A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN

2014 ◽  
Vol 2 (2) ◽  
pp. 1-4 ◽  
Author(s):  
S.K.R Parasiya ◽  
V Balamuralidhara ◽  
Pramod T.M. Kumar ◽  
R Gujarati ◽  
A Shukla ◽  
...  

Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for instance, can be taken as an example. Taiwan has one of Asia's most highly-praised healthcare systems with excellent provision of healthcare and key health outcomes. Nevertheless, the government is facing new pressures for public healthcare reforms as result of a rapidly ageing population and rising healthcare costs. This paper provides an introductory overview of Taiwan’s sudden changes in its Drug regulations due to TFDA (The Taiwan Food and Drug Administration) establishment in 2010, TFDA of the Department of Health (DOH) made an advance announcement about the “amendment draft of the Provisions Governing the Registration and Market Approval of Drugs”, which amends a total of 40 Articles. Without impeding the quality, safety and therapeutic effect of Drugs, most of the amended Articles are about simplification of application procedures and loosening of regulations for Drug registration and market approval. Regulations loosened are imposed on new Drugs, Radioactive Drugs, Allergenic Drugs and Drugs for export that is intended to accelerate the process to sell new Drugs on the market and promote the export of domestically manufactured Drugs. As a result of these changes in regulations many pharmaceutical MNCs and local manufacturers explored their business in Taiwan due to quick approval of their NDAs and gained more flexibility in the local market. To support Taiwan's generic Drug industry, DOH has also decided to take measures to simplify and reduce the ANDA application time.

2019 ◽  
Vol 255 ◽  
pp. 04005
Author(s):  
Paul K.Y. Siu ◽  
K.L. Choy ◽  
H.Y. Lam

Due to the advancement of living standard and medical technologies, the life expectancy of people is further extended which brings tremendous impact to the society in the near future. The ageing population not only increases the pressure to public healthcare services, but also brings urgent needs in long term healthcare resources allocation planning in the society. This paper presents an Elderly Behaviour Analytics Model (EBAM) to identify the hospital healthcare service preferences of elderly for the future planning of healthcare industry. By conducting an elderly-targeted survey, the collected data is analysed to understand the factors affecting the decision of elderly to acquire healthcare services in hospitals. The model applies the genetic algorithm-guided clustering-based association rule mining approach for the segmentation of hospital service preferences of the elderly, and, the identification of relationship between personal characteristics within each cluster. This research study contributes to the understanding the actual healthcare needs of elderly which allows the government and healthcare service providers to adjust or modify the elderly policies and service content.


2019 ◽  
Vol 10 (1) ◽  
pp. 43-52
Author(s):  
Matthew Quinn ◽  
Nigel McKelvey

Norway spends more on public healthcare per person than any other European country. The government and the Norwegian health authorities are committed to improving the country's healthcare service through the use of innovative information and communication technology, generally referred to as ehealth. Society in Norway benefits from an integrated ehealth care system where the patient is at its centre regardless of the person's level of income or geographical location. The long-term national ehealth strategy “one citizen – one record” is the basis for all ehealth national strategies and initiatives. With its challenging geographical environment and ageing population, telemedicine and other ehealth developments such as eprescription and electronic health records (EHR) are important tools in successfully implementing new ehealth reforms that continue to impact society in Norway.


Author(s):  
Verena Seibel ◽  
Jeanette A J Renema

Abstract Public healthcare is still one of the main pillars of European welfare states, despite the increasing number of migrants, we know little about migrants’ attitudes toward healthcare. We used recent data from the MIFARE survey and compared natives with a variety of nine migrant groups living in Denmark, Germany, and the Netherlands, focusing on migrants’ preferred level of governmental involvement and their satisfaction with public healthcare. We found that, compared to natives, migrants held the government less responsible for providing healthcare while expressing a higher level of satisfaction. Whereas health differences among migrants and natives did not explain this ethnic gap, we found that these ethnic gaps are moderated by socialization processes and knowledge of healthcare rights.


Antibiotics ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 1123
Author(s):  
Anita Kotwani ◽  
Jyoti Joshi ◽  
Anjana Sankhil Lamkang

India has one of the highest rates of antimicrobial resistance (AMR) worldwide. Despite being prescription drugs, antibiotics are commonly available over-the-counter (OTC) at retail pharmacies. We aimed to gain insight into the OTC sale of antibiotics at retail pharmacies and to elucidate its underlying drivers. We conducted face-to-face, in-depth interviews using convenience sampling with 22 pharmacists and 14 informal dispensers from 36 retail pharmacies across two Indian states (Haryana and Telangana). Thematic analysis revealed that antibiotics were often dispensed OTC for conditions e.g., fever, cough and cold, and acute diarrhea, which are typically viral and self-limiting. Both Access and Watch groups of antibiotics were dispensed for 1–2 days. Respondents had poor knowledge regarding AMR and shifted the blame for OTC practices for antibiotics onto the government, prescribers, informal providers, cross practice by alternative medicine practitioners, and consumer demand. Pharmacists suggested the main drivers for underlying OTC dispensing were commercial interests, poor access to public healthcare, economic and time constraints among consumers, lack of stringent regulations, and scanty inspections. Therefore, a comprehensive strategy which is well aligned with activities under the National Action Plan-AMR, including stewardship efforts targeting pharmacists and evidence-based targeted awareness campaigns for all stakeholders, is required to curb the inappropriate use of antibiotics.


2021 ◽  
Vol 124 ◽  
pp. 03006
Author(s):  
Abdul Mutalib Embong ◽  
Norzamziah Afzainizam ◽  
Mariati Norhashim ◽  
Amirsaman Ahmadi

Population ageing; where there is growth in the percentage of older persons in the population; is becoming a worldwide phenomenon due to better healthcare and lower birth rates. The phenomenon of population ageing brings with it both challenges and opportunities. The challenges of an ageing population include social, health and economic support of the elderly. Malaysia is recognizing the need to address this issue of financially supporting an ageing population. The purpose of the paper was to investigate the impact of business on the financial well-being (FWB) of the ageing, specifically the government retirees. A questionnaire-based survey was conducted among retirees who were in business throughout Malaysia that employed a cross sectional design. Forty-one respondents were successfully interviewed. Statistical procedures for the analyses included descriptive analysis and a profile analysis using scatterplot on the perceived business performance vs financial well-being. The survey revealed that the majority of the respondents operated business in the services, trade or retail industries which were set up and fully owned by themselves. Resource wise, the majority had very low financial capital, human capital and social capital. The study provides some empirical evidence that the retirees in business may be categorized into opportunity driven and necessity driven groups. The paper concludes that there is a need to find alternative income generation methods for the necessity driven group. Making paid work accessible to the elderly must be urgently put on the national agenda.


2020 ◽  
Vol 3 ◽  
Author(s):  
Syed A Jilani

The exit of nurses from the Irish healthcare system is a growing concern especially coupled with the ageing population of Ireland. The article explores the many reasons nurses are leaving the country: mainly the disrespect by management, unfair compensation and the shortage of staff leading to professionals being overworked and eventually experiencing burnout. For many professionals, it has become an issue of their own physical and mental well-being. There are a few recommendations discussed to solve the issue of nurses, which includes a strong push to change perspectives of management and a change of policy by the government. These include retraining healthcare management, an emphasis on hiring and retaining nurses by increasing incentives and making the workload easier to carry.


1978 ◽  
Vol 16 (17) ◽  
pp. 68.2-68

We rarely review books, but in this one Laurence and Black write clearly and authoritatively about the benefits and risks of using drugs; how new drugs are developed; the role of industry; the government control of medicines and the problems of prescribing and drug consumption. It also contains a glossary of technical terms used in the book, which is helpful for the lay reader.


2020 ◽  
Vol 8 (3) ◽  
pp. 11-20
Author(s):  
Lindawati Kartika

The SME Assist concept was formulated in August 2009 in line with the philosophy of university-industry engagement. Small Medium Enterprises (SMEs) are important economic driving force in many countries. Previous researches show that efforts taken by various parties and governments of different countries have helped improve and transform SMEs to be competitive in the fast changing global economy. In Indonesia specifically in Bogor regency, West Java, there are different models or approaches adopted and implemented by various parties. However, competitiveness of SME  remains an area of concern. For Handycrafts-based SME, in order to meet these expectations and fulfil their contributions to the development process, it is absolutely important that they have high productivity. It is essential that these industries provide productive and remunerative employment and, for their survival and growth, offer products and services at competitive quality and price. The Handycrafts-based SME has a potential to develop in Bogor Regency which is located in tourism area and divided into Villages (Cilember, Leuwimalang, Cisarua, Cibeireum, Kopo and Jogjogan) in Cisarua District.             Handycrafts is the dominant cluster that can generate earning sources and give role of economics which is very significant. Unfortunately, the existence of the Handycrafts-based SME is not as good as most people expected, because there are many constraints faced. In the mean time, the infrastructure and access information concerning capital, technology, management and marketing are limited. Therefore, it is essential to formulate strategy to develop handycrafts-based SME based on internal and external factors. The objectives of this research are to identify the characteristics of handycrafts-based SME in Bogor Regency to have actual conditions, and to analyze the SME’s internal-external environment and to select the alternative strategies for development .             The development strategies of handycrafts-based SME are proposed according to external and internal factors. These factors influence and determine the development dynamic and growth of handycrafts-based SME. The combination of strength and weaknesses together with external situation will determine the development posibility of SME. The score analysis method was used to analyze the internal external environment used for generating strategy using analytical Hierarchy Process (AHP) method. Hierarcy decisions was based on interpretation of secondary data concerning external and internal factors which influence the growth of SME and early discussion with experts from the SME entrepeneurs, academics, and local government. The prioritation of alternatives strategy was determined synchronization of literature and opinion of expert responder, then the result was processed with AHP. The results of this research show that the characteristics of handycrafts-based SME in Bogor Regency are: using traditional management, simple record-keeping administration, having local market and regional sale, utilize local or regional raw material, perform continous production system, having good quality awareness, using self or family capital resource, utilize simple equipments and technology and also having good innovation capability. According to the score assessment of AHP, the main strategy for the development of handycrafts-based SME in Bogor Regency is give more or better attention for policy formulation and based on socialpreneurship. This strategy means that the government policy should enhance or at least not constraining the development of handycrafts-based SME. The policy should also accommodate the necessity of all stakeholders related to handycrafts-based SME


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
Felipe G. Gercovich ◽  
Ernesto Gil Deza ◽  
Eduardo L. Morgenfeld ◽  
Marcelo Muino ◽  
Marvin Albert Mizrahi ◽  
...  

e14580 Background: It has been consistently proven that pivotal clinical trials (PCT) for drug registration or new drug indications (NDI), sponsored by the pharmaceutical industry, obtain better results than independent confirmatory studies (ICS). The interplay between PCT and ICS has supported better treatment selections and more realistic expectations: hope vs hype.The aim of this paper is to analyze the amount of ICS publications in Oncology within the last decade. Methods: All new FDA approved oncological drugs or NDI for solid tumors between 2005 and 2017 were taken into account. The PCT that led to their approval were identified, and between October and November 2019 a thorough search for related ICS (published or ongoing) was conducted on MEDLINE, ASCO Abstracts, NEJM, Lancet Oncology, JAMA, JCO, Cancer, PLOS ONE, PLOS Medicine and www.Clinicaltrials.gov. Results: Fifty-five new drugs or NDI were analyzed (Abemaciclib, Abiraterone, Ado-trastuzumab emtasine, Afatinib, Alectinib, Atezolizumab, Avelumab, Axitinib, Bendamustine, Bevacizumab, Brigatinib, Cabozantinib, Ceritinib, Cobimetinib, Crizotinib, Dabrafenib, Degarelix, Denosumab, Durvalumab, Eribuline mesylate, Everolimus, Ipilimumab, Irinotecan liposome, Ixabepilone, Lapatinib, Lenvatinib, Necitumumab, Neratinib, Nilotinib, Niraparib, Nivolumab, Olaparib, Osimertinib, Paclitaxel protein bound, Palbociclib, Panitumumab, Pazopanib, Pembrolizumab, Pertuzumab, Ramucirumab, Regorafenib, Ribociclib, Rucaparib, SipuleucelT, Sonidegib, Sorafenib, Sunitinib, Topotecan, Trabectedin, Trametinib, Trastuzumab, Vandetanib, Vemurafenib, Vismodegib, Ziv-afilbercept). Until November 30, 2019, no published or ongoing ICS were found in any of the cases. Conclusions: a) For the past decade, none of the PCT used for approval of new oncological drugs or NDI were replicated by ICS (without pharmaceutical industry sponsorship). b) We ignore the reasons for these approval methods but they raise suspicion and unnecessary discomfort. c) From an ethical point of view, patients’ Informed Consent must specify that expected results for the new drug or NDI are based exclusively on trials sponsored by the selling pharmaceutical company, unless other ICS are published. d) The current state of affairs can only be reverted if regulatory agencies and the scientific community demand ICS as part of the drug approval process or post-marketing duties.


Author(s):  
Lars Thorup Larsen

Danish health policy is dominated by a national health service that combines a tax-financed universal health insurance with healthcare delivery through public hospitals and primary care physicians operating in private practices. This basic structure has been stable for almost half a century and is likely to remain so due to a strong consensus among voters and the political parties about the public system. Underneath the wide consensus, however, there is a ‘submerged’ political conflict and party competition between the left and the right about the degree to which the public healthcare system should use private providers and marketized patient rights. In part because of party competition and strong patient rights, there has been a significant drive towards higher total health costs over the past two decades. The Danish healthcare system is thus hardly challenged from political contestation since few politicians would dare to propose a real alternative. Nonetheless, the healthcare system is challenged by structural factors similar to what other countries face, such as an ageing population, as well as difficulties in controlling costs related to both pharmaceuticals and a scarce supply of healthcare professionals.


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