• Toxicological Research
• /
• 제17권
• /
• pp.211-216
• /
• 2001

Drugs can have various adverse effects on the immune system including unintended immun-osuppression, induction of both drug-specific immune responses (including drug allergies) and non-specific immunostimulation (including autoimmune reactions), and direct activation of effector mechanisms (such as histamine release). As a practical matter, the Center for Drug Evaluation (CDER) relies on standard non-clinical toxicology studies to detect unintended immunosuppression. Specific assays using guinea pigs and mice are available to identify drugs that can induce immune-mediated dermal hypersensitivity reactions. Respiratory and systemic hypersensitivity and autoimmune reactions are more difficult to model in non-clinical studies. Unintended nonspecific immunstimulation can be detected in animal studies. CDER is currently developing specific guidance for evaluating potential drug immunotoxicity.

• International Journal of Stem Cells
• /
• 제17권2호
• /
• pp.113-119
• /
• 2024

This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss-threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.

• Journal of Digestive Cancer Research
• /
• 제11권2호
• /
• pp.104-107
• /
• 2023

The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

• 한국임상약학회지
• /
• 제19권2호
• /
• pp.105-109
• /
• 2009

In July 2008, The National Police Hospital has developed the CPOE system(Computerized Physician Order Entry system) which links the medicine master and introduced the new program for the injectable antimicrobial agents. After introducing new system, we wanted to check the management of oral antimicrobial agents. Because new system has limitation that new system control only the use of the injectable antimicrobial agents. So we tried to evaluate the use of oral levofloxacin, which was chosen by a medical specialist of the infection. We retrospectively analyzed the appropriateness of oral levofloxacin through EMR(Electric Medical Record) of 72 inpatients who received oral levofloxacin in National Police Hospital in December 2008. We applied the modified ASHP(American Society of Health- System Pharmacists) DUE(Drug Use Evaluation) criteria, which is composed of justification of drug use, critical indicators, complications and outcome measures. Acceptable cases of use of levofloxacin were 67(93.01%) and 57cases(79.2%) showed good outcome. However critical indicators were not performed very well. We want to suggest the new system for the management of the medical therapeutics by the pharmacist in charge.

• 한국병원경영학회지
• /
• 제8권1호
• /
• pp.1-23
• /
• 2003

General drug prices involve three stages: shipment stage, wholesaler stage and retail stage. Policies on drug price differ from country to country. Shipment stage prices are tightly regulated in countries like France and Netherlands. They are free in only a minority of advanced countries, even if these include some major players such as the US, Germany and, in a very limited sense, Japan. The situation in the UK is very complex with a semi-free system, where drug companies are free to set their own prices but cannot exceed a predetermined profit ceiling. Mark-up at both wholesaler and retail stages is formally admitted in most countries observed. Apart from the general drug prices, reimbursement price of insured drugs has been major policy concerns. Most countries reviewed in this study has exerted some control over reimbursement prices, but differ both in the way how and in the extent to which prices are admitted or fixed. Price fixing has been used in France and Japan. Some countries have transformed their system over time, particularly to move to reference pricing in the last decade. This mechanism has empowered the customer, and improved price competition on the market. Referring to the drug price policies in the advanced countries, this study makes some suggestions for the redirection of Korean price policy for reimbursement drug in health insurance as follows: to match appropriate policy tools to each policy goal; to maximize market mechanism through effective reimbursement price fixing which admits mark-ups in wholesaler and retail prices; to introduce reference pricing system in order to redirect patient's demand with a financial incentive to choose the best-priced drugs and to save the finance of health insurance; and to strengthen surveillance and monitoring mechanism in the drug market.

• 한국임상약학회지
• /
• 제15권2호
• /
• pp.127-138
• /
• 2005

This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

• 한국임상약학회지
• /
• 제33권1호
• /
• pp.22-34
• /
• 2023

Background: With the increasing use of narcotic analgesics, the Ministry of Food and Drug Safety has been operating the National Narcotics Information Management System (NIMS) since 2018 in Korea. Some studies are related to the narcotic analgesics use, but the evaluation studies of system, including NIMS users are insufficient. Objective: This study evaluated the NIMS enforcement process through in-depth interviews on the experience of using NIMS of doctors and pharmacists who prescribe or dispense opioid analgesics. Methods: Participants in this study were selected through purposeful sampling as three doctors and two pharmacists in the metropolitan area. The interviews were conducted from August 27 to October 19, 2022. Each interview was analyzed using a phenomenological method. Results: Six components of this study included "Doctors and pharmacists come across drug abusers", "They respond individually to drug abusers", "They use NIMS tailored to the needs of system managers", "They are concerned about the role of NIMS in practice settings", "They face challenges against drug abusers" and "They find a way to utilize the system to deal with drug abusers." The interviews confirmed that doctors and pharmacists used NIMS little in their work, and they only reported data. Therefore, it might be difficult for doctors and pharmacists to take measures for the safe use of narcotic analgesics. Conclusion: It is likely that adding data-feedback and medication-check function can reduce the abuse of narcotic analgesics. In the future, further studies on the evaluation of the empirical results of NIMS and review of systems in other countries will be required.

• 약학회지
• /
• 제50권3호
• /
• pp.145-153
• /
• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• 한국콘텐츠학회논문지
• /
• 제19권1호
• /
• pp.234-241
• /
• 2019

의약품을 사용할 때 나타나는 부작용은 국민의 건강을 크게 위협할 수 있다. 현재 의약품 부작용에 대한 보고가 매우 미흡한 것이 현실이다. 이에 현재 약국에서 사용하고 있는 의약품 사용평가(DUR:Drug Utilization Review)에 의약품 부작용 보고를 연계하게 된다면 활성화될 수 있다. 의약품 사용평가가 활성화되어 있는 미국 의약품 관리 체계 연구를 통해 의약품 부작용 보고 활성화 방안을 찾을 수 있다. 약국에서 의약품 관리 프로그램으로 사용되는 'Pharm IT 3000'에서 의약품 부작용 보고의 활성화 방안을 연구해 보았다. 문헌연구와 실제 프로그램 운영 방식 연구를 통해 Pharm IT 3000 처방 조제 현황 항목에 의약품 사용평가를 연동시켜 부작용 보고가 편리하게 되는 방안을 찾게 되었다.

• 약학회지
• /
• 제47권6호
• /
• pp.390-397
• /
• 2003

It is common that geriatric patients are on several medications at the same time. With this situation on hand, this study has collected prescriptions of individual geriatric patient and investigated possible drug interactions. In order to minimize the drug interactions and protect those patients from adverse reactions of medication, the gradual implementation and management of the medication history of each individual patient, the establishment of medication counseling system on medicines particularly in need of obligatory advice, the use of an inspection system on drug interactions at the time of prescription, and the implementation of a patient monitoring system on the drugs with narrow margin of safety at hospitals.