals are a class of emerging environmental contaminants that are extensively and increasingly being used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have been detected in many environmental samples worldwide. The establishment of chemical analysis methods able to determine more polar compounds allow the determination and identification of trace quantities of drugs and their metabolites. Most regulatory agencies require that environmental risk assessment is performed as an integral part of their approval procedures for the marketing for medicinal products. Marketing approval for medicinal products in the European Union is regulated by the Directive 2001/83/EC. Based on the Directive, the European Medicines Agency (EMA has published guidelines describing the procedure for the environmental risk assessment for medicinal products marketed in the EU. The requirements for the Environmental risk assessment (ERA in Croatia are regulated by the Medicinal Products Act (Official Gazette No. 71/07 and the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08.
Fisher, Jill A; Ronald, Lorna M
Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and
Brown, P.; Calnan, M.
Pharmaceutical products are commonly relied upon by professionals, and correspondingly patients, within a wide range of healthcare contexts. This dependence, combined with the inherent risk and uncertainty surrounding both medical practice and the drugs it harnesses, points towards the importance of
Full Text Available Taking into account global trends in the development of healthcare, there were scientifically grounded conceptual model of pharmaceutical care to outpatients with diabetes mellitus and the integrated technology of managing processes of pharmaceutical care on the basis of personalization in pharmaceutical care, specialization of pharmacies, modeling procedures of information exchange between medical institutions and pharmacies, optimization of prescription and providing drugs, providing information and consulting services with the use of methods and means of modern information technologies, the development of step-by-step guides for the implementation of control technologies, the creation of a system of continuous professional education of pharmacy specialists in the field of diabetes mellitus.
...] Rollins College; T.A. Loving Co.; US Ecology Idaho, Inc.; and West Pharmaceutical Services, Inc... Pharmaceutical Services, Inc. V-77-9 01/20/1978 43 FR 2945 1910.217(c)(3)(i)(e) and (formerly The West Co.). 1910... the variance (Ex. 2--OSHA-2012-0024). 3. West Pharmaceutical Services, Inc. The Agency granted The...
Rose-Ackerman, Susan; Tan, Yingqi
Calls for reform of the Chinese healthcare system are voiced at the highest levels of the Chinese government, but reform cannot succeed unless policymakers confront the incentives for corruption built into the institutional structure of the healthcare system. Focusing on the markets for pharmaceuticals and medical equipment, this article isolates the special features of the Chinese healthcare system that are conducive to corruption. Without denying the responsibility of individual corporate r...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency... Organization (HRO) staff, and healthcare system staff in various teamwork, communication, and patient safety... understand the extent to which this infrastructure of patient safety knowledge and skills has been created...
This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.
Epstein, Richard J
The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceutical companies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets.
Sasu, Samuel; Kümmerer, Klaus; Kranert, Martin
The practice of use and disposal of waste from pharmaceuticals compromises the safety of the environment as well as representing a serious health risk, as they may accumulate and stay active for a long time in the aquatic environment. This article therefore presents the outcome of a study on pharmaceutical waste management practices at homes and hospitals in Ghana. The study was conducted at five healthcare institutions randomly selected in Ghana, namely two teaching hospitals (hospital A, hospital B), one regional hospital (hospital C), one district hospital (hospital D) and one quasi-governmental hospital (hospital E). Apart from hospital E which currently has a pharmaceutical waste separation programmr as well as drug return programme called DUMP (Disposal of Unused Medicines Program), all other hospitals visited do not have any separate collection and disposal programme for pharmaceutical waste. A survey was also carried out among the general public, involving the questioning of randomly selected participants in order to investigate the household disposal of unused and expired pharmaceuticals. The results from the survey showed that more than half of the respondents confirmed having unused, left-over or expired medicines at home and over 75% disposed of pharmaceutical waste through the normal waste bins which end up in the landfills or dump sites.
Tahir, Shaila; Rafique, Adeela; Ghafoor, Farkhanda; Saleem, Akif; Khan, Amanullah
Interaction of pharmaceutical companies (PC) with healthcare services has been a reason for concern. In medicine, awareness of the ethical implications of these interactions have been emphasized upon, while this issue has not been highlighted in dentistry. This study undertook a cross-sectional rapid assessment procedure to gather views of dentists in various institutions towards unethical practices in health care and pharmaceutical industry. The purpose of this study was to assess the need for the formulation and implementation of guidelines for the interaction of dentists with the pharmaceutical and device industry in the best interest of patients. A group of 209 dentists of Lahore including faculty members, demonstrators, private practitioners and fresh graduates responded to a questionnaire to assess their attitudes and practices towards pharmaceutical companies' marketing gifts. The study was conducted during 2011 and provided interesting data that showed the pharmaceutical industry is approaching private practitioners more frequently than academicians and fresh graduates. Private practioners accepted the gifts but mostly recognized them as unethical (over 65%). Both groups considered sponsoring of on-campus lectures as acceptable (over 70%). Respondents are not fully aware of the ethical demands which are imperative for all health care industries, and there is a dire need of strict guidelines and code of ethics for the dentist's interaction with the pharmaceutical and device industry so that patient interest is protected.
Feibert, Diana Cordes; Andersen, Bjørn; Jacobsen, Peter
Logistics processes in hospitals are vital in the provision of patient care. Improving healthcare logistics processes provides an opportunity for reduced healthcare costs and better support of clinical processes. Hospitals are faced with increasing healthcare costs around the world and improvement...... initiatives prevalent in manufacturing industries such as lean, business process reengineering and benchmarking have seen an increase in use in healthcare. This study investigates how logistics processes in a hospital can be benchmarked to improve process performance. A comparative case study of the bed...... logistics process and the pharmaceutical distribution process was conducted at a Danish and a US hospital. The case study results identified decision criteria for designing efficient and effective healthcare logistics processes. The most important decision criteria were related to quality, security...
..., RAs will observe case managers/social workers during their interaction with the patients. To evaluate... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency... implementers of the EDT (RNs, case managers, social workers, research assistants), the objectives will include...
Stinchcomb, Audra L
Academic pharmaceutical science research is expanding further and further from the University setting to encompass the for-profit private company setting. This parallels the National Institutes of Health momentum to include multiple funding opportunities for University and private company collaboration. It has been recognized that the nonprofit and for-profit combination research model can accelerate the commercialization of pharmaceutical products, and therefore more efficiently improve human health. Entrepreneurial activities require unique considerations in the University environment, but can be modeled after the commercialization expansion of the academic healthcare enterprise. Challenges and barriers exist to starting a company as an entrepreneurial faculty member, but the rewards to one's personal and professional lives are incomparable. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association
Marlies ME Geurts
Full Text Available Background To facilitate collaboration between different healthcare providers and to exchange patient data we developed a paper-based tool, which also enabled to plan interventions and follow-up activities: the PCP. Interviews with participating healthcare providers concluded the PCP was a very useful tool to collect and share patient data. A disadvantage was the time spent to collect all information. We therefore developed our PCP into a web-based tool: the web-based PCP (W-PCP.Objectives Development of a W-PCP to (1 provide healthcare providers with information from pharmacist- and GP computer systems and (2 facilitate collaboration between healthcare providers and patients.Method The W-PCP was used in three research lines, two in primary care and one in a hospital setting. Outcomes measures were defined as satisfaction about efficiency and effectiveness during data sharing and documentation in providing care and conducting medication reviews using the W-PCP.First experiences concerning the use of W-PCP in a primary care setting were collected by a questionnaire and interviews with pharmacists and GPs using the W-PCP.Results A questionnaire was sent to 38 healthcare providers. 17 healthcare providers returned the questionnaire. The use of W-PCP resulted in positive experiences from participating healthcare providers. On the basis of experiences and requirements collected, the application will be further developed.Conclusions The W-PCP application can potentially support successful collaboration between different healthcare providers and patients, which is important for medication therapy management. With this application, a successful collaboration between different healthcare providers and patients could be achieved.
AbstractDemographic change and advances in medical science pose increased challenges to healthcare systems globally: The economic basis is aging and thus health is becoming more and more a productivity factor. At the same time, with today’s new communication possibilities the demand and expectations of effective medical treatment have been increased. This presentation will illustrate the need for the “industrialization” of healthcare in order to achieve highest results at limited budgets. Thereby, industrialization is not meaning the medical treatment based on the assembly line approach. Rather it is to recognize the cost of medical care as an investment with respective expectations on the return of the investment. Innovations in imaging and pharmaceutical products as well as in processes - that lead to similar medical results, but with lower efforts - are keys in such scenarios.BiographyProf. Dr. Hermann Requardt, 54, is a member of the Managing Board of Siemens AG and Chief Executive Officer of the He...
Full Text Available The aim of this study was to understand online public perceptions of the debate surrounding the choice of annual influenza vaccinations or wearing masks as a condition of employment for healthcare workers, such as the one enacted in British Columbia in August 2012.Four national and 82 local (British Columbia Canadian online news sites were searched for articles posted between August 2012 and May 2013 containing the words "healthcare workers" and "mandatory influenza vaccinations/immunizations" or "mandatory flu shots and healthcare workers." We included articles from sources that predominantly concerned our topic of interest and that generated reader comments. Two researchers coded the unedited comments using thematic analysis, categorizing codes to allow themes to emerge. In addition to themes, the comments were categorized by: 1 sentiment towards influenza vaccines; 2 support for mandatory vaccination policies; 3 citing of reference materials or statistics; 4 self-identified health-care worker status; and 5 sharing of a personal story.1163 comments made by 648 commenters responding to 36 articles were analyzed. Popular themes included concerns about freedom of choice, vaccine effectiveness, patient safety, and distrust in government, public health, and the pharmaceutical industry. Almost half (48% of commenters expressed a negative sentiment toward the influenza vaccine, 28% were positive, 20% were neutral, and 4% expressed mixed sentiment. Of those who commented on the policy, 75% did not support the condition to work policy, while 25% were in favour. Of the commenters, 11% self-identified as healthcare workers, 13% shared personal stories, and 18% cited a reference or statistic.The perception of the influenza vaccine in the comment sections of online news sites is fairly poor. Public health agencies should consider including online forums, comment sections, and social media sites as part of their communication channels to correct
Garattini, Livio; Padula, Anna
Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side. Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without 'revolutionizing' the whole present system. The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date. Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role.
... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5376-N-65] Insured Healthcare Facilities 232 Loan Application AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY... Proposal: Insured Healthcare Facilities 232 Loan Application. OMB Approval Number: 2502-New. Form Numbers...
... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5376-N-23] Insured Healthcare Facilities 232 Loan Application AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY...: Title of Proposal: Insured Healthcare Facilities 232 Loan Application. OMB Approval Number: 2502-New...
This two-day conference was organized by The Financial Times, in association with PriceWaterhouseCoopers LLP. The general theme of the event was the state of the healthcare industry, past, present and future. The main areas covered included addressing the challenges of the 1990s, anticipating the challenges of the next decade, the changing shape of global marketing, IT in healthcare, consolidation challenges, shareholder expectations, and new strategies and technologies for growth sustenance within the industry. Key speakers within the industry addressed these issues to an audience of approximately 200 healthcare business executives. The first day was chaired by Mr Robert Cawthorn (Chairman Emeritus, Rhone-Poulenc Rorer Inc) and the second by Professor Trevor Jones (Director General, Association of the British Pharmaceutical Industry).
Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Mzoughi, Olfa; Toumi, Mondher
The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the 'EU Pharmaceutical expenditure forecast'; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and discount price, distribution chains, and the time
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.
Comments: Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential.
Wu, Jing; Xu, Judy; Liu, Gordon; Wu, Jiuhong
High pharmaceutical prices and over-prescribing of high-priced pharmaceuticals in Chinese hospitals has long been criticized. Although policy makers have tried to address these issues, they have not yet found an effective balance between government regulation and market forces. Our objective was to explore the impact of market competition on pharmaceutical pricing under Chinese government regulation. Data from 11 public tertiary hospitals in three cities in China from 2002 to 2005 were used to explore the effect of generic and therapeutic competition on prices of antibiotics and cardiovascular products. A quasi-hedonic regression model was employed to estimate the impact of competition. The inputs to our model were specific attributes of the products and manufacturers, with the exception of competition variables. Our results suggest that pharmaceutical prices are inversely related to the number of generic and therapeutic competitors, but positively related to the number of therapeutic classes. In addition, the product prices of leading local manufacturers are not only significantly lower than those of global manufacturers, but are also lower than their non-leading counterparts when other product attributes are controlled for. Under the highly price-regulated market in China, competition from generic and therapeutic competitors did decrease pharmaceutical prices. Further research is needed to explore whether this competition increases consumer welfare in China's healthcare setting.
Our Healthcare and Public Health (HPH) sector is vast, complex and essential to virtually all other sectors of our nation’s infrastructure. Without a healthy workforce modern society quickly grinds to a halt. The often messy networks of healthcare providers, insurance companies, emergency departments, pharmaceutical manufactures and other equally important actors are bound together in fragile alliances to maintain and restore basic health. Thus the HPH sector becomes an important cog in the w...
Pharmacy benefit management companies (PBMs) perform functions in the US market-based healthcare system that may be performed by public agencies or quasi-public institutions in other nations. By aggregating lives covered under their many individual contracts with payers, PBMs have formidable negotiating power. They influence pharmaceutical insurance coverage, design the terms of coverage in a plan's drug benefit, and create competition among providers for inclusion in a plan's network. PBMs have, through intermediation, the potential to secure lower drug prices and to improve rational prescribing. Whether these potential outcomes are realized within the relevant budget is a function of the healthcare system and the interaction of benefit design and clinical processes-not just individually vetted components. Efficiencies and values achieved in price discounts and cost sharing can be nullified if there is irrational prescribing (over-utilization, under-utilization and mis-utilization), variable patient adherence to medication regimens, ineffective formulary processes, or fraud, waste and abuse. Rising prescription drug costs and the increasing prevalence of 'high deductible health plans', which require much greater patient out-of-pocket costs, is creating a crisis for PBM efforts towards an affordable pharmacy benefit. Since PBM rebate and incentive contracts are opaque to the public, whether they add value by restraining higher drug prices or benefit from them is debatable.
Hurst, Daniel J
In public health, the issue of pharmaceutical pricing is a perennial problem. Recent high-profile examples, such as the September 2015 debacle involving Martin Shkreli and Turing Pharmaceuticals, are indicative of larger, systemic difficulties that plague the pharmaceutical industry in regards to drug pricing and the impact it yields on their reputation in the eyes of the public. For public health ethics, the issue of pharmaceutical pricing is rather crucial. Simply, individuals within a population require pharmaceuticals for disease prevention and management. In order to be effective, these pharmaceuticals must be accessibly priced. This analysis will explore the notion of corporate social responsibility in regards to pharmaceutical pricing with an aim of restoring a positive reputation upon the pharmaceutical industry in the public eye. The analysis will utilize the 2005 United Nations Educational, Scientific, and Cultural Organization's Universal Declaration on Bioethics and Human Rights (UDBHR) to establish implications regarding the societal responsibilities of pharmaceutical companies in a global context. To accomplish this, Article 14 of the UDBHR-social responsibility and health-will be articulated in order to advocate a viewpoint of socially responsible capitalism in which pharmaceutical companies continue as profit-making ventures, yet establish moral concern for the welfare of all their stakeholders, including the healthcare consumer.
Maharaj, S R; Paul, T J
The four goals of good healthcare are to relieve symptoms, cure disease, prolong life and improve quality of life. Access to healthcare has been a perpetual challenge to healthcare providers who must take into account important factors such as equity, efficiency and effectiveness in designing healthcare systems to meet the four goals of good healthcare. The underlying philosophy may designate health as being a basic human right, an investment, a commodity to be bought and sold, a political demand or an expenditure. The design, policies and operational arrangements will usually reflect which of the above philosophies underpin the healthcare system, and consequently, access. Mechanisms for funding include fee-for-service, cost sharing (insurance, either private or government sponsored) free-of-fee at point of delivery (payments being made through general taxes, health levies, etc) or cost-recovery. For each of these methods of financial access to healthcare services, there are ethical issues which can compromise the four principles of ethical practices in healthcare, viz beneficence, non-maleficence, autonomy and justice. In times of economic recession, providing adequate healthcare will require governments, with support from external agencies, to focus on poverty reduction strategies through provision of preventive services such as immunization and nutrition, delivered at primary care facilities. To maximize the effect of such policies, it will be necessary to integrate policies to fashion an intersectoral approach.
...:00 a.m. to 8:30 a.m. on on October 17 and closed for remainder of the meeting) 4. Healthcare Safety.... Bonnie Campbell, Committee Management Officer, Office of Extramural Research Education and Priority Populations, AHRQ, 540 Gaither Road, Suite 2000, Rockville, Maryland 20850, Telephone (301) 427-1554...
Coderch, Jordi; Sánchez-Pérez, Inma; Ibern, Pere; Carreras, Marc; Pérez-Berruezo, Xavier; Inoriza, José M
To develop a predictive model for the risk of high consumption of healthcare resources, and assess the ability of the model to identify complex chronic patients. A cross-sectional study was performed within a healthcare management organization by using individual data from 2 consecutive years (88,795 people). The dependent variable consisted of healthcare costs above the 95th percentile (P95), including all services provided by the organization and pharmaceutical consumption outside of the institution. The predictive variables were age, sex, morbidity-based on clinical risk groups (CRG)-and selected data from previous utilization (use of hospitalization, use of high-cost drugs in ambulatory care, pharmaceutical expenditure). A univariate descriptive analysis was performed. We constructed a logistic regression model with a 95% confidence level and analyzed sensitivity, specificity, positive predictive values (PPV), and the area under the ROC curve (AUC). Individuals incurring costs >P95 accumulated 44% of total healthcare costs and were concentrated in ACRG3 (aggregated CRG level 3) categories related to multiple chronic diseases. All variables were statistically significant except for sex. The model had a sensitivity of 48.4% (CI: 46.9%-49.8%), specificity of 97.2% (CI: 97.0%-97.3%), PPV of 46.5% (CI: 45.0%-47.9%), and an AUC of 0.897 (CI: 0.892 to 0.902). High consumption of healthcare resources is associated with complex chronic morbidity. A model based on age, morbidity, and prior utilization is able to predict high-cost risk and identify a target population requiring proactive care. Copyright © 2013 SESPAS. Published by Elsevier Espana. All rights reserved.
Ang, Darwin; McKenney, Mark; Norwood, Scott; Kurek, Stanley; Kimbrell, Brian; Liu, Huazhi; Ziglar, Michele; Hurst, James
Improving clinical outcomes of trauma patients is a challenging problem at a statewide level, particularly if data from the state's registry are not publicly available. Promotion of optimal care throughout the state is not possible unless clinical benchmarks are available for comparison. Using publicly available administrative data from the State Department of Health and the Agency for Healthcare Research and Quality (AHRQ) patient safety indicators (PSIs), we sought to create a statewide method for benchmarking trauma mortality and at the same time also identifying a pattern of unique complications that have an independent influence on mortality. Data for this study were obtained from State of Florida Agency for Health Care Administration. Adult trauma patients were identified as having International Classification of Disease ninth edition codes defined by the state. Multivariate logistic regression was used to create a predictive inpatient expected mortality model. The expected value of PSIs was created using the multivariate model and their beta coefficients provided by the AHRQ. Case-mix adjusted mortality results were reported as observed to expected (O/E) ratios to examine mortality, PSIs, failure to prevent complications, and failure to rescue from death. There were 50,596 trauma patients evaluated during the study period. The overall fit of the expected mortality model was very strong at a c-statistic of 0.93. Twelve of 25 trauma centers had O/E ratios benchmarking method that screens at risk trauma centers in the state for higher than expected mortality. Stratifying mortality based on failure to prevent PSIs may identify areas of needed improvement at a statewide level. Copyright © 2015 Elsevier Inc. All rights reserved.
Piening, Sigrid; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Straus, Sabine M J M; Mol, Peter G M
In Europe, Direct Healthcare Professional Communications (DHPCs) are important tools to inform healthcare professionals of serious, new drug safety issues. However, this tool has not always been successful in effectively communicating the desired actions to healthcare professionals. The aim of this study was to explore healthcare providers' experiences and their preferences for improvement of risk communication, comparing views of general practitioners (GPs), internists, community pharmacists and hospital pharmacists. A questionnaire was developed and pilot tested to assess experiences and preferences of Dutch healthcare professionals with DHPCs. The questionnaire and two reminders were sent to a random sample of 3488 GPs, internists and community and hospital pharmacists in the Netherlands. Descriptive statistics were used to describe demographic characteristics of the respondents. Chi squares, ANOVAs and the Wilcoxon signed rank test were used, when appropriate, to compare healthcare professional groups. The overall response rate was 34% (N = 1141, ranging from 24% for internists to 46% for community pharmacists). Healthcare providers trusted safety information more when provided by the Dutch Medicines Evaluation Board (MEB) than by the pharmaceutical industry. This was more the case for GPs than for the other healthcare professionals. Respondents preferred safety information to be issued by the MEB, the Dutch Pharmacovigilance Center or their own professional associations. The preferred alternative channels of drug safety information were e-mail, medical journals and electronic prescribing systems. Safety information of drugs does not always reach healthcare professionals through DHPCs. To improve current risk communication of drug safety issues, alternative and/or additional methods of risk communication should be developed using electronic methods and medical journals. Moreover, (additional) risk communication coming from an independent source such as the
Full Text Available Introduction and purpose: Improper management of healthcare waste (HCW can pose considerable risks to human health and the environment and cause serious problems in developing countries such as Iran. In this study, we sought to determine the hazards of HCW in the public hospitals affiliated to Abadan School of Medicine using the preliminary hazard analysis (PHA method. Methods: In this descriptive and analytic study, health risk assessment of HCW in government hospitals affiliated to Abadan School of Medicine (4 public hospitals was carried out by using PHA in the summer of 2016. Results: We noted the high risk of sharps and infectious wastes. Considering the dual risk of injury and disease transmission, sharps were classified in the very high-risk group, and pharmaceutical and chemical and radioactive wastes were classified in the medium-risk group. Sharps posed the highest risk, while pharmaceutical and chemical wastes had the lowest risk. Among the various stages of waste management, the waste treatment stage was the most hazardous in all the studied hospitals. Conclusion: To diminish the risks associated with healthcare waste management in the studied hospitals, adequate training of healthcare workers and care providers, provision of suitable personal protective and transportation equipment, and supervision of the environmental health manager of hospitals should be considered by the authorities.
Full Text Available Pharmaceutical companies play a critical role in healthcare economy. Articulating mission statement of a Pharmaceutical company results in guiding strategies and activities of the firm. In this survey, mission statements of Iranian, Turkish, Indian and American pharmaceutical companies are analyzed. By using content analysis, frequencies of nine elements of the mission statement according to Fred R. David including: customers, product/service, market, technology, survival/growth/profitability, philosophy, self-perception, public image and employee were investigated. 98 mission statements of pharmaceutical companies (32 iranain companies, 16 Turkish companies, 30 Indian companies, and 20 American companies were analyzed. Simple correspondence analysis was used to extract the perceptual map. Results indicate that two dimensions of perceptual map include: focus of mission (throughput or input/output, and focus of mission elements (market or support. Iranian companies placed on the quarter of throughput /support, American and Turkish companies placed on the quarter of throughput/market. Indian companies placed on the quarter of input and output/market.
A Panel on the Radiosterilization of Medical Products, Pharmaceuticals and Bioproducts was convened by the International Atomic Energy Agency on 17-19 January 1966 at its headquarters in Vienna. The purpose of the meeting was to survey the activities of the Member States in this field with a view to preparing the way for an international code of practice for the radiosterilization of medical products, in conformity with existing legal international rules. Refs, figs and tabs
Eriksen, Ida Iren; Melberg, Hans Olav; Bringedal, Berit
The objectives of this study are to measure physicians' knowledge of the prices of pharmaceuticals, and investigate whether there are differences in knowledge of prices between groups of physicians. This article reports on a survey study of physicians' knowledge of the prices of pharmaceuticals conducted on a representative sample of Norwegian physicians in the autumn of 2010. The importance of physicians' knowledge of costs derives from their influence on total spending and allocation of limited health-care resources. Physicians are important drivers in the effort to contain costs in health care, but only if they have the knowledge needed to choose the most cost-effective treatment options. A survey was sent to 1543 Norwegian physicians, asking them for price estimates and their opinions on the importance of considering the cost of treatment to society as a decision factor when treating their patients. This article deals with a subsection in which the physicians were asked to estimate the price of five pharmaceuticals: simvastatin, alendronate (Fosamax), infliximab (Remicade), natalizumab (Tysabri) and escitalopram (Cipralex). The response rate was 65%. For all the five pharmaceuticals, more than 50% and as many as 83% gave responses that differed more than 50% from the actual drug price. The price of more expensive pharmaceuticals was underestimated, while the opposite was the case for less expensive medicines. The data show that physicians in general have poor knowledge of the prices of the pharmaceuticals they offer their patients. However, the physicians who frequently deal with a drug have better knowledge of its price than those who do not handle a medication as often. The data also suggest that those physicians who agree that cost of care to society is an important decision factor have better knowledge of drug prices.
Nishijima, Kazumi; Katsuya, Yoshio
The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)
Michael F Brooks; Maggie Ehrenfried
In a departure from traditional “vertical” healthcare interventions in low-resource settings that work to combat a single specific health issue, LifeNet International (LN) uses a horizontal conversion franchise to develop and measure healthcare capacity and quality in primarily faith-based health centers in East Africa. Through a comprehensive franchise package of Medical Training, Management Training, Pharmaceutical Supply, and Growth Financing, LN is able to leverage existing resources and ...
Full Text Available Various regulatory authorities such as the International Conference on Harmonization (ICH, the United States Food and Drug administration (FDA, and the Canadian Drug and Health Agency (CDHA are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs. The various sources of impurity in pharmaceutical products are - reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \\ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas-liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid-liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC-Mass Spectroscopy (MS, LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.
[Non-pharmaceutical therapy of candidates for geriatric rehabilitation: Non-pharmaceutical therapy prescribed by SHI-accredited doctors after application for outpatient geriatric rehabilitative care].
Krupp, Sonja; Schnoor, Maike; Lohse, Kristina; Katalinic, Alexander; Willkomm, Martin
The rejection of an application for ambulant geriatric rehabilitation (AGRV) is usually justified by the argument that non-pharmaceutical therapy prescribed by doctors accredited by social housing institutions (SHI) would suffice. The reality in healthcare during the 6 months following an application is unknown. In this study 203 patients who had made an application for AGRV in the second half of 2010 in Flensburg, Lübeck or Ratzeburg were interviewed by telephone. The survey revealed that 25.7% of the applications for AGRV had been rejected. The majority of these patients received no ambulant non-pharmaceutical therapy (e.g. physical therapy, physiotherapy, occupational therapy, speech therapy or psychological therapy), less than 20% received more than 12 therapy sessions and in most cases exclusively physiotherapy. The 141 successful AGRV applicants received additional ambulant therapies of a similar magnitude. The difference between the intensified interdisciplinary therapy offered in the AGRV and additionally and the offer to rejected applicants is substantial.
Full Text Available Veterinary pharmaceutical products intended for use in fish should comply with all usual requirements regarding approval for marketing, according to the Order of the President of the National Sanitary Veterinary Agency and for Food Safety No.187/2007, with subsequent amendments and additions. According to the legislation the technical file should containe documentation of quality, safety of animals, consumer, user and environment and demonstration of efficacy and tolerance in the target species. This paper provides the important information on requirements for demonstration on efficacy of pharmaceutical products indended for use in fish. The principal aim of the efficacy data is to prove the therapeutic value of pharmaceutical products and to establish an optimal dose and period of dose administration. In efficacity clinical trial is needed, also, to take into account, the various conditions such as climatic aspects, disease situation, water temperature and salinity, because these may influence the outcome and veracity of the studies.
Gregório, João; Pizarro, Ângela; Cavaco, Afonso; Wipfli, Rolf; Lovis, Christian; Mira da Silva, Miguel; Lapão, Luís Velez
Chronic diseases are pressing health systems to introduce reforms, focused on primary care and multidisciplinary models. Community pharmacists have developed a new role, addressing pharmaceutical care and services. Information systems and technologies (IST) will have an important role in shaping future healthcare provision. However, the best way to design and implement an IST for pharmaceutical service provision is still an open research question. In this paper, we present a possible strategy based on the use of Design Science Research Methodology (DSRM). The application of the DSRM six stages is described, from the definition and characterization of the problem to the evaluation of the artefact.
To contribute to current discussions about budget impact modeling, two different approaches for the impact of a new pharmaceutical product were analyzed: firstly considering the impact on annual healthcare expenditures only, and secondly additional inclusion of lost insurance premiums due to possible early retirement in patients with chronic diseases. The dynamic model calculates the budget impact from two different perspectives: (a) the impact on healthcare expenditures and (b) on expenditures as well as on health insurance revenues due to premiums. The latter approach could especially be useful for patients with chronic diseases who have higher probabilities of early retirement. Early retirement rates and indirect costs were derived from published data. Healthcare premiums were calculated based on an average premium and a mean income. Epidemiological input data were obtained from the literature. Time horizon was 10 years. Results in terms of reimbursement decisions of the budget impact analysis varied depending on the assumptions made for the insurance premiums, costs, and early retirement rate. Sensitivity analyses revealed that in extreme cases the decision for accepting a new pharmaceutical product would probably be negative using approach (a), but positive using approach (b). Depending on the disease and population of interest in a budget impact analysis, not only the healthcare expenditures for a health insurance have to be considered but also the revenue side for an insurance due to retirement should be included.
Khudair, Imran Fahmi; Raza, Syed Asif
The aim of this paper is to study pharmacy service impact on patient satisfaction and to determine what factors saliently link with pharmaceutical service performance at Hamad General Hospital. A patient satisfaction questionnaire was designed using the literature and consultation with Hamad General Hospital medical experts. The questionnaire contained 22 items that focused on five influencing factors: promptness; attitude; supply; location; medication education; and respondent demographic aspects. A total of 220 respondents completed the questionnaire. An exploratory factor analysis was used to group items and a structural equation model was developed to test causality between five factors along with their influence on patient satisfaction. The study establishes statistical evidence that patient satisfaction is positively influenced by service promptness, pharmacist attitude, medication counseling, pharmacy location and waiting area. Several socio-demographic characteristics have statistically different effect on satisfaction, notably: gender; marital status; health status; age; educational level; and ethnicity. However, medication supply did not influence patient satisfaction. Pharmaceutical services are recognized as an essential healthcare-system component. Their impact on customer satisfaction has been investigated in many countries; however, there is no such study in Qatar. The findings identify pharmaceutical service performance indicators and provide guidelines to improve Qatari pharmaceutical services.
Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have struggled with RCRA's empty container requirements when it comes to disposing of visually empty warfarin and nicotine containers, and this issue is in need of investigation. For example, nicotine gums, patches and lozenges are hazardous wastes because nicotine and its salts are listed as P075, and Coumadin (also known as warfarin) is hazardous because warfarin and its salts are listed as P001 (when warfarin is present at concentrations greater than 0.3%). Therefore, when unused nicotine-based smoking cessation products (e.g., patches, gum and lozenges) and Coumadin are discarded, they are acute hazardous wastes and must be managed in accordance with all applicable RCRA regulations. Furthermore, due to additional management requirements for P-listed wastes, any acute hazardous water residues remaining in containers (and therefore the container itself) must be managed as hazardous unless the container has been rendered
Ketikidis, Panayiotis H.; Kontogeorgis, Apostolos; Stalidis, George; Kaggelides, Kostis
One of the goals of procurement is to establish a competitive price, while e-procurement utilises electronic commerce to identify potential sources of supply, to purchase goods and services, to exchange contractual information and to interact with suppliers. Extensive academic work has been extensively devoted to e-procurement in diverse industries. However, applying e-procurement in the healthcare sector remains unexplored. It lacks an efficient e-procurement mechanism that will enable hospitals and healthcare suppliers to electronically exchange contractual information, aided by the technologies of optimisation and business rules. The development and deployment of e-procurement requires a major effort in the coordination of complex interorganisational business process. This article presents an e-procurement optimised system (EPOS) for the healthcare marketplace, a complete methodological approach for deploying and operating such system, as piloted in public and private hospitals in three European countries (Greece, Spain and Belgium) and suppliers of healthcare items in the fourth country (Italy). The efficient e-procurement mechanism that EPOS suggests enables hospitals and pharmaceutical and medical equipment suppliers to electronically exchange contractual information.
Schuster, Nathaniel M; Rogers, Mary A M; McMahon, Laurence F
To examine temporal and geographic associations between Google queries for health information and healthcare utilization benchmarks. Retrospective longitudinal study. Using Google Trends and Google Insights for Search data, the search terms Lipitor (atorvastatin calcium; Pfizer, Ann Arbor, MI) and simvastatin were evaluated for change over time and for association with Lipitor revenues. The relationship between query data and community-based resource use per Medicare beneficiary was assessed for 35 US metropolitan areas. Google queries for Lipitor significantly decreased from January 2004 through June 2009 and queries for simvastatin significantly increased (P patent (P global revenues from 2004 to 2008 (P search engine queries for medical information correlate with pharmaceutical revenue and with overall healthcare utilization in a community. This suggests that search query data can track community-wide characteristics in healthcare utilization and have the potential for informing payers and policy makers regarding trends in utilization.
Kamal, Susan; Holmberg, Christine; Russell, Jean; Bochenek, Tomasz; Tobiasz-Adamczyk, Beata; Fischer, Christiane; Tinnemann, Peter
Pharmaceutical promotion activities in low and middle-income countries are often neither regulated nor monitored. While Egypt has the highest population and per capita use of medicines in the Arab world, we know very little about pharmaceutical companies promotional activities in the country. To explore and analyze the perceptions of physicians towards promotional and marketing activities of pharmaceutical companies among physicians and pharmacists in Egypt. Perspectives of different healthcare system stakeholders were explored through semi-structured, in-depth interviews conducted in 2014 in Cairo, Egypt. Interviewees were chosen via purposive sampling and snowball technique. Each interview was recorded and transcribed. Then qualitative, thematic analysis was conducted with the help of NVIVO software. The majority of physicians and pharmacists acknowledged exposure to pharmaceutical promotion. It was commonly believed that interaction with the pharmaceutical industry is necessary and both associated risks and benefits were acknowledged. The interviewed physicians considered themselves competent enough to minimize risks and maximize benefits to their prescribing habits. Views diverged on the extent and magnitude of the risks and benefits of pharmaceutical promotion, especially in regard to the influence on patients' health. Pharmaceutical promotion in Egypt is intensely directed at prescribers and dispensers. Physicians, pharmacists and policymakers expressed little skepticism to the influence of promotion towards their individual prescribing. Raising awareness of the pitfalls of pharmaceutical promotion is necessary, especially among the less experienced physicians.
Angelovska, Bistra; Drakalska, Elena
The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry
China's healthcare system is experiencing significant growth from expanded government-backed insurance, greater public-sector spending on hospitals, and the introduction of private insurance and for-profit clinics. An incremental reform process has sought to develop market incentives for medical innovation and liberalize physician compensation and hospital finance while continuing to keep basic care affordable to a large population that pays for many components of care out-of-pocket. Additional changes presently under consideration by policymakers are likely to further restructure insurance and the delivery of care and will alter competitive dynamics in major healthcare industries, notably pharmaceuticals, medical devices, and diagnostic testing. This article describes the institutional history of China's healthcare system and identifies dilemmas emerging as the country negotiates divisions between public and private in healthcare. Building on this analysis, the article considers opportunities for public-private partnerships and greater systems integration to reconcile otherwise incommensurable approaches to rewarding innovation and improving access. The article concludes with observations on the public function of health insurance and its significance to further development of China's healthcare system.
Sun, Tara Qian; Medaglia, Rony
Public healthcare ecosystems are complex networks of diverse actors that are subject to pressures to innovate, also a result of technological advancements. Artificial Intelligence (AI), in particular, has the potential to transform the way hospitals, doctors, patients, government agencies...
Ade-Oshifogun, Jochebed Bosede; Dufelmeier, Thaddeus
This article describes a quality improvement process for "do not return" (DNR) notices for healthcare supplemental staffing agencies and healthcare facilities that use them. It is imperative that supplemental staffing agencies partner with healthcare facilities in assuring the quality of supplemental staff. Although supplemental staffing agencies attempt to ensure quality staffing, supplemental staff are sometimes subjectively evaluated by healthcare facilities as "DNR." The objective of this article is to describe a quality improvement process to prevent and manage "DNR" within healthcare organizations. We developed a curriculum and accompanying evaluation tool by adapting Rampersad's problem-solving discipline approach: (a) definition of area(s) for improvement; (b) identification of all possible causes; (c) development of an action plan; (d) implementation of the action plan; (e) evaluation for program improvement; and (f) standardization of the process. Face and content validity of the evaluation tool was ascertained by input from a panel of experienced supplemental staff and nursing faculty. This curriculum and its evaluation tool will have practical implications for supplemental staffing agencies and healthcare facilities in reducing "DNR" rates and in meeting certification/accreditation requirements. Further work is needed to translate this process into future research. © 2012 Wiley Periodicals, Inc.
U.S. Environmental Protection Agency — This GIS dataset contains point features that represent healthcare facilities associated with a single NAICS code. Establishment-specific information except the...
Hospitals represent a substantial market for pharmaceutical and medical device companies. The typical approach by healthcare manufacturers and suppliers to hospitals is to send representatives or detailers to hospitals and meet with representatives of hospital formularies and purchasing officials. Classic channels systems, and specifically, Category Captain Management ("CCM") may provide more of a sustainable competitive advantage than traditional hospital detailing. The purpose of this article is to discuss how CCM might apply as an approach for healthcare suppliers to truly partner with their hospital customers.
... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... of Qualitative Feedback on Agency Service Delivery AGENCY: Agency for Healthcare Research and Quality... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...
Geissler, Kimberley H; Becker, Charles; Stearns, Sally C; Thirumurthy, Harsha; Holmes, George M
Many legal residents in the United States (US)-Mexico border region cross from the US into Mexico for medical treatment and pharmaceuticals. We analyzed whether recent increases in homicides in Mexico are associated with reduced healthcare access for US border residents. We used data on healthcare access, legal entries to the US from Mexico, and Mexican homicide rates (2002-2010). Poisson regression models estimated associations between homicide rates and total legal US entries. Multivariate difference-in-difference linear probability models evaluated associations between Mexican homicide rates and self-reported measures of healthcare access for US residents. Increased homicide rates were associated with decreased legal entries to the US from Mexico. Contrary to expectations, homicides did not have significant associations with healthcare access measures for legal residents in US border counties. Despite a decrease in border crossings, increased violence in Mexico did not appear to negatively affect healthcare access for US border residents.
Voigt, Kristina; Brüggemann, Rainer
-known and highly produced pharmaceuticals is far from being satisfactory. For the two well-known pharmaceuticals roxithomycin (antibiotic) and diatrizoate (contrast media), the data-situation is extremely bad, independent of how the weighting is performed. The data-availability for diatrizoate is a little better. The best data coverage is detected for the chemicals carbamazepine, diazepam, ethinyl estradiol, 5-fluorouracil, and phenazone. The issue of pharmaceuticals in the environment and the unavailability of data necessitate much closer communication between science and medical healthcare and politicians in the future.
Loozen, Edith M H
Several countries have introduced competition in their health systems in order to maintain the supply of high quality health care in a cost-effective manner. The introduction of competition triggers competition enforcement. Since healthcare is characterized by specific market failures, many favor healthcare-specific competition enforcement in order not only to account for the competition interest, but also for the healthcare interests. The question is whether healthcare systems based on competition can succeed when competition enforcement deviates from standard practice. This paper analyzes whether healthcare-specific competition enforcement is theoretically sound and practically effective. This is exemplified by the Dutch system that is based on regulated competition and thus crucially depends on getting competition enforcement right. Governments are responsible for correcting market failures. Markets are responsible for maximizing the public healthcare interests. By securing sufficient competitive pressure, competition enforcement makes sure they do. When interpreted according to welfare-economics, competition law takes into account both costs and benefits specific market behavior may have for healthcare. Competition agencies and judiciary are not legitimized to deviate from standard evidentiary requirements. Dutch case law shows that healthcare-specific enforcement favors the healthcare undertakings concerned, but to the detriment of public health care. Healthcare-specific competition enforcement is conceptually flawed and counterproductive. In order for healthcare systems based on competition to succeed, competition enforcement should be strict. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.
Clauson, Kevin A.; Latif, David A.
Objectives. To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists’ perceptions regarding them. Methods. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists’ perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Results. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). Conclusion. An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market. PMID:22611273
Alkhateeb, Fadi M; Clauson, Kevin A; Latif, David A
To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists' perceptions regarding them. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists' perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market.
The pharmaceutical sector has been established as the primary cost driver in health. The scope of this paper is to explore the drivers of pharmaceutical expenditure in Cyprus by decomposing sales and assessing impact of prices, volumes and substitution effect. We used a statistical approach to decompose the growth of public pharmaceutical expenditure during 2005-2011 into three elements: 1) substitution effect; 2) price effect; and 3) increase of consumption. We further decomposed consumption into: 1) prescription/visits; 2) visits/beneficiaries; and 3) beneficiaries. Pharmaceutical expenditure grew by 31.4 % and volume of medicines dispensed increased by 55%. Prices declined by 11% and product-mix residual was -5.5%, indicating that Cyprus experienced a switch to cheaper medicines (generics) without compromising access of patients to innovative medicines. This was enhanced by guidelines, monitoring of prescribing behavior, generic substitution and efficient tendering. The increasing number of products per prescriptions should be monitored with caution.
Mugoša Snežana S.
Full Text Available Introduction: Spontaneous reporting of adverse reactions is of greatest importance for obtaining information about adverse drug reactions (ADRs after granting the marketing authorization. The most important role and also the greatest responsibility belong to healthcare professionals. Their active participation is a prerequisite for the existence of an effective national drug safety monitoring. Methods: This paper examines the legislative framework concerning the pharmacovigilance system in Montenegro. The information was collected from scientific articles and the website of the Agency for Medicines and Medical Devices of Montenegro. Topic: Key segments of pharmacovigilance system are presented, with a special reference to the importance of spontaneous reporting of ADRs, results of spontaneous reporting of ADRs according to the latest Agency's Annual report on the results of spontaneous reporting of adverse reactions to medicines, possible reasons for underreporting ADRs, as well as the new EU regulation on pharmacovigilance. Conclusions: Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance systems. Hence, continuous education of healthcare professionals is needed, with the aim of improving their awareness of the importance of ADRs and risk factors that lead to them, in order to reduce the incidence of ADRs and to increase the number of reported suspected ADRs.
O. V. Sokolova
Full Text Available Pharmacy organizations are an element of regional pharmaceutical market infrastructure formation. They have different character and activity type, organizational and legal forms, types of properties. The revelation of the features of retail pharmaceutical market of Yaroslavl oblast was the purpose of the study. The analysis of the data of regional department of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation n Yaroslavl oblast in the beginning of 2014 showed that there are 137 acting commercial entities, which have licenses for pharmaceutical activity. The region has 487 pharmacy organizations which implement pharmaceutical activity of state (14.6%, municipal (7.4%, and private (78.0% forms of ownership. Some companies function in Yaroslavl (43.9% and Rybinsk (22.4% municipal district. The analysis of organization and legal forms revealed that 48.9% of pharmacy organizations are registered as ltd, 14.6% are state, and 14.2% are private entrepreneurs, public limited companies amount to 10.9%, the rest pharmacy organizations are included into municipal unitary enterprises and private limited companies – 7.39% and 4.1% correspondingly. The structure of retail market is represented by single pharmacy organizations (51.1% as well as organizations joined into pharmacy chains from two and more PO (48.9%. The share of commercial entities which include one PO amounted to 14.4% of all PO. Share of pharmacy chains (42.3% which include from 2 to 9 PO are 46.8% of all PO. Pharmacy chains, which have more than 9 retails spots amount to 6.6% of the total number of commercial entities. 38.8% of PO function within them. Pharmacy chains prevalence (42.3%, joined into 9 PO; pharmacy chains, which have more than 9 PO, and include state sector PO (14.6% are the features of the regional market.
Milton, Constance L
Current healthcare advertising and customer relations terminology acknowledge that healthcare providers, including nurses, are to act as hosts for persons who enter into healthcare agencies and institutions. Indeed, much has been written aligning nursing and other healthcare services with consumer-oriented roles of the hospitality service industry commonly associated with hotels and restaurants. From a human becoming perspective, this article discusses possible ethical, administrative, and practice implications of nurses acting as guests entering into the lives of those we serve.
The trading of illicit and falsified pharmaceuticals is a growth market. Factors influencing this illegal market are high profit margins, a low risk of detection, low control density, an obscure legal situation, and lastly, the easy and anonymous ways of selling over the Internet, usually across national borders. This situation was the background for the research project on the impact of European e‑commerce liberalisation on pharmaceutical crime (ALPhA). The goal of the project was to develop concrete recommendations for action regarding the improved prosecution of internet-based pharmaceutical crime and to create a broad body of data for effective law-making by legislators.In this article the initial situation regarding pharmaceutical crime and its risk potential is described and some of the results from the comparative-law investigation of the ALPhA research project are presented along with its final recommendations. The latter are directed at policy-makers and law enforcement agencies in addition to industry and science and demonstrate the type of framework to be designed to increase safety for the public and to minimize risks when purchasing pharmaceuticals.
... Veterans Healthcare Barriers Survey Activity: Comment Request AGENCY: Veterans Health Administration... Healthcare Barriers Survey'' in any correspondence. During the comment period, comments may be viewed online... of automated collection techniques or the use of other forms of information technology. Title: Women...
Full Text Available Recently, a part of healthcare services has been assigned to the private sector to increase the quality of medical services, increase patient satisfaction and reduce costs. In this regard, the outsourcing approach has been significantly considered for pharmaceutical services provided by healthcare centers. The purpose of this study is to evaluate the effect of outsourced pharmacies of rural healthcare centers on service quality using structural equations modelling. The methodology used was descriptive using correlation by structural equations modelling. The studied population included those patients who provided their medicines from pharmacies of rural healthcare centers in Abhar and Soltanieh counties. The samples included 384 of these patients. Data was collected by outsourcing and service quality questionnaires. A structural equation modelling was used to analyze data by LISREAL software. Results indicated a positive significant effect of outsourced pharmacies of rural healthcare centers on quality of tangibles, reliability, responsiveness, assurance and empathy. findings emphasize the role of outsourcing on quality of services. Outsourced pharmacies of rural healthcare centers of Abhar and Soltanieh counties lead to improved service quality.
... proposed information collection project: ``AHRQ Grants Reporting System (GRS).'' In accordance with the... consistent with the AHRQ enterprise architecture model and aligned with AHRQ systems development standards... Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research...
U.S. Environmental Protection Agency — Data from pharmaceutical paper. This dataset is associated with the following publication: Furlong, E., A. Batt, S. Glassmeyer, M. Noriega, D. Kolpin, H. Mash, and...
Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen
Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan.
Winchester, Margaret S; King, Brian
Healthcare access and utilization remain key challenges in the Global South. South Africa represents this given that more than twenty years after the advent of democratic elections, the national government continues to confront historical systems of spatial manipulation that generated inequities in healthcare access. While the country has made significant advancements, governmental agencies have mirrored international strategies of healthcare decentralization and focused on local provision of primary care to increase healthcare access. In this paper, we show the significance of place in shaping access and health experiences for rural populations. Using data from a structured household survey, focus group discussions, qualitative interviews, and clinic data conducted in northeast South Africa from 2013 to 2016, we argue that decentralization fails to resolve the uneven landscapes of healthcare in the contemporary period. This is evidenced by the continued variability across the study area in terms of government-sponsored healthcare, and constraints in the clinics in terms of staffing, privacy, and patient loads, all of which challenge the access-related assumptions of healthcare decentralization. Copyright © 2018 Elsevier Ltd. All rights reserved.
Gascón, Fernando; Lozano, Jesús; Ponte, Borja; de la Fuente, David
This paper evaluates the relative efficiency of a sample of 37 large pharmaceutical laboratories in the period 2008-2013 using a data envelopment analysis (DEA) approach. We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms-taking into consideration the strategic importance of R&D-suggest that the pharmaceutical industry is a highly competitive sector given that there are many laboratories at the efficient frontier and many inefficient laboratories close to this border. Additionally, we use data from S&P Capital IQ to analyze 2071 financial transactions announced by our sample of laboratories as an alternative way to gain access to new drugs, and we link these transactions with R&D investment and DEA efficiency. We find that efficient laboratories make on average more financial transactions, and the relative size of each transaction is larger. However, pharmaceutical companies that simultaneously are more efficient and invest more internally in R&D announce smaller transactions relative to total assets.
Nguyen, Tuan Anh; Knight, Rosemary; Roughead, Elizabeth Ellen; Brooks, Geoffrey; Mant, Andrea
Pharmaceutical expenditure is rising globally. Most high-income countries have exercised pricing or purchasing strategies to address this pressure. Low- and middle-income countries (LMICs), however, usually have less regulated pharmaceutical markets and often lack feasible pricing or purchasing strategies, notwithstanding their wish to effectively manage medicine budgets. In high-income countries, most medicines payments are made by the state or health insurance institutions. In LMICs, most pharmaceutical expenditure is out-of-pocket which creates a different dynamic for policy enforcement. The paucity of rigorous studies on the effectiveness of pharmaceutical pricing and purchasing strategies makes it especially difficult for policy makers in LMICs to decide on a course of action. This article reviews published articles on pharmaceutical pricing and purchasing policies. Many policy options for medicine pricing and purchasing have been found to work but they also have attendant risks. No one option is decisively preferred; rather a mix of options may be required based on country-specific context. Empirical studies in LMICs are lacking. However, risks from any one policy option can reasonably be argued to be greater in LMICs which often lack strong legal systems, purchasing and state institutions to underpin the healthcare system. Key factors are identified to assist LMICs improve their medicine pricing and purchasing systems. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2014; all rights reserved.
Tariq M. Alhawassi
Full Text Available Low-quality medicines deliver sub-optimal clinical outcomes and waste precious health resources. It is important to ensure that public funds are spent on healthcare technologies that meet national regulatory bodies such as the Saudi Food and Drug Authority (SFDA, quality standards for safety, efficacy, and quality. Medicines quality is a complicated combination of pre-market regulatory specifications, appropriate sourcing of ingredients (active pharmaceutical ingredient (API, excipients, etc., manufacturing processes, healthcare ecosystem communications, and regular and robust pharmacovigilance practices. A recent conference in Riyadh, sponsored by King Saud University, sought to discuss these issues and develop specific policy recommendations for the Saudi 2030 Vision plan. This and other efforts will require more and more creative educational programs for physicians, pharmacists, hospitals, and patients, and, most importantly evolving regulations on quality standards and oversight by Saudi health authorities.
Maïga, D; Maïga, S; Maïga, M D
The healthcare and pharmaceutical professions in Mali were privatized in 1985. Privatization led to swift expansion of the private sector and upset the balance that had existed between the public and private sectors. A national pharmaceutical policy did not emerge until a decade later. Its purpose was to promote a system ensuring fair access to essential generic medicines for all. It was hoped that synergy between the two sectors would promote that objective. However, the policy calling for distribution of essential generic medicine through the private sector was not accompanied by an adequate system for pricing. This problem led the government to adopt a price regulation policy to realign market dynamics with public health goals. This experience shows that a sustained effort from public policy makers is necessary to prevail against the professional and business interests that can conflict with the public interest. Analysis of this experience also demonstrates the need to improve, restructure, and control the pharmaceutical industry. The government must continue to play its crucial role in the context of limited resources and inequality between consumers and pharmaceutical companies.
Anna Bryndis Blondal
Full Text Available Even though pharmaceutical care is not a new concept in pharmacy, its introduction and development has proved to be challenging. In Iceland, general practitioners are not familiar with pharmaceutical care and additionally no such service is offered in pharmacies or primary care settings. Introducing pharmaceutical care in primary care in Iceland is making great efforts to follow other countries, which are bringing the pharmacist more into patient care. General practitioners are key stakeholders in this endeavor. The aim of this study was to introduce pharmacist-led pharmaceutical care into primary care clinics in Iceland in collaboration with general practitioners by presenting different setting structures. Action research provided the framework for this research. Data was collected from pharmaceutical care interventions, whereby the pharmaceutical care practitioner ensures that each of a patient’s medications is assessed to determine if it is appropriate, effective, safe, and that the patient can take medicine as expected. Sources of data included pharmaceutical care notes on patients, researcher’s notes, meetings, and interviews with general practitioners over the period of the study. The study ran from September 2013 to October 2015. Three separate semi-structured in-depth interviews were conducted with five general practitioners from one primary health care clinic in Iceland at different time points throughout the study. Pharmaceutical care was provided to elderly patients (n = 125 before and between general practitioners’ interviews. The study setting was a primary care clinic in the Reykjavik area and the patients’ homes. Results showed that the GPs’ knowledge about pharmacist competencies as healthcare providers and their potential in patient care increased. GPs would now like to have access to a pharmacist on a daily basis. Direct contact between the pharmacist and GPs is better when working in the same physical space
This two-day conference, organized by The Economist, focused on R and D productivity, strategic and innovative methodologies, M and A activities and knowledge management within the pharmaceutical industry. Key speakers within the industry addressed these issues to an audience of approximately 100 healthcare business executives. The first day was chaired by Barrie Haigh (Quintiles Translational Corp) and the second day by Tobias Rooney (Gemini Consulting).
An important requirement of therapeutics for extended duration exploration missions beyond low Earth orbit will be the development of pharmaceutical technologies suitable for sustained and preventive health care in remote and adverse environmental conditions. Availability of sustained, stable and targeted delivery pharmaceuticals for preventive health of major organ systems including gastrointestinal, hepato-renal, musculo-skeletal and immune function are essential to offset adverse effects of space environment beyond low Earth orbit. Specifically, medical needs may include multi-drug combinations for hormone replacement, radiation protection, immune enhancement and organ function restoration. Additionally, extended stability of pharmaceuticals dispensed in space must be also considered in future drug development. Emerging technologies that can deliver stable and multi-therapy pharmaceutical preparations and delivery systems include nanotechnology based drug delivery platforms, targeted-delivery systems in non-oral and non-parenteral formulation matrices. Synthetic nanomaterials designed with molecular precision offer defined structures, electronics, and chemistries to be efficient drug carriers with clear advantages over conventional materials of drug delivery matricies. Nano-carrier materials like the bottle brush polymers may be suitable for systemic delivery of drug cocktails while Superparamagnetic Iron Oxide Nanoparticles or (SPIONS) have great potential to serve as carriers for targeted drug delivery to a specific site. These and other emerging concepts of drug delivery and extended shelf-life technologies will be reviewed in light of their application to address health-care challenges of exploration missions. Innovations in alternate treatments for sustained immune enhancement and infection control will be also discussed.
Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.
Edwards, Brian; Chakraborty, Sweta
Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards 'Dear Healthcare Professional Communications', there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the fundamental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company's risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are
Fetter, Marilyn S
As the learning laboratory for gaining actual patient care experience, clinical agencies play an essential role in nursing education. With an information technology revolution transforming healthcare, nursing programs are eager for their students to learn the latest informatics systems and technologies. However, many healthcare institutions are struggling to meet their own information technology needs and report limited resources and other as barriers to nursing student training. In addition, nursing students' information technology access and use raise security and privacy concerns. With the goal of a fully electronic health record by 2014, it is imperative that agencies and educational programs collaborate. They need to establish educationally sound, cost-effective, and secure policies and procedures for managing students' use of information technology systems. Strategies for evaluating options, selecting training methods, and ensuring data security are shared, along with strategies that may reap clinical, economic, and educational benefits. Students' information technology use raises numerous issues that the nursing profession must address to participate in healthcare's transformation into the digital age.
Kohler Jillian C
Full Text Available Abstract Background Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals 2. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments, and distribution. Methods Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. Results The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. Conclusion Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the
Garuba, Habibat A; Kohler, Jillian C; Huisman, Anna M
Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals 2. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution. Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and
Nadine van Dongen
Full Text Available Nadine van DongenVan Dongen Research Ltd, London, UKAbstract: This paper examines the interaction of patients within the context of efficiency in the pharmaceutical environment. Measurements of quality standards in healthcare are reviewed with an emphasis on the question of whether ‘patient intelligence’ can improve quality standards in healthcare. Something given particular consideration is the ethical point of view versus the business point of view, in relation to the integration of patients into the decision-making process of a healthcare organization. The paper focuses on the formal and informal reasons for involvement of patients in corporate and/or market access strategies for healthcare organizations.Keywords: healthcare, decision-making process, efficiency, patient intelligence, patients
Choi, Sol Ji; Jo, Ae Jeong; Choi, Jin A [Div. for Healthcare Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, Seoul (Korea, Republic of); and others
This paper is a summary of the methodology including protocol used to develop evidence-based clinical imaging guidelines (CIGs) in Korea, led by the Korean Society of Radiology and the National Evidence-based Healthcare Collaborating Agency. This is the first protocol to reflect the process of developing diagnostic guidelines in Korea. The development protocol is largely divided into the following sections: set-up, process of adaptation, and finalization. The working group is composed of clinical imaging experts, and the developmental committee is composed of multidisciplinary experts to validate the methodology. The Korean CIGs will continue to develop based on this protocol, and these guidelines will act for decision supporting tools for clinicians as well as reduce medical radiation exposure.
Choi, Sol Ji; Jo, Ae Jeong; Choi, Jin A
This paper is a summary of the methodology including protocol used to develop evidence-based clinical imaging guidelines (CIGs) in Korea, led by the Korean Society of Radiology and the National Evidence-based Healthcare Collaborating Agency. This is the first protocol to reflect the process of developing diagnostic guidelines in Korea. The development protocol is largely divided into the following sections: set-up, process of adaptation, and finalization. The working group is composed of clinical imaging experts, and the developmental committee is composed of multidisciplinary experts to validate the methodology. The Korean CIGs will continue to develop based on this protocol, and these guidelines will act for decision supporting tools for clinicians as well as reduce medical radiation exposure
Huff-Rousselle, M; Burnett, F
This article discusses the potential for health sector cost containment in developing countries through improved pharmaceutical procurement. By describing the specific example of the Eastern Caribbean Drug Service (ECDS), which provides a pooled procurement service to nine ministries of health in the small island nations of the Caribbean, it examines the elements of the procurement operation that allowed ECDS to reduce unit costs for pharmaceuticals by over 50 per cent during its first procurement cycle. The analysis of ECDS considers: (1) political will, institutional alliances, and the creation of a public sector monopsony; (2) pooling demand; (3) restricted international tendering and the pharmaceutical industry; (4) estimating demand and supplier guarantees; (5) reducing variety and increasing volume through standardizing pack sizes, dosage forms and strengths; (6) generic bidding and therapeutic alternative bidding; (7) mode of transport from foreign suppliers; (8) financing mechanisms, including choice of currency, foreign exchange, and terms of payment; (9) market conditions and crafting and enforcing supplier contracts; and, (10) the adjudication process, including consideration of suppliers' past performance, precision requirements in the manufacturing process, number of products awarded to suppliers, and issues of judgment. The authors consider the relevance of this agency's experience to other developing countries by providing a blueprint that can be adopted or modified to suit other situations.
... research Feasibility: consideration of the resources available to conduct the study Twenty-two volunteer..., the public health community, and government agencies have recognized multiple gaps in knowledge..., and the safety profile of pharmaceuticals in the long term. These gaps have frequently resulted in...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency... Organization (HRO) staff, and health care system staff in various teamwork, communication, and patient safety... TeamSTEPPS. To understand the extent to which this expanded patient safety knowledge and skills have...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency... promoting improvements in the quality and safety of health care in nursing home settings. The survey... homes, to facilitate the use of these materials for nursing home patient safety and quality improvement...
... implement an ASP. Reflections and feedback directly from prescribers and the ASP team using qualitative data...,629 Project Development 84,944 169,400 Data Collection and Analysis.... 169,888 339,776 Technical... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency...
There are serious problems with the way in which pharmaceutical research is currently practiced, many of which can be traced to the influence of commercial interests on research. One of the most significant is inadequate dissent, or organized skepticism. In order to ameliorate this problem, I develop a proposal that I call the "Adversarial Proceedings for the Evaluation of Pharmaceuticals," to be instituted within a regulatory agency such as the Food and Drug Administration for the evaluation of controversial new drugs and controversial drugs already in the market. This proposal is an organizational one based upon the "science court" proposal by Arthur Kantrowitz in the 1960s and 1970s. The primary benefit of this system is its ability to institutionalize dissent, thereby ensuring that one set of interests does not dominate all others.
Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.
Scott, Tia-Marie; Phillips, Patrick J.; Kolpin, Dana W.; Colella, Kaitlyn M.; Furlong, Edward T.; Foreman, William T.; Gray, James L.
Discharges from pharmaceutical manufacturing facilities (PMFs) previously have been identified as important sources of pharmaceuticals to the environment. Yet few studies are available to establish the influence of PMFs on the pharmaceutical source contribution to wastewater treatment plants (WWTPs) and waterways at the national scale. Consequently, a national network of 13 WWTPs receiving PMF discharges, six WWTPs with no PMF input, and one WWTP that transitioned through a PMF closure were selected from across the United States to assess the influence of PMF inputs on pharmaceutical loading to WWTPs. Effluent samples were analyzed for 120 pharmaceuticals and pharmaceutical degradates. Of these, 33 pharmaceuticals had concentrations substantially higher in PMF-influenced effluent (maximum 555,000 ng/L) compared to effluent from control sites (maximum 175 ng/L). Concentrations in WWTP receiving PMF input are variable, as discharges from PMFs are episodic, indicating that production activities can vary substantially over relatively short (several months) periods and have the potential to rapidly transition to other pharmaceutical products. Results show that PMFs are an important, national-scale source of pharmaceuticals to the environment.
Gisele de Lima
Full Text Available Objective: To study solid medications for oral delivery on the formulary of Hospital Israelita Albert Einstein (HIAE, investigating the possibility of using these drugs through enteral feeding tubes, and recommending appropriate administration. Methods: Study carried out through survey of solid medications for oral delivery included on the formulary of HIAE, literature review, and analysis of medication monographs, manufacturer information and pharmacotechnical data of active ingredients and excipients. It was observed the factors that might hinder or complicate the administration of these drugs though enteral tubes, and was drawn an information chart with recommendations about drug administration in this context. Rresults: The study evaluated 234 medications; and the main problems of administering these drugs through enteral feeding tubes were as follows: changes in drug pharmacokinetics (38; gastrointestinal damage (9; risk of obstruction (40, drug-nutrient interactions (7; biological hazards (5 and no information (33. Cconclusions: Compiling this information helps the healthcare team to choose the appropriate pharmaceutical formulation for medications administered through enteral tubes, and may help identify adverse events related to this technique.
Adeoye, Sanjo; Bozic, Kevin J
Physicians, health plans, hospitals, pharmaceutical companies, and medical device manufacturers have all recognized the benefits of marketing their products and services directly to the end user. As a result, there has been tremendous growth of direct-to-consumer advertising (DTCA), illustrated by the increase in spending on DTCA related to prescription drugs from an estimated $55 million in 1991 to $3.2 billion in 2003. This increase in DTCA has sparked vigorous debate among the major stakeholders in healthcare over the benefits and drawbacks of advertising directly to the healthcare consumer. Issues with DTCA include its impact on the doctor-patient relationship, patient education, inappropriate resource utilization, healthcare costs, healthcare quality, and overall patient wellbeing. Orthopaedic surgery is no longer insulated from this expanding trend in DTCA, as orthopaedic surgeons and hospitals are responsible for a substantial portion of DTCA related to orthopaedic devices and procedures. The Food and Drug Administration has a limited regulatory role and limited power related to DTCA due to considerable inefficiencies in its review and disciplinary processes. Therefore, physicians, including orthopaedic surgeons, must take a leadership role on this issue to ensure the integrity of information provided to patients and to protect the sanctity of the doctor-patient relationship.
Full Text Available Introduction: Due to a variety of circumstances and world-wide research findings, patient safety andquality care during hospitalization have emerged as major issues. Patient safety deficits may burdenhealth systems as well as allocated resources. The international community has examined severalproposals covering general and systemic aspects in order to improve patient safety; several long-termprograms and strategies have also been implemented promoting the participation of health-relatedagents, and also government agencies and non-governmental organizations.Aim: Those factors that have negative correlations with patient safety and quality healthcare weredetermined; WHO and EU programs as well as the Greek health policy were also reviewed.Method: Local and international literature was reviewed, including EU and WHO official publications,by using the appropriate keywords.Conclusions: International cooperation on patient safety is necessary in order to improvehospitalization and healthcare quality standards. Such incentives depend heavily on establishing worldwideviable and effective health programs and planning. These improvements also require further stepson safe work procedures, environment safety, hazard management, infection control, safe use ofequipment and medication, and sufficient healthcare staff.
... implement an ASP. Reflections and feedback directly from prescribers and the ASP team using qualitative data... $28,315 $56,629 Project Development 84,944 169,400 Data Collection and Analysis 169,888 339,776... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency...
Scoutaris, Nicolaos; Ross, Steven; Douroumis, Dennis
Inkjet printing is an attractive material deposition and patterning technology that has received significant attention in the recent years. It has been exploited for novel applications including high throughput screening, pharmaceutical formulations, medical devices and implants. Moreover, inkjet printing has been implemented in cutting-edge 3D-printing healthcare areas such as tissue engineering and regenerative medicine. Recent inkjet advances enabled 3D printing of artificial cartilage and skin, or cell constructs for transplantation therapies. In the coming years inkjet printing is anticipated to revolutionize personalized medicine and push the innovation portfolio by offering new paths in patient - specific treatments.
Dzhalilova, K I
Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.
Андрій Ігорович Бойко
Full Text Available Aim. Implementation of pharmaceutical informatics methods in the system of pharmaceutical care for diabetes patients in Ukraine.Methods. System method was used for the analysis of status and reforming the pharmaceutical care for patients with diabetes; program-oriented management at informatization project realization; pharmaceutical informatics in the creation of computer pharmaceutical knowledge bases; methods of data synthesis and summarizing.Results. System analysis of the basic directions of reforming the pharmaceutical care for patients with diabetes in Ukraine was carried out. Ways of it’s of optimization were processed: establishment of specialized pharmacies with implementation of modern information technologies and special postgraduate education for pharmacists. Structure and information providing of computer knowledge base “Pharmaceutical care for patients with diabetes” was substantiated.Conclusion. Based on the regional project “Informatization of prescription antidiabetic drugs circulation in Ukraine” realization, the necessity of establishment of specialized pharmacies providing pharmaceutical care for patients with diabetes was substantiated. Ways for optimization of postgraduate education for pharmacists of the specialized pharmacies by implementation of special thematic improvement cycles were proceed. Computer knowledge base as an effective tool for optimization of pharmaceutical care for patients with diabetes was realized
Tlaiss, Hayfaa A
As the under-representation of women in management positions continues to persist globally, little is known about the experiences of women in the healthcare sector in the context of the developing Middle Eastern nations. In an attempt to address this knowledge gap, the current study explores some of the barriers that hinder and the enablers that foster women's career advancement in the healthcare sector. To meet its objectives, the current study uses a relational approach that integrates the macro socio-cultural, meso-organisational, and micro-individual levels of analysis. Guided by institutional theory as a theoretical framework and social constructionism as a philosophical stance, the current study adopts a qualitative research methodology. It capitalizes on in-depth, semi-structured, face-to-face interviews with women managers in different occupational fields, across the managerial hierarchy in the healthcare sector in Lebanon. Snowballing and purposeful sampling procedures were used, and the interviews were analysed using thematic analysis, focusing on identifying new, emerging themes. The results of the study confirm the salience of discriminatory cultural values, gendered social roles and expectations in Middle Eastern societies, and illustrate their role as barriers hindering women's career advancement. The results also portray the spillover effect of societal expectations and cultural gender stereotypes into the organisational realm, resulting in widely experienced attitudinal and structural organisational barriers. This study also illustrates how the enablers that facilitate and promote women's career progression unfold amidst the interplay between the macro and meso factors, lending credence to the role of women's agency at the individual micro level. Amongst the toll of barriers, Middle Eastern women navigate the patriarchy of their cultures and the discrimination inherent in their organisations by using their agency and persistence as they construct
Kazzazi, Fawz; Pollard, Cleo; Tern, Paul; Ayuso-Garcia, Alejandro; Gillespie, Jack; Thomsen, Inesa
The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry.
Wu, Huiquan; Khan, Mansoor
As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.
Kaltoft, Mette Kjer; Nielsen, Jesper Bo; Salkeld, Glenn
In this protocol for a pilot study we seek to establish the feasibility of using a web-based survey to simultaneously supply healthcare organisations and agencies with feedback on a key aspect of the care experience they provide and increase the generic health decision literacy of the individuals...
Full Text Available Aim: Clarity on health expenditures is essential for the timely identification of risks that jeopardize the democratic provision of health services and the credibility of health insurance systems. Furthermore, observing health outcomes with geographical scope is essential for making multilateral associations. This study aimed at conveying information on the variability of important economic parameters of the health sector of Serbia and Greece from 2007 to 2012, when the most serious financial crisis in the post-war economic history hit the global economy. Methods: Exchange rates, purchase-power-parities (PPP and price indices were used for the bilateral review of health and pharmaceutical expenditure dynamics during 2007-2012. Prescription and dispensing changes were also studied taking into account the anatomical therapeutic chemical (ATC structure of drugs consumed. Results: Greece was forced to cut down its total health care and pharmaceutical expenditure and mainly its out-of-pocket payments were more seriously affected by the recession. Surprisingly, emerging market of Serbia, although severely damaged by global recession, succeeded to maintain 19% growth of its per capita health expenditure and even 25% increase of its per capita spending on pharmaceuticals. Innovative pharmaceuticals showed an upward trend in both countries. Conclusions: These two countries might serve as an example of two distinct pathways of mature and emerging health care markets during financial constraints caused by global recession. Our findings show that producing disease-based feedback, in the long run, may empower the assessment of the return on investment on medical technology and healthcare systems’ cost-effectiveness.
Reich, M R
An analysis of the politics of Bangladesh pharmaceutical policy in the 1980s shows how significant health policy reforms in developing countries depend on political conditions both inside and outside the country. Bangladesh's drug policy of 1982 illustrates that governments can sometimes change public policy in ways unfavourable to multinational corporations, while the failed health policy reform of 1990 shows that reforms unfavourable to powerful domestic interest groups can be more difficult to achieve, even contributing to a government's downfall. The case provides evidence of basic changes in how the international agenda for health policy is set, especially the growing role of non-governmental organizations in international agencies and national policy debates. Understanding the political patterns of policy reform in Bangladesh has important implications for strategies to affect health policy in developing countries.
Chen, Dengyue; Sirkar, Kamalesh K; Jin, Chi; Singh, Dhananjay; Pfeffer, Robert
Membrane technologies are of increasing importance in a variety of separation and purification applications involving liquid phases and gaseous mixtures. Although the most widely used applications at this time are in water treatment including desalination, there are many applications in chemical, food, healthcare, paper and petrochemical industries. This brief review is concerned with existing and emerging applications of various membrane technologies in the pharmaceutical and biopharmaceutical industry. The goal of this review article is to identify important membrane processes and techniques which are being used or proposed to be used in the pharmaceutical and biopharmaceutical operations. How novel membrane processes can be useful for delivery of crystalline/particulate drugs is also of interest. Membrane separation technologies are extensively used in downstream processes for bio-pharmaceutical separation and purification operations via microfiltration, ultrafiltration and diafiltration. Also the new technique of membrane chromatography allows efficient purification of monoclonal antibodies. Membrane filtration techniques of reverse osmosis and nanofiltration are being combined with bioreactors and advanced oxidation processes to treat wastewaters from pharmaceutical plants. Nanofiltration with organic solvent-stable membranes can implement solvent exchange and catalyst recovery during organic solvent-based drug synthesis of pharmaceutical compounds/intermediates. Membranes in the form of hollow fibers can be conveniently used to implement crystallization of pharmaceutical compounds. The novel crystallization methods of solid hollow fiber cooling crystallizer (SHFCC) and porous hollow fiber anti-solvent crystallization (PHFAC) are being developed to provide efficient methods for continuous production of polymer-coated drug crystals in the area of drug delivery. This brief review provides a general introduction to various applications of membrane technologies in
Bárbara Posse Reis Martins
Full Text Available The aim of Pharmaceutical Care programs is to improve patients' quality of life, and such programs are particularly effective in the case of chronic diseases such as hypertension. The objective of this longitudinal study was to analyze a Pharmaceutical Care model for hypertensive patients receiving care within the Family Health Strategy (FHS. All patients were being seen by an FHS team affiliated to a primary healthcare unit in Goiânia, Goiás, Brazil. Fourteen patients participated in the study, with each patient receiving six home visits during the Pharmaceutical Care. Overall, 142 drug-related problems were reported, the most common concerning the ineffectiveness of treatment (33.8%. A total of 135 pharmaceutical interventions were performed, 92.6% of which involved pharmacist-patient communication, with 48.8% of these interventions being implemented. Cardiovascular risk decreased in three patients and remained unchanged in nine. In hypertensive patients with diabetes, fasting glucose levels were reduced in six out of nine cases. The Pharmaceutical Care model proposed here was effective in detecting drug-related problems and in proposing interventions to resolve or prevent these problems. Consequently, this may have contributed towards improving clinical parameters, such as fasting glucose levels and cardiovascular risk in hypertensive patients receiving care within the FHS.
Assistência Farmacêutica no Programa Saúde da Família: encontros e desencontros do processo de organização Pharmaceutical Assistance in the Family Healthcare Program: points of affinity and discord in the organization process
Tatiane de Oliveira Silva Alencar
Full Text Available Estudo sobre a organização da Assistência Farmacêutica no Programa Saúde da Família (PSF. Tem-se como objetivo discutir a organização da Assistência Farmacêutica no PSF. Pesquisa qualitativa, numa perspectiva crítico-analítica, tendo como campo de investigação as Unidades de Saúde da Família de um município da Bahia. As técnicas de produção dos dados foram observação sistemática, entrevista semi-estruturada e análise de documentos. O método de análise foi o hermenêutico-dialético. A organização da Assistência Farmacêutica, demarcada pelas ações de seleção, programação, aquisição, armazenagem, distribuição e dispensação, apresentou-se como uma realidade ainda em construção, que se dá de modo centralizado e desarticulado das demais ações de saúde, divergindo da proposta de trabalho em equipe; excesso de atividades realizadas pelos trabalhadores de saúde; e a ausência de uma política de educação permanente para os trabalhadores. Para a transformação dessa realidade, de modo a assegurar a organização da Assistência Farmacêutica com qualidade e integralidade, faz-se necessário uma reconstrução do modo de pensar e fazer dos sujeitos (gestores, trabalhadores e usuários que participam diretamente da organização, rompendo as práticas impessoais, burocráticas e pouco comunicativas que as caracterizam.The scope of this study was to discuss the organization of the pharmaceutical assistance service in the family healthcare program. Qualitative research from a critical/analytical perspective was conducted in family healthcare units in a municipality of the state of Bahia, Brazil. Data was collected on the basis of systematic observation, semi-structured interviews and documents analysis from a dialectic standpoint. The organization of Pharmaceutical Assistance consisted of selection, planning, acquisition, storage and dispensing activities. The process was studied in the implementation phase
Chabrol, Fanny; David, Pierre-Marie; Krikorian, Gaëlle
New powerful drugs against hepatitis C can cure the disease, but they are not widely distributed because their exorbitant prices are destabilizing healthcare systems in both African and European countries. This article takes access to hepatitis C treatments since 2013 in France and in Cameroon as a lens to analyze the rationing of pharmaceutical treatments in relation to recent transformations of health systems. Access to these treatments is analyzed thanks to ethnographic observation and interviews lead in Paris and Yaoundé, with patients, associations, health professionals and public health experts. In Cameroon, rationing takes place through various layers of socio-economic restrictions, and no patient organization advocates for hepatitis treatment. In France, access to hepatitis C treatments has become politicized, and collective mobilizations have denounced rationing as a threat to the promise of universal social security. In this study, we examine Africa's long experience with rationing in the context of structural adjustment, and we bring together experiences in France and Cameroon. This article analyses the phenomenon of the pharmaceuticalization of healthcare systems, that is to say the growing use of pharmaceuticals in healthcare systems, by documenting the social and political construction of scarcity. Indeed, whereas pharmaceuticalization is a concept that has often been used in situations of drugs abundance, a parallel analysis of rationing highlights a political economy of pharmaceuticals that shapes public health debates and policies according to an economy of scarcity, especially in times of austerity. Copyright © 2017. Published by Elsevier Ltd.
Reifels, Lennart; Nicholas, Angela; Fletcher, Justine; Bassilios, Bridget; King, Kylie; Ewen, Shaun; Pirkis, Jane
Improving access to culturally appropriate mental healthcare has been recognised as a key strategy to address the often greater burden of mental health issues experienced by Indigenous populations. We present data from the evaluation of a national attempt at improving access to culturally appropriate mental healthcare for Indigenous Australians through a mainstream primary mental healthcare program, the Access to Allied Psychological Services program, whilst specifically focusing on the implementation strategies and perspectives of service providers. We conducted semi-structured interviews with 31 service providers (primary care agency staff, referrers, and mental health professionals) that were analysed thematically and descriptively. Agency-level implementation strategies to enhance service access and cultural appropriateness included: the conduct of local service needs assessments; Indigenous stakeholder consultation and partnership development; establishment of clinical governance frameworks; workforce recruitment, clinical/cultural training and supervision; stakeholder and referrer education; and service co-location at Indigenous health organisations. Dedicated provider-level strategies to ensure the cultural appropriateness of services were primarily aimed at the context and process of delivery (involving, flexible referral pathways, suitable locations, adaptation of client engagement and service feedback processes) and, to a lesser extent, the nature and content of interventions (provision of culturally adapted therapy). This study offers insights into key factors underpinning the successful national service implementation approach. Study findings highlight that concerted national attempts to enhance mainstream primary mental healthcare for Indigenous people are critically dependent on effective local agency- and provider-level strategies to optimise the integration, adaptation and broader utility of these services within local Indigenous community and
Gontijo Guerra, Samantha; Vasiliadis, Helen-Maria
Healthcare service use among suicide decedents must be well characterized and understood since a key strategy for preventing suicide is to improve healthcare providers' ability to effectively detect and treat those in need. To determine gender differences in healthcare service use 12 months prior to suicide. Data for 1,231 young Quebec residents (≤ 25 years) who died by suicide between 2000 and 2007 were collected from public health insurance agency databases and coroner registers. Healthcare visits were categorized according to the setting (emergency department [ED], outpatient, and hospital) and their nature (mental health vs. non-mental health). Girls were more likely than boys (82.5% vs. 74.9%, p = .011) to have used healthcare services in the year prior to death. A higher proportion of girls had used outpatient services (79.0% vs. 69.5%, p = .003), had been hospitalized (25.7% vs. 15.6%, p suicide decedents who did not receive a mental health diagnosis and healthcare services in the year prior to death. Future studies should focus on examining gender-specific individual and health system barriers among suicide decedents as well as the quality of care offered regarding detection and treatment.
da Fonseca, Elize Massard
The global health community is increasingly advocating for the local production of pharmaceuticals in developing countries as a way to promote technology transfer, capacity building and improve access to medicines. However, efforts to advance drug manufacturing in these countries revive an old dilemma of fostering technological development versus granting access to social services, such as healthcare. This paper explores the case of Brazil, a country that has developed large-scale health-inspired industrial policies, but is, yet, little understood. Brazil's experience suggests that progressive healthcare bureaucrats can create innovative practices for technology and knowledge transfers. It also demonstrates that highly competitive pharmaceutical firms can collaborate with each other, if a government provides them the right incentives. Reforming regulatory policies is crucial for guaranteeing high-quality products in developing countries, but governments must play a crucial role in supporting local firms to adapt to these regulations. These findings send a strong message to global health policymakers and practitioners on the conditions to create a suitable environment for local production of medical products.
Bittner, S; Meuth, S G
The treatment of patients with multiple sclerosis (MS) is associated with constantly rising costs for the healthcare system and pharmaceuticals constitute 60 % of the direct medical costs. The Pharmaceutical Market Restructuring Act (Arzneimittelmarkt-Neuordnungsgesetz, AMNOG) came into force on 1 January 2011 with the aim of limiting the costs of pharmaceuticals by obligating newly approved products to be subjected to an early evaluation of the additional benefits by the Federal Joint Committee (FJC, Gemeinsamer Bundesausschuss, G‑BA). The majority of products evaluated up to October 2015 in neurology (5 out of 8) were approved for treatment of MS. Has the AMNOG been able to fulfill the original aims? Analysis of available information on MS therapies evaluated by the FJC between December 2010 and October 2015. For various reasons an additional benefit could be shown in only 2 out of 5 assessment procedures for MS drugs. It is obvious that some methodological shortcomings of the process have to be improved. Additionally requirements for pivotal clinical trials have to be harmonized with AMNOG requirements taking the best available evidence and real-life data into consideration (e.g. non-interventional studies) and a closer collaboration between the FJC, healthcare providers and the neurological societies is necessary. The AMNOG procedure currently only partially fulfills the original aims, which could be the reason why guidelines play a more important role for therapy decision-making than FJC decisions. As the early evaluation procedure is an adaptive process methodological shortcomings might be overcome in the future; however, this requires a much closer collaboration between the FJC and neurological societies.
Traulsen, Janine Morgall; Almarsdóttir, Anna Birna
Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.
Chaffee, Tonya; English, Abigail
Sex trafficking of adolescents and young adults is both a human rights violation and a public health problem, globally and in the United States. Healthcare providers, including obstetricians and gynecologists, interact with victims, often while they remain under their traffickers' control, but because of providers' lack of training in identification and response many victims go unrecognized and unaided. This review provides an overview of the definitions of sex trafficking and commercial sexual exploitation, contributing factors, health consequences, recruitment of victims, and identification and response by healthcare providers. The literature on definitions and risk factors associated with sex trafficking is growing; however, literature on healthcare providers' role in addressing sex trafficking remains more limited. It is increasingly recognized that healthcare providers have an important role in victim identification and response and as advocates, collaborating with national, regional, and local agencies to increase awareness of sex trafficking as a public health problem and to address the needs of adolescent and young adult victims and survivors globally and in the United States. As professionals who interact with adolescent and young adult victims of sex trafficking, healthcare providers have an important role: in collaboration with other professionals and agencies they can help to identify, respond to, extricate, protect, and advocate for victims and survivors.
... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-New (VA Form 10-0503)] Agency Information Collection (Dental Patient Satisfaction Survey) Activities Under OMB Review AGENCY: Veterans Health...).'' Title: Survey of Healthcare Experiences, Dental Patient Satisfaction Survey, VA Form 10-0503. OMB...
Full Text Available Jiun-Wen Guo,1 Yu-Hsuan Lee,2 Hsiau-Wen Huang,3 Mei-Chyun Tzou,3 Ying-Jan Wang,2 Jui-Chen Tsai1,4 1Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Chung Kung University, Tainan, Taiwan; 2Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 3Food and Drug Administration, Ministry of Health and Welfare, Taiwan; 4Center for Pharmaceutical Regulatory Science, National Cheng Kung University, Tainan, Taiwan Abstract: Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may
Stanko, P; Fulmeková, M
The conception of the field of pharmaceutical service defines pharmaceutical service as the basic part of pharmacy, the principal task of which is to provide pharmaceutical care as an inseparable part of providing health care. It represents a set of professional activities of the pharmacist oriented to securing human and veterinary pharmaceutical products and health care products and to optimising effective, safe and quality pharmacotherapy. Technically, pharmaceutical service is an applied discipline, as it makes use of knowledge gained in other pharmaceutical, medical, psychological, social, and economic sciences. Because of its interdisciplinary character it is necessary to extend the theory of pharmaceutical service in such a way so that it may reflect all aspects of its sphere of activity. One of the possibilities is to define the pharmacy premises as an independent functional unit which operates on the basis of valid legal standards in such a way that on the one hand it secures the provision of health (pharmaceutical) care, and on the other hand it maintains its cost-effectiveness. To keep the quality of care of the patient and the economic aspect in balance, it is necessary to define the term pharmaceutical logistics also under the conditions of Slovak (Czech) pharmacy as early satisfaction of the requirements of the patient (client) in the pharmacy premises, which means that the appropriate pharmaceutical product or health care product and the appropriate information must be at the right time in the required amount and required quality in the right place.
Tlaiss, Hayfaa A.
Background: As the under-representation of women in management positions continues to persist globally, little is known about the experiences of women in the healthcare sector in the context of the developing Middle Eastern nations. In an attempt to address this knowledge gap, the current study explores some of the barriers that hinder and the enablers that foster women’s career advancement in the healthcare sector. To meet its objectives, the current study uses a relational approach that integrates the macro socio-cultural, meso-organisational, and micro-individual levels of analysis. Methods: Guided by institutional theory as a theoretical framework and social constructionism as a philosophical stance, the current study adopts a qualitative research methodology. It capitalizes on in-depth, semi-structured, face-to-face interviews with women managers in different occupational fields, across the managerial hierarchy in the healthcare sector in Lebanon. Snowballing and purposeful sampling procedures were used, and the interviews were analysed using thematic analysis, focusing on identifying new, emerging themes. Results: The results of the study confirm the salience of discriminatory cultural values, gendered social roles and expectations in Middle Eastern societies, and illustrate their role as barriers hindering women’s career advancement. The results also portray the spillover effect of societal expectations and cultural gender stereotypes into the organisational realm, resulting in widely experienced attitudinal and structural organisational barriers. This study also illustrates how the enablers that facilitate and promote women’s career progression unfold amidst the interplay between the macro and meso factors, lending credence to the role of women’s agency at the individual micro level. Amongst the toll of barriers, Middle Eastern women navigate the patriarchy of their cultures and the discrimination inherent in their organisations by using their
Hayfaa A. Tlaiss
Full Text Available Background: As the under-representation of women in management positions continues to persist globally, little is known about the experiences of women in the healthcare sector in the context of the developing Middle Eastern nations. In an attempt to address this knowledge gap, the current study explores some of the barriers that hinder and the enablers that foster women’s career advancement in the healthcare sector. To meet its objectives, the current study uses a relational approach that integrates the macro socio-cultural, meso-organisational, and micro-individual levels of analysis.Methods: Guided by institutional theory as a theoretical framework and social constructionism as a philosophical stance, the current study adopts a qualitative research methodology. It capitalizes on in-depth, semi-structured, face-to-face interviews with women managers in different occupational fields, across the managerial hierarchy in the healthcare sector in Lebanon. Snowballing and purposeful sampling procedures were used, and the interviews were analysed using thematic analysis, focusing on identifying new, emerging themes.Results: The results of the study confirm the salience of discriminatory cultural values, gendered social roles and expectations in Middle Eastern societies, and illustrate their role as barriers hindering women’s career advancement. The results also portray the spillover effect of societal expectations and cultural gender stereotypes into the organisational realm, resulting in widely experienced attitudinal and structural organisational barriers. This study also illustrates how the enablers that facilitate and promote women’s career progression unfold amidst the interplay between the macro and meso factors, lending credence to the role of women’s agency at the individual micro level. Amongst the toll of barriers, Middle Eastern women navigate the patriarchy of their cultures and the discrimination inherent in their organisations by
Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan
The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
Parker-Lue, Sara; Santoro, Michael; Koski, Greg
The cost of drugs is a major and rapidly rising component of health-care expenditures. We survey recent literature on the ethics and economics of skyrocketing pharmaceutical prices and find that advances in economic research have increased the sharpness and focus of the ethically based calls to increase access by modifying patent protection and reducing prices. In some cases, research supports ethical arguments for broader access. Other research suggests that efforts to broaden access result in unintended consequences for innovation and the medical needs of patients. Both ethicists and economists need to be more cognizant of the real clinical settings in which physicians practice medicine with real patients. Greater cross-disciplinary interaction among economists, ethicists, and physicians can help reduce the disjunction between innovation and access and improve access and patient care. This dialogue will impact private industry and may spur new multistakeholder paradigms for drug discovery, development, and pricing.
"Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel...
Stevenson, Matt; Tappenden, Paul; Squires, Hazel
This article provides a position statement regarding decision making under uncertainty within the economic evaluation of pharmaceuticals, with a particular focus upon the National Institute for Health and Clinical Excellence context within England and Wales. This area is of importance as funding agencies have a finite budget from which to purchase a selection of competing health care interventions. The objective function generally used is that of maximising societal health with an explicit acknowledgement that there will be opportunity costs associated with purchasing a particular intervention. Three components of uncertainty are discussed within a pharmaceutical funding perspective: methodological uncertainty, parameter uncertainty and structural uncertainty, alongside a discussion of challenges that are particularly pertinent to health economic evaluation. The discipline has focused primarily on handling methodological and parameter uncertainty and a clear reference case has been developed for consistency across evaluations. However, uncertainties still remain. Less attention has been given to methods for handling structural uncertainty. The lack of adequate methods to explicitly incorporate this aspect of model development may result in the true uncertainty surrounding health care investment decisions being underestimated. Research in this area is ongoing as we review.
Full Text Available Background A study is reported that examines the use of electronic health record (EHR systems in two UK local health communities.Objective These systems were developed locally and the aim of the study was to explore how well they were supporting the coordination of care along healthcare pathways that cross the organisational boundaries between the agencies delivering health care.Results The paper presents the findings for two healthcare pathways; the Stroke Pathway and a pathway for the care of the frail elderly in their own homes. All the pathways examined involved multiple agencies and many locally tailored EHR systems are in use to aid the coordination of care. However, the ability to share electronic patient information along the pathways was patchy. The development of systems that enabled effective sharing of information was characterised by sociotechnical system development, i.e. associating the technical development with process changes and organisational changes, with local development teams that drew on all the relevant agencies in the local health community and on evolutionary development, as experience grew of the benefits that EHR systems could deliver.Conclusions The study concludes that whilst there may be a role for a national IT strategy, for example, to set standards for systems procurement that facilitate data interchange, most systems development work needs to be done at a ‘middle-out’ level in the local health community, where joint planning between healthcare agencies can occur, and at the local healthcare pathway level where systems can be matched to specific needs for information sharing.
Marco, Catherine A
Promotion of prescription drugs represents a growing source of pharmaceutical marketing expenditures. This study was undertaken to identify the frequency of items containing pharmaceutical advertising in clinical emergency departments (EDs). In this observational study, emergency physician on-site investigators quantified a variety of items containing pharmaceutical advertising present at specified representative times and days, in clinical EDs. Measurements were obtained by 65 on-site investigators, representing 22 states. Most EDs in this study were community EDs (87% community and 14% university or university affiliate), and most were in urban settings (50% urban, 38% suburban, and 13% rural). Investigators measured 42 items per ED (mean = 42; median = 31; interquartile range of 14-55) containing pharmaceutical advertising in the clinical area. The most commonly observed items included pens (mean 15 per ED; median 10), product brochures (mean 5; median 3), stethoscope labels (mean 4; median 2), drug samples (mean 3; median 0), books (mean 3.4), mugs (mean 2.4), and published literature (mean 3.1). EDs with a policy restricting pharmaceutical representatives in the ED had significantly fewer items containing pharmaceutical advertising (median 7.5; 95% CI = 0 to 27) than EDs without such a policy (median 35; 95% CI = 27 to 47, p = 0.005, nonparametric Wilcoxon two-sample test). There were no differences in quantities of pharmaceutical advertising for EDs in community compared with university settings (p = 0.5), rural compared with urban settings (p = 0.3), or annual ED volumes (p = 0.9). Numerous items containing pharmaceutical advertising are frequently observed in EDs. Policies restricting pharmaceutical representatives in the ED are associated with reduced pharmaceutical advertising.
Leto di Priolo, Susanna; Fehervary, Andras; Riggins, Phil; Redmond, Kathy
The relationship between the pharmaceutical industry and cancer patient groups has been the subject of much scrutiny and skepticism, and some high-profile negative media coverage has focused attention on some of the problematic aspects of the relationship. Both the pharmaceutical industry and cancer patient groups have made an effort in recent years to improve the transparency and openness of their relations, specifically with regard to the financial support offered by pharmaceutical companies to patient groups. The objectives of this survey were to benchmark perceptions held by different stakeholder groups about current relationships between cancer patient groups and pharmaceutical companies in Europe, and to explore opinions about ways in which partnerships between patient groups and pharmaceutical companies could evolve to the benefit of cancer patients. The survey was conducted using a structured questionnaire that contained a combination of matrix, scaled, and open-ended questions. The questionnaire was developed based on a literature search and the findings from ten in-depth interviews conducted with policy makers and advocates working at an EU level. Telephone interviews were carried out using a structured questionnaire with a convenience sample of 161 policy makers, cancer healthcare group representatives, and cancer patient group leaders from France, Germany, Hungary, Italy, Latvia, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, and the UK. The interviews took place in the relevant language of the country. The current relationship between the pharmaceutical industry and cancer patient groups in Europe is generally viewed as positive, but it is also viewed as being unequal, not transparent enough, and not sufficiently patient-centric. There is broad agreement that cancer patient groups can help companies identify unmet needs and contribute to the development of innovative medicines; however, there is some concern about cancer patients
Full Text Available After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The
After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for
Xu, Wei; Boehm, Garth; Zheng, Qiang
Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically available.This is justified as the article is only concerned with inherent product quality risks. After establishing a link between Chinese essential medicines and those available in the US, we examine US recall data to separate product specific recalls. We conclude that, in addition to existing manufacturing based risks, there are two other product specific risks that stand out from all others, degradation and dissolution failure. Methodology for relative product risk for degradation is needed to be developed and further work is required to better understand dissolution failures which largely occur with modified-release solid oral products. We conclude that a product specific quality risk profile would be enhanced by including a risk assessment for degradation for all products, and in the case of solid oral products, dissolution.
Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally effluent had median concentrations ranging from 3.4 to >400 μg/L. Maximum concentrations of oxycodone (1700 μg/L) and metaxalone (3800 μg/L) in samples from NY3 effluent exceeded 1000 μg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 μg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847
Occupational health and safety research rarely makes use of data on employee healthcare utilization to gain insight into the physical and mental health of healthcare staff. This paper aims to fill this gap by examining the prevalence of two relevant types of healthcare utilization among staff working in healthcare organizations: physical therapy and mental healthcare utilization. The paper furthermore explores what role employee and organizational characteristics play in explaining differences in healthcare utilization between organizations. A Dutch healthcare insurance company provided healthcare utilization records for a sample of 417 organizations employing 136,804 healthcare workers in the Netherlands. The results showed that there are large differences between and within healthcare industries when it comes to employee healthcare utilization. Multivariate regression analyses revealed that employee characteristics such as age and gender distributions, and healthcare industry, explain some of the variance between healthcare organizations. Nevertheless, the results of the analyses showed that for all healthcare utilization indicators there is still a large amount of unexplained variance. Further research into the subject of organizational differences in employee healthcare utilization is needed, as finding possibilities to influence employee health and subsequent healthcare utilization is beneficial to employees, employers and society as a whole.
Full Text Available Currently, one of the environmental issues is waste of hospitals and healthcare facilities which due to hazardous, toxic, and disease-causing agents such as pharmaceutical, chemical and infectious disease, is of particular sensitivity. According to a 2002 survey by WHO, it was determined that 22 million people worldwide suffer from infectious diseases annually, because of contacting hospital wastes. Also based on a research conducted in 22 countries, 18 to 64 percent of hospitals wastes are not disposed properly . The purpose f the study is to appraise collection and disposal of hospital wastes in hospitals and healthcare centers of Shahroud.In this sectional study, 3 university hospitals (580 beds and 10 healthcare facilities were investigated for six months (mehr-azar 89 at Shahroud. In order to determine the amount of waste, produced waste of an entire day was weighted in hospitals and health centers. In this research, proposed questionnaires of WHO for developing countries was used to evaluate collection and disposal system of hospitals waste. Collected data was coded and analyzed by SPSS ver.15.
Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.
Olga Vladimirovna Kudelina
Full Text Available An evaluation of healthcare systems effectiveness of the regions of the Russian Federation (federal districts was conducted using the Minmax method based on the data available at the United Interdepartmental Statistical Information System. Four groups of components (i.e. availability of resources; use of resources; access to resources and medical effectiveness decomposed into 17 items were analyzed. The resource availability was measured by four indicators, including the provision of doctors, nurses, hospital beds; agencies providing health care to the population. Use of resources was measured by seven indicators: the average hospital stay, days; the average bed occupancy, days; the number of operations per 1 physician surgical; the cost per unit volume of medical care: in outpatient clinics, day hospitals, inpatient and emergency care. Access to the resources was measured by three indicators: the satisfaction of the population by medical care; the capacity of outpatient clinics; the average number of visits to health facility. The medical effectiveness was also measured by three indicators: incidence with the "first-ever diagnosis of malignancy"; life expectancy at birth, years; the number of days of temporary disability. The study of the dynamics of the components and indexes for 2008–2012 allows to indicate a multidirectional influence on the regional healthcare system. In some federal districts (e.g. North Caucasian, the effectiveness decreases due to resource availability, in others (South, North Caucasian — due to the use of resources, in others (Far Eastern, Ural — due to access to resources. It is found that the effectiveness of the healthcare systems of the federal districts differs significantly. In addition, the built matrix proves the variability the of effectiveness (comparison of expenditures and results of healthcare systems of the federal districts of the Russian Federation: the high results can be obtained at high costs
Polyzos, Nikolaos; Kastanioti, Catherine; Zilidis, Christos; Mavridoglou, George; Karakolias, Stefanos; Litsa, Panagiota; Menegakis, Valantis; Kani, Chara
In Greece, due to the ongoing economic crisis a number of measures aiming at rationalising expenditure implemented. A new e-prescribing system, under a unified healthcare fund was the main pillar of these reforms focus on monitoring and auditing prescribing patterns. Main objective of this study was to document the Greek experience with the new national e-prescribing system. We analyse the dispensed prescriptions over the period 2013-2014, stratified into four levels: therapeutic subgroup, patent status, physician's specialty and geographical region. Data analysis offered a comprehensive insight into pharmaceutical expenditure over the timeframe and revealed discrepancies regarding composition of spending, brand-generic substitution within certain therapeutic subgroups, physicians' prescribing behaviour based on medical specialty, therapeutic subgroup as well as regional per capita measures. E-prescribing system is a valuable tool providing sound information to health policymakers in order to monitor and rationalize pharmaceutical expenditure, in value and volume terms.
Chakraborty, Sweta; Bouder, Frederic
Risk communication is an interactive two-way process that various stakeholders (e.g., patients, regulators, industry) utilize to address prescription drug safety. This paper will specifically examine the pharmaceutical industry's engagement with risk communication as a tool for information exchange with patients and other stakeholders about the associated risks related to its medicines. Risk communications are not solely meant to inform; and rather effective two-way risk communications have the potential to change behavioral outcomes for the purpose of individual and societal benefit. Despite this indispensable role of risk communication for the pharmaceutical industry, more research is needed for the appropriate development and dissemination of risk communications. A crucial missing component for the crafting of pharmaceutical risk communications is the understanding of risk perceptions from the patient/consumer's perspective. This is necessary to see where any divergences in views may lie between the industry and its final consumer, which is crucial in tailoring communications to target a specific erroneous belief or to address what might be deemed as a needed behavioral shift. It is also necessary to develop communications in consideration of the levels of public trust in the industry as well as other perceived actors in the healthcare system. Even the most meticulously crafted and tested risk communications will fail to fulfill their purpose if the role of trust is not taken into consideration. These considerations can lead to the establishment of a "social contract" that effectively addresses what is required from both parties for continued and mutually beneficial interactions. Conducting risk perception research, addressing the role of trust, establishing a social contract, and having a realistic outlook on the impact of risk communications are necessary considerations as pharmaceutical risk communication evolves for the future.
Fischer, Melissa A; Keough, Mary Ellen; Baril, Joann L; Saccoccio, Laura; Mazor, Kathleen M; Ladd, Elissa; Von Worley, Ann; Gurwitz, Jerry H
Research suggests that pharmaceutical marketing influences prescribing and may cause cognitive dissonance for prescribers. This work has primarily been with physicians and physician-trainees. Questions remain regarding why prescribers continue to meet with pharmaceutical representatives (PRs). To describe the reasons that prescribers from various health professions continue to interact with PRs despite growing evidence of the influence of these interactions. Multi-disciplinary focus groups with 61 participants held in practice settings and at society meetings. Most prescribers participating in our focus groups believe that overall PR interactions are beneficial to patient care and practice health. They either trust the information from PRs or feel that they are equipped to evaluate it independently. Despite acknowledgement of study findings to the contrary, prescribers state that they are able to effectively manage PR interactions such that their own prescribing is not adversely impacted. Prescribers describe few specific strategies or policies for these interactions, and report that policies are not consistently implemented with all members of a clinic or institution. Some prescribers perceive an inherent contradiction between academic centers and national societies receiving money from pharmaceutical companies, and then recommending restriction at the level of the individual prescriber. Prescribers with different training backgrounds present a few novel reasons for these meetings. Despite evidence that PR detailing influences prescribing, providers from several health professions continue to believe that PR interactions improve patient care, and that they can adequately evaluate and filter information presented to them by PRs. Focus group comments suggest that cultural change is necessary to break the norms that exist in many settings. Applying policies consistently, considering non-physician members of the healthcare team, working with trainees, restructuring
Ciani, Oriana; Armeni, Patrizio; Boscolo, Paola Roberta; Cavazza, Marianna; Jommi, Claudio; Tarricone, Rosanna
Innovation is constantly evoked as an imperative to drive growth, however identifying an actionable and agreed upon definition that applies to different settings and purposes is not trivial. In healthcare, innovation has often been described in relation to pharmaceuticals. Defining innovation allows for proper recognition and rewarding, thus fostering present and future innovativeness in the system. Current definitions adopted by payers are focused on therapeutic added value and more specific...
Higashi, Taishi; Iohara, Daisuke; Motoyama, Keiichi; Arima, Hidetoshi
Supramolecular chemistry is an extremely useful and important domain for understanding pharmaceutical sciences because various physiological reactions and drug activities are based on supramolecular chemistry. However, it is not a major domain in the pharmaceutical field. In this review, we propose a new concept in pharmaceutical sciences termed "supramolecular pharmaceutical sciences," which combines pharmaceutical sciences and supramolecular chemistry. This concept could be useful for developing new ideas, methods, hypotheses, strategies, materials, and mechanisms in pharmaceutical sciences. Herein, we focus on cyclodextrin (CyD)-based supermolecules, because CyDs have been used not only as pharmaceutical excipients or active pharmaceutical ingredients but also as components of supermolecules.
Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.
The presence of social inequalities in health requires a multi-faceted intervention, focusing on the social determinants as well as the provision of care and prevention strategies. Regional health agencies have important levers at their disposal, as illustrated by the example of the Île-de-France region. Copyright © 2017 Elsevier Masson SAS. All rights reserved.
Ellenbecker, Carol Hall; Cushman, Margaret
This paper discusses additions to an empirically tested model of home healthcare nurse retention. An argument is made that the variables of shared decision-making and organizational commitment be added to the model based on the authors' previous research and additional evidence from the literature. Previous research testing the home healthcare nurse retention model established empirical relationships between nurse, agency, and area characteristics to nurse job satisfaction, intent to stay, and retention. Unexplained model variance prompted a new literature search to augment understanding of nurse retention and patient and agency outcomes. Data come from the authors' previous research, and a literature search from 1990 to 2011 on the topics organizational commitment, shared decision-making, nurse retention, patient outcomes and agency performance. The literature provides a rationale for the additional variables of shared decision-making and affective and continuous organizational commitment, linking these variables to nurse job satisfaction, nurse intent to stay, nurse retention and patient outcomes and agency performance. Implications for nursing. The new variables in the model suggest that all agencies, even those not struggling to retain nurses, should develop interventions to enhance nurse job satisfaction to assure quality patient outcomes. The new nurse retention and patient outcome model increases our understanding of nurse retention. An understanding of the relationship among these variables will guide future research and the development of interventions to create and maintain nursing work environments that contribute to nurse affective agency commitment, nurse retention and quality of patient outcomes. © 2011 Blackwell Publishing Ltd.
Ahmad, Akram; Patel, Isha; Parimilakrishnan, Sundararajan; Mohanta, Guru Prasad; Chung, HaeChung; Chang, Jongwha
Phamacoeconomics can aid the policy makers and the healthcare providers in decision making in evaluating the affordability of and access to rational drug use. Efficiency is a key concept of pharmacoeconomics, and various strategies are suggested for buying the greatest amount of benefits for a given resource use. Phamacoeconomic evaluation techniques such as cost minimization analysis, cost effectiveness analysis, cost benefit analysis, and cost utilization analysis, which support identification and quantification of cost of drugs, are conducted in a similar way, but vary in measurement of value of health benefits and outcomes. This article provides a brief overview about pharmacoeconomics, its utility with respect to the Indian pharmaceutical industry, and the expanding insurance system in India. Pharmacoeconomic evidences can be utilized to support decisions on licensing, pricing, reimbursement, and maintenance of formulary procedure of pharmaceuticals. For the insurance companies to give better facility at minimum cost, India must develop the platform for pharmacoeconomics with a validating methodology and appropriate training. The role of clinical pharmacists including PharmD graduates are expected to be more beneficial than the conventional pharmacists, as they will be able to apply the principles of economics in daily basis practice in community and hospital pharmacy.
Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary
Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.
Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M
The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.
Koolivand, Ali; Mahvi, Amir Hossein; Alipoor, Vali; Azizi, Kourosh; Binavapour, Mohammad
The objective of this study was to identify the composition and production rate of healthcare waste and associated management practices in healthcare centres in Bandar Abbas, southern Iran. A total of 90 centres, including 30 physician offices, 30 dental offices and 30 clinics were selected in random way. Two samples in summer and two samples in winter were taken and weighed from each selected centre at the end of successive working day on Mondays and Tuesdays. Results showed that the mean of daily production rate for each clinic, dental and physician office were 2125.3, 498.3 and 374.9 g, respectively. Domestic-type and potentially infectious waste had the highest and chemical and pharmaceutical waste and sharps had the lowest percentages in all centres. Questionnaire results indicated that there were no effective activity for waste minimization, separation, reuse and recycling in healthcare centres and management of sharps, potentially infectious and other hazardous waste was poor.
Tordoff, June M; Norris, Pauline T; Reith, David M
In 2002, as part of a National Hospital Pharmaceutical Strategy, the New Zealand (NZ) government agency PHARMAC commenced a 3-year period of negotiating prices for 90% of hospital pharmaceuticals on behalf of all NZ public hospitals. The present study was undertaken to determine the effects of this first year of "pooled procurement." Using price changes and volume data for each of their top 150 pharmaceutical items, chief pharmacists at 11 public hospitals calculated projected cost savings for the financial year July 2003 to June 2004. Researchers calculated total projected savings for all 11 hospitals, and for three types of hospitals. Estimates of projected savings were made for all 29 major public hospitals by using savings per bed and savings per bed-day. A sensitivity analysis was undertaken. Items showing savings were categorized by using the Anatomical Therapeutic Chemical classification system. For the 11 hospitals, the top 150 items comprised 612 different items. Projected savings for 2003 to 2004 were NZ dollar 2,652,814, NZ dollar 658,984, and NZ dollar 127,952 for tertiary, secondary, and rural/special hospitals, respectively. Percentage savings as a median (range) of the total top 150 expenditure were: tertiary 5.28% (3.09-16.05%), secondary 7.41% (4.67-12.85%), and rural/special 9.55% (6.27-10.09%). For all 29 hospitals, estimated projected savings were NZ dollar 5,234,919 (NZ dollar 3,304,606-NZ dollar 8,044,482) by savings per bed, and NZ dollar 5,255,781 (NZ dollar 2,936,850-NZ dollar 8,693,239) by savings per bed-day. The main contributors to savings were: agents for infections, the nervous system, musculoskeletal system, and blood/blood-forming organs. The first year of pooled procurement under the National Hospital Pharmaceutical Strategy (2002-2003) has resulted in moderate savings. For all 29 major public hospitals, savings of around NZ dollar 5.2 million (dollar 2.9 million-dollar 8.7 million) or 3.7% were projected for 2003 to 2004. Longer
Casey, Murray Joseph; O'Brien, Richard; Rendell, Marc; Salzman, Todd
The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance.
La industria farmacéutica y la sostenibilidad de los sistemas de salud en países desarrollados y América Latina The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America
European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.
Lulin, Zhou; Antwi, Henry Asante; Wang, Wenxin; Yiranbon, Ethel; Marfo, Emmanuel Opoku; Acheampong, Patrick
China has become the world's second largest healthcare market based on a recent report by the World Health Organization. Eventhough China achieved universal health insurance coverage in 2011, representing the largest expansion of insurance coverage in human history achieved; health inequality remains endemic in China. Lessons from the effect of market crisis on health equity in Europe and other places has reignited interest in exploring the potential healthcare market aberrations that can trigger distributive injustice in healthcare resource allocation among China's provinces. Recently, many healthcare investors in China have become more concerned about capital preservation, and are responding by abandoning long term investments strategies in healthcare. This investment withdrawal en mass is perceived to be influenced by herding tendencies and can trigger or consolidate endemic health inequality. Our study simultaneously employs four testing models (two state spaced models and two return dispersion models) to establish the existence of procyclical (herding) behavior among the stocks and its health equity implications. These are applied to a large set of data to compare and contrast results of herd formation among investors in fourteen healthcare sectors in China. The study reveals that apart from the cross sectional standard deviation (CSSD) model, the remaining two models and our augmented state space model yields significant evidence of herding in all subsectors of the healthcare market. We also find that the herding effect is more prominent during down movements of the market. Herding behavior may lead to contemporaneous loss of investor confidence and capital withdrawal and thereby deprive the healthcare sector of the much needed capital for expansion. Thus there may be obvious delay in efforts to bridge the gap in access to healthcare facilities, medical support services, medical supplies, pharmaceuticals, biotechnology, diagnostic substances, medical
Full Text Available Kimberly Ovsag, Sabrina Hydery, Shaker A MousaPharmaceutical Research Institute at Albany College of Pharmacy, Albany, New York, USAObjectives: To analyze the implementation of Medicaid preferred drug lists (PDLs in a number of states and determine its impact on quality of care and cost relative to other segments of healthcare.Methods: We reviewed research and case studies found by searching library databases, primarily MEDLINE and EBSCOHost, and searching pertinent journals. Keywords initially included “drug lists,” “prior authorization,” “prior approval,” and “Medicaid.” We added terms such as “influence use of other healthcare services,” “quality of care,” and “overall economic impact.” We mainly used primary sources.Results: Based on our literature review, we determined that there are a number of issues regarding Medicaid PDLs that need to be addressed. Some issues include: (a the potential for PDLs to influence the utilization of other healthcare services, (b criteria used by Medicaid for determining acceptance of drugs onto a PDL, (c the effect of PDL implementation on compliance to new regimens, (d the potential effects of restricting medication availability on quality of care, (e administrative costs associated with PDLs, and (f satisfaction rates among patients and medical providers. This review highlighted expected short-term cost savings with limited degree of compromised quality of PDL implementation, but raised the concern about the potential long-term decline in quality of care and overall economic impact.Conclusions: The number of concerns raised indicates that further studies are warranted regarding both short-term cost benefits as well as potential long-term effects of Medicaid PDL implementation. Objective analysis of these effects is necessary to ensure cost-effectiveness and quality of care.Keywords: preferred drug lists, medicaid, healthcare costs, managed care
... up. To compound the problem, many pediatric audiologists may be proficient evaluating children age 5... Agencies (DSHPSHWA), Healthcare Resources and Services Administration (HRSA), University of Maine Center..., on-demand access by the audiologists. Financial cost is minimized because no mailing fee will be...
Basanta, W Eugene
In today's healthcare industry, many hospitals utilize outside agencies for both business and clinical functions. This Article acknowledges the prevalence of outsourcing contract labor in the healthcare arena and focuses on the restrictive provisions included in these employment contracts, particularly "no-hire" clauses. No-hire clauses are often included in contracts between healthcare providers and professional groups that provide clinical service employees to the provider, such as a medical practice group providing physicians to a hospital or an agency providing nurses to a nursing home. These clauses usually provide that the healthcare provider may not directly hire an employee provided by the professional group, nor may it contract with another professional group that later hires the employee. The purpose of a no-hire clause is two-fold: to protect the professional group's investment of time and moneyfor recruiting, training, and establishing the employee's clinical practice, and to give the professional group leverage to retain its employees. While noncompete clauses in employment contracts have traditionally been the subject of litigation, no-hire clauses raise distinct legal issues. Case law provides conflicting views as to the enforceability of these provisions. Some courts find no-hire clauses to be per se illegal restrictions on trade, while others will permit them when they are reasonable within a specific context. The author proposes that a multifactor test be applied on a case-by-case basis to determine the reasonableness of the no-hire provision in a given employment contract and suggests drafting improvements to facilitate enforcement.
Datta, Anusua; Dave, Dhaval
Spending on prescription drugs (Rx) represents one of the fastest growing components of US healthcare spending and has coincided with an expansion of pharmaceutical promotional spending. Most (83%) of Rx promotion is directed at physicians in the form of visits by pharmaceutical representatives (known as detailing) and drug samples provided to physicians' offices. Such promotion has come under increased public scrutiny, with critics contending that physician-directed promotion may play a role in raising healthcare costs and may unduly affect physicians' prescribing habits towards more expensive, and possibly less cost-effective, drugs. In this study, we bring longitudinal evidence to bear upon the question of how detailing impacts physicians' prescribing behaviors. Specifically, we examine prescriptions and promotion for a particular drug class based on a nationally representative sample of 150,000 physicians spanning 24 months. The use of longitudinal physician-level data allows us to tackle some of the empirical concerns in the extant literature, virtually all of which have relied on aggregate national data. We estimate fixed-effects specifications that bypass stable unobserved physician-specific heterogeneity and address potential targeting bias. In addition, we also assess differential effects at both the extensive and intensive margins of prescribing behaviors and differential effects across physician-level and market-level characteristics, questions that have not been explored in prior work. The estimates suggest that detailing has a significant and positive effect on the number of new scripts written for the detailed drug, with an elasticity magnitude of 0.06. This effect is substantially smaller than those in the literature based on aggregate information, suggesting that most of the observed relationship between physician-directed promotion and drug sales is driven by selection bias. We find that detailing impacts selective brand-specific demand but does
Happe, Laura E; Walker, Desiree'
To assess the impact of using "grey literature" (information internally produced in print or electronic format by agencies such as hospitals, government, businesses, etc) rather than a textbook in a course on healthcare delivery systems on students' perception of the relevance of healthcare delivery system topics and their ability to identify credible sources of this information. A reading from the grey literature was identified and assigned to the students for each topic in the course. Pre- and post-course survey instruments were used for the assessment. Students reported healthcare delivery systems topics to be moderately relevant to the profession of pharmacy on both the pre- and post-course survey instruments. Students' knowledge of current and credible sources of information on healthcare delivery system topics significantly improved based on self-reports and scores on objective assessments (pgrey literature in a course on healthcare delivery systems can be used to ensure that information in the pharmacy school curriculum is the most current and credible information available.
Gil, Eric de Souza; Melo, Giselle Rodrigues de
Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, fo...
Alaiad, Ahmad; Zhou, Lina
Home healthcare robots promise to make clinical information available at the right place and time, thereby reducing error and increasing safety and quality. However, it has been frequently reported that more than 40% of previous information technology (IT) developments have failed or been abandoned due to the lack of understanding of the sociotechnical aspects of IT. Previous home healthcare robots research has focused on technology development and clinical applications. There has been little discussion of associated social, technical and managerial issues that are arguably of equal importance for robot success. To fill this knowledge gap, this research aims to understand the determinants of home healthcare robots adoption from these aspects by applying technology acceptance theories. We employed both qualitative and quantitative methods. The participants were recruited from home healthcare agencies located in the U.S. (n=108), which included both patients and healthcare professionals. We collected data via a survey study to test a research model. The usage intention of home healthcare robots is a function of social influence, performance expectancy, trust, privacy concerns, ethical concerns and facilitating conditions. Among them, social influence is the strongest predictor. Monitoring vital signs and facilitating communication with family and medication reminders are the most preferable tasks and applications for robots. Sociotechnical factors play a powerful role in explaining the adoption intention for home healthcare robots. The findings provide insights on how home healthcare service providers and robot designers may improve the success of robot technologies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
was prepared, there have been no similar announcements from Thomson Healthcare for Redbook or from Elsevier for Gold Standard [ProspectoRx], who are 2 other publishers of prescription drug prices). Furthermore, several manufacturers have announced that they will no longer provide either an AWP or a markup percentage on certain pharmaceuticals.3 Thus, by 2011, the AWP benchmark as we know it will no longer be widely available for use by public or commercial payers for payment of pharmaceutical products.
Full Text Available Introduction. Parliaments of both Ukraine and the EU have ratified Association Agreement (hereinafter – Agreement, a comprehensive document which envisages bringing all areas of the law of our country in line with European Union norms. Therefore, chapter 22 of the Agreement "Public Health" gave attention as one of the most important areas of implementation. That is, the need for introduction in Ukraine of the approach, called "Health in all policy areas” provides consider of the interests of public healthcare in approving of political solutions in any area of the state activities. The organizational, medical and pharmaceutical approaches to optimization of the medicines’ circulation is the improvement of the legal system of regulation of prescription and OTC medicines (drugs, determination of the circulation of drugs of different classification and legal groups, assigning drugs to one of nomenclature and legal groups (prescription or non-prescription. Materials and methods. Forensic and pharmaceutical researches conducted in countryside areas at the regional level on example of the Kharkiv region based on 54 communal health institutions (CHI. Materials of the research: legal framework for the organization of pharmacy of the CHI; forensic and pharmaceutical practice for the period of 2012-2015 concerning the provision with the medicines of all legal, nomenclature and classification groups for the pharmacotherapy of hypertension in the village. In conducting the research, we used the following methods: legal, documentary, comparative analysis, forensic and pharmaceutical monitoring. Results and discussion. According to the Statement of the Cabinet of Ministers of Ukraine from 17.08.1998 N1303 was sorted the procedure of the concessional dispensing of the drugs (for free or at 50% discount. The procedure applies to certain categories of the population and some diseases for which benefits established by applicable law. Despite the potential of
Mohiuddin, Mahrukh; Rashid, Sabina Faiz; Shuvro, Mofijul Islam; Nahar, Nahitun; Ahmed, Syed Masud
The pharmaceutical market in Bangladesh is highly concentrated (top ten control around 70 % of the market). Due to high competition aggressive marketing strategies are adopted for greater market share, which sometimes cross limit. There is lack of data on this aspect in Bangladesh. This exploratory study aimed to fill this gap by investigating current promotional practices of the pharmaceutical companies including the role of their medical representatives (MR). This qualitative study was conducted as part of a larger study to explore the status of governance in health sector in 2009. Data were collected from Dhaka, Chittagong and Bogra districts through in-depth interview (healthcare providers and MRs), observation (physician-MR interaction), and round table discussion (chief executives and top management of the pharmaceutical companies). Findings reveal a highly structured system geared to generate prescriptions and ensure market share instituted by the pharmaceuticals. A comprehensive training curriculum for the MRs prepares the newly recruited science graduates for generating enough prescriptions by catering to the identified needs and demands of the physicians expressed or otherwise, and thus grab higher market-share for the companies they represent. Approaches such as inducements, persuasion, emotional blackmail, serving family members, etc. are used. The type, quantity and quality of inducements offered to the physicians depend upon his/her capacity to produce prescriptions. The popular physicians are cultivated meticulously by the MRs to establish brand loyalty and fulfill individual and company targets. The physicians, willingly or unwillingly, become part of the system with few exceptions. Neither the regulatory authority nor the professional or consumer rights bodies has any role to control or ractify the process. The aggressive marketing of the pharmaceutical companies compel their MRs, programmed to maximize market share, to adopt unethical means if
Gómez, Eduardo J
This article proposes an approach to comparing and assessing the adaptive capacity of multilateral health agencies in meeting country and individual healthcare needs. Most studies comparing multilateral health agencies have failed to clearly propose a method for conducting agency comparisons. This study conducted a qualitative case study methodological approach, such that secondary and primary case study literature was used to conduct case study comparisons of multilateral health agencies. Through the proposed Sequential Comparative Analysis (SCA), the author found a more effective way to justify the selection of cases, compare and assess organizational transformative capacity, and to learn from agency success in policy sustainability processes. To more affectively understand and explain why some multilateral health agencies are more capable of adapting to country and individual healthcare needs, SCA provides a methodological approach that may help to better understand why these agencies are so different and what we can learn from successful reform processes. As funding challenges continue to hamper these agencies' adaptive capacity, learning from each other will become increasingly important.
Ershova Elena Vladimirovna
Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.
To investigate which factors and criteria are used in priority setting of pharmaceuticals, in what contexts health economic evaluations are used, and barriers to the use of health economic evaluations at micro, meso, and macro health-care levels. The search for empirical articles was based on the MeSH index (Medical Substance Heading), including the search terms "economic evaluation," "cost-effectiveness analysis," "cost-utility analysis," "cost-benefit analysis," "pharmacoeconomic," AND "drug cost(s)," AND "eligibility determination," AND "decision-making," AND "rationing," AND formulary. The following databases were searched: PubMed, EconLit, Cochrane, Web of Science, CINAHL, and PsycINFO. More than 3100 studies were identified, 31 of which were included in this review. The use of health economic evaluations at all three health-care levels was investigated in three countries (United States [US], United Kingdom [UK], and Sweden). Postal and telephone survey methods dominated (n = 17) followed by interviews (n = 13), document analysis (n = 10), and observations of group deliberations (n = 9). The cost-effectiveness criterion was most important at the macro level. A number of contextual uses of health economic evaluations were identified, including importantly the legitimizing of decisions, structuring the priority-setting process, and requesting additional budgets to finance expensive pharmaceuticals. Factors that seem to support the increased use of health economic evaluations are well-developed frameworks for evaluations, the presence of health economic skills, and an explicit priority-setting process. Differences in how economic evaluations are used at macro, meso, and micro levels are attributed to differences in the preconditions at each level. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)
Sonali S. Bharate
Full Text Available Studies of active drug/excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. The potential physical and chemical interactions between drugs and excipients can affect the chemical nature, the stability and bioavailability of drugs and, consequently, their therapeutic efficacy and safety. The present review covers the literature reports of interaction and incompatibilities of commonly used pharmaceutical excipients with different active pharmaceutical ingredients in solid dosage forms. Examples of active drug/excipient interactions, such as transacylation, the Maillard browning reaction, acid base reactions and physical changes are discussed for different active pharmaceutical ingredients belonging to different therapeutic categories viz antiviral, anti-inflammatory, antidiabetic, antihypertensive, anti-convulsant, antibiotic, bronchodialator, antimalarial, antiemetic, antiamoebic, antipsychotic, antidepressant, anticancer, anticoagulant and sedative/hypnotic drugs and vitamins. Once the solid-state reactions of a pharmaceutical system are understood, the necessary steps can be taken to avoid reactivity and improve the stability of drug substances and products.
Salami, Joseph A; Valero-Elizondo, Javier; Ogunmoroti, Oluseye; Spatz, Erica S; Rana, Jamal S; Virani, Salim S; Blankstein, Ron; Younus, Adnan; Arrieta, Alejandro; Blaha, Michael J; Veledar, Emir; Nasir, Khurram
Atherosclerotic cardiovascular disease (ASCVD) causes most deaths in the United States and accounts for the highest healthcare spending. The association between the modifiable risk factors (MRFs) of ASCVD and pharmaceutical expenditures are largely unknown. We examined the association between MRFs and pharmaceutical expenditures among adults with ASCVD using the 2012 and 2013 Medical Expenditure Panel Survey. A 2-part model was used while accounting for the survey's complex design to obtain nationally representative results. All costs were adjusted to 2013 US dollars using the gross domestic product deflator. The annual total pharmaceutical expenditure among those with ASCVD was $71.6 billion, 33% of which was for medications for cardiovascular disease and 14% medications for diabetes mellitus. The adjusted relationship between MRFs and pharmaceutical expenditures showed significant marginal increase in average annual pharmaceutical expenditure associated with inadequate physical activity ($519 [95% confidence interval (CI), $12-918; P =0.011]), dyslipidemia ($631 [95% CI, $168-1094; P =0.008]), hypertension: ($1078 [95% CI, $697-1460; P expenditures among patients with established ASCVD regardless of non-ASCVD comorbidity. In-depth studies of the roles played by other factors in this association can help reduce medication-related expenditures among ASCVD patients. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.
The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.
Full Text Available This research evaluates reconfiguration opportunities in Pharmaceutical Supply Chains (PSC resulting from technology interventions in manufacturing, and new, more patient-centric delivery models. A critical synthesis of the academic and practice literature is used to identify, conceptualise, analyse and categorise PSC models. From a theoretical perspective, a systems view of operations research is adopted to provide insights on a broader range of OR activities, from conceptual to mathematical modelling and model solving, up to implementation.The research demonstrates that: 1 current definitions of the PSC are largely production-centric and fail to capture patient consumption, and hence healthcare outcomes; 2 most PSC mathematical models lack adequate conceptualisation of the structure and behaviour of the supply chain, and the boundary conditions that need to be considered for a given problem; 3 models do not adequately specify current unit operations or future production technology options, and are therefore unable to address the critical questions around alternative product or process technologies; 4 economic evaluations are limited to direct costing, rather than systemic approaches such as supply chain costing and total cost of ownership.While current models of the PSC may help with the optimisation of specific unit operations, their theoretical benefits could be offset by the dynamics of complex upstream (supply and downstream (distribution and healthcare delivery systems. To overcome these limitations, this research provides initial directions towards an integrated systems approach to PSC modelling. This perspective involves problem conceptualisation and boundary definition; design, formulation and solution of mathematical models, through to practical implementation of identified solutions. For both academics and practitioners, research findings suggest a systems approach to PSC modelling can provide improved conceptualisation and
Mebane, Felicia E
In response to mass media's role in the national and global system of pharmaceutical risk communication, the Centers for Education and Research on Therapeutics (CERTs) convened a 'think tank' session on the 'Importance of Media in Pharmaceutical Risk Communication'. Prominent journalists and experts from the pharmaceutical industry, academia, medical practice and government were invited to consider the benefits and challenges of improving the way we communicate the benefits and risks of therapeutics via mass media, especially news media. Workshop discussions revealed a paucity of systematic research directed towards understanding how and why news media report on therapeutic risk, the impact of this coverage and how coverage can be improved. Consequently, participants produced a research agenda capturing the key aspects of the flow of information around this topic, including the meaning of risk, how news audiences process and use therapeutic risk information in the news, how and why news organizations report on therapeutic risk, and the role and impact of the pharmaceutical industry, government officials and academic researchers as sources of therapeutic risk information. The workshop ended with a discussion on action items addressing what news professionals, representatives of regulatory agencies and the medical products industry, and academic researchers can and should do to enable news media to effectively report therapeutic risk information. In sum, this proceedings report provides an outline for developing mass media risk communication research, influencing the practices of journalists and expert sources and ultimately, improving the quality of the public's life. Copyright (c) 2004 John Wiley & Sons, Ltd.
Lassen, Lars Christian; Thomsen, Mads Krogsgaard
Health as a global issue concerns all and clearly manifests global inequality. All stakeholders of the healthcare systems and disease treatment--including the pharmaceutical industry--have an ethical obligation to contribute to promoting global health. At Novo Nordisk we primarily focus on providing our contribution to global health through defeating diabetes. At the same time we stand by being a private company required to deliver a financial profit, which is why we must create positive results on the financial, the environmental and the social bottom lines. In this article we attempt to provide a brief overview of some of the initiatives that we think business companies can take--and therefore are also obliged to in promoting global health. Further, we have pointed out a number of dilemmas within research and development as well as business ethics that all companies face when they convert the ethical principles to daily practice globally.
Elliott, Sarah M.; Erickson, Melinda L.
The U.S. Geological Survey, in cooperation with the Minnesota Pollution Control Agency, completed a study on the occurrence of pharmaceutical compounds and other contaminants of emerging concern in shallow groundwater in non-agricultural areas of Minnesota during 2013. This report describes the study design and methods for the study on the occurrence of pharmaceuticals and other contaminants of emerging concern, and presents the data collected on pharmaceutical compounds. Samples were analyzed by the U.S. Geological Survey National Water Quality Laboratory for 110 pharmaceutical compounds using research method 9017. Samples from 21 of 45 wells had detectable concentrations of at least one of the 110 compounds analyzed. One sample contained detectable concentrations of nine compounds, which was the most detected in a single sample. Fewer than five compounds were detected in most samples. Among all samples, 27 of the 110 compounds were detected in groundwater from at least one well. Desmethyldiltiazem and nicotine were the most frequently detected compounds, each detected in 5 of 46 environmental samples (one well was sampled twice so a total of 46 environmental samples were collected from 45 wells). Caffeine had the highest detectable concentration of all the compounds at 2,060 nanograms per liter.
Full Text Available Prison healthcare is an important public health concern given the increasing healthcare needs of a growing and aging prison population, which accumulates vulnerability factors and suffers from higher disease prevalence than the general population. This study identifies the key factors associated with outpatient general practitioner (GP, nursing or psychiatric healthcare utilization (HCU within prisons. Cross-sectional data systematically collected by the prison medical staff were obtained for a sample of 1664 adult prisoners of the Canton of Vaud, Switzerland, for the year 2011. They contain detailed information on demographics (predisposing factors, diagnosed chronic somatic and psychiatric disorders (needs factors, as well as prison stay characteristics (contextual factors. For GP, nurse and psychiatric care, two-part regressions are used to model separately the probability and the volume of HCU. Predisposing factors are generally not associated with the probability to use healthcare services after controlling for needs factors. However, female inmates use higher volumes of care, and the volume of GP consultations increases with age. Chronic somatic and psychiatric conditions are the most important predictors of the probability of HCU, but associations with volumes differ in their magnitude and significance across disease groups. Infectious, musculoskeletal, nervous and circulatory diseases actively mobilize GP and nursing staff. Schizophrenia, illicit drug and pharmaceuticals abuse are strongly positively associated with psychiatric and nurse HCU. The occupancy rate displays positive associations among contextual factors. Prison healthcare systems face increasingly complex organizational, budgetary and ethical challenges. This study provides relevant insights into the HCU patterns of a marginalized and understudied population.
This article examines online exchanges of advice and knowledge among patients. It draws a distinction between explicit healthcare knowledge (i.e., facts about symptoms and treatments) and tacit healthcare knowledge (i.e., know-how about navigating the healthcare system). Based on analysis of message board interactions at a prominent online illness community, I find that patients routinely encourage one another to exercise agency strategically in clinical encounters by honing specific interactional skills. I isolate three major techniques that are advocated within the community (affect regulation, information management, and treatment persistence) and frame them as discrete examples of tacit healthcare knowledge. I argue that tacit healthcare knowledge constitutes a potentially potent source of empowerment for patients that can help them to receive their desired form of care from the health system and to negotiate relationships with medical professionals and institutions. I conclude by discussing how the concept of tacit healthcare knowledge further clarifies the wide variety of lay knowledge exchanged among patients online. Copyright © 2016 Elsevier Ltd. All rights reserved.
Chua, Siew Siang; Kok, Li Ching; Yusof, Faridah Aryani Md; Tang, Guang Hui; Lee, Shaun Wen Huey; Efendie, Benny; Paraidathathu, Thomas
The roles of pharmacists have evolved from product oriented, dispensing of medications to more patient-focused services such as the provision of pharmaceutical care. Such pharmacy service is also becoming more widely practised in Malaysia but is not well documented. Therefore, this study is warranted to fill this information gap by identifying the types of pharmaceutical care issues (PCIs) encountered by primary care patients with diabetes mellitus, hypertension or hyperlipidaemia in Malaysia. This study was part of a large controlled trial that evaluated the outcomes of multiprofessional collaboration which involved medical general practitioners, pharmacists, dietitians and nurses in managing diabetes mellitus, hypertension and hyperlipidaemia in primary care settings. A total of 477 patients were recruited by 44 general practitioners in the Klang Valley. These patients were counselled by the various healthcare professionals and followed-up for 6 months. Of the 477 participants, 53.7% had at least one PCI, with a total of 706 PCIs. These included drug-use problems (33.3%), insufficient awareness and knowledge about disease condition and medication (20.4%), adverse drug reactions (15.6%), therapeutic failure (13.9%), drug-choice problems (9.5%) and dosing problems (3.4%). Non-adherence to medications topped the list of drug-use problems, followed by incorrect administration of medications. More than half of the PCIs (52%) were classified as probably clinically insignificant, 38.9% with minimal clinical significance, 8.9% as definitely clinically significant and could cause patient harm while one issue (0.2%) was classified as life threatening. The main causes of PCIs were deterioration of disease state which led to failure of therapy, and also presentation of new symptoms or indications. Of the 338 PCIs where changes were recommended by the pharmacist, 87.3% were carried out as recommended. This study demonstrates the importance of pharmacists working in
Full Text Available Abstract Background The roles of pharmacists have evolved from product oriented, dispensing of medications to more patient-focused services such as the provision of pharmaceutical care. Such pharmacy service is also becoming more widely practised in Malaysia but is not well documented. Therefore, this study is warranted to fill this information gap by identifying the types of pharmaceutical care issues (PCIs encountered by primary care patients with diabetes mellitus, hypertension or hyperlipidaemia in Malaysia. Methods This study was part of a large controlled trial that evaluated the outcomes of multiprofessional collaboration which involved medical general practitioners, pharmacists, dietitians and nurses in managing diabetes mellitus, hypertension and hyperlipidaemia in primary care settings. A total of 477 patients were recruited by 44 general practitioners in the Klang Valley. These patients were counselled by the various healthcare professionals and followed-up for 6 months. Results Of the 477 participants, 53.7% had at least one PCI, with a total of 706 PCIs. These included drug-use problems (33.3%, insufficient awareness and knowledge about disease condition and medication (20.4%, adverse drug reactions (15.6%, therapeutic failure (13.9%, drug-choice problems (9.5% and dosing problems (3.4%. Non-adherence to medications topped the list of drug-use problems, followed by incorrect administration of medications. More than half of the PCIs (52% were classified as probably clinically insignificant, 38.9% with minimal clinical significance, 8.9% as definitely clinically significant and could cause patient harm while one issue (0.2% was classified as life threatening. The main causes of PCIs were deterioration of disease state which led to failure of therapy, and also presentation of new symptoms or indications. Of the 338 PCIs where changes were recommended by the pharmacist, 87.3% were carried out as recommended. Conclusions This study
Full Text Available Abstract Background This study systematically compares newspaper coverage of clinical trials for herbal remedies, a popular type of complementary and alternative medicine, with clinical trials for pharmaceuticals using a comparative content analysis. This is a timely inquiry given the recognized importance of the popular press as a source of health information, the complex and significant role of complementary and alternative medicine in individual health-care decisions, and the trend toward evidence-based research for some complementary and alternative medical therapies. We searched PubMed for clinical trials, Lexis/Nexis for newspaper articles in the UK, US, Australia/New Zealand, and Factiva for Canadian newspaper articles from 1995 to 2005. We used a coding frame to analyze and compare 48 pharmaceutical and 57 herbal remedy clinical trials as well as 201 pharmaceutical and 352 herbal remedy newspaper articles. Results Herbal remedy clinical trials had similar Jadad scores to pharmaceutical trials but were significantly smaller and of shorter duration. The trials were mostly studies from Western countries and published in high-ranking journals. The majority of pharmaceutical (64% and herbal remedy (53% clinical trials had private sector funding involvement. A minority declared further author conflicts of interest. Newspaper coverage of herbal remedy clinical trials was more negative than for pharmaceutical trials; a result only partly explained by the greater proportion of herbal remedy clinical trials reporting negative results (P = 0.0201; χ2 = 7.8129; degrees of freedom = 2. Errors of omission were common in newspaper coverage, with little reporting of dose, sample size, location, and duration of the trial, methods, trial funding, and conflicts of interest. There was an under-reporting of risks, especially for herbal remedies. Conclusion Our finding of negative coverage of herbal remedy trials is contrary to the positive trends in most
Shan, Ning; Zaworotko, Michael J
Pharmaceutical cocrystals, a subset of a long known but little-studied class of compounds, represent an emerging class of crystal forms in the context of pharmaceutical science. They are attractive to pharmaceutical scientists because they can significantly diversify the number of crystal forms that exist for a particular active pharmaceutical ingredient (API), and they can lead to improvements in physical properties of clinical relevance. In this article we address pharmaceutical cocrystals from the perspective of design (crystal engineering) and present a series of case studies that demonstrate how they can enhance the solubility, bioavailability, and/or stability of API crystal forms.
Holgersson, Marcus; Phan, Tai; Hedner, Thomas
Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.
Rodwin, Marc A
Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. © 2013 American Society of Law, Medicine & Ethics, Inc.
Shapiro, M F
As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public's lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public.
textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to
Guise, Jeanne-Marie; Chang, Christine; Viswanathan, Meera; Glick, Susan; Treadwell, Jonathan; Umscheid, Craig A; Whitlock, Evelyn; Fu, Rongwei; Berliner, Elise; Paynter, Robin; Anderson, Johanna; Motu'apuaka, Pua; Trikalinos, Tom
The purpose of this Agency for Healthcare Research and Quality Evidence-based Practice Center methods white paper was to outline approaches to conducting systematic reviews of complex multicomponent health care interventions. We performed a literature scan and conducted semistructured interviews with international experts who conduct research or systematic reviews of complex multicomponent interventions (CMCIs) or organizational leaders who implement CMCIs in health care. Challenges identified include lack of consistent terminology for such interventions (eg, complex, multicomponent, multidimensional, multifactorial); a wide range of approaches used to frame the review, from grouping interventions by common features to using more theoretical approaches; decisions regarding whether and how to quantitatively analyze the interventions, from holistic to individual component analytic approaches; and incomplete and inconsistent reporting of elements critical to understanding the success and impact of multicomponent interventions, such as methods used for implementation the context in which interventions are implemented. We provide a framework for the spectrum of conceptual and analytic approaches to synthesizing studies of multicomponent interventions and an initial list of critical reporting elements for such studies. This information is intended to help systematic reviewers understand the options and tradeoffs available for such reviews. Copyright © 2014 Elsevier Inc. All rights reserved.
Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O
Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108
Nunes, Miguel Baptista
Background This paper reports on a research study that aims to identify and explain barriers to knowledge sharing (KS) in the provision of healthcare referral services in Chinese healthcare organisations. Design An inductive case study approach was employed, in which 24 healthcare professionals and workers from four healthcare organisations in the province of Hubei, Central China, were interviewed using semi-structured scripts. Results Through data analysis, 14 KS barriers emerged in four main themes: interpersonal trust barriers, communication barriers, management and leadership barriers, and inter-institutional barriers. A cause–consequence analysis of the identified barriers revealed that three of them are at the core of the majority of problems, namely, the absence of national and local policies for inter-hospital KS, lack of a specific hospital KS requirement, and lack of mutual acquaintance. Conclusions To resolve KS problems, it is of great importance that healthcare governance agencies, both at the national and regional levels, take leadership in the process of KS implementation by establishing specific and strong policies for inter-institutional KS in the referral process. This paper raises important issues that exceed academic interests and are important to healthcare professionals, hospital managers, and Information communication technology (ICT) managers in hospitals, as well as healthcare politicians and policy makers. PMID:26895146
A non-clinical randomised controlled trial to assess the impact of pharmaceutical care intervention on satisfaction level of newly diagnosed diabetes mellitus patients in a tertiary care teaching hospital in Nepal.
Upadhyay, Dinesh Kumar; Mohamed Ibrahim, Mohamed Izham; Mishra, Pranaya; Alurkar, Vijay M
Patient satisfaction is the ultimate goal of healthcare system which can be achieved from good patient-healthcare professional relationship and quality of healthcare services provided. Study was conducted to determine the baseline satisfaction level of newly diagnosed diabetics and to explore the impact of pharmaceutical care intervention on patients' satisfaction during their follow-ups in a tertiary care teaching hospital in Nepal. An interventional, pre-post non-clinical randomised controlled study was designed among randomly distributed 162 [control group (n = 54), test 1 group (n = 54) and test 2 group (n = 54)] newly diagnosed diabetes mellitus patients by consecutive sampling method for 18 months. Diabetes Patient Satisfaction Questionnaire was used to evaluate patient's satisfaction scores at baseline, three, six, nine and, twelve months' follow-ups. Test groups patients were provided pharmaceutical care whereas control group patients only received their usual care from physician/nurses. The responses were entered in SPSS version 16. Data distribution was not normal on Kolmogorov-Smirnov test. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences among the groups before and after the intervention (p ≤0.05). There were significant (p patients' satisfaction scores in the test groups on Friedman test. Mann-Whitney U test identified the significant differences in satisfaction scores between test 1 and test 2 groups, control and test 1 groups and, control and test 2 groups at 3-months (p = 0.008), (p satisfaction level of diabetics in the test groups compare to the control group. Diabetic kit demonstration strengthened the satisfaction level among the test 2 group patients. Therefore, pharmacist can act as a counsellor through pharmaceutical care program and assist the patients in managing their disease. This will not only modify the patients' related outcomes and their
Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H
Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.
Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.
Юрий Владимирович Тарасов
Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1
Nnamdi, Jolly A; Arhewoh, Ikhuoria M; Okhamafe, Augustine O; Enato, Ehijie F O
The purpose of this study was to determine the pharmaceutical quality of quinine preparations sold in Nigerian markets. The organoleptic and physicochemical properties of quinine tablets, as well as oral liquids and parenteral quinine preparations, were assessed according to British Pharmacopoeia (BP) and unofficial standards as recommended by the manufacturers. Of the 6 brands of tablets assessed, 4 passed the uniformity of content test and 5 the disintegration test, but only 2 the dissolution test. The pH of 2 of the 6 brands of oral liquid preparations met BP standards, while only 1 oral liquid met the BP standard for percentage content. The assay further demonstrated that 4 brands of the parenteral preparations met BP standards for quinine content. All the parenteral preparations were found to be sterile. Quinine preparations sold in Nigeria varied considerably in their pharmaceutical quality. A strict check of the quality of brands of quinine by regulatory agencies and distributors before they are sold to the public is therefore recommended. Copyright 2009 S. Karger AG, Basel.
Full Text Available The purpose of this article is to estimate the economic and environmental impacts of energy consumption derived from healthcare buildings and proposes several energy-saving options in the sector. An experimental energy consumption study was development between 2005 and 2013 in 12 hospitals and 70 healthcare centres in Spain, built between 1980 and 2005 through audits carried out between 2005 and 2012, performed by the Extremadura Energy Agency. The study focused on electric energy, HVAC, DWH, lighting systems, renewable energies, maintenance strategy, thermal insulation, and optimal building size. Specifically, the following parameters were evaluated: energy savings, investment emission of CO2, NO2, and SO2 gases, and payback. The results revealed that through an appropriate energy management of healthcare buildings it is possible to save up to 8.60 kWh/m2 per year, for buildings of less than 5000 m2 (with no beds, which represents an expense of 1.55 €/m2. In healthcare buildings larger than 5000 m2 (with beds, it was possible to save up to 6.88 kWh/m2 per year, which represents an expense of 1.25 €/m2.
Badawi, Dalia A; Alkhamis, Yousif; Qaddoumi, Mohammad; Behbehani, Kazem
Corruption is one of several factors that may hinder the access to pharmaceuticals. Since Kuwait has the highest per-capita spending on pharmaceuticals in the region, we wanted to evaluate the level of transparency in its pharmaceutical sector using an established assessment tool adapted by the World Health Organization. Standardized questionnaires were conducted via semi-structured interviews with key informants to measure the level of transparency in eight functions of the public pharmaceutical sector. The scores for the degree of vulnerability to corruption reflected marginal to moderate venerability to corruption for most pharmaceutical sectors. The perceived strengths included availability of appropriate laws, the presence of clear standard operating procedures, and the use of an efficient registration/distribution system. Weaknesses included lack of conflict of interest guidelines and written terms of reference, absence of pharmacoeconomic studies, and inconsistencies in law enforcement. Findings reveal that few functions of Kuwait pharmaceutical sector remain fairly vulnerable to corruption. However, the willingness of Kuwait Ministry of Health to adopt the assessment study and the acknowledgement of the weaknesses of current processes of the pharmaceutical sector may assist to achieve a transparent pharmaceutical system in the near future. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Honcharova Svіtlana Yu.
Full Text Available The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in pharmaceutical industry. It specifies the role and advantages of methods of strategic analysis in the system of management of a pharmaceutical enterprise. It considers the essence of “innovation development” and “innovation model of development” notions and analyses their organisational and legal provision. It justifies strategic tasks of the pharmaceutical filed to focus on in order to achieve a breakthrough when building an innovation model of economic development. The article proves that the most important factors that ensure growth of efficiency of pharmaceutical production are: wide application of the concept of strategic management and creation of innovations.
Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li
A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.
Yamamoto, Michiko; Doi, Hirohisa; Watanabe, Kazuhiro
According to the Japanese revitalization strategy endorsed by the government in June, 2013, pharmacies are expected to play an active role as the hub of health information. But this is not sufficiently organized: an infrastructure for providing neutral information which becomes the basis of such health information is not yet established for healthcare professionals, patients and consumers. As for drug information available subsequent to the marketing of pharmaceutical products, information from the pharmaceutical companies including Package Inserts and Interview-forms are often found. However, though such information from companies is important, it is necessary for healthcare professionals and patients to have access to the information evaluated by a trustworthy third party. With overseas distribution, the dissemination of drug information is provided by third parties, which are independent of regulatory agencies. For example, National Health Service (NHS) Evidence in the UK offers wide-ranging information based on evidence from a disease to pharmaceutical products, and is a widely available information source for healthcare professionals, patients and consumers. With regard to therapeutic medications, drug information and health foods in the Japanese community, it is necessary for patients and healthcare professionals that we establish neutral and common systematic information based on the research evidence. By providing information on the Internet, which enables people to access the information easily and to assess a product's usefulness objectively, we hope to eventually develop a system that ensures a patient's safety in the use of drugs.
Aho, Johanna; Hvidt, Søren; Baldursdottir, Stefania
Rheology is the science of flow and deformation of matter. Particularly gels and non-Newtonian fluids, which exhibit complex flow behavior, are frequently encountered in pharmaceutical engineering and manufacturing, or when dealing with various in vivo fluids. Therefore understanding rheology......, together with the common measurement techniques and their practical applications. Examples of the use of rheological techniques in the pharmaceutical field, as well as other closely related fields such as food and polymer science, are also given....... is important, and the ability to use rheological characterization tools is of great importance for any pharmaceutical scientist involved in the field. Flow can be generated by shear or extensional deformations, or a combination of both. This chapter introduces the basics of both shear and extensional rheology...
Bagley, Constance; Tvarnø, Christina D.
This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... and a practical perspective on how properly crafted PPPP arrangements can promote innovation more efficiently than traditional self-optimizing contracts. In particular, a properly framed binding contract, coupled with respect for positive incentives, can move the parties away from an inefficient prisoners...... systems to build and share innovation. When coupled with appropriate attention to the difficult task of coordinating the actions of interdependent actors, a PPPP arrangement can enhance the likelihood of successful commercialization of pharmacological discoveries by flipping the par- ties’ incentives...
Kennewell, Suzanne; Baker, Laura
Purpose - The purpose of this paper is to explore the experiences of staff in a large, public health service involved in transitioning support services to a shared services model. It aims to understand their perceptions of the benefits and risks arising from this change. Design/methodology/approach - Thematic analysis of qualitative data from semi-structured interviews with both service provider and customer agency staff was used to identify, analyze and report patterns of benefits and risks within data. Findings - Staff expressed the need for relevant subject-matter-experts to work within customer agencies to facilitate effective communication between the customer agency and shared services provider, reflecting observations found in out-sourcing literature. Research limitations/implications - Results point to significant challenges continuing to occur for shared services in healthcare. Risks identified suggest a more intimate relationship between clinical and support services than previously discussed. Originality/value - Previous discussion of the shared services model has not considered the skills, knowledge and ability required by staff in the customer agency. This research indicates that in the absence of such consideration, the concepts of the shared services model are weakened.
Grevsen, Jørgen V; Kruse, Edith; Kruse, Poul R
The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The
Oortwijn, Wija; Mathijssen, Judith; Banta, David
Middle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage. We selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA. All countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation. The study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.
Srivastava, L M
Biotechnology in India has made great progress in the development of infrastructure, manpower, research and development and manufacturing of biological reagents, biodiagnostics, biotherapeutics, therapeutic and, prophylactic vaccines and biodevices. Many of these indigenous biological reagents, biodiagnostics, therapeutic and prophylactic vaccines and biodevices have been commercialized. Commercially when biotechnology revenue has reached $25 billions in the U.S. alone in 2000 excluding the revenues of biotech companies that were acquired by pharmaceutical companies, India has yet to register a measurable success. The conservative nature and craze of the Indian Industry for marketing imported biotechnology products, lack of Government support, almost non-existing national healthcare system and lack of trained managers for marketing biological and new products seem to be the important factors responsible for poor economic development of biotechnology in India. With the liberalization of Indian economy, more and more imported biotechnology products will enter into the Indian market. The conditions of internal development of biotechnology are not likely to improve in the near future and it is destined to grow only very slowly. Even today biotechnology in India may be called to be in its infancy.
Full Text Available Quality of medicinal product is an important facet throughout lifecycle owing to its importance as acceptance criteria at customer’s end. Drugs regulatory agencies have issued guidelines for quality risk evaluation, mitigation and review management. Quality risk management has become an integral part of quality management system at manufacturing plants. Procedures for deviation control, change control, investigations of market complaints and batch failures are dealt with the principle of quality risk management at the manufacturing facility. The exploratory study shows a dearth of research on quality risk management during supply chain operation, however, a few study has been carried out by keeping financial risk into account. This study addresses the gap in literature on quality risk management during supply chain operations. There are cases of unresolved customer complaints and batch failures originated due to inadequacies during distribution of pharmaceutical products. In absence of established quality risk management system during product shipment, there is no effective preventive plan related to risk factors. A corollary of manufacturing quality risk management has been drawn to the distribution of pharmaceutical products through this study. The quality risk management during pharmaceutical distribution may be useful to avoid market complaints, drug recalls, and regulatory actions. This study produces one unique model solution for industry professionals and policymakers opening a scope to reduce the product rejection thereby paving the way for substantial business growth.
Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel
In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....
... CAHPS Health Plan Database uses data from AHRQ's standardized CAHPS Health plan survey to provide... Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the... Comparative Database Request for information collection approval. The Agency for Healthcare Research and...
Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John
The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...
Prematunge, Chatura; Corace, Kimberly; McCarthy, Anne; Nair, Rama C; Roth, Virginia; Suh, Kathryn N; Garber, Gary
Influenza is a major concern across healthcare environments. Annual vaccination of healthcare workers (HCW) remains a key mode of influenza prevention in healthcare settings. Yet influenza vaccine coverage among HCWs continues to be below recommended targets, in pandemic and non-pandemic settings. Thus, the primary objective of this analysis is to identify motivators and barriers to pandemic (panINFLU) and seasonal influenza vaccination (sINFLU) through the qualitative analysis of HCW provided reasons driving HCW's personal vaccination decisions. Data were collected from a multi-professional sample of HCWs via a cross-sectional survey study, conducted at a tertiary-care hospital in Ontario, Canada. HCW provided and ranked qualitative reasons for personal (1) panINFLU (pH1N1) and (2) sINFLU (2008/2009 season) vaccine uptake and avoidance were used to identify key vaccination motivators and barriers through content analysis methodology. Most HCW vaccination motivators and barriers were found to be similar for panINFLU and sINFLU vaccines. Personal motivators had the greatest impact on vaccination (panINFLU 29.9% and sINFLU 33.9%). Other motivators included preventing influenza in loved ones, patients, and community, and awareness of HCW role in influenza transmission. In contrast, concerns of vaccine safety and limited HCW knowledge of influenza vaccines (panINFLU 46.2% and sINFLU 37.3%). HCW vaccination during the pandemic was motivated by panINFLU related fear, epidemiology, and workplace pro-vaccination policies. HCW perceptions of accelerated panINFLU vaccine development and vaccine safety compromises, negative views of external sources (i.e. media, pharmaceutical companies, and regulatory agencies) and pandemic management strategies were barriers specific to panINFLU vaccine. HCW panINFLU and sINFLU vaccine coverage can increase if future vaccination programs (1) highlight personal vaccination benefits (2) emphasize the impact HCW non-vaccination on family
Santos, Lúcia H M L M; Gros, Meritxell; Rodriguez-Mozaz, Sara; Delerue-Matos, Cristina; Pena, Angelina; Barceló, Damià; Montenegro, M Conceição B S M
The impact of effluent wastewaters from four different hospitals: a university (1456 beds), a general (350 beds), a pediatric (110 beds) and a maternity hospital (96 beds), which are conveyed to the same wastewater treatment plant (WWTP), was evaluated in the receiving urban wastewaters. The occurrence of 78 pharmaceuticals belonging to several therapeutic classes was assessed in hospital effluents and WWTP wastewaters (influent and effluent) as well as the contribution of each hospital in WWTP influent in terms of pharmaceutical load. Results indicate that pharmaceuticals are widespread pollutants in both hospital and urban wastewaters. The contribution of hospitals to the input of pharmaceuticals in urban wastewaters widely varies, according to their dimension. The estimated total mass loadings were 306 g d(-1) for the university hospital, 155 g d(-1) for the general one, 14 g d(-1) for the pediatric hospital and 1.5 g d(-1) for the maternity hospital, showing that the biggest hospitals have a greater contribution to the total mass load of pharmaceuticals. Furthermore, analysis of individual contributions of each therapeutic group showed that NSAIDs, analgesics and antibiotics are among the groups with the highest inputs. Removal efficiency can go from over 90% for pharmaceuticals like acetaminophen and ibuprofen to not removal for β-blockers and salbutamol. Total mass load of pharmaceuticals into receiving surface waters was estimated between 5 and 14 g/d/1000 inhabitants. Finally, the environmental risk posed by pharmaceuticals detected in hospital and WWTP effluents was assessed by means of hazard quotients toward different trophic levels (algae, daphnids and fish). Several pharmaceuticals present in the different matrices were identified as potentially hazardous to aquatic organisms, showing that especial attention should be paid to antibiotics such as ciprofloxacin, ofloxacin, sulfamethoxazole, azithromycin and clarithromycin, since their hazard quotients
McIntosh, Heather M; Calvert, Julie; Macpherson, Karen J; Thompson, Lorna
Rapid review has become widely adopted by health technology assessment agencies in response to demand for evidence-based information to support imperative decisions. Concern about the credibility of rapid reviews and the reliability of their findings has prompted a call for wider publication of their methods. In publishing this overview of the accredited rapid review process developed by Healthcare Improvement Scotland, we aim to raise awareness of our methods and advance the discourse on best practice. Healthcare Improvement Scotland produces rapid reviews called evidence notes using a process that has achieved external accreditation through the National Institute for Health and Care Excellence. Key components include a structured approach to topic selection, initial scoping, considered stakeholder involvement, streamlined systematic review, internal quality assurance, external peer review and updating. The process was introduced in 2010 and continues to be refined over time in response to user feedback and operational experience. Decision-makers value the responsiveness of the process and perceive it as being a credible source of unbiased evidence-based information supporting advice for NHSScotland. Many agencies undertaking rapid reviews are striving to balance efficiency with methodological rigour. We agree that there is a need for methodological guidance and that it should be informed by better understanding of current approaches and the consequences of different approaches to streamlining systematic review methods. Greater transparency in the reporting of rapid review methods is essential to enable that to happen.
Reiss, John B; Crowder, Dawn; McCabe, Brittany; DeFeo, Marisa; Rifin, Marta; Talbot, Meghan
FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.
Vataire, Anne-Lise; Cetinsoy, Laurent; Aball?a, Samuel; R?muzat, C?cile; Urbinati, Duccio; Kornfeld, ?sa; Mzoughi, Olfa; Toumi, Mondher
Background and objective: The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical e...
M. Šabić; M. Vuković Domanovac; Z. Findrik Blažević; E. Meštrović
In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...
Mendel, Peter; Siegel, Sari; Leuschner, Kristin J; Gall, Elizabeth M; Weinberg, Daniel A; Kahn, Katherine L
In 2009, the US Department of Health and Human Services (HHS) launched the Action Plan to Prevent Healthcare-associated Infections (HAIs). The Action Plan adopted national targets for reduction of specific infections, making HHS accountable for change across the healthcare system over which federal agencies have limited control. This article examines the unique infrastructure developed through the Action Plan to support adoption of HAI prevention practices. Interviews of federal (n=32) and other stakeholders (n=38), reviews of agency documents and journal articles (n=260), and observations of interagency meetings (n=17) and multistakeholder conferences (n=17) over a 3-year evaluation period. We extract key progress and challenges in the development of national HAI prevention infrastructure--1 of the 4 system functions in our evaluation framework encompassing regulation, payment systems, safety culture, and dissemination and technical assistance. We then identify system properties--for example, coordination and alignment, accountability and incentives, etc.--that enabled or hindered progress within each key development. The Action Plan has developed a model of interagency coordination (including a dedicated "home" and culture of cooperation) at the federal level and infrastructure for stimulating change through the wider healthcare system (including transparency and financial incentives, support of state and regional HAI prevention capacity, changes in safety culture, and mechanisms for stakeholder engagement). Significant challenges to infrastructure development included many related to the same areas of progress. The Action Plan has built a foundation of infrastructure to expand prevention of HAIs and presents useful lessons for other large-scale improvement initiatives.
Ethnographic inquiry into Ayurvedic commodification in Kerala revealed the prevalence of a distinct regional pharmaceutical market dominated by physician-manufacturers, oriented towards supplying classical medicines to Ayurvedic doctors. This stands in sharp contrast to mainstream Ayurveda that is observed to have undergone biomedicalization and pharmaceuticalization. This paper argues that Kerala's classical-medicine-centric pharmaceutical market constitutes an alternative modernity because it provided Kerala Ayurveda with a different route to modernization impervious to the biomedical regime, as well as endowing it with the institutional power to safeguard its regional identity. Although physician-entrepreneurs are its key architects, it is sustained by value regimes shaped by a unique regional medico-cultural milieu. Even when industrially produced, classical medicines remain embedded within Ayurveda's socio-technical network; unlike proprietary drugs sold as individual product-identities through non-Ayurvedic channels, they travel together as a pharmacopeia, distributed through exclusive doctor-mediated agencies. This clinic-centric distribution format is best conceptualized as an open-source business model as it made low-margin generics viable by packaging them with therapies and services. Besides ensuring better access and affordability, it provided resistance to pharmaceuticalization and intellectual property concentration. By keeping the doctor in the loop, it prevented medicines from degenerating into de-contextualized commodities; the service component of Ayurveda therein preserved went on become the unique selling point in the health-tourism market. The tourism-inspired proliferation of Brand Kerala eventually triggered a paradigm shift in mainstream Ayurveda - shifting focus from 'pharmaceuticals' to 'services' and from 'illness' to 'wellness'. Furthermore, interacting with hybrid Ayurvedas in transnational markets, Kerala Ayurveda co-produces new
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.
Barros, Pedro Pita
Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).
Lichtenberg, Frank R
In Slovenia during the period 2000-2010, the number of years of potential life lost before the age of 70 years per 100,000 population under 70 years of age declined 25 %. The aim of this study was to test the hypothesis that pharmaceutical innovation played a key role in reducing premature mortality from all diseases in Slovenia, and to examine the effects of pharmaceutical innovation on the age-standardized number of cancer deaths and on hospitalization from all diseases. Estimates and other data were used to calculate the incremental cost effectiveness of pharmaceutical innovation in Slovenia. Longitudinal disease-level data was analyzed to determine whether diseases for which there was greater pharmaceutical innovation-a larger increase in the number of new chemical entities (NCEs) previously launched-had larger declines in premature mortality, the age-standardized number of cancer deaths, and the number of hospital discharges. My methodology controls for the effects of macroeconomic trends and overall changes in the healthcare system. Premature mortality from a disease is inversely related to the number of NCEs launched more than 5 years earlier. On average, the introduction of an additional NCE for a disease reduced premature mortality from the disease by 2.4 % 7 years later. The age-standardized number of cancer deaths is inversely related to the number of NCEs launched 1-6 years earlier, conditional on the age-standardized number of new cancer cases diagnosed 0-2 years earlier. On average, the launch of an NCE reduced the number of hospital discharges 1 year later by approximately 1.5 %. The estimates imply that approximately two-thirds of the 2000-2010 decline in premature mortality was due to pharmaceutical innovation. If no NCEs had been launched in Slovenia during 1992-2003, the age-standardized number of cancer deaths in 2008 would have been 12.2 % higher. The NCEs launched in Slovenia during 2003-2009 are estimated to have reduced the number of
Kligerman, Maxwell; Barry, Michele; Walmer, David; Bendavid, Eran
The reconstruction of healthcare systems in developing countries after natural disasters is poorly understood. Using data collected before and after the 2010 Haiti earthquake, we detail the response of aid agencies and their interaction with local healthcare providers in Leogane, the city closest to the epicenter. We find that the period after the earthquake was associated with an increase in the total number of healthcare facilities, inpatient beds, and surgical facilities and that international aid has been a driving force behind this recovery. Aid has funded 12 of 13 new healthcare facilities that have opened since the earthquake as well as the reconstruction of 7 of 8 healthcare facilities that have been rebuilt. Despite increases in free, aid-financed healthcare, private Haitian healthcare facilities have remained at a constant number. The planned phase-out of several aid-financed facilities, however, will leave Leogane with fewer inpatient beds and healthcare services compared with the pre-earthquake period. © The American Society of Tropical Medicine and Hygiene.
А. А. Kotvitska
Full Text Available For the effective functioning of pharmaceutical companies in the current economic conditions it is necessary to carry out product policy aimed to expanding the range of medicines that are most popular. In order to make the efficient product range of drugs in the pharmaceutical industrial enterprises the aim of our research was an analysis of the socio economic factors affecting the quantitative potential of the pharmaceutical market on the example of a group of dexketoprofen. Materials and methods. During the research we used retrospective, logical, correlation-regression methods, mathematical modeling and methods of factor analysis. In order to determine the dependence of the influence of socio economic factors on the quantitative potential of the pharmaceutical market and prediction of its development, we developed and tested on the example of a group of dexketoprofen the method of predicting the capacity of the pharmaceutical market with the definition of factors influencing its size, which is based on the correlation-regression method of analysis and which consists of eight main stages. Results. The article presents the results of the study of the impact of various socio economic factors on the development of quantitative potential of the pharmaceutical market. Considered twenty three factors combined into six groups. According to the results of correlation analysis, 14 factors that have the greatest impact on sales are selected. Using a step-by-step regression method, a regression model was developed, which included such factors as the average monthly wage and household expenditure on healthcare. The prediction of the quantitative potential of the pharmaceutical market for 2018 is carried out on the basis of extrapolation of the values of the factors that have the most effect on the resultant variable. Conclusions. A method for predicting the size of the potential of market of dexketoprofen based on multiple regression was developed. This
Cheng, Zhongyao; Lian, Yumei; Kamal, Zul; Ma, Xin; Chen, Jianjun; Zhou, Xinbo; Su, Jing; Qiu, Mingfeng
Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described. Secondly, the application of nanocrystals technology in pharmaceutical science is mainly discussed followed by the introduction of sustained release formulations. Then, the scaling up process, marketed nanocrystal drug products and regulatory aspects about nanodrugs are summarized. Finally, the specific challenges and opportunities of nanocrystals technology for pharmaceutical science are summarized and discussed. This review will provide a comprehensive guide for scientists and engineers in the field of pharmaceutical science and biochemical engineering. Copyright© Bentham Science Publishers; For any queries, please email at firstname.lastname@example.org.
Challa S.S.R. Kumar
Nanotechnology is a new approach to problem solving and can be considered as a collection of tools and ideas which can be applied in pharmaceutical industry. Application of nanotechnology tools in pharmaceutical R&D is likely to result in moving the industry from ‘blockbuster drug’ model to ‘personalized medicine’. There are compelling applications in pharmaceutical industry where inexpensive nanotechnology tools can be utilized. The review explores the possibility of categorizing various nan...
... Facilities, and Hospital Mortgage Insurance Premiums for Fiscal Year (FY) 2014 AGENCY: Office of the... with HUD regulations, this Notice announces the mortgage insurance premiums (MIPs) for Federal Housing Administration (FHA) Multifamily, Healthcare Facilities, and Hospital mortgage insurance programs that have...
Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao
Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.
Rothe, C; Schlaich, C; Thompson, S
Healthcare-associated infections (HCAIs) are the most frequent adverse consequences of healthcare worldwide, threatening the health of both patients and healthcare workers (HCWs). The impact of HCAI is particularly felt in resource-poor countries, with an already overstretched health workforce and a high burden of community-acquired infection. To provide an overview of the current situation in sub-Saharan Africa with regards to the spectrum of HCAI, antimicrobial resistance, occupational exposure and infection prevention. We reviewed the literature published between 1995 and 2013 and from other sources such as national and international agencies. Sparse data suggest that HCAIs are widespread in sub-Saharan Africa, with surgical site being the dominant focus of infection. Nosocomial transmission of multidrug-resistant tuberculosis is a considerable concern, as is the prevalence of meticillin-resistant S. aureus and resistant Enterobacteriaceae. In HCWs, vaccination rates against vaccine-preventable occupational hazards are low, as is reporting and subsequent human immunodeficiency virus-testing after occupational exposure. HCWs have an increased risk of tuberculosis relative to the general population. Compliance with hand hygiene is highly variable within the region. Injection safety in immunization programmes has improved over the past decade, mainly due to the introduction of autodestruct syringes. Despite the scarcity of data, the burden of HCAI in sub-Saharan Africa appears to be high. There is evidence of some improvement in infection prevention and control, though widespread surveillance data are lacking. Overall, measures of infection prevention and occupational safety are scarce. Copyright © 2013 The Healthcare Infection Society. All rights reserved.
Lehoux, Pascale; Miller, Fiona A.; Daudelin, Geneviève; Denis, Jean-Louis
Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology—as a health intervention and as an economic commodity—and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. PMID:28949463
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Puthli, Shivanand P
Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.
Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.
Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance...
Rosati, Robert J; Marren, Joan M; Davin, Denise M; Morgan, Cynthia J
Greater accountability for patient outcomes, reduced reimbursement, and a protracted nursing shortage have made employee and patient satisfaction results central performance metrics and strategic imperatives in healthcare. Key questions are whether the two interact and if so, how can that relationship be leveraged to obtain maximum gains in both employee and patient satisfaction. This article examines the experience of a large, nonprofit home care agency in exploring these issues. The agency found that organizational commitment to patient care and customer service are fundamental to patient satisfaction. The more employees perceived that the organization is focused on quality and customers, the more patient satisfaction increased. Among nurses, work-life balance, fair compensation, and regard for employees all influenced patient satisfaction.
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527
Lorente, Maria-Reyes; Hernández, Juana; Antoñanzas, Fernando
Assisted reproduction is one of the health services currently being considered for possible limitation or exclusion from the public health services portfolio in Spain. One of the main reasons claimed for this is the impact on the budget for pharmaceutical expenditure. The objective of this study was to assess the significance of the pharmaceutical costs of assisted reproduction in Spain. This study focused on medical practice in Spain, and is based on the opinions of experts in assisted reproduction and the results provided by professional societies' publications. The reference year is 2012 and the setting was secondary care. We have included all existing pharmaceutical modalities for assisted reproduction, as well as the most common drug for each modality. We have considered the pharmaceutical cost per cycle for artificial insemination, in vitro fertilisation with or without intracytoplasmic sperm injection (IVF_ICSI), and cryotransfer and donated fresh oocytes reception. In Spain, artificial insemination has a pharmaceutical cost per cycle of between €69.36 and €873.79. This amounts to an average cycle cost of €364.87 for partner's sperm and €327.10 for donor sperm. The pharmaceutical cost of IVF_ICSI ranges between €278.16 and €1,902.66, giving an average cost per cycle of €1,139.65. In the case of cryotransfer and donated fresh oocytes reception, the pharmaceutical cost per cycle is between €22.61 and €58.73, yielding an average cost of €40.67. The budgetary impact of pharmaceutical expenditure for assisted reproduction in Spain for the year 2012 was estimated at €98.7 million. In Spain, the total pharmaceutical cost of assisted reproduction is substantial. According to our results, we can say that about 29% of the total pharmaceutical expenditure for assisted reproduction techniques is funded by the National Health System and the rest represents 2.4% of the total annual out-of-pocket family expenditure on drugs.
Full Text Available Abstract Background When a new drug is launched onto the market, information about the new manufactured product is contained in its monograph and evaluation report published by national drug agencies. Health professionals need to be able to determine rapidly and easily whether the new manufactured product is potentially useful for their practice. There is therefore a need to identify the best way to group together and visualize the main items of information describing the nature and potential impact of the new drug. The objective of this study was to identify these items of information and to bring them together in a model that could serve as the standard for presenting the main features of new manufactured product. Methods We developed a preliminary conceptual model of pharmaceutical innovations, based on the knowledge of the authors. We then refined this model, using a random sample of 40 new manufactured drugs recently approved by the national drug regulatory authorities in France and covering a broad spectrum of innovations and therapeutic areas. Finally, we used another sample of 20 new manufactured drugs to determine whether the model was sufficiently comprehensive. Results The results of our modeling led to three sub models described as conceptual maps representingi the medical context for use of the new drug (indications, type of effect, therapeutical arsenal for the same indications, ii the nature of the novelty of the new drug (new molecule, new mechanism of action, new combination, new dosage, etc., and iii the impact of the drug in terms of efficacy, safety and ease of use, compared with other drugs with the same indications. Conclusions Our model can help to standardize information about new drugs released onto the market. It is potentially useful to the pharmaceutical industry, medical journals, editors of drug databases and medical software, and national or international drug regulation agencies, as a means of describing the main
Weigel, Fred K; Switaj, Timothy L; Hamilton, Jessica
Healthcare delivery in America is extremely complex because it is comprised of a fragmented and nonsystematic mix of stakeholders, components, and processes. Within the US healthcare structure, the federal healthcare system is poised to lead American medicine in leveraging health information technology to improve the quality of healthcare. We posit that through developing, adopting, and refining health information technology, the federal healthcare system has the potential to transform federal healthcare quality by managing the complexities associated with healthcare delivery. Although federal mandates have spurred the widespread use of electronic health records, other beneficial technologies have yet to be adopted in federal healthcare settings. The use of health information technology is fundamental in providing the highest quality, safest healthcare possible. In addition, health information technology is valuable in achieving the Agency for Healthcare Research and Quality's implementation goals. We conducted a comprehensive literature search using the Google Scholar, PubMed, and Cochrane databases to identify an initial list of articles. Through a thorough review of the titles and abstracts, we identified 42 articles as having relevance to health information technology and quality. Through our exclusion criteria of currency of the article, citation frequency, applicability to the federal health system, and quality of research supporting conclusions, we refined the list to 11 references from which we performed our analysis. The literature shows that the use of computerized physician order entry has significantly increased accurate medication dosage and decreased medication errors. The use of clinical decision support systems have significantly increased physician adherence to guidelines, although there is little evidence that indicates any significant correlation to patient outcomes. Research shows that interoperability and usability are continuing challenges for
Traulsen, Janine Marie; Almarsdóttir, Anna Birna
In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and indu......In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...
Mbongwe, Bontle; Mmereki, Baagi T; Magashula, Andrew
Healthcare waste management continues to present an array of challenges for developing countries, and Botswana is no exception. The possible impact of healthcare waste on public health and the environment has received a lot of attention such that Waste Management dedicated a special issue to the management of healthcare waste (Healthcare Wastes Management, 2005. Waste Management 25(6) 567-665). As the demand for more healthcare facilities increases, there is also an increase on waste generation from these facilities. This situation requires an organised system of healthcare waste management to curb public health risks as well as occupational hazards among healthcare workers as a result of poor waste management. This paper reviews current waste management practices at the healthcare facility level and proposes possible options for improvement in Botswana.
Seay, Melicia; Varma, Priya
The enactment of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) gave states the option of offering pharmaceutical benefits within their Medicaid programs. But the law placed restrictions on states' flexibility to control what prescriptions they would cover and required the states to reimburse outpatient prescription drugs from manufacturers that signed rebate agreements with the U.S. Department of Health and Human Services. Forty-nine states--Arizona is excluded, based on its program structure--and the District of Columbia currently offer prescription drug coverage under the Medicaid Drug Rebate Program. During the past four years, states all over the country have been plagued with revenue shortfalls in their state Medicaid budgets. While the fiscal situation improved for most states in the 2004 legislative session, many states still face budget pressures in 2005. Compounding existing budget pressures are threats from the Bush Administration to shift increased costs of the Medicaid program on to the states. All things considered, the economic pressure of funding Medicaid is at the top of legislative agendas in 2005. As in previous years, states are attempting to reduce costs to their Medicaid programs by seeking savings in their pharmaceutical programs. Prescription drug costs are highly attributed as a contributing factor to the fiscal climate of state Medicaid programs. Currently, prescription drug spending outpaces that of every other category of health care and drug prices are rising faster than inflation. In response, states are instituting a variety of pharmaceutical cost control measures such as creating preferred drug lists (PDLs), negotiating supplemental rebates, forming bulk purchasing pools, promoting generic drug substitution and implementing price controls. As prescription drug cost containment tools have gained acceptance and momentum, they continue to be controversial. This issue brief explores the debate, history, methodology, utilization
Keli Regina DAL PRÁ
Full Text Available This article presents a report on the experience of healthcare professionals in Florianópolis, who took the course La Atención Primaria de Salud y la Medicina Familiar en Cuba [Primary Healthcare and Family Medicine in Cuba], in 2014. The purpose of the study is to characterize the healthcare units and services provided by the Cuban National Healthcare System (SNS and to reflect on this experience/immersion, particularly on Cuba’s Primary Healthcare Service. The results found that in comparison with Brazil’s Single Healthcare System (SUS Cuba’s SNS Family Healthcare (SF service is the central organizing element of the Primary Healthcare Service. The number of SF teams per inhabitant is different than in Brazil; the programs given priority in the APS are similar to those in Brazil and the intersectorial nature and scope of the services prove to be effective in the resolution of healthcare problems.
Michael F Brooks
Full Text Available In a departure from traditional “vertical” healthcare interventions in low-resource settings that work to combat a single specific health issue, LifeNet International (LN uses a horizontal conversion franchise to develop and measure healthcare capacity and quality in primarily faith-based health centers in East Africa. Through a comprehensive franchise package of Medical Training, Management Training, Pharmaceutical Supply, and Growth Financing, LN is able to leverage existing resources and respond to a greater number of the obstacles preventing facilities from providing quality care. Through its Quality Score Card, LN measures improvements in quality of care within its network. This tool has measured consistent and significant improvements in quality of care following LN partnership. Together, these services improve quality of care at East African primary care facilities in ways that issue-specific, “vertical” interventions cannot.
Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B
Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients' quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. To investigate pharmacy students' attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists' physical separation from patient care areas (82.6%). Pharmacy students' attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also
Sapkota, Binaya; Gupta, Gopal Kumar; Mainali, Dhiraj
Healthcare waste is produced from various therapeutic procedures performed in hospitals, such as chemotherapy, dialysis, surgery, delivery, resection of gangrenous organs, autopsy, biopsy, injections, etc. These result in the production of non-hazardous waste (75-95%) and hazardous waste (10-25%), such as sharps, infectious, chemical, pharmaceutical, radioactive waste, and pressurized containers (e.g., inhaler cans). Improper healthcare waste management may lead to the transmission of hepatitis B, Staphylococcus aureus and Pseudomonas aeruginosa. This evaluation of waste management practices was carried out at gynaecology, obstetrics, paediatrics, medicine and orthopaedics wards at Government of Nepal Civil Service Hospital, Kathmandu from February 12 to October 15, 2013, with the permission from healthcare waste management committee at the hospital. The Individualized Rapid Assessment tool (IRAT), developed by the United Nations Development Program Global Environment Facility project, was used to collect pre-interventional and post-interventional performance scores concerning waste management. The healthcare waste management committee was formed of representing various departments. The study included responses from focal nurses and physicians from the gynaecology, obstetrics, paediatrics, medicine and orthopaedics wards, and waste handlers during the study period. Data included average scores from 40 responders. Scores were based on compliance with the IRAT. The waste management policy and standard operating procedure were developed after interventions, and they were consistent with the national and international laws and regulations. The committee developed a plan for recycling or waste minimization. Health professionals, such as doctors, nurses and waste handlers, were trained on waste management practices. The programs included segregation, collection, handling, transportation, treatment and disposal of waste, as well as occupational health and safety issues
Ramesh N. Patel
Full Text Available The production of single enantiomers of drug intermediates has become increasingly important in the pharmaceutical industry. Chiral intermediates and fine chemicals are in high demand from both the pharmaceutical and agrochemical industries for the preparation of bulk drug substances and agricultural products. The enormous potential of microorganisms and enzymes for the transformation of synthetic chemicals with high chemo-, regio- and enantioselectivities has been demonstrated. In this article, biocatalytic processes are described for the synthesis of chiral pharmaceutical intermediates.
Raila, Emilia M; Anderson, David O
Despite growing effects of human activities on climate change throughout the world, and global South in particular, scientists are yet to understand how poor healthcare waste management practices in an emergency influences the climate change. This article presents new findings on climate change risks of healthcare waste disposal during and after the 2010 earthquake and cholera disasters in Haiti. The researchers analysed quantities of healthcare waste incinerated by the United Nations Mission in Haiti for 60 months (2009 to 2013). The aim was to determine the relationship between healthcare waste incinerated weights and the time of occurrence of the two disasters, and associated climate change effects, if any. Pearson product-moment correlation coefficient indicated a weak correlation between the quantities of healthcare waste disposed of and the time of occurrence of the actual emergencies (r (58) = 0.406, p = 0.001). Correspondingly, linear regression analysis indicated a relatively linear data trend (R 2 = 0.16, F (1, 58) = 11.42, P = 0.001) with fluctuating scenarios that depicted a sharp rise in 2012, and time series model showed monthly and yearly variations within 60 months. Given that the peak healthcare waste incineration occurred 2 years after the 2010 disasters, points at the need to minimise wastage on pharmaceuticals by improving logistics management. The Government of Haiti had no data on healthcare waste disposal and practised smoky open burning, thus a need for capacity building on green healthcare waste management technologies for effective climate change mitigation.
Full Text Available Food dyes are largely used in the process of manufacturing pharmaceutical products. The aim of such a procedure is not only to increase the attractiveness of products, but also to help patients distinguish between pharmaceuticals. Various dyes, especially organic colouring agents, may in some cases have a negative impact on the human body. They are incorporated into pharmaceutical products including tablets, hard gelatine capsules or soft gelatine capsules, lozenges, syrups, etc. This article provides an overview of the most widely used colouring agents in pharmaceuticals, their characteristics and the EU legislation which regulates their use.
Lin, Angela Yu-Chen; Tsai, Yu-Ting
We investigated the occurrence and distribution of pharmaceuticals (including antibiotics, estrogens, non-steroidal anti-inflammatory drugs (NSAIDs), beta-blockers, and lipid regulators) in three rivers and in the waste streams of six hospitals and four pharmaceutical production facilities in Taiwan. The most frequently detected pharmaceuticals were acetaminophen, erythromycin-H(2)O, sulfamethoxazole, and gemfibrozil. NSAIDs were the next most-often detected compounds, with a detection frequency >60%. The other analytes were not detected or were seen in only a few samples at trace concentrations. The present study demonstrates a significant discharge of human medications from hospital and drug production facilities into surface waters in the Taipei district. The high concentrations of pharmaceuticals found in the Sindian and Dahan rivers demonstrate the alarming degree to which they have been impacted by urban drainage (waste effluents from hospitals, households, and pharmaceutical production facilities). The ubiquitous occurrence at extremely high concentrations of acetaminophen and erythromycin-H(2)O in both rivers (up to 15.7 and 75.5 microg/L) and in wastewater from hospitals and pharmaceutical production facilities (up to 417.5 and 7.84 microg/L) was unique. This finding, in combination with acetaminophen's status as the drug most often prescribed by Taiwan's dominant clinical institute, suggests the potential use of acetaminophen as a molecular indicator of contamination of Taiwan's aqueous environments with untreated urban drainage.
Santos, Maiara da S.
The need for effective and reliable quality control in products from pharmaceutical industries renders the analyses of their active ingredients and constituents of great importance. This study presents the theoretical basis of ¹H NMR for quantitative analyses and an example of the method validation according to Resolution RE N. 899 by the Brazilian National Health Surveillance Agency (ANVISA), in which the compound paracetamol was the active ingredient. All evaluated parameters (selectivity, linearity, accuracy, repeatability and robustness) showed satisfactory results. It was concluded that a single NMR measurement provides structural and quantitative information of active components and excipients in the sample. (author)
Regnstrom, Jan; Koenig, Franz; Aronsson, Bo; Reimer, Tatiana; Svendsen, Kristian; Tsigkos, Stelios; Flamion, Bruno; Eichler, Hans-Georg; Vamvakas, Spiros
To identify factors associated with success of Market Authorisation Applications (MAAs) for pharmaceutical drugs submitted to the European Medicines Agency (EMEA), with an emphasis on the Scientific Advice (SA) given by the Committee for Human Medicinal Products (CHMP). MAAs with a CHMP decision (outcome) between 1 January 2004 and 31 December 2007 were included in the analysis. Factors evaluated were: company size, orphan drug (OD) status, product type, existence of SA, compliance with SA, therapeutic area and year of outcome. Compliance with SA was retrospectively assessed with reference to three critical clinical variables in pivotal studies: choice of primary endpoint, selection of control and statistical methods. Of 188 MAAs with an outcome, 137 (72.9%) were approved, whereas 51 (27.1%) were not approved or were withdrawn by the company. In the simple logistic regression analysis, company size [odds ratio (OR) 2.96, 95% confidence interval (CI) 1.92; 4.56, p related to one or more of the three critical variables. Thirty-nine of these were assessed as being compliant with SA. Obtaining an SA per se was not associated with outcome (SA vs. no-SA: OR 0.96, 95% CI 0.49; 1.88, p = 0.92), but complying with SA was significantly associated with positive outcome (compliant with SA vs. no-SA: OR 14.71, 95% CI 1.95; 111.2; non-compliant with SA vs. no-SA: OR 0.17, 95% CI 0.06; 0.47, p Factors related to compliance with SA were company size and OD status (25, 60 and 84% for small, medium-sized, and large companies, respectively; 77 and 38% for non-OD and OD status, respectively). The strong association between company size and outcome suggests that resources and experience in drug development and obtaining regulatory approval are critical factors for a successful MAA. In addition, obtaining and complying with SA appears to be a predictor of outcome. Based on this analysis, companies, particularly smaller ones and those developing orphan drugs, are recommended to engage in
Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.
Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation
Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3280-FN] Medicare and Medicaid Programs; Initial Approval of Center for Improvement in Healthcare Quality's (CIHQ's) Hospital Accreditation Program AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Final...
Montreuil, Marjorie; Carnevale, Franco A
The capacity of children to act as agents is being increasingly recognized and has important implications for health research and practice. However, there are various discrepancies in how children's agency is defined in the literature. The aim of this analysis was to examine the concept of children's agency within the health-related literature, using Rodgers evolutionary method. The following questions were addressed: How did the concept of agency become associated with children in the health-related literature? What are the sociocultural and legal contexts that surround the concept of children's agency? What is the meaning of children's agency? Forty-five articles were included in the analysis. An inductive approach was used to identify the attributes of children's agency as well as the temporal, disciplinary, and paradigmatic trends in its conceptualization. The concept of children's agency first appeared in the health literature in the 1980s and was defined as an ability children could gradually develop. Later on, children's agency was used to refer to the capacity of all children to influence their own and others' health-care needs and is now increasingly used to refer to children as active agents who reflect on and construct their social worlds. © The Author(s) 2015.
Subhas C. Misra
Full Text Available Biomedical engineering has grown as a vast field of research that includes many areas of engineering and technology also. Personalized Medicine is an emerging approach in today’s medicare system. It bears a very strong potential to consolidate modern e-health systems fundamentally. Scientists have already discovered some of the personalized drugs that can shift the whole medicare system into a new dimension. However, bringing the change in the whole medicare system is not an easy task. There are several factors that can affect the successful adoption of Personalized Medicine systems in the healthcare management sector. This paper aims at identifying the critical factors with the help of an empirical study. A questionnaire was distributed amongst some clinicians, clinical researchers, practitioners in pharmaceutical industries, regulatory board members, and a larger section of patients. The response data collected thereby were analyzed by using appropriate statistical methods. Based on the statistical analysis, an attempt is made to prepare a list of critical success factors in the adoption of personalized medicine in healthcare management. The study indicates that eight of the thirteen hypothesized factors have statistical relationship with “Success”. The important success factors detected are: data management, team work and composition, privacy and confidentiality, mind-set, return on investment, sufficient time, R&D and alignment. To the best of our knowledge, this is the first academic paper in which an attempt has been made to model the vital critical factors for the successful implementation of Personalized Medicine in healthcare management. The study bears the promise of important applications in healthcare engineering and technology. Keywords: Healthcare management, Personalized medicine, E-health, Success factors, Medicare systems, Regression analysis
Full Text Available Background: The CMDA/MedSend Healthcare Missions Leadership Summit is an annual gathering of leaders from 75 mission sending agencies who work around the world in healthcare missions. The summit is jointly sponsored by MedSend and the Christian Medical & Dental Associations (CMDA. The purpose of the meeting is to share best practices, network, and examine cutting edge research issues in the field of healthcare missions. Objective: The purpose of the 2015 Launch survey was to learn from medical missionaries how to more effectively recruit and launch new healthcare professionals and their families into long-term missions. The objective of the 2016 Relocating for the Gospel survey was to learn from students and other aspiring healthcare missionaries the obstacles they perceive in their journey into long-term missions. Results were presented at the 2015 and 2016 Healthcare Missions Leadership Summits. Methods: Two multiple-choice surveys were developed to ascertain the positive and negative factors involved in the decision making process to launch into the healthcare mission field. Participants were invited to participate in the surveys via email. Results: The 2015 Launch survey analyzed 177 responses from healthcare missionaries with 63% of respondents still currently serving as long-term missionaries. 37% of the respondents were missionaries previously. Participants included millennials (n=39, Gen Xers (n=54, and baby boomers (n=84. Responses indicated that key positive factors include personal interaction with a long-term worker as well as a supportive agency, leader, or team to join. The 2016 Relocating for the Gospel survey analyzed responses from students and other aspiring missionaries who are millennials (n=79. The strongest overall factor that discouraged missions involvement was student loan debt. Other key obstacles include concerns over being lonely or isolated overseas, as well as difficulty in finding a good fit with a team or
In this article, we make the etiologic diagnosis for a sick patient named Healthcare: the cancer of greed. When we explore the two forms of this cancer--corporate and bureaucratic--we find the latter is the greater danger to We the Patients. The "treatments" applied to patient Healthcare by the Congressional "doctors" have consistently made the patient worse, not better. At the core of healthcare's woes is the government's diversion of money from healthcare services to healthcare bureaucracy. As this is the root cause, it is what we must address in order to cure, not sedate or palliate, patient Healthcare.
Юрий Владимирович Тарасов
Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2
Vandoros, Sotiris; Stargardt, Tom
Following the financial crisis of 2008, Greece has been facing severe fiscal problems associated with high public debt and deficit. Given their significant contribution to public sector expenditure, part of the effort to reduce public expenditure has involved a focus on pharmaceutical markets. Our aim is to provide an overview of recent policy changes in the Greek pharmaceutical market as a response to the crisis. We also discuss other potential measures that can be implemented. The recommendations are relevant to European countries facing debt crises, but also to any other country, as improving efficiency makes funds available to be used on other interventions. In 2010 and 2011, following the debt crisis and the agreement with the IMF, EU and ECB, the Greek government introduced several policy measures aimed at cost-containment. These changes included (a) price cuts, (b) the re-introduction of a positive list, (c) changes in the profit margins of pharmacies and wholesalers, and (d) tenders for hospital drugs. As a result, public drug expenditure decreased from €5.09 billion in 2009 to €4.25 billion in 2010 and €4.10 billion in 2011. As the need to cut expenditure becomes more urgent, seeking efficiency is possibly the only option for countries that do not wish to compromise quality of healthcare and public health. However, efficiency and cost containment are not only about introducing new policies, but also about the enforcement of existing laws and fighting corruption. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
Sacristán, José A; Lizan, Luís; Comellas, Marta; Garrido, Pilar; Avendaño, Cristina; Cruz-Hernández, Juan J; Espinosa, Javier; Dilla, Tatiana
The purpose of this study was to explore the main factors explaining the relative weight of the different attributes that determine the value of oncologic treatments from the different perspectives of healthcare policy makers (HCPM), oncologists, patients and the general population in Spain. Structured interviews were conducted to assess: (1) the importance of the attributes on treatment choice when comparing a new cancer drug with a standard cancer treatment; (2) the importance of survival, quality of life (QoL), costs and innovation in cancer; and (3) the most worrying side effects related to cancer drugs. A total of 188 individuals participated in the study. For all participants, when choosing treatments, the best rated characteristics were greater efficacy, greater safety, treatment adaptation to patients' individual requirements and the rapid reincorporation of patients to their daily activities. There were important differences among participants in their opinion about survival, QoL and cost. In general, oncologists, patients, and the general population gave greater value to gains in QoL than healthcare policy makers. Compared to other participants healthcare policy makers gave greater importance to the economic impact related to oncology treatments. Gains in QoL, survival, safety, cost and innovation are perceived differently by different groups of stakeholders. It is recommended to consider the perspective of different stakeholders in the assessment of a new cancer drugs to obtain more informed decisions when deciding on the most appropriate treatment to use. Eli Lilly & Co, Madrid (Spain).
Full Text Available Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods: A descriptive, cross-sectional survey of pharmacy students (n=126 was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results: The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%, lack of pharmacist time (83.3%, organizational obstacles (82.6%, and pharmacists’ physical separation from patient care areas (82.6%. Conclusion: Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University
Medicines are special commodity related to people’s lives and health, therefore, pharmaceutical distribution is an industry affecting the national economy and the people's livelihood. With health care reform, changeable pharmaceutical policy and fiercely increasing competition in the medical industry, pharmaceutical distribution companies should improve their level of logistics operations and reduce overall logistics management costs in order to gain a leading position in the competition. In ...
Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.
Beall, P.T.; Good, W.R.
Described is the technique of NMR-imaging in diagnostic medicine. Proton and phosphorus NMR in diagnosis of abnormal tissue pathology. Discussed is the value of NMR to the pharmaceutical sciences. NMR may play an important role in monitoring the response of tissues to drugs, determining the localization of drugs, performing real time pharmacokinetics and testing the use of NMR contrast pharmaceuticals
Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public’s enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental
Healthcare Policy Statement on the Utility of Coronary Computed Tomography for Evaluation of Cardiovascular Conditions and Preventive Healthcare: From the Health Policy Working Group of the Society of Cardiovascular Computed Tomography.
Slim, Ahmad M; Jerome, Scott; Blankstein, Ron; Weigold, Wm Guy; Patel, Amit R; Kalra, Dinesh K; Miller, Ryan; Branch, Kelley; Rabbat, Mark G; Hecht, Harvey; Nicol, Edward D; Villines, Todd C; Shaw, Leslee J
The rising cost of healthcare is prompting numerous policy and advocacy discussions regarding strategies for constraining growth and creating a more efficient and effective healthcare system. Cardiovascular imaging is central to the care of patients at risk of, and living with, heart disease. Estimates are that utilization of cardiovascular imaging exceeds 20 million studies per year. The Society of Cardiovascular CT (SCCT), alongside Rush University Medical Center, and in collaboration with government agencies, regional payers, and industry healthcare experts met in November 2016 in Chicago, IL to evaluate obstacles and hurdles facing the cardiovascular imaging community and how they can contribute to efficacy while maintaining or even improving outcomes and quality. The summit incorporated inputs from payers, providers, and patients' perspectives, providing a platform for all voices to be heard, allowing for a constructive dialogue with potential solutions moving forward. This article outlines the proceedings from the summit, with a detailed review of past hurdles, current status, and potential solutions as we move forward in an ever-changing healthcare landscape. Copyright © 2017 Society of Cardiovascular Computed Tomography. All rights reserved.
... identified 24 drugs that fit the NIOSH definition of hazardous drugs. The second draft list also proposed... Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010 AGENCY: National Institute for Occupational... publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in...
Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)
The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).
Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.
The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH-190] Revised Document Posted: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012, Correction AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the...
The ability to communicate effectively as a healthcare professional has come into greater focus as the role of pharmacists expands from "medicine-based" to "client-based" (e.g., working with patients, their families, and in multidisciplinary interactions). The ability to communicate cannot be acquired solely in the classroom; a large part of acquiring such skill is based on practical experience. Role-playing with simulated patients has already been implemented in pharmaceutical education; in that sense, opportunities to receive education in practical communication are increasing. However, in order to assure that these educational opportunities are more than "experiences" in theory alone, aspects of communications training that are satisfactory or need improvement must be clarified through empirical studies. While data used in pharmaceutical studies have mainly been quantitative in nature, data required for medical communication studies is generally more qualitative. Only recently the importance of qualitative research has been recognized in pharmaceutical studies, a field in which any aspect difficult to express numerically has been considered subjective, and thus less acceptable. Against this backdrop, this report introduces an aspect of communication research that employs the Roter method of interaction process analysis (RIAS), a medical communication analyzing method by Professor Debra Roter at Johns Hopkins University. RIAS is a quantitative analysis of qualitative data. I want to discuss the significance of using results of research based on qualitative data to improve the quality of communication.
Pedroso, Marcelo Caldeira; Malik, Ana Maria
This article presents a model of the healthcare value chain which consists of a schematic representation of the Brazilian healthcare system. The proposed model is adapted for the Brazilian reality and has the scope and flexibility for use in academic activities and analysis of the healthcare sector in Brazil. It places emphasis on three components: the main activities of the value chain, grouped in vertical and horizontal links; the mission of each link and the main value chain flows. The proposed model consists of six vertical and three horizontal links, amounting to nine. These are: knowledge development; supply of products and technologies; healthcare services; financial intermediation; healthcare financing; healthcare consumption; regulation; distribution of healthcare products; and complementary and support services. Four flows can be used to analyze the value chain: knowledge and innovation; products and services; financial; and information.
Yan, Yu-Hua; Hsu, Shuofen; Yang, Chen-Wei; Fang, Shih-Chieh
The main purposes of this study are to clarify the agency problems in the hospitals participating in self-management project within the context of Global Budgeting Payment System regulated by Taiwan government, and also to provide some suggestions for hospital administrator and health policy maker in reducing the waste of healthcare resources resulting from agency problems. For the purposes above, this study examines the relationships between two agency problems (ex ante moral hazard and ex post moral hazard) aroused among the hospitals and Bureau of National Health Insurance in Taiwan's health care sector. This study empirically tested the theoretical model at organization level. The findings suggest that the hospital's ex ante moral hazards before participating the self-management project do have some influence on its ex post moral hazards after participating the self-management project. This study concludes that the goal conflict between the agents and the principal certainly exist. The principal tries hard to control the expenditure escalation and keep the financial balance, but the agents have to subsist within limited healthcare resources. Therefore, the agency cost would definitely occur due to the conflicts between both parties. According to the results of the research, some suggestions and related management concepts were proposed at the end of the paper.
The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's.......The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's....
Bean, James R
Growth of national healthcare spending is a problem confronting national governments of all industrially advanced countries. Healthcare spending in the U.S. reached 13.9% of the Gross Domestic Product (GDP) in 2003, compared to only 8% in Japan. In the U.S., health insurance is voluntary, with 15% of the population uninsured. In Japan, health insurance is mandatory and virtually universal, with growth in national health costs about half the rate of growth in the U.S. U.S. healthcare costs are projected to reach 18.4% of GDP 2013. The predicted growth in health care costs is expected to cause strain on the federal budget and a growing inability of employers and employees to pay for private insurance. Different national policies are the reason for different national health care costs in the U.S. and Japan. The U.S. has higher healthcare prices for salaries, equipment, supplies, and pharmaceuticals as compared to Japan. Higher prices, higher service intensity and volume during hospitalization create higher total cost in the U.S. Price controls in Japan kept medical inflation low at 0.46%/yr from 1980-2000. Market-pricing mechanisms in the U.S. have proven ineffective in controlling national healthcare costs, while Japan's national fee and price control policies have kept national costs among the lowest within the Organization for Economic Cooperation and Development. To guide insurance coverage policy, neurosurgery and other highly technical specialties should better define the comparative health benefit of high price technical services by prospective outcome studies.
Full Text Available This paper examines how gamification affects user intention to use mobile healthcare applications (mHealth and how the effect of gamification works differently according to health status, age, and gender. We use data from a mobile survey conducted by a Korean representative survey agency. We estimate the effect of gamification on user intention to use mobile healthcare applications based on a structural equation model and examine the moderating effects of self-reported health status, age, and gender. We find that gamification is effective in increasing user intention to use mHealth, especially in the healthy and younger groups. These findings suggest that mHealth, with the gamification factor, would encourage healthy (but lack exercise people as well as unhealthy people to maintain their health status, and thus the mHealth developers need to consider the gamification factor when they develop mHealth services for healthy people.
Beran, Roy G
The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.
Cerri, Karin H; Knapp, Martin; Fernandez, Jose-Luis
The College Voor Zorgverzekeringen (CVZ) provides guidance to the Dutch healthcare system on funding and use of new pharmaceutical technologies. This study examined the impact of evidence, process and context factors on CVZ decisions in 2004-2009. A data set of CVZ decisions pertaining to pharmaceutical technologies was created, including 29 variables extracted from published information. A three-category outcome variable was used, defined as the decision to 'recommend', 'restrict' or 'not recommend' a technology. Technologies included in list 1A/1B or on the expensive drug list were considered recommended; those included in list 2 or for which patient co-payment is required were considered restricted; technologies not included on any reimbursement list were classified as 'not recommended'. Using multinomial logistic regression, the relative contribution of explanatory variables on CVZ decisions was assessed. In all, 244 technology appraisals (256 technologies) were analysed, with 51%, of technologies recommended, 33% restricted and 16% not recommended by CVZ for funding. The multinomial model showed significant associations (p ≤ 0.10) between CVZ outcome and several variables, including: (1) use of an active comparator and demonstration of statistical superiority of the primary endpoint in clinical trials, (2) pharmaceutical budget impact associated with introduction of the technology, (3) therapeutic indication and (4) prevalence of the target population. Results confirm the value of a comprehensive and multivariate approach to understanding CVZ decision-making.
Block, Lawrence H.
The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…
As healthcare organizations look for new and improved ways to reduce costs and still offer quality healthcare, many are turning to the Toyota Production System of doing business. Rather than focusing on cutting personnel and assets, "lean healthcare" looks to improve patient satisfaction through improved actions and processes.
Egorova, S N; Akhmetova, T
The number of pharmacies, which produce drug formulations locally, has recently considerably reduced in Russia. Pharmacies mainly operate as retailers of industrially manufactured drugs.Pharmaceutical consultation of customers at pharmacies aimed at responsible self-medication is the most popular and accessible feature of pharmaceutical care. In Russia there is a significant list of medicines approved for sale in pharmacies on a non-prescription basis that is specified in the product label. In this regard, the role of pharmacists in public health in Russia increases. Pharmacist, working directly with population, is an important figure for the rational use of medicines. This type of work requires high level of professional training and appropriate ethics. To explore the current status of pharmaceutical counseling in Russia. Situation analysis, surveys of pharmacists. Our experience in the system of postgraduate professional education, the results of the survey of pharmacists, and the long-term dialogue with pharmacists allowed us to identify several unresolved issues in the work of a pharmacist selling non-prescription drugs.Lack of differentiation in the functions of a pharmacist with a higher education and pharmaceutical technologist: In production/industrial pharmacy technicians are engaged in manufacturing of pharmaceutical formulations. However, due to the loss of production functions technologists had to move away from production laboratories of apothecaries to the sales area. Currently, the apothecary's assignment to receive prescriptions and dispense medications can be fulfilled by either a pharmacist or a pharmaceutical technician. It significantly discerns the pharmacy from the medical organization with clearly delineated functions of doctors and nurses. Russian regulations should consider the level of education required for high-quality pharmaceutical counseling.Contradiction between the pharmacist's special functions and trade procedure with the lack of
Full Text Available The pharmaceutical market is characterized by the existence of state regulations restricting his freedom to market and is one of the fastest growing sectors of the economy all over the world. Factors that have a real impact on determining the price of drugs can be grouped into three categories: medical factors, economic factors, political and environmental factors. In the group of medical factors can be distinguished patent protection, the cost of producing the drug and the value of the drug. To economic factors, taking into account the aspect of market competitiveness of companies, include: the size of the producer, nature of the company - whether it is a research unit of the pharmaceutical company, return on investment – effectiveness of use of expenditure with the aim of achieving a profit (return on investment, ROI, profitability entity. The remaining group of factors (environmental, and political relate mainly to national regulations. They are connected with among others the registration system of marketing authorization, whether a reimbursement system that determines whether and how drugs are financed from public funds. Membership in the European Union forces on all Member States to make reimbursement decisions by the so-called Transparency Directive. It is connected with the obligation to justify decisions, and calling upon objective reasons. Medical Technology Assessment Agency formulating recommendations take into account factors i.e. a therapeutic, benefits for the patients, cost-effectiveness, impact on the budget.
Turró-Garriga, O; Calvó-Perxas, L; Albaladejo, R; Alsina, E; Cuy, J M; Llinàs-Reglà, J; Roig, A M; Serena, J; Vallmajó, N; Viñas, M; López-Pousa, S; Vilalta-Franch, J; Garre-Olmo, J
Drug spending increases exponentially from the age of 65-70 years, and dementia is one of the diseases significantly contributing to this increase. Our aim was to describe pharmaceutical consumption and cost in patients with dementia, using the Anatomical Therapeutic Chemical (ATC) classification system. We also assessed the evolution of costs and consumption, and the variables associated to this evolution during three years. Three years prospective cohort study using data from the ReDeGi and the Health Region of Girona (HRG) Pharmacy Unit database from the Public Catalan Healthcare Service (PCHS). Frequency of consumption and costs of ATC categories of drugs were calculated. Sample of 869 patients with dementia, most of them with a diagnosis of degenerative dementia (72.6%), and in a mild stage of the disease (68.2%). Central nervous system (CNS) drugs had the highest consumption rate (97.2%), followed by metabolic system drugs (80.1%), and cardiovascular system drugs (75.4%). Total pharmaceutical cost was of 2124.8 € per patient/year (standard deviation (SD)=1018.5 €), and spending on CNS drugs was 55.5% of the total cost. After 36 months, pharmaceutical cost increased in 694.9 € (SD=1741.9), which was associated with dementia severity and institutionalization at baseline. Pharmaceutical consumption and costs are high in patients with dementia, and they increase with time, showing an association with baseline dementia severity and institutionalization. CNS drugs are the pharmaceuticals with highest prescription rates and associated costs. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Dzhalilova, K I; Alieva, K Ia
The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers.
Meredith-Williams, Melanie; Carter, Laura J.; Fussell, Richard; Raffaelli, David; Ashauer, Roman; Boxall, Alistair B.A.
The uptake and depuration of a range of pharmaceuticals in the freshwater shrimp (Gammarus pulex) and the water boatman (Notonecta glauca) was studied. For one compound, studies were also done using the freshwater snail Planobarius corneus. In G. pulex, bioconcentration factors (BCFs) ranged from 4.6 to 185,900 and increased in the order moclobemide < 5-fluoruracil < carbamazepine < diazepam < carvedilol < fluoxetine. In N. glauca BCFs ranged from 0.1 to 1.6 and increased in the order 5-fluorouracil < carbamazepine < moclobemide < diazepam < fluoxetine < carvedilol. For P. corneus, the BCF for carvedilol was 57.3. The differences in degree of uptake across the three organisms may be due to differences in mode of respiration, behaviour and the pH of the test system. BCFs of the pharmaceuticals for each organism were correlated to the pH-corrected liposome–water partition coefficient of the pharmaceuticals. - Highlights: ► One of the first studies exploring the uptake of pharmaceuticals into aquatic invertebrates. ► Data presented on uptake, depuration rates and bioconcentration for a range of pharmaceuticals. ► Uptake is correlated with the pH-corrected liposome–water partition coefficient. ► Findings can be used to better predict impacts of pharmaceuticals on the aquatic environment. - The factors affecting the degree of uptake of pharmaceuticals into aquatic invertebrates were studied. The results indicate that species traits such as respiration and behaviour of the organisms and pH-corrected liposome–water partition coefficients are important factors in determining pharmaceutical uptake.
Bhardwaj, S.; Sain, M.; Lee, H.-J.; Chung, W.Y.; Slezak, D.; et al., xx
Due to recent development in Ubiquitous Healthcare now it’s time to build such application which can work independently and with less interference of Physician. In this paper we are try to build the whole architecture of personal Healthcare information system for ubiquitous healthcare which also
Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.
Full Text Available The purpose of this paper is to determine the factors in marketing most relevant to achieving pharmaceutical sales success and their interrelations, as well as providing a prescription-pharmaceuticals sales process model. This will enable scholars to obtain a better understanding of the marketing process for prescription pharmaceuticals, as well as enabling marketers to apply more efficient marketing approaches. The study uses a unique data set, combining primary data and secondary data from the Swiss prescription-pharmaceuticals market. The data is analysed using a multiple-regression based model. A multi-level data structure is found, suggesting that factors concerning the specific brand and also the pharmaceutical substance itself are relevant to sales success. It is revealed that the factors most relevant to sales success are: order of market entry, perceived product-quality, average price, and marketing expenditures, leading to practical recommendations for scholars and marketing professionals. The study focuses only on the Swiss prescription-pharmaceuticals market, investigating five medical drug classes. The assumption is made that these results can be generalised to similar markets and drug classes. The study develops a conceptual prescription-pharmaceuticals sales-process model; offers practical guidelines and a good basis for further scholarly research are provided; and identifies several research gaps by giving proposals for future research.
Adini, Bruria; Laor, Danny; Cohen, Robert; Lev, Boaz; Israeli, Avi
In the last decade, the Israeli healthcare system dealt with many casualties that resulted from terrorist actions and at the same time maintained preparedness for other potential hazards such as natural disasters, toxicological, chemical, radiological and biological events. There are various models for emergency preparedness that are utilized in different countries. The aim of the article is to present the structure and the methodology of the Israeli healthcare system for emergencies. Assuring emergency preparedness for the different scenarios is based on 5 major components that include: comprehensive contingency planning; control and command of operations; central control of readiness; capacity building; coordination and collaboration among the numerous emergency agencies. CLose working relationships between the military and civilian systems characterize the operations of the emergency system. There is a mutual sharing of information, coordinated operations to achieve risk assessment and determine priorities, and consensual allocation of resources. The ability of the medical system to operate in optimal coordination with interface bodies, including the Israel Defense Forces, is derived from three main elements: the shortage of resources necessitate that all agencies work together to develop an effective response to emergencies; the Israeli society is characterized by transition of personnel from the military to the civilian system which promotes joint operations, whereas in most other countries these systems are completely separated; and also developing mechanisms for continuous and coordinated operation in routine and emergency times, such as the Supreme Health Authority. The Israeli healthcare system was put to the test several times in the Last decade, during the terror wave that occurred between 2001-2006, the 2nd Lebanon War and in operation "Cast Lead". An extensive process of learning lessons, conducted during and following each of these periods, and the
African policymakers are pushing for local pharmaceutical manufacturing as a ... Africa Development Community Pharmaceutical Business Plan (2007-2013) and ... IDRC congratulates first cohort of Women in Climate Change Science Fellows.
Aleksandr Petrovich Petrov
Full Text Available This paper substantiates the necessity of cluster organization of the pharmaceutical industry in the region. The estimation of the state and prospects of development of such structures in the domestic economy is given. Sverdlovsk region was chosen as the object of study on the possibility of forming a pharmaceutical cluster. Objective prerequisites for the organization of a cluster of pharmaceutical production in Sverdlovsk region are considered, among these were distinguished: capacious and fast-growing market for pharmaceutical products, availability of potential development of the pharmaceutical industry in the territory and the key success factors for enterprises - potential participants of the cluster. Indicated key success factors are: presence of a creative team and close interaction between business and government, high level of cooperation among the enterprises of the cluster and commercialization of products, implementation of research and development expenditures etc. Thus, it was substantiated that in there all references and resources for the formation of a pharmaceutical cluster. The concept of formation and development of the Ural pharmaceutical cluster was elaborated. Inside the concept, the goals, objectives, processing, product and organizational priorities for cluster formation are identified. Architecture of this structure with a justification of its members and certain forms of interaction between them is proposed. The stages of formation and development of the Ural pharmaceutical cluster on the basis of a ten-year settlement period for the full range of activities for this project are substantiated. At each stage, a set of key objectives and results of the cluster was defined. The choice of phases was carried out on the basis of investment programs of cluster's enterprises strategic position on the mastering of markets and infrastructure development. An assessment of socio-economic efficiency of the Ural pharmaceutical
Mortier, S.T.F.C.; Vedantam, S.; De Beer, T.
Tablets are conventionally produced via consecutive batch process steps. Recent introduction of continuous process equipment is gaining industrial importance in pharmaceutics. Transition to continuous production requires improved understanding of all operations, necessitating the development...... of mechanistic models of multi‐phase systems which in the end allow process control. This contribution focuses on continuous fluidized bed drying of pharmaceutical wet granules. A stepwise approach is used in model development, starting with the drying behaviour of single granules. Experiments to determine...
Full Text Available The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM regulation in order to achieve “Cara Pembuatan Obat yang Baik” (CPOB of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI as final polisher for controlling conductivity, and finally Ultra Violet (UV disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.
Kartono, R.; Basuki, Y. T.
The purpose of this paper is to examine the sets of model and literature review to prove that strategy of applying free chemical usage in purified water system for pharmaceutical industry would be help the existing and new pharmaceutical companies to comply with part of Natioanal Agency of Drug and Food Control / Badan Pengawas Obat dan Makanan (NADFC/BPOM) regulation in order to achieve "Cara Pembuatan Obat yang Baik" (CPOB) of Indonesia pharmaceutical industry. One of the main reasons is when we figured out the number of Indonesian pharmaceutical industries in 2012 are kept reducing compare to the increasing numbers of Indonesian population growth. This strategy concept also might help the industries to reducing environmental pollution, and operational cost in pharmaceutical industries, by reducing of the chemical usage for water treatment process in floculation and cougulation and chlorination for sterillization. This new model is free usage of chemicals for purified water generation system process and sterilization. The concept offering of using membrane technology- Reverse Osmosis (RO) membrane base treatment to replace traditional chemical base treatment, following enhance Electrodeionization (EDI) as final polisher for controlling conductivity, and finally Ultra Violet (UV) disinfectant technology as final guard for bacteria controls instead of chemical base system in purified water generation system.
problems. Pharmaceutical product cross-contamination is a serious problem which has been detected as an obstacle ... In the pharmaceutical care of patients in developed countries, cross-contamination ..... neonatal intensive care units.
quality standards imposed on local pharmaceutical manufacturers. Keywords: Quality/ .... GMP is concerned with both production and quality control. It is aimed ... in the European pharmaceutical industry in designing their quality systems:.
Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.
Full Text Available The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the recent health policies implemented by newly industrialized countries that are aimed at ensuring increased access to care. Analysts see the field phenomenon called "Farma-merger" a good chance for European pharmaceutical companies oriented to developing countries where drug sales should record a double-digit annual growth until 2017. In Erste Group reports stated that the impact of the crisis on the pharmaceutical industry should be limited markets for EU only their economic slowdown. This will be possible because the external indebtedness of pharmaceutical companies in the EU remains at a minimum, they are able to finance their investment plans without tapping financial markets, are not adversely affected by the current limited availability of credit resources. Therefore major pharmaceutical companies in the EU will remain a solid investment on the long term, the negative developments are limited due to high resistance to the crisis their business model segment "generic". The consequence of these developments is reflected in the recognition for the first time, the pharmaceutical sector as a strategic sector for the Romanian economy. In the context of public debate launching the National Strategy for Competitiveness 2014-2020, Generic Medicines Industry Association of Romania (APMGR local pharmaceutical industry reminds the Government proposals on correcting the current fiscal and operational regulatory framework, to allow unlocking investments in facilities
Bauer, Scott R; Monuteaux, Michael C; Fleegler, Eric W
Geographic location is an important factor in understanding disparities in access to health-care and social services. The objective of this cross-sectional study is to evaluate disparities in the geographic distribution of income-related social service agencies relative to populations in need within Boston. Agency locations were obtained from a comprehensive database of social services in Boston. Geographic information systems mapped the spatial relationship of the agencies to the population using point density estimation and was compared to census population data. A multivariate logistic regression was conducted to evaluate factors associated with categories of income-related agency density. Median agency density within census block groups ranged from 0 to 8 agencies per square mile per 100 population below the federal poverty level (FPL). Thirty percent (n = 31,810) of persons living below the FPL have no access to income-related social services within 0.5 miles, and 77 % of persons living below FPL (n = 83,022) have access to 2 or fewer agencies. 27.0 % of Blacks, 30.1 % of Hispanics, and 41.0 % of non-Hispanic Whites with incomes below FPL have zero access. In conclusion, some neighborhoods in Boston with a high concentration of low-income populations have limited access to income-related social service agencies.
Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude
Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.
Sadat, Theo; Malcolm, Fiona
The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned
Mikkelsen, Anne Sophie Bech; Lund, Rikke; Kristiansen, Maria
at nursing homes in Denmark. Methods/design: A combined quantitative register-based approach and a qualitative implementation approach will be applied in this study. First, we will quantitatively analyse the relationship between social relations, health status and use of healthcare services among middle......Background: While previous research establishes an association between social relations, health and use of healthcare services among older people, how to implement this knowledge in real-life settings has received much less attention. This study will explore the relationship between social...... relations among older people at nursing homes. Trial registration: The study has been registered and approved by the Danish Data Protection Agency. Seperate approvals have been attained for the qualitative data (Approval No. SUND-2016-08), and for the quantitative data in the CAMB database which has also...
Sackett, Kay; Jones, Janice; Erdley, W Scott
The purpose of this article is to describe the incorporation of healthcare informatics into the strategic planning process in nursing education. An exemplar from the University at Buffalo, the State University of New York School of Nursing, is interwoven throughout the article. The challenges and successes inherent in a paradigm shift embracing the multifaceted adoption of technology in higher education are illustrated. The paradigm shift that necessitated this change, the need for informatics standards and competencies identified by regulatory agencies and the relationship of the triad mission of the Academy which includes research, teaching and service are then elucidated. Information pertinent to the strategic planning process is described including the use of a strengths, weaknesses, opportunities and threats (SWOT) analysis to facilitate the integration of a healthcare informatics model into a nursing curriculum.
Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard
In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).
Shapovalov VV (Jr
pharmaceutical law. In the study researched the particularities of legal documents in the Ukraine and Russian Federation aimed at organizing rules regulating circulation of the drugs used in the pharmacotherapy of diabetes. Found that pharmaceutical law in the field of public administration in the Russian Federation and Ukraine is the foundation and guarantor in protecting the rights of states declared the privileged category of people suffering from diabetes mellitus on unrestricted access to essential drugs. Established that the Ministry of Healthcare of Ukraine and the Ministry of Healthcare of Russian Federation must provide scientific advice for the prevention of diabetes mellitus; update in accordance to the European standards and directives, standards of diagnosis, clinical protocols and rules of care for patients suffering from diabetes mellitus; raise public awareness about the global epidemic of diabetes; analyze forensic and pharmaceutical practice as a result of violations of the rights of patients with diabetes to ensure preferential (free drugs. Ensuring the rights of patients with diabetes mellitus and providing vital medicines of all classification and legal groups, should base solely on the norms of medical and pharmaceutical law, the Constitution and laws of Ukraine. This will enable to the government to control the process of the licensing conditions for the implementation of activities related to the circulation of drugs among the healthcare facilities (pharmacies and hospitals.
Lind, Johanna; Kälvemark Sporrong, Sofia; Kaae, Susanne; Rantanen, Jukka; Genina, Natalja
Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles, such as pharmacoprinting, will challenge the entire drug distribution chain and affect the society at different levels. Areas covered: This work summarizes the concept of personalized medicine and gives an overview of possibilities for monitoring patients' health. The most recent activities in the field of printing technologies for fabrication of dosage forms and 'polypills' with flexible doses and tailored release profiles are reviewed. Different scenarios for the drug distribution chain with the required adjustments in drug logistics, quality systems and environmental safety are discussed, as well as whether AM will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted. Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized drug production. With the recent approval of the first printed medicine, society should be prepared for the changes that will follow the introduction of printed pharmaceuticals.
Enzmann, Harald; Broich, Karl
For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate
Madathil, Kapil Chalil; Rivera-Rodriguez, A Joy; Greenstein, Joel S; Gramopadhye, Anand K
This article reviews the peer-reviewed literature addressing the healthcare information available on YouTube. Inclusion and exclusion criteria were determined, and the online databases PubMed and Web of Knowledge were searched using the search phrases: (1) YouTube* AND Health* and (2) YouTube* AND Healthcare*. In all, 18 articles were reviewed, with the results suggesting that (1) YouTube is increasingly being used as a platform for disseminating health information; (2) content and frame analysis were the primary techniques employed by researchers to analyze the characteristics of this information; (3) YouTube contains misleading information, primarily anecdotal, that contradicts the reference standards and the probability of a lay user finding such content is relatively high; (4) the retrieval of relevant videos is dependent on the search term used; and (5) videos from government organizations and professional associations contained trustworthy and high-quality information. YouTube is used as a medium for promoting unscientific therapies and drugs that are yet to be approved by the appropriate agencies and has the potential to change the beliefs of patients concerning controversial topics such as vaccinations. This review recognizes the need to design interventions to enable consumers to critically assimilate the information posted on YouTube with more authoritative information sources to make effective healthcare decisions. © The Author(s) 2014.
Edilaine Conceição Rezende
Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.
Love, Dianne B.; Ayadi, M. Femi
As the healthcare industry has evolved over the years, so too has the administration of healthcare organizations. The signing into law of the Patient Protection and Affordable Care Act (ACA) has brought additional changes to the healthcare industry that will require changes to the healthcare administration curriculum. The movement toward a…
Mittermayer, Renato; Huić, Mirjana; Mestrović, Josipa
Avedis Donabedian defined the quality of care as the kind of care, which is expected to maximize an inclusive measure of patient welfare, after taking into account the balance of expected gains and losses associated with the process of care in all its segments. According to the World Medical Assembly, physicians and health care institutions have an ethical and professional obligation to strive for continuous quality improvement of services and patient safety with the ultimate goal to improve both individual patient outcomes as well as population health. Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner, with the aim to formulate safe and effective health policies that are patient focused and seek to achieve the highest value. The Agency for Quality and Accreditation in Health was established in 2007 as a legal, public, independent, nonprofit institution under the Act on Quality of Health Care. The Agency has three departments: Department of Quality and Education, Department of Accreditation, and Department of Development, Research, and Health Technology Assessment. According to the Act, the Agency should provide the procedure of granting, renewal and cancellation of accreditation of healthcare providers; proposing to the Minister, in cooperation with professional associations, the plan and program for healthcare quality assurance, improvement, promotion and monitoring; proposing the healthcare quality standards as well as the accreditation standards to the Minister; keeping a register of accreditations and providing a database related to accreditation, healthcare quality improvement, and education; providing education in the field of healthcare quality assurance, improvement and promotion; providing the HTA procedure and HTA database, supervising the healthcare insurance
The present paper surveys analytical methods recently employed in the field of healthcare products such as cosmetics, drugs, and foods by using Spring-8 facility which delivers high-intensity X-ray beams from electron cyclotron accelerator. These X-ray beams can be used to analyze atoms and their chemical state in human tissues such as skin, hair, whisker, teeth, and new developed products. Thus, a variety of products related with medical supplies, health food products, health maintenance, and preventive medicine concern this research group. Here, the results on colloidal states, such as lipid-molecule aggregates and lamellar structure type, generally present in cosmetic products and food substances, are focused and reported, specifically focusing on hair cuticle and honey cell layer of the skin regarding to cosmetic and pharmaceutical products. (S. Ohno)
Marsh, Kevin; Lanitis, Tereza; Neasham, David; Orfanos, Panagiotis; Caro, Jaime
The objective of this study is to support those undertaking a multi-criteria decision analysis (MCDA) by reviewing the approaches adopted in healthcare MCDAs to date, how these varied with the objective of the study, and the lessons learned from this experience. Searches of EMBASE and MEDLINE identified 40 studies that provided 41 examples of MCDA in healthcare. Data were extracted on the objective of the study, methods employed, and decision makers' and study authors' reflections on the advantages and disadvantages of the methods. The recent interest in MCDA in healthcare is mirrored in an increase in the application of MCDA to evaluate healthcare interventions. Of the studies identified, the first was published in 1990, but more than half were published since 2011. They were undertaken in 18 different countries, and were designed to support investment (coverage and reimbursement), authorization, prescription, and research funding allocation decisions. Many intervention types were assessed: pharmaceuticals, public health interventions, screening, surgical interventions, and devices. Most used the value measurement approach and scored performance using predefined scales. Beyond these similarities, a diversity of different approaches were adopted, with only limited correspondence between the approach and the type of decision or product. Decision makers consulted as part of these studies, as well as the authors of the studies are positive about the potential of MCDA to improve decision making. Further work is required, however, to develop guidance for those undertaking MCDA.
Carina Akemi Nakamura
Full Text Available The objective of this study was to investigate the scientific output on health promotion within the pharmaceutical field and its relation with the development of pharmaceutical services within health systems. A comprehensive review of published scientific articles from the Medline and Lilacs databases was carried out. The review comprised articles published until December 2011, and used combinations of the terms 'health promotion' or 'health education' and 'pharmacy', 'pharmacist' or 'pharmaceutical'. The articles were selected according to inclusion and exclusion criteria. A total of 170 full texts and 87 indexed abstracts were analyzed, evidencing that most described actions of health promotion in community pharmacies and other services. Following the Ottawa Charter, most of the studies dealt with new guidance of the service and the supply of pharmaceutical information and services. It was concluded that there is a lack of theoretical background on health promotion in the pharmaceutical field to sustain the professional education and practice required by the health system and the population.
An Approach to Effective Disinfection of Salon Items [clippers, combs and scissors]. O.S. OLONITOLA'*, P.F. OLURINOLA~ ... 2~epartment of Pharmaceutics and Pharmaceutical Microbiology, Faculty of Pharmaceutical. Sciences, Ahmadu Bello ... antimicrobial products with increased value over those currently available.
Traulsen, Janine Marie; Almarsdóttir, Anna Birna
Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisati......Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient...... organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry....... The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation...
van Mil, J.W F
The evolving concept of Pharmaceutical Care knows different interpretations in a different countries. In the Netherlands community pharmacists already perform several functions which may be part of the Pharmaceutical Care concept. The Dutch concept of Pharmaceutical care is tested in the TOM and
Carnevale, Anthony P.; Smith, Nicole; Gulish, Artem; Beach, Bennett H.
This report, provides detailed analyses and projections of occupations in healthcare fields, and wages earned. In addition, the important skills and work values associated with workers in those fields of healthcare are discussed. Finally, the authors analyze the implications of research findings for the racial, ethnic, and class diversity of the…
Edwards, Nancy V
Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.
Berthod, Laurence; Roberts, Gary; Whitley, David C.; Sharpe, Alan; Mills, Graham A.
The partitioning of pharmaceuticals in the environment can be assessed by measuring their adsorption coefficients (Kd) between aqueous and solid phases. Measuring this coefficient in sewage sludge gives an indication of their partitioning behaviour in a wastewater treatment plant and hence contributes to an understanding of their subsequent fate. The regulatory approved method for measuring Kd in sewage sludge is the US Environmental Protection Agency's Office of Prevention, Pesticides and Toxic Substances (OPPTS) guideline 835.1110, which is labour intensive and time consuming. We describe an alternative method for measuring the Kd of pharmaceuticals in sewage sludge using a modified solid-phase extraction (SPE) technique. SPE cartridges were packed at different sludge/PTFE ratios (0.4, 6.0, 24.0 and 40.0% w/w sludge) and eluted with phosphate buffer at pH 7.4. The approach was tested initially using three pharmaceuticals (clofibric acid, diclofenac and oxytetracycline) that covered a range of Kd values. Subsequently, the sorption behaviour of ten further pharmaceuticals with varying physico-chemical properties was evaluated. Results from the SPE method were comparable to those of the OPPTS test, with a correlation coefficient of 0.93 between the two approaches. SPE cartridges packed with sludge and PTFE were stable for up to one year; use within one month reduced variability in measurements (to a maximum of 0.6 log units). The SPE method is low-cost, easy to use and enables the rapid measurement of Kd values for a large number of chemicals. It can be used as an alternative to the more laborious full OPPTS test in environmental fate studies and risk assessments. PMID:25299795
Björkman, Ingeborg K; Bernsten, Cecilia B; Sanner, Margareta A
Different ways to practice pharmaceutical care have been developed. One expression of this fact is the existence of many different classification systems to document drug-related problems (DRPs). Evidence suggests that classification systems have different characteristics and that these characteristics reflect different conceptions of pharmaceutical care. To increase the understanding of conceptions of pharmaceutical care, underlying values and beliefs (ideologies) can be explored. To explore various conceptions of pharmaceutical care to identify the care ideologies on which these conceptions are based. Representatives of 4 selected conceptions of pharmaceutical care were interviewed in face-to-face meetings. During the interviews, 4 basic questions were asked. Three were focused on pharmaceutical care and 1 on DRPs. Interview transcripts were analyzed by an inductive method inspired by grounded theory. The conceptions studied were Strand, Granada-II, PCNE v5.0, and Apoteket. In Strand, patients are given a more active role in the pharmaceutical care process, as compared to Granada-II, PCNE v5.0, and Apoteket. Pharmacists in all the conceptions of pharmaceutical care assume they have special knowledge that patients benefit from. However, they use their knowledge in different ways in the various pharmaceutical care conceptions. In Strand, individual goals of drug therapy are established together with the patient, whereas in Granada-II, PCNE, and Apoteket goals are not explicitly discussed. The identified differences correspond to different care ideologies. The pharmaceutical care conceptions are based on different care ideologies. The ideology is expressed in how therapy goals are set and patient needs defined. Strand is based on a patient-centered ideology; patient therapy goals and needs are defined by the patient together with the practitioners. Granada-II, PCNE, and Apoteket are based on an evidence-based medicine approach; patient therapy goals and needs are
Edwards, Kasper; Nielsen, Anders Paarup
still is in its infancy and it is just a matter of letting sufficient time pass in order have a successful implementation of lean in all areas of healthcare. The second hypothesis states that a major barrier to lean management in healthcare simply is lacking understanding of the lean concepts leading......The ideas and principles from lean management are now widely being adopted within the healthcare sector. The analysis in this paper shows that organizations within healthcare most often only implement a limited set of tools and methods from the lean tool-box. Departing from a theoretical analysis...... of the well-known and universal lean management principles in the context of the healthcare this paper will attempt to formulate and test four hypotheses about possible barriers to the successful implementation of lean management in healthcare. The first hypothesis states that lean management in healthcare...
Faltus, Timo; Brehm, Walter
Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.
Deshpande, Praful Balavant; Kumar, G Aravind; Kumar, Averineni Ranjith; Shavi, Gopal Venkatesh; Karthik, Arumugam; Reddy, Meka Sreenivasa; Udupa, Nayanabhirama
In light of environmental apprehension, supercritical fluid technology (SFT) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Supercritical fluid extraction using carbon dioxide (CO(2)) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The present commentary provides an overview of different techniques using supercritical fluids and their future opportunity for the drug delivery industry. Some of the emerging applications of SFT in pharmaceuticals, such as particle design, drug solubilization, inclusion complex, polymer impregnation, polymorphism, drug extraction process, and analysis, are also covered in this review. The data collection methods are based on the recent literature related to drug delivery systems using SFT platforms. SFT has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This cutting-edge technology is growing predominantly to surrogate conventional unit operations in relevance to the pharmaceutical production process. Supercritical fluid technology has recently drawn attention in the field of pharmaceuticals. It is a distinct conception that utilizes the solvent properties of supercritical fluids above their critical temperature and pressure, where they exhibit both liquid-like and gas-like properties, which can enable many pharmaceutical applications. For example, the liquid-like properties provide benefits in extraction processes of organic solvents or impurities, drug solubilization, and polymer plasticization, and the gas-like features facilitate mass transfer processes. It has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This review is
Full Text Available Abstract Background International initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the President's Emergency Plan for AIDS Relief and the President's Malaria Initiative have significantly increased availability and access to medicines in some parts of the developing world. Despite this, however, skills remain limited on quantifying needs for medications and ordering, receiving and storing medications appropriately; recording medications inventories accurately; distributing medications for use appropriately; and advising patients on how to use medications appropriately. The Regional Technical Resource Collaboration for Pharmaceutical Management (RTRC has been established to help address the problem of skills shortage in pharmaceutical management in East Africa. Methods The initiative brings together academic institutions from four East African countries to participate in skills-building activities in pharmaceutical supply management. The initiative targeted the institutions' ability to conduct assessments of pharmaceutical supply management systems and to develop and implement effective skills-building programmes for pharmaceutical supply chain management. Results Over a two-year period, the RTRC succeeded in conducting assessments of pharmaceutical supply management systems and practices in Kenya, Rwanda, Tanzania and Uganda. In 2006, the RTRC participated in a materials-development workshop in Kampala, Uganda, and contributed to the development of comprehensive HIV/AIDS pharmaceutical management training materials; these materials are now widely available in all four countries. In Tanzania and Uganda the RTRC has been involved with the training of health care workers in HIV/AIDS pharmaceutical management. In Kenya, Tanzania and Uganda the RTRC has been conducting operations research to find solutions to their countries' skills-shortage problems. Some of the interventions tested include applying and evaluating the
Vashi, Neelam A; Latkowski, Jo-Ann M
Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.
Marín Armero A
Full Text Available Alicia Marín Armero,1 Miguel A Calleja Hernandez,2 Sabina Perez-Vicente,3 Fernando Martinez-Martinez4 1Community Pharmacy, Murcia, Spain; 2Hospital Pharmacy, University Hospital Virgen de las Nieves, Granada, Spain; 3Result Evaluation Unit, Institute of Biomedicine, Sevilla, Spain; 4Research Unit in Pharmaceutical Care, University of Granada, Granada, Spain Abstract: As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. Keywords: community pharmacy, health campaign, tobacco cessation, nicotine replacement therapy
Breitling, Rainer; Takano, Eriko
Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems.
Sandeep Kumar Gupta
Full Text Available The position of regional medical advisor (RMA is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry′s increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP guidelines.
Newhouse, Joseph Paul; Berndt, Ernst R.
In this survey chapter on pricing and reimbursement in U.S. pharmaceutical markets, we first provide background information on important federal legislation, institutional details regarding distribution channel logistics, definitions of alternative price measures, related historical developments, and reasons why price discrimination is highly prevalent among branded pharmaceuticals. We then present a theoretical framework for the pricing of branded pharmaceuticals, without and then in the pre...
Enick, O.V.; Moore, M.M.
The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development
Ryvicker, Miriam; McDonald, Margaret V; Trachtenberg, Melissa; Peng, Timothy R; Sridharan, Sridevi; Feldman, Penny H
The Care Transitions Measure (CTM) was designed to assess the quality of patient transitions from the hospital. Many hospitals are using the measure to inform their efforts to improve transitional care. We sought to determine if the measure would have utility for home healthcare providers by predicting newly admitted patients at heightened risk for emergency department use, rehospitalization, or increased home health nursing visits. The CTM was administered to 495 home healthcare patients shortly after hospital discharge and home healthcare admission. Follow-up interviews were completed 30 and 60 days post hospital discharge. Interview data were supplemented with agency assessment and service use data. We did not find evidence that the CTM could predict home healthcare patients having an elevated risk for emergent care, rehospitalization, or higher home health nursing use. Because Medicare/Medicaid-certified home healthcare providers already use a comprehensive, mandated start of care assessment, the CTM may not provide them additional crucial information. Process and outcome measurement is increasingly becoming part of usual care. Selection of measures appropriate for each service setting requires thorough site-specific evaluation. In light of our findings, we cannot recommend the CTM as an additional measure in the home healthcare setting. © 2013 National Association for Healthcare Quality.
Gilligan, Tony; Alamgir, Hasanat
Healthcare workers are exposed to a variety of work-related hazards including biological, chemical, physical, ergonomic, psychological hazards; and workplace violence. The Occupational Health and Safety Agency for Healthcare in British Columbia (OHSAH), in conjunction with British Columbia (BC) health regions, developed and implemented a comprehensive surveillance system that tracks occupational exposures and stressors as well as injuries and illnesses among a defined population of healthcare workers. Workplace Health Indicator Tracking and Evaluation (WHITE) is a secure operational database, used for data entry and transaction reporting. It has five modules: Incident Investigation, Case Management, Employee Health, Health and Safety, and Early Intervention/Return to Work. Since the WHITE database was first introduced into BC in 2004, it has tracked the health of 84,318 healthcare workers (120,244 jobs), representing 35,927 recorded incidents, resulting in 18,322 workers' compensation claims. Currently, four of BC's six healthcare regions are tracking and analyzing incidents and the health of healthcare workers using WHITE, providing OHSAH and healthcare stakeholders with comparative performance indicators on workplace health and safety. A number of scientific manuscripts have also been published in peer-reviewed journals. The WHITE database has been very useful for descriptive epidemiological studies, monitoring health risk factors, benchmarking, and evaluating interventions.
... 42 Public Health 3 2010-10-01 2010-10-01 false Condition for coverage-Pharmaceutical services. 416... Coverage § 416.48 Condition for coverage—Pharmaceutical services. The ASC must provide drugs and... direction of an individual designated responsible for pharmaceutical services. (a) Standard: Administration...
Caudron, Jean Michel; Schiavetti, Benedetta; Pouget, Corinne; Tsoumanis, Achilleas; Meessen, Bruno; Ravinetto, Raffaella
Introduction The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. Methods This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Results Local private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. Conclusion The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection
Serajuddin, Hamida K; Serajuddin, Abu T M
To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after
Nozal, Raúl Rodríquez
The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.
Full Text Available Abstract Background The U.S. Agency for Healthcare Research and Quality's (AHRQ Integrated Delivery Systems Research Network (IDSRN program was established to foster public-private collaboration between health services researchers and health care delivery systems. Its broad goal was to link researchers and delivery systems to encourage implementation of research into practice. We evaluated the program to address two primary questions: 1 How successful was IDSRN in generating research findings that could be applied in practice? and 2 What factors facilitate or impede such success? Methods We conducted in-person and telephone interviews with AHRQ staff and nine IDSRN partner organizations and their collaborators, reviewed program documents, analyzed projects funded through the program, and developed case studies of four IDSRN projects judged promising in supporting research implementation. Results Participants reported that the IDSRN structure was valuable in creating closer ties between researchers and participating health systems. Of the 50 completed projects studied, 30 had an operational effect or use. Some kinds of projects were more successful than others in influencing operations. If certain conditions were met, a variety of partnership models successfully supported implementation. An internal champion was necessary for partnerships involving researchers based outside the delivery system. Case studies identified several factors important to success: responsiveness of project work to delivery system needs, ongoing funding to support multiple project phases, and development of applied products or tools that helped users see their operational relevance. Factors limiting success included limited project funding, competing demands on potential research users, and failure to reach the appropriate audience. Conclusion Forging stronger partnerships between researchers and delivery systems has the potential to make research more relevant to users
McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E
The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).
Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando
As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.
Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars
Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.
Pozo Muñoz, F; Padilla Marín, V
1) To describe the frequency of positive attitudes and behaviours, in terms of patient safety, among the healthcare providers working in a healthcare district; 2) to determine whether the level of safety-related culture differs from other studies; and 3) to analyse negatively valued dimensions, and to establish areas for their improvement. A descriptive, cross-sectional study based on the results of an evaluation of the safety-related culture was conducted on a randomly selected sample of 247 healthcare providers, by using the Spanish adaptation of the Hospital Survey on Patient Safety Culture (HSOPSC) designed by the Agency for Healthcare Research and Quality (AHRQ), as the evaluation tool. Positive and negative responses were analysed, as well as the global score. Results were compared with international and national results. A total of 176 completed survey questionnaires were analysed (response rate: 71.26%); 50% of responders described the safety climate as very good, 37% as acceptable, and 7% as excellent. Strong points were: «Teamwork within the units» (80.82%) and «Supervisor/manager expectations and actions» (80.54%). Dimensions identified for potential improvement included: «Staffing» (37.93%), «Non-punitive response to error» (41.67%), and «Frequency of event reporting» (49.05%). Strong and weak points were identified in the safety-related culture of the healthcare district studied, together with potential improvement areas. Benchmarking at the international level showed that our safety-related culture was within the average of hospitals, while at the national level, our results were above the average of hospitals. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.
Almarsdóttir, Anna Birna; Traulsen, Janine Marie
and profit controls; 2) reimbursement system charges; 3) other fiscal measures; 4) quality measures. Pharmaceuticals policy has suffered from the pervasive misunderstanding that drugs are like any other commodity; resulting in policy makers viewing pharmaceuticals expenditures without thinking about drugs...
The study investigated the adequacy of pharmaceutical scientists' information environment in feeding their occupational activities. Data was collected through observation and through questionnaire administration to all the twenty-seven scientists in two large pharmaceutical companies in Lagos, Nigeria. Findings revealed ...
Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune
This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.
Pharmaceutical management involves a set of practices aiming at ensuring timely availability and appropriate use of safe, effective and quality pharmaceuticals and services in any health care setting. Rational use of medicines is often associated with efficiency of pharmaceutical supply system that operates in the health ...
Matthias de Cazes
Full Text Available The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds.
Kim, Younghee; Jung, Jinyong; Kim, Myunghyun; Park, Jeongim; Boxall, Alistair B A; Choi, Kyungho
Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the environment, and toxicological hazard. Twenty compounds were identified in the top priority class, most of which were antibiotics. Among these compounds, 8 were identified as deserving more immediate attention: amoxicillin, enramycin, fenbendazole, florfenicol, ivermectin, oxytetracycline, tylosin, and virginiamycin. A limitation of this study is that we initially screened veterinary pharmaceuticals by sales tonnage for veterinary use only. However, this is the first attempt to prioritize veterinary pharmaceuticals in Korea, and it provides important concepts for developing environmental risk management plans for such contaminants in aquatic systems. Copyright © 2008 Elsevier B.V. All rights reserved.
Dube, Kudakwashe; Shoniregun, Charles A
The ever-increasing healthcare expenditure and pressing demand for improved quality and efficiency of patient care services are driving innovation in healthcare information management. The domain of healthcare has become a challenging testing ground for information security due to the complex nature of healthcare information and individual privacy. ""Electronic Healthcare Information Security"" explores the challenges of e-healthcare information and security policy technologies. It evaluates the effectiveness of security and privacy implementation systems for anonymization methods and techniqu
Bester, Kai; Hansen, Kamilla S; Spiliotopoulou, Aikaterini
-pollutants (Antoniou et al., 2013). In the present work, ozonation of biological treated hospital wastewater spiked with pharmaceuticals were performed to determine the required ozone dose for 90 % removal of the investigated pharmaceuticals. Effluents with different DOC level were used to investigate the effect...... of DOC on the removal of the pharmaceuticals. Furthermore, the effect of pH on ozone decomposition was investigated in relevant pH range....
Pharmaceuticals are biologically active compounds that may be consumed in hundreds of tonnes per year, and which are excreted into municipal sewerage systems. Many pharmaceuticals persist during sewage treatment, and significant environmental risk has been linked to incomplete removal of pharmaceuticals. Evaluation of this risk is important and should be as representative as possible, taking into consideration all significant exposure routes and removal processes. Sludge treatment processes a...
With the rapid economic development, a better living condition leads to longer life expectancy, which increased the total population, in particular the elderly group. It may result in increase in the demand of pharmaceuticals for people in domestic use or in hospital. Although most sewage treatment plants or waste water treatment plantsmet the regulatory requirement, there are still many pharmaceuticals removed incompletely and thus discharged to the environment. Therefore, the pharmaceuticals residue draws the public concern because they might cause adverse effects on the organism even human beings. Recently, many studies have published on the source and occurrence as well as the fate of pharmaceuticals all over the world. This paper summarized and reviewed the recent studies on the sources, occurrence, fate and the effects of the most common pharmaceuticals. Finally, it gave the suggestion and risk management for controlling the pharmaceuticals. - Highlights: • The sources of pharmaceutical residuals are studied. • Occurrence and fate of pharmaceutical in environment are studied. • Risk management and recommendation are provided on pharmaceutical pollution. - Concentration of pharmaceuticals in the natural environment is lower than in effluent of sewage treatment plants in which carbamazepine is found frequently in soil and water body
Hillisch, Alexander; Heinrich, Nikolaus; Wild, Hanno
Computational chemistry within the pharmaceutical industry has grown into a field that proactively contributes to many aspects of drug design, including target selection and lead identification and optimization. While methodological advancements have been key to this development, organizational developments have been crucial to our success as well. In particular, the interaction between computational and medicinal chemistry and the integration of computational chemistry into the entire drug discovery process have been invaluable. Over the past ten years we have shaped and developed a highly efficient computational chemistry group for small-molecule drug discovery at Bayer HealthCare that has significantly impacted the clinical development pipeline. In this article we describe the setup and tasks of the computational group and discuss external collaborations. We explain what we have found to be the most valuable and productive methods and discuss future directions for computational chemistry method development. We share this information with the hope of igniting interesting discussions around this topic. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Breitling, Rainer; Takano, Eriko
Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872
Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile pharmaceuticals immediately after collection and one year later. Methods: All pharmaceutical samples were subjected to the following examinations: total bacterial count and presence of microbial pathogens, using ...
Li, Zhenchen; Yang, Ping
Due to the needs of human life and health, pharmaceutical industry has made great progress in recent years, but it has also brought about severe environmental problems. The presence of pharmaceuticals in natural waters which might pose potential harm to the ecosystems and humans raised increasing concern worldwide. Pharmaceuticals cannot be effectively removed by conventional wastewater treatment plants (WWTPs) owing to the complex composition, high concentration of organic contaminants, high salinity and biological toxicity of pharmaceutical wastewater. Therefore, the development of efficient methods is needed to improve the removal effect of pharmaceuticals. This review provides an overview on three types of treatment technologies including physicochemical, chemical and biological processes and their advantages and disadvantages respectively. In addition, the future perspectives of pharmaceutical wastewater treatment are given.
Yousefi, Nazila; Alibabaei, Ahmad
Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.
Greene, Jeremy A
Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.
Lybecker, Kristina M; Freeman, Robert A
Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.
Yue, Xiao; Wang, Huiju; Jin, Dawei; Li, Mingqiang; Jiang, Wei
Healthcare data are a valuable source of healthcare intelligence. Sharing of healthcare data is one essential step to make healthcare system smarter and improve the quality of healthcare service. Healthcare data, one personal asset of patient, should be owned and controlled by patient, instead of being scattered in different healthcare systems, which prevents data sharing and puts patient privacy at risks. Blockchain is demonstrated in the financial field that trusted, auditable computing is possible using a decentralized network of peers accompanied by a public ledger. In this paper, we proposed an App (called Healthcare Data Gateway (HGD)) architecture based on blockchain to enable patient to own, control and share their own data easily and securely without violating privacy, which provides a new potential way to improve the intelligence of healthcare systems while keeping patient data private. Our proposed purpose-centric access model ensures patient own and control their healthcare data; simple unified Indicator-Centric Schema (ICS) makes it possible to organize all kinds of personal healthcare data practically and easily. We also point out that MPC (Secure Multi-Party Computing) is one promising solution to enable untrusted third-party to conduct computation over patient data without violating privacy.
Barrett, J S; Koprowski, S P
The highly competitive pharmaceutical industry has seen many external changes to its landscape as companies consume each other increasing their pipelines while removing redundant functions and processes. Internally, companies have sought to streamline the discovery and development phases in an attempt to improve candidate selection and reduce the time to regulatory filing. In conjunction with efforts to screen and develop more compounds faster and more efficiently, database management systems (DBMS) have been developed for numerous groups supporting various R&D efforts. An outgrowth of DBMS evolution has been the birth of data warehousing. Often confused with DBMS, data warehousing provides a conduit for data residing across platforms, networks, and in different data structures. Through the use of metadata, the warehouse establishes connectivity of varied data stores (operational detail data, ODD) and permits identification of data ownership, location and transaction history. This evolution has closely mirrored and in some ways been driven by the electronic submission (formerly CANDA). The integration of the electronic submissions and document management with R&D data warehousing initiatives should provide a platform by which companies can address compliance with 21 CFR Part 11. Now more than ever "corporate memory" is being extended to the data itself. The when, why and how of successes and failures are constantly being probed by R&D management teams. The volume of information being generated by today's pharmaceutical companies requires mining of historical data on a routine basis. Data warehousing represents a core technology to assist in this endeavor. New initiatives in this field address the necessity of data portals through which warehouse data can be web-enabled and exploited by diverse data customers both internal and external to the company. The epiphany of data warehousing technologies within the pharmaceutical industry has begun and promises to change
Andradas, Elena; Blasco, Juan-Antonio; Valentín, Beatriz; López-Pedraza, María-José; Gracia, Francisco-Javier
The aim of this study was to explore the needs and requirements of decision makers in our regional healthcare system for health technology assessment (HTA) products to support portfolio development planning for a new HTA agency in Madrid, Spain. A Delphi study was conducted during 2003. Questionnaires were developed based on a review of products and services offered by other agency members of the International Network of Agencies for Health Technology Assessment, and included preference and prioritization questions to evaluate twenty-two different products and services. The initial Delphi panel involved eighty-seven experts from twenty-one public hospitals, eleven primary healthcare centers, six private hospitals, and eight departments of the Regional Ministry of Health of the Community of Madrid. The global participation rate was 83.9 percent. Ten of the twenty-two possible products were rated of high interest by more than 80 percent of respondents. Important differences in preferences and priorities were detected across different settings. Public hospitals and primary healthcare centers shared a more "micro" perspective, preferring classic technology-centered HTA products, whereas private hospitals and Ministry representatives demanded more "macro" products and services such as organizational model and information system assessments. The high participation rate supports the representativeness of the results for our regional context. The strategic development of an HTA portfolio based on decision makers' needs and requirements as identified in this type of exercise should help achieve a better impact on policy development and decision making.
Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan
Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of bacterial contaminants. Forty-one bacterial contaminants were isolated from 31 of the tested preparations. These isolates were subjected to biochemical identification by both conventional tests as well as API kits, which were sufficient for the accurate identification of only 11 out of the 41 bacterial contaminants (26.8%) to the species level. The remaining isolates were inconclusively identified or showed contradictory results after using both biochemical methods. Using molecular methods, 24 isolates (58.5%) were successfully identified to the species level. Moreover, polymerase chain reaction (PCR) assays were compared to standard biochemical methods in the detection of pharmacopoeial bacterial indicators in artificially-contaminated pharmaceutical samples. PCR-based methods proved to be superior regarding speed, cost-effectiveness and sensitivity. Therefore, pharmaceutical manufacturers would be advised to adopt PCR-based methods in the microbiological quality testing of pharmaceuticals in the future.
Rehman, Muhammad Saif Ur; Rashid, Naim; Ashfaq, Muhammad; Saif, Ameena; Ahmad, Nasir; Han, Jong-In
Global pharmaceutical industry has relocated from the west to Asian countries to ensure competitive advantage. This industrial relocation has posed serious threats to the environment. The present study was carried out to assess the possible pharmaceutical contamination in the environment of emerging pharmaceutical manufacturing countries (Bangladesh, China, India and Pakistan). Although these countries have made tremendous progress in the pharmaceutical sector but most of their industrial units discharge wastewater into domestic sewage network without any treatment. The application of untreated wastewater (industrial and domestic) and biosolids (sewage sludge and manure) in agriculture causes the contamination of surface water, soil, groundwater, and the entire food web with pharmaceutical compounds (PCs), their metabolites and transformed products (TPs), and multidrug resistant microbes. This pharmaceutical contamination in Asian countries poses global risks via product export and international traveling. Several prospective research hypotheses including the development of new analytical methods to monitor these PCs/TPs and their metabolites, highly resistant microbial strains, and mixture toxicity as a consequence of pharmaceutical contamination in these emerging pharmaceutical exporters have also been proposed based on the available literature. Copyright © 2013 Elsevier Ltd. All rights reserved.
Suzuki, Keiichiro; Kojina, Moeko; Aiba, Tetsuya
Similarities among non-prescription pharmaceutical vitamin products generally available in community pharmacies were examined based on their vitamin components, and a chart was constructed to differentiate products to assist in appropriate product choice. In the analysis of the similarities, two hundred and seventy-six data entries on vitamin products were extracted from the database on the package inserts of the pharmaceutical products provided by the Pharmaceuticals and Medical Devices Agency, and they were reviewed for the amounts of vitamins they contained, in which the B vitamins, or vitamin B 1 , B 2 , B 6 , B 12 , and niacin, were considered as well as vitamins C and E. Pantothenic acid and L-Cysteine that are frequently used in combination with those vitamins are also taken into consideration. The data entries were then processed by classical multi-dimensional scaling to evaluate the inter-product similarities. As a result, it was shown that the products categorized as pharmaceutical nutrients and tonics containing vitamins (NTcV) are similar to one another, reflecting the fact that they are less characteristic regarding their vitamin components. As for the products in other categories, they were generally found to be featured for their unique content of vitamin components, and thereby, each category includes products with a wide range of variation. It was also indicated that some products categorized as vitamin B 1 , B 2 , and C products are less distinguishable from those categorized as NTcV. These findings will assist pharmacists to decide on an appropriate product for a customer following consultation.
Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan
Background Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Results Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of b...
Mosammod Mahamuda Parvin; M M Nurul Kabir
The Pharmaceutical sector plays a vital role in underpinning the economic development of a country. This study attempts to evaluate job satisfaction of employees in different pharmaceutical companies. It focuses on the relative importance of job satisfaction factors and their impacts on the overall job satisfaction of employees. It also investigates the impacts of pharmaceutical type, work experience, age, and sex differences on the attitudes toward job Satisfaction. The result shows that sal...
Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.
Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area. (paper)
Riek, Laurel D.
Robots have the potential to be a game changer in healthcare: improving health and well-being, filling care gaps, supporting care givers, and aiding health care workers. However, before robots are able to be widely deployed, it is crucial that both the research and industrial communities work together to establish a strong evidence-base for healthcare robotics, and surmount likely adoption barriers. This article presents a broad contextualization of robots in healthcare by identifying key sta...
Müller, Beate; Scheytt, Traugott; Asbrand, Martin; de Casas, Andrea Mross
A set of human pharmaceuticals enables identification of groundwater that is influenced by sewage and provides information on the time of recharge. As the consumption rates of the investigated pharmaceuticals have changed over time, so too has the composition of the sewage. At the study area, south of Berlin (Germany), irrigation was performed as a method of wastewater clean-up at sewage irrigation farms until the early 1990s. Today, treated wastewater is discharged into the surface-water-stream Nuthegraben. Groundwater and surface-water samples were analyzed for the pharmaceutical substances clofibric acid, bezafibrate, diclofenac, carbamazepine and primidone, the main ions and organic carbon. The pharmaceutical substances were detected at concentrations up to microgram-per-liter level in groundwater and surface-water samples from the Nuthegraben Lowland area and from the former irrigation farms. Concentrations detected in groundwater are generally much lower than in surface water and there is significant variation in the distribution of pharmaceutical concentrations in groundwater. Groundwater influenced by the irrigation of sewage water shows higher primidone and clofibric-acid concentrations. Groundwater influenced by recent discharge of treated sewage water into the surface water shows high carbamazepine concentrations while concentrations of primidone and clofibric acid are low.
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Faltus, Timo; Brehm, Walter
Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965
Ali Mohammad Mosadeghrad
Full Text Available Background The main purpose of this study was to identify factors that influence healthcare quality in the Iranian context. Methods Exploratory in-depth individual and focus group interviews were conducted with 222 healthcare stakeholders including healthcare providers, managers, policy-makers, and payers to identify factors affecting the quality of healthcare services provided in Iranian healthcare organisations. Results Quality in healthcare is a production of cooperation between the patient and the healthcare provider in a supportive environment. Personal factors of the provider and the patient, and factors pertaining to the healthcare organisation, healthcare system, and the broader environment affect healthcare service quality. Healthcare quality can be improved by supportive visionary leadership, proper planning, education and training, availability of resources, effective management of resources, employees and processes, and collaboration and cooperation among providers. Conclusion This article contributes to healthcare theory and practice by developing a conceptual framework that provides policy-makers and managers a practical understanding of factors that affect healthcare service quality.
Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry National Industrial ...
Bochenek, Tomasz; Kocot, Ewa; Rodzinka, Marcin; Godman, Brian; Maciejewska, Katarzyna; Kamal, Susan; Pilc, Andrzej
The appropriate access to public information is very important for healthcare system stakeholders. The goal of this study was to examine how the execution of the formally existing right to public information on the HTA-based recommendations on reimbursement of new health technologies from public funds has been changing in Poland. All recommendations published within two predefined equal periods of time between 2013 and 2015 were analyzed. The gathered data was subjected to statistical analysis. The frequency and intensity of censoring the published HTA-based recommendations on the pharmaceutical reimbursement has diminished. The text readability and clarity of message has improved, although the degree of decisiveness of the recommendations has dropped. The positive changes in the public communication policy should be continued. The transparency of the HTA-based recommendations should be increased further in some areas in the future.
Bond, A. D.
Modern instruments for small-molecule crystallography continue to become more sophisticated and more automated. This technical progress provides a basis for frontier research in chemical and pharmaceutical crystallography, but it also encourages analytical crystallographers to become more...... are presented for pharmaceutical compounds, and the potential importance of the "details" in pharmaceutical crystallography is discussed....
Carter, Laura J.; Ryan, Jim J.; Boxall, Alistair B.A.
Pharmaceuticals can enter the soil environment when animal slurries and sewage sludge are applied to land as a fertiliser or during irrigation with contaminated water. These pharmaceuticals may then be taken up by soil organisms possibly resulting in toxic effects and/or exposure of organisms higher up the food chain. This study investigated the influence of soil properties on the uptake and depuration of pharmaceuticals (carbamazepine, diclofenac, fluoxetine and orlistat) in the earthworm Eisenia fetida. The uptake and accumulation of pharmaceuticals into E. fetida changed depending on soil type. Orlistat exhibited the highest pore water based bioconcentration factors (BCFs) and displayed the largest differences between soil types with BCFs ranging between 30.5 and 115.9. For carbamazepine, diclofenac and fluoxetine BCFs ranged between 1.1 and 1.6, 7.0 and 69.6 and 14.1 and 20.4 respectively. Additional analysis demonstrated that in certain treatments the presence of these chemicals in the soil matrices changed the soil pH over time, with a statistically significant pH difference to control samples. The internal pH of E. fetida also changed as a result of incubation in pharmaceutically spiked soil, in comparison to the control earthworms. These results demonstrate that a combination of soil properties and pharmaceutical physico-chemical properties are important in terms of predicting pharmaceutical uptake in terrestrial systems and that pharmaceuticals can modify soil and internal earthworm chemistry which may hold wider implications for risk assessment. - Highlights: • Uptake of pharmaceuticals into earthworms is influenced by soil parameters. • Presence of pharmaceuticals in the terrestrial environment influences soil pH. • Uptake of pharmaceuticals by earthworms changes internal earthworm pH. - The uptake of pharmaceuticals into soil invertebrates is dependent on the complex interplay between pharmaceutical physico-chemical properties and soil
Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E
Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the
Full Text Available Sowmya P Lakshmi,1,2 Aravind T Reddy,1,2 Raju C Reddy1,2 1Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh School of Medicine, 2Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA, USA Abstract: COPD, for which cigarette smoking is the major risk factor, remains a worldwide burden. Current therapies provide only limited short-term benefit and fail to halt progression. A variety of potential therapeutic targets are currently being investigated, including COPD-related proinflammatory mediators and signaling pathways. Other investigational compounds target specific aspects or complications of COPD such as mucus hypersecretion and pulmonary hypertension. Although many candidate therapies have shown no significant effects, other emerging therapies have improved lung function, pulmonary hypertension, glucocorticoid sensitivity, and/or the frequency of exacerbations. Among these are compounds that inhibit the CXCR2 receptor, mitogen-activated protein kinase/Src kinase, myristoylated alanine-rich C kinase substrate, selectins, and the endothelin receptor. Activation of certain transcription factors may also be relevant, as a large retrospective cohort study of COPD patients with diabetes found that the peroxisome proliferator-activated receptor γ (PPARγ agonists rosiglitazone and pioglitazone were associated with reduced COPD exacerbation rate. Notably, several therapies have shown efficacy only in identifiable subgroups of COPD patients, suggesting that subgroup identification may become more important in future treatment strategies. This review summarizes the status of emerging therapeutic pharmaceuticals for COPD and highlights those that appear most promising. Keywords: pulmonary, PPAR, phosphodiesterase, emphysema, cigarette, mucus
Comanor, William S; Scherer, F M
Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.
Sass, Julian; Becker, Kim; Ludmann, Dominik; Pantazoglou, Elisabeth; Dewenter, Heike; Thun, Sylvia
A nationally uniform medication plan has recently been part of German legislation. The specification for the German medication plan was developed in cooperation between various stakeholders of the healthcare system. Its' goal is to enhance usability and interoperability while also providing patients and physicians with the necessary information they require for a safe and high-quality therapy. Within the research and development project named Medication Plan PLUS, the specification of the medication plan was tested and reviewed for semantic interoperability in particular. In this study, the list of pharmaceutical dose forms provided in the specification was mapped to the standard terms of the European Directorate for the Quality of Medicines & HealthCare by different coders. The level of agreement between coders was calculated using Cohen's Kappa (κ). Results show that less than half of the dose forms could be coded with EDQM standard terms. In addition to that Kappa was found to be moderate, which means rather unconvincing agreement among coders. In conclusion, there is still vast room for improvement in utilization of standardized international vocabulary and unused potential considering cross-border eHealth implementations in the future.
Laitinen, Niklas; Antikainen, Osmo; Rantanen, Jukka
The utilization of descriptive image information in pharmaceutical powder technology is rather limited. Consequently, the development of this discipline is a challenge within physical characterization of pharmaceutical solids. The aim of this study was to develop and evaluate an inventive visual...... in particle size analysis also enabling the evaluation of the further product quality in the end of the granulation process. The idea of characterization of bulk surface images opens new perspectives for characterization of pharmaceutical solids....
Postma, Jeroen; Roos, Anne-Fleur
In many OECD countries, healthcare sectors have become increasingly concentrated as a result of mergers. However, detailed empirical insight into why healthcare providers merge is lacking. Also, we know little about the influence of national healthcare policies on mergers. We fill this gap in the literature by conducting a survey study on mergers among 848 Dutch healthcare executives, of which 35% responded (resulting in a study sample of 239 executives). A total of 65% of the respondents was involved in at least one merger between 2005 and 2012. During this period, Dutch healthcare providers faced a number of policy changes, including increasing competition, more pressure from purchasers, growing financial risks, de-institutionalisation of long-term care and decentralisation of healthcare services to municipalities. Our empirical study shows that healthcare providers predominantly merge to improve the provision of healthcare services and to strengthen their market position. Also efficiency and financial reasons are important drivers of merger activity in healthcare. We find that motives for merger are related to changes in health policies, in particular to the increasing pressure from competitors, insurers and municipalities.
Yusefzadeh, Hassan; Hadian, Mohammad; Abolghasem Gorji, Hassan; Ghaderi, Hossein
Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran's intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. This study assessed the factors associated with Iran's intra-industry trade in pharmaceuticals with the rest of the world during the 2001-2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran's pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran's IIT in pharmaceuticals. The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran's intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn't have the expected signs. In addition, we found that Iran's IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. In order to get more prepared for integration into the global economy, the development of Iran's IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade.
Zukov, V.; Mende, V.
The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)
Pindelska, Edyta; Sokal, Agnieszka; Kolodziejski, Waclaw
The main goal of a novel drug development is to obtain it with optimal physiochemical, pharmaceutical and biological properties. Pharmaceutical companies and scientists modify active pharmaceutical ingredients (APIs), which often are cocrystals, salts or carefully selected polymorphs, to improve the properties of a parent drug. To find the best form of a drug, various advanced characterization methods should be used. In this review, we have described such analytical methods, dedicated to solid drug forms. Thus, diffraction, spectroscopic, thermal and also pharmaceutical characterization methods are discussed. They all are necessary to study a solid API in its intrinsic complexity from bulk down to the molecular level, gain information on its structure, properties, purity and possible transformations, and make the characterization efficient, comprehensive and complete. Furthermore, these methods can be used to monitor and investigate physical processes, involved in the drug development, in situ and in real time. The main aim of this paper is to gather information on the current advancements in the analytical methods and highlight their pharmaceutical relevance. Copyright © 2017 Elsevier B.V. All rights reserved.
Feulefack, Joseph; Sergi, Consolato
A systematic literature review on pharmaceutical companies may be a tool for guiding some procedures of R&D implementation in a department of Laboratory Medicine and Pathology. The use of pharmaceutical companies for this specific analysis arises from less variability of standards than healthcare facilities. In this qualitative and quantitative analysis, we focused on three useful areas of implementation, including R&D productivity, commercialization strategies, and expenditures determinants of pharmaceutical companies. Studies and reports of online databases from 1965 to 2014 were reviewed according to specific search terms. Initially, 218 articles and reports were found and examined, but only 91 were considered appropriate and used for further analysis. We identified some suggested implementation strategies relevant for marketing to enhance companies' own R&D strategies; such as reliability of companies on "sourcing-in" R&D facilities and "think-tank" events. Regardless of the study and of the country, cash flow and profitability always positively influenced R&D expenditure, while sales and firm size did not. We consider that handling R&D determinants should require caution. It seems critical that implementation of R&D systems is directly related with productivity, if it reflects dual embodiment of efficiency and effectiveness. Scrutinizing the determinants of R&D expenditures emphasizes significant factors that are worth to highlight when planning an R&D investment strategy. Although there is no receipt fitting every situation, we think that health care plan makers may find relevant data in this systematic review in creating an initial implementation framework.
Rogers, S J; Tureski, K; Cushnie, A; Brown, A; Bailey, A; Palmer, Q
While considerable research has documented stigma toward key populations affected by HIV and AIDS - men who have sex with men (MSM), sex workers (SWs) - it provided limited empirical evidence on the presence of layered stigma among health-care professionals providing services for these populations. C-Change conducted a survey among 332 staff of health-care and social service agencies in Jamaica and The Bahamas to understand the levels of stigma toward people living with HIV (PLHIV), including MSM and SWs and factors associated with stigma. While most health-care professionals responding to the survey said that PLHIV, MSM, and SWs deserved quality care, they expressed high levels of blame and negative judgments, especially toward MSM and SWs. Across a stigma assessment involving eight vignette characters, the highest levels of stigma were expressed toward PLHIV who were also MSM or SWs, followed by PLHIV, MSM, and SWs. Differences were assessed by gender, country, type of staff, type of agency, and exposure to relevant training. Findings indicate higher reported stigma among nonclinical vs. clinical staff, staff who worked in general vs. MSM/SW-friendly health facilities, and among untrained vs. training staff. This implies the need for targeted staff capacity strengthening as well as improved facility environments that are MSM/SW-friendly.
Calis, S; Oner, F; Kas, S; Hincal, A A
Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.
Full Text Available Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality
The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.
Jun 1, 2004 ... PHARMACEUTICAL PRODUCTS MANUFACTURED IN KENYA. J. A. ORWA, L. K. ... Design: Cross-sectional study. ... of good manufacturing practices has been used in the production of each pharmaceutical product by ...
Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D
This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for
Blackburn, R.; Iddon, B.; Moore, J.S.; Phillips, G.O.; Power, D.M.; Woodward, T.W.
Sterilization of pharmaceuticals by radiation is accompanied by chemical degradation which must be eliminated or minimised if the method is to be successfully applied. In order to devise ways in which the pharmaceutical can be protected it is necessary to know the yield and nature of the decomposition products, the mechanisms by which degradation occurs, and the rate constants for the reactions involved. We have obtained such data for a variety of pharmaceutical compounds, viz. vitamin B12, benzyl penicillin, sulphonamides, indoles, heparin, alginates and phenylmercurics, both in the solid state and in aqueous solution. The scope and limitations of radiation sterilization are discussed in the light of these results. (author)
Kimura, Atsushi; Osawa, Misako; Taguchi, Mitsumasa
Pharmaceuticals in wastewater were treated by the combined method of activated sludge and ionizing radiation in laboratory scale. Oseltamivir, aspirin, and ibuprofen at 5 μmol dm −3 in wastewater were decomposed by the activated sludge at reaction time for 4 h. Carbamazepine, ketoprofen, mefenamic acid, clofibric acid, and diclofenac were not biodegraded completely, but were eliminated by γ-ray irradiation at 2 kGy. The rate constants of the reactions of these pharmaceuticals with hydroxyl radicals were estimated by the competition reaction method to be 4.0–10×10 9 mol −1 dm 3 s −1 . Decompositions of the pharmaceuticals in wastewater by ionizing radiation were simulated by use of the rate constants and the amount of total organic carbon as parameters. Simulation curves of concentrations of these pharmaceuticals as a function of dose described the experimental data, and the required dose for the elimination of them in wastewater by ionizing radiation can be estimated by this simulation. - Highlights: ► We treat pharmaceuticals in wastewater by activated sludge and ionizing radiation. ► Activated sludge decreases the amounts of total organic carbons in wastewater. ► Pharmaceuticals were decomposed by γ-ray irradiation at 2 kGy. ► We construct simulation for treatment of pharmaceuticals by ionizing radiation.