• 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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• 제28권4호
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• pp.263-272
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• 2018

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

• 한국임상약학회지
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• 제28권4호
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• pp.342-346
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• 2018

Background: Green tea extracts are approved as nonprescription drug and available as health functional foods, health foods, and beverages. Clinical information on the products is lacking. Methods: Information about the products on green tea nonprescription drugs was obtained from the website of the Korea Pharmaceutical Information Center. The Naver, i.e., a top ranking online search portal, was used for compiling the list of the health functional food products using key words of 'green tea catechin' on August 23, 2018. The recommended daily dosages of catechins were calculated as 30% of the total dried mass of green tea and about 50% of the catechins were considered as epigallocatechin gallate (EGCG). Results: A total of two types of nonprescription drugs containing green tea powder or extracts, nine health functional food products, and three types of health foods were found. The regulatory requirements of the EGCG exceeding 800 mg were reported to be associated with adverse effects of elevated liver enzyme. If consumers take several green tea products concurrently, such as nonprescription drugs with health functional foods or health foods, it could exceed the recommended amount of EGCG. Conclusion: The concurrent use of green tea products as nonprescription drugs, health functional foods, and healthy foods may lead to an increased exposure to EGCG. Pharmacists should be aware the availability of various types of green tea products and the potential risk of liver toxicity due to excessive consumption of EGCG.

• 대한임상독성학회지
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• 제16권1호
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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.

• 한국임상약학회지
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• 제26권4호
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• pp.324-329
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• 2016

Background: With the development of information and communication technology, there is a growing number of people looking for health information on the internet. This pilot study was performed to analyze the pattern of pharmacist consultation on the internet portal site. Methods: Questions and answers posted on the portal site "Naver Jisik-iN" from March 1st to 31th in 2016 were collected. Medications asked were categorized into prescription drugs, nonprescription drugs, sanitary aids, emergency drugs, functional health foods, and others. Medications were subcategorized into 14 according to the anatomical therapeutic chemical classification system. Questions were divided into 10 categories based on Hepler's drug-related problems. Results: Of the 955 cases, females accounted for 59.5% and inquirers from 11 to 40 years old, 89.4%. The number of prescription drugs, nonprescription drugs, sanitary aids, emergency drugs, functional health foods, and others were 428 (44.8%), 328 (34.3%), 31 (3.3%), 2 (0.2%), 122 (12.8%), and 44 (4.6%), respectively. Questions for drugs acting on alimentary tract and metabolism took up 27.4% followed by those on nervous system, 13.6% and anti-infectives for systemic use, 12.2%. Pharmacist consultation regarding drug information, drug interaction, and adverse reaction occupied 47.9%, 15.2%, and 12.3%, respectively. Conclusion: Health counseling through online is predicted to increase steadily, so pharmacists should broaden their boundaries beyond off-line pharmacies to meet social needs.

• 한국임상약학회지
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• 제24권1호
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• pp.45-52
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• 2014

Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.

• 약학회지
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• 제55권5호
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• pp.432-439
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• 2011

The effects of characteristics of community pharmacists on consultation time for prescription (RX) and nonprescription drugs (nRX) were investigated. A crosssectional descriptive design was established with a self-administered anonymous mail survey. Response rate was 52%. Significant pharmacists' factors related to having less than 3 minutes consultation for RX were one's dispensing duties exceeding 50%, low satisfaction with one's own level of consultation, working at the pharmacies nearby clinics, or shorter duration of consultation time for nRX. Consultation promoting conditions should be built up for the provision of sufficient consultation.

• 대한지역사회영양학회지
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• 제3권1호
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• pp.76-93
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• 1998

Three hundred sixty-two(male 131, female 231) elderly aged over 65 in Chungb- uk area were interviewed to determine the disease states and drug usage patterns. The prebalence of disease was 78% and women reported more chronic diseases(83%) than men(71%). Elderly who live with spouse and have an occupation have a lower rate of disease. Average number of diseases of the elderly was $1.8\pm{1.1}$, and women$(2.1\pm{1.3)}$ have significantly higher average number of diseases than that of men$(1.4\pm{0.7)}$. Also the elderly in urban areas$(2.1\pm{1.4)}$ have significantly higher number of diseases than that of the elderly in rural areas$(1.6\pm{0.9)}$. Arthritis, hypertension, cardiovascular and gastric diseases were the most frequently listed chronic diseases in order for both men and women. Anemia and fracture of bone were relatively higher in women than in men. Particularly, the arthritis of the urban elderly have a rate of 1.5 times higher than that of the rural elderly. Fifty-two percent of the elderly were currently using drugs ; among drug users 71.2% used prescription drugs and 20.5% used nonprescription drugs. The average number taken per person was 2.1$\pm$1.4 and there was no sex or age difference. However, the elderly in rural areas $(2.7\pm{1.7)}$ consumed a significantly higher number of drugs than those in urban areas$(1.7\pm{0.7)}$. The average number of prescripti- on drugs taken was 2.0$\pm$1.4 while the average of nonprescription drugs taken was $(1.3\pm{0.6)}$. Analgesics and antihypertensive drugs were most commonly used. Vitamin and analgesics were the most frequently used self-prescribed drugs. It was noted that potential adverse drug interaction by concominant drug consumption for arthritis and antihypensive drug, abuse of digestants and antiacid without treatment of the underlying disease, and misuse of quick-acting bowel medications were problematic for the elderly. In addition drugs used for the elderly have some adverse effect on the digestive system. The types and composition of drugs used by the elderly were identified and presented. Medication compliance was poor and 13.5% reported adverse reactions such as edema, heartburn, nausea, and difficulty with eating. Seventeen percent of the elderly obtained drugs arranged by those other than medical staff. Also, even among those elderly who obtained drugs prescribed by a doctor, 69.1% of subjects had not receive instruction about potential adverse reactions. These results suggest that nutritional problems related to drug usage might exist and so dietitians, either individually or as members of health teams, need to have a better understanding of drug-nutrient interaction and closer supervision, and drug information/education service should therefore be provided to prevent or minimize adverse drug reaction in elderly users of medication.

• 정신신체의학
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• 제26권2호
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• pp.172-178
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• 2018

연구목적 본 연구에서는 독거노인에서의 비처방 일반의약품의 사용행태를 조사하고 그 예측 인자를 확인하고자 하였다. 방 법 본 연구는 일 지역에 거주하는 독거노인 1,099명을 대상자로 시행되었다. 비처방 일반의약품의 사용행태, 인구사회학적 정보, 신체 건강상태(Cumulative illness rating scale, CIRS), 인지기능, 기분 장애 등을 자가설문지와 훈련된 간호사의 면담을 통해 조사하였다. 통계분석은 비처방 약물 사용행태나 인구학적 변인에 대해서는 기술적 통계분석을 시행하였으며 비처방 약물 사용과 관련된 예측인자를 확인하기 위해 로지스틱 회귀분석을 사용하였다. 결 과 전체 대상자의 35.4%가 비처방 약물을 복용하고 있었으며 진통제는 가장 많이 처방되는 약물로서 비처방 약물 복용군의 38.3%가 진통제를 처방받았다. 우울증(OR=1.44, 95% CI=1.10~1.87)과 누적질환평가척도(Cumulative illness rating scale, CIRS)로 측정한 신체건강 중증도(OR=1.08, 95% CI=1.03~1.12)가 비처방 약물 사용과 유의한 상관성이 있었다. 결 론 독거노인에게서 우울장애와 신체건강 중증도는 비처방 약물 사용의 예측인자가 될 수 있으며 임상가는 노인의 비처방 약물의 사용에 대해 주의를 기울여야 한다.

• 대한임상독성학회지
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• 제16권2호
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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.