• 한국임상약학회지
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• 제30권4호
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• pp.226-233
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• 2020

Background: Currently, the over-the-counter (OTC) drug market is flooded with series OTC products. The pharmacist must follow the OTC product's indication, given that the most critical role of a pharmacist is the right selection and recommendation of an OTC drug for a patient's symptoms in a dynamic pharmacy environment. Therefore, pharmacists must know each OTC product information precisely to avoid any ambiguity due to several OTC series brand names. Objective: We evaluated the risk and effectiveness of OTC series medicines. Methods: From December 5 to December 18, 2019, an online survey was conducted among 145 community pharmacists. Results: A total of 51.0% of pharmacists knew the difference between products named in a series and could explain it spontaneously. Only 0.7% of the pharmacists admitted to not knowing the difference between products named in a series. While 42.9% of pharmacists who owned a pharmacy opined that the OTC medicines named in a series have health benefits for patients, 50.0% of employee pharmacists admitted that they were rather confused because there are several OTC series medicines. In contrast, 69.2% of pharmacists who owned pharmacies and 72.2% of employee pharmacists admitted that OTC series drugs with names similar to popular OTC drugs sell better. Conclusion: While pharmacists had different opinions regarding OTC series drugs per employment status, they opined that OTC series are more helpful in pharmacy management than completely new brand names. Further studies in this regard are needed.

• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• 한국임상약학회지
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• 제3권2호
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• pp.131-137
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• 1993

The effects of gastric acidity on the bioavailability of scopolamine hydrobromide and ${\ell}$-hyoscya-mine were studied in rabbits. Each drug was administered orally at dose of 0.2mg/kg to gastric acidity controlled rabbits. The plasma concentration of scopolamine and ${\ell}$-hyoscyamine were determined by selected ion monitoring in GC/MSCScopolamine; m/Z= 138, ${\ell}$-Hyoscyamine; m/z= 124). Rabbits with hypoacidity showed significantly higher Cp and AVC than rabbits with hyperacidity after oral administration of each drug. From the results of this experiment, it is desirable that dosage regimen of dose of scopolamine and hyoscyamine should be adjusted when the drugs should be administered with antacids in clinical practice.

• 대한한의학방제학회지
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• 제12권1호
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• pp.123-130
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• 2004

Aconiti Root(AR), has been used for about 2000 years, since recorded for low grade in 'Shinnongbonchokyung(Divine Husbandman's Herbal Foundation canon)'. It also recorded for Poisonous Drug in 'Myunguibyullok', 'Yaksungron', etc, and they advised when the AR is using for clinical desease it has to be processed. There are more than 13 processing methods, in records that related 39 parts which is recorded in ancient documents. In China, there are no standard of herb that using for clinical, cause of the traditional processing methods was cut since 1960s. In these days, they are using AR that recorded in Aconiti Tuber part of the processing records, in Guangdong and Shantung. In addition, the modification of Processed Aconiti Root(PAR) is also used for goods in Hongkong, Macao, and Southeast Asia. We studied the PAR for enhancing the importance of it, and multiply using. In this study, we search for the history of processing of AR, traditional theories of processing and clinical adaptation.

• Clinical and Experimental Vaccine Research
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• 제13권3호
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• pp.259-262
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• 2024

There have been many studies on the adverse effects of coronavirus disease 2019 (COVID-19) vaccines but the urinary incontinence after COVID-19 vaccination is rare. Here, we report an 8-year-old boy presented to outpatient department, Thai Binh University of Medicine Hospital, Thai Binh, Vietnam with complaints of urinary incontinence for the past 2 weeks, following the first dose of the messenger RNA vaccine. He had no other abnormalities in clinical and laboratory exams. This clinical situation suggested vaccine side effects. No specific treatment was administered upon diagnosis without toilet and bladder training. Subsequent monitoring revealed a gradual reduction in symptoms over 2 months, with complete recovery achieved at the 14th week from the onset of symptoms, without necessitating any medical intervention. This case highlights the need for thorough evaluation and assessment of potential adverse effects following vaccination, including uncommon presentations.

• 한국임상약학회지
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• 제24권4호
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• pp.288-295
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• 2014

Background: The pharmacy education system in South Korea has changed from four-year degree program to two-year pre-pharmacy program plus four-year professional degree program (a total of six years) since 2009. Objectives: The purpose of this study is to assess final year student's satisfaction on this new pharmacy education system and to explore factors related to student satisfaction. Methods: A paper-and-pencil survey instrument was administered to all final year pharmacy students at four universities located in South Korea during September of 2014. The self-administered questionnaire contained 39 items. In part 1, the quality of education with regards to school utilities, education system, human resources, and communication domains were measured. In part 2, overall satisfactions with the new education system were asked to students. Responses were recorded on a seven point Likert scale. Results: A total of 207 students were participated in this study. Students showed low satisfaction on school utilities and standardization of education while they displayed high level of satisfaction on the quality of the faculty members and preceptors at clerkship sites. Factor analysis showed that education service was the most significant factor that affects students' satisfaction followed by facilities, standardized education, communication, administration, pharmacy practice (p<0.05). Conclusion: The qualification of faculty and preceptors ranked number one in students' satisfaction and it was the most significant factor. School facilities were found to be the second most significant factor in students' satisfaction while students displayed poor satisfaction. The study results might need to be reflected in future education planning to improve students' satisfaction.

• 한국임상약학회지
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• 제22권1호
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• pp.21-29
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• 2012

Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.

• 한국임상약학회지
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• 제21권1호
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• pp.36-38
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• 2011

We report an unusual case of respiratory depression and prolonged apnea after the second dose of 100-mg intravenous tramadol. Due to continuous pain at foley catheter keep site, intravenous tramadol was administered to the patient. Soon after the second dose of tramadol injection, the patient became apneic. The patient did not respond to verbal command and started exhibiting oxygen desaturation. The patient was quickly treated with 100% oxygen, and it took 4 hours for the spontaneous respiration to return to regular. This case report demonstrates that even two doses of tramadol administered intravenously may manifest as sudden and prolonged apnea. Respiratory depression with tramadol has been reported in patients with impaired renal functions and Cytochrome P(CYP) 2D6 gene duplication.

• 한국임상약학회지
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• 제21권3호
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• pp.276-279
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• 2011

We report an unusual case of lupus flare induced by intravenous vancomycin in a patient with systemic lupus erythematosus. Due to methicillin resistant staphylococcus aureus in wound culture, intravenous vancomycin was administered to the patient. The patient had been on vancomycin for several days then she experienced fever, malar rash, and vomiting. Based on laboratory results, it was confirmed as lupus flare. Oral prednisolone was given to the patient for symptom control. However, when vancomycin was readministered, the patient had similar symptom to the previous one more intensively. Vancomycin was stopped then the patient became stable. This case report demonstrates that intravenous vancomycin may manifest as lupus flare in patients with systemic lupus erythematosus.

• 한국임상약학회지
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• 제22권3호
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• pp.274-282
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• 2012

현재 HIV(human immunodeficiency virus) 감염에 대하여 보다 많은 효과적인 약물치료법이 가능하다. Highly active antiretroviral therapy (HAART)로 언급되는 이 치료법은 항 HIV치료제의 다양한 병용법으로 구성된다. 그러나, 최근에 이렇게 치료된 환자들에게 중요한 독성들(toxicities)로서 빈번하게 상당한 지질이상과 혈중당의 항상성 조절장애와 연관된 몸의 지방 분포 비정상으로서 나타나는, 광범위한 대사성 합병증(metabolic complications)이 출현해왔다. 이러한 합병증의 관리는 표준적인 치료 중재(interventions)와 연관하여 지질과 당 대사와 관련된 항 HIV치료제의 특성 있는 효과를 이해하면서, 항 HIV 약물들을 조절하는 것을 포함한다. 본 증례는 항HIV 약물요법과정에서 나타난 상당한 지질 이상, 매우 높은 LDL 수치와 높은 TG수치에 따르는 후속 약물요법을 보여주며, 개별화된 항 HIV 약물요법을 수행하면서, 대사성 합병증에 관련된 수치의 검사와 주기적인 약물치료과정의 모니터링을 권하여 HIV에 감염된 환자들의 효과적인 치료를 향상시키기 위한 것이다.