COMMENTARY

Choosing Commercial or Compounded Medicines

Richard M. Plotzker, MD

Disclosures

September 20, 2016

My professional organization, the Endocrine Society, issued a brief statement[1] about 2 months ago on the role of individually compounded products custom-made by trained pharmacists to physicians' specifications. To distill what must have been arduous professional deliberations and literature reviews, the committee basically recommended just using commercially available products to treat patients.

Richard M. Plotzker, MD

Unfortunately, in order to be invited to a committee of that distinction, the members would be expected to have experience in testing commercial products—which they did and included in their financial disclosures. This might leave room for a certain amount of finger-pointing from compounding pharmacists, but there's no credible challenge to the genuine expertise of the committee members.

However, a very real question remains. Are the medicines that we usually prescribe really good enough, or might there be room for improvements that never make it to the patients who might benefit because large-scale developments to assure safety and efficacy have gotten beyond the reach of individual innovators?

At one time, all medicinals were custom-assembled. Most US high schoolers, myself among them, had to either delight in or suffer through Shakespeare's Romeo and Juliet, which included a bit part for the apothecary who was asked to create not a curative substance, but a poisonous one. Over the centuries, if you were wounded in war, somebody would create some form of Atomic Balm to apply over broken skin for a combination of relief and healing. People figured out that foxglove might have some cardiac benefit and that rauwolfia could lower blood pressure—sometimes a good tradeoff for suicidal ideation, sometimes not.

But for every successful innovation, there were others that probably enabled a certain amount of human experimentation without what we would regard as informed consent. Thorough analysis of safety did not really appear until legislation mandated it, starting with the Pure Food and Drug Act of 1906, which required products to contain what the label said they did. Subsequent additions were directed at products not being unsafe even if they were labeled accurately. In the 1960s, products were required to be not only safe but also efficacious.

Regulation has had both favorable and unfavorable consequences. Our products are well-tested. Barriers to just anybody entering the market have enabled the many innovative therapeutic options that we enjoy (though often at premium prices) to commonly manage diseases that were once fatal or disabling.

Some products still get pulled from the market as safety concerns emerge that were not apparent in testing. Such was the case with Synthroid® in the 1990s. This otherwise respected product had a manufacturing glitch: The pills that were perfectly fine in an amber tube degraded while sitting atop reflective foil in the sample blister packs, which were distributed to physicians' offices. The company representative had the unenviable task of coming to my office and confiscating all my samples.

So, as the committee concluded, we have quite a lot of good products that can manage most patients reasonably safely and that are made by companies that are fully accountable for their quality.

However, this doesn't really address the question of whether we really have as many products as we should if we create barriers to new options. That's where the advocates of compounding emerge. Because physician prescribers order the custom product, these specific custom adaptations are part of the wish lists that physicians often have.

One of the classics of endocrinology would be the treatment of thyrotoxic crisis in a critically ill NPO patient in the intensive care unit. It would be nice to have a parenteral thionamide for these patients, but there is no commercial value to its development. The dire need of the patient demands something that doesn't exist, so we adapt what is available by having the hospital pharmacist modify propylthiouracil so that it can be administered rectally. It is a form of custom compounding, though one driven more by desperation than trendiness.

For some medicines, the optimal dose falls between the available pill strengths, so there may be a very legitimate reason to tweak something that has already been deemed appropriate treatment. However, there is quite a difference between minor modifications to meet a specific need and the more widespread issue of compounding custom products on the basis of a prescriber's druthers—bypassing the known safety and efficacy of available products that would at least be good enough, if not optimal.

We also can't overlook the role of compounding in what seems like one of commercial medicine's soft underbellies: profiteering without regard to patient need. As a prolific prescriber of diabetic testing supplies for very mainstream management of the often challenging patients with diabetes who get referred to specialty care, forms to obtain test strips await my signature in sufficient volume. About a year or two ago, more of those forms than I care to count started arriving, prefilled by the company for more frequent testing than medically justified, along with prefilled requests for compounded wound creams and topical analgesics where I was clearly not the expected prescriber. Many of my patients had no pain problems or chronic wounds. These forms would invariably derive from companies that I had not heard of despite my years of experience.

Sometimes, all it takes is a busy provider who needs to move through forms quickly in order to spend more time in the exam rooms to get snookered into authorizing something that is lucrative to the supplier but was not requested by the treating physician at all. My response to this was to cross out the unwanted product and handwrite "OMIT THIS" or to send the form back unsigned, with a request for a blank form. Somebody must have done some whistle-blowing, because these requests, once common, have slowed to a trickle.

Was the distinguished panel of the Endocrine Society correct in their judgment? I think that fundamentally, they were. Unless we have an uncommon specific problem to solve, the commercial products with demonstrated safety and efficacy—or at least knowing what to expect for medicines that have serious but known adverse effects—have an advantage over those for which claims are made without presenting evidence.

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