Resource Library
The Resource Library is a compendium of consent forms, risk management recommendations, sample documents, articles, and other risk management materials to promote ophthalmic patient safety and reduce liability. Contact riskmanagement@omic.com with questions.
Found
31
resources.
Mar 13, 2020
| Consent Form
...Letterhead] Informed Consent for Avastin™ (bevacizumab) You have [Condition], and your doctor, [Name, MD/DO], is recommending Avastin™ (bevacizumab) . What is [Condition]? · [State the condition and how it impacts the patient.] About Avastin™ (bevacizumab) Ophthalmologists (eye surgeons) treat some types of eye problems with a medication called Avastin. Avastin...
Nov 15, 2015
| Consent Form
...FDA, issued a warning about AVASTIN. Here is more information about the warning. Tests on animals show that anti-VEGF drugs like AVASTIN may not be safe for the fetus. The FDA does not know if AVASTIN causes birth defects in humans. This drug should only be used during pregnancy if...
Jun 30, 2015
| Risk Management Bulletin
There are two Avastin consent forms. Use the Avastin form for all adult patients receiving Avastin. This form was revised on 3/13/2020. Ask women of child-bearing age to sign Avastin.Possible risk for the fetus about the possible risk to the fetus. This form was revised on 11/5/2015. Review our risk...
Feb 21, 2023
| Recommendation
...needs, and leaves this decision up to the physician’s judgment. Ophthalmologists use the FDA-approved medications just discussed to treat other eye conditions. All such use is off-label. Ophthalmologists use Avastin (bevacizumab), which has not been approved for intravitreal use or for eye conditions. All ophthalmic use of Avastin is off-label....
Jun 30, 2015
| Risk Management Bulletin
...the last dose of Avastin.” It is not clear whether intravenous Avastin causes harm to the human fetus. The FDA warning did not address intravitreal Avastin, as this use is off-label. Nor did it address intravitreal Eylea. To reduce the potential liability for ophthalmologists using Eylea, we feel it is...
Oct 23, 2020
| Recommendation
...for another use, and provides treatment results that are comparable to approved drugs or devices, considered “off-label” and legal if part of the “practice of medicine.” Example: Avastin for eye conditions If so, but using it prior to any FDA approval, riskier Example: Using Restylane for lip augmentation and facial...
Mar 25, 2015
| Article
OMIC handles hundreds of claims and lawsuits every year. However, many insureds are unaware of the additional benefits and services beyond claims handling that OMIC provides to policyholders and their staff. Over the past five years, OMIC has spent more than $1.8 million to help insureds proactively manage a myriad...
Mar 10, 2022
| Recommendation
...vasculosa lentis. Some infants have disease that persists despite laser. Other means of arresting ROP are thus needed. Adult patients with retinal conditions due at least in part to VEGF have been successfully treated with intravitreal injections of anti-VEGF agents such as AvastinTM (bevacizumab), MacugenTM (pegaptanib), LucentisTM (ranibizumab), and EyleaTM...
Apr 1, 2022
| Recommendation
...weeks between examinations, depending upon the findings. b. Infants at high risk for ROP may need more frequent examinations. c. Infants treated with an anti-VEGF medication (i.e., Avastin or Lucentis) need to be monitored until at least 65 weeks postmenstrual age (PMA). 5. The ophthalmologist writes an order for the...
Oct 14, 2018
| Case Study
...addition of dexamethasone. The records were sloppy and inaccurate with no specific operative note. Adding steroids to an anti-VEGF medication was unnecessary: there are no clinical trials demonstrating that adding steroids increases the effectiveness of Avastin or Eylea. Puncturing a single-dose vial multiple times with the needle from the Avastin...
Aug 4, 2020
| Recommendation
...the injection for each eye as a separate procedure. Use separate site preparation, individual syringes, needles, etc. Use a different medication batch if using a compounded medication such as Avastin. Patient monitoring and education Monitor patients for symptoms suggestive of elevated IOP and endophthalmitis. Instruct patients to contact you immediately...
Mar 13, 2020
| Consent Form
...on embryo-fetal toxicity. In that warning, the FDA instructs physicians to “advise females of reproductive potential to use effective contraception during treatment with and for 6 months after the last dose of Avastin.” It is not clear whether intravenous Avastin causes harm to the human fetus. The FDA warning did...
Feb 13, 2020
| Consent Form
...medication during the surgery. Scarring can block the channel and develop weeks or months after surgery. Mitomycin-C (MMC), 5-Fluorouracil (5FU), and Avastin (bevacizumab) are the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin were originally...
Feb 13, 2020
| Consent Form
...the shunt. If that happens, your ophthalmologist may recommend anti-scarring medication or surgery to fix the shunt. Anti-scarring medication. Mitomycin-C (MMC), 5-Fluorouracil (5FU), and Avastin (bevacizumab) are the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and...
Feb 13, 2020
| Consent Form
...restore the flow of fluid through the channel. Mitomycin-C (MMC), 5-Fluorouracil (5FU), and Avastin (bevacizumab) are the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin were originally approved by the FDA for cancer treatment. However,...
Feb 13, 2020
| Consent Form
...ophthalmologist may recommend more anti-scarring medication or surgery to fix the bleb. Mitomycin-C (MMC), 5-Fluorouracil (5FU), and Avastin (bevacizumab) are the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin were originally approved by the FDA...
Feb 12, 2020
| Consent Form
...5-Fluorouracil (5FU), and Avastin (bevacizumab) are the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin were originally approved by the FDA for cancer treatment. However, physicians can use FDA-approved drugs for other purposes (this is...
Feb 21, 2020
| Consent Form
...recommend an injection of more anti-scarring medication or a surgery to fix the bleb so fluid flows again. Mitomycin-C (MMC), 5-Fluorouracil (5FU), and Avastin (bevacizumab) are the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin...
Oct 18, 2019
| Consent Form
...6 months after the last dose of Avastin.” It is not clear whether intravenous Avastin causes harm to the human fetus. The FDA warning did not address intravitreal Avastin, as this use is off-label. To reduce the potential liability for ophthalmologists using BEOVU, we feel it is prudent to address...
Mar 13, 2020
| Consent Form
...on embryo-fetal toxicity. In that warning, the FDA instructs physicians to “advise females of reproductive potential to use effective contraception during treatment with and for 6 months after the last dose of Avastin.” It is not clear whether intravenous Avastin causes harm to the human fetus. The FDA warning did...
Mar 9, 2023
| Consent Form
...an alternative to laser surgery, ophthalmologists can inject anti-VEGF medication into the baby’s eye to treat ROP. This is called an intravitreal injection. There are many anti-VEGF medications but the ones which are used to treat ROP include Avastin (bevacizumab), Eylea (aflibercept), and Lucentis (ranibizumab). The ophthalmologist will talk to...
Apr 1, 2022
| Recommendation
...high risk for ROP may need more frequent examinations. c. Infants treated with an anti-VEGF medication (i.e., Avastin or Lucentis) need to be monitored until at least 65 weeks postmenstrual age (PMA). 5. The ophthalmologist writes an order for the next exam indicating the interval and approximate date (e.g., next...
Apr 1, 2022
| Recommendation
...[Table 3. Follow-up exams]. a. Current guidelines indicate a range of 1 to 3 weeks between examinations, depending upon the findings. b. Infants at high risk for ROP may need more frequent examinations. c. Infants treated with an anti-VEGF medication (i.e., Avastin or Lucentis) need to be monitored until at...
Jun 30, 2015
| Risk Management Bulletin
Vascular endothelial growth factor, or VEGF, is a protein that stimulates the growth of new blood vessels. Ophthalmologists administer intravitreal anti-VEFG agents to adults for a variety of indications. These include Avastin, BEOVU, Lucentis, and Eylea. Sometimes the indication has been approved by the Food and Drug Administration (FDA), other...
Jun 14, 2023
| Risk Management Bulletin
Recently OMIC Risk Management has received a number of inquiries regarding the use of biosimilar medications for ophthalmic care. We would like to clarify our position on this topic. 1. Bevacizumab (Avastin®) biosimilars There is limited intraocular experience with bevacizumab biosimilars because studies leading to their FDA approval were for...
Jan 1, 2023
| Recommendation
Screening and treating premature infants for ROP (retinopathy of prematurity) is an important aspect of ophthalmic care that provides a valuable service to not only the individual baby but also to society as a whole. Although claims for mismanagement of ROP are relatively infrequent, indemnity payments for these claims can...
Nov 5, 2015
| Consent Form
...show that drugs like Lucentis given directly into the vein may not be safe for the fetus. Two drugs called Avastin and Eylea were recently tested on pregnant rabbits. The rabbits were given very high doses of these drugs every three days. The drugs were injected directly into the vein...
Dec 22, 2015
| Case Study
...noted that vision in the left eye was virtually gone and diagnosed a central retinal vein occlusion (CRVO). A retina consult confirmed the diagnosis of CRVO and the left eye was injected with Avastin. One week later, the insured examined the patient, who complained of a rapid visual decrease in...
Oct 18, 2019
| Risk Management Bulletin
...on the use of anti-VEGF drugs in adults AntiVEFG drugs for adults addresses on- and off-label use, preventing endophthalmitis, informed consent issues, and documentation. It incorporates key guidelines on intravitreal injection published by a panel of experts. It also addresses the FDA warning about Avastin in more detail. Conduct a time...
Aug 14, 2019
| Article
Ophthalmologists regularly use equipment and medical devices (EMDs) while caring for their patients. Sometimes, things go wrong. Injured patients may allege that an EMD malfunctioned or was used improperly. They may sue the ophthalmologist, the surgery center, and the manufacturer of the EMD. This issue of...
Aug 15, 2018
| Article
...plaintiffs (72%) developed endophthalmitis following cataract surgery (58) or intravitreal injections (21: Avastin 12, Eylea 5, Lucentis 3, Kenalog 1). Others filed claims after pars plana vitrectomy or PPV (13), trauma (5), systemic infections (4), and corneal transplants (3). The remaining 5 plaintiffs alleged malpractice after an IOL exchange, a...