Half a century of pharmacovigilance

Driven by WHO, by UMC and by determined individuals, organisations and countries, there has been great progress in making the use of medicines safer and more effective in the last fifty years. Progress, however, has also revealed that there is still much to be done.

The overall health and safety of all people has been a major preoccupation in many parts of the world for the last half century. Within healthcare itself, pharmacovigilance and the patient saftey movement emerged as major priorities in this field. In its early days, from the time of the 1960s thalidomide disaster, pharmacovigilance was associated more or less exclusively with the safety of medicinal products. The core concerns of contemporary pharmacovigilance are:

The quality of therapy has also become an important issue. This includes safer use of medicines (a much broader concern than the intrinsic safety of the physical properties medicinal products); patients’ opinions and experiences of both beneficial and harmful treatment; and quality of life issues. Countries representing 90% of the world’s population currently have national pharmacovigilance systems; the welfare of patients in all aspects of healthcare, especially through the safer and more effective use of medicines, is high on the agenda for many of them.

The global system

General health and medicines vigilance must be embedded in the life of health providers and all related organisations. This implies a constant state of watchfulness to recognise when things are going wrong, to take action to solve immediate problems, and to share information about the causes of harm to influence future policy and practice. The essential role of vigilance applies to:

The formal, systematic expression of health vigilance for medicines use is found in local and national pharmacovigilance centres, in regional organisations, and in the WHO Programme for International Drug Monitoring, which was mandated by the World Health Assembly in the 1960s. These systems have conscientiously sought to record and assess incidents of medicinal harm suffered by patients, to communicate the risks nationally and internationally and to reduce injury and death. Many are actively involved in collaborative networks at regional and global level, in which UMC often plays an influential role.

50 years of progress but with much still to be done

In spite of great progress, adverse effects remain a major cause of illness, injury and death in all parts of the world. The habits of prescribers have proved resistant to change even when there is substantial information and evidence about harm. A full picture of the damage caused by some drugs has taken many years to emerge before regulatory action was taken.

Apart from the essential safety information generated through clinical trials before medicines are approved for us and are widely used, voluntary, ‘spontaneous’ reports as they are known, submitted by health professionals (and, more recently, by patients), have been the principal source of information about adverse effects. Though the picture is rapidly changing, pharmacovigilance has been a largely paper-based process, and there have been problems with delays, motivating people to report, and the quality of data recording.

More about spontaneous reporting

Sources of information about the safety of medicines

Since the 1960s spontaneous and other reports have been submitted to VigiBase, the WHO global database of individual case safety reports (ICSRs). These come from members of the WHO Programme. Some countries accept reports from pharmaceutical companies. VigiBase, which is managed by UMC, contains over 16 million reports (as of November 2017). It includes most of the data from other major databases such as those for the European Union, China, and the US.

Spontaneous reports are not sufficient on their own to provide a reliable or comprehensive picture of the harm caused by drugs; other investigative methods are essential and, worldwide, there are hundreds of research projects, conducted by health authorities, academics, practitioners and manufacturers, active at any one time. Direct patient reporting has been established in many countries and is recognised as a valuable, complementary source of information about medicines safety and patients’ experience of therapy. New electronic methods of reporting, online and mobile apps for example, show promise in enriching and enlarging the information available.

Many pharmacovigilance centres and other organizations, including UMC, promote the message about safer use of medicines and the importance of reporting problems. Efforts to inform patients about the active part they should play in their own welfare and treatment are gaining ground. A priority has been to motivate patients to report adverse events to their health professionals or directly to local or national pharmacovigilance centres. Within the context of this global activity the WHO Programme and UMC have played a prominent role.

Establishment of the WHO Programme: read the WHO decision – WHO Technical Report no. 498 here

Story of the thalidomide disaster: read about Just a little white sleeping pill here

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Last modified on: November 22, 2017