• Molecules and Cells
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• v.39 no.2
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• pp.77-86
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• 2016

Cancer is a heterogeneous disease caused by diverse genomic alterations in oncogenes and tumor suppressor genes. Despite recent advances in high-throughput sequencing technologies and development of targeted therapies, novel cancer drug development is limited due to the high attrition rate from clinical studies. Patient-derived xenografts (PDX), which are established by the transfer of patient tumors into immunodeficient mice, serve as a platform for co-clinical trials by enabling the integration of clinical data, genomic profiles, and drug responsiveness data to determine precisely targeted therapies. PDX models retain many of the key characteristics of patients' tumors including histology, genomic signature, cellular heterogeneity, and drug responsiveness. These models can also be applied to the development of biomarkers for drug responsiveness and personalized drug selection. This review summarizes our current knowledge of this field, including methodologic aspects, applications in drug development, challenges and limitations, and utilization for precision cancer medicine.

• Korean Journal of Clinical Pharmacy
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• v.22 no.4
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• pp.291-303
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• 2012

As respiratory tract infections (RTI) account for about 60% of all antibiotic prescriptions in outpatient care setting, there are significant concerns about emerging resistance that are largely due to the excessive or inappropriate use of antibacterial agents for viral respiratory infections. This study was aimed to develop retrospective drug utilization review (DUR) program of antibiotics for RTIs using Delphi methods. Retrospective DUR criteria of antibiotics for RTIs were identified based on clinical practice guidelines and opinion of experts. Expert panel members were clinical doctors and pharmacists and Delphi method was applied by survey on 16 members of panels. The claim data from Korean Health Insurance Review & Assessment (HIRA) were used to examine trends in outpatient antibiotic prescription between Janunary to December of 2008. As results, Quality index for RTI was assessed for the claim type, antibiotics use of quantity, duration, number and cost. Antibiotic prescription rate for RTIs, Defined Daily Dose (DDD), and duration of antibiotics use were more recognized as significant quality index by experts' opinion. Use of first line agents suggested by guidelines was low and duration of antibiotics use was shorter compared to the recommendations. Antibiotics were over prescribed for RITs. However, dose and duration of antibiotics were under-used.

• Korean Journal of Clinical Pharmacy
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• v.21 no.4
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• pp.339-346
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• 2011

Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.

• YAKHAK HOEJI
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• v.55 no.6
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• pp.500-509
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• 2011

This study was to identify factors influencing drug compliance based on the subjects' interview regarding community pharmacy utilization for 2 weeks, in 2005 KNHANES. Good compliance was regarded as important factors in improving the effectiveness and minimizing adverse drug reaction, resulting in reducing the medical costs. 83% of total 11,208 pharmacy visits in 7,066 subjects showed good compliance. Good satisfaction for pharmacist's medication counseling (OR=2.23, 95% CI 1.92-2.58), higher out-of-pocket money (OR=1.32, 95% CI 1.14-1.54), and users of prescription drugs than non-prescription (OR=2.21, 95% CI 1.91-2.57) drugs were significant factors for better compliance. Disease of nervous system and mental and behavioral disorders showed lower drug compliance.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.81-87
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• 2018

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

• Health Policy and Management
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• v.23 no.2
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• pp.188-195
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• 2013

Background: The separation of pharmaceutical prescription and dispensing law was implemented in July 1st of 2000. This law was initiated by government without a through consensus among related stakeholders in the process of policy decision, eventually raising contention about decision making process rather than the performance of the policy. Methods: Therefore, this study tries to identify the accomplishment of the policy goals; based on the last decade's research we assessed inhibition of unnecessary prescription, drug misuse and overuse prevention, prevention of drug-related sentinel events, reducing unnecessary drug utilization, and reducing nation's medical cost. Results: Assessment results represent that government-suggested goal of the policy lacks sufficient evidence to evaluate accomplishment. Conclusion: Unlike other studies that evaluate problems regarding drug dispensing policy in the policy decision process, this study is meaningful in that it evaluated the policy goal based on the last ten years of related study results.

• Health Policy and Management
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• v.16 no.4
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• pp.147-168
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• 2006

Technological innovation has been regarded as the core competence for the economic growth of individual, as well as organization and country. Pharmaceutical innovation, what we call new medicines, influence people's longevity and productivity by increasing output per hour worked. Therefore, using claims data on virtually all the drugs and diseases of over 550,000 people enrolled in National Health Insurance Program in Korea, we examined the impact of the vintage (original FDA and KFDA approval year) of drugs used to treat a patients from July 1st to December 31st in 2002 on the patient's mortality at the end of 2004, controlling for demographic characteristics(age and sex), utilization of medical services, and the nature and complexity of illness. We found that people using newer drugs are less likely to die at the end of 2004, conditional on covariates. The estimated mortality rates were declining with respect to drug vintage for 1970s, 1980s and 1990s and highly significant. In addition to estimating the model for the entire sample, we estimated the model separately for several disease categories classified by Korean Classification of Disease. Estimates of three drug vintage variables for subgroups of people with (1)neoplasms, (2)endocrine, nutritional and metabolic diseases, and (3)the diseases of circulatory system displayed similar patterns.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.4
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• pp.2159-2165
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• 2013

Cancer registries help to establish and maintain cancer incidence reporting system, serve as a resource for investigation of cancer and its causes, and provide information for planning and evaluation of preventive and control programs. However, their wider role in directly enhancing oncology drug access has not been fully explored. We examined the value of cancer registries in oncology drug access in the Asia-Pacific region on three levels: (1) specific registry variable types; (2) macroscopic strategies on the national level; and (3) a regional cancer registry network. Using literature search and proceedings from an expert forum, this paper covers recent cancer registry developments in eight economies in the Asia-Pacific region - Australia, China, Hong Kong, Malaysia, Singapore, South Korea, Taiwan, and Thailand - and the ways they can contribute to oncology drug access. Specific registry variables relating to demographics, tumor characteristics, initial treatment plans, prognostic markers, risk factors, and mortality help to anticipate drug needs, identify high-priority research area and design access programs. On a national level, linking registry data with clinical, drug safety, financial, or drug utilization databases allows analyses of associations between utilization and outcomes. Concurrent efforts should also be channeled into developing and implementing data integrity and stewardship policies, and providing clear avenues to make data available. Less mature registry systems can employ modeling techniques and ad-hoc surveys while increasing coverage. Beyond local settings, a cancer registry network for the Asia-Pacific region would offer cross-learning and research opportunities that can exert leverage through the experiences and capabilities of a highly diverse region.

• Korean Journal of Clinical Pharmacy
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• v.25 no.1
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• pp.50-55
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• 2015

Background: Phosphodiesterase Type 5 Inhibitors (PDE5Is), which are prescription drug in South Korea, have been concerned about misuse, overuse and illegal provision of the drugs. This study was performed to investigate utilization and safety of illegal Phosphodiesterase Type 5 Inhibitors (PDE5Is), and related factors among South Korean men. Methods: A questionnaire survey was conducted from May to July in 2013 among 1,500 nationally representative general males using computer-assisted telephone interview (CATI). The questionnaire included the characteristics of population, the characteristics of PDE5Is use, the experience with the use of illegally obtained PDE5Is, and adverse events after PDE5Is use. Results: Among study population, the 1,015 (67.7%) men answered that they have used the illegally obtained PDE5Is. Younger age, single, lower frequency of PDE5Is use in a lifetime was associated with an increased use of illegally obtained PDE5Is. The men experienced adverse events after PDE5Is use is 528 (35.2%). The most common adverse event was mild to moderate hot flashes. Conclusion: We need to enhance awareness about the risk of illegally obtained PDE5Is use, especially in younger men and single. Proactive educations and public relations on safe use of PDE5Is for proper patients are needed.

• Health Policy and Management
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• v.22 no.1
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• pp.65-84
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• 2012

Because of the rising healthcare costs, there is a growing need for developing efficiency indicators for medical resources use and measuring efficiency of healthcare providers and healthcare systems using them. In this study, we aimed to develop efficiency indicators for medical resources use by means of Delphi technique. We systematically reviewed the existing measures of medical resource use. Thirty nine indicators were selected as a candidates across the six domains: medical personnel, medical equipment, medical facilities, ethical management, resource efficiency, and drug use. To develop efficiency indicators with professional consensus, a 2-round Delphi survey was conducted among 29 professional experts. The following indicators were selected based on the Delphi survey results: adjusted number of the patient per day and level of the nurse number medical personnel in medical personnel domain; the number of the scan a professional physician and the quality of the scan in medical equipment domain; bed utilization rate in medical facility domain; drug price reported pharmaceutical price by medical institutions, medical fee billing transparency, and medical care appropriateness in ethical management domain; costliness index in resource efficiency domain; and utilization of high cost drug and items per prescription in drug use domain. The efficiency indicators could provide valid information about efficiency of healthcare providers and healthcare systems with respect to their resources use and facilitate policies to improve their efficiency.