A busy and fruitful Annual Meeting took place last December as representatives of National Centers participating in the WHO International Drug Monitoring Program met in New Delhi, India. Dr. S. K. Gupta, Professor of Pharmacology at the All India Institute of Medicinal Sciences and Head of the Indian National Pharmacovigilance Center, welcomed the delegates. The meeting was inaugurated by Dr. S. P. Agrawal, Director General of Health Services India. Mr Ashul Kumar, the Drug Controller General of India, announced major changes to the Indian Pharmacovigilance system including the setting up of two zonal centers, 6 regional centers and 40 peripheral centers to improve the quality and quantity of reporting and the sharing of information.

Dr. Mary Couper, (Quality Assurance and Safety of Medicines, World Health Organisation) gave an update from her department. She mentioned the new organizational structures within WHO with the assumption of duty of Dr. Jong-wook Lee as Director-General; pharmacovigilance activities remain under the Health Technology and Pharmaceuticals cluster currently headed by Dr. Vladimir Lepakhin. Dr. Couper identified several highlights of the year:

• Growth in the WHO Programme to 72 countries, with Kyrgyzstan, Moldova, Jordan and Guatemala becoming full members
• Eight new Associate Members (Malta, Zambia, Democratic Republic of Congo, Ethiopia, Mozambique, Nigeria, Eritrea and Colombia)
• ICH meetings in Tokyo in January and Osaka in November
• Pharmacovigilance training workshop in Zambia in March (with the WHO malaria control programme)
• The 8th biennial pharmacovigilance training course organized by the UMC in Uppsala
• First meeting of the Advisory Committee for Safety of Medicinal Products in Geneva in October (see report elsewhere in this issue).

In the Uppsala Monitoring Center (UMC) report, Dr. Ralph Edwards mentioned that Vigibase is now fully operational and has moved from a development project to routine operations. He spoke about the 10th ICDRA (International Conference of Drug Regulatory Authorities) meeting in Hong Kong, which recommended 'use of best methods to ensure timely reporting to WHO of case information by taking steps to increase national reporting rates' and asked member countries to consider sending reports more regularly, including daily, if at all possible. Dr. Edwards believes developments at ICH could result in conflicting/incompatible regional/international coding systems and in the long run may jeopardize the WHO Drug Dictionary and the sustainability of the WHO Drug Monitoring Program. Knowledge detection has improved following extension of the 'Bayesian Confidence Propagation Neural Network (BCPNN) tool kit' to identify previously unknown patterns even in the presence of missing data.

Main theme — Improving Reporting
Dr. Kees van Grootheest and Dr. Edwards gave lectures on ways of improving the reporting of adverse drug reactions (ADRs). The sessions underscored the universal nature of under-reporting in pharmacovigilance and suggested ways of overcoming it. Dr. Edwards questioned the basis upon which claims of under-reporting are made. When the term 'under-reporting' is used, what does it mean and what is the standard by which current reporting is compared with? Is it the number of doctors per population or the number of people within a country?

Since most important ADRs occur in very rare cases there is a need for good clinical information upon which good clinical judgements and effective regulatory actions could be based. Under-reporting is not uniform; wide variations occur relating to the type of ADR and whether it is known or not, the type of medicine and the type of ADR reporting system.

Drugs of Current Interest and Working Groups
15 Drugs of Current Interest presentations were made in theme-based sessions (epidemiological studies, CNS effects, Anaphylaxis and related reactions). Working Groups focused on only one issue: Improving Reporting. Four working groups, broadly representing National Centers at similar levels of development, deliberated extensively over two days. Their work is continuing and will hopefully form the basis for a published consensus document.

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