Avastin doesn’t blind people, people blind people  / By Dr. Helene A. Sairany:

There has been a substantial media reaction in the Kurdish region of  Iraq over the 30 patients who have been allegedly harmed by the ocular injections of Avastin (Benvacizumab). Avastin is a monoclonal antibody developed by Genentech/Roche used for cancer patients to minimize the blood supply to the tumor cell. By causing the tumor to go through starvation, it shrinks in size and becomes more medically manageable.

Though not Food and Drug Administration (FDA) approved for use in the eye, some ophthalmologists continue to use it “off label” for macular degenerations, viewing it as a cost-effective alternative to the FDA-approved Lucentis for wet age related macular degeneration.

Lucentis is admittedly a safer choice, but the cost is as much as 2,000 US dollars, compared to 50 dollars for one Avastin shot. The use of Avastin for eye disease is a cumbersome process involving a vial divided into numerous tiny doses and each dose placed in a tiny syringe before being injected into the eye. The extra handling and exposure increases the risk of bacterial contamination and other problems.

A report by the New York Times in August of 2011 indicated that 16 people in Florida and Tennessee had lost their eye sight following treatment of macular degeneration with Avastin. The report also noted how court cases were being brought in both states against the medical  professionals, hospitals and clinics where the treatments were carried out. The indications were that the patients were blinded as a result of  a bacterial infection of the eye and that the bacteria were a by-product of contaminated Avastin, when the medical personnel divided the contents of vials into smaller amounts to be injected into the eyes of patients. This procedure was necessary as the drug was being used off-label and not supplied in the small doses required for ophthalmic use, but as a vial suitable for a single chemotherapy dose for a cancer  patient.

A study by the American Journal of Ophthalmology took a closer look at  the events surrounding the recent clusters of infectious endophthalmitis cases occurring after the intravitreal injection of Avastin and suggested that vision loss is not the result of the drug or the injection technique, but rather the compounding procedures used to prepare the syringes containing the Avastin. Noncompliance with recognized standards and poor aseptic technique are the most likely causes of these outbreaks. The key to preventing these catastrophic occurrences depends on the implementation of and strict adherence to United States Pharmacopoeia chapter 797 requirements.

Recommendations arising from a root cause analysis of infectious endophthalmitis outbreaks should focus on the procedures used by the involved parties to compound Avastin. Microbial contamination of Avastin-containing syringes prepared from the same vial of drug can be avoided by using a single vial of Avastin for each eye, or by following strict adherence to United States Pharmacopoeia chapter 797 requirements when compounding a single vial of Avastin into multiple syringes. Professional compounding center, prepares sterile compounds in a certified microsphere biological safety cabinet. All members are advanced-trained with sterile techniques.

I owe this idea to my 3rd year pharmacy students at University of  Sulaimani, College of Pharmacy. The outbreak of infectious  endophthalmitis and blindness was first introduced by myself in my drug information class. I then took advantage of the incident and turned it to a drug information question where the students were required to use  a minimum of 15 scientific references to address the question. The ministry of health in the Kurdistan region of Iraq (KRI) claims that the Avastin vials were not counterfeit; hence the government is free of  any blame for allowing the import of counterfeit Avastin into the region. I asked the students if the medication was not counterfeit,  what justified the blindness outbreak? And here is where they stated  that, based on the evidence, the repackaging a single vial to tiny doses is problematic. So, if Avastin did not cause blindness, the involved medical personnel definitely did, said my students.

This outbreak continues to be a systematic error that warrants  immediate attention from the ministry of higher education due to lack of standards and quality control body in place to sustain these standards in hospitals of Kurdistan.

Dr. Helene A. Sairany is a lecturer at the American University of Iraq in Sulaimania. Originally from Kurdistan of Iraq, she grew up in the  USA.

Helene’s Blog

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