Health and Social Care Agency, Emilia Romagna Region
Do try and find someone asserting that information in pharmacovigilance is useless. I am sure you will not be very successful. Nevertheless, there are no clear indications on how and when these instruments for information and communication should be used. Even though the new European Regulation – within the Risk Management Plan - pledges for “educational” activities, you will definitely encounter several difficulties if looking for a more precise idea about what to do – or to expect – in regard to information or communication in pharmacovigilance.
First of all, it is worthy to agree on terms. Information activity on drugs safety concerns the whole collection of data and concepts that international regulatory agencies have made available for prescribers, health workers and patients since the thalidomide disaster. From the Sixties, the task of informing health workers and patients about the risks they might incur by taking drugs has never since been left to pharmaceutical companies only.
In practice, over the time, technical files for prescribers and patients information leaflets have even improved in what concerns language and efficacy. However, this does not resolve what kind of communication is needed for the management of drugs-associated risks. This last activity, in fact, requires a more active role and participation from the information receivers, while the mere availability of safety data is not considered to be sufficient.
From this point of view, the instruments must be able to interact in different way, depending on the specific requirements.
In the past, drugs information centres, anti-poison centres or broadened editorial instruments tried to carry out this role. Rarely, regulatory agencies themselves made bulletins or newsletters available. Even more rarely these necessities have been “assessed” to ascertain the capability of a real impact on the prescribing attitudes and, consequently, on the exposition to the risks associated with drugs use. Considering this premise, it is now opportune to wonder how much the new rules in pharmacovigilance will add to the activities on drugs-safety communication. At the moment, the listed educational activities do not answer this question.
A recent survey, conducted on all medicines registered with centralized procedure (until December 2011) and including additional measures for risk management (listed as educational), shows that there is still a lot to do in the field.1 In fact the data confirm that the majority of programs developed to communicate a risk failed to define many essential aspects: whom the communication has to be directed to, using what instruments, in what times and with what aims? Yet, at the act of registration, these campaigns are considered so necessary for the risk management to be integrative part of the pharmacovigilance plans. The consequence of this is even more worrying when considering that the absence of specific indications often allows pharmaceutical industries to utilize these commitments and conduct information campaigns which totally lack the essential requirements to reduce the possible risks. Besides, the absence of these elements makes difficult to assess the impact of information/communication activity respect to the generic aim to reduce the theoretical or real risk associated with the drug use. Companies receive precise indications on studies typologies depending on what they aim to achieve in terms of regulatory options (authorization, dosage change, etc.). On the contrary, when a medicine has such a high uncertainty level that it becomes necessary to pay particular attention in communicating its characteristics (alert card, check list, patient information cards, etc.), Agencies in our continent are still very evasive. In this scenario, then, the member States act in different ways. Some, profiting of dedicated structures, are able to guarantee anyway some sort of evaluation and control on how risk communication activities is carried out by pharmaceutical industries.
In general, it is worthy to remark that the lack of adequate communication on drug-use associated risks is one of the risk factors (not the more negligible) that expose to drug adverse reactions. In this sense communication and update on the subject meet continuing education, which is essential to be able to understand when we are actually observing an adverse reaction after prescribing of a new drug.
- Pharmacoepid Drug Safety 2012;21(suppl 1):461.