Abstract
ObjectiveTo 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.MethodsIn 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.FindingsFor 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.ConclusionThere 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.
Highlights
Despite the regulation of medicines, by the relevant regulatory authorities working in partnership with civil society, customs, health departments and law-enforcement agencies, exposure to substandard and/or falsified medicines remains an alltoo-common experience, especially for patients in low- and middle-income countries.[1]To ensure that a medicine meets the relevant, internationally-accepted quality standards, regulators perform analytical testing of medicines, along with other regulatory functions, such as inspection, pharmacovigilance and registration
The quality standards used are those given in a pharmacopeial monograph on the medicine of interest, not all medicines are covered by such monographs
Across the eight compendia we studied, we found 2091 monographs for the 669 unique medicines on the Model List (Fig. 1)
Summary
Despite the regulation of medicines, by the relevant regulatory authorities working in partnership with civil society, customs, health departments and law-enforcement agencies, exposure to substandard and/or falsified medicines remains an alltoo-common experience, especially for patients in low- and middle-income countries.[1]To ensure that a medicine meets the relevant, internationally-accepted quality standards, regulators perform analytical testing of medicines, along with other regulatory functions, such as inspection, pharmacovigilance and registration. A pharmacopeial monograph provides detailed parameters that are used to determine whether a medicine meets key quality attributes and can be marketed legally in any given country.[2] ideally, every generic medicine sold in a country should be covered by a pharmacopeial monograph, many countries around the world do not have their own national pharmacopeias. Many countries legally adopt the monographs of several of the larger pharmacopeias, such as the British, European, Japanese and/or United States Pharmacopeias. These larger pharmacopeias tend to be focused on the medicines commonly used in a particular high-income country or area of the world and may fail to cover some other medicines that are commonly used in developing countries.
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