Intravitreal injections – Legal aspects

Intravitreal injections have become commonplace in ophthalmic practice nowadays. The total number of global intravitreal injections in 2016 was estimated to be over 20 million, with numbers increasing over time. Post-injection risks of intravitreal injections can be vision-threatening and require prompt diagnosis and treatment.[1] The significant impact of these adverse events on a patient’s quality of life can lead to legal actions, with an ever-growing number of malpractice claims for huge compensation. In ophthalmology, between 5–10% of physicians face a malpractice claim each year.[1] Out of the several cases of medical negligence decided by the NCDRC from 2002 to 2018, about 3% of cases were related to ophthalmology. A total of 73.3% of the alleged cases of medical negligence in ophthalmology were proved, and compensation for the cases ranged between Rs. 200,000 and Rs. 10 million.[2] Judgment was given against the ophthalmologist even for a complication well-reported in the published literature. For example, an ophthalmologist in Gujarat was asked by the consumer court to pay Rs. 100,000 compensation to a patient for vitreous hemorrhage following an anti-VEGF (Avastin) injection in the patient’s eye, leading to temporary blindness.[3] In another case reported from Punjab (2017), the State Consumer Disputes Redressal Commission passed a judgment against the hospital and the ophthalmologists for their medical negligence in the treatment of the patient and failure to produce the pertaining medical records.[4] It was alleged that the ophthalmologist could not prove that adequate measures were taken to control diabetes before the procedure that led to eye infection. WHAT IS THE REMEDY? SALIENT POINTS Create a protocol that puts multiple checks in place. The eye to be operated on should be marked in the ward itself and confirmed in the operation theater. In case of intravitreal injection, it is also important to double-check which injection must be administered to the eye. It is a good practice to ask your staff to read out the patient’s name, the eye to be injected, and what injection is to be given just before the procedure. Injections are given under topical anesthesia. It is always better to avoid unnecessary talk in the operation room, which may create inadvertent confusion regarding the procedure in the mind of the patient. Cleaning of the eye using povidone iodine, use of adhesive drapes, and local application of povidone iodine both before and after the procedure help to avoid endophthalmitis in most patients. A proper consent, preferably in the patient’s own language, clearly mentioning the complications of the procedure, should be taken. In an ideal situation, the consent must be written by the patient himself/herself. If it is a printed consent, the patient can be asked to write that he has read and understood what is printed, in his own handwriting at the end. Documentation is also very important. Investigation reports, treatment data, and the course of treatment should be documented with the time and date. Simple things like instillation of povidone iodine drops before and after the procedure should be entered in the case sheet. Finally, clear communication with the patient and relatives before and after the procedure is vital. A good doctor–patient relationship is the foundation of efficient service delivery, as effective communications help both the doctor and the patient to understand each other’s perspective. This ultimately minimizes the chances of mishaps leading to legal suits.[5] TAKE HOME MESSAGE Protocol-based practice, prompt documentation, and good doctor–patient communication are key factors that can minimize litigation following intravitreal pharmacotherapy. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.