The Inside Story of Drug Safety for the General and Specialist Reader: Viewpoint, Part 1 - Watching for safer medicines

'No drug is 100% safe for all people in all circumstances'

You are warmly invited to attend
the launch of this important publication,
or to note it in your diary for coverage at the time.

[Press Conference/Swissôtel, room Le Monet/
Thursday 7 March /5 pm/ Basel, Switzerland]
The UMC will be represented at stand 12, hall 4.1

For the first time in a widely distributed publication, the issues and questions surrounding the safety of drugs will be discussed in a simple and accessible way for the general and specialist reader.

Viewpoint, Part 1 will be published in March 2002 by the Uppsala Monitoring Centre (UMC), based in Uppsala, Sweden and part of the World Health Organisation (WHO).

Since the thalidomide disaster of the 1960s, reports of adverse reactions to drugs (ADRs) have been collected by many countries for their own use and for the WHO's international database of adverse drug reactions. These reports provide vital early indication of possible drug hazards.

That no drug is 100% safe for all people in all circumstances,
in other words that risk in medicines cannot be reduced to zero, is a truth little discussed or understood - and probably rather uncomfortable in an increasingly risk-averse culture. Even penicillin can cause serious or fatal reactions in some people, and there are few drugs which have no actual or potential adverse effects. The commonest and most familiar drugs like paracetamol and aspirin - with billions of doses taken every year - equally have the potential for serious harm in some circumstances and at some levels of dose.

New drugs are marketed after thorough clinical trial testing, but only on relatively small numbers of subjects, maybe two or three thousand. It's likely therefore that an adverse reaction with a frequency of, say, 1 in 10,000 may not be revealed in the trial. Information about such reactions can be gathered only once the drug is licensed and generally available for prescription. This information comes through adverse reaction reporting systems where doctors and other healthcare personnel note and report the event to their national authority.

Most drugs are known to have side-effects with varying degrees of severity (maybe mild headache at one end of the spectrum) and there needs to be a negotiation between the doctor and patient as to whether or not the benefits of a particular drug truly outweigh the harm - or negative effects - which are known to occur or could occur. Here is one of the critical issues for patients: is there enough good information about these things, do doctors know enough about them and do doctors involve patients in the decision to use one drug or another, to take a riskier or a safer therapy?

These are just some of the vital and fascinating issues which will be covered in Viewpoint, Part 1 and which the UMC believes need to be widely discussed and understood if patients are to get the best deal from their medical care, if public health is to be protected, and the occurrence of serious - and costly - adverse reactions is to be reduced. (It's estimated, for example, that drug-related problems cost the USA in the region of $177 billion dollars a year.)

Viewpoint, Part 2 will be published later in 2002, and will provide a comprehensive and detailed technical account of the work of the UMC and the WHO in the science of pharmacovigilance - the scientific study of drug safety. This will be of greater interest to technical and medical specialists, and to member countries of the WHO Programme for International Drug Monitoring (which currently has 66 full members). However, the concerned layperson will also find much of interest to build on the more general foundation of Part 1.

Further information may be obtained from:
Cecilia Biriell, +46 18 65 60 73, cecilia.biriell@who-umc.org
or from
Ralph I Edwards, + 46 18 65 60 65, ralph.edwards@who-umc.org
or from our website: www.who-umc.org

Notes for Editors:
The Uppsala Monitoring Centre (the UMC) is the field-name of the WHO Collaborating Centre for International Drug Monitoring. The business of the UMC is
· To co-ordinate the WHO Programme for International Drug Monitoring and its growing number of member countries
· To collect, assess and communicate information from member countries about the benefits, harms, effectiveness and risks of drugs and other substances used in medicine
· To draw the attention of the regulatory authorities of member countries to signals of potential drug hazards
· To improve patient therapy and public health worldwide
· To collaborate with member countries in the development and practice of the science of pharmacovigilance.
The main focus and source of data in pharmacovigilance are reports of Adverse Drug Reactions (ADRs) from healthcare providers and patients in member countries of the Programme.