Selling medications in supermarkets: progress in access or a health risk?

In September, the debate over the sale of medicines in supermarkets in Brazil gained momentum. The discussion arose after the approval, in the Federal Senate, of bill (PL) 2.158/2023, which authorizes the installation of pharmacies inside supermarkets. The change, as approved by the senators, does not stipulate that medicines be displayed on shelves with the same accessibility as other products, as suggested in the initial text, inspired by a model similar to that of the United States. Even so, it raised concerns about the risks of this measure, especially those related to self-medication.
“The discussion must be conducted responsibly, considering not only convenience but, above all, patient safety, and guided by clear guidelines with specific limits on permissions, restrictions, and health education mechanisms,” says family and community physician Wilands Procópio Gomes, from Einstein Hospital Israelita.
According to the current text, supermarkets wishing to sell medications will have to house complete pharmacies, separate from the supermarket structure, with the mandatory presence of a pharmacist during all operating hours. The project also provides for consultation rooms where individual and confidential care can be provided, as already occurs in independent establishments. The physical model is similar to that of existing pharmacies in hypermarkets, with the difference that they would be located within the checkout area. Payments could be made along with other purchases, but with sealed packaging in the case of controlled medications.
Initially opposed to the change, fearing the trivialization of drug consumption, the Federal Council of Pharmacy (CFF) came to support the proposal in the version approved by the Senate. "The model reconciles convenience with the preservation of public health, maintaining technical control and professional guidance as pillars of the rational use of medicines," assesses Walter Jorge João, president of the CFF.
In public hearings on the subject, when the proposal was still under consideration, both the Ministry of Health and the National Health Surveillance Agency (Anvisa) had positioned themselves against the measure. The National Health Council (CNS) opposed "any legislative proposal that provides for the sale of medicines in supermarkets." Contacted by Agência Einstein , the agencies did not respond as to whether the changes made to the text before its approval by the Senate were sufficient to avoid the risks of trivializing self-medication and difficulties in maintaining surveillance over the controlled substances that had been indicated in the negotiation rounds.
Between 1994 and 1995, Brazilian supermarkets sold medicines, representing up to 1.3% of the total analgesic sales market during that period. At the time, the measure was a "jabuti" (a legislative change included within the text of a proposal with a topic unrelated to it) inserted into the provisional measure that instituted the Real Plan.
When the economic measure became law, the provisions regarding the locations where medicines could be sold were excluded from the text. The decision to abandon these articles came after opinions from the Federal Council of Pharmacy (CFF), the Federal Council of Medicine (CFM), and other health entities alerting parliamentarians that the measure trivialized the use of medications and reduced the possibilities of controlling potentially harmful substances.
The risk of self-medication is a concern.
Although the measure currently under discussion offers more control in terms of health, the fear that it would facilitate self-medication remains. This is because even over-the-counter medications, such as analgesics, can have serious consequences if used excessively or incorrectly. “Self-medication, even with over-the-counter medications, can cause adverse reactions, poisoning, and mask diseases that require diagnosis. Without proper monitoring, it can put lives at risk,” warns the doctor from Einstein Hospital.
Data from the most recent Post-Market Monitoring Information Bulletin released in June of this year by Anvisa reveals that, in 2024, 56,500 adverse drug reactions were reported in Brazil, of which 40% were serious and 3.2% resulted in death. The drug most associated with these events was dipyrone, which is available over-the-counter. The first report on the subject, referring to 2021, already indicated that, of the total intoxications involving products subject to health surveillance (91,883), 79.7% were related to medications (74,123).
A survey published in March of this year in Research, Society and Development reveals that, although over-the-counter medications have been linked to deaths only rarely, with risks 50 times lower than prescription medications, they are not risk-free, precisely because they are frequently used. For example, maintaining home stockpiles and the practice of donating pills among acquaintances are common.
That is why the full-time presence of a pharmacist in drug sales environments is considered essential. "The presence of a professional allows each patient to receive safe guidance on the use of medications, a requirement that, combined with ethical and sanitary oversight, guarantees the rational and responsible use of medicines," states Walter João.
The discussion surrounding this measure is likely to generate further debate, as the proposal approved by the Senate will still be debated in the legislature and, consequently, in society as a whole. "We need to find the exact point where the potential benefits of expanding access and reducing pharmaceutical shortages do not outweigh the concrete risks of self-medication," emphasizes the doctor from Einstein Hospital.
Source: Einstein Agency
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