Last week in this blog we discussed how important drug identification is, since it allows reporting of adverse reactions and monitoring that drugs are used safely throughout their life cycle.

La prescription by trade name, and the registration of the same and of the batch in the pharmaceutical dispensing, are sufficient guarantee of the traceability of the biological product that is administered at all times to each patient. Spain, and in general any country covered by the European Medicines Agency (EMA), has established a rigorous pharmacovigilance process.

This control mechanism allows us to state that, since the first biosimilar was launched in 2006, no increase in notifications of adverse effects or clinical consequences associated with immunogenicity has been reported. That is there is no medical evidence that there is a particular therapeutic risk attributable to the biosimilar condition.

For example, to ensure the identification and traceability of all erythropoietin products, in December 2009, the Pharmacovigilance Working Group (PhVWP) of the EMA “considered the maintenance of accurate medication histories important for those patients treated with epoetins; that is to say, that the commercial name or the scientific name be registered with the name of the manufacturer in the patient file”.

As a result of the PhVWP recommendations, the Summary of Product Characteristics (SmPC) for all erythropoietin products (original and biosimilar) has been updated to include the following special warning: “In order to improve traceability of stimulants of the erythropoiesis, the name of the drug administered should be clearly noted (or stated) in the patient's medical record.

La traceability It is not a minor issue, but fortunately in Spain we are protected, with the support of the European Union, by a very guaranteeing legal system in this regard.