By Daniel R. Matlis
It’s a trick question. Technically both should be sterile.
But you would think that cardioplegia, the solution used to stop the heart during bypass surgery, would be more stringently tested since it is infused directly into the heart.
According to a recent USA Today article, at least 11 cardiac surgery patients were stricken with an infection during a 10-month period from the end of December 2004 to September 2005, and three of them died at Mary Washington Hospital. After a thorough investigation, tests confirmed the presence of several types of bacteria in the cardioplegia solution injected into patients’ hearts during surgery.
I can already hear the cry from the trial lawyers: “Which Pharmaceutical Do We Go After?
The answer? None, the reason is that the products leaving the Pharmaceutical companies were perfectly safe and sterile, but some drugs, including high-risk sterile preparations, are made in pharmacies under less-restrictive rules than those that drug companies follow. Almost all hospital pharmacies do some type of drug making, called compounding. Pharmacist duties may range from low-risk procedures, such as grinding tablets to put them into liquid suspension, to high-risk work, such as making sterile treatments from scratch.
I’m in favor of compounding, and cannot thank Andrew, my local pharmacist, enough for compounding prescriptions when my kids need them. Try to get a 3 year old to swallow an adult size tablet. It goes much smoother when it is ground and suspended in strawberry flavored syrup.
But there is a big difference between grinding tablets and preparing a sterile solution to be injected into the heart. This is not an issue of qualifications, but one of oversight and facilities. Hospital pharmacies are regulated by each state, and the frequency and thoroughness of state inspections vary widely. The FDA’s role in oversight is hampered by questions of jurisdiction over what’s generally state matter. To make matters worse, in most states hospitals are not required to test the sterility or potency of products made in their own pharmacies or purchased from outside pharmacies. So while a drug company could not sell saline solution without testing sterility, hospital pharmacies and their suppliers are not required to test for it.
I am not a big proponent of government regulations, but this is a case of public safety and the proverbial “what’s good for the goose is good for the gander” theory of enforcement. Having 50 different state statues regulating sterility and potency requirements for drugs is impractical, when the FDA has the mandate, know-how and capabilities to regulate them. If hospital pharmacies and suppliers want to continue manufacturing sterile solutions, they ought to be held to the same standards as the Sesame Street Band-Aid I put on my kid’s “boo-boo”.