NombrANDWe understand that, as expert naming professionals, we must take into account aspects, requirements and specifications (which may or not influence its success) in order for a medicine to be registered by the regulators. The recent “compulsory prescription” of generic drugs in Spain (and then, everybody’s knowledge of their active principle), contributes to the relevance of watching these aspects even closer, to avoid confusions or medical problems, particularly among our eldest.
Those acquainted with these issues know that, from the very beginning, the methodological process of creating a name for a pharmaceutical product is longer and more complex than for a “normal” product or service.
Regulating organizations and agencies (the American FDA or the European EMEA), who accept and sign the approval of a drug in the end, are becoming increasingly more demanding and examine with increasing precision the risks of confusion or error in pharmaceutical names. These agencies have developed their own systems, parameters and measurements to assess and compare names objectively.It is obviously convenient to know those criteria and measurements well in order to guarantee the success of the corresponding applications and procedures.
Data from the American FDA indicate that, among their more than 400 yearly applications, one third of them (!) are not approved due to naming issues. A very high percentage that makes us think of how serious the matter is and of the saturation of approved brand registrations. Regulators follow a very strict control of possible errors and, therefore, tend to watch the whole chain of use (from storage, purchase or prescription to use or final effects). The reputational risk of not doing it would be very high for all (government, lab, hospital, doctors, patients, …) and the social and economic cost would be enormous. In the USA, for example, there are 3.9 million wrong prescriptions out of 400 million yearly prescriptions, 6% of which are clinically relevant, and a significant percentage is due to a problem with the name. Due to errors in purchase, logistics, hospitals, purchasing offices, nurses, chemists, doctors, medical assistants, elderly patients, etc., risks are, unfortunately, still being produced. And the recent introduction of prescribing generic drugs makes the matter even more complex (!), particularly for elderly patients, who are used to their medication patterns, to the habits they have acquired over the years, and whose memory is not always brilliant.
In order to avoid those problems related to availability and safety, the FDA recommends to present 3 names in the application so that the regulator can make sure he has an acceptable one, and then not hinder commercial plans or put population’s health at risk.
As we can see, pharmaceutical naming needs specific treatment, and it is a matter of capital importance which requires knowledge, experience and effective tools. Besides, the naming team has to work in perfect coordination with the legal, medical, marketing and pharmaceutical team developing it. The study and verification of names presented at the American FDA is carried out by means of a sophisticated software and algorithms developed by the giant computer companies that detect – through the distance between letters and syllables or the sonorous and written typology – the degree of error that may be produced, and it even classifies the risk. No less no more!
Being prepared for that is necessary. That is why in Nombra we prepare a specific file for pharmaceutical cases in advance, in the first stages of development, in which we include and integrate complete use filters, research and simulations carried out with the affected population groups. We also track the different relevant pharmaceutical and medical registers to assess all possible risks in advance (including vaccinations and INN substances). All that as external and independent expert’s report, which we provide the regulators as one more opinion.
This report, carefully written and documented with all the research done, is added to the final documentation, thus providing the whole process with more security, reliability and effectiveness.
