Update: FDA formally requests recall of AmEx Pharmacy sterile products

UPDATE: FDA issues formal request to AmEx Pharmacy to recall sterile products. AmEx issues voluntary recall.

This is an update to OMIC’s earlier guidance on the FDA’s recommendation of a voluntary recall. The FDA has now issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. Here are excerpts from the August 27, 2019 FDA press release, which is available at https://www.fda.gov/news-events/press-announcements/fda-requests-recall-sterile-compounded-drug-products-produced-pacifico-national-inc-dba-amex.

AmEx issued the voluntary recall on August 30, 2019: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacifico-national-inc-dba-amex-pharmacy-issues-voluntary-nationwide-recall-all-lots-bevacizumab. 

Excerpts from the FDA press release

“An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. As a result, the agency recommended on June 25 that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy declined to initiate a recall of all unexpired drugs intended to be sterile and has not provided adequate assurances regarding the sterility and quality of its remaining and newly manufactured products.”

“Because of this, on August 27^th, 2019, the agency issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. The FDA is also urging consumers to stop using these drugs and dispose of them immediately. Additionally, the agency is requesting the outsourcing facility cease production of drugs intended to be sterile until adequate remediation actions have been taken.”

“Health care professionals should immediately check their medical supplies, quarantine any drugs intended to be sterile and prepared by AmEx Pharmacy, and not administer or provide them to patients. The FDA urges health care professionals who obtained drugs from AmEx Pharmacy to make alternative arrangements to obtain medications from sources that adhere to proper quality standards.”

OMIC Risk Management Advice

• Follow the FDA advice:
  • Quarantine all these drugs
  • Do not administer them
  • Obtain sterile drugs from another source

OMIC policyholders are encouraged to contact our confidential Risk Management Hotline if they need further assistance. Please call 800-562-6642 option 4 or email riskmanagement@omic.com.

Dear Leadership Class of 2019

Dear Leadership Class of 2019,

On behalf of everyone at OMIC, we thank you for your leadership and commitment to improving your profession, protecting sight, and empowering lives. Since our founding in 1987 by the American Academy of Ophthalmology, OMIC has similarly taken a leading role in the protection and support of the practice of ophthalmology.

Before OMIC, ophthalmologists experienced wide fluctuations in the cost of insurance and had to endure cycles of “crisis” when coverage was unavailable in many areas of the U.S. This was a direct threat to ophthalmic practice. There were also reports of traditional insurance companies subsidizing higher risk medical specialties by shifting the costs to relatively lower risk ophthalmologists.

After OMIC, rates for all ophthalmologists stabilized and have remained much lower than they were prior to our entry into the market. Furthermore, during deteriorating insurance cycles in the early 1990’s and again in the early 2000’s, OMIC maintained rates 40% lower than the industry and we were the only carrier writing new policies in some areas of the country.

OMIC was created by the American Academy of Ophthalmology as an independent company that would be devoted solely to the practice of ophthalmology. The goal is to provide comprehensive medical liability coverage and services at the lowest possible cost. The philosophy is to run the company similar to a non-profit in that any funds above which is needed to prudently operate the company would be returned immediately to insureds through dividends. Since 1987, OMIC has declared cumulative dividends totaling more than $85 Million, and no traditional insurance company has produced comparable results. For instance during the past five years, OMIC’s dividend returns averaged 20.7% of earned premium vs. 6.7% for the other carriers in our industry that declared dividends.

Another goal of OMIC is to create materials and resources that improve the quality of care and enhance the practice of ophthalmology. Throughout OMIC’s 32-year existence, we have produced and perfected a wide collection of patient education materials that will inform and protect patients, improve care, and protect ophthalmologists from litigation. We encourage you to browse OMIC.com, specifically the vast risk management library of articles, studies, closed claim reviews, consent forms, and sample documents and recommendations for all ophthalmic subspecialties.

Finally, our success depends on your continuing support of OMIC. Thank you for spreading the word, as a leader in ophthalmology, to remind colleagues that there is only one carrier supporting ophthalmology through financial support of state, subspecialty, and special interest societies, dissemination of ophthalmic risk management resources, and consistent superior performance in defending the specialty.

Sincerely,

Tim Padovese

President and CEO

Raindrop Near Vision Inlay Recalled

3/5/2019 FDA Recalls Raindrop Near Vision Inlay

On December 28, 2018, Allergan issued an “Urgent Drug Recall” of 22 lots of OZURDEX. The recall was prompted by the finding of a silicone particulate of 300 microns diameter in dispensed OZURDEX implants. Allergan determined that the particulate originated from the needle sleeve.

Allergen identified the following safety risks: “Mild transient visual disturbances or intraocular inflammatory reaction in sensitive patients” and “…a remote possibility of corneal reaction if the particulate migrates to the anterior chamber.” Allergan categorized the risk probability as low, based on the infrequent dosing of OZURDEX.

However, OMIC has received 1 report to date of a reaction in a bilaterally treated patient who experienced a reaction in one eye, resulting in hand motion vision. Therefore, the potential side effects should not be minimized, and patients should be counseled carefully about watching for and immediately reporting signs and symptoms.

Insureds who have lots of OZURDEX should follow Allergans’ advice regarding inspecting the lot numbers in your inventory and returning any recalled lots to Allergan, preserving evidence, and reporting adverse reactions.

OMIC risk management recommendations

1. Follow the recommendations of the manufacturer.
2. Disclose the recall to the affected patients (see attached sample letter to patients) and add the letter to the patient’s medical record.
3. Monitor patients for signs and symptoms.
4. Report adverse reaction to Allergan.
5. Treat the symptoms.
6. Document your discussions and treatment in the medical record.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.

Allergan Voluntary Recall of OZURDEX

12/28/2018 Allergan issued an “Urgent Drug Recall” of 22 lots of OZURDEX

On December 28, 2018, Allergan issued an “Urgent Drug Recall” of 22 lots of OZURDEX. The recall was prompted by the finding of a silicone particulate of 300 microns diameter in dispensed OZURDEX implants. Allergan determined that the particulate originated from the needle sleeve.

Allergen identified the following safety risks: “Mild transient visual disturbances or intraocular inflammatory reaction in sensitive patients” and “…a remote possibility of corneal reaction if the particulate migrates to the anterior chamber.” Allergan categorized the risk probability as low, based on the infrequent dosing of OZURDEX.

However, OMIC has received 1 report to date of a reaction in a bilaterally treated patient who experienced a reaction in one eye, resulting in hand motion vision. Therefore, the potential side effects should not be minimized, and patients should be counseled carefully about watching for and immediately reporting signs and symptoms.

Insureds who have lots of OZURDEX should follow Allergans’ advice regarding inspecting the lot numbers in your inventory and returning any recalled lots to Allergan, preserving evidence, and reporting adverse reactions.

OMIC risk management recommendations

1. Follow the recommendations of the manufacturer.
2. Disclose the recall to the affected patients (see attached sample letter to patients) and add the letter to the patient’s medical record.
3. Monitor patients for signs and symptoms.
4. Report adverse reaction to Allergan.
5. Treat the symptoms.
6. Document your discussions and treatment in the medical record.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.

FDA recalls CyPass glaucoma device

11/29/18 Updated FDA and OMIC Advice

On October 24, 2018, the FDA issued an update on the CyPass device: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624283.htm. The device status has been changed from a voluntary market withdrawal initiated by Alcon to an FDA Class 1 recall.

Latest FDA recommendations

• Do not implant CyPass Micro-Stents and return unused devices to Alcon. Call Alcon at 1-800-862-5266 for directions on how to return the devices.
• All patients who have the CyPass device should be evaluated periodically for endothelial cell density using specular microscopy until the rate of loss stabilizes.
• Eye care providers should evaluate all patients with CyPass to assess device positioning by visualization of the number of retention rings visible on the proximal end of the device. Patients with two or more rings visible upon examination should be evaluated for endothelial cell loss as soon as possible.
• Based on the endothelial cell density levels, and other factors such as age and time post-implantation, the surgeon should determine if additional surgical interventions (that is, trimming, repositioning, or removal) are appropriate.

OMIC risk management recommendations

Disclosure

• OMIC advised ophthalmologists to notify their patients when CyPass was voluntarily withdrawn from the market.
• If you have already notified the patient as advised, documented the notification, examined the patient, and developed and communicated a monitoring plan, we do not feel you need to send another letter. Instead, discuss the recall at the next appointment.
• If you have not yet notified your patients, do so now. Here is a Letter to patients about the CyPass recall.

Monitoring

• At the next visit, revisit the monitoring plan, and remind patients of symptoms that should be reported to you.
• Evaluate the endothelial cell count if you have not already done so.
• Document the disclosure, exam, and discussion about the endothelial cell count.

If you do not have a specular microscope

• Identify practices or academic centers where counts are available, and determine the cost of the count.
• If the exam does not indicate any relevant problems, tell the patient that you do not feel a count is needed at this time, and explain your monitoring plan AND
• Give the patient the option of having the count done, and explain the cost.
• Document the disclosure, exam, and discussion about getting an endothelial cell count.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com. 

Alcon information provided after the market withdrawal

During the September 17, 2018 conference call for physicians who have implanted the device, the physician speakers noted that due to fibrosis around the implant, the risk of complications with removal is high. Clinical guidance is available at  https://www.alcon.com/sites/www.alcon.com/files/CyPass_US_Customer_Letter-8-29_Final.pdf. Results of the Compass XT clinical trial were presented at ESCRS. The presentation can be accessed through the Alcon website at https://www.alcon.com/content/cypass-micro-stent-market-withdrawal.

Initial FDA announcement

The FDA released statement about Alcon’s voluntary withdrawal of CyPass may be viewed at https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm620646.htm. In its release, the FDA provides the following advice:

• Do not implant CyPass Micro-Stents and return unused devices to Alcon. Call Alcon at 1-800-862-5266 for directions on how to return the device.
• Review Alcon’s recommendations for evaluating and managing CyPass Micro-Stents in patients who have already received the device, such as repositioning or trimming.
• At the current time it is not known how endothelial cell density loss might continue to progress more than five years after the original surgery, and what impact surgery to remove the device may have on further endothelial cell density loss.

ASCRS interim guidance provided after the market withdrawal

The ASCRS documents can be accessed at the following link: http://ascrs.org/sites/default/files/Preliminary_ASCRS%20_yPass_Withdrawal_Consensus_Statement.pdf.