Portugal cracks down on pharmaceutical misuse with fines and new alerts

Portugal's pharmaceutical regulator, Infarmed, has taken firm action against irregularities in the distribution and dispensing of medicines. Recent inspections uncovered multiple breaches, leading to penalties, warnings, and proposed system changes to tackle misuse.

The crackdown follows concerns over excessive medication dispensing, suspected overbilling, and failures to meet distribution standards.

Infarmed carried out a series of inspections across the pharmaceutical sector. These included three visits to marketing authorisation holder (MAH) labs, twelve at wholesalers, sixty-nine at pharmacies, and five at treatment centres. The checks revealed widespread issues, prompting further action.

One wholesale distribution licence was suspended for failing to comply with Good Distribution Practice standards. Additionally, four administrative offence proceedings were launched against pharmacies, with two more targeting wholesalers for irregularities in pharmaceutical practice. The regulator also identified 27 cases where pharmacies dispensed excessive amounts of medication, resulting in administrative proceedings. Suspected overbilling led to 19 reports being filed with the Public Prosecutor's Office. Official warnings about improper practices were sent to pharmacy associations and the Order of Pharmacists. While no shortages or procurement problems were found for insulin pumps, Infarmed noted high prescription rates for off-label uses, such as weight loss, contributing to insulin shortages. To address these issues, the agency plans to introduce an alert system flagging pharmacies with unusually high dispensing rates for certain drugs. Further measures include legislative amendments and IT system updates to prevent misuse of technical justifications for excessive dispensing. These steps aim to tighten oversight and reduce irregularities in the pharmaceutical supply chain.

Infarmed's actions highlight ongoing efforts to enforce compliance and prevent misuse within Portugal's pharmaceutical sector. The proposed alert system, legislative changes, and stricter inspections are expected to reduce irregularities and improve medication distribution. The regulator continues to monitor the situation closely.