On Friday, the company Infarmed clarified that it was able, through imports labeled in a foreign language, to replace the drug Fluorouracil, used in cancer and which laboratories reported to be broken, with three thousand packages already delivered to Portugal.
In response to Lusa, the National Medicines and Health Products Authority explained that both marketing authorization holders (AIM) in Portugal – Accord and Hikma laboratories – had been violating the rules since mid-April due to increased demand. and that there are restrictions “in most European countries.”
Infarmed’s response follows the news published this Friday by the journal Jornal de Notícias, according to which the drug was “distributed in a limited manner, as a mitigation measure, because it is out of stock.”
The hospital also clarified that there are patients taking alternative therapeutic regimens, as there are other drugs on the market that can be used.
Infarmed told Lusa that to mitigate the impact of ruptures of this drug (fluorouracil 50 mg/ml injection solution), which has a monthly consumption of approximately 5,000 packs, the company has asked distributors specialized in importing these drugs to submit requests for exclusive use authorization. (AUE) with markings in a foreign language.
Through this mechanism, 11 AUEs have been issued for this medicine since April 12, according to Infarmed, which states that around three thousand units have already arrived in Portugal, with another 6,100 units still to arrive.
Infarmed ensures that hospitals are supplied and must “coordinate with its distributors.”
In the information sent to Lusa, the medical body also states that the Accord laboratory presentation will be reinstated on June 11, 2024, and Hikma’s on July 1, 2024.
However, he adds, “it is possible that these dates may be postponed by holders.”
Regarding therapeutic adjustments, Infarmed reminds that “they are another possible tool in case of difficulties with access to a certain medicine”, emphasizing that in such situations “the treating physicians are the ones who can best carry out this adjustment, according to the opinion of the need and the characteristics of their patients.”
Author: Lusa
Source: CM Jornal
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