The VOX Parliamentary Group has registered a non-legal proposal for debate in the Health and Consumption Commission in which it requests that pharmacies be allowed to manufacture pediatric amoxicillin by means of magisterial formulation to deal with the shortage suffered by Spain. In the registered text, it is recalled that the Spanish Agency for Medicines and Health Products already warned in an informative note in November 2022 about the supply problems of amoxicillin 250mg/5ml and that community pharmacists were authorized to substitute the pharmaceutical formula by amoxicillin 250mg in sachets and also to replace the dose by amoxicillin 500mg in divided tablets. The authorities of the European Union have warned of the shortage of certain medicines and the increase in respiratory infections that have led to a strong demand for antibiotics such as amoxicillin, especially as pediatric formulas.
With the Law of Guarantees, the magistral formula is conceptualized as: “the medicine intended for an individualized patient, prepared by a pharmacist, or under his direction, to expressly fill out a detailed pharmaceutical prescription of the active principles that it includes, according to the rules of correct elaboration and quality control established for this purpose, dispensed in the pharmacy office and with the proper information to the user”.
The deputies signing the initiative request to promote the harmonization of the different regional regulations regarding authorizations of the different health administrations for the elaboration of magisterial formulas and officinal preparations based on amoxicillin so that their elaboration is promoted by pharmacies in periods of shortage . “It should be authorized that pharmacies that already manufacture third parties and that supply, through the appropriate agreements authorized by the health administration, the different formulas and preparations that are requested by dispensing pharmacies, could also supply dispensing pharmacies that do not manufacture” , explains the initiative. [email protected] For all these reasons, the GP VOX requests the Government: -Enabling pharmacies to manufacture amoxicillin-based medicines for pediatric use or by diluting presentations for adults, for dispensing. -Promote the authorization of pharmacies that already produce master formulas for third parties so that they can supply dispensing pharmacies that do not manufacture them. -Adopt the necessary measures to guarantee the supply of the raw materials necessary for the elaboration of the magisterial formulas.