• 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.

• Health Policy and Management
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• v.24 no.2
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• pp.164-171
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• 2014

Background: Safety of drugs has become a major issue in public healthcare. Spontaneous reporting of adverse drug reaction (ADR) is the cornerstone in management of drug safety. We aimed to investigate the awareness and knowledge of spontaneous ADR reporting in general public of Korea. Methods: A total of 1,500 study subjects aged 19-69 years were interviewed with a questionnaire for their awareness and knowledge related to spontaneous ADR reporting. Computer assisted telephone interview was performed from 27th February 2013 to 4th March 2013. Target population was selected with quota sampling, using age, sex, and residence area. Healthcare professionals such as physicians, pharmacists, and nurses were excluded. The survey questions included awareness of spontaneous ADR reporting, opinions on ways to activate ADR reporting, and sociodemographic characteristics. Results: Overall awareness of spontaneous ADR reporting system was 8.3% (${\pm}2.53%$) among general population of Korea. Major source from which people got the information regarding ADR reporting was television/radio (69.9%), followed by internet (19.3%), and poster/brochure (6.1%). Awareness level differed between age groups (p<0.0001) and education levels (p<0.0001). Upon learning about the ADR reporting system, 88.5% of study subjects agreed on the necessity of ADR reporting system, while 46.6% thought promotion through internet and mass media as an effective way to activate ADR reporting. Conclusion: The overall awareness of spontaneous ADR reporting should be enhanced in order to establish a firm national system for drug safety. Adequate promotions should be performed targeting lower awareness groups, as well as various publicity activities via effective channels for the general population.

• Korean Journal of Clinical Pharmacy
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• v.20 no.3
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• pp.171-182
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• 2010

Adverse drug reactions (ADR) including allergy are more preventable if patients recognize. This study was to investigate ADR recognition by patients who visited one university hospital located in Seoul, by face-to-face or telephone interviews using questionnaires. Recognitions, understandings, and managements on ADR in 225 adult patients enrolled in this study, were compared between ADR experienced group (n=89) and no-experienced group (n=137). Common knowledges and direct experiences on ADR were attributable to high perceptions on ADR, and lacking of active communications with clinical professionals to manage ADR was shown. In general, there were no significant differences in ADR perceptions between ADR experienced and no-experienced groups in almost items. This study findings would be useful to discuss clinical solutions for preventing ADR including drug allergy from patient individual level, and strategies including public education, guidebook on drug allergy, patient medication history record, and proactive efforts by professionals to improve ADR perception levels would be suggested.

• 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.

• The Korean Journal of Emergency Medical Services
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• v.25 no.3
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• pp.93-109
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• 2021

Purpose: This study aims to investigate the knowledge and attitudes regarding adverse drug reactions (ADR) of emergency medical services (EMS) students, so that suggestions for further education on ADR can be made. Methods: A survey on knowledge and attitude was created and modified according to Lee's and Kim's test tool. In total, 149 students' data were collected and compared with previous studies. Results: Knowledge of ADR was relatively low (54%) but attitude was relatively high (75%). Clinical experience was important in knowledge and attitude. Knowledge and attitude showed a positive correlation. Conclusion: Increased knowledge of ADR leads to a more active attitude towards it. Hence, modification of the education system to provide a more personalized education is required.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.3
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• pp.91-102
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• 2015

Objective : The purpose of this study is to find out the possibility of application to herbal medicine's report form for adverse drug reaction (ADR) by reviewing and analyzing Asian countries's ADR report forms. Method : We investigated, compared, and analyzed ADR report forms (ADR-RF) of Asian countries's ADR institutions (ACAI), such as, Korea institute of drug safety & risk management and Dongguk university Ilsan oriental hospital (DUIOH) in Korea, national center for ADR monintoring (NCAM) in China, pharmaceuticals and medical devices agency (PMDA) in Japan, Ministry of Health and Welfare (MOHW) in Taiwan, and drug office, department of health, the government of the Hong Kong special administrative region (GHKSAR) in Hong Kong. Results : ADR-RF for ACAI included common contents, such as, patients information (name(initial), gender, age, weight), adverse event (AE)'s report information (Recognition and report for AE occurrence, first or follow up report, Severe AE), the detailed information of AE (the title of AE, onset & closing date of AE symptoms, the progress & results detailed test of AE), the information of AE's medicine (the types of medicine, product name, ingredient name, suspected or combination drug, single dose & frequency, dosage form, administration route, dealing for AE-suspected medicine), and AE reporter's information (reporter's information, institution's information). Taiwan had ADR-RF and the department exclusively for herbal medicine (HM), but others (except DUIOH) had not only no ADR report form but also contents for HM. Conclusion : ADR-RF for HM have to include the common contents of ACAI at least, as well as HM information related to ADR, such as the title, composition and types of HM, history related to HM's ADR, and the contents of drug-induced liver injury and so on. In addition, the main department of government for HM's ADR will be needed.

• Korean Journal of Clinical Pharmacy
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• v.13 no.2
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• pp.72-81
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• 2003

Adverse drug reaction (ADR) may increase hospital admission, morbidity and mortality and adding extra cost to healthcare expenditures. AIMS: This study was performed to identify the types of ADR being reported in a tertiary hospital, and to find out the ways to improve current ADR monitoring system. To investigate the attitudes of hospital pharmacists towards, and their understanding of ADR reporting. METHODS: Of 117 reports submitted to the pharmacy department during 3 months survey period, A questionnaire survey of 75 randomly selected hospital pharmacists was conducted. RESULT: Of the report was from patients aged between 60 and 70. The medical department with the high frequency in ADR reporting was Internal Medicines $(60\%)$. The most common ADR manifestations were gastrointestinal complaints $(47.8\%)\;and\;80\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $38.4\%.\;55.5\%$ of respondent were aware of the need to education and information about ADR monitoring. The important reasons for unreporting ADR were unknown of how to report ADRs $(94.6\%)$. CONCLUSIONS: An ADR reporting system based on reporting by staff pharmacists has been effective increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs. Pharmacists have the knowledge and responsibility to contribute to ADR reporting program. A great opportunity exists for pharmacists to contribute in this area of patient care.

• Journal of Korean Academy of Nursing Administration
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• v.22 no.1
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• pp.91-98
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• 2016

Purpose: The aim of this study was to identify the relationship between nurses' knowledge of adverse drug reactions (ADR), attitudes, and monitoring practices and to establish an effective ADR reporting system and provide baseline data for its activation. Methods: The participants in this study were chosen by convenience sampling and included 182 nurses working at major general hospitals that operate a Regional Drug Safety Center. Data were collected from June 1 to 12, 2015 and analyzed using Cronbach's ${\alpha}$, descriptive statistics, independent t-test, one way ANOVA, Pearson correlation coefficient and stepwise regression with the SPSS program. Results: The nurses' average score for knowledge was 7.62 points, for attitude, 41.04 points and for monitoring practices, 34.22 points. ADR monitoring practices positively correlated with knowledge (r=.19, p=.011), attitude (r=.41, p<.001), drug performance competency (r=.54, p<.001), and drug education satisfaction (r=.54, p<.001). Drug performance competency, drug education satisfaction, and attitudes explained 42.0% of the ADR monitoring practices (Adj $R^2=.42$, F=43.95, p<.001). Conclusion: In order to facilitate and encourage nurses' voluntary monitoring practice of ADR, efforts must be made to create positive attitudes toward ADR, and to increase drug performance competency and drug education satisfaction.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.111-118
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• 2014

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.256-268
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• 2013

Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.