Winter 2024 Issue

Happy New Year OAS Members!

We are eagerly looking forward to an exciting 2024, starting with our Annual Meeting February 9-10 in Houston with the addition of an Ophthalmic Block Workshop on February 11^th.

Hot Topics and Speakers for Next Month!

-International Mission Work with Ophthalmology
David Markoff, MD

-Pediatric Anesthesia- Clinical Tools for the Everyday Practitioner
Neil Masters, MD

-International Speakers

Adrian Kwa, MD, Nottingham University Hospitals NHS Trust, UK

Iosifina Giannakikou, MD, Hygeia Hospital, Greece

Lakshmi Prasanna Srinivasan, MD, Sankara Nethralaya, India

-Incision Free eye Blocks- American Approach                      
Howard Palte, MD, University of Miami

And more!

For the OAS to continue to provide these essential Educational & Networking programs, we need everyone’s help in promoting the value of the OAS to our colleagues.

Please feel free to share the meeting information with your colleagues that may not be on our distribution list. 

Hope to see everyone in Houston next month!

Workshop Overview: 

Orbital Anatomy
Randy Harvey, BS, RRT, APRN, CRNA, FAANA, Orbital Compliance Group

Ophthalmic blocks
Randy Harvey, BS, RRT, APRN, CRNA, FAANA, Orbital Compliance Group

Simulation Training

Randy Harvey, BS, RRT, APRN, CRNA, FAANA, Orbital Compliance Group

Adrian Kwa, MD, Nottingham University Hospitals NHS Trust, UK

Matthew Springer, DNAP, CRNA, Lincoln Surgical Hospital

Whether you are an anesthesiologist, CRNA, ophthalmologist, nurse, resident or student, there is something for everyone at the OAS Annual Scientific Meeting.

ADD on the fun

Puttshack is an upscale, tech-infused mini golf experience that pairs modern technology with crazy courses and trendy vibes for an experience of teamwork and fun. 

Join your fellow attendees at this fun evening event on Saturday, evening 6:30 - 8:30 PM.

FOLLOW US

RENEW NOW and benefit from reduced registration at the conference.

FEATURING Practice Discounts

3 practice members- ($1,000/year) $185 savings

5 Practice members- ($1,600/year)  $375 savings

7 practice members-  ($2,200/year)  $565 savings

OAS Members enjoy exclusive benefits:

•         OASIS Newsletter Archives
•         OAS Member Directory
•         OAS Program Archive
•         Scientific Forum

• FDA challenges quality requirements for ophthalmic drugs with revised draft guidance

Member Opportunity

Take a survey for a chance to win $500 AMAZON Card

OAS President, Dr. Maggie Jeffries, recently published a paper regarding opiate use in cataract surgery. Below is a follow up survey she helped design to gain even more information to share with the ophthalmic anesthesia industry. Please take a few minutes to complete the survey, results will be shared later this year in a recap from Dr. Jeffries. A randomly selected winner will receive an electronic $250 Amazon Card. Be sure to fill out the survey for a chance to win!

Topic: Recent FDA Warning to Enhance Patient Awareness of Unapproved Eye Treatments

Authors:

Momin, Sibtainzehra MD MPH

Yerabolu, Krishin Undergraduate Student

Singh, Vinodkumar MD

University of Alabama at Birmingham

Birmingham VA Medical Center, Birmingham, AL

Introduction:

The U.S. Food and Drug Administration (FDA) has issued a stern warning indicating that eight companies are not in compliance with FDA regulations. This pertained to unapproved eye products being sold without adequate regulatory oversight. These products, which include various eye drops and ointments, pose a significant risk to consumers’ eye health. In this article, we will delve into this warning and why it’s crucial to be cautious while choosing eye products.

The FDA Warning:

In recent years, there has been a growing concern regarding the safety and efficacy of eye medications marketed to the common consumer. The FDA from time to time issues warning letters to inform the public of medications that could potentially harm instead of helping cure the problem at hand.

On September 12^th, the FDA issued a letter stating that Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/ Similasan USA, TRP Company Inc., and Walgreens Boots Alliance Inc. were all not in compliance with the regulations (Administration, 2023). Moreover, the FDA issued an urgent warning, emphasizing the vital need to remove all products linked to the claim within a strict 15 day timeframe. This pertains to a range of eye drops, ointments, and similar products that are being marketed and sold without the agency’s approval. The warning highlights several key concerns:

• 1.      Lack of efficacy data: Unapproved eye products may not have undergone rigorous testing for efficacy, meaning there’s no guarantee they will work as intended.
• 2.      Safety concerns: These products may contain ingredients that can cause irritation, allergies, or other adverse effects on the eyes, potentially leading to vision problems.
• 3.      Quality control issues: Unregulated manufacturing processes can result in inconsistent product quality and contamination risks.
• 4.      False claims: Some unapproved products make unfounded claims about their ability to treat various eye conditions, misleading consumers.

This poses a serious concern as the US Ophthalmic drug market continues to rise and individuals are put at risk every day due to drug companies not making medication safe to use (Figure 1).

Figure 1: Research done by Grand View research shows that the US Ophthalmic drug market continues to increase in market share. The jump from 2021 to 2022 shows a 113% percent increase and decade trajectories indicate the market share will continue to increase (Region, 2022).

Why the Warning Matters:

The human eye is a delicate organ, and using unapproved and potentially unsafe products can have serious consequences. For example, these eye drops/ointments may contain silver, and long-term usage of silver has been shown in literature reports to cause necrosis of conjunctival epithelia cells, argyria, irritation, corneal opacity, and symblepharon (Waszczykowska et al., 2021). It is imperative to understand that FDA approval is not a mere formality but a rigorous evaluation of products’ safety and efficacy. Unapproved products bypass this step, leaving consumers vulnerable to potentially harmful consequences. For this reason, the FDA has stated that legal action will be pursued if the claims are not addressed by the companies. FDA Director of Compliance Jill Furman ensures that the FDA continues to work hard to ensure that the unapproved eye medications are removed from the market to foster greater patient safety.

Protecting the Patients:

To safeguard your patients, consider:

• 1.      Check FDA Approval: Always look for FDA approval on the packaging of any eye products that you dispense or use. If the certification is not present, exercise caution and skepticism.
• 2.      Consult a Friend: Before prescribing or dispensing any new eye product, consult your reliable pharmacy or colleague. They can recommend safe or alternate options for your needs.
• 3.      Report Suspected Issues: If you suspect any issues with the eye products, report it to the FDA’s MedWatch Program. This helps in monitoring and addressing safety concerns.
• 4.      Be Skeptical of “Miracle” Claims: Beware of using products that promise beyond reason. If it sounds too good to be true, it probably is.

Conclusion:

The well-being of both your patient's eyes and your own is invaluable and deserves utmost care and attention. Thisdecisive action by the FDA stands as an imperative component in elevating patient awareness of the harmful effects of unregulated treatments. By highlighting the violations, clarifying regulatory status, and promoting transparency, the FDA letter gives the public the information needed to make informed decisions about different treatment avenues for their eye conditions. As the industry continues to grow, the FDA needs to work to make sure patient safety is the highest priority to help avoid any unnecessary complications. Always trust in regulated and approved treatments, and always seek help and guidance when in doubt.

References:

Administration, F. a. D. (2023). FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products

Region, a. S. F. (2022). Ophthalmic Drugs Market Size, Share & Trends Analysis Report by Drug Class, by Disease (Dry Eye, Glaucoma), by Dosage Form, by Route of Administration, by Product Type (Prescription, OTC), by Region, and Segment Forecasts, 2022-2030. Retrieved September 29 from https://www.researchandmarkets.com/reports/4429696/ophthalmic-drugs-market-size-share-and-trends

Waszczykowska, A., Zyro, D., Ochocki, J., & Jurowski, P. (2021). Clinical Application and Efficacy of Silver Drug in Ophthalmology: A Literature Review and New Formulation of EYE Drops with Drug Silver (I) Complex of Metronidazole with Improved Dosage Form. Biomedicines, 9(2). https://doi.org/10.3390/biomedicines9020210

Summer 2023 Issue

Greetings OAS Members!

2023 has been a year of excitement.  Next year we are hosting the 37th Annual OAS Scientific Meeting in Houston, Texas on February 9-10, 2024.  The society first met in Houston, so this journey has brought us full circle to where it all began.  As the fourth largest city in the US, Houston is a fantastic city to get to know.  We have a wealth of academic support from our partners in the Texas Medical Center - the largest medical center in the world!!  We are hoping that a central location will appeal to our bicoastal colleagues and with two airports, there are many options to get here.  

Our society is also working on increasing our international footprint with involvement from our colleagues in the British and Indian Ophthalmic Anesthesia Organizations.  The OAS continues it’s tradition of being an organization that brings together ophthalmologists, anesthesiologists, registered nurse anesthetists and other clinicians to improve the quality of care for our patients.

Can’t wait to see you in Houston!

Maggie Jeffries, MD

President, Ophthalmic Anesthesia Society

The OAS Annual Scientific Meetings are held each year and feature scientific programs designed to feature the latest education, techniques, and research in the realm of ophthalmic surgery and anesthesia. We look forward to meeting you in Houston, February 9-10, 2024. 

·        Hands-on workshops with certificates of attendance

·        Exclusive lectures from anesthesia, ophthalmology and surgery experts 

·        Round table events with other physicians and registered nurses  

·        Valuable networking opportunities

·        Slides and notes from speakers at all presentations

Whether you are an anesthesiologist, CRNA, ophthalmologist, nurse, resident or student, there is something for everyone at the OAS Annual Scientific Meeting.

Budget now to renew your membership for next year and benefit from reduced registration at the conference.

OAS Members enjoy exclusive benefits:

•         OASIS Newsletter Archives
•         OAS Member Directory
•         OAS Program Archive
•         Scientific Forum

No formal gatherings are scheduled for the current year. However, we encourage you to avail yourself of a comprehensive array of resources, including last year's presentations and an extensive repository of information accessible via past newsletters. These invaluable assets facilitate engagement with the scientific community, fostering collaborative opportunities among peers. Anticipate forthcoming dynamic updates on society initiatives that promise enhanced interactivity and engagement.

• FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination

• Turning medicine caps into mosaic

Meet the OAS Board

President       

Maggie Jeffries, MD, Avanti Anesthesia

President-Elect/VP  

Jefferson Doyle, MD, Johns Hopkins

Immediate Past-President   

George Dumas, MD, University of Alabama Birmingham

Secretary       

Kay Phelan, CRNA, Connecticut Eye Surgery Center

Treasurer      

Robert Gauvin, CRNA, Anesthesia Professionals

Directors                 

Eric Fry, MD, Fry Eye Associates, P.A.

Pete Spitellie, MD, JJM Medical Services

Elaine Liew, MD, University of California, Los Angeles

Tina Tran, MD, Johns Hopkins

Brenton Rains, CRNA, Center for Sight 

Scientific Advisory Chair                

Randolf Harvey, CRNA, Florida Eye Clinic / ASC

At-Large Director                

Vinodkumar Singh, MD, University of Alabama Birmingham

Repository

Take a survey for a chance to win $250 AMAZON Card

OAS President, Dr. Maggie Jeffries, recently published a paper regarding opiate use in cataract surgery. Below is a follow up survey she helped design to gain even more information to share with the ophthalmic anesthesia industry. Please take a few minutes to complete the survey, results will be shared later this year in a recap from Dr. Jeffries. A randomly selected winner will receive an electronic $250 Amazon Card. Be sure to fill out the survey for a chance to win!

GLP-1 receptor agonists and sedation for Ophthalmic surgery

Many of us are now aware of the reports of retained gastric contents in patients take glucagon-like peptide-1 (GLP-1) receptor agonists despite being appropriately NPO.  These medications work by the inhibition of gastric emptying and stimulation of insulin production and reduction in glucagon secretion leading to lower insulin levels.   The delayed gastric emptying reduces hunger, leading to a reduction in food intake and subsequent weight loss. 

It is advisable to familiarize yourself with the generic and brand names of these medication and ensure that your preoperative staff is educated as well.  There are various routes of administration such as oral pills and subcutaneous injections and administration could be daily or weekly.  As of publication of this article, the current FDA approved GLP-1 medications are:

Dulaglutide (trulicity)

Exenatide (Bydureon, Byetta)

Semaglutide (Ozempic, Wegovy, Rybelsus)

Liraglutide (Victoza, Saxenda)

Lixisenatide (Adlyxin)

Tirzapatide (Mounjaro)

If the patient has GI symptoms such as nausea, vomiting, dyspepsia and abdominal distention, current evidence indicates there is an increased likelihood of retained gastric contents.² Because of concerns over an increased risk of aspiration associated with GLP-1 agonists, the ASA Task Force on Preoperative Fasting reviewed the limited existing literature and compiled the following recommendations for elective procedures.³ This is taken directly from their statement which is linked in the references below. 

“Day or week prior to the procedure:

·        Hold GLP-1 agonists on the day of the procedure/surgery for patients who take the medication daily.

·        Hold GLP-1 agonists a week prior to the procedure/surgery for patients who take the medication weekly.

·        Consider consulting with an endocrinologist for guidance in patients who are taking GLP-1 agonists for diabetes management to help control their condition and prevent hyperglycemia (high blood sugar).

Day of the Procedure:

• ·        Consider delaying the procedure if the patient is experiencing GI symptoms such as severe nausea/vomiting/retching, abdominal bloating or abdominal pain and discuss the concerns of potential risk of regurgitation and aspiration with the proceduralist or surgeon and the patient.
• ·        Continue with the procedure if the patient has no GI symptoms and the GLP-1 agonist medications have been held as advised.
• ·        If the patient has no GI symptoms, but the GLP-1 agonist medications were not held, use precautions based on the assumption the patient has a “full stomach” or consider using ultrasound to evaluate the stomach contents. If the stomach is empty, proceed as usual. If the stomach is full or if the gastric ultrasound is inconclusive or not possible, consider delaying the procedure or proceed using full stomach precautions. Discuss the potential risk of regurgitation and aspiration of gastric contents with the proceduralist or surgeon and the patient.
• ·        Full stomach precautions should be used in patients who need urgent or emergency surgery.”

This is all well and good for general anesthetics, but what about procedures/surgery under light sedation such as cataract surgery?  These medications are being prescribed in ever increasing amounts and not always by legitimate health care providers.  Compounding pharmacies are now offering these medications as well as online websites.  Further concerning is that patients may not disclose taking these medications as they don’t see it as a “medication.”

The Ophthalmic Anesthesia Society has received numerous inquiries as to what guidance, if any, we can provide.  We recommend that patients be specifically asked if they are taking any GLP-1 medications, in what dose and delivery form, for what indication, and if they are having any GI side effects.  Preferably this occurs at the surgeon’s office so that an intervention in dosing might be made.  At the very least, sedation should be tailored to keep these patients as awake as possible.  As sedation is a spectrum from light to deep, the final decision on how to proceed remains with the anesthesia provider and should be influenced by both patient and surgical factors.  The OAS will continue to monitor the available evidence which will continue to evolve as more research is performed. 

It is our expectation to perform a survey of our members regarding their anesthesia practices related to GLP-1 medications and present the data at our annual meeting.  There will be a lecture and further discussion regarding this important subject.  See you there!!

Vinodkumar Singh, MD FRCA MRCP

Professor

Department of Anesthesiology and Perioperative Medicine

Division of Critical Care Medicine

University of Alabama at Birmingham Hospital

619 S. 19th Street JT 804

Birmingham, AL 35249

References:

1. Klein SR, Hobai IA. Semaglutide, delayed gastric emptying, and intraoperative pulmonary aspiration: A case report. Can J Anesth. 2023. DOI: 10.1007/s12630-023-02440-3.
2. Silveira SQ, da Silva LM, Abib ACV et al. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023; 87: 111091.
3. Powell K. Did you know that the ASA has offered guidance on preoperative management of patients on glucagon-like peptide-1 (GLP-1) receptor agonists for elective procedures?  Online, August 2, 2023.