• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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• pp.127-138
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• 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.

• Korean Journal of Food Science and Technology
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• v.43 no.5
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• pp.641-647
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• 2011

Polyphenols in green tea are biologically active and may interact with commonly-consumed over-the-counter (OTC) drugs in the body. In this study, modulation of cytotoxicity of polyphenon 60 (PPE, tea polyphenol mixture) with co-treatment of several OTC drugs, including ibuprofen (Ibu), acetaminophen (AAP), and aspirin was investigated in intestinal cells. PPE showed more potent cytotoxic effects on colon cancer HCT 116 cells than on normal intestinal INT 407 cells. Ibu had the strongest cytotoxic effects on both cell types. Cytotoxicity of PPE on HCT 116 and INT 407 cells was not markedly altered by co-treated OTC drugs. Cytotoxicity of the OTC drugs was not affected by PPE. When HCT 116 cells were incubated with AAP before or after PPE treatment, cytotoxicity was slightly enhanced more than their additive effect. The present study may provide basic information of possible toxicity due to interaction of the polyphenols and the OTC drugs.

• International Journal of Human Ecology
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• v.12 no.2
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• pp.1-12
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• 2011

Many pharmaceutical products are available through prescription (Rx) only status. As a result, access to physicians and insurance coverage play a key role in the use of these products, and therefore may affect the population to whom advertising is targeted at. The movement of pharmaceutical products from prescription (Rx) to Over-the-Counter (OTC), or Rx-to-OTC switch changes the cost of acquiring the drug and therefore may change the incentives manufacturers have at targeting particular population segments. This study examines whether Rx-to-OTC switch changes the frequency and the distribution of who is exposed to pharmaceutical advertising. Using an archive of pharmaceutical advertisements and National Consumer Survey, this study examines how individuals with particular demographic characteristics are exposed to pharmaceutical advertisements before and after drugs are moved from Rx to OTC. The results provide evidence that individual's advertising exposure increases after Rx-to-OTC switch. Moreover, the increase in advertising exposure is greater for the low socioeconomic status (SES) consumers which implies they may get more information about the disease, treatment and product after the Rx-to-OTC switch through advertising. If low SES consumers have more exposure to the advertising after products switched to OTC, then FDA policies regulating this switch should recognize the potential role of advertising providing access to health-related information.

• Journal of The Korean Society of Clinical Toxicology
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• v.16 no.1
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• pp.42-48
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• 2018

Purpose: On November 15, 2012, sales of OTC (Over-The-Counter) drugs began at convenience stores, which changed the accessibility of some drugs. As a result, the exposure and access patterns of these drugs could have changed. In this study, we reviewed the changes in the characteristics of drug poisoning patients because of the reposition of nonprescription drugs according to the revised Pharmaceutical Affairs Act. Methods: A retrospective study was conducted to evaluate changes in characteristics of drug poisoning patients between 2008 and 2016. A registry was developed by an emergency medical center in a local tertiary teaching hospital, and patients who visited the center were enrolled in this registry. We compared two periods, from 2008 to 2012 (Pre OTC) and from 2013 to 2016 (Post OTC), for type of intoxicant, time from poisoning to visiting the emergency center, intention, psychiatric history, previous suicidal attempt, alcohol status, and emergency room outcomes. The primary outcome was the number of patients who took acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Secondary outcomes were ICU admission rate, mortality rate, and number of patients who visited the ER when the pharmacy was closed after taking acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Results: Among 1,564 patients, 945 and 619 patients visited the emergency room during pre and post OTC periods. The number of patients with acetaminophen and NSAIDs poisoning decreased from 9.2% to 6.1% (p=0.016). The ICU admission rate and mortality rate in the emergency room did not show significant results in the relevant patient groups, and so was the number of patients visiting ER when the pharmacy was closed taking acetaminophen and NSAIDs. Conclusion: Despite the sales of nonprescription drugs at convenience stores, the number of acetaminophen and NSAIDs poisoning patients decreased.

• The Korea Journal of Herbology
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• v.30 no.5
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• pp.75-83
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• 2015

Objectives : The aim of this study was to find how Northeast Asia(Korea, China, Taiwan, Japan) supervise herbal formulas in their pharmacopoeia.Methods : We compared items, formula's effects, formulations, etc and analyzed common formulas among Northeast Asia`s herbal pharmacopoeia (Korea(2010), China(2010), Taiwan(2013), Japan(16th Edition), drugs in Japan OTC Drugs (2007-2008))Results : The Korean Pharmacopoeia, the Korean Herbal Pharmacopoeia, Taiwan herbal pharmacopoeia, the japanese pharmacopoeia, drugs in Japan OTC drugs and pharmacopoeia of the People's Republic of China have 5, 251, 200, 20, 294, 1059 formulas, respectively. In comparison of pharmacopoeia`s test item, Korea and Japan has many similarity, for example, not refer to the effect of formulas. Korea and China have many inspection test of formulations in pharmacopoeia. Each country has differences in ratio of efficacy categories. For example, China especially has a higher ratio of formulas that regulate the blood and Korea has higher ratio of formulas that calm the spirit and open the sensory orifices than those of other 3 countries. There are 17 common formulas among the 4 countries and 43 common formulas among Korea, Taiwan and Japan. Comparing dosage forms, Korea, Japan, Drugs In Japan OTC drugs, Taiwan, China uses 4, 2, 14, 3, 21 formulations, respectively.Conclusions : China has many formulations and new formulas. Taiwan and Japan supervised formulas only selected by the authorities. However, Korean pharmacopoeia has similar form with Japan and need to add more formulas on demand and new formulations.

• YAKHAK HOEJI
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• v.53 no.6
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• pp.334-341
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• 2009

Aging society and aged society are determined by the component ratio of the elderly to the whole population; aging society is defined as a society whose ratio of the elderly population is less than 7%, and it is called aged society when the ratio is over 14%. Korea's aging process is so fast and unprecedented over the world according to many statistical data and investigations. The purpose of this study was to provide guidance and basic data to educate the elderly for the proper use of medication and health functional food. This study was carried out on 80 subjects of age 65 or older in Cheong Jusi in Choogncheongbuk-do. They answered questionnaire that was prepared for this study. The data were collected from August 4, 2008 to August 18, 2008. The collected data were analyzed by using the SPSS 12.0OK (for window) program and Microsoft EXCEL. The following is a summary of the results of this study. First, in the aspect of purchasing, the majority of respondents bought OTC drugs and health functional food for health and illness prevention. Purchasing places of drugs were diverse. Second, in the aspect of taking drugs, the older answerers were, the higher the number of drugs being taken was. Third, in the aspect of proper storage of drugs, most respondents have no specific spaces. Finally, regarding recognition of drug abuse and disposal, most people have little awareness or have no idea.

• Journal of The Korean Society of Clinical Toxicology
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• v.16 no.2
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• pp.141-148
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• 2018

Purpose: The Korean government approved selected nonprescription drugs (Over-The-Counter drug; OTC drug) to be distributed in convenience stores from 15. Nov. 2012. This study examined the changes in the incidence and the clinical outcome of acute pharmaceutical drug poisoning after the deregulation of OTC drug sales. Methods: This study analyzed the data of Emergency Department based Injury In-depth Injury Surveillance (EDIIS), Korea Centers for Disease Control and Prevention, from 2011 to 2014. The following items were examined: age, gender, intention, alcohol association, pharmaceutical drugs resulting acute poisoning, the clinical outcomes in emergency department, and the admission rate of intensive care unit (ICU). This is a retrospective cross section observational study. Results: A total of 10,162 patients were subject to pharmaceutical drug poisoning. Acute poisoning by acetaminophen and other drugs were 1,015 (10.0%) and 9,147 (90.0%) patients, respectively. After the deregulation of OTC drug sales, acute poisoning by other drugs increased from 4,385 to 4,762 patients but acute poisoning by acetaminophen decreased from 538 to 477 patients (p<0.05). The rate of admission of acetaminophen poisoning increased from 36.1% (194/538) to 46.8% (223/477). The admission rate to the ICU by acetaminophen poisoning increased from 4.6% (25/538) to 11.3% (54/477) after the deregulation of OTC drug sales (p<0.05). Conclusion: Since the deregulation of OTC drugs sales, pharmaceutical drug poisoning has increased but acetaminophen poisoning has decreased. The rate of hospitalization and ICU admission by pharmaceutical drug poisoning with or without acetaminophen has also increased.

• Proceedings of the Korea Environmental Mutagen Society Conference
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• 2004.11a
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• pp.26-31
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• 2004

• Proceedings of the Korea Environmental Mutagen Society Conference
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• 2004.11a
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• pp.32-34
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• 2004

• Proceedings of the Korean Society of Toxicology Conference
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• 2004.11a
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• pp.26-31
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• 2004