Patient Drug Database: 환자 생성 건강 데이터를 활용한 환자 주도적 약물 부작용 탐색을 위한 데이터베이스 구축
Patient Drug Database: Construction of Database for Patient Leading Drug Side Effects Exploration Using Patient Generated Health Data
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Objectives: This study focuses on building a database for patient-led search on drug side effects using basic drug information, drug analysis results information, patient information, and patient-generated health data (PGHD). Methods: After collecting data from the Health Insurance Review and Assessment Institute, the Korean Pharmaceutical Information Center, the Ministry of Food and Drug Safety, and the Korean Pharmaceutical Association, basic drug information was created. By utilizing the Korea Average Event Reporting System (KAERS) side effect report data provided by the Korea Drug Safety Administration and MetaLAB, a drug side effect detection algorithm applied on the Konyang university hospital’s real data, we designed and built a database using Oracle DB, which contains a table of patient information and PGHD. For drug information, a total of 49,553 drugs were mapped, and drug analysis results used KAERS and MetaLAB. Results: Based on the collected drug information, a total of 15 tables containing basic drug information (7 tables), drug analysis results (2 tables), patient information (1 table), and patient generation information (5 tables) were created using EDI codes, following mapping and normalization. Basic drug information included 49,553 EDI and 2,099 ATC codes. Drug analysis results included 2,046 KAERS ATC codes, 1,701 WHOART-ARRN (PT) that the result of 33 WHOART-SEQ (IT), 15,861 MetaLABEDI codes, and 101ATC codes. TheADR results were constructed using 62 DRUG_IDs and 73 MedDRA_PTI_IDs. Conclusions: The Patient Drug Database (PD2B) in this study was employed to allow patients to voluntarily report on their perception and drug side effects through application tools, which can provide quick measures against drug side effects and assist in the discovery of new ones.
Abstract
Objectives: This study focuses on building a database for patient-led search on drug side effects using basic drug information, drug analysis results information, patient information, and patient-generated health data (PGHD). Methods: After collecting data from the Health Insurance Review and Assessment Institute, the Korean Pharmaceutical Information Center, the Ministry of Food and Drug Safety, and the Korean Pharmaceutical Association, basic drug information was created. By utilizing the Korea Average Event Reporting System (KAERS) side effect report data provided by the Korea Drug Safety Administration and MetaLAB, a drug side effect detection algorithm applied on the Konyang university hospital’s real data, we designed and built a database using Oracle DB, which contains a table of patient information and PGHD. For drug information, a total of 49,553 drugs were mapped, and drug analysis results used KAERS and MetaLAB. Results: Based on the collected drug information, a total of 15 tables containing basic drug information (7 tables), drug analysis results (2 tables), patient information (1 table), and patient generation information (5 tables) were created using EDI codes, following mapping and normalization. Basic drug information included 49,553 EDI and 2,099 ATC codes. Drug analysis results included 2,046 KAERS ATC codes, 1,701 WHOART-ARRN (PT) that the result of 33 WHOART-SEQ (IT), 15,861 MetaLABEDI codes, and 101ATC codes. TheADR results were constructed using 62 DRUG_IDs and 73 MedDRA_PTI_IDs. Conclusions: The Patient Drug Database (PD2B) in this study was employed to allow patients to voluntarily report on their perception and drug side effects through application tools, which can provide quick measures against drug side effects and assist in the discovery of new ones.
참고문헌 (38)
- "Drug safety country, Children’s medicine information, Beware of side effects!"[URL]
- van Grootheest K, "Consumer adverse drug reaction reporting: a new step in pharmacovigilance?", Drug Saf, 26(4), pp.211~217 (2003)[DOI]
- de Langen J, "Adverse drug reaction reporting by patients in the Netherlands : three years of experience", Drug Saf, 31(6), pp.515~524 (2008)[DOI]
- Rolfes L, "Adverse drug reaction reports of patients and healthcare professionals–differences in reported information", Pharmacoepidemiol Drug Saf, 24(2), pp.152~158 (2015)[DOI]
- Blenkinsopp A, "Patient reporting of suspected adverse drug reactions: a review of published literature and international experience", Br J Clin Pharmacol, 63(2), pp.148~156 (2007)[DOI]
- 윤수진, "원내 자발적 약물 부작용 모니터링 활동 분석", 병원약사회지, 29(4), pp.430~436 (2012), 한국병원약사회[DOI]
- Yoon NK, "A study of adverse drug event reporting systems in Korea", Korean J Community Pharm, 5(1), pp.56~65 (2019)
- Margraff F, "Adverse drug reaction reporting by patients : an overview of fifty countries", Drug Saf, 37(6), pp.409~419 (2014)[DOI]
- 안소현, "일반인에서의 의약품 부작용보고제도 인식도", 보건행정학회지, 24(2), pp.164~171 (2014), 한국보건행정학회[DOI]
- Al Zaabi MSR, "Assessment of incidence, causality, severity, and preventability of suspected adverse drug reactions to antidepressant medications in a psychiatry outpatient setting of a secondary care hospital", J Pharm Bioallied Sci, 12(2), pp.131~138 (2020)[DOI]
- "What is KAERS?"[URL]
- 최남경, "우리나라 약물유해반응 감시체계", 예방의학회지, 40(4), pp.278~284 (2007), 대한예방의학회
- Chae JI, "The comparison of spontaneous adverse event reporting between consumers and healthcare professionals using Korea Adverse Event Reporting System(KAERS)Database", J Korean Acad Manage Care Pharm, 6(1), pp.31~37 (2017)
- Mann RD, "Pharmacovigilance", pp.237~247 (2007), John Wiley & Sons, Ltd
- "MedWatch onlinevoluntary reporting form (3500)"[URL]
- Medawar C, "A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine", Int J Risk Saf Med, 16(1), pp.5~19 (2014)
- Blenkinsopp A, "Patient reporting of suspected adverse drug reactions: a review of published literature and international experience", Br J Clin Pharmacol, 63(2), pp.148~156 (2007)[DOI]
- Avery AJ, "Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’ : literature review, descriptive and qualitative analyses, and questionnaire surveys", Health Technol Assess, 15(20), pp.1~234 (2011)[DOI]
- van Hunsel F, "The proportion of patient reports of suspected ADRs to signal detection in the Netherlands : case–control study", Pharmacoepidemiol Drug Saf, 20(3), pp.286~291 (2011)[DOI]
- Rajh A, "Digitalizacija, prihvat i migracija gradiva u sustav upravljanja zapisima sa ciljevima ostvarivanja temeljnih funkcija HALMED-a i očuvanja gradiva", S. Babić, Ur. Radovi, 48, pp.213~228 (2015)
- Montastruc F, "Adverse drug reaction reports received through the mobile App, VigiBIP® : a comparison with classical methods of reporting", Drug Saf, 41(5), pp.511~514 (2018)[DOI]
- "The center of change in digital healthcare is PGHD"[URL]
- Shapiro M, "Patient-generated health data", pp.1~24 (2012), RTI International
- Jim HSL, "Innovations in research and clinical care using patient-generated health data", CA Cancer J Clin, 70(3), pp.182~199 (2020)[DOI]
- Blenkinsopp A, "Patient reporting of suspected adverse drug reactions: a review of published literature and international experience", Br J Clin Pharmacol, 63(2), pp.148~156 (2007)[DOI]
- Durrieu G, "Overview of adverse reactions to nefopam : an analysis of the French Pharmacovigilance database", Fundam Clin Pharmacol, 21(5), pp.555~558 (2007)[DOI]
- Kuhn M, "The SIDER database of drugs and side effects", Nucleic Acids Res, 44(D1), pp.D1075~D1079 (2016)[DOI]
- "Korea Pharmaceutical Information System"[URL]
- "Korea Pharmaceutical Information Center"[URL]
- "Ministry of Food and Drug Safety"[URL]
- "Drug and health"[URL]
- Lee SH, "Development of a pharmacovigilance system based on electronic medical records to search for drug side effects", pp.2017
- Kim JH, "Big data knowledge base construction of Multivariate electronic medical records publish data model (EHR_CDM) based adverse drug effects" (2019), Ministry of Food and Drug Safety
- Rothman KJ, "The reporting odds ratio and its advantages over the proportional reporting ratio", Pharmacoepidemiol Drug Saf, 13(8), pp.519~523 (2004)[DOI]
- Evans SJ, "Use of proportional reporting ratios(PRRs)for signal generation from spontaneous adverse drug reaction reports", Pharmacoepidemiol Drug Saf, 10(6), pp.483~486 (2001)[DOI]
- 신주영, "환자안전을 보장하기 위한 약물의 안전한 사용", 약 학 회 지, 64(3), pp.185~190 (2020), 대한약학회[DOI]
- Bates DW, "Incidence of adverse drug events and potential adverse drug events : implications for prevention", JAMA, 274(1), pp.29~34 (1995)
- Park JW, "Spontaneous adverse drug reaction reporting program in Korea", JPERM, 1, pp.20~24 (2008)