Global Public Health Division, United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, United States of America.
Bull World Health Organ. 2018 Jun 1;96(6):378-385. doi: 10.2471/BLT.17.205807. Epub 2018 Mar 28.
To raise awareness about the importance of public pharmaceutical standards, identify if and, if so, where current pharmacopeias are falling short in the development of new and complete monographs and foster collaboration among the various pharmacopeias, to prioritize, develop and make available standards for those key medicines for which no complete monographs exist.
In August 2017, we mined eight pharmacopeias to identify which of the 669 medicines in the 20th edition of the World Health Organization's Model List of Essential Medicines were covered by complete or incomplete monographs. The pharmacopeias we included were the Brazilian Pharmacopoeia, the British Pharmacopoeia, the Indian Pharmacopeia Commission, the International Pharmacopoeia, the Japanese Pharmacopoeia, the Mexican Pharmacopoeia, the Pharmacopeia of the People's Republic of China and the United States Pharmacopeia.
For 99 (15%) of the medicines on the Model List, no monographs were available in any of the eight pharmacopeias investigated. Only 3% (1/30) of the cardiovascular medicines listed, but 28% (9/32) of the antiretroviral medicines and 23% (6/26) of the antimalarial medicines lacked monographs.
There appear to be no public standards for many so-called essential medicines. To address this shortfall, a greater collaboration in the global health community is needed.
提高对公共制药标准重要性的认识，确定当前药典在制定新的完整专论方面是否存在不足，如果存在不足，在哪些方面，并促进各药典之间的合作，优先为那些没有完整专论的关键药物制定和提供标准。
2017 年 8 月，我们对 8 部药典进行了挖掘，以确定在世界卫生组织 20 版基本药物示范清单中的 669 种药物中，有哪些被完整或不完整的专论所涵盖。我们纳入的药典包括巴西药典、英国药典、印度药典委员会、国际药典、日本药典、墨西哥药典、中华人民共和国药典和美国药典。
在示范清单上的 99 种（15%）药物中，没有任何专论在调查的 8 部药典中可用。在列出的 30 种心血管药物中，只有 3%（1/30）有专论，而 28%（9/32）的抗逆转录病毒药物和 23%（6/26）的抗疟药物没有专论。
许多所谓的基本药物似乎没有公共标准。为了解决这一不足，全球卫生界需要加强合作。
