Abstract
Purpose :
Low-concentration atropine is commonly prescribed to slow myopia progression in children but is not FDA-approved for that indication and is only available in the US from compounding pharmacies. The purpose of this study was to ascertain the most common procedures used to compound low concentration atropine.
Methods :
US compounding pharmacies were identified via a survey of myopia management doctors in practice and at optometry schools, via social media, conferences, email, and web search. Based on this screen, a total of 28 pharmacies were contacted via telephone and asked a standard set of questions about their pharmacy practices regarding the preparation and storage of their compounded atropine product.
Results :
Twenty-six pharmacies across 19 US States provided answers to at least three questions. The most frequently reported bottle size was 5 ml (IQR: 3.5-10). For storage, 7 of 18 pharmacies (39%) recommended refrigeration and 11 (61%) stated room temperature was sufficient. The median beyond use date provided was 60 days (IQR: 45-180).
For preparation, 14 pharmacies (54%) used commercially available 1% atropine solution, 9 (34%) used powdered atropine, 2 (8%) used either, and 1 (4%) stated their approach was proprietary. For the added inactive ingredients, 10 pharmacies (42%) used commercially available artificial tears only, 6 (25%) added saline only, 6 (25%) used more than one ingredient, and 2 (8%) were proprietary. Only two pharmacies mentioned adding Boric acid and one mentioned “pH adjusted” saline.
Conclusions :
There were a wide variety of methods used to compound low-concentration atropine, which may alter the pH and affect its stability and potency. Whether these differences ultimately affect the efficacy and safety of low-concentration atropine is not known. Further research is needed to assess how these variations may affect the outcomes of myopia management.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.