The Portuguese Society of Diabetology (SPD) today classified as an “unprecedented clinical setback” the decision of the National Medicines Authority (Infarmed) to allow the prescription of continuous glucose monitoring sensors to become generic.
“The measure is considered an unprecedented clinical setback, with the potential to compromise the safety and quality of life of thousands of people with diabetes in Portugal,” the scientific society warned in a statement.
At issue is an information circular released in April, in which Infarmed considers the need to change the prescription model for these medical devices, as generic models, thus replacing proven commercial brands.
The national authority explains the measure by saying that generics offer “greater access to health technologies,” noting that the availability of blood glucose monitoring sensors has increased and provides a practical alternative to traditional monitoring methods.
The SPD stressed that, unlike medicines, continuous glucose measurement systems are not equivalent to each other, as each device has unique and clinically relevant characteristics that determine its suitability for each patient.
The differences between sensors include analytical accuracy, unique reading and interpretation algorithms, whether or not manual calibration is required, the ability to connect with insulin pumps and digital health platforms, as well as ease of use and customizable alarms is of paramount importance,” the statement said.
“Equating these devices with generic medicines is a technically wrong and potentially dangerous simplification,” warn the SPD, stressing that the choice of the appropriate sensor results from a deep knowledge of the patient, their life context, their literacy, and their ability to use technology.
The scientific society also said that European countries with reference health systems in the area of diabetes, such as Spain, France, Germany, and Italy, have not adopted models of undifferentiated prescription and, with this measure, Portugal “would risk moving away from the best European practices at a time of unprecedented technological acceleration.”
SPD regretted that Infarmed had not consulted or created conditions for scientific societies, health professionals, and patient associations’ dialogue to ensure that decisions are based on evidence and focused on the well-being of diabetes sufferers.”
Furthermore, the Order of Doctors (OM) today demanded that Infarmed revoke its decision to allow the prescription of glucose monitoring sensors as generics, claiming that this represents a “real danger” to patient safety. While acknowledging the importance of ensuring equitable and efficient access to devices, the OM warned that this goal cannot be achieved through an “administrative solution that treats complex medical devices as if they were generic medicines.”
“The comparison does not make sense from a clinical point of view,” the order stressed, adding that, unlike generic medicines, continuous glucose monitoring systems are patient-specific.
Samantha Gannon
info at madeira-weekly.com
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