Entecavir (Baraclude(R), Bristol-Myers Squibb) is a potent and selective antiviral agent that has demonstrated efficacy in patients with chronic hepatitis B. The most frequent adverse events attributed to entecavir include increased alanine aminotransferase, upper respiratory tract infection, headache, abdominal pain, cough, pyrexia, fatigue, and diarrhea. Although quite a few randomized double-blind studies including ones investigating adverse events along with these general symptoms have been reported, few cases of cutaneous adverse events have been described in detail. We demonstrate a case of granulomatous drug eruption as a cutaneous adverse event induced by entecavir.
Abdominal Pain ; Alanine Transaminase ; Cough ; Diarrhea ; Double-Blind Method ; Drug Eruptions* ; Fatigue ; Fever ; Guanine ; Headache ; Hepatitis B, Chronic ; Humans ; Respiratory Tract Infections

Purpose: With the release of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for HumanUse E6 addendum, it is very important to establish risk-based quality management systems which meet good clinical practice.The aim of this research was to propose for risk-based quality management practices in the organizations that conduct clinicaltrials in South Korea. Materials and Methods: The survey participant pool consisted of domestic or multinational pharmaceutical companies and fullserviceclinical research organizations operating in South Korea that had one or more clinical trials approved by the Korean Ministryof Food and Drug Safety in 2018. Results: Of the 97 selected companies, a total of 61 companies completed the survey. A total of 42 companies (68.9%) had employeesdesignated to quality management activities. The minimum and maximum numbers of dedicated personnel for quality managementwere one and 12, respectively, and the average was three. Regarding the role of quality management personnel in companies,standard operating procedure management, issue/corrective action and preventive action (CAPA) management, and preparinginspection were selected the most (81%). The system considered to be the most important for risk management was monitoring system(41 companies, 67.2%), followed by both vendor management and CAPA management systems (17 companies, 27.9%). Conclusion In the future, organizations conducting clinical and subsequent pilot studies trials in South Korea should followthese quality management practice to share information with each other.

BACKGROUND/AIMS: Despite increased demand for cancer patient's to make their own decisions based on an adequate understanding of what is involved in chemotherapy, the primary signing agent and the reasons for surrogate signing have not been appropriately evaluated. METHODS: The ethics committee of the palliative medicine subgroup of the Korean Cancer Study Group designed this study and solid cancer patients to whom chemotherapy was offered, from seven institutions, were evaluated. The details relating to surrogate's signing of chemotherapy consent were evaluated. Then, we analyzed the factors associated with surrogate's signing according to patient's demographics and characteristics related to chemotherapy consent. RESULTS: Surrogate's signing was noted for 20.7% (84/405) of patient and over half of surrogate signings were performed by the patients' son or daughter (60.7%). Two main reasons for surrogate signing were patient's incapacity (34.5%) and taking over authorization from patients (33.3%). The factors associated with more frequent surrogate's signing were absence of spouse, lower education level, outpatient, and when residents played a role as a principle provider of chemotherapy consent. CONCLUSIONS This study suggests the lack of patients' own decision making for chemotherapy in some situations. This ethical dilemma must be considered for adequately informed decision making for chemotherapy while ensuring the patients' autonomy is maintained.