| Project/Area Number |
17406005
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| Research Category |
Grant-in-Aid for Scientific Research (B)
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| Allocation Type | Single-year Grants |
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| Section | 海外学術 |
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| Research Field |
Environmental pharmacy
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| Research Institution | Kanazawa University |
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Principal Investigator |
KIMURA Kazuko Kanazawa University, Graduate School of Natural Science and Technology, Professor, 自然科学研究科, 教授 (80324094)
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| Co-Investigator(Kenkyū-buntansha) |
OKUMURA Junko Kanazawa University, Graduate School of Natural Science and Technology, assistant professor, 自然科学研究科, 助教授 (40323604)
MATSUSHITA Ryo Kanazawa University, Graduate School of Clinical Pharmaceutics, assistant professor, 自然科学研究科, 助教授 (20293368)
HOMMA Takayuki Kanazawa University, Graduate School of Natural Science and Technology, assistant, 自然科学研究科, 助手 (90401893)
TANIMOTO Tsuyoshi Doshisya Women's college, Department of Pharmaceutical Sciences, Professor, 薬学部, 教授 (80142123)
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| Project Period (FY) |
2005 – 2006
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| Project Status |
Completed (Fiscal Year 2006)
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| Budget Amount *help |
¥6,400,000 (Direct Cost: ¥6,400,000)
Fiscal Year 2006: ¥3,100,000 (Direct Cost: ¥3,100,000)
Fiscal Year 2005: ¥3,300,000 (Direct Cost: ¥3,300,000)
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| Keywords | counterfeit drugs / counterfeit medicines / fake drugs / authenticity / substandard drugs / regulatory control / anti-retroviral drugs / anti-malarial medicines / カウンターフェイトドラッグ / カウンターフィット薬 / 偽造医薬品 / 規格外医薬品 / 薬事規制 / 真正性調査 / 同一性 / 出所起源 / 虚偽表示 / サブスタンダードドラッグ / 含量測定 |
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| Research Abstract |
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
… More
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. Less
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