scholarly journals Collaborative Use Repurposing Engine (CURE): FDA-NCATS/NIH Effort to Capture the Global Clinical Experience of Drug Repurposing to Facilitate Development of New Treatments for Neglected and Emerging Infectious Diseases

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S12-S12 ◽  
Author(s):  
Heather Stone ◽  
Leonard Sacks ◽  
Rosemary Tiernan ◽  
Mili Duggal ◽  
Timothy Sheils ◽  
...  

Abstract Background Repurposing approved products has proven a critical strategy to serve unmet medical needs. Historically, 40% of drugs approved for treatment of tropical diseases were repurposed, including albendazole for echinococcosis and neurocysticercosis, and azithromycin for trachoma. Advantages of repurposing include that approved drugs are well characterized, do not require expensive development programs needed for new drugs, and are frequently active against multiple diseases. Owing to the limited number of drugs approved to treat neglected tropical diseases (NTDs) and emerging or drug-resistant infections, healthcare practitioners use existing drugs in novel ways to treat patients with these conditions. This clinical experience, regardless of whether the outcomes are positive or negative, often is not reported or shared, and the knowledge is therefore lost. Methods FDA and NCATS/NIH have built a pilot program called Collaborative Use Repurposing Engine (CURE) to capture and centralize the global experience of new uses of approved medical products to treat emerging threats, NTDs, and multidrug-resistant organisms. CURE includes a website (https://cure.ncats.io/) and a mobile app (download “PROJECT CURE” at Google Play Store). CURE provides a simple case report form for health care providers to report their experiences, and a collection of cases that have already been reported (including successful and unsuccessful treatments) which they can browse. Healthcare providers who register can also participate in a Treatment Discussion Forum, allowing for engagement with fellow clinicians. CURE could be a global network connecting major treatment centers, academics, private practitioners, government facilities, and other clinicians serving as a means of rapid communication of treatment outcomes between providers treating patients with these conditions. Results See attached screen shots. Conclusion Although this evidence may be insufficient to establish the safety or effectiveness of a new use for an existing product, this clinical experience may provide signals and generate hypotheses for future clinical study. It may allow for rapid identification of promising treatment approaches in urgent situations such as during outbreaks of emerging infectious threats. Disclosures All authors: No reported disclosures.

2020 ◽  
Vol 32 (5) ◽  
pp. 276-284
Author(s):  
William J. Jefferson

The United States Supreme Court declared in 1976 that deliberate indifference to the serious medical needs of prisoners constitutes the unnecessary and wanton infliction of pain…proscribed by the Eighth Amendment. It matters not whether the indifference is manifested by prison doctors in their response to the prisoner’s needs or by prison guards intentionally denying or delaying access to medical care or intentionally interfering with treatment once prescribed—adequate prisoner medical care is required by the United States Constitution. My incarceration for four years at the Oakdale Satellite Prison Camp, a chronic health care level camp, gives me the perspective to challenge the generally promoted claim of the Bureau of Federal Prisons that it provides decent medical care by competent and caring medical practitioners to chronically unhealthy elderly prisoners. The same observation, to a slightly lesser extent, could be made with respect to deficiencies in the delivery of health care to prisoners of all ages, as it is all significantly deficient in access, competencies, courtesies and treatments extended by prison health care providers at every level of care, without regard to age. However, the frailer the prisoner, the more dangerous these health care deficiencies are to his health and, therefore, I believe, warrant separate attention. This paper uses first-hand experiences of elderly prisoners to dismantle the tale that prisoner healthcare meets constitutional standards.


Medicina ◽  
2007 ◽  
Vol 43 (6) ◽  
pp. 441 ◽  
Author(s):  
Donatas Stakišaitis ◽  
Indrė Špokienė ◽  
Jonas Juškevičius ◽  
Konstantinas Valuckas ◽  
Paola Baiardi

Currently in Europe, approximately 30 million people suffer from rare diseases, and a major problem is that many patients do not have access to quality healthcare for their disorders. Moreover, there is also a lack of quality information and a networking system aimed at supporting interaction among patients, clinicians, researchers, pharmaceutical industries, and governmental bodies. The purpose of this article is to inform physicians, public health care professionals, and other health care providers about EuOrphan service, the aim of which is to ensure easier access to quality information on rare diseases and their treatment. A set of web-based services is available at www.euorphan.com where information for target-users on treatments and products available worldwide for rare disease care as well as indications about healthcare centers are provided. Moreover, the service aims at providing consultancies for pharmaceutical companies to ultimately support the European legislation in bringing new drugs of a high ethical standard to the market and to exert a positive impact on the large population of patients suffering from rare diseases in Europe. The services provided by EuOrphan can facilitate concrete networking among patients, patient associations, doctors, and companies and also support the organization of clinical trials. In this perspective, EuOrphan could become a very valuable tool for globalizing the information about the availability of treatment (authorized or under development) of orphan patients.


2020 ◽  
Author(s):  
Chunying Shen ◽  
Bin Jiang ◽  
Qilian Yang ◽  
Chengnan Wang ◽  
Kevin Z Lu ◽  
...  

BACKGROUND As a computerized drug–drug interaction (DDI) alert system has not been widely implemented in China, health care providers are relying on mobile health (mHealth) apps as references for checking drug information, including DDIs. OBJECTIVE The main objective of this study was to evaluate the quality and content of mHealth apps supporting DDI checking in Chinese app stores. METHODS A systematic review was carried out in November 2020 to identify mHealth apps providing DDI checking in both Chinese iOS and Android platforms. We extracted the apps’ general information (including the developer, operating system, costs, release date, size, number of downloads, and average rating), scientific or clinical basis, and accountability, based on a multidimensional framework for evaluation of apps. The quality of mHealth apps was evaluated by using the Mobile App Rating Scale (MARS). Descriptive statistics, including numbers and percentages, were calculated to describe the characteristics of the apps. For each app selected for evaluation, the section-specific MARS scores were calculated by taking the arithmetic mean, while the overall MARS score was described as the arithmetic mean of the section scores. In addition, the Cohen kappa (κ) statistic was used to evaluate the interrater agreement. RESULTS A total of 7 apps met the selection criteria, and only 3 included citations. The average rating score for Android apps was 3.5, with a minimum of 1.0 and a maximum of 4.9, while the average rating score for iOS apps was 4.7, with a minimum of 4.2 and a maximum of 4.9. The mean MARS score was 3.69 out of 5 (95% CI 3.34-4.04), with the lowest score of 1.96 for Medication Guidelines and the highest score of 4.27 for MCDEX mobile. The greatest variation was observed in the information section, which ranged from 1.41 to 4.60. The functionality section showed the highest mean score of 4.05 (95% CI 3.71-4.40), whereas the engagement section resulted in the lowest average score of 3.16 (95% CI 2.81-3.51). For the information quality section, which was the focus of this analysis, the average score was 3.42, with the MCDEX mobile app having the highest score of 4.6 and the Medication Guidelines app having the lowest score of 1.9. For the overall MARS score, the Cohen interrater κ was 0.354 (95% CI 0.236-0.473), the Fleiss κ was 0.353 (95% CI, 0.234-0.472), and the Krippendorff α was 0.356 (95% CI 0.237-0.475). CONCLUSIONS This study systematically reviewed the mHealth apps in China with a DDI check feature. The majority of investigated apps demonstrated high quality with accurate and comprehensive information on DDIs. However, a few of the apps that had a massive number of downloads in the Chinese market provided incorrect information. Given these apps might be used by health care providers for checking potential DDIs, this creates a substantial threat to patient safety.


Author(s):  
Syamprashanth Pedada ◽  
Jyotsna Allamsetty ◽  
Meena Ujwala Garikapati ◽  
Navya Burreddy ◽  
Umasankar Viriti

Present work was done to evaluate the occurrence of medication errors in general ward of institute of medical sciences to assess the role of clinical pharmacist in error management. The study was conducted for 9 months and Data was acquired from inpatients of general medicine dept by using standard case report form through direct patient interview. The collected data was to identify medication errors by using drug information tools such as , drug interaction checker and reputed journals and statistical interpretations were done. 400 prescriptions were and in that 300 prescriptions were presented with medication errors. 202 were found to be Prescribing errors, 111 Administration errors,45 were dispensing errors, Monitoring errors were 123. Interaction errors (81.18%), prescription in small letters (34.65%), wrong frequency of administration error (32.43%) and wrong time administration of medicine (85.58%), Dispensing wrong quantity of drug (95.5%) were the major medication errors that were observed. Medication errors have been occurring frequently in the general medicine department out of which prescribing errors were more common. Clinical Pharmacist could act as an medical staff by performing consciousness and teaching to medical professionals and by maintaining positive collaboration with other health care providers for patients.


Author(s):  
Jan Hajek

This chapter on neglected tropical diseases (NTDs) provides an overview of the background and main contextual features of NTDs, and includes clear guidance on their clinical recognition and management. Recognizing the prevalence of NTDs in humanitarian settings, with their disproportional effect on the poor, this chapter covers the fundamentals of management of NTDs, and is especially helpful for the provider who may have little prior clinical experience with such conditions. It also includes detailed guidance on recognition and diagnosis of the main NTDs, such as dengue, human African trypanosomiasis, leishmaniasis, leprosy, and schistosomiasis, in settings with very limited diagnostic testing available.


2019 ◽  
Vol 4 (1) ◽  
pp. 53 ◽  
Author(s):  
Cathyryne Manner ◽  
Katy Graef ◽  
Jennifer Dent

Tropical diseases, including malaria and a group of infections termed neglected tropical diseases (NTDs), pose enormous threats to human health and wellbeing globally. In concert with efforts to broaden access to current treatments, it is also critical to expand research and development (R&D) of new drugs that address therapeutic gaps and concerns associated with existing medications, including emergence of resistance. Limited commercial incentives, particularly compared to products for diseases prevalent in high-income countries, have hindered many pharmaceutical companies from contributing their immense product development know-how and resources to tropical disease R&D. In this article we present WIPO Re:Search, an international initiative co-led by BIO Ventures for Global Health (BVGH) and the World Intellectual Property Organization (WIPO), as an innovative and impactful public-private partnership model that promotes cross-sector intellectual property sharing and R&D to accelerate tropical disease drug discovery and development. Importantly, WIPO Re:Search also drives progress toward the United Nations Sustainable Development Goals (SDGs). Through case studies, we illustrate how WIPO Re:Search empowers high-quality tropical disease drug discovery researchers from academic/non-profit organizations and small companies (including scientists in low- and middle-income countries) to leapfrog their R&D programs by accessing pharmaceutical industry resources that may not otherwise be available to them.


2017 ◽  
pp. 1-7 ◽  
Author(s):  
Callie M. Berkowitz ◽  
Leah L. Zullig ◽  
Bridget F. Koontz ◽  
Sophia K. Smith

Introduction Although there are over 500 mobile health (mHealth) applications (apps) available for download in the field of oncology, little research has addressed their acceptability among health care providers. In addition, the providers’ perspectives regarding patient app use has been largely unexamined. We conducted a qualitative study to explore opportunities and barriers for mHealth app use for oncology care. Methods We developed a structured interview guide focusing on acceptability, appropriateness, feasibility, and sustainability of the use of apps in cancer care. We interviewed 15 oncology providers about their attitudes and preferences. De-identified audio recordings were transcribed and coded for emerging themes. Results Providers interviewed included physicians (n = 8) and advanced practice (n = 3) and supportive services (n = 4) providers who care for a wide range of cancer types; ages ranged from 32 to 68 years. Interviews lasted approximately 30 minutes. Oncology providers reported limited exposure to mHealth apps in patient care, but were generally open to recommending or prescribing apps in the future. Key themes included opportunities for mobile app use (including general health promotion, tracking symptoms, and engaging patients) and barriers to implementation (including access to technology, responsibility, workflow, and the source of the app itself). Conclusion Our results show openness among oncology providers to using mHealth technology as part of patient care, but concerns regarding implementation. Designing acceptable apps may be challenging and require involvement of key stakeholders, partnering with trustworthy institutions, and outcome-based research.


2009 ◽  
Vol 51 (5) ◽  
pp. 247-253 ◽  
Author(s):  
José Angelo L. Lindoso ◽  
Ana Angélica B.P. Lindoso

Poverty is intrinsically related to the incidence of Neglected Tropical Diseases (NTDs). The main countries that have the lowest human development indices (HDI) and the highest burdens of NTDs are located in tropical and subtropical regions of the world. Among these countries is Brazil, which is ranked 70th in HDI. Nine out of the ten NTDs established by the World Health Organization (WHO) are present in Brazil. Leishmaniasis, tuberculosis, dengue fever and leprosy are present over almost the entire Brazilian territory. More than 90% of malaria cases occur in the Northern region of the country, and lymphatic filariasis and onchocerciasis occur in outbreaks in a particular region. The North and Northeast regions of Brazil have the lowest HDIs and the highest rates of NTDs. These diseases are considered neglected because there is not important investment in projects for the development of new drugs and vaccines and existing programs to control these diseases are not sufficient. Another problem related to NTDs is co-infection with HIV, which favors the occurrence of severe clinical manifestations and therapeutic failure. In this article, we describe the status of the main NTDs currently occurring in Brazil and relate them to the HDI and poverty.


Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1058
Author(s):  
Laura Reinman ◽  
Helen L. Coons ◽  
Jenna Sopfe ◽  
Robert Casey

Adolescent and young adult (AYA) survivors of cancer have diverse psychosocial and medical needs, including those related to fertility and sexual health. Much of the focus of care around issues such as fertility and sexual health tends to be filtered through a biomedical lens. However, it is essential that health care providers assess and support AYA survivors using a biopsychosocial and contextual framework to ensure the most comprehensive and accurate understanding of AYA survivor needs, especially those related to psychosexual health. A trusting relationship between the multi-disciplinary medical team and the AYA survivor that allows for open discussion about the physical and psychosocial components of sexual health is key to providing best care and outcomes.


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