• Biomolecules & Therapeutics
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• v.14 no.1
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• pp.56-65
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• 2006

Adverse drug events (ADEs) are the most common type of adverse events in medical practice. Hospital admissions related to ADEs cost high and should be monitored to prevent them. While concerns about the ADEs are increasing, the frequency and characteristics of admissions related to ADEs have not been reported in Korea. The objective of the study was to assess the rate of hospital admission related to ADEs and their characteristics through ADE signal-based retrospective reviews of medical records. As results, a total of 1,420 patients had ADE signals suggesting potential ADEs from 3,494 patients who discharged from an academic medical center over one month period. Six pharmacists independently assessed the presence of ADEs after the review of patients' medical records. Among the 3,494 discharges, 62 admissions (1.8%) were found to be realted to ADEs. Of admissions with ADEs, 83.9% were moderate (category F by the NCC MERP classification), 37.2% were preventable, and 85.5% were type A reaction. The most frequent suspected drugs causing ADEs were antineoplastics (48.9%), and the most frequent ADE signal detecting hospital admissions related to ADEs was white blood cell count (24.2%). Hospital admissions related to ADEs were found through screening the ADE signals. The ADE signal-based retrospective review could be a practical approach for identifying hospital admissions related to ADEs.

• Korean Journal of Clinical Pharmacy
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• v.22 no.1
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• pp.30-40
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• 2012

In Korea, elderly population aged 65 and older are about 5.0% and 10.7% in 1990 and 2009, respectively. Since elderly people may experience physiologic changes with aging and their pharmacodynamic and pharmcokinetic parameters also have been undergone changes, several adverse drug reactions can occur more frequently than young people. Especially, neuropsychiatric adverse drug reactions such as delirium and drowsiness endanger elderly patients more. The purpose of this study is to evaluate the outpatient prescriptions using drug causing delirium and drowsiness in elderly patients aged 65 and older. We retrospectively reviewed prescriptions for elderly patients collected from four community pharmacies from January 2nd to February 1st, 2010. One pharmacy was located closed to a general hospital, and others were located closed to a internal medicine or an ENT clinic. The each number of the collected prescriptions was followings; Group A (n=496) from internal medicine department of a general hospital; Group B (n=44) from ENT department of general hospital; Group C (n=144) from internal medicine clinic; Group D (n=110) from ENT clinic. In result, in Group A, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.38 In Group B, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.09 In Group C, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.51. In Group D, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.72. Especially, in Group D, the percentage of prescription that drugs causing delirium or drowsiness per Rx prescribed more than 3 is 52.73% In all the 4 groups, over the 60% of drugs causing delirium and/or drowsiness per prescription of elderly patients were prescribed. It means elderly patients take 2 drugs causing delirium and/or drowsiness among 3 drugs, which is very serious. Frequently prescribed drugs causing delirium and/or drowsiness were followings; GI agents, antitussives & expectorants, histamine H1 antagonist, analgesics, antibiotics. Among these drugs, GI agents was high raking in all the 4 groups, and pharmacists should caution elderly patients when counseling. In the internal medicine groups (Group A,C), drugs concerning chronic diseases were prescribed frequently. In conclusion, pharmacist's role is important. Pharmacists are well informed of the drugs causing delirium or drowsiness and it is important to explain about ADRs slowly and easily to the elderly patients that receive drugs causing delirium or drowsiness. And institutional device is needed. For example, when doctors prescribe drugs for the elderly patients, message is needed that supply some informations about drugs causing delirium or drowsiness.

• The Journal of Pediatrics of Korean Medicine
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• v.28 no.1
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• pp.52-60
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• 2014

Objectives The purpose of this study is to report the clinical effects of oriental medical treatment on Extensive limb swelling which is rare adverse reaction of vaccination. Methods A 11 months old infant who appealed unilateral thigh swelling after immunization and signs of local inflammation was administered a complex herbal medicine consisting of five decoctions; Gwakhyangjunggisan, Binsosan, Danggwisusan, Samchulgunbitang and Gwibitang. The length of the constant regions of the thigh circumference was measured every visit. Each process was recorded by photograph. After one year from the first visit, phone call was conducted to follow-up. Results The length of the thigh after administration of herbal medicine did not change much, but the part where swelled hard became little bit softer. A year later, patient's growth and walking was normal but the swollen part not changed. Since then the similar adverse effects did not recur on booster doses vaccines. Conclusions The adverse reactions of vaccination are rarely reported and there is no specific treatment for swelling from Hepatitis B vaccine. It will be more helpful to study if more cases reported about any adverse drug reactions or any side effects from the immunization.

• Journal of Applied Biological Chemistry
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• v.56 no.4
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• pp.205-211
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• 2013

Nitrate is a naturally occurring compound in plant and can be converted to nitrite in the nitrogen cycle and vice versa. Therefore, it is easy to find nitrate in plants including vegetables. Especially, it is known that high levels of nitrate found in leafy vegetables. Nitrate itself is relatively non-toxic but its metabolites and reaction products such as nitrite, nitric oxide and N-nitroso compounds, may produce adverse health effects such as methaemoglobinaemia and carcinogenesis. To execute the risk assessment of dietary nitrate and nitrite for the intake of vegetables, it is investigated that the levels of nitrate and nitrite in 23 vegetables (798 samples). The range of concentration were 0-6,719mg/kg for nitrate and 0-1,635mg/kg for nitrite, respectively. The Estimated daily intakes (EDI) were 0.85-1.38 mg/kg body weight/day for nitrate and 0.02-0.03 mg/kg body weight/day for nitrite by ages. We conclude that there are no health concerns for eating various vegetables since the EDI were below the Tolerable Daily Intake (3.7 mg/kg body weight/day for nitrate, 0.06 mg/kg body weight/day for nitrite) level established by WHO.

• Korean Journal of Clinical Pharmacy
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• v.21 no.4
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• pp.311-318
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• 2011

Misinformation and inappropriate use of medication has become one of the most pressing concerns in drug safety. The purpose of this study was to survey public perception on drug safety as well as the channels most relied upon providing such information. The survey was performed for patients or their families visiting pharmacies in a local city in Korea. Analysis was performed from 367 respondents to the survey. The contents of this survey revealed that consumers were aware of the fact that medications should not be taken at any higher dosage or more often than directed by their prescriptions. The survey revealed a general awareness that symptoms might not be relieved immediately by their medications. However, the perception that there could be adverse drug reaction (ADR) at therapeutic dose was low except among the young or highly educated members. Respondents recognized that skin rashes were the most whereas drowsiness was the least common ADR symptom. There was a high awareness of drug-food or drug-drug interactions except in the case of certain nutraceuticals. Doctors and pharmacists were ranked as the most reliable resources to the consumer for providing drug related information. However, public relations or education programs were in need since there were still not negligible numbers of consumers depending on personal experience rather than health professionals.

• The Korean Society of Law and Medicine
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• v.21 no.3
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• pp.77-116
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• 2020

The use of drugs that reflect the experiences and achievements of modern science has given human being the benefits of treating diseases and improving health conditions. However, in addition to the benefits of those, medicines have inherently inevitable adverse reactions. Many countries are taking measures such as market entry regulations or post-marketing surveillance to minimize damage caused by drug side effects, but the occurrence of side effects cannot be eliminated. Although the damage is force majeure, in some cases, the doctor who prescribed the drug or the pharmacist who administered the drug may have to compensate for the damage. The liability depends on whether the side effects were known in advance, the type of medicine, etc. On the other hand, in some cases, drug manufacturer may have to take liability for the side effect itself. As it is not easy for victims to be compensated for damages in those cases, many countries, including Korea, are setting to protect victims through the Product Liability Act. Drugs are also one of the product, so liability set by the Product Liability Act may apply. Even before the enactment and enforcement of the Product Liability Act, damage caused by drug has occurred. To resolve them, precedents have developed case law, which have many similarities with the Product Liability Act, but also have differences. Damage caused by drug manufactured prior to the enforcement of the Product Liability Act may occur in the future. In this context, the legal principles of the case laws will remain valid and be applied. This is an important reason to review the case law of precedents.

• Korean Journal of Clinical Pharmacy
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• v.23 no.4
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• pp.344-364
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• 2013

Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are immune-complex-mediated hypersensitivity reactions that predominantly involve skin and mucous membranes. Despite the low incidence, both are considered medical emergencies as the mortality rate has been estimated at 30-50%. Although as many as half of cases are idiopathic, several drugs have been implicated as main cause of SJS/TEN. This review therefore aimed to identify drugs that were potentially associated with SJS/TEN and compare the relative risk of the medications. Method: A comprehensive search was performed using MEDLINE, EMBASE and 5 Korean databases. We defined study drugs as non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, antiepileptics, and allopurinol. Only epidemiologic studies investigating associations between the above drugs and drug-induced SJS/TEN were included. Two reviewers independently selected and evaluated candidate papers and extracted odds ratios or incidence rates. Meta-analysis was performed only for drugs that were reported from 4 or more studies. Results: We found 8 case-control studies, 3 cohort studies and 1 RCT. The ranges of adjusted ORs were 0.6-34.0 for NSAIDs, 1.6-302.0 for antiepileptics, 0.3-10.0 for antibiotics and 1.0-187.0 for allopurinol. The drug with the highest incidence of SJS/TEN was carbamazepine (40 persons/1,000 DDD). Conclusion: Finally, the risk was highest in first 8 weeks after onset of treatment in all drugs.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.165-181
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• 2024

Objectives: This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea. Methods: This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO's global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed. Results: Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death. Conclusions: This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.

• Korean Journal of Clinical Pharmacy
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• v.22 no.3
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• pp.268-273
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• 2012

The definition of anaphylaxis is 'a serious, life-threatening generalized or systemic hypersensitivity reaction' and is considered as the life threatening adverse drug reaction. We experienced a case of cefotetan induced anaphylaxis with negative pre-skin test, used for surgical prophylaxis. A 82-year-old female was scheduled for total knee replacement therapy. She had no previous history of allergy and her skin test results were also negative. On her right knee surgery, she underwent cefotetan therapy as a surgical prophylaxis for a week with no problems identified. Next left knee surgery, she also received the prophylaxis of intravenous cefotetan. However, a few minutes later, anaphylactic reaction developed with vomiting, severe hypotension, bronchospasm, and dyspnea. After immediate intensive care treatment, she recovered without significant complications. Though commonly used laboratory data in case reports, such as the specific IgE, tryptase, histamine, or allergic skin prick test were limited, we successfully confirmed anaphylaxis based on clinical criteria for diagnosing anaphylaxis based on WAO 2011 guideline with through concurrent patient°Øs medical history review and the process of identifying the causes.

• Korean Journal of Clinical Pharmacy
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• v.29 no.4
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• pp.223-230
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• 2019

Background: Small-molecule tyrosine kinase inhibitors (TKIs) have had major impacts on anticancer therapy by targeting the catalytic activities of dysregulated tyrosine kinases. TKIs have not presented traditional toxicities; however, some serious adverse effects, including hepatotoxicity, have been documented in clinical trials and post-marketing surveillance. Although TKI-induced hepatotoxicity can cause severe clinical complications in patients, the underlying mechanism is still unclear. Methods: Studies on TKI-induced hepatotoxicity were identified by Pubmed search, and relevant articles were reviewed. Results: Immunoallergic reaction, cytochrome P (CYP) 450 polymorphisms, and formation of reactive metabolites are under consideration as mechanisms of TKI-induced hepatotoxicity. Host protein-drug metabolite conjugates are recognized as antigens by class II major histocompatibility complexes and are believed to cause liver injuries. Polymorphisms in CYP, which influences TKI metabolism, can slow TKI metabolism and may induce development of hepatotoxicity. The formation of reactive metabolites during drug metabolism can induce hepatotoxicity by directly causing cytotoxicity, leading to cell dysfunction, and indirect toxicity by mediating secondary immune reactions. Concurrent use of various medications with TKI can also cause hepatotoxicity by affecting drug transporter or enzyme activities. Conclusion: Periodic monitoring of patients taking TKIs and risk/benefit reassessments though post marketing surveillance are necessary to prevent hepatotoxicity.