2019 January Alert: OZURDEX Recall
January 15, 2019 OMIC Announcement
Allergan Voluntary Recall 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 recommends that insureds respond by doing the following:
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- Follow the recommendations of the manufacturer.
- Disclose the recall to the affected patients (see attached sample letter to patients) and add the letter to the patient’s medical record.
- Monitor patients for signs and symptoms.
- Report adverse reaction to Allergan.
- Treat the symptoms.
- 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.
| Denise R. Chamblee, MD Chair, OMIC Risk Management Committee |
Linda D. Harrison, PhD Director, OMIC Risk Management |
2019 January Bulletin: Cataract Surgery
January 2019 Risk Management Bulletin
Cataract Surgery Risk Reduction
Cataract surgery is the second most frequently performed ophthalmic procedure in the United States, and remains the source of the majority of the medical malpractice claims reported to OMIC. Patient expectations about the outcome of cataract surgery are heavily influenced by advertising that promises to reduce or completely eliminate dependence upon glasses and contact lens. Many patients undergoing cataract surgery thus have very high visual goals, especially if they invest their own money to upgrade to specialty IOLs. When the outcome does not match these heightened expectations, patients are more apt to complain not only to their ophthalmologist, but to acquaintances, insurance companies, regulatory agencies, and malpractice attorneys.
Our risk management recommendations and sample consent forms can help you reduce your liability exposure.
RESOURCES
2018 Archives – Risk Management Bulletin
2018 December Bulletin: Service Animals
2018 November Bulletin: Giant Cell Arteritis
2018 October Bulletin: Social Media
2018 September Alert: CyPass Advice
2018 September Bulletin: ED & After-Hours Calls
2018 August Bulletin: OMIC CyberNET
2018 July Bulletin: Comanagement
2018 December Bulletin: Service Animals
December 2018 Risk Management Bulletin
Service Animals
Do you have a Service Animal Policy?
Do you know the two questions you are allowed to ask about the service animal?**
Do you know what the ADA requirements are regarding posting a sign in your office stating, “Service Animals Welcome”?
Facts:
A patient showed up for a scheduled medical appointment at an OMIC insured retina practice with a dog. The patient did not call ahead to let the practice know that he was bringing a service animal with him to the appointment. When the doctor told the patient that the animal was not allowed into the sterile treatment room, words were exchanged, and the patient left the office prior to the exam. The patient filed a claim with the U.S. Department of Justice and the State Medical Board alleging discrimination and a violation of the ADA requirements regarding service animals.
The medical office was required by the U.S. Department of Justice to draft and submit for approval their service animal policy. They were also required to post a sign informing patients that SERVICE ANIMALS ARE WELCOME. The sign had to be in a font of 26 or larger, on a contrasting white background.
The insured was required to pay the patient a $1000 fine.
**The two questions you are allowed to ask about the service animal are:
- Is this animal required because of a disability?
What tasks has the animal been trained to perform?
RESOURCES
ADA Requirements Overview: Overview and Miniature Horse Addendum
FAQ about Service Animals and the ADA: ADA Regulations
Understanding How to Accommodate Service Animals in Healthcare Facilities: HHS Document
OMIC Sample Policy: Policy
OMIC Example of Sign for Office: Service Animal Flyer and Court Document Service Animals
2019 April Bulletin: Duty of Care
April 2019 Risk Management Bulletin
When is a Physician’s Legal Duty of Care Established?
Physicians often ask at what point the physician-patient relationship begins Does a scheduled appointment for a new patient create a legal duty? What about a curbside consult? Does treatment in the ED establish a duty for follow up care? As with many medico-legal issues, it depends. OMIC has created resources to answer such questions. Click on the links at right to learn more about how to reduce your liability in these situations.
RESOURCES
