Inès Ben Ghezala, Laure-Anne Steinberg, Maxime Sibert, Aline Lazzarotti, Aude Ambresin, Pierre-Henry Gabrielle, Catherine Creuzot-Garcher
{"title":"玻璃体内抗vegf药物在家庭储存过程中的温度偏移","authors":"Inès Ben Ghezala, Laure-Anne Steinberg, Maxime Sibert, Aline Lazzarotti, Aude Ambresin, Pierre-Henry Gabrielle, Catherine Creuzot-Garcher","doi":"10.1001/jamaophthalmol.2024.5884","DOIUrl":null,"url":null,"abstract":"ImportanceSome patients worldwide are asked to acquire an anti–vascular endothelial growth factor (anti-VEGF) agent from a pharmacy, store it, and then bring it to a physician for intravitreal injection (IVT). Anti-VEGF agents must be stored in the refrigerator to avoid bacterial contamination or denaturation. Some cases of severe intraocular inflammation have been reported following IVT of more recently approved anti-VEGF agents, which might be explained by thermal instability.ObjectiveTo investigate whether patients followed the storage temperature guidelines for intravitreal anti-VEGF agents in daily clinical practice.Design, Setting, and ParticipantsThis quality improvement study, performed between May 27 and June 7, 2024, at the Ophthalmology Department of Dijon University Hospital in Dijon, France, included all consecutive patients with new or renewed prescriptions for intravitreal anti-VEGF agents for any macular disease.Main Outcomes and MeasuresAll participants were given 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.ResultsDuring the study period, 50 participants were prescribed intravitreal anti-VEGF agents and were given a time-temperature indicator. A total of 38 participants (24 [63.2%] female; median age, 79.3 [IQR, 74.3-86.3] years) returned for their IVT with an analyzable indicator. 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. Following anti-VEGF agent IVT, no participant experienced any ocular adverse effect that might be associated with severe intraocular inflammation.Conclusions and RelevanceIn this quality improvement study, temperature excursions of anti-VEGF agents above 8 °C for 48 hours or longer were recorded for 28.9% of participants during home storage. 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 education about the importance of rigorous maintenance of cold storage of their anti-VEGF agents.","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"43 1","pages":""},"PeriodicalIF":7.8000,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Temperature Excursion of Intravitreal Anti-VEGF Agents During Home Storage\",\"authors\":\"Inès Ben Ghezala, Laure-Anne Steinberg, Maxime Sibert, Aline Lazzarotti, Aude Ambresin, Pierre-Henry Gabrielle, Catherine Creuzot-Garcher\",\"doi\":\"10.1001/jamaophthalmol.2024.5884\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"ImportanceSome patients worldwide are asked to acquire an anti–vascular endothelial growth factor (anti-VEGF) agent from a pharmacy, store it, and then bring it to a physician for intravitreal injection (IVT). Anti-VEGF agents must be stored in the refrigerator to avoid bacterial contamination or denaturation. Some cases of severe intraocular inflammation have been reported following IVT of more recently approved anti-VEGF agents, which might be explained by thermal instability.ObjectiveTo investigate whether patients followed the storage temperature guidelines for intravitreal anti-VEGF agents in daily clinical practice.Design, Setting, and ParticipantsThis quality improvement study, performed between May 27 and June 7, 2024, at the Ophthalmology Department of Dijon University Hospital in Dijon, France, included all consecutive patients with new or renewed prescriptions for intravitreal anti-VEGF agents for any macular disease.Main Outcomes and MeasuresAll participants were given 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.ResultsDuring the study period, 50 participants were prescribed intravitreal anti-VEGF agents and were given a time-temperature indicator. A total of 38 participants (24 [63.2%] female; median age, 79.3 [IQR, 74.3-86.3] years) returned for their IVT with an analyzable indicator. 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. Following anti-VEGF agent IVT, no participant experienced any ocular adverse effect that might be associated with severe intraocular inflammation.Conclusions and RelevanceIn this quality improvement study, temperature excursions of anti-VEGF agents above 8 °C for 48 hours or longer were recorded for 28.9% of participants during home storage. 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 education about the importance of rigorous maintenance of cold storage of their anti-VEGF agents.\",\"PeriodicalId\":14518,\"journal\":{\"name\":\"JAMA ophthalmology\",\"volume\":\"43 1\",\"pages\":\"\"},\"PeriodicalIF\":7.8000,\"publicationDate\":\"2025-01-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamaophthalmol.2024.5884\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamaophthalmol.2024.5884","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Temperature Excursion of Intravitreal Anti-VEGF Agents During Home Storage
ImportanceSome patients worldwide are asked to acquire an anti–vascular endothelial growth factor (anti-VEGF) agent from a pharmacy, store it, and then bring it to a physician for intravitreal injection (IVT). Anti-VEGF agents must be stored in the refrigerator to avoid bacterial contamination or denaturation. Some cases of severe intraocular inflammation have been reported following IVT of more recently approved anti-VEGF agents, which might be explained by thermal instability.ObjectiveTo investigate whether patients followed the storage temperature guidelines for intravitreal anti-VEGF agents in daily clinical practice.Design, Setting, and ParticipantsThis quality improvement study, performed between May 27 and June 7, 2024, at the Ophthalmology Department of Dijon University Hospital in Dijon, France, included all consecutive patients with new or renewed prescriptions for intravitreal anti-VEGF agents for any macular disease.Main Outcomes and MeasuresAll participants were given 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.ResultsDuring the study period, 50 participants were prescribed intravitreal anti-VEGF agents and were given a time-temperature indicator. A total of 38 participants (24 [63.2%] female; median age, 79.3 [IQR, 74.3-86.3] years) returned for their IVT with an analyzable indicator. 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. Following anti-VEGF agent IVT, no participant experienced any ocular adverse effect that might be associated with severe intraocular inflammation.Conclusions and RelevanceIn this quality improvement study, temperature excursions of anti-VEGF agents above 8 °C for 48 hours or longer were recorded for 28.9% of participants during home storage. 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 education about the importance of rigorous maintenance of cold storage of their anti-VEGF agents.
期刊介绍:
JAMA Ophthalmology, with a rich history of continuous publication since 1869, stands as a distinguished international, peer-reviewed journal dedicated to ophthalmology and visual science. In 2019, the journal proudly commemorated 150 years of uninterrupted service to the field. As a member of the esteemed JAMA Network, a consortium renowned for its peer-reviewed general medical and specialty publications, JAMA Ophthalmology upholds the highest standards of excellence in disseminating cutting-edge research and insights. Join us in celebrating our legacy and advancing the frontiers of ophthalmology and visual science.