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More Global commitment needed to monitor Safety and Quality of medicines

Developing countries must be given better access to information that can improve safety and quality of medicines.

“We must strengthen safety monitoring activities of medicines at a global level,” says Anarfi Asamoa-Baah, Executive Director for Health Technology and Pharmaceuticals at the World Health Organization (WHO). “Lower-income countries must be allowed to benefit from the sophisticated monitoring systems that already exist in industrialized nations. This can only be done through a truly multilateral system. WHO is uniquely placed to promote information exchange, mutual support and equal access for all.”

In many developing countries, it is currently difficult to estimate the casualties of adverse drug reactions as national vigilance networks do not function in an optimal way and because there is a growing presence of substandard or counterfeit medicines on the market.

But despite good regulations and safety measures, adverse drug reactions occur often even in the best regulated countries. In 1998, negative effects from medicines were estimated to be between the fourth and sixth largest cause of death in the United States. In Europe, adverse drug reactions are the cause of up to 15% of hospital admissions. The reasons are varied: inappropriate prescription of a medicine; inappropriate dosage, or substandard quality.

At a meeting in Amsterdam this week, the World Health Organization (WHO) will make a case for greater global attention to be paid to the issues of safety and quality of medicines. The meeting, organized by WHO and its partner national drug monitoring centres, will review the WHO Programme for International Drug Monitoring and set the future agenda for pharmaco-vigilance.

Among the urgent topics to be discussed at the Amsterdam meeting are the expansion of drug monitoring in developing countries; the establishment of a system to monitor herbal medicines, and safety monitoring of drugs for neglected and tropical diseases.

The WHO Programme for International Drug Monitoring was established in the wake of the thalidomide disaster in the 1960s to avoid other such crises and promote greater patient safety. The Programme and its network are supported by the world's largest medicines database, housed in the Uppsala Monitoring Centre, Sweden, which contains almost 3 million recorded cases of adverse drug reactions.

The network functions as an alert and response system. Member countries in which adverse drug reactions have been reported send information to Uppsala, where the pooled data from all countries are analysed using modern IT technologies. When a significant number of similar reports are detected a 'signal' is issued alerting all drug regulatory authorities. Countries can take a medicine off the market if the risks outweigh the benefits.

More than 50 countries will participate in the meeting together with independent pharmacology experts, drug regulatory authorities and international professional organizations.

A press conference will be held at 12:30 on Wednesday, 16 October at the Royal Tropical Institute, Amsterdam. Full details are available from the website:

For more information contact:

Dr Mary Couper
Telephone: (+41 22) 791 3643

Dr Lembit Rago
Mobile phone: (+41 22) 79 249 35 11