Viewpoint represents a first attempt, in a widely-available document for a general audience, to discuss the issues, controversies and complexities of the question of the safety of drugs.

That no drug (or medical intervention) is 100% safe for all people in all circumstances is a truth little acknowledged or understood. Unreasonable expectations that a 'good' drug should never harm anyone at any time, frequently give rise to panics and crises which can do great damage to patient welfare and public health.

The business of the Uppsala Monitoring Centre (part of the World Health Organisation) is to collect data about the safety of drugs from members countries of the WHO Programme for International Drug Monitoring. This data comes in the form of reports of adverse drug reactions which are submitted by healthcare professionals all over the world, first to their own national authorities, and then to the WHO.

(The thalidomide disaster of the 1960s - when large numbers of children were born with physical deformities because their mothers took the drug while pregnant - occurred before this international system was established, and was the principal motivation behind it.)

Viewpoint sets out the range of issues and questions in a straightforward, attractive format, and urges more open discussion of them, greater accessibility to information about drug safety in general, and a commitment to public education.

The following are the major sections in the publication:
The risks of being alive
A discussion of the ways in which we perceive and manage risk in our everyday lives. People engage in risky activities - driving, smoking, skiing, for example - accepting instinctively or calculating the ratio of benefit and potential harm, willingly accepting an element of risk.

In some matters - drug safety being one of them - there is commonly little or no tolerance of risk, even though the fact is that no medical intervention is without some risk.

There are also problems in the way in which medical risk is communicated. The discovery that a new drug may have some harmful effects on some people may be reported as a 'doubling of risk' or '100% increase' (compared with an established treatment) even though the numbers may have increased only from 1 in 10,000 to 2 in 10,000. Such dramatic language can lead to drug scares which may be quite disproportionate to the facts.

Viewpoint spends some time examining the differences between
· absolute
· reference
· attributable, and
· reference
risk. These are important distinctions often poorly communicated and little understood.

The problem with unreasonable expectations and overreaction is that drugs which are highly effective for many people may be withdrawn by the authorities because they are perceived to have what are publicly regarded as unacceptable risks associated with them. (Some drugs, of course, do turn out to be risky to the extent that they should be taken off the market.)

Benefit, harm, effectiveness and risk in drugs
These four critical concepts are examined and discussed. It is suggested that a more considered approach to all four concepts is necessary when analysing the quality of any individual drug and its effects.

Finding out about the safety of drugs
Pharmacovigilance is the science of collecting, monitoring, researching and assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines, with a view to:
· identifying new information about hazards, and
· preventing harm to patients
This is the core activity of the Uppsala Monitoring Centre and of member countries of the WHO Programme.

'Spontaneous' or voluntary reporting is the main source of data about adverse drug reactions (ADRs). The system's principal weakness is that it provides information about only a very small percentage of all ADRs.

Viewpoint also examines the range and quality of information about drug safety collected through
· clinical trials
· pharmacoepidemiology
· other specialised methods such as prescription event monitoring

Why Adverse Drug Reactions (ADRs) are so important
ADRs represent a major cause of illness and death all over the world. Their cost is huge in terms of financial burden and human suffering.

Given that even the most benign and familiar drugs (penicillin and aspirin, for example) can cause serious illness, even death for some people, it is not surprising that among the many thousands of other products on the market, there are many which can have minor or major adverse effects on some people. Keeping abreast of the vast range of information about such things is extremely problematic for busy healthcare professionals.

The challenge is also for healthcare personnel to recognise the symptoms of ADRs for what they are - and not to mistake them for the symptoms of disease.

Viewpoint - other major topics
Among the many other issues examined in the twenty-four pages of the publication are:
· The responsibilities and dilemmas of national drug regulatory authorities
· The encouragement of greater openness and transparency in drug safety communications between pharmaceutical manufacturers, national authorities, doctors and patients, the media, lawyers, academics and all the other players in the field
· The need for education and public debate about the issues
· The question of quality of life for patients, and the need to take a more patient-centred view of therapeutic and social priorities
· The safety of herbal and traditional medicines
· The questions which doctors and patients need to be asking at the point of diagnosis and prescription
· The current state of the science of pharmacovigilance
· A glossary of terms

Viewpoint provides the basis for a new and reasonable debate about the realities and possibilities of safety in medicine; a debate which will acknowledge the huge benefits which drugs have brought to mankind, but will also include enlightened understanding of the inevitable risks associated with any medical intervention, and how they can be managed.

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