TY - JOUR
T1 - Clinical impact of the worldwide shortage of verteporfin (Visudyne®) on ophthalmic care
AU - Sirks, Marc J.
AU - van Dijk, Elon H. C.
AU - Rosenberg, Noa
AU - Hollak, Carla E. M.
AU - Aslanis, Stamatios
AU - Cheung, Chui Ming Gemmy
AU - Chowers, Itay
AU - Eandi, Chiara M.
AU - Freund, K. Bailey
AU - Holz, Frank G.
AU - Kaiser, Peter K.
AU - Lotery, Andrew J.
AU - Ohno-Matsui, Kyoko
AU - Querques, Giuseppe
AU - Subhi, Yousif
AU - Tadayoni, Ramin
AU - Wykoff, Charles C.
AU - Zur, Dinah
AU - Diederen, Roselie M. H.
AU - Boon, Camiel J. F.
AU - Schlingemann, Reinier O.
N1 - Publisher Copyright: © 2022 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.
PY - 2022/11/1
Y1 - 2022/11/1
N2 - INTRODUCTION: Since July 2021, a worldwide shortage of verteporfin (Visudyne®) occurred: an essential medicine required for photodynamic therapy (PDT). PDT with verteporfin has a broad range of indications in ophthalmology, including chronic central serous chorioretinopathy, polypoidal choroidal vasculopathy and choroidal haemangioma. For these disorders, PDT is either the first-choice treatment or regarded as a major treatment option. MATERIALS AND METHODS: A questionnaire was sent to key opinion leaders in the field of medical retina throughout the world, to assess the role of PDT in their country and the effects of the shortage of verteporfin. In addition, information on the application of alternative treatments during shortage of verteporfin was obtained, to further assess the impact of the shortage. RESULTS: Our questionnaire indicated that the shortage of verteporfin had a major impact on ophthalmic care worldwide and was regarded to be a serious problem by most of our respondents. However, even though there is ample evidence to support the use of PDT in several chorioretinal diseases, we found notable differences in its use in normal patient care throughout the world. Various alternative management strategies were noted during the verteporfin shortage, including lowering the dose of verteporfin per patient, the use of alternative treatment strategies and the use of a centralized system for allocating the remaining ampoules of verteporfin in some countries. CONCLUSION: The shortage of verteporfin has had a large effect on the care of ophthalmic patients across the world and may have resulted in significant and irreversible vision loss. Mitigation strategies should be developed in consultation with all stakeholders to avoid future medication shortages of verteporfin and other unique ophthalmic medications. These strategies may include mandatory stock keeping, compulsory licensing to an alternative manufacturer or incentivizing the development of competition, for example through novel public-private partnerships.
AB - INTRODUCTION: Since July 2021, a worldwide shortage of verteporfin (Visudyne®) occurred: an essential medicine required for photodynamic therapy (PDT). PDT with verteporfin has a broad range of indications in ophthalmology, including chronic central serous chorioretinopathy, polypoidal choroidal vasculopathy and choroidal haemangioma. For these disorders, PDT is either the first-choice treatment or regarded as a major treatment option. MATERIALS AND METHODS: A questionnaire was sent to key opinion leaders in the field of medical retina throughout the world, to assess the role of PDT in their country and the effects of the shortage of verteporfin. In addition, information on the application of alternative treatments during shortage of verteporfin was obtained, to further assess the impact of the shortage. RESULTS: Our questionnaire indicated that the shortage of verteporfin had a major impact on ophthalmic care worldwide and was regarded to be a serious problem by most of our respondents. However, even though there is ample evidence to support the use of PDT in several chorioretinal diseases, we found notable differences in its use in normal patient care throughout the world. Various alternative management strategies were noted during the verteporfin shortage, including lowering the dose of verteporfin per patient, the use of alternative treatment strategies and the use of a centralized system for allocating the remaining ampoules of verteporfin in some countries. CONCLUSION: The shortage of verteporfin has had a large effect on the care of ophthalmic patients across the world and may have resulted in significant and irreversible vision loss. Mitigation strategies should be developed in consultation with all stakeholders to avoid future medication shortages of verteporfin and other unique ophthalmic medications. These strategies may include mandatory stock keeping, compulsory licensing to an alternative manufacturer or incentivizing the development of competition, for example through novel public-private partnerships.
KW - age-related macular degeneration
KW - central serous chorioretinopathy
KW - choroidal haemangioma
KW - photodynamic therapy
KW - polypoidal choroidal vasculopathy
KW - verteporfin
UR - http://www.scopus.com/inward/record.url?scp=85132801255&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/aos.15148
DO - https://doi.org/10.1111/aos.15148
M3 - Article
C2 - 35388619
SN - 0001-639X
VL - 100
SP - e1522-e1532
JO - Acta ophthalmologica
JF - Acta ophthalmologica
IS - 7
ER -