National Coordinating Center Research Articles

Completeness and Quality of ADR reports published in Leading Biomedical Journals

To study the completeness of ADR reports published in leading Indian biomedical, pharmacological or medical journals.The quality and completeness of published ADR reports in leading Bio Medical Journals can prove very vital in the effective implementation of drug safety programmes in the form of PvPI in the country. It will further, go long ways to assure the quality assurance of PvPI not only at National Coordination Centre but also at the respective AMC level.

Delivering Telegenetics Services: Review and Synthesis of Best Practices.

Introduction: Before the COVID-19 public health emergency, few genetics providers used telehealth. As a response to this, many genetics providers began conducting telehealth care, referred to as telegenetics, usually with guidance from their institutions but without specific guidance related to the uniqueness of genetic services. Objectives: The Telegenetics Workgroup of the National Coordinating Center for Regional Genetics Networks convened a panel of experts in the fields of telemedicine, genetics, and genomics to review the existing literature on telegenetics and synthesize best operating practices for medical geneticists, genetic counselors, and metabolic dietitians providing telegenetics services. Methods: The group searched PubMed using the terms "telegenetics," "telemedicine + genetics," and "telehealth + genetics." The group also reviewed the Northeast Telehealth Resource Center's telegenetics webliography. Websites were searched, including the American Telemedicine Association's website, Center for Connected Health Policy, and National Telehealth Resource Center for position statements, standards documents, and guidelines. The group met frequently by videoconference and discussed the literature, and using expert consensus, the group determined best practices in providing telegenetics services. Results: These telegenetics best practices cover important aspects of telegenetics services, including, but not limited to, ongoing delivery of telegenetics services, use of special technology, legal and regulatory requirements, and considerations regarding special settings and circumstances in which telegenetics may be conducted. Conclusions: Recognizing the growing use of telegenetics and a future in which telegenetics continues to be part of the regular practice of genetics, this guide informs genetics providers of best practices for delivering telegenetics services to patients.

Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

With the establishment of 12 regional centers, India implemented a comprehensive system for monitoring drug reactions in 1986. In 1997, India became a member of the Uppsala Monitoring Centre in Sweden, which oversees the World Health Organization's Programme for International Drug Surveillance. Beginning at the outset, six regional centers were created in Chandigarh, New Delhi, Mumbai, Kolkata, Lucknow, and Pondicherry. ADR is being watched throughout the nation. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. We currently have 179 adverse drug reactions under observation. At the moment, the National Coordination Centre receives adverse event reports from centers in India.Reporting Form; Phocomelia; Vigiflow; UMC; Death; Thalidomide

Legal aspects of the cybertechnology development and the cyberweapon use in the state defence sphere: Global and Ukrainian experience

The research relevance is determined by the development of the digital sphere, which entails an increase in the number of cybercrimes and cyberattacks that pose a threat to the security of people and organisations and can lead to serious consequences. The study aims to examine how cyber technologies are formed and developed, as well as how they are used in the field of state defence in Ukraine and some European Union countries, namely Germany, France, the United Kingdom, and Indonesia. In the course of the study, were used structural-functional and dialectical methods, the method of synthesis, logical and comparative analysis, and the method of generalisation. It is established that cybertechnologies are gaining more and more development both in the world and in Ukraine, and cyberweapons, due to their effectiveness and negative consequences, are equated with methods of mass destruction. That is why the issue of cyber defence is one of the main challenges of our time. Ukraine needs to adopt international experience to successfully formulate policies and create its own legal and organisational framework for cybersecurity. Using the experience of other countries, Ukrainian experts will be able to improve their technologies and strategies, strengthen defences in the information space, and develop new advanced defence systems. The importance of the National Coordination Centre for Cybersecurity should be emphasised. The body’s work is focused on ensuring coordination of the activities of the national security and defence entities of Ukraine in the implementation of the cybersecurity strategy in the country and on improving the efficiency of the public administration system in the formation and implementation of the state policy in the field of cybersecurity. The study is practically important, since all the theoretical provisions, conclusions and recommendations can be used by legislators and other specialists to improve the system of legal guarantees of cybersecurity in the field of defence of the State

Study on Shielding Effectiveness of High Transmittance Coating Film Glasses against Electromagnetic Pulse

This study investigated the shielding effectiveness (SE) of glass materials with conductive coatings by establishing a 3000 × 3000 × 3000 mm electromagnetic pulse (EMP)—shielded room according to the EMP shielding requirements in the US military standard MIL-STD-188-125-1. The EMP SE of conductive-coated glass samples was measured and verified with the broadband EMP conditions of 10 kHz∼1 GHz. The conductive thin film coating on the glass was made by mixing conductive materials, including In2O3, SnO2, Ta2O5, NbO, SiO2, TiO2, and Al2O3, at different ratios. The mixed solutions were then coated onto the glass targets to facilitate conductive continuity between the conductive oxides and the shielding metal structure. The glass samples had dimensions of 1000 × 600 mm, which had electrolytic conductivity σ = 4.0064 × 103∼4.7438 × 103 (S/cm), 74∼77% transmittance, and 6.4∼6.8 Ω/□ film resistance. The experimental results indicated that the glass had SE of 35∼40 dB under 1 GHz EMP, satisfying the US National Coordinating Center for Communications’ Level 3 shielding protection requirement of at least 30 dB. The glass attenuated energy density by more than 1000 times, which is equivalent to shielding over 97% of EMP energy. Accordingly, the glass materials can be used as high-transmittance conductive glass for windows of automobiles, vessels, and aircrafts to protect from EMPs.

National Center for Interprofessional Practice and Education 2023: reflecting back, looking forward

ABSTRACT The United States (US) National Center for Interprofessional Practice and Education was funded at the University of Minnesota to serve as the National Coordinating Center for Interprofessional Education and Collaborative Practice (IPECP) in the US In 2012, the funders had specific expectations for operationalizing their vision that included scholarship, programs and leadership as an unbiased, neutral convener to align education with health system redesign. While US specific, the National Center benefited from and contributed to the international maturity of the field over the past decade. Through its various services and technology platforms, the National Center has a wide reach nationally and internationally. This perspective provides a unique view of the field in the US with observations and implications for the future.

Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals

Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.

Drug Safety Alerts Issued by the National Coordination Centre for Pharmacovigilance Programme of India

Background: Adverse drug reactions (ADRs) due to drug therapy are inevitable and prior knowledge of their causative agents can avoid unnecessary economic burden on patients as well as on the health-care system. Objectives: To create awareness among health-care professionals about the drug safety alerts (DSAs) issued by the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI) till December 2022 and to reiterate the importance of spontaneous reporting of adverse events for better patient care. Methodology: A retrospective analysis of 141 DSAs issued from March 2016 to December 2022 was done. The ADRs were analyzed for the type of reactions, system organ class, and according to drug class. Microsoft Office 2007 was used to formulate the data and presented it in a descriptive manner using numbers and percentages. Results: Out of 141 DSAs under analysis, 101 individual drugs, 2 drug classes, and 7 drug combinations have developed 144 ADRs. These ADRs were compressed into 86 different types as similar ADRs were caused by more than one drug. Drug Reaction with Eosinophilia and Systemic Symptoms is the most common ADR noticed, followed by skin manifestations such as toxic epidermal necrolysis, acute generalized exanthematous pustulosis, skin hyperpigmentation, fixed drug eruption, symmetrical drug-related intertriginous and flexural exanthema, and photosensitivity reaction. The most common causative drugs for ADRs were antimicrobial agents, cephalosporins being the most commonly implicated medication class. Conclusions: Most of the ADRs advised to closely monitor by the NCC-PvPI through DSAs were treatable by early and appropriate management. Due to the high number of skin manifestations observed in the analysis, the role of dermatologists in taking detailed drug history is critical when making a differential diagnosis of skin lesions. Motivation and creating awareness among health-care professionals and patients to spontaneously report adverse events can only strengthen the pharmacovigilance system in India.

SITUATION CENTER OF THE MINISTRY OF DEFENSE OF UKRAINE – A MODEL OF EARLY DETECTION AND ANALYSIS OF CRISIS SITUATIONS IN THE STATE SECURITY SECTOR

The article examines the issue of creating and ensuring the functioning of the situation center in the system of the Ministry of Defense of Ukraine. The necessity of creating a specialized organizational structure, one of the main tasks of which is to respond to military cyber threats directly under the general coordination of the National Coordination Center for Cyber Security in cooperation with other actors in the field of cyber security. The ways of creation and functioning of the situation center are analyzed, the list of threats to which the separate structure (or its separate elements) and joint performance of the tasks defined by the provisions with the Situational Center of the Armed Forces of Ukraine during the Armed Forces respond to the crisis situations in the cyberspace of Ukraine. In the context of constant militarization of cyberspace of the national segment, the National Security and Defense Council of Ukraine decided to expand and further develop a single network of situation centers and equip them with unified software and hardware that will increase decision-making efficiency at all levels of government. The reason for this growth is precisely the crisis phenomena, which become long-lasting, and management processes are transformed from “crisis prevention” to, mainly, “crisis management”. Under these conditions, there is a significant problem with the interaction of the network of situational centers not only in the field of national security and defense, but also situational centers of public authorities (reserve, mobile) on one platform in real time. In this situation, in order to achieve interoperability, it is extremely important to systematize uniformity in the use of special software and software and hardware to ensure interoperability, stable and continuous operation, testing, configuration and performance monitoring in decision making and monitoring. It is obvious that the State Service for Special Communications and Information Protection of Ukraine will play one of the key roles in the process of expanding and increasing the capacity of the network of situational centers. It is becoming clear that such centers should be integrated into a single secure network, with the ability to quickly collect information, analyze it and make critical decisions for the state.

Addressing the human costs and consequences of the Pakistan flood disaster

Addressing the human costs and consequences of the Pakistan flood disaster

Regional Public Health Training Centers: An Essential Partner in Workforce Development.

Regional Public Health Training Centers: An Essential Partner in Workforce Development.

National Coordinating Center for the George M. O'Brien Kidney National Resource Centers (NIDDK)

National Coordinating Center for the George M. O'Brien Kidney National Resource Centers (NIDDK)

Proposal for Life Course Intervention Researcher Core Competencies.

Proposal for Life Course Intervention Researcher Core Competencies.

Historical Background of Pediatric Kidney and Liver Transplantation in Turkey

The cornerstone events of kidney and liver transplant history in Turkey are summarized herein. In 1975, we performed the first pediatric living-related renal transplant in Turkey. We followed this in 1978 with the first deceased donor kidney transplant, using an organ supplied by Eurotransplant. In 1979 the law on harvesting, storage, grafting, and transplant of organs and tissues was enacted; the first local deceased donor kidney transplant was performed by our team in 1979. In 1988, another ground-breaking event in Turkey, the Middle East, and North Africa was successfully achieved: the first successful deceased-donor liver transplant, and in 1990, the first pediatric living-related segmental liver transplant in Turkey, the region and Europe was performed by our team. One month later, an adult-to-adult living-related liver transplant (left lobe) in the World was successfully performed. On May 16, 1992, we performed the first combined liver-kidney transplant from a living-related donor, which was the first operation of its kind in the World. Between November 1975 and January 2022, we have performed 3288 kidney (380 pediatric) at the Hacettepe University Hospitals and later on at Baskent University; since 1988, 701 (334 pediatric) liver transplants have been performed. In over 40 years of kidney and liver transplants history in Turkey, 46876 kidney (2502 pediatric patients) and 18203 liver (2612 pediatric patients) transplants have been performed nationwide. In 2001, the Ministry of Health established the National Coordination Center as an umbrella organization to promote transplant activities, especially for deceased donor organ procurement. Transplant activities are accelerating daily throughout the country, but deceased donors are still far below the desired rates.

Transplantation in Turkey and region

The article provides insight into significant milestones in the history of organ transplantation in Turkey and region.
 In 1975, we were the first in Turkey to perform living‑related kidney transplantation and, in 1978, deceased‑donor kidney transplantation, using an organ supplied by Eurotransplant. In 1979, the law on harvesting, storage, grafting, and transplantation of organs and tissues was enacted. The first local deceased‑donor kidney transplantation was performed by our team in 1979. The first successful deceased‑donor liver transplantation, which was a groundbreaking surgery procedure for Turkey, the Middle East and Northern Africa, was carried out by our team in 1988. In 1990, we were the first not only in Turkey but also in the Middle East region as well as Europe to perform pediatric living‑related segmental liver transplantation. One month later, an adult‑to‑adult living‑related liver transplant (a left lobe) was successfully performed for the first time in the history of organ transplantation. On May 16, 1992, we carried out the first combined liver‑kidney transplantation from a living‑related donor, which was the first operation of its kind in the world. Between November 1975 and October 2021, we performed 3,256 kidney transplantations at Hacettepe University Hospitals . Since 1988 to date, we have carried out 695 liver transplantations at Baskent University. According to the registry of the Ministry of Health, from 2002 to 2021, 46,115 kidney transplants were performed nationwide, as compared with 17,868 liver transplants, 1,153 heart transplants and 198 pancreas transplants. In 2001, the Ministry of Health established the National Coordination Center as an umbrella organization to promote transplantation activities, especially deceased‑donor organ procurement. Despite constantly increasing overall living‑donor transplant rate across the country, overall deceased‑donor transplant rate is still far below the desired level.

OP058: 2021 genetics policies in state Medicaid programs

The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services supports the National Coordinating Center for the Regional Genetics Networks (NCC) to improve access to underserved populations throughout the US. As the National Coordinating Center for the RGN system, NCC is tasked with tracking and reporting information on genetics policy, including coverage of genetic services in Medicaid.

EP499: Performance measures for evaluating access to genetic services: Work of the National Coordinating Center for the seven Regional Genetics Networks

The National Coordinating Center for the seven Regional Genetics Networks (NCC) is funded by the Health Resources and Services Administration (HRSA) and is housed at the American College of Medical Genetics and Genomics (ACMG). One of the NCC’s responsibilities, under this grant, is to evaluate access to genetic services, particularly for underserved populations.

EP426: Utilization of the ACMG ACT sheets and algorithms on the ACMG website

Since 2004, the American College of Medical Genetics and Genomics (ACMG) has housed the National Coordinating Center for the Regional Genetics Networks (NCC), funded through a cooperative agreement with the Health Resources and Services Administration (HRSA). NCC’s mission is to improve access to genetic services for underserved populations. NCC accomplishes this mission through various programs, including developing the ACMG ACTion (ACT) Sheets and Algorithms. The ACMG ACT Sheets and Algorithms are a clinical decision support tool for non-genetic providers on specific genetic conditions identified primarily through newborn screening, but also encompass certain disorders identified as secondary findings and noninvasive prenatal screening. At present, there are 129 ACT Sheets with corresponding algorithms available on the ACMG website. In January 2021, NCC added a pop-up website survey on the ACMG ACT Sheet and Algorithms webpage (https://www.acmg.net/act) to assess who is accessing and utilizing this resource. Utilizing the survey platform, Qualtrics, NCC developed a four-question survey that appears prior to accessing the ACMG ACT Sheets at https://www.acmg.net/act. The survey asks the following questions: 1. What type of professional are they?; 2. How often (on average) they access the ACT Sheets and Algorithms?; 3. Whether the ACMG ACT Sheets and Algorithms have improved their genetics knowledge?; and 4. If they have any additional feedback to provide to NCC on the ACMG ACT Sheets and Algorithms. Response to each of these questions is optional. Due to the mechanism of how the survey is distributed, the survey is a convenience sampling of those ACMG ACT Sheet users on the ACMG website who opt-in to taking the survey. From January 13 to November 10, 2021, NCC received 294 responses. Of these: • 58.5% were genetics providers; o Defined as a geneticist, genetic counselor, metabolic dietician, genetic nurse. • 17% were primary care providers; • 7.8% were public health professionals; • 7.1% were professional students (graduate or medical student); and • 6.4% were other professionals; sixty-two point two percent (n=281) reported that they accessed the ACMG ACT Sheets and Algorithms either once per week or once per month. 78.4% (n=283) stated that the ACMG ACT Sheets and Algorithms improved their genetics knowledge. NCC found that ACMG ACT Sheets and Algorithms accessed on the ACMG website are primarily accessed by genetics professionals. Professionals who access the ACMG ACT Sheets and Algorithms report an increase in genetics knowledge. Although this survey is a convenience sampling over a short time interval and could include multiple responses from the same individual, the survey demonstrates the potential clinical utility of the ACMG ACT Sheets and Algorithms. NCC will continue to collect this information on the ACMG website as we implement efforts to increase awareness of the resources to non-genetic providers.

EP497: Interpreting for genetics: Crossing the language barrier in communities

The National Coordinating Center for the Regional Genetics Networks (NCC) works with the seven Regional Genetics Networks (RGNs) and the National Genetics Education and Family Support (NGEFSC) to improve access to genetic services for underserved populations. One way this mission is accomplished is by educating healthcare providers, advocates, representatives, and families. In 2017, NCC initiated their Interpreting for Genetics program with the assistance of Cynthia E. Roat, a nationally-recognized healthcare interpreter trainer, and consultant.

EP427: Disseminating genetics policy information on social media

The National Coordinating Center for the Regional Genetics Networks (NCC), a cooperative agreement between the Health Resources and Services Administration (HRSA) and ACMG, mission is to improve access to genetic services for underserved populations. NCC accomplishes this mission is by disseminating educational materials related to genetics policy to providers and patients. Through the utilization of the FiscalNote Legislative Tracking System, NCC shares proposed legislation and regulation at the state and federal level across the United States on Twitter.