The state of the art of techno-surveillance in Brazil and some recommendations
regarding its development
Evelinda
Trindade (Consultant of the After Sales Health Safety of Health Products
General Division ANVISA, 2001.
Health control concerning the sale of drugs, medicines, pharmaceutical
inputs and health-related products throughout Brazilian territory is
governed by Law 6360, passed in 1976. The provisions of this Law take
into account all the health surveillance units in Brazil with respect
to concepts, definitions and technical responsibilities. In accordance
with this Law, only those products which meet officially recognised
standards of quality can be marketed.
The whole concept
of guaranteeing quality, especially insofar as safety is concerned,
was in addition acknowledged to be a right of all Brazilian citizens
by the 1988 Constitution and the Consumer Protection Code, in accordance
with Law No 8078 of 11 September 1990.
The core responsibility
of Health Surveillance was reaffirmed in Law No 9782. This set in motion
the National Health Surveillance Agency (ANVISA), with the overriding
aim of bringing enhanced stability to the technical sector and of creating
appropriate conditions for the development of scientific support programmes
aimed at the decentralisation to the Brazilian states and municipalities
of linked to inspection and enforcement.
Through a well-tried
system of "registration" permit control, basically amounting
to a contract between a given company and society as a whole, and focused
essentially on giving a stamp of approval for the marketing of the formers'
products, ANVISA is in a position to obtain information on the efficacity
(the outcome of controlled clinical studies) and safety (risk evaluation)
of the products involved. This "baseline" allows the different
practitioners within the health system to monitor the products that
can be purchased, incorporated and used in Brazil. This information,
moreover, enables practitioners to acquire knowledge about the technical
characteristics, size, useful operating life and usage methods - basic
qualities looked for during the registration process - maintenance and
the various precautions required, together with known risks that cannot
be identified in specific examples of the product. This data is increasingly
useful for the development of the Health Surveillance Information System
(SIVS). SIVS-TV (SIVS for Techno-surveillance) is the standard nomenclature
for products used in the public health sphere. The project to develop
the nomenclature is being managed by ANVISA. It has already been agreed
with a group of scientists and academics with recognized expertise in
this particular area, who assist in the development of product modules
for health products as well as diagnostic kits.
The reorganizing
of databases containing approved registration permits and the records
giving details of companies authorized to market health products is
also gradually being carried forward by ANVISA.
These developments will permit a systematic approach to be adopted involving
an overall and accessible view of "complaints" regarding products,
the numerous measures taken to improve quality of the products, and
the pertinent corrective and preventive actions adopted. It will also
permit dissemination of appropriate information in a quicker and more
effective way to interested parties. Given the speed at which knowledge
is constantly generated, a good team is obviously needed to keep this
information up to date, and to research, validate and place knowledge-based
data at the disposal of the SIVS-TV. In order to achieve this objective,
ANVISA has already begun assembling a team of doctors, clinical engineers,
nurses and administrators. This team of health professionals will certainly
benefit from the advice of scientists with acknowledged expertise in
the various disciplines involved. Participation by a wide range of practitioners
in health matters will be assured, including the invaluable contributions
made by representatives of the National Weights and Measures System
and of the other bodies representing consumer rights in this country.
In ANVISA, information in the area of techno-surveillance filters through
to the Agency in two ways, notably through (i) the Ombudsman's Office,
which receives unsolicited "complaints" from product users
and (ii) the Techno-surveillance Unit, which is the recipient of the
mandatory reports from professionals. Reports are also received from
health-related establishments and manufacturers and service providers.
The entire structure outlined above is being developed with the purpose
of stimulating good interaction between the different practitioners.
A parallel objective is to ensure that the quality of products marketed
in Brazil is closely monitored and followed up.
The Techno-surveillance
Unit is also responsible for ensuring that contact is maintained with
international partners, for compiling reports of major adverse events
which occur in other jurisdictions, which concern products marketed
in Brazil, and to take appropriate action.
At the local level,
a wide range of techno-surveillance activity is being undertaken by
the Health Surveillance Units of the states and municipalities, as well
as by academics with acknowledged expertise in the field. These activities
include for example withdrawing from the consumer market the so-called
"problematic products", refusing to purchase goods from manufacturers
unable to provide adequate technical backup or which delay doing so,
dealing with manufacturers producing faulty goods, insisting on proper
information and advice from trained personnel at the point of sale,
carrying out tests to ensure that products work according to specification
(as observed in the course of normal routine use), paying particular
attention to the safety aspects of the products involved (studies on
quantified adverse events, evaluation calibration tests, academic theses
on preventive maintenance etc), and ensuring that purchasers get the
best possible value from the products concerned (cost-effectiveness).
Although the above
should take full account of basic consumer rights, the activities carried
out and the relationships involved in selling and purchasing products
and services are not always problem-free, or successful.
Difficulties often
arise from a lack of correlation between the interests and expertise
of the various practitioners in the health field. Moreover, since the
various activities and the relationships which they involve are not
set out or recorded in any systematic way, to be applicable to all,
negotiations between the various actors have to begin at zero on each
separate occasion. A classic example of this lack of a coherent approach
is the existence of detailed comparisons of product alternatives existing
on the market and of the minutely descriptive explanations which accompany
official reports on tenders or bids, most of them done in a conscientious
but haphazard way and which are frequently unrelated to one another.
Employees of the
same establishment are often prone to duplicating previous efforts,
due to the absence of written reports or correct and accurate documentation.
SIVS -TV is in a position to assist with (i) the systemization and dissemination
of such information (ii) the updating of knowledge about products and
(ii) keeping abreast of companies authorized to market their products
in Brazil.
In addition, ANVISA
- well aware of the tense situations which often arise from difficult
negotiation - has it in mind to give legal support to the various players
so that negotiations can be carried forward on a more equitable basis.
The Techno-surveillance Unit would be responsible for directing relevant
pertinent requests to the Attorney's Department of ANVISA, which in
turn would be charged with maintaining contact with the players, with
the ultimate aim of providing useful backup to their negotiations and
helping the players to arrive at constructive solutions. Failing satisfactory
resolution of a dispute, the Attorney's Department of ANVISA would call
upon the Public Prosecutors Office settle the dispute through appropriate
corrective action. The Techno-surveillance Unit would monitor progress
in this respect and keep an accurate record of the relevant cases, and
their solution , for future reference purposes.
Manufacturers obviously
have an interest in the current development of SIVS-TV, mainly because
dependable information regarding their products also serves to demonstrate
the quality of the products.
The different practitioners within the Brazilian health system are coming
together to reduce duplication of effort and to optimize the scarce
human, financial and technical resources currently available. It should
be noted that Techno-surveillance in itself is not the responsibility
of one particular section or one group of people. Rather, it represents
a social commitment by all the players to the basic right of any citizen
to health. It also affirms people's right to adequate Consumer Protection.
The growth and systemization
of techno-surveillance in Brazil is progressing, but it is apparent
that a fully trained workforce is crucial to the success of the enterprise.
For this reason, training and updating of all the health professionals
involved is called for as a matter of urgent concern. A career in Health
Surveillance needs to be given official status, and the job should be
sufficiently well-paid to encourage health professionals to study hard
in order to keep abreast of the wealth of new expertise and knowledge
being constantly generated in the area.
Additionally, since
the number of clinical studies on correlated health products is still
insufficient, there is a parallel need for close collaboration at different
levels in order to take forward the development of effectiveness and
safety tests needed for filling the many gaps encountered in the area
of "user" protection. These studies are also needed in order
to provide legal justification or support for the granting of registration
permits by ANVISA. Moreover, investment is required for the development
and updating of our network of laboratories. To run new and innovative
products through the appropriate tests, our scientists and technicians
need to be adequately trained. Furthermore, new laboratory apparatus
and instruments are constantly required, as well as up to date scientific
and normative reference materials. It is also obvious that experience
generates new ideas, new developments, new expertise and new applications.
If our scientists are able to increase their participation in international
forums dealing with the drawing up of norms (for example, ISO, IEC etc),
and if they are able to report more widely on the proceedings of such
forums, a better basis will be established on which we can choose to
reject or accept the norms which other countries have agreed upon.
Another area in
Brazil requiring much investment is follow-up on studies and materials
and new technologies within Brazil itself. A number of original ideas
have been developed in the fields of product effectiveness and safety,
but there is still room for making this expertise more widely known
within this country. Various promising products developed in Brazil
need to be given appropriate incentives within and outside the immediate
ambit of the health system. The "oral culture" of Brazil needs
to be modified, and the SIVS will doubtless have an important role to
play in this. It is notable that the market for health products originating
in Brazil has decreased substantially over recent years. Techno-surveillance
of our home-produced, "national" products, keeping close watch
over the quality of the same and taking appropriate constructive actions
vis-à-vis Brazilian products can help to achieve a degree of
"sovereignty" in this respect.
While the word "techno-surveillance"
is a neologism in itself, the quality control activities associated
with products are on the increase. They tend to affect in one way or
another all the players within the health system, including the users
of the system. The responsibilities undertaken by the National Health
Surveillance System and knowledge of its successful activities, duly
and correctly documented, should serve as a good example to the other
players in the system to demonstrate to all of Brazil's citizens that
we are indeed fulfilling our stated mandate and that we are truly in
the business of protecting and promoting the health of each and every
one of our citizens.
As part of the project to enhance health surveillance in hospitals,
joint activities will be mounted with the Pharmaco-surveillance, Hospital
Infection Control and Blood-Surveillance Units.
The following is a summary of current activities undertaken by the Techno-surveillance
Unit of ANVISA:
1. To create a network of "sentinel" doctors focusing on surveillance
of implanted prostheses
2. To analyze data available in the hospital admissions system regarding
surveillance of implanted prostheses
3. To educate Brazilian firms in incident notification procedures
4. To encourage the carrying out of epidemiological studies involving
health products
5. To translate and standardize the nomenclature of health products
6. To create an interactive dictionary to avoid errors in the information
system regarding product codification
7. To monitor international techno-surveillance activities
8. To review scientific literature at the time of the registration of
new products
9. To participate in the revision and creation of government regulations
and technical standards for the registration of health products.
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