The objective of this study was to investigate drug classification system in Korea and other developed countries. Laws and regulations of Korea regarding the system were retrieved from sources posted in Ministry of Government Legislation. We also reviewed previous research reports performed as part of government’s effort to reform the system The system in the foreign countries was retrieved from the official homepage operated by each country’s government. There have been two research funded by Korean government, which strongly suggested that the system should be reformed. However, we found that the system was never reformed and still effective. Drug classification system in US and most western countries consists of two categories, i.e., prescription drugs and non-prescription drugs except UK, which classifies into three categories: Prescription Only Medicines, Pharmacy Medicines, and General Sales List Medicines. Interestingly, in Japan, non-prescription drugs are further classified into three groups: Group 1, 2, and 3. Recently, Ministry of Health and Welfare (MOHW) in Korea proposed a plan to reclassify all the approved drugs according to purportedly rational and scientific criteria. However, the plan does not include reform of the existing laws and regulations, which appears that it is just one-time action rather than a sustainable administration backed up by law. Therefore, it is recommended that Korean MOHW take appropriate action on laws and regulations with regard to the system to meet global harmonization standard.
Objective: To assess the cost effectiveness of newborn screening for congenital adrenal hyperplasia (CAH) in the U.S. newborn population. Methods: We constructed a decision model to estimate the incremental cost-effectiveness ratio (ICER) of CAH screening compared to a strategy of no screening. Two types of cost effectiveness analyses (CEA) were conducted to measure ICER as net cost per life year (LY): (1) traditional CEA with sensitivity and scenario analyses, and (2) probabilistic CEA. Results: ICERs for (1) base-case analysis in traditional CEA and (2) probabilistic CEA were USD 292,000 and USD 255,700 per LY saved in 2005 USD, respectively. ICERs were particularly sensitive to assumptions regarding the mortality rate for the salt wasting type of CAH, in a range from 2 to 9%. The ICERs for best-case and worst-case scenarios were USD 30,900 and USD 2.9 million per LY saved, respectively. Conclusions: Using common benchmarks for cost effectiveness, our results indicate that CAH screening would be unlikely to be considered cost effective unless assumptions favorable to screening were adopted, although it could meet economic criteria used to assess U.S. regulatory policies. A limitation is that the analysis excludes outcomes such as correct assignment of gender and quality of life.
OBJECTIVE To evaluate the literature characterizing the mechanism of action, pharmacokinetics, pharmacodynamics, and therapeutic efficacy of plerixafor for hematopoietic stem cell (HSC) mobilization for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma. DATA SOURCES A PubMed search (1966-September 2009) was conducted using the key words plerixafor and AMD3100. Manufacturer's prescribing information was also used. STUDY SELECTION AND DATA EXTRACTION English-language articles were selected and data were extracted with a focus on clinical studies of HSC mobilization in patients with NHL or multiple myeloma. DATA SYNTHESIS Plerixafor exerts its effect by reversibly blocking the ability of HSC to bind to the bone marrow matrix. When used with granulocyte colony-stimulating factor (G-CSF), plerixafor helps increase the number of HSCs in the peripheral blood, where they can be collected for use in autologous transplantation. In clinical studies, plerixafor was rapidly absorbed after subcutaneous injection, reaching a maximum plasma concentration at approximately 0.5 hours. Plerixafor is renally excreted as the parent drug, with an elimination half-life ranging from 3 to 5 hours. Plerixafor increases circulating CD34+ cells in the peripheral blood, with a peak effect about 6–9 hours after subcutaneous administration. An approximate 2- to 3-fold increase in the CD34+ cell count is seen by the first dose of plerixafor after 4 consecutive days of G-CSF treatment. In 2 Phase 3 studies in patients with NHL or multiple myeloma, addition of plerixafor to G-CSF resulted in a higher CD34+ cell collection with fewer apheresis days, but failed to show better graft durability or overall patient survival for up to 12 months of follow-up. CONCLUSIONS Clinical trials have demonstrated that the addition of plerixafor to G-CSF was beneficial for HSC mobilization to peripheral blood for collection and subsequent transplantation in patients with NHL or multiple myeloma. Further studies should assess the benefit of the additive use of plerixafor on clinical outcomes.
The pharmacokinetic parameters of theophylline in rats did not change significantly when the drug was intravenously administered after three consecutive days of pretreatment with 17 mg/kg, orally, of 1-furan-2-yl-3-pyridine-2-yl-propenone (FPP-3), an investigatory drug having dual inhibitory action on cyclooxygenase (COX) and 5-lipoxygenase (5-LOX). However, significant changes were found in the pharmacokinetic parameters of the drug at doses of 34 mg/kg and more of FPP-3. Results of cytochrome P450 activity test indicated that the alteration in pharmacokinetic parameters of the drug appears to be due to the inhibitory effect of FPP-3 on cytochrome P450 1A which is responsible for the metabolism of theophylline. Methoxyresorufin-O-demethylase (MROD) and ethoxyresorufin-O-deethylase (EROD) activity assays revealed that the relative activities of cytochrome P450 1A1 and 1A2 were dose-dependently reduced in the presence of 1, 5, and 10 μM FPP-3 concentrations. Taking into consideration that FPP-3 is intended to be primarily used by geriatric patients with chronic diseases and therefore may be used in long-term basis, the investigatory drug needs to be assessed thoroughly in terms of drug interaction with other commonly prescribed medications.
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