지역약국에서 보고된 전문의약품과 일반의약품의 이상사례 보고현황 비교 분석

이모세,박소희,김나영,오인선,이정민,이의경,신주영 한국임상약학회 2018 한국임상약학회지 Vol.28 No.3

Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs fromcommunity pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reportingdatabase, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Associationbetween January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-thecounterdrugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, seriousadverse events, and causality assessment results, where causality assessments were performed according to the World HealthOrganization-The Uppsala Monitoring Centre’s system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counterdrugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the mostfrequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, “possible” (75.4%) wasthe most commonly assigned category for ethical-the-counter drugs, while “possible” (44.0%) and “unlikely” (47.7%) were the mostcommon categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-thecounterand over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptomsfor both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse eventcharacteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.

근·현대사 이후 한국인의 최다 선호 일반의약품의 추이에 대한 연대별 분석 및 종합적 의의에 대한 평가

이윤정,강태진,임성실,Lee, Yun Jeong,Kang, Tae Jin,Lim, Sung Cil 대한약학회 2016 약학회지 Vol.60 No.3

Over-the-counter (OTC) drugs refer to medicines that are generally safe when used according to the product label. We aimed to assess and reflect upon changes in perception of health and health-related demands by decades in Korea according to the consumption and sales trends of OTC drugs. This study was conducted by literature search on the production and sale rankings of OTC drug market in Korea. Changes in the OTC drug market were analyzed and organized by decades to evaluate changes in drug demands and the influence of national and societal factors. There was a specific trend in the most popular drugs by decades. In the 1950s, drugs of top necessity were antibiotics and helminthics. In the 1960s, the pharmaceutical industry quickly grew and invigorators, such as Bacchus$^{(R)}$, Alps$^{(R)}$, Aronamin$^{(R)}$, were top manufactured drugs. Popularity of these invigorating drinks and vitamin products continued until the 1990s. In 1990s, sales of topical nonsteroidal anti-inflammatory drugs (Ketotop Plaster$^{(R)}$, Trast Patch$^{(R)}$), and in 2000s, gum disease medicine (Insadol$^{(R)}$) and liver and intestine supplement (Ursa$^{(R)}$) were prominent. However, after the separation of prescribing and dispensing in 2000, the sales of OTC drugs decreased dramatically from 58.7% of the total market share in 1990s to 39.6% in 2000 and this trend has continued. In 2012, thirteen OTC drugs were allowed to be sold in convenience stores, and as the sales of health functional foods have been expanding beyond pharmacies, sales of invigorators and nutritional supplements in pharmacies have continued to decrease. As government's drug expenditure will continue to grow, reclassification of OTC drugs based on established safety information and deliberate team efforts on continued development of OTC drugs to meet the health demands of Koreans are required by the healthcare professionals, pharmaceutical industries, and the government.

안전상비의약품 판매 이후 중독환자 특성 변화

김창영,이의중,이성우,김수진,한갑수,Kim, Chang Yeong,Lee, Eui Jung,Lee, Sung Woo,Kim, Su Jin,Han, Kap Su 대한임상독성학회 2018 대한임상독성학회지 Vol.16 No.1

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.

의약품의 분류에 따른 약사의 주의의무와 일반의약품 약국외 판매(OTC 판매)의 허용가능성

백경희(Baek, Kyoung Hee) 인하대학교 법학연구소 2011 法學硏究 Vol.14 No.2

우리나라의 현 의약품 분류체계는 전문의약품과 일반의약품으로 나뉘는 2분류 체계이고 의약품은 약국에서 약사만이 판매할 수 있도록 되어 있다. 전문의약품은 의사의 처방을 통해서만 이루어지고 있으므로 의사와 약사 사이의 의약분업과 신뢰의 원칙과 연계되어 있고, 일반의약품은 자가요법의 개념이 주가 되어 환자의 자기결정권의 영역이므로 약사의 개입이 전문의약품에 비하여 상대적으로 약화되는 특성이 있다. 그런데 우리나라의 현 의약품 2분류 체계 하에서 최근 일부 일반의약품을 약국이 아닌 곳에서 판매할 수 있도록 하는, 약국외 판매(이하 OTC 판매) 제도의 도입과 관련하여 찬반의견이 대립하고 있다. OTC 판매 제도는 미국을 중심으로 유럽, 그리고 일본에서 각국의 특성에 맞게 제도에 변형을 가하면서 발전해 왔는데, 우리나라도 과거와 달리 국민의 의약품 정보에 대한 접근성이 높아지고 자가요법이 대중화됨에 따라 OTC 판매 제도를 우리나라의 현실에 맞게 도입하자는 움직임이 거세어 진 것이다. 본고에서는 위와 같은 전문의약품과 일반의약품의 특수성에 의거하여 약사의 주의의무를 살펴본 후 일반의약품 OTC판매의 우리나라에의 도입가능성을 살펴본 후 OTC 판매 후에 따른 부작용에 대한 대응방안을 제시하고자 하였다. 특히 의약품 분류 및 그에 의거한 약사의 주의의무, OTC 판매 제도의 도입과 향후 제도개선의 방향은 모두 국민의 입장에서 의약품에 관한 접근성을 제고하여 건강권을 확보하여야 하는 거시적인 측면에서 고찰되어져야 할 것이다. Current drug classification system in Korea has two category, which is consist of prescription and nonprescription-drugs, and drugs must be sold by pharmacist in pharmacy. Prescription-drugs by the doctor’s prescription is linked to the principle of treatment-pharmacy professional policy and reliability, and nonprescription-drugs, which is involved in the selfmedication and the right of self-determination of patient, is characterized by a weak pharmacist’s assistance. Sales of over-the-counter (OTC) drug have been implemented in USA, EU, and Japan and been established in various OTC sales forms, depending on the each nation’s chracteristics and culture. Recently, there was a sharp division of opinions about sales of a part of nonprescriptiondrugs at the outside of pharmacy between those who approve and disapprove. This thesis deals with an attention-duty of pharmacist on the basis of the distinct characteristics in prescription and nonprescription-drugs and possibility of introducing OTC sales, and then suggests the counterplan against side effect of implementation of OTC sales.

Intentional Death Caused by the Overdose of Nonprescription Drugs: An Autopsy Case of Acetaminophen Poisoning

김미림,이숭덕,김문영 대한법의학회 2020 대한법의학회지 Vol.44 No.3

Acetaminophen or paracetamol (N-acetyl-para-aminophenol [APAP]) is a safe and effective antipyretic and analgesic drug and is a representative nonprescription drug. However, APAP is one of the most common nonprescription drugs used for intentional overdose or suicide, thereby resulting in hundreds of deaths annually in the United States. Moreover, the misuse of nonprescription drugs is a cause of increasing concern in Korea with the revision of the Pharmaceutical Affairs Law in 2012. Generally, the mortality rate of APAP overdose is extremely low due to the well-established treatment guidelines and availability of antidotes. However, it should not be overlooked because of the high number of either accidental or intentional APAP overdose cases recorded every day. To achieve a good prognosis, individuals with APAP overdose must be immediately identified and brought to the hospital. Herein, we report an autopsy case of an individual with APAP overdose who died due to acute liver injury.

독거노인의 일반의약품 사용에 영향을 미치는 요인

윤여송,백기청,이경규,이석범,김경민,이정재 한국정신신체의학회 2018 정신신체의학 Vol.26 No.2

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 비처방약물 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 약물사용과 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. Objectives:This study aimed to describe the use of over-the-counter (OTC) drugs and to identify predictors for their use in the elderly living alone. Methods:This is a cross-sectional study that enrolled 1,099 subjects. Data regarding socio-demographic status, medical condition, cognition, mood disorder and use of OTC drugs were collected using self-administered questionnaire and from a specific semi-structured interview by a trained nurse. Data regarding use of OTC drugs were analyzed using descriptive statistics. Logistic regression analysis was applied to examine factors associated with the use of OTC drugs. Results:The use of OTC drugs were reported by 35.4% of the subjects. Analgesics (13.6%) was the most frequent drugs. Depression (OR=1.10, 95% CI=1.10-1.87) and comorbidities measured by cumulative illness rating scale (CIRS) (OR=1.08, 95% CI=1.03-1.12) were significantly associated with the use of OTC drugs in the elderly living alone. Conclusions:Depression and severity of underlying medical conditions could be a predictor of the use of OTC drugs in the elderly living alone. The clinicians should be vigilant regarding the potential use of nonprescription medications in the elderly.

일반의약품 포장 기재사항의 글자 크기별 가독성

이은주 ( Eun Joo Lee ),정인숙 ( Ihn Sook Jeong ) 대한보건협회 2014 대한보건연구 Vol.40 No.4

연구목적 : 일반의약품을 안전하게 사용하기 위해서는 사용자가 의약품의 포장 기재사항을 쉽게 읽고 이해할 수 있어야 한다. 본 연구의 목적은 일반의약품 포장 기재사항에 대해 글자 크기에 따른 가독성을 평가하고 일반의약품 포장 기재사항에 적합한 글자 크기를 확인하는 것이다. 연구방법 : 연구 대상은 20세 이상 79세 이하의 일반 성인 400명으로 동일한 크기의 5개 연령대(20-30대, 40대, 50대, 60대, 70대)로 범주화하여 구성하였다. 연구 도구는 구조화된 설문지이며, 대상자의 글자 크기별 선호도와 가독성은 글자 크기 6포인트, 8포인트 및 10포인트를 기준으로 평가하였다. 연구결과 : 대상자 366명이 설문지 작성을 완료하였다. 대상자들은 연령, 성별 및 교육수준의 차이에도 불구하고 큰 글자 크기, 즉 10포인트를 가장 선호하였고, 또한 10포인트에서 가독성이 가장 높게 나타났다. 결론 : 20세 이상 79세 이하의 일반 사용자에게 적합한 일반의약품 포장 기재사항의 글자 크기는 10포인트이므로 일반의 약품 포장 기재사항을 최소 10포인트의 글자 크기로 제작할 것을 권장한다. Objective : The package labeling should be readable and understandable for the safe use of nonprescription drugs. This study was aimed to investigate the readability and identify adequate font size for package labeling of nonprescription drugs. Methods : The study subjects were 400 adults between 20 and 79 years old composed of equal size in five age-category (20s to 30s, 40s, 5s, 60s, and 70s). The study instrument was self-administered structured questionnaire including preference and readability of drug labeling in 6, 8 and 10 point. Results : 366 participants completed the questionnaire. Participants preferred 10 point regardless of age, sex, or education level, showed the highest level of readability in 10 point. Conclusion : The adequate font size of drug labeling between 20 and 79 years old adults was 10 point, and we、 recommend the package labeling of nonprescription drugs should be at least 10 point.

국민의 보건권과 안전상비의약품 표시제도

손성구,권경희 위기관리 이론과 실천 2014 Crisisonomy Vol.10 No.8

헌법에 따라 모든 국민은 보건에 대하여 국가의 보호를 받을 권리가 있으며 국가는 국민 보건에 대하여 보호할 의무가 있다. 국가의 보호활동 중 건강을 위협하는 상품을 사전에 차단하거나 올바르게 사용될 수 있도록 하는 것은 각종 규제를 통해 이루어진다. 상품들 중에서도 식품과 의약품은 인체에 직간접적으로 적용되는 상품으로 보다 엄격한 규제가 가해지고 있다. 상품은 구성성분의 안전성도 중요하지만 목적에 맞게 올바르게 사용할 수 있는 정보를 제공하는 것도 또한 중요하다. 상품에 있어 이러한 정보전달을 하는 것이 표시이며, 의약품은 본질적으로 내포된 위험을 알리고 사용자가 그 위험을 방지할 수 있는 사용자 친화적인 최적의 표시가 되도록 해야 하는 만큼 다른 어느 상품에 비교해서도 표시에 대한 규제가 까다롭다. 의약품이 가지고 있는 위험성과 예방방법 등에 관한 사항은 의학, 약학 등 전문적인 지식이 필요한 내용이어서 일반 소비자가 표시사항만 보고 제대로 이해하기는 어렵다. 이러한 이유로 국가는 소비자와 상품 사이에 의사와 약사라는 전문가를 개입시켜 소비자를 의약품의 잠재적 위험으로부터 보호하고 있다. 의약품 중 위험성이 큰 그룹(전문의약품)과 위험성이 상대적으로 크지 않은 그룹(일반의약품)과의 보호정도가 다르다. 안전상비의약품 제도를 도입하면서 24시간 운영하는 편의점에서 소비자가 안전상비약을 직접 구매할 수 있게 되었는데 이는 소비자와 새로 분류된 의약품 사이에 소비자 보호를 위한 전문가를 더 이상 두지 않게 되었다는 것을 의미한다. 소비자와 의약품 간에 전문가 개입을 배제하는 것은 이에 상응하는 보호조치가 수반되지 않는다면 국민 보건에 대한 국가의 의무를 다하지 않은 것이 된다. 한편, 미국의 표시제도와 우리나라와의 차이점을 비교해 볼 때 2012년 11월 15일에 도입된 안전상비의약품 제도는 의약품의 잠재적 위험성으로부터 국민을 직접적으로 노출시키면서 이에 상응하는 보호조치를 수반하지 않아 국민 보건에 대한 국가의 의무를 저버린 헌법위반의 소지가 있다. According to the Constitutional Law, people have the right to be guarded by their country in matters that relate to public health and the country has the responsibility to guard the health of their people. Filtering bad products and setting a standard of testing the products in advance of public distribution is an important guarding activity of the country, which is executed through many regulations. Especially, Food and drug have the biggest effect on human health because they are used to influence the body’s physiological function. Therefore, there are strict regulations on them. The safety of ingredients of products is important, and providing information so that consumers can utilize this information properly is important as well. It is the label in a product that provides this important information. It is necessary to provide information about risks which are intrinsically included in a drug. Since the label is meant to be user friendly, the regulation on the drug label is very strict compared to other products. But, general consumers without professional knowledge about medicine and pharmacy have difficulty in understanding the risks and preventive method by using only the label. For that reason, the country forces experts to intervene between the consumers and the drug companies to protect consumers against potential drug risks. There have been 2 groups of drugs until the new system allowed for the selling of drugs in the CV store out of the pharmacy area. This means that there is no expert to protect the consumers against potential drug risks between the consumers and the new group. Eliminating experts intervening needs corresponding protection measures can be interpreted as discarding the country's duties towards people's health.

우리나라 현행 의약품분류체계에 대한 고찰 및 개선 방안

손현순,오옥희,김종주,이소현,변선혜,신현택 한국임상약학회 2005 한국임상약학회지 Vol.15 No.2

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.

비처방의약품 허가 제도의 국가별 비교 연구 및 고찰

김주희(Joo Hee Kim),이정,이관영,이경은,곽혜선 한국임상약학회 2018 한국임상약학회지 Vol.28 No.4

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducingexpenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individualconsumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry forqualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professionalopinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC MonographProcess. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment requiredwhen 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 withreference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of theregulatory framework and the requirements for nonprescription approval process in different countries, several ways to improveregulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.