Pharmacovigilance System in Korea ` Joon Su, Shin(Deputy director) Korea Food & Drug Administration(KFDA) shinjs@kfda.go.kr
Regulations Facts Commitments Goals To build up the infrastructure for the rational and safe use of drugs To activate the ADR reports PV System To induce and settle the careful use of drugs for healthcare professionals
Regulations Facts Commitments Systems Regulations The Re-examination of the new drugs Mandatory Regulation on the Reexamination of New drugs The Re-evaluation of drugs Mandatory Regulation on the Reevaluation of Drugs Spontaneous ADR Monitoring Spontaneous Regulation on the Management of Safety information of the drugs, etc.
Regulations Facts Commitments Partners of Pharmacovigilance WHO, UMC National Health Authorities PV centers of foreign countries Health Professionals Doctors / Pharmacists / Nurses, etc. KFDA Academia Clinical pharmacology and pharmacy Pharmaceutical Industry Distributors / Manufacturers / Importers Patients and Others Media, Consumer advocacy groups, lawyers, etc.
Regulations Facts Commitments Regulations Pharmaceutical Affairs Law The Regulation on the Management of Safety information of the drugs, etc. Prompt and systematic Collection & evaluation of safety information (ex. ADR/AE) Providing measures to eliminate risk factors Dissemination of information on safety to Health Professionals and consumers
Regulations Facts Commitments Report of Safety Information KFDA Fax, Mail, E-mail, E KFDA Homepage, Phone, etc. Report Manufacturers (Importers) / Clinical Pharmacists Clinical MD, Dentist, Traditional MD Patients / Consumers
Regulations Facts Commitments Time limit for reports Within 15 days Manufacturers (Importers) / Clinical Pharmacists Serious AE, ADR Unexpected ADR Withdrawal or recall taken by foreign governments
Regulations Facts Commitments Kinds of Safety Information - Serious AE/ADR - (Un)expected ADR - Drug Interactions - Other AE/ADR - Information published in domestic/overseas medical/pharmaceutical Journals - Information on the safety measures taken by foreign regulatory authorities - Other safety-related information
해당항목의 에 V 표시하시오 Patient Info 발생인지일 ( 년 / 월 / 일 ): 최초보고 추적보고 ( 번째보고 ) Section 1. 환자정보 환자등록번호 : 환자구분 : 외래 입원 응급실 성명 : 나이 : 성별 : 남 여 과거약물알러지반응발현여부등환자병력 : AE/ADR Report form 진단명 : Section 2. 약물유해반응정보주증상 : 기타증상입력사항 : ADR Info 발현일시 : 년월일종료일시 : 년월일현재진행중 : 예 아니오 약물유해반응의내용 ( 약물유해반응과관련된환자의상태및진행과정, 특이사항등을자세하게 서술한다 ) Administered Drug Info Section 3. 투약했던의약품 -투여하여사용한의약품등을모두기록하고약물유해반응과인과 관계가의심되는의약품등에 V 표시하여주십시오 상품명 성분명 제약회사 일회용량 투여횟수 투여경로 투여기간 투여목적 과거사용여부 유 무 유 무 유 무 Measures Taken & Results Reporter Info 유 무 Section 4. 약물유해반응에대한조치및결과조치내용 : 없음 투여, 사용중지 투약변경 용량변경 용법 / 투여경로변경 약물변경약물유해반응진행결과 : 자연회복일 처치후회복 ( 통원일, 입원 / 입원연장일 ) 회복되지않음 ( 중대한불구나기능저하, 선천적기형, 생명위협, 사망 ) 판정불능재투여시약물유해반응발현여부 : 발현 발현안됨 재투여하지않음약물유해반응과의약품등의인과관계에대한소견등기타의견 : Section5. 보고자보고자성명 : 직업 : 의사, 치과의사, 한의사 약사, 한약사 간호사 기타보고기관명 : E-mail 주소 : 전화번호 : 팩스번호 :
KFDA Home Page ADR reporting site
KFDA Home Page ADR reporting site
Regional Pharmacovigilance Center Home Page ADR reporting site
Regulations Facts Commitments Administrative Process on ADR Report Review AE/ADR Hospitals/clinics, Pharmacies Manufacturers/Importers Patients/consumers Administrative Measures
Regulations Facts Commitments Administrative Process on ADR Report Review Managing Data Base Classification of the reports (Event/Signal) Analysis & Assessment - Considering causality, intensiveness, frequency, etc. - Additional collection of foreign cases * Consult to Central Pharmaceutical Affairs Council Administrative Measures
Regulations Facts Commitments Casuality Assessment of suspected ADR Certain Probable/Likely Possible Unlikely Conditional/Unclassified Unassessable/Unclassifiable adopting WHO categories
Regulations Facts Commitments Administrative Process on ADR Report Review Administrative Measures Safety action - Withdrawal, Recall, etc. - Labeling Changes - Additional Intensive Monitoring on safety Dissemination - Alert, Dear Healthcare Professional/ Pharmacist Letter etc. - Periodic Safety Information Magazine -Website Report to WHO
Regulations Facts Commitments Administrative Process on documented safety information Safety Information collected Administrative Measures 1 Assessment of credibility and causal sequence 2 Investigation of using situation in domestic and overseas 3 Review of other countries responses and measures 4 Further collection of the relevant materials (information) Analysis / Assessment (Consult to CPAC, if necessary) 1 Withdrawal, Recall etc. 2 Labeling changes 3 Intensive safety monitoring 4 Control as Signal, etc. * Dissemination - Alert, Dear Healthcare Professional Letter etc. - Safety Information Magazine -Website
Regulations Facts Commitments Number of ADR reports 4000 3,750 3500 3000 2500 2467 2000 1841 1500 1000 637 907 500 0 363 393 185 148 5 11 30 48 55 79 79 46 13 23 64 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 '04 '05 '06 '07.10 Year
Regulations Facts Commitments Report trends according to sources of reports 90 80 70 82.6 86.3 2005 2006 2007 60 52.4 (%) 50 40 44.4 30 20 10 3.3 8.5 2.2 1.3 1.9 4.1 2.4 1.2 7.8 1.5 0.1 0 Hospitals Pharmacies Companies Consumers Etc. Sources of reports
Regulations Facts Commitments Improvement of PV System in Korea Enlargement of Regional PV Centers (9 in present) Dissemination of drug safety information linked to health insurance billing system ADR-report evaluation of healthcare organizations Reinforcement of education and public relations eg. On-line ADR-reporting education program (for healthcare professionals and for consumers) Development of statistical analysis methods for causality assessment More ADR reporting to WHO-UMC
Regulations Facts Commitments Commitments 1 Government (KFDA) To furnish the necessary information to other partners - Alert, Dear healthcare professional letter Periodic safety information bulletin - Labeling updates Promoting ADR reporting (the efficient PV system) 2 Healthcare Professionals To participate actively in the ADR report - carry out the social accountability * medical treatment / medication counseling 3 Patients (Consumers) To use drugs with compliance of the doctor s consultation and the pharmacist s counseling - well acquainted with the insert papers (OTC)
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