• Proceedings of the PSK Conference
• /
• 2003.04a
• /
• pp.91-92
• /
• 2003

Virtually every state in US has adopted laws and regulations that mandate the generic substitution of brand-named prescription drugs in order to reduce sky-rocketing drug costs. In the late 1970s, many state governments began to recognize the need of generic substitution and requested Food and Drug Administration (FDA) to consult with this issue. FDA did consult which drugs were interchangeable each other based upon the available scientific and experimental evidences given to the agency along with New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). (omitted)

• Korean Journal of Clinical Pharmacy
• /
• v.16 no.2
• /
• pp.96-100
• /
• 2006

Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towards doctors working at local clinics by using a questionnaire. Most influential factor to doctors' decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preferred measure to expedite generic substitution.

• YAKHAK HOEJI
• /
• v.55 no.3
• /
• pp.195-202
• /
• 2011

Generic medication market has been increased for economic reasons in Korea. Health authorities worldwide recommend the use of generic medications nowadays. However, patients in Korea are not familiar with the generic medications and considerable percent of those do not know the definition of the generic medications. The purpose of this study was to evaluate adults' knowledge and perception on the generic medications at community pharmacies in Korea. This study was a 11-questionnaire survey conducted from August 9, 2010 to August 27, 2010. Of the 204 respondents, 63 (30.9%) responded that they knew what a generic medication was, but only 16 (25.4%) of those answered that generic medications had the same efficacy as brand medications. When pharmacists were the source of generic medication information, more patients reported having knowledge about the definition of generic medications correctly compared with other sources. Patients with negative experience with generic medications within 6 months were more reluctant to generic substitution suggested by a pharmacist than those with positive experience. Based on the results of this study, further studies should be conducted to establish the best way to provide generic medication information for patients.

• 대한임상약리학회:학술대회논문집
• /
• 2000.10a
• /
• pp.1-2
• /
• 2000

• Health Policy and Management
• /
• v.23 no.3
• /
• pp.210-223
• /
• 2013

Backgrounds: Escalating pharmaceutical expenditure has threatened the sustainability of National Health Insurance system in Korea. Generic medicines allow patients to access safe, effective, high-quality medicines at low cost, thus insurers could achieve significant financial savings by promotion of generics, if they are priced much lower than the originator. The purpose of this study was to review generic pricing as well as promotion policies in other countries and assess the implication of those policies. Methods: We reviewed the main measures adopted by the developed countries such as Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Sweden, United Kingdom, especially in countries where governments are the largest third-party payers or insurance finance resource is the national health insurance. Results: The foreign countries's experience with generic medicine policy shows that demand-side policies such as physician budgets, international nonproprietary name prescribing, generics substitution, patients co-payment as well as supply-side policies relating to pricing and reimbursement seems to play a critical role in developing the generic medicines market. Conclusion: Various strategy should be implemented to promote generic drug use.

• Korean Journal of Clinical Pharmacy
• /
• v.16 no.2
• /
• pp.139-146
• /
• 2006

Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and ${\chi}^2$ analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

• YAKHAK HOEJI
• /
• v.49 no.4
• /
• pp.255-259
• /
• 2005

Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

• 한국임상약학회:학술대회논문집
• /
• 2007.12a
• /
• pp.170-170
• /
• 2007

• Korean Journal of Clinical Pharmacy
• /
• v.15 no.2
• /
• pp.82-88
• /
• 2005

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

• Korean Journal of Agricultural Science
• /
• v.43 no.3
• /
• pp.496-505
• /
• 2016

The purpose of this study was to investigate the economic effects of a flame retardant aluminum screen developed by a company Economic effects were analyzed in terms of micro and macro-economic aspects. In the macro-economic aspect, economic effects were analyzed under the assumptions that the total import volume of flame retardant aluminum screen was approximately $50m^2$ in 2015 and that possible import substitution rates were 100%, 80%, and 60%. Results showed economic values of 2.25 billion won (100% import substitution rates), 1.8 billion won (80% import substitution rates), and 1.35 billion won (60% import substitution rates). If existing farms which had been using imported flame retardant aluminum screen replaced it newly developed with the flame-retardant aluminum screen developed in this study at rates of 100%, 80%, and 60%, the farms could save 750 million won, 60 million won, and 45 million won, respectively. Furthermore, the social cost savings from fire prevention could be 1.184 billion won. In the micro-economic aspect, if a farm with a typical-size ($1,000m^2$) greenhouse growing red pepper wanted to install flame retardant aluminum screen instead of generic aluminum screen, the farm may only pay an additional cost of 720,000 won. In comparison, if the farm chose fire insurance instead of flame-retardant aluminum screen, then the farm would pay 21,000,000 won for fire insurance. The above results show that the economic effect of flame retardant aluminum screen developed by the company would be be very efficient compared to the imported one.