Protect patients’ ocular health using these action steps

Recently, there have been multiple recalls on OTC drops, due to concerns regarding bacteria. While serious adverse events and several deaths have been attributed to two of the recalled drops, optometrists can play a significant role in protecting their patients’ ocular health by both staying informed and informing patients.

STAYING INFORMED

As this column goes to press, four recalls have occurred:

1. EzriCare Artificial Tears produced at the Global Pharma facility. This recall transpired in early January 2023.
2. Delsam Pharma’s Artificial Tears and Eye Ointment also produced at the above facility. This recall occurred in February, 2023.As of the press date of this column, 68 patients in 16 states have contracted drug-resistant VIM-GES-CRPA (carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase), from both EzriCare and Delsam products. There have been three reported deaths, eight reports of vision loss, and four reports of enucleation. The product used by most infected patients was the EzriCare AT preservative-free multidose bottle (PFMB).^1,2 VIM-GES-CRPA was found in multiple lots of open EzriCare PFMB collected from patients.^1,2
3. Generic Brimonidine Tartrate Ophthalmic Solution 0.15% (Apotex). This voluntary recall occurred on March 2, 2023. Apotex initiated the recall of six lots of drops due to cracks in some of the bottle caps, which could cause insterility.² Thus far, there have been no reported issues with these lots of drops, distributed within the United States between April 5, 2022 and Feb. 22, 2023.
4. Purely Soothing 15% MSM Drops (Pharmedica). This recall occurred March 3, 2023, due to non-sterility.³ Thus far, there have been no reported adverse events.³
   The Centers for Disease Control and FDA recommend ceasing use these products.

INFORMING PATIENTS

With more PFMD drops available and the concern with the aforementioned drops, which drop is OK? Companies offering PFMD artificial tear bottles have undergone years of painstaking development and testing and adhere to Current Good Manufacturing Practice to help ensure that this risk is mitigated. Regardless, ODs should have a plan to address it with patients. My suggestions:

• Inform all patients. ODs should address it with everyone. After all, some patients “go rogue” and decide to buy OTC products to replace or supplement whatever treatments they are already using, and they may not be forthcoming about that. Consider placing signs in the reception area and exam rooms that contain the name(s) of the recalled product(s), recall reason, possible adverse events, and to immediately cease use.
• Prepare to answer follow-up questions. The one I get the most: “How do I know other drops aren’t contaminated?” My answer: “I don’t have a crystal ball, so I can’t be 100% sure that they aren’t, but I vet the OTC products I recommend, and I make sure they are from reputable companies.”
• Remind them of what you’ve always told them. Reemphasize that any ocular treatment can result in adverse effects. For this reason, it’s crucial the patient cease use and contact the practice immediately should the patient experience any sudden symptoms. These symptoms are yellow, green, or clear discharge from the eye with pain, redness of the eye or eyelid, and increased sensitivity to light. OM

References
 
1. Centers for Disease Control and Prevention. Healthcare-Associated Infections (HAIs). Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears. https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html#anchor_08711. Accessed 3/3/23

 2. U.S. Food & Drug Administration. Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due#:~:text=February%2022%2C%202023.-,Product,TK0262,-Apotex%20Corp.%20is. Accessed 3/30/23.

3. U.S. Food & Drug Administration. Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility#:~:text=LOT%23%3A%202203PS01%2C%201%20oz%2C%20UPC%207%2031034%2091379%209%3B%20and%20LOT%23%3A%201808051%2C%20%C2%BD%20oz%2C%20UPC%207%2031034%2091382%209. Accessed 3/30/23. 

DR. KOETTING practices in Denver, Colo. She is a fellow of the American Academy of Optometry, diplomate of the American Board of Optometry, an active member of AOA, and a speaker and consultant for multiple companies. Follow her on Instagram at Dr_Jazz_Hands, or email her at Dr.CeceliaKoetting@gmail.com.