World Health Organization

Citation

Morris, B. (2003), "World Health Organization", International Journal of Health Care Quality Assurance, Vol. 16 No. 4. https://doi.org/10.1108/ijhcqa.2003.06216dab.001

World Health Organization

Edited by Barbara Morris

World Health Organization

International Pharmacopoeia

Keywords: WHO, Drugs, Poor quality medicines

In March the World Health Organization (WHO) released a new edition of the International Pharmacopoeia (IntPh), whose aim is to improve the quality and efficacy of medicines, facilitate control of counterfeit and sub-standard drugs and address problems of drug resistance. The IntPh provides specifications for the content, purity and quality of active ingredients and pharmaceutical products according to internationally approved standards. Although it is a practical tool for all settings, it is aimed especially at those countries where national regulatory authorities (bodies charged with assuring the quality and safety of medicines) may not have enough funds or staff to function effectively.

The IntPH will be useful particularly in identifying counterfeit and sub-standard medicines. These are growing concerns worldwide, and especially affect developing countries. Although countries do not always reveal data about the sub-standard quality of their medicines, those that do demonstrate that, on average, 10-20 per cent of medicines in developing country markets are sub-standard. Poor quality medicines may cause death, serious harm to health or, at best, have no therapeutic effect. Counterfeit and poor quality antimalarial medicines for example also contribute to the dramatic growth in resistance to antimalarials, which has serious health and economic impacts.

Gro Harlem Brundtland, Director-General of WHO, said: "The consequences of sub-standard or counterfeit medicines are extremely serious and detrimental to all efforts to control disease and save lives. This is a critical aspect of the struggle for access to medicines, and a fundamental feature of WHO's work on this issue."

Concerned especially with increasing access to effective treatment, the IntPh gives priority to medicines for illnesses affecting developing country populations disproportionately, such as HIV/AIDS, tuberculosis, malaria and diseases neglected by conventional pharmaceutical markets. Publication of the IntPh is part of a comprehensive WHO programme to help regulatory authorities, health services, and manufacturers to assure the quality of medicines and to eliminate sub-standard products. Other elements of the programme include active support to regulatory authorities on combating counterfeit medicines; training in good manufacturing practices; and quality assessment of manufacturers of medicines including for HIV/AIDS, malaria, and tuberculosis.

Further information: The International Pharmacopoeia can be accessed at: http://www.who.int/medicines/library/pharmacopoeia/pharmacop-content.shtml