• 한국임상약학회지
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• 제15권2호
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• pp.139-148
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• 2005

Appropriate drug classification is important fur rational drug consumption. This study was conducted to evaluate the appropriateness of current drug classification system and suggest possible ways for improving the system. Nonprescription drug market has been decreased. Since total 27,962 products had been classified (prescription 17,187 vs. nonprescription 10,775 products, 61.5% vs. 38.5%) in July 2000 for implementing separation of drug prescribing and dispensing system, there are no classification changes. Reclassification is not motivated by product holder and regulatory system did not lead classification change either. Consumers' ease access to some nonprescription drugs is demanded. But point of public awareness and cultural and health environmental views, saff drug use rather than advantages from broad supply of nonprescription drugs is more critical. We concluded that current 2-categorized (prescription and nonprescription) drug classification system is appropriate, and addition of general sale category should be approached carefully with long term Preparations such as establishment of better nonprescription drug consuming infrastructure by public information provision and education for improving public medicinal knowledge and strengthening self medication guidance, and review of current classification status of marketed drugs and switching possibilities. For systemizing and encouraging reclassification, introduction of regulatory renewal system as a continuous reevaluation program which is the best way to review appropriateness of drug classification as well as provision of detailed guidance for industry including policy, requirement and process fer reclassification application, are necessary.

• 한국임상약학회지
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• 제24권4호
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• pp.272-281
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• 2014

Objective: The provision of pharmaceutical care service in compliance with good pharmacy practice (GPP) standards is important, but there is lack of studies to investigate the barriers that significantly hinder community pharmacies in Korea from adhering to the standards. This study was aimed to identify the major barriers to provision of pharmaceutical care service in compliance with the proposed pharmacy practice standards which have been developed based on the GPP standards recommended jointly by WHO and FIP. Methods: Questionnaires reviewed by the expert committee were posted for 32 days on the website which is most frequently accessed by community pharmacists. The respondents completed them by checking the scores (Max=5, Min=1) for major barriers to provision of pharmaceutical care service focusing on patient information management and drug use review process in prescription fillings. The answered scores were automatically collected using online data processing. Mean differences between scored data were assessed by ANOVA. Results: Total 321 pharmacists participated in the survey. Results indicated that 'difficulty of diagnosis identification' (m=3.92, SD=1.21), 'lack of time' (m=3.48, SD=1.22) and 'lack of updated clinical information' (m=3.17, SD=1.10) were the major barriers to provision of pharmaceutical care service in patient information management. The main barriers to drug utilization review were 'lack of time' (m=3.32, SD=1.21), 'lack of updated clinical information' (m=3.11, SD=1.17), and 'negative feedbacks or refusals from prescribers' (m=3.00, SD=1.38). There were significant differences among the groups by location, employed number of pharmacists and acceptability to the proposed GPP standards. Conclusion: Difficulties in managing patient clinical information and lack of time were found to be the major barriers in providing pharmaceutical care services in community pharmacies in Korea. Further research is recommended to determine ways to reduce these barriers in order to provide quality pharmaceutical care service that is in compliance with the internationally recognized GPP guidelines.

• 한국임상약학회지
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• 제23권4호
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• pp.334-343
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• 2013

Purpose: This study aims to investigate consumers' demand of and perspective on drug information domestically available and uncover hurdles that they faced while utilizing information. Methods: We conducted a survey of 101 consumers, face-to-face after obtaining informed consent. Chi-squared, or Fisher's exact tests, and multivariate logistic models were used to investigate the association between participants' perceptions and characteristics. Results: As results, participants showed the highest demand for "Adverse effects >90%"; "Drug interactions/Dosage/Drug-food interactions/Indication >80%", and utilized package inserts (52%), doctors (41%) and pharmacists (36%) most often as information sources. Generally, the most common difficulty consumers suffered with was that "it is hard to understand (51%)". With public sources of drug information, sixty one percent of participants were "unaware of the provision of information", resulting in strikingly low usage rates (5~11%). Subgroup analyses indicated that the older (${\geq}50$ years) and the disadvantaged might have been placed in the blind spot of information mostly developed online (p<0.05).Conclusion: In conclusion, public sources of drug information that have been developed online might fail to meet consumers' demand. Greater efforts should be made to balance the development of the information sources between online and offline, and to increase accessibility of the established information sources.

• 한국임상약학회지
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• 제30권3호
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• pp.143-148
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• 2020

Objective: This study aimed to investigate pharmaceutical care for critically ill neonates and suggest targeted strategies compatible with the Korean health-system pharmacy. Methods: Articles that reported pharmacy practices for critically ill neonates were reviewed. Pharmaceutical care practices and roles of neonatal pharmacists were identified, and criteria were developed for neonates in need of specialized care by clinical pharmacists. Results: Neonatal pharmacists play many roles in the overall medication management pathway. For clinical decision support, multidisciplinary ward rounds, clinical pharmacokinetic services, and consultation for pharmacotherapy and nutrition support were conducted. Prevention and resolution of drug-related problems through review of medication charts contributed to medication safety. Pharmaceutical optimization of intravenous medication played an important role in safe and effective therapy. Information on the use of off-label medicine, recommended dosage and dosing schedules, and stability of intravenous medicine was provided to other health professionals. Most clinical practices for neonates in Korea included therapeutic drug monitoring and nutrition support services. Reduction in medication errors and adverse drug reactions, shortening the duration of weaning medicines, decreasing the use and cost of antimicrobials, and improvement in nutrition status were reported as the outcomes of pharmacist-led interventions. The essential criteria of pharmaceutical care, including for patients with potential high-risk factors for drug-related problems, was developed. Conclusion: Pharmaceutical care for critically ill neonates varies widely. Development and provision of standardized pharmaceutical care for Korean neonates and a stepwise strategy for the expansion of clinical pharmacy services are required.

• Genomics & Informatics
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• 제11권4호
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• pp.289-291
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• 2013

Human papillomavirus (HPV) infection is the leading cause of cancer mortality among women worldwide. The molecular understanding of HPV proteins has significant connotation for understanding their intrusion in the host and designing novel protein vaccines and anti-viral agents, etc. Genomic, proteomic, structural, and disease-related information on HPV is available on the web; yet, with trivial annotations and more so, it is not well customized for data analysis, host-pathogen interaction, strain-disease association, drug designing, and sequence analysis, etc. We attempted to design an online reserve with comprehensive information on HPV for the end users desiring the same. The Human Papillomavirus Proteome Database (hpvPDB) domiciles proteomic and genomic information on 150 HPV strains sequenced to date. Simultaneous easy expandability and retrieval of the strain-specific data, with a provision for sequence analysis and exploration potential of predicted structures, and easy access for curation and annotation through a range of search options at one platform are a few of its important features. Affluent information in this reserve could be of help for researchers involved in structural virology, cancer research, drug discovery, and vaccine design.

• Journal of Pharmaceutical Investigation
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• 제39권4호
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• pp.299-307
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• 2009

Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

• 의료법학
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• 제24권2호
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• pp.119-145
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• 2023

약사법은 의약품 조제의 경우 복약지도를 의무사항으로 규정하고 있음에도 불구하고, 실제로 이루어지고 있는 복약지도의 내용을 보면 복용량과 시간만을 알려주는 것에 불과한 경우가 많다. 그런데 비대면진료를 시도하는 현 상황에 비추어 볼 때, 복약지도 미비를 원인으로 하여 약화사고가 발생하기 쉽다는 우려가 상당하다. 또한, 고령화 사회가 진전됨에 따라 의약품에 대한 설명의 필요성이 증가하고 있다. 관련하여, 약사의 복약지도의무 위반으로 인하여 적절한 복용이 이루어지지 않아 환자에게 손해가 발생한 경우, 환자측은 알권리 및 자기결정권, 신체적 인격법익과 재산적 법익의 침해를 이유로 손해배상을 청구할 수 있다. 그런데 의약품 조제의 경우와 같이 의약품 사고가 약사의 복약지도의무와 의사의 설명의무가 경합하여 발생한 경우 약사와 의사의 공동불법행위가 성립할 것임에도, 의사의 설명의무 위반으로 인하여 약사의 복약지도의무 위반이 다투어지지 않는 경우가 있다. 현행 약사법은 복약지도의 내용에 일반의약품 선택을 위한 정보 제공 역시 복약지도 의무의 범주에 포함시키고 있는바, 복약지도의무의 중요성을 재고하기 위하여 의약품정보 제공행위와 복약지도의무를 별개의 개념으로 나누어 규정할 필요가 있다. 또한 복약지도가 의약품의 부작용이나 병용의약품과의 상호작용 등에 이르기까지 자세한 내용으로 이루어질 수 있도록 관련 규정을 환자 중심으로 개정할 필요가 있다.

• 한국임상약학회지
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• 제9권2호
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• pp.109-118
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• 1999

The need for and components of a contemporary community pharmacy externship for pharmacy students have not been clearly identified in Korea. Mail survey was performed among 20 college of pharmacy deans and 800 community pharmacists to analyze the current status and develop a consensus regarding major focus area and criteria of community pharmacy externship to be implemented under the separation of dispensary from medical practice in year 2000. Mail survey yielded $80\%\;and\;23.5\%$ response rate for pharmacy school deans and community pharmacists, respectively. Of the 16 pharmacy schools that responded 14 said they have externship program in hospital pharmacy, and only 8 pharmacy schools responded of having externship program for community pharmacy. However, these community pharmacy programs lacked criteria and standard guideline for the externship. The results of survey revealed that community pharmacy externship program for students should be organized and directed toward developing expert knowledge and skills in pharmacy practice activities, clinical services, communications, pharmacy management, and professionalism. Pharmacy practice components should include competencies and skills in computer application, prescription processing, dispensing, pharmaceutical compounding, Narcotics Control Law application, maintenance and provision of drug information, and laws and regulations. Clinical service components should include the ability to identify patient's drug-related problems, provide long-term patient care and appreciate drug therapy services. Communication skills should be taught to effectively express his/her professional opinion, deduce the needs of others, utilize appropriate techniques and media to communicate ideas and conduct a patient interview and to obtain patient drug history. Pharmacy management skills should be taught to be efficient in medical insurance and drug control process. It was found that professionalism, morality, pharmacy practice experience, ability to provide clinical services, collect and provide drug information and regality are important criteria of preceptors. Externship sites should possess the ability to stock various drugs, access and provide diverse pharmacy services and should have private patient counseling area. Most pharmacists agreed that top 200 drugs' generic and brand name, indications, dosage, side effects, and contraindication should be instructed during the externship. It was also found that student and preceptor should be evaluated for their performances during the externship. This information will be incorporated into teaming objectives for students and to develop Academic Extemship Program Guidelines.

• 동아시아식생활학회지
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• 제17권3호
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• pp.456-462
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• 2007

Food safety has been a growing consumer concern over the last few decades, and remains a priority for consumers, the food industry, and regulatory agencies alike. Although consumer concern for food safety has increased, consumer confidence has decreased. The emphasis on food safety is related to that of preliminary risk management. The ability to collect and provide food risk information is a key element in enhancing the way food safety authorities protect consumers from risk. This review aims to investigate the current situations of international organizations, as well as several countries' systems for collecting and providing food risk information. Through the comparison and analysis of each system, this review proposes strategies to establish a systematic collecting of information and provision of infrastructure in Korea. To develop an information collection system suited to Korea's situation, it is necessary for Korea to strengthen interactions and cooperation with other trade partners through the enlargement of international networks. Such efforts on food risk communication should be made by providing high quality and clear information.

• 병원약사회지
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• 제35권4호
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• pp.441-452
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• 2018

Background : The prevalence of the chronic metabolic disease is increasing due to the aging society. Therefore, Korean Society of Health-system Pharmacists (KSHP) has a specialty pharmacist system to improve the professionalism of pharmacists. The purpose of this study is to suggest the difference between specialty pharmacist and non-specialty pharmacist with regards to their knowledge, delivery of information on medication, service provision, and job satisfaction. Methods : An online survey research was conducted for hospital pharmacists. The reliability of the questionnaire items was presented using Cronbach's ${\alpha}$ test. The t-test or ANOVA analysis was used for evaluating differences in continuous variables. Results : A total of 171 pharmacists responded to the questionnaire, and 87.7% of the respondents were aged less than 30 years (76.6%) and four-year graduates (86.0%). Typically, 108 (63.2%) were candidates for the pharmacist's specialty certificate, and the remaining 63 (36.8%) were not enrolled. Considering the field of specialty with overlapping, the total number of certificated patients was 140 (26.3% of the total of 532 in 2016). The results of the reliability analysis of the specific questionnaire showed that the Cronbach's ${\alpha}$ value was over 0.78. There was no significant difference in customer directionality between the two groups. However, there was a significant difference (p<0.05) with respect to overall knowledge about the treatment process, drug efficacy, and side effects, information about medicines and adverse drug reactions, and in providing appropriate information to medical staff including patients and physicians. Conclusions : The pharmacist with specialization showed a positive result of self-evaluation of items such as knowledge about drugs, communication of information on medications, and service provision, compared to other pharmacists, and the result was in correlation with the numbers of specialization. There was no difference in job satisfaction related to working environment. Henceforth, it is hypothesized that there is a necessity for continuous improvement in the working environment to suit the purpose of the pharmacy specialist system.