scholarly journals Delays in access to affordable medicines: putting policy into perspective

2012 ◽  
Vol 36 (4) ◽  
pp. 412 ◽  
Author(s):  
Alison Pearce ◽  
Kees van Gool ◽  
Philip Haywood ◽  
Marion Haas
Keyword(s):  
Health Care ◽  
Drug Evaluation ◽  
New Drugs ◽  
Approval Process ◽  
Health Care Managers ◽  
Policy Makers ◽  
New Chemical Entities ◽  
New Treatments ◽  
Pharmaceutical Benefits Scheme

Background. To save costs, the Australian Government recently deferred approval of seven new medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for up to 7 months. Objectives. The aim of this research is to examine the timelines of PBAC applications following approval by the Therapeutic Goods Administration (TGA), allowing the recent Cabinet delays to be considered in the context of the overall medicines approval process. Methods. All new chemical entities and products for new indications approved in 2004 by the Australian Drug Evaluation Committee (ADEC) were identified. Outcomes of PBAC meetings from 2004 to 2010 were then searched to identify if and when these products were reviewed by PBAC. Results. ADEC recommended 63 eligible products for registration in 2004. Of the 113 submissions made to PBAC for these products, 66 were successful. Only 43% of the products were submitted to PBAC within 2 years, with an average 17-month delay from TGA approval of a product to consideration by the PBAC. Conclusions. Cabinet decisions to defer listing of new medicines delays access to new treatments. This occurred in addition to other longer delays, earlier in the approval process for medicines, resulting in a significant impact on the overall timeliness of listing. What is known about the topic? There is evidence that the time from registration of new drugs on the TGA to their listing for subsidised availability is increasing. The government’s recent decision to delay the listing of seven new drugs for subsidisation raised concerns about the potential for additional delays to impact the accessibility of new, affordable medicines for patients. What does this paper add? This paper examines delays at various stages in the process of approval for pharmaceutical subsidies on the Pharmaceutical Benefits Scheme (PBS), putting the deferral of new medicine listings in the overall context of the approval process. It identifies the potential role of pharmaceutical companies and product sponsors in delaying access to new, affordable medicines early in the approval process. What are the implications for practitioners? Delays in the subsidisation of medicines, wherever they occur in the process, not only reduce patient access, but may also lead to pressure in other areas of the health care system to finance such medicines. This makes these results of particular interest to clinician managers, health care managers and policy makers.

Towards systematic reviews that inform health care management and policy-making

2005 ◽  
Vol 10 (1_suppl) ◽  
pp. 35-48 ◽  
Author(s):  
John Lavis ◽  
Huw Davies ◽  
Andy Oxman ◽  
Jean-Louis Denis ◽  
Karen Golden-Biddle ◽  
...  
Keyword(s):  
Health Care ◽  
Systematic Reviews ◽  
Policy Making ◽  
Care Management ◽  
Contextual Factors ◽  
Health Care Management ◽  
Health Care Managers ◽  
Executive Summary ◽  
Policy Makers ◽  
Care Managers

Objectives To identify ways to improve the usefulness of systematic reviews for health care managers and policy-makers that could then be evaluated prospectively. Methods We systematically reviewed studies of decision-making by health care managers and policy-makers, conducted interviews with a purposive sample of them in Canada and the United Kingdom (n=29), and reviewed the websites of research funders, producers/purveyors of research, and journals that include them among their target audiences (n=45). Results Our systematic review identified that factors such as interactions between researchers and health care policy-makers and timing/timeliness appear to increase the prospects for research use among policy-makers. Our interviews with health care managers and policy-makers suggest that they would benefit from having information that is relevant for decisions highlighted for them (e.g. contextual factors that affect a review's local applicability and information about the benefits, harms/risks and costs of interventions) and having reviews presented in a way that allows for rapid scanning for relevance and then graded entry (such as one page of take-home messages, a three-page executive summary and a 25-page report). Managers and policy-makers have mixed views about the helpfulness of recommendations. Our analysis of websites found that contextual factors were rarely highlighted, recommendations were often provided and graded entry formats were rarely used. Conclusions Researchers could help to ensure that the future flow of systematic reviews will better inform health care management and policy-making by involving health care managers and policy-makers in their production and better highlighting information that is relevant for decisions. Research funders could help to ensure that the global stock of systematic reviews will better inform health care management and policy-making by supporting and evaluating local adaptation processes such as developing and making available online more user-friendly ‘front ends’ for potentially relevant systematic reviews.

Positioning Nurses in Primary Health Care in Bhutan

2018 ◽  
Vol 4 (1) ◽  
pp. 33-41
Author(s):  
Diki Wangmo ◽  
Carol Windosr ◽  
Michele Clark
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Nursing Education ◽  
Central Place ◽  
Policy Makers ◽  
Primary Health ◽  
Auxiliary Nurse ◽  
Nurses Role ◽  
The 1960S

Introduction: Nursing in Bhutan had its beginning in the early 1960s, approximately 20 years prior to the Alma Ata Conference. From basic nursing care and housekeeping roles, Bhutanese nurses have now occupied central place in nursing service, administration and management and education. Nursing education has progressed from certificate level in the 1960s to bachelor, master and PhD levels in 2014. Although nurses have been closely associated with Primary Health Care development in Bhutan, apart from the role of the Auxiliary Nurse Midwives, nurses have rarely been explicitly associated with this area of practice. Therefore, the objective of this study was to find out the role of Bhutanese Nurses in PHC. Methods: qualitative case study method was used to carry out focus group and in-depth interviews with 66 respondents that included policy makers, planners, educators, regulators and implementers. Data were analyzed through manifest and latent content analysis. Results: The centrality of the nursing role in the area of PHC has not been realized. Discharge of the PHC role was identified more in terms of the place of work and by title or designation of the nurses. Primary Health Care momentum appeared to have slowed down and nurses differed in their understanding of PHC concept. Conclusion: Although Nursing in Bhutan has made much progress, the uneven development of the nurses’ role in PHC in Bhutan and globally suggests a need to identify and implement strategies such as standardizing, role profiling, curricula review and leadership improvement to ensure progress in this area.

scholarly journals Analyzing U.S. nurse turnover: Are nurses leaving their jobs or the profession itself?

2015 ◽  
Vol 4 (4) ◽  
pp. 48 ◽  
Author(s):  
Olena Mazurenko ◽  
Gouri Gupte ◽  
Guogen Shan
Keyword(s):  
Health Care ◽  
Registered Nurses ◽  
Quality Care ◽  
The United States ◽  
National Sample ◽  
Sample Survey ◽  
P Value ◽  
Health Care Managers ◽  
Policy Makers ◽  
Care Managers

Objective: To examine and compare factors associated with making the decision to vacate a job (organizational turnover) versus leaving the profession (professional turnover) among registered nurses (RN) in the United States (U.S.).Methods: Nationally representative data from the 2008 National Sample Survey of Registered Nurses was used. The sample consisted of 8,796 RNs who held an active RN license as of March 10, 2008, but changed a place of work or left the profession entirely. The analysis has been performed using SAS, version 9.3.Results: The results of binary logistic regression revealed that RNs who reported work-related disability (OR = 14.51; p-value: < .001), illness (OR = 3.32; p-value: < .001), experienced high physical demands (OR = 1.57; p-value: < .001) or burnout (OR = 1.39; p-value: < .001), were unsatisfied with their schedule (OR = 2.16; p-value: < .001), or staffing arrangements (OR = 1.41; p-value: < .001) were more likely to leave the profession. Whereas RNs who reported high levels of stress (OR = 0.59; p-value: < .001) were unsatisfied with the organization’s leadership (OR = 0.22; p-value: < .001), unsatisfied with their opportunity to advance their career (OR = 0.56; p-value: < .001), or were not adequately compensated (OR = 0.63; p-value: < .001), were more likely to leave the organization.Conclusions: Policy makers and health care managers should be aware of the different factors that are associated with RNs’ decision to leave the profession or an organization. Health care managers involved in the development of nurse retention strategies should address organizational leadership and consider development of comprehensive career development programs. Policy makers should consider allocating additional resources to ensure that RN workforce is of adequate size, is qualified, and is able to provide high quality care in the U.S..

scholarly journals Enhancing the uptake of systematic reviews of effects: what is the best format for health care managers and policy-makers? A mixed-methods study

2018 ◽  
Vol 13 (1) ◽  
Author(s):  
Christine Marquez ◽  
Alekhya Mascarenhas Johnson ◽  
Sabrina Jassemi ◽  
Jamie Park ◽  
Julia E. Moore ◽  
...  
Keyword(s):  
Health Care ◽  
Mixed Methods ◽  
Systematic Reviews ◽  
Mixed Methods Study ◽  
Health Care Managers ◽  
Policy Makers ◽  
Care Managers

scholarly journals Pharmacy Patronage: Identifying the Roles of Nepalese Pharmacists in Tacking COVID-19

2020 ◽  
Vol 14 (suppl 1) ◽  
pp. 937-943 ◽  
Author(s):  
Asmita Priyadarshini Khatiwada ◽  
Sunil Shrestha
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Pharmaceutical Care ◽  
Health Care System ◽  
Health Care Professionals ◽  
Drug Evaluation ◽  
Pharmacy Services ◽  
The Public ◽  
New Information

Coronavirus disease (COVID-19) pandemic is one of the dire issues currently worldwide. With increasing death tolls every day and with new information regarding disease every minute, it is very important to disseminate the updated and reliable information to the public. Along with other health care professionals, the pharmacists’ role is crucial in preventing the spread and management of the disease. The involvement of pharmacists from clinical trials, drug evaluation to providing pharmaceutical care and other basic pharmacy services in the frontline in this health emergency is undeniable. This commentary focuses on the role of pharmacists in different settings of the health care system and the degree of recognition of the work in Nepal.

scholarly journals New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels

2020 ◽  
Author(s):  
Katrine Schultz-Knudsen ◽  
Ugne Sabaliauskaite ◽  
Johan Hellsten ◽  
Anders Blaedel Lassen ◽  
Anne Vinther Morant
Keyword(s):  
Drug Development ◽  
Patient Experience ◽  
Drug Evaluation ◽  
Patient Empowerment ◽  
Drug Approval ◽  
New Drugs ◽  
Systematic Analysis ◽  
Regulatory Decision ◽  
Patient Reported

Abstract Background The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the presence and role of PED in drug approval and translation into product label claims. Methods PED reported in approval packages of the 48 drugs approved by FDA’s Center for Drug Evaluation and Research in 2019 was identified and categorized. PED in the form of clinical outcome assessments (COAs) was characterized by endpoint positioning and outcome. The product labels were analyzed for PED-related claims. Results PED was reported as relevant for 39 of 48 (81.3%) drugs approved in 2019. COAs were the predominant PED type; other PED was identified for only 9 (18.8%) drugs, and none included qualitative or patient preference studies. COAs were the only type of PED for which associated claims were identified in the product labels. 27 out of 48 (56.3%) labels contained one or more efficacy claims based on COAs; of these, patient-reported outcomes were the most prevalent with claims identified in 19 labels (39.6%). Conclusion There are ample opportunities for incorporating PED beyond COAs to inform drug development and facilitate availability of medicines tailored to patient needs. A higher level of transparency on the role of PED in regulatory decision-making and a clear path to PED-based label claims could incentivize sponsors and enable patient empowerment in treatment decisions.

Mobilising Social Capital in Healthcare Industry of Pakistan

2020 ◽  
Vol 4 (2) ◽  
pp. 101-118
Author(s):  
Mahreen Hussain ◽  
Mahwish Zeeshan ◽  
Abid Ghafoor Chaudhry
Keyword(s):  
Health Care ◽  
Social Capital ◽  
Social Identity ◽  
Target Population ◽  
Health Care Facilities ◽  
Public Health Care ◽  
Validity And Reliability ◽  
Policy Makers ◽  
The Social

This study intended to learn the mobilization of social capital for the access to better health care facilities emphasizing the role of religiosity culture and social identity. Social capital was limited to religiosity culture and the social identity using the bonding and bridging concepts for this study. The three variables gauged in the study were social capital, religiosity culture and social identity which are barely used for the health care industry. The target population was public health care practitioners of the Federal Capital with sample size of 215 doctors and nurses over a period of six months. The data was quantitative and analyzed through co-relational tests. Questionnaire was developed for the study using the validity and reliability statistics. However, the results from the study reflected the significant impact of religiosity culture and social identity. Thus, it was concluded that positive and negative externalities affect the social identity in the creation of social capital. The findings of this study can provide a framework for future reference and to the policy makers in enhancing the social responsibility through mobilization of social capital of healthcare professionals in the industry.

Recognizing the Role of Chaplaincy in Healthcare: Perspectives on the COVID-19 Pandemic

2021 ◽  
pp. 154230502110649
Author(s):  
Olamma C. Otisi
Keyword(s):  
Health Care ◽  
Side Effects ◽  
Health Care Delivery ◽  
Spiritual Care ◽  
Care Delivery ◽  
Healthcare Systems ◽  
Policy Makers

The COVID-19 pandemic has been a difficult and trying time, but as most situations in life, it brought both good and bad side effects. Concerning chaplaincy, COVID-19 reveals that we have not arrived yet in the effort to incorporate spiritual care into essential health care delivery. Although chaplaincy is beginning to have a voice, we have been mostly speaking to ourselves. We need an advocacy voice that healthcare systems and policy makers can hear.

A Role of Clinical Trial in Management of Hypertension and Medication of Hypertension

2021 ◽  
pp. 3215-3222
Author(s):  
Minesh Patel ◽  
G.S. Chakraborthy
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Left Ventricle ◽  
New Drugs ◽  
Research Review ◽  
Incremental Growth ◽  
Indian Food ◽  
New Treatments

Clinical trials are essence for the progress of new treatments. Whether a person should engage confide in on their compassionate of the liability and gain for themselves and for society as an entity. Clinical trials are research review in which people volunteer to attempt major treatments, interventions or experiment as a means to forbid, detect, evaluate or manage assorted diseases or medical conditions. Some investigations glance at how people react to a new arbitration and what side effects valor occur. Every new medicine and treatment initiated with volunteers engage in clinical trials. We incur our present high ideal of medical care to studies that have been operate in the past under guidance of the INDIAN Food and Drug Administration (FDA). In addition to Research on new drugs and devices, clinical trials bring a scientific footing for urge and treating patients. Even when researchers do not achieve the conclusion they anticipate; trial results can help point scientists in the mend direction. Blood pressure is great because the larger than your blood pressure is, the larger than your risk of health problems in the future. If your blood pressure is higher than it is putting extra ache on your arteries and on your heart. High blood pressure clouts your heart to work higher to pump blood to the comfort of your body. This causes part of your heart (left ventricle) to congeal. A congeal left ventricle high your risk of heart attack, heart failure and sudden cardiac death. Heart failure. The arena for clinical trials of hypertension management is in transition. The stage of mega trials may not be bygone but is assuredly in decline. Incremental growth in the therapies assessable in the face of a high global disease hardship has imply that hypertension researchers have also attract on getting beat efficacy and value from the available treatments through arrangement improvement, combinations, and algorithms. There has been go on amuse in the role of nonpharmacological compute in cure and management of hypertension.

scholarly journals Approaches for implementation and updation of community health needs assessment: an updated review

2018 ◽  
Vol 6 (1) ◽  
pp. 440
Author(s):  
Kalidas D. Chavan ◽  
Purushottam A. Giri ◽  
Savita Rajurkar ◽  
Satish D. Pawar
Keyword(s):  
Health Care ◽  
Needs Assessment ◽  
Community Health ◽  
Health Assessment ◽  
Health Needs ◽  
Community Members ◽  
Health Needs Assessment ◽  
Policy Makers ◽  
Community Health Needs Assessment

Implementation of assessment is utmost significant to enhance the prospects and strengths of Community Health Needs. Addressing community health needs has been a challenge for the Governments of various nations in the world due to various reasons like rising number of recipients, insufficient resources, increase in demands of resources and discrimination in their supply. The role of community health assessment is central in enabling practitioners, managers and policy makers to identify, categorize and prioritize demands, update the policies and then, to ensure that these health care resources are supplied to optimize health care and maximize its outreach to community members. It has a great potential to be a vital tool which can empower the management and planning of health care across the countries at the level of nationwide, state-wide and district wide communities, populations and families. The objective of this review article is to present the systematic and updated approaches to implement community health needs assessment at multiple levels i.e. district, state and national, keeping those aligned with the approaches indicated within global policies. It’s measurable outcomes are to identify and list the priority health needs, target resources to address inequalities, involve local people, educate and train the stakeholders and provide evidence based updated data for amending existing policies. The process of undertaking community health needs assessment and the importance of contribution of health care personnel in this process is also included here. 

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