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Changes can result in bacterial contamination, loss of drug activity, and inflammation
A European study found that temperature changes have the potential to adversely affect anti-vascular endothelial growth factor (VEGF) drugs when patients store them in their homes. These changes can result in bacterial contamination, loss of drug activity, and inflammation,1 according to first author Inès Ben Ghezala, MD, PhD. She is from the Ophthalmology Department, Dijon University Hospital, and Inserm, CIC 1432, Clinical Investigation Center, Clinical Epidemiology/Clinical Trials Unit, Dijon University Hospital, both in Dijon, France.
Increasing numbers of patients are being treated with anti-VEGF drugs worldwide. In some cases, according to the investigators, patients are instructed to obtain the drugs from a pharmacy, store them in their homes, and then bring them to their physicians for intravitreal injection.
Because of this step in the treatment process, the researchers conducted a quality improvement study to determine both if patients were adhering to the drugs’ storage guidelines and the effects on the drugs if they were not adhering to the storage guidelines. The study included all consecutive patients with new or renewed prescriptions for intravitreal anti-VEGF agents prescribed to treat any macular disease.
The investigators gave the participants a time-temperature indicator that changed color according to brief (2-12 hours), moderate (12-48 hours), and prolonged (≥48 hours) exposure over 8 °C. The indicator was activated at the time of the anti-VEGF agent delivery to the participant in community pharmacies, they explained.
During the study period that ranged from May 27 to June 7, 2024, 50 participants who were treated with intravitreal anti-VEGF agents received a time-temperature indicator. Of those, 38 participants (24 [63.2%] women; median age, 79.3 years) returned with their drugs to undergo an intravitreal injection with an analyzable indicator.
The authors reported, “Of the 38 analyzable indicators, all showed temperature excursions above the threshold of 8 °C, including 26 (68.4%) for 12 to 48 hours and 11 (28.9%) for 48 hours or longer.”
After the injection of the anti-VEGF drugs, no ocular adverse effect developed that might be associated with development of severe intraocular inflammation.
In commenting on their findings, the authors pointed that the anti-VEGF agents were exposed to temperatures above 8 °C for 48 hours or longer in 28.9% of participants while the drugs were stored in their homes.
“While it is unknown how these 38 participants relate to other patients worldwide who are required to obtain their own anti-VEGF agents, these findings suggest that patients need to be educated about the importance of rigorous maintenance of cold storage of their anti-VEGF agents,” Ben Ghezala and colleagues concluded.