Are the risks of ‘kitchen pharmacy’ a justified concern?

Physicians have responsibility to use regimen

Per Montan

Physicians have a responsibility to the patient to use the regimen of intracameral antibiotics unless they have a prophylactic topical protocol that is equally effective, which I doubt.

We must always raise the question of potential risks whenever we are treating patients off-label. However, one thing we should remember is that there is no labeled treatment for the prevention of endophthalmitis because there is no registered pharmaceutical agent that has this indication. In that sense, we are always acting off-label when we are dealing with this problem.

In the case of intracameral cefuroxime, it is either us or the hospital pharmacy that dilute the agent, and this could be called “kitchen pharmacy.” On the other hand, this is an antibiotic that should provide, by itself, broad coverage against bacteria and contamination, and we do this preparation according to a strict protocol. So far, we have not seen adverse effects that could be attributed to the production and use of this agent. Our data, and the ESCRS data, which in total are on more than 760,000 cases, speak for themselves, and I think there is nothing we should be afraid of. Kitchen pharmacy is not a valid argument against this treatment.

A labeled product would, of course, be better and better accepted by most physicians, but because we do not have it, we cannot let our patients run the risk of getting endophthalmitis. This is not a good treatment principle. We need to take our responsibilities and go on using intracameral antibiotics, although they are not licensed.

Appeals to the industry to provide commercially available cefuroxime for intracameral use have been around for 3 years, and nothing has happened, which is quite disheartening.

The risk of dragging this matter for too long is that in clinics where cefuroxime is currently prepared and used at such a low cost, companies may not be able to place a more expensive preparation.

Per Montan, MD, is a consultant at the anterior segment department, St. Erik Hospital, Stockholm, Sweden.

There are risks of mistakes with this off-label use

Alain Bron

I was impressed by the ESCRS study design, high standards and results, but personally I am not a cefuroxime fan. In my department, we do not inject cefuroxime in our cataract patients, and I am convinced that when the surgeons respect all the conditions of antisepsis and hygiene, 98% to 99% of the whole prophylaxis is covered. Like many surgeons, I only use povidone iodine in the conjunctival sac before surgery and antibiotic drops after surgery. In all these years, we did not have a single case of endophthalmitis.

It is true that some of my colleagues do not have their own operating room, but have to share it with other specialties. In these cases, antibiotic prophylaxis is useful, and I think cefuroxime is indeed the best choice. It is cheap, and unlike fluoroquinolones, it seems to produce no resistance.

Using a drug off-label is not a problem from a legal point of view. In France, like in most European countries, ophthalmologists are used to working with unlicensed medications, such as mitomycin C, bevacizumab, and intravitreal antibiotics and corticosteroids.

However, I think that the risk of kitchen pharmacy does exist with cefuroxime.

When the preparation is done by the hospital pharmacy, dosage, hygiene and sterile conditions are respected. However, if cefuroxime is prepared on the table of the operating room, there are indeed risks of all sorts. At the French Society of Ophthalmology meeting last May, a colleague reported that, due to a mistake of the operating room nurse, gentamycin instead of cefuroxime was injected in six patients. The cornea became completely cloudy, and these patients ended up with a corneal graft.

The other risk is that with antibiotic prophylaxis, as a routine, some surgeons might forget the importance of antisepsis and hygiene, which are the most important measures against infection.

In addition, I object to the indiscriminate use of antibiotics in all patients. In France, where we perform approximately 700,000 cataracts per year, for the ecology of the country, I would not feel comfortable at all with the use of an antibiotic in all patients. Although the substance is rapidly eliminated, the risk of resistance in the long term cannot be excluded.

Alain Bron, MD, is a professor of ophthalmology at the University Hospital, Dijon, France.