• 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.29 no.2
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• pp.125-132
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• 2019

Objective: To examine the perceptions and attitudes toward spontaneous adverse drug reaction (ADR) reporting system among community pharmacists and identify factors that influence reporting, by implementing a survey. Methods: A structured questionnaire was developed and distributed online. Request for the survey was posted on the website of pharmacy's billing program, and the survey was conducted for 8 days. We collected the participants' response on their work environment, experience of ADR reporting, and their perception and attitude on the reporting system. Multivariate logistic regression was used to evaluate factors influencing ADR reporting. Results: A total of 382 pharmacists participated in the survey. Significant contributing factors for reporting level were age (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84-0.96), knowledge of reporting method (OR, 53.56; 95% CI, 9.10-315.41), installation of reporting program (OR, 31.92; 95% CI, 4.16-244.75), and encouragement from the Korean pharmaceutical association (OR, 4.13; 95% CI, 1.11-15.35). Regarding the attitude toward spontaneous ADR reporting system, 'lack of time for reporting' (OR, 0.29; 95% CI, 0.15-0.53) and 'complexity of reporting procedure' (OR, 0.51; 95% CI, 0.31-0.84), were associated with a low likelihood of reporting. Conclusion: Our results indicated that the knowledge of ADR reporting method, installation of the reporting program, and encouragement from the Korean Pharmaceutical Association contribute to active reporting. It is necessary to simplify the reporting method, make the ADR reporting program user-friendly, and provide educational interventions to increase participation in spontaneous reporting by the community pharmacists.

• 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.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.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.45-60
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• 2015

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.32 no.1
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

• KIPS Transactions on Software and Data Engineering
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• v.10 no.11
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• pp.465-472
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• 2021

In this paper, we present an approach for detection of adverse drug reactions from drug reviews to compensate limitations of the spontaneous adverse drug reactions reporting system. Considering negative reviews usually contain adverse drug reactions, sentiment analysis on drug reviews was performed and extracted negative reviews. After then, MedDRA dictionary and named entity recognition were applied to the negative reviews to detect adverse drug reactions. For the experiment, drug reviews of Celecoxib, Naproxen, and Ibuprofen from 5 drug review sites, and analyzed. Our results showed that detection of adverse drug reactions is able to compensate to limitation of under-reporting in the spontaneous adverse drugs reactions reporting system.

• Korean Medical Education Review
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• v.22 no.1
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• pp.32-45
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• 2020

This narrative review introduces global trends in pharmacovigilance (PV) education for healthcare professionals and the status of PV education in Korea. Proactive participation of healthcare professionals, including physicians, pharmacists, and nurses in reporting suspected adverse events is the main driving force for effective operation of the spontaneous adverse event reporting system database, which in turn facilitates early safety signal detection of otherwise unknown suspected adverse events. The World Health Organization recognizes PV education curriculum as a key aspect in promoting awareness of PV and adverse event reporting among healthcare professionals, and multiple studies have demonstrated that PV educational interventions for healthcare professionals have increased overall adverse event reporting. Considering the global trends in PV education, the curriculum in Korean universities still has room for improvement in promoting PV obligation among future healthcare professionals. Further research is needed to develop PV education curriculum. We suggest a three-step project for innovating PV education in Korea to meet the global PV educational standards: a survey to gauge current PV competencies among healthcare professionals, reform of current PV academic curriculum, and evaluation and fine-tuning of the reformed curriculum.

• Korean Journal of Clinical Pharmacy
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• v.30 no.1
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• pp.19-30
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• 2020

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.