Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table of Contents
View the documentINTRODUCTION
View the document1. WHY PHARMACOVIGILANCE?
View the document2. DEFINITION AND AIMS
Open this folder and view contents3. HOW TO START A PHARMACOVIGILANCE CENTRE
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Close this folder5. SPECIAL ISSUES IN REPORTING
View the document5.1 Central or decentralised reporting?
View the document5.2 Stimulation of reporting
View the document5.3 Under-reporting
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Open this folder and view contents7. ASSESSMENT OF CASE REPORTS
Open this folder and view contents8. USE OF THE DATA
Open this folder and view contents9. RELATIONS WITH OTHER PARTIES
View the document10. OTHER SOURCES OF INFORMATION
View the document11. FUNDING
View the documentREFERENCES
View the documentGLOSSARY
View the documentCAUSALITY CATEGORIES
View the documentWHO CONTACTS
 

5.3 Under-reporting

Under-reporting is a common phenomenon in all countries. Correcting for under-reporting is difficult, however, because its extent is unknown and very variable. Even at established centres the reported proportion of serious reactions may not be more than 10%. Several of the countries participating for many years in the WHO Drug Monitoring Programme receive 200 or more adverse reactions per million inhabitants annually from about 10% of physicians. In many other countries, however, the reporting rates are much lower.

Under-reporting may delay signal detection and cause underestimation of the size of a problem. However, in signal detection not only the quantity but also the relevance of case reports and the quality of data are important.

There are also a number of more elusive issues which require attention. Sometimes healthcare professionals fear that the acknowledgement of adverse reactions may reflect negatively on their competence or put them at risk of litigation. Some are reluctant to report adverse reactions because of doubts regarding the causal role of the drug (although, of course, it is essential that suspected reactions are reported). Under-reporting is both a technical and a psychological issue. Clarity of criteria for reporting, simple procedures and good motivational practice are all influential in addressing the problem.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017