Biological medicinal are not generic, therefore they are not replaceable by pharmacy commissions. “In fact, the substitution between biologicals is the sole responsibility of the prescribing physician, so it cannot be done without his authorization, as it could be danger to patients and it could have serious consequences for them”, said Dr. Miguel Ángel Caracuel from the Spanish Society of Rheumatology, during the II Training Seminar on biosimilar.
In the opinion of the specialist, a rheumatologist at Reina Sofía University Hospital (Córdoba), “biosimilars are reliable products that favor competition, and will result in a more efficient management of rheumatic patients who require this type of therapy. However, it is essential to affirm that biological drugs are not substitutable by the hospital pharmacy and that their interchangeability is a medical act -exclusively- that is limited to the relationship between doctor and patient, always with the consent of the latter ”. In this new scenario of increasing the therapeutic offer of biologics, “it is essential to preserve the freedom of prescription of the doctors who carry out the prescription of drugs according to the individual characteristics and circumstances of each patient, without forgetting the economic aspects that derive from such action ”, according to Dr. Caracuel, who also highlighted that “rheumatologists are committed to the sustainability of the health system, so they will support measures that, without reducing the quality of care, aim to ensure its continuity.”
With the aim of improving the knowledge of rheumatologists SER has organized the II Training Days in Biosimilars, which will be held in several cities over the next few months, with the aim of reaching specialists from all over Spain. To date, the conferences have already taken place in Córdoba and Valencia, and the next meetings are scheduled for Bilbao (May 13rd) and Murcia (May 27th).In this event, the SER’s position on biological medicines is announced (accessible through this link), in addition to review the current legislative framework for the prescription and dispensing of biological medicines; and an effective negotiation workshop.
Manuel Pérez Sarabia, Andalusian Council of Medical Associations lawyer has said “substitution in biological drugs, without the express authorization of the prescribing physician, is not allowed in the Spanish legal system. Any action to replace a biological one. it will entail, where appropriate, the corresponding civil, criminal, administrative or ethical responsibilities. Hence the need for the interchangeability of biologics to be an exclusive decision of the prescribing physician, in his scientific deduction of the possible therapeutic equivalence. Therefore, the pharmacy commissions do not have competence to impose treatments against medical criteria”, he said.
According to Pérez Sarabia’s “the doctor must comply with the protocols, guidelines and technical records of the medicines, and in the case of compassionate use medicines, he must also comply with the referred protocols, expressing his criteria in a reasoned manner in the medical history”.
He added that “”the diagnosis and treatment prescribed by a doctor should not be modified, as this would mean a breach of the guarantees. In case of scientific objection, the doctor will act in the best interest of the patient by motivating his decision in the medical history .”
On the other hand, the lawyer explained that “biological and biosimilar medicines require a specific authorization procedure and post-authorization pharmacovigilance, due to their particular complexity and risk forecast. They have a specific regulation that differentiates them from chemical medicinal and, according to scientists, it is due to their molecular complexity and consequences .”
Dr. Cracuel said “the safety of biologicals and biosimilars must be guaranteed by prescribing, by trade name and batch number, measures that guarantee their traceability”. Finally, he added “the optimal use of biosimilars requires continuous dialogue and interaction between doctors, pharmacologists and regulatory bodies, with the intention offer patients effective and safe quality products.”
Source: Sociedad Española de Reumatología