The Internet and Drug safety : What are the implications for pharmacovigilance ?
Use of the Internet is becoming widespread throughout the world.
Its use in the domain of drug safety and pharmacovigilance is spreading rapidly.
Governments and industry have taken the lead in developing extensive web sites.
The US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other agencies have developed sites containing enormous amounts of information both on pharmacovigilance in general and on specific drugs in particular.
Under the US'Freedom of Information Act'the FDA has put major parts of its adverse event database on line.
Regulatory documents are also available from the FDA site or from hyperlinks described in the site.
The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announcement service of these updates.
Similarly, the EMEA updates its site frequently and publishes extensive material including regulatory documents, guidelines, European Public Assessment Reports on newly approved medications and other useful information.
A free update service by e-mail is also available.
Although English is the primary language used on the EMEA site, some of the information is available in other languages.
Pharmaceutical companies are not using the Internet for pharmacovigilance yet. (...)
Mots-clés Pascal : Pharmacovigilance, Médicament, Toxicité, Assistance ordinateur, Internet, Ressource Internet, Utilisation, Industrie pharmaceutique, Echange donnée informatisé, Food and Drug Administration
Mots-clés Pascal anglais : Pharmacovigilance, Drug, Toxicity, Computer aid, Internet, Internet resource, Use, Pharmaceutical industry, Electronic data interchange, Food and Drug Administration
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0171331
Code Inist : 002B30A01C. Création : 16/11/1999.