Compounding issues

NASEM, FDA, and the compounded pain creams study

The issue

The FDA, no fan of compounding, commissioned a study from the National Academies of Sciences, Engineering, and Medicine on the "Safety, Effectiveness, and Use" of ingredients in compounded topical pain creams.

NASEM released a report that, not surprisingly, echoed all the FDA's concerns, and made some inappropriate recommendations even after admitting that there was a scarcity of research and evidence on the issue.

APC's official statement

NASEM releases compounded pain creams report

The National Academies of Sciences, Engineering, and Medicine has released the first of two FDA-funded studies — this one regarding compounded topical pain creams.

The background: "The FDA has made clear that it has concerns with compounded pain creams," explained APC CEO Scott Brunner, "so, considering that the FDA paid for this report, we've always felt it was likely a foregone conclusion that it would reflect FDA's position."

Now that the the report is now out, we can see that its conclusions, while not surprising, are also to some extent, well, inconclusive.

NASEM's overall conclusions:

  • There is not enough information "to conclusively support conclusions regarding safety and risks" of compounded pain creams, nor about the risk of individual APIs when absorbed.
  • That lack of evidence "gives rise to a substantial public health concern" and HHS should focus on those APIs that "enter the bloodstream and act systemically within the body."

That said, the study panel had these recommendations:

  • Use "utmost caution" when prescribing or dispensing compounded pain creams.
  • Do more research on the safety and efficacy of the ingredients, especially when absorbed through the skin.
  • State boards of pharmacy should require additional training for clinicians (especially pain specialists), as well as pharmacy compounders.
  • The FDA, possibly with USP, should develop safety tests for the APIs and excipients being used.
  • States should increase their oversight of the use of these creams.

"Yes, there is clearly a scarcity of research on the effectiveness of compounded pain creams," agreed APC President Shawn Hodges. So we wholeheartedly support the study’s call for additional studies — double-blind, placebo-controlled clinical studies. If the FDA is going to take a position, it should do so with verifiable, objective data."

And in a media statement, APC's Brunner pointed out some obvious concerns with the report: First, it failed to consider the relative risks of topical pain gels — for example, compared to treatment options such as narcotics. Especially for patients with chronic pain, those risks are negligible in comparison. "We're facing an opioid crisis," he said, "not an analgesic-cream crisis."

Secondly, the study treats patients as faceless data points; it doesn't consider the critical measure: outcomes. Patient-reported results are an integral and appropriate component of any report on the effectiveness of a drug.

Resources

A short PowerPoint-style overview of the NASEM report (1.6 MB PDF)

The full, 353-page report (5.4 MB PDF).