Background

Creation of The National Drug Monitoring Centre

The National Health Surveillance Agency (ANVISA), created in 1999, gradually becomes more structured. The National System of Pharmacovigilance, managed by the Pharmacovigilance Unit, which is a part of the Health Products Post-Marketing Surveillance Department, was created in this period.

The most recent tragedy that occurred in Brazil was in 2000, and it concerned the use of meglumine antimonate: over 300 patients had serious lesions caused by the injections. This fact reinforced the initiative of developing drug monitoring processes in Brazil.

The Brazilian National Drug Monitoring Centre was created in 2001 by Decree 696 in May, 7th by The Ministry of Health, and takes place in Pharmacovigilance Unit to obtain legal background to expand our field of action. After that we were admitted, in August 3rd, 2001, as the 62nd country in the WHO International Drug Monitoring Programme coordinated by the Uppsala Monitoring Centre, in Sweden, a WHO Collaborative Centre.
Brazilian Pharmacovigilance Programme was planned to integrate strategically four principles: safety, effectiveness, rationality and quality of marketed drugs.

Operational Guidelines

The Pharmacovigilance Unit is responsible for planning, coordinating and supervising the formulation and implementation of the guidelines and operational technical norms on the safe use and surveillance of drugs. The creation of a wide network for the communication and reporting of information enables to detect, evaluate and trigger the necessary measures if any product damages the health and well-being of the drug users. This began as a strategy to accumulate information on the safety, effectiveness, quality and rational use of marketed medicines. Among all the strategies for 2002/2003, we should emphasize four of these operational guidelines:

a) Spontaneous reporting of adverse drug reactions: Using an adverse drug reaction form, specially through the Internet, any health professional can report adverse drug reactions directly to Anvisa. This method aims mainly the identification of serious reactions of drugs marketed in Brazil, whether or not they have been previously described. Special attention shall be given to recently marketed drugs, for early identification of poorly described reactions or others still unknown that may be hazardous to public health.

b) Establishment of a network of 100 Sentinel Hospitals: Distributed nationwide, this network will monitor the quality and safety profiles of drugs used in hospitals and promote their rational use. The hospitals were chosen by their size according to the number of beds and the number of internal medical training programs. This network will also provide surveillance of medical devices (technovigilance) and surveillance of blood (hemovigilance).

c) Establishment of Regional Centres: one is in the state of Ceará and the other is in São Paulo. It is expected that a total of 27 centres will be reached in the future, one in each state of Brazil.

d) Creation of a net of Sentinel Pharmacies: Pharmacies who works with Pharmaceutical Healthcare are going to contribute with earlier detection of adverse drug reactions of prescription, over the counter, herbal and registry free medicines.

Activities

The Pharmacovigilance Unit is not limited to assessing reports of suspected adverse reactions, although this represents an indispensable part of its attributions. Moreover, not only the binomial safety and effectiveness is at the center of the Pharmacovigilance process in Brazil, but also quality and rationality aspects were included therein as important aspects in the challenge to assure suitable products that offer lower risks to the population.

Along with the Department of Inspection, of the National Health Surveillance Agency, The Pharmacovigilance Unit monitors the processes of mandatory and voluntary drug recalls in Brazil through the international communication network. In order to evaluate safe and effective products available in the market, they strive to identify problems of quality deviations and drug counterfeiting and to carry out "in loco" investigations of serious adverse events, during epidemic drug-related outbreaks.

A review process of the profile of benefits and risks of drugs already in the market is being carried out by identifying products banned in other countries, products requiring changes in their restrictions of use, and products of unacceptable or no any therapeutic value and whose license should be cancelled, especially drugs formulated with irrational associations of active ingredients. Also, within the scope of the market profile review, new regulatory laws are being consolidated, with a view to the updating of the information contained in drug usage directions and to the registry renewal, which shall include the reassessment of their effectiveness and safety profile.

Rational drug use has been object of training and multiple courses sponsored by The National Health Surveillance Agency, with the objective of enhancing health professionals' capability to prescribe in a rational basis, to identify drug-related problems and to notify adverse drug reactions to the National System of Pharmacovigilance.