It is very easy to make the mistake of considering "generics" series B drugs, instead of defining them more properly as "equivalents". «Generic drugs – explains the pharmacologist of the University of Milan Francesco Scaglione, president of the Italian Society of Chemotherapy (Sic) – allow effective treatments at lower costs. But it is essential that, alongside the cheapness of the drug, the safety of the patient is also guaranteed, because these drugs can give rise to problems". Problems related to the concept of bioequivalence: a drug can be defined as "bioequivalent" if it shows an efficacy that is maintained within a range of about 20 percent compared to the original brand drug. But also the traceability of raw materials, which involves all drugs: the origin of the active ingredient is never reported on the box. However, companies that produce branded drugs are subjected to greater controls in addition to dealing with the market, while in the case of equivalent drugs it is much more difficult for the patient to trace this information. Crucial then is the formulation, especially of injectable drugs: the more concentrated they are, the greater the risk of the formation of suspended particles capable of seriously endangering the patient's life. This is the case of the injectable antibiotic piperacillin / tazobactam, which forced the British Ministry of Health to issue a note with the obligation to inform doctors on the precautions to be taken when administering a generic, as well as requiring drug manufacturing companies general practitioners to accompany the product with an information sheet to advise healthcare professionals on the precautions to be taken. «We need more controls – declares Saglione both when the drug enters the market and during its production and distribution. For this reason, the Italian Society of Chemotherapy (Sic), the Italian Society of Hospital Pharmacy (Sifo), the Italian Society of Pharmacology (Sif) have for some time been involved in drafting a document, which will be issued within a month, with the requisites generics must meet to ensure total patient safety', (gc)
Corriere Medico dated 20/04/2009 N.8 – 2 APRIL 2009 p. 11
AF
