Infarmed carried out 89 inspections in 2025 after reporting failures in the supply of diabetes medicines, which resulted in 19 reports to the Public Ministry on suspicion of overbilling the SUS and 27 administrative offense cases.
A limitation is due, in part, to the high prescription of these medications, which have been used for unapproved indications such as weight loss, even in people who are not obese.
The inspections were supported by the analysis of data on the placement of medicines by holders of Marketing Authorization (AIM) and Medical Devices by their representatives in Portugal, distribution data from community pharmacies on the continent and individual data on the dispensing of medicines reimbursed by the National Health Service (SNS).
As part of the implementation of the new prescription and dispensing circuit for insulin pumps and their medical devices, Infarmed also carried out a series of inspections in pharmacies and treatment centers with Continuous Subcutaneous Insulin Infusion (PSCI) devices.
According to Infarmed, three inspections of laboratories holding AIM, 12 of wholesale distributors, 69 of pharmacies and five of treatment centers.
From these inspections, resulted in 19 reports to the Public Ministry, “because it was understood that there was a potential case of overbilling of the SUS in community pharmacies, says the report “Thematic Inspections: Diabetes”.
They were also “27 infringement cases were initiated against pharmacies following the detection of dispensing of packaging in quantities greater than that permitted by law for each medical prescription, without justification or with inadequate justification”like “prolonged absence from the country” or “dosage”, reveals the report, to which Lusa had access, also pointing out specific cases of these medicines being dispensed without a prescription.
Following the detection of irregularities within the scope of compliance with the Good Distribution Practices System, a Wholesale Distribution Authorization was suspended.
The report states that four administrative offense cases were also initiated against pharmacies and two against distributors wholesale for having been detected “Irregularities in activities related to pharmaceutical practice”.
Regarding insulin pumps, no availability problems or constraints on acquisition were identifiedand it was found that the users’ choice of PSCI was respected, without interference from pharmacies, and that some treatment centers carry out manual registration of the devices before the user’s choice, to guarantee immediate delivery of the device and supplies.
Infarmed states in the statement that letters were sent to the National Association of Pharmacies, the Association of Pharmacies of Portugal, the Order of Pharmacists warning of “the bad practices/illegalities identified, and the need to adopt a judicious dispensation of available stocks, based on criteria for the rational use of the medicine”.
“Community pharmacies will also be recipients of information, reinforcing the need for adequate compliance with critical provisions of the legislation”, adds Infarmed, announcing that these inspection actions will be continued this year.
The authority will propose short-medium term measures, changes in legislation (prescription and dispensation rules) and IT systemsto avoid inappropriate use of technical justifications.
Go still propor “the creation of an alert system at pharmacy level with a high practice of resorting to dispensation with technical justifications, in medicines with high cost, low availability, or potential abuse”.
In 2025, the Infarmed launched 951 inspection actions against the entities it oversees in the medicine and health products circuitan increase of 28% compared to the previous year.
