What we did from 2000 to 2002

Results


The Pharmacovigilance Unit made 3 National Pharmacovigilance Alerts in 2000, 12 in 2001 and 12 Alerts in 2002. We've made 90 International Pharmacovigilance Alert versions to Portuguese from FDA, EMEA, MCA and other regulatory boards. We also made 7 Technical Bulletins in 2001 and 10 in 2002.

In 2000, the Pharmacovigilance Unit was directly involved in more than 12 scientific meetings, congresses and seminaries, in 2001, they were 41 and in 2002 were 58 (until the middle of November) about Pharmacovigilance as a principal theme with health professionals and pharmaceutical manufacturers in Brazil.

To improve the voluntary notification process, more than 200.000 ADR empty forms were sent in 2002 (Brazilian Official Form) to health professionals, half of them were supported by pharmaceutical manufacturers.

We trained 38 doctors, from the most important universities, in rational drug use, with the objective of enhancing health professionals capability to prescribe in a rational basis, to identify drug-related problems, to notify adverse drug reactions to the National System of Pharmacovigilance and to propagate this subject in their medicine graduate schools. We are planning other 6 more training courses.

The Pharmacovigilance Unit monitors voluntary or obligate drug recalls through the international communication network in other countries. Since last March until December, we identified 85 international recalls and, 9 medicines needed to have some action in Brazil.

In order to evaluate safe and effective products available in the market, Pharmacovigilance Unit did two "in loco" investigations of serious adverse events, during drug epidemic outbreaks.

The Pharmacovigilance Unit is working to develop a database, called SISFARMACO, with notification, codification, causality assessment and report modules.

The Pharmacovigilance team had 5 people in 2000 and now we are 19. All the pharmacists and doctors from the staff of the Pharmacovigilance Unit (UFARM) currently attend international courses in Pharmacovigilance, in order to be able to better carry out their tasks in this new activity.
We started the drug legislation about package insert information, registry renewals and periodic safety update reports (PSUR).

We had in our database more than 600 spontaneous reported forms received, and more than 5,000 ADR forms which need technical harmonization with other National Centres. We gave some interviews to the press (23 from 2000 to 2002) to disseminate Drug Safety information to consumers.

The Pharmacovigilance Unit e-mail is available since January of 2001 and until now, we have replied about 950 technical questions. We're having a visiting improvement on our website (about 3000 visitors per month) so we passed from the 7th place in 2001 to the 5th place in August of 2002 in the number of visits to the site of ANVISA, totalizing almost 76.000 visits since 2001.

The ADR and the technical complaints forms are available on Internet since July of 2001, for all health professionals and this ADR was tested before in each technical event that we participated so that we could hear all the opinions to improve it.