カウンターフェイトドラッグの蔓延とその対策に関する調査研究

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Author: 木村, 和子ほか

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Publication date: 2008-05-26

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Note (General)：: 金沢大学大学院自然科学研究科1.サンプル:2005年は駆虫薬、抗生剤、解熱鎮痛薬353検体(コートジボワール(CIV)4都市の薬局と違法市場)を解析。2006年は抗HIV薬8検体(La pharmacie de la sante publique (PSP))と抗マラリア薬167検体(薬局、違法市場...

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Material Type: 文書・図像類
Title: カウンターフェイトドラッグの蔓延とその対策に関する調査研究
Author/Editor: 木村, 和子
Kimura, Kazuko
Author Heading: 木村, 和子
Kimura, Kazuko
Publication Date: 2008-05-26
Publication Date (W3CDTF): 2008-05-26
Alternative Title: Prevalence of counterfeit drugs and the countermeasures to be taken
Periodical title: 平成18(2006)年度科学研究費補助金基盤研究(B) 研究成果報告書概要 = 2006 Fiscal Year Final Research Report Summary
No. or year of volume/issue: 2005 – 2006
Volume: 2005 – 2006
Pages: 2p.-
Text Language Code: jpn
Subject Heading: カウンターフェイト
カウンターフィット
偽造
真正
規格外
レギュラトリー
抗HIV薬
抗マラリア薬
counterfeit drugs
counterfeit medicines
fake drugs
authenticity
substandard drugs
regulatory control
anti-retroviral drugs
anti-malarial medicines
Target Audience: 一般
Note (General): 金沢大学大学院自然科学研究科
1.サンプル:2005年は駆虫薬、抗生剤、解熱鎮痛薬353検体(コートジボワール(CIV)4都市の薬局と違法市場)を解析。2006年は抗HIV薬8検体(La pharmacie de la sante publique (PSP))と抗マラリア薬167検体(薬局、違法市場とPSP)。西太平洋諸島から19検体入手2.カウンターフェイト薬の同定法:(1)真正調査:353検体の製造国とCIV薬事当局で適法性調査(医薬品登録と製造業者許可の有無)。製造業者の出所起源調査。カウンターフェイト薬51(14%)、真正品247(70%)(2)定量試験:カウンターフェイト薬の規格外は16%。真正品では31%。真正調査と定量試験の一致率0.58(3)薬事規制:薬局60品目中カウンターフェイトは2(3%)、違法市場293品目中49(17%)(p<0.05)。登録医薬品75品目中カウンターフェイトは2(3%)、無登録278品目中49(18%)(p<0.05)。3.抗HIV薬:(1)流通:世界エイズ・結核・マラリア対策基金。PSPがWHO事前認定製造者から調達、配布。指定専門治療施設で診断、抗HIV薬処方(2)真正調査:すべて表示業者が製造(3)定量試験:98.3±1.4%〜101.1±0.8%4.抗マラリア薬:(1)真正調査:18(10.8%)がカウンターフェイト。(2)定量試験:46(38.0%)が規格外(3)一致率:真正調査と定量試験の一致率0.488(p<0.001)(4)薬事規制:医薬品未登録とカウンターフェイト薬出現のオッズ比29.079(95% CI:3.721-227.268)、違法市場ではカウンターフェイト薬が18(19.6%)、薬局は0(5)バヌアツ検体:artesunateの1検体はカウンターフェイト結論:カウンターフェイト同定は真正調査で可。薬事規制不履行がカウンターフェイト出現に関係。
1. Sampling : A total of 353 samples of antiparasitics, antibiotics and analgesics from pharmacies and illegal shops in Cote d'Ivoire (CIV) were investigated in 2005. Eight ARVs donated by la pharmacie de la sante publique(PSP) and a total of 166 antimalarias from pharmacies and illegal shops as well as PSP in CIV were investigated in 2006. 18 antimalarias were obtained from the western pacific island countries.2. Identification methods of counterfeit medicines : (1) authenticity investigation : Legitimacy of medicines and manufacturers were investigated by medicines regulatory authorities in originating countries and CIV. Genuineness were investigated by labeled manufacturers. 51 (14%) counterfeit medicines and 247 (70%) genuine were identified. (2) Quantity of active ingredients : 16% of counterfeit medicines were out of specifications while 31% of genuine were. Agreement between authenticity and quantity tests was 0.58. (3) Relation with regulatory control : 2 (3%) out of 60 samples from pharmacies were counterfeit while 49 (17%) out of 278 from illegal markets were (p<0.05). 49 (18%) out of 278 non-registered drugs were counterfeit while 2(3%) out of 75 registered drugs were counterfeit (p<0.05).3. Distribution and quality of ARVs : (1)Distribution : CIV is supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria. PSP is the only one governmental organization in charge of procuring medicines against them from the WHO pre-qualified manufacturers, keeping stocks and distributing them in the territory. ARVs are prescribed only in the accredited centers where biological diagnosis are undertaken. Private pharmacies do not sold them. (2) Authenticity : all samples were verified as genuine by the labeled manufacturers. (3) Quantity of active ingredients : The contained active ingredients are from 98.3±1.4% to 101.1±0.8% of labeled amounts.4. Quality of antimalarial medicines : (1) Authenticity : 18 (14.9%) samples were identified as counterfeits by labeled manufacturers and/or medicines regulatory authorities. (2) Quantity of active ingredients : 46(38.0%) samples were identified to be out of specifications. Agreement between counterfeits and substandards is 0.488 (p <0.001). (3) Regulatory Control : Odds ratio (OR) of non-registration and counterfeits is 29.079 (95%CI : 3.721-227.268). Illegal shops sold 18(19.6%) counterfeit drugs while pharmacies did none.(4) Samples from the Western Pacific Islands : A counterfeit artesunate was identified among 19 anti-malarias. Consideration and Conclusion : Counterfeit medicines could be identified by means of authenticity investigation. Loose implementation of pharmaceutical regulation relates to prevalence of counterfeit medicines.
研究課題/領域番号:17406005, 研究期間(年度):2005 – 2006
出典：「カウンターフェイトドラッグの蔓延とその対策に関する調査研究」研究成果報告書　課題番号17406005（KAKEN：科学研究費助成事業データベース（国立情報学研究所））（https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-17406005/174060052006kenkyu_seika_hokoku_gaiyo/)を加工して作成
DOI: 10.24517/00063253
Access Restrictions: 限定公開
Related Material: https://nrid.nii.ac.jp/ja/search/?kw=80324094
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-17406005/
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-17406005/174060052006kenkyu_seika_hokoku_gaiyo/
Data Provider (Database): 国立情報学研究所 : 学術機関リポジトリデータベース（IRDB）（機関リポジトリ）
https://irdb.nii.ac.jp
Original Data Provider (Database): 金沢大学 : 金沢大学学術情報リポジトリKURA