• Health Policy and Management
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• v.23 no.2
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• pp.112-123
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• 2013

Background: Under the risk of financial sustainability of National Health Insurance, Korean government attempted a series of regulations over pharmaceutical prices. The first price-cut was implemented to the hyperlipidemial treatments, and the prices of statins were reduced on 15th, April in 2009. The purposes of this study are 1) to investigate the impact of this price-cut on pharmaceutical expenditure, and 2) to identify the factors associated with drug-switch among statins. Methods: Using the national patients sample data, this study conducted time series analysis on the expenditures, prices, and volumes of statin drugs. To understand the factors associated with drug-switch, the multinomial logit model was analyzed at the patients level. Results: The results of time series analysis demonstrated that the price-cut of hyperlipidemic medicines did not lead to the reduced expenditure, suggesting the increased volume was the major cause. The multinomial logit analysis identified the switch of healthcare provider as the significant factor that was highly associated with drug-switch, implying the physicians' preference was the major motivation of drug-switch. Conclusion: Without control of utilization, price regulation itself could not reduce pharmaceutical expenditure. This suggests that the pharmaceutical regulations should be implemented on the basis of understanding of provider behaviors. The findings of this study will form the first step for further empirical studies.

• Journal of Genetic Medicine
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• v.17 no.2
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• pp.62-67
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• 2020

Purpose: Eliglustat is an oral substrate reduction therapy (SRT) approved for adults with Gaucher disease type I (GD1) who are extensive, intermediate, or poor CYP2D6 metabolizers. Here we report one-year experience of eliglustat switch therapy from long-term enzyme replacement therapy (ERT) in three adult patients with GD1. Materials and Methods: Medical history, clinical (hemoglobin concentration, platelet count, and bone mineral density) and biochemical parameters (angiotensin converting enzyme, total acid phosphatase, and lyso-gb1) of the patients were collected and evaluated by retrospective review of medical records at every 3, 6, or 12 month after switch to SRT. Results: Patient 1 was a 43-year old female diagnosed GD1 and her clinical and biochemical parameters were stabilized for more than 20 years by ERT. Due to the burden of regular hospital visit, she switched to SRT. During one-year of SRT, clinical parameters and biomarkers were maintained stable. However, after suffering acute febrile illness during SRT, she decided to re-switch to ERT due to concerns about drug interaction. Patient 2 was 41-year old male, younger brother of patient 1 and Patient 3 was 31-year old male. They switched to SRT in clinically stable condition with long-term ERT. The one-year SRT was tolerable without specific safety issue and the clinical parameters were maintained stable. Conclusion: One-year eliglustat therapy in three adult patients with GDI was generally tolerable and effective for maintaining the clinical parameters and biomarkers. However, the drug compliance, concurrent drug interactions, and long-term safety of eliglustat should be carefully monitored.

• International Journal of Human Ecology
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• v.12 no.2
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• pp.1-12
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• 2011

Many pharmaceutical products are available through prescription (Rx) only status. As a result, access to physicians and insurance coverage play a key role in the use of these products, and therefore may affect the population to whom advertising is targeted at. The movement of pharmaceutical products from prescription (Rx) to Over-the-Counter (OTC), or Rx-to-OTC switch changes the cost of acquiring the drug and therefore may change the incentives manufacturers have at targeting particular population segments. This study examines whether Rx-to-OTC switch changes the frequency and the distribution of who is exposed to pharmaceutical advertising. Using an archive of pharmaceutical advertisements and National Consumer Survey, this study examines how individuals with particular demographic characteristics are exposed to pharmaceutical advertisements before and after drugs are moved from Rx to OTC. The results provide evidence that individual's advertising exposure increases after Rx-to-OTC switch. Moreover, the increase in advertising exposure is greater for the low socioeconomic status (SES) consumers which implies they may get more information about the disease, treatment and product after the Rx-to-OTC switch through advertising. If low SES consumers have more exposure to the advertising after products switched to OTC, then FDA policies regulating this switch should recognize the potential role of advertising providing access to health-related information.

• BMB Reports
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• v.55 no.11
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• pp.565-570
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• 2022

Pulmonary arterial hypertension (PAH) is a progressive and devastating disease whose pathogenesis is associated with a phenotypic switch of pulmonary arterial vascular smooth muscle cells (PASMCs). Bone morphogenetic protein (BMP) signaling and potassium two pore domain channel subfamily K member 3 (KCNK3) play crucial roles in PAH pathogenesis. However, the relationship between BMP signaling and KCNK3 expression in the PASMC phenotypic switching process has not been studied. In this study, we explored the effect of BMPs on KCNK3 expression and the role of KCNK3 in the BMP-mediated PASMC phenotypic switch. Expression levels of BMP receptor 2 (BMPR2) and KCNK3 were downregulated in PASMCs of rats with PAH compared to those in normal controls, implying a possible association between BMP/BMPR2 signaling and KCNK3 expression in the pulmonary vasculature. Treatment with BMP2, BMP4, and BMP7 significantly increased KCNK3 expression in primary human PASMCs (HPASMCs). BMPR2 knockdown and treatment with Smad1/5 signaling inhibitor substantially abrogated the BMP-induced increase in KCNK3 expression, suggesting that KCNK3 expression in HPASMCs is regulated by the canonical BMP-BMPR2-Smad1/5 signaling pathway. Furthermore, KCNK3 knockdown and treatment with a KCNK3 channel blocker completely blocked BMP-mediated anti-proliferation and expression of contractile marker genes in HPAMSCs, suggesting that the expression and functional activity of KCNK3 are required for BMP-mediated acquisition of the quiescent PASMC phenotype. Overall, our findings show a crosstalk between BMP signaling and KCNK3 in regulating the PASMC phenotype, wherein BMPs upregulate KCNK3 expression and KCNK3 then mediates BMP-induced phenotypic switching of PASMCs. Our results indicate that the dysfunction and/or downregulation of BMPR2 and KCNK3 observed in PAH work together to induce aberrant changes in the PASMC phenotype, providing insights into the complex molecular pathogenesis of PAH.

• Sleep Medicine and Psychophysiology
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• v.19 no.1
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• pp.18-21
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• 2012

Parasomnias induced by hypnosedatives are rare but serious side effect. Such parasomnias have not been reported with all hypnosedatives. However, frequent use of hypnosedatives, particularly nonbenzodiazepine receptor agonists is associated with parasomnias. Associated symptoms are sleep eating, sleepwalking with object manipulation, sleep conversations, sleep driving, sleep sex and sleep shopping etc. Mechanisms include high affinity for $GABA_A$ receptor, interruption of the consolidation phase of memory formation by drug, pharmacokinetic or pharmacodynamic drug-drug interaction and concomitant administration with alcohol. Managements for parasomnias induced by hypnosedatives involve stopping medication, switch to other medications or nonpharmacological treatment, lowest effective dose of NBRAs (Non-Benzodiazepine Receptor Agonists), taking into consideration drug-drug interactions, identification and treatment of underlying disease states.

• Korean Journal of Biological Psychiatry
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• v.8 no.1
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• pp.140-146
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• 2001

In clinical setting, treatment-refractoriness, medication induced tardive dyskinesia and amenorrhea in chronic schizophrenia are frequently problematic. However, there are few guideline solving these problem available to clinicians. The goal of this study was collecting clinical data on clinical effectiveness and predictors of response of switching to olanzapine. We attempted to switch to olanzapine from risperidone and clozapine in chronic 31(risperidone 17, clozapine 14) schizophrenia and schizoaffective disorder patients suffering from sustained symptoms, weekly blood monitoring, medication induced tardive dyskinesia and amenorrhea. Previous antipsychotics dosage was gradually decreased for 2 or 3weeks, at the same time olanzapine dosage was gradually increased. At baseline, after 1 week, after 2 weeks and after 4 weeks we checked Brief Psychiatric Rating Scale, Clinical Global Impression Scale, Sympson-Angus Rating Scale, Barnes Akathisia Rating Scale and followed up after 12 months. Successful switch after 4 weeks was achieved in 25 patients(clozapine 9(64.2%), risperidone 16(94.1%)). Overall, mean BPRS and CGI scores increased significantly. Successful maintenance after 12 months was achieved in 17 patients(clozapine 5(35.7%), risperidone 12(70.5%)). Overall, mean BPRS and CGI scores increased significantly too. Switching to olanzapine from other atypical antipsychotics is recommendable in chronic schizophrenia with treatment refractoriness and drug induced side effect.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.239-247
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• 2013

Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.1
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• pp.205-213
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• 2014

The outcomes of first-generation EGFR-TKIs (Gefitnib and Erlotinib) have shown great advantages over traditional treatment strategies in patients with non-small cell lung cancer (NSCLC), but unfortunately we have to face the situation that most patients still fail to respond in the long term despite initially good control. Up to now, the mechanism of acquired resistance to EGFR-TKIs has not been fully clarified. Herein, we sought to compile the available clinical reports in the hope to better understanding the subsequent treatment choices, particularly on whether restoring after a drug holiday or switching to another EGFR-TKI is the better option after failure of one kind of EGFR-TKI.

• BMB Reports
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• v.51 no.5
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• pp.219-224
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• 2018

Necroptosis is an emerging form of programmed cell death occurring via active and well-regulated necrosis, distinct from apoptosis morphologically, and biochemically. Necroptosis is mainly unmasked when apoptosis is compromised in response to tumor necrosis factor alpha. Unlike apoptotic cells, which are cleared by macrophages or neighboring cells, necrotic cells release danger signals, triggering inflammation, and exacerbating tissue damage. Evidence increasingly suggests that programmed necrosis is not only associated with pathophysiology of disease, but also induces innate immune response to viral infection. Therefore, necroptotic cell death plays both physiological and pathological roles. Physiologically, necroptosis induce an innate immune response as well as premature assembly of viral particles in cells infected with virus that abrogates host apoptotic machinery. On the other hand, necroptosis per se is detrimental, causing various diseases such as sepsis, neurodegenerative diseases and ischemic reperfusion injury. This review discusses the signaling pathways leading to necroptosis, associated necroptotic proteins with target-specific inhibitors and diseases involved. Several studies currently focus on protective approaches to inhibiting necroptotic cell death. In cancer biology, however, anticancer drug resistance severely hampers the efficacy of chemotherapy based on apoptosis. Pharmacological switch of cell death finds therapeutic application in drug- resistant cancers. Therefore, the possible clinical role of necroptosis in cancer control will be discussed in brief.

• Korean Journal of Clinical Pharmacy
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• v.28 no.4
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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.