• Health Policy and Management
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• v.34 no.2
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• pp.106-119
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• 2024

Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of this study is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and some European countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholar by using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements on advance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promote the communication and coordination of responses, and expedited drug regulatory processes. Similarly, Canada established the Multi-Stakeholder Steering Committee on drug shortages by involving representatives from central and local governments and private sectors. Canada also adopted a tiered approach to the communication of drug shortages based on the assessment of the severity of the shortage problem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agency and the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countries reviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. The efforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmental coordination and development of guidelines.

• Journal of Pharmacopuncture
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• v.25 no.2
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• pp.79-87
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• 2022

Since ancient times, plants have been a major source of novel drug molecules and have been used in the treatment of different infectious diseases. Secondary plant metabolites have miraculous healing properties and show potent therapeutic responses when used in combination drug therapy. The prime objective of this review is to summarize the concept of drug combination with special emphasis on the synergistic interactions between plant-derived bioactive phytochemicals with commercially available antimicrobial agents. The study also assesses the roles, importance, and applicability of phytochemicals in the management of different diseases. The review focuses on different aspects of combined antimicrobial activities, the possible mechanisms involved, and the current status of research in the field. The study was conducted based on an extensive literature survey that resulted in the following hypothesis: secondary metabolites derived from plants possess remarkable therapeutic activities. The study was designed as a systematic review that ensures unbiased and accurate representations of the relevant data and information. Jadad scale selection criteria were used for qualitative analysis of the articles to assess them based on the relevant secure score (minimum and maximum scores range between 1 and 5, respectively). Articles with secure scores > 3 were considered for the study. A comprehensive literature survey was conducted using resource databases including PubMed, Google Scholar, Bielefeld Academic Search Engine, Research Gate, Scopus, Medline, and Science Direct up to June 2019. This article contains concise information about the most commonly used bioactive phytochemicals with potent antifungal and antibacterial effects.

• Korean Journal of Clinical Pharmacy
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• v.18 no.2
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• pp.84-96
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• 2008

In the recent, pharmacokinetic (PK)/pharmacodynamic (PD) modeling has appeared as a critical path tools in new drug development to optimize drug efficacy and safety. PK/PD modeling is the mathematical approaches of the relationships between PK and PD. This approach in new drug development can be estimated inaccessible PK and PD parameters, evaluated competing hypothesis, and predicted the response under new conditions. Additionally, PK/PD modeling provides the information about systemic conditions for understanding the pharmacology and biology. These advantages of PK/PD model development are to provide the early decision-making information in new drug development process, and to improve the prediction power for the success of clinical trials. The purpose of this review article is to summarize the PK/PD modeling process, and to provide the theoretical and practical information about widely used PK/PD models. This review also provides model schemes and the differential equations for the development of PK/PD model.

• Journal of Pharmacopuncture
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• v.19 no.1
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• pp.7-15
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• 2016

Objectives: Malaria has been a major global health problem in recent times with increasing mortality. Current treatment methods include parasiticidal drugs and vaccinations. However, resistance among malarial parasites to the existing drugs has emerged as a significant area of concern in anti-malarial drug design. Researchers are now desperately looking for new targets to develop anti-malarials drug which is more target specific. Malarial parasites harbor a plastid-like organelle known as the 'apicoplast', which is thought to provide an exciting new outlook for the development of drugs to be used against the parasite. This review elaborates on the current state of development of novel compounds targeted againstemerging malaria parasites. Methods: The apicoplast, originates by an endosymbiotic process, contains a range of metabolic pathways and housekeeping processes that differ from the host body and thereby presents ideal strategies for anti-malarial drug therapy. Drugs are designed by targeting the unique mechanism of the apicoplasts genetic machinery. Several anabolic and catabolic processes, like fatty acid, isopenetyl diphosphate and heme synthess in this organelle, have also been targeted by drugs. Results: Apicoplasts offer exciting opportunities for the development of malarial treatment specific drugs have been found to act by disrupting this organelle's function, which wouldimpede the survival of the parasite. Conclusion: Recent advanced drugs, their modes of action, and their advantages in the treatment of malaria by using apicoplasts as a target are discussed in this review which thought to be very useful in desigining anti-malarial drugs. Targetting the genetic machinery of apicoplast shows a great advantange regarding anti-malarial drug design. Critical knowledge of these new drugs would give a healthier understanding for deciphering the mechanism of action of anti-malarial drugs when targeting apicoplasts to overcome drug resistance.

• Journal of Pharmaceutical Investigation
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• v.32 no.4
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• pp.241-258
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• 2002

Such osmotic drug delivery systems are based on osmosis, the diffusion of water transversely from a medium with a low osmotic pressure to a medium with a high osmotic pressure for the controlled delivery of active agents. In this review, U.S. Patents on osmotic drug delivery analyze 261 patents until December 2001. These devices form now a major market of drug delivery products. Because of their advantage and innovate idea, it appears that the future of oral drug delivery mark,εt in Korea is promising.

• Interdisciplinary Bio Central
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• v.2 no.4
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• pp.9.1-9.5
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• 2010

Many neurodegenerative diseases, such as Alzheimer's and Parkinson's disease, are devastating disorders that affect millions of people worldwide. However, the number of therapeutic options remains severely limited with only symptomatic management therapies available. With the better understanding of the pathogenesis of neurodegenerative diseases, discovery efforts for disease-modifying drugs have increased dramatically in recent years. However, the process of translating basic science discovery into novel therapies is still lagging behind for various reasons. The task of finding new effective drugs targeting central nervous system (CNS) has unique challenges due to blood-brain barrier (BBB). Furthermore, the relatively slow progress of neurodegenerative disorders create another level of difficulty, as clinical trials must be carried out for an extended period of time. This review is intended to provide molecular and cell biologists with working knowledge and resources on CNS drug discovery and development.

• Toxicological Research
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• v.29 no.1
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• pp.1-6
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• 2013

The process of drug discovery and development requires substantial resources and time. The drug industry has tried to reduce costs by conducting appropriate animal studies together with molecular biological and genetic analyses. Basic science research has been limited to in vitro studies of cellular processes and ex vivo tissue examination using suitable animal models of disease. However, in the past two decades new technologies have been developed that permit the imaging of live animals using radiotracer emission, X-rays, magnetic resonance signals, fluorescence, and bioluminescence. The main objective of this review is to provide an overview of small animal molecular imaging, with a focus on nuclear imaging (single photon emission computed tomography and positron emission tomography). These technologies permit visualization of toxicodynamics as well as toxicity to specific organs by directly monitoring drug accumulation and assessing physiological and/or molecular alterations. Nuclear imaging technology has great potential for improving the efficiency of the drug development process.

• YAKHAK HOEJI
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• v.54 no.4
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• pp.258-269
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• 2010

As people are easy to access the National Health Insurance, medical health service has been increased. It contributed to extend human's average life expectancy and to get better health care. But also increased unnecessary health service or inappropriate drug use. Therefore, DUR (Drug Use Review) is needed to induce appropriate drug use. The purpose of this study is to evaluate outpatient prescriptions by General Practitioner (GP) and Specialized Practitioner, especially indication for ENT referral including common cold which is the frequent indications that have patient see doctor. This study was reviewed retrospectively prescriptions for ENT referral collected at the A pharmacy for ENT Clinic in Cheong-Ju, B pharmacy for GP Clinic in BoEun from Feb 2nd, 2009 to Feb 28th, 2009. Each pharmacy located closed to the each enrolled clinic. The numbers of collected prescriptions were each A pharmacy (n=2501), B pharmacy (n=1343). This study was classified Drug Related Problems (DRPs) those prescriptions had as total 6 groups according to following 6 categories; 1) Unnecessary Drug, 2) Wrong Drug, 3) Low Dose, 4) Overdose, 5) Wrong Instruction, 6) Wrong Combination. In results, Specialized Practitioner's prescriptions had more DRPs than General Practitioner's prescriptions (ENT 155.34% vs GP 130.01%). In detail, Specialized Practitioner's prescriptions had more DRPs in Low Dose (ENT 16.95% vs GP 4.77%), Overdose (ENT 6.72% vs G.P 5.51%), Wrong Instruction (ENT 7.91% vs GP 5.81%), Wrong Combination (ENT 29.31% vs GP 25.09%). These DRPs would be caused from lack of consideration for dosage and drug interaction. General Practitioner's prescriptions had more DRPs in Unnecessary Drug (ENT 70.37% vs GP 78.85%), Wrong drug (ENT 4.12% vs GP 9.98%). These DRPs would be associated with drug selection. This study was assumed that Specialized Practitioner is better prescriber than General Practitioner because Specialized Practitioner complete additional intern and residency training. But, Specialized Practitioner is not always better prescriber than General Practitioner. Furthermore, prescriptions of both Specialized Practitioner and General Practitioner had many problems. In conclusion, It could be cut down the excessive medical expense and expected more efficient medical care by reducing DRPs, thus contributing to the improvement of national health. In order to pharmacist must have good professional ability of pharmacotherapy to help the physician for the drug selection.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.22-24
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• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• Biomolecules & Therapeutics
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• v.26 no.4
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• pp.335-342
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• 2018

The incidence and mortality of various cancers are associated with sex-specific disparities. Sex differences in cancer epidemiology are one of the most significant findings. Men are more prone to die from cancer, particularly hematological malignancies. Sex difference in cancer incidence is attributed to regulation at the genetic/molecular level and sex hormones such as estrogen. At the genetic/molecular level, gene polymorphism and altered enzymes involving drug metabolism generate differences in cancer incidence between men and women. Sex hormones modulate gene expression in various cancers. Genetic or hormonal differences between men and women determine the effect of chemotherapy. Until today, animal studies and clinical trials investigating chemotherapy showed sex imbalance. Chemotherapy has been used without consideration of sex differences, resulting in disparity of efficacy and toxicity between sexes. Based on accumulating evidence supporting sex differences in chemotherapy, all clinical trials in cancer must incorporate sex differences for a better understanding of biological differences between men and women. In the present review, we summarized the sex differences in (1) incidence and mortality of cancer, (2) genetic and molecular basis of cancer, (3) sex hormones in cancer incidence, and (4) efficacy and toxicity of chemotherapy. This review provides useful information for sex-based chemotherapy and development of personalized therapeutic strategies against cancer.