Browsing articles from "January, 2019"

Allergan Voluntary Recall of OZURDEX

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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.

 

Coordinating care with optometrists

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OMIC policyholders report on renewal applications that they are increasingly incorporating optometrists (ODs) into their practices. While optometrists are independent practitioners, there are differences in education and legal scope of practice between eye physicians/surgeons and ODs, as well as different scopes of practice among traditional optometrists and those with therapeutic certification. All these differences must be respected in order to comply with state laws and provide safe care. Coordinating Care with Optometrist within a Practice addresses the key issues.

For a discussion of surgical comanagement, please see Comanagement of Surgical Patients.




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Consistent return of premium.

Publicly-traded insurance companies exist to make profits for shareholders while physician-owned carriers often return profits to their policyholders. Don’t underestimate this benefit; it can add up to tens of thousands of dollars over the course of your career. OMIC has one of the most generous dividend programs for ophthalmologists and has returned more than $90 Million to our members through dividends.

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