"Public standards for such medicines are urgently needed to help ensure that patients in all parts of the world have access to good quality medications," said Roger L. Williams, M.D., USP executive vice president and CEO. "These international standards will make it easier for healthcare organizations in countries without sufficient regulatory and pharmacopeial resources of their own to ensure the quality and purity of medications."
The World Health Organization estimates that 1 billion people -- one sixth of the world's population -- suffer from neglected tropical diseases. Widespread counterfeiting and distribution of sub-standard drugs has worsened this situation.
The initial two drugs included in the International Standards program are used in the treatment of HIV-AIDS: Abacavir Sulfate, and Efavirenz. These monographs are posted in draft form, with a 90-day period for public comment that ends on April 30, 2007. Instructions for submitting comments are at http://www.usp.org/internationalStandards/. Monographs for drugs used to treat malaria will be added shortly as part of the ongoing program.
USP's standards are widely recognized internationally as authoritative, science-based, and credible. They are developed through a process that is transparent and open to public comment. As the world's only private pharmacopeia, USP has the unique ability to work across borders, giving it the ability to set voluntary standards for medicines used outside the United States.
The worldwide public health benefits of the International Standards initiative include:
- Supporting the effort to provide quality drugs to patients with the greatest need;
- Helping ensure that medicines for neglected infectious diseases in international commerce meet a high standard of quality;
- Ensuring the availability of science-based public standards that help prevent counterfeit, sub-standard, or adulterated medicines; and
- Assisting foreign regulatory bodies, customs officials, purchasing agents, and others by providing information for testing the quality of medicines within a country or in international commerce.