• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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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.

• Journal of Pharmaceutical Investigation
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• v.36 no.4
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• pp.239-243
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• 2006

Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

• YAKHAK HOEJI
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• v.60 no.3
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• pp.146-153
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• 2016

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.

• Journal of Yeungnam Medical Science
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• v.37 no.4
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• pp.277-285
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• 2020

Tuberculosis (TB) is still a major health problem worldwide. Especially, multidrug-resistant TB (MDR-TB), which is defined as TB that shows resistance to both isoniazid and rifampicin, is a barrier in the treatment of TB. Globally, approximately 3.4% of new TB patients and 20% of the patients with a history of previous treatment for TB were diagnosed with MDR-TB. The treatment of MDR-TB requires medications for a long duration (up to 20-24 months) with less effective and toxic second-line drugs and has unfavorable outcomes. However, treatment outcomes are expected to improve due to the introduction of a new agent (bedaquiline), repurposed drugs (linezolid, clofazimine, and cycloserine), and technological advancement in rapid drug sensitivity testing. The World Health Organization (WHO) released a rapid communication in 2018, followed by consolidated guidelines for the treatment of MDR-TB in 2019 based on clinical trials and an individual patient data meta-analysis. In these guidelines, the WHO suggested reclassification of second-line anti-TB drugs and recommended oral treatment regimens that included the new and repurposed agents. The aims of this article are to review the treatment strategies of MDR-TB based on the 2019 WHO guidelines regarding the management of MDR-TB and the diagnostic techniques for detecting resistance, including phenotypic and molecular drug sensitivity tests.

• Journal of Korean Academy of Nursing
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• v.48 no.3
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• pp.255-265
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• 2018

Purpose: The purpose of this study was to analyze the effect of emergency contraceptive pill on adolescent sexuality and contraceptive behaviors through a meta - analysis of intervention studies on advance provision of emergency contraceptives. This study aimed to provide objective data on the transition of general medicines to be discussed in relation to the reclassification of emergency contraceptive pills. Methods: Using electronic database, 1,820 studies written in Korean or English without limitation of the year were reviewed and for analysis, 5 studies were selected, in which emergency contraceptives were provided to adolescents. Results: The advance provision of emergency contraceptives has increased their use and shortened the time it takes to take contraceptive pills after unprotected sex. There was no change in the frequency of engaging in sexual intercourse and unprotected sex or in existing contraceptive behavior, pregnancy rates decreased, but there was no increase in sexually transmitted infection. Conclusion: The results of this study provide objective grounds for the reclassification of emergency contraceptive pills and propose effective interventional programs on contraceptive education, such as on efficacy and side effects of the contraceptive drug and its proper use among the youth who engage in sexual activity, to improve their reproductive health.

• The Korean Society of Law and Medicine
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• v.12 no.2
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• pp.265-291
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• 2011

Changes in a drug's availability from prescription only to over-the-counter (OTC) status is of concern to physicians from both public health and individual patient perspectives. Government has generally been supportive of changes in medications from prescription(Rx) to over-the-counter (OTC) status in Korea, however, recognizing that there are both benefits and risks to any health care intervention, health care professionals are conservative in implementing changes to either the process or structure of health care. Changes in status of a drug from Rx to OTC can represent a change in both structure and process. Cost and convenience seem to be major factors in determining whether, given the choice, patients purchase a medicine over the counter or obtain it on prescription. With current arrangements, exemption from prescription charges provides an incentive to continue to obtain products on NHS prescription even when they are available over the counter. There is therefore no simple relation between the availability of over the counter medicines and the level of prescribing of deregulated products. The appropriate use of over the counter medicines-particularly those that have only recently been deregulated-places a burden of care on community pharmacists and calls for closer working relationships with general practitioners. In particular, systems for referral and for recording details of both prescribed and over the counter medicines need to be developed, and a direct route needs to be established for community pharmacists to report adverse drug reactions to over the counter products. Reclassification of prescription medicines-by making them available through pharmacies without a prescription-provides the opportunity for consumers to purchase a wider range of medicinal products without making a demand on NHS resources. There is, however, no simple relation between availability of over the counter medicines and demand for NHS prescriptions. In the late 1980s the UK government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. To explore the influence of deregulation of medicines on NHS prescribing, this article presents analyses of consumer behaviour in using medicines and prescribers' attitudes to over the counter medication and collates findings from research. Policy makers should be aware that patients' expectations in relation to OTC medicines may be in conflict with evidence-based practice.