Slimming pen prescriptions will be withheld starting this Monday

Starting this Monday (23), pharmacies and drugstores will begin to retain prescriptions for GLP-1 agonist medications , popularly known as slimming pens.

The category includes semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, and lixisenatide.

The decision to impose stricter controls on the prescription and dispensing of this type of medication was taken by the collegiate board of the National Health Surveillance Agency (Anvisa) in April and came into effect 60 days after publication in the Official Gazette of the Union.

In a statement, the agency reported that the measure aims to protect the health of the Brazilian population, “especially because a high number of adverse events related to the use of these medications outside the indications approved by Anvisa were observed”.

The analysis, according to the agency, was based on notification data from VigiMed, a system made available by Anvisa so that citizens, health professionals, drug registration holders and study sponsors can report suspected adverse events related to drugs and vaccines.

In a comparative analysis, the pharmacovigilance system, according to the agency, flagged “many more adverse events related to use outside the indications approved by Anvisa in Brazil than the global data”.

When presenting his vote in April, the acting CEO of Anvisa, Rômison Rodrigues Mota, highlighted that encouraging the use of slimming pens for aesthetic purposes only, accompanied by promises and testimonials of rapid weight loss and without proper medical supervision, puts the health of users at risk:

“We are talking about new drugs, whose long-term safety profile is not yet fully known. Therefore, monitoring and surveillance are essential. Use without evaluation, prescription and monitoring by qualified professionals, in accordance with the authorized indications, can increase the risks and potential harm to health.”

Understand

With the decision of the Anvisa collegiate board, the prescription of GLP-1 agonist drugs, including Ozempic, Mounjaro and Wegovy, must be made in two copies, and the sale can only occur with the retention of the prescription in pharmacies and drugstores, as is the case with antibiotics.

Prescriptions will be valid for up to 90 days from the date of issue, during which time they may be used by the patient.

Pharmacies and drugstores, in turn, must include, in the National Controlled Products Management System (SNGPC), the recording of the purchase and sale of medicines.

According to the agency, the decision does not alter the medical professional's right to prescribe medications for purposes other than those described in the package insert.

The practice, known as off-label use, occurs when the doctor understands that, for a given patient, the benefits of the treatment outweigh the risks.

“It is a decision taken responsibly by the doctor and always with due clarification to the patient, ensuring that he or she is well-informed about the procedure,” highlighted Anvisa.

Indiscriminate use

The retention of prescriptions for slimming pens was already advocated by health entities, including the Brazilian Society of Endocrinology and Metabolism, the Brazilian Diabetes Society and the Brazilian Association for the Study of Obesity and Metabolic Syndrome.

In an open note, the entities mention that the indiscriminate use of this type of medication raises concerns regarding the health of the population and the access of patients who really need this type of treatment.

“The sale of GLP-1 agonists without a prescription, although irregular, is frequent. Current legislation requires a prescription for the dispensing of these medications, but does not require pharmacies to retain the prescription. This gap facilitates indiscriminate access and self-medication, exposing individuals to unnecessary risks,” the document highlighted.