(2000; 28 pages) [French]
4.3 What to report?
In the early stages of any pharmacovigilance system, reports on all suspected adverse reactions - known or not, serious or not - are welcome and useful, because it is necessary to create a notification culture in which the instinctive response to any suspected adverse drug reaction is to report it. Healthcare professionals need to learn how and what to notify, and the staff of the pharmacovigilance centre need to gain experience in assessment, coding and interpretation.
In established pharmacovigilance systems it is common practice to request the reporting of all suspected reactions, including minor ones for new drugs. For established drugs the reporting of serious or unusual suspected adverse reactions is of particular importance, whereas known and minor reactions are of less interest (see Glossary for the definition of a serious reaction). If an increased frequency of a given reaction is suspected this is also a reason for reporting.
Although pharmacovigilance is primarily concerned with pharmaceutical medicines (including radiologic contrast media, vaccines and diagnostics), adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies) should also be considered. Special fields of interest are drug abuse and drug use in pregnancy (teratogenicity) and lactation.
In addition, the reporting of lack of efficacy and suspected pharmaceutical defects is recommended, especially when there is the possibility of manufacturing problems, counterfeit pharmaceuticals or of the development of resistance (e.g. antibiotics). Pharmacovigilance and poison control are closely related activities, since the problems encountered with accidental or intentional overdose may cast doubt on the safety of a medical drug.
Also, adverse reactions to cosmetics may need to be reported, especially when cosmetics contain obsolete or toxic ingredients (e.g. mercury compounds or corticoids in bleaching creams). If there is no other organisation in the country dealing with the issues, a pharmacovigilance centre may also cover problems related to medical devices and equipment, although different expertise may be needed.
The reporting of adverse events occurring during clinical trials are not covered by these guidelines. Recommendations on how to record and report such events are included in guidelines on good clinical practice for trials on pharmaceutical products (GCP).