The president of the Spanish Society of Individualized Medication (LASEMI), Tomás Abascal, has defended the magistral formulation "as a necessary response to the shortage of treatments for menopause" that has been recorded in Spain in recent times.
Abascal has emphasized that "a correctly prescribed, prepared, and controlled formula can be used with guarantees within an adequate clinical care," stressing that "pharmaceutical rigor and medical follow-up are the basis for its safe use." In this line, he has claimed the magistral formulation as a tool to provide coverage for patients suffering from the lack of hormonal treatments for menopause.
The president of LASEMI has reiterated the guarantees of individualized medication and has put the experience of professionals at the service of patients and prescribers. In his opinion, when a woman needs a treatment and does not have a suitable marketed alternative, the magistral formulation should be considered as a specific therapeutic option.
He has reminded that "addressing needs that industrial medication cannot cover is one of its essential functions" and that this practice contributes to maintaining continuity of care. In his view, "presenting the formulation solely as a last resort does not reflect its contribution in the face of a shortage," while he has emphasized that "formulating pharmacists provide knowledge and experience in the design, preparation, and quality control of individualized medications."
Legal framework and quality guarantees
In relation to the regulatory fit, Abascal has pointed out that the magistral formulation is integrated into the usual pharmaceutical practice and allows for responses to specific needs of doses and presentations. He has emphasized that "magistral formulas are medications recognized by Spanish legislation" and that "their preparation is regulated by the Law of guarantees and rational use of medications and health products and by Royal Decree 175/2001, which establishes the Standards of Correct Preparation and Quality Control."
As explained, "these guarantees are based on quality raw materials, adequate facilities and equipment, standardized procedures, controls, documentation, and traceability," to which it is added that "they also include packaging, storage conditions, a justified expiration date, and information for their correct use." In addition, it has been emphasized that "the activity is subject to the supervision of the competent health authorities."
Finally, Abascal has warned that "the absorption of hormones transdermally depends on the formulation, so the transition from a patch, gel, or spray requires a specific guideline and monitoring, without assuming automatic equivalences." In this context, he has proposed collaborating with scientific societies, medical organizations, and institutions to develop prescription and monitoring protocols that allow for the safe and effective use of these individualized treatments.