• 대한임상약리학회:학술대회논문집
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• 2001.12a
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• pp.31-31
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• 2001

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

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

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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• pp.138-144
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• 2011

In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

• 한국임상약학회:학술대회논문집
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• 2007.12a
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• pp.196-197
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• 2007

• Journal of Interdisciplinary Genomics
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• v.3 no.1
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• pp.7-12
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• 2021

Adverse drug reactions (ADRs) is a hypersensitivity reactions to specific medications, and remain a common and major problem in healthcare. ADRs suchc as drug-induced liver injury and life-threatening severe cutaneous adverse drug reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms can be occurred by uncontrolled expansion of oligoclonal T cells according to genetically predisposing HLA. In this review, I summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.

• Biomolecules & Therapeutics
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• v.15 no.3
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• pp.156-161
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• 2007

Rapid advances in pharmacogenomic research have provided important information to improve drug selection, to maximize drug efficacy, and to minimize drug adverse reaction. The SNPs that are the most abundant type of genetic variants have been proven as valid biomarkers to give information on the prediction of pharmacokinetic/pharmacodynamic properties of drugs based on genotype. In order to elucidate a correlation between SNPs of calcium channel encoding gene and adverse reactions of calcium channel blockers, we investigated SNPs in CACNA1C gene known as a binding site of calcium channel blocker. 96 patients with hypertension who had taken or are taking an antihypertensive drug, 1,4-dihydropyridine (DHP) were included for analysis. These patients were composed of 47 patients with adverse drug reactions (ADR) such as edema from calcium channel blockers and 49 patients without ADR as a control group. The exons encoding the drug binding sites were amplified by PCR using specific primers, and SNPs were analyzed by direct sequencing. We found that there was no SNP in the exons encoding DHP binding site, but four novel SNPs in the exon-intron junction region. However, four novel SNPs were not associated with the ADR of calcium channel blockers. In conclusion, this study showed that ADR from calcium channel blockers may not be caused by SNPs of the binding sites of calcium channel blockers in CACNA1C gene.

• Korean Journal of Clinical Pharmacy
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• v.27 no.4
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• pp.221-227
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• 2017

Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.

• Korean Journal of Clinical Pharmacy
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• v.32 no.4
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• pp.303-312
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• 2022

Objective: The purpose of the study was to analyze the difference in the importance and performance of the educational content of the community pharmacy practice and find the factors that influence it. Methods: A 5-point Likert scale questionnaire asked about the importance and performance of the pharmacy practice education items to community pharmacy preceptors, current students, and professors. Data were analyzed using Microsoft office 365 Excel and IBM SPSS 21.0. Results: A total of 117 people participated. The averages of importance and performance were 4.34±0.34 and 3.71±0.45, respectively. Except for the computational entry of prescriptions and medication history, the average score for the importance of all educational items was statistically significantly higher than the one for performance. Importance Performance Analysis (IPA) identified over-the-counter medication counseling, over-the-counter drug selection consultation, pharmacy management, adverse drug reaction monitoring, and understanding and implementation of drug use evaluation as the items that needed focused effort. Borich's needs were highest in the adverse drug reaction monitoring. Conclusions: Overall, high importance and low performance indicate a need for improvement in community pharmacy practice education. Since the demand for education was high in over-the-counter medication counseling, adverse drug reaction monitoring, and OTC drug selection consultation, various supports are urgently needed to strengthen pharmacy practice education in this area in the future.

• Korean Journal of Clinical Pharmacy
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• v.18 no.1
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• pp.18-27
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• 2008

This study investigated social relief schemes for serious adverse drug reactions in foreign countries and deduced lessons and implications for Korea to implement the scheme. A social relief scheme for serious adverse drug reactions provides reliefs for diseases and such health effects as disabilities or deaths that were caused by adverse reactions to pharmaceuticals prescribed at hospitals and clinics as well as those purchased at pharmacies notwithstanding their proper use. The US and the UK do not have specific relief schemes for adverse drug reactions but apply rules of strict liability or negligence. New Zealand and Nordic countries provide no-fault compensation schemes for health effects or injuries caused by medical treatments or medicinal products. Japan and Taiwan have operated the schemes since 1980 and 2000, respectively. In designing the scheme in Korea, we suggested that cases eligible for relief be confined to serious adverse reactions such as death or disability and then extended to diseases. It is desirable to encourage the reporting system of adverse drug reactions and quality use of medicines for the relief scheme to work efficiently.

• Korean Journal of Clinical Pharmacy
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• v.19 no.2
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• pp.159-166
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• 2009

The purpose of this study was to evaluate the attitude and knowledge of community pharmacists to spontaneous adverse drug reaction (ADR) reporting. A survey was conducted in 103 community pharmacists in Seoul and Kyung-Gi Province from September to October, 2009. Almost half (53, 51.5%) and three-fourths (79, 76.7%) of respondents knew they could participate in ADR reporting in the Regional Pharmacovigilance Center (RPC) or Korean Food and Drug Administration (KFDA). However, only three of them have reported an ADR to the RPC and none of them have reported to KFDA. A majority of the respondents (96, 93.2%) felt that ADR reporting was a professional obligation for pharmacists. The purpose of an ADR reporting was incorrectly identified by most pharmacists. ADR reporting was encouraged if the reaction was serious and a new product. The most frequently mentioned barriers to reporting were: uncertainty concerning the causal relationship (86.3%) and not knowing how to report an ADR (83.2%). Only 19 (18.4%) respondents had received education on how to report ADR. Education was the most recognized method of improving ADR reporting. This study showed the knowledge of ADR reporting among community pharmacists is inadequate. Education and training should be reinforced in order to improve ADR reporting by community pharmacists.