The World Health Organisation set up its International Drug Monitoring Programme following the thalidomide disaster, and since 1978 the Programme has been carried out by the Uppsala Monitoring Centre (UMC) in Sweden. An independent centre of scientific excellence, the Uppsala Monitoring Centre is responsible for the collection of data about adverse drug reactions from around the world, especially from countries that are members of the WHO, and the generation of signals of drugs, which might possibly have problematic side effects. Through a range of products and services, derived from the WHO database, the UMC provides essential resources for regulatory agencies, health professionals, researchers, the pharmaceutical industry and prescribing physicians. One of the major objectives of UMC is to promote existing National ADR Centres and to assist countries set up pharmacovigilance centers across the world. The activities of all such National Centres are reviewed and shared in the annual meeting called by UMC.

The 26th Annual Meeting of National Centres Participating in WHO Programme for International Drug Monitoring was held in Delhi recently. On the sidelines of the conference, Dr Ralph Edwards, director, UMC spoke to Joe C Mathew of Pharmabiz.com on the activities of the centre and matters related to the programme of International drug monitoring.

What exactly is the mandate of Uppsala Monitoring Centre?

Our vision is to support WHO's leadership in the field of world health by providing excellence in the science and concepts of all aspects of pharmacovigilance and thus minimize the harm to humans from the effects of medicines. The centre gathers and shares objective intelligence and opinion in the field of drug safety through open and transparent means of communication. It supports the promotion of the rational use of drugs, and the achievement of improved patient therapy and public health and plays a major role in global education and communications in benefit, harm, effectiveness and risk in medical therapy.

The centre is in the forefront of developing leading-edge systems and science for the identification and communication of safety hazards in drugs and other substances used in medicine. It is carrying out research pushing forward the ethical, intellectual and scientific boundaries of theory and practice in pharmacovigilance through active collaboration and communication with all stakeholders. UMC is pursuing the goal of a single, global database for drug safety data.

What are the hurdles before UMC in its march towards its goal for a single, global drug safety profile?

Absence of proper pharmacovigilance centers in many parts of the world is the biggest challenge we are facing today. The centre needs to ensure that effective, timely international collective effort will never miss a signal of a potential hazard and be certain that all stakeholders evaluate and learn from decisions and actions through positive impact-assessment, follow-up and debates. We are encouraging the growth of pharmacovigilance activities around the world, in particular the establishment of new National Centres, but we need to go a long way. Adequate cooperation from health professionals is also not an easy task. We need to make them share their experiences for proper feedbacks.

Could you comment on the current activities of the centre?

UMC is engaged in editing, updating and publishing the Drug Dictionary. It is maintaining and publishing the Adverse Reaction Terminology (WHO-ART) and carrying out special searches of the database by request. Publishing a range of special reports, providing assistance to potential members of the Programme in developing their pharmacovigilance systems, running training courses in pharmacovigilance, organising annual meeting for member and associate member countries, publishing scientific articles and contributing to international conferences are all part of the routine activities of UMC.

How big is your drug database? What are the drugs of current interest for UMC?

The WHO Programme for International Drug Monitoring has just logged the 3 millionth adverse drug reaction (ADR) report from a country contributing reports to the international database. All the countries that belong the WHO Programme commit to work together to monitor the safety of medical drugs. The UMC receives around 200,000 reports from member countries each year.

We are at present monitoring about 30,000 drugs categorized under drugs of current interest. Many of them are multiple drug products. Among this, 2,000 drugs are the most widely used ones and needs stricter monitoring for ADRs.

Health professionals in member countries report suspected problems with ADRs to their national centre, which assesses them locally and then forwards them to the UMC. Through membership of the WHO Programme one country can know if similar reports are being made elsewhere.

After they are processed, and entered into the WHO International Database the three million ADR reports are subject to further analysis. When there are several reports of a specific, new adverse reaction to a particular drug this process may lead to the detection of a signal - a notice of a need for increased awareness of a possible hazard communicated to countries in the Programme. This happens after preliminary evaluation and expert review, prior to detailed work on the ground by individual national authorities.

How would you react to the recent comments made by a top executive of a leading global pharmaceutical company that majority of their drugs are not effective?

Response to a drug can be anywhere between 30 to 70%. Percentage of the adverse reactions also varies. We are primarily concerned with the seriousness of ADRs. Our aim is not to ban any drug, as banning a drug also depends on various factors like risk-benefit ratio. We are attempting to ensure that the ADRs are minimized and the positive effects of the drugs are enhanced through proper usage.

The admission of the ineffectiveness of the drugs in majority of cases should be considered as a very bold statement. In fact one can never assess the real problems associated with a new drug unless years long ADR monitoring is carried out. The clinical trial data can never be depended upon completely as trials take place in controlled conditions. The volunteers taking part in the trials are constantly monitored, and are not allowed to take other drugs. But when a drug is marketed, it can be consumed along with other medicines prescribed for several symptomatic problems. This is a major issue. Here we have to take many precautionary measures based on our experience of drugs similar chemical structures or that belong to same therapeutic groups.