Why should access to independent information on the
risks of medicines be guaranteed? |
|
Leaflet
N°3 |
|
09 September
2002 |
|
Transparency of the management of drug safety issues in Europe
must be ensured. Optimal risk management cannot be guaranteed
unless access to information for patients, health professionals
and citizens in general is improved. This will also mean fewer
rumours, fewer doubts, less unjustified panic, and fewer lawsuits.
This is the meaning of Medicines in Europe Forum's amendments
to the proposed European Directive and Regulation.
French
List of leaflets
Previous leaflet
Next leaflet
Medicines in Europe Forum
Click here |
|
While you are having your breakfast, you hear on the radio that a
certain medicine (name not given) against cholesterol or against insomnia
or pain has been taken off the market, that there have been some deaths,
that the health authorities are aware of but have not yet divulged
any information
This is not very reassuring for the patient
who takes this medicine, or for the professionals who prescribe or
dispense it!
These
crises worry patients and generate confusion in doctors and pharmacists.
They do not allow anyone to fully understand what the actual risk
is, or what should be done to prevent other crises. They are detrimental
to everyone involved, from the patient suffering from side effects
to the pharmaceutical firm concerned.
To
avoid these crises should be a primary objective. Why isn't it the
case?
Among
the identifiable causes, we note that:
-risk assessment is not a priority for the development of medicines,
clinical trials focus predominantly on efficacy, instead of comparing
benefits and side effects relative to those of existing drugs;
-post-marketing follow-up of risks is mainly passive, patients and
health professionals are not encouraged to report side effects;
-manufacturers and regulatory agencies view information on risks
as an umbrella to protect them against law suits, and not as a normal
part of education on risk prevention;
-a tradition of secrecy in safety issues means that the bare minimum
is divulged to health professionals and patients, that their strong
involvement is not really welcome, on the pretext that they lack
abilities or are going to be disturbed;
-the stock market repercussions of communication of risk are taken
into account sometimes before the general interest.
Improvement
could be achieved:
-by demanding more thorough assessment of unexpected side effects
during the development of medicines;
-by organising an active follow up of side effects after marketing,
which would involve patients and carers as responsible players,
possibly through well conducted prospective surveys for the medicines
not yet widely known;
-by providing better and more regular information, giving health
professionals access to all information on the safety of medicines,
so that they can speak frankly with their patients and make informed
choices; by designing prioritised information leaflet for patients,
to help them understand the most frequent and serious risks and
how to avoid them.
|