Yonsei Student Pharmacist
THE
BLUE
VANGUARD
04 PHARMACEUTICALS
Pharmacovigilance, Keep the Trust of Medicines
14 COLUMN
Potentiating Immunotherapies with Oncolytic Viruses
2018
summer
Vol. 13
20 NATIONAL ISSUES
Where Does the Fault Lie ? Reflecting on Ewha Woman’s U. Mokdong Hospital NICU Scandal
EDITOR’S NOTE
Editor's Note Shame, stigma, and drugs : A REFLECTIVE POINT OF VIEW The over t theme of this issue of Yonsei Pharmacy is to harken back to the social stigma surrounded with Ewha Mokdong Hospital's walk of shame—an accident that can never be a misdemeanor. Shedding light on shame in the context of healthcare is of utmost importance when it comes to practitioners and pharmacy education, yet we come to unheeded results. In our thirteenth story, we look back on the innocent death of a young child, to once again put heavy weight on the roles of pharmacists. While there are so many rich insights to be gleaned from this, another horde of articles in this issue brings an entirely different perspective on our roles. Be it the future prospects of pharmacovigilance, or immunotherapies, it is evident that there is so much more to say—that we are only beginning to scratch the surface.
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THE BLUE VANGUARD
CONTENTS
10-11
12-13
6-7
22-23
14-15
16-17
Pharmaceuticals 4-5 Pharmacovigilance, Keep the Trust of Medicines 6-7 XOFLUZA, New Anti-influenza medication 8-9
Interviews Tae Kyu KIM, CEO of BnP Care
Column
10-11 The Development of Gene Technology 12-13 Insomnia : How Can We Overcome The Sleepless Night? 14-15 Potentiating Immunotherapies with Oncolytic Viruses
20-21
National Issues 16-17 VR Technology and Medical Field 18-19 The Emergence Of Oriental Pharmacy Where Does the Fault Lie ? Reflecting on Ewha Woman’s U. Mokdong Hospital NICU Scandal
International Issues
22-23 Clean Pyeongchang for Doping-Free Olympic Games 24-25 Pharmacy Specialists : Clinical professionals in Hospital 26-27
Campus Life Freshman and Graduate, The Beginning from Different Sites
2018 VOL.13
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PHARMACEUTICALS
Pharmacovigilance, Keep the Trust of Medicines
W
Ha Yan Jang
jhywhite1004@naver.com
hat do you want to do as a pharmacist after graduation? Even pharmacy students who are interested in a field of pharmaceutical company are familiar with the ‘Sales and Marketing’ or ‘Regulatory Affair’ department, but often are not aware of what ‘PV’ work is. When I joined the internship program of Handok pharmaceutical company, other colleagues often asked me what I would do at the PV team. In this article, I would like to explain what the Pharmacovigilance team does in a pharmaceutical field.
Do you know Pharmacovigilance? In Pharmacovigilance Department, ‘Pharmaco’ is derived from the Greek word ‘Pharmakon’ which means medicine, and ‘Vigilance’ from ‘Vigilare’ which means to watch and watch out. According to WHO, pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It was the ‘Thalidomide accident’ in the 1960s that attracted the world’s attention to the adverse effects of drugs. This incident, one of the most tragic cases of adverse drug reaction, raised awareness of the safety of medicine and strengthened regulations on drug licensing and safety testing. The reason why the Pharmacovigilance task is important is that despite enhanced clinical trial regulations, it is not possible to test all safety information in advance. Clinical trials are conducted on limited research subjects, so pediatric, geriatric, pregnant and patients who use other drugs are excluded from the study. Therefore, safety information is inadequate before such drugs are marketed to those who actually need them. PV team collects and manages drug safety information on whether there are any adverse reactions in patients who take the drug which had already been approved and marketed.
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PHARMACEUTICALS
The Importance of PV The PV team usually belongs to the Medical Affair Department with the Medical Science Liasion or Medical Information Review teams. To summarize the many tasks of the PV team in short, it is the management of all safety information on drugs. It is easy to recall the Adverse Drug Reaction in terms of drug safety information, but the range is actually very wide. Symptoms of child or elderly use of medications, medication errors, and interactions with other drugs or foods are all part of safety information. Even, a report that a pregnant woman has no side effects when exposed to the drug is also considered as safety information. The reason for this is that each information is valuable because pregnant or lactating women cannot undergo clinical trials.
What the PV dose Specifically, the tasks of the PV team are as follows; First, The PV team trains all employees to collect safety information, because safety data for company products soon leads to company’s credibility. This is especially important for the sales teams or the customer service teams that meet customers directly. Second, PV makes an Individual Safety Case Report (ICSR) based on the data collected from various sources. The most widely used report format for reporting adverse events is called the CIOMS-I form, which was created by the Council for International Organizations of Medical Sciences.
Third, the collected safety data should be reported and shared. PV team can also send their ICSRs to the original developer, or report to the Korea Food and Drug Administration (KFDA) or the Korea Institute of Drug Safety and Risk Management (KIDS) in accordance with national regulations. If the accumulated data is statistically significant, new data may be added to the drug label. Lastly, the PV team develops the Risk Management Plan (RMP). Since all medications have side effects instead of treating uncomfortable symptoms, you should determine how much benefit you can have compared to possible risks. Therefore, it is important to try to minimize the risks when using drugs, and the plan for this is RMP. For example, the SOLIRIS injection, therapeutic drug for Paroxysmal Nocturnal Hemoglobinuria (PNH), may weaken human immunity. However, since the PNH is a fatal disease and there is no alternative treatment, it is evaluated that the benefit of taking medicine is greater than the risk due to side effects of the drug. So, to minimize the expected risk of SOLIRIS, its vaccine should be administered first beforehand.
Prospects of PV team Recently, interest in post-marketing surveillance has increased in Korea, and the Pharmaceutical Affairs Law was amended in 2008 to make pharmaceutical companies appoint a safety manager who responsible for managing safety data. In most companies, a safety manager is a pharmacist of the PV team. Also, as KFDA became an ICH member country in 2016, post-marketing surveillance work became more important. ICH, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, aims to harmonize the regulatory requirements at the international level for the development and registration of high quality medicine. More efforts are needed to ensure that Korean pharmaceuticals are suitable for these strict regulations. Now is the time for personalized drug therapy. In order to recommend the optimal medication for the patient, it is important to consider what side effects will occur depending on the individual characteristics of the patient. If you have a sense of mission to help people safely use medicines, try to challenge the Pharmacovigilance work. If your work help patients avoid the redundant adverse drug reaction, you will certainly feel rewarded. B 2018 VOL.13
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PHARMACEUTICALS
XOFLUZA
New Anti-influenza medication Dayoung Kim
961211dy@yonsei.ac.kr
Xofluza’s Background Xofluza (Baloxavir marboxil) was invented in 2015 by
H
Shionogi, a pharmaceutical company in Japan. It is a prodrug which has to be hydrolyzed to
ave you ever been infected with influenza
virus? If so, you might have been absent from
become the active form of baloxavir marboxil
on the contagious virus to other people. However, in
a novel type of anti-influenza medication
patients to avoid infection, as the newly approved drug
B through inhibition of cap-dependent
classes for about a week to prevent passing
in the small intestine. The drug works as
recent days, we do not need to stay away from influenza
that kills the influenza virus type A and
called ‘Xofluza’ would make it possible by killing the virus
endonuclease. Unlike other drugs treating
overnight.
influenza so far, a one-time oral administration of Xofluza can completely destroy the viruses by intervening in their RNA replication. Last February, Xofluza was approved for sale in Japan and it is expected to be commercialized in May, 2018.
Mechanism RNA transcription (viral mRNA synthesis) in nuclei of the host cell can be suppressed through selective inhibition of cap-dependent endonuclease activation, thus limiting protein synthesis which is needed for the replication of virus. A Ribonucleoprotein (RNP) complex, in which a complex of three RNA polymerases binds to riboprotein composed of virus RNA and nucleoprotein (NP), is inside the virus particle. Each of the three RNA polymerases (PB1, PB2, PA) in the viral RNP complex plays a significant role in viral mRNA synthesis during a process called “cap snatching”: 1. PB2 perceives and binds to cap structure of mRNA precursor of host cell. 2. PA severs the bottom side of the cap structure. 3. PB1 makes use of the cap structure as a transcription initiation primer and lengthens the viral mRNA.
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the blue vanguard
PHARMACEUTICALS
Once the virus particle enters an endosome of the host cell through endocytosis, fusion of envelope and endosome membrane occurs. Then, the virus RNP complex is released into the cytosol, subsequently moving inside the DNA and Influenza begins to propagate through cap snatching. In the course of mRNA synthesis mentioned above, Xofluza binds to a part of PA showing cap-dependent endonuclease activity, selectively inhibiting cap-dependent endonuclease. Consequently, the bottom side of the cap structure cannot be severed, which leads to limitation of mRNA synthesis and virus proliferation.
Comparison with Tamiflu
Influenza Virus
Tamiflu has been one of the Influenza. Anti-Influenza medications according to the mechanism. Xofluza and Tamiflu act differently, blocking different steps of RNA replication. As
cap-dependent endonuclease inhibitor
release from host cell
inhibition
most effective medications to treat can be categorized into several types
neuraminidase inhibitor
membrane fusion
mRNA synthesis
mRNA elongation
RNA replication
virus genome RNA
mentioned above, Xofluza is a capdependent
endonuclease
inhibitor.
In addition to differences in mechanism, several different results appeared
Tamiflu, on the other hand, is a
between Tamiflu and Xofluza in a series of clinical trials conducted in the
neuraminidase inhibitor, suppressing
course of inventing Xofluza. First of all, Xofluza can destroy viruses by just
neuraminidase activity which has a
one pill, while two pills of Tamiflu should be taken daily for five days to cure
vital role in the outbreak of virus by
the virus. On top of that, Xofluza takes only 24 hours, while Tamiflu takes
helping the virus particle escape from
three times longer to obliterate the virus. As a consequence, Xofluza is more
the infected host cell.
effective than Tamiflu in blocking viral transmission.
Although it is indubitable that Xofluza is an innovational drug, there are several limitations: Xofluza can cure only the flu at early stage and the time taken to alleviate symptoms has not become short compared to that of existing drugs. Furthermore, Xofluza has a risk of causing unpredicted adverse drug response due to its unprecedented mode of action. From now on, pharmaceutical companies trying to develop new flu drugs should focus more on current drugs’ limitation. However, the drug is sufficiently meaningful for its decreased dosage and shortened period to eradicate the virus. These enhanced functions of anti-influenza medication would definitely make not only influenza patients but also people around the patients overcome the flu in better conditions as far as severe adverse drug reaction is not observed. B
2018 vol.13
7
INTERVIEW
U
nder the vision of becoming a consulting company pioneering the global leap forward, BnP Care introduces the strategies through its management philosophy of “Quality Is Competitiveness“. This consulting firm specializes in biotechnology, drug development, and production activities, and is mainly comprised of QMS, QbD, and validation departments. Each builds and develops quality systems, advises on the understanding of modernized process, and verifies pharmaceutical equipment, facilities, and processes. The Blue Vanguard interviewed Tae Kyu Kim, founder and a CEO of BnP Care in May 2018 With his own stories, Tae Kyu Kim was kind to share what he knows to students and humbly gave an advice based on his own experiences.
Tae Kyu KIM CEO of BnP Care Prior Experiences Before BnP care was founded, I worked in Quality Control (QC) and Quality Assurance . (QA) Department of several bio-pharmaceutical . manufacturing companies for about 15 years. Working in . Korea Vaccine Co., Ltd. helped me to have established a solid mindset about production and quality of pharmaceuticals. Thereafter, I moved to QA department of Isu Abxis Co., Ltd. We have developed and produced monoclonal antibody drugs for the first time in Korea, obtained approval, and exported this product to various countries. Throughout this procedure, GMP facilities, documentation and quality system of the company have been gradually improved. In college, I worked in a laboratory dealing with microorganisms, especially pathogenic ones. However, this wasn’t what I dreamt in the first place. My very first interest was in architecture major eversince highschool, however, biotechnology was what I chose as my teacher highly recommended me to do. After being discharged from the army, I was given the chance to visit a professor big in pathogenic microbiology lab at a chance. The lab was looking for a laboratory research assistant, and joining this lab became a significant turning point in my life; from the point of affiliated to the lab, I was able to push myself into working in pharmaceutical industries and eventually to establish BnP Care. Working with microorganisms are
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truly interesting – microorganisms are what people get sick from while can get helthy despite their expressionless, emotionless behavior and the simplistic morphology. The more you know about them, the more you will be attracted to. While working for the pharmaceutical company, I could learn a lot from seniors and consultants that weren’t even affiliated to the company. By taking advantage of my strengths and experiences that I have built so far, I dreamed of helping start-up ventures by creating a professional consulting company to ultimately support Korean pharmaceutical companies. As global pharmaceutical companies obtaining achievements in development and quality sectors, I have been thinking there should, indeed, be more specialized consulting companies in Korea. Making money was not my major interest. I initiated this business in a way to assist newly-founded companies to get permission in a faster and safer manner, also with less trials and errors. If the company does so, I would be proud of it. These are the reasons why I founded my company — I had the idea that it could be.
Do Hyun Lee
dhleeaa@yonsei.ac.kr
About Quality by Design Starting it up with members of the ICH, regulatory agencies and similar industries are rapidly changing and reforming. All of our employees are taking the lead in establishing quality system (QMS) and developing advanced design quality (QbD) in drug development and production. It is our goal and vision to approach customers with an open mind and to give them back as great quality. Quality by Design (QbD) is a scientific approach for the development of a design space, where the main ingredients (drug substance), additive substances, and input variables interact multi-dimensionally within process parameters. Pharmaceuticals are manufactured by raw materials, and many R&D and investment are being made to target the global market as a future growth engine for the next generation. The application of the concept of QbD to product development and quality control is becoming an international standard in the field of pharmaceuticals.
INTERVIEW
Q8 (R2) “Pharmaceutical Development”, Q9 “Quality Risk Management”, Q10 “Pharmaceutical Quality System”, and Q11 “Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/ Biological Entities)” of ICH are the bases of QbD, describing principles of process validation. All medicines must be designed and developed to meet patients’ needs and to achieve product performance goals. You can adopt an empirical approach, a more systematic approach, or a combination of these two. A more systematic development method is called the QbD method. We use the prior knowledge, Design of Experiment (DoE), quality risk management and knowledge management throughout the product life cycle to understand the product and the process. To sum up, QbD is the process of development and improvement based on accumulation of all these matters. The U.S. and the EU have already begun or are in the process of implementing the QbD / PAT concepts and principles in various aspects and positions. Not only the regulatory agencies, but also the pharmaceutical industries are also adapting to this big change.
1. Be prepared with a second language ! The beginning of the global era roots from communication and language with no doubt. One may lose a chance by failing to overcome language barriers. In other words, one will have many opportunities with fluent language skills. Cultivating foreign language skills as one’s primary goal would be helpful in comprehending global trends in new drug development study, marketing, as well as quality management, and it would be a great opportunity in a near future. 2. Become a global talent ! I would like to advice them to read concurrent pharmaceutics-related guidelines and comprehend the market trend. It is important to fully understand ICH, FDA, EMA, and WHO guidelines. If one discusses explores materials and gains understanding of the guidelines through school clubs, he or she may soon have become a global talent. The future pathway of the College of Pharmacy student is somehow already specified to some extent. In addition to that, knowing the latest trend above all would be a good preparation for one to pursue goals as global talents.
Advices to Pharmacy Students BnP Care wants talented people who are “creative”, “cooperative”, “trustful”, and “risk-taking”, going on a way that nobody goes. The nature of the consulting company is that people must collaborate based on their in-house supports and capabilities. Also, we prefer people who would complete their job with confidence, trust and respect for each other. Lastly, we consider setting high goals and taking challenge as utmost important. If pharmacy students apply, I would possibly recommend them to apply for QbD or QMS department. Should one’s demand for risk-taking and passion added on to knowledge that they have learned in college, one could be a great consultant with synergistic effect.
3. Health care and exercise is essential ! Even if you have a successful career, you will be unfortunate if you have health related issues. Therefore, it is important for you to exercise routinely, strengthen your own stamina, and maintain a healthy body. It is said that a healthy idea comes from a healthy body. No one can make a healthy body for you; only you can do it thoroughly. Control yourself and make your own health. Also, make a steady effort for your health. 4. Be passionate ! Many companies like the word ‘enthusiasm’. Anything with dreams and goals will soon to become true. What you need is passion. However, it is not created in sudden; passion is emerged by concentration and love for work. Therefore, you must love yourself and know what you want. Then, you will have an enthusiasm and you will be able to achieve your goal based on that avidity. Believe in yourself and try to create your own goals. It does not matter if it is a goal of either one or ten years. If your target is set up, challenge yourself and create your own pathway. At the same time, ‘enthusiasm’ will be created by oneself. B 2018 VOL.13
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COLUMN
The Development of Gene Technology
G
HyeongGu Kwon
rgr4208@naver.com
enes have many effects on our lives. Their effect may not be absolute but they have great influence on people’s appearance as well as characteristics and onset of many diseases. Researchers have been assuming about the role of genes for a long time and they discovered the fact that many diseases are intimately connected with genes. Such discovery naturally turned their attention toward the treatment of disease. Because various hereditary diseases are originated from gene problems, if the gene is modified correctly, the diseases can be cured. Thus, researchers have been studying how to modify genes for a long time.
Gene Recombination The technique that modifies an existing gene into another is called ‘gene recombination’. This technique started from bacteria. As we suffer from infection by many antigens, one of the most fatal threats to bacteria is virus. Some viruses use bacteria as hosts, and bacteria naturally provide a defense system for them. The first defense system that people have discovered is called ‘restriction enzyme’. The enzyme recognizes a specific gene sequence and cuts the gene into fragments containing those sequences. The way of cutting is variable depending on the types of enzyme. Researchers wanted to apply this enzyme in gene recombination. If they could cut the target gene using a restriction enzyme and insert a specific sequence between the junction, they would move one step closer to gene therapy. The following figure is about the principle of EcoR1, the most famous restriction enzyme, and the method of gene modification using this enzyme. As you can see in the picture, EcoR1 enzyme recognizes the specific ‘GAATTC’ sequence, and cuts that region. The next insertion step of the new sequence is quite simple: the sequences’ ends are matched, and put together with ligase, a sticking enzyme.
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THE BLUE VANGUARD
CRISPR-Cas9 Technology However, this restriction enzyme technique has some defects. Restriction enzyme codes for a specific sequence, so it is useless if the target gene does not have that sequence. Besides, restriction enzymes have their own specific feature and this makes designing experiments hard. To solve these problems, researchers developed a new technology that can cut and paste genes where they want to change. This technology is called ‘CRISPR-Cas9’. CRISPR-Cas9 technology was started from bacteria’s enzyme, just as the restriction enzyme was. CRISPR is the abbreviation of Clustered Regularly Interspaced Short Palindromic Repeats. These palindromic repeats are fragments of viral DNA, and when they are overlapped with external DNA fragments taken from Cas9 protein, they cut those fragments. Cas9 can cut not only fragments from virus, but also fragments which are made artificially. This way, in contrast to restriction enzymes, it is much easier to modify genes by targeting DNA sites. This is called ‘gene scissors’.
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Before the CRISPR-Cas9 technique was developed, researchers found similar immune systems among bacteria. These are called ‘Zinc finger Nuclease’ and ‘TALEN’. Zinc finger Nuclease and TALEN are each known as the 1st generation and 2nd generation gene scissors. But these techniques were not effective. CRISPRCas9, the 3rd generation gene scissors, made of for the shortcomings the preceding generations and is applied in many experiments worldwide. The 1st generation and 2nd generation gene scissors used protein to find target sequences, so it was to hard to modify 3D structures of protein. Eventually, researchers began considering DNA’s complicated sequences. Unlike these scissors, CRISPRCas9 uses DNA as sequence finder. It can be handled easily, and modify target protein directly. So now, it is used in animal experiments, GMO, and manufacturing drugs. China is already trying to use gene scissors in human embryo. It is clear that the CRISPR-Cas9 technology’s goal is to cure the human cell by editing genes, but it is too early for now.
Dark Sides of Gene Technology
Moreover, if gene modifications ran rampant in society, it could cause tragedy. Many movies warn the situation in which humans overuse the gene modification technology. ‘GATTACA’ is a prime example of such movies. In GATTACA, people have to live by the way their genes are set up, not by their own free will. The movie delivers the message that if we become fanatical about the power of genetics, we can ignore each individual’s potential. However, the development and commercialization of the technology will be bound to happen sometime in the future. Then what is the importance of gene editing technique in pharmacy? CRISPR-Cas9 can be used as ‘drug’ itself. Just like the current chemical material, gene scissors have the purpose of curing diseases. And it has the advantage of targeting the diseases’ key cause. We, the pharmacists, have only studied chemicals so far. Therefore, when such bio-critical drugs are developed, our knowledge will be limited to a narrow scope in the medical field. Still, gene therapy technology has problems, it will be solved as soon as possible. It seems necessary to accumulate knowledge based on genetics to become the leading pharmacists of the future. B
2018 VOL.13
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COLUMN
How Can We Overcome The Sleepless Nights? Sol Kwon
H
rnjsthf94@naver.com
ave you ever heard about the worldwide hit song that has an addictive chorus, ‘feels like insomnia, feels like insomnia’.
This song, insomnia, sings about one man who can’t fall asleep because of the girl whom he loves.
One of the reasons that this song attracted worldwide attentions is that many people have such experiences
of sleepless night to think about their lovers. Not only love, there are so many stressful things, such as work and
money, that make people awake at night. Lots of people around the world are struggling with sleepless nights.
As much as insomnia is a problem for people today, the same occurred to people in the past as well. The ancient people also suffered from insomnia. There is an ancient record of consuming large amounts of alcohol as a solution to sleeping difficulties. Alcohol binds to the gamma amino acid (GABA) receptor which suppresses the nerve system. So people who take alcohol become blurred and sleepy. However, they cannot sleep soundly. This is because each stage of the sleep is not advanced enough. It is understandable that excess alcohol consumption was used as a suitable solution long time ago, because it was urgent to solve the problem of staying awake all night and ancient people didn’t have a wide range of choices. The herbs that make people hazy were also used to treat insomnia. As people know well now, however, reckless use of drugs can cause dependence and make people unable to sleep without drugs. Also there are more frightening side effects, including hallucinations. When did the modern definition of sleeping pills come into play? As chemistry developed in the 19th century, sleeping pills appeared. For example, Ether was used as an anesthetic for surgical procedures, and it was often prescribed to treat insomnia during this time. Since then, lots of sleeping pills have been developed and have rescued many people from the nights without sleep.
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In today’s society, the drugs you take to treat insomnia do not just make people blurred, but actually turn the brain and body into a sleeping stage. These drugs are divided into hypnotics and sleep derivatives. Hypnotics are specialty medicines and cannot be purchased without a doctor’s prescription. On the other hand, sleep derivatives are categorized as over-the-counter drugs, so people can buy them at pharmacy without a doctor’s prescription. Both drugs are used to treat insomnia, but they have different medicinal properties, such as ingredient and effect. Usually, the effects of the sleep derivatives last about two to three hours, and that of the hypnotics last from four hours to twelve hours.
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All these sleeping drugs induce sleep by stabilizing the brain’s nerve system or maintain sleeping state by preventing brain from awakening when once fall asleep. People can get help from sleeping pills when they have a difficulty of falling asleep in the short term or when the condition is serious enough to disturb your daily lives due to insomnia. However, sleeping pills do not directly cure insomnia. All of them indirectly control the neural activity to create a more likely situation of sleeping. They may have effects temporarily, but as drugs they cause complications and adverse effects such as dependencies, addiction, tolerance, and withdrawal symptoms and so on. For example, Benzodiazepines, leading sleeping pills, may cause dizzy or anxious. Barbiturates, another hypnotics, are highly dangerous because they have a small lethal dose which means that people can die even take very small dose. Also benzodiazepines and barbiturates have high dependencies that make people hard to give up drugs. Although Non-barbiturates such as Zolpidem are developed as low-dependence sleeping pills, they still cause problems of hallucinations or confusion.
If insomnia lasts for months and is very serious, it is strongly recommended to seek a solution through consultation with specialists such as doctors or pharmacists. Because it is difficult to expect the exact cause of side effects which are the combination of multiple unintended actions, taking sleeping pills as one pleases is very dangerous. Thus, many specialists recommend safer way rather than taking sleeping pills to people who suffer from insomnia for a long time. They say that ‘sleep hygiene’, which refers to a series of lifestyle habits for good sleeping, can help those. They are as follows. First, exercise lightly during the day. This is because physical fatigue can trigger sleepness. Second, it is recommended to enjoy the sunshine outdoors during the day time. When people are exposed to sunshine, the body releases serotonin, which means people are fully awake during the day. As a result, they sleep relatively deeply at night. Also, proper exposure to sun makes melatonin, a hormone that induces sleep, and releases it at night. In addition to these, avoiding taking alcohol, caffeine, and overeating before bed time is another method of sleep hygiene. B
2018 VOL.13
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COLUMN
Potentiating Immunotherapies with Oncolytic Viruses Seo Bin Park
jensbpark@yonsei.ac.kr
I
mmunotherapy is becoming a promising approach to treating cancer. Its prospects are boundless and is expected to revolutionize the field of cancer treatment. Previous cancer drugs specifically targeted cancer cells, while cancer immunotherapy drugs exploit the components of patients’ immune system to remove tumors. Therapies targeting T cell inhibitory checkpoint signaling pathways, including programmed cell death protein 1 (PD1) monoclonal antibody and PDL1, a ligand of PD1, have produced unprecedented results. However, only a minority of patients benefit and those with cancers, such as prostate cancer fail to experience the clinically desired antitumor immune reaction, due to the immunosuppressive tumor microenvironment. On the contrary, the newly emerging oncolytic viruses that preferentially infect and kill cancer cells represent a new class of therapeutic agents that promote antitumor immune responses.
What is Immunotherapy? Cancer cells thrive as they hide from our immune system, yet immunotherapies harness the body’s natural strength to fight cancer. The goal of most immunotherapies is to activate immune effectors, such as T cells and natural killer (NK) cells, to increase patient outcomes. Immunological targeting of cancer requires the coordinated actions of innate and adaptive immune systems. When activated, effector immune cells attack tumor cells and destroy them. During normal immune responses, the activities of the cells of the innate immune system, such as NK cells, macrophages (Mφs), and dendritic cells (DCs), initiate the cascading events that prime the antigen-specific adaptive immunity that is mediated by T and B lymphocytes. Antigen-presenting cells (APCs) internalize tumor antigens and present processed antigens through class I and class II major histocompatibility complex (MHC) molecules on their
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THE BLUE VANGUARD
surface and facilitate the activation of CD8+ and CD4+ T cells, respectively. Any impairment of the cancerassociated immune checkpoints, such as the PDL1-PD1 interaction results in defective antitumor immune responses. Hence, immune checkpoint inhibitors, such as anti-PD1 and anti-PDL1 (Fig. 1), are used to boost T cell activities. Despite the high potential cancer immunotherapy has, there are currently only five drugs approved by the FDA.
Combination of Therapies Oncolytic Viruses, abbreviated as OVs, have been originally used for their preferential cancer-killing activities without harming normal cells, yet they are now being recognized for their ability to overturn cancer-
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associated immune evasion and promote an otherwise absent antitumor immunity. There are three mechanisms to OV-based cancer therapy. First is direct oncolysis; progeny viruses released during oncolysis spread to neighboring cancer cells, amplifying the effect. Next is vascular destruction, during which OVs target tumor endothelial and stroma cells and promote neutrophildependent blood clots. These cause the collapse of tumor vasculature and apoptosis of tumor cells. Last is antitumor immunity, in which OVs promote the activation of both the innate and adaptive immune response against tumor, establishing otherwise lacking antitumor immune reaction. While countless clinical trials regarding immunotherapies and virotherapies are ongoing, researchers realize that no therapy alone can produce optimal anticancer benefits, and thus strategic combinations of therapies are required.
Figure 1. The mechanism of anti-PD1 and anti-PDL1 to achieve effective antitumor immune response.
What is so Promising about Combination Therapy? In the presence of immune checkpoint inhibitors, such as antibodies against PD1 alone, T cells are rescued and activate immune-mediated tumor cell death, yet with reduced MHC expression, immunosuppressive tumor microenvironment remains intact. OVs overcome the suppressive mechanisms and promote antitumor T cell response with increased MHC expression; however, OVs do not alter immune dysregulation imparted by the inhibitory immune checkpoint molecules. Hence, our expectation is that when immunotherapy and virotherapy are applied in combination, OVs could overturn immunosuppression and initiate antitumor immune response, while immune checkpoint inhibitors deal with
checkpoint-molecule mediated immune dysregulation. Sillajen’s Pexa-Vec (JX-594) is currently one of the most promising OVs being evaluated in patients with hepatocellular carcinoma 1L in the global Phase 3 clinical trial. In preclinical studies, Pexa-Vec’s unique mechanism of action has shown synergy with anti-PD-1 antibodies and anti-CTLA-4 antibodies; thus, SillaJen is continuously launching new clinical programs to explore the power of combination therapy. Indeed, combination of the two therapeutic interventions could markedly synergize the clinical effectiveness of cancer immunotherapy.
Conclusion In the last few years, significant progress has been made in the development of both immunotherapy and virotherapy, and strategic management of these cancer therapies in combination results in better patient outcomes than those achieved by either treatment alone. Going forward, further investigations should focus on optimal selection of viruses depending on the types and stages of cancers and routes of delivery, ultimately achieving the next breakthrough in combination cancer therapy. B
2018 VOL.13
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national issue
VR Technology and Medical Field
Jeyoung Son
wpdud3944@naver.com
W
e call the next era of smart technologies, “post-smart times”. PC’s, smart phones and tablet PC’s require internet connection, while in post-smart times technology will be based on IoT(Internet of Things), the interconnection of computing devices via embedded internet in everyday objects.
ICT(Information and Communications Technologies) is at the heart of this promising technology, and aims to develop a wearable technology for a more advanced goods and services. Nowadays, ICT center provides programs that fuse art with social science and these are continuously being developed with engineering, medical and environment science as well. Most people may have heard about the word “VR”, which stands for Virtual Reality. VR technology is the most advanced computer technology we have, to experience virtual reality. The most commercialized field of VR is games. We can find so many VR game stores or VR cafes easily on the streets. However, VR technology is an infinite area that can be also applied to our daily lives, not only limited to games. In reality, medical-ICT convergence technology that applies VR to rehabilitation medical science is becoming more and more recognized in both medical world and pharmaceutical field. In fact, “medical ICT convergence consortium” that is managed by industry-academia department of Chungang university
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and supported by the Ministry of science, ICT and National IT industry promotion agency will develop their business with many hospitals and medium sized firms from April 2017 to March 2019. It has only been two years since rehabilitation medical specialists started to apply VR technology to rehabilitation. There are two domestic hospitals that currently integrate VR technology to medical science: CHA Hospital in Bundang and Gil Hospital of Gacheon University. The medical specialists in CHA hospital meta-analyzed 35 reports for the 195 paralyzed patients and they realized that their motion ability was enhanced after the VR rehabilitation treatments. In Gil hospital, paralyzed patients by stroke can experience their normal life such as crossing the crosswalk and shopping at the market in the virtual reality through VR rehabilitation treatment program. Patients can concentrate on the treatment and the compliance to the treatment has been better than the previous rehabilitation treatment. Furthermore the notable company for the domestic
NATIONAL ISSUES
digital technology, Samsung Electronics is developing VR technology for rehabilitation and pain treatment. Samsung will test the effects of the “digital pain relief kit“ with their products, GearVR and Gearfit2 in the US. Injured people with fractured leg or waist not only can rehabilitate with VR, but also can relieve pain. A Digital Pain Relief kit can make patients more comfortable with VR, wearable technology and low frequency treats instead of manual drugs in this case. That is, VR can control the chronic pain patients with VR. On top of that, VR can provide a more relaxed environment and a low frequency therapy when the pain breaks. A wearable kit will be used for monitoring the patient’s condition. If this technology is commercialized, we can expect various economic and medical advantages. The medical expenses can be decreased because digital pain therapy can replace the drugs and narcotic analgesic abuse and addiction. Not only does the field of rehabilitation makes use of VR technology but also a manifold of medical specialists. The department of neurology, for example, started to introduce the VR technology into their field, brain science and neurology. Professor Donghwa Kang of Seoul Asan Hospital established a venture company called “Deepbrain” in the hospital. Deepbrain developed a content that can help the non-visible patients by brain damages. It can recover the patients’ eye sight by VR technology. In addition, VR technology can be introduced to the field of psychiatry. VR is now considered that it can have great effects for the patients who have social phobia and depression. It can visualize the virtual phobic situations to patients and the patients can try to overcome the circumstances. If this treatment is used with drug therapy, it will provide a much better result than the previous cures. As you can see from the diverse examples, VR technology has infinite prospects for various fields including medical treatments. Nowadays many hospitals, medium sized firms and major company like Samsung are trying to develop the latest platform for integrating VR technology to medical businesses. It can provide the most optimized health care condition to patients, exceeding the limitations of space and time. Many specialists are expecting that VR technology can be more commercialized and modernized in medical fields because it has benefits for the limited space and time and also can reduce the medical expenses of patients in the long run, since VR therapy can reduce the use of drugs like narcotic analgesics. In fact, a handful of large domestic hospitals express their opinions that they seriously consider using the VR technology for the medical cures and also many firms are established for the developing of the medical VR technology. We can anticipate a brighter future with VR tools integrated with medical therapies. B 2018 VOL.13
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NATIONAL ISSUES
The Emergence of Oriental Pharmacy Chaeyeon Won sophiachaeyeon@gmail.com
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riental medicine, which has been studied for decades in Asia, roots from the laws and patterns of nature and applies it to the human body. Acupuncture, Moxa treatment and acupressure are amongst the most common oriental therapies that base their understandings on such empirical studies. On the other hand, Western medicine is based on a rather scientific data and hence consists of surgical methods, ultrasonic laser and electric stimulus. The coexistence of oriental medicine and western medicine seemed controversial in the past. Unlike in the past, when the coexistence of oriental medicine and western medicine have been controversial for decades, the mixture of them seems more natural nowadays. Nowadays, scientific evidences supporting the effectiveness of oriental medicine are emerging. For example, some researchers have found out that acupuncture is actually effective through monitoring fMRI. This enabled people in the field of oriental medicine to quantitatively measure the therapeutic effects and provide scientific evidences. These evidences and news enabled the public to realize the importance of oriental medicine.
Having heard of the importance of oriental medicine, many pharmacies are beginning to host more of oriental medicines and promoting themselves as integrated pharmacies of the two fields. Some may wonder about the need of this type of pharmacy. However, this type of pharmacy can actually provide better education for patients and increase the therapeutic effect by combining both eastern and western medicinal approaches. Western medicine which is supported by scientific evidences is based on surgery, ultrasonic laser and electric stimulus. Since it directly attacks the risk factor, it is effective in treating severe diseases and alleviating symptoms. As Korean food is becoming more and more westernized, many Koreans suffer from western diseases such as adult disease, cancer and obesity. However, there are some parts where Western medicine cannot reach. Sometimes you can come across some patients who still could not recover even after major
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surgeries. In this case, oriental medicine can be helpful. Oriental medicine focuses on making balance of body and increasing immune system in general. By making balance of body and boosting their strength, oriental medicine can make people healthier and immuned to other possible diseases. Therefore, oriental medicine can be treated for prevention of disease or curing lesion. In fact, there are some cases where some people recover from a sequela of western medicine via oriental medicine. For instance, in modern society that emphasizes on apperances, lots of modern people pay special attention to their actual appearances. In the case of skin diseases such as acne and pimples, western medicine generally focuses on treating only the outer skin, from phenol treatment using acid properly, antibiotics and hormone treatment such as oral contraceptive to laser treatment, rather than the inner side of the acne and pimples. After all, only the symptoms of the disease have been treated, but the cause
NATIONAL ISSUES
has been left untouched, so when it is treated naturally, it gets better but soon it will recur again. A large number of acne patients go through numerous treatments and recur. For the last choice, they choose oriental medicine. Since oriental medicine regards the human body as a closed organism rather than dividing it independently, considering our human body from a holistic perspective is possible. Therefore, there is such a saying called, ‘The face expresses everything implicitly with a short word of the mirror of the book.’ For treating pimples, eastern medicine focuses on fixing patients’ current problems first, such as chronic fatigue, stiff shoulders, menstrual cramps, dyspepsia, and hemorrhagic fever. Many peole become puzzled at the fact that it does not focus on skin problem. But this is actually how it works. It is difficult to expect a cure of acne and other skin diseases without treating other problems. Oriental medicine focuses on making balance of body and increasing the immune system. Therefore, it can be effective on not only treating but also preventing diseases that cannot be cured through western medicine. By making balance of body and boosting strength, oriental medicine can make people healthier and immuned to other diseases. Therefore, oriental medicine can be treated for prevention of disease or curing lesion. The eligibility condition for being able to host oriental medicine depends on the formula of medicine. For instance, if the medicine consist of granules, there is no barrier on hosting it. Every pharmacist can sell oriental medicine in granule formula. However, if the oriental medicine is in liquid formula, then pharmacists are only eligible to sell those only if they pass the qualification test for preparing oriental medicine specifically. Only people who graduated from pharmacy schools and those with a pharmacist license are eligible to apply for this qualification test. They also need to take courses related to oriental medicine. However, this qualification test is not getting its popularity despite of its crucial role. From the last twelve years, only one person has applied. Since its needs are very low compared to its supply, this test is on the verge of being banned. Compared to its application fee, 90,000 won, its preparation fee is very high, 900,000 won. Since this qualification test itself is very economically inefficient, measures must be taken. People, especially those working in medical field, need to realize and acknowledge the importance of oriental medicine. Changes in employment rate is also another aspect to be accomplished. By lowering the barrier of oriental medicine, more pharmacists will easily access oriental medicine. Oriental medicine has a long way to go to become more acknowledged for its therapeutic benefits. In the context of Korean medicine, oriental medicine is considered as an adjunctive treatment, not the main one. This is why doctors sue oriental doctors for using high technological machines such as CT or MRI. At the same time, oriental doctors sue those doctors in turn, for prescribing oriental medicine. These demonstrate how each field refuses to communicate and it seems like a long way to intertwine the two. Pharmacists’ main job is not only filling prescriptions, but also giving advices on patients general health states. Therefore, it is crucial for pharmacists to provide suitable treatment and education for patients. As a matter of fact, pharmacist is the only occupation that can provide a comprehensive and balanced medical information to the public. According to current law, pharmacists can use both synthetic drugs based on western medicine and herbal drugs based on eastern medicine. Therefore, pharmacist can become a better educator and advisor to the public by providing a balanced medical advice. To sum up, pharmacist is the only career that can use both fields and provide the most appropriate treatment to patients. Therefore, pharmacists should study more about medicine in depth, become more open minded and have higher career-esteem of their career. B
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NATIONAL ISSUES
Where Does the Fault Lie ? Reflecting on Ewha Womans U. Mokdong Hospital NICU Scandal Claudia You Sun Choi
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ast December, four consecutive deaths of neonates ensued at the NICU of Ewha Mokdong Hospital within just eighty-one minutes. This chain of events was unprecedented in that newborns died in a row at the same hospital, and it was even more striking that it happened in a renowned university hospital. This January, the National Forensic Service (NFS) concluded that the cause of death was sepsis due to Citrobacter freundii infection, and held the Hospital responsible. The epidemiological investigation revealed that the lipid emulsion given to the infants or the process of injecting must have been infected. As contamination within the hospital was confirmed, the police arrested five medical staff at the NICU for alleged accidental homicide.
Although improper handling of the lipid injection is undoubtedly the most definite cause of such heart-rending event, it is indisputable that there were other significant causes that set the stage for this tragedy to unfold. The NFS only appeared to have put a conclusive ending to the dispute when it brought forth evidence for the malpractice of doctors at the NICU. The turmoil became even more frantic when the lax management of drugs became the next object of public criticism as they found out that the same bottle of lipid emulsion was used to treat multiple neonates. Criticism rose because not only that same bottle made the infection spread among victims, but also the hospital overcharged the fee for drugs as if different bottles were used for each infant. Currently in the market, lipid emulsions come in large volumes; the smallest bottle contains 100 mL which is too big of a size to be used for one neonate. For the hospital, small-sized bottles are not
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clauchoik@gmail.com
the best option since large bottles can be used for both infants and adult patients, and inventory is easier to control. The problem is, NICU is maintained in a condition high in temperature and humidity which makes it a perfect place for germs to propagate. The accused medical staff nevertheless chose to economize on the drug costs, thus compromising the health of patients.
Excuse the Accused In response to the allegation, practitioners justified their mistake in shifting blame to the feeble institutional framework they claim to have been coping for the past years. They declare to have ended up in a predicament of financial incapability and meager governmental aid, aggravated by an ever-rising employee turnover and lack of professional personnel. NICU is short for Neonatal Intensive Care Unit, and it serves to provide focused medical attention to babies born prematurely. This may translate to a high level of training and tough labor intensity for the workers. Unfortunately, however, most of the time work conditions were not commensurate with the efforts made by medical staff. According to the Ministry of Health and Welfare, the nurse-to-bed ratio dropped from 1.18 in 2011 to 1.04 in 2015, despite the addition of over 400 beds in the NICU wings of Korean hospitals during the same period. Although recent governments have tried much to decrease fatality rates of neonates, they seemed to have overlooked the fact that building more NICUs would not necessarily favor hospitals’ profit system, as the pricey requirements of
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NICU write an income statement that would never turn profit. Critics point to the fact that the Health Insurance Review and Assessment Service (HIRA) put more pressure by setting stringent guidelines on medical billing, pushing on the custom of sharing drugs and cutting costs. The government is even said to have played favorites in restricting national aid to just a select list of “Big Five Hospitals”, which inevitably led to those left-outs to suffer from overwork and uncompetitive medical fee. Such state of affairs speak in favor of doctors who believe that simply punishing the medical staff at Mokdong Hospital would not make amends for the inferior condition of Korean NICUs, but would rather blow off an opportunity to root out customs of long standing.
Pharmacy in Action In response to elevated concerns, the Ministry of Health and Welfare announced a short-term plan for safety control. This includes reinforcement of human resources at the NICU, production of small quantity vials for neonate use, and higher medical fee for hospital pharmacists working at weekend and night shifts, among many others. These regulations may help keep an eye on safer production and administration of drugs. Meanwhile, there are opinions that staffing up is the upmost priority, and protocols must help support this.
What role can we suggest pharmacists take up regarding this change for the better? The current pharmaceutical law fails to detail out the full scope of duties that hospital pharmacists perform. They are merely expected to be the ones that give out drugs from the dispensary room. Since the Patient Safety Law implementation in 2016, efforts have been made regarding the safe administration and management of drugs towards patients. It is thus hard to believe that pharmacists, who take care of drug safety, are not an essential part of the task force for patient safety. The number of pharmacists at medical institutions fixed by the 38th article of the current law falls short to provide enough medical service. Adding to the matter, there are some articles that recognize an activity fee for compounding sterile injections and medication counseling, but surprisingly none for clinical drug management. In regards to this situation, the Korea Hospital Pharmacist Association brought forth the idea of adding a member of the Korean Pharmaceutical Association at the National Patient Safety Committee. It further plans to put hospital pharmacists at the core of drug management and administration in medical institutions. Fundamentally, new law must guarantee an essential labor force for provision of medication that is patient-centered, safe, and efficient. The Seoul National University Bundang Hospital’s Pharmacy Department is frequently referred to as a successful case of clinical drug control. It has a self-developed drug management system through which every type of medication used in the hospital is tagged with an RFID and barcode that provides an expiry date, stock, and manufacture serial number. Furthermore, as prescription is given out by a doctor, safety info regarding drug-drug interaction and dose calculations based on the individual patient’s kidney function is immediately added. Hospital pharmacists examine this data when manufacturing each drug and provide comments to foresee any side effect. The drug package has another barcode containing patient data, prescription details and administration frequency. Besides working in the drug delivery room, pharmacists are a vital part of teams like the infectional medicine, critical care medicine and intensive nutrition support team. Hope is raised for taking this tragedy as an expensive lesson as well as following the above example to ensure active participation of pharmacists in hospitals’ day-to-day activities. This should bring a synergistic outcome and fulfill unmet needs in the field of medicine. B 2018 VOL.13
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INTERNATIONAL
A
world festival took place in Korea for the second time since 1988. 2,925 athletes from 93 countries participated in the Pyeongchang Winter Olympics. Throughout the season, the Russian flag could not be seen anywhere in Pyeongchang. This was no exception at the medal ceremony and even at the opening ceremony in which 1218
drones embroidered flags from all. Why was that we could not spot the Russian flag?
Russia had tampered with the doping results on a state-run basis at the 2014 Sochi Winter Olympics. At that time, samples were switched in the drug-testing analysis room. Due to this incident, the International Olympic Committee (IOC) punished Russia by restricting its official participation in the Pyeonchang Olympics. It charged Russia with fifteen million dollars in anti-doping funds, and only players who were not related with the doping scandal were allowed to join the competition as OAR (Olympic Athletes from Russia). IOC expressed its intention to lift the discipline if Russia were to implement sanctions. Eventually Russian athletes could not hold their national flags even at the closing ceremony, since two cases of doping were detected in OAR during the Olympics. The dictionary defines doping as athletes’ use of banned drugs, injections, or special physical treatments for the purpose of promoting extreme physical fitness in athletics. Taking a prohibited drug is primarily intended for improving performance, for example increasing muscle growth, endurance, and concentration, relieving fatigue, and reducing weight. World Anti-Doping Agency(WADA) has published an annual List of Prohibited Substances and Methods. The List identifies the substances and methods prohibited in and out of competition, and particularly in sports. If two of the three following criteria are met, the substance is included in the Prohibited List: 1) potential to enhance performance in sport, 2) actual or potential risk to health, 3) violation of the spirit of sport. A banned drug, Meldonium, was detected from the doping sample of Alesksandr Krushelnitckii, a bronze medalist in the curling mix double at the Pyeonchang Winter Olympics. Meldonium improves performance by increasing blood flow, and it was included in the Prohibited List on Jan 1st, 2016. Nadezhda Sergueeva, an OAR bobsleigh athlete, also tested Trimetagidine. Trimetagidine is commonly used to treat angina, but since it can also be abused as a stimulant, it is illegal.
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INTERNATIONAL
g n a h c g n o e y es P m a G n c i a p m e y l l C ee O Fr g n i p o D r o f
Soyeon Kim
ssoyeon5012@naver.com
At Polyclinic, a medical center in Gangneung Olympic Village, seven pharmacists dispatched from Seoul National University Hospital provided medical assistance to the patients sports season. They played various roles such as pharmaceutical care providers, management teams, and volunteers at the athletes’ village, but most of all, their attentions were given to the athletes. They first checked to see if any of the drugs prescribed to athletes were prohibited. And then, in the event of using banned drugs, they reviewed and reported to the team doctor for approval by the IOC. The IOC also asked for a daily report on what drugs participants were taking. The Polyclinic members said they felt responsible for being pharmacists during their busy schedules. Increasingly clever doping methods and technology detecting them have been developed one after another. Recently, a growing number of doping cases have been using new drugs like biosimilars that resemble substances that exist in the body. Indeed, it is important to find out a doping case through precise analysis. However, as doping may damage a player’s health, we should reconsider the role of pharmacists in doping. Just like they did at Pyeongchang Winter Olympics Medical Center. B
Role of Pharmacists in the Fight against Doping in Sports from FIP World Congress of Pharmacy and Pharmaceutical Sciences
Pharmacists should 1. Keep up-to-date on the contests of the WADA Code 2. Remain vigilant to difference between the justified use of medication and illegitimate practice 3. Refuse to supply a medicine when it is clearly intended to be used to improve performance illegitimately 4. Provide information to those identified as being involved in a competitive sport, to help them to recognize which medicines contain a substance included in the list in the WADA Code 5. Provide information to those involved in athletic sports on the benefits of nutritional supplements and the risks associated with using them. 2018 VOL.13
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INTERNATIONAL ISSUE
Pharmacy Specialists : Clinical Professionals At The Hospital Kim Yong Wook
demosca1911@naver.com
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n October 14, 2017, 193 pharmacists took the 8th pharmacy specialist certification examination. Today,
pharmacists are getting opportunities to work in multidisciplinary clinical fields. Therefore, pharmacists working in medical institutions are required to have professional knowledge in order to cooperate with their colleagues.
Pharmacy specialists are clinical pharmacists who are experts in pharmacotherapy. When pharmacy specialists work in medical institutions, they are usually free from simple tasks like dispensing and medication counseling. Instead, they work as members of ‘Team medication’. They become the UM (Unit Manager) of their major field and monitor the patients’ medication history. They also check medications of each patient to minimize side effects. Therefore, the pharmacy specialists are an essential part of medical institutions in providing advanced medical services, meaning their roles are becoming more patientcentered. In Korea, Seoul National University Hospital benchmarked the residency program of ASHP in 1983 and introduced a pharmacist specialist program. This program has spread to some general hospitals located in Seoul and has been conducted in seven general hospitals. In 2008, KSHP (The Korean Society of Health-system Pharmacists) established regulations for the operation of pharmacy specialists. The first certification examination was conducted in 2010 by the KSHP. KSHP is making efforts to legalize the system.
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Because the Korean system benchmarked the American system, there are lots of similarities. The residency program of ASHP consists of two steps, PGY1 and PGY2. PGY refers to Post-Graduate Year, which means that candidates of pharmacy specialists have to continue studying clinical pharmacy even after getting their pharmacist licence. First, candidates have to take a course of PGY1. During the PGY1 course, candidates learn the basic elements for pharmacy specialists regardless of their major areas. It takes a year to finish the PGY1 course. Also, candidates can choose one of three PGY1 courses: community pharmacy practice, managed care pharmacy practice, and general hospital pharmacy practice. After the completion of PGY1 course, they take a PGY2 course for an additional year. PGY2 consists of nineteen areas of clinical pharmacy. Each area of PGY2 courses is the most advanced knowledge, and pharmacy specialists will work on it in the team medication.
INTERNATIONAL ISSUE
PGY1 Course (American System) 1.community pharmacy practice 2.managed care pharmacy practice 3. general hospital pharmacy practice
Common Subjects (Korean system) 160~200 hours course for basic knowledges
Major Subjects PGY2 Course (American System) 1.Ambulatory Care 2.Critical Care 3.Emergency Medicine 4.Health-system Pharmacy Administration 5.Informatics, 6.Managed Care Pharmacy Systems 7.Nuclear Pharmacy 8.Oncology 9.Pharmacotherapy
10.Solid Organ Transport 11.Cardiology 12.Drug Information 13.Geriatrics 14.Infectious Diseases, 15.Internal Medicine 16.Medication Safety 17.Nutrition Support 18.Pediatrics 19.Psychiatry
To be a pharmacy specialist in Korea, applicants are required to finish a course of common subjects and major subjects. In most cases, they have to take at least 200 hours of common courses and 160 hours of major courses to get an opportunity to apply for the pharmacy specialist certification examination. Candidates can skip the basic subject course if they have a master’s degree in pharmacy, because they are regarded as having basic knowledge of clinical pharmacy. In Korea, new majors are being added every year. In 2017, the examination was conducted on ten professional areas including the geriatric medicine newly introduced that same year. As mentioned in the paragraph above, the Korean and American systems have some similarities in the curriculum. Both systems have a two-step curriculum. The Korean system has common and major subjects, and the American system has PGY1 and PGY2 courses. Both common subjects and PGY1 courses consist of basic knowledge for pharmacy specialists comprising every area. On the other
1.Infectious Diseases 2.Endocrine Diseases 3.Pediatric Medicines 4.Cardiovascular Disease Medicines 5.Nutritional Medicines
6.Medical Information 7.Organ Donation Medicines 8.Tumor Medicines 9.Intensive Care Medicine 10.Geriatric Medicine
hand, major subjects and PGY2 courses consist of professional areas for pharmacy specialists. These curriculahelps candidates and groups related to the examination to save resources. By dividing the curriculum into two parts, it is possible for a person who has basic knowledge on clinical pharmacy to skip the basic subject courses. The Korean pharmacy specialist system has evolved into a KSHP’s certification system different from the 1980s. However, unlikethe system that has been developed by ASHP long ago, it still needs improvements. There should be more major courses and courses related to government policies. Although KSHP continues to add major subjects, there should be more when they are compared to ASHP’s nineteen courses. Because the number of major subjects relates to the scope of fields in which pharmacy specialists can use their specialties, it is important for their competitiveness. Also, it is essential to link the pharmacy specialist system to the government to get credit outside the pharmacist society. At present, pharmacy specialists are hard to be credited when they are working overseas. However, as we have seen in this article, they are improving through the years. I expect the future of this system to be bright. B
2018 VOL.13
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CAMPUS LIFE
Freshman and Graduate The Beginning from Different Sites
Yoonju Jang Freshman EunChan Lee 2010-2013 Busan International High School 2013-2014 Korea University, English Literature major 2018~ Yonsei University, College of Pharmacy, Editor of The Blue Vanguard
Why did you choose Pharmacy as your new major while your previous one was English Literature? I attended an International High School, which only had Literature classes. Even though I loved my major, I have always wanted to gain professional knowledge in a particular field such as science, since I never had a chance. Although I started studying science with some level of curiosity in the beginning, I later became deeply interested in the field. In fact, I found myself enjoying Biology, which enhanced my confidence while preparing for PEET. Knowing the fact that you went to Korea University in the past, what made you come to Yonsei? Even when I went to Korea University, I knew that I would be well suited with the atmosphere of Yonsei. Korea Uiversity has a tough and spirited atmosphere, while Yonsei is soft but strong.
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sarahjang99@naver.com
Besides, I loved the fact that Yonsei had a church on campus. The reason why I chose Yonsei Pharmacy is because it is newly established. I want to become an alumni who pioneers a path for future students. Also, I consider Yonsei’s graduate school to be the right place to pave a way for my second dream. What motivated you to apply for The Blue Vanguard, and what article do you want to write? Ever since high school, I really enjoyed writing. So when I first got to know about this club, I wanted to apply right away. I am very happy and excited now, and can't wait to write my own article. I have a rough idea on writing an article about a public issue, and one that non-pharmacy-related people can easily understand. I guess this is the ultimate goal of The Blue Vanguard magazine. What are your plans after graduation? What is your dream? If I can afford it, I want to go to Law school after graduation. I want to use my acquired expertise in pharmacy, and apply it to others fields that I am interested in. This will give me specialties in both areas of expertise, and help me become more competitive and capable.
CAMPUS LIFE
Graduate Songhee Min 2012-2013 Sungkyungwan university, Biology and Psychology double major 2014-2017 Yonsei University, College of Pharmacy 2015-2016 Editor-in-chief of The Blue Vanguard 2018~ MSD pharmaceuticals, Marketing Department
What was an enjoyable moment during your four years at Yonsei? I remember pulling an all-nighters to study organic chemistry and biochemistry in the study room, recalling Blue Vanguard or RA, going on a trip to Australia with my colleagues, and going on a graduation trip. Every moment at college became beautiful memories. What made you decide to find a job at a pharmaceutical company? I had positive thoughts about pharmaceutical industries ever since I was admitted to college, and hence was able to make my decision solid while participating in field training. When choosing a career, I think it was important for me to know what I really liked. I have gained a variety of experience while in university and life abroad, met many people and learned about myself. I also had a career counseling at the Yonsei’s Counseling Center, and all of these became baselines for me to decide on my career at a pharmaceutical company. Can you tell me the atmosphere and what is like to work there? MSD is a global pharmaceutical company with original drugs in various fields such as chronic diseases, vaccines, and infectious drugs. I am in charge of Zepatier, a hepatitis C treatment, of the CallME team from the marketing department. It is a medical professional detailing service that provides doctors with various contents such as diseases, products, salaries, and latest
pharmacy issues. If doctors have any questions about insurance or drug-drug interaction (DDI), our team passes the information through oral or video calls. I am quite satisfied with my job because it is a field that can maximize the ability of pharmacists in that it transfers expert pharmaceutical knowledge to other experts. Do you have any advice for freshmen? You do not have to study hard. Do not study too much nor play too much. Instead, try new things that you wanted to do other than studying. I personally like to travel, so I traveled on every vacation, I worked part time at Gongcha, amd tried out study clubs and RAs. If you have clear goals for your future, it is good to build experience towards it. But if you have not decided yet, it is good to do something unrelated and enjoy your last free time before you step into society. Do you have words to tell to new Blue Vanguardians? Make good use of the Blue Vanguard. Everytime I tried to apply for something that I wanted to do, the first thing I could think and proudly write on my application resume was the Blue Vanguard. During two and a half years of activity, writing an article can be time-consuming and difficult. But after time has passed and you have graduated from Blue Vanguard, you will never regret being a Blue Vanguardian. Even when you graduate from college, you will see people amazed when you show them magazines that boast tremendous quality. So please be proud and enjoy your club activities! B
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Farewell
Leaving words form the 6th members... YOONJU JANG The two and a half years, which seemed to never end, are over. If someone asks me what the most shining moments in college was, I would doubtlessly say it was Blue Vanguard. I personally felt and learned a lot while creating a magazine, and this gave me a precious opportunity to look at myself. Thank you and cheers to the next Blue Vanguardians!
DOHYUN LEE As T.S. Eliot said, “What we call the beginning is often the end. And to make an end is to make a beginning. The end is where we start from.” After two years of hard work, the Blue Vanguard remained one of the precious learning experiences for me. Thanks to all who shared wonderful memories with me.
SOL KWON I can’t believe it’s already been two and a half years in the Blue Vanguard. I’m not sure I was a great writer. But It is quite sure the Blue Vanguard will remain the best club for me!
HAYAN JANG It seems like it has not been a long time since I was delighted to have joined for The Blue Vanguard(BV), I’m surprised that I already finished a training period for one semester and four magazine publications. Every semester, I struggled to think about the topic of the article, writing and designing my article. Now that I made it myself, I have become deeply attached to the magazine. Thanks to everyone who helped BV, and I want to thank all club members I’ve been with.
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SOYEON KIM Being a Blue Vanguardian was one of the best things I did in Yonsei Pharmacy. A sense of pride felt whenever our journal was published would have never been mine unless I was part of the Blue Vanguard. Thanks once again to our fellow members who worked hard together. Goodbye!
SOHEE JO I still remember the tremor when I first published Blue Vanguard Magazine. Time is going so fast, and two and a half years later I am writing this farewell greeting. Everytime the magazine was published I felt so much pride. The Blue Vanguard meant a lot to me and will always be. I will be looking forward to the upcoming issues. Thanks to every Blue Vanguardians and see you soon!
SEOBIN PARK It was at times challenging to think of what to write about and design my own articles afterwards. However, thinking back, being part of the Blue Vanguard allowed me to look more into pharmaceutical issues and even meet some of the experts in this area. Moreover, the Blue Vanguard activity was worthwhile, as we received our very own published journals. Thanks the Blue Vanguard for the memorable experience!
SOYEON KIM It was such a pleasure to be as The Blue Vanguard, create our own magazine, and have fun with Blue Vanguardians. I will keep in mind the precious memories as a senior, and as a reader. As the only English magazine club in pharmaceutical schools, and the best club of the Yonsei Pharmacy, I wish Blue Vanguard to maintain its reputation and spread across widely.
CHAEYEON WON It was a pleasure to spend two and a half year as a Bluevanguardian. I had such a joyful time of writing articles and meeting a lot of people in various fields. It was such a good memory and experience that will continue to support me in the future as a pharmacist. Thank you :D
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BLUE VANGUARDS THE
7th
Editor in chief
Managing editor
Grace Eun Yi Kim
Je Young, Sohn
Designer Yoon Sung, Baek
Finance Director Da Young, Kim
Chief-
copy editor Claudia You Sun, Choi
Corporate Affairs director Hyeong Gu, Kwon
Designer
Promotion Manager
Do Yoon, Oh
Yong Wook, Kim
8th Ye Ji Jeon
Seong Hyun CHoi
Jae Min Cha
Jun Seo Oh
Eun Chan Lee
Ji Eun Ryoo
Su Min Yoon
Kyungeun Lee
Seo Kyuong Kim
서울특별시 강서구 등촌로 49-5 해민빌딩 6층 TEL: 02-2603-1480, E-mail: sjlee@ibpcare.com