• Title/Summary/Keyword: 의료 질 개선

Search Result 228, Processing Time 0.036 seconds

The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
    • /
    • v.21 no.1
    • /
    • pp.223-259
    • /
    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

Evaluation of Retro recon for SRS planning correction according to the error of recognize to coordinate (SRS의 좌표 인식 오류 시 Retro recon을 이용한 수정 방법에 관한 평가)

  • Moon, hyeon seok;Jeong, deok yang;Do, gyeong min;Lee, yeong cheol;Kim, sun myung;Kim, young bum
    • The Journal of Korean Society for Radiation Therapy
    • /
    • v.28 no.2
    • /
    • pp.101-108
    • /
    • 2016
  • Purpose : The purpose of this study was to evaluate the Retro recon in SRS planning using BranLAB when stereotactic location error occurs by metal artifact. Materials and Methods : By CT simulator, image were acquired from head phantom(CIRS, PTW, USA). To observe stereotactic location recognizing and beam hardening, CT image were approved by SRS planning system(BrainLAB, Feldkirchen, Germany). In addition, we compared acquisition image(1.25mm slice thickness) and Retro recon image(using for 2.5 mm, 5mm slice thickness). To evaluate these three images quality, the test were performed by AAPM phantom study. In patient, it was verified stereotactic location error. Results : All the location recognizing error did not occur in scanned image of phantom. AAPM phantom scan images all showed the same trend. Contrast resolution and Spatial resolution are under 6.4 mm, 1.0 mm. In case of noise and uniformity, under 11, 5 of HU were measured. In patient, the stereotactic location error was not occurred at reconstructive image. Conclusion : For BrainLAB planning, using Retro recon were corrected stereotactic error at beam hardening. Retro recon may be the preferred modality for radiation treatment planning and approving image quality.

  • PDF

Sleep Quality and Sleep Patterns of Patients Treated by the Hemopoietic Stem Cell Transplantation (조혈모세포 이식환자의 입원 후 수면의 질과 수면양상의 변화)

  • Choi, So-Eun;Park, Hae-Ryung;Park, Ho-Ran
    • Journal of Hospice and Palliative Care
    • /
    • v.8 no.1
    • /
    • pp.37-44
    • /
    • 2005
  • Purpose: To provide the basic data in developing the nursing intervention for patients who have symptoms of insomnia after undergoing hemopoietic stem cell transplantation (HSCT). This was achieved through investigating sleep quality and sleep patterns according to admission time, and discharge time. Methods: Data was put together by studying 52 HSCT patients who have been admitted to the department of HSCT from August 2002 to August 2003, in a university hospital. Research instruments used were, PSQI for sleep quality and a specified questionnaire for sleep patterns. Results: The PSQI regarding the past mono which was measured at the last day of hospitalization, was 11.8. This was significantly higher than 5.3, which was a measurement for the past month before the hospitalization (t=11.41, P=0.000). Looking at it with 7 categories-quality of sleep, consistency of sleep, sleep period, effectiveness of sleep, sleeping disorder, usage of sleeping pills, impediment of daily life- the PSQI for a month after admission increased significantly compared to the rate measured for a month before admission. Comparing the subjects sleep pattern before and after admission, it showed a significant difference regarding time attending sleep, time it takes to sleep, wake-up time, total time of sleep, day time sleep, number of times waking up during sleep, number of usage of sleeping pills, actions that are taken during sleep disorder, reasons for insomnia. Conclusion: The PSQI score of patients who undergo hemopoietic stem cell transplantation have increased significantly after hospitalization. Compared to the change of sleep patterns when hospitalized, significant changes were observed. Therefore nursing interventions addressing sleep are needed.

  • PDF

The effect of Type 2 diabetes management using a smartphone-based blood glucose management training program (모바일 자가혈당관리 교육프로그램을 이용한 2형 당뇨병 관리 효과 분석)

  • Lee, Jung-Hwa;Jung, Jin-Hee;Sim, Kang-Hee;Choi, Hee-Sun;Lee, Jeong-Rim;Kang, Yang-Gyo;Song, Bok-Rye
    • Journal of Industrial Convergence
    • /
    • v.20 no.9
    • /
    • pp.59-70
    • /
    • 2022
  • Background: Diabetes education is an important factor in blood glucose control. Reinforced education is necessary for effective diabetes education. However, it is difficult to provide reinforced diabetes education within Korea's medical environment. Therefore, we want to analyze the effect of continuous diabetes education using mobile health care that can effectively provide repeated education without having to face the patient. Methods: This study is a multicenter, randomized, controlled, pre-post design study conducted to analyze the effect of a continuous diabetes education method. A total of 109 people were registered at five hospitals in south Korea, and they were randomly assigned to the app group (34 people) who received real-time coaching and repetitive training, the logbook group (37 people) who received face-to-face training after writing a blood glucose logbook, and the general group (38 people) who received a one-time diabetes education. The study was conducted for a total of 24 weeks. Twenty-one patients withdrew their consent and failed to perform an HbA1c. A final 88 patients were analyzed. The difference in HbA1c, Self-management behavior, and Quality of life before and after education was analyzed. Results: The study involved 51 (58%) male subjects, mean age was 55.8 years and mean duration of diabetes was 7.6 years. After 24 weeks of intervention, there was no significant difference in self-care behavior and quality of life between the three groups, but the HbA1c of the app group significantly decreased after education compared to the logbook group and the general group (F=4.62, p=.013). Conclusion: It can be seen through the app group that receiving real-time education is more effective in improving blood glucose management and continuous diabetes education is important.

Fabrication of Gd2O2S:Tb fine scintillator film and evaluation of image quality for resolution improvement of X-ray imaging based on CMOS (CMOS 기반 X선 영상의 해상력 향상을 위한 Gd2O2S:Tb 미세형광체 필름 제작 및 영상 질 평가)

  • Kang, Sang-Sik;Choi, Young-Zoon;Jung, Bong-Jae;No, Si-Cheul;Cho, Chan-Hoon;Yoon, In-Chan;Park, Ji-Koon
    • Journal of the Korean Society of Radiology
    • /
    • v.5 no.5
    • /
    • pp.283-287
    • /
    • 2011
  • In this study, fine $Gd_2O_2S$:Tb powder was synthesized by using a low temperature solution-combustion method for a high-resolution digital x-ray imaging detector. From the fabricated phosphor power, the fine scintillator films was fabricated by particle sedimentation method and was investigated the luminescent property. From the experimental results of relative light output as a function of terbium concentration, the highest luminescent efficiency has at 5 wt% Tb concentration, and luminescent intensity decreased rapidly according to quenching effect about higher Tb concentration. Also, the relative light output of $270{\mu}m$-$Gd_2O_2S$:Tb film has 2945 pC/$cm^2$/mR. And light intensity was saturated at higher film thickness. Finally, to evaluate an image acquisition performance of fabricated phosphor, images were obtained by using commercial CMOS sensor and measured the MTF, NPS, and DQE. DQE(0 lp/mm) of fine phosphor film has 37%. But, DQE improvement of fine phosphor film is possible by resolving problem of film fabrication process and has a significant potential in the application of digital radiation imaging system later.

A Survey on Utilization of Dental Services by Foreign Children in Seoul (서울 거주 외국인 아동의 치과 이용 실태 조사)

  • Vanda, Rute Mateus;Sun, Yeji;Lee, Hyseol;Kim, Seunghye;Lee, Jaeho
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.44 no.2
    • /
    • pp.154-163
    • /
    • 2017
  • This study aims to investigate the utilization status of dental services by foreign children living in Seoul and their level of satisfaction with the treatments. We developed a structured questionnaire with 35 questions, which comprised 14 questions (demographic characteristics) and 21 questions (oral hygiene and dental experience of the child). In this study, the distribution of nationality of 391 participants differed from the actual statistics in Korea. It consisted of high percentage of participants from African countries (23.6%), as well as North American countries (24.1%). In addition, the education status of most parents was above the level of college graduate. Despite the relatively high socioeconomic status of the participants, they showed minimal dental health knowledge regarding the aspect of oral hygiene. Utilization of dental health services and the types of dental clinics visited by them were similar before and after coming to Korea. The participants showed overall satisfaction with the care, but many of them expressed the need for improvement with regard to treatment fee and communication. In conclusion, foreign children living in Seoul require appropriate dental health education and governmental support to promote regular dental check-ups, to improve their overall oral health, and prevent the incidence of dental caries.

Breakthrough Cancer Pain (돌발성 암성 통증)

  • Seo, Min Seok;Shim, Jae Yong
    • Journal of Hospice and Palliative Care
    • /
    • v.18 no.1
    • /
    • pp.1-8
    • /
    • 2015
  • Breakthrough cancer pain is a transient exacerbation of pain that occurs despite relatively well controlled background pain with around-the-clock analgesia. It is highly prevalent in patients with cancer pain, with an overall prevalence of 70~90%. Breakthrough cancer pain has several negative effects on quality of life, including a decrease in functional status and social relationship, and higher incidence of anxiety/depression. It also places a detrimental burden on their families, society, and the healthcare system. According to the pathogenic mechanism, breakthrough cancer pain is classified into two categories: idiopathic (or spontaneous) pain and incident pain. Episodes of breakthrough cancer pain have typical characteristics, including rapid onset (5~10 min), severe intensity, and short duration (30~60 min). However, there are some variations in timing and severity of pain among patients and episodes. Therefore, a thorough assessment of pain episodes is needed and management plan must be individualized to provide optimal treatment. Several immediate-release formulations such as oxycodone, morphine, and hydromorphone are widely used despite relatively slow onset of action. Recent studies have shown that transmucosal fentanyl preparations were effective for faster control of breakthrough pain. We hope to improve management of breakthrough cancer pain with more efficient analgesics in line with currently available evidence.

Inpatient Dental Consultations to Pediatric Dentistry in the Yonsei University Severance Hospital (연세대학교 세브란스 병원 내 입원한 환자의 소아치과 의뢰 현황)

  • Joo, Kihoon;Lee, Jaeho;Song, Jeseon;Lee, Hyoseol
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.41 no.2
    • /
    • pp.145-151
    • /
    • 2014
  • The goal of this study was to describe dental consultation of pediatric inpatients to the department of pediatric dentistry at Yonsei University Severance Hospital. 391 dental consultations at Yonsei University Severance Hospital referred to pediatric dentistry in the year 2012 were included in this study. Consultations were categorized according to patients' gender, age, chief complaint, referred department and diagnosis. 288 patients (166 males and 122 females) with an average age of 5.9 were referred to the Department of Pediatric Dentistry. 129 cases (33.1%) from Department of Rehabilitation Medicine, 80 cases (20.5%) from Pediatric Hematology- Oncology, 51 cases (13.0%) from Pediatric Cardiology, and 44 cases (11.3%) from Pediatric Neurology. Chief complaints were ranked from oral examination (39.7%), dental caries (14.0%), pre-operative evaluation (12.8%) and others (33.5%); including oral pain, trauma, tooth mobility, orthodontic treatment, self-injury, fabrication of obturator and etc. Dental consultations should be encouraged as dental care and treatment could affect the control of systemic diseases of admitted patients. Pediatric inpatients have been referred to pediatric dentistry for not only comprehensive oral exam but also various chief complaints. The most frequent dental diagnosis made and treatment performed were dental caries and non-invasive/preventive care respectively.

XOR-based High Quality Information Hiding Technique Utilizing Self-Referencing Virtual Parity Bit (자기참조 가상 패리티 비트를 이용한 XOR기반의 고화질 정보은닉 기술)

  • Choi, YongSoo;Kim, HyoungJoong;Lee, DalHo
    • Journal of the Institute of Electronics and Information Engineers
    • /
    • v.49 no.12
    • /
    • pp.156-163
    • /
    • 2012
  • Recently, Information Hiding Technology are becoming increasingly demanding in the field of international security, military and medical image This paper proposes data hiding technique utilizing parity checker for gray level image. many researches have been adopted LSB substitution and XOR operation in the field of steganography for the low complexity, high embedding capacity and high image quality. But, LSB substitution methods are not secure through it's naive mechanism even though it achieves high embedding capacity. Proposed method replaces LSB of each pixel with XOR(between the parity check bit of other 7 MSBs and 1 Secret bit) within one pixel. As a result, stego-image(that is, steganogram) doesn't result in high image degradation. Eavesdropper couldn't easily detect the message embedding. This approach is applying the concept of symmetric-key encryption protocol onto steganography. Furthermore, 1bit of symmetric-key is generated by the self-reference of each pixel. Proposed method provide more 25% embedding rate against existing XOR operation-based methods and show the effect of the reversal rate of LSB about 2% improvement.

Current Status of End-of-Life Care Education in Undergraduate Nursing Curriculum (간호학부 말기환자간호 교육 현황)

  • Kwon, So-Hi;Cho, Yeon-Su
    • Journal of Hospice and Palliative Care
    • /
    • v.22 no.4
    • /
    • pp.174-184
    • /
    • 2019
  • Purpose: The aim of this study was to analyze the current status of end-of-life (EoL) care education of the undergraduate nursing curriculum and senior students' EoL care experience and competency. Methods: A survey was conducted with 41 nursing schools and 622 senior nursing students on June 2018. The questionnaire consisted of 38 items on teaching regarding EoL care and 17 items on EoL care competencies based on the suggestions made by the American Nurses Association. Results: Only 20% among 41 nursing schools opened an EoL care course as an elective, and the course was taken by 5.1% students. Of 622 students, 70.7% witnessed death of patients during their clinical training, but 74.8% received no or little education on EoL care from their clinical training instructors. Two of 38 education contents on EoL care were taught in class for over 80% of the students. All students scored below 3 points (2.31±0.66) for all 17 competencies, which means that they cannot perform EoL care. Conclusion: This study showed that there was a serious deficiency in undergraduate nursing education on EoL care. Accordingly, most nursing students who would graduate soon considered themselves incapable of performing EoL care. Nurses experience death and dying as a part of their practice and should be prepared to provide adequate EoL care. Therefore, it is urgent to improve EoL care training in the undergraduate nursing education.