Platform ban: learn precautions when accessing weight-loss pens
Anvisa (National Health Surveillance Agency) banned, this Friday (26), the operation of the Voy weight loss platform, responsible for offering personalized treatments and health assessments for obesity.
CNN Brasil listened to experts to understand the necessary precautions that patients can take before starting treatment with so-called "weight loss pens".
For Neuton Dornelas Gomes, endocrinologist and president of SBEM (Brazilian Society of Endocrinology and Metabology), safe treatment is based on four pillars: correct diagnosis, medication registered by Anvisa, medical prescription and purchase from regulated pharmacies.
Understand the precautions for accessing medications
Correct diagnosis
According to endocrinologist Carla Adlung, the first step is to confirm whether there is a medical indication for the use of these medications.
"Before starting treatment, a complete clinical evaluation is essential, including health history, associated diseases, medications in use and definition of individualized therapeutic objectives", he explained.
For the specialist, each patient has different clinical characteristics. "A medicine that was suitable for one person may not be safe for another [...] Obesity treatment is individualized, based on scientific evidence and involves more than just the use of medication", he highlighted.
Medical prescription
According to Dornelas, while treatment requires a correct diagnosis, it is necessary for the patient to have a "safe source" of prescription medications.
To CNN Brasil, Carla reinforced the same as the endocrinologist and advised the patient to check whether the professional has an active registration with the CRM (Regional Council of Medicine).
Anvisa approves Brazilian weight-loss pen after Ozempic patent expires | LIVE CNN
Also, in the case of presentation as a "specialist", Carla points out the need for the doctor to also indicate that he has the RQE (Specialist Qualification Register).
In this same aspect, experts warn about the risks of self-medication, a factor that reinforces the lack of knowledge of contraindications and can lead to inappropriate use of the dose [of the medicine], in addition to delaying possible diagnoses of diseases that require specific treatment.
Medicine registered by Anvisa
For specialists, it is important to require an invoice, check the integrity of the product packaging and check whether the medicine has a valid registration with Anvisa.
For Adlung, products sold through informal channels, without adequate identification or with unknown origin represent a health risk, as they may not meet the quality, conservation and safety standards required by regulatory bodies.
"When treating a chronic disease such as obesity, the safety of the medicine is as important as its effectiveness. Access through regular routes protects the patient and ensures that they receive a reliable product that meets health standards", said the doctor.
Purchase from regulated pharmacies
For Neuton, in addition to a medical prescription, it is necessary for the patient to purchase medications only from authorized pharmacies.
The endocrinologist also highlighted the importance of understanding the origin and proper storage of the product, since purchasing medicines outside official channels can pose health risks.
Read also: Weight loss pens begin to be offered to SUS patients
Dornelas also adds that medicines purchased without a prescription also raise doubts about their origin and conservation conditions, a factor that must be taken into consideration before purchasing the medicines.
According to Carla, the problem is not with online monitoring. "The most important thing is that the care follows technical criteria, preserves medical autonomy, complies with health standards and keeps the patient monitored throughout the treatment", concluded the endocrinologist.
Platform suspension
The measure, published in the Official Gazette of the Union, determined the prohibition, commercialization, distribution, advertising and use of services offered by the platform.
This occurs because the company responsible, Revia Gestão de Negócios Ltda., does not have operating authorization for this type of activity, according to the agency itself.
Slimming pens should not be used alone, warns association | CNN 360º
According to Anvisa, platforms that indicate medications and their respective dosages are classified as medical software.
In this case, the company Revia does not have authorization to act as a pharmacy or drug store and, therefore, cannot sell medicines of any nature.
To CNN Brasil, Voy stated that "the appropriate administrative measures have already been adopted and, under the terms of the legislation, the company remains authorized to operate normally".
Read in full:
Voy was surprised to receive the publication of the notification from the National Health Surveillance Agency (Anvisa), since the discussion in question refers exclusively to the regulatory framework of a digital questionnaire and its possible need for registration as software. This is a strictly administrative issue, with no direct relation to patient safety, the quality of care provided or medications.
It is important to clarify that the process is ongoing and there is still no definitive decision from the Agency on the matter. The appropriate administrative measures have already been adopted by Voy and, under the terms of the legislation, the company remains authorized to operate normally.
Voy emphasizes that it does not sell medicines, does not carry out distribution or dispensing activities and, for this reason, does not fit into the legal hypotheses that require Company Operating Authorization (AFE). The company remains committed to responsible innovation, patient safety, ethics, transparency and full respect for regulatory standards, confidently awaiting Anvisa's definitive statement on this regulatory discussion.
Source: CNN