Are you a compounder? You are if you mix up a special dentifrice or mouthwash for your patients. And if you want to go this route, you need to be aware of the responsibilities it entails.
It’s a waiting room more or less like any other, clean and quiet. Magazines slightly past their prime. Tropical fish. An iron cauldron bubbling beneath a stuffed crocodile. Background music, bland but pleasant. ... Hold on there. Have I wandered onto the set of "Egbert, Medieval Dentist"? Or is this a vision of things to come? Sometimes I wonder.
We live in a time when scientific medical knowledge, as well as access to that knowledge, is growing exponentially, with no sign of slowing down. Most of the dread diseases of past generations have been tamed or eliminated, to the point where the jumbo cheeseburger is now considered America’s No. 1 health threat.
Yet, despite all this demonstrably science-driven success, a sizeable segment of the public is demanding something else. Give me something natural, they say, or herbal or traditional or holistic or non-Western—just as long as it hasn’t been tainted by the bad ol’ Food and Drug Administration. I can’t fully explain this attitude—it probably arises from the same primal "back-to-nature" urge that drew Thoreau to Walden Pond—but unquestionably it is real and it is growing. And if you don’t think it’s having an impact on dentistry, how else do you explain the runaway success not so long ago of a certain baking-soda-and-peroxide regimen?
How should we respond? And, in the final analysis, does it matter?
The whole issue of nontraditional therapies, ranging from flagrant quackery to cutting-edge technology, is much too broad to address in this space. Instead, I want to comment on just one area where concern for the patient’s wishes can lead the unsuspecting dentist into dangerous territory: compounding.
Compounding, in this context, is when a licensed individual (pharmacist or doctor) makes up a custom drug preparation in the office, rather than using an off-the-shelf manufactured product. Back in 1938 when the Food, Drug and Cosmetic Act was passed, it was still quite common for local pharmacists to prepare medicines by mixing ingredients. The Act was aimed at industrial manufacturers, and was never intended to interfere with what was considered a normal professional function. Though the neighborhood pharmacy technically fell under its provisions, there was never any attempt to enforce them.
The 1997 FDA Modernization Act1 attempted to regularize compounding by, first, explicitly recognizing and exempting compounding and, second, by defining how compounding differed from manufacturing. Unfortunately, a side effect of a 2002 Supreme Court ruling was to invalidate the entire provision, returning compounding to its former murky status, neither regulated nor unregulated.
Are you a compounder? You are if you mix up a special dentifrice or mouthwash for your patients. (Pouring mouthwash from a big bottle to a little bottle doesn’t qualify.) And if you want to go this route, you need to be aware of the responsibilities it entails.
First of all, although compounding may not be clearly regulated today, it may become so at any moment. It’s a growing segment of the pharmacy business, and reports of abuse are on the rise. It is especially important to note that the now-defunct 1997 Act did not permit dentists to act as compounders—only physicians and pharmacists. It would be surprising if a future law differed in this respect, abruptly and unambiguously outlawing dental compounding.
Second, you’d better be absolutely sure of your pharmacology. Preparations designed for other applications may not be safe or effective in the oral cavity. The ratios of active ingredients, as well as the formulation of carriers and other "inert" ingredients, make the difference between a product that works and one that doesn’t. Non-steroidal anti-inflammatory creams are perhaps one of the safest agents commonly compounded by dentists, but since they are readily available off the shelf, why take a chance on a carrier that might block or neutralize the active ingredient? And for goodness’ sake, get the proportions right. The complaint most often leveled at compounders is incorrect strength—preparations either too weak or too strong, sometimes dangerously so.
Third, be aware of sources of supply. More than once, I have spoken with dentists who thought they were doing their patients a favor by advising them to rinse with chlorhexidine hand soap instead of the more expensive oral rinse. There are several problems with such a substitution. For example, when I last looked, there were only three sources in the world approved to supply chlorhexidine pure enough to be ingested. How do you know that the hand soap was made from one of the approved sources?
The long and costly process of drug approval, flawed though it might be, allows our treatments to be based on sound evidence of safety and efficacy.
Fourth, beware of contamination. Though pharmaceuticals produced in FDA-inspected plants are not immune to problems, they are immeasurably safer in this regard than those compounded on site. Even a conscientious compounder lacks the resources to guarantee the purity of ingredients and the absolute sterility of preparation and packaging. Some very serious illnesses have been traced to bizarre contamination of compounded medicines.2 Sterile injections have an especially high potential for risk.
Fifth and last, don’t become a manufacturer by default. Under the law, compounding may be done only for the needs of individual patients. As soon as you start producing a stock of some concoction and putting it on the shelf for future use, you have left the realm of compounding and put yourself under the full manufacturing regulations. No matter how innocent the intent, this is a very serious business indeed.
In case you haven’t already guessed, my advice on compounding is simple: don’t do it. To do it properly is difficult and ultimately uneconomical; but cut corners and you put your patient, yourself and your practice at risk. The long and costly process of drug approval, flawed though it might be, allows our treatments to be based on sound evidence of safety and efficacy.
Yes, there’s a chance we will miss out on some wonderful treatments from unexpected quarters. Maybe sulfur and bat wings will prevent periodontal disease, sweeten the breath and settle the stomach. But I wouldn’t bet on it.
