TY  -  JOUR
AU  -  Bégaud, Bernard
T1  -  Le due morti della farmacovigilanza
PY  -  2019
Y1  -  2019-01-01
DO  -  10.1702/3129.31107
JO  -  Assistenza Infermieristica e Ricerca
JA  -  Assist Inferm Ric
VL  -  38
IS  -  1
SP  -  31
EP  -  35
PB  -  Il Pensiero Scientifico Editore
SN  -  2038-1778
Y2  -  2026/04/09
UR  -  http://dx.doi.org/10.1702/3129.31107
N2  -  Summary. The double death of drug surveillance. Pharmacoepidemiology, as the study of the interactions between drugs and populations, started in 1961 with the scandal of thalidomide and the development of specific methodological approaches and large databases. This birth of pharmacoepidemiology resulted from a long period where the target of medicines, i.e., patients in real-life settings, was not considered, the information being provided solely by pre-approval or peri-approval clinical trials. To complement existing activities and regulations, an additional approach blending evidence derived from both pharmacological and organizational science, need to be considered, allowing to understand how problems occur and how they might be prevented in the future. The challenge is now to avoid focusing excessively on the method and blindly following rules, to the detriment of pharmacological and public health objectives.
ER  -